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Most vitamin supplements have taken a beating in the press over the past few years. That’s because so many studies of vitamin pills to prevent cancer or heart disease have come up short.

As a result of the negative news, some doctors discourage patients from taking big doses of separate vitamins. They recommend eating a well-balanced diet with nothing more than a multi-vitamin for nutritional insurance.

The one exception is vitamin D. It is becoming a shining star in the nutritional universe.

For decades doctors thought that vitamin D deficiency was a thing of the past. They rarely saw rickets in children. This bone deformity is brought on by a severe lack of vitamin D during development. Fortification of foods such as milk and breakfast cereal made rickets rare.

When most people think of vitamin D bones come to mind. Research over the past several years has shown, however, that this nutrient affects many other organs in the body. Scientists have found associations between low vitamin D levels and a variety of chronic conditions including arthritis, high blood pressure, heart disease, diabetes and depression. People with insufficient vitamin D also seem more susceptible to respiratory tract infections such as influenza (Epidemiology and Infection, Dec. 2006).

Many other studies have found that when people get adequate amounts of vitamin D they have a lower risk of developing cancer of the colon, breast, ovaries or prostate (American Journal of Public Health, Feb. 2006).

Despite its glowing reputation, the number of Americans who are deficient in this nutrient is increasing at an alarming rate. A recent analysis reveals that approximately three out of every four adults is low in vitamin D. That’s up dramatically over the last decade (Archives of Internal Medicine, March 23, 2009).

The investigators hypothesize that this negative trend may be due in part to more time spent inside working on computers, playing video games or watching TV. Even people who go outside have become more conscientious about covering up and using high SPF sunscreen, which prevents the formation of vitamin D by the skin. The researchers also suggest that current recommendations (200 to 600 IU daily) for vitamin D supplementation are inadequate.

There may be another reason why many people should be getting more vitamin D. Millions of Americans take statin-type cholesterol-lowering medications like Crestor, Lipitor or Zocor. These drugs can cause muscle pain and weakness. Preliminary studies suggest that people who have inadequate vitamin D levels may be more susceptible to such muscle problems (Translational Research, Jan. 2009).

One woman suffered severe muscle pain while on a statin until she was diagnosed with insufficient vitamin D. Once her vitamin D level was normalized, her muscle pain disappeared.

With so many people low in this critical nutrient, doctors should be testing their patients for vitamin D levels. Those found to be low should be getting more time in the sun or taking vitamin D supplements to bring vitamin D levels into the optimal range. This simple approach could alleviate a lot of suffering.

The old wives have just been proven right again. They always claimed that if you wanted to stay healthy you needed to get a good night’s sleep. That was usually defined as about eight hours.

In our modern, fast-paced lives, many of us act as if this advice were a quaint relic of a bygone era. And with the downturn in the economy, money worries have many people tossing and turning. A recent survey by the National Sleep Foundation found that one in five Americans gets less than six hours of sleep a night. Only about one fourth of us follow grandmother’s advice to get at least eight hours of shuteye. Scientists are confirming, though, that ignoring the old wives’ wisdom may have negative consequences for our health.

Researchers at the University at Buffalo recently reported to a conference of the American Heart Association that people who habitually get less than six hours of sleep nightly are at higher risk of developing type 2 diabetes. The investigators measured fasting blood glucose levels in volunteers. The participants were queried about their work-week sleep habits. After six years, fasting blood glucose was measured again. Those who got less than six hours of sleep daily were more likely to have higher levels of blood sugar, a condition that can lead to diabetes.

This isn’t the first study suggesting that inadequate sleep might be linked to a higher risk of blood sugar problems. In 2005 researchers reported that either too little or too much sleep was associated with diabetes (Archives of Internal Medicine, Apr. 25, 2005).

Blood sugar control isn’t the only problem associated with sleep disturbances. Other research has shown that cardiovascular complications are more common when people don’t sleep well.

But wait, there’s more. The immune system also seems to be sensitive to sleep time. A recent study revealed that subjects who averaged less than 7 hours of sleep a night were roughly three times “more likely to develop a cold than those with 8 hours or more of sleep” (Archives of Internal Medicine, Jan. 12, 2009).

Other health hazards associated with too little sleep include depression, heart disease and weight gain. This may be part of a vicious cycle, since obesity can contribute to sleep apnea, which in turn contributes to insomnia and heart disease.

With so many people sleeping poorly, it is hardly any wonder that the pharmaceutical industry promotes pills for insomnia. Drugs like Ambien (zolpidem) and Lunesta (eszopiclone) are very popular, but they do have side effects.

To learn more about the pros and cons of sleeping pills and many non-drug approaches to overcoming insomnia, readers of this column may wish to review our new Guide to Getting a Good Night’s Sleep.

Exercise during the day, a hot bath an hour before bedtime and dietary supplements such as melatonin or magnesium may help many people relax and get the sleep they need to stay healthy.

The law of unintended consequences can lead to devastating outcomes. During the 1950s thalidomide was developed and prescribed in Europe to help pregnant women cope with morning sickness and insomnia. Tragically, the drug led to an epidemic of birth defects.

No one intended for babies to be born with deformed limbs. It was an unexpected side effect of the drug that was not immediately recognized.

Unintended consequences are not always so dramatic, but they may go equally unrecognized. They may be especially common when it comes to older patients taking multiple medicines.

One example is Bob, an 82-year-old reader who shares the following story of woe and intrigue: “I take 14 medications plus supplements. My nine doctors (four of whom are specialists) often disagree about what is best for me. My diabetes doctor says that the hydrochlorothiazide (HCTZ) diuretic for my blood pressure could make blood sugar rise, but my cardiologist disagrees.

“I was given 14 different blood pressure medications at different times. They included amlodipine, Benicar, clonidine, diltiazem, felodipine, methyldopa, Toprol XL and Ziac. Most knocked me out and made me feel dizzy and dazed. I rarely got a decent night’s sleep. Some of these drugs made it hard for me to urinate.
“I have tried many drugs to control my cholesterol, including statins, Zetia and Tricor. They all gave me severe explosive diarrhea.

“Several doctors prescribed Indocin to treat arthritis. All together, I took it for 28 years, until three years ago when they recognized that it was killing my kidneys. I now take Tylenol for pain relief, but I worry that 1500 mg daily will affect my liver.

“Doctors prescribed a dozen different medicines for depression, including citalopram, mirtazapine, trazodone, alprazolam, clonazepam and temazepam. None of them really helped, and the side effects were severe. I don’t take anything for depression now.

“I think I am taking too many medicines that may conflict with each other or aggravate my conditions.”

Bob’s situation may seem extreme, but it is not truly unusual. Older people frequently take handfuls of pills to treat a variety of conditions. Sometimes drugs are prescribed to counteract side effects from other medications.

When doctors disagree, as they have in Bob’s case, it puts the patient in a difficult position. As people age, their bodies change. Bob may have done fairly well with Indocin (indomethacin) for his arthritis pain when he was in his 50s. But as he neared his 80s, his kidneys were less capable of withstanding the assault.

Older people need all the help they can get to navigate the pitfalls of the medical system. It can be extremely confusing, so family members and physician allies are crucial.

To help people ask the right questions, we offer our Guide to Drugs and Older People with a Drug Safety Questionnaire for doctors to fill out.

Can the FDA be fixed?

Once upon a time the Food and Drug Administration was highly regarded by physicians, pharmacists and the public. People trusted the agency to protect them from contaminated food and dangerous drugs.

Congress established the FDA in 1906 in reaction to public disgust about adulterated food and medicines. Snake oil salesmen roamed the countryside selling nostrums cooked up in bathtubs. There was no oversight or quality control.

The FDA went after abuses, and both food and medicine improved markedly. In the 20th century, many of the medicines we swallowed were actually made in America. FDA officials inspected pharmaceutical plants on a regular schedule to make sure good manufacturing practices were in use.

Today, the FDA is overwhelmed, understaffed and underfunded. It did not inspect the plant in Georgia that shipped tainted peanut butter around the country. Salmonella has been found in other food products from fresh chili peppers and alfalfa sprouts to children’s crispy snacks.

There are also problems with pharmaceuticals. Many of the prescription drugs and over-the-counter medications Americans swallow are made overseas. The FDA has great difficulty inspecting manufacturing plants in China, India, Indonesia and other countries where the chemicals for our medicines originate.
A year ago, an adulterated blood thinner (heparin) killed dozens of Americans. The backyard factories in China that produced the raw ingredient were probably no more sanitary than the snake oil salesmen’s stewpots of yesteryear.

There have also been numerous recalls of generic drugs. Despite frequent assurances that such copycat medications are identical to their brand name counterparts, scores of products have been recalled.
Last fall the FDA banned a huge Indian pharmaceutical company, Ranbaxy, from bringing 30 different generic drugs into the U.S. Nothing more specific than “manufacturing violations” was cited. Nevertheless, Ranbaxy’s generic versions of drugs such as the cholesterol lowering medicine simvastatin or the antibiotic ciprofloxacin were not allowed into the U.S.

More recently, a generic manufacturer called ETHEX, a division of KV Pharmaceutical, withdrew 60 generic drugs from the market. Among them were metoprolol succinate and nitroglycerin sublingual tablets. As a result, shortages of these important heart medicines have developed.

It will take time for the brand name companies to ramp up their manufacturing lines and supply these critical drugs in adequate quantities. Many patients who have been left in the lurch are wondering how this could have happened.

This might be just the tip of an iceberg. Hundreds of people have been complaining to their physicians and online (www.peoplespharmacy.com) that their generic drugs are not performing as expected. No one knows how big a problem this may be.

Contaminated heparin syringes were shipped around the country from a North Carolina plant for two years after the FDA was notified of problems. Hundreds were sickened and five died according to the Raleigh News & Observer.

It seems that FDA monitoring leaves a lot to be desired. With all the talk about reforming health care, perhaps Congress should take a close look at the FDA first.

Starting a new medicine is easy. Stopping can be hell.

Mention the word “withdrawal” and images of dope addicts or alcoholics come to mind: a junkie trying to kick a heroin habit or a wino going through the hallucinations and shakes of delirium tremens.

But a surprising number of upstanding citizens who have done nothing more insidious than take their prescription medicine “as directed” suffer severe symptoms of withdrawal when they stop their medication suddenly.

Get a new prescription and the chances are pretty good that the doctor will tell you how to take it and some common side effects. Often neglected, however, is information about how to discontinue the drug. That can lead to disaster.

Something as seemingly simple and benign as a heartburn medicine that suppresses acid formation can lead to excruciating withdrawal pain. Here is one reader’s story:

“I have tried to stop Prilosec or Prevacid THREE times! Each time I try, I get so bent over in pain that I go back on the drug.

“I started taking Prevacid in 2000 and was on it until 2007. Then I switched to Prilosec OTC with wonderful results. When I stopped the Prilosec, however, my stomach lining became so inflamed that it burned (like a bad sunburn) from the bottom of my tummy to my throat. It was horrid.

“I could not take the burning, especially when my stomach was empty. I had to go back on Prilosec and now am pain free. I don't know what to do, as I want to quit this acid-suppressing medicine but the pain is more horrible than anything else I’ve experienced.”

Readers have experienced similar difficulties trying to stop other proton pump inhibitors such as Nexium or Protonix. The hyperacidity that occurs as a rebound effect when such drugs are discontinued can last for weeks or even months. It drives many people back to the medication.

Stopping an antidepressant suddenly can also pose problems. One reader shared this story: “I thought I was literally going crazy from brain shivers. These started when I stopped Cymbalta. I've been so incredibly uncomfortable the last couple of days I have wanted to lock my head in a vice.

“I am attempting to stop taking Cymbalta because it makes me sick to my stomach. If I miss just one dose I get brain zaps. I can't even see straight or drive, they are so bad.”

People who suddenly stop drugs like Celexa, Cymbalta, Effexor, Lexapro, Paxil or Zoloft may experience dizziness, headaches, mood swings, anxiety, insomnia, irritability, sweats and electric shock sensations in the limbs or the head. These can be extremely distressing and may take a long time to wear off.

Other medications that can trigger symptoms upon sudden discontinuation include anti-anxiety drugs such as Ativan (lorazepam) or Xanax (alprazolam); oral corticosteroids such as prednisone; pain relievers taken for migraines; and even decongestant nasal sprays that have been used for more than three days.

To avoid being blind-sided by withdrawal symptoms, be sure to talk with your doctor about how to stop a medicine before you start taking it. That way you may be able to avoid an unpleasant surprise when it comes time to discontinue the drug.

Americans are not used to good news about life’s little pleasures. We are told that salt will raise our blood pressure, saturated fat will clog our arteries and that high fructose sweeteners in soft drinks will make us fat.
Our Puritan heritage dictates that suffering is good for the soul and that indulgence is suspect. That’s why it comes as such a shock to learn that coffee and chocolate might have health benefits.

Evidence is accumulating, however, that both of these tropical treats may have unexpected bonuses. Coffee drinkers appear to be at lower risk for developing type 2 diabetes (Nutrition Reviews, Apr. 2007). Several studies support this association and, if proven true, it could represent a huge public health advantage.

Coffee is a complex mixture of chemicals and provides more antioxidants in the diet than many other foods, including many vegetables. That may explain why it is associated with a reduced risk of several cancers including those of the mouth, throat and esophagus (American Journal of Epidemiology, Dec. 15, 2008). Other cancers (colon, liver and endometrium) also appear less common among coffee drinkers (International Journal of Cancer, Apr. 1, 2009).

Women who drink at least four cups of coffee a day appear to be somewhat less likely to suffer a stroke than women who sip less than one cup a month (Circulation, online, Feb. 16, 2009). Coffee may also have some protective effect against heart disease, but the research is contradictory. That might be in part because unfiltered coffee actually seems to raise cholesterol levels.

Another unexpected outcome linked to coffee drinking could be a lower risk of Alzheimer’s disease. Researchers collected data on coffee drinking habits from a large group of Finns in the 1970s and 1980s. Those who drank three to five cups of coffee daily were 65 percent less likely to be diagnosed with Alzheimer’s 20 to 30 years later (Journal of Alzheimer’s Disease, Jan. 2009).

If you think coffee is cool, just imagine the health benefits of dark chocolate. The evidence continues to accumulate that a little high-quality dark chocolate can relax blood vessels, making them more flexible (American Journal of Clinical Nutrition, Dec. 2008).

A study in the same journal (July 2008) found that dark chocolate or cocoa helped blood vessels dilate and lowered blood pressure in overweight people. Other research has shown that dark chocolate can improve insulin sensitivity as well as blood pressure (Journal of Nutrition, Sept. 2008). Increased insulin sensitivity means better blood sugar control.

Dark chocolate also seems to impact the blood in important ways, lowering platelet reactivity, improving cholesterol profiles and decreasing inflammatory markers such as C-reactive protein (Southern Medical Journal, Dec. 2008).

Despite all this good news, it is possible to consume too much of a good thing. Excess caffeine can raise blood pressure, cause anxiety and insomnia and aggravate heartburn. Chocolate can also trigger reflux in some people and indulging in too many sugar-rich chocolate bars will lead to weight gain.

Enjoying coffee and chocolate in moderation, however, could be one of life’s guilt-free pleasures.

What is it about winter that puts us out of sorts? Right about now a lot of people are feeling morose, or even downright depressed.

Psychologists have a name for the winter blues. They call it seasonal affective disorder, appropriately shortened to SAD. People suffering from this problem don’t have much energy and feel lethargic or even hopeless. They may sleep more than usual and sometimes crave carbs. As a result, they may gain weight—which can make them feel even worse.

Although experts do not agree on the causes of SAD, one leading hypothesis focuses on sunlight. Scanty sunshine may affect brain chemistry, including neurotransmitters like serotonin as well as melatonin. But perhaps vitamin D deprivation is one reason for winter blues.

The lack of energy and aches and pains that so often make it difficult for people to exercise can be consequences of inadequate vitamin D. Few foods contain much vitamin D, so most of the vitamin D in our bodies is made by skin exposed to sunlight. It’s no wonder that vitamin D deficiency is common in places like Maine, Michigan or Manitoba.

Even in places where there is lots of sunshine, like southern Arizona, many people are still low in vitamin D. One study found that about a quarter of adults tested there were in the danger zone (American Journal of Clinical Nutrition, March, 2008).

Low vitamin D levels are associated with depression. They are also linked to a higher risk of several cancers and type 2 diabetes. Many physicians now screen for vitamin D along with things like cholesterol and thyroid function. When vitamin D levels are normalized with supplements, people often find their mood improves and their aches and pains diminish.

With less muscle and joint discomfort, people may find it easier to exercise. This in itself can be an effective strategy for dealing with depression.

Combining exercise with full spectrum light exposure plus talking therapy may be better than any one of these non-drug approaches by itself.

Medications may also have a role in the treatment of SAD. Drugs like Prozac (fluoxetine), Zoloft (sertraline), Paxil (paroxetine) or Wellbutrin (bupropion) may be helpful for some people, though all of them have potential side effects. What’s more, it can be difficult to stop taking some of these antidepressants suddenly once warm weather arrives, even though people with SAD usually don’t need treatment in the summertime.
We have included information on antidepressant withdrawal problems as well as many non-drug approaches to overcoming the blues in our brand-new Guide to Dealing with Depression.

People suffering from seasonal depression have a hard time imagining that things will ever get better. Within a few weeks, though, daylight savings time will begin, the weather will improve and we can spend more time outside chasing the blues away.

At one time, used car salesmen were down near the bottom of the ladder of respect and reputation. But now that automobile sales are scraping bottom, people are actually feeling sorry for the poor guys.

Bankers and Wall Street power brokers have taken their place on the scum scale. But despite al the abuses—the bad judgment and the big bonuses—there has been relatively little illegal activity revealed.

Pharmaceutical industry big wigs, on the other hand, have not gotten much public scrutiny. These executives have largely escaped criticism despite decisions that have been unethical at best and in many cases downright illegal. What’s worse, despite stiff fines, many drug companies are repeat offenders.

In recent weeks, drug giant Pfizer agreed to pay a record-breaking settlement of $2.3 billion. The federal government has been investigating whether the company marketed its painkiller Bextra for purposes the FDA had not approved. Such “off-label” promotion is against the law.

Earlier, Pfizer agreed to pay nearly $900 million for personal injury lawsuits brought against it for heart attacks and strokes attributed to Bextra and Celebrex and for claims from state attorneys general and consumer fraud cases.

This isn’t the first time Pfizer has had to pay big fines. Back in 2004 the justice department exacted $430 million in penalties from the company’s subsidiary, Warner-Lambert. That company had been promoting the epilepsy medicine Neurontin for migraine headaches, bipolar disorder and other off-label uses. The company pled guilty to two felonies related to fraudulent promotion and promised to clean up its act so that such violations would not happen again.

Pfizer isn’t the only drug company paying out huge settlements. Eli Lilly has agreed to pay $1.4 billion for off-label promotion of its schizophrenia drug Zyprexa. Acting U.S. Attorney Laurie Magid commented, “Eli Lilly completely ignored the law.”

Sales representatives were encouraging doctors to prescribe Zyprexa for problems such as bipolar disorder and dementia, including Alzheimer’s disease, although the company did not have FDA approval for those uses. Such drugs increase the risk of heart attacks, especially in frail, elderly people with dementia (Lancet Neurology, Feb. 2009).

Another drug giant, GSK (GlaxoSmithKline), has been charged with fraud. They have had to settle legal claims for overcharging Medicare and Medicaid. They have also settled charges of illegal marketing and withholding negative information on some of their medications, notably the antidepressant Paxil.

In 2006, GSK paid the IRS $3.4 billion to resolve a tax dispute. It was the largest fine levied by the IRS to that point in history. The company may soon have to pay a new fine of $400 million as a result of a separate federal investigation into illegal marketing and promotional practices.

Other pharmaceutical firms that have had to pay huge fines for misconduct include Schering-Plough, Bayer, Merck, Abbott and Astra-Zeneca. In an industry that is supposed to be putting patients first, it seems that executives are sometimes willing to break the law in order to improve profits. Perhaps they deserve to take their place in public esteem somewhere south of bankers, Wall Street whiz kids and used car salesmen.

In answering the question What are Generic Drugs? on its Web site, the Food and Drug Administration states unequivocally: “A generic drug is identical, or bioequivalent to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use.”
If you check the Oxford Dictionary, you will find this definition for the word “identical:”
adj. 1 agreeing in every detail. 2 one and the same. The Merriam-Webster Dictionary defines identical as 1: being the same 2: having such close resemblance as to be essentially the same.

Given such definitions, it’s only logical that patients, physicians and pharmacists would assume that all generic drugs are exactly the same as their brand name counterparts. The reality, however, is not so clear.
For one thing, the FDA does not require generic drugs to contain the same inactive ingredients as the brand name product. That means colors, binders and fillers (that often make up the majority of the pills) can be quite different. In some cases this may mean someone is allergic to one formulation of a generic drug even though he tolerates the brand name.

Many pills are designed to release the active ingredient over a sustained period of time. Generic products may use a different formulation. This could alter the way in which the medicine gets into the blood stream.

A few years ago we started hearing from readers of this column that the generic drug Budeprion XL 300 was affecting them quite differently from the brand name Wellbutrin XL 300. When we investigated, we learned that the generic used a different technology to control the release of the active ingredient bupropion. This resulted in the drug getting into the blood stream faster.

Here is just one of the hundreds of stories we have received about this: “Wellbutrin XL has worked wonders for me. Recently, however, my insurance provider substituted Budeprion for the Wellbutrin and my experience has been awful. Soon after starting it I began having feelings of despair, hopelessness, disorganized thinking, anxiety and depression.

“I’ve had physical problems as well: migraines of greater duration and intensity, sleep disturbances and night sweats. All of these changes coincide with my taking Budeprion. I have resumed taking Wellbutrin and I am feeling better and thinking more clearly.”

Readers have also reported problems with other generic formulations. The generic form of the heart and blood pressure pill, Toprol XL, has produced dozens of complaints: “I've taken Toprol XL for 11 years. When my insurance company dropped the name brand for generic metoprolol, the pharmacy re-filled without advising me. I noticed the change once my blood pressure went through the roof along with pounding heart rate, flushing and very swollen ankles. I was weak and dizzy. I demanded the pharmacy give me the correct prescription; after two months I was back to normal.”

You can read more stories at www.peoplespharmacy.com. Anyone who has a problem with a generic drug can report it to us or directly to the FDA at www.fda.gov/medwatch.

Some doctors are defensive about their handwriting. Years ago we criticized prescriptions that patients could not read. One reader shared our column with her physician and got in trouble:
 
"I have never been able to read his handwriting so when you wrote a column about illegible Latin abbreviations I took it in almost as a joke and showed it to him. He exploded and told me that if I didn't like his handwriting I could damn well find another physician with perfect penmanship."
 
When doctors scribble prescriptions, pharmacists make mistakes. That's why patients sometimes get the wrong medicine or the wrong dose.
 
In one case, years ago, a patient with an earache was prescribed combination drops containing an antibiotic and a local anesthetic. They were to be given in the right ear, abbreviated r ear (no period). Three doses were administered rectally before someone figured out the problem.
 
Other examples are numerous. A pharmacy once filled a prescription for the diabetes drug chlorpropamide with the anti-psychotic medicine chlorpromazine. Had the diabetic patient actually taken the medication, he would have been too sedated to notice the blood sugar disturbance this medication can cause. The Institute for Safe Medication Practices (www.ISMP.org) has more examples.
 
One way to reduce misunderstandings between physicians and pharmacists is through e-prescribing. Doctors use computers or handheld digital devices similar to Palm Treos, BlackBerries or iPhones. When equipped with special software, the device allows a physician to send prescriptions wirelessly and securely directly to the selected pharmacy.
 
E-prescribing also does away with called-in prescriptions, which are also susceptible to misinterpretation. A busy pharmacy technician might well confuse the sound of Xanax with Zantac, for example.
 
Patients like the speed of electronic prescribing. When people are ill they would like to have their prescription waiting when they get to the pharmacy. The digital system can also alert doctors to mistakes. Most programs can catch potential drug interactions and dosage errors.
 
Some insurance companies offer doctors financial rewards to switch over to e-prescribing. In addition, the government itself is encouraging doctors by paying them for entering the digital age. Doctors who use the technology will get a bonus of 2 percent of their Medicare charges for 2009 and 2010.
 
Despite such incentives, it is estimated that only 12 percent of office-based doctors are currently prescribing medicines electronically. Patients may want to encourage their doctors to consider this step.
 
E-prescriptions will never be foolproof. Mistakes will happen, even with computers. That's why it is essential for every patient to request a printout of the prescription along with detailed instructions before leaving the doctor's office. When picking up the prescription at the pharmacy, the printout should be used to confirm the pharmacy has prepared the right drug at the right dose.

Hundreds of years ago, people with mental illness might be burned at the stake or locked away in a dungeon. In the early 20th century, some patients with schizophrenia were lobotomized with an ice pick to blunt emotions and reduce agitation.

Other treatments included padded cells, straitjackets, cold wet sheets and electroshock therapy. Mental institutions in the first part of the 20th century were sometimes referred to as “snake pits.”

It was in this barbaric context that the first antipsychotic drugs were developed. In 1952, when Thorazine (chlorpromazine) was first introduced, it was hailed as a breakthrough.

Other drugs such as Stelazine (trifluoperazine), Mellaril (thioridazine) and Haldol (haloperidol) followed. Although these antipsychotic medications were popular with psychiatrists, patients often thought of them as chemical straitjackets.
Such drugs helped reduce hallucinations and agitation. But there was a high price to pay for the apparent benefits. The drugs made people feel sedated and slowed them down, resulting in a zombie-like shuffle.

Other side effects included dizziness, slurred speech, seizures, and a variety of movement disorders such as severe neck muscle spasms causing head twitches or uncontrollable rhythmic movements such as sticking out the tongue. Urinary retention, constipation and sexual difficulties also contributed to the drugs’ unpopularity with patients, who often discontinued their medicines as soon as they were discharged.

A newer generation of schizophrenia drugs was introduced in the early 1990s with great fanfare. Drugs like Clozaril (clozapine), Risperdal (risperidone), Zyprexa (olanzapine), Seroquel (quetiapine), Geodon (ziprasidone) and Abilify (aripiprazole) are known as atypical antipsychotics.

Psychiatrists hoped that these medications would be better tolerated and much more effective than older antipsychotics. Some even believed the new drugs would help schizophrenic patients return to normal.

Over $13 billion is spent on antipsychotic medications each year. They are prescribed for a range of conditions beyond schizophrenia, including Alzheimer’s and dementia, bipolar disorder, insomnia, autism, obsessive-compulsive disorder, ADHD and major depression.
Despite the initial enthusiasm, there is growing consternation about the safety and effectiveness of these powerful mind medicines. A few years ago a study found that the newer and far pricier drugs were no more effective or less likely to cause troublesome side effects than an older antipsychotic (New England Journal of Medicine, Sept. 22, 2005). A new study in the same journal (Jan. 15, 2009) reported an alarming rate of sudden cardiac death linked to the newer drugs.

It’s no wonder that patients and families are nervous about these medicines, especially when you consider that they can cause other complications such as dramatic weight gain, diabetes, strokes and irregular heart rhythms. Children and older people may be particularly vulnerable.

People with mental illness deserve much better treatment than they have received to date. Although lobotomies and straitjackets are no longer used, modern medications leave a lot to be desired.

Drug companies justify the high cost of prescription medicines to help pay for breakthroughs of the future. One company even advertises: “Today’s medicines finance tomorrow’s miracles.”

The implication is that if we want wonderful medications to cure Alzheimer’s disease, cancer or diabetes, we should be happy to pay whatever they charge us for drugs to control heartburn, depression or high cholesterol.

The trouble is, there have been relatively few miracles in recent years. To date, there is nothing very exciting to slow the progression of Alzheimer’s, let alone cure this dreadful disease. Even unbelievably expensive cancer therapies may only prolong life for a few months.

When you look at last year’s crop of FDA drug approvals, there are few breakthroughs. A new antidepressant was approved called Pristiq. The generic name for this medicine is desvenlafaxine. If that sounds familiar, there’s a good reason. The generic name for the antidepressant Effexor, introduced in 1993, is venlafaxine. In other words, these drugs are chemically related.

The same company makes both Effexor and Pristiq. Why would Wyeth spend countless millions to develop a similar antidepressant? Effexor went off patent in 2006 and a long-acting version, Effexor XR, will lose its patent protection next year.

This type of drug development, whether done by the same company or a competitor, is known in the trade as a “me-too” medicine. It certainly doesn’t represent a major advance in the treatment of depression. Quite a few other antidepressants are already available, including Celexa, Cymbalta, Lexapro, Paxil, Prozac and Zoloft.

A similar situation occurred some years ago when the highly successful acid-suppressing drug Prilosec (omeprazole) lost its patent. Facing a huge loss in revenue due to generic competition, the company brought out a chemical cousin, esomeprazole. It was (and still is) sold under the name Nexium and was widely promoted as “The Purple Pill.”

Although Nexium doubtless has made billions for the company, it was hardly a miraculous development in heartburn treatment. There are now several acid-suppressing drugs on the market that all work in a similar manner. There is little data to suggest than Nexium is head and shoulders above Aciphex, Prevacid, Prilosec or Protonix.

Another product the FDA approved in 2008 is even harder to label as a miracle breakthrough. The glaucoma drug Lumigan may have represented an advance in the treatment of glaucoma when the eye drops were approved in 2001. But should Americans really celebrate approval of the exact same medicine under the name Latisse to lengthen eyelashes?

We will never know how many millions of dollars were spent on the development of Latisse, as that sort of information is usually kept secret. But it will be expensive to use. A month’s prescription is expected to cost consumers $120. It may take two to four months to see significant results. Once the topical treatment is discontinued, eyelashes are likely to return to their original state.

If the pharmaceutical industry expects Americans to continue spending billions for pricey prescriptions, it will have to come up with more miraculous medicines than me-too drugs and eyelash lengtheners.

At this time of year we get inundated with queries about dry, cracked fingertips. It may seem like a minor annoyance compared to health problems like diabetes or high blood pressure. For those who suffer, though, this can truly make life miserable. Here are just a few sad stories:

“I have suffered from split fingertips for years, as has my brother. Even as I write, I am having difficulty typing with bandages on my fingertips!”

“Every winter my wife and I are bedeviled with split skin on the tips of our fingers. The tiny cuts are extremely painful.”

“I’ve been suffering since I was 17 (I'm 64 now). I thought after menopause my splits would go away or ease up some. Instead, I don’t get relief in the summer anymore. There are times I literally cry with pain. It gets so bad I drop stuff. I can hide them under gloves in the winter, but in the summer they’re out in plain view. Bandages bring me some relief, but don't solve the problem. As soon as they come off, the splits start to open again. I've seen so many dermatologists in my lifetime I have lost count. They prescribe a steroid cream and tell me to keep my hands out of water as much as possible... ha!”

Readers of this column love to offer suggestions to fellow sufferers. We have received dozens of suggestions. Here is a sample of the solutions people have offered to be helpful:

“As a lifelong sufferer of those painful cracks on fingers and hands, I am compelled to pass along a word-of-mouth tip. Zim's Crack Creme--a product I have never seen advertised--was recommended to me. It works wonders, and I am not one to exaggerate. It is just that good. It not only prevents cracks, it quickly heals the ones you have. It’s at pharmacies or discount stores in the first-aid section, or sometimes the skin care section.”

“I also have a similar problem which I treat very effectively with Burt's Bees Beeswax Lip Balm. It works like magic for me. In the past before discovering this remedy, my fingers would crack so bad they sometimes bleed and hurt like fury.” (Other readers have suggested ChapStick for cracked fingertips.)

“Here's my solution for split fingertips. Use grey duct tape. Cut in small pieces and cover the split. This keeps in the moisture and helps keep the split from opening up further. It may take several weeks. You have to be persistent to keep it covered and you may have to answer dumb questions about it, but it works.”

“I am a carpenter and I have had split fingers and thumbs every winter for years, I read about Super Glue being used in Vietnam by medics so I tried it. It works great, seals splits so the pain is gone.” (Some readers use liquid bandage for a similar result.)

“I have cracked fingertips every time the weather gets cold. The skin on my finger joints and knuckles will even split.  I found a product called Badger Balm at the auto parts store and it is wonderful. I try to grease my hands in it at night and wear gloves to bed when having this problem.”

With cold dry weather getting worse this winter, many folks will be looking for a way to cope with splitting fingertips. We hope that some of these suggestions from other readers will help skin heal and ease the pain.

Americans take way too many medications. They mix and match with barely a second thought.

Researchers found that 81 percent of older adults took prescribed drugs. More than half “used 5 or more prescription medications, over-the-counter medications, or dietary supplements” (Journal of the American Medical Association, Dec. 24/31, 2008).

Some combinations are potentially dangerous, if not lethal. We often hear from readers of this column concerned about their relatives:

“My mother is 85 and under the care of an internist, a cardiologist and a neurologist. She has almost no energy and is quite depressed. She takes: Aldactone, atenolol, Crestor, Diovan, hydrochlorothiazide, Lexapro, Miacalcin, Neurontin, Nexium, Nitro-Dur, Norvasc, Plavix, Rhinocort, Synthroid and tramadol. In addition, she takes Aleve for arthritis pain and aspirin twice a day as needed.”

Counting the OTC pain relievers, this woman is taking 17 different drugs. Some combinations could be life threatening. Taking aspirin, Aleve and Plavix together could increase the risk of hemorrhage, including bleeding ulcers. Perhaps that is why the internist prescribed the acid-suppressing drug Nexium. The trouble is, Nexium and similar medicines may undo the vascular benefits of Plavix.

Aleve can increase drowsiness resulting from Neurontin and reduce the effectiveness of atenolol to lower blood pressure. There are other potential interactions, but the point is that three specialists each prescribed medicines that may not play well together.

This is not an isolated case. Many elderly people have several health conditions and see a range of experts.
Another woman was worried about her sister who is taking two antidepressants: Prozac (fluoxetine) and Zoloft (sertraline) plus a sleeping pill (Ambien). In addition, she takes Tegretol (carbamazepine), atenolol, Lipitor, Zantac and several more drugs for high blood pressure and diabetes. Is it any wonder that this woman is drowsy, weak, unsteady on her feet and has breathing problems?

One of the findings of the recent study is that older adults often add over-the-counter drugs and dietary supplements to their prescription medications. They might not realize that pain relievers like aspirin or Aleve can cause mischief with prescribed medications.

Some years ago we heard from a retired judge who took enalapril to control his blood pressure. It worked well until he started taking coated aspirin for back pain. Then his blood pressure soared to over 210/90.

Physicians and pharmacists are so busy these days that they may not take time to look up every possible drug interaction. That is why people have to look out for themselves and each other.

We include a Drug Safety Questionnaire in our Guide to Drugs and Older People. This can prompt a conversation about incompatible drug combinations with both the doctor and pharmacist.

The history of asthma medicine is a tale of woe and intrigue. In the 1960s there was a surprising increase in deaths from asthma over previous decades, especially in Australia and England.

Many patients were found dead with their inhalers clutched tightly in their hands. Experts blamed the deaths on high doses of a bronchodilator called isoproterenol. This drug opened airways quite effectively, but it also increased heart rate and triggered potentially fatal heart rhythms.

The United States appears to have escaped that epidemic of asthma deaths largely because isoproterenol was available only at much lower doses.

Americans escaped another asthma tragedy in the 1970s. A new asthma drug was introduced in New Zealand in 1976 called fenoterol. It was a more potent asthma inhaler also designed to open airways. The trouble was that the more people used fenoterol, the more asthma deaths occurred (Thorax, Feb. 1991).

This observation, along with similar episodes in Canada, led some physicians to wonder whether drug therapy might be part of the problem rather than the solution (Medical Clinics of North America, July 1996).

Fast forward to 2008. The mainstays of asthma treatment these days still involve bronchodilators. These drugs open constricted airways during an asthma attack. They work on the same principle as the old drugs of the 1960s and 1970s.

But drug companies always like an edge. They have created longer-acting bronchodilators with twice-a-day dosing. Instead of puffing on an inhaler like albuterol every four to six hours, patients use drugs like Serevent and Foradil every twelve hours.

The convenience was supposed to be beneficial, but some researchers now question the safety of these long-acting puffers. After reviewing data from 110 clinical trials involving more than 60,000 patients, FDA safety officials concluded that these drugs are linked to higher rates of asthma-related hospitalizations and deaths.

How paradoxical. The very medicines intended to open airways and improve breathing appear to be contributing to complications. The FDA staffers who reviewed the data recommended banning Serevent and Foradil for treating asthma.

Some agency safety experts even advocated banning all long-acting bronchodilators for children. That includes combination drugs like Advair and Symbicort. These inhalers contain steroids that are intended to calm inflammation along with the bronchodilators.

The manufacturers maintain that adding a steroid reduces the danger from bronchodilators. Safety reviewer Andrew Mosholder, MD, counters that there is inadequate evidence to show that adding steroids eliminates the risk.

An FDA advisory panel of outside experts recently voted to ban both Foradil and Serevent for use in asthma, but suggested that Advair and Symbicort should remain on the market. Despite this recommendation, some panel members called for further research on the long-term safety of these combination drugs.

All this controversy means that people with breathing problems, whether due to asthma or chronic obstructive pulmonary disease (COPD), face a difficult dilemma. Even after 40 years, questions remain about the safety of some of their medications.

“Physician, heal thyself” is a proverb from the Bible. It is often interpreted to mean that people should tend to their own frailties before trying to correct the defects of others.

Doctors frequently offer lifestyle advice to their patients. “Lose weight” and “exercise” are common admonitions. These are, of course, highly desirable. But one other important aspect of healthy living, a good night’s sleep, may get short shrift.

When people are sleep deprived, their judgment is impaired, their immune system may not function optimally and they may be at greater risk for obesity, diabetes and high blood pressure.

One would hope that physicians would encourage patients to get enough sleep. But the medical system is set up so that doctors-in-training themselves are chronically sleep deprived.

The Institute of Medicine would like to see that changed. This prestigious body, which advises the federal government on health policy, recently issued a report addressing lack of sleep for doctors in training. It called for significant changes in scheduling medical residents’ hours on duty.

Historically, residents put in unbelievable hours, often exceeding 100 in a week. That was supposed to be reduced to 80 hours a week in 2003, but residents still regularly work 30-hour shifts. The IOM now recommends that residents should get five hours to sleep after working 16 hours straight.

Why? Research has shown that residents leaving the hospital at the end of their 30-hour shifts are more likely to fall asleep at the wheel or be involved in traffic accidents. If they can’t drive home safely, can residents be expected to make life-and-death decisions on patient care properly? Many experts feel that fatigue probably contributes to the high rate of medical errors that harm patients in U.S. hospitals each year.
Doctors who have been through this barbaric system often defend it as a useful trial-by-fire experience. They argue that it offers an intense learning environment, like boot camp for Marines.

No other professional is expected to work 30 hours straight without sleeping. The FAA won’t let pilots plan to fly for more than 8 hours at a time.  Federal regulators know exceeding that time frame wouldn’t be safe. Truck drivers are limited to driving 11 hours in a shift. Doctors’ work is at least as demanding as flying a plane or driving a truck.

Like it or not, health care providers often serve as role models for their patients. An obese physician has little credibility when he tells a patient to lose weight. A doctor who smokes can’t easily convince a patient to give up a nicotine addiction.

If physicians don’t value sleep, how can they encourage their patients to get enough for good health? We have prepared a Guide to Getting a Good Night’s Sleep that offers dos and don’ts, non-drug options and discusses the pros and cons of most sleeping pills.

For a different perspective on this issue, look for John Grohol's comment at e-patients.net

 

Fungi love damp dark places, so they often thrive in the crevices between toes and in folds of skin. The groin is especially susceptible. That’s why men often complain of jock itch.

Women can have jock itch too. But they may also suffer from fungal infections under the breast. Judging from our mail bag, this is far more common than many people realize.

Several weeks ago we heard from a woman who asked for help: “For years I have had a yeast infection under my breasts, under my arms and in the groin. Nothing works. I know other women have this problem. I would be grateful for any remedies that might help.”

Our answer was fairly lame. We suggested old-fashioned amber Listerine. This mouthwash contains herbal oils with antifungal activity, plus a substantial dose of alcohol. Some men have found it can conquer jock itch.

We were unprepared for the outpouring of suggestions from other women who also suffer from this problem. Not surprisingly, many have found that antifungal medicines are especially helpful: “I had a similar problem. My doctor prescribed Nystatin cream. It works wonderfully and I haven’t had a problem since.”

Over-the-counter antifungal creams also have enthusiastic boosters: “I too had a yeast infection under my breasts. Even my doctor did not know exactly what to do. So I bought Monistat vaginal cream and applied it. The infection cleared right up!”

Another woman prefers a different Monistat product: “I found wonderful relief for my yeast infection. In the feminine product aisle of stores is something called ‘Soothing Care Medicated Powder’ made by Monistat Intimate Care.

“I bought it and tried it, applying it right after my bath. I was amazed because after using it for several weeks my yeast infection was gone from under my breast, under my arms and my groin.”

Soothing Care Medicated Powder does not contain antifungal medication . Instead, the active ingredient is zinc oxide (often found in diaper rash cream), with inactive ingredients of cornstarch, aloe extract and vitamin E.

Cornstarch is an old-fashioned favorite, as we heard from this woman: “I used every expensive cream formula, both prescription and OTC, without success. In desperation due to itching one night, I tried my Grandma's cornstarch cure.

“Be sure areas are clean and dry. Then dust the affected areas with a thin coating of cornstarch. (Use a flat powder puff to apply.) Do this at least twice daily.

“After months of creams, it took only a few weeks for the underarm area to dry. The itching stopped. The dead skin peeled off and it has never returned. My dermatologist couldn't believe it worked so well. The groin and areas under the breasts took a bit longer, but they’ve also healed. Grandmas do know best.”

Cornstarch and zinc oxide are both working on the principle that drying the skin will deprive the fungus (yeast, in this case) of the moisture it needs to thrive.

Who knew that so many women suffer from fungal infections under the breasts? With various possible remedies, however, we hope this troublesome problem is no longer a deep, dark secret.

Everyone loves a bargain. Imagine buying a new Mercedes-Benz worth $60,000 for the price of a Hyundai, say around $20,000. As long as the vehicle had Mercedes parts and performed like a Mercedes, you would be thrilled.

In reality, no one gets a 66 percent discount on a new luxury car. Even with the automobile market in desperate shape, no one gives away Mercedes at bargain basement prices.

Most people believe that you get what you pay for. That’s why they are justifiably suspicious when someone offers a Rolex-brand watch over the Internet at a Timex price. The likelihood is pretty high that there is some counterfeiting going on.

When it comes to prescription drugs, however, this law of economics has been suspended. According to the FDA, “A generic drug is identical, or bioequivalent to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use.”

Despite being identical to its brand-name counterpart, the generic drug costs much less. Now that many discount chains are selling a month’s supply of many popular prescriptions for $4, the savings are truly spectacular.

Take the antidepressant Prozac, for example. A month’s supply would cost around $150. The generic fluoxetine might run about one-tenth as much or roughly $15. But if you shopped at a big-box discount drugstore you could get a 90-day supply for $10. Over three months, the savings would add up to $440. Who wouldn’t want to save 98 percent on prescription drugs?

Some patients and physicians have voiced concern about the quality of generic drugs. The extraordinary savings are only a bargain if the generic is truly identical in safety and effectiveness.

A recent review of generic drug research carried out since 1984 concluded that “generic and brand-name cardiovascular drugs are similar in nearly all clinical outcomes” (Journal of the American Medical Association, Dec 3, 2008).

Although this research is reassuring, it has some limitations. More than half of the studies included in the review were published before 2000 and only about a third were conducted in the U.S.

Before 2000 we had little worry about the quality of generic drugs. We encouraged readers to buy low cost medicines whenever possible. We would still do so if we thought that someone was monitoring the quality of the products on pharmacy shelves.

After 2000 an increasing proportion of generic drugs originated overseas. The weak link in our national drug supply system is that the FDA operates mostly on the honor system. The agency expects manufacturers to be honest. There are few resources devoted to verifying that generic drugs (or even branded products) contain what they claim.

Ever since patients died from a contaminated blood thinner (heparin), Americans have lost faith in government oversight. New reports that minuscule amounts of melamine have been found in baby formula in the U.S. and Canada suggest that Chinese suppliers should not always be trusted.

We’ve been promised a change in Washington come the new year. One change we would like to see is FDA monitoring the quality of imported pharmaceuticals so that Americans can have confidence in the drug supply once again.

Are you taking a placebo? This may be a shocking idea. A placebo, after all, is a pill, potion or patch that is not expected to have any particular therapeutic effect on your condition. So, surely, your doctor would never prescribe one.

Actually, your doctor might, and with good reason. According to a study published last month, about half of the rheumatologists and internists who responded to a survey said they sometimes prescribe a placebo (BMJ, online Oct. 23, 2008).

Now, these doctors were not writing prescriptions for sugar pills. Most were recommending vitamins or over-the-counter pain relievers such as aspirin or acetaminophen. About two-thirds of the respondents thought there was nothing unethical about this. After all, the treatments were meant to make the patient feel better without creating complications.

This research made headlines, perhaps because the placebo response is fascinating and mysterious. Astute observers have known for centuries that the expectation of getting benefit can have a powerful healing impact.

One of the most dramatic examples in the medical literature comes from the middle of the 20th century. A man with lymphoma had large tumors throughout his body and was expected to die within a few weeks. As a last resort, his physician injected a dose of an experimental treatment called Krebiozen. The response was dramatic: “The tumor masses had melted like snow balls on a hot stove, and in only these few days they were half their original size! This is, of course, far more rapid regression than the most radiosensitive tumor could display under heavy x-ray given every day…” (quoted by Larry Dossey in the  book, The Extraordinary Healing Power of Ordinary Things).

The patient’s response to the treatment was amazing, but even more amazing was what happened when, months later, news media reported that Krebiozen was useless. At that point, his health deteriorated rapidly, but his doctor gave him a second injection. He told the patient that it was a new, far more powerful form of Krebiozen, but it was in fact sterile water. Nonetheless, the patient had another dramatic recovery and enjoyed two more apparently healthy months. Then the American Medical Association announced its findings that Krebiozen was without any merit. Within a few days, the patient was admitted to the hospital and died shortly thereafter.

Medical research on new treatments relies on placebo. Without a randomized, placebo-controlled trial, scientists don’t know how well the drug or device really works. In fact, the FDA requires that new medicines be proven more effective than placebo—and that can be harder than you might imagine. In most studies of conditions such as pain, depression or even heartburn, one- to two-thirds of patients respond to the inert pill. The drug being tested has to provide benefit to significantly more subjects.

All this points up a few quirks in current medical practice. Most doctors like to think of themselves as practicing “evidence-based medicine.” They look down their noses at unproven approaches like herbs, homeopathy or home remedies. Yet a majority is willing to utilize unproven treatments when they have nothing better to offer a patient.

When you take more than one medication at a time, it’s a little like rolling dice. You never know when a particular combination will put you out of the game.

Take statins, for example. These cholesterol-lowering medications are taken by millions of Americans every day. We’re talking about drugs such as Crestor, Lescol and Lipitor or generics like lovastatin, pravastatin or simvastatin.

Insurance companies may consider them interchangeable, but not all these drugs are equally compatible with foods or other medicines. Grapefruit can raise blood levels and increase the potential for side effects of Lipitor, lovastatin and simvastatin. Grapefruit has little or no effect on Crestor, Lescol or pravastatin.

Then there is the case of the 82-year-old Norwegian lady who had been taking the blood thinner warfarin (Coumadin) for almost 30 years. It was prescribed because she had several blood clots deep in her legs (deep vein thrombosis) and one in her lungs (pulmonary embolism). She had been taking Lipitor together with Coumadin with no problems.

When the Norwegian government decided in 2005 to save money by switching people to generic simvastatin, her doctor changed her prescription. Within a month she showed up for a routine check of her anticoagulant. The doctors were alarmed to discover that her INR value (a measure of blood clotting) was almost four times higher than it had been for two years and in the danger zone (over 8).

Even though this woman was immediately hospitalized and given vitamin K to reverse the excessive blood-thinning effect of warfarin, the treatment didn’t work. Several hours later she died of a hemorrhagic stroke.
Her story was written up in the medical literature to alert physicians to the possibility of a dangerous interaction between simvastatin and warfarin (Annals of Pharmacotherapy, July, 2007). How many American doctors are aware of this potentially lethal interaction?

Keeping track of drug interactions is very complicated. Most insurance companies are more concerned about costs than potential incompatibility. Patients are frequently switched from a brand name drug to a different but related generic without a lot of consideration for the other medications they may be taking.

The FDA frequently doesn’t know about all dangerous interactions when it approves a new medicine. Consider the widely prescribed blood thinner Plavix. People with stents in their coronary arteries are often prescribed this medication to keep these tiny mesh tubes open.

A new report shows that people on Plavix who also take acid-suppressing drugs such as Nexium, Prevacid, Prilosec or Protonix are more likely to suffer a heart attack than those who take Plavix alone.

Nearly half the people who take Plavix are prescribed one of these stomach medicines, called a proton-pump inhibitor (PPI). That’s because Plavix can cause heartburn, nausea, stomachache and other digestive distress.
There are thousands of dangerous drug combinations. That’s why it is crucial for doctors and pharmacists to double-check compatibility before any new medicine is added. Readers can check for themselves by entering their medicines on the Web site www.iguard.org.

Ten years ago we received an amazing letter from Donald Agar in Pittsfield, Massachusetts: “I have had Crohn's disease for 40 years, and during that time I have had a never-ending battle with diarrhea. Lomotil helps some, but it doesn't eliminate the problem.

“Three months ago, I bought a box of Archway Coconut Macaroon cookies. I've been eating two a day and I have not experienced diarrhea in that time. If by chance I eat three in a day, I get constipated. Believe me, I have a new life now.

“My brother-in-law has a friend who just had cancer and suffered diarrhea as a consequence of the operation. We told him about the cookies and they corrected his diarrhea. I would be delighted if others were helped by my discovery, too.”

We invited others to share their experiences with coconut macaroon cookies for diarrhea. Over the next decade we heard from hundreds of readers, most reporting amazing results. Here are just a few examples:

“I read your column on the effect that coconut macaroons might have on Crohn's Disease. Having suffered with this dread disease for years with little relief, I bought four boxes of Archway's product. Much to my shock, there has been dramatic improvement in my symptoms in less than one week. My gastroenterologist pooh-poohed the idea, but I can honestly state that the macaroons have given me far more relief than any medication I have taken.”

Another reader had a different health problem that caused diarrhea: “I had a kidney transplant (donated by my beautiful daughter Lizzie) and the medicines I have to take really do a number on my stomach. I was having so much diarrhea that it made my hemorrhoids bleed. When I read about the coconut cookies, I tried them and you know what? They worked!”

This reader offered another story: “I shared this information with my brother-in-law who'd had diarrhea since radiation treatment on his prostate burned his colon and caused demoralizing daily diarrhea. The macaroons worked for him. He is elated and is actually planning to take some extended driving trips. He eats two a day.”

Sadly, all the enthusiasm for Archway Coconut Macaroon Cookies wasn’t enough to keep the company out of bankruptcy. A reader just lamented: “We recently learned that Archway has gone out of business. No longer will we be able to get their coconut macaroons. Do you have a suggestion for another brand or will any coconut macaroon work?”

We have heard from many readers that the coconut is the critical ingredient in the cookies. Homemade coconut macaroons have been used effectively by a number of readers. Here is one recipe from Stephanie Muravchik of Charlottesville, VA: Preheat oven to 250. Cover a cookie sheet with greased tinfoil. Mix 2/3 c. sweetened condensed milk, one egg white, 1.5 tsp. vanilla, and a pinch of salt until well combined. Add 3.5 c. shredded sweet coconut and mix well. Drop by tablespoons onto sheet and bake 20 to 25 minutes until well browned.

For a fluffier cookie, beat the egg white separately and fold in after the coconut has been added. We make no guarantees that these cookies will work as well as the Archway brand. Since Archway is no longer available, though, they are worth a try.

We are often asked about long-term side effects of medications people will be taking for a long time. Drugs to treat osteoporosis are usually taken for years, if not decades.

FDA usually does not require long-term tests to determine safety. As a result, there may be significant delays before scientists learn about potentially serious adverse drug reactions.

That appears to be the case with the osteoporosis drugs called bisphosphonates. Some popular brands include Actonel, Boniva, Fosamax, Reclast and Zometa.

Millions of women rely on these medications to keep their bones strong and prevent debilitating fractures. They have been widely advertised on television as a way of maintaining an active lifestyle without worrying about breaking bones.

A new report suggests that these medications are not innocuous. Earlier this year the FDA issued a warning that such medications can sometimes cause severe, even incapacitating, muscle, bone or joint pain.

Such admonitions frequently seem abstract. When you hear a disembodied voice during a TV commercial rattle off a string of side effects, it may be hard to imagine that they might happen to you.

One reader told us about her experience: “I took two doses of Boniva, a month apart. Following the first dose, I experienced shooting pains in my arms and legs for about six hours, but considered this to be normal after I read the information that came with the prescription.

“Following the second dose, I had severe, flu-like symptoms including fever, unrelenting chills and spasms and intense pains in all of my limbs. I was left with low back pain that made me double up after sitting for short periods of time.

“The experience left me drained and debilitated for nearly a month, and I am just beginning to feel normal again.”

Debilitating pain is not the only possible side effect of these medications that was discovered years after they were approved. Jawbone death (osteonecrosis of the jaw) is a rare but very serious complications associated with bisphosphonate drugs. Oral surgeons worry about tooth extraction for women on these medications.

More recently, researchers have discovered that such osteoporosis drugs may increase the risk of an irregular heart rhythm called atrial fibrillation. Dr. Jennifer Miranda reported to the American College of Chest Physicians (Oct 27, 2008) that serious atrial fibrillation requiring hospitalization was more common in women taking bisphosphonates. This condition can raise the risk of having a stroke, but it is not listed in the official prescribing information for most of these medications.

The FDA began reviewing this issue more than a year ago. A recent update from the agency downplays the danger and concludes, “healthcare professionals should not alter their prescribing patterns for bisphosphonates and patients should not stop taking their bisphosphonate medication.” The agency does request reports of atrial fibrillation associated with this class of bone drugs be made to MedWatch (www.fda.gov/medwatch.htm).

Here is one such report we received from a reader: “I took Fosamax for osteoporosis for over five years and then Boniva for one year. I recently began experiencing shortness of breath when walking or exercising. I could not finish a treadmill stress test because a rapid and irregular heartbeat (atrial fibrillation) was detected.

“My doctor put me through lots of tests and then took me off Boniva. I now take metoprolol and warfarin for the atrial fibrillation. Before all of this, I was an extremely healthy and active 67-year-old woman who walked two miles every day. The atrial fibrillation came on almost overnight.”

These medications offer benefit for those who can tolerate them, but the range of side effects being discovered might make doctors a little more cautious about prescribing them in the future.

Does FDA approval guarantee safety? If the Supreme Court rules as expected, patients will have no legal recourse if they are harmed by an FDA-approved medicine.

The case that will soon be decided by the Supreme Court involves a musician who was treated for a migraine. The medicine that was injected to stop her nausea was administered incorrectly. This led to gangrene of her arm and eventual amputation just below the elbow.

The Vermont Supreme Court upheld a Superior Court finding that the drug company was negligent because it did not provide adequate warning about the injection process. The manufacturer maintains that the FDA approved the prescribing information that was used and therefore the drug company has no liability. In other words, FDA approval gets the pharmaceutical firm off the hook for any complications that might arise. Think of it as a Monopoly-style “get out of jail free” card.

This case could well set a precedent for all future pharmaceutical-related litigation. If FDA approval means that drug companies are not liable, then there will be no recourse if someone experiences a serious or even deadly adverse reaction.

Take Vioxx, for example. At last count tens of thousands of patients may have experienced heart attacks as a side effect of this arthritis medicine.

Questions about what the company knew about these potential problems and when it knew them have been raised. Many answers have been discovered only through the disclosure required in the process of lawsuits.

In recent years the FDA has approved many medicines that have later been shown to carry serious risks. In some cases the drugs have had to be removed from the market.

Rezulin was supposed to be a groundbreaking diabetes medicine. It was later discovered to cause liver damage that sometimes resulted in death. The FDA eventually asked the manufacturer to remove Rezulin from the market.

In another example, millions of patients took antidepressant medications before the FDA required a black box warning that these drugs might trigger suicidal thoughts or actions. No one knows how many deaths may have resulted during those decades.

A recent editorial in the Journal of the American Medical Association (Oct. 22/29, 2008) points out that FDA approval is often flawed: “The FDA is not infallible and the recently increased resources do not include a crystal ball. Therefore, unless and until the FDA drug approval process and the postmarketing surveillance system improve significantly, patients must have a means to seek recourse through tort litigation against product manufacturers. Anything less may well preempt the well-being and safety of the public.”

Postmarketing surveillance has long been a weak link at FDA. If the Supreme Court decides that drug companies are not legally vulnerable once the FDA grants approval, patients will need to be even more vigilant. Since all drugs have the potential to cause side effects, there will be no protection if things go seriously awry.

The FDA insists that bisphenol A (BPA), the chemical found in hard clear plastic and the lining of soda and beer cans is perfectly safe. But its counterpart to the north, Health Canada, has just declared that BPA is hazardous to human health.

The Food and Drug Administration is in a bind. For decades the agency has insisted that baby bottles, water bottles and other food and beverage containers with BPA pose no risk. Even as scientists uncovered evidence that BPA can mimic estrogen and disrupt hormone balance in animals, our regulators have supported the chemical industry’s position that there is nothing to worry about.

The FDA’s conclusion came despite a report from the National Toxicology Program that BPA might trigger “neural and behavioral” effects in fetuses, babies and very young children. Health Canada will put BPA on a list of toxic substances and ban it from baby bottles.

Last month, an article in the Journal of the American Medical Association (Sept. 17, 2008) raised additional concerns for adults. Researchers discovered that “higher urinary concentrations of BPA were associated with an increased prevalence of cardiovascular disease, diabetes, and liver-enzyme abnormalities.”

Virtually all Americans have some BPA circulating throughout their bodies. That’s because this chemical is found in the plastic lining of most canned food. It is almost impossible to avoid exposure to BPA if you use any cans or hard clear plastic containers.

The FDA is on the hot seat for its defense of this chemical. The scientist who chairs the expert panel that is analyzing the safety of BPA also heads a research center at the University of Michigan. His organization accepted a $5 million gift from a maker of medical devices who has been outspoken in his views that BPA is “perfectly safe.” Congress is investigating whether there is a conflict of interest.

In the meantime, millions of Americans are wondering whether they should throw out their plastic water containers and give up on canned soup. Many scientists who have studied BPA are concerned enough to avoid it in their own homes.

We have interviewed experts who advise consumers not to use any plastic containers in microwave ovens. To avoid BPA, consumers should look for food storage containers that are labeled BPA free or that are not clear hard polycarbonate plastic. Some also recommend minimizing the use of canned food.

Anyone who would like to learn more about the potential hazards of plastics and how to reduce BPA exposure may be interested in the radio interview we did with some of the country’s leading experts on sex-hormone disruption. To order this one-hour CD, please send $16 to Graedons’ People’s Pharmacy (CD-670); PO Box 52027; Durham, NC 27717-2027. Show #670 is also available as a free podcast at www.peoplespharmacy.com.

Plastic is everywhere. It’s almost impossible to find fruit juice or ketchup in glass containers any more. Soft plastics used in teethers, toys and flexible containers may contain phthalates, another class of potential hormone disruptors. Although plastic is convenient, it may be prudent to rethink the ways we use it.

Little kids catch lots of colds. That’s because they’re not very careful about washing their hands or keeping their fingers out of eyes, noses and mouths.

When children catch colds, everyone sneezes. They spread their viruses generously to teachers, friends and family members.

Until last year parents routinely dosed their toddlers with over-the-counter cough and cold medicines. Then a group of pediatricians challenged the FDA’s oversight of such medications. The president of the American Academy of Pediatrics, Jay Berkelhamer, MD, said that these drugs have “been found not to be effective in this population at all.”

Pediatrician Joshua Sharfstein, MD, led the charge against marketing these OTC products to parents. As Baltimore’s health commissioner, he not only questioned their effectiveness, but also pointed out that they pose safety hazards.

Eventually, the industry caved in and voluntarily agreed not to sell cough and cold products aimed at infants below two years of age. Infant drops with cold medicine under such familiar names as Dimetapp, Robitussin, Triaminic or Tylenol disappeared.

You might think that would have been the end of the controversy. But Dr. Sharfstein and his pediatric colleagues are still concerned about children between two and six years of age. He recently stated, “There is no evidence that these products work in kids, and there is definitely evidence of serious side effects.”

Roughly 7,000 children under 11 years old are rushed to hospitals every year as a consequence of a bad reaction to a cough or cold medicine. Up to two thirds of these emergencies are due to accidental overdoses. Some, however, are adverse reactions to decongestants or antihistamines, common ingredients in such products.

Although doctors’ groups have petitioned the FDA to ban cough and cold products for children under the age of six, the agency has declined. Instead, the growing furor has led the drug companies to warn parents not to administer the products to children under four.

Of course, this still leaves questions about safety and effectiveness for older children and adolescents. Some pediatricians have even gone so far as to suggest that home remedies, such as honey or chicken soup, might be viable options.

Parents who would like to know more about non-drug ways to ease cold symptoms may be interested in our Guide to Cold Remedies, including a recipe for chicken soup from Joe’s mom.

Last winter, pediatrician Ian Paul, MD, made headlines with his research showing that dextromethorphan, a common ingredient in cough medicine, was less effective than placebo for children’s coughs. His recommendation: try a little honey. In his study, it worked better than placebo. (Children less than a year old should never be given honey.)

Cough and cold medicines do nothing to speed recovery, so it makes sense to play it safe and trust Grandma’s homespun wisdom.

Do you consume carcinogens? These cancer-causing chemicals are everywhere, but most people either don’t recognize them or can’t avoid them.

Obviously, cigarette smoke is one of the most notorious sources of carcinogens. Other compounds that have been linked to cancer include asbestos, benzene and formaldehyde. Prudent people try to avoid exposure to such chemicals.

But what about prescription drugs? It comes as a shock to both patients and physicians that many commonly prescribed medicines have been shown to cause cancer in animals.

Hormone replacement therapy (HRT) is among the most controversial medications in this regard. Estrogen can promote uterine as well as breast cancer. Millions of women have taken HRT to ease symptoms of menopause. How many have developed cancer because of this treatment is unknown.

A surprising number of other prescription medications have warnings in their labels about cancer. For example, the popular heartburn medicine omeprazole (Prilosec) causes abnormal cell growth and stomach tumors (carcinoids) in rats. No one seems to know whether this constitutes a problem for people.

Spironolactone (Aldactazide, Aldactone) is a blood pressure medicine that is sometimes prescribed for hormonal imbalances and facial hair growth in women. It causes tumors in rats.

Parents of children with eczema have been worried by reports that the prescription topical skin treatments, Elidel cream and Protopic ointment, are associated with lymphoma and skin cancer. The FDA has warned against using these drugs in children under two years of age. It also states that, “The long term safety of Elidel and Protopic are unknown.”

Such cautions are not reassuring; they leave patients and physicians in a quandary. The same is true for the rheumatoid arthritis injections Cimzia, Enbrel, Humira and Remicade. These very expensive bio-tech drugs have revolutionized the treatment of rheumatoid arthritis and Crohn’s disease. Last summer the FDA announced that it was investigating an association between these medications and the development of lymphoma or other cancers.

Another hugely controversial cancer connection has to do with cholesterol-lowering drugs. An article in the Journal of the American Medical Association (Jan. 3, 1996) warned over a decade ago that, “All members of the two most popular classes of lipid-lowering drugs (the fibrates and the statins) cause cancer in rodents, in some cases at levels of animal exposure close to those prescribed to humans.”

Recent research in the New England Journal of Medicine (Sept. 25, 2008) has cast a spotlight on Vytorin (ezetimibe and simvastatin), a different kind of cholesterol drug. Investigators noted a higher incidence of cancer in subjects taking this medicine, although a separate analysis concluded there was no risk.

An editorial in the Journal noted that these findings leave both doctors and patients uncertain about the safety of this medicine. That could also be said of dozens of other drugs that cause cancer in animals. The FDA ought to require studies that would clarify the risk, rather than asking Americans simply to ignore warnings of cancer.

Senior citizens are getting slammed. Just when their retirement savings are being affected by the Wall Street boondoggle, they will have to pay more for Medicare drug coverage in 2009.

Here’s a quick refresher on the Part D Medicare prescription drug plan. In 2005, politicians reacted to growing outrage from older citizens. These voters were fed up with skyrocketing medication prices and demanded relief. The response was Part D of Medicare, which launched in January of 2006. There were penalties for older people who failed to select a plan from one of the competing insurers, so most signed up.

In the beginning people were pleased. After the initial $250 deductible was paid, the government picked up 75 percent of prescription drug costs up to $2,250. For people with modest medication needs, this was a real blessing.

But those who needed more medicine fell into the dreaded donut hole. This often happened around August or September. A bottle of pills that cost $30 in March might cost $120 or more by October.

In addition to their monthly insurance premiums, seniors in the hole had to pay 100 percent of their prescription drug costs until the total outlay for the year reached $5,100. If their bills exceeded that amount, they emerged from the donut hole and 95 percent of their drug costs were paid by the government until the whole process started again in January of the next year.

If that sounds complicated, it is. Pharmaceutical manufacturers love Medicare Part D because it has boosted revenues. The government caved in to drug companies’ demands not to negotiate prices, so patients and taxpayers pay full price.

Now premium prices are rising again. According to government analysts, the average insurance premium for Part D will go up about 24 percent, from roughly $30 a month to $37. On top of rising prescription prices, this will take a bite out of a fixed income.

One reader asked for help: “My husband reached the donut hole by June taking both Elmiron and Flomax for interstitial cystitis. Elmiron costs $960 for a three-month supply. It is the only specific drug for this condition. Is there a legitimate pharmacy outside this country where I can purchase these medications more affordably?”

Not surprisingly, many seniors look for more affordable ways to buy their prescription medicines once they hit the donut hole. Buying Elmiron from a legitimate online Canadian drugstore could cost around $500 for a three-month supply. That’s a significant savings.

We offer some guidelines to finding legitimate online pharmacies in our Guide to Saving Money on Medicine. The only trouble with this approach is that any medicines purchased outside the country do not count towards getting out of the donut hole. If total drug costs will exceed $5,726.25 in 2008, it may make more sense to bite the bullet and get the benefit of a 95 percent subsidy on the other side of the donut hole.

Here we go again. First it was pet food from China contaminated with melamine. Then it was Chinese-made toothpaste containing diethylene glycol, an ingredient found in some antifreeze.

Another scandal erupted earlier this year when patients developed severe allergic reactions to the blood thinner heparin. More than a dozen people died. The investigation that followed found that some Chinese suppliers apparently added a cheap, dangerous compound to the raw ingredient.

Now thousands of Chinese babies are sick because melamine, the same chemical that killed cats and dogs, was added to milk to disguise dilution. Other dairy products, including yogurt and ice cream, may also have been contaminated.

All these incidents suggest that food and drug quality control is lax in China. Few Americans realize that raw ingredients for many of our medications are sourced from China.

Generic drug companies undersell brand name products in part because they buy their raw ingredients for less. How else could a discount drug chain offer a cholesterol-lowering drug like pravastatin at $10 to $12 for a three-month’s supply? The brand name Pravachol goes for over $300 for the same amount.

We do not know where discount drugstores buy their low cost medicines. One possible source is India. The FDA recently banned importation of 30 generic drugs (including pravastatin) from Ranbaxy Labs, India’s largest pharmaceutical firm. The agency cited lapses in manufacturing process and quality control. The U.S. Department of Justice is pursuing separate action alleging that Ranbaxy distributed adulterated and misbranded products.

Unfortunately it is impossible for pharmacists or patients to identify the source of their medication. For the last several years we have been hearing from readers and visitors to our Web site (www.peoplespharmacy.com) about problems with certain generic drugs. That is why we have become critical of FDA oversight.

We were recently taken to task by a Houston Chronicle reader who wrote, “The Graedons have been anti-generic drugs for years. They never miss an opportunity to denigrate generics. I wonder which companies’ stock they own.”

Just for the record, for 25 years we were strong advocates for generic drugs. Even when physicians and pharmacists questioned quality, we encouraged patients to insist on generics. We believed the FDA that generics were always identical to brand name drugs. We are no longer confident that is true for all generics. We own no stock in any pharmaceutical company, brand or generic.

We think the FDA needs to take a far more active role in monitoring foreign and domestic drug manufacturing. Currently, many companies are on the honor system: FDA checks paperwork and does little if any analysis of actual medications off pharmacy shelves to make sure they meet quality standards.

The events in China and India suggest that the honor system is no longer adequate. To keep Americans safe, our federal watchdogs need more resources and willingness to safeguard our drug supply.

Here we go again. As flu season approaches, everyone will be urged to get a shot. Vaccinations against influenza are supposed to keep us from getting sick and protect us from potentially lethal complications.
That’s the promise. What’s the reality?

Last year’s flu vaccine was a big bust.

Every year the flu shot is supposed to protect against three different strains of influenza virus. Public health officials have to guess eight months in advance which flu viruses are likely to be causing trouble.

Last year they guessed wrong. Two out of three strains did not match the bugs that made people sick. Perhaps that is why a Harris Poll found that people who got the shot last year were just as likely to have suffered flu as those who skipped the vaccine.

This is not the first time the vaccine has failed to match. Several years ago the shot only protected 38 percent of those at high risk because it did not include the dominant strain of influenza that year.

But even when the crystal ball predicts correctly, the benefits of flu vaccination may have been oversold, especially for the elderly. Older people have been warned to get their annual flu shots or risk an early appointment with the Grim Reaper.

While it is true that older, frail adults are more likely to come down with pneumonia and other complications of influenza, it’s not clear that vaccination will protect them. A study in The Lancet (Aug. 2, 2008) concluded that even when the vaccine was a good match for flu viruses circulating in the community, it did not reduce the risk of pneumonia in the elderly.

The investigators point out that many previous studies of vaccination were flawed because they did not take into account the “healthy user effect.” Seniors who are health conscious—eating properly, exercising regularly, not smoking—are more likely to request flu shots. They are also more likely to survive the flu whether they are vaccinated or not. This skews the statistics when public health officials look at the effectiveness of vaccination.

Even younger healthy adults may not get much benefit from flu shots. Research published in the British Medical Journal (Oct. 28, 2006) showed that flu vaccination for healthy people under 65 “did not affect hospital stay, time off work, or death from influenza and its complications.”

What about kids? Children are little virus factories. They catch lots of colds and other infections in day care and kindergarten and bring them home to the rest of the family.

Unfortunately, the data for vaccine effectiveness in young kids are surprisingly thin. The non-profit, highly-regarded Cochrane Collaboration published a review concluding that in children under two, flu shots are no better than placebo and safety has not been established.

Maybe we’ll be lucky this year and the flu shot will match the viruses that cause illness. Prescription flu drugs like Tamiflu, Flumadine (rimantadine) and Relenza can sometimes speed recovery. Vitamin D may enhance the immune system. Before there were flu shots, grandmothers used to insist on cod liver oil, high in vitamin D, for everyone in the winter. Maybe those old wives were wise.

Video Games or Vitamin D?

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There was a time when children played outdoors. Not only did they go outside for recess, but they spent long summer days and many afternoons during the school year playing in the backyard or on the playground.
In those days, there were few fears about abduction, so parents didn’t worry about supervising their kids’ play. There also weren’t good sunscreens, so children frequently were tanned by the end of the summer.

Nowadays, many children spend most of their time indoors. Physical education classes have been trimmed in many schools for budgetary reasons. Television, video games and loads of homework keep many children busy inside after school.

Even children who play organized sports such as soccer, swimming or tennis are loaded up with high SPF sunscreen before they go outside. Such products are helpful in preventing sunburn and possibly future skin cancer. They may, however, be responsible in part for a growing dearth of vitamin D in children and adolescents. Sunscreens block the formation of this nutrient by the skin.

A review of 14 studies found that vitamin D insufficiency was widespread in American children (Archives of Pediatrics and Adolescent Medicine, June, 2008). Research published in the same issue of the journal showed that 12 percent of otherwise healthy babies and toddlers in the Boston area were deficient in vitamin D.
In Brooklyn, New York, more than half of the overweight children and adolescents studied had inadequate levels of vitamin D (Journal of Pediatric Endocrinology and Metabolism, July, 2007).

Vitamin D is crucial for strong bones. At the turn of the 20th century, deficiency of this nutrient frequently resulted in rickets (malformation of bones). Most health professionals believed that this condition had been eliminated through vitamin supplementation. But over the last couple of decades, pediatricians have noted a growing number of cases (Pediatrics, Aug, 2008).

Children are not the only ones at risk of vitamin D deficiency. Many adults also have low levels of the vitamin. This may increase their risk of diabetes, hypertension, heart disease, arthritis and depression. People with inadequate vitamin D in their bodies appear to be more prone to many cancers.

We interviewed two of the country’s leading experts on vitamin D, Dr. Michael Holick and Dr. James Dowd, on our radio show. A one-hour CD is available.  Show #672 is also available as a free podcast at www.peoplespharmacy.com.

Perhaps it is time for both parents and children to get a little more sun exposure, without overdoing it. Experts suggest that 10 to 15 minutes of sun three or four times a week can improve vitamin D levels in the body.

When that is impractical, either because of nasty weather or indoor activities, vitamin D supplementation may be necessary to maintain adequate levels of this essential nutrient.

For millions of families, back to school means shopping for new clothes and supplies, backpacks and lunch bags. For others the big question is which pill will go into the backpack.

Experts estimate that nearly 9 percent of American youngsters have attention deficit hyperactivity disorder (ADHD). These children are easily distracted, often fidget or squirm, may talk excessively or interrupt others and may have trouble focusing or waiting their turn.

There is no simple test for attention deficit disorder (ADD) or ADHD. No blood test or questionnaire is adequate to make the diagnosis. Experienced therapists make this diagnosis on the basis of the clinical history and a thorough interview.

Few school health issues are more controversial. Some people believe that ADHD is vastly over-diagnosed. Large classes or poor teaching could lead some kids to act up out of boredom.

Teachers, however, must deal with youngsters with poor impulse control who may disrupt an entire class and interfere with everyone’s ability to learn. Children with ADHD often struggle with social relationships as much as with lessons and homework.

Parents frequently feel conflicted. One reader wrote: “I think my son has ADD. His teachers say he has trouble staying focused and staying on task.

“I hate the idea of giving him powerful medications. He's a sweet-tempered kid and they don’t have any discipline problems with him, but he is failing his grade. At the urging of the school, I have put him on Adderall.

“I hate it. It’s been just one week, but he’s come home moody and often times in tears. What can I do?”

Some children do well on stimulant medicines like Adderall or Ritalin. They are able to focus in school and achieve goals that would otherwise be out of their reach. But others suffer side effects such as loss of appetite, stomachaches, mood swings, insomnia, weight loss, nervousness and tics.

Parents may also be confused and concerned about whether children need an electrocardiogram (ECG) before taking such medicines. Last spring the American Heart Association suggested that might be advisable, causing many parents to wonder if the drugs could cause heart problems.

There have been cases of heart rhythm disturbances and even sudden death associated with stimulants. Nevertheless, the American Academy of Pediatrics recently declared that healthy children don’t need routine heart screening or ECGs before taking these drugs.

Medications are not the whole story on treating ADHD. According to expert Edward Hallowell, MD, author of Delivered from Distraction, medicines can be helpful but need to be supported by behavioral approaches, sound nutrition, adequate sleep and exercise.

When Dr. Hallowell spoke on our radio show, he also described the use of dietary supplements such as fish oil, grape seed extract and pine bark extract. The best approach to ADD and ADHD involves teamwork. Parents, physicians, teachers and children need to work together to meet the challenges posed by this complex condition.

How good are generic drugs? The FDA tells everyone—patients, physicians, pharmacists, hospitals and insurance companies—that generic drugs are identical to their brand name counterparts.

But the FDA has no police force. It relies mostly on the honor system to ensure the integrity of the nation’s drug supply.

Drug manufacturers, wholesalers and other drug distributors are expected to monitor the quality of their products and fill out forms honestly. Do they deserve our trust?

Over the last few years, the international market in raw ingredients has grown enormously. In many ways it resembles a wild west show without a sheriff.

The first inkling of a problem came when thousands of pets were poisoned by melamine. Chinese manufacturers added it to gluten (a pet food ingredient) to help them game the tests and increase profits.

Something similar happened to the blood thinner heparin last year. The consequences were even more tragic. People died because the Chinese suppliers of raw ingredients seemed to have added a compound to once again fool the tests and boost their income.

Chinese drug manufacturers aren’t the only ones suspected of taking short cuts. Ranbaxy is India’s largest drug company. It supplies a large number of generic drugs to the U.S. market.

Investigators have accused Ranbaxy of falsifying statements and fabricating information. U.S. prosecutors have alleged that the company forged documents regarding drug quality and covered up violations of manufacturing practices.

What did the FDA know about this and when did it know it? Lawmakers charge that the agency knew about Ranbaxy’s problems for at least 18 months but did not address them. The FDA has continued to approve generic drugs from the company during the ongoing investigation.

Now that many discount drugstores are offering generic medicines for about $1 per week, Americans are starting to ask where the raw ingredients come from. When people buy a shirt or a pair of shoes, the label tells you whether it was made in Brazil or Thailand. Even food has country-of-origin labeling. But drugs do not.

The next time you pick up a prescription, ask the pharmacist where the pills were made. Chances are that the pharmacist will not have a clue.

Readers of this column have noted some apparent differences in quality among generic drugs: “I was prescribed Toprol XL 50 mg for high blood pressure and an irregular heart rhythm (PVCs) about six years ago. It worked well to control these problems.

“At some point I was switched to a generic (small oval pills) that also seemed to work OK. Recently I got a refill, but my pharmacy had switched generic providers and now gave me some large oval pills.

“Over the next two weeks my PVCs increased and I had a number of bouts with racing heartbeat. My blood pressure was 150/100.

“I took that generic back to the pharmacy and asked for regular Toprol XL instead. Today the PVCs are gone and my blood pressure is 126/79.”

Americans should be able to trust their medicines. Until the FDA can monitor the marketplace more thoroughly, patients must be vigilant. Anyone who would like to report a generic drug problem may do so at www.peoplespharmacy.com or go to the FDA’s web site: www.FDA.gov/MedWatch.

There are few normal body functions that generate more jokes and embarrassment than gas. In fact, the F word that is the common term for this act is frequently banned from newspapers and airwaves.

 Flatulence is a fact of life. We all pass gas, whether we admit it or not. When undigested sugars reach the large intestine, billions of bacteria are waiting to feast. Their output is gas.

Some people are so troubled that they become reclusive: “I am a 44-year-old female battling a daily, uncontrollable gas problem. This is so embarrassing I have quit going to social events or anywhere quiet, like church services. I've tried watching what I eat, but it seems that everything causes trouble. Maybe I should just stop eating!”

Certain foods are notorious for causing gas. Beans, bran, broccoli, cabbage, cauliflower, onions, prunes and radishes are well known for this problem. Less recognized are apples, bagels, dried apricots or raisins. Many people cannot digest milk sugar and get into trouble with dairy products. Others have trouble with sugar substitutes like sorbitol.

Sometimes the cause is sudden and mysterious:

“I had a huge problem with gas after returning from a trip to Turkey where I caught some type of intestinal bug. After nine months of horrible gas, I finally tried your remedy of fennel, which ended the problem.

“Having gas like this can ruin a person's life. The stress and worry that accompany the problem actually changes who you are as a person. It affects friendships and sleep patterns, and gives you a feeling of loss of hope or even serious depression.

“I couldn't explain to people why I could not eat at a luncheon, or why I had to leave quickly after eating lunch with them, or why I could not attend meetings. This was too embarrassing for me.

“I could not talk about it with other people as I might have with another health problem. When I tried, all I heard from my doctor, my best friend and my daughter was that gas is ‘normal.’ I felt toward the end that no one understood how bad the gas was. Thank you so much for writing about fennel!”

Anyone who would like to know more about how to use fennel seeds and many other natural approaches to alleviate gas will be interested in our chapter on Gas in Best Choices From The People’s Pharmacy. It is available in libraries and at bookstores or online (www.peoplespharmacy.com).

Besides fennel, other spices that have traditionally been used to combat gas include asafetida, ginger, turmeric and caraway. One reader reported: “I have had a chronic problem with flatulence and had given up hope that I would ever find anything to help. I’ve lived on a very simple diet for many years, making my own sourdough bread with white organic flour because my body can’t handle whole grains.

“In an experiment, I put some caraway seeds into my bread before I baked it. Lo and behold, the flatulence disappeared. It hasn’t troubled me for two years now, and my acne rosacea has also cleared up. What relief!”

Other strategies include sipping a dash of bitters in club soda or donning a pair of carbonized undies. Activated charcoal is used in gas masks and also works well to trap odors as they emerge.

How effective is your medicine? If you are like most of us, you have no idea. What’s worse, neither does your doctor.

FDA approval is a little misleading. Although the law requires that all medicines be proven “safe and effective,” no one has really defined effective.

The agency demands that the drug under review perform a specified task--lower blood pressure or cholesterol, for example—better than a sugar pill. That doesn’t tell you whether the medicine does anything more meaningful, such as prevent a heart attack or help you live longer.

When people buy a new car, they expect it to work every time they turn it on. If it doesn’t get them to their destination without a breakdown, they will be back at the dealer the next day demanding it be repaired under warranty.

Drugs, on the other hand, do not come with warranties. If people applied the same criteria to their medicine as they did to other consumer products, they would be surprised at how poorly drugs performed.

Treatments for nail fungus are pricey. A prescription nail lacquer called Penlac costs almost $200 per bottle. It must be applied every day for almost a year. One pharmacist estimated that this could take as many as six bottles, for a price tag of over $1,000. Insurance companies don’t always cover the cost.

For this investment, you would anticipate extraordinary success. A TV which cost that much should work every time for years.

Penlac, on the other hand, provides a complete cure of nail fungus from 5 to 8.5 percent of the time. According to the company’s own data, only 10 people out of 119 achieved a complete cure of their nail fungus using Penlac daily for 48 weeks.

Compared to nail fungus, hypertension, diabetes and heart disease seem a lot more serious. Patients are told that taking their medicine is critical to preventing bad consequences such as heart attacks, strokes and early death.

People with high cholesterol read that Lipitor lowers the risk of a heart attack by 36 percent. But according to the company: “That means in a large clinical study, 3 percent of patients taking a sugar pill or placebo had a heart attack compared to 2 percent of patients taking Lipitor.”

In other words, if 100 people took Lipitor and another 100 people took an inactive placebo, there would be one less heart attack among those on Lipitor after about three years. If you had to pay $120 a month for three years, you might want a better than 1 in 100 chance the drug would really protect you from a heart attack.
Earlier this year, a large study to find out how well diabetes drugs prevent the complications of the disease was stopped because patients were not benefiting. The drugs were lowering blood sugar just as they were supposed to, but patients under the most intensive treatment were more likely to die. Doctors had expected that these patients would be more likely to survive.

People with heart disease and diabetes need to take their medicine, of course. But shouldn’t we all know more about the effectiveness of our medicines? For a fascinating analysis of this controversial issue, we recommend a new book by Nortin Hadler, MD: Worried Sick: A Prescription For Health in an Overtreated America (UNC Press).
 

Who would imagine that guacamole, cranberries or mango could interact with a medicine to cause a potentially life-threatening interaction? All these foods may alter the action of Coumadin (warfarin), an anticoagulant used to prevent blood clots.

Food and drug interactions are frequently overlooked when medication is prescribed. As a result, patients may not realize when their eating habits put them in harm’s way.

Coumadin is actually an exception. Most prescribers are aware of potential interactions between this blood-thinner and the vitamin K contained in green leafy vegetables. Excess vitamin K can reverse the effect of Coumadin and lead to dangerous blood clots.

The resulting advice may be overly restrictive, however. Some patients become frustrated wondering how to get their vitamins because they have been told to swear off all salads, vegetables and multi-vitamins containing vitamin K. They should be counseled that getting the same amount of vitamin K each day (as they would from a multivitamin) allows the dose to be adjusted appropriately.

Very few people taking warfarin are warned that avocados, green tea or menthol cough drops could also have a negative impact on their anticoagulant. Dietary supplements may pose a risk as well. St. John’s wort, Co-enzyme Q10 and ginseng may interact in the same way.

Cranberry juice, mango, garlic, fish oil and turmeric (in curry or curcumin pills) may increase the blood thinning activity of warfarin.

Many other drugs and dietary supplements can be affected by food or drink. Tea (hot or iced) can reduce the absorption of iron from pills or non-meat foods such as spinach. Fiber in bran can diminish the absorption of a powerful heart medicine called Lanoxin (digoxin) and statin-type cholesterol-lowering medicines such as Lipitor (atorvastatin) and Zocor (simvastatin). High fiber foods such as bran muffins can also make certain antidepressants less effective.

Peppermint is a popular ingredient in candy, chewing gum, cough drops and herbal tea. It is used in dietary supplements for treating irritable bowel syndrome. Research shows that peppermint may affect enzymes in the body that that help process many medicines. Blood pressure pills like Plendil (felodipine) may produce more side effects because of higher blood levels. Statins may also be affected by peppermint.

Grapefruit has a similar but stronger impact. It can raise blood levels of a range of medications including Lipitor, Mevacor and Zocor as well as BuSpar, Estrace, Plendil, Sonata, Tegretol and Viagra.

Such interactions can be confusing. Anyone who would like to know more may want to consult our book, Dangerous Drug Interactions and our Guides to Coumadin, Food and Grapefruit Interactions.

Drugs can interact with other medicines as well as with foods, beverages or dietary supplements. Bad combinations cause thousands of deaths each year. The best protection is information and vigilance. Your health professional may not warn about every possible danger, so you need to protect yourself.

Sunscreens have changed the way Americans play. There was a time when tennis players, golfers, swimmers and just about anyone else who needed to be outside was at the mercy of the sun’s rays.

People frequently got bad sunburns or, if they were being prudent, built up a tan gradually in the early summer. Even then, cautious people wore hats and long sleeves if they had to be outside in the middle of the day.

Nowadays you could sunbathe in the nude for 8 hours and not turn pink, provided you slathered on the sunscreen every few hours. Most products block the UVB radiation that causes sunburn.

The very effectiveness of modern sunscreens, which allow people to spend so much time outdoors, has put them at greater risk of exposure to UVA radiation. These rays are less likely to burn the skin, but they can cause long-lasting damage leading to premature aging and skin cancer. Few sunscreens block UVA rays effectively.

Perhaps even more disturbing are reports about toxic ingredients in commonly used sunscreens. Oxybenzone, also known as benzophenone-3 (BP-3), is found in hundreds of sunscreens, moisturizers, lip balms, conditioners and anti-wrinkle creams.

Animal studies have suggested that oxybenzone may affect the liver and kidneys. More alarming, though, are reports that this chemical may be a hormone disruptor.

There is growing concern that environmental exposure to estrogen-mimicking compounds could alter nervous system development in fetuses, babies or young children. Compounds such as bisphenol A, found in clear, hard plastics, are suspected hormone disruptors. Animal research suggests that prostate or breast tissue exposed at a vulnerable time might be at increased risk of cancer later in life.

If BP-3 acts in a similar way, parents might want to think twice before slathering this sunscreen ingredient on their babies’ skin. The compound is absorbed through the skin. New research reveals that 97 percent of Americans studied between 2003 and 2004 had BP-3 in their bodies (Environmental Health Perspectives, July, 2008).

So what’s a parent to do? According to the Environmental Working Group, an independent non-profit collaboration of scientists, people should avoid sunscreens with BP-3 and seek sunscreens that contain the minerals titanium dioxide and zinc oxide.

These compounds are not absorbed through the skin and do not have any hormonal activity. Instead they provide mechanical protection from both UVA and UVB radiation.

For more information about our favorite sunscreens, sunless tanning products and medicines that may make the skin more sensitive to a sunburn we offer our new Guide to Skin Care and Treatment.

It is sad that after almost 30 years of discussion, the FDA has still not established safety standards for sunscreens. Europeans have access to a wider range of effective products to block both UVA and UVB radiation. Don’t Americans deserve the same?

Antihistamines like Benadryl (diphenhydramine) often make people drowsy. No surprise.

Antibiotics frequently cause diarrhea and digestive upset because they wipe out helpful intestinal bacteria along with the infection.

Doctors often warn patients about such predictable side effects. But other side effects may slip past the experts because they are unexpected.

Antidepressants such Prozac, Paxil or Zoloft belong in a class called SSRIs (selective serotonin reuptake inhibitors). Hardly anyone is surprised if such a medication causes anxiety or insomnia. Psychological side effects seem consistent with a drug that affects the brain.

New research suggests, though, that these SSRI antidepressants also increase the risk for bleeding ulcers (Archives of General Psychiatry, July, 2008). These drugs have been on the market for two decades, but only in the last several years have researchers recognized a link between upper GI bleeding and these antidepressants.

Part of the delay is because our medical system is fragmented. Psychiatrists prescribe antidepressants but they rarely see people with serious digestive distress. Gastroenterologists see people with bad bellyaches, but may not associate a hemorrhage in the stomach with an antidepressant.

When the right hand doesn’t know what the left hand is doing, patients can suffer. Uncoordinated care can lead to complications from many medications.

Take antibiotics, for example. Doctors often prescribe drugs like Cipro or Levaquin for sinus or urinary tract infections. One side effect of these medications that may come as a surprise is tendon rupture.

One reader shared this story: “I took Levaquin to treat a lung infection. After five days I noticed tightness in my left Achilles’ tendon that hampered my ability to walk. Three days later my left ankle was so swollen I could hardly hobble. An MRI showed a completely severed Achilles’ tendon. I needed surgery and then spent six weeks in a wheelchair.”

Who would guess that a snapped Achilles’ tendon could be the consequence of treating bronchitis with an antibiotic?

Hundreds of drugs have unexpected side effects. The popular class of reflux medications that includes Aciphex, Nexium, Prilosec and Protonix has been linked to hip fractures (JAMA, Dec. 27, 2006). Because these heartburn drugs are so effective at suppressing acid, they may interfere with the absorption of certain nutrients such as calcium. Theoretically this could contribute to weakened bones.

The doctors who deal with patients’ heartburn symptoms usually aren’t consulted if a patient breaks a hip. The orthopedic surgeons who fix broken hips may not link such fractures to medication taken for reflux.
It can take a long time for the FDA to warn the public about unexpected drug side effects, such as tendon rupture with Cipro-type antibiotics. Even though epilepsy medicines have been on the market for many decades, it is only now that the FDA is considering a black box warning about the potential for these drugs to cause suicidal behavior.

To help the FDA discover unanticipated reactions to prescription medications, such side effects should be reported to MedWatch (www.fda.gov/medwatch).

When automobiles first started showing up on America’s streets, a lot of people were skeptical. Cars were noisy and unreliable and many people thought they were just a passing fancy.

Within a few decades, though, cars ruled the roads. Those with horse-drawn buggies were left in the dust.
Computers and email have now become standard means of transmitting information. Compared to handwritten notes, email is quicker, convenient and far more legible. Business relies on email and the Web for efficient communication.

But one sector is lagging far behind. Next time you visit your doctor, chances are very good that you will get a slip of paper hand written in Latin code. It is estimated that fewer than six percent of community physicians prescribe electronically.

In a lot of doctors’ offices, a nurse or receptionist will call in a prescription over the phone. The most high-tech method for transmitting prescription information to the pharmacy is likely to be a fax machine.
These old technologies have not yet reached the status of buggy whips, but they should. They contribute to the millions of prescription errors that occur each year.

A prescription that is called in over the telephone makes it way too easy to confuse sound-alike drug names. A drug for attention deficit disorder, Adderall, might be mixed up with Inderal, a beta blocker for heart and high blood pressure problems. There are hundreds of such combinations, such as the antidepressant Celexa and the schizophrenia medicine Zyprexa.

Look-alike names (Lamisil vs. Lamictal) are also a problem for hand written prescriptions whether they are carried in person or sent by fax. In fact, the fax machine is likely to distort a hard-to-read scrawl and make it illegible.

Medical school professors have admonished their students to do away with Latin abbreviations and codes for decades. But many prescriptions still contain inscrutable instructions such as ac (ante cibum) that means “before meals,” hs (hora somni) that stands for “at bedtime” and qid (quater in die) for “four times a day.” This kind of gibberish doesn’t foster good communication with patients and lends itself to medication mistakes.

Electronic prescribing is not perfect, but it does eliminate the problem of poor handwriting and misunderstood abbreviations. E-prescriptions can be transmitted directly from a doctor’s computer or handheld wireless device to the pharmacy, using secure encrypting technology rather than ordinary email.
When this is done, the pharmacy saves on labor because the e-prescription does not have to be collected and transcribed like a fax. What’s more, e-prescribing usually offers doctors advice on the most commonly approved dosages and the types of serious drug interactions that might occur.

If the doctor has access to the patient’s record electronically, she can check for allergies and drug incompatibilities. This can protect the patient from suffering avoidable complications.

As much as physicians like tradition, the prescription pad is rapidly going the way of the buggy whip. Medical students who have grown up with computers and wireless communication should be far more comfortable with e-prescribing than their mentors.

Blood pressure measurement is one of the most fundamental tests any health professional performs. No physical exam would be complete without it.

Despite its importance, blood pressure measurement is frequently done incorrectly. That’s the consensus of experts at a scientific meeting of the American Society of Hypertension (JAMA, June 25, 2008).

The procedure may seem simple, but in reality it is more complex than most people (including physicians and nurses) realize. In one of the studies presented at the meeting, it was revealed that only about a quarter of specialized doctors and nurses took blood pressure readings properly.

The American Heart Association has published guidelines on how to measure blood pressure accurately, but only 8 percent of the health care providers participating in another study had read them. Here’s a checklist for proper blood pressure measurement:

- Are you seated in a chair with back support so that your feet can rest on the floor?

- Are you allowed to sit quietly for five minutes before your blood pressure is measured?

- Is your arm resting on a table so that the cuff is the same height as your heart?

- Is the cuff the right size for your arm? Big arms need larger cuffs.

- Is the health care provider silent while taking your blood pressure? Engaging in conversation may be a friendly gesture, but talking can raise a person’s blood pressure significantly.

If any of these guidelines are not followed, there is a good chance that the resulting blood pressure measurement will not be accurate. Clearly, this approach takes more time and care than the usual routine. Health care providers are not compensated for the extra time involved, despite the likelihood of error when they are rushed.

Since everyone assumes that blood pressure measurement is easy and does not require special training, the accuracy of results is rarely verified. The consequences of errors can be serious.

When the blood pressure reading is falsely low, patients and physicians may be lulled into an unwarranted sense of security. Needed treatment may not be given.

If the reading produced is higher than the patient’s actual blood pressure, he may be subjected to unnecessary medication that can have side effects as well as financial costs. In fact, according to hypertension expert Clarence E. Grim, MD, an extra 5 mm of mercury in diastolic reading between 85 and 90 would expose about 27 million Americans to a false diagnosis of hypertension and to the risks of medication.

We address proper blood pressure measurement, white coat hypertension and non-drug approaches to lower blood pressure in our new Guide to Blood Pressure Treatment.

Home measurement of blood pressure is one way to monitor progress. Only about one third of people with hypertension control their blood pressure adequately, even though this is a critical step to help prevent heart attacks and strokes.
When Tim Russert died unexpectedly of a heart attack, millions of Americans mourned his passing and wondered what he had been doing wrong. The answer is nothing.

Unlike most people, Tim Russert got superb medical care. Although he suffered from high blood pressure and elevated cholesterol, he was controlling them with blood pressure pills and a statin-type cholesterol-lowering medication.

Tim Russert also exercised vigorously almost every day. He passed a recent treadmill stress test designed to evaluate heart health.

According to the autopsy report, the rupture of plaque in one of Mr. Russert’s coronary arteries led to ventricular fibrilliation, an abnormal heart rhythm that resulted in sudden cardiac arrest. Such a heart attack is often so quickly fatal that even emergency care is not fast enough.

The American Heart Association says that roughly 300,000 other Americans will also die suddenly this year because of cardiac arrest.

Most people think that a heart attack evolves slowly with chest pain as the prime symptom. Mr. Russert experienced no such early warning.

Something very similar happened to James Fixx on July 20th, 1984. He died of a sudden massive heart attack at age 52 while running in Vermont. He had no symptoms, though he regularly ran 10 miles daily.

Mr. Fixx was the poster child for changing lifestyle and becoming more active. When he started running at age 35, he was grossly overweight and a heavy smoker. But his intense exercise program enabled him to lose 60 pounds and keep them off. He gave up smoking and became an apostle for jogging. His book, The Complete Book of Running, sold over a million copies. He was a vegetarian and advocated a low-fat diet.

People were as shocked with Jim Fixx’s death in the 1980s as they are today with Tim Russert’s tragic demise. The lesson is that there are no guarantees.

It still makes sense to quit smoking, lose weight and control familiar risk factors like high blood pressure and cholesterol. These are easy to measure and many can be treated with medications.

But there are nearly 250 other potential contributors to heart disease. One that is frequently overlooked is stress. It is very difficult to assess or treat stress, but it may be equally as important as cholesterol in determining heart health.

While covering the never-ending primary campaign, it is likely that Mr. Russert was under constant deadline pressure and that he was getting too little sleep. Certainly, he had a very high-stress job.

Another important risk factor is low HDL, or good cholesterol. This seems to have been a problem for Mr. Russert. Unfortunately, it is hard to raise HDL, although exercise can help somewhat.

We discuss those elusive risk factors, including triglycerides, Lp(a) and CRP (a marker of inflammation), along with natural ways to control cholesterol in our book, Best Choices From The People’s Pharmacy. It is available in libraries, bookstores and online at www.peoplespharmacy.com.

Jim Fixx and Tim Russert were both working hard to avoid heart attacks. Their tragic deaths remind us that there is still a lot to learn about keeping hearts healthy.
Maybe doctors could take a lesson from Goldilocks. In this nursery tale, Goldilocks didn’t like porridge that was too hot or too cold. She wanted it “just right.”

People usually relate to this fable because moderation seems to make sense. But many physicians believe in driving lab values down as much as possible, no matter what. A cardiologist friend likes to proclaim that no one can have too low a golf score or cholesterol level.

Diabetes doctors were disappointed recently when three studies showed that aggressive blood sugar control did not protect people with diabetes from heart attacks and other cardiovascular complications. In fact, one well-designed study (ACCORD) showed more heart attacks and deaths among patients who kept their blood sugar near normal (New England Journal of Medicine, June 12, 2008).

Such results defy conventional wisdom. Diabetologists expected that “tight” control of blood sugar would improve survival. The idea that it might lead to the very complications treatment is supposed to prevent is hard to accept.

And yet some previous studies have produced similar results. In 1970 the results of the University Group Diabetes Program shocked physicians. This study was the most ambitious diabetes trial at the time, but patients who received the oral diabetes medication tolbutamide (Orinase) had a higher rate of cardiovascular death than patients on placebo or insulin.

Soon after that, British researchers recruited thousands of diabetic subjects to a ten-year study. Those who received “intensive” drug therapy to lower blood sugar did not have fewer heart attacks, strokes or deaths (Lancet, Sept. 12, 1998).

When doctors treat numbers instead of patients, they may overlook complications of the therapy. In the ACCORD trial, many of the subjects treated aggressively gained weight, some as much as 20 pounds. Others experienced symptoms associated with lowering blood sugar too much (hypoglycemia). These can include dizziness, weakness, anxiety, sweating, shakiness, palpitations and confusion. Severe hypoglycemia can be life threatening.

Where does this new research leave patients with type 2 diabetes and their physicians? If this disease is left untreated, it increases the risk for many serious health problems including kidney disease, blindness, nerve damage, heart attacks and strokes. Clearly, doing nothing is unacceptable.

But aggressive treatment may have the unexpected outcome of causing some of the very cardiovascular complications it is intended to prevent, which leads us back to the story of Goldilocks. Getting the porridge just right takes some effort.

Keeping blood sugar neither too high nor too low requires careful management. The role of exercise, diet, blood pressure and cholesterol control must not be overlooked.

There is more information about diabetes treatment in an hour-long interview we conducted with one of the country’s leading experts, John Buse, MD, PhD. For a CD of this radio show, please send $16 in check or money order to Graedons' People's Pharmacy, No. CD-646, P. O. Box 52027, Durham, NC 27717-2027. An extended audio interview with Dr. Buse is available for free at www.peoplespharmacy.com.

Imagine a wonder drug that could reduce your risk of developing arthritis, high blood pressure, many common cancers, diabetes, depression and heart disease. What would it be worth?

If drug companies could patent such a miracle medicine they might well charge $5 a pill. But you can get these benefits for free.

Vitamin D does all this and probably much more. Your body makes it when skin is exposed to sunshine.
In just the last several weeks there have been reports in major medical journals about the varied benefits of vitamin D. Researchers have found that serious health consequences are more likely when people have low levels of vitamin D in their bodies.

Harvard scientists examined their data from 18, 225 men in the Health Professionals Follow-up Study. They found that those considered deficient in vitamin D, at or below 15 nanograms/milliliter, were twice as likely to suffer a heart attack as those who had adequate blood levels of 30 ng/ml or higher (Archives of Internal Medicine, June 9, 2008).

Scientists have found that higher blood levels of vitamin D are associated with reduced rates of type 1 diabetes. This metabolic disease, also known as early onset or juvenile diabetes, occurs when the immune system attacks insulin-producing cells in the pancreas (Diabetologia, online, June 5, 2008).

In addition, people with type 2 diabetes are more susceptible to a painful complication called peripheral neuropathy when they are low in vitamin D. Australian researchers have found that the condition improves by about 40 percent when low vitamin D levels are corrected (Archives of Internal Medicine, April 14, 2008).

Another painful condition associated with inadequate vitamin D is peripheral artery disease, which makes walking difficult and increases the risk of heart attacks and strokes (Arteriosclerosis, Thrombosis and Vascular Biology, April, 2008).

Scientists reported at this year’s meetings of the American Society of Clinical Oncology that women who are deficient in vitamin D at the time of diagnosis with breast cancer are more likely to die than women with adequate levels. This is not the first time that lower vitamin D levels have been linked to cancer. Prostate, breast, colon, lung and ovarian cancers are less common in people who get regular sun exposure.

Increasingly, however, investigators find that Americans are not getting very much sun. In one study of seniors, over half the women and 40 percent of the men had low levels of vitamin D (Archives of General Psychiatry, May, 2008). At the other end of the age spectrum, 12 percent of apparently healthy babies and toddlers in Boston were deficient in vitamin D, and 40 percent had less than optimal blood levels (Archives of Pediatric and Adolescent Medicine, June, 2008).

Anyone who would like to know more about the best levels to achieve the health benefits of vitamin D may be interested in a one-hour radio interview with experts Drs. James Dowd and Michael Holick.

“Are you experiencing crushing chest pain with shortness of breath? Are you sweating profusely? You could be having a heart attack! Ask your doctor whether Zycrox is right for you.”

Would an ad like that sound preposterous? We have to admit that Zycrox is a figment of our imaginations. But the idea of advertising a medication for a serious condition like a heart attack is not so farfetched.

Plavix is advertised to consumers even though this heavy-duty drug is prescribed to prevent life-threatening blood clots that could cause a heart attack or a stroke. Sales have soared since people started watching Plavix commercials on TV.

TV commercials have touted everything from drug-coated stents for clogged coronary arteries to potent anemia drugs like Procrit for cancer patients on chemotherapy. Before prescription drug advertising came to dominate prime time television, TV drug ads featured over-the-counter products. If you asked a physician from that era whether he could imagine a patient asking for a prescription drug seen on a TV commercial, he would have laughed in your face.

Doctors spend years in medical school learning about the benefits and risks of medications and devices such as drug-coated stents. The notion that a patient could request a powerful prescription medicine based on a 30-second TV spot would have seemed ludicrous. Today, of course, it is commonplace. You can’t watch the evening news without seeing several prescription drug ads.

Most people tell us they hate TV drug ads. They especially hate ads for prescription drugs to treat erectile dysfunction or overactive bladder. But they also dislike commercials for drugs that lower cholesterol, control blood sugar or ease arthritis pain. Many ask us why the FDA permits such ads at all, even though few realize that only one other industrialized country allows direct-to-consumer prescription drug advertising.

FDA’s authority to regulate drug ads goes back to a 1962 act of Congress. Drug advertising must not be false and misleading, and it must offer a “fair balance” of benefit and risk information.

Until the 1980s, drug companies assumed they couldn’t use television to advertise prescription drugs: 30-second ads are too short to allow the listing of all the possible negative effects of a drug. Then the FDA decided that broadcast ads could cover only the “major risk information.” In practice TV ads cover many fewer side effects than print ads (New England Journal of Medicine, May 22, 2008).

The pharmaceutical industry likes to frame prescription drug ads as educating the consumer, but in fact they generate big bucks. Ten of the top 12 brand-name drugs advertised to consumers rake in more than $1 billion a year.

The industry’s other argument is that commercials are protected as free speech. We wonder if that is what John Adams, Thomas Jefferson, James Madison and the other founding fathers had in mind.

The only way consumers could have an effect on such television commercials would be to contact their Congressional representatives. A Congressional hearing in May investigated misleading ads about prescription drugs. Unless Congress changes the law, the FDA has no power to make the industry change its ways.
Doctors don’t like the word addiction. It has overtones of moral weakness when applied to drugs like alcohol, nicotine, cocaine or heroin.

Physicians prefer the term dependence because it describes withdrawal symptoms rather than depravity. Problems with withdrawal don’t only occur with drugs of abuse. Many prescription medications can cause unpleasant symptoms if they are stopped suddenly.

Doctors sometimes fail to warn patients ahead of time that a medicine may be difficult to discontinue. One reader shared an experience with an antidepressant: “I have just been through detox hell from stopping Cymbalta. After a week of dizziness, nausea, diarrhea, sweats, chills, itching, disorientation, mood swings and headaches, I am angry! My doctor did not tell me about this.

“I had been on Zoloft and Cymbalta for about a year. I stopped the Zoloft with no problems and then was weaned off Cymbalta by gradually dropping the dosage until stopping completely. I expected some emotional consequences, but did not expect to be a prisoner in my own home for over a week, unable to function in any way. If I had not had the Internet to confirm my suspicions that the symptoms were Cymbalta-related, I would have assumed I was dying of some strange flu!

“My point is not to rant and rave about the horrible time I had withdrawing from Cymbalta, but to question why? Why wasn't I warned? Why couldn't I have been told up front, before starting the drug, that the possibility of severe withdrawal existed? Why wasn't I given suggestions to ease the withdrawal symptoms?

“I know that I am not the only one who has been blind-sided by this drug. Are doctors not allowed to tell?

“It must truly be up to the consumer to read every line of the insert to determine the safety of a medicine. I don't even know if the insert included possible withdrawal effects, as I am still too dizzy to read the small print!”

Other antidepressants like Lexapro, Paxil and Effexor can also cause distressing symptoms upon discontinuation. Another reader related this experience with Effexor: “I tapered off the medicine as told, but even months later I still have feelings like electrical shocks going through the brain. I finally got relief from the other symptoms, but getting off this drug has been a nightmare. If a person had to stop suddenly, he would probably go crazy with the withdrawal. Once I forgot to take my medicine with me on a short trip and the withdrawal symptoms were excruciating.”

Doctors are alert to problems of withdrawal from narcotic pain medicines or benzodiazepine anti-anxiety drugs like Xanax. They are adjusting to the idea that some antidepressants can be difficult to stop.

Even heartburn medicine like Aciphex, Nexium or Prilosec may pose problems. Some people experience rebound hyperacidity when they stop such medications. One patient reported “within a week of stopping Protonix I had to start taking it again due to severe heartburn. I asked my pharmacist how to discontinue use, but she couldn’t find out.”

Before starting any drug, ask when and how you should stop it. Getting off some medications can be far more difficult than you imagine.
For decades Americans have embraced plastic. Its popularity is reflected in this famous dialog from the 1967 movie, “The Graduate:”

“Mr. McGuire: I just want to say one word to you--just one word.

“Ben: Yes sir.

“Mr. McGuire: Are you listening?

“Ben: Yes I am.

“Mr. McGuire: ‘Plastics.’

“Ben: Exactly how do you mean?

“Mr. McGuire: There’s a great future in plastics. Think about it. Will you think about it?

“Ben: Yes I will.”

Dustin Hoffman’s character had other things on his mind beside plastics, but Mr. McGuire correctly predicted the future. Plastic containers are now used for just about everything in the supermarket, including water, milk, juice, ketchup, mustard, vinegar, soy sauce and most other products. It’s hard to find liquids that are not in plastic.

Despite its widespread utility, our love affair with plastic may be winding down. A recent report from the National Toxicology Program acknowledged that bisphenol A (BPA), an important component in many clear hard plastics, may pose health hazards.

The comprehensive review of research triggered concern that exposure to BPA might result in “neural and behavioral” effects on the rapidly developing nervous systems of babies, young children and fetuses.

Changes in prostate and breast tissue among young animals exposed to BPA, which can mimic estrogen, raises the possibility that human exposure at vulnerable ages might increase the risk of breast or prostate cancer.

After this report came out, the Canadian government announced that it would likely ban baby bottles containing BPA. In this country, consumer concern has prompted manufacturers to take it out of certain products such as Nalgene water bottles and Playtex baby bottles.

BPA is also used in the plastic coating found in many cans that hold food or beverages. Soft drinks, beer and baby formula may contain BPA that has leached out of the lining.

The plastics industry maintains that BPA levels are too low to pose a hazard. The FDA has sided with the industry but reportedly may review the data.

Consumers who would like to avoid bisphenol A should look for containers that are not polycarbonate plastic or that are labeled BPA free. Experts we have consulted tell us to avoid using any plastic containers in the microwave.

Anyone who would like to learn more about the potential hazards of plastics and how to identify and avoid BPA might wish to listen to a radio interview we did with some of the country’s leading experts on sex-hormone disruption.

BPA may not be the only problem with plastic. A whole class of chemicals called phthalates may also have estrogenic activity. Unlike BPA, which is frequently found in hard clear plastic, phthalates help make plastic flexible. This class of chemicals can be found in teethers, toys, cosmetics and many plastic containers.

Plastics are useful. But perhaps in the future we need to be more cautious about how we use them.
Doctors love Lipitor. Last year this cholesterol-lowering drug was the single most prescribed brand-name medicine in the country. Over 50 million prescriptions were filled.

Doctors also loved Vytorin. Almost 20 million prescriptions were dispensed for this cholesterol drug. When you add these medications to other statin-type medicines like simvastatin, lovastatin, pravastatin, Crestor and Lescol the total number of bottles purchased exceeded 150 million.

Many physicians see statins as a magic bullet for high cholesterol. Even if patients cheat and eat burgers or steak, their cholesterol levels often stay under control.

Unfortunately, these highly effective medications have some serious drawbacks. They can cause severe muscle pain and weakness. These are recognized complications of statins, but too often physicians fail to mention these side effects.

The Web site www.iGuard.org recently surveyed its members. Approximately 40 percent of the 100 participants questioned reported experiencing muscle pain and weakness. Fewer than half had been warned of this side effect by their physicians.

It can be very frustrating for patients when doctors don’t take their symptoms seriously. One reader reported: “I was diagnosed with high cholesterol and put on Crestor. At the follow-up I was put on an arthritis drug to help with the sudden joint pain. I told the doctor I felt like I was 80. I was really in my late 30's, very active and healthy--biking, hiking and walking.

“Before the Crestor prescription ran out, I was miserable with severe muscle pain in my joints, legs, arms and a severe hip pain that required shots. I couldn't get my prescription filled right away after it expired, and while I waited I started to feel better with each passing day. I called the doctor and left a message but I never heard back from him. Two weeks later when I called for my medical records so I could go somewhere else, the office was shocked that I didn't want to return to their care.

“Eventually I went to another physician. I explained I wanted no statins because my last experience was so bad. He convinced me to take Vytorin. I used it and didn't even see the train coming. My vision got bad, my memory was shot, and I couldn't speak without being laughed at because I sounded like a mental case.

“When my Vytorin prescription expired I forgot to refill it in time and the doctor screwed up the refill to the pharmacy. I started to feel better not taking it. I read up about the side effects of Vytorin and was not surprised to learn that my body is still intolerant of statin drugs, no matter what the name.”

Vytorin contains simvastatin. Like other statin drugs, it can cause muscle problems. People who cannot tolerate such drugs need different alternatives. We offer a variety of non-drug approaches as well as medicines other than statins to help control cholesterol and improve heart health in our book, Best Choices From The People’s Pharmacy. It is available from libraries and bookstores or online at this website.

People who would like personalized information about the specific risks, benefits and interactions of their drugs will find it at www.iGuard.org.

 
Patients should not have to choose between bladder control and brain function, but some medications prescribed for overactive bladder can have a negative impact on memory and concentration.

In a recent study, researchers followed more than 800 older Catholic nuns, priests and brothers for eight years, testing mental function annually. Those who were taking medications called anticholinergics (drugs for overactive bladder, Parkinson’s disease, stomach cramps, motion sickness and ulcers) had greater declines in test scores.

This finding should not come as a great surprise to doctors. The neurochemical acetylcholine is essential for nervous system function. Anticholinergic drugs interfere with its ability to bind to nerve cells.

Loss of bladder control is extremely distressing to older people and their families. That’s why doctors prescribe drugs like Detrol (tolterodine) or Ditropan (oxybutynin). They don’t always warn people, however, about side effects such as disorientation, drowsiness, insomnia, agitation or hallucinations.

One reader described her mother’s situation: “My mother was recently prescribed Detrol. She has become increasingly disoriented and has a lot of trouble sleeping. It’s really heartbreaking to see her go this way in bits and pieces.

“She has no appetite or energy but they keep piling on more and more medication. Her kidney doctor said that the Detrol had no side effects, but a regular doctor said it could cause disorientation. Her quality of life (and ours) is suffering. She is becoming less and less able to take care of herself.”

A study at Wake Forest University School of Medicine found that older people taking such anticholinergic medicines slow down physically as well as mentally. They walk slower and are less able to care for themselves.

Drugs for overactive bladder are not the only problem. A surprising number of medications can interfere with the action of acetylcholine, leading to negative effects for both physical and mental wellbeing.

In addition to medications for bladder control, many old-fashioned antidepressants such as amitriptyline (Elavil) also have anticholinergic activity. These drugs are not prescribed as much for depression these days, but they are increasingly used to treat debilitating nerve pain.

More surprisingly, the antihistamine diphenhydramine (Benadryl) also has significant anticholinergic action. Because this drug causes drowsiness, it is frequently found in over-the-counter sleep medications such as Nytol, Simply Sleep, Sominex and Unisom SleepGels. It is also a key ingredient in popular nighttime pain relievers such as Advil PM, Alka-Seltzer PM, Excedrin PM or Tylenol PM.

Many other medications also have some anticholinergic activity. The list is too long to reproduce here, but some of the medicines include scopolamine (Transderm Scop) for motion sickness, prednisone for inflammation, nifedipine (Adalat, Procardia) for blood pressure control and phenobarbital for sedation.

No one should stop such medications without consulting a physician, but older people experiencing symptoms of disorientation or memory loss should have their medications evaluated. A family member may need to request this if the patient is unable to do so.
There’s an epidemic of thyroid disease in the U.S. and no one seems to know quite why. It has been quietly growing for years.

Just check the number of prescriptions filled for thyroid medicine and you’ll realize that there is something strange going on. Synthroid is the fifth most prescribed drug in America, with 25 million bottles dispensed last year. When you add in generic levothyroxine plus products like Armour Thyroid, Levothroid and Levoxyl, the total comes to nearly 90 million.

That doesn’t even count the millions of people with undiagnosed thyroid problems. Some experts estimate that as many as one out of five women over 60 are suffering from “subclinical hypothyroidism” (American Family Physician, Oct. 2005).

That makes thyroid disorders among the most common conditions affecting Americans. What accounts for this epidemic?

The experts don’t have good answers, but house dust is one possible culprit. The dust itself is not the problem. But chemicals carried on dust may be partly to blame.

Dustborne compounds called PBDEs (polybrominated diphenyl ethers) have been used for years as fire retardants. They can be found in mattresses, carpets, couches, computers, TVs and cell phones.

Although it seemed like a good idea to protect flammable furniture like couches and mattresses, scientists didn’t anticipate that fire-retardant chemicals would end up in us. But Americans have levels of PBDEs in their bodies that are 7 to 35 times higher than those in Europeans (Environmental Health Perspectives [EHP], May, 2008).

Most European countries banned some PBDEs years ago. Americans, however, are still being exposed. When these chemicals get trapped in house dust, they can be easily transferred to skin and lungs.

Cats may be serving as the canaries in the coal mine. Veterinarians began noticing an epidemic of feline hyperthyroidism in the 1980s. This corresponds to the introduction of PBDEs. When cats groom themselves, they are exposed to chemicals in house dust. Recent research confirms that the hyperthyroid cats have high levels of PBDEs circulating in their bodies (EHP, Dec. 2007).

Young children crawling on the floor or carpet are also exposed to relatively high levels of house dust and PBDEs as well. Thyroid hormone imbalances during development may affect the brain.

Adults with an underactive thyroid gland may experience symptoms such as fatigue, constipation, dry skin, lower libido, depression, brittle nails and elevated cholesterol. Worse, even mild hypothyroidism may increase the risk of fatal heart disease (Archives of Internal Medicine, April 28, 2008).

Diagnosing and treating thyroid problems can be complicated. Our Guide to Thyroid Hormones has information about interpreting tests, selecting treatments and drugs that can affect thyroid function. It can be downloaded for $2 from this Website.

Although we don’t know why so many Americans have thyroid problems, PBDEs are one suspect. Getting them out of the environment will be a major challenge.

 
The high cost of prescription medicines used to be a hot-button campaign issue. Electioneering politicians would empathize loudly with senior citizens who had to choose between buying groceries and paying for pills.

You won’t hear about prescription drug prices during the coming election season. That’s because Congress passed legislation called the Medicare Prescription Drug, Improvement, and Modernization Act. It went into effect in 2006 and defused much of the uproar about seniors not being able to afford their medications.

How well is Medicare Part D working? This prescription drug plan was supposed to ease the burden for senior citizens who take multiple medications for chronic conditions.

Many have benefited. According to research published in the Journal of the American Medical Association (April 23/30, 2008), only about 10 percent of eligible seniors now remain without any prescription drug coverage.

In the basic Part D plan, the individual pays a monthly premium. The deductible ($275 in 2008) is paid by the insured before any cost savings kick in. Then, the person pays 25 percent of his prescription bills, up to $2,510 (2008).

So far, so good. But once drug bills reach that limit, many of the insured fall into a big black donut hole. Researchers found that only 40 percent of seniors knew about this coverage gap ahead of time.

In the donut hole, people cover every last penny of their prescription drug costs out of their own pockets, unless they have purchased a plan that offers assistance. (Plans are not required to cover the gap, and charge higher premiums for doing so.) They emerge from the donut hole only after a total of $5,726.25 has been spent at the prescription counter. Usually, more than $4,000 of that comes out of the person’s own pocket.

Hitting the donut hole can come as quite a shock. We heard last fall from a woman who had been treated for breast cancer: “I have exceeded my Medicare drug coverage limit and must now pay the full amount for my Arimidex prescription.” That runs $200 to $300 per month for a medicine to keep the cancer from recurring.

People who have very high drug bills may well emerge from the other side and benefit from the catastrophic coverage that kicks in at that point. They shell out only a small co-pay, $2.25 for generic and preferred drugs or $5.60 for other drugs, with the rest of the tab picked up by the plan.

Part D was supposed to make it possible for senior citizens to afford the drugs their doctors prescribe, but one study found that the poorest and sickest Medicare beneficiaries were still skipping some medicines because they were concerned about costs.

Another study found that those who were least knowledgeable about Medicare Part D were also most likely to do without other necessities such as groceries or electricity.

Medicare Part D means that politicians will not be talking about seniors dining on dog food or bussing to Canada to smuggle in blood pressure pills because of the high cost of prescription drugs. But many Medicare citizens will be feeling the pinch by Election Day. Part D may have calmed the controversy, but it hasn’t solved all the problems, particularly for those most in need.
For years, the FDA has reassured everyone who prescribes, dispenses or pays for prescription medicine that generic drugs are absolutely equivalent to brand-name drugs. Because brand name medications are so expensive, most people embrace the opportunity to save money.

If generic fluoxetine is only $4 per month at a discount drug store while brand name Prozac costs $175 for a month’s supply at a neighborhood pharmacy, it is understandable why consumers would opt for the cheaper generic.

Insurance companies are enthusiastic about generic drugs. They encourage patients to accept generic prescriptions by lowering the co-payment for these medicines and raising it for brand names. They may even refuse to pay for certain brand-name products.

But are generic drugs truly identical to their brand-name counterparts? Patients, physicians, pharmacists, nurses, hospitals and insurance companies all depend on the FDA to ensure that generic drugs will work just like the originals.

We used to recommend generic drugs as a great way to save money. We were convinced that the FDA had a rigorous approval process.

Several years ago, however, we began getting reports from readers of this column that their generic medicines weren’t always working as expected. We heard from people who suddenly experienced seizures after being switched from the brand-name epilepsy drug Dilantin to the generic phenytoin. Others reported problems with the generic blood-thinner warfarin when it was substituted for Coumadin.

An avalanche of complaints started last year, from patients reporting problems with the generic antidepressant Budeprion XL 300. Many had had their depression well controlled while taking the brand Wellbutrin XL 300 (bupropion). On the generic formulation, however, they reported side effects such as agitation, anxiety, nausea, headache and insomnia.

Patients taking the generic frequently reported feelings of despair, hopelessness and depression. Some said they started crying for no apparent reason and others described thoughts of suicide occurring for the first time.

We forwarded many of these reports to the FDA and asked the agency to investigate. The report is now in and the FDA has announced that everything is fine with generic Budeprion XL 300 mg. Or is it?

The FDA appears to explain the return of depression on Budeprion XL 300 as a natural recurrence of depression. Oddly, relatively few people have complained about depression recurring on other generic formulations of bupropion.

We had always assumed that all generic products were tested before approval. To our surprise, the FDA revealed that it did not require tests on Budeprion XL 300. The generic manufacturer submitted data for a 150 mg formulation, not a 300 mg tablet. Based on the data, the agency approved Budeprion XL 300.

Even the 150 mg formulation differs noticeably from the brand name in the way in which it enters the blood stream. The FDA says it doesn’t think this matters. We disagree, and hundreds of readers seem to as well.

Anyone who would like to report a problem with a medication may do so at www.peoplespharmacy.com. We will pass your information along to the FDA. To report directly to the agency go to www.FDA.gov/MedWatch.

 

What may be good for the heart could be bad for the brain. Lowering cholesterol, especially bad LDL cholesterol, appears to reduce the risk of heart attacks. But new studies suggest that very low cholesterol might pose unexpected problems for the nervous system.

Researchers have analyzed data from a long-term study of Japanese American men in Honolulu. Blood samples of healthy men were measured in the early 1990s. During the next decade researchers noted who was diagnosed with Parkinson’s disease. Those with low LDL cholesterol initially were significantly more likely to develop this neurological disorder (Movement Disorders, online, March 31, 2008).

This is not the first time that low LDL cholesterol has been linked with a higher risk of Parkinson’s disease. Other neurological problems may also be associated with low cholesterol. One study uncovered a link between low cholesterol and Alzheimer’s disease (Neurology, Aug. 11, 1999).

Scientists in New Zealand have been monitoring adverse effects of cholesterol-lowering medications. They have noted that statins may be associated with depression, memory loss, confusion and aggressive behavior (Drug Safety, March, 2007). The authors point out that “Cholesterol is crucial to brain functioning.”

A new study (Neurology, March 25, 2008) links low LDL cholesterol to worsening of ALS (Lou Gehrig’s disease). In fact, the researchers conclude that, “The beneficial effect of hyperlipidemia [high cholesterol] on survival of more than 12 months is, to our knowledge, one of the most important documented.”

Probably the most controversial issue hinges on whether lowering cholesterol with statin-type medications is linked to ALS-like syndrome. The French researcher who conducted the study on LDL and ALS, Vincent Meininger, MD, PhD, was asked in a Neurology journal podcast whether there could really be a statin-related ALS connection. He responded, “I think yes.”

It is very difficult for scientists to determine whether statin-type medicines trigger or worsen ALS. Many people have reported their experiences to www.peoplespharmacy.com (analyzed in Drug Safety, Feb. 2008).
Here is one example:

“My husband took Lipitor for several years. After a knee replacement, his leg muscle deteriorated and no amount of exercise could bring it back. Then he developed swallowing problems. He had trouble breathing but at the emergency room they found nothing wrong.

“He had a lot of pain and no relief even with pain medicine. His muscles weakened so much that he could not eat food unless it was put in a blender. He went from 165 to 113 pounds, losing so much muscle that he fell many times and could only walk with a walker.

“He was an active man before all this happened and exercised every day. He had so many tests to find his problem, but it was not diagnosed as ALS until the morning of the day he died in July 2007. This is a horrible disease and a horrible way to die.”

No one knows whether there truly is a relationship between statin-type cholesterol-lowering medicine and ALS-like syndrome. The FDA is investigating this issue. Anyone who would like to report serious problems with such medications can do so at the FDA’s Web site (www.fda.gov/medwatch).

Doctors go into medicine because they want to help people. They put in extraordinarily long hours during their training that no other profession is expected to endure.

Caring and compassionate physicians are challenged these days by a medical system that is badly broken. The amount of time a doctor can spend with a patient is limited and insurance companies may restrict treatments or challenge doctors’ judgment.

It’s no wonder that many doctors dread having to answer questions from patients who have consulted Dr. Google or who bring their own ideas about a diagnosis or treatment to the visit.

Many physicians don’t like to hear about drug side effects, either. They don’t like being reminded that something they prescribed might have caused harm.

One reader shared the following doctor-patient interaction: “My husband's a type 2 diabetic. Before going on insulin, he tried some new oral medicines, but he reacted badly to them. The endocrinologist he was seeing just paid attention to his blood sugar number, at the high end of ‘acceptable,’ and didn't care that the drugs blew up his weight rapidly to where it peaked at 320 pounds.

“He'd been a bit too heavy before the drugs, but when he started the medicines, his weight began to climb, and his health began to fail. She said he was ‘just an overeater’ and if he didn't lose weight she'd drop him as a patient.

“He asked her if he could try to control his blood sugar, cholesterol and blood pressure through diet and exercise alone. She told him she didn't think he had enough self-control. Finally, he snapped.

“At his final appointment with her, she and he had a shouting match during which she called him names in a voice they heard at the reception station. ‘Fat,’ ‘whiny,’ ‘argumentative’ and ‘non-compliant.’ She didn't know him at all as a person, didn't remember him from visit to visit and barely read his file. He'd gotten to where he was precisely because he was taking the drugs she prescribed and making every effort to be compliant. He's a very intelligent and diligent man, hard-working with a lot of self-control. He is NOT a whiner.

“She ‘fired’ him as a patient and he ‘fired’ her as a doctor. Now he has a new doctor, is on a low dose of insulin, has lost all the weight he'd packed on and is exercising regularly. He has energy and good health and enjoys life again. He may be able to control his condition with diet and exercise alone in the future, with his doctor’s help.

“If we were to run into his former endocrinologist she'd no doubt still see him as a ‘problem patient’ because he dared to stand up to her to save himself.”

This is not the first time we have heard about a doctor-patient relationship that went off the tracks. Even though a physician may find a patient annoying, there is no excuse for shouting or name-calling.

Patients know that doctors have valuable education and experience to contribute. Doctors also need to acknowledge the role that patients must play in their own care. If a medication causes uncomfortable side effects, a physician should not dismiss them as unimportant.

Like all human relationships, doctors and patients do best when there is mutual respect and shared responsibility.

What should the FDA do when a drug might make someone depressed or even suicidal? The agency has wrestled with this dilemma for decades.

When reports surfaced in the 1990s that the antidepressant Prozac might trigger “intense, violent suicidal preoccupation,” the FDA responded that depressed people sometime commit suicide. Regulators resisted the notion that antidepressants could cause the very problem they were supposed to prevent.

After years of bitter wrangling, the agency revised the official labeling for popular antidepressants. It began by cautioning that children and adolescents might be at greater risk of suicide when given medications like Paxil, Prozac or Zoloft.

Later, the FDA decided that the “black box warning” for such medications should be extended to include young adults, to the age of 24. It states that patients started on antidepressant therapy should be observed closely in case their condition worsens, their behavior becomes weird or they start to be preoccupied with suicide. Families are urged to monitor loved ones closely.

There are still many psychiatrists who find this advice objectionable. Nevertheless, the FDA has determined that the data support such a warning.

Now, the FDA has discovered that other kinds of medication may also increase the risk of depression and suicide. An advisory has been issued for the stop-smoking medicine Chantix (varenicline): “Healthcare professionals, patients, patients’ families, and caregivers should be alert to and monitor for changes in mood and behavior in patients treated with Chantix. 
Symptoms may include anxiety, nervousness, tension, depressed mood, unusual behaviors and thinking about or attempting suicide. [In some cases] “symptoms developed following withdrawal of varenicline therapy.”

At first many people assumed that their irritability was related to stopping smoking. Nicotine withdrawal is notoriously unpleasant. But we have received scores of messages to the web site www.peoplespharmacy.com suggesting that the Chantix effect goes beyond the usual difficulties of quitting.

Although most people noted that Chantix did help them stop smoking, many also suffered horrifying side effects: “I was on Chantix for about 5 to 6 weeks. The drug helped me quit smoking but I had nausea, severe abdominal pain and low back pain. Soon after I stopped taking it, I started feeling severely depressed and attempted suicide by overdosing on muscle relaxants. I was taken to the hospital for treatment. I have two teenage daughters and had never thought about suicide in my whole life before taking Chantix.”

The most recent unexpected warning from the FDA involves the asthma medicine Singulair. The agency has issued an early communication that Singulair has been associated with mood changes, suicidal thinking and suicide. Although it is not clear that Singulair causes depression, the FDA is being far more cautious these days than in past decades.

Hundreds of prescription medicines can cause depression as a side effect. Anyone who experiences deteriorating mood or thoughts of suicide should discuss such symptoms with a physician promptly.

Americans have been repeatedly told that we have the safest medicines in the world. That’s because the FDA has the reputation for policing our drug supply conscientiously.

The recent scandal over the anticoagulant heparin, however, has many people wondering just how safe our drugs really are.

Over the last several weeks, investigators have begun to piece together the puzzle. It all started when patients experienced severe allergic reactions to this injectable blood thinner: abdominal pain, nausea, vomiting, diarrhea, fever and low blood pressure. More than a dozen people have died.

Eventually, the problem was traced to China where the raw ingredients for heparin are produced from pig intestines. Early speculation attributed the problem to unsanitary manufacturing conditions or sick pigs.

Recent revelations, however, suggest that a contaminant was intentionally added to fool testers into thinking there was more heparin than was the case. This compound has been identified as over-sulfated chondroitin sulfate. Even though it hard to distinguish from heparin with basic tests, it has no anticoagulant activity.

This should ring some bells with alert readers who remember the pet food scandal from last year. Chinese suppliers added melamine to wheat gluten bought by American pet food manufacturers. Melamine was added to make the gluten appear to have more protein in it, so it could command a higher price. Dogs and cats died as a result of this adulteration.

Toxic toothpaste from China also had to be pulled off the market last year. It contained the poisonous antifreeze diethylene glycol that had been substituted for the more expensive ingredient, glycerin.

The heparin incident now looks like another instance of Chinese manufacturers charging more for less. The fact that the FDA had inspected the wrong Chinese plant adds to the calamity.

These incidents may be the tip of a giant iceberg. Over 500 factories in China export drug ingredients or finished pills to the United States. Last year, the FDA inspected 13.

Because of cutthroat competition, especially for generic drug ingredients, China and India have emerged as major suppliers. There is no system in place to insure that these products contain what they claim and nothing more. The heparin example demonstrates how vulnerable we are to counterfeit or adulterated medication.

Readers have reported failures and adverse effects from many generic drugs. Some may be related to imported ingredients. Others may be traced to shortfalls in FDA’s generic drug approval and monitoring process.

We recently warned about the special problems associated with some generic forms of the antidepressant Wellbutrin XL 300 and the heart and blood pressure pill Toprol XL. You can read more about this at this website,  www.peoplespharmacy.com.

Anyone who has had a problem with a generic drug can report to us or directly to the FDA at www.fda.gov/medwatch.

Physicians, pharmacists, insurance companies and hospitals have relied upon the FDA to guarantee that American medications are reliable and safe. They have assumed that the agency was capable of monitoring the drug supply chain. Perhaps it is time to reevaluate that assumption.

 

Some home remedies seem logical. Soaking fungus-infected toes in a footbath containing dilute vinegar and old-fashioned amber Listerine makes some sense. After all, fungus hates acid and the herbal oils and alcohol in Listerine may also have anti-fungal activity.

Using soap to combat leg cramps, on the other hand, makes no sense at all. We don’t know where the idea came from to put soap under the bottom sheet to prevent leg cramps. Regardless of its origins, many readers of The People’s Pharmacy are excited about its benefits.

One reader testified: “I have had a bar of soap under my sheet for almost six months and never once have I had any more cramping in my toes, feet and legs. It may be an old wives’ tale, but I can say that it works great because I get a good night's sleep!”

Another one cheered, “I have tried many home remedies, and this is the first that is absolutely effective. I have always experienced moderate to severe leg and foot cramps, and also RLS [restless leg syndrome]. I read about the soap remedy and have used it for nearly two years. I’ve had only a few cramps that lasted only a minute or two until I got the soap on my leg or foot. Even better--NO RLS! This is an amazing home remedy. No exaggeration, no kidding!”

Not everyone is so enthusiastic about soap in bed. One told his story: “It’s a placebo. It only works if you believe it will. My mother-in-law told my wife to try it. I told my wife, ‘it’s just a placebo. If you want to try it, wait until I’m not expecting it.’ She waited a few weeks, slipped the soap under the sheet and I still suffered from leg cramps. If you don’t believe in it, it won’t work either.”

Another wife did a similar experiment but got different results: “I put a bar of soap under my husband’s sheets without his knowledge. It worked. So this proves that it is not all psychosomatic.
“When he saw the soap, he couldn't believe it had helped. It probably wouldn't have worked if he had known in advance that I’d put it there.”

One reader doesn’t care if the effect is psychosomatic: “I suffered from calf muscle cramps (charley horses) at night for years. I read about the soap trick and thought, what the heck. I put several motel soap bars under the sheets. A couple of weeks later, I suddenly realized I had not had any charley horses for quite a while. When I changed the bed, I would put the soap in a cup while I washed and dried the sheets.

“About two weeks ago, I started having those damned cramps again. I figured, ‘Well, that soap stuff is all just suds.’ I had cramps for several nights, and then I found the cup with the soap sitting out. I had forgotten to put it back in the bed. Back it went pronto, and I have not had a cramp since. If it's psychosomatic, so be it, as long as I don't have those charley horses any more.”

Anyone who would like to learn more about remedies for leg cramps or restless leg syndrome may want our Guide to Leg Pain.

Most physicians and pharmacists have a secret they don’t share with patients. The FDA is in on it and so are drug companies. One out of five of the prescriptions written in this country are for unapproved uses. Some put the number much higher.

Most Americans assume that whenever their doctor prescribes a drug it has been extensively tested and proved to be both safe and effective for their condition. They’re wrong. In reality, many medications are prescribed without this supporting evidence.

When a pharmaceutical company submits a medicine to the FDA for review, it must prove that the compound works and that the benefits outweigh the risks for one particular ailment.

Once that drug receives approval for that particular indication, doctors can prescribe it for anything else, as they see fit. This is called “off-label” prescribing. The FDA does not regulate the practice of medicine, leaving doctors free to make decisions on their own.

Until now, the FDA has not allowed drug companies to promote off-label uses of their products. In fact, some manufacturers have gotten themselves into big trouble when they stepped over the line. Pfizer was slapped with a $430 million fine because it was promoting Neurontin, a drug approved to control epileptic seizures, for a range of other problems, including pain, bipolar disorder, restless legs, ALS, ADD or migraines.

Some medicines commonly prescribed for unauthorized purposes include the schizophrenia drug Risperdal for Alzheimer’s dementia; the antidepressants Prozac and Zoloft for premature ejaculation; and beta blocker heart medicines like atenolol and propranolol for stage fright.

What’s wrong with off-label prescribing? For some conditions, unauthorized prescribing may be appropriate. Without rigorous scientific studies, however, doctors have no way to evaluate the benefits and risks of unauthorized uses. It has been estimated that three quarters of the prescriptions for off-label uses are not backed up by solid evidence (Archives of Internal Medicine, May 8, 2006).

That puts patients in the position of guinea pigs. They are unwitting experimental subjects, but no one is collecting data or protecting their safety. This kind of prescribing can lead to serious adverse reactions or even death. This has happened when anti-psychotic medications are prescribed to older patients with senile dementia.

The FDA is preparing to change the rules that regulate how the pharmaceutical industry promotes off-label indications. Companies will be allowed to give doctors copies of journal articles mentioning drugs for unapproved purposes. With such a green light, manufacturers could easily overwhelm busy doctors with promotional messages about uses for which drugs have not been thoroughly tested.

Drug companies understandably emphasize the positive and downplay bad news. When two studies show contradictory findings, will sales representatives show doctors both of them? The track record is not reassuring.

More alarming, though, is the message that the FDA is sending the pharmaceutical industry. No longer will firms have to fund expensive research to prove their medicines work for off-label purposes. Without such studies patients will be even more vulnerable than they already are.
In 1953 the Dean of Harvard Medical School, George Packer Berry, MD, told the students, “half of what is taught in medical school is wrong. The problem is that we don’t know which half.”

Since that time, his admonition has been repeated by many medical school leaders. Although medical knowledge has grown enormously over the last half century, there is still tremendous uncertainty about what works and what doesn’t.

Physicians are supposed to practice “evidence-based medicine.” To do that, they need to know that the procedures they perform and the drugs they prescribe have been carefully tested in well-designed clinical trials. They need to understand when a treatment is worthwhile and when it might be worthless or even harmful.

Sadly, many studies never get published, particularly the ones that show no benefit from the medication being tested. That makes it hard for doctors to evaluate all the evidence.

This was brought home in an article published in the New England Journal of Medicine (Jan. 17, 2008). Erick Turner, MD, and his colleagues reviewed studies of 12 antidepressant drugs. There were 74 studies that had been registered with the FDA, but roughly one third of them were not published.

When trials produced positive results they were reported as such 97 percent of the time. Only 8 percent of antidepressant trials that showed no effectiveness reported the negative findings.

When negative as well as positive antidepressant trials are analyzed together, something strange happens. The overall results turn out to be surprisingly disappointing.

A recent “meta-analysis” did just that [Public Library of Science (PLoS) Medicine, February, 2008]. Researchers obtained FDA studies under the freedom of information act (including unpublished research) for four antidepressants: Effexor, Paxil, Prozac and Serzone.

When the data was crunched the antidepressants turned out to be no more effective in relieving mild to moderate depression than sugar pills. Severely depressed patients did seem to benefit a bit from the drugs, but the investigators determined that this was probably more because the placebos stopped working rather than because patients were responding better to medication.

The authors concluded that, “Given these data, there seems little evidence to support the prescription of antidepressant medication to any but the most severely depressed patients, unless alternative treatments have failed.”

Antidepressants are among the most widely prescribed drugs in the world. Tens of millions of people take drugs like Effexor, Paxil and Prozac every day. They expect such medicine to work, especially since they are pricey. A month’s supply of Effexor or Prozac can cost more than $150.

Such drugs can also cause side effects such as nausea, headache, insomnia, nervousness, dizziness, dry mouth, rash, sweating and sexual dysfunction. Many patients would be willing to accept some of these symptoms if they were guaranteed relief from depression.

The new data, however, suggests that the benefits may be too uncertain to justify the risks. Physicians and patients deserve access to all the evidence so they can better determine what works and what doesn’t.
There was a time when most of the medicines we purchased in our neighborhood drug stores were made in America. These days, though, medicines come from all over the globe.

Despite the high cost of prescription drugs, generic manufacturers compete on the basis of price. Just like trousers or televisions, ingredients for many medications now come from India and China where they are made at lower cost.

Although it is impossible to get exact numbers, some experts estimate that one fifth of all generic drugs and over-the-counter medicines are now made in China and India. Approximately 40 percent of the raw ingredients in our pills come from those countries.

The FDA is supposed to inspect all American drug manufacturers every two years. That’s the law. But there are no specific regulations covering plants in foreign countries. Last year, the agency inspected 13 of the 700 known Chinese factories making medicines for export to the U.S.

Even when the FDA does inspect a plant, it might be the wrong one. That’s what happened last year when the FDA confused the names of two Chinese companies. The one that was actually making the raw ingredient for heparin did not get inspected.

The current scandal surrounding heparin, an injectable blood thinner used during surgery and dialysis, revealed weaknesses in the regulatory process.

The FDA has reported hundreds of allergic reactions and four deaths linked to multiple-dose vials of Baxter brand heparin. The raw ingredients for heparin come from pig intestines often processed in factories in China.

Investigations reveal that some plants processing heparin do so as a sideline to their sausage-casing business. As a result, these firms are not registered as pharmaceutical companies and are exempt from regulation by the Chinese equivalent of the FDA.

Pig intestines are purchased from slaughterhouses, often with no paperwork to enable anyone to track the source. If the animals were sick, there is no way to detect the disease.

Some factories are literally cottage industries with low standards of sanitation and quality control. Raw heparin may be spread out on a table in a courtyard to dry. This crude ingredient is sold to middlemen who then sell it to manufacturers around the world. Their records may also be deficient.

The problems with heparin may be especially dramatic but could represent the tip of the iceberg. Many firms in China making drug ingredients are registered as chemical companies rather than pharmaceutical manufacturers. As a result, they may escape scrutiny by the Chinese drug regulatory authorities and the U.S. FDA.

Raw ingredients for many medicines are traded around the globe and the original source may be obscured in the process.

With more big-box retailers selling low-cost generic drugs, consumers may want to know where these medicines were made. We have heard from hundreds of readers about problems with certain generic drugs. To read their stories, search this Website.

Until the FDA institutes better oversight of foreign drug makers, consumers in the U.S. have no way of knowing for sure whether their medications meet quality control standards.
Americans are awed by celebrities. That’s why drug companies love to have people like Sally Field selling the osteoporosis drug Boniva.

Dorothy Hamill was another famous personality enlisted to advertise drugs. The Olympic ice skating champion promoted the ill-fated arthritis medicine, Vioxx. And football coach Mike Ditka urged men to “take the Levitra challenge” to solve erectile dysfunction.

One might argue that although Sally Field, Dorothy Hamill and Mike Ditka are high-profile personalities, they have no particular medical expertise. Why should we take their advice to ask our doctors for the pills in their ads?

On the other hand, Dr. Robert Jarvik has a medical degree. As the inventor of the Jarvik artificial heart, he seems to have an enormous amount of credibility regarding heart disease. When Dr. Jarvik tells us that he takes Lipitor and encourages viewers to “ask your doctor; don’t wait,” people take him seriously.

But Dr. Jarvik has kicked up an enormous amount of controversy with one of his TV commercials. It opens with his name and credential underneath a man rowing across a beautiful lake. This is no rowboat, but a racing scull that exemplifies fitness. We even see a close-up of Dr. Jarvik rowing energetically.

Trouble is, Dr. Jarvik doesn’t actually row a scull in this commercial--or in real life. The ad agency hired a stunt double to do the rowing. The creators of the ad went to a fair amount of trouble to give the impression that Dr. Jarvik is a rowing enthusiast, even filming him rowing.

The cat was let out of the bag by a rowing club newsletter in Seattle, Washington. One of their members had been chosen to do the ad, purportedly because he is roughly the same size as Robert Jarvik and has a similarly receding hairline. Unlike Jarvik, however, he is an expert rower. Dr. Jarvik’s rowing was reportedly done on an apparatus, not a real boat.

There’s another problem with the Jarvik commercials. Even though he did invent an artificial heart, Dr. Jarvik is not a cardiologist and doesn’t even practice medicine.

Americans hate deception. Perhaps that is why Congress is investigating whether the Jarvik commercials are misleading.

If truth be told, a great many prescription drug ads are confusing, if not downright deceptive. For one thing, the actors are almost always upbeat and enthusiastic, whether they are talking about erectile dysfunction or osteoporosis.

When it comes time for the disclosure of side effects required by law, people on the screen are frequently having a great time. The video distracts from the scary message being delivered and the voice sounds soothing and reassuring.

Even when a drug can cause dizziness, drowsiness, fainting, nausea, vomiting, headache or muscle pain and weakness, everyone seems cheery and unconcerned. Most of the side effects such medicines can cause aren’t even mentioned.

It’s time Congress told the FDA to get these commercials off the air. Only the U.S. and New Zealand permit such direct-to-consumer advertising of prescription drugs. Let’s just say NO to drug ads and rely on practicing doctors, not celebrities, to tell us which medicines are right for us.

 
Taking medicine is often a gamble. You are betting that the benefits will outweigh the risks. But do you realize a payoff is far from certain?

Drug companies rarely have to prove that their pills actually produce the desired outcome. All they have to show is that the medication moves the needle on some gauge or lab test.

These numbers are called surrogate endpoints. They are things like blood pressure, cholesterol or blood sugar. If you have hypertension, elevated cholesterol levels or diabetes, it is assumed that getting the numbers down is good enough. But the real aim is reducing the risk of kidney disease, strokes and heart attacks. Few drugs are proven to accomplish those goals.

Imagine going to a casino. If you want to play poker or roulette, you buy chips. Those chips are your surrogate money. If you win, you get to cash the chips back in for real money.

Any gambler would be outraged if the casino refused to trade the chips for cash at the end of a successful night. No casino would last long if it didn’t pay up.

Drug companies, though, get away without delivering on the eventual outcome because such studies are expensive and take a long time to complete. It is far easier just to prove that your pills lower cholesterol or blood sugar—and that is all that the FDA requires.

Several recent studies suggest that such surrogates are no longer adequate. A huge diabetes study financed by the federal government was halted prematurely because the results were so disappointing.

The ACCORD trial (Action to Control Cardiovascular Risk in Diabetes) was designed to lower blood sugar aggressively in high-risk diabetes patients. To everyone’s surprise, those who got the most intensive treatment with insulin and oral medications were more likely to die than those on standard therapy.

Researchers were shocked that better blood sugar control did not result in an improved outcome as expected. In fact, just the reverse occurred. It would be like winning the lottery and discovering you had to pay money instead of taking your winnings.

Another study, ALLHAT, shocked the cardiology community when it revealed that an inexpensive diuretic outperformed newer, fancier drugs in preventing heart attacks and heart failure. All the drugs lowered blood pressure, but most doctors expected the more expensive drugs to provide a survival advantage. Some of the most popular pills actually increased the risk for heart failure.

These disappointments are reminiscent of another recent setback. The ENHANCE study was supposed to prove that lowering bad LDL cholesterol aggressively with a combination pill called Vytorin (Zetia plus simvastatin) would reduce clogging of carotid arteries. Vytorin did work better than simvastatin alone to reduce LDL. But to everyone’s surprise, the lower cholesterol numbers did not lead to cleaner arteries.

The study was not large enough to tell scientists whether the drug would reduce the likelihood of heart attacks or strokes. Those studies will take years to complete. In the meantime, the unexpected outcome of the ACCORD trial should make everyone wary of just assuming that lower numbers by themselves mean better health and longer survival.

Beware Of Drug Name Mix-Ups

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What’s in a name? According to William Shakespeare, not much: “That which we call a rose by any other name would smell as sweet.” In this famous line, Juliet complains that it is Romeo’s name that keeps them apart because of a family feud.

In the world of pharmaceuticals, the wrong name can make the difference between life and death. That’s because look-alike and sound-alike drugs are frequently confused.

The U.S. Pharmacopeia (USP) has just issued a report documenting that drug name mix-ups are rising at an alarming rate. USP is an organization that sets standards for drugs and dietary supplements. It runs a clearing-house for hospitals to report medication errors anonymously.

The USP report says that there are more than 3,000 pairs of look-alike or sound-alike drugs that could lead to serious problems. Here are just a few examples:

  • Celebrex (for arthritis) vs. Celexa (an antidepressant)
  • Ferro-Sequel (an iron supplement) vs. Seroquel (an antipsychotic)
  • Fosamax (for osteoporosis) vs. Topamax (for epilepsy)
  • Lamictal (for epilepsy) vs. Lamisil (for fungal infections)
  • Zestril (for high blood pressure) vs. Zetia (for cholesterol) vs. Zyrtec (for allergies) vs. Zyprexa (for schizophrenia)

Imagine yourself behind the counter of a busy pharmacy. The phone is ringing nonstop and messages are being left on voice mail. Some prescriptions are coming in on the fax machine and impatient customers are queued up at the counter waiting for their prescriptions.

Amidst the hustle and bustle, it is not surprising that drug names get mixed up. Someone could easily end up with Zantac instead of Xanax or Topamax instead of Fosamax.

How often are mistakes made? One survey reported that 2 percent of all prescriptions are dispensed incorrectly. That may seem trivial, but when you consider that billions of pill bottles are sold each year that totals over 50 million mistakes annually (Journal of the American Pharmaceutical Association, March-April, 2003). Many are trivial, but some can be life threatening.

Several years ago we heard from a woman whose mother died because of a pharmacy mix-up. The woman was dispensed an estrogen hormone instead of the blood thinner warfarin (Coumadin).

To avoid being a victim of a mistake, here are some People’s Pharmacy tips:

  • Never have your prescription phoned in. There is too much opportunity for sound-alike drugs to be confused over the phone.
  • Make sure your prescription is printed or typed in English. Do not accept Latin code or illegible scrawl.
  • Do not allow your prescription to be faxed. The loss of quality in transmission might foster confusion.
  • Keep a photocopy of your prescription so you can verify that what you get at the pharmacy is what your doctor ordered.
  • Double-check the label and the pills before you leave the pharmacy counter. If you count the bills a bank teller hands you, you should be even more careful with your medicine.
  • If you have any suspicions that a mistake has been made, do not hesitate to speak with the pharmacist.

A rose by any name would smell as sweet. A drug by the wrong name, on the other hand, could be lethal.

 

Parents are caught in a double bind when a child is diagnosed with ADD or ADHD (attention deficit hyperactivity disorder). On the one hand, they want to help their child focus and do well in school. Treating the condition can make a big improvement in how well a child does in school or even how he plays with friends.

On the other hand, though, many parents are concerned about stimulant medications. Far too often, a diagnosis is made and a prescription is written for Ritalin or Adderall without adequate counseling. Parents may be taken aback if they read the official prescribing information on these drugs. Adderall, for example, has a scary warning inside a black box:

“Amphetamines have a high potential for abuse. Administration of amphetamines for prolonged periods of time may lead to drug dependence and must be avoided...Misuse of amphetamine may cause sudden death and serious cardiovascular adverse events.”

Any parent who reads such a caution may wonder whether a school year is a “prolonged period of time.” The information also lists side effects such as psychotic episodes, tics, stomach upset, restlessness, insomnia, tremor, heart rhythm disturbances, loss of appetite and weight loss. No wonder parents or grandparents may worry that the treatment could be worse than the condition.

We recently heard from a woman concerned about her 9-year-old grandson: “He has behavioral issues and has been diagnosed with ADHD.

“During his visit, we did not give him his usual medications. His behavior improved considerably. After five or six days, I took him to visit my friend who is a school psychologist. She found NOTHING: no ADD or ADHD.

“He does have some behavior problems, but they respond to therapy and discipline. I am very worried about the effects drugs are having on his young organs and brain.”

Diagnosing attention deficit disorder is actually more complicated than many people assume. There is no single test for ADD or ADHD. Instead, it must be diagnosed from behavioral patterns. Inconsistent focus and unexplained underachievement are tip-offs, according to Edward Hallowell, MD.

Dr. Hallowell is author of Delivered From Distraction and is one of the country’s leading experts on ADD and ADHD. He suggests that successful management of these conditions requires four basics: adequate sleep, daily exercise, structure with reliable routines and diet. There is growing evidence that junk food with additives may make ADD worse (Lancet, Nov. 3, 2007).

Dr. Hallowell believes that medications can play a valuable role in treatment but the basics must come first. He also recommends dietary supplements including Pycnogenol (pine bark extract), grape seed extract and fish oil. For more details on Dr. Hallowell’s approach to ADD we offer a CD of our recent one-hour radio interview with him. Anyone who wants this CD may send $16 to: Graedon Enterprises; Dept. CD-663; P. O. Box 52027; Durham, NC 27717-2027. You can also find show #663 on this web site.

Kids don’t automatically outgrow ADD. Many adults have a history of inconsistent performance and underachievement. They too can benefit from sleep, exercise, diet and appropriate structure in their daily routines.
It all seemed so simple. If you just lowered your cholesterol you could reduce your risk of a heart attack or stroke.

Drug companies have done their best to keep you focused on medications that bring cholesterol levels down. Turn on TV or open a magazine and you are likely to see an ad featuring Dr. Robert Jarvik, known as the inventor of the artificial heart. He promotes Lipitor to lower cholesterol and he has been wildly successful.

The company brags that its statin-type medication has been prescribed to more than 26 million Americans. Lipitor earned its manufacturer more than $13 billion in 2006.

Lipitor is not alone. Millions of Americans take cholesterol-lowering drugs like Crestor, Mevacor, Pravachol, Vytorin, Zocor and Zetia. But puzzling new data have many patients confused.

Headlines recently announced the results of a study comparing Vytorin, which contains both Zetia (ezetimibe) and Zocor (simvastatin), to Zocor alone. Although Vytorin lowered bad LDL cholesterol 17 percent more than Zocor, the combination pill did not reduce dangerous plaque buildup in neck arteries. The patients on Vytorin may even have had slightly more plaque buildup.

Cleveland Clinic cardiologist Steven Nissen was stunned by the results and called on his colleagues to reconsider routine use of Zetia or Vytorin as first-line treatments. In 2006 18 million prescriptions were written for Vytorin and 14 million for Zetia.

Lowering cholesterol, especially bad LDL cholesterol, is supposed to be the Holy Grail for preventing atherosclerosis and cardiovascular events. But an earlier study of a novel medication called torcetrapib that lowers LDL and raises good HDL cholesterol was abandoned when patients taking the medicine actually had more heart attacks and strokes. The new study of Vytorin suggests that reducing LDL numbers may not be enough.

Even for tried-and-true cholesterol-lowering drugs, the benefit for any given individual may be smaller than people imagine. Lipitor, for example, has been shown in studies to prevent heart attacks.

Newspaper ads capitalize on this, announcing that Lipitor reduces the risk of heart attack by 36 percent. There is an asterisk next to that number, however, and here is the fine print: “That means in a large clinical study, 3 percent of patients taking a sugar pill or placebo had a heart attack compared to 2 percent of patients taking Lipitor.” (See Business Week, Jan. 17, 2008.)

In other words, if you had 100 people taking Lipitor and another 100 people taking an inactive placebo, there would be one less heart attack after several years among the folks on Lipitor. That certainly matters a great deal if you are the one who was spared. But if you are one of the other 99, the cost and risk of side effects may seem high.

No one should stop taking cholesterol-lowering medicine without medical supervision, but cholesterol is not the only thing that matters. Physicians have known for decades that there are over 200 risk factors for heart disease (New England Journal of Medicine, Nov. 14, 2002). Inflammation, stress, hostility, depression and high triglycerides are just a few of the other contributors to heart disease. Focusing on cholesterol alone could be a big mistake.
Savvy patients have learned that it is essential to ask physicians and pharmacists about side effects before they take any medicine. Drugs can cause reactions that range from mild discomfort to life-threatening complications.

Even a thoughtful consumer may forget another crucial question: What will happen when I stop this medication? Many drugs can cause trouble if they are stopped abruptly.

The Patient Information on the back of an Effexor XR ad has a heading, “What happens when I stop using Effexor XR?” When people stop suddenly, they may experience symptoms such as agitation, anxiety, confusion, diarrhea, dizziness, dry mouth, muscle twitching, headaches, insomnia, loss of appetite, nausea, nervousness, nightmares, poor coordination, seizures, sensory disturbances (like electric shock sensations), sleepiness, sweating, tinnitus, tremor, unpleasant mood or vomiting.

That’s hardly a pleasant prospect. We wonder if people review that list before they begin taking the antidepressant.

Effexor XR is not the only medicine that can cause symptoms if it is stopped abruptly. Other antidepressants, such as Paxil or Zoloft, may cause similar problems.

Anti-anxiety medications are notorious for causing withdrawal symptoms when they are stopped suddenly. We heard from one person: “I would like to warn your readers about the dangers of long-term use of benzodiazepines (tranquilizers like Klonopin, Valium, Ativan or Xanax). A psychiatrist prescribed Klonopin for me for a year because of an anxiety disorder. I became addicted to it and began to have severe withdrawal symptoms between doses. I tried to taper off the drug but was unsuccessful.

“Finally, I checked into a psychiatric hospital for detox. The withdrawal from this drug was HORRIBLE, with extreme agitation, sensitivity to light and noise, sweating, cold chills, muscle twitching, and fear of being left alone. Some days all I could do was sit and rock and cry.

“It has taken me a year to recover. Some people are extremely sensitive to these drugs and should not take them longer than several weeks.”

We discuss getting off such medicines in our Guide to Psychological Side Effects. It can be downloaded for $2 from this Web site.

Psychiatric drugs aren’t the only ones that may be hard to stop. Acid-suppressing medicines such as Prilosec or Nexium can trigger severe stomach acidity when they are discontinued. One reader wrote: “I have tried to get off Prilosec. I am strong willed and can do almost anything I set my mind to--except stop this drug.

“The first day I stopped was not too bad. The next day, my empty stomach was on fire. It felt like I had a bad second-degree sunburn inside my stomach. I was in tears, bent double at times, and my husband and a friend told me to PLEASE start back on Prilosec because they could not take my moaning. I took the Prilosec and felt much better the next day. I’ll never try that again!”

People need to understand the consequences of stopping medication before they begin. Whether it’s an over-the-counter decongestant nasal spray or a prescription antidepressant, getting off the drug can be extremely challenging.

Don't Be A Good Patient

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Doctors like “good” patients. They even have a technical term for these people. Physicians call them compliant. Bad patients are non-compliant.

A compliant patient follows doctor’s orders. In most cases that means taking the pills that are prescribed without too many complaints.

This makes complete sense from the physicians’ perspective. After all, doctors want their patients to avoid having heart attacks or other health catastrophes. Controlling cholesterol and blood pressure are good ways to reduce those risks.

The trouble with this approach is that it tends to focus the doctor’s attention on numbers: blood pressure numbers or LDL cholesterol. As a result, the patient as a person may fade from view. At times, a person having trouble with a treatment may have difficulty getting the physician to address it.

This patient’s reaction to medication was treated with another drug, time after time:

“First I was put on Zocor to control my cholesterol. That caused Restless Leg Syndrome (RLS), so I was prescribed Requip. I then became depressed and was prescribed the antidepressant Lexapro. It made me into a zombie, so I was prescribed a low dose of Ritalin, a stimulant drug for ADHD.

“I developed a mild heart arrythmia [likely an effect of the Ritalin] and was prescribed a calcium channel blocker (CCB) to control the heart rhythm. I took the CCB for about three weeks and felt so bad I wanted to commit suicide.

“When I tried to refill the Zocor at the local pharmacy instead of through mail order, the pharmacist told me he could not give me the CCB and a statin at the same time. That did it for me. I had been a zombie for far too long.

“I swore off all prescription medicine. Without all these pills, my mental fog lifted, the terrible muscle spasms I had everywhere relaxed and I no longer had RLS.”

We don’t condone people stopping their prescription drugs without their doctors’ involvement and advice. But we hate it when doctors just prescribe more medicine to treat drug side effects, instead of stepping back to see if there is some other way to accomplish the goal. Every problem this person developed was a medication side effect—and each one was treated with yet another drug that caused an additional complication.

When a patient suffers a side effect, the experience should be acknowledged. One person told us: “My psychiatrist prescribed Geodon [an antipsychotic drug] for bipolar disorder. After two days on Geodon, I had a serious side effect. I started shaking uncontrollably. I also had chills and my heart was racing. Then I started having hallucinations.

“I saw psychedelic colors and birds flying around the room. I heard voices and a song that kept repeating itself over and over again. The hallucinations ended after a few hours, but the shaking continued for a couple of days.

“My psychiatrist's only response was, ‘That’s interesting.’ I was infuriated because it was such a scary experience. I have no personal or family history of schizophrenia or hallucinations and I have not had a hallucination since.”

Physicians must warn patients of common or serious drug side effects and patients have a responsibility to let doctors know if they run into problems. Being a “good” patient and keeping quiet could cause terrible harm.

 
Would you take a medicine that listed death as a possible side effect? Lots of people do.

If you read drug ads in popular magazines, you might end up wondering who would ever beg a doctor for a prescription.

Abilify is a case in point. This drug was originally approved to treat schizophrenia but is now being advertised aggressively for bipolar disorder (manic-depressive illness). One ad promotes the drug for managing mood swings and implies that Abilify might help you “feel more like yourself.”

That sounds appealing, but read on and you learn that elderly dementia patients who take Abilify are at increased risk of death “when  compared to patients who are treated with a placebo (sugar pill).”

Not elderly, you say? Another complication is rare but potentially fatal: neuroleptic malignant syndrome, characterized by “very high fever, rigid muscles, shaking, confusion, sweating, or increased heart rate and blood pressure.”

Abilify can also cause headache, anxiety, insomnia, nausea, vomiting, constipation, dizziness, restlessness, high blood sugar, seizures, uncontrollable facial movements and suicidal thoughts.

Speaking of suicidal thoughts, a widely advertised stop-smoking medicine also comes with such a warning. Chantix commercials feature a tortoise and a hare with the slogan, “It’s all about getting there.” There is a brief mention of side effects including “nausea, trouble sleeping, changes in dreaming, constipation, gas and vomiting.”

Such symptoms sound like a small price to pay for help quitting smoking. But read the official prescribing information and you will discover that Chantix has been linked to diarrhea, headache, high blood pressure, changes in the sense of taste, nosebleeds, sweating, chest pain, muscle cramps and pain, dizziness, anxiety, irritability and depression.

Most people find such a list of side effects overwhelming and tend to stop reading before they reach the end. Such symptoms may seem abstract until someone like Pam shares her story: “I started taking Chantix three and a half weeks ago. At first I felt great and stopped smoking after the first five days. The vivid, crazy dreams were even kind of fun, but now I am so depressed I can barely get up in the morning… All I want to do is sleep and cry. I thought about killing myself yesterday... The nausea, stomach pain and constipation are so bad it’s been a chore to function. I have never suffered from depression in my life, so I was kind of blind-sided by all this.

“I didn't associate any of this with Chantix. My mother mentioned that there were some horrible side effects associated with Chantix that she just heard about on the news today.” Having read similar posts on our Web site, Pam feels relieved to know she is not alone.

The point here is not that Chantix is a bad drug. Smoking puts health at risk, and helping people quit is valuable.

All medications have risks, however. Even rare side effects do happen. Whether the medicine is Abilify, Chantix or any other prescribed medication, take a few minutes to read the small print. Being well informed about risks and side effects could save your life.

Winter is hard on skin and scalp. With its low humidity, heated air pulls moisture out of the skin. This time of year millions of people suffer from dry skin, chapped lips and dandruff.

Frequent hand washing also dries skin out in the winter. We are all urged to wash our hands frequently to avoid colds or the flu. Health workers are especially susceptible to dry skin since they must wash before and after each patient.

People with eczema also suffer with itchy rashes, particularly on the hands or where the skin creases. Dry skin makes it worse.

What can people do at this time of year to keep from aggravating dry skin? Dermatologists often suggest using a less drying cleanser than soap. Some waterless hand cleansers are formulated to be less drying. For the face or body, consider a nonsoap cleanser such as Cetaphil or CeraVe. Both contain cetearyl alcohol, a nondrying cleaning ingredient.

Once skin is clean, particularly if it was washed with water, excess dampness should be gently patted off and the moisture should be trapped on the skin with a moisturizer. This helps ease itching and reduces skin cracking on knuckles and fingertips. The idea is the same as covering a slice of apple with plastic wrap to keep it from drying out.

In recommending moisturizers, dermatologists used to say, “The greasier, the better.” That’s not always practical: greasy skin doesn’t work well at a computer keyboard or on a cell phone. Instead, look for a product that rubs in well. Save the greasier formulation (for example, Aquaphor, A&D Ointment or Vaseline petroleum jelly) for nighttime when you can wear cotton gloves or socks after applying it.

Barnyard beauty aids originally developed for cows’ udders are also excellent skin moisturizers. They have the advantage of being very affordable. Bag Balm from the Dairy Association Company of Lyndonville, VT, is greasy and smelly but effective (800-232-3610). Udder Cream from Redex Industries in Salem, OH, is more appealing and also quite helpful against dry skin (800-345-7339). (Redex Industries underwrites the People’s Pharmacy radio show.)

Dandruff requires a different approach. It’s not practical to put moisturizer on the scalp.

Dermatologists believe many cases of dandruff are due to a yeast infection on the scalp. Controlling the yeast often cuts down on flakes. Some people report great success rinsing the scalp with dilute vinegar or Listerine (apply for five minutes before shampooing).

Others find that using different kinds of dandruff shampoo in rotation every few weeks helps control itching and flaking. Start with an antifungal product such as Nizoral A-D and then switch to a selenium-containing shampoo like Selsun Blue. Next, try a zinc pyrithione preparation such as Head & Shoulders.

For more information on dry skin solutions and dealing with dandruff we offer our Guides to Skin, Hair and Nail Care.

With care, indoor heating and frequent hand washing need not dry out your skin and scalp this winter.

 

Big Pharma Fails To Deliver

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The pharmaceutical industry is breaking its promise to the American public. People in the United States pay far more for prescription drugs than people anywhere else in the world. Drug companies vowed to use the proceeds from pricey prescription drugs to develop wonderful new medicines to cure devastating diseases. But Big Pharma is not delivering.

Over the last 30 years drug prices have skyrocketed, far outstripping inflation. In some cases the increase has been astronomical.

In 1975 the blood thinner Coumadin (warfarin) cost $9.40 for 100 pills. Thirty years later the same prescription had zoomed to $133.49. The anti-anxiety agent Valium (diazepam) went from $8.99 per 100 tablets in 1975 to $217.74 in 2007.

Both Coumadin and Valium have been on the market for decades. Newer drugs such as the cholesterol-lowering drug Lipitor could cost $128 for a month’s supply. Enbrel for rheumatoid arthritis or psoriasis can cost as much as $1400 for one month of treatment.

Pharmaceutical companies justify such high prices on the grounds that they help pay for the drugs of tomorrow. Research and development is extremely expensive. A company may have to test up to 10,000 compounds to find just one new drug that it can take to market.

But that’s not the whole story. The pharmaceutical industry has historically been one of the most profitable sectors of the economy.

Shareholders expect double-digit profits. That’s why the markup on prescription drugs is so high.

A tablet that costs a few pennies to make is frequently sold for more than a dollar. If your computer were priced on the same principle, it would cost tens of thousands of dollars.

With such profits, it would be reasonable to expect lots of breakthroughs from the pharmaceutical industry. Instead, companies have little to show for the billions they have invested in research and development.

Last year only a handful of new compounds (18) were approved by the FDA, and many were just variations of existing drugs. In 1996, the agency approved more than 50 new medications.

In response to shrinking pipelines, many major drug companies are laying off employees. Pfizer has cut 2,100 people from its research labs and Bristol-Myers Squibb is planning to send out 4,300 pink slips.

What happened to the promise of breakthroughs against Alzheimer’s disease, mental illness or cancer? There have been some interesting new compounds developed for rare cancers like chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST).

Unfortunately, these drugs are unaffordable for most people. Gleevec, the breakthrough for CML and GIST, can cost more than $3,000 a month. Other new cancer treatments such as Revlimid for multiple myeloma can cost more than $6,000 a month.

Even such expensive advances are few and far between. We still lack cures for big killers like lung, pancreatic or prostate cancer.

If the pharmaceutical industry cannot deliver on its promise of breakthrough drugs, Americans will be reluctant to keep paying such high prices for prescription medicines. Perhaps the industry should consider spending less money on marketing, lobbying and television commercials and find better ways to develop innovative drugs.

Cold Remedy Ads Fool Parents

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Parents ought to be outraged. They have been betrayed by drug companies as well as the Food and Drug Administration.

For decades the FDA has allowed hundreds of cough and cold remedies to be sold for treating kids with sniffles and coughs. These products were permitted even though there wasn’t any scientific proof that they worked to help children recover more quickly or even to alleviate their symptoms.

Since 1985, six scientific studies of cough or cold preparations have been conducted on children under 12. None found a difference between the active drugs and the placebo (New England Journal of Medicine, Dec. 6, 2007).

Nonetheless, drug companies spend roughly $50 million annually promoting these products to parents. They frequently tout them as  “pediatrician recommended,” even though the American Academy of Pediatrics discourages their use. It is estimated that more than one-third of American households has bought a pediatric cough or cold remedy in the last few years.

If such products were merely ineffective, that would be bad enough. The problem is that they can also cause harm. The Centers for Disease Control and Prevention report that in 2004 and 2005 more than 1500 emergency room visits were linked to cough and cold products in children under two.

Oral decongestants in young children can affect heart rhythm and occasionally cause hallucinations. Adolescents sometimes abuse cough medicines containing dextromethorphan. Toxic effects can range from nausea, vomiting and dizziness to clumsiness, slurred speech, stupor or coma. FDA has identified 123 deaths in young children that can be attributed to cough and cold remedies.

Why has the FDA been so slow to act? Perhaps the problem is that children don’t have an active lobby. And no one bothered to look carefully at the data, or lack thereof.

It was only after pediatrician Joshua Sharfstein, MD, mobilized his colleagues to petition the FDA that the agency roused itself from its lethargy. Dr. Sharfstein, commissioner of health for Baltimore, asked the FDA to declare publicly that these cough and cold products “have not been shown to be safe and effective for children under six.” He and his petitioners also want the agency to crack down on misleading marketing.

The FDA is not likely to ban cold and cough remedies for children, even though the data are so discouraging. So what should parents do when kids come down with sniffles, sneezes and coughs?

For nasal congestion a saline spray is certainly safe. Coughs may respond better to old-fashioned home remedies than drugstore formulas. New research from Penn State College of Medicine (Archives of Pediatrics and Adolescent Medicine, Dec. 2007) suggests that buckwheat honey may be effective for calming a child’s cough. (Honey is not appropriate for babies under one year old.)

Parents also tell us that a dab of Vicks VapoRub on the soles of the feet can relieve a nighttime cough. Anyone who would like more details will find them in our Guides to Cold Remedies and Unique Uses for Vicks.

Compared to most health problems, cracked fingertips seem trivial. But anyone who has ever struggled with sore painful fingers will tell you they can turn normal daily activities into agony.

A reader confided: “It is very frustrating and sometimes depressing to be in so much discomfort and have to refrain from peeling and eating an orange, washing dishes, buttoning clothes, putting on jewelry and other normally enjoyable activities.”

It is not entirely clear why fingertips sometimes split open. This problem is most common in winter, so dry skin is the usual suspect. People who wash their hands a lot, from mechanics to health care providers, are especially vulnerable. When thyroid hormone levels drop too low, dry skin, particularly cracked fingertips, may result.

Fungal infections may be an unsuspected contributing factor, as one reader discovered: “While using the antifungal shampoo Nizoral for a dandruff condition, I noticed the cracked skin on my hands also improved tremendously. Now when symptoms appear I wash my hands using Nizoral (ketoconazole) three times a week. I've tried everything my dermatologist had to offer but this is the only treatment that actually worked.”

Nizoral shampoo is available over the counter. A Baltimore reader used a prescription drug: “I had a prescription for nystatin and triamcinolone cream. After applying it to my fingers several times a day they healed quickly. I suspect the cracks may be caused by a fungal infection, since nystatin is an antifungal medicine.”

Another reader uses a natural product: “Fingertip splitting can be very painful, especially since I'm using (and washing) my hands a lot as a massage therapist. I found that applying tea tree oil to the splits helps them heal in just a few days. It takes much longer when treating with moisturizers alone. I now apply the oil at the first sign of cracks and haven't had much pain from them in years.”

Tea tree oil has antifungal activity, which may explain the success. Beware, though, that some people break out in a rash when they are exposed to tea tree oil.

A quick fix may be as close as your lip balm. One person shared this: “ChapStick works for temporary relief of cracked fingertips.”

Many readers have discovered that sealing the cracks can help them heal faster, too: “I am a carpenter and I have had split fingers and thumbs every winter for years. I read about instant glue being used by medics in Vietnam so I tried it. It works great to seal splits and make the pain go away. This approach is easy and cheap.”

Household instant glue may be irritating for some. Liquid bandage could accomplish the same outcome and be safer, though more expensive.

Protecting hands from water and detergent is also important, as one reader reports: “What helped me most was rubber gloves. Now I never put my hands in water, except to shower. This is a great preventive measure, and well worth the cost and the inconvenience.”

A latex-free protective glove called DermaSoft is especially comfortable. Information is available at www.thedermasoftgloves.com.

Moisturizers are also important in the fight against cracked fingertips. Adding some of these other tricks may help ease winter discomfort.

We first heard about the stop-smoking drug Chantix earlier this year. A physician called our syndicated radio show in February to tell us that this pill was working miracles for his patients. He was extremely enthusiastic.

Anything that can help hard-core smokers quit is indeed wonderful. Nicotine can be one of the hardest addictions to overcome. Some people tell us that it can be more difficult to give up smoking than to kick a heroin habit.

But by September we were beginning to catch whispers of a darker side of Chantix. One reader wrote: “I am taking Chantix to quit smoking. I have had no urge to smoke, but I am seriously depressed.

“I attempted suicide 10 years ago and was hospitalized for depression. I am concerned that my recent bout of severe depression may be a result of taking Chantix.”

Not long after that, we received dozens of similar reports to our Web site, www.peoplespharmacy.com. One reader reported: “I started taking Chantix 12 days ago. For the first week I had night wakefulness and vivid dreams but no other side effects. By day 9 I had a constant metallic taste in my mouth and felt exhausted and nauseated. On day 11 I was depressed and on day 12 I thought about killing myself.

“I'm 49 years old and have never taken any drugs or had any type of mental illness. Chantix did help me not want to smoke.”

Some doctors have questioned whether quitting smoking alone might be enough to trigger depression. There is no doubt that nicotine withdrawal can produce irritability and other psychological side effects.

But many people who have quit before said their reactions to Chantix were unlike previous experiences of giving up cigarettes. One woman with bipolar disorder said: “I have stopped smoking for three or four weeks before and NEVER experienced what I did with Chantix. I think the makers of this med need to do more research on this before they just start tossing it out to people, especially the ones with a history of a mental disorder.”

Now the FDA has issued an early communication about the safety of Chantix: “FDA has received reports of suicidal thoughts and aggressive and erratic behavior in patients who have taken Chantix, a smoking cessation product…A preliminary assessment reveals that many of the cases reflect new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment.”

The agency has not determined whether Chantix is actually responsible for such symptoms, but it encourages health care professionals to “monitor patients taking Chantix for behavior and mood changes.” The FDA also recommends that “patients taking Chantix should contact their doctors if they experience behavior or mood changes.” Another part of this communication has to do with possible drowsiness impairing driving while taking Chantix.

Quitting smoking is one of the most important things a person could do for her health. It is also one of the hardest. If Chantix can help without causing devastating side effects, it is a welcome tool. But some people may not tolerate this drug. For them, other strategies will be more appropriate.

Leg cramps hurt like hell. They can wake you up out of a sound sleep and make you scream in agony. The pain can bring tears to the most stoic individual.

What causes such cramps remains mysterious. And doctors have very little to offer as treatment. They used to prescribe quinine, an anti-malarial drug derived from the bark of a South American tree. But earlier this year the FDA banned the use of quinine for leg cramps. Quinine can sometimes cause life-threatening blood disorders as well as serious allergic reactions or heart rhythm disturbances.

Without quinine, physicians have no approved drugs for patients in pain from leg cramps. Some doctors prescribe Valium (diazepam) or anti-seizure drugs like Tegretol (carbamazepine) or Dilantin (phenytoin). Such medicines have side effects, however, and none have been approved by the FDA for this purpose.

So, what’s a patient to do? For years, we have been telling people about the power of putting a bar of soap under the bottom sheet of the bed in the neighborhood of the legs. It makes no sense, but hundreds of readers tell us it works.

Recently we were taken to task: “You folks are ridiculous, superstitious and ignorant. How can you recommend a bar of soap under the bottom sheet for leg cramps? It's just plain dumb. Please spare us such silliness.”


At first we felt chastised. But then our readers came to the rescue: “The individual who complained about the silliness of soap under the bed sheet to prevent leg cramps has never had them—especially on the inside of the thighs!


“When I read about this remedy in your column, I too was a doubter. But my niece who is a nurse said, ‘You will laugh, but I hurt so bad I would try anything.’ She was amazed to find out it works wonders.


“I tried it too and have been without leg cramps. I also get cramps in my hands and find that holding a bar of soap between them makes the cramps disappear.”


Another reader won her husband over: “One night my husband was having a really bad leg cramp. I offered the extra bar of soap that I keep on my side of the bed on my nightstand. He asked me why I would offer SOAP during his PAIN!

“I asked him where the pain hurt worst, slipped the bar of soap under that spot and in seconds, mere seconds, he stopped his moaning and said, ‘WOW.’

“I keep two bars under the bottom sheet at all times to help prevent restless leg syndrome. After a while they lose their effect. Just replace them for a dollar or so. Many brands work. I have used hotel soaps while traveling.”

Some people prefer different home remedies, such as yellow mustard or low-sodium V-8 juice. Like soap, none of these approaches has been scientifically proven, but neither have medications other than quinine.

We have collected the most popular remedies, from stretching exercises to tonic water or baking soda, in our Guide to Leg Pain. It can be downloaded for $2 from this Website. Go to “Buy In Depth Guides.”

 
When a child has a drippy nose or a nasty cough, parents are caught in a bind. They want to do something to ease cold symptoms, but pediatricians and now the FDA warn against giving kids cold medicines.

Research shows the drugs in such formulations are not effective for kids. There is also concern that some children may suffer side effects. In fact, although it’s rare, there have been serious reactions and even deaths reported to the FDA.

Pseudoephedrine, a decongestant that used to be popular in cold medicines, is available behind the counter. Adults rarely have problems with this drug, but children may experience visual hallucinations of spiders, insects or snakes.

The oral decongestant phenylephrine has now replaced pseudoephedrine in many cold medicines. It may be less likely to produce hallucinations in children, but there isn’t any convincing data that it is very helpful.

An expert panel for the FDA has recommended that the agency not allow such products to be sold for children under the age of six. Pediatricians and lung experts have been telling parents for years that OTC cough medicines don’t work for children and do pose hazards. The FDA has been slow to act.

Millions of kids have been treated with ineffective and potentially harmful cold medicines for decades. It’s hard to imagine a more vulnerable population than little children. And yet the watchdog agency has let them down.

Another question remains unanswered. How effective are cold and cough remedies for children over the age of six, teenagers or adults? We asked Dr. Ian Paul, a pediatrician at Penn State College of Medicine who has conducted research on cough and cold medicines, if these medicines are effective for anybody. He replied that there is very limited evidence that some of these medicines are effective even for adults with colds.

Most cold and cough medicines contain a conglomeration of ingredients, including pain relievers like acetaminophen or ibuprofen. As far as we can tell, there is no justification for including a pain reliever in cold medicine. Most colds do not cause pain and fevers are generally mild.

There are studies showing that medicines such as aspirin, acetaminophen and ibuprofen may actually increase viral shedding. That means a person might spread cold viruses to others more readily.

So what can you do if you catch a cold? Chicken soup remains a time-honored cold remedy supported by science, and it has no side effects. A dab of Vicks VapoRub on the soles of the feet may help a nighttime cough. (Socks help keep sheets clean.)

Although most home and herbal remedies have not been tested any better than some drugstore products, many readers report success with Chinese botanical medicines such as astragalus or andrographis.

We have collected a number of alternative approaches (and our favorite chicken soup recipe) in our Guide to Cold Remedies.
 

Cheap Drugs May Be No Bargain

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“Made in America” used to be both a sign of quality and a source of pride. But Americans care much more about saving money. That’s why so many of our consumer products—from clothes to electronics to toys—are coming from China and other low-wage countries.

We’ve learned the hard way that such products may not always meet safety standards. Lead in toys, for example, has led to a number of recalls. Toothpaste contaminated with antifreeze alarmed Americans for a few weeks, but not enough to change buying habits.

Most people assume that their medicines are still made in America. Nothing could be further from the truth. Experts estimate that 80 percent of the active ingredients in our prescription drugs come from abroad. Increasingly, this means India and China.

According to Marc Kaufman of the Washington Post, “Neither country has a strong drug regulatory agency.” The former head of China’s Food and Drug Administration was executed a few months ago because he accepted bribes from the companies he was supposed to be overseeing.

Don’t count on our FDA to protect you, though. The U.S. watchdog agency doesn’t have the budget or the manpower to inspect more than a handful of the hundreds of manufacturing plants in Southeast Asia. This year the FDA only plans to visit 13 out of 714 drug firms in China.

Often, FDA officials don’t even know where to look. Some senior FDA officers have said there are 2,100 companies that would need inspection. The Government Accountability Office estimates that nearly 7,000 companies will export pharmaceutical materials into the U.S. in 2007.

What difference does this make? In some cases, manufacturing overseas may meet high standards. A former pharmaceutical industry executive told us that the plants he has seen in India rival those in this country. But there have also been reports of drugs or ingredients being made in sub-standard overseas facilities that manufacture industrial chemicals, with no oversight to prevent contamination.

Generic drugs may be especially likely to contain imported ingredients. The whole point of generics is to save money. To get the price down below the competition, small U.S. generic drug companies may seek the cheapest chemicals abroad and do little testing.

Over the last several years we have received thousands of complaints about generic drug quality. You can read some of the messages by going to www.peoplespharmacy.com. Here is one example:

“I have ventricular fibrillation and have an implanted defibrillator and pacemaker. I was on Cordarone but when the generic came out I was switched over.

“Not long after I started taking generic amiodarone, I started having irregular heart beats and my defibrillator started shocking my heart. About $23,000 later, it was determined that the generic was not working for me and I was put back on Cordarone.

“My doctor had to write letters to the company to get them to permit me the brand name drug, but he could not convince them to give me the generic price.”

We have no way of knowing whether this reader’s generic drug contains ingredients from overseas. But the story indicates the potential hazard that can result if a generic is not identical to its brand name counterpart.

Pharmaceutical giant Pfizer recently announced it will stop selling Exubera, a relatively new inhaled insulin product. The tab for this marketing mistake is $2.8 billion, one of the biggest boondoggles in the history of the industry.

Exubera is not being yanked because it doesn’t work or has a known safety problem. It simply flopped in the marketplace. Too few patients decided to take Exubera, so it was cheaper for the company to stop selling it than to keep on manufacturing and marketing this medication.

The company was apparently surprised to learn that diabetics and their doctors weren’t exuberant about Exubera. If they’d asked patients at the outset, they might have avoided a $2.8 billion debacle.

If you start with incorrect assumptions, it’s hard to reach the right conclusion. Pfizer made two assumptions, both incorrect, about people with diabetes who use insulin.

First, Pfizer assumed that most diabetics find injecting insulin so unpleasant that they’d do almost anything to avoid it. Some people with diabetes would like an alternative to injection, but most don’t find modern insulin pens difficult or painful to use. In addition, insulin pumps are in widespread use. As a result, instead of two or more injections a day, many diabetics need to inject the tip of a slender plastic line under their skin just once every few days.

The second incorrect assumption was that people with diabetes would not be concerned about potential long-term health effects of blowing powdered insulin into their lungs for the rest of their lives. There is no data to suggest that this is a problem for otherwise healthy diabetics, but product testing is short term and doesn’t always reveal what may happen over years of use.

Smokers and asthmatics are warned against using Exubera. Even those without lung problems are cautioned to get regular lung function tests.

Exubera has other problems as well. It costs more, around $5 a day compared to $2 or $3 for injectable insulin. Exubera doesn’t work any better, though. The inhaler is large and cumbersome. It is challenging and time-consuming to adjust the dosage, especially since Exubera doses are calculated in grams. Physicians and patients alike are much more familiar with the international units (IU’s) used for all other insulin products.

Pfizer failed to get physicians excited about Exubera. As a result, many weren’t willing to take the extra time needed to teach patients how to use inhaled insulin properly.

Pfizer’s stockholders are no doubt disappointed by the $2.8 billion loss, and perhaps equally upset by not making the projected $2 billion Pfizer had foreseen for this product. Some people worry that the tab for this marketing mistake might one day be added to the cost of other medications in the company’s portfolio. That means patients could pay for this miscalculation.

Other companies should pay attention to Pfizer’s faux pas. If drug company executives had bought dinner for groups of people with diabetes and their physicians they could have asked them what they thought about inhaled insulin. This might have left Pfizer execs breathless, but saved the company billions.

If you’ve been reading headlines this fall you are likely confused about flu shots. Several weeks ago you were told: “Proof Lacking for Flu Vaccine,” or “Flu Vaccine Mortality Benefits For Elderly Vastly Overstated.”

One week later headlines proclaimed: “Flu Shots for Elderly Are Effective,” and “Flu Shots Halve Risk of Death, Cut Illness in Elderly.”

So which is it? These contradictory reports can’t both be right. The trouble is that there is not enough data to know for sure. Experts have been arguing about this issue for decades.

Last year an article in the British Medical Journal (Oct. 28, 2006) suggested that flu vaccination for healthy people under 65 “did not affect hospital stay, time off work, or death from influenza and its complications.”

Public health officials worry a lot more about older people, of course. That’s because they are especially vulnerable to death from influenza or its complications. Scientists have found that older people do not mount as strong an immune response to the vaccination as younger people.

A recent pair of studies has created consternation because of conflicting conclusions. An analysis in The Lancet Infectious Diseases (Oct. 2007) concludeed that vaccinating frail elderly people has not been shown to protect them from influenza death. Even though a majority (65 percent) of senior citizens now get a flu shot each year compared to 15 percent in 1980, mortality rates from flu and pneumonia have not dropped.

This bleak outlook was challenged the following week in the New England Journal of Medicine (Oct 4, 2007). Researchers pulled together 10 years of data from health maintenance organizations. They found that older people who were vaccinated were 27 percent less likely to need hospitalization for influenza or pneumonia. The death rate was halved, according to this analysis.

The problem with both studies is that they depend on observational data instead of placebo-controlled trials. The gold standard for scientific evidence is from experiments where one group gets an active shot and the other receives an inactive saline injection. Such studies are expensive and many public health officials worry that they would be ethically questionable. Depriving elderly patients of a flu shot is considered immoral.

Without such data, however, experts have to sort through statistical tea leaves trying to determine how well flu shots work. We may never know how effective flu immunization really is for the elderly.

There are some other options that may help this flu season, though. These include antiviral flu drugs such as Flumadine or Tamiflu that can be taken to speed recovery.

Vitamin D is also important for a strong immune system. It increases production of a natural infection-fighting chemical that can help ward off illnesses caused by bacteria, fungi and viruses, including influenza. Levels of vitamin D frequently drop in the winter when people don’t go out in the sun. Many elderly people don’t get outside even in the summer and are deficient in vitamin D year round.

That may be why grandmothers used to insist on dosing the family with cod liver oil. It is rich in vitamin D. People who don’t like the flavor might want to take a supplement instead.

For decades the FDA has been telling everyone—physicians, pharmacists and patients—that generic drugs are just as good as their brand name counterparts. According to the feds there’s no need to worry about quality control just because a generic medicine costs 50 percent less than the original. As for the $4 generics at big-box discount chains, celebrate, don’t hesitate!

Everyone loves a bargain—consumers, hospitals and especially insurance companies that have to pay big bills for brand name drugs. That is why generic medications are starting to dominate drugstore sales.

But are generics as good as the FDA claims? Over the last few years we have been hearing from more and more consumers that they are sometimes disappointed with the effects of certain generic drugs.
M.C. wrote to tell us: “My doctor prescribed Toprol-XL several years ago to control hypertension. All went well. Last week my pharmacist refilled my prescription with generic metoprolol succinate. Within two days my blood pressure was sky high--190/100. This has never happened before, so there may be a problem with this generic for Toprol-XL.”

This report is worrisome, especially since we have heard from other patients who experienced heart rhythm abnormalities when switched to the generic form of Toprol-XL. We have also heard from hundreds of people who have been distressed when switched from the brand name antidepressant Wellbutrin XL 300 to a generic.

One person recounted his experience: "Several months ago I switched over to generic Wellbutrin. Within two weeks I experienced the worst case of depression that I can remember. I had the most severe suicidal thoughts ever.

“I had experienced suicidal thoughts before but this time I actually wrote a letter to my therapist and sent it to an email account that would not be found until after the fact. Fortunately, I called him about 30 minutes later and he reminded me of a story   we had talked about in the paper a few weeks earlier about another person who had gotten extremely depressed after switching to the generic.

"I immediately called my pharmacist and got a refill of the regular Wellbutrin. Within a few days I was fine. This ordeal was incredibly frightening.”

Other readers have reported side effects with the generic bupropion (Budeprion XL 300) that they did not experience while taking Wellbutrin XL 300. Some complained of headaches and nausea while others noted anxiety and insomnia.

These are side effects that might be expected if a person got a high dose of bupropion. We asked ConsumerLab.com, an independent testing organization, to analyze the pills. Laboratory tests revealed that “the generic product released drug at a very different rate than the original Wellbutrin XL.”

The news release is available online at www.peoplespharmacy.com. People can post generic drug experiences there and read other people’s stories. The full report is available at www.ConsumerLab.com.

The manufacturer of generic Budeprion XL 300 has responded that its product meets FDA standards. That may be true, but many consumers have noted a difference in the clinical effect. Although the FDA assures us that its approval process for generic drugs is rigorous, we are beginning to wonder whether it is good enough.

Once upon a time you could buy just about anything at the neighborhood drug store. “Doc,” as the pharmacist was called a century ago, could dispense medications like marijuana or opium. The neighborhood pharmacist was frequently consulted about a range of health problems and provided advice on how to use the remedies he dispensed.

Eventually the Food, Drug and Cosmetic act of 1938 limited the sale of dangerous drugs to prescription-only status. But the definition of dangerous is surprisingly arbitrary.

Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen and naproxen were prescription drugs for years. Such pain relievers can cause serious side effects such as bleeding ulcers or high blood pressure and may even increase the risk for heart attacks or strokes.

These NSAIDs were eventually given the green light to go over the counter under brand names such as Advil and Motrin IB (ibuprofen) and Aleve (naproxen). Now anyone can buy these drugs in huge quantities.

With the stroke of a bureaucratic pen, the FDA changed the public perception of these medications. One day they were potent prescription pain relievers with serious side effects. The next day they were mild nonprescription headache remedies.

Americans tend to think of over-the-counter drugs as wimpy. They are not perceived as powerful as their prescription cousins and they’re also not seen as potentially dangerous.

Surveys have shown that less than one out of five consumers actually reads the information on NSAID drug labels. As a result, many people are unaware of the proper dose and possible side effects.

The FDA faces a difficult balance between making helpful drugs more easily available and making sure people know how to use them safely. That’s why the agency is beginning to look around the world to see how other countries handle this dilemma.

The solution appears to be a return to the old days when the pharmacist played a far more active role in dispensing drugs. Many countries including Australia, Britain, Canada, Denmark, France, and New Zealand allow pharmacists to dispense certain medications from behind the counter.

For example, the cholesterol-lowering drug simvastatin (Zocor) is available in England without a prescription. Pharmacists can perform a blood test in the pharmacy to see if a person would benefit from this medication. Advice and warnings are given in person and the pharmacist is available to answer questions.

If the FDA adopts this model, it could open the door to behind-the-counter sale of antiviral herpes medicines such as Zovirax (acyclovir) or Valtrex (valacyclovir). Other possibilities could include drugs for the flu such as Tamiflu (oseltamivir) or Flumadine (rimantadine).

In truth, this system has already begun. Decongestants containing pseudoephedrine do not require a prescription but can only be purchased by speaking with a pharmacist. The morning after pill (Plan B) is also only available from behind the counter.

If pharmacists actually counseled people on how to use medications properly, there might be fewer complications. Behind-the-counter dispensing could make many useful medicines readily available in a safer fashion.

Does anyone like prescription drug ads on TV? We've taken several informal, unscientific polls and discovered that no one we know seems to like commercials about erectile dysfunction, overactive bladder or prostate enlargement.

Most people we ask express annoyance at best and outrage at worst. Parents have complained that some ads give rise to uncomfortable questions from young children.

There are only two countries in the industrialized world that permit this sort of direct-to-consumer (DTC) advertising of prescription drugs: The United States and New Zealand. The European Union expressly forbids this kind of promotion.

Congress recently contemplated restrictions on such drug ads. Legislators considered giving the FDA power to restrict advertising for drugs that have serious safety concerns.

They were encouraged to do so by a report issued last year by the prestigious Institute of Medicine. The scientists recommended that the FDA should require a special warning symbol for new medications during their first two years on the market and prohibit DTC promotion during that time.

Instead of beefing up oversight, though, Congress only gave the FDA the right to review ads before they are aired. The agency can make recommendations for changes, but has no authority to actually require ad agencies to redo commercials.

What happened on the way to the big vote? Pharmaceutical companies, advertising agencies and media lobbyists all objected to tougher regulations on drug ads. More than $5 billion was spent on prescription drug advertising in 2006.

Television broadcasters and magazine publishers have come to rely on this revenue. According to the Wall Street Journal, pharmaceuticals were the 10th biggest advertiser in 2006 and growing fast. Nobody wants to kill or even slow down the goose that is laying so many golden eggs.

The media lobby worked hard to convince Congressmen that drug ads provide valuable information for consumers. They also portrayed commercials on TV as a free speech issue. Under such lobbying pressure, legislators caved.

One reason the pharmaceutical industry keeps spending so much on advertising to consumers is that it works. People who see ads for Vytorin to lower cholesterol, Lunesta to counter insomnia and Boniva to build bones often ask their doctors for a prescription.

Even though doctors may not like having patients request specific drugs, they frequently go along with the program and write a prescription. Although consumers may complain about having to watch people in bathtubs waiting for their Cialis moment, for example, many viewers are obviously following instructions to ask their doctors for a prescription for a medicine they see on TV.

Consumers seemingly ignore the list of potentially serious side effects that are often read quickly while the onscreen picture shows someone having fun. Warnings about drug-induced complications such as severe heartburn, cataracts, glaucoma, osteoporosis, hemorrhage or even heart attack don't seem to faze viewers.

Next time you find yourself watching a commercial for a prescription medication, ask yourself whether the information is really helpful. If not, perhaps it is time to exercise your own first amendment right to free speech and tell your legislators what you think about DTC ads.

 

Messing with Mother Nature sometimes leads to unintended consequences. This is especially true when it comes to your body.

Drug companies are quite adept at developing medications that make us feel better. They often have a harder time dealing with the fallout of their efforts.

Take decongestant nose drops, for example. Anyone with a stuffy nose will tell you it is a very uncomfortable feeling. Congestion can be brought on by a cold, allergies or a sinus infection.

Pharmacies sell lots of nasal sprays like Afrin (oxymetazoline) and Neo-Synephrine 4-Hour (phenylephrine). Such drugs are effective because they constrict blood vessels in the nose. Used for a couple of days, they can relieve symptoms with relatively few side effects.

But if you use a nasal decongestant spray for more than a few days, your body begins to compensate. The tiny blood vessels in the lining of the nasal passages try extra hard to bring blood to the tissues that have been deprived. As the medication wears off, the blood vessels dilate and cause rebound nasal congestion.

This can lead to a vicious cycle. We have heard from readers who were so dependent on their Afrin nasal spray that they kept containers under their pillow, in the car and on their desk at work. They may keep on using the spray long after the cold or allergy is gone, sometimes even for years.

The same thing can be true for acid-suppressing drugs. Medications such as Aciphex, Nexium, Prevacid, Prilosec and Protonix are best sellers in the pharmacy. They are known as proton pump inhibitors (PPIs). These drugs are very helpful for healing ulcers and can also ease symptoms of serious heartburn (acid reflux).

The body, however, seems to think that acid in the stomach is a good idea. Just as the blood vessels in your nose dilate after repeated use of a vasoconstrictor, so too the cells in your stomach lining work extra hard to make acid when repeatedly exposed to one of these powerful medications.

If a PPI is discontinued abruptly, acid-making cells go into overdrive, sometimes for weeks or months. Rebound acid production is a lot like rebound congestion. The resulting discomfort makes it hard not to start using the medication again.

One reader wrote: “I have been taking Protonix for heartburn for about six months. After learning of potential ill effects from long-term use (weak bones or pneumonia), I tried to stop taking it. After about a week, I had to start taking it again due to severe heartburn--the rebound effect, I suppose. I asked my pharmacist how one should discontinue use, but she was unable to find out.”

There is very little information about how to stop taking PPIs. Some doctors suggest gradual dose tapering and using weaker drugs such as Tagamet, Pepcid or Zantac during the transition.

A leading expert on natural medicines, Tierenoa Low Dog, MD, has had success helping patients with this problem by using a natural licorice compound called DGL (deglycyrrhizinated licorice). You can listen to Dr. Low Dog discussing the issue at www.peoplespharmacy.com.

Before you start taking medicine, find out how and when to stop. Sometimes getting off a drug can be harder than you expect.

Americans love to plug and play. Reading instructions takes time and is incompatible with our fast paced life.

Does anyone bother to read the instruction booklet that comes with a cell phone? Most people just want to hit the buttons and talk.

When it comes to prescriptions, all most folks want to do is pop the pills. Reading the stickers on the bottle may seem like a waste of time.

Even if you want to be a conscientious consumer and take your medicine correctly, the label that is stuck on your prescription medicine container can be awfully hard to read. You might need a magnifying glass to make out the small print.

A recent study of prescription drug containers found that the warnings and instructions, which might be considered among the most important information on the label, were in the smallest type (Archives of Internal Medicine, Sept. 10, 2007).

The warning stickers were often slapped on the bottle haphazardly in a different direction from the rest of the label, making them hard to read.

The researchers had doctors in four different cities write identical prescriptions for Lipitor, Fosamax, Bactrim and ibuprofen. They were filled in six different pharmacies in each city.

There was a huge variability between pharmacies, especially with regard to warnings and instructions. For example, only 14 of the 24 bottles of the osteoporosis drug Fosamax had directions that the patient should not lie down for at least 30 minutes after swallowing the pills. This instruction is critical for preventing serious injury to the esophagus.

In the case of the pain reliever ibuprofen, only 15 percent of the bottles cautioned patients to avoid aspirin. Fewer than a third warned that this drug can cause drowsiness or dizziness. A medication guide required by the FDA gives more information on the safe use of ibuprofen, but not a single prescription for this anti-inflammatory drug included it.

It should be obvious that a small pill bottle is not the optimum way to transmit critical information about the correct use of medicine. The researchers observe that patients should be counseled more completely by doctors or pharmacists, but in practice this rarely occurs.

One way to get this essential data is to ask for it. Have your physician and pharmacist fill out a detailed checklist for each medicine you take. We have created a Drug Safety Questionnaire you can give to your health professionals to organize this information. It is available for free at www.peoplespharmacy.com.
Over-the-counter medications also pose a problem. Although the FDA specifies warning information for many nonprescription drugs, it too is frequently hard to read. Perhaps that’s why a previous study found that very few consumers—less than 20 percent—actually read the instructions on the labels of OTC pain relievers like ibuprofen or naproxen (Journal of Rheumatology, Nov. 2005). As a result, nearly half of those questioned took too high a dose of these medications.

It’s time for people to take their medicine seriously. Over a million medication errors occur each year, leading to serious illness, disability and death. Clear and complete information could save lives.
 

Everyone knows you are supposed to eat right to stay healthy. That usually translates into lots of vegetables, fiber, low-fat dairy products and fish instead of red meat. Reducing sodium by avoiding table salt and processed foods is considered the Holy Grail of a healthful diet.

This is all very good advice if you want to live to a ripe old age. But what if you already have achieved that milestone?

We recently received the following question from a reader: “I accompanied my 91-year-old mother to her doctor this morning. He seems great: young, energetic and interested. He's treating her for degenerative arthritis and gave her a cortisone shot for her shoulder.

“I asked him what she should be eating and he said ‘Oh, I let everybody over 90 eat whatever they want.’

“Later I said to my mother, ‘Well, if you want to live to be 100, it would be good to eat carefully and take appropriate supplements.’ I wonder what you think about her doctor’s cavalier attitude regarding her diet.”

We actually side with your mother’s physician. When you reach a certain age, there should be relatively few restrictions. There isn’t a lot of data on what a 90-something should do to stay healthy. Most physicians assume that they should do the same things younger people do, but that may not be true.

For example, lowering cholesterol does not appear to provide the same survival benefit for people over 80. In fact, there is even some data to suggest that older people with low cholesterol don’t live as long as those with higher levels (Archives of Internal Medicine, May 10, 1993).

We hear from too many older people that the quality of their lives has been compromised by side effects from cholesterol-lowering drugs. Someone who is 80 or 90 should not be crippled by muscle pain or weakness just to lower cholesterol. That’s doubly true since there is little, if any, evidence that there will be substantial benefit.

Sometimes, strict adherence to rules can be counterproductive. Dr. Peter Lamy, a world-renowned expert in geriatric pharmacology and nutrition, offered the following anecdote:

“A 73-year-old man told me this story. His father is a 93-year-old immigrant from Russia, who likes pickles, salted herring, borscht, and other good, salty foods. His new physician cautioned him strongly: ‘How can you eat those foods? Don't you know they contain salt, and salt is a risk factor?’

“The 93-year-old man, trained to respect authority, was in fact told not to eat the foods he likes because of the potentially life-shortening risk factor. What we have now is a not-so-healthy 93-year-old because he does what the physician tells him and a 73-year-old son trying to get his father to eat.” (Currents: Journal of Food, Nutrition & Health, 1985).

When you reach your 90s, you have already beaten the odds. At that age, it makes more sense to enjoy every day as it comes along rather than deprive yourself in an effort to extend your life a few more months or years. As a relative once said, “It’s not how long you live, but how you live that counts.”

Check your email and chances are you will find spam. Even with a filter to block out unwanted messages, some junk slips through. These ads frequently offer to enhance your sex life.

But what if you don’t want a more active sex life? We frequently hear from women who would prefer to dampen their partners’ desire: “Can saltpeter lower a man’s sex drive? If not, is there a natural herb that will?”

Saltpeter (potassium nitrate) has been used in fertilizer and fireworks. It was also used at one time to cure meats. Although it has a reputation for lowering libido, this is a myth. Potassium nitrate could be dangerous if consumed, however. It can cause kidney damage or anemia as well as headaches and digestive distress.

As for natural herbs to reduce libido, there is only one we know of. It is chaste tree berry (Vitex agnus-castus). This herb was known as “monk’s pepper” and was purportedly used to dampen libido in the Middle Ages.

Women aren’t the only ones who are interested in suppressing sex drive. One reader recently contacted us with this question: “I desperately need your help. Neither my primary doctor nor my psychiatrist is interested, so I turn to you.

“What can I take to reduce my libido? I have a lovely wife who for the last seven years has not been interested. She is the only person in my life. Your input on this would help keep me from driving myself nuts as well as her. I'm currently taking lithium, sertraline, lorazepam and trazodone. After the ridicule both doctors put me through, I certainly hope you can help.”

Your physicians should not be giving you any grief, especially since the combination of medicines you are taking could be hazardous. What’s more, trazodone may be aggravating your situation.

Ask a urologist or a specialist in sexual medicine whether a medication for prostate enlargement might be safe for you. Drugs such as Avodart or Proscar can sometimes lower libido as a side effect. That is because they block the conversion of testosterone to dihydrotestosterone (DHT).

Progesterone is another hormonal treatment that may be useful in suppressing sexual interest. This drug does have numerous side effects, however, so you will need to discuss it in detail with your physician. The herb Vitex appears to have a mild, progesterone-like effect and may be safer.

Counseling is essential, regardless of drug treatment. Although your wife is not interested, physical intimacy is usually part of a wholesome relationship. Invite your wife to join you in therapy with an expert who specializes in human sexuality.

We would like to send you a CD of a recent hour-long radio show interview we did with one of the country’s leading experts in sexual medicine. Irwin Goldstein, MD, is Director of Sexual Medicine at Alvarado Hospital in San Diego and Editor-in-Chief of the Journal of Sexual Medicine. During the interview, he addressed problems of both high and low libido as well as erectile dysfunction and other sexual problems.

 

There is something about the sight of blood that really gets your attention--especially if it is your own. Stopping the bleeding can be a challenge.

When your father nicked himself shaving, the chances were good that he either tore off some toilet paper and stuck it to his chin or dug a styptic pencil out of the medicine cabinet. The aluminum sulfate (alum) in this old-fashioned item constricted blood vessels to stop the flow of blood.

Some new products on drugstore shelves go far beyond the styptic pencil. Whether it’s a nosebleed, a shaving nick or a kitchen cut, high-tech advances can stop the flow of blood surprisingly well.

QR products, sold by Biolife, have been available for a few years. There are formulations for cuts, lacerations and nosebleeds. They contain hydrophilic polymer powder combined with potassium salt which help blood clot quickly. Information is available online at www.biolife.com or by phone at 800-722-7559.
Another high-tech blood stopper is QuikClot Sport from Z-Medica (www.z-medica.com). It contains the mineral zeolite in a powdered formulation that absorbs water quickly. This concentrates the natural clotting properties of blood. QuikClot has been used by the military in Afghanistan and Iraq where it is credited with saving lives on the battlefield.

There are also bandages and gauze that can stop bleeding more quickly than the old-fashioned variety. Some contain cellulose, which forms a gel in contact with blood. Look for BloodSTOP gauze from LifeScience PLUS (www.lifescienceplus.com). CVS pharmacies also sell BloodStop Sheer Bandages.

Another interesting product for nosebleeds is called NasalCEASE (www.nasalcease.com). This biopolymer releases calcium and helps control a nosebleed quickly.

In the event you don’t have one of these new products available the next time you need to stop a minor cut or nosebleed, you may want to resort to a home remedy. Readers of this column have shared some amazing stories. Glenda, a veteran teacher, sent this one:

“I was teaching in a rural school in South Georgia with 120 first graders and four teachers. Kids played hard in the heat and humidity and many children came in with nosebleeds.

“I tried the old methods of squeezing their nostrils and having them hold their heads back while sitting quietly or putting ice on the backs of their necks to try to stop the bleeding. One day an elderly custodian who had lived in the south all of her life said to me, ‘You Yankees don't know how to do much, do you?’

“She took out her car keys, tied some string through the key ring, placed the string around the neck of the child with the nosebleed and dropped the keys down the child's back under her shirt. That nosebleed was no longer a frightening problem for the child or the teachers trying to help! For the next 15 years I treated nosebleeds as Daisy showed me and never had a problem again.”

For minor cuts, ground black pepper helps: “I sliced my forefinger instead of my bagel this evening. Fortunately, the pepper was in easy reach. It took 3 applications to finish the job, but the bleeding stopped.” One advantage of black pepper is that you don’t have to rush to the drugstore when you need it.

 

Americans are justifiably bewildered. On the one hand they are told to “take your medicine—it’s necessary to maintain good health.” On the other, they read that many of their medicines may cause the very problems they are trying to prevent. Some drugs may trigger troubles they never even imagined.

The asthma drug salmeterol (found in Advair and Serevent) is supposed to improve lung function for people with this serious breathing problem. But in recent years physicians have been warned not to use this drug as initial treatment for asthma. It may increase the risk of serious asthma attacks and asthma-related deaths.

Pain relievers like ibuprofen and diclofenac may raise blood pressure and increase the risk for heart attack or stroke. Some data even suggest that such nonsteroidal anti-inflammatory drugs are not very effective over the long term against osteoarthritis of the knee. NSAIDs might even accelerate joint degeneration.

After years of foot dragging, the FDA now warns that antidepressants might prompt suicidal thoughts in some vulnerable patients.

Heartburn drugs that suppress acid such as Aciphex, Nexium, Prevacid or Prilosec have become incredibly popular. But recent reports have linked long-term use of these drugs to an increased risk of hip fractures (Journal of the American Medical Association, Dec. 27, 2006) and pneumonia (Archives of Internal Medicine, May 14, 2007).

The most recent example of a confusing drug dilemma involves the diabetes medicine Avandia. On July 30, 2007, the FDA convened a panel of experts to make sense out of the murky data surrounding this popular medication. Diabetes doctors and drug experts determined that Avandia increases the risk of heart attacks. This medicine also carries a clear risk for heart failure.

One FDA safety officer, David Graham, MD, encouraged the agency to take the drug off the market. According to his calculations more than 200,000 people might have suffered heart attacks or strokes from this medicine. He estimated that for every month it remains on the market as many as 2,200 patients may suffer a serious cardiovascular complication.

Nevertheless, the assembled experts recommended that Avandia stay on the market. They encouraged the FDA to strengthen the warning on the label, however.

This mixed message leaves physicians and patients in a quandary. On the one hand, diabetes drugs are supposed to prevent the complications of diabetes. That means lowering the risk for heart problems. Taking a drug that might increase this risk seems counterintuitive.

Doctors may wonder why patients have become skeptical about new drug breakthroughs. The Vioxx and Avandia spectacles have made some people question whether they are guinea pigs in huge drug experiments.

New drugs are usually promoted aggressively. Sometimes older medications are safer solutions. There are many ways to treat arthritis, depression, diabetes, heartburn and high cholesterol. Surprisingly, even inexpensive home remedies are sometimes helpful. We discuss many alternate approaches in our book, Best Choices From The People’s Pharmacy. It is also available in public libraries and bookstores.

Millions of people swallow a little white oblong pill called Lipitor every day. Others take Zocor, Crestor or some other statin-type cholesterol-lowering drug.

These medications work extremely well to lower bad LDL cholesterol. They prevent heart attacks and strokes. For those who do not suffer side effects, such medicines are indeed lifesavers.

For others, though, adverse reactions can make life miserable. When physicians treat numbers instead of people, quality of life can suffer. One reader shared the following story:

“Three years ago my father (now 85) was placed on Lipitor as a treatment for elevated cholesterol. After hearing a report that higher doses could reverse arterial narrowing, his physician doubled his daily dose. Within a month, my father began experiencing progressive weakness in his legs along with bad balance. His condition worsened over the next six months but his physician discounted the problems as due to aging.

“Before taking Lipitor, my father had exceptional strength and stamina for a man of his age. Each day he played 18 holes of golf, walking the entire distance and wheeling his golf clubs behind him. His mind was clear and he had a vibrant sense of humor.

“After six months on Lipitor, my father was diagnosed with Primary Lateral Sclerosis. His doctor stopped the Lipitor but then prescribed a series of other statin drugs. He is currently taking Vytorin. His condition has continued to deteriorate over the past few years and his symptoms now include: severe loss of muscle mass in his legs, weakness, lack of balance with frequent falls, difficulty swallowing, memory loss, dementia, emotional swings, incontinence, depression and erectile dysfunction.

“He has been transformed from a man who embraced life to its fullest into a person who must use a cane to walk and who is now filled with despair and hopelessness. I am convinced that my father's abrupt change in health can be attributed to his use of statins. He has finally decided to discontinue his statin usage despite his doctor's denial of their possible link to his condition.”

Many physicians chalk up this kind of story to coincidence. With so many people on statins, they reason, some are bound to experience unrelated health problems. But we have also heard from many people who got better when they discontinued a statin-type medication.

“I started taking Zocor about six months ago. I gradually developed leg, hip and back pain. I also noticed increasing fatigue and loss of stamina. At the gym I had increasing difficulty doing the same exercises I had performed for more than a year. Going to the supermarket with my wife also became more difficult with increasing discomfort in standing and walking on a concrete floor.

“After discussing these symptoms with my doctor I stopped taking Zocor. The symptoms began to dissipate and have almost completely disappeared.”

When drug side effects interfere with a person’s ability to exercise or socialize, the balance of benefit to risk should be re-evaluated. To read more reports of serious side effects from statin cholesterol-lowering drugs or share your own experience, go to: www.peoplespharmacy.com.

People will do almost anything to save a buck. They clip coupons, drive miles out of their way to get cheaper gasoline and line up at the crack of dawn for special sales.

Not surprisingly, most people are more than happy to save money on pricey prescriptions by taking generic medicine. Insurance companies coerce patients into accepting generics by charging substantially lower co-pays for such pills. In some cases, they charge four times more for a brand. An insurance company may even refuse to pay at all for certain brand name medications.

The FDA insists that the inexpensive generic drugs it approves are just as good as the pricey brand names they replace. If people complain that they experience problems with generic drugs, we are told that it is all in their heads. FDA officials believe that people expect a certain color and shape and become upset when the pills look different.

We think the problem is far more complex. Plenty of readers tell us that they are thrilled to get a generic drug at one-third the cost, as long as it works. When it doesn’t, however, people become angry. Here are just a few of the stories that have been posted to our Web site:

“I got switched to the generic Wellbutrin XL and endured one month of hell. My world crashed and suicide began to feel inevitable. Fortunately, between my psychologist and my clinical nurse specialist, we determined that the issue may have been the generic drug. Within three days of returning to Wellbutrin XL, my life was returned to me. This was a VERY scary experience! I now have to pay $45/month instead of $10/month, but I really don't have a choice. This particular generic is too dangerous for me!”

Another reader had a similar experience: “After some devastating life events last year, my husband and I were put on Wellbutrin. It was very effective. Not long ago we were switched from Wellbutrin XL to the generic. We both inexplicably gained weight. He got night sweats and I'm experiencing insomnia. We are both anxious and depressed.

“I'm sorry others have also gone through this, but I’m glad to know it isn't all in my head as my doctor seems to think. The generic costs $10 for 30 pills. It will be $110 for Wellbutrin. Who can afford that? The generic is ineffective and could cost someone his life.”

An antidepressant that leaves people suicidal is no bargain, regardless of how little it may cost. Neither is a sleeping pill that leaves folks tossing and turning: “I have been on Ambien for several years. When I went to pick my latest prescription up at the pharmacy, I was told I would be receiving the generic. I was happy about that because it was cheaper.

“I took the pill at my usual time, 9:00 PM. I am usually asleep by 9:30, but I was still wide-awake at 2:30 AM. I slept at most 2 hours. These generic Ambien are nothing like the real thing.”

We wish we could rely on the FDA’s reassurance that generic drugs are just as good as brand name products. Unless the agency starts monitoring drugstore shelves for quality, consumers are on their own. Anyone who would like to report a generic drug problem may do so at our Web site: www.peoplespharmacy.com.

If there were a medicine that could make your blood vessels more flexible, lower your blood pressure, prevent blood clots and improve insulin sensitivity, it would be phenomenally successful. The company that produced this wonder drug would likely charge an arm and a leg for it. Your doctor would prescribe it enthusiastically.

There is such a drug, but your doctor doesn’t prescribe it and might even chastise you for consuming it. That’s because the drug is dark chocolate.

Many health professionals tend to have a puritanical streak, so if something tastes too good, they get nervous. That’s why we get scolded every time we write about the health benefits of chocolate.

More than a year ago we described a Dutch study showing that older men who ate chocolate were 50 percent less likely to die of a heart attack during the 15 year follow-up (Archives of Internal Medicine, Feb. 27, 2006).

It didn’t take long for someone to object: “You are irresponsible to suggest that chocolate has health benefits. Chocolate is high in calories and full of fat and sugar. Anyone who eats chocolate should not be kidding himself that it’s good for him.”

This spring, newscasts reported that a review of randomized controlled clinical trials showed significant blood pressure lowering benefit from chocolate. Again, the naysayers responded quickly: “A lot of press attention has been given to the benefits of dark chocolate for lowering blood pressure. But the average systolic pressure was only lowered 5 points and the diastolic pressure by about 3 points. These numbers are hardly anything to get excited about. Why are people so enthusiastic?”

While it is true that these numbers don’t indicate a dramatic change, even standard blood pressure pills don’t lower blood pressure much more than that. A study in the Journal of the American Medical Association (Nov. 10, 2004) found the popular medications Norvasc (amlopidine) and Vasotec (enalapril) lowered systolic pressure by 5 points and diastolic by about 2.5 points.

A new study published in the Journal of the American Medical Association (July 4, 2007) confirms that dark chocolate can indeed lower blood pressure. The difference in the new research is that it only took a little bit of chocolate.

Many previous studies ran for just a few weeks and volunteers were given 100 grams of chocolate a day. That is quite a large chunk of chocolate. (Chocolate aficionados may recognize the size of a Ritter Sport square bar.) Weight gain would be a realistic concern.

The most recent study ran several months, but the volunteers got much less chocolate, just about 6 grams daily. Those 30 calories a day didn’t lead any of the volunteers to gain weight, but it was enough chocolate to reduce blood pressure.

Although the reduction was modest, it was enough to be clinically noteworthy. The investigators concluded that this effect would be enough to reduce the risk of stroke, heart attack and overall mortality in a population.

For people who want to learn more about selecting high-quality cocoa and want to enjoy chocolaty desserts with less fat and calories, we offer our cookbook, Chocolate Without Guilt. It is available online at http://ppcart.fountainshosting.com/p-247-chocolate-without-guilt.aspx.

In the 1960s Alka-Seltzer came up with a new reason for people to plop-plop and fizz-fizz. The company invented a new disease called the “blahs.”


It wasn’t exactly clear what the blahs were, though. The TV commercial described the blahs as kind of like the blues, only physical. If you were down in the dumps and not feeling right but you didn’t know what was wrong, you might have the blahs. Alka-Seltzer was the answer.


Ever since then, drug companies have been working very hard to convince Americans that there is a pill to solve life’s problems. Medications for anxiety and depression were developed to treat serious psychological disorders but they are often promoted and prescribed for people who are not mentally ill.


Life often deals us a bad hand. Sometimes we end up in a horrible job with the boss from hell. Other times we lose a job that we needed to pay the bills. Either of those situations could make us feel anxious and depressed.


Loved ones die. Marriages fall apart. When they do, it is natural to feel sad.


For thousands of years people dealt with such tragedies by calling on friends and family for help. Grieving was a normal part of life.


Now, though, we are frequently told that we need medicine to deal with emotions such as sadness and despair. Rather than pay for therapy that would allow people to talk about their loss and develop coping skills, insurance companies prefer a quick prescription.


A study in the Archives of General Psychiatry (April, 2007) revealed that many patients are misdiagnosed as depressed when in fact they are reacting normally to bereavement or other loss.


So what’s the problem? If you feel sad, why not take an antidepressant that might help you feel better?
For one thing, a diagnosis of depression goes in your medical record. It may negatively affect future job opportunities or insurability.


For another, not all antidepressants are innocuous. Side effects such as nausea, headache, nervousness, insomnia, dry mouth, diarrhea and sexual dysfunction can be troubling. What’s more, stopping certain antidepressants can be far more difficult than most people realize at the outset. One reader wrote: “A close friend was placed on Paxil following the traumatic death of a loved one. Now, three years later, he wants to get off this drug but every time he skips even one day or decreases dosage, he develops a sensation of water sloshing around in his head. He starts feeling so bad with the decreased dosage that he gets back on the prescribed amount. His doctor has been of no help.”


Others report symptoms such as night sweats, dizziness, electrical shock-like sensations in the extremities or the head, nausea, diarrhea, insomnia, alternating chills and perspiration and fatigue. When patients are prescribed antidepressants they are rarely warned about withdrawal difficulties.


Drugs can be helpful, but not all of life’s disappointments require a prescription. To learn more about non-drug approaches for depression, we offer our new book, Best Choices From The People’s Pharmacy.

A trip to the emergency room is stressful. The only reason you go is because of a health crisis. These days you almost have to be at death’s doorstep to make a trip to the ER. That’s because the waits can be interminable.

A few weeks ago we landed in the local emergency department of a major university hospital. Severe stomach pain and a fever turned out to be acute appendicitis. Although we arrived at 9:00 in the morning, the emergency surgery didn’t take place until 7:00 pm that evening. Ten hours in a little cubicle when you aren’t feeling well can seem like a very long time.

Actually, ten hours IS a long time! Some folks report even longer waits. We were admitted through the “fast track.” Imagine how long someone might have to wait if they were “only” dealing with bad sunburn or a severe headache.

When we left home we did not anticipate surgery or a stay in the hospital. Most people don’t think about staying overnight when they go to the local ER. But more than half of the people admitted to community hospitals for anything other than pregnancy come in through the emergency department.

Planning ahead can help prevent problems in the hospital. During a crisis it is hard to think straight. We were fortunate, though. We had reviewed a video several months ago: “Things You Should Know Before Entering the Hospital.”

Most important is having a patient advocate. When you are ill you cannot think clearly or ask tough questions. Your advocate can do that for you. When the surgical resident informed us that he would be doing the emergency appendectomy, we asked how many he had done. Then we asked to speak with the attending surgeon who would supervise. As a result, the more experienced attending surgeon did the operation.

The advocate also spoke with the anesthesiologist in detail about the patient’s previous experience with anesthesia. Consequently, lower doses and more thoughtful monitoring led to a much more rapid recovery from anesthesia.

The advocate was also paying attention to the hospital room post surgery. Half an hour after the patient was settled in, the name over the bed was still that of the previous patient. The advocate insisted that the name be corrected to prevent medication errors.

The Institute of Medicine reports that the average patient experiences at least one error every day he is hospitalized. The annual death toll from medical errors is estimated at up to 98,000 Americans.

Too often patients get the wrong drug or the wrong dose or incompatible medications. When you pick up your medicine at the local pharmacy you get far more information than you do when the nurse hands you a pill cup in the hospital. Your advocate can request details you may not be capable of evaluating.

Always take a detailed list of your medications and supplements with you whether you anticipate being hospitalized or you are going to the emergency department. This can help prevent drug interactions.

To learn how to prepare for a hospital stay, the DVD is available for $29.95 from www.PatientSafetyVideo.com.

You never know when you may need to hospitalized. Prepare ahead to prevent medical errors that could threaten your life.

The first email message in February piqued our interest: “I have been taking Budeprion XL 300 mg for 3 months instead of Wellbutrin XL 300 mg. I find that I am easily upset and cry very easily. Sometimes I feel aggressive. I also have short stabbing pains in my head.

“Taking the brand name drug (Wellbutrin) helped me feel the best I have felt in 20 years—not depressed and able to enjoy being with my family and friends.”

Wellbutrin XL is a long-acting antidepressant different from Prozac and SSRI medicines. The XL formulation from GlaxoSmithKline (GSK) is designed to be taken once a day to release a steady level of the active ingredient, bupropion, over 24 hours.

The patent on this pill recently expired and a generic version called Budeprion XL became available. Not long after, we started receiving letters and email messages about problems with Budeprion XL. At last count, more than 100 readers have reported their experiences with this generic drug.

One reader wrote: “I just had a nightmare experience switching from brand name Wellbutrin XL 300 mg to the generic Budeprion XL 300 mg, both extended-release. I have no history of ‘suicidality,’ but after switching to the generic, I went into a week of steadily rising panic. Then I hit rock bottom. I wanted to die.

“I made it through the worst of it, called a suicide hotline and didn't take any more Budeprion. The next day I felt much better and today I'm back to my normal self.

“I just saw my psychiatrist who said my reaction was almost certainly from a toxic dose of bupropion building up in my body. He says many of the generics are not absorbed or metabolized at the same rate as the brand name drugs, so you can get unpredictable effects. This one nearly killed me.”

We have no way to verify whether there is a problem with this generic drug. We notified the FDA of the messages we received. The agency assures us that it will analyze the drug and the reports it has received.

Anyone who would like to report a generic drug problem may visit our Web site (www.peoplespharmacy.com) and add comments to the growing list.

We have heard from several people that their depression returned when they started on the generic formulation. Another reader also became suicidal: “The pharmacy gave me Budeprion instead of brand name Wellbutrin. I steadily deteriorated into a suicidal crisis. I had never been suicidal before! My therapist gave me a new prescription for Wellbutrin and within a week, I was better.”

Others have reported side effects: “Soon after starting Budeprion I started having feelings of despair, hopelessness, disorganized thinking and anxiety, and fell into a depression. I have had physical problems as well: migraines of prolonged duration and greater intensity, sleep disturbances, night sweats, rapid weight gain, low energy and abrupt and painful changes in my menstrual cycle.  All of these changes coincide with my taking Budeprion instead of Wellbutrin XL. I have just resumed taking Wellbutrin XL and I am already feeling better and thinking more clearly.”

The FDA assures us that the approval process ensures that generic drugs are as good as their brand name equivalents. Our readers’ reports make us wonder if that is true.

Most doctors dismiss home remedies as unscientific at best or harmful at worst. They have a hard time understanding why anyone would choose an unproven folk treatment over an FDA approved prescription drug.

Several years ago a furious podiatrist chastised us for writing about remedies for toenail fungus: “There are real, doctor-prescribed, FDA-approved, clinically tested medications to treat toenail fungus. These include topical Penlac or oral Lamisil or Sporanox. I have successfully treated hundreds of patients with these drugs.
“The unproven treatments you mentioned are little more than urban legends. In 23 years in practice I have never seen even one patient who has responded favorably to Vicks VapoRub or dilute vinegar soaks. Don’t make me waste time dispelling these myths.”

While the podiatrist is correct that there are prescription drugs for nail fungus, he didn’t mention that these drugs are often quite expensive. The oral medicines also have side effects.

Lamisil, for example, may cost as much as $1200 for a full course of treatment (12 weeks). Sporanox can run more than $1600. Both drugs can be toxic to the liver and require medical monitoring. They can also cause digestive upset, rash or headache.

Neither drug is foolproof against nail fungus. According to the manufacturer of Sporanox, the success rate is 35 percent. That’s hardly anything to shout about.

Is it any wonder that people consider a remedy like Vicks VapoRub? The familiar blue jar costs under $9 and lasts for months. It won’t work for everyone, but a small study at Michigan State University found that daily applications of Vicks VapoRub cleared nail fungus in 32 of 85 patients. That’s as good as Sporanox at less than 1 percent of the price.

Doctors trust the FDA approval process to produce safe and effective medications. But patients are losing faith in the feds. Vioxx for arthritis and Avandia for diabetes have both reinforced the fear that long-term side effects may not show up for years. Vioxx increased the risk for heart attacks and strokes, while Avandia boosted the odds for heart failure.

It should be clear by now that FDA approval does not guarantee safety. Doctors should not be upset if people can get relief from arthritis pain with home remedies. We have heard from hundreds of readers that golden raisins soaked in gin, plant pectin (Certo) dissolved in grape juice or the Indian spice turmeric can be an affordable alternative to pricey prescription pain relievers. For those who would like details on some of our favorite remedies, we offer our Guides to Unique Uses for Vicks, Alternative Treatments for Arthritis and Home Remedies.

Home remedies are never FDA approved. Nevertheless, readers of this column have often found relief from problems such as leg cramps, coughs, hiccups, dandruff, athlete’s foot, arthritis and nail fungus. If it might help, won’t hurt and is affordable, we love to share such folk wisdom.

“Follow the money.” This famous line, written by William Goldman for the movie “All the President’s Men,” was the key to unlocking the mysteries behind Watergate.

If you follow the money, you can discover the motivation behind skullduggery. Who profits and who loses?
When it comes to food and drugs, following the money is good advice. North American manufacturers, looking to save money, have increasingly turned to China for cheap ingredients. The consequences appeared earlier this year when more than 4,000 cats and dogs died as a result of tainted pet food.

If you follow the money in China, however, you will discover that the story gets even scarier. The former head of China’s State Food and Drug Administration has just been sentenced to death for accepting bribes and gifts that totaled more than $800,000.

At last count, roughly 170,000 drug licenses must now be reviewed. There is a fear that corruption in the Chinese FDA led to many drug approvals without proper oversight. Counterfeit drugs are common in China.

Gao Chun is a Chinese whistleblower. According to the Wall Street Journal, more than 10 years ago the drug company he worked for used an antibiotic (clarithromycin) made by the American company Abbott to win approval for the Chinese generic equivalent. Mr Gao quit and tried to report this illegal action and the bribes that accompanied the drug’s approval.

In China, whistleblowers don’t fare well. Although he gave the faulty pills to drug regulators for testing, they tried to destroy the evidence. His efforts to report corruption ultimately failed and he now works odd jobs to support himself. The questionable drug is still on the market.

Most Americans have assumed that counterfeit Chinese drugs are purely a Chinese problem. But what if some of those Chinese drugs were exported? Remember the admonition to follow the money! A surprising number of U.S. pharmaceutical companies buy raw ingredients from China. Why? Because they are cheaper in China.

We learned that Chinese manufacturers put melamine in wheat gluten. This chemical created the illusion that the gluten had a higher protein concentration, allowing the Chinese manufacturers to charge more for less. Even so, they undercut the price of many other suppliers for pet food manufacturers. That is why so many companies ended up with contaminated products.

No one knows whether any of the chemicals used to make pharmaceuticals sold in the U.S. were approved by corrupt Chinese regulators. It could take a long time to sort out the mess created by the Chinese FDA.
We do know that some toothpaste exported from China was contaminated with antifreeze (diethylene glycol). It reached Australia, Panama and the Dominican Republic. The U.S. FDA is now checking Chinese toothpaste shipments for this toxic chemical.

Paradoxically, it was this very chemical that led to the drug safety laws that govern today’s FDA. In the 1930s more than 100 Americans died because diethylene glycol was used in a liquid antibiotic preparation.
The FDA is still struggling with safety issues. Until it is adequately funded so that it can monitor ingredients from places as far away as China, Americans will wonder about the safety of their food and drug supply.

The saying goes that when all you have is a hammer, everything looks like a nail. Doctors may not be carpenters, but when it comes to heartburn, the hammer they wield most frequently is an acid-suppressing drug.

Drug companies have been very good at creating medications that shut down stomach acid production. Medications like Aciphex, Nexium, Prevacid, Prilosec and Protonix are among the most frequently prescribed drugs in the country. Prilosec OTC, available without a prescription, has become one of the most popular heartburn pills in the pharmacy.

Indigestion is unpleasant. It can turn a delightful dining experience into a bad memory and wake you in the middle of the night. Repeated reflux can scar the esophagus and possibly even increase the risk of cancer.

Suppressing acid seems like a logical solution. But why do we have acid in the first place? Most animals (dogs, cats, cows, snakes, sheep and sharks) make a lot of stomach acid. In fact, paleontologists have found sophisticated systems for creating stomach acid in just about every vertebrate species for the past 350 million years.

Could something that has survived for so long be a cosmic mistake? Just because we can now suppress acid production so effectively does not mean that this is the perfect solution to heartburn.

Controversy about the long-term effects of acid suppression has been swirling in the medical community for decades. Concerns have been raised about reduced absorption of important nutrients such as vitamin B12 or an increased risk of stomach cancer.

In recent months scientists reported that long-term use of proton pump inhibitors (PPIs) like Nexium, Prilosec or Prevacid is associated with an increased risk of hip fracture (Journal of the American Medical Association, Dec. 27, 2006). The authors suggested that the PPIs might interfere with absorption of calcium so that a deficit develops over time.

There have also been warnings that PPIs may be associated with an increased risk of infections. An article in the Archives of Internal Medicine (May 14, 2007) reports that PPIs are associated with pneumonia. Other studies have linked these acid-suppressing drugs to digestive tract infections.

The authors hypothesize that stomach acid serves as a barrier against bacteria. Because extreme acidity in the stomach kills germs, little can survive passage through this hostile environment. When acid is suppressed, however, bacteria may thrive and cause trouble.

In our new book, Best Choices From The People’s Pharmacy (Rodale Books), we discuss the acid controversy in far greater detail and recommend many other approaches to controlling heartburn and reflux. It is available in libraries, bookstores or on the Web (www.peoplespharmacy.com).

Other ways to soothe symptoms of heartburn include antacids such as calcium carbonate (Maalox Quick Dissolve, Rolaids Extra Strength, Tums E-X) or even baking soda in water (1/2 tsp. in 4 oz. water). These short acting solutions don’t appear to carry the same complications as PPIs. Chewing sugarless gum and sipping tea (chamomile or ginger) are other time-honored ways to ease indigestion.

They say that men are from Mars and women are from Venus. That’s because they have such different approaches to life.


If that’s true, then perhaps physicians are from Oz and patients are still in Kansas. They too have difficulty communicating.


Doctors scrutinize numbers like cholesterol or blood pressure. When they see something they don’t like, they frequently prescribe a medication to nudge it back to “normal.” They may see side effects as minor bumps on the yellow brick road to better health.


Sometimes, though, the cure can be worse than the disease. Pursuing numbers instead of quality of life can lead to unintended consequences. One reader shared the following tale of woe:


“My doctor put me on Lipitor a couple of years ago. At first I thought it was great because my cholesterol came down fast. But within the last six months, I have become extremely weak, especially in my legs. I told my doctor, but she did not seem to hear me. I stayed on the medicine because she never told me to stop.


“In the last few months I have fallen four times. The last time, I really hurt myself and now can’t go to work. My job requires me to be on my feet all the time.


“I am getting around the best I can with a walker. I do feel that I was wronged by taking this medicine. I hope you can get the word out so other patients will not end up like me.”


Lowering cholesterol with statin-type medicine can be beneficial, but not if a patient becomes an invalid. Other readers have shared a range of complications including nerve damage (peripheral neuropathy and incapacitating pain).


According to one reader, “I am unable to take Lipitor, Zocor, Pravachol or Crestor. I develop the same problems every time--muscle and body aches that affect my hips, arms, legs and neck.”


Another reader reports, “I had gotten to the place where I could not go up steps. I kept telling my doctor that my legs were not working. I was also having trouble remembering names, common nouns and descriptive words. Finally my doctor said I should stop the Lipitor because my muscle enzymes were too high. She said my memory loss should be better soon.”


Memory problems are a repeating theme: “I lost my job due to memory problems, but my doctor and pharmacist said this wasn’t a side effect of Lipitor. A psychiatrist I consulted said it is a well-known complication.”


Perhaps the psychiatrist was familiar with memory-related side effects because that is his area of expertise. Doctors may sometimes think patients are exaggerating the problems they are having. Or perhaps they believe an inability to climb stairs or remember the neighbor’s name pales in comparison to avoiding a heart attack or stroke.


Some patients might even agree. Others would not trade the quality of their life for longer survival. The trouble is, most of the time doctors and patients don’t discuss such trade-offs. Whether it’s controlling cholesterol, blood sugar or hypertension, patients need to evaluate the pros and cons of their treatment.
To assist readers in communicating better with their doctors about these matters, we offer our new book, Best Choices From The People’s Pharmacy (Rodale Books). It is available in libraries and bookstores as well as online at www.peoplespharmacy.com.

Cancer is one of the scariest words in medicine. Decades ago the diagnosis seemed like a death sentence. Many doctors didn’t even tell the patient because they didn’t want to deliver such bad news.

Today, cancer is still not good news, but there are effective treatments for many types of cancer. Exciting new advances are under development.

In the old days patients were dependent on the knowledge and skill of the cancer doctor who treated them. Today, the Internet has opened the door to the latest breakthroughs and centers for excellence.

Tom’s experience offers a good example. He was diagnosed with a life-threatening blood cancer called multiple myeloma in 1991. The expected survival at that time was about three years. Tom got excellent care at a respected cancer center. Initially he did well after a bone marrow transplant. As time went on, though, he wasn’t content simply to follow doctors’ orders.

Instead of accepting the standard regimen of the day, Tom went online and searched for promising new multiple myeloma treatments. He learned about a clinical trial with thalidomide. Although this compound was vilified as the agent responsible for horrific birth defects, cancer doctors were beginning to experiment with thalidomide’s ability to control myeloma.

Tom ended up at the Myeloma Institute for Research and Therapy at the University of Arkansas. While there, he got the most advanced treatment available for his cancer.

Tom died last year, more than fifteen years after his original diagnosis. During that time he wrote several books and a research paper called “e-patients: how they can help us heal health care” (www.acor.org/e-patients).

Tom served as a role model for what he called e-patients (individuals who are equipped, enabled, empowered and engaged in their health care decisions). He envisioned health care as an equal partnership between e-patients and the health professionals who support them.

The Internet has made this approach possible. It has revolutionized access to information about new treatments. Patients gain support and knowledge from online communities. One of the best is ACOR (Association of Cancer Online Resources at www.acor.org). This Web site provides email lists in which cancer patients offer each other support and information, including valuable updates about clinical trials.

Many Web sites post information on clinical trials for cancer. They include: www.cancer.gov/clinicaltrials, with links to ongoing clinical trials and National Cancer Institute fact sheets; www.clinicaltrials.gov/, which offers information on government and privately funded clinical trials; www.cancertrialshelp.org/, covering trials through ten of the nation’s federally funded cancer Cooperative Groups, as well as cancer centers, academic medical centers, and patient advocacy groups; and www.cancer411.org/clinicaltrials/index.asp, offering a directory of clinical trials by cancer type. Basic information on clinical trials is available at FDA’s Clinical Trials page (www.fda.gov/oashi/clinicaltrials).

Becoming an e-patient increases the likelihood that a person will be able to find the resources and support that she needs. The Internet is changing the nature of health care for cancer and other serious conditions.

Most doctors think they are way too smart to be influenced by drug companies. Physicians believe that they choose the best medicine for their patients based on science, not bribery.

Although almost all doctors in America accept free lunches for staff, pens, pads coffee mugs and other doodads, these gifts are considered so trivial that they have no impact.

Yet several recent reports suggest that drug company sales representatives do shape prescribing patterns. AstraZeneca recently fired one of its managers after his motivational comments to the sales force were leaked to the public.

Mike Zubillaga was a regional sales director for cancer drugs. In an internal company newsletter he was quoted as saying: “There is a big bucket of money sitting in every [doctor’s] office. Every time you go in, you reach your hand in the bucket and grab a handful. The more times you are in, the more money goes in your pocket. Every time you make a call, you are looking to make more money."

Less controversial was Mr. Zubillaga’s exhortation to use doctors to spread the drug company’s message to other doctors through speaker programs. This is a common tactic within the industry.

A survey of 1,662 physicians published in The New England Journal of Medicine (April 26, 2007) revealed that 94 percent “reported some type of relationship with the pharmaceutical industry.” Over three fourths acknowledged accepting free food or drug samples. One third of the doctors surveyed were reimbursed for expenses, “including the costs of travel, time, meals, lodging or other personal expenses for attending meetings and free or subsidized admission to meetings…”

Most alarming of all, more than one fourth of the doctors in this survey were paid by drug companies for services such as consulting, lecturing or signing up patients for clinical trials. Influential doctors are more likely to receive large honoraria or consulting fees.

It is these “thought leaders” who end up writing guidelines about best medical practices. Powerful physicians can sway their peers to select certain medications over others to treat conditions like high blood pressure, depression, diabetes or heart disease.

Despite protests to the contrary, it is hard to imagine that a cardiologist who receives more  than $100,000 from a pharmaceutical company will not favor that company’s cholesterol-lowering medicine.

What is particularly worrisome about all the free food and gifts, not to mention the outright payments, is that they appear to be increasing. In 2002 pharmaceutical manufacturers adopted a new code of conduct. It was supposed to limit the freebies and guarantee that physician-industry interactions “should primarily benefit patients and enhance the practice of medicine.”

The new study suggests that over the last few years Big Pharma has intensified its outreach to doctors. Whether this effort has enhanced the practice of medicine is anyone’s guess. What is clear, however, is that the cost of medications keeps going up. When doctors prescribe the most expensive drugs the pharmaceutical companies take their big buckets of money to the bank.

Ask a sex therapist about the most common complaint couples have and it is likely to be mismatched sex drives. In other words, one partner desires sex more frequently than the other.

In a recent column, a woman complained that she didn’t have enough energy for sex after working, housekeeping, cooking and taking care of a baby grandson. She wanted to know if there was anything she could feed her husband to dampen his desire.

Other women wrote in to sympathize with her. Most felt her husband should pitch in with the housework and the cooking. They suggested that if he had to work as hard as she did, he’d be worn out and less interested in sex too.

A couple of male readers disagreed. One said, “Are you kidding me? While the man is doing all the chores, he’ll be thinking about his reward when he finishes. A man is never too tired for sex! He will swim the widest ocean, climb the highest mountain and fight the strongest lion, all in the interest of sex.”

Another shared his perspective: “You apparently seem to know very little about what factors affect one’s sexual drive. I have been married three times, and in all cases my wives were unable to keep up with my sexual needs.

“I consider myself fairly intelligent, a good conversationalist, empathetic to all life and fairly good looking. I adore women and respect their individuality and personal beliefs. But sex is always at the front of my mind.
“Even when I worked long days and came home exhausted, my sex drive was always in high gear. It still is, even though I am now 71 and retired.

“I do not pretend to understand what determines sex drive. I only know that I have always enjoyed my own sexual appetite and hope to do so until I die. Perhaps someday I will meet a lady of a like mind where sex is concerned and we can both be happy and totally satisfied.”

Most people assume that men are more likely to have strong sexual appetites, but sometimes the roles are reversed. This man was open about his situation: “I'm 39 years old and have been married for over two years now. Unfortunately, I find myself in a position where I have a low sex drive, while my wife has a strong one.”

We have also heard from women like this one: “My husband and I are in our early 50s and are newlyweds (three years). Shortly after we were married, he was diagnosed with high blood pressure. His medicine has affected his health in many ways. He is depressed, tired all the time and has very little sexual interest. I really feel that the doctor is only interested in controlling the blood pressure and is not concerned about the side effects. Our sex life is suffering.”

Medications can be a contributing factor in sexual problems. Antidepressants, blood pressure pills and prostate medicine are just some of the drugs that can depress libido or interfere with enjoyment. Our Guides to Drugs That Affect Sexuality and Treating Sexual Dysfunction lists some of these and offers some alternatives that are less likely to cause sexual issues. Anyone who would like copies, please send $3 in check or money order with a long (no. 10) stamped (63 cents), self-addressed envelope: Graedons' People's Pharmacy, No. YP-96, P. O. Box 52027, Durham, NC 27717-2027.

One of the most controversial drug issues of the last several decades has been the safety of hormone replacement therapy (HRT). For years, many physicians encouraged women to take drugs like Premarin, Provera or Prempro as soon as they began having hot flashes. HRT was supposed to keep bones strong and the heart healthy. Concerns about breast cancer were often downplayed.

Even after the Women’s Health Initiative suggested that women taking HRT were at higher risk of breast cancer, many health professionals were skeptical. Now, however, the research seems even more compelling.

When all the bad publicity about HRT came out, millions of women stopped taking hormones. Within a year breast cancer rates had dropped by almost seven percent. That might not seem like much, but in the world of cancer epidemiology it was the equivalent of a tsunami.

Normally, the number of new cancer cases doesn’t change very much from year to year. Many scientists didn’t believe there would be such a dramatic drop as a result of declining HRT prescriptions. Some hormone enthusiasts tried to rationalize the results by suggesting that women were not going in for mammograms so the discovery of new cases would be delayed.

The second year of data is now in, however, and it reinforces the earlier findings. New breast cancer cases are still down (New England Journal of Medicine, April 19, 2007).

The biggest decline (more than 11 percent) came among women who were 50 or older. Scientists compared statistics from 2001 (at the peak of the HRT bandwagon) to those from 2004 (after HRT prescriptions had dropped 38 percent). Estrogen-positive tumors were reduced by nearly 15 percent in that age group.

It all makes sense pharmacologically. Researchers have known for decades that estrogen can act like fertilizer for breast cancer. This can be inferred from at least three sources of information: animal research, epidemiology and the effectiveness of anti-estrogen breast cancer treatments.

As far back as 1977, veterinarians had identified estrogen as a carcinogen for breast tissue. Epidemiologists also linked higher lifelong estrogen exposure to a greater risk of breast cancer in humans. Women who start menstruating at younger ages and go through menopause at older ages are at higher risk. That is presumably because they have been exposed to their natural estrogen for a longer period of time.

The most important advances in breast cancer treatment over the last couple of decades involve ways to block estrogen. Tamoxifen was the first anti-estrogen and is still an important way to prevent recurrence. Now, drugs that keep the body from making estrogen (aromatase inhibitors like Arimidex, Aromasin or Femara) have also become valuable tools in the fight against breast cancer.

Our Guide to Estrogen: Benefits, Risks and Interactions discusses some of the controversial issues surrounding HRT and offers plant-based alternatives. Anyone who would like a copy please send $2 in check or money order with a long (no. 10) stamped (63 cents), self-addressed envelope: Graedons' People's Pharmacy, No. W-49, P. O. Box 52027, Durham, NC 27717-2027. It can also be downloaded for $2 from the Website: www.peoplespharmacy.com.


Allergy sufferers get very little sympathy. People with migraines or arthritis endure hardship, but at least everyone recognizes the difficulties of living with such chronic conditions.

The tens of millions who sniffle and sneeze throughout allergy season are mostly ignored. And yet their symptoms also make life miserable.

For example, take our friend George. He is one giant puddle. His nose runs, his eyes water and he can barely think straight. Even with allergy medicine, George feels befuddled much of the spring. As a research scientist he relies on his mental clarity to solve complex problems, but during allergy season he is unproductive.

Most people don’t realize that allergic reactions to pollen can affect concentration and driving ability. Studies have found that allergies can slow reaction time, interfere with sleep, make people tired and irritable and impair concentration, memory and cognition.

Unfortunately, the medicines many people take to relieve their symptoms can also contribute to poor driving performance and mental cloudiness. Some antihistamines can interfere with reaction time and judgment almost as much as alcohol.

So what’s an allergy victim to do if he wants to survive the sneezing season? A pollen mask can help filter out allergens, but most people are too embarrassed to wear one when they are outside. Staying indoors with a high-efficiency particulate air filter (HEPA) may help somewhat, but such devices are not inexpensive.

There are pharmaceutical solutions, though none is perfect. Non-prescription oral decongestants like pseudoephedrine (Sudafed) have moved behind the counter at the drugstore. They can help relieve stuffiness. People with high blood pressure, heart conditions, diabetes, glaucoma or prostate problems can’t tolerate such drugs, however.

A nonprescription nasal spray called NasalCrom is a relatively benign option. It stabilizes mast cells in the nose and keeps them from releasing histamine. The only downside of this medicine is the relatively short action. You have to use it four times a day to really get much benefit.

Speaking of nasal sprays, avoid topical decongestants. Products that contain vasoconstrictors like oxymetazoline or phenylephrine can only be used for three days. Beyond that the allergy victim runs the risk of developing rebound nasal congestion caused by the medicine. Since allergies almost always last longer than three days, such nose sprays are not the solution.

Prescription allergy medicine includes a number of steroid nasal sprays. For many, this is one of the most effective treatment options. Drugs like Beconase, Flonase, Nasarel, Nasonex, Rhinocort or Vancenase can ease allergy symptoms without causing drowsiness. There are almost too many to choose from.

Other options include oral antihistamines (Alavert, Allegra, Clarinex, Claritin and Zyrtec). Although they are not supposed to cause as much drowsiness as old-fashioned antihistamines like diphenhydramine (Benadryl), some people may still experience mental fog while on an antihistamine.

To better understand these and other allergy treatment options, we offer our new book, Best Choices From The People’s Pharmacy (Rodale Books). It is available from the local library, bookstores or online at www.peoplespharmacy.com.

Life is not a bowl of cherries. People get fired or divorced. Investments go sour and savings are lost. Friends and family members die. It’s inevitable.

When bad things happen, people frequently feel sad. It’s normal.

Over the last couple of decades, our culture has lost sight of this truth. People are being medicated in an attempt to counteract natural human emotions.

A new study shows that as many as one fourth may be misdiagnosed as depressed when what they are really experiencing is an appropriate reaction to life’s occasional setbacks (Archives of General Psychiatry, April, 2007). Not infrequently they get a prescription for an antidepressant.

Part of the problem is that depression is diagnosed based on a standard checklist of symptoms. They include sadness, anxiety, feelings of hopelessness or helplessness, difficulty concentrating, fatigue, changes in appetite or altered sleep patterns. If a patient shows up with at least five items from the list for more than two weeks, he or she is considered clinically depressed and in need of medication.

Drug makers and insurance companies have embraced this approach. For one thing, it has facilitated diagnosis by non-psychiatrists. With a checklist, almost any health professional can hypothetically diagnose depression, eliminating the need for an expensive psychiatric consultation. A prescription for antidepressant medications seems like a cheap fix. It is believed that such drugs can take the place of talk therapy, which can last for several weeks and appear expensive.

This simplistic tactic ignores the fact that antidepressants have side effects and do not necessarily improve coping skills. Someone who is going through a divorce may need counseling at least as much as a prescription. And a person who has just been fired may need encouragement and advice on how to find a new job.

Antidepressants may improve outlook, but not insight. Once someone starts down the antidepressant path, he may have a hard time getting off. Many readers have shared experiences like this one:

“I take Zoloft and have tried to stop taking it several times. Each time I stop I experience a very strange thing. I get extremely dizzy and have electrical shock-like sensations in my head. I absolutely know this is associated with not taking Zoloft. Less than two hours after I take it again the overwhelming symptoms completely disappear. Doctors, nurses and pharmacists dismiss me as if I'm a nut case, but I swear this is true.”

Other readers describe withdrawal symptoms such as nausea, diarrhea, loss of appetite, sweating, chills, irritability and insomnia. Gradual tapering may reduce the severity of these symptoms.

Facing such a difficult withdrawal from a drug prescribed for job loss or divorce adds insult to injury. True depression requires appropriate treatment, but life circumstances don’t always deserve drugs.

We offer many non-drug approaches to depression and discuss the value of cognitive behavioral therapy for depression in our new book Best Choices From The People’s Pharmacy (Rodale Books). It is available at libraries, bookstores or online at www.peoplespharmacy.com.

Unless you have been hibernating for the last few weeks, you have probably heard that Anna Nicole Smith died of an accidental overdose. According to the Broward County Medical Examiner, the legal medicines she was taking led to “combined drug intoxication.”


She apparently stopped breathing because her nervous system couldn’t handle all the chemicals floating around in her blood stream.


The autopsy report listed chloral hydrate, an old-fashioned sleep aid that is sometimes used to help a person withdraw from alcohol dependence. Also found in her blood stream were traces of methadone, a pain reliever also used to treat narcotic dependence.


She also seems to have been taking clonazepam, a sedative and anti-seizure drug that is sometimes used as a sleeping pill. Other drugs in her body included diazepam (Valium), lorazepam (Ativan) and oxazepam (Serax). These are all benzodiazepines used as anti-anxiety agents or sleeping pills. The over-the-counter allergy and sleeping pill diphenhydramine (Benadryl) was also detected.


One wonders who prescribed all these drugs to Anna Nicole Smith and what pharmacy dispensed them. Taking them all together was a prescription for death.


Chloral hydrate was developed in 1832 but it wasn’t used medicinally until 1869. That makes it one of our oldest sleeping medicines. It gained notoriety for its part in the “Mickey Finn,” also known as knockout drops. Folklore claims that bartenders in cahoots with sea captains would slip chloral hydrate into a drink. The hapless sailor would pass out and wake up on board a ship miles from shore.


Why did Anna Nicole take so much sleeping medicine? One theory involves an interaction between the antibiotic Cipro, which she was taking for an infection, and the caffeine in soft drinks that were found around her bed. Cipro magnifies the effects of caffeine. This might have made it difficult for her to get to sleep, leading her to take too many sedatives.


Although the Broward County Medical Examiner ruled it non-contributory, Cipro might have had another potentially lethal interaction with her mix of medicines. The combination of methadone with ciprofloxacin can throw the heart out of rhythm.


We may never know which interaction actually killed Anna Nicole, but it is clear that she was taking way too many medications. Therein lies a lesson for all of us.


Millions of Americans suffer adverse drug reactions each year from legitimate medicines. Many die. Deadly combinations are far more common than most people imagine.


Every time you get a new prescription, remind the doctor of all the other drugs you are taking. Include the dietary supplements, even if you don’t consider them drugs. Make sure the pharmacist double-checks the safety of any combination of drugs you are taking.


Then do your own homework as well. Our book, Dangerous Drug Interactions (St. Martin’s Press), offers guidelines and provides examples of food, drug and supplement interactions. It is available online (www.peoplespharmacy.com) or from your local library.


If you are taking a lot of different drugs, it may take time to check the safety of all the possible combinations. It’s worth taking the time. Your life could be on the line.

Imagine the outrage of basketball fans if they learned that the referees in the championship game were being paid by one of the teams. People would be equally upset if they discovered that a judge had a financial interest in a case before the bench.

We expect umpires and judges to be impartial. They must make their decisions based on the evidence and they must completely avoid any conflict of interest. Were they to get caught accepting money, they would be fired or prosecuted.

Physicians are also expected to avoid conflicts of interest. A patient’s treatment should be selected on the basis of objective evidence. Too often, however, influential doctors take money from drug companies.
Until recently, such payments have been secret. But several states have enacted legislation requiring drug companies to disclose payments to doctors.

A new study in the Journal of the American Medical Association (March 21, 2007) examined these records in two states. The researchers found that in Minnesota, more than 7,000 payments were reported over three years (2002 through 2004).

More than $30 million was designated for speaking, research, consulting and education. Nearly half the funds, however, were for unspecified purposes. In Vermont, more than half such payments were not disclosed, on the grounds that they were “trade secrets.”

According to an investigative report in the New York Times, nearly one out of every five licensed doctors in Minnesota received a payment between 1997 and 2005. The median amount was $1,000. More than 100 people took in over $100,000.

The American Medical Association recommends that drug companies limit their gifts to doctors to no more than $100. But there are no limits on payments for speaking or consulting. Many physicians, especially opinion leaders, are paid hundreds of thousands of dollars by the pharmaceutical industry.

Such influential physicians are often the very ones who write guidelines on how to treat serious conditions such as heart disease, diabetes or kidney disease. They frequently tell their colleagues which are the best medications to prescribe.

Many of these same respected clinicians and researchers sit on advisory panels for the FDA. They influence which drugs get approved for sale and which do not.

Most doctors who take money from drug companies maintain that these gifts or payments do not affect their treatment decisions. But the JAMA study noted that research has shown prescribing patterns are influenced by financial relationships with drug companies. Pharmaceutical marketers do not throw away money. They realize that when doctors are sent to beautiful resorts and paid to speak or consult, they are more likely to prescribe the company’s products.

Do patients know about these cozy relationships? Most doctors in Minnesota didn’t feel it was necessary to reveal their drug company ties. But a New York Times/CBS News poll found that 85 percent of the public believes this kind of payment is inappropriate. They also think it would influence doctors’ prescribing.

It is unacceptable for judges, umpires or other professionals to take money that could influence their decisions. Shouldn’t we hold physicians to the same standards?

If you come down with cancer you had better have health insurance. Otherwise, prepare to go bankrupt or die.

Cancer treatment has become so expensive that if you are not very rich or poor, well-insured or covered by Medicare, you will miss out on the latest breakthroughs. Anyone who is middle class and uninsured is in big trouble.

The FDA just approved a new drug for breast cancer. Tykerb is an exciting advance because it improves survival in women with aggressive tumors that no longer respond to standard treatments.

The trouble with Tykerb is that it costs about $2,900 per month and has to be given with another medicine called Xeloda that can run more than $1,500 a month.

Such prices are by no means unusual. In the last few years, drug companies have developed important new treatments for a variety of cancers. They are charging enormous amounts for these advances.

According to an analysis by Geeta Anand of the Wall Street Journal, the kidney cancer drug Sutent can cost $46,500 for the average patient. Erbitux, for colorectal cancer, can cost $10,000 per month or $40,000 for a course of treatment.

Avastin is a completely different kind of cancer treatment. It cuts off blood flow to tumors and is being prescribed to patients with colorectal, breast or lung cancer. A course of treatment can reach more than $50,000.

But even that pales in comparison to a medicine developed for a rare blood cancer called multiple myeloma. A year’s treatment with Revlimid could reach over $60,000. When it is used in combination with another new cancer drug called Velcade, the annual bill could top $100,000.

Such medicines prolong life far more effectively than classic chemotherapy. Often they are better tolerated.
The trouble is that the longer you live, the bigger the bills. Someone with myeloma could survive many years thanks to Revlimid and Velcade. A family without insurance could end up with a bill in the hundreds of thousands of dollars.

The only way to pay for such treatment is to sell your home. Even then you may only be able to afford a few years’ treatment. Ultimately, families go deeply into debt or give up.

Even with insurance, a 20 percent co-pay could represent a bill of thousands of dollars a year. Few families can come up with that kind of cash, especially if the patient is the breadwinner.

Insurance companies are no happier about these bills than patients. As a result, some payers are unlikely to cover treatments that are considered experimental.

A drug that has been approved by the Food and Drug Administration for treating one type of cancer may prove beneficial for another. But it can take years for the FDA to acknowledge this new use. In the meantime, doctors who administer a cutting-edge therapy that could prolong life may not be reimbursed by an HMO or insurance company. Few oncologists can foot this kind of bill for very long.

Drug companies may argue that life-saving therapies are worth the astronomical prices people have to pay. But when ordinary citizens, Medicare, HMOs and private insurance companies can no longer afford the bill, Congress may act to rein in the high cost of surviving cancer.

By now you’ve probably heard that the Atkins folks won the big food fight. The high-fat Atkins diet trumped the low-fat Dean Ornish diet in a year-long face off (JAMA, March 7, 2007). Atkins also beat out the Zone diet and a standard physician-recommended low-fat, reduced-calorie regimen.

Most of the news reports about this well-designed government-funded study have focused on weight loss. While it is true that the Atkins diet helped people lose more pounds than the others, that’s not the most interesting aspect of the study.

The message that has been mostly overlooked is that people on the Atkins diet also benefited in other important ways. The blood fat profile was improved, with higher levels of good HDL cholesterol and lower levels of bad triglycerides among the Atkins dieters than among the others.

Most dietitians would have predicted that Atkins dieters would have had higher cholesterol levels than their low-fat counterparts. After all, these people were eating red meat, butter and other dietetically disapproved foods. There were, however, no significant differences in total cholesterol among the groups.

Atkins dieters also got their blood pressure down better than people in the other groups. This may have been partly a result of more weight lost, but even after making that statistical adjustment, Atkins dieters came out lower.

Such results fly in face of everything we have been told for the last couple of decades. Millions of Americans believe that eating bacon or steak is tantamount to playing Russian roulette. The notion that the bun might be worse than the burger sounds like heresy.

These findings are not as new as they seem. Prior studies have consistently shown that a low-carb diet can lower blood pressure and triglycerides and raise good HDL cholesterol. In addition, blood sugar may be better controlled on such a program.

How is it possible that dietary dogma--red meat is bad and bread is good—could be so wrong? It clearly was based primarily on belief rather than data. When Dr. Robert Atkins proposed his diet, doctors and dietitians recoiled in horror. They assumed that saturated fat would raise cholesterol and increase the risk of heart attacks.

We still do not have really long-term studies to show whether the Atkins diet actually protects against heart attacks. But this one-year trial has demonstrated better than any other research to date that our current dietary guidelines and prohibitions do not produce the expected results.

We have summarized some of the most controversial research about diet, heart disease and diabetes in our new book, Best Choices From The People’s Pharmacy (Rodale). Information is available at www.peoplespharmacy.com or look for it at your local public library.

We are not suggesting that Americans should pig out on bacon, burgers and butter. Nevertheless, it may be time to reexamine our dogma about diet. These research results suggest that pizza and pasta may be more problematical than steak and eggs.

People in pain are caught between a rock and a hard place. On the one hand, they have to deal with sore joints or chronic back problems that make it hard to enjoy everyday activities. On the other hand, the pain relievers they count on to ease their discomfort pose serious risks.

We have known for decades that nonsteroidal anti-inflammatory drugs (NSAIDs) can be irritating to the digestive tract. That's true whether someone is taking a prescription like diclofenac (Cataflam or Voltaren) or an over-the-counter pain reliever such as ibuprofen (Advil, Motrin) or naproxen (Aleve). Regular use may lead to life-threatening bleeding ulcers.

Vioxx and Celebrex were supposed to be safer for the digestive tract. But when Merck revealed that Vioxx increased the risk for heart attacks and strokes, scientists started looking at all pain relievers. What they found is deeply disturbing.

Researchers who studied nearly 100,000 people between 2000 and 2004 found that those taking Vioxx were more likely to suffer heart attacks than those taking no pain relievers. But those taking ibuprofen were 24 percent and those taking diclofenac were 55 percent more likely to have a heart attack (British Medical Journal, June 11, 2005).

A new study just out may offer one possible explanation (Archives of Internal Medicine, Feb. 26, 2007). Investigators followed 16,000 male health professionals for four years. Those who regularly took pain relievers had a greater likelihood of being diagnosed with high blood pressure.

Men taking NSAIDs six or seven days a week had 38 percent greater risk of hypertension. Those who took acetaminophen (Tylenol) that often had a 34 percent higher chance of that diagnosis.

Most people assume that acetaminophen is relatively safe since it is unlikely to cause stomach irritation. But the new finding that it too may affect blood pressure means that people in pain have no easy options.

Even aspirin may pose a risk. Although it helps protect men and women from heart attacks, the male health professionals who took aspirin daily were also one fourth more likely to have elevated blood pressure than those who took nothing.

For those without any risk of heart disease, such drugs may offer more benefit than harm as long as blood pressure is carefully monitored. But 65 million Americans have hypertension and most do not control it adequately. For them, relying on acetaminophen, ibuprofen or other popular pain relievers could promote this "silent killer."

Hypertension increases the risk of heart attacks, strokes, kidney disease and dementia. Treating it with medication while you are taking a pain reliever may be a little like running up stairs with lead overshoes.
The American Heart Association has responded to the new research with a recommendation that physicians first try non-drug treatments for their patients in pain. They suggest physical therapy, exercise, weight loss and heat or cold therapy.

To learn more about other non-drug approaches such as vitamin D, fish oil, glucosamine and chondroitin, cherry or pomegranate juice, magnets and anti-inflammatory herbs, consider Best Choices From The People's Pharmacy (Rodale Books).

One of Ronald Reagan’s most memorable quotes was “Trust but Verify.” He used this phrase dozens of times when speaking about U.S. relations with the Soviet Union.


In his farewell speech to the nation after two terms in office, President Reagan cautioned: “It's still trust but verify. It's still play, but cut the cards. It's still watch closely. And don't be afraid to see what you see.”


We only wish the U.S. Food and Drug Administration would heed Ronald Reagan’s advice. For far too long the FDA has relied on the honor system when it comes to pharmaceuticals. Nobody’s “cutting the cards.”
The agency trusts drug companies, wholesalers and drug distributors to be honest. The FDA does not verify that the bottles on pharmacy shelves contain the medications on the label.


In other areas where lives are at stake there is a reliable verification system. If you build a house in America the local municipality periodically sends a building inspector to make sure your contractor is following code regulations.


Although the FDA is supposed to send inspectors to check up on pharmaceutical manufacturing plants every couple of years, the agency does not routinely pull pills off pharmacy shelves to verify ingredients and potency. Based on what the agency has told us, officials examine only about 300 bottles a year. That’s out of more than three billion dispensed, which boils down to one bottle per 10 million sold.


With such lax verification it is not surprising that some greedy pill pushers might try to get counterfeit medicines into the marketplace. Billions of dollars are being made on bogus drugs. There is no organized system in the United States to check for these black market medicines.


We have heard from hundreds of readers who report that their generic drugs are not working as well as the brand name did. We worry that counterfeiters may have penetrated this marketplace.


A reader recently shared this: “For many years I took Vasotec which kept my high blood pressure around 150/90. When a generic became available, I was given enalapril. I experienced a pounding in my head, which felt like it would explode. My heart felt like it was stuttering. My blood pressure was 210/110. I immediately got Vasotec from the pharmacy and over the next few days, the symptoms disappeared.

“Upon further investigation, I learned that the enalapril I was taking was manufactured in India. The Vasotec came from Canada.”


Few Americans realize that many of the raw materials for their medicine come from India and China. A few weeks ago the past head of China’s FDA was arrested on charges that he had accepted bribes to approve counterfeit drugs. Corruption within that agency will require investigation of 170,000 production licenses issued over the last decade. No one knows if that includes medicines sold in the U.S., whether brand or generic.


Anyone who has experienced a generic drug problem may report it on our Web site (www.peoplespharmacy.com). You will also find our new book, Best Choices From The People’s Pharmacy (Rodale Books) with an in-depth discussion of the generic drug issue and guidelines on how to use such medicine safely. If the FDA isn’t up to the task, consumers will have to trust but verify.

Americans are confused about sex. Many of the first colonists were Puritans and a strong puritanical streak still runs through our culture.


Although our sitcoms and soap operas rely on sex to keep viewers watching, many of us consider this type of entertainment a guilty pleasure.


Despite our seeming obsession with sex on television, in movies and on the Web, Americans are actually more watchers than doers. We’re a voyeuristic society that seems content to observe others acting sexy.
According to some global sex surveys, Americans lag behind people in France, Greece, Croatia, Poland, Great Britain and even Kazakhstan.


Part of the problem may be that Americans work too hard. A survey for the National Sleep Foundation found that nearly one fourth of the couples surveyed were often too tired to engage in sexual activity.


We are so busy with work, family responsibilities, email, television and other distractions that we just don’t find enough time to relax and get in the mood. A commercial on television for the erectile dysfunction drug Cialis asks, "If a relaxing moment turns into the right moment, will you be ready?" If there are no relaxing moments, however, Cialis won’t do much good.


Besides being overscheduled and stressed out, many people are unclear about the differences between an anti-impotence drug like Cialis or Levitra and an aphrodisiac. When the first medication against erectile dysfunction, Viagra, was introduced, it quickly became a household name. People talked about it with the kind of leer reserved for raw oysters.


Those who expected Viagra to increase libido were soon disappointed. While this medication is considered effective for helping a man achieve an erection, that achievement is possible only in the presence of sexual desire. Medical science is still looking for ways to increase libido.


Too many medicines do the opposite--dampen desire. Many Prozac-like antidepressants interfere with arousal or function. Birth control pills, hormone replacement therapy and even some blood pressure medications can reduce interest in making love.


We have listed many common culprits in our Guide to Drugs That Affect Sexuality and we have discussed ways to overcome low libido in our Guide to Treating Sexual Dysfunction. Anyone who would like copies, together with a one-hour CD radio interview with Irwin Goldstein, MD, one of the country’s leading experts on human sexuality, may send $18 to Graedons' People's Pharmacy, No. YP-561, P. O. Box 52027, Durham, NC 27717-2027.


There are a few compounds that may eventually turn out to be helpful for improving libido. Some years ago, Dutch researchers discovered that giving women a small dose of testosterone under the tongue increased their interest in an erotic video (Archives of General Psychiatry, Feb., 2000).


A recent study found that sniffing a compound isolated from men’s sweat, androstadienone, could increase cortisol levels in women’s blood and make their hearts beat faster (Journal of Neuroscience, Feb. 7, 2007). It also improved their mood and boosted their sexual arousal.


Perhaps someday scientists will create a true aphrodisiac. Until then, Americans may need to learn how to relax and rediscover romance.

When a young child catches a cold—which they do far too frequently—parents want to do something to ease the suffering. Watching a child struggle with a drippy nose or listening to a nagging nighttime cough is torture for parents.


Moms and Dads should think twice, or maybe three times, before rushing to the drugstore for an over-the-counter cold remedy. Even medicines that are labeled for children have not, for the most part, been proven effective for little ones. And they do present possible risks.


Earlier this year, the Centers for Disease Control and Prevention announced the results of a study showing that over a two-year time span, more than 1,500 babies and toddlers were taken to emergency rooms because of bad reactions to OTC cough or cold medicines. Three babies actually died.


The deaths were linked to dangerously high blood levels of pseudoephedrine, a decongestant common in cold remedies. Pseudoephedrine is available without a prescription, although now it is kept behind the counter and customers have to ask the pharmacist and sign for it.


Giving kids under two years of age any nonprescription medicine poses serious risks. Parents should do this only when the child’s doctor recommends a product and gives specific instructions for its use, including the dose.


Even when a doctor or nurse makes a recommendation, be extra careful about checking the dose and administering the medicine. Doctors may need to estimate the right dose based on the child’s weight, and these calculations can be subject to error.


Even when the dose is correct, administering it can be a challenge. Anyone who has ever tried to get a two-year-old to swallow medicine she doesn’t want can attest that this can turn into a dreadful scene. The kid screams, the parent fusses, the medicine is spread all around, and there’s no good way to tell how much medicine actually gets into the youngster.


Parents should be very careful with both prescription and over-the-counter liquids. Liquid medicine doses may be expressed as teaspoons, but parents should resist the temptation to pull a spoon out of the kitchen drawer.


Studies have shown that most people use household spoons when they have to administer liquid medicine. Some have a hard time telling the difference between a teaspoon and a tablespoon. (There are three teaspoons in a tablespoon.)


Household spoons are not accurate measuring devices. Although a medical teaspoon contains exactly 5 milliliters, the spoon you use to stir your coffee might hold as little as 2 ml, and the one you use for your breakfast cereal might accommodate 10 ml.


Giving a child too little liquid antibiotic might not clear up an infection. But too much might result in side effects. That’s why we strongly recommend that parents use an oral syringe. It may look intimidating, but there is no way to put a needle on the end. The markings on the barrel are easy to read and the plunger allows a parent to suck a precise amount of medication into the syringe and to squirt it gently into a squirming infant's mouth.


By the way, kids with colds usually do fine without medicine. Before giving the child any drug, check with his or her doctor.

Sometimes a remedy defies logic. Usually there’s no science to support it either. That’s certainly the case when it comes to putting a bar of soap under the bottom sheet to stop leg cramps or restless legs.

One reader (who happens to have doctorates in biomedical engineering and physics) took us to task for suggesting this remedy. He asked, “What is the mechanism of action for a bar of soap under your sheets for relieving any type of pain? Answering that this is anything but an old wives’ tale discredits everything you have done in the name of science.

“As a fellow scientist and university faculty member, I feel it is your responsibility to educate your readers using accepted scientific principles. When you do not, you are performing a disservice to the rest of us.

“What's next? ‘We have heard from many readers that it helps to have a leprechaun in your pocket when looking for gold at the end of the rainbow, and we can’t see how it would hurt.’”

We can’t pretend that soap under the sheet is anything more than a folk remedy. We can’t explain how it would work, and we don’t know for sure that it does. Nonetheless, we have been impressed with readers reporting success.

One wrote: “I've been a long-time sufferer of sciatica.  Recently, I was diagnosed with degenerative joint disease resulting in tarsal tunnel syndrome in my left foot. The pain was nearly unbearable. After your column on the soap mystery, I could not believe it but I thought I have little to lose.

“I keep the bar of soap underneath my sheets all the time. It's been over a month, and I've been noticing much less pain and more energy. I shared the article with a co-worker who also is benefiting. Her sister, a nurse, is puzzled by this.”

Their training may predispose nurses to be cautious: “Being a nurse, I was VERY skeptical about the soap remedy. Statin medicines give me leg cramps. I decided the bar of soap could do no harm. It worked the very first night and has continued to work for the past three months. I can't figure out how it can possibly help, but it does.”

Another reader found a bar of soap more helpful than prescription pain relievers: “I had an unsuccessful replacement of my right knee 18 months ago and my left thigh suffers from meralgia paresthetica (thigh nerve pain).

“The bar of soap works wonders. The pain in both legs almost disappears when I go to bed. I tried to do without soap one night and after about 30 minutes of tossing and turning I put the bar back under the sheet to relieve the pain.

“I have to replace the soap about every two months to stay pain free. I said good-bye to Celebrex and Mobic, which were not easing the pain.”

Leg cramps can be extremely painful and there are no drugs approved to treat them. We only wish there were some studies to help us understand the soap phenomenon.

Anyone who is fascinated by such oddball remedies may be interested in our new book, Best Choices From The People’s Pharmacy (Rodale Books).

Our rule of thumb with such remedies is, if they won’t hurt and might help and are inexpensive, why not give them a try? We can’t explain the soap remedy, but doctors can’t explain how many prescription drugs work, either.

Birth control pills were a revolutionary advance in contraception back in the 1960s. They were unquestionably more effective and convenient than any other form of contraception.

In theory, only one woman out of 100 who took the Pill for a year became pregnant. This seemed like an acceptable failure rate to the FDA and to most women.

To achieve this level of protection, drug companies used high doses of hormones (estrogen and progestin). Women often experienced side effects such as breast tenderness, nausea, vomiting, headaches and weight gain. More serious complications included gallbladder disease, diabetes, high blood pressure and blood clots that caused heart attacks or strokes.

Fortunately, such adverse events were relatively rare. But with millions of women on birth control pills, cases began to add up. That’s why drug companies looked for ways to reduce the likelihood of side effects. Over the decades, hormone levels in oral contraceptives have dropped.

Low-dose birth control pills are less likely to trigger nausea and vomiting. The trade off, however, is lower effectiveness. Newer pills fail twice as often as earlier ones.

For women, this has become a balancing act. Lower dose pills are easier to tolerate, but they are less forgiving when it comes to forgetting. They must be taken at the same time every day. Skipping just one dose can result in pregnancy.

Drug interactions are also a significant concern. Other medications may reduce contraceptive effectiveness, as this reader discovered:

“I have two lovely children, and my husband and I did not want any more. I have been on birth control pills for four years, but now I am pregnant again. Abortion is not an option.

“I never missed a single pill. I am sure the antibiotic I took for a sinus infection interfered with my oral contraceptive. My doctor seems defensive and says I must have forgotten a pill. Are there any other drugs that can do this? I never want this to happen to me or anyone else again.”

We discuss medications that interact with birth control pills in our Guide to Estrogen: Benefits, Risks and Interactions. Anyone who would like a copy, please send $2 in check or money order with a long (no. 10) stamped (63 cents), self-addressed envelope: Graedons' People's Pharmacy, No. W-49, P. O. Box 52027, Durham, NC 27717-2027. It can also be downloaded for $2 from the Website: www.peoplespharmacy.com.

The medical profession has been arguing for years about whether antibiotics can reduce oral contraceptive effectiveness. Studies have been inconclusive, but we have heard from women who insist that they never missed a birth control pill yet became pregnant when they took an antibiotic.

Other medications that can impact the Pill include headache medicines containing barbiturates, anti-seizure drugs and some antifungal medications. Even the herbal remedy St. John’s wort that may be taken for depression could reduce effectiveness.

Like walking a tight rope, choosing a birth control pill requires consideration of the potential consequences of pregnancy versus the risk of dangerous reactions. The FDA should require head-to-head comparative studies of contraceptives so women can make informed choices.

Hiccups can be embarrassing. They can occur unpredictably, for mysterious reasons. An involuntary spasm of the diaphragm causes a sudden intake of air into the lungs. When this happens, the diaphragm pulls the glottis in the voice box closed and creates the familiar sound called a hiccup.

Doctors have some pretty extreme treatments for persistent hiccups. Major tranquilizers or anticonvulsants are sometimes prescribed. Rectal massage has also been recommended.

It’s hardly any wonder that people prefer to start with home remedies. A few weeks ago a reader of this column suggested eating one or two green olives to chase hiccups away: “I don't know why it works, it just does. It stops them almost immediately. It even worked on a friend who had been through surgery and had suffered for three weeks until I gave him an olive.”

Although we have been collecting hiccup remedies for more than 30 years, we had never heard of green olives for this purpose. Readers wrote in to suggest some interesting possibilities:

“The little girl next door used to come for dill pickle juice when she had hiccups. It worked right away. I wonder if it is the vinegar in the olives that helps.”

Another reader had a similar thought: “I have been using vinegar as a remedy for hiccups for over 20 years. I know of no instance when a teaspoon of vinegar did not eliminate even the most stubborn case of hiccups. Usually I use white vinegar, but I have used balsamic and rice vinegar with success. I believe this answers the question of why green olives cure hiccups. It is not the olive but the vinegar in the brine!”

Vinegar is quite a popular hiccup remedy. Bartenders often have a remedy to recommend, partly because their customers have a lot of experience with this problem. Drinking alcohol, like swallowing hot peppers, can trigger a case of hiccups. Here is what one reader remembers:

“I've never read about an instant remedy for hiccups I got from a bartender years ago. He gave me a shot glass of a clear liquid and instructed me to ‘swig it, don't sip it.’ “It gave instant results, so I asked what the liquid was. He said, ‘Pure white vinegar!’ I used it later with excellent results."

Another reader dilutes the vinegar: "For an instant hiccup remedy, mix 1 tsp. apple cider vinegar in 1/3 cup water. Only one or two sips are needed to stop hiccups every time!"

Another bartender favorite is to sprinkle a few drops of Angostura bitters on a wedge of lemon and suck on the lemon. Like the ever-popular spoonful of sugar, this probably stimulates the phrenic nerve to reverse the spasm.

We heard of an entirely different approach from this woman: “I had a bad attack of the hiccups when my daughter was visiting recently. She suggested an unlikely cure she learned from a bartender. Just to keep the peace, I tried it and to my amazement it worked: Fill a glass with water. Cover with a clean handkerchief and drink the water through the handkerchief.”

Hiccups can be incredibly annoying, especially if they persist for more than a few minutes. If none of these simple remedies works, and hiccups last for hours or days, they could signal a serious problem and deserve medical attention.

Car buyers used to be advised that it would be prudent to wait at least a year after a new model was introduced before making a purchase. That way, the manufacturer had a chance to detect and correct unexpected flaws.

The same precaution applies to new computer programs. Many businesses wait several months, if not longer, for bugs to be worked out of new software before they switch over.

We wish more doctors exercised the same level of prudence. The question is how long should we wait to discover unanticipated adverse drug effects?

Some experts recommend waiting at least a year. Others say that’s not long enough. Despite the fact that the FDA proclaims all drugs it approves are safe and effective, there are many examples of serious complications discovered well after a drug comes on the market.

The best known is Vioxx. This pain reliever was introduced in 1999 as a breakthrough for arthritis. It was supposed to be safer for the stomach than older NSAIDs like ibuprofen. It wasn’t until 2004 that the company pulled Vioxx off the market because it increased the risk of heart attacks and strokes. Thousands of patients may have died during that time.

It took even longer to discover complications from hormone replacement therapy (HRT). Drugs like Premarin (first marketed in 1942) and Prempro (introduced in 1995) were taken by millions of menopausal women. It wasn’t until the Women’s Health Initiative in 2002 that the risks of heart attacks, strokes and cancer associated with HRT were widely acknowledged.

The antidepressant Prozac hit the market in 1987. It quickly became one of the most popular drugs in the pharmacy. It wasn’t until 2004 that the FDA required manufacturers of antidepressants like Prozac to warn about suicidal thoughts and actions in children and adolescents taking these medications. Late last year the agency was advised to extend that warning to young adults.

More recently we have learned that people who take powerful acid-suppressing drugs (including Aciphex, Nexium, Prevacid, Prilosec and Protonix) for more than a year may have an increased risk of hip fractures (Journal of the American Medical Association Dec. 27, 2006). A possible explanation for this effect may be too little calcium. A low-acid environment in the stomach could make it more difficult to absorb this crucial nutrient.

Because this is such a new discovery, the FDA has not included any warning about bone problems in the official label information. It could be a long time before doctors or patients will be cautioned about this potential effect since the FDA often moves slowly when it comes to labeling changes.

What we’ve learned over the last few decades is that it can take years before serious side effects surface. The FDA approves most medicines on the basis of relatively short-term studies that last several weeks to several months. As a result, we often don’t know the long-term risks of a new medicine.

To be safer, monitor how your body reacts to a new medication. If you suspect that something is not right, talk it over with your doctor. And when you see an ad on TV for a new prescription drug, don’t beg your doctor to prescribe it. It may have unexpected hazards.

Quinine is one of the oldest drugs in the pharmacy. Even before the Spanish discovered the New World, native healers in Peru were using the bark of the cinchona tree to treat fever, malaria and indigestion. An Augustinian monk wrote about the uses of the “fever tree” back in 1633.

In Europe, this bark proved useful for treating the fever and chills of malaria. Chemists later determined that the active ingredient in this healing bark was quinine, and it was used around the world wherever mosquitoes carried the disease. The British even incorporated it into their “tonic water.”

No one in the United States has worried about malaria for decades. But quinine was popular as a treatment for nighttime leg cramps. For years, people bought this drug in over-the-counter products such as Legatrin, Q-vel and Quinamm to relieve muscle cramps.

In 1994 the FDA banned quinine from over-the-counter sale. The agency decided that quinine was too dangerous for people to take without medical supervision.

Quinine can cause serious side effects, including life-threatening anemia and irregular heartbeats. Other hazards include severe headache, visual disturbances, rash, itching, ringing in the ears, nausea, diarrhea and liver damage. If a pregnant woman took quinine, her baby could be born with a defect.

The FDA maintains that leg cramps are not a serious health problem, while quinine can be lethal. Over the years, more than 90 people have died of quinine complications. Despite this, nearly two million Americans took quinine to relieve their leg cramps.

Doctors continued to prescribe quinine sulfate for restless legs as well as leg cramps. Now, however, the FDA is cracking down. Only one brand of quinine will be allowed on the market. Qualaquin is approved only for treating certain types of malaria, and it costs more than $4 per pill.

The more rigorous ban may pose problems for millions. One reader wrote, “It was refreshing that our doctor prescribed quinine sulfate for my husband’s restless leg syndrome. He takes one pill each night before bedtime and gets wonderful results.”

Even people who have used quinine successfully for years won’t have access to it now. The trouble is that there aren’t very many other medications that can relieve leg cramps.

We discuss a number of home remedies and other approaches to this common problem in our Guide to Leg Pain. Anyone who would like a copy, please send $2 in check or money order with a long (no. 10) stamped (63 cents), self-addressed envelope: Graedons' People's Pharmacy, No. RLS-5, P. O. Box 52027, Durham, NC 27717-2027. It can also be downloaded for $2 from the Website: www.peoplespharmacy.com.

One reader had good results from an inexpensive remedy: “After suffering with leg cramps for over 30 years, I heard about putting a bar of soap under the bottom sheet of the bed. Nothing kept me from having to get up and massage my feet and legs until I tried the soap. What a relief to be able to finally get a good night’s sleep!”

Other approaches to leg cramps include drinking low-sodium V-8 juice, consuming extra calcium, magnesium and B vitamins. Some even report that a little yellow mustard can relieve nighttime leg cramps.

Imagine going out to eat at a nice restaurant, getting an impressive menu, but not finding prices for anything. Most people would find such a situation disorienting. They would hesitate to order a meal at a restaurant that won’t tell its patrons beforehand what the food will cost.

When it comes to drugs, however, most people have no idea what they will cost until they get the bill. Millions of Americans routinely visit a doctor’s office and rarely ask what their medications will cost until they are standing in the pharmacy.

A recent study published in the American Journal of Managed Care (Nov. 2006) revealed that physicians and patients rarely talk about how much prescription medicines will cost. The researchers tape-recorded office visits.

When prescribing a new drug, doctors discussed the subject of medication costs and insurance only one time out of eight. Patients were even less likely to bring up the subject. They asked about price less than 2 percent of the time. It was a classic case of don’t ask, don’t tell.

The trouble is that when patients get to the pharmacy and discover how much their medicine will cost, they often experience sticker shock. Some just turn around and walk out the door without even filling the prescription. Others ask the pharmacist to come to their rescue.

Pharmacists spend hours on the telephone with doctors’ offices negotiating about drugs not covered by the patient’s insurance. Since physicians may not realize how expensive their prescriptions can be, the pharmacist is frequently the one who breaks the bad news.

The consequence is what doctors refer to as “noncompliance.” This means patients don’t take their medicine. Although noncompliance implies a patient who is being uncooperative, often it’s a matter of financial survival.

One reader shared her situation: “I am 79, single and have no pension after 40 years of work as a paralegal in Washington DC law firms. I get less than $900 Social Security per month plus a small dividend income. I was never married so do not benefit from a dead husband's insurance. I suffer from asthma, GERD, pancreatitis and am a cancer survivor. I cannot afford all the drugs that are prescribed for me, so I do without all but the two most essential.”

This person is not unique. Researchers have found that 25 percent of older people skip medicines for high blood pressure, high cholesterol, asthma or emphysema because of cost. The consequences are more frequent emergency room visits and serious health complications.

It is time both patients and physicians stop pretending that money doesn’t matter. Discussions of prescription drug costs are essential before the patient leaves a doctor’s office.

To help facilitate this difficult conversation, we have prepared a Guide to Saving Money on Medicine. It covers tips for cutting costs and tells consumers how to find reputable Canadian pharmacies online. Anyone who would like a copy, please send $2 in check or money order with a long (no. 10) stamped (63 cents), self-addressed envelope: Graedons' People's Pharmacy, No. CA-99, P. O. Box 52027, Durham, NC 27717-2027. It can also be downloaded for $2 from the Website: www.peoplespharmacy.com.

When the FDA switched the prescription pain reliever Motrin (ibuprofen) to over-the-counter status in 1984, a lot of physicians were unhappy. They feared that this powerful NSAID (non-steroidal anti-inflammatory drug) might cause serious harm without medical supervision.

Many doctors opposed easy access to NSAIDs because of side effects such as fluid retention, elevated blood pressure, rash, stomach irritation and ulcers.

The FDA downplayed such concerns. Officials at the agency seemed to think that OTC NSAIDs offered people another valuable option for pain relief without serious risk.

It wasn’t long before brands like Advil and Motrin IB became big sellers. Eventually Aleve (naproxen) hopped on the bandwagon. It is estimated that over 20 million Americans take the OTC NSAIDs ibuprofen or naproxen each day.

Now the FDA has decided the labels on common pain relievers need to be revised. The new warnings will caution consumers that NSAIDs can cause stomach bleeding in people over 60 or those who have had ulcers or are taking a blood thinner. It will also point out hazards for people who combine these drugs with alcohol or take the medicines for longer than directed.

Despite this increased emphasis on stomach problems (and liver toxicity associated with acetaminophen), there will be no warnings that regular use of NSAID pain relievers may increase the risk of heart attack or stroke. These adverse reactions were discovered relatively recently, in the wake of the Vioxx scandal.

What the FDA doesn’t seem to realize is that whatever they put on the label may be irrelevant. Studies have shown that only about one consumer in five reads the instructions and warnings on the label. A few more—nearly one in three—bother to check the dose.

Perhaps that’s why one person in four takes more than the recommended dose of OTC pain reliever. Most consumers seem to think that any drug available without a prescription is safe enough that they just don’t need to worry about it.

Sadly, that leads to far too many overdoses and hospitalizations. Currently, the FDA estimates that as many as 200,000 Americans are hospitalized each year with serious reactions to NSAID pain relievers, as well as acetaminophen and aspirin.

People in pain are caught in a bind. Many of the drugs they rely on for relief may raise blood pressure, cause bleeding ulcers or even increase the risk for a heart attack or stroke. No wonder people are so anxious to find other alternatives to ease their discomfort.

In our new book, Best Choices From The People’s Pharmacy (Rodale Books) we discuss many other options for pain relief, including home remedies, herbal approaches and topical NSAIDs. Drugs like Pennsaid, Voltaren Emulgel or Feldene Gel can provide relief without typical NSAID side effects. The FDA has never approved such medications for sale in the U.S., but they are available in other countries.

We’re pleased the FDA has finally recognized that warnings for OTC pain relievers need to be improved. We only wish all consumers would read the labels and take these drugs seriously.

Can antidepressants really drive some people to commit suicide? That is a question the FDA has had to wrestle with for nearly two decades.

For most of that time the agency has insisted that SSRI-type antidepressants such as Prozac or Paxil are life savers that prevent suicide. When someone taking one of these medications considered or even committed suicide, this tragedy was frequently explained as the result of the underlying illness, not the medicine.

After years of denying any link, however, a panel for the FDA has recommended a warning be added to the official label. It will warn physicians and patients that the risk of suicide is almost twice as high among young adults taking such medicines.

This caution comes too late for many. Over the years we have heard from distraught family members who reported that a loved one committed suicide shortly after starting on one of the SSRI antidepressants. We’ll never forget the father who reported that his son, a graduate student, shot himself less than three weeks after starting Paxil. The father blamed the FDA and the drug manufacturer for failing to warn of this danger.

Lest we demonize these drugs, however, it is important to recognize that many people do experience benefit. One wrote, “I was very sad to hear of the young man who committed suicide after taking Paxil for 17 days. Since I have had good results with Paxil, I am disturbed when I hear of someone's tragic results.

“After a year of counseling and resisting taking antidepressants, I gave it a try. I'll never forget how I felt on the ninth day of taking it. I felt alive for the first time in my life, at age 27.

“After ten years of taking Paxil, I noticed a change when I tried to increase the dosage. I thought it would make me feel better, but it had the opposite effect. I was very moody and miserable for a month before going back to the previous dosage.

“I think Paxil is an incredible breakthrough for the treatment of chronic depression, but more studies need to be done on the effects on different mental illnesses and different dosages.”

Antidepressant medications such as Paxil (paroxetine), Prozac (fluoxetine) and Zoloft (sertraline) help many people overcome depression and may prevent suicides. But not everyone experiences the same benefit. Some people become agitated, irritable, hostile and cannot get a good night’s sleep. For them, such drugs can be a hazard, especially if they begin to think about suicide.

For a deeper understanding of the benefits and risks of antidepressants and many non-drug approaches to dealing with depression, we offer our new book, Best Choices From The People’s Pharmacy (Rodale Books). It is available at booksellers or on the Internet.

After dragging its feet for years, the FDA seems poised to admit that SSRI antidepressants may pose a suicide risk for some people. It is considering expanding the “black box” warning that alerts doctors and patients to this danger.

Family, friends and health professionals should now be more vigilant when patients with depression start, stop or change the dose of these powerful medications. If this awareness can prevent just one needless death it will be worthwhile.

Until 1989, grapefruit was just another citrus fruit. It had a pronounced taste that some people found refreshing and others rejected as bitter. But then Canadian scientists published a surprising finding: taking the blood pressure pill Plendil (felodipine) with double-strength grapefruit juice could triple blood levels of the drug in some people.

The researchers had not set out to study grapefruit juice, so the discovery was almost incidental. They had chosen grapefruit juice because it masked the flavor of alcohol better than orange or apple juice did. They had planned to study the interaction of alcohol and felodipine and needed a way to give an inactive placebo that couldn’t be distinguished from the beverage containing alcohol.

That was just the beginning. During the 90s, investigators reported interactions between grapefruit and many different medications. Other blood pressure medications were also affected. So were cholesterol lowering drugs like Lipitor (atorvastatin), Mevacor (lovastatin) and Zocor (simvastatin).

Although we warned consumers about this interaction for years, most pharmacists and physicians found it more amusing than frightening. But by the end of the decade the FDA, drug companies and health professionals were all taking grapefruit interactions seriously.

Although there are now warnings on drug labels, there is a lot of confusion. We recently responded to a reader who hoped to save money on his cholesterol medicine by using grapefruit juice. We suggested that he might try this, but only if his doctor agreed to supervise: “Check with your doctor before trying this approach. We know one man who breaks his Lipitor in half, takes it with grapefruit juice and gets good results on his cholesterol tests.”

Many readers issued indignant howls in response: “Your answer regarding grapefruit juice and Lipitor was very dangerous. My 82-year-old mother has been on Lipitor for many years. ALL her medical doctors, including her cardiologist, have told us that she CANNOT have grapefruit juice!”

Another confused reader wrote, “I have been warned by pharmacists NOT to eat grapefruit or drink grapefruit juice as I am taking lovastatin because it reduces the drug's effectiveness. I was eating grapefruit for weight control and gave it up. Yet Lipitor is a statin and your column suggest that grapefruit increases its effectiveness. Please clarify.”

Grapefruit raises blood levels of atorvastatin (Lipitor) by about 80 percent (British Journal of Clinical Pharmacology, Nov. 2005). Other drugs may be affected more strongly. This can increase effectiveness as well as the risk of side effects.

Anyone who would like to learn more about this fascinating field may wish to order our Guides to Food, Drug and Grapefruit Interactions. Please send $3 in check or money order with a long (no. 10) stamped (63 cents), self-addressed envelope: Graedons' People's Pharmacy, No. FJ-19, P. O. Box 52027, Durham, NC 27717-2027.

If people attempt to utilize the potential of grapefruit juice to increase the effective dose of a medicine, it must be done under medical care. Individuals vary in their susceptibility to this interaction and their doses need to be adjusted accordingly.

Physicians frequently look down on home remedies and other alternative therapies because there is rarely scientific evidence to support them. In an age of “evidence-based medicine,” there is no room for folklore.

When our readers tell us that Vicks VapoRub helps heal nail fungus, Listerine cures dandruff or that putting keys down the back of the neck can stop a nosebleed, many medical experts sneer.

The only trouble with this condescending attitude is that the evidence supporting many conventional treatments is often surprisingly inadequate.

A recent report in the Journal of the American Medical Association (Nov. 22/29, 2006) revealed that spinal surgery on herniated disks was not clearly better than standard therapy for sciatica.

Patients with arthritis were told that a new generation of anti-inflammatory drugs, the COX-2 inhibitors, would be much safer than older medications such as ibuprofen or naproxen. Tens of millions of patients were prescribed drugs like Vioxx, Bextra and Celebrex because they were supposed to be better. Now we know the evidence of safety was illusory and many people suffered heart attacks or strokes as side effects.

The most recent shocker involves drug-coated stents. These devices are tiny mesh tubes that prop open clogged coronary arteries. Bare metal stents had been used for years, but the arteries frequently clogged up again. Coating the metal with a medication designed to retard cell growth seemed like a breakthrough. Initial studies suggested that the pricey “drug-eluting stents” would be safer over the long term.

A new study from the Cleveland Clinic (American Journal of Medicine, Dec., 2006) now suggests that these new and improved stents are actually four or five times more likely to result in a blood clot that can lead to a heart attack. Millions of people now worry that they may be at increased risk of fatal heart attacks because of an intervention that was supposed to save them from this very fate.

Physicians want to do the right thing. Making good decisions does require scientific evidence. But too often the evidence is not as strong as manufacturers claim.

For years, makers of hormone replacement therapy (HRT) told doctors that estrogen and progestin would prevent a variety of serious health problems. Women were encouraged to take hormones to protect their hearts, their bones and their brains. We now know, however, that HRT can increase the risk of heart attacks, strokes and breast cancer.

The new generation of antipsychotic medications was supposed to be substantially better than older drugs for schizophrenia. But a new study shows that the pricey new pills offer no clear advantage over older medicines (American Journal of Psychiatry, Dec. 2006). Is it any wonder that patients are becoming skeptical about so-called drug breakthroughs?

Doctors and patients alike should have better information on which to base treatment decisions. People often turn to Consumer Reports for head-to-head evaluations of toasters, TVs or automobiles. The same type of objective analysis should be available for medication interventions.

For generations Americans have been told, “you get what you pay for.” That’s why many people are willing to pay extra for Hershey’s Kisses, Dole pineapple or Hellmann’s mayonnaise. When you buy new tires for your car, you know you will have to pay more if you expect them to last 75,000 miles instead of just 25,000. But in the field of pharmaceuticals, Americans have been told that price doesn’t matter. Generic drugs are supposed to be identical to their brand name counterparts even if they only cost $4 a month from Wal-Mart. In fact, they are supposed to be just as good even if they’re free. Some insurance companies are so eager to get patients to switch to generic drugs that they are willing to give them away for a time without a co-pay. How is it that a fundamental law of economics—you get what you pay for—has been suspended? Does it make sense that a generic pill you get for nothing could compete in quality with a brand name product that costs more than $100? The FDA takes pains in approving generic drugs to make sure the generic contains the same active ingredient at the same dose as the brand name product it replaces. According to the government, this process guarantees that generic drugs are every bit as good as pricey brand name prescriptions. For nearly 30 years we believed this argument. We encouraged people to save money by insisting that their physicians prescribe generics whenever they were available. All that changed several years ago when some pharmacists started telling us they had doubts about the quality of certain generic products. We also began getting letters from readers who had trouble with their generic prescriptions: “My husband has been taking Dilantin as a seizure preventive for some time with great success. A generic came out that would save him a lot of money, so he tried it, and had a seizure. The neurologist made him promise not to do that again.” Other readers have shared their disappointment with generic pain relievers, antidepressants, blood pressure medicines and diabetes drugs. The generic drug manufacturers discount these reports. Kathleen Jaeger, president and ceo of the Generic Pharmaceutical Association, has written: “To set the record straight, there are no differences between FDA-approved brand and generic medicines. A generic must meet the same high standards as the brand-name drug, with the same safety and effectiveness, same active ingredients, same strength and dosage, same labeling and use and same high quality manufacturing standards.” While we agree with Ms. Jaeger that FDA approval is rigorous, we worry that once drugs are approved and marketed, monitoring is spotty at best. For the most part, the pharmaceutical industry runs on the honor system. The FDA is not capable of analyzing more than a handful of pill bottles from pharmacy shelves each year. As a result, unscrupulous manufacturers or counterfeiters may be slipping substandard generics into the marketplace. Anyone who would like to report a problem with a generic drug can go to our Web site, www.peoplespharmacy.com, and email us from there. We will forward messages to the FDA and the Generic Pharmaceutical Association.

For decades, the “old wives” have been ridiculed as superstitious know-nothings. Now science seems about to vindicate them.

The old wives maintained that a dose of cod liver oil would do a body good. Many children dreaded it because it tasted so awful. But come the dark days of winter, mothers and grandmothers insisted that all family members should hold their noses and swallow a spoonful of cod liver oil.

Over the last couple of decades this practice has gone the way of the manual typewriter. Few children get cod liver oil these days. Doctors don’t recommend it because it seems like such an unscientific relic of the past.

The vitamin D that is abundant in cod liver oil has numerous health benefits though, especially in the winter. That’s because levels of vitamin D frequently drop when people are not exposing their skin to the sun.

Cold, dreary weather and diminished sunlight can create borderline vitamin D deficiency in a surprising number of people. In Boston, 42 percent of people studied had too little vitamin D in winter. In Calgary, Canada, almost no one maintains adequate vitamin D in the winter.

In 2005, a psychiatrist who treated his patients for vitamin D deficiency noticed something odd. Influenza hit the Atascadero State Hospital, a maximum-security psychiatric hospital, hard. His ward was spared, with not a single person catching the flu even though they had been exposed to the virus just like everyone else. The psychiatrist wondered whether the vitamin D he had prescribed had anything to do with their immunity.

This question led to an interesting review of research and a credible hypothesis. Studies over the last 70 years hint at a connection between vitamin D and overall immunity.

The active form of vitamin D greatly increases the body’s production of a natural infection-fighting chemical called cathelicidin. Cathelicidin seems to help fight off illnesses caused by bacteria, fungi and viruses, including influenza.

This may help explain why people are more susceptible to colds and flu in the winter. If their vitamin D levels drop, so does their production of cathelicidin and their overall resistance to infection.

Vitamin D also appears to have anti-cancer activity. People who get regular sun exposure are less susceptible to common cancers that affect the colon, breast, prostate, ovaries and lungs. Even conditions like multiple sclerosis, arthritis and type 2 diabetes are less common in people with ample vitamin D levels.

Vitamin D has long been associated with stronger bones, but there is also research showing that it contributes to stronger muscles and fewer falls in the elderly.

Anyone who would like to know more about the multiple health benefits of vitamin D may be interested in a one-hour radio interview with Dr. Michael Holick, one of the world’s leading experts on this nutrient. For a CD of this show, please send $16 in check or money order to Graedons' People's Pharmacy, No. CD-502, P. O. Box 52027, Durham, NC 27717-2027.

The old wives did not have sophisticated scientific tools or methods, but they were skilled observers. It’s fascinating when the scientists supply the explanation behind their wisdom.

Millions of people experience serious drug side effects each year. Far too often they don’t realize a medication is causing their distress. A recent study revealed that only about one doctor in three informs patients about possible side effects when prescribing medication (Archives of Internal Medicine, Sept. 25, 2006).

This omission means that serious consequences may not be recognized. Sometimes a patient or family member is able to find this critical information on the Internet. We heard recently from one woman who may have saved her husband’s sight:

“This past spring my husband was in severe diabetic crisis, and needed to have all the toes on one foot amputated. Along with serious sugar imbalances, his blood pressure rose alarmingly to 227/162. “When his numbers were this high, he was put on Micardis to try to check that rapid rise. Within a day he experienced blurred vision, which we reported to doctors and nurses. They responded that he was probably experiencing diabetic retinopathy.

“When I got my husband home from the hospital I had to lead him around, for he was unable to see. The next day I called the VA Hospital eye clinic and advised them my husband was going blind and needed an emergency eye exam. That very day he was seen by an ophthalmologist who did extensive testing and concluded his vision was now 20/200. The diagnosis was diabetic retinopathy, with extreme cloudiness in both eyes. The prediction was that my husband’s vision would worsen rapidly.

“I took him home and called the endocrinologist who had prescribed Micardis. I expressed concern and said I had checked MedlinePlus at www.nlm.nih.gov/medlineplus/. There I learned that the rare side effects of this drug include ‘changes in vision’ and ‘blurred vision’ (incidence unknown). The doctor had never heard of vision problems with this drug and said my husband needed to remain on it since his blood pressure was so high.

“My husband and I discussed this and concluded he was NOT going to remain on Micardis. I did not give him his evening dose, and in less than 8 hours my husband's vision had completely returned! The following day I took him back to the ophthalmologist and also met with a retinologist who ran tests and exams on my husband's eyes. They were dumbfounded that this man's vision was now 20/40!

“I told both doctors I was concerned that it was so easy to diagnose my husband with diabetic retinopathy, forever sentencing him to blindness. I am convinced many diabetics with high blood pressure are told they are now permanently blind with retinopathy though they might actually be suffering an extreme reaction to a drug. The retinologist immediately agreed and said he had never seen a case like this before.

“I have filed a report about this bad reaction to Micardis with the FDA on their MedWatch site. So has the retinologist. I've checked for a response to this alert on www.fda.gov and have found nothing so far. Please alert diabetics to the dangers of Micardis.”

Discontinuing blood pressure medicine without medical supervision is hazardous, but sometimes continuing a drug that is causing side effects is also dangerous. The Web can be a valuable resource for patients such as this woman’s husband.

How Good Is Your Flu Shot?

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The annual flu-season ritual has begun again. First you will be admonished to get your flu shot.

Then you will be scared by reports of influenza outbreaks all around the nation.

The trouble is that it isn’t clear whether flu shots make much difference. A recent analysis in the British Medical Journal (Oct. 28, 2006) casts doubt on the effectiveness of flu shots, especially for the elderly.

Dr. Tom Jefferson is a vaccine epidemiologist who has reviewed all the influenza research and concluded that it leaves a lot to be desired. He notes that, “in healthy people under 65 vaccination did not affect hospital stay, time off work, or death from influenza and its complications.?

Public health officials might argue that healthy younger people are not the primary target for flu shots. It is the older, more vulnerable population that is most at risk of serious complications or death from influenza, so they should benefit more from vaccination.

Unfortunately, the statistics don’t support this assumption either. Over the last three decades the death rate from flu in older people hasn’t changed much despite the fact that many more senior citizens are being vaccinated. Scientists reviewing these data concluded that flu shots don’t protect older, more susceptible people very well (Archives of Internal Medicine, Feb. 14, 2005).

Another analysis of flu vaccine effectiveness leads to the conclusion that flu shots are approximately 23 percent effective for elderly people in nursing homes (Lancet, Oct. 1, 2005). One might assume that those outside of nursing homes would fare better, but according to the scientists, “In elderly individuals living in the community, vaccines were not significantly effective against influenza, influenza-like illness, or pneumonia.?

The public is sometimes suspicious of flu shots, claiming that they may give people flu-like symptoms. There is no evidence that this happens, but when it comes to vaccine safety the studies are unexpectedly scarce. According to Dr. Jefferson, there’s not much data on this score: “Although there appears to be no evidence that annual revaccination is harmful, such a lack of knowledge is surprising.?

We’re not suggesting that people should skip their flu shots this year, but we do think more research is needed. Physicians pride themselves on practicing evidence-based medicine. Many would be shocked to discover that the science supporting influenza vaccination is so inadequate. We need better studies that prove flu vaccines are effective, especially in older people.

What alternatives do patients have? Some may wish to discuss antiviral flu medicine with their physicians. The evidence on these drugs is also imperfect, but they seem to speed recovery if taken early enough.

The Centers for Disease Control and Prevention says that older flu drugs like amantadine and rimantadine “are approximately 70 percent to 90 percent effective in preventing symptoms of influenza A illness.? Newer medications such as Tamiflu or Relenza also seem to provide some protection, perhaps with fewer side effects.

How Good Are Generic Drugs?

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The high cost of prescription drugs has everyone looking for ways to save. Hospitals, HMOs and insurance plans are as upset about their pharmacy bills as individual patients are.

One popular solution is to buy generic drugs . Doctors are encouraged to prescribe generic equivalents when possible. Patients may be penalized if they insist on a brand name. The co-pay for branded medications is often double or triple that for generics.

People without insurance often can’t afford anything other than generic medicine. How good are these substitutes?

For 30 years we have defended generic drugs. The FDA assured us that their rigorous standards ensured quality. A few years ago, however, we started to get reports from readers about generic drug failures.

Some parents claimed that when a child with ADHD was shifted from Ritalin to generic methylphenidate, his behavior and attention deteriorated. Patients whose epilepsy was well controlled on the anticonvulsant Dilantin reported seizures when switched to generic phenytoin.

An article in the journal Neurology (Oct. 2004) confirmed that some generic phenytoin did not perform up to standards. The neurologists reported breakthrough seizures in patients under good control for years.

We also heard from people who had problems with irregular heartbeats, hypertension, acid reflux or pain when they were switched. Many found the generic version of their medication seemed less effective than the original.

We were puzzled by this spate of reported problems with generic medicines, so we contacted the FDA to find out how the agency monitors the quality of drugs after they are approved. We were not reassured by what we learned.

As far as we can tell, the pharmaceutical marketplace in the U.S. works on the honor system. The FDA relies on drug companies to be honest.

For such a profitable industry, there is remarkably little oversight. Airplanes, elevators and even restaurants are inspected on a regular basis. But more than three billion bottles of pills are dispensed in the U.S. each year and only a relative handful are actually tested. The FDA says it pulls about 300 pill bottles off shelves to test for content and dosage strength. This amounts to 1 in 10,000,000.

Where do ingredients for generic drugs come from? More and more often, countries like China and India are getting into the game. The competitive nature of the generic drug market makes low-cost source materials very attractive. Without constant quality surveillance, we worry that U.S. consumers may not always be getting what they expect.

We have examined the controversy over generic drugs in much greater depth in our new book, Best Choices From The People’s Pharmacy (Rodale Books). It offers guidelines for using generic drugs safely. Some include:

  • Record numbers (blood pressure, blood sugar, etc) that show if the drug is working.

  • Monitor lab results (cholesterol, thyroid, INR).

  • Observe your subjective response to antidepressants, pain medicine or sleeping pills. With care, you can use generic drugs safely. If you suspect your medicine is not working properly, notify your doctor immediately. Switching back to the brand name might cost more, but it could save your health.

Most people dread a trip to the emergency room. First, there’s the trauma and anxiety of whatever brought them there—chest pain, uncontrolled bleeding or perhaps a broken bone.

Then there’s the ordeal of a waiting room full of other sick people, some of whom are likely to be in much worse shape. Many could be contagious.

And finally, there’s the waiting. Unless the problem is a heart attack or stroke, many hours can go by before they are seen by a physician.

With such hurdles, it’s no wonder most folks do their best to avoid the emergency department (ED). But according to a new report, more than 700,000 people make this frightening trip each year because of bad drug reactions (JAMA, Oct. 18, 2006).http://jama.ama-assn.org/cgi/content/abstract/296/15/1858

They were not junkies overdosing on heroin. These patients were having trouble with medicines like the anticoagulant Coumadin (warfarin), the heart medicine Lanoxin (digoxin), the antibiotic amoxicillin or insulin to control blood sugar.

This surveillance program is a unique collaboration among the FDA, the CDC (Centers for Disease Control and Prevention) and the Consumer Product Safety Commission. Researchers reviewed patient records in hospital emergency departments to identify cases.

Since many adverse drug reactions are misdiagnosed, or never even reported by the patient, the investigators suggest that 700,000 is likely to be a conservative estimate for serious drug side effects. People over 65 years old were far more likely to experience such reactions. This group represents only 12 percent of the US population, but reported one fourth of the drug-related ED visits and more than half of the resulting hospitalizations.

One of the most surprising results of this study was that old familiar drugs accounted for the vast majority of problems. Although great public attention has been focused on the dangers of newer medicines such as Vioxx, this research suggests that some of the worst offenders have been on the market for decades.

Perhaps physicians take such drugs for granted and forget to provide careful dosing instructions. Unintentional overdoses accounted for a third of the visits to the ED. Patients also need guidance on early warning signs that would allow them address problems before they become emergencies. In our brand new book, “Best Choices From The People’s Pharmacy,? we provide guidelines for safer use of drugs and many non-drug alternatives. To purchase this book, see your local bookseller or send $23.95 to Graedon Enterprises; PO Box 52027; Durham, NC, 27717-2027.

America has become a pill-popping society. In 2004, four out of five citizens reported taking at least one prescription drug, over-the-counter medicine or dietary supplement in the preceding week. According to the article in JAMA, “30% reported using 5 or more of these drugs.?

With so many people taking so many different medicines, it is hardly any wonder that adverse drug reactions have become one of our most common health problems. Millions of people are hospitalized each year because the drugs that are supposed to help have instead caused harm.

To keep that from happening to you or someone you love, make sure that you have all the necessary information about taking medicine safely.

For decades many doctors have encouraged patients to skip vitamins and eat a “well balanced diet.? What that means exactly has been hotly debated for a very long time. One key component, though, has always been whole grains like wheat, barley and rye.

The only trouble with this recommendation is that for millions of Americans it is poison. People with celiac disease cannot tolerate gluten, a protein found in these grains.

When they eat foods made with flour such as pasta, pizza or even whole wheat bread, the lining of the small intestine is severely damaged. As a result, such patients cannot absorb key nutrients from their diet and they may suffer from a range of serious symptoms.

Digestive tract upset is not uncommon. Many people complain of discomfort ranging from heartburn, gas and bloating to cramping and diarrhea. Others experience fatigue, anemia, an itchy skin rash, nerve pain, migraines or osteoporosis.

But one of the most insidious and easily overlooked complications of celiac disease may be dementia. Physicians are rarely taught that cognitive impairment might be a symptom of celiac disease, so forgetfulness is usually attributed to aging or Alzheimer’s disease.

After listening to a radio show we hosted on celiac disease, a listener shared this story: “Your program may have saved my life. I know it saved my sanity.

“The more people talked on the show, the more I thought ‘That sounds like me!’ I had heard of celiac disease, but I did not know it could show up in adulthood. I figured I had nothing to lose by eliminating wheat from my diet for a while.

“After a week of rice and vegetables, I couldn't believe how much better I felt. The bloating, gas, diarrhea, and puffiness were gone. Best of all, though, the depression, lethargy and inability to concentrate and think began to lift.

“Not long before, I had insisted my doctor test me for Alzheimer's! I was losing my ability to recognize faces. I couldn’t have written a letter because I wouldn't have been able to sustain a train of thought long enough to get past the first paragraph.?

New research from the Mayo Clinic suggests that celiac disease should be considered when people start having trouble thinking, doing simple math or remembering things (Archives of Neurology, Oct. 2006). A review of patient records revealed several people who had been diagnosed with both celiac disease and dementia. In two cases, following a gluten-free diet reversed the cognitive decline.

Earlier diagnosis and treatment of celiac disease with a completely gluten-free diet might be able to keep some people from developing cognitive problems that resemble Alzheimer’s disease.

Celiac disease is far more common than most people realize. It often goes undiagnosed for years because symptoms are varied and nonspecific. Perhaps as this condition gets more attention, it will become rare for people to suffer from the debilitating consequences.

Readers who would like to learn more about celiac disease may want a CD of our one-hour radio interview. The show covers symptoms, diagnosis and treatment. It is available for $16 from the People’s Pharmacy (CD- 594), P. O. Box 52027, Durham, NC 27717-2027 or from www.peoplespharmacy.com.

Humans have a terrible time communicating. Just ask any teenager how well his parents listen. Or turn the tables and ask the parents whether their adolescent son or daughter pays attention to what they say. We’re told that men are from Mars and women are from Venus and that creates all kinds of misunderstandings.

Nowhere is clear communication more critical than between doctors and patients. Unfortunately, this exchange often falls short.

Most physicians think they do a good job listening to patients and imparting crucial information. But studies have reported that, on average, a busy doctor interrupts a patient after about 12 to 22 seconds. Unless a patient knows which of two or three issues is most important and gets it out first, a health concern could be overlooked.

Doctors frequently overestimate how much information they share with patients. Studies frequently find that physicians report giving much more information about prescriptions, for example, than patients report hearing. That could be chalked up to patients not paying attention, but a new study using actual audiotapes of office visits found that a quarter of doctors did not name the drug they were prescribing, nearly half did not tell the patient how many tablets to take, and roughly two-thirds did not mention any possible side effects (Archives of Internal Medicine, Sept. 25, 2006).

No wonder some patients long for a different type of interaction with a doctor, as we heard from one gentleman: “I am a 62-year-old man with a few medical problems. Mostly I've decided to ‘watch and wait’ in the hope they will get better with time.

“This might seem like a faulty plan, but in my 62 years, I’ve seen a dozen doctors and found only one willing to actually TALK to me. I've had a couple of physicians enter the exam room reading the medical files, ask why I'm there and leave (all in less than 4 minutes--I've timed it) and NEVER LOOK AT ME. They looked at records, lab reports, current weight and BP but never at me.

“It gets worse. When I had the temerity to ask a question, I've had doctors get up and leave, saying that the nurse will explain it to me. How do I find a doctor willing to answer questions? I have a Ph.D. and can understand explanations.

“I’ve almost given up on finding such a doctor, but waiting for time to resolve issues isn't a good strategy and as I age, it is becoming less viable. I really need to find a doctor who will diagnose, answer, explain, treat and respect me as a patient and a fellow human being.?

Patients can help in keeping the lines of communication open. Writing down your major questions and concerns beforehand will help you stick to the basics and not get sidetracked. When you get a prescription, make sure you understand:

*what it is *what it is for *how to take it *when to stop taking it *any interactions *any signs of serious side effects that should prompt you to contact the doctor.

Taking responsibility for getting these details will make it easier for the doctor to communicate more completely. Our free Drug Safety Questionnaire will help you organize the information. Download it from our Web site: www.peoplespharmacy.com

Americans like to think they are Number One in everything. Our politicians frequently tell us that we have the best health care system and the safest drugs in the world.

Myths die hard. In truth, we are nowhere near the top when it comes to providing health care for all our citizens. And a new report on the FDA suggests that this watchdog agency is in disarray.

The Institute of Medicine (IOM) is a prestigious panel of experts that advises the nation on critical health matters. A committee of the IOM was asked to review the Food and Drug Administration. The results of this analysis are shocking.

The committee observed, “There is a perception of crisis that has compromised the credibility of FDA and of the pharmaceutical industry.? That might be due to highly publicized drug scandals such as the Vioxx withdrawal.

The fact that the FDA did not catch this drug disaster itself and was slow to respond has left lingering doubts about the agency’s ability to protect the public health.

The IOM found that the drug safety system in America is threatened by organizational problems such as poor management, infighting, low morale and unclear and insufficient regulatory authority.

These are aggravated because FDA lacks adequate funds to carry out its mission. In recent years the agency has taken huge sums from the pharmaceutical industry in the form of “user fees.? This money goes mostly towards facilitating the drug approval process. Drug companies want their products moved through regulatory hurdles quickly. Very little funding, however, is available to monitor safety once these drugs hit the marketplace.

Perhaps most worrisome, the IOM committee concluded that FDA does not “consistently demonstrate accountability and transparency to the public by communicating safety concerns in a timely and effective fashion.? As a consequence, the FDA has lost the trust of the American people.

Patients who have lost confidence in the nation’s medicines may be more likely to stop taking potentially life-saving medicines. A study in the Archives of Internal Medicine (Sept. 25, 2006) shows that one patient in eight quit crucial heart medicines within a month of hospital discharge after a heart attack. Such patients increase the likelihood that they will die within the year.

To restore faith in the FDA the IOM committee made a number of valuable recommendations. Physicians and patients need better information about both risks and benefits of medications. To this end, the committee suggested a moratorium on TV ads during the first two years after a drug is approved for sale.

When a drug first appears on pharmacy shelves information is often missing about side effects and dangerous interactions. These may only be uncovered after many more people have taken it. The IOM suggested that during this critical early period the packaging for a new medicine should have a special symbol. This would alert patients and physicians alike to the fact that it is new and may cause unexpected effects.

Until these new guidelines are adopted, the drug watchdog agency may not be up to its task. To stay safe, people need to be well informed and alert for the effects, both good and bad, of any medicine they take.

There was a time when buying over-the-counter medicines was pretty simple. If you wanted a non-aspirin pain reliever you bought Tylenol, the brand name for acetaminophen. If heartburn was a problem you might choose Maalox. It contained antacids—aluminum and magnesium hydroxide. A woman with PMS might take Midol, with acetaminophen and diuretics (pamabrom and pyrilamine).

These brands were so successful the companies decided to extend them. Name recognition is powerful. To take advantage of it, drug companies created many products capitalizing on the same brand name. This may seem like a brilliant marketing strategy, but it creates confusion and possibly danger in the pharmacy. For example, there are five different versions of Midol. Unless a woman reads the fine print and knows what the ingredients are, she may not understand that one Midol formula could be safe for her while another might pose risks.

Unlike Midol PMS, which contains acetaminophen, Midol Extended Relief contains naproxen as its pain reliever. People with sensitive stomachs or who are taking the anticoagulant Coumadin (warfarin) could suffer a serious reaction with this formula. The company warns about this risk, but someone who does not take time to read the label because she’s used to taking “Midol? could get into trouble.

Maalox is another familiar brand name that has been extended. A new formulation contains bismuth subsalicylate, the active ingredient in Pepto-Bismol, instead of the old familiar antacids.

An elderly gentleman recovering from surgery was suffering from nausea and upset stomach. His daughter bought him Maalox to help ease his discomfort. When he developed black stools a few days later, she was alarmed. Black stools can be a symptom of intestinal bleeding.

Fortunately, a pharmacist helped her pin down the cause. She had unwittingly bought Maalox Total Stomach Relief instead of Maalox Regular. Bismuth subsalicylate causes black stools. Without the pharmacist’s sleuthing, the patient might have had to undergo extensive testing.

Perhaps the greatest brand name proliferation involves Tylenol. There are now more than 50 different Tylenol brand products. There’s the old familiar regular strength Tylenol with 325 mg of acetaminophen in each tablet. Then there’s Extra Strength Tylenol with 500 mg of acetaminophen and Tylenol Arthritis Pain with 650 mg per pill.

In addition you can find Tylenol PM, which contains acetaminophen and a sedating antihistamine (diphenhydramine). That doesn’t take into account all the various Tylenol cold and flu, allergy and sinus products.

Someone who trusts the Tylenol brand and doesn’t bother to look closely at the label might end up overdosing on acetaminophen. By taking three or four different products throughout the day for headache, a cold, allergies or insomnia, he could go over the maximum daily dose of acetaminophen without realizing it. Excessive amounts of acetaminophen can be dangerous to the liver.

Drugstore shelves are now cluttered with complicated, confusing brand-extension products. The smart consumer will read the fine print carefully and consult with the pharmacist before relying on a trusted brand name.

Before Bob Dole went on television to talk about ED and Viagra, men’s sexual problems were rarely discussed in public. Impotence was a source of shame.

Now that ads for Viagra, Cialis and Levitra are commonplace, people no longer seem reluctant to discuss erectile dysfunction. But there is another aspect of men’s sexual health that remains taboo.

Premature ejaculation is still forbidden territory. Few men can bring themselves to talk about this issue with their partners, much less their doctors. But PE, as it is abbreviated, is extremely common and can have devastating consequences for a relationship. Experts estimate that nearly one man in three suffers from this condition (International Journal of Impotence Research, Sept./Oct. 2006).

Defining PE precisely has been a challenge. Investigators haven’t had an objective measure for diagnosis. A large study found that most men lasted a little more than seven minutes, on average. Those with PE lasted less than two minutes.

Many men suffering with severe PE last less than one minute. They often feel that they have little or no control over their ejaculation and they believe that PE has a negative effect on their relationship. Because they cannot satisfy their partners in such a short time, many men feel inadequate. Their self-confidence may suffer, but they often don’t know what to do to solve the problem.

Until recently, doctors had little to offer. Sex therapists recommended behavioral strategies to delay orgasm, but not all men were able to master the techniques. Anesthetic creams that reduce sensation have been marketed for the problem, but the FDA has not approved such products for this use.

In fact, there is no FDA sanctioned treatment for PE. Nevertheless, physicians are prescribing antidepressant medications off-label for premature ejaculation. Drugs such as Prozac, Paxil and Zoloft frequently delay ejaculation as a side effect.

The problem is that these powerful medications have other side effects as well. In addition, men who are not depressed may be reluctant to take an antidepressant daily just to prolong intercourse.

A new drug called dapoxetine may some day offer men an alternative approach to treating PE. This medication is in the same family as other SSRI (selective serotonin reuptake inhibitor) antidepressants, but it is not as powerful or long lasting. Dapoxetine has been developed specifically to be used “on-demand? rather than on a daily basis.

A new study in the journal The Lancet (Sept. 9-15, 2006) reports that men taking dapoxetine one to three hours before sexual activity were able to extend intercourse from less than one minute prior to treatment to nearly three minutes after using the drug. That may not seem like much improvement, but many men reported better control over ejaculation and greater sexual satisfaction. Partners seemed to benefit as well.

No one knows whether the FDA will approve dapoxetine for PE. The agency rejected an initial application last year. The drug can cause nausea, diarrhea, headache and dizziness.

Perhaps now with the hope of an effective treatment, PE will come out of the closet and more men will seek help for this common condition.

People in pain are often treated like criminals. Narcotics may be the best treatment for severe pain, but they can also be drugs of abuse.

Readers have shared horror stories in which loved ones have suffered because doctors were unwilling to prescribe adequate pain relief. Sometimes pharmacists refused to dispense a legitimate prescription for a narcotic.

That’s because both physicians and pharmacists often worry about getting into trouble with the DEA (Drug Enforcement Administration). The war on drugs has led this federal agency to restrict access to medications like Vicodin and OxyContin that could be abused.

One controversial policy prohibited physicians prescribing more than 30 days’ worth of narcotic at a time. This meant that many people suffering from debilitating pain had to trek back to their doctors each month. Not only was this expensive; traveling can be challenging for patients with severe back problems or cancer. Any doctor who gave a patient more than a single month’s prescription could have been prosecuted.

After receiving over 600 comments from physicians, nurses, pharmacists and people in pain, the DEA has just revised its two-year-old rule. Doctors will now be permitted to give a patient three 30-day prescriptions in one visit, to cover 90 days of pain relief.

This step is certainly welcome, but it does not address all the problems arising from fear of addiction. More than a decade ago, the American Pain Society admonished doctors: "Undertreatment of acute pain and chronic cancer pain persists despite decades of efforts to provide clinicians with information about analgesics" (Journal of the American Medical Association, Dec 20, 1995). Pain specialists insist that adequate pain relief—including narcotics, if necessary—should be provided for all patients who need it, not only those who have cancer.

Unfortunately, that guideline is not always followed. We recently received the following account: “I endure constant suffering from chronic pancreatitis. I do everything in my power: eschew alcohol, avoid fatty foods and take supplements that may help.

“But getting relief for my pain is beyond my power. I take OTC pain relievers, but they don’t touch it. Yet I have been to five different physicians and all refuse to provide pain medication. Two stated that they do not write prescriptions for narcotics, since these drugs lead to substance abuse.

“Before I moved to this new city, I was treated with methadone or Percocet and never abused them. In fact, they helped improve my quality of life immensely.

“I am at my wit's end and beginning to wonder if my sole recourse will be to lurk on dark street corners at night in search of a 'street pharmacist.' Imagine that, the medical community forcing me to become a criminal.?

We discussed the treatment of severe chronic pain, including pharmaceutical and non-drug approaches, with two physicians who specialize in pain management. Anyone who would like a CD of this one-hour radio interview can order it for $16 from the People’s Pharmacy (CD-576), P. O. Box 52027, Durham, NC 27717-2027 or from www.peoplespharmacy.com.

Many studies show that, despite popular belief, people in pain rarely become addicted. They deserve to be treated with compassion.

The Food and Drug Administration is being dragged kicking and screaming toward a whole new category of medications. Until the recent approval of Plan B, the FDA allowed only two kinds of drugs: those that require a physician’s prescription and those that you can buy over the counter.

Because the emergency contraceptive Plan B was a political hot potato, the FDA had to come up with a third approach—“behind the counter? drugs. Any woman who wants to purchase Plan B must ask the pharmacist and establish that she is at least 18 years old. Only then can the pharmacist sell this medication to her.

For reasons that are unclear to us, the FDA has resisted the concept of behind-the-counter dispensing for decades. Even when the decongestant pseudoephedrine was being widely used to make illicit methamphetamine, the FDA took no action.

State and federal legislators passed laws restricting the sale of this drug to try to reduce the availability of meth. Now, if you want to buy an allergy or cold medicine such as Advil Allergy Sinus Caplets, Claritin-D or Sudafed Nasal Decongestant Tablets, you must ask the pharmacist for it. Drugs containing pseudoephedrine are kept behind the counter.

Though you don’t need a prescription to buy such medicines, you do need a photo ID and you will need to sign for them. In this respect, buying cold medicine resembles getting codeine cough medicine in some states.

Although codeine is considered an effective cough remedy, it is also a narcotic. Many states permit cough syrup containing low-dose codeine to be sold without a prescription, as long as the person signs a register that shows name and address.

The FDA has long resisted the idea of behind-the-counter drugs even though this practice is not unusual in many other countries. In Great Britain, for example, you can buy the cholesterol-lowering drug simvastatin (Zocor) without a prescription. You will have to talk to a pharmacist, however, and if there is any doubt whether you need it, the pharmacy is often equipped to do a cholesterol test on the spot.

The FDA refused to allow over-the-counter sale of simvastatin in the U.S. and also rejected OTC sale of the antiviral drug acyclovir (Zovirax) against cold sores. On the other hand, the agency has allowed unrestricted sale of NSAID pain relievers such as ibuprofen (Advil, Motrin IB) and naproxen (Aleve). This often surprises visitors from other countries where NSAIDs are often sold from behind the counter or only in small quantities (16 pills per pack).

There is a growing recognition that NSAIDs not only cause severe digestive tract irritation, but they may also increase the risk of hypertension or heart attack. A survey found that only one in five consumers actually read the label on these OTC drugs. Almost half took more than the recommended dose.

If pharmacists controlled the dispensing of such medications and counseled people on their proper use, the rate of complications might drop. Behind-the-counter dispensing could make more treatments available without a prescription, if the precedent that the FDA has set with Plan B leads the agency to include other medicines in this new category.

Americans are fat. One third of us are obese. And another third are overweight. A new study suggests that carrying around even a few extra pounds may shorten our lives.

If you happen to be 5 foot 9 and you weigh between 169 and 202 pounds, you are considered overweight. The study in the New England Journal of Medicine (Aug. 24, 2006) suggests that middle-aged people in that category are 20 to 40 percent more likely to die prematurely. If you are over that range, your risk is substantially higher.

So, what are we to do? Almost everyone knows that losing weight means eating less and exercising more, but that is very hard work. Americans want instant results.

This explains the eternal popularity of diet books. Nonprescription diet pills are also big sellers. Products sold on cable TV and on the Web offer dramatic results for minimal effort.

Whenever you see someone promoting a miracle weight loss pill or dietary program, be suspicious. Hucksters have been taking advantage of desperate dieters for decades.

It astonishes us that people would spend hard-earned money to buy juice from the rare Mongo-Bongo tree found only on the volcanic mountains of Vanuatu. Just because some beautiful babe says Mongo-Bongo helped her shed 150 pounds in three weeks while she slept with no exercise or dietary restraint does not mean it will work for you.

How can we lose weight? Some will opt for stomach surgery. While this can work for some truly obese people, there are risks and it is inappropriate for the merely overweight.

Others are turning to medications that were developed for other purposes. Some doctors are willing to prescribe “off label.? Drugs like Adderall or Ritalin for attention deficit disorder tend to suppress appetite and may cause weight loss as a side effect. Adderall contains amphetamines, compounds that were abused in earlier decades. These stimulants are not very different from some prescription diet pills that come with a long list of warnings.

People are willing to risk serious side effects (such as addiction or serious cardiovascular complications) from these off-label medicines because there are only a few approved diet pills. Xenical (orlistat) will soon become available over the counter as Alli, but it may not lose the side effects that have made it famous: fecal incontinence, oily spotting and “flatus with discharge.?

That’s why there is such excitement about a new drug awaiting approval by the FDA. Acomplia (rimonabant) has recently gone on sale in Europe. Studies show that people taking rimonabant for a year lost about 15 pounds more than those on placebo.

It also improves insulin efficiency and has a beneficial impact on blood fats, lowering triglycerides and raising good HDL cholesterol. Side effects may include diarrhea, nausea, anxiety, headache, dizziness and depression. None of these would normally be expected to keep the FDA from approving a drug. But the agency has not said if or when it may approve Acomplia.

Even if this new prescription medicine gets a green light, don’t expect a miracle in a bottle. Losing weight will still require exercise and dietary restraint.

A few years ago diet and exercise were considered crucial cornerstones of a heart-healthy lifestyle. Now, drugs seem to have replaced willpower and fitness. We recently received an email from Steve that epitomizes this mindset: “Is it necessary to watch your diet and exercise when you are taking Lipitor or will Lipitor be effective all by itself?? If you read the official prescribing information for Lipitor you will discover, “Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol only when the response to diet and other nonpharmacological measures have been inadequate.? What that means in ordinary English is that people should watch their diet first and maintain prudent, low-fat eating habits even while they are taking Lipitor and related cholesterol-lowering drugs. That’s the theory. In practice, though, people learn quite quickly that statin-type medications such as Crestor, Lipitor, Pravachol or Zocor (now available generically as simvastatin) are so effective that they don’t have to fret about dietary indiscretions. One person we know found that by taking Lipitor he could enjoy baked Brie without worry. Other folks relish steak and baked potato with sour cream, while those with a sweet tooth find that cheesecake is still on the menu so long as they take their medicine. It doesn’t take people long to realize that they can “cheat? on their diet and still have fabulous results when they get their blood test back. If they can eat burgers, fries and shakes and still have low cholesterol, why not indulge? The problem with this approach is that cholesterol is only one contributor to heart disease. There are over 240 other risk factors. A high-fat diet may increase inflammation, for example, and bring on other problems. Statin-type drugs are not without cost, both financially and physically. Some people cannot tolerate the muscle pain and weakness that may accompany statins. Other side effects may include memory problems, nerve damage, sexual difficulties and joint pain.

Some people cannot get their cholesterol under control no matter how careful they are with diet and other lifestyle changes. But many people can be successful at reducing their risks by taking several crucial steps:

  • Cut back on carbs, especially refined flour and sugar. They raise triglycerides.

  • Go for fiber. Psyllium can lower cholesterol. So can vegetables rich in soluble fiber.

  • Include nuts such as almonds or walnuts in the diet. They lower cholesterol and reduce the risk of heart disease.

  • Ditch trans fats. Use olive oil instead.

  • Eat fish and/or take fish oil.

  • Ask your doctor about niacin or red yeast rice. The B-vitamin can lower cholesterol. So can the dietary supplement, which contains natural statin compounds.

  • Exercise.

Readers who would like more information on natural approaches to cholesterol control may find helpful information in our book, The People’s Pharmacy Guide to Home and Herbal Remedies. It can be purchased at your local bookstore or from our Web site: www.peoplespharmacy.com.

Statin drugs can save lives. But they should not take the place of a prudent diet and healthy lifestyle.

Drug companies spend billions of dollars on TV commercials that are supposed to entice viewers to beg their doctors for the latest and greatest prescription medicine. But you have to wonder why anyone would want to take pills that can cause so many scary side effects.

Last night we thought we saw a commercial for a new drug to treat bashful bladder syndrome, also known as BBS. The drug, E-Z-P, sounded fabulous. Everyone was dancing, smiling and having a good time. But the voiceover gave us momentary pause. The announcer said in a cheerful tone that E-Z-P could cause galloping gallstones, fearsome nail fungus, purple spots, excessive growth of nasal hairs and huge hemorrhoids.

We’re kidding of course, but many of the medications that are advertised on television come with such a long list of serious complications it’s puzzling that drug companies would bother to promote their pills directly to the public.

For example, Americans are being urged to be on the lookout for the frustrating condition called Restless Leg Syndrome (RLS). There is a prescription drug called Requip that has been approved to treat RLS.

The TV commercials make this medicine seem wonderful until the voiceover starts reciting the following problems: “Requip may cause you to fall asleep or feel very sleepy during normal activities such as driving or to faint or feel dizzy when you stand up. Tell your doctor if you experience these problems, or if you drink alcohol or are taking medicines that make you drowsy. Side effects include nausea, drowsiness, vomiting and dizziness.?

Why would people take a medicine that might cause them to faint or fall asleep while driving? Evidently the drug company assumes that most viewers don’t pay much attention to such warnings, or if they do, they don’t really worry about them.

The same must be true of the drug ads you see in magazines. A new promotion for the “PurplePlus? Program shows a dad climbing a ladder to his two little boys in a tree house. He knows they have homework, chores and a favorite hiding place, but he “Doesn’t Know acid reflux may be damaging his esophagus.?

This advertisement for Nexium (the “purple pill?) has another page with a black bar at the top. In small print, the reader is told to “Please read this summary carefully and then ask your doctor about Nexium.? The only trouble is that the summary is in print so fine that we need a magnifying glass to read it at all. Even if the average reader could read the tiny print, would he understand what it says? We found words like lymphocyte chromosome aberration test, epistaxis, dysplasia, cervical lymphoadenopathy and thrombocytopenia.

Most people find their eyes glaze over after one or two lines of unreadable print. This is probably not an accident. Although the ad agencies are abiding by FDA rules, they know how to present information for maximum impact. Adverse reactions are not something they choose to highlight.

People deserve to know about the risks as well as the benefits of drugs they may take. As long as consumers are the targets of aggressive ad campaigns, they will need to seek out more information than they are likely to get from 30 second TV commercials.

Drug companies are eating doughnuts while millions of senior citizens are left with the doughnut hole. Medicare Part D was supposed to benefit older Americans but it has turned out to be a windfall for the pharmaceutical industry.

For years one of the hottest issues in American politics has been the high cost of medicines. Senior citizens were hardest hit and politicians paid attention because older people vote.

Eventually, Medicare Part D was passed with great fanfare and presented as the solution to this problem. Millions signed up, expecting that their drug tab worries would be over.

In the first several months, most recipients were pleased. After paying the $250 deductible, Uncle Sam picked up three fourths of the drug bill. Many didn’t realize that there was a catch in the plan.

Once people’s drug expenses total $2,250 they enter the dreaded doughnut hole. Not only must they continue to pay monthly premiums to insurance companies, they must also pay 100 percent of their prescription drug costs until the total outlay for the year reaches $5,100. At that point, they leave the doughnut hole and 95 percent of their drug costs will be paid until the whole thing starts over again in January.

Many older people now feel betrayed. In the rush to sign up before the May deadline, most were encouraged to pay attention to premiums and formularies to make sure their medicines would be covered. Few realized that come August or September they would be on their own.

Some senior citizens are finding that the bottle of pills that was $20 in July costs more than $150 in August. Now that they are in the doughnut hole, some older people are spending $300 or $400 a month for crucial medications. A premium of $30 or $40 a month that offers no benefits just adds insult to injury.

At the same time seniors are feeling pinched, drug companies are reaping a bonanza. According to the Wall Street Journal, the Medicare Part D benefit is fueling profits for big pharma.

Part D has allowed older folks who used to skip doses or skimp on their medication to take the prescribed dose. This has boosted sales of drugs such as Lipitor to lower cholesterol and Diovan for high blood pressure.

Companies are reporting higher sales and robust profits. That is in part because when the Medicare Part D program was written, the pharmaceutical industry made sure that Medicare would not be allowed to negotiate prices.

Government officials and members of Congress are starting to hear the complaints of seniors who are likely to vote this November. The main solution is to encourage folks with big drug bills to beg their doctors for less costly generic prescriptions.

That may work for some, but not all drugs are available generically. What’s more, readers tell us that certain generics don’t work as well as the brand name medicine. One man found that his blood sugar levels climbed dramatically when he was switched to a generic diabetes medication.

Medicare Part D was supposed to ease the pain of high drug costs. But what started as a good idea has become a confusing challenge for senior citizens. The next five months may be especially difficult as increasing numbers of older people have nothing left but the hole in the doughnut.

Physicians are admonished never to let the cure be worse than the disease. And yet far too often the very medicines meant to soothe symptoms or overcome illness cause more harm than good.

The Institute of Medicine (IOM) offers objective and independent advice to health care leaders. It is one of the most prestigious organizations in the nation. Its latest analysis of medication mistakes should scare everyone involved in taking care of patients.

According to the IOM report, 1.5 million Americans are injured or killed every year as a result of prescription or over-the-counter medication mistakes. Many of these errors are preventable.

The review paints an especially bleak picture of hospital drug prescribing and dispensing: “When all types of errors are taken into account, a hospital patient can expect on average to be subjected to more than one medication error each day.?

This shocking revelation suggests that every patient who enters a hospital needs an advocate who can monitor every pill, injection, patch or potion that is administered to make sure it’s the right drug, in the right dose, given at the proper time.

But even outpatients must be vigilant. Some of the most common and serious complications identified by the IOM committee are drug interactions. Readers of The People’s Pharmacy have been reporting frightening experiences for decades. One recently responded to a column about serotonin syndrome: “I took the antidepressant Zoloft together with an antibiotic and had disastrous results including seizures, tremors and severe anxiety problems for several months. After visiting two emergency rooms and numerous physicians, I felt like I had no hope of recovering. None of the doctors diagnosed me with serotonin syndrome. Instead they sent me on my way without any guidance.

“Luckily I finally found a doctor who figured out my symptoms were caused by the interaction of these two medicines. My original physician gave me samples of Zoloft so the pharmacist didn't realize that I was taking it with an antibiotic.

“I wonder whether most pharmacists would even understand the relationship between these drugs and the potential harm they could do. As a nurse, I want to help protect others from what I went through.?

Far too frequently there is not a happy ending to such a story. A patient may die as a result of incompatible medications, but the death certificate lists “cardiac arrest? or some other medical condition as the cause. When drug errors are not identified as the cause of death, such tragic mistakes may be repeated.

The Institute of Medicine report suggests that patients need to take a more active role in their own health care. “Trust but verify? is an old Russian proverb. It should be applied to any medication you take. Whether you are in the hospital or your neighborhood pharmacy, double-check each prescription before taking it.

We have prepared a Drug Safety Questionnaire for readers of this column. It is available free of charge on our Web site: www.peoplespharmacy.com. By getting your physician and pharmacist to answer the questions that are provided, we hope you and your loved ones can avoid becoming a sad statistic.

Two years ago we got a desperate phone call from a friend. He was afraid his wife had suffered a stroke.

She was in a coma, unresponsive and he feared he would soon be forced to decide whether to discontinue life support.

A CT scan, however, revealed no signs of stroke. The neurologists were puzzled. They began to suspect an infection in the brain, but cultures came back negative.

After four days she began to return to consciousness and gradually recovered full brain function. The doctors were mystified.

Our friend began doing some research and asked us whether the Maxalt his wife took for a migraine headache might have interacted with the Zoloft she was taking to prevent migraines. Bingo! Both medications can raise serotonin levels and together they can cause serotonin syndrome.

This woman had experienced all the symptoms of this potentially deadly condition. Although her experience was reported to the FDA, the agency did not express much interest in it. For the most part, doctors do not recognize serotonin syndrome, and consequently it is infrequently diagnosed.

At last, though, the FDA has issued a Public Health Advisory to warn physicians of the hazards of mixing migraine medicines such as Amerge, Axert, Frova, Imitrex, Maxalt, Naramig, Relpax and Zomig with many popular antidepressants. Drugs like Celexa, Lexapro, Paxil, Prozac, Symbyax and Zoloft, or related medications such as Cymbalta and Effexor fight depression in part by changing levels of the brain chemical serotonin. Combining them with other medicines that affect serotonin, including the migraine drugs above, could be dangerous. Other drugs that may interact badly with these antidepressants include the diet pill Meridia, prescription pain relievers such as Demerol or tramadol (Ultram), the nonprescription cough medicine dextromethorphan (Robitussin DM, among others) and some herbal products containing St. John’s wort.

Some people may experience serotonin syndrome as a result of interaction with an OTC drug. Several years ago, we heard from a teacher who was taking Paxil. When he caught the flu, he took a nighttime cold medicine so he could get some sleep. Instead, by the middle of the night he was extremely agitated, dizzy and shaking. When he began throwing up, his wife took him to the emergency room, where he was diagnosed with serotonin syndrome.

As the FDA cautions, people taking two prescribed medicines that may interact should talk with their doctors before discontinuing either drug. But it makes sense to be aware of the danger.

Symptoms of excess serotonin include anxiety, restlessness, rapid heart beat, sweating, nausea, vomiting, diarrhea, uncontrollable tremors or muscle contractions, lack of coordination, confusion, high blood pressure, hallucinations or coma. The syndrome may be mild, with dizziness, nausea and sweating, or it may be severe, landing someone in the hospital in a coma, or even killing him.

We are grateful that our friend’s wife survived her terrible experience with serotonin syndrome. We are glad the FDA is finally warning the American public and their doctors about this potentially deadly drug interaction.

Imagine what it would be like to suffer fatigue, anemia, diarrhea, cramps, bloating, reflux, osteoporosis, depression or an unbearable, itchy rash. Now, imagine that your doctor keeps telling you that there’s nothing really wrong with you and that it’s all in your head.

This is a surprisingly familiar scenario for too many people. They suffer from a common but often unrecognized condition called celiac disease that can cause such symptoms and many more.

This autoimmune disorder is often called the “Great Imposter? because it frequently mimics chronic fatigue, osteoporosis, irritable bowel syndrome (IBS), dermatitis or dementia. Some people suffer from migraines while others experience infertility. All these problems can be caused by an inability to tolerate gluten, a protein found in wheat, barley and rye.

Who would ever suspect that such all-American favorites as pizza, pasta and pretzels could be poison? But for those with celiac disease, such foods and many others create a chain of events that destroys the lining of the small intestine.

When this happens, people with celiac cannot absorb critical nutrients such as iron, calcium and magnesium from the food they eat. Bones can become brittle, blood has a harder time carrying oxygen and brain function may be compromised. Nerves that detect pain may go haywire, resulting in tingling, burning or numbness in the hands or feet and legs.

Most doctors learned in medical school that celiac disease is a rare pediatric condition, affecting only one child in 5,000 and that it results in diarrhea and failure to thrive. Researchers now have data showing that celiac actually affects one person out of 100. That makes it the most common inherited autoimmune disease in the United States.

Millions of adults have celiac and don’t even know it. Peter Green, MD, Director of the Celiac Disease Center at Columbia University, estimates that 97 percent of such victims are undiagnosed. Their symptoms may be as varied as severe heartburn or migraine headaches. A rash, called dermatitis herpetiformis, may be mistaken for mosquito bites, eczema, allergies, psoriasis or hives.

If celiac patients continue to eat foods containing gluten they increase their risk of developing certain cancers, including non-Hodgkin’s lymphoma, esophageal cancer and adenocarcinoma of the small intestine.

Diagnosis is easier than it used to be. There are blood tests (tTG, EMA) that can be helpful, although they are not perfect. The gold standard for diagnosis is an endoscopy in which a tiny bit of intestinal tissue is snipped out for examination (biopsy). All of these tests are accurate only if the patient eats gluten in the weeks beforehand. A gene test under development should show who is susceptible to celiac disease.

Readers who would like to learn more about celiac disease may want a CD of our recent one-hour radio interview with Dr. Green. The show covers symptoms, diagnosis and treatment. It is available for $16 from the People’s Pharmacy (CD- 594), P. O. Box 52027, Durham, NC 27717-2027 or from www.peoplespharmacy.com.

Now that celiac disease is known to be common, patients deserve to be tested. A strict gluten-free diet may be life saving.

It’s too bad our bodies don’t come equipped with “idiot lights.? If they did, more people might avoid heatstroke.

When your car overheats, a red light on the dashboard warns you that the engine is getting too hot. If you don’t pull over immediately, you can ruin your engine.

When your body overheats, you could risk brain damage or death. Athletes, firefighters and military personnel are all warned about the early signs of overheating. But older people and those on certain medications may not realize that they are just as vulnerable.

It’s easy to get heat exhaustion and heatstroke confused. Heat exhaustion is a consequence of dehydration and salt depletion. In hot weather when a person is sweating heavily, drinking too little water to replace the loss may make him feel lightheaded, nauseated, weak and anxious. The skin may be clammy and pale, the blood pressure can drop and the person may faint. He should be treated with cooling and rehydration.

Heatstroke is a life-threatening condition that occurs when core body temperature rises too high and the heat cannot be dissipated. Heat stroke may come on suddenly, with headache, disorientation, weakness and loss of consciousness. The temperature is high, and the skin is usually hot, dry and flushed.

Exercising strenuously in the heat can cause trouble. But simply being exposed to an excessively hot environment can bring on heatstroke, too. Heatstroke must be treated as a medical emergency.

Some medicines make people more vulnerable to hyperthermia because they hamper the body’s ability to get rid of heat. Sweating is important for dissipating heat because the evaporation of moisture from the skin leads to cooling.

If you disabled your car’s radiator in the summer, it wouldn’t be long before the engine temperature would zoom into the danger zone. Sweaty skin is your body’s natural radiator. Taking certain antidepressants, antihistamines or drugs for overactive bladder is akin to disconnecting the radiator on a car.

Older drugs for depression, like amitriptyline, desipramine, doxepin or imipramine, can interfere with sweating. So can over-the-counter remedies such as diphenhydramine (Benadryl) for allergies and insomnia or dimenhydrinate (Dramamine) for motion sickness.

An older person relying on a drug like Tylenol PM, which contains diphenhydramine, or an athlete taking clemastine to ease nasal congestion could end up with heat stroke. Diuretics for high blood pressure get rid of fluid and minerals, so they can put a person at risk of heat exhaustion.

The elderly are especially susceptible to heat problems. Their internal thermostats are not as sensitive as a younger person’s and their ability to regulate temperature is easily compromised by medication.

Someone taking a drug (Detrol or Ditropan) for urinary incontinence or overactive bladder is especially vulnerable. These medicines can cause dry mouth or dry eyes. That is an early warning sign that sweating may also be reduced.

As the temperature rises in coming weeks, find out if your pills are putting you at risk for heat stroke. If so, stay out of the sun and do your best to stay cool.

When’s the last time you checked out your first aid kit or rearranged your medicine cabinet? If you’re like most folks you have an odd assortment of old bandages, tape and antibiotic ointments.

Admit it, you probably have half-empty boxes of adhesive bandages that mostly contain tiny strips too small to be useful. That’s why they’re still there. Now would be a good time to discard those dinosaurs.

Adhesive bandages have branched out from Band-Aids. There are waterproof bandages that are so cleverly designed that you can shower or swim without exposing a cut to water. There is also such a variety of shapes and sizes that you can find one to fit most any body part: knuckles, fingers, elbows or knees. Your first aid kit should include enough bandages to take care of almost any minor injury.

In addition to standard bandages, you can now find products that include antibiotics already built into the pad. There are also some with silver in the pad as a natural antibacterial agent.

An antibiotic ointment is also a good thing to have handy. Some people are allergic to neomycin, so we would suggest a mixture of bacitracin and polymixin as an alternative (Polysporin). If your doctor will prescribe mupirocin ointment (Bactroban), you will have an even more powerful topical antibiotic available for skin infections.

If you think such products are unnecessary and Mother Nature knows best, you’re out of date. Although mom believed that a scrape should be exposed to the air so it could form a scab, dermatologists now recommend covering cuts and abrasions and keeping them moist with antibiotic ointment. That way they heal faster and have less risk of infection.

Liquid bandages offer another way to seal cuts and scrapes. Some brands contain a form of instant glue that closes a small cut quickly and stops bleeding.

Speaking of bleeding, there are other products designed specifically to stop bleeding. Urgent QR contains hydrophilic polymer and potassium salts that help blood clot almost instantly.

If you don’t have such a product on hand and you want to stop bleeding from a minor cut, you could keep a couple of packets of ground black pepper in your first aid kit. It is surprisingly effective to help stop bleeding.

Another essential item for your revamped first aid kit is 2nd Skin. This dressing is great for burns and blisters. It contains a water-based gel that is soothing to the skin.

With all your new first aid equipment you are faced with a familiar dilemma. Where should you store all this stuff? Most people stuff it into the medicine cabinet or a cluttered bathroom drawer. When you need something in an emergency you have to rummage around looking for just the right bandage.

Our number one choice for first aid gear is a small fishing tackle or tool box. Make sure your new first aid kit has a couple of trays with several compartments so you can see everything at a glance. What’s especially nice about such a box is that you can keep it at home or throw it in the back of the car for a camping trip, picnic or a vacation.

They call it the doughnut hole. It’s more like a black hole that Medicare recipients fall into when their prescription drug benefits come to a screeching halt.

Millions of Americans signed up for prescription drug plans under the new Medicare Part D. They were told they would save lots of money and in the early going this has been true. Uncle Sam picked up 75 percent of the cost once a $250 dollar deductible was met.

But lots of folks did not realize that once they spent $2,250 on top of their monthly insurance premiums, they would be responsible for 100 percent of their prescription drug bills. Many are once again experiencing sticker shock when they purchase their medicine.

To make things worse, prescription drug prices are rising at an alarming rate. The advocacy organization for older Americans, AARP, recently reported that the cost of brand name pharmaceuticals is up substantially since the new Medicare Part D drug coverage went into effect last January.

AARP reports that prices have increased by nearly 4 percent during the first quarter. That is considerably more than the inflation rate and represents the steepest increase in brand name prescription prices in six years.

According to AARP, the popular sleeping aid Ambien jumped more than 13 percent during the first three months of 2006. Lipitor was also up significantly in that same time period. The trade organization for the pharmaceutical industry challenges AARP’s numbers, but another group of consumer advocates called Families USA has reported similar increases.

This is really bad news for senior citizens who hit the doughnut hole over the next several weeks. First, they will they have to keep paying their insurance premiums (which can cost $15 to $40 per month depending on the insurance plan) even though they may get no prescription drug coverage for the rest of the year. Second, they will pay full cost for all their drugs until their total annual drug bill reaches $5100.

Some Medicare recipients with extra-high drug bills will actually emerge from the doughnut hole before the end of the year. Then they will be covered for roughly 95 percent of their drug costs. Most won’t make it through, however, and will find the next several months taxing on the pocketbook.

Those who are unlikely to get through the doughnut hole may want to consider saving money by purchasing their medicines from Canada. Drugs bought outside the U.S. don’t count towards the total, though, so this is not a good strategy for those who expect to spend more than $5100 this year.

People who are not eligible for Medicare and lack drug coverage have to pay full cost. With prices skyrocketing, this represents a tremendous burden for millions of Americans.

We have prepared a Guide to Saving Money on Medicine to help people use generic drugs safely and learn more about buying drugs from Canada. Anyone who would like a copy, please send $2 in check or money order with a long (no. 10) stamped (63 cents), self-addressed envelope: Graedons' The People's Pharmacy®, No. CA-99, P. O. Box 52027, Durham, NC 27717-2027. It can also be downloaded for $2 from the Website: www.peoplespharmacy.com.

Breathe deeply. This simple act sustains life and yet most of the time we don’t even notice it.

Not being able to catch your breath can be terrifying. People with asthma may gasp desperately for air. Sometimes they even die with their inhalers in their hands.

Asthma deaths have been rising for decades, although the drugs to treat it are more powerful than ever before. Researchers now blame some of the most popular asthma drugs for this increased mortality.

A new analysis published in the Annals of Internal Medicine (June 20, 2006) reports that “salmeterol may be responsible for approximately 4000 of the 5000 asthma-related deaths that occur in the United States each year.?

Salmeterol is one of the most widely prescribed asthma drugs in the world. It is a long-acting bronchodilator found in inhalers such as Advair and Serevent.

The FDA has strengthened the labeling for salmeterol and another long-acting bronchodilator, formoterol (Foradil). Physicians are warned that such medications should not be used as initial treatment since they may increase the risk of serious asthma attacks and asthma-related deaths.

What’s an asthma patient to do? Experts encourage physicians to consider other kinds of asthma medicines. Inhaled corticosteroids can ease the underlying inflammation that triggers breathing problems. When a bronchodilator is needed, shorter-acting beta-agonist medicines may be somewhat safer than long-acting ones. Whatever bronchodilator is used, however, it must not be overused.

Other asthma medications that ease inflammation include montelukast (Singulair), zafirlukast (Accolate) or zileuton (Zyflo). Cell stabilizers such as cromolyn (Intal) or nedocromil (Tilade) are different prescription options. An anticholinergic asthma medicine called ipratroprium (Atrovent) can be helpful for some asthma victims.

In addition, there is interest in breathing exercises to help asthma patients. A study published in the journal Thorax (online June 5, 2006) showed that people with mild asthma may benefit from practicing breathing techniques.

In the study, asthma patients who were using reliever medication four or more times a week were given a video instructing them in one of two breathing techniques. One focused on shallow breathing through the nose, capturing elements of a complementary therapy called Buteyko. A control program coordinated breaths with gentle upper body movements.

Practicing either technique reduced the use of reliever drugs by 86 percent. Patients also needed lower doses of their inhaled corticosteroids. These results suggest that breathing lessons may be worthwhile for asthmatics.

We have spoken with experts about how changing breathing patterns can affect health, especially asthma and blood pressure. Those who would like to learn more about Buteyko and other breathing approaches may want to order a CD of this hour-long interview. This CD is available for $16 from the People’s Pharmacy (CD-489), P. O. Box 52027, Durham, NC 27717-2027. Order online at www.peoplespharmacy.com.

Asthmatics must not change their use of medicine on their own, but check with their doctors about breathing exercises or a safe drug regimen.

Can cholesterol-lowering drugs like Lipitor cause memory loss and debilitating muscle pain? That’s the allegation made by two men who have filed lawsuits against Pfizer Inc, the maker of Lipitor. They claim the company did not adequately warn them about complications.

Charles Wilson, 67, used to be an insurance executive from Atlanta. He claims that Lipitor produced memory loss, weakness in arms and legs, fatigue and nerve damage.

Michael Mazzariello is a 47-year-old lawyer in New York. He maintains that Lipitor contributed to extreme muscle weakness, nerve pain and memory problems.

The company says that very few people who take Lipitor experience serious problems. In addition, Pfizer maintains that all the potential side effects are described in the labeling provided to doctors. The company denies that it has withheld any information.

But how well informed are most patients about such side effects? Physicians are often skeptical that the cholesterol-lowering drugs they prescribe could have any effect on mental function or muscles and may not discuss these reactions with patients.

The first inkling we had of memory problems related to statins came from a reader six years ago: “Last fall my doctor prescribed Lipitor, and after several months I found I was having trouble remembering names and coming up with the right word. At dinner once I said ‘please pass the elephant’ though I wanted the bread. I was afraid I'd had a stroke.

“Then a friend came to visit. She was worried about her memory and couldn't think of her daughter's name on the telephone. She too was on Lipitor.

“I asked my doctor to prescribe a different cholesterol medicine. Within a couple of weeks I was more mentally alert. But my friend (still on Lipitor) was in worse shape and afraid she would lose her job. Her doctor said her forgetfulness could not be due to the drug. She stopped taking Lipitor anyway and now is much sharper.

“I am concerned that some people taking Lipitor might think such a reaction was just due to getting older. Is this side effect well known??

At that time, there was nothing in the prescribing information to indicate memory problems or cognitive difficulties. That may explain why we heard from so many readers that their doctors refused to believe the drug could be responsible.

Over the last several years we have heard from hundreds of readers about memory or muscle problems. Many reported that their backs or legs hurt so much they could barely walk, even though their blood tests were normal. Others complained of joint problems or unrelenting nerve pain.

Lipitor isn’t alone. Many readers have experienced difficulties while taking other statin medications including Zocor, Crestor and Pravachol.

Anyone who would like to learn more about the dark side of statins may be interested in a radio interview we conducted with several physicians who have studied such issues. To order a CD of this one-hour conversation, please send $16 to: People’s Pharmacy (CD-523), P. O. Box 52027, Durham, NC 27717-2027. It is also available at www.peoplespharmacy.com. Look for radio show No. 523.

Millions have benefited from these drugs. But some people cannot tolerate the side effects.

In 1995 the FDA approved a new drug for treating osteoporosis. Fosamax was heralded as a major breakthrough.

Before this pill was introduced, there were no easy ways to combat osteoporosis. This condition weakens bones and can lead to life-threatening fractures.

Over the last decade, Fosamax was joined by Actonel and more recently Boniva. All three “bisphosphonates? work by slowing down cells that break bone down. This allows other cells to build bone and make it stronger. People with osteoporosis who take these medicines are less likely to suffer fractures.

The manufacturers have marketed these drugs aggressively to consumers. Last year more than 30 million prescriptions were filled for such medications. But new safety concerns are worrying patients and doctors.

From the time Fosamax was introduced, patients were warned about the possibility of severe damage to the esophagus if pills got stuck. That’s why people are warned not to lie down for at least 30 minutes after taking their medicine. Now another issue is causing alarm.

There are growing reports that bisphosphonates may lead to a rare but serious complication called osteonecrosis of the jaw. Hundreds, perhaps thousands, of cases of death of part of the jaw bone are surfacing. Many seem to be triggered by dental procedures such as extractions or implants.

One reader who was taking Fosamax experienced this complication after she had a tooth pulled. Many hours of dental surgery and thousands of dollars later, she is still dealing with the consequences.

Doctors and dental surgeons still don’t know how common this problem is or exactly how to treat it. Other concerns are also emerging.

Another reader reported her experience with Boniva: “After my first dose, I experienced shooting pains in my arms and legs for about 6 hours, but considered this to be normal after reading the information in the package. After the second dose, I had violent flu-like symptoms for a 12-hour period: excruciating, unrelenting chills, tremors and spasms; severe aches and pains that encompassed my whole body; fever and intense sweats.

“The next morning I was so drained and debilitated from the episode that I nearly fainted in the shower as I prepared to go to work. For the next three weeks I had low back pain that made me double over after sitting for short periods of time.? She was so shaken by this experience that she has decided not to continue taking this medicine to prevent osteoporosis.

We also received this disturbing question: “A friend had a heart attack that was attributed to Boniva. Is that possible??

There is nothing in the official drug labels about bisphosphonates and heart attacks. Chest pain that could signal severe heartburn might be confused with heart trouble. Then again, until recently there was nothing about osteonecrosis of the jaw.

What is clear is that these medications are not risk free. Complications such as jaw bone death may be very rare, but research is just now getting under way to determine how often they may occur.

These are valuable drugs, especially for people at high risk of bone fractures. A broken hip can be a life-threatening event. But as with Vioxx, it may take years before all serious reactions are detected.

Most of us have experienced a moment or two of forgetfulness. We can’t find our keys, even though they are right where we left them. Or we can’t remember precisely where we parked the car at the mall.

Perhaps running into a neighbor at the grocery store is enough to make us forget the one thing we really wanted there even though we remember seven other items on the list.

In most cases, this is a temporary annoyance. But for those who have a family member with dementia, these little lapses can be far more frightening. What if, we wonder, this is the first sign of developing dementia ourselves?

Alzheimer’s disease and other dementias take a huge toll. The costs of getting adequate help and 24-hour supervision for a family member in decline can be a significant burden. Nursing home care can cost $60,000 a year and up.

Preventing dementia would be well worth whatever it takes. Although there are no guarantees, evidence is mounting that there are things people can do to reduce their risk of cognitive decline.

Exercise may be one of the most effective strategies for maintaining a sound mind in a healthy body. A recent study of more than 2,000 older people found that poor balance and slower walking speed both predicted a greater drop in mental function scores after nearly six years of follow-up (Archives of Internal Medicine, May 22, 2006).

Trying to sort out the chicken from the egg here could be tricky. Early changes in the brain may have an impact on physical abilities. And alterations in physical function could have an impact on mental alertness. Other studies show, however, that elders who exercise regularly and maintain fitness are less likely to experience significant cognitive decline.

In addition to exercise there are other ways to improve your odds against dementia. Researchers now believe that inflammation in the brain plays an important role in the development of Alzheimer’s disease. Epidemiological studies suggest that anti-inflammatory drugs such as aspirin, ibuprofen and naproxen may be somewhat protective.

Dietary supplements may also provide some anti-inflammatory activity. They include omega-3 fatty acids found in fish oil and curcumin, the active ingredient in turmeric. This Indian spice has been used for centuries to flavor curry. Recently, scientists have found that this antioxidant compound fights inflammation and discourages the build-up of amyloid plaques in the brain (Current Alzheimer’s Research, April 2005). Such plaques are characteristic of Alzheimer’s disease.

Other supplements that are being considered for their potential against dementia include aged garlic extract, green tea, Ginkgo biloba extract, antioxidant vitamins such as C and E, and the sleep-related brain hormone melatonin (Annals of Clinical Psychiatry, Oct-Dec, 2005).

Resveratrol also looks as though it may be promising. This compound is abundant in grape seed and in red wine. Perhaps that is why older people who enjoy a glass of wine or two a day are less likely to develop dementia. Overindulgence in alcohol is bad for the brain, of course.

There is no cure for Alzheimer’s disease. Until there is, prevention may be the best medicine.

Millions of people dread flying. It’s not really the long security lines, the puny snacks or the lack of leg room. It’s not even the frequent delays or the lost luggage. For a lot of fliers the problem is ear pain.

Airplane ears are caused when the pressure inside the middle ear doesn’t equalize to the pressure in the cabin. During descent, atmospheric pressure in the cabin increases rapidly. If the tube that connects the nose and the ear (eustachian tube) is blocked because of a cold, allergies or sinus problems, it’s difficult to balance the pressure.

The consequences can be temporary hearing loss, ringing in the ears, excruciating pain, dizziness or even bleeding in the middle ear. People who are prone to airplane ears have developed many strategies for dealing with this vexing problem.

Some take oral antihistamines and decongestants before flying. Others use nose spray to open sinuses just before descent. Chewing gum is a time-honored technique. But none of these strategies works for everyone.

We have collected many recommendations from readers. Here are a few of our favorites: “I read an article in your column about flying with ear pain. My daughter had this problem and it was agonizing. Then a passenger sitting next to me on a flight told me about “hot cups.?

“The stewardess was very familiar with hot cups. These are Styrofoam coffee cups with a paper towel in the bottom and a small amount of very hot water poured into the cup. Then the cups are held over the ears. The steam helps the pressure stabilize and eases the pain. It worked wonderfully!?

Other readers have also endorsed the “hot cup? approach: “I had airplane ears until I started using Nasacort daily. My ears would REALLY hurt and I’d hear all this squealing. When we went to Acapulco a few years ago, it was the second day before I could even hear again.

“But my flight attendant friend gave me a tip. She said on her planes they would take coffee cups and put wet paper towels in them. They would then heat them in the microwave and bring them to you. You hold a cup tightly over each ear, sealing it up. The hot vapor opens your ears every time!

“If they are reluctant to fix the cups, insist. My husband's boss actually ended up with a punctured eardrum one time from having to fly while he had a cold.?

An elegantly simple and effective recommendation came from a diver: “We are taught about backpressure during SCUBA class. If the person holds the nostrils shut with forefinger and thumb and gently tries to force air out the nose, the resulting backpressure escapes to the ears, forcing the eardrums outward. The reason for the pain on descending in an airplane is the same as when diving below 20 feet: the eardrums are being forced inward beyond tolerance.?

One last tactic is technological. Ear plugs called EarPlanes have a ceramic filter that slows the change in pressure. One reader says his wife went from bleeding eardrums to being comfortable flying wearing these.

We hope one of these strategies will help relieve ear pain while flying. Unfortunately, we don’t have any solutions for long lines, delayed flights or cramped seats.

One of the last big secrets of American medicine involves a practice called “off-label? prescribing. Most people assume that the pills their doctors prescribe have been carefully tested and approved by the FDA for their condition. They don’t realize that one out of five prescriptions written in the U.S. is for a purpose that the FDA has not vetted.

The FDA allows a drug company to seek approval for one specific condition. All it need do is demonstrate that the medicine works better than placebo for that particular problem.

Once that hurdle is overcome, a quirk in the system lets the drug loose. It can be prescribed for anything a doctor deems appropriate, whether there is evidence to support its use or not. The FDA does not regulate the practice of medicine.

One fascinating example of off-label use involves the notorious drug thalidomide (Thalomid). It caused horrible birth defects in Europe during the 1960s when it was prescribed as a sedative. During the 1990s the FDA approved Thalomid for the treatment of a rare form of leprosy.

The company showed that the drug worked for this very narrow indication. The manufacturer knew it couldn’t get rich on fewer than 100 patients who might need the treatment each year, but it hoped that the drug would prove useful for more common conditions.

This gamble paid off. Before long, physicians started prescribing Thalomid for multiple myeloma (a blood cancer) and other hard-to-treat conditions such as Crohn’s (inflammatory bowel disease), HIV, macular degeneration, rheumatoid arthritis and many other types of cancer.

Within a few years the maker of Thalomid was bringing in millions of dollars, mostly from cancer treatment, not leprosy. Eventually, Thalomid was approved for treating multiple myeloma, but it is still being used off-label for many other conditions.

A new study has found that over 150 million prescriptions are being written for unapproved indications. Antidepressants (Prozac or Paxil, for instance) are prescribed for premature ejaculation. We’ll probably never know whether the benefits outweigh the risks for this purpose, since the company is not required to do any additional research.

Other examples of such off-label prescribing include beta-blocker heart medicines (propranolol, metoprolol, atenolol) for stage fright or performance anxiety. Neurontin (gabapentin) is an epilepsy medicine that has also been approved for pain that lingers after a shingles attack. But it is probably used more frequently for chronic pain, bipolar disorder, migraines, ADD or drug and alcohol withdrawal as well as restless leg syndrome.

If doctors had really good data to support unapproved uses, there would be little concern. But three quarters of the prescriptions for off-label uses are not backed up by solid evidence (Archives of Internal Medicine, May 8, 2006). That means patients are frequently participating in an uncontrolled experiment that they haven’t agreed to. This could result in serious adverse reactions or even death.

The next time you receive a prescription, ask your doctor if the medicine has been approved for that use. If not, you may want to find out more about the benefits and risks before popping that pill.

Just over half of all prescriptions sold in this country are now generic drugs. Before long these copycat medicines will dominate the market.

That’s because some very popular brand name medications are losing their patents. Drugs like the sleeping pill Ambien, the cholesterol-lowering drugs Pravachol and Zocor and the antidepressant Zoloft will soon be up for generic competition.

Insurance companies, government health programs and ordinary citizens will all be able to save billions of dollars when the new generics come on line.

To give you some idea of the savings, just check out the price of Prozac. This popular antidepressant can cost about $140 for a month’s supply. The generic fluoxetine is closer to $20.

To entice people to switch from pricey brands to the generic equivalents some insurance companies are suspending co-payments for up to six months. In essence, the consumer is getting his generic medicine for free.

That’s a pretty big carrot. Then come the sticks. Many insurance companies now have a multi-tiered co-pay structure. If you are taking a generic drug, the cost is often modest, only $5 or $10. If you take a brand that is on the preferred list (formulary), the co-pay may be $25 or $30. But if your doctor insists that you take a brand name drug that is not on the formulary, you may end up paying $50 or $60 for that prescription.

Insurance companies are desperate to control their ever-escalating drug bills. Switching patients to less expensive generics is their solution.

From a purely bottom-line perspective, generic drugs are a great deal. Who wouldn’t want to get the same medicine for much less money? But how good are generic drugs?

There was a time when the big brand-name manufacturers used to bad-mouth generic medicine as inferior. These days they have joined the bandwagon. The giant pharmaceutical company Novartis that makes brand name medicines is also striving to become a major player in the generics field.

The competition is stiff, however. Generic companies from all over the world (Israel, India and Brazil) are vying for market share. Price is often the deciding factor when wholesalers and hospitals decide which generic drugs to buy.

According to the FDA, all generic drugs licensed in the U.S. must go through a rigorous approval process to demonstrate that they are equivalent to the “innovator? compounds. But the real issue is who is monitoring the marketplace after a generic drug is approved?

The FDA is supposed to visit every drug manufacturing plant (big brand names or little generics) every two years. But agency officials admit that they don’t have the manpower to accomplish this goal.

More worrisome is the danger of counterfeits or substandard products. For the most part, the government relies on the honor system. FDA staffers have told us that they analyze about 300 pill bottles a year to make sure they contain what they claim. This amounts to about one in ten million.

If unscrupulous manufacturers and wholesalers slip poor quality products into the supply chain, it is unlikely that anyone will catch them. Generic drugs do offer substantial savings, but consumers will need to be vigilant to make sure they are getting their money’s worth.

The Government Accountability Office (GAO) is the investigative arm of Congress. It studies how the federal government spends your tax dollars.

The GAO recently evaluated the Food and Drug Administration (FDA) and concluded the FDA belongs in the doghouse. Not only does this dog not hunt, it doesn’t bark very loudly and it’s nearly toothless.

The issue is drug safety. There is growing concern that the country’s health watchdog is not protecting the public adequately. Once a medicine has been approved and made it to the market, the FDA has difficulty detecting problems and doing something effective about them. According to Senator Charles Grassley, some agency employees have been intimidated or reassigned when they raised questions about the FDA’s oversight.

This issue became evident with Vioxx. Instead of noticing an increased risk of heart attacks and strokes, the agency seemed oblivious to any problems with the drug. Although some individuals at the FDA sounded a warning, they were ignored.

In response to Senator Grassley’s concerns about the Vioxx debacle, the GAO looked at the agency’s handling of four drugs with safety issues—Arava for rheumatoid arthritis, Baycol for high cholesterol, Bextra for pain and Propulsid for acid reflux.

The report concluded, “The FDA lacks clear and effective processes for making decisions about, and providing management oversight of, postmarket safety issues.?

This report undermines public confidence in the FDA, which was not very strong to begin with. A survey last year found only 14 percent of consumers have great confidence in the FDA’s ability to safeguard the country’s drug supply.

The report also suggests that steps the FDA has already undertaken to fix what’s broken leave too many gaps. The FDA has created a Drug Safety Oversight Board, but the agency has not figured out how to “address the lack of systematic tracking of ongoing safety issues.?

Although the FDA frequently requests that drug companies carry out safety studies on drugs that have recently been approved, an article in the Journal of the American Medical Association (JAMA, Dec. 1, 2004) indicates that the studies often don’t get done. It’s as if a student didn’t turn in his final paper for a class but the teacher let him graduate anyway. As a result of this cavalier approach, the FDA often lacks data it needs to make informed decisions about drug safety.

Another problem facing the FDA is the objectivity of its outside experts. Frequently the agency convenes an advisory panel of specialists to consider a new medication or review safety concerns. But agency officials seem to have difficulty finding experts without financial ties to the very drug makers the agency is supposed to be regulating.

Almost 30 percent of these advisors had financial conflicts of interest (JAMA Apr. 26, 2006). Almost a quarter of the drug-company contracts were for more than $100,000.

Experts claim that these relationships do not sway their judgment. But sports fans would never tolerate having Super Bowl referees getting money on the side from one of the teams. Isn’t drug safety at least as important as the outcome of an athletic contest?

If the FDA is to regain the confidence of the American public it will need to implement the GAO’s recommendations on drug safety. For this to happen, Congress needs to beef up the watchdog’s bite.

Most people look forward to spring. Warm weather means the birds are singing, the flowers are blooming and the grass is growing…and pollinating. That’s why 36 million Americans may wish it were still freezing cold.

In the winter, there’s no pollen in the air. But this time of year the air is filled with allergens. For people who react to them with sneezing, sniffling and red itchy eyes, May is the cruelest month.

Treating allergy symptoms used to be fairly simple. You went to the doctor for an antihistamine or decongestant. In those days, Benadryl and Sudafed were available only with a doctor’s prescription.

Now, you can buy dozens of antihistamines (including Benadryl) without prescriptions. Claritin used to be the most prescribed allergy medicine in America, but when it lost its patent, the manufacturer took it over the counter. Although expensive, it offers symptom relief without drowsiness. There is some controversy, however, as to whether it is as effective as the old-fashioned sedating antihistamines.

Decongestants containing pseudoephedrine are a little trickier to purchase these days because many states have restricted access to this compound. Too many people were using it as an ingredient to make methamphetamine. You can still buy pseudophedrine, but you will have to ask the pharmacist.

Manufacturers have come up with alternatives such as phenylephrine, which is now available in Sudafed PE. It can’t be converted into methamphetamine.

The real action in allergy treatment these days is back in your doctor’s office. There are so many prescription allergy options that it is bewildering. Not only are there prescription oral antihistamines such as Clarinex, Allegra and Zyrtec, there are also nasal sprays like Astelin.

Doctors can also prescribe steroid nasal sprays that calm inflammation in the nasal passages. Products such as Beconase, Flonase, Nasarel, Nasonex, Rhinocort or Vancenase ease allergic symptoms, usually without triggering serious side effects. In addition, a totally different type of nasal spray called Atrovent dries up nasal secretions and eases symptoms that way.

Another type of medication reduces inflammation although it contains no steroids. Singulair is a prescription medicine that blocks leukotrienes. These compounds are crucial to the development of inflammation. Unfortunately, a recent study showed that over-the-counter pseudoephedrine is just as helpful for allergy symptoms as Singulair (Archives of Otolaryngology—Head and Neck Surgery, Feb. 2006).

If prescription and over-the-counter drugs are too daunting, perhaps an herbal remedy would be appealing. European physicians sometimes prescribe the herb Urtica dioica (stinging nettle) to relieve nasal allergy symptoms.

The Ayurvedic tradition of India encourages nasal washing with a “neti pot.? This “Aladdin’s lamp? device allows salt water to be poured into one nostril and exit the other. This is supposed to clear the nasal passages of pollen and other allergens.

Given how many allergy treatments are available, figuring out which to take can be a challenge. Ask your doctor which ones will be most effective for you and least likely to cause side effects.

Suffering is the mother of creativity. People will do almost anything to relieve their discomfort. Perhaps that is why some folks have tried rinsing their scalps with Listerine for flaky dandruff. Others have dabbed vodka on their itchy poison ivy.

People reach for what they have on hand, which might account for why common household products show up so frequently in strange home remedies. Who knew you could use Phillip’s Milk of Magnesia as an underarm deodorant instead of a laxative?

Perhaps the most versatile of all is Vicks VapoRub. This old-fashioned salve has been used for more than a century to ease chest congestion. But there is an astonishing assortment of other uses that people have invented.

Seven years ago we heard from Jane Kelley, RN, a foot care nurse in Massachusetts. She told us that some of her colleagues were using Vicks VapoRub on patients’ fungus-infected toenails.

Then we heard from another nurse that smearing Vicks on the soles of the feet could help a child with a cough sleep through the night. It wasn’t long before the floodgates opened and we began to hear about using Vicks on paper cuts, mosquito and fire ant bites and seborrheic dermatitis.

Some folks use Vicks to keep frisky kittens from scratching their legs. Others find it useful for softening calluses on their feet or scaly skin on elbows.

One woman insisted that Vicks can relieve the discomfort of hemorrhoids, but we generally advise against this application. John Welter, an essayist who tried it, reported that “The active ingredients in VapoRub—which I think are menthol, camphor and napalm—instantly engulfed my hemorrhoidal locality in spontaneous combustion.?

There is another place one should probably not put Vicks. We recently received this message from a reader: “I was experimenting with Vicks VapoRub to see if it would help my jock itch. I inadvertently got some where I shouldn’t. I believe I have found a poor man's Viagra!?

This is not the first we had heard of this effect of Vicks. Pharmacist Anna Barrigan told us of her experience in Alaska in the 1950s, when most of the jobs were in construction, gold dredges, bars and the military. With a ratio of 50 to 60 men for every woman, there were long lines outside the houses of prostitution every payday. The “ladies of the evening? all got paid the same, so if they wanted to make more they had to work quicker. Apparently some of them sped things along with a tiny dab of Vicks in a critical location. According to Ms. Barrigan, “It would get the blood flowing to that organ in very little time. I guess this was a very early form of Viagra.?

We urge readers NOT to try this at home! Vicks is intended for external use only and is not for delicate tissues.

If you’d like to know more about the fascinating things people do with Vicks VapoRub and other household products such as vinegar and baking soda, we offer our Guides to Home Remedies and Unique Uses for Vicks. Anyone who would like copies, please send $3 in check or money order with a long (no. 10) stamped (63 cents), self-addressed envelope: Graedons' The People's Pharmacy®, No. RVi-77, P. O. Box 52027, Durham, NC 27717-2027.

Do sunscreens create a false illusion of safety? A new lawsuit charges that many sunscreen manufacturers are misleading Americans into thinking that their products can protect people from sun damage.

Decades ago there were few effective sunscreens. If you spent too much time in the sun you were bound to burn. That’s why farmers wore hats and long sleeves, vacationers took umbrellas to the beach and lifeguards put white zinc oxide on their noses.

Now, the chemicals in most sunscreens prevent sunburn so well you could spend all day outside with no clothes on and still not get pink. Because of this protection people spend more time in the sun biking, swimming, gardening or golfing.

Just because you don’t burn, however, does not mean your skin is safe. The lawsuit against the makers of Banana Boat, BullFrog, Coppertone, Hawaiian Tropic and Neutrogena brand sunscreens claims that longer ultraviolet-A rays can still damage skin. UV-A is associated with skin cancer, wrinkling and aging. The lawyers point out that despite increasing use of sunscreen over the last few decades, skin cancer has been rising at an alarming rate.

Consumers are understandably confused. On the one hand, they are told to slather on the sunscreen to protect their skin from sun damage. Now they are being told that many sunscreens won’t protect them very well.

To make matters even more baffling, scientists have announced new health benefits from vitamin D, the sunshine vitamin. Two studies have found that women who have the highest levels of vitamin D have the lowest risk of breast cancer. Sun exposure during adolescence seemed to protect women later in life, reducing their risk of breast cancer by 25 to 45 percent.

These new studies confirm previous research suggesting that cancers of the colon, breast, prostate and lung are less common among people who get regular sun exposure. It’s harder to get adequate amounts of vitamin D from the diet, because the amounts in fortified milk or fish like salmon, tuna or sardines are small.

Vitamin D may also help protect people from developing type 2 diabetes (Diabetes Care, March 2006). A large study followed the diets and health habits of more than 80,000 women for 20 years. Women who got the most vitamin D and calcium were least likely to develop this condition.

What should consumers do with this conflicting information? Dermatologists warn that excess sun exposure is harmful, but some vitamin D is beneficial. Sunscreen can keep the skin from making vitamin D, but it might not provide real protection from skin cancer.

One possible way out of the dilemma is to be sensible about sun exposure. As little as 10 or 15 minutes of sun on arms and face three or four times a week without sunscreen should be enough to provide adequate vitamin D. The alternative is to take supplements adding up to approximately 1000 IU daily. After 10 minutes, make sure you have complete protection from harmful solar rays. Look for a physical sunblock with zinc oxide, titanium dioxide or both. Choices include Blue Lizard Australian Suncream, Solbar Zinc or Vanicream.

It’s possible to get enough vitamin D and protect your skin from damaging UV rays.

A few weeks ago we ordered a bookshelf and tried to assemble it. Our crew of two was divided on the proper way to proceed.

One of us thinks that such tasks should be intuitive and you should just dive in and do it. The other one likes to sit down with the instructions and read them cover-to-cover before beginning.

Unfortunately, the impatient one (Joe) wouldn’t wait for the methodical one to finish reading. As a result, the bookshelf, while assembled, is not quite right. Some pieces got put in upside down and backwards. Because it could not be disassembled again, we will live with this mistake.

Too many Americans use Joe’s plug-and-play approach. They don’t want to spend time reading manuals or instructions. That may be fine when it comes to microwave ovens, TVs or computers, but this approach could lead to disaster when applied to over-the-counter medicines.

Most consumers assume that if you can buy a drug without a prescription it must be perfectly safe. After all, if you needed a medical degree to use it properly, it couldn’t be sold OTC, could it?

The National Consumers League (NCL) discovered just how widespread this attitude is when it polled people about their use of nonprescription pain relievers such as ibuprofen and naproxen. These non-steroidal anti-inflammatory drugs (NSAIDs) were once popular prescription pills (Motrin and Naprosyn), but Advil and Aleve have been available over the counter for years.

Researchers report that more than 80 percent of the people responding to the NCL survey had taken OTC ibuprofen or naproxen in the past year (Journal of Rheumatology, Nov. 2005). Half of them were not worried about any potential side effects.

Maybe that’s because fewer than one in five of the people taking one of these pain relievers actually bothered to read the whole label. Less than a third read the dosing instructions, which may account for why almost half took more than the recommended dose.

If such drugs were benign, this might not pose a problem. But NSAIDs have a long list of potential side effects. They can cause serious heartburn or even bleeding ulcers. Such drugs may raise blood pressure, contribute to heart attacks or strokes and put people at risk of kidney disease. Other possible reactions include dizziness, ringing in the ears, fluid retention, rash or breathing difficulties.

Experts estimate that more than 100,000 people are hospitalized each year because of NSAID-related ulcers and other adverse effects. Over 15,000 die. Some of those deaths may be caused by the use of seemingly safe OTC pain relievers.

Drug interactions are another huge concern with nonprescription drugs. NSAIDs can interact with dozens of prescription medications to cause more serious complications. Even if you wanted to find out about possible incompatibilities, there’s not enough room on the OTC label to list every risky combination.

NSAIDs are not the only nonprescription drugs that have potential side effects. Almost every medication may cause adverse reactions in some people. To avoid becoming a statistic, take a few moments to read the label before you pop that pill. And if you are taking other medicine, check with your doctor or pharmacist to avoid dangerous interactions.

When you’re being robbed at gunpoint, the question is often “your money or your life?? Increasingly, that is the choice cancer patients are being offered.

The cost for many new cancer drugs is almost unbelievable. Herceptin, a drug for breast cancer patients, costs $3,200 per month. Avastin for colorectal cancer can cost $4,400 per month. Rituxan, for non-Hodgkin’s lymphoma, runs $13,000 to $25,000 for one cycle of treatment. Revlimid, a newly approved treatment for multiple myeloma could cost up to $60,000 per year. And Erbitux for head and neck cancer or colorectal cancer might exceed $110,000 annually.

Even for people with insurance these bills are traumatic. Some plans require patients to pay a steep co-payment or a percentage of the total cost. Even 10 percent of such big bills can add up to thousands of dollars.

Insurance companies faced with budget-busting bills for such cancer agents do their best to wiggle out of covering “experimental? therapies. No matter how much they raise their premiums, it is hard to keep up with the skyrocketing increases in cancer drug costs.

A revolutionary medicine like Avastin that is approved by the FDA for colon cancer may not yet have official approval against ovarian cancer, even though oncologists are prescribing it for this malignancy. Because this is considered an unapproved use, some insurance companies may try to get out of paying for this potentially life-extending therapy.

Anyone without insurance is out of luck. Although some people are poor enough to qualify for company-sponsored assistance, middle-class cancer patients often aren’t eligible.

There are 45 million Americans without health insurance. And once you have a diagnosis of cancer, your chances of getting independent insurance drop dramatically. That means that millions are left with astronomical bills for medications they need to survive.

What’s behind the enormous cost of cancer medicine? Two decades ago we spoke with a drug company insider. This former executive related a top-level meeting in which the question was raised, “if you found a cure for cancer, what would you charge for it?? The executive who was being grilled admitted that they would almost have to give it away. At that time, pharmaceutical leaders feared they would be seen as unethical if they gouged patients for life-saving medicine.

Those restraints have disappeared. These days, cancer therapies have become the holy grail for profitability. Many new high-tech compounds don’t cure people but they do extend lives. The drugs are more effective and often better tolerated than old-fashioned chemotherapy. A patient who survives an extra 10 years could run up a bill of $1,000,000.

Drug companies often justify high prices by pointing to the expense of conducting research. No one doubts that developing anti-cancer compounds is expensive. But when a year’s treatment tops $100,000 per patient, the industry risks killing the goose producing its golden eggs.

Too soon, neither Medicare nor private insurance companies will have money enough to cover these costs, even with higher premiums. If no one can afford these pricey pharmaceuticals, the manufacturers themselves may fall on hard times.

Is there anything more annoying than hearing a mosquito buzzing around your head and not being able to catch it? A dentist’s drill might be a close match. Now imagine what it would like to have crickets chirping in your ear 24 hours a day seven days a week.

Millions of people with tinnitus hear a constant noise in their ears. Some describe the sound as hissing, humming, chirping, squeaking or roaring. Many tinnitus victims talk about a high-pitched ringing. Others complain of radio static or an electronic whine.

The sounds never let up, but nobody else can hear them. People with tinnitus look normal, but the affliction can be as crippling as arthritis. Some people are so distressed by the sounds that they become severely depressed and contemplate suicide.

We heard from one wife: “My husband has a constant buzz in his ears and also hears a sound he likens to a dishwasher running. This particular sound bothers him most when he goes to bed or wakes up at night, and it wakes him frequently. The doctor says lots of people have tinnitus and the problem isn’t serious, but it has my husband on the ropes.?

The cause of tinnitus remains somewhat mysterious. Traumatic noise, such as an explosion, can trigger life-long tinnitus as well as hearing loss.

Drugs can also bring on ringing. Aspirin and other anti-inflammatory drugs can cause it. So can some antibiotics and antidepressants.

In rare instances, tinnitus may signal a serious condition called acoustic neuroma. This tumor of the acoustic nerve should be ruled out with a test.

What can be done for tinnitus? More than ten years ago, investigators suggested that Xanax (alprazolam) could improve life for people with disabling tinnitus. We don’t know if this anti-anxiety drug actually affected the sound, or if it just helped them cope with it better. It has not been widely adopted as a treatment.

A new study suggests that a natural compound called melatonin may be helpful. This hormone is produced by the brain and is important for establishing the sleep cycle.

Researchers at Washington University found that patients taking 3 mg of melatonin one to two hours before bedtime both slept better and suffered less from their tinnitus (Otolaryngology-Head and Neck Surgery, Feb. 2006). An earlier melatonin study had found similar benefit (Laryngoscope, Mar. 1998).

One reader wrote that he found zinc citrate or zinc methionine supplements helpful. Research supported his observation that 50 mg of zinc daily may reduce tinnitus severity (Otology and Neurotology, Jan. 2003).

A medication prescribed to protect the stomach from ulcers may also provide benefit for tinnitus sufferers. One small, controlled trial of Cytotec (misoprostol) found that it worked twice as well as placebo to relieve tinnitus loudness (Otolaryngology-Head and Neck Surgery, May 2004). Cytotec can cause diarrhea, abdominal pain, nausea and flatulence. It can also cause premature labor or miscarriage so pregnant women must avoid it.

Although a cure for tinnitus remains elusive, these measures may help some victims. People who don’t suffer this devastating condition should protect their precious hearing from loud noises and drugs that may do damage.

Peyronie’s disease is not a household name. Most people have never heard of this condition, which affects the most private part of a man’s anatomy. Yet it can have a major impact on self esteem or even marital relations.

No one knows exactly how common Peyronie’s really is. Many men are too embarrassed to discuss it with their doctors. Often, it’s the wife who insists on a medical consultation.

An anatomist named Giulio Cesare Aranzi described an unusual curvature of the penis in the medical literature of his day—1587. But the condition bears the name of a Frenchman, Francois de la Peyronie, who described three cases in 1743. As the King’s surgeon, he was already a celebrity, so perhaps that’s why he grabbed the glory.

Peyronie’s disease hasn’t changed much in the centuries since then. Doctors still puzzle over why it occurs and what to do about it. The best guess is that a small tear or injury during intercourse results in scar tissue formation. As a patch of tissue becomes fibrous, it cannot expand normally. The result can be a crooked erection.

For some men the condition is temporary, though unsettling: “While living in Sweden in 1990 I got Peyronie’s disease. It seemed to come literally from one day to the next for no known reason. The curvature was inconvenient but did not prevent me from continuing to have sexual relations.

“A doctor suggested surgery, but added that sometimes it just went away. A year or so later, that is exactly what happened--again, very rapidly. It has not recurred. I did not treat it in any way.?

Others, however, discover that the condition is so disabling that it prevents intercourse: “My husband developed Peyronie’s disease and has such a bend that sexual relations are nearly impossible. He has been taking vitamin E and an anti-inflammatory drug, but erections are still painful. This has altered our sex life and is affecting our marriage.?

There are treatments for Peyronies disease. Although oral medications are not an instant cure, some men benefit from vitamin E and an old-fashioned gout medicine, colchicine. Potaba (potassium para aminobenzoate) may also help soften the scar tissue.

If these oral medicines don’t work, a urologist may inject the scar tissue with a blood pressure drug called verapamil. It has shown some benefit in clinical trials. So has another compound called alpha-interferon. The FDA has not approved either drug for treating Peyronie’s.

During the first year or two, Peyronie’s may disappear all by itself, as our visitor to Sweden reported. Men who continue to have severe curvature or pain after this time may require surgery.

A skilled surgeon has several techniques that can be useful. Men who consider this approach, however, need to know what to expect. Although satisfaction scores are generally high, the surgery may result in a shorter penis.

No one knows for sure, but Peyronie’s disease seems to be more common these days. Some urologists believe this is because ED drugs like Viagra or Cialis unmask a problem that would have gone undetected in times past. Now that men can talk about such things, they need to seek treatment for Peyronie’s disease. It need not ruin a relationship.

Grapefruit has long had a reputation as a health food. Not only is it loaded with nutrients like vitamin C, potassium and folic acid, but it also has been reported to help people lose weight.

For decades, dieters were convinced that grapefruit had special fat-burning power. This idea was bolstered by advertisements like one for a diet plan in which a muscular construction worker pulled a grapefruit out of his lunchbox with disdain, squeezed it and tossed it away. Then he held up a little grapefruit pill and sang the praises of its grapefruit essence for weight loss.

One popular grapefruit diet has people eating either half a grapefruit or drinking 8 ounces of grapefruit juice three or four times daily.

We haven’t seen any studies showing that eating grapefruit will actually make anyone thinner, but new research does demonstrate that grapefruit can help lower cholesterol.

Scientists divided 57 volunteers into three groups of 19 people each. All the subjects had undergone coronary bypass surgery, and all had high cholesterol and triglycerides.

One group got a red grapefruit each day with meals for a month; a second group got a white grapefruit. The control group got no grapefruit.

At the end of the month, those who had eaten red grapefruit had total cholesterol levels 15 percent lower. The group that had eaten white grapefruit had lowered their cholesterol by about half that much. Dangerous LDL cholesterol had also dropped, by 20 and 10 percent respectively, and triglycerides were lower as well (Journal of Agricultural and Food Chemistry, March 22, 2006).

Although grapefruit has ample dietary fiber, the scientists suspect that some other component of the fruit might be responsible for this fascinating effect.

But before anyone adopts a grapefruit approach to cholesterol control, beware of drug interactions. Back in 1989, Canadian researchers discovered, almost by accident, that grapefruit juice significantly increased levels of the blood pressure medicine felodipine (Plendil). At first, this finding seemed like a curiosity. One person who read about grapefruit interactions in this column was laughed out of the pharmacy when he asked about it.

No one is laughing any more. Grapefruit can interact with dozens of drugs, including some very popular cholesterol-lowering medications (Lipitor, Mevacor and Zocor). Because of biological variability, the effects differ from one person to another—and even from one batch of grapefruit juice to another (Journal of Agricultural and Food Chemistry, Jan. 11, 2006). But in some cases, drinking grapefruit juice raises levels of drugs in the blood and increases the risk of side effects. Dozens of drugs such as BuSpar (buspirone), Cordarone (amiodarone), Tegretol (carbamazepine) or Viagra (sildenafil) may be affected.

To learn more about this important issue, we offer our Guide to Grapefruit Interactions. Anyone who would like a copy, please send $2 in check or money order with a long (no. 10) stamped, self-addressed envelope: Graedons' The People's Pharmacy®, No. J-91, P. O. Box 52027, Durham, NC 27717-2027. It can also be downloaded for $2 from the Website: www.peoplespharmacy.com.

Is it any wonder people are feeling betrayed and bewildered? Over the last couple of decades they have been given a lot of advice on healthy living. Most of the suggestions required sacrifice and self-denial.

The message from the “experts? has been that if you follow our recommendations, you will live longer and avoid horrible health consequences like heart attacks, strokes and cancer. Ignore us, and you could die young.

Millions of people took this advice to heart. They struggled to adopt healthy lifestyles. When they slipped up, they felt guilty.

One of the first major dietary restrictions was cholesterol. Butter and eggs were off the menu. Then salt was sinful. People were told to banish the salt shaker even if they were healthy.

It wasn’t enough that people were staying away from cholesterol-containing foods. Next they were told that all fat was bad. They were encouraged to dramatically cut fat intake. Many people turned to fat-free foods and fake fats to accomplish this goal, even though they didn’t taste as good.

Although consumers were warned away from whole milk, they were urged to get lots of calcium to build strong bones. Millions of women started swallowing calcium supplements to avoid osteoporosis.

All these recommendations were presented as if they were chiseled in stone. The health gurus set them forth as facts rather than articles of faith.

Now it turns out that most, if not all, of these guidelines were built on a foundation of shifting sand. The dietary prohibition against eggs was based on belief, not science. That’s because egg yolks contain cholesterol. The experts believed that eating cholesterol would raise cholesterol levels and increase the risk of heart attacks.

When scientists actually did research, they found out that egg consumption was not associated with elevated cholesterol levels in most people. Even more astonishing, scientists have found no significant relationship between dietary cholesterol consumption and death from heart disease (Current Opinion in Clinical Nutrition and Metabolic Care, Jan. 2006).

Over the last several weeks, we have also learned that low-fat diets do not necessarily protect women from heart disease, strokes, breast cancer or colon cancer (JAMA Feb. 8, 2006).

Another balloon burst when scientists reported that calcium supplements did not appear to prevent broken hips, which was the goal (New England Journal of Medicine, Feb. 16, 2006). To make matters worse, women who took extra calcium had an increased risk of kidney stones.

Even salt has come under increasing scrutiny. Although experts have been arguing for decades whether salt restriction will benefit the public health, most Americans have been told they should consume less sodium. A new study demonstrates that the salt slopes are slippery.

Researchers report in The American Journal of Medicine (March, 2006) that people who follow the government’s guidelines and consume less than 2300 mg of sodium daily actually increase their risk of dying from a heart attack or stroke. Those with high blood pressure and heart failure must still follow their doctor’s recommendations about salt, but otherwise healthy people may not benefit from eating tasteless food.

Health experts are suffering a credibility crisis. They need to learn that crying wolf has led to a lack of trust. Consumers deserve good evidence of benefit before they are asked to change their lifestyles.

For years we have been critical of “me-too? drugs. These are copy-cat medicines. When a pharmaceutical company comes up with a brilliant new compound, it doesn’t take competitors long to create variations on the theme.

For example, Prilosec (omeprazole) was the first “proton pump inhibitor? (PPI). It was introduced as a new and more powerful way to suppress stomach acid and fight reflux. Prilosec became a billion-dollar success and one of the most prescribed drugs in the country.

Other companies followed up with their own PPIs. Now we have Aciphex, Nexium, Prevacid and Protonix. Viagra certainly made a splash when it came along as the first pill for erectile dysfunction. Now there’s also Cialis and Levitra.

Drug companies justify these me-too medications on the grounds that they often represent improvements on the original compound. They point out that some patients may not respond well to the original product or that longer-acting variations offer advantages.

We used to think that these were just excuses the companies used to rationalize getting into a lucrative new market. But we have come to recognize that not all drugs in a class are created equal.

Several years ago we heard from a mail carrier about his experience with drug substitution. He had taken Zantac for years to treat severe heartburn brought on by a hiatal hernia. It kept the condition under control with no side effects.

His managed care company decided to save money on his prescription and had his doctor switch the prescription to cimetidine (generic Tagamet). In theory, the two drugs work in a similar fashion. In less than two weeks, though, the mailman had developed pancreatic inflammation and was in the intensive care unit of the hospital. He nearly died and needed months to recover.

After he was discharged from the hospital, his insurance company still refused to cover Zantac. That is despite the fact that his doctors confirmed that cimetidine had caused his life-threatening complication that had cost the managed care company tens of thousands of dollars. He paid for his next Zantac prescription out of his own pocket.

Insurance companies often establish favorable relationships with certain drug companies. That means that those firms’ medicines are included on the approved list, while others are left off. If the doctor writes a prescription for a drug that is not on the list, the co-pay can be $50 or more each month. In some cases, patients may have to pay for the entire cost out of pocket.

The new Medicare Plan D program providing prescription drugs for senior citizens is full of such pitfalls. An insurance company may have only one or two drugs in a particular category.

It’s a travesty when, instead of your doctor, bureaucrats who know nothing about your specific medical history make decisions about the drugs you should take.

We are strongly in favor of people being able to save money on medicine when they can. But we also advocate individuals using the medicine that works best for them, with the fewest side effects. That does not always correspond to the insurance company’s objective to save money at all costs.

A century ago, our forebears were happy to eat eggs and bacon for breakfast and a big meal of steak or fried chicken for dinner. They worked hard, they liked the taste, and they didn’t worry about high-fat food.

Then, in the middle of the 20th century, the cholesterol theory of heart disease was developed. Scientists found they could force rabbits to develop plaque in their arteries by feeding them butter and cheese. Fat was vilified, and most physicians forbade eggs.

Eating eggs, in fact, became tantamount to a sin. Needless to say, eating butter or steak was even worse. The late Robert Atkins was ostracized when he challenged the low-fat orthodoxy. Cardiologists condemned his high-protein weight-loss diet, which included bacon and steak. Studies that showed the Atkins approach did not raise cholesterol were ignored.

Nutrition experts were convinced that if people stuck to a low-fat, high-vegetable diet, they would be much healthier. But that theory has taken a beating lately.

Most of what we know about diet and health has come from observational studies: ask people what they eat and see what happens to them. This is the way we learned that eating fish can reduce the risk of fatal heart attacks and that a diet rich in vegetables and fruit seems to lower the risk of many kinds of cancer.

At the end of the 20th century, scientists decided to test these ideas in a giant experiment. More than 48,000 women over 50 years old were recruited into a dietary intervention trial.

Some (40 percent) of the women were instructed to reduce the amount of fat in their diet, replacing it with extra vegetables, fruits and grains. The training took place in groups and one-on-one, and the women made dietary changes. The other 60 percent of the women were not asked to change the way they ate.

After approximately 8 years of follow-up and massive number crunching, the news is in and it’s disappointing. The researchers had expected that women who adopted the more virtuous low-fat, high-veggie diet would be protected from heart attacks, strokes, breast cancer and colorectal cancer. But despite the large number of women participating, the results were not significant.

For cardiovascular disease, the investigators found a trend favoring survival in women who ate the least saturated fat and trans fatty acids (and the most vegetables). But a trend is hardly the kind of solid evidence policy makers need before they recommend major changes in a country’s diet.

For breast cancer, too, there were not significant differences between the women following a low-fat diet and those continuing on their regular regimen. A trend favored the low-fat lifestyle, but the scientists were left scratching their heads about why the results were not more definitive.

No one is suggesting that a high-calorie, high-fat diet of eggs and bacon, burgers and shakes, steak and fries is good for health. But the dietary changes that seemed so obviously beneficial in the early 1990s can no longer be treated as gospel.

Dietary recommendations have too often been based on dogma rather than on data. If the facts don’t fit our preconceived notions, perhaps we need to reexamine our faith in the low-fat approach.

Everyone wants an easy way to lose weight. That’s why diet pills have been greeted with such enthusiasm over the years. But safe and easy weight loss has been an unfulfilled promise—until now, that is. Rimonabant (Acomplia) may break the curse.

Starting in the 1950s, millions of overweight Americans were prescribed amphetamines to shed a few extra pounds. Although such stimulants were only supposed to be taken for a few months at a time, many respectable housewives became dependent on “speed.?

During the 1990s doctors began to combine two diet pills that had been around for decades. The combination of fenfluramine and phentermine (“fen-phen?) seemed to work better than either drug alone. The only trouble was, the combination led to heart valve complications.

About the same time, a new appetite suppressant, Redux, was approved. It too was associated with heart problems and a potentially life-threatening condition called pulmonary hypertension.

Xenical is another prescription weight loss product. It works by blocking the absorption of fat from the digestive tract. A recent FDA panel recommended that this medication be made available over the counter. It is expected to be marketed under the name Alli. The downside: it can cause unpleasant, even embarrassing, digestive tract problems such as flatulence, leakage or loss of bowel control.

With such an uninspiring track record, it is hardly any wonder that Americans are dubious about new diet pills. The claims being made about Acomplia are so extraordinary, it is easy to understand why some people might be skeptical.

The manufacturer, Sanofi-Aventis, is being especially careful to downplay the cosmetic weight-reducing potential of Acomplia. Instead, other benefits are being highlighted.

In two large clinical trials, Acomplia produced metabolic gains beyond those expected from the pounds lost. Good HDL cholesterol rose and bad triglycerides dropped. Insulin efficiency improved and blood sugar levels came down. These positive changes were twice what researchers would have anticipated from the weight loss alone. These metabolic effects may be especially beneficial for people with type 2 diabetes.

But what will really excite millions of Americans is Acomplia’s ability to help people lose weight. After one year on the drug, subjects lost approximately 15 pounds more than those on placebo. In the world of diet pills, such a loss is impressive.

Reported side effects were relatively mild and temporary. Some people reported nausea, diarrhea, dizziness, headache, anxiety and depression.

The buzz on Acomplia is already enormous. Weight loss and improvements in both blood glucose and lipids are exciting enough on their own. In addition, though, investigators are studying whether Acomplia may help smokers quit. There is even some hope that the compound may help people deal effectively with other drug dependencies.

Whether Acomplia will live up to all the hype remains to be seen. The FDA may well approve the drug sometime soon. But it may take time, perhaps even years, to assess long-term safety.

Can cholesterol-lowering drugs affect memory? That is a question we have wrestled with for nearly six years.

It started when we received a letter from a woman who complained that several months after starting on Lipitor she was “having trouble remembering names and coming up with the right word. At dinner once I said, ‘Please pass the elephant’ though I wanted the bread.?

We didn’t know what to make of this concern because we could find nothing in the medical literature connecting statin-type medicines like Lipitor to memory loss. Before long, however, letters started pouring in.

One reader wrote: “Thank You. Validation at last! I have had enormous problems with concentration. I get confused and feel like there are big ugly holes burned in my memory. I am certain that Lipitor is causing my problems, but my doctor refuses to believe me and denies any connection.?

Letters like these led us to suspect that some people develop cognitive problems on statins. We became alarmed when we received this story:

“I am a retired family doctor and former astronaut. Two years ago at my annual astronaut physical at Johnson Space Center (JSC) I was started on Lipitor. Six weeks later I experienced my first episode of total global amnesia lasting six hours. They couldn't find anything wrong with me so I suspected Lipitor and discontinued it.

“Other doctors and pharmacists were unaware of similar problems. Believing it must have been a coincidence, I restarted Lipitor a year later. After six weeks I landed in the ER with a twelve-hour episode of total global amnesia. I am more convinced than ever of a Lipitor relationship.?

The astronaut-physician is Duane Graveline, M.D. In response to his experience, we heard from other readers who had suffered episodes of total global amnesia while taking Lipitor, Zocor or similar drugs.

Total global amnesia is a temporary but frightening loss of memory. Dr. Graveline forgot that he was a physician or an astronaut and didn’t even recognize his wife. He has summarized his experiences in a new book called “Statin Drugs: Side Effects and the Misguided War on Cholesterol? (available on the Web at: www.spacedoc.net).

Recently we heard of another disturbing experience. Michael Kirk-Duggan was a retired professor of business law and computer science. He was diagnosed with probable Alzheimer’s disease that was progressing very rapidly. He went to his 50th college reunion with a sign around his neck that said, “I’m Mike. I have Alzheimer’s disease.? At his youngest daughter’s wedding, he did not recognize people he had known more than 20 years.

His decline made it clear that he would need long-term nursing care. But then he read our column about statins and memory problems. With his doctor’s awareness, he discontinued the Zocor he had been taking. Although it took many months, he gradually regained his memory and cognitive ability. He is back to reading three newspapers a day and is sharp as a tack. A complete neurological workup showed no signs of Alzheimer’s disease.

Cholesterol-lowering drugs save lives. Many people take them safely. But for those few who develop memory problems, such drugs can be devastating. More research into this complicated issue is urgently needed.

Doctors are way too busy these days. Full waiting rooms and crammed schedules mean physicians rush from one patient to another with barely enough time to do scribble a prescription.

Because of this frenetic pace, many doctors don’t take much time to read drug labels. Surveys suggest that only one physician in ten actually reviews the official prescribing information that accompanies every medication.

Even more alarming, many doctors ignore the warning associated with some high-risk drugs or fail to follow the precautions.

A black box warning (BBW) is reserved for a small number of prescription medications. The FDA devised this BBW system to alert doctors to certain extraordinary dangers that require careful medical attention.

One example of such a warning is found with the anti-seizure drug Tegretol (carbamazepine). Doctors are informed that this medicine can cause very serious blood disorders and are encouraged to order pre-treatment blood tests and then monitor patients periodically.

A BBW that accompanies the diuretic triamterene (Dyazide, Maxzide) urges physicians to measure potassium levels frequently, especially during the early months of a patient’s treatment.

A study by Harvard researchers found that physicians order such lab tests only about half the time (Pharmacoepidemiology and Drug Safety, Nov. 18, 2005). This means many patients were taking high-risk drugs without the kind of supervision the FDA sought.

Another weak link in the drug safety chain is the possibility of drug interactions. Many BBWs specify incompatible medications that should never be prescribed together. The Harvard investigators discovered that nearly one out of ten patients received two medicines on the same day that should not be taken simultaneously.

Deadly drug interactions are a serious problem. The FDA has taken the extreme step of removing some valuable medications from the market because warnings about lethal interactions were ignored. The antihistamines Seldane and Hismanal and the heartburn medicine Propulsid disappeared due to interaction issues.

Because hundreds of thousands of people are injured by prescription drugs each year, the FDA has proposed major modifications for drug labels. The hope is that by reorganizing the prescribing information, physicians will pay more attention to black box warnings and other key guidelines.

Even with a more streamlined system, doctors still have to take time out of their busy schedules to read this critical information. The FDA cannot force them to do this homework.

That’s why patients must be proactive and learn about any special tests, drug interactions or food restrictions that apply to their medicine. After all, the patient has the most at stake.

To help you and your health care providers communicate about these crucial matters, we have prepared a drug safety check list. It can be downloaded for free from our Web site, www.peoplespharmacy.com, so that you can give it to your physician and pharmacist.

When it is filled in, the key information regarding dose, timing, interactions, side effects and special precautions will be available at a glance. Ensuring drug safety requires everyone’s collaboration.

Once upon a time, before the end of the last century, Americans could buy cough medicines that worked. Codeine-containing syrups were widely available without prescription. Physicians also recommended terpin hydrate, an expectorant, from the late 1800s until the early 1990s.

Codeine is now much harder to find over the counter, although some states allow people to buy low-dose cough syrups. The purchase requires the extra security step of signing for the syrup, presumably to discourage abuse.

Terpin hydrate was removed from the market because the FDA had not received enough data to support its effectiveness. (A high-ranking FDA official admitted to us off the record that he had personally used it and found it helpful.)

As a result, we entered the 21st century with dextromethorphan as the primary ingredient in OTC cough remedies. It is the DM in Robitussin DM and other popular brands.

Now, though, the effectiveness of dextromethorphan is being questioned. The American College of Chest Physicians has issued new guidelines on the diagnosis and management of cough.

According to Richard Irwin, M.D., the head of the committee, "There is no clinical evidence that over-the-counter cough expectorants or suppressants actually relieve cough.?

This shouldn’t come as a big surprise. In 2004, a study showed that neither dextromethorphan nor diphenhydramine (the antihistamine in Benadryl) worked better than placebo for kids’ coughs (Pediatrics, July 2004). Ian Paul, M.D., assistant professor of pediatrics at Penn State Hershey Medical Center, headed the study up. He told us, “One of the conclusions you could come to from the results of our study is that these medicines don’t work [for kids].?

What makes DM more troubling is its potential for abuse. Some teenagers take high doses and may experience irregular heart rhythms, high blood pressure, confusion, hallucinations or seizures.

What can you do for a stubborn cough, then? If it is just a temporary symptom due to a cold, doctors mostly recommend “tincture of time.? In other words, it will go away on its own.

That’s not entirely satisfying if someone in the household is hacking away and keeping the whole family awake. We’d like to suggest a different tincture of thyme—a nice warm cup of thyme tea, made with a half-teaspoon of thyme leaves per cup of water. A tea made from grated fresh ginger root can also be helpful. Either may be sweetened to taste, and both contain compounds that help suppress cough.

Another approach is to apply Vicks VapoRub to the soles of the feet. Socks will protect the sheets. We can’t explain how it works, but many readers vouch for it as a nighttime cough suppressant.

If your doctor will prescribe a codeine-containing cough medicine (Cheracol Cough syrup, Guiatuss AC syrup, Romilar AC liquid or Tussi-Organidin NR), you’ll get relief from a hard-to-control cough and it may help you fall asleep.

Another surprising option might be dark chocolate. Scientists at the National Heart and Lung Institute in London have found that theobromine, a compound in chocolate, is more effective than codeine for suppressing a cough. Someday it may show up in a good-tasting, effective cough medicine.

Americans are obsessed with sex. All you have to do is turn on television in the middle of the day and you will see steamy scenes on the soap operas. “Desperate Housewives? is one of the more popular prime time shows, and sex is an underlying theme.

Given our national pre-occupation with sex, you would think that the drugs designed to facilitate intercourse would be blockbusters and would practically sell themselves. That has obviously not been the case. Manufacturers spend hundreds of millions of dollars each year advertising their ED drugs on television, in newspapers and in magazines.

Viagra did become a household word almost overnight. Sales were initially strong. Some Wall Street analysts predicted that worldwide revenue for this drug alone would exceed $2 billion in 2000 and $4 billion by 2004.

That never happened. Combined sales for all three ED drugs (Viagra, Cialis and Levitra) reached $2.5 billion in 2004. Despite intense marketing, sales are flat or even declining. Prescriptions dropped 10 percent between October of 2004 and October of 2005.

The reasons for this disappointing performance are complex, but one may be that marketing has created unrealistic expectations. Television advertising for these products is often suggestive, and some viewers might conclude these pills act as aphrodisiacs.

ED medications can only help with vascular problems due to poor circulation. They don’t work for everyone, however. Up to one-third of the men who take them are not satisfied with the results.

In addition, these drugs have no impact on libido, so people who anticipate that they will increase sexual desire will be sorely disappointed.

Some men may have hoped that drugs like Cialis would make them better lovers. The warning on TV commercials about the dangers of a prolonged erection may have seemed like an enticement for men who wanted such drugs to enhance their performance or endurance.

In truth, those who do not suffer from impotence do not benefit from these medications. The drugs can’t make up for poor technique or lack of attention to romance.

The manufacturers may have overlooked the fact that satisfying intercourse requires a positive relationship. Drugs by themselves can’t improve communication.

Most men affected with erectile dysfunction are middle-aged and older, and their partners are also aging. Wives may also suffer with sexual dysfunction. Menopausal symptoms, lower libido or physical conditions like arthritis can make intercourse uncomfortable.

Other downsides to ED medications are high cost and side effects. Some men find that the headache and flushing that can result make sexual activity uncomfortable. Others must avoid all ED drugs because of dangerous interactions with other medications.

For many men with erectile problems, however, these drugs can be helpful. When used appropriately with realistic expectations, they can help a couple maintain a satisfying sexual relationship into a ripe old age.

Whoever coined the phrase “sleeping like a baby? must have been childless. No parent who’s walked the floor for hours with a fussy infant or gotten up for numerous nighttime feedings would imagine babies sleep well.

At the other end of the lifespan, sleep problems are also common. Older people frequently have trouble getting to sleep. Another common complaint is that they wake up far too early. Some have to get up to visit the bathroom and then have difficulty falling back to sleep. Others find that they are wide awake at 3 am and toss and turn until morning.

This kind of chronic sleep deprivation takes a toll. It has been associated with high blood pressure, weight gain, reduced immunity and daytime drowsiness.

When people see the doctor, the usual solution for insomnia is a prescription for sleeping pills. An in-depth analysis suggests some sleep medications are more likely to hurt than help (British Medical Journal, Nov. 19, 2005).

Some older individuals may fall asleep more quickly with sleeping pills, while others sleep longer on medication. But this overview reports that for the most part, sleeping pills have only a modest effect.

The possibility of dangerous side effects is even more troubling. Older people taking a sleeping pill were nearly five times more likely to become confused or forgetful as those taking an inactive placebo.

Dizziness that could lead to falls and daytime drowsiness that could lead to accidents were also significantly more common.

Many people can relate to this reader’s dilemma: “I suffer from insomnia. Doctors have given me two drugs. One is Sonata, which only helps for about three hours. The other is Ambien, which seems to affect my balance the next day and make me light-headed.?

People who suffer side effects from prescription sleeping pills or worry about dependence may turn to over-the-counter sleep aids. But even the antihistamine diphenhydramine can make some people drowsy the next day. This compound is the active ingredient in Benadryl and is the PM in many nighttime pain relievers.

What can an insomniac do? Lack of sleep undermines health, but sleeping pills may carry risks. One promising option is behavioral therapy. Learning practical ways to cope with sleep problems, adopting new attitudes toward insomnia and practicing relaxation techniques were all helpful for older as well as younger people (Health Psychology, Jan. 2006). Such approaches have no risky side effects, which is a big advantage.

Other tactics that can help include keeping a regular schedule for retiring and rising, setting aside time for relaxation before getting into bed and taking a hot shower or bath an hour before bedtime.

We discussed sleep problems in children and adults with sleep researcher Martin Scharf, PhD, director of the Tri-State Sleep Disorders Center in Cincinnati, Ohio. For more details about non-drug options as well as the pros and cons of sleeping pills such as Ambien, Sonata or Lunesta, you can order a CD of this hour-long interview on our national radio show. The CD is available for $16 from the People’s Pharmacy (CD-565), P. O. Box 52027, Durham, NC 27717-2027 or order it online at www.peoplespharmacy.com.

How Safe Is Aspartame?

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People love to hate artificial sweeteners. Starting with saccharin in the late 1950s, some have enthusiastically embraced the idea of sweets without calories. Others have warned that saccharin, cyclamate and aspartame are too dangerous for human consumption.

The debate is often intensely emotional. Cyclamate was removed from the market in 1969 when animal studies showed an excess of tumors in rats exposed to the sweetener. This decision remained controversial for the next 20 years, but the FDA did not reverse itself.

The FDA proposed pulling saccharin off the market in the mid 1970s, also on the suspicion that it might cause cancer. The agency let those plans drop due to public outcry and Congressional outrage.

The most popular non-caloric sweetener for the past few decades has been aspartame. This artificial sweetener was introduced with great fanfare in 1981 as one of the safest alternatives to sugar ever created. The FDA announced when it approved aspartame, "Few compounds have withstood such detailed testing and repeated, close scrutiny, and the process through which aspartame has gone should provide the public with additional confidence of its safety."

That’s their story and they’re sticking to it. Over the years, though, frightening tales of aspartame toxicity have circulated on the Internet.

One reader wrote: “I know from first-hand experience that there are very serious problems with aspartame. In 1996 I was diagnosed with epilepsy. At that time I was trying to lose weight and eating a lot of products with aspartame.

“I became suspicious and stopped eating aspartame-laced products. Even though my neurologist was skeptical, I was able to discontinue my seizure medicine and have not had further seizures.?

Others have blamed aspartame for a wide variety of health problems including headaches, dizziness, confusion, memory loss, depression, blindness, ADD, ALS, lupus and multiple sclerosis.

With dozens of symptoms attributed to aspartame, it is easy to discount the diatribes. We were skeptical about the more exaggerated claims, especially regarding links to cancer.

Recent research by a European Foundation has forced us to look at aspartame in a new light, however. A study published online in the journal Environmental Health Perspectives (Nov. 17, 2005) involved 1800 rats and 6 dosage levels of aspartame in their chow. Some of the dosage levels were comparable to levels of aspartame in the human diet.

The rats in this study were not sacrificed but lived out their natural lives and were examined upon death. The authors report an excess of leukemias, lymphomas and malignant tumors among rats fed aspartame at several dosage levels.

Critics charge that the researchers did not follow standard protocols for this type of study. The investigators respond, “the findings speak for themselves.?

If you would like more details, we did an in-depth interview about this research on our national radio show. The CD is available for $9 from the People’s Pharmacy (CD-568), P. O. Box 52027, Durham, NC 27717-2027 or order it online at www.peoplespharmacy.com.

The FDA and the industry trade organization, the Calorie Control Council, maintain that aspartame is totally safe. Despite their reassurances, this new research may prompt a re-evaluation of this popular sweetener.

There’s increasing encouragement for people to drink alcohol. Headlines state that a drink or two a day may protect against heart attacks, strokes and maybe even Alzheimer’s disease. At holidays, the social pressure to drink a toast is even greater.

But some people should never drink, even at holidays. Despite the apparent health benefits of a glass or two of wine, these folks may be at risk when alcohol interacts with their medicine. Some could even get into trouble with the law.

Several years ago we heard from a reader who was arrested for driving while intoxicated. He admitted he’d had two glasses of wine at a holiday party, but that didn’t seem enough to raise his blood alcohol level into the danger zone.

He hadn’t realized that the aspirin he took to protect his heart and the cimetidine he took for an ulcer teamed up to boost his blood alcohol. Although the clinical implications of these drug and alcohol interactions are debated, there is reason to be cautious.

More than a decade ago, alcohol expert Charles Lieber, MD, reported that aspirin, cimetidine and ranitidine could all increase blood alcohol concentrations in susceptible people. He told his colleagues that such interactions “may result in unexpected impairment to perform complex tasks, such as driving. Thus, patients treated with these drugs should be warned of this possible side effect? (Digestive Diseases Nov/Dec 1994).

More recently Dr. Lieber warned, “Under conditions mimicking social drinking, ranitidine increases blood alcohol to levels known to impair psychomotor skills needed for driving? (American Journal of Gastroenterology, Jan. 2000). Prescription blood pressure medications such as verapamil (Calan, Covera-HS, Isoptin, Verelan) may also increase blood alcohol levels. Physicians and pharmacists should warn patients about this, but sometimes they forget.

Many other medications are incompatible with alcohol. If you would like to learn more about them, you can request a copy of Graedons' Guide to Drugs that Interact with Alcohol. Please send a large (no. 10) self-addressed stamped envelope and $2 to: Graedons' The People's Pharmacy®, Dept. K, P. O. Box 52027, Durham, NC 27717-2027.

Over-the-counter remedies could also pose a risk. Since cimetidine and ranitidine are available without prescription, many people rely regularly on such drugs to combat heartburn. They may not realize there are potential interactions.

Most people don’t consider that prescription or OTC drugs might be incompatible with alcohol. Someone with the sniffles might reach for a cold remedy containing an antihistamine or acetaminophen. Both ingredients can be hazardous in combination with alcohol.

Many antihistamines are sedating by themselves. Combined with alcohol they would make someone a threat on the highway. Acetaminophen, which is found in hundreds of over-the-counter and prescription products, can damage the liver in the presence of alcohol. Even ibuprofen (Advil Motrin IB, etc) is risky. It is more likely to damage the digestive tract if someone has been drinking.

Moderate alcohol consumption may have health benefits, but revelers should be wary. Mixing alcohol with many medications could be life threatening.

New Lesson from COX-2 Catastrophe

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Even before aspirin was developed, people with arthritis used willow bark to ease their pain and inflammation. By the 1850s, natural derivatives of the bark were widely used in Germany.

But even then people recognized that these salicylates were tough on the tummy. Taking these products was described as “having fire ants in the stomach.?

When aspirin came along in 1899, it was supposed to be easier on the digestive tract. We now know, however, that aspirin can cause heartburn, nausea, stomach pain and even ulcers.

Over the last 100 years the pharmaceutical industry has developed many more nonsteroidal anti-inflammatory drugs (NSAIDs) to alleviate pain. Drugs like ibuprofen, naproxen, diclofenac and piroxicam were all immensely popular as prescription drugs when they were first introduced.

Yet each one shares the same complication as aspirin or salicylic acid derived from willow bark. They can all cause digestive tract distress or worse. Experts have estimated that more than 100,000 people are hospitalized annually and over 16,000 die because of complications caused by NSAIDs (New England Journal of Medicine, June 17, 1999).

What makes this especially troubling is that bleeding or perforated ulcers can occur without warning at any time. Just being vigilant may not be enough to prevent a fatal reaction.

With such a sword of Damocles hanging over patients’ heads, it is hardly surprising that physicians eagerly embraced a new class of NSAIDs called COX-2 inhibitors. Drugs like Vioxx, Celebrex and Bextra were supposed to ease pain without causing the gastrointestinal problems associated with traditional NSAIDs.

Despite the reputation these drugs enjoyed, however, it is not clear that they delivered on the promise. Canadian researchers tracked hospital admissions due to GI bleeding following the introduction of the COX-2 inhibitors (British Medical Journal, June 12, 2004). Instead of dropping, as investigators expected, the rate of this serious problem paradoxically rose 10 percent.

A recent study from Great Britain compared COX-2 inhibitors with conventional NSAIDs (British Medical Journal, Dec. 3, 2005). The researchers concluded that the new COX-2 inhibitors did not offer a significant GI safety advantage over drugs like diclofenac or naproxen.

This revelation is especially disheartening in light of the additional risk COX-2 inhibitors pose for heart attacks and strokes. Vioxx and Bextra were both removed from the market because the cardiovascular risks outweighed the benefits.

Even more alarming is a recent study from the Netherlands suggesting that the NSAID “diclofenac may not be harmless and may induce accelerated progression of hip and knee OA? [osteoarthritis] (Arthritis and Rheumatism, Oct. 2005). Scientists don’t know whether other prescription arthritis drugs might also accelerate joint deterioration.

If there is a lesson to be learned from the COX-2 catastrophe, it is that we need to be more cautious before adopting new medications. Ideally they should be safer and more effective than those they replace. It now appears that the COX-2 inhibitors were neither.

Are you sniffling, sneezing and coughing? If so, you’ve joined millions of others infected with a cold virus.

Traveling, shopping and holiday stress can all increase the possibility of catching a cold at this time of year. What should you do?

Or perhaps more importantly, what shouldn’t you do? There are dozens of remedies on drugstore shelves. Despite the claims, none will cure the common cold or even speed recovery. In fact, many might end up prolonging your symptoms.

Many over-the-counter cold and cough medicines contain pain relievers. A few rely on aspirin, ibuprofen or naproxen. The vast majority include acetaminophen.

Taking an analgesic for a cold doesn’t make much sense. Colds don’t usually cause pain or fever the way the flu does. But aspirin, ibuprofen and acetaminophen may all extend viral shedding and make a sufferer contagious longer.

A more worrisome complication of acetaminophen found in many cold and cough products is that a person could unwittingly overdose. There is a growing concern that acetaminophen poisoning can contribute to liver damage.

A recent study published in the journal Hepatology (Dec. 2005) shows that accidental acetaminophen overdose accounts for many cases of acute liver failure.

Here’s how this might happen. Someone with a sore throat might opt for TheraFlu Flu & Sore Throat Hot Liquid with 1000 mg of acetaminophen in each packet. The maximum dose of four packets a day adds up to 4,000 mg of acetaminophen. The same person might turn to a night-time formulation to try to get some sleep, getting more acetaminophen. Taking medicine such as Tylenol Arthritis Pain for aching joints might add as much as 3900 additional mg of acetaminophen.

Many product labels warn consumers against mixing medicines containing acetaminophen, but some people may not always take the time to look closely at the labels of their OTC remedies.

Lots of cold remedies also contain antihistamines. Ingredients such as chlorpheniramine or diphenhydramine may slow down sniffles by drying out mucus secretions, but they can also make a person drowsy or spacey. Driving under the influence of an antihistamine could be dangerous.

Some people turn to herbs to avoid problems with OTC drugs. Studies of echinacea have produced mixed results, however. The most recent research was disappointing.

Alternatives include astragalus or andrographis. These Chinese herbs have a long history of use against upper respiratory symptoms.

Zinc is also promoted as a way to combat the common cold. As with echinacea, though, the research is inconsistent. Some studies show benefit, while others show none.

We discuss several approaches to the common cold along with our favorite chicken soup and hot toddy recipes in our Guide to Cold Remedies. Anyone who would like a copy may download it for $2 from the Web site: www.peoplespharmacy.com. Or send $2 in check or money order with a long (no. 10) stamped, self-addressed envelope: Graedons' The People's Pharmacy®, No. Q-20, P. O. Box 52027, Durham, NC 27717-2027.

With a cold it’s important to stay home and not share it. That’s why we love garlic-based remedies. They may not cure a cold, but they keep others far enough away that they’re less likely to catch it!

Between now and New Year’s Day we put a terrible strain on our stomachs. Holiday parties and family feasts mean overindulgence: rich food and too much of it.

For millions of people this means heartburn. The new fangled term is acid reflux, also known as GERD (gastro-esophageal reflux disease).

What this means in practical terms is that stomach acid splashes up into the esophagus, producing pain, burning and even scarring of the food tube. Experts estimate that 100 million Americans experience heartburn every month.

Humans have suffered from indigestion since recorded time. Centuries ago, doctors called it dyspepsia, from Greek words meaning hard to digest.

Although the ancient Greeks may have overindulged in wine and other delicacies during holiday feasts, normally they ate a very sensible Mediterranean diet. There was no fast food, no hot donuts, cheese pizza or chocolate pie. Americans, on the other hand, eat on the run and frequently choose foods that aggravate heartburn.

The most popular solution is to pop a pill. The manufacturers of acid-suppressing medicines like Prilosec, Prevacid and Nexium (the purple pill) reinforce this approach.

There are, however, other ways to reduce heartburn without potent medications. Diet does matter. Some people find that cutting back on carbohydrates helps. We have heard from readers of this column that the Atkins diet was surprisingly beneficial in reducing chronic reflux: “I lost my heartburn, even before the weight came off. I no longer need to take antacids.?

A preliminary report in the medical literature documents other cases of acid reflux disappearing on a carbohydrate-restricted diet (Alternative Therapies in Health and Medicine Nov.-Dec. 2001).

Some people find that particular foods give them grief. Tomatoes, salsa, soft drinks, coffee (even decaf), tea and orange juice are common culprits. Using a product like Prelief (calcium glycerophosphate) can reduce the acid in the foods without affecting stomach acid.

Others find that simple antacids relieve their discomfort. Old-fashioned calcium carbonate (Chooz, Maalox Quick Dissolve or Tums) usually works quite well for occasional indigestion. So does baking soda, for that matter. Half a teaspoon in four ounces of water is a time-honored recipe for heartburn.

Some people find home remedies do the trick. Chewing on gum or sucking on hard candy can stimulate the flow of saliva. Two decades ago, an article in The New England Journal of Medicine (Feb 2, 1984) showed that this tactic helps rinse and buffer acid in the esophagus. Since then other studies have confirmed that chewing sugarless gum for 30 minutes after a meal can help ease acid reflux.

We offer more information on treating heartburn in our Guide to Digestive Disorders. Download it for $2 from www.peoplespharmacy.com or send check or money order with a long (no. 10) stamped (60 cents), self-addressed envelope: Graedons' The People's Pharmacy®, No. G-3, P. O. Box 52027, Durham, NC 27717-2027.

As challenging as it may be, eating sensibly during the holidays could be the best solution for reducing holiday heartburn. When all else fails, though, simple remedies can bring quick relief.

Orphan: Noun: 1a. A child whose parents are dead. b. A child who has been deprived of parental care and has not been adopted...4. An orphan technology or product.

Adjective: 1. Deprived of parents…5. Affecting so few people that the development of treatment is neglected or abandoned for being unprofitable: an orphan disease.

This definition is from the American Heritage Dictionary of the English Language. For a more vivid description of an orphan’s experience, all you have to do is open Charles Dickens’ book, Oliver Twist. The children in the story are abused and neglected and survive by scrounging.

Like orphan children, orphan diseases are often neglected. People who suffer from rare conditions are frequently left to their own devices. Without treatment, they could expect their lives to be nasty, brutish and short.

All that was supposed to change in 1983. That’s when Congress passed the “Orphan Drug Act.? It offered incentives to drug companies so they would develop treatments for uncommon diseases.

Because pharmaceutical research and development is so costly, Congress recognized that most companies wouldn’t bother unless they didn’t lose too much money in the process. There was no expectation that orphan drugs would ever turn a significant profit. The whole enterprise was supposed to be altruistic.

That’s why drug companies were given a 50 percent tax credit on research and development for these drugs, grants to help them test drugs in patients and extended patent-like protection.

Twenty years later, though, the charitable impulse has been subverted. Orphan drugs are now among the most expensive in the pharmacy.

Rituxan, a medication used to treat non-Hodgkin’s lymphoma, saves lives from this cancer, but costs around $12,500 annually. The life-saving leukemia drug Gleevec averages $37,000 a year.

Cerezyme is a bio-engineered enzyme for Gaucher disease. It costs an average of $200,000 annually per patient. That includes babies and children who need lower doses. Some adults have to spend $600,000 a year just to stay alive. That’s over $1,500 a day.

No one can afford that kind of drug bill. Even with insurance, families struggle. Those without insurance may have to impoverish themselves so they qualify for Medicaid benefits.

When Congress and the FDA dreamed up the orphan drug bill they didn’t consider limiting profitability. They simply assumed that with so few patients as a market, these products had limited commercial value. The legislation was based on the concept of compassion.

By charging whatever they want, however, some companies that make orphan drugs are getting rich. According to the Wall Street Journal (Nov 16, 2005) Genzyme, the maker of Cerezyme, makes a gross profit margin of 90 percent on this medicine. Sales exceeded $800 million last year. Genzyme gets away with it because patients have no alternative if they want to stay alive.

Some pharmaceutical executives with million-dollar salaries like to think of themselves as benevolent. Perhaps instead they should imagine themselves in the role of Dickens’ character Fagin, exploiting orphans to enrich themselves.

As the old saying goes, if it hurts or tastes bad it must be good for you. That may be why generations of children were dosed with cod liver oil or had their skinned knees doused with alcohol.

Those practices have faded, but people still have trouble imagining that their little vices might be healthy. Research shows that moderate alcohol consumption can protect the heart. But many doctors are reluctant to tell patients they can have a glass of wine or a mug of beer. They may worry that any patient who has a drink might be unable to stop after just one.

Of course, alcohol is not appropriate for everyone. Some people don’t like it, while others can’t tolerate the effects. Anyone with alcoholism in the family might do better to avoid drinking. There are, after all, many other ways to help the heart.

One of those is exercise, which sounds enough like punishment that health experts have no qualms recommending it. But there’s a catch. The only way most people manage regular exercise is if they find some activity they enjoy, whether it’s gardening, roller-blading, dancing or simply strolling in the park. And that sounds a lot like indulging yourself. When work stress piles up, physical fun may be the first sacrifice.

Sleep is another simple pleasure that is essential for good health. Lots of people feel guilty if they go to bed when they’re tired. They forge on with work or email into the wee hours.

Adequate sleep can assist with weight control and improve immune responses. It also aids alertness and enhances memory. But don’t let anyone know you just enjoy slipping between the sheets and closing your eyes.

One way people often try to stave off sleep is with coffee. It too has a reputation for being a vice. But although coffee, like alcohol, can be overdone, recent research indicates some unexpected benefits.

Coffee is a major source of antioxidants in the American diet. Coffee drinkers are less likely to develop type-2 diabetes and new research suggests it does not increase the risk of hypertension in women.

Perhaps the greatest indulgence of all is chocolate. Some people find it hard to accept that chocolate could have health benefits. Yet the evidence keeps accumulating.

Researchers in Italy found that dark chocolate lowers blood pressure and helps improve the response to insulin (American Journal of Clinical Nutrition, March 2005). Enhanced insulin sensitivity may lower the risk of type-2 diabetes.

Previous studies have shown that cocoa compounds improve blood vessels’ flexibility and keep blood platelets from clumping together to form clots. Some data indicate that dark chocolate may raise good HDL cholesterol and prevent the bad cholesterol from promoting atherosclerosis.

We discuss research on chocolate, offer guidelines on selecting healthful chocolate and tell how to make lower-fat, lower-calorie chocolate desserts in our cookbook, Chocolate Without Guilt. To order a copy, visit the Web site www.peoplespharmacy.com or send $18.95 to: Graedons' The People's Pharmacy®, No. CWG, Durham, NC 27717-2027.

Just because something tastes good doesn’t mean it is bad for you. Some simple pleasures can be healthy.

Three years ago the world of women’s health turned upside down. That was when a large study, the Women’s Health Initiative, showed that hormone replacement therapy could have serious health consequences.

HRT was expected to protect women from heart attacks and strokes. Instead, it actually increased the risk of cardiovascular complications. The study also confirmed that hormones like estrogen and progestin elevated a woman’s chance of developing breast cancer.

Ever since these alarming results hit the headlines, prescriptions for Premarin and Prempro have plummeted. During the heyday of HRT, almost 80 million prescriptions were filled every year for estrogen or estrogen and progestin products. So far this year, fewer than half that many prescriptions have been filled.

Now women are looking for alternatives. It is estimated that 5,000 American females enter menopause every day. They are experiencing symptoms such as hot flashes, night sweats and vaginal dryness. Many women have questions about what to do: “I am 55 and going through menopause. My physician had me on Premarin for several years. We discussed the advantages and disadvantages of this treatment several times, and he assured me that Premarin helped with bone density and heart attacks as well as other problems associated with the change of life.

“When I heard of the study showing problems with Prempro, he finally agreed that I should stop. I would still like some relief from my uncomfortable symptoms and I asked him about natural hormones. His answer was ‘I don't know anything about that, so I can't give any advice on it.’

“I have gone to this doctor for years and I felt abandoned. I am really suffering with hot flashes, mood swings and trouble sleeping. My physician has no suggestions for me at all.?

Many women like her are looking for alternatives to relieve symptoms without increasing their risk of heart attacks, strokes or breast cancer.

Over the last few years there has been a huge increase in the sales of so-called bio-identical hormones. Compounding pharmacists use soy and yams to formulate estrogen and progesterone that are supposed to mimic the hormones a woman’s own body used to produce. Proponents claim these products are safer.

Despite their popularity, bio-identical hormones are coming under scrutiny. The FDA says that doctors and patients should assume that all hormones have a similar profile of benefits and risks, regardless of how they are made.

Susan Love, MD, a leading advocate for women’s health, points out that high levels of progesterone are not natural after menopause. The American College of Obstetricians and Gynecologists also warns that there is no evidence that long-term use of bio-identical hormones is safe.

For women suffering severe menopausal symptoms, short-term use of female hormones can be helpful. This is still the most effective treatment for hot flashes and night sweats.

We have summarized the pros and cons of hormones in our Guide to Estrogen: Benefits, Risks & Interactions. Anyone who would like a copy may download it from www.peoplespharmacy.com or send $2 in check or money order with a long (no. 10) stamped, self-addressed envelope: Graedons' The People's Pharmacy®, No. W-49, Durham, NC 27717-2027.

Have you eaten a pomegranate? The fruit features in Greek mythology in the story of Persephone, daughter of the harvest goddess Demeter. Hades, the lord of the underworld, kidnapped the beautiful maiden. Because she ate a few pomegranate seeds before being rescued, she had to spend several months every year in the underworld with him. According to the myth, that’s when the earth was forced to endure winter.

Modern stories about pomegranates are not quite as fanciful as the myth, but there is a lot of buzz lately about the exotic fruit. How much is supported by scientific research?

Pomegranates grow wild from Iran to northern India, but they are cultivated throughout India, the Middle East, southern Europe and California. Scientists in Israel have been conducting research on the health benefits of pomegranates and pomegranate juice for years, and now others have joined in.

What are pomegranates good for? Researchers report that they are rich in antioxidants that can keep bad LDL cholesterol from oxidizing (American Journal of Clinical Nutrition, May 2000). This degradation of LDL seems to be an initial step in the development of atherosclerosis. In addition, pomegranate juice, like aspirin, can help keep blood platelets from clumping together to form unwanted clots.

Does this make any difference clinically? More recent research has found that eight ounces of pomegranate juice daily for three months improved the amount of oxygen getting to the heart muscle of patients with coronary heart disease (American Journal of the College of Cardiology, Sept. 2005). Other researchers report that long-term consumption of pomegranate juice may help combat erectile dysfunction (Journal of Urology, July 2005).

Investigators are also excited about the possibility that pomegranate compounds might prevent prostate cancer or slow its growth. In mice, treatment with pomegranate extract delayed the development of tumors and improved survival (Proceedings of the National Academy of Sciences, Sept. 26, 2005). Other research reports suggest that pomegranate juice might help reduce the risk of breast cancer.

Even arthritis may yield to the power of pomegranates. Scientists at Case Western Reserve University have reported that tissue cultures of human cartilage cells respond to pomegranate extract. Inflammation is reduced and the enzymes that break down cartilage become less active (Journal of Nutrition, Sept. 2005). This is still far from a prescription for aching joints, but most experts agree that a little pomegranate won’t hurt and might help.

One traditional use of pomegranate juice is to calm diarrhea. We have seen no research supporting this claim, but we have heard from a reader with personal experience: “One of the best things to take for diarrhea is pomegranate juice, which can be found in grocery stores. You can actually get constipated if you drink too much (as I found out!)?

A word of caution: Pomegranate juice appears to interfere with certain medications much as grapefruit juice does (Drug Metabolism and Disposition, May 2005). So when grapefruit juice is risky, pomegranate juice might be as well.

Persephone might have done better to resist eating pomegranate seeds, but modern science suggest most of us could benefit.

The smell and taste of original Listerine are so distinctive that, once experienced, they can never be forgotten. Gargling with this mouthwash can’t be described as pleasant. The taste is bitter. It puckers the mouth and makes the tongue tingle. The aftertaste lingers.

For a product that has been described as tasting terrible, it is astonishing that Listerine has remained so popular for so long. It was originally developed in 1879, not as a mouthwash, but as an antiseptic for physicians to use prior to surgery. Its inventor, Jordan Lambert, named it Listerine in honor of Dr. Joseph Lister, the pioneer of antiseptic surgery.

In 1895 the product was marketed to dentists to kill bacteria in the mouth. By 1914, Lambert and his son Gerald began offering Listerine to the public as a mouthwash, and one of America’s most enduring personal care products was launched.

Listerine has maintained its popularity in part because it tastes so distinctive. Although the company has come up with new flavors and colors, the old-fashioned amber liquid still has devotees. And we keep hearing from readers about new uses for this old patent medicine:

“Over twenty years ago, I was hiking with my nephews and one of them asked me to break a branch lying on the ground so he could use it as a walking stick. I did so, and the next day both my palms and arms were covered with a rash that itched terribly.

“A dermatologist said it was probably poison sumac. He put me on prednisone and gave me a cortisone shot. The rash spread up my arms and I suffered for about three weeks.

“Every summer thereafter, I’d break out several times during the summer months even though I hadn’t touched any sumac. He told me I could get it from the pollen, even from a mile away.

“Then I read in your column about a woman who used Listerine for her shingles. I thought, what the heck, give it a try. Imagine my surprise when the itching stopped. Within a few days the rash was gone.

“I now keep a large bottle of Listerine on hand and each time I work in the garden, I slosh it on any exposed skin and then shower. If I forget, I start itching but I use it immediately. Even if I’m starting to break out, the rash clears up in a day or two instead of the usual three weeks.

“For $4.99 I have a year’s supply that works instantly versus the $80 (plus doctor’s visit), three weeks of constant itching, blisters and slow healing that I used to go through three or four times a summer.?

Readers praise Listerine for relieving a wide variety of other skin conditions. Some tell us that full-strength Listerine massaged into the scalp can ease itchy dandruff or even psoriasis.

The combination of thymol, eucalyptol, methyl salicylate and menthol in an alcohol base may have antifungal activity. That could explain why others report that original formula Listerine works against nail fungus, athlete’s foot, jock itch and “trucker’s bottom? (whatever that is).

It’s hard to imagine how a product that has been around for so long continues to generate such loyalty and excitement. Even though the FDA has not given its blessing for these unusual uses, many people still find Listerine beneficial, despite the memorable aroma.

How Effective Are Flu Shots?

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People are freaked out about the flu. Public health officials have been fretting about bird flu and the possibility that it could turn into a worldwide pandemic.

There is not much anybody can do about avian flu. No vaccine has been developed, and there is not enough antiviral flu medicine to treat everyone. No one even knows yet whether the bird flu will actually morph into a real danger or if it will just remain a threatening prospect.

In the meantime, public health pundits are urging high-risk Americans to sign up for their annual flu shots. Last year, shortages of flu vaccine created panic as people waited in long lines, only to have supplies run out.

This year experts do not expect a shortfall of flu vaccine. But the heavy emphasis on immunization does not fit well with research on the efficacy of flu vaccine, especially for older, sicker people. Although policy makers pay homage to the concept of evidence-based medicine, the scientific basis for influenza immunization is not that impressive.

Two years ago, for example, the flu shot protected nearly half the healthy adults who got it. But only 38 percent of those at high risk because of chronic illness were protected by the immunization. This was due in part to the fact that the vaccine that year was not a close match for the dominant strain of influenza.

But even in years when the vaccine matches the various types of flu virus circulating in the community, immunization for the elderly may not be as effective as most people think. A study of mortality records for the past three decades shows that death rates from the flu among older people has not changed much during that time. Over the same period, there was a dramatic increase in the rate of flu vaccination, from 15 percent to 65 percent. The investigators concluded that flu shots do not protect this vulnerable population particularly well (Archives of Internal Medicine, Feb. 14, 2005).

A systematic review of many studies of flu vaccine effectiveness suggests that vaccinating elderly people in nursing homes is about 23 percent effective in protecting them from flu-like illness (Lancet, Oct. 1, 2005). According to the researchers, “In elderly individuals living in the community, vaccines were not significantly effective against influenza, influenza-like illness, or pneumonia.?

Of course, this does not mean older people should skip their annual flu shots. But it does mean that we need better data--or better vaccines.

In the meantime, people may want to talk to their physicians about antiviral medications. According to the Centers for Disease Control and Prevention, old-fashioned drugs such as amantadine and rimantadine “are approximately 70 percent to 90 percent effective in preventing symptoms of influenza A illness.?

Newer flu medicines have fewer side effects and work against type B as well as type A flu. These drugs, Tamiflu and Relenza, are the only drugs also proven to fend off bird flu.

Let’s hope that this virus does not mutate and create a worldwide pandemic this winter. There’s still no vaccine to protect people against this disease and even if there were, it would take many months to make enough for everyone.

For decades medical students were taught a simple rule: "no acid, no ulcer." It was an article of faith that stress and an executive life style contributed to acid-induced stomach ulcers.

Millions of ulcer patients were advised to eat a bland diet and take antacids like Maalox or Mylanta. Although these recommendations were standard, they weren't very effective.

When strong acid-suppressing drugs like Tagamet, Zantac and Pepcid came along, they were hailed as a huge advance in ulcer therapy. Although such medicines reduced acid in the stomach, ulcers and stomach irritation often returned when the medicine was discontinued.

In 1982, Australian gastroenterologist Barry Marshall, MD, and his colleague, pathologist Robin Warren, MD, developed a completely new theory about the cause of stomach ulcers. These Australian researchers had data linking a bacterial infection (Helicobacter pylori) to the development of gastritis and ulcers.

In other words, ulcers could be "caught" like other infectious diseases and were not the result of bad diet or a high-pressure lifestyle. To cure them, a person needed antibiotic treatment, not just acid suppression.

Despite the evidence, physicians were reluctant to accept this radical concept. Fighting acid was so ingrained in ulcer treatment that antibiotics seemed irrational.

It took years before the medical establishment accepted the idea that ulcers could be caused by infection. This month, Drs. Marshall and Warren were awarded the highest honor a researcher can receive: the Nobel Prize in medicine.

Although this recognition vindicates their work, many doctors still rely on acid-suppressing drugs like Prilosec, Prevacid and Nexium to treat gastritis and stomach ulcers. Antibiotics to eradicate H. pylori are prescribed far less frequently.

According to Marshall, this bug may lie behind some cases of hard-to-treat bad breath. Antibiotic therapy to eradicate the infection sometimes cures the bad breath. Other research has linked Helicobacter infections to even more serious conditions, such as stomach cancer or heart rhythm abnormalities.

To learn more about Helicobacter and its treatment, you may wish to read our Guide to Digestive Disorders. Anyone who would like a copy, please send $2 in check or money order with a long (no. 10) stamped (60 cents), self-addressed envelope: Graedons' The People's Pharmacy®, No. G-3, P. O. Box 52027, Durham, NC 27717-2027.

If someone is infected with H. pylori, taking acid-suppressing drugs like Zantac, Tagamet or Prevacid won't cure the infection. Some experts maintain that suppressing stomach acid without eliminating the bacteria might even increase a person's risk of developing "atrophic gastritis," a condition that appears to be a precursor for stomach cancer. This issue remains quite controversial.

One lesson to be taken from the Helicobacter-ulcer story is that infection and resulting inflammation might lie behind other chronic conditions. Scientists are looking for the agents that might trigger type-1 diabetes, inflammatory bowel disease or even arthritis. If this line of research proves fruitful, it could be another consequence of the creative thinking of Warren and Marshall.

When a child is diagnosed with attention-deficit hyperactivity disorder, a parent is put in a terrible bind. On the one hand, teachers may push for medications like Ritalin or Strattera. That's because kids with ADHD can be inattentive, disruptive and have a hard time getting schoolwork done in an orderly fashion.

On the other hand, parents hear that such drugs may have serious side effects. Ritalin makes some children nervous and may cause insomnia. Other children get stomachaches, headaches, heart palpitations or muscle tics. Many lose their appetites.

The drug Strattera now carries a black box warning about irritability and suicidal thoughts or behaviors. Such a caution can't help but worry concerned parents.

The dilemma of dealing with ADHD is no longer of mere academic interest. An estimated four million U.S. children have ADHD. More than half have taken medication to help them pay attention in class and control their impulses.

Many parents feel torn between their desire to help a child perform well in school and their fear of doing harm:

"Our daughter has ADD but I am scared of the meds. Ritalin gave her tics and antidepressants made her sleepy and depressed. She took Cylert for about a year until we learned that it could harm the liver. Our daughter has been on no medications for almost five years. She is a senior in high school but it's a daily struggle."

Not all parents are able to help their child manage school without medication: "My grandson has had ADHD for years. (It was noticed when he was 2 years old.) He's now 13, and has been on Ritalin for about 8 years. The school won't allow him in if he doesn't have his medication; they administer it in the office."

Many parents feel coerced by this type of school policy. They want their children to do well, but are concerned about potential side effects. They would like to believe that medicines such as Adderall, Concerta, Ritalin and Strattera are safe and that long-term consequences have been well studied. But there are relatively few clinical trials that run more than several months or a few years. Some children are prescribed stimulant medicines for decades, even after they grow up.

When parents read about Canada taking Adderall XR off the market because of toxicity issues, they naturally wonder whether it is safe enough for their own children. Despite assurances from the FDA, the safety of such stimulants remains controversial.

Most experts agree that medication alone is not ideal. Behavioral and dietary approaches can also be helpful. Edward Hallowell, MD, is one of the country's leading experts on ADD. He recently published a book, Delivered from Distraction, that provides thoughtful information on how to assist people with attention problems.

We spoke with Dr. Hallowell about ADD treatments, including dietary supplements such as fish oil. Anyone who would like a CD of this hour-long interview may send $15 in check or money order to: Graedons' The People's Pharmacy®, No. CD-541, P. O. Box 52027, Durham, NC 27717-2027.

Integrating diet, exercise and structured activities can help parents cope with the challenges of a child with ADHD, whether or not medication is prescribed.

The mentally ill have been tortured throughout history. Many past cultures interpreted the delusions of schizophrenics as signs of demonic possession. In some cases holes were drilled in their skulls so that evil spirits could escape.

The Romans used electric eels to shock such people. They also used starvation and flogging to subdue unruly patients.

During the middle ages, people were jailed, chained or put in stocks. Women might be burned at the stake as witches.

In the 20th century, physicians administered electroshock therapy or injected high doses of insulin to induce seizures. In 1946, the lobotomy was developed. In this procedure, the frontal lobe of the brain was surgically destroyed with a tool like an ice pick. Lobotomies were widely used because they calmed agitated people and made them docile.

In the 1950s drugs for schizophrenia were hailed as a humane advance in the treatment of mental illness. Chlorpromazine (Thorazine), haloperidol (Haldol) and thioridazine (Mellaril) became the standard treatments for schizophrenia.

The drugs reduced agitation and helped control hallucinations. Some mental health experts believed that these medications would empty the back wards of mental institutions. In the 1970s patients were discharged from psychiatric hospitals to the community under the false assumption that on these drugs they could lead almost normal lives.

Experts didn't foresee how unpleasant the side effects of these medicines would be. Many patients found the drugs so sedating that they felt like zombies. They escaped "ice pick" surgery only to experience a "chemical lobotomy."

Others discovered that after months or years of treatment they developed uncontrollable muscle twitches or tics that were often irreversible, even after stopping the drugs. Other side effects included dizziness, urinary retention, dry mouth, constipation, blurred vision, nasal stuffiness, heart palpitations, fainting, sexual problems and seizures.

Drugs like chlorpromazine can also cause akithesia, a profound restlessness that makes it hard for people to sit still. They feel as if they are about to jump out of their skin.

In the 1990s, a new class of anti-psychotics was introduced with great expectations. Medications like Clorazil and Zyprexa seemed less likely to cause troublesome side effects. These "atypical antipsychotics" were followed by other new-generation schizophrenia medications such as Risperdal, Seroquel and Geodon.

Although very expensive, often costing hundreds of dollars a month, these drugs rapidly replaced older generic drugs like chlorpromazine or perphenazine. A new study demonstrates, however, that the more recent drugs are not much of an advance.

When compared to old-fashioned perphenazine, several new drugs were no more effective or better tolerated. Zyprexa was somewhat better, but it can cause serious weight gain that may predispose patients to diabetes and heart disease. Over the course of 18 months, nearly three fourths of patients stopped taking their medicines due to lack of effectiveness or intolerable side effects.

Although we no longer burn mental patients at the stake or perform lobotomies, this new research demonstrates that our treatments for schizophrenia are still far from ideal.

After years of wrangling, Congress finally passed a prescription drug benefit for senior citizens. The Medicare program will launch in January of 2006, but over the next several weeks, people who are eligible for Medicare will be bombarded with competing offers from private insurers.

On October 1, mailboxes will start filling with promotions for a variety of plans. There will also be ads on television and radio, in magazines and newspapers. There will be intense pressure to pick a program starting on November 15.

Those who don't sign up within six months will have their premiums increase by

one percent per month. The longer you wait the more it will cost.

This kind of pressure will make some senior citizens very anxious, especially when they discover how complex the decisions will be. For one thing, each plan will charge a premium. Some may be as little $20 a month while others may be well over $30. Some plans will have deductibles or co-payments, while others won't.

Here's where it gets really complicated. The basic plan has a $250 deductible that you pay out of pocket before you get any drug assistance. Then you pay 25 percent of your prescription drug bills from $250 to $2,250 (not including premiums).

At that point, you are on your own. You pay 100 percent of your medication bills for the next $2,850. This is the so-called donut hole, where the Medicare program won't cover you. Once you have shelled out $3,600, the Medicare drug benefit kicks in again. It is supposed to pay 95 percent of your prescription bills for the rest of the year. Of course, this does not include your monthly premiums.

Confused? Wait, it gets even more bewildering. Not all drugs are covered, and plans are allowed to change the drugs they approve at any time. (Seniors are only permitted to switch plans once a year, though.)

If your doctor prescribes a medication that is not on your plan's official list, you will have to contact the plan to ask for an "exception." If the plan says no, you are allowed to appeal the decision. (Good luck.)

Some plans may be very flexible in permitting people access to their prescribed medicines. Others may be bureaucratic and hard-nosed. You probably won't know in advance which way your plan will be administered.

In theory, the government will help people sort through the confusion. It is preparing to roll out a Web site designed to compare various plans (www.medicare.gov). We'll have to wait and see how easy it is to navigate. Those without access to the Internet can call 800-MEDICARE.

Of course, none of this will do you any good if you are not yet 65. If you are ineligible for the prescription drug plan but still struggling to pay for your pills, we have prepared a Guide to Saving Money on Medicine. Anyone who would like a copy, please send $2 in check or money order with a long (no. 10) stamped (60 cents), self-addressed envelope: Graedons' The People's Pharmacy®, No. CA-99, P. O. Box 52027, Durham, NC 27717-2027.

Millions of people are desperate for relief from high drug bills. The new Medicare plan may help, if they can figure out how to use it wisely.

Are you a hazard on the highways? Do you drive impaired? Most people would answer no, but they might be deluding themselves.

Far too many people drink and drive. Even a few glasses of wine can slow reaction time and interfere with judgment.

But almost everyone knows about the dangers of alcohol. Millions are unaware of two other factors that can make people dangerous behind the wheel-medications and insomnia.

An astonishing number of Americans are not getting enough sleep. Some push their bodies to the limits and beyond because they're holding down two or three jobs. Others stay up late to do email, surf the Web or watch TV.

New research suggests that lack of sleep can be just as dangerous as too much alcohol. A recent study of interns and residents underscores the impact of sleep on performance.

The young doctors were tested for vigilance, attention and performance on a realistic driving simulator. Those who were working 90 hours a week reacted 7 percent more slowly and were 40 percent more likely to make mistakes.

Their lack of sleep led to poor performance that was comparable to the deterioration seen after alcohol ingestion (JAMA, Sept. 7, 2005).

These results help explain the higher-than-average risk of car crashes for doctors in training. (They are three times more likely than average to be involved in a driving accident.) Like people who drink too much, these sleep-deprived health professionals were not very good at judging how much their reaction time had slowed.

Although most people don't have to work non-stop for 36 hours like interns and residents, millions of Americans are also sleep deprived. The trouble is that some of the sleeping pills that people use to combat insomnia may also leave them groggy and slow the next day.

For example, the new and highly advertised sleeping pill Lunesta comes with a warning for patients: "When you first start taking LUNESTA or any other sleep medicine, until you know whether the medicine will still have some effect on you the next day, use extreme care while doing anything that requires complete alertness, such as driving a car, operating machinery, or piloting an aircraft."

For those who would like more information on non-drug approaches to overcoming insomnia, we offer our Guide to Getting a Good Night's Sleep. Please send $2 in check or money order with a long (no. 10) stamped (60 cents), self-addressed envelope: Graedons' The People's Pharmacy®, No. I-70, P. O. Box 52027,

Durham, NC 27717-2027.

Sleeping pills are not the only medications that could interfere with alertness, judgment or reaction time. Anti-anxiety medications such as diazepam or alprazolam can affect vigilance. So can many allergy medicines.

Over-the-counter antihistamines that contain diphenhydramine (like Benadryl) are especially sedating.

Research has shown that people who took this allergy medicine were just as impaired as if they had been drinking alcohol (Annals of Internal Medicine, March 2000).

Most people, including medical residents, are responsible and would not deliberately put others at risk. But driving while impaired, whether because of lack of sleep, medications or alcohol, is risky business.

The FDA is in hot water. Not long ago the agency was under scrutiny for its handling of the Vioxx problem. Critics charged that the Food and Drug Administration was more concerned about the health of the pharmaceutical industry than about patient safety.

Now the FDA is on the hot seat again because it has put off its decision on whether emergency contraception should be sold over the counter.

The morning-after pill (Plan B) has been sold by prescription since 1999. It consists of the hormone levonorgestrel, a common ingredient in birth control pills.

Plan B is effective in preventing pregnancy after unprotected intercourse. But the sooner it is taken, the more likely it is to work. That is why British regulators allow emergency contraceptives to be sold without prescription. Some states also permit ready access to morning-after contraception.

In 2003 the maker of Plan B asked FDA to allow OTC sale of the drug. An expert panel overwhelmingly recommended approval. The agency’s own professional staff agreed with this conclusion.

Normally, the agency follows such recommendations. But in this case management overruled both its outside experts and its own staff. FDA leadership objected that OTC availability of emergency contraception might not be safe for young teenagers and could encourage sexual promiscuity.

After promising a final ruling by this September, FDA has again delayed a decision. As a result, Dr. Susan Wood, Director of the FDA’s Office of Women’s Health, has resigned. She protested that postponing a decision indefinitely was not based on scientific or clinical evidence.

Critics complain that politics has again trumped science at the FDA. They suggest that the professed concern about safety in adolescents is a smokescreen for abortion politics. People who oppose abortion maintain that emergency contraception may prevent implantation of a fertilized egg.

The FDA is caught on the horns of a dilemma. If over-the-counter safety is truly the issue, then the agency may need to re-evaluate many other products.

New research suggests that regular use of popular pain relievers, such as acetaminophen and ibuprofen, can raise blood pressure in women. Aspirin and drugs like ibuprofen and naproxen can cause life-threatening ulcers. Dextromethorphan, the DM in many OTC cough medicines, can be abused.

Yet all of these medicines are widely available to the public, including teenagers, without prescription.

One solution to the morning-after pill problem might also solve other safety concerns. Many countries permit behind-the-counter sale of various pharmaceuticals. In England, for example, people can buy the cholesterol-lowering drug simvastatin (Zocor) without a prescription. But they first have to discuss the drug with a pharmacist.

The FDA has been unwilling to consider pharmacist supervision for drugs such as Plan B or the herpes medicine acyclovir (Zovirax). Even pain relievers like ibuprofen, naproxen or codeine might be sold from behind the counter. This approach would allow easier access to some drugs but still improve safety through counseling.

The FDA may not like this idea, but until it finds a way out of its current predicament, it will continue to take criticism from all sides.

Pity anyone with pain that lasts more than 10 days. That's how long the FDA says you can safely take an over-the-counter analgesic such as Advil, Aleve or Tylenol on your own.

The trouble is that one in three adults (66 million people) suffer chronic joint pain. That means millions need something to ease their discomfort almost every day.

One reason the FDA limits the use of nonprescription pain relievers is that many of them can irritate the digestive tract. Doctors have estimated that more than 100,000 people land in the hospital each year with drug-induced ulcers and over 15,000 die from complications of these medicines.

A study from Spain shows that one-third of the hospitalizations and deaths from gastrointestinal bleeding in that country are due to the use of nonsteroidal anti-inflammatory drugs (NSAIDs) or aspirin. Even low doses of aspirin can cause serious problems (American Journal of Gastroenterology, Aug. 2005).

Worries over NSAID complications fueled the development of medicines like Bextra, Celebrex and Vioxx. These COX-2 inhibitors were designed to protect the digestive tract from damage while providing pain relief.

Unfortunately, the cardiovascular complications of these drugs have often outweighed their benefits. That's why Vioxx has been taken off the market and Celebrex has a prominent warning about heart attacks and strokes. As a result of the COX-2 debacle, researchers are now scrutinizing other NSAIDs to see whether they also have cardiovascular complications. Preliminary data suggest that drugs like ibuprofen, naproxen and prescription NSAIDs may pose a risk. Aspirin is the exception.

Acetaminophen seems like the ideal solution to this dilemma. It relieves pain but does not irritate the digestive tract. New research suggests, however, that regular use may elevate blood pressure.

The Nurses Health Study has been following thousands of women for decades. Women who regularly took more than 500 mg of acetaminophen daily nearly doubled their chance of developing hypertension over three years. Long-term use of NSAIDs like ibuprofen and naproxen was also associated with a greater risk of hypertension. Only aspirin was not found to raise blood pressure (Hypertension, Sept. 2005).

What does this mean for people with arthritis or other chronic conditions? Sadly, there are no easy answers.

Allowing pain to restrict activities is a bad solution. That's why millions of arthritis victims are looking for alternative therapies. For some, glucosamine and chondroitin may provide relief. Others turn to massage, acupuncture or home remedies such as gin-soaked raisins, Certo and grape juice or the Indian spice turmeric.

We have collected a number of these suggestions in our Guide to Alternatives for Arthritis. Readers who would like a copy, please send $3 in check or money order with a long (no. 10) stamped (60 cents), self-addressed envelope: Graedons' The People's Pharmacy®, No. AA-2, P. O. Box 52027, Durham, NC 27717-2027.

Until safer pain relievers become available, people will need to experiment to find ways to manage their chronic pain.

Old Scams In New Bottles

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Why is the grass always greener someplace else? The idea that remedies from a far-away, exotic location are more potent than anything home grown harkens back to the traveling medicine shows of the 19th century.

These days, instead of snake oil salesmen hawking their wares from the back of a wagon, we have late-night cable television infomercials and Web-based promotions. But the same principles apply.

Beware anyone selling the famous Bora-Bora Beetle Juice that is guaranteed to grow hair, improve your love life, relieve arthritis pain, eliminate wrinkles and cure cancer. Such claims are often accompanied by amazing testimonials: "I lost 350 pounds overnight without any dieting thanks to 3-B juice."

Keep in mind that testimonials, as fascinating as they may be, do not constitute scientific evidence. Sometimes they are completely fictitious. If someone maintains that royal bee dandruff enlarged his penis by 4 inches, be skeptical, especially if it costs $29.95 for a three-day supply.

You might think that the FDA would crack down on the scamsters. In truth, neither the Food and Drug Administration nor the Federal Trade Commission is able to police the Internet for fraudulent claims. That means you are on your own. Here are some claims that should make you suspicious:

The product is a "breakthrough," especially one that doctors don't want you to know about. Actual medical breakthroughs are rare, and you will read about them in the paper or see them on the news.

Also watch out for "miracle cures." They are few and far between, and rarely come in a bottle.

Desperate people are especially vulnerable. When traditional treatments fail for serious conditions like cancer, rheumatoid arthritis or Alzheimer's disease, people may cling to any glimmer of hope. But the claim that a product can cure an incurable disease should sound alarms.

Beware anything that relies on a bizarre ingredient from some remote and hard-to-reach locale. The quackmeisters are counting on the mystique factor to capture your imagination-and your dollars. An ad may imply that the nectar of the rare Tibetan tutsi-tutsi flower will cure every ache and pain in your body, but if it's so rare, why are they selling so much of it?

Pyramid marketing schemes raise another red flag. Your next-door neighbor or your second cousin Clarissa may sing the praises of a supplement she's taking (and selling). Don't let the social pressure overwhelm your common sense.

Speaking of common sense, it's your best defense against quackery. If a product sounds too good to be true, don't spend your money on it. The claims are almost certainly inflated, and may be completely bogus.

Money-back guarantees are another tip-off. People have made fortunes selling products to increase bust or penis size. They accumulated luxury cars, mink coats and mansions, not to mention millions in cash, despite offers to refund money to dissatisfied customers. But buyers who expected to see a dramatic difference in their anatomies were sorely disappointed.

When the snake oil salesmen came to town, your great-grandparents probably knew enough to listen to the music, laugh at the pitches and not get taken. Follow their good example.

Ever since 1999, when the Institute of Medicine (IOM) published its landmark report on medical error, health care leaders have been bemoaning the sorry state of American medicine. Authors of the study, "To Err Is Human," estimated that nearly 100,000 people die in American hospitals each year because of mistakes, many of which could be prevented.

The actual problem may be far worse. A more recent estimate pushes the death toll to nearly 200,000.

One of the biggest problems is medication blunders. Too often hospitalized patients receive the wrong drug or the wrong dose or the wrong combination of medicines. When Mrs. Jones is discharged from room 476 and Mr. Smith is given that bed, he may also get the medicine that was intended for her.

Other times a nurse may ask about a drug allergy but the information may not be highlighted on a patient's chart. When an intern comes by the next day, she may not notice the drug allergy and may administer a life-threatening medicine.

Now, some hospitals are turning to the supermarket for technology that could prevent such common mistakes.

For decades, bar codes have been used to improve efficiency at check out and track sales and inventory. Look on a box of Cheerios or a jar of peanut butter and you will see the familiar thick and thin black lines that are instantly read by a scanner.

Bar codes on drugs will look quite similar, but the purpose is completely different. Instead of speeding check-out, medication codes should reduce the number of patients who get the wrong drug or the wrong dose.

The Veterans Administration has led the way in this effort. When a doctor orders a prescription, the order goes electronically to the pharmacy, where a bar code is generated and attached to the proper medicine.

Once the medicine gets to the patient's room, the nurse matches the bar code on the medicine to one on the patient's ID bracelet with a handheld scanner. The VA reports that this bar coding system has reduced the number of medication errors by 24 percent.

Why don't more hospitals embrace this familiar technology? It is estimated that only about one hospital in 20 uses bar codes for verifying patient medications.

One reason may be cost. Partners, a big Boston health care system affiliated with Harvard Medical School, recently spent about $10 million on its bar code effort.

This big bill was deemed worthwhile because it has already cut drug dispensing errors in half. Analysts there calculate that 20 adverse drug events are prevented every day because of this technology.

Physicians involved in this effort conclude: "Although the ultimate goal is to protect patients, these measures also save on the bottom line, since the average adverse event costs an estimated $4,700 in extra hospital bills and ancillary services-excluding the cost of litigation." (New England Journal of Medicine, July 28, 2005)

Until your hospital joins the 21st century and institutes bar coding and other safety measures, you and your family will need to be extremely vigilant whenever someone is hospitalized. Make sure your loved one is getting the right drug at the right time and in the right dose!

In 1997 the FDA opened Pandora's box when it changed its rules to permit widespread advertising of prescription drugs to consumers. Before that, regulations were so strict that most drug companies didn't see any value in promoting such products to anyone but health professionals.

Last year, the pharmaceutical industry spent over $4 billion on TV and radio commercials, print ads and Web-based promotions to the public. But a chorus of criticism from Congress, physicians and the public has the FDA and the drug industry scrambling to reevaluate this strategy.

We often hear from parents who are dismayed that their young children see ads on television for drugs to relieve erectile dysfunction. Some physicians are also weary of fielding questions about prescription drugs from patients who saw them advertised on TV. This year the American Medical Association considered resolutions urging restrictions or even an outright ban on direct-to-consumer commercials.

The AMA is studying this issue until its next annual meeting. In the meantime, however, we have received letters like the following:

"I am a doctor and have been practicing for 35 years. I am disgusted by the ads on TV advising patients about the advantages and disadvantages of certain drugs. When you hear the side effects, you are almost ready to throw up because they are sometimes worse than the benefits. I think the government should intervene into the commercialism that is shown by the pharmaceutical industry because most of these ads are very misleading."

The FDA is sensitive to such critiques. For the first time in a decade, the agency is planning a public meeting to kick off its review of direct-to-consumer prescription drug advertising.

With this initiative on the horizon, the Pharmaceutical Research and Manufacturers of America (PhRMA) is proposing some changes of its own. This industry trade group has just issued voluntary guidelines to its member companies.

They include submitting new TV commercials to the FDA for review before broadcast. Major risks associated with an advertised medicine should be stated in clear, understandable language without distraction.

If this recommendation is adopted, perhaps we will see fewer ads in which actors are laughing, dancing or partying while the announcer rushes through a long list of scary side effects.

PhRMA is also encouraging drug firms to target only appropriate audiences. Theoretically, this should reduce the number of erectile dysfunction drug ads airing when many children are watching.

While these steps may begin to curb some of the abuses that have taken place, many consumers question the value of so many drug ads. Except for New Zealand, no other industrialized nation permits advertising of prescription medicines directly to consumers.

If you have views on this topic and want the industry and the FDA to consider them, you can contact Billy Tauzin, President and CEO of PhRMA; 1100 Fifteenth Street, NW; Washington, DC 20005 and Sheila Dearybury Walcoff, FDA Associate Commissioner; Food and Drug Administration; 5600 Fishers Lane; Rockville, MD 20857.

LICE! Just reading the word can make your head itch.

What is it about lice that inspires such loathing? Otherwise normal people become hysterical at the mere thought of these bloodsuckers.

Many people associate lice with uncleanliness. This idea is false. Economic status and personal hygiene make no difference to lice.

As children come home from camp and prepare to return to school, some parents are becoming anxious. In many communities lice have become resistant to standard treatments. "No-nit" policies in some schools can mean an

embarrassing phone call to "come get your child."

No wonder parents are tempted to take desperate measures to get rid of lice. We recently heard from one mother:

"I hope our tale will keep someone else from going through the nightmare we did. In kindergarten my daughter brought home lice. We didn't know much about them and we all ended up catching them.

"We tried over-the-counter remedies. They worked initially, but the lice kept coming back even though we washed and fumigated everything.

"The standard treatment didn't seem to be working and I didn't want to subject my 5-year-old to chemicals over and over, so I called the doctor. His terrible nurse sounded like she was holding the phone away from her head while talking to me, as though she could catch them over the line. She suggested Vaseline.

"We bought a jar of Vaseline and put it in our hair quite liberally. We felt rather silly, but then after several hours, we tried to get it out. NOTHING worked. Not shampoo, not dish soap, not laundry soap. Mechanics' 'Goop' came the closest, but even that wasn't enough.

"At 4 am I called the hospital's ask-a-nurse line for help. The nurse was flabbergasted that a medical professional had told us to use Vaseline. She called the pharmacist, who said that the only way to get it out was to work mineral oil into the Vaseline to cut it and then shampoo several times. That helped get the Vaseline out, but what a mess!

"For the record, the Vaseline did not get rid of the lice. In the end, what worked was diligent daily use of a good lice comb for several days."

After a bout with lice, old clichés about nit-picking and fine-tooth combs take on new meaning. Tedious though it is, combing the hair to get rid of lice eggs (nits) is an essential part of any lice treatment plan.

Using Vaseline is clearly an extreme approach. Pediatricians sometimes suggest it when all else fails. Petroleum jelly, mayonnaise and mineral oil seem to smother live lice. To work, though, you have to leave the goo on under a shower cap for eight hours or so.

Getting petroleum jelly out of hair is indeed a nightmare. Mineral oil may help cut the grease. Some parents rub cornmeal or cornstarch liberally over the petrolatum and then brush the mess out. Afterwards, they wash the head with Dawn dish detergent, taking care to keep suds out of eyes.

If the usual lice treatments fail, parents may want to wash hair with alternatives such as HairClean 1-2-3 or Listerine. Both contain herbal oils and alcohol, which may help kill lice. Leave on for 15 minutes before rinsing.

Despite the persistence of resistant lice, they can be overcome with patience and strategy.

Some psychiatrists may have been shocked by the FDA's recently revised labeling for antidepressants: "Adults being treated with antidepressant medication, particularly those being treated for depression, should be watched closely for worsening of depression and for increased suicidal thinking or behavior."

This warning follows a similar one directed towards children and adolescents.

These cautions are doubly troubling because they are long overdue. For years the FDA has reassured physicians and patients that drugs like Prozac, Paxil and Zoloft would not make people worse or lead them to suicide.

Shortly after Prozac was introduced, however, we heard from a bereaved father about the death of his daughter who was given Prozac for an eating disorder: "One month later, after taking this medication, she committed suicide by hanging herself. What was so strange about this unsuspected action was that she was not behaving like a person who was depressed or suicidal."

When we first heard from him in the late 1980s, we checked published reports of Prozac side effects and found nothing to suggest this could be a drug reaction. In 1990, however, a case report was published in the American Journal of Psychiatry. Harvard psychiatrists described six patients who suddenly developed "intense violent suicidal preoccupation after 2-7 weeks of fluoxetine [Prozac] treatment."

When we asked the drug company and the FDA about this report, we were told that depressed people sometimes commit suicide and that the drug was not to blame.

Over the last fifteen years we have heard of many other instances in which people became preoccupied with harming themselves or others after starting on an antidepressant.

A man taking Zoloft woke in the middle of the night with a strong urge to kill himself. A woman reported wild thoughts on Prozac about ramming her car into other cars and getting a gun to kill an irritating co-worker.

One reader shared this sad story: "I am convinced that Zoloft caused my cousin to kill himself even though he was strongly opposed to suicide. He saw Zoloft advertised on television and asked his family doctor about it.

"The night my cousin told me he had started taking Zoloft, I immediately looked up the drug in your book, The People's Pharmacy®. I became alarmed when I read this sentence: 'Family members should help monitor people on Zoloft for suicidal thoughts or self-destructive behaviors. The doctor must be notified immediately in such cases.'

"I didn't know what to do. I didn't feel I could tell my cousin to stop taking the Zoloft. I regret to this day that I didn't call him back immediately and read that warning to him.

"One week later, he went out to check on his cattle. When he didn't return, his wife and sons went looking for him. They found him dead under his favorite tree. He had shot himself in the head with his father's double-barrel shotgun."

Over the last 15 years, too many families have had to suffer like this one. We wish the FDA had moved sooner on the analysis that led to its recent warning. Perhaps now, though, patients will be watched more closely and given the support they need during treatment for depression.

Dermatologists hate the sun. There's a good reason for their loathing. They see the effects of excessive sun exposure-not just wrinkles, age spots and leathery skin, but also a variety of skin cancers.

But do dermatologists go too far in advising everyone to shun the sun completely? Several weeks ago we wrote that a modest amount of sunhsine might be beneficial.

Dr. Edward Giovannucci of Harvard started a controversy by reporting that common cancers such as colon, lung, prostate or breast are less prevalent in sunnier states and countries where people get more sun exposure. The anti-cancer benefits of vitamin D may be due to its ability to suppress abnormal cell growth.

Human skin makes vitamin D when it is exposed to sunshine. But high SPF sunscreen blocks this biochemical activity. Fortunately, it doesn't take much sun for adequate vitamin D. According to Dr. Michael Holick of Boston University, five or ten minutes on face, arms and legs two or three times a week is enough for fair-skinned people. Darker-skinned individuals need a little more time in the sun.

Dermatologists worry about any sun exposure. We received the following letter in response to our previous column:

"As the President of the American Academy of Dermatology, I am deeply concerned that your recent article is contributing to public confusion about sun exposure and vitamin D and ultimately doing a disservice to the public.

"The health benefits of vitamin D are well known. Prescribing sunshine to get vitamin D is highly irresponsible, however. People should NOT increase their exposure to UV light because there is a high risk of developing skin cancer from repeated exposure.

"At current rates, an estimated 105,750 people in the U.S. will be diagnosed with melanoma (the most serious form of skin cancer) this year. This is a 10 percent increase in new cases since 2004 and melanoma will claim approximately 7,770 lives this year alone.

"Rather than seek intentional sun exposure, the American Academy of Dermatology recommends that anyone concerned about getting enough vitamin D should supplement a healthy diet with multivitamins and fortified foods and beverages. Individuals who seek the sun are putting their health at risk.

"The Academy's message is one of common sense and caution. When enjoying the outdoors, we recommend everyone take protective steps: seek shade, wear sunscreen and cover up with a wide-brimmed hat, long sleeves, pants and sunglasses. Also, avoid tanning beds.

"Sincerely, Clay J. Cockerell, MD"

We appreciate the call for common sense. Too much sun is clearly harmful.

But we are skeptical of getting adequate vitamin D from a multivitamin. Multivitamins contain only 400 IU (international units) of vitamin D, often in a less usable form than the skin makes.

Current estimates suggest adults may need 1,000 IU daily, and Dr. Giovannucci believes 1,500 IU might be closer to the mark. Taking several multiple vitamins to provide that much D would result in a dangerous overload of other vitamins. Vitamin D itself is toxic if too much is taken orally.

The inescapable conclusion, we feel, points to moderation in sun exposure as well as vitamin consumption for most people. A sunburn or even a tan is unhealthy, but a few minutes of sun a few times a week might have real benefit.

Many Americans suffer sticker shock when they buy medicine at their local drugstore. They would like to save money by purchasing prescription drugs from Canada. But they are bewildered by contradictory messages about Canadian pharmacies.

States are also having a hard time balancing their budgets due to skyrocketing drug costs for employees and retirees. To ease the burden, several states have set up Web sites to help citizens order prescription medicines from approved Canadian online pharmacies. Prices of brand name prescriptions are often significantly lower north of the border.

The FDA is furious. It is illegal to import drugs although the agency rarely enforces this law. The FDA also argues that Americans buying drugs abroad could get substandard medicines.

The feds have warned governors like Rick Perry of Texas that encouraging residents to buy Canadian drugs will endanger their health. State lawmakers respond, "what's more unsafe: Taking a drug from Canada or not taking your medication because you cannot afford it?"

To confuse matters more, Canada's Health Minister, Ujjal Dosanjh, made headlines when he announced that Canada will no longer be the "drug store for the United States." He plans to ban bulk drug exports to America.

Headlines make it seem as if this maneuver will shut down the online, cross-border trade in prescription medicine. But consumers don't buy in bulk. The proposed ban shouldn't affect individuals trying to save money on their own medications.

The pharmaceutical industry has also weighed in on this controversy. Several companies have cut off supplies to Canadian drug stores that sell prescription medicines to Americans.

The crux of the argument is that Canada is a source of counterfeit drugs. The pharmaceutical industry maintains that importation represents a safety risk.

It is certainly true that consumers need to be wary of Web-based pharmacies. Many that claim to be based in Canada are really located elsewhere, with little or no regulation. A person who intends to purchase from a Canadian Web site should check for the provincial pharmacy license number and a physical address and telephone number in that province.

We offer more details in our Guide to Saving Money on Medicine. Anyone who would like a copy, please send $2 in check or money order with a long (no. 10) stamped (60 cents), self-addressed envelope: Graedons' People's Pharmacy, No. CA-99, P. O. Box 52027, Durham, NC 27717-2027.

Counterfeit drugs are uncommon in Canada. In a recent case a pharmacy dispensed counterfeit Norvasc, but such incidents are rare. Unlike the U.S., Canada establishes prescription drug prices. There are relatively few wholesalers and no repackaging of medications.

In the U.S., however, repackaging is common and there is a flourishing wholesale trade. Small companies buy and sell a variety of prescription medicines, which allows counterfeit drugs to enter the supply chain. In the book Dangerous Doses: How Counterfeiters Are Contaminating America's Drug Supply, author Katherine Eban documents the nature of this gray market.

The FDA won't admit it, but buying drugs from legitimate Canadian pharmacies may be safer than buying from the drugstore down the block.

Are you fed up with prescription drug ads? If so, you are not alone. For the last several years Americans have been bombarded with commercials that promote drugs for satisfying sex or overactive bladder. Readers have complained about trying to explain erectile dysfunction or PMS to pre-teens.

Such ads are almost uniquely American. Except for New Zealand, no other country in the industrialized world permits prescription drugs to be advertised straight to consumers. You can't run to the store to buy any of these products. They all require a doctor's prescription.

Some physicians are also getting sick and tired of the hard sell. At a recent meeting of the American Medical Association, several resolutions were introduced urging restrictions or even an outright ban on direct-to-consumer commercials.

Doctors supporting the resolutions tried to convince their colleagues to take action. When the pharmaceutical industry got wind of this effort, it responded quickly. Its Washington lobbyists usually put pressure on Congress, but that week they went to the AMA national meeting in Chicago instead.

Whether the professional persuaders were successful, or whether most doctors are lukewarm on the issue, we don't know. The AMA concluded the discussion by resolving to study the question for another year.

The Pharmaceutical Research and Manufacturers Association (PhRMA) must have been pleased. This drug industry trade organization maintains that such ads improve patients' awareness of disease and encourage them to visit their doctors.

One ad proponent, Richard E. Ralston, Executive Director of Americans for Free Choice in Medicine, says, "Keeping patients barefoot and ignorant is not the solution. Despite the tireless efforts of pharmaceutical salesmen, physicians in general practice or internal medicine can't possibly keep up with all the features of the many new drugs and how they might apply to every patient.When you see a commercial for a new drug it offers the potential to make somebody feel better. Let's leave those commercials and the drug companies alone."

The trouble is that many 30-second commercials don't actually provide much balanced scientific information. They are designed to make drugs seem appealing rather than to present benefits and risks clearly so they can be evaluated.

That's why Vioxx became so successful and was taken by many people for whom it may not have been appropriate. We now know, of course, that some of those patients might have suffered heart attacks needlessly.

No wonder some doctors are annoyed. They complain that patients hassle them to prescribe drugs they've seen on television. Doctors resent spending valuable time explaining why an advertised medicine might be inappropriate.

Even though the AMA has deferred its decision on consumer drug advertising for

a year, patients should still be cautious.

Before begging a doctor for a heavily advertised, high-priced prescription, do your homework. Find out what the most common or dangerous side effects are. Sift through the fine print to see who should not take it.

Once you have accurate information, you and your doctor can consider carefully whether the new drug is the right one for you.

here's more bad news for people in pain. First we learned that Vioxx could increase the risk of heart attack and stroke. Then Bextra and Celebrex came under similar scrutiny.

Now the entire category of pain relievers called NSAIDs (non-steroidal anti-inflammatory drugs) is under a cloud. Research published in the British Medical Journal (June 11, 2005) suggests that drugs like ibuprofen (Advil, Motrin IB), naproxen (Aleve, Naprosyn) and diclofenac (Cataflam, Voltaren) are also associated with cardiovascular complications.

The scientists studied 9,000 patients who had first heart attacks between 2000 and 2004. They were compared to more than 86,000 other people.

Those who took Vioxx were 32 percent more likely to suffer a heart attack. This statistic resembles what the manufacturer discovered just before it took Vioxx off the market.

More surprising was the discovery that ibuprofen raised the risk of a heart attack by 24 percent. Diclofenac increased a patient's likelihood of suffering such a complication by 55 percent.

The real shocker was that naproxen also appeared to pose a problem. During recent hearings at the FDA, experts testified that naproxen might protect the heart, almost like aspirin. But the data from England led researchers to conclude, "No evidence was found to support a reduction in risk of myocardial infarction [heart attack] associated with current use of naproxen." In fact, their data indicate that naproxen carries a risk similar to that of ibuprofen.

Most people think over-the-counter pain relievers like ibuprofen or naproxen are extremely safe. Why else would the FDA allow them to be purchased without a doctor's prescription?

It comes as a huge shock for people to realize that a medicine they take for granted to relieve the pain of a bad back, tennis elbow or arthritis could affect kidney or liver function, raise their blood pressure, cause a bleeding ulcer or increase their risk of a heart attack.

Although millions take NSAIDs without serious side effects, some people experience unexpected complications. And the possibility of a serious problem poses a dilemma for patients. A person in pain wants relief. But what can a person take?

People with chronic pain need to discuss this double-bind with their doctors. Old-fashioned aspirin is still the gold standard for pain relief and heart protection. A doctor might prescribe aspirin in conjunction with a stomach-protecting medicine called Cytotec. An acid-suppressing drug might also prevent the development of stomach ulcers.

Others may find that alternative therapies such as glucosamine offer relief. We have gathered information on a range of home remedies and other approaches in our Guide to Alternatives for Arthritis. Anyone who would like a copy, please send $3 in check or money order with a long (no. 10) stamped (60 cents), self-addressed envelope: Graedons' People's Pharmacy, No. AA-2, P. O. Box 52027, Durham, NC 27717-2027.

People in pain deserve relief. For some, NSAIDs may be the best solution. But those at risk for heart disease may have to rely on other approaches to ease their discomfort.

Sleeping is supposed to be relaxing. It's a time when the body rejuvenates itself. But for millions of people, getting to sleep is difficult because they suffer from restless leg syndrome (RLS).

In this condition, people have an insatiable urge to move their legs. Some describe it as a creepy-crawly sensation. Others call it "jumpy legs." The feeling of pulling, tugging, burning or irritation inside the legs eases only when the sufferer moves the legs around.

Some people get up and pace the floor, others climb stairs or jerk their legs in bed. One woman described a situation in which she ended up literally kicking her husband out of the bed. Because of her endless thrashing, he had to sleep in another room.

A couple in a similar dilemma found a solution: "My husband has suffered from RLS for as long as I have known him. Until several years ago we didn't even know it had a legitimate name. We called it 'leg-i-tis'!

"He tried everything he could think of-calcium, magnesium, quinine, etc. His doctor told him to march around the house until it stopped. (This was usually done in the middle of the night since that was when it occurred.) It would start right back up when he laid down to try to sleep.

"I was watching 'Good Morning America' a while ago and heard about RLS. The doctor said a medication called Mirapex works.

"My husband's doctor prescribed it for him and it has been a miracle for us. I say us because his horrible condition kept us both from sleeping."

Mirapex (pramipexole) is a medicine used to treat Parkinson's disease. Another drug for Parkinson's disease, Requip (ropinirole), was approved earlier this year for treating RLS. It is the first medicine the FDA has officially sanctioned for this use.

In one study, a low dose (1.8 mg) of Requip reduced the average number of leg twitches in sufferers from 49 per hour to just 12. The placebo was no match for this drug.

The most common side effects of Requip include headache, nausea and dizziness. Daytime fatigue or sleepiness is also a risk and could make driving or operating machinery dangerous.

Not everyone benefits from such prescription medicine. Home remedies, while not scientific, do seem to help some people: "Any time I take an antihistamine, my legs begin to jerk. The first time it happened, I had to get up out of bed and do jumping jacks, because it affected my arms as well. Now I avoid antihistamines, and I sleep with a bar of soap under the sheet near my legs."

Another reader uses a dietary supplement: "I too have suffered the overwhelming desire to move my legs again and again when sleeping. It's worse when I'm tense or over tired. Trying to stay still just makes it worse. I find that a little melatonin helps. Now, I rarely need to use it."

We discuss home remedies and other treatments for leg cramps and restless leg syndrome in our Guide to Leg Pain. Anyone who would like a copy, please send $3 in check or money order with a long (no. 10) stamped (60 cents), self-addressed envelope: Graedons' People's Pharmacy, No. RLS-5, P. O. Box 52027, Durham, NC 27717-2027.

Millions of people are apprehensive about flying. It's more dangerous to drive to the airport than it is to fly across the country, but a lot of folks worry that there could be a plane crash.

Imagine their consternation if the flight attendant announced before takeoff that pilot error was common and that passengers might suffer serious injuries or even death before arriving at the destination.

Fortunately, you never hear such announcements. The airlines have multiple systems in place to counteract pilot error and keep passengers safe.

The same cannot be said for hospitalization. Five years ago the Institute of Medicine (IOM) rocked the medical community with its report, "To Err is Human." The authors estimated almost 100,000 Americans die each year due to medical errors, many of them preventable.

Even more alarming, an analysis last year showed that the IOM probably underestimated. The actual hospital death toll from errors is closer to 200,000.

A recent update (JAMA, May 18, 2005) concludes that: "progress is frustratingly slow. Building a culture of safety is proving to be an immense task and the barriers are formidable."

Medication mistakes have turned out to be one of the most prevalent problems. Any pharmacist could tell you that it is not uncommon for a patient to receive the wrong medicine, the wrong dose or a combination of medications that are incompatible.

One survey found that community pharmacies make mistakes on roughly two percent of the prescriptions they dispense. That may not seem serious, but when you consider that around three billion prescriptions are filled each year, it comes to over 50 million mistakes.

Such big numbers are hard to grasp. Although many errors are so trivial they do no harm, others cause great suffering or even death.

In one classic case, a 67-year-old woman was mistakenly dispensed the diabetes drug glyburide instead of her blood pressure medicine metoprolol. When her blood sugar levels dropped dangerously low, doctors were mystified. She could easily have died. The doctor who reported the case noted: "If the patient's husband had found her dead on the floor at their home, the dispensing error would have gone unrecognized. Because of the patient's history of hypertension and acute myocardial infarction, her death would most likely have been reported to be due to a 'heart attack.'"

To prevent such dangerous medication misadventures, every patient must guard against mistakes. Instead of grabbing your prescription bag and heading out of the drugstore as fast as possible, take a moment to read the label and examine your pills. If it is a medicine you take regularly, ask the pharmacist about any change in the appearance of the pills.

It helps to have the label indicate the use of the medicine. One pharmacist told us this story: "A patient picked up his medications and returned immediately from the parking lot. He objected, 'This bottle says to take 1 teaspoonful 4 times a day for cough. I don't have a cough.'"

It turned out the customer's prescription was meant for someone else. Being an alert patient, whether in the hospital or in the community drugstore, could save your life.

Is it any wonder so many people are confused about the sun? On the one hand, dermatologists have been issuing dire warnings for decades. They tell us that sun exposure causes wrinkles, age spots and skin cancer. If we go out in the sun without slathering on the sunscreen we've been led to believe we're living dangerously. No one is supposed to spend time in the midday sun (defined as any time between 10 am and 2 pm) unless they are well covered with protective clothing.

On the other hand, research has been mounting that sunshine prevents cancer. Numerous studies have demonstrated that cancers of the colon, breast, prostate and lung are less common among people who get some regular sun exposure. There is even research to suggest that a little sunlight may help against skin cancer.

Harvard professor, Edward Giovannucci, ScD, stirred up a hornet's nest with his recent keynote speech to the American Association for Cancer Research. Dr. Giovannucci suggested that exposure to the sun might prevent 30 deaths from other cancers for every death caused by skin cancer.

To achieve this benefit, though, people may need over 1000 International Units (IUs) of vitamin D daily. The current recommendation is for only 400 IUs. Sunshine is important because it stimulates the production of vitamin D in the skin. It is possible to overdose with oral supplements, but the skin only makes as much as the body can use.

Unfortunately, many Americans do not get enough vitamin D. They spend most of their time inside. Even in the summer they may prefer to spend their time in air-conditioned comfort. If they do engage in outside activities they put on a high SPF sunscreen before they even go out the door. This dramatically reduces the amount of vitamin D the skin can make.

Is it possible to get the benefits of the sun without putting yourself at risk of premature aging or skin cancer? According to Michael Holick, MD, PhD, Professor of Medicine, Physiology and Biophysics at Boston University School of Medicine, sensible exposure is absolutely necessary for good health.

Vitamin D made in the skin circulates throughout the body. Tissues that need to use this compound as a hormone are capable of transforming it into the activated compound that seems to be responsible for its cancer-preventive properties. The form of vitamin D produced by sun-exposed skin may be more efficient for this purpose than oral supplements.

For those who would like to know more about the benefits of vitamin D and sensible sun exposure we offer a one-hour radio interview with Dr. Michael Holick. For a CD of this show, please send $15 in check or money order to Graedons' People's Pharmacy, No. CD-502, P. O. Box 52027, Durham, NC 27717-2027.

In addition to the anti-cancer benefits of vitamin D, a recent analysis (JAMA, May 11, 2005) reveals that this nutrient can help protect bones. Supplements of at least 800 IUs of vitamin D reduced the risk of hip fracture by 26 percent.

Although some dermatologists still maintain that people should stay out of the sun at all times, there is a growing recognition that prudent exposure to the sun may have a wide variety of health benefits.

Experts are worried about the next big flu outbreak. While most of the rest of us don't give influenza a single thought in the spring and summer, world health authorities are preparing for a possible pandemic.

Virologists are already concerned that there may not be enough flu vaccine next year to fight the standard types of influenza. They are even more alarmed that bird flu (H5N1) from Southeast Asia may begin spreading from person to person. There is still no vaccine against this potential killer.

What makes bird flu so scary is that no one in the world has developed antibodies to this particular strain of flu. Of the 92 humans who have been infected so far, 52 have died.

Epidemiologists worry that this virus could sweep the globe, infecting tens of millions of vulnerable people. A flu pandemic in 1918 killed more people throughout the world than died on the battlefields of the First World War.

Another concern is that this influenza virus is spreading in poor countries with few resources to stop an epidemic. Researchers are hoping that most cases of bird flu that have infected people in Southeast Asia were caught from chickens or other birds. But new reports from Vietnam suggest that bird flu may be adapting to human hosts. If the virus evolves so that it can be easily transmitted from human to human, the world could face its biggest health challenge in a century.

Fortunately, there is a medication that appears to work reasonably well against bird flu. It is called Tamiflu and was developed several years ago to fight the standard flu we are all used to. That it also seems effective against H5N1 (the bird flu) is fortuitous.

That's the good news. The bad news is that the manufacturer is having a hard time keeping up with demand. It takes a year to make a batch of Tamiflu and as a consequence, the drug is expensive (more than $3 per pill).

European countries have been especially aggressive about stockpiling this medicine. The United Kingdom already has stored up 14.6 million doses, enough to cover 24 percent of its population. France has 13 million doses, adequate for 22 percent of its citizens.

Vietnam and Cambodia, on the other hand, have miniscule stores of Tamiflu, even though that's where this potential epidemic is starting. U.S. authorities have been slow to respond to the threat. This huge country only has 2.3 million doses of Tamiflu on hand, barely enough for one percent of the population.

Public health authorities discourage individuals from stockpiling this type of preventive medicine. Nevertheless, it might be worth talking to a physician now, before flu season is even on the radarscope. That way it might be possible to have a prescription on hand before flu starts to rear its ugly head. Vaccines may run out again, and Tamiflu can be used to prevent as well as treat both Type A and Type B influenza.

In the event that bird flu becomes a public health menace around the world, those with Tamiflu on hand could protect themselves. But public health authorities need to figure out effective ways to help the poor nations that are the incubators so that this pandemic could be stopped before it even takes hold.

Judging from the popularity of laxatives, a lot of Americans think that regularity is essential for good health. But is this true or is it a myth? Although grandmothers in many countries have promoted daily bowel movements for generations, there is no evidence that a trip to the bathroom each morning is necessary. Some people do quite well on an intermittent schedule-as infrequently as two or three times a week or as often as a few times a day.

Doctors and patients don't always agree on what constitutes constipation. Physicians may prefer objective measures like the number of days between bowel movements. But people are often concerned about consistency as much as frequency. They complain about the effort of passing hard "golf balls" or "bricks."

There is no dearth of advice for people who suffer. Those who are constipated are often urged to drink more water. Unless someone is actually dehydrated, though, drinking extra water does not solve the problem.

Others believe that constipation can be traced to inadequate fiber in the diet. This letter is typical: "Shame on you! You mentioned prescription laxatives for a constipated patient. Many people are not aware of the fiber-deficient western diet and assume they are eating healthfully. You should educate them about eating fruits, nuts and veggies, beans and popcorn, instead of bleached white flour bread and pasta."

Although fiber is certainly helpful, and we are the first to recommend vegetables, fruits and nuts, people who are chronically constipated eat about the same amount of fiber as those who are not. They simply need more

Fiber can have side effects, though: "I have trouble with chronic constipation. Extra fiber doesn't help. It just bloats me and causes gas."

Sometimes constipation can be traced to medication or dietary supplements:

"I know how desperate people feel because I suffered the same problem for years. Those who haven't cannot imagine the severity of the problem.

"I tried fiber, fluids and more, to no avail. I became convinced it was related to my medication. By a process of trial and error, I narrowed it down to a calcium supplement I had been taking for years. As soon as I stopped taking it, the constipation disappeared and has not returned since."

Hundreds of prescription and over-the-counter medications can cause constipation. Neither water nor fiber is a guaranteed solution.

We have prepared a Guide with a list of medicines that contribute to constipation and tips to combat it. Anyone who would like a copy, please send $2 in check or money order with a long (no. 10) stamped, self-addressed envelope: Graedons' People's Pharmacy, No. GG-30, P. O. Box 52027, Durham, NC 27717-2027.

One reader found a unique approach: "Antidepressant medication gave me a new lease on life and I felt wonderful, except for the side effect of severe constipation. I tried everything. Nothing helped until I ate fresh pineapple. To my surprise, it worked. I now eat about 1/3 of a fresh pineapple every morning with breakfast."

Other tried-and-true favorites include bran, ground flaxseed, prunes or psyllium (Metamucil or similar products). No single approach works for all, but with experimentation most people should find relief.

People often think that the most dangerous time to drive is between Christmas and New Year's. That's because of all the holiday parties that lead revelers to drink too much and get behind the wheel.

While it is certainly true that far too many people drive while intoxicated, we would argue that spring is actually a more dangerous time to be on the roads. More than 50 million Americans suffer from allergies. At this time of the year they can be a hazard on the highways.

Allergies make people dopey and sleepy as well as sneezy. Red itchy eyes, a drippy nose and frequent sneezing can make it hard for a victim to drive safely. Trying to see clearly and steer straight in the middle of a gigantic sneeze is next to impossible.

The trouble is that the medications people rely on to control allergy symptoms may also make allergy sufferers dangerous behind the wheel. Driving under the influence of certain antihistamines could make a driver as impaired as drinking an alcoholic beverage.

Diphenhydramine (DPH) is found in many over-the-counter products, including Benadryl and house brand allergy pills. It is also included in some cough medicines (AllerMax) and a variety of pain relievers including Alka-Seltzer PM, Excedrin PM and Tylenol PM.

A study published in the Annals of Internal Medicine (March 7, 2000) reported that DPH "had a greater impact on driving than alcohol did." There is a warning on the label of Benadryl and other OTC allergy medicine warning patients that "marked drowsiness may occur" and urging them to "be careful when driving a motor vehicle or operating machinery."

Such cautions are as meaningless as telling a drunk to be careful behind the wheel. The scientists discovered that "drowsiness ratings were not a good predictor of impairment, suggesting that drivers cannot use drowsiness to indicate when they should not drive."

A recent review (Annals of Allergy, Asthma and Immunology, March 2005) of 16 double-blind studies evaluating driving in actual traffic found that most other antihistamines can also interfere with drivers' performance. The authors concluded that Allegra did not impair driving ability, however.

What can allergy sufferers do to relieve their symptoms without endangering themselves or others if they get behind the wheel? An over-the-counter nasal spray, Nasalcrom, makes tissues less reactive to pollen. An herbal extract that may be helpful is stinging nettle (Urtica dioica).

Steroid nasal sprays such as Beconase, Flonase, Nasacort, Nasalide, Nasonex or Rhinocort prevent allergy symptoms without causing drowsiness. These are available only by prescription.

Another option involves a new kind of oral treatment. Singulair interrupts the inflammation that leads to allergy symptoms. This medication was originally developed for asthma but was found to be helpful against allergies as well.

Allergy victims who have to make important decisions, operate machinery or drive a car during allergy season must be very careful at this time of year. Their symptoms put them at a disadvantage, but the treatment could be worse than their affliction.

When people hear music no one else can hear or see things that aren't really there, they may worry they are going crazy. If they tell anyone what's happening, they may be taken in for a psychiatric evaluation. In some cases, though, a prescribed medicine could be responsible for the hallucinations. You don't have to be on an acid trip to experience altered perceptions.

Several weeks ago we received a question from a reader: "Amitriptyline is causing the strangest experience: I hear music all day, both classical and rap. No one has ever heard of such a reaction. When I stop the amitriptyline, the music fades out."

We assured her that drug-induced hallucinations happen, though they are uncommon. Then we heard from another reader: "A friend taking the same medication also hears music day and night. The neighbors are not playing music, so she thought she was crazy. She is happy to learn she is not."

Yet another opined: "I imagine you're going to hear from a lot of readers who've experienced hallucinations on antidepressants. Years ago, I was treated for back pain with an antidepressant, muscle relaxers and a pain medicine. Shortly after starting on them, I began to experience auditory hallucinations:

I heard a full orchestra playing wildly dramatic classical music.

"The final straw came when I was riding my motorcycle (not a quiet machine) and couldn't hear the sound of the engine and wind over the orchestra playing in my head! I took myself off the antidepressant, and the hallucinations disappeared."

Antidepressants are not the only medicines that may trigger auditory or visual hallucinations. Some antiviral drugs prescribed for flu and antibiotics may also have this consequence: "My husband developed a really bad cold. I took him to the doctor, who prescribed Flumadine and gave him samples of Avelox. The doctor told us nothing about this drug except that it was strong. Last night my husband was talking to people who were not there."

It is not too surprising that her husband experienced such a reaction. Both Flumadine, an antiviral prescribed for influenza, and Avelox, a powerful antibiotic, can cause hallucinations.

Other readers have reported their own experience with antibiotics such as Biaxin. Most are unprepared for hallucinations and find them extremely frightening. As one woman wrote, "Within three days, I thought I was losing my mind and nearly had my husband commit me."

Children are also vulnerable. There have been reports in the medical literature of kids who saw insects or spiders when taking certain decongestant cold medicines.

We discuss some of the medications associated with hallucinations, anxiety or depression in our Guide to Psychological Side Effects. Anyone who would like a copy, please send $2 in check or money order with a long (no. 10) stamped (60 cents), self-addressed envelope: Graedons' People's Pharmacy, No. M-21, P. O. Box 52027, Durham, NC 27717-2027.

Unexplained auditory hallucinations call for a thorough medical exam. One reader shared her experience: "Singing in my head was the main symptom of my benign brain tumor. I almost died before it was correctly diagnosed."

Pharmacists have consistently ranked among the most highly respected professionals in the country. According to a Gallup poll, Americans consider pharmacists highly ethical, above medical doctors, police officers and clergy. That lofty position may soon change. Despite the trust they have long enjoyed, pharmacists are now raising questions of conscience that could polarize the profession and the public they serve.

Over the last few years some pharmacists have refused to dispense morning-after pills. These are prescribed in cases of rape or incest as well as contraceptive failure.

The hormones provide effective emergency contraception if taken within a few days of unprotected intercourse. Morning-after pills work by keeping a fertilized egg from implanting in the uterus, so abortion opponents object on the grounds that a fertilized egg is a human life.

Now some pharmacists are refusing to fill other prescriptions as well on religious grounds. Women with prescriptions for ordinary birth control pills have been turned away empty-handed.

This has created a firestorm of controversy. State legislatures are getting

into the act, some with bills to protect the pharmacists' right of refusal. Others are preparing counter legislation that would require pharmacists to fill every legitimate prescription.

All the talk of ethics in the pharmacy has opened the door to other potential conflicts. For example, imagine a young woman who has been prescribed birth control pills, not for contraception, but to treat painful menstrual cramps or severe acne. Does the pharmacist have a right to grill her about her sex life before dispensing the pills?

What about a man who has a prescription for Viagra or some other erectile dysfunction drug? Should a pharmacist demand that he present a marriage license?

Other potential ethical conflicts could take this issue to extremes. Many people don't approve of stimulant medication for attention deficit disorder. Others, especially Scientologists, object to psychiatric drugs such as antidepressants. Should such a pharmacist be allowed to turn away a patient with a prescription for Prozac on the grounds that it violates his religious principles?

Pain poses other ethical dilemmas. Powerful narcotic medications like OxyContin or Vicodin can be abused. But people in agony from severe back pain or cancer need the relief such drugs provide.

Should a pharmacist be allowed to turn down a legitimate prescription from a physician just because she has doubts about a patient? We heard from one reader about such a case: "We have a close friend who was injured in a car accident and is now disabled. She is in constant pain. When she moved to a new small town, the pharmacist was unwilling to fill her prescriptions for pain medicine. Our friend now has to drive over 100 miles to get the medications she needs to function."

Pharmacists have historically had the right to refuse to fill prescriptions. But they risk alienating many customers if they allow their religious or moral convictions to affect their professional responsibility.

Americans are cynical about statistics. They know that numbers can be tortured to tell tales. Two new studies on the cost of prescription drugs illustrate the problem.

One was announced by PhRMA, the Pharmaceutical Research and Manufacturers of America. This trade organization represents most major drug companies.

The industry reports, "Prescription drug price increases have been lower than overall medical price increases." Lumping brand-name and generic drugs together, drug prices rose 4 percent last year. The inflation index of consumer medical costs for the same time frame was 4.7 percent.

The comparison is supposed to make prescription medicine look like a bargain.

It has been presented as a response to a study from AARP.

Numbers from the powerful senior lobby tell a different story. According to the AARP, the manufacturers' wholesale prices for brand-name prescription drugs soared 7.1 percent last year. But generic drug prices rose less than 1 percent. General inflation ran approximately 2.7 percent in 2004.

From the AARP perspective, brand name pharmaceuticals don't look like such a good deal. According to its analysis of 150 popular products, these brand name drugs have risen an average of 35 percent since 1999. That's almost three times higher than overall inflation during that time (13.5 percent).

However the numbers get crunched, consumers are paying more for their medicines. The popular sleeping pill Ambien, which is advertised directly to consumers, jumped 11.9 percent last year. A month's supply could cost about $100, more than $3 per pill.

The price of your medicines might give you a migraine, but treating it will be pricey. Imitrex, one of the most successful migraine medications, can run $20 a tablet.

When challenged about such prices, the industry always responds that it has to charge a lot to cover research and development costs. If Americans want better medicines in the future, they have to pay now.

Critics complain that the industry spends too much on marketing, especially on advertising prescription drugs directly to consumers. When you count in free samples (designed to get people accustomed to taking a new medicine), free lunches for doctors and their staffs and junkets in the name of continuing medical education, promotional dollars add up.

Regardless of how the numbers are analyzed, if your prescription bills are too high, you may be looking for ways to save money. Generic drugs are a first step, although some readers report that they don't always perform as expected.

Drug companies give away free medicine to patients in need who meet strict eligibility requirements. And even though the pharmaceutical industry disapproves of importing drugs from Canada, that avenue is still open.

You can learn about access to free drugs, the pros and cons of generics and reputable Canadian online pharmacies in our Guide to Saving Money on Medicine. Anyone who would like a copy, please send $2 in check or money order with a long (no. 10) stamped (60 cents), self-addressed envelope: Graedons' People's Pharmacy, No. CA-99, P. O. Box 52027, Durham, NC 27717-2027.

Guidelines for cholesterol control have become much more stringent. For millions of Americans, achieving the new targets requires strong medicine. Over the last decade, prescriptions for statin-type cholesterol-lowering drugs have soared. Such medications are extremely effective at getting the numbers under control and reducing the risk of heart attacks and strokes.

As good as these drugs are, though, some people can't handle them. We have heard from many readers like this one:

"My husband and I were both put on statins, one on Lipitor and one on Zocor. With time we both experienced serious side effects. My husband had severe memory problems and confusion. Once he could not find a warehouse that he has been going to for years. Another time he got lost coming home from the VA hospital, even though it is a well-known and rather simple route. I thought he must be getting Alzheimer's disease.

"I also had problems with my memory, often forgetting what I was saying but more often not being able to retrieve ordinary words used in everyday conversation. In addition, I had problems with my balance, bumping into walls and staggering when I walked.

"Both of us had muscle and leg pain. Neither of us associated our memory loss, confusion or loss of balance to statins. We knew that muscle pain could be a side effect, though, so when the pain became intolerable we weaned ourselves off the statins.

"To our surprise and delight, our other symptoms began to diminish. It has taken a full year, but I can finally carry on a conversation without feeling that I'm losing my mind. Neither of us will ever use statins again.

"In talking with people we know, we have heard other stories that sound

similar. I am extremely concerned that serious harm is being done to the health and well being of many people. The health care industry is pushing statins even for people who do not have high cholesterol. I fear that the damage done may make the problems with Vioxx, hormone replacement therapy and fen-phen look small in comparison."

No one should ever stop cholesterol-lowering medicine without consulting a physician. Some doctors, however, have a hard time believing that these miracle medicines could have unacceptable side effects. Another reader reported:

"I have been on cholesterol-reducing medication for some time. I had been telling my doctor that my medication was doing something to my muscles and he would not believe me.

"I changed doctors and the new one discovered that my muscle enzymes were 800 (normal is 200). He took me off the medicine and my enzymes came down, though they are not yet normal. When I went on a different statin, they climbed back up again."

If you would like to learn more about the dark side of statins, you may be interested in a radio interview we conducted with several physicians who have studied such issues. To order a CD of this one-hour conversation, please send $15 to: People's Pharmacy (CD-523), P. O. Box 52027, Durham, NC 27717-2027.

Physicians know that life-saving drugs like penicillin can sometimes cause life-threatening reactions. It's time to recognize that even great drugs like statins can cause some people serious harm.

Americans are obsessed with sex. Racy innuendos sell everything from soap to cars. Now the ads are practically selling sex itself. Turn on the evening news and you are likely to see a commercial featuring a drug to treat erectile dysfunction. Viagra ads showed a man with devil horns urging viewers to "get back to mischief."

A Levitra commercial stars a babe who smiles provocatively while bragging coyly about her secret: " My man takes Levitra. Let's just say he notices a difference in the experience, like a we-should-do-this-more-often difference.Just look at that smile!"

A Cialis ad takes advantage of the long-acting nature of this drug by asking: "If a relaxing moment turns into the right moment, will you be ready?"

The trouble is, Americans have too few relaxing moments. Sex has become an elusive fantasy for millions who don't have the time or the energy to actually make love.

A new survey by the National Sleep Foundation reports that fewer than half of Americans are getting enough sleep. Nearly 25 percent of couples report that their sexual relationship suffers because they are just too tired.

It's little wonder, if you look at our busy American lifestyle. Every moment of the day seems taken up with work or family responsibilities, carting the kids to sports events or music lessons, attending PTA meetings or undertaking other civic duties.

Add in email, television and hobbies, and most people are exhausted by the time they fall into bed. This is hardly the best condition in which to pursue romance. Then in the morning the alarm goes off too early and the race begins all over again.

Another often-overlooked factor that may interfere with sleep or sex is medication. Many people taking antidepressants do not realize that drugs such as Prozac, Paxil or Zoloft could cause both insomnia and sexual difficulties. Studies have found that from 30 to 60 percent of patients on such medications experience sexual problems such as lowered libido or inability to achieve orgasm.

Certain blood pressure medications can also interfere with sexual ability or with sleep. Many men may not realize that their erectile dysfunction could be traced to a prescription.

Many people feel embarrassed about discussing intimate details with their doctors. But physicians cannot read minds. If someone gradually loses interest in sex or has problems with arousal or enjoyment, the doctor may be able to prescribe a different medicine less likely to produce such complications.

To help with that discussion, we offer our Guides to Getting a Good Night's Sleep and Treating Sexual Dysfunction. Anyone who would like copies, please send $3 in check or money order with a long (no. 10) stamped (60 cents), self-addressed envelope: Graedons' People's Pharmacy, No. IP-793, P. O. Box 52027, Durham, NC 27717-2027.

Sometimes it seems as if we are surrounded by sexual messages, but lack the time to nurture our love lives. It's like the old mariner's lament, "water, water everywhere and not a drop to drink."

Perhaps we need to give romance--and sleep--higher priority in our hectic schedules. That way there will be more opportunity for relaxing moments that turn into the right moment.

Millions of people have taken Vioxx, Celebrex and Bextra for pain. These new COX-2 inhibitor drugs were prescribed for a variety of conditions, including arthritis, muscle strains and bad backs.

Then evidence about heart attacks and strokes led to the removal of Vioxx. Scary headlines also undermined sales of Celebrex and Bextra.

With all the bad news, many physicians started looking for alternatives. Some are prescribing older NSAIDs (nonsteroidal anti-inflammatory drugs) like ibuprofen, naproxen or diclofenac.

Others are turning to newer drugs, such as Mobic, for patients in pain. This anti-inflammatory medication has avoided controversy largely because it was not advertised as heavily as Vioxx or Celebrex. But some scientists have begun to question whether Mobic or even some NSAIDs are much safer than the drugs they are replacing.

Mobic also affects the COX-2 enzyme. Australian drug regulators have classified it as a COX-2 inhibitor and warn against its use by patients with cardiovascular risk factors.

American patients are puzzled. One reader wrote:

"I've read that Mobic is a COX-2 inhibitor. I am confused since my doctor told me it isn't.

"I'm trying to figure out what my risk would be with this drug if it were a COX-2 inhibitor. I'm 43 and not overweight, run 40 miles a week and don't smoke or drink. My cholesterol and blood pressure are low, and I have no personal or family history of heart disease. Should I be concerned about using Mobic or any other COX-2 inhibitor?"

Most doctors would conclude this patient's risk is extremely low. But even some people without obvious heart problems may be vulnerable.

One reader shared her tragic story:

"I have read recent reports about the drug Mobic and its possible link to heart attacks. I have been so frustrated trying to find out why my 39-year-old husband suddenly collapsed and died from a fatal heart arrhythmia.

"He was taking Mobic prescribed by his internist after a minor car accident. My vibrant and healthy husband, father of two little girls who were 3 and 7 years old at the time, had excellent blood pressure, no cholesterol problems and was not overweight.

"Please help me get the word out about the dangers of this drug. I am in the process of reporting his death to the FDA. My daughters and I miss their father daily."

While it is impossible to determine whether Mobic caused this cardiac arrest, some warning flags are flying. FDA safety officer, David Graham, MD, reported preliminary findings that Mobic may also increase the risk of heart attacks.

The manufacturer of Mobic maintains it has not seen problems. Dr. Graham is the first to admit that a single study is not enough to tell whether a drug carries unacceptable hazards. But there is growing concern that many of the new anti-inflammatory drugs may require patients to make difficult decisions.

It can be hard to weigh the chance of stomach ulcers against the possibility of a heart attack.

Until these issues are resolved, Americans might want to follow Australian guidelines for the use of these drugs. They call for heart patients to avoid COX-2 inhibitors and others to take them for the shortest time needed.

Rheumatoid arthritis patients have been on a roller coaster the last couple of years. Their potentially debilitating disease still remains mysterious, and promising treatments have turned out to have serious side effects. Unlike osteoarthritis, which is associated with aging and mild inflammation in several joints, rheumatoid arthritis affects the entire body. It can affect children (juvenile RA) as well as adults.

Joints are attacked by the immune system and without intervention can become gnarled and crippled. People can experience aching muscles, anemia, exhaustion, fever and nerve damage.

A few years ago, an entirely new class of high-tech medicines was introduced. Enbrel, Humira and Remicade are injectable medications that alter the course of RA. These drugs keep a natural immune system compound called tumor necrosis factor (TNF) from starting a cascade of events resulting in joint destruction.

For many patients, these anti-TNF drugs have revolutionized treatment by relieving symptoms and restoring the ability to move without pain. But such relief comes at a cost. These medications are very expensive and they may also have worrisome side effects.

TNF plays an important role in the body when it comes to fighting infection. By blocking TNF, these medicines can increase the risk of tuberculosis and several other serious infections.

Concern has been raised that such drugs may worsen heart failure or multiple sclerosis. There is also controversy about their role in the development of lymphoma, a cancer of the immune system.

Another group of medications that was supposed to relieve joint inflammation is the COX-2 inhibitors. RA patients were happy to learn about Celebrex, Bextra and Vioxx because regular use of high-dose conventional anti-inflammatory drugs like aspirin, ibuprofen or naproxen can lead to bleeding ulcers.

But the evidence that these medicines can increase the risk of heart attacks or strokes has dampened enthusiasm for them. This has left RA patients looking for alternatives. Some are returning to old-fashioned approaches. One reader shared the following thoughts:

"I do not understand why you ignore an alternative remedy my rheumatologist uses. I have rheumatoid arthritis, and for nearly twenty years she has been giving me, at five-week intervals, an injection of the gold solution myochrisine. I also take small daily doses of prednisone and methotrexate.

"I have a blood test and urinalysis each time I get a shot. So far, there are no bad effects, and I am quite mobile and pain free. Why do people ignore an old remedy that works so well, apparently just because it's old?"

Gold shots have been available for more than 70 years. Not everyone can tolerate gold because it can cause an itchy rash, mouth ulcers and more seriously, kidney damage. But some patients, like this reader, do surprisingly well. Gold salts are also available in an oral formulation (Ridaura).

Given all the disappointing news about the COX-2 inhibitors, it makes sense for doctors treating RA patients to consider all the options and not just the latest, most heavily advertised products.

According to the old proverb, "He who pays the piper calls the tune." FDA officials are now facing the music. They must answer to the American public, the people who really pay the bills.

For decades Congress has allocated billions of taxpayer dollars to the FDA to ensure that our medications are safe and effective. For the most part the agency has been left on its own to carry out this mission. But now Americans are worried about confusing headlines regarding the safety of Vioxx and a variety of other medicines.

FDA officials have been called on the carpet by Senators anxious to get to the bottom of the pain reliever puzzle. Some wonder if FDA can police drug safety on its own. Experts have proposed a separate body, independent of the agency, for this task. FDA officials do not want to give up this responsibility.

But consumers are nervous. In a recent survey, only 14 percent said they have great confidence in the FDA's ability to safeguard the country's drug supply. The majority of consumers in this poll favor an independent drug watchdog agency.

The FDA has maintained for months that it did nothing wrong with respect to its oversight of Vioxx and other COX-2 inhibitors like Celebrex or Bextra. But during Senate hearings, one agency official recently admitted to "lapses."

Dr. Sandra Kweder, deputy director of the Office of New Drugs, bemoaned that it took the agency and the manufacturer more than a year to negotiate wording on heart risk for the Vioxx label. The other shortcoming she mentioned was a failure to get doctors to pay close attention to these dangers.

It's hardly any wonder patients and physicians were so enthusiastic about Vioxx and Celebrex. The advertising on television and in magazines was compelling.

Experts have criticized this "direct to consumer" (DTC) advertising. Many physicians feel it puts them under inappropriate pressure to prescribe. And the public is getting weary of watching commercials for erectile dysfunction drugs or other prescription products.

Even the FDA is beginning to question whether DTC ads are such a good idea. Dr. Janet Woodcock, acting deputy commissioner for operations, told the Senators that such advertising leads doctors to write prescriptions many patients don't need. She believes that some consumers don't get an adequate understanding of risks from these commercials.

Balancing benefits against risks is difficult enough for physicians and patients. There's often too little information when a drug is first released to evaluate long-term safety. Some critics maintain that the FDA has put too many resources into new drug approval and not enough into monitoring for hazards.

Dr. Bruce Psaty, professor of medicine and epidemiology at the University of Washington, pointed out to the Senators: "In the office of new drugs, more than 1000 employees work to review a few dozen new drugs per year. In the office of drug safety, 109 employees work to evaluate the safety of thousands of drugs currently on the market."

If the FDA cannot respond to the American public's concerns about drug safety, perhaps it is time for Congress to establish an independent center to do the job.

Graduating medical students are sometimes told: "Half of what we have taught you is wrong...we just don't know which half." As amusing as this sounds, it rings true for a complex condition called celiac disease.

For decades medical students were taught that celiac disease is rare, that it affects the digestive tract and that afflicted children grow out of it. All these myths are now disproved.

Celiac disease was once thought to affect only one child in 5,000. That makes it so uncommon that few doctors would ever make the diagnosis. With such statistics, a pediatrician might see a handful of cases in a lifetime. But now researchers have found that celiac is actually quite common, affecting one person out of 100. Because genetics play a role, a person with a family member who has celiac disease has one chance in 22 of being affected.

Millions of Americans are afflicted, but most don't even know it. It may take years or even decades for the problem to be diagnosed. By then, it could too late to undo the damage.

In celiac disease, the immune system reacts to a protein called gluten found in wheat, barley or rye. This triggers an inflammatory response in the small intestine that can interfere with efficient absorption of nutrients. Early recognition of digestive tract involvement led doctors to pay attention to symptoms such as stomachaches or diarrhea.

But many patients diagnosed with irritable bowel syndrome (IBS) may not realize their discomfort could be due to celiac disease. One study found that 12 percent of patients with IBS were gluten intolerant.

Many patients don't have classic symptoms, however. Chronic fatigue and anemia that can't be attributed to other causes may well be signs of celiac disease. Other immune conditions such as type-1 diabetes and thyroid disease may be associated with celiac disease. A chronic itchy rash known as dermatitis herpetiformis is another odd sign of an immune reaction to gluten.

People with gluten intolerance cannot absorb adequate amounts of calcium, magnesium, iron or other essential nutrients from food. As a result their bones become weak and brittle.

New research shows that celiac disease is common among adults with osteoporosis, affecting more than 3 in 100 (Archives Internal Med., Feb. 28, 2005). The investigators conclude that anyone diagnosed with osteoporosis should be screened for celiac disease.

Debilitating neurological disorders may also signal celiac disease. Some patients may appear to have early-onset dementia. Others experience chronic migraine or peripheral neuropathy (pain, tingling or burning in feet or hands).

For readers who would like to learn more about celiac disease, we offer a CD of a one-hour radio interview with one of the world's leading experts on celiac disease. The show offers information on diagnosis and treatment. It is available for $15 from The People's Pharmacy (CD- 455), P. O. Box 52027, Durham, NC 27717-2027.

Many physicians practicing medicine today never learned about the range of problems celiac disease can cause. With evidence mounting that it is common, patients deserve to be tested. For those who are affected, a strict gluten-free diet can prevent many complications.

Can Drugs Trigger Violence?

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Americans have a hard time imagining that a drug could change someone's behavior. Maybe that's why the Zoloft defense failed.

A jury took just six hours to decide that Christopher Pittman was guilty of murder in the death of his grandparents. The defense claimed that the then-12-year-old was "involuntarily intoxicated" by the antidepressant Zoloft. But the jury didn't believe that a drug confused him so he couldn't tell right from wrong.

For decades experts argued whether this class of medications (Prozac, Paxil, Zoloft, etc) could make someone suicidal. Recently the FDA issued a warning that states: "Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior."

Although the FDA acknowledges that some people on such drugs may harm themselves, many Americans can't believe that drugs could lead someone to harm another person. Yet we have heard from readers of this column that such drugs have affected their thinking and judgment:

"Several years ago, on a recommendation from a counselor, I started Prozac. I was hesitant to start, since I had heard of a man who committed suicide after starting Prozac. But I went ahead and began taking the minimum dose.

"Side effects started immediately. I had headaches, constipation and a total loss of sexual feelings. After a month, wild thoughts came into my mind, especially while driving. I wanted to ram into other cars to show them they shouldn't drive so rudely. I wanted to get a gun and kill a coworker who irritated me.

"The counselor said it was all in my mind and that the drug was really going to help me eventually. Ha.

"After I stopped taking it, the side effects gradually went away. Prozac is a dangerous drug and it should be closely monitored in everyone who takes it, not just children."

Most people can use these drugs safely. But for some, SSRI antidepressants radically change their perceptions of reality.

Antidepressants aren't the only medications that affect personality. High doses of corticosteroid medicines like prednisone are notorious for causing euphoria, depression, anxiety, agitation, insomnia, mood swings or even hallucinations.

The Armed Forces are also struggling with the possibility that an antimalarial drug (Lariam) taken by troops in Iraq may cause serious psychological reactions. The FDA now requires that patients be warned that some people taking Lariam experience paranoia, severe anxiety, depression, hallucinations or suicidal thoughts.

Readers who would like to know more about such unexpected consequences may wish to consult our Guides to Antidepressants Pros and Cons and Psychological Side Effects. Anyone who would like copies should send $2 in check or money order with a long (no. 10) stamped (60 cents), self-addressed envelope: Graedons' People's Pharmacy, No. MX-23, P. O. Box 52027, Durham, NC 27717-2027.

Friends and family need to be vigilant whenever they suspect a person may be experiencing personality changes brought on by medication. Whether it's a heart medicine, an antibiotic or an antidepressant, such drug-induced episodes can be disastrous

Allergies and skin rash are common adverse reactions to drugs. But they rarely considered serious. Patients and doctors alike may brush off such symptoms as a minor annoyance. In too many cases, though, skin reactions can be life threatening.

A surprising number of medications can cause Stevens Johnson Syndrome, erythema multiforme (EM) or Toxic Epidermal Necrolysis (TEN). For some a mild rash may begin within hours of starting a new drug. Others may not notice any symptoms for several weeks. A fever and sore throat may develop and lesions can start to appear in the mouth, eyes, digestive tract and lungs.

If the drug isn't stopped at the first sign of trouble, the skin can literally peel away from the body. This can lead to severe infection, which explains why Stevens Johnson Syndrome can be lethal.

With all the attention recently given to heart attacks caused by Vioxx or possibly Celebrex, the black box warning FDA issued for a similar pain reliever called Bextra has been largely overlooked. It cautions that patients should be alerted to discontinue the drug at the first sign of a skin rash or allergic reaction.

But even when patients stop their medicine immediately, the aftermath can be unbearable. One reader shared his experience:

"I had an allergic reaction to Bextra after two weeks of use for back pain. I immediately stopped the medication when I developed a whole body rash and intense itching. I experienced extreme external feelings of cold, yet there was a simultaneous burning sensation from inside. My skin sloughed off my entire body.

"The allergic reaction happened in early June. A local dermatologist administered cortisone injections with little or no improvement. In November I was prescribed 30 days of prednisone in pill form. This stopped the sloughing of skin, and the chilling and burning was diminished, but not the itching.

"I was given a powerful immune suppressing drug for organ transplant patients called cyclosporine. So far, the problem with the intense itching continues."

This patient was so desperate that he mentioned to a friend that he was considering suicide to end the misery.

Hundreds of drugs can cause allergic skin reactions. Anti-inflammatory arthritis drugs are known for this type of complication. Many antibiotics can also trigger severe itching and rash. Even over-the-counter remedies like Motrin or Tagamet HB can occasionally set off a serious skin reaction.

Cholesterol-lowering medications are now widely prescribed and can prompt such a complication in some people:

"Three years ago, my doctor prescribed Lipitor. After three months on this drug, I developed a rash all over my body that required a trip to a dermatologist. He took one look at my itchy hide and asked if I was on Lipitor. When I said yes, he said 'GET OFF!' My physician switched me to another cholesterol fighter, but the rash is just now starting to go away."

Allergic skin reactions should never be taken lightly. Some people develop a rash suddenly while other may go weeks or even months on a medication before experiencing problems. Immediate treatment is necessary because sometimes skin complications can be deadly.

If men are from Mars and women are from Venus, then doctors may be from Pluto. Communication is hard enough between men and women, but doctors and patients might as well be speaking different languages.

In fact, doctors do speak a different language, much of it based on Latin or Greek. Why use a simple word like headache when you can say cephalalgia? Ear wax is cerumen. Rapid heartbeat turns into tachycardia and a heart attack is a myocardial infarction.

Doctors argue that such terms are more precise and help avoid misunderstanding, but they also create barriers. A secret language understood only by the initiated makes the patient feel left out and intimidated.

Nowhere is this more apparent than in the world of prescription drugs. An arcane abbreviation like bid (bis in die) stands for take two times a day. When you see q6h (quaque 6 hora), do you immediately think, as the doctor does, every six hours? Perhaps, if you love watching medical shows on TV, you'll recognize stat (for statim, meaning right now) or p.r.n. (pro re nata) for "as needed." But is that really all you need to know?

Actually understanding what your doctor intends may mean asking questions, even if you know what the abbreviations mean. When the doctor writes q6h, for example, does that mean you need to get up in the middle of the night to take your medicine?

Does "before meals" mean 5 minutes before eating or an hour? The difference could be crucial for the medicine to work correctly.

The issue of drug side effects is even more complex. Many physicians are reluctant to warn a patient about a rare but potentially dangerous side effect. They worry that suggesting such a possibility might discourage a patient from taking needed medicine. They may also fear that some patients could experience symptoms due to psychological suggestion-a sort of psychosomatic reaction.

Without such information, however, patients may not realize a problem might be related to the medicine they are taking. A young woman who developed a series of sore throats did not realize that her infections were caused by a reaction to the thyroid medicine she was taking. By the time she ended up in the hospital with a urinary tract infection, she had no white blood cells left. The doctors were unable to save her life.

A recent study reveals that if patients tell their doctors about drug side effects and if the doctors listen attentively and adjust the treatment, many harmful reactions can be avoided. Conversely, reactions that are not recognized or reported can lead to serious adverse reactions (Archives of Internal Medicine, Jan. 24, 2005).

According to the researchers, nearly 8 million adverse events could be prevented "if patients and their physicians communicated better and if physicians acted more reliably to address medication symptoms."

To help readers of this column communicate with their doctors, we offer our free Drug Safety Questionnaire and Medical History. Anyone who would like a copy, please send a long (no. 10) stamped, self-addressed envelope: Graedons' People's Pharmacy, No. QH-3, P. O. Box 52027, Durham, NC 27717-2027.

Winter Blues Can Be Beaten

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Apologies to T.S. Eliot who said April is the cruelest month, but we think it's February. The days are too short and the nights are too long. Cold, dreary weather keeps people inside.

For many, the lack of sunlight contributes to seasonal affective disorder (SAD), depression that grips most strongly in the dead of winter. It can creep up, almost unnoticed, until the person realizes that life has lost its luster.

Symptoms to be especially alert for at this time of year include: feeling pessimistic or gloomy for weeks at a time, low energy, difficulty concentrating, sleeping problems, loss of sex drive, carbohydrate cravings and lack of interest in socializing.

Feelings of hopelessness and helplessness are red flags. Thoughts of suicide deserve immediate professional attention.

If you cannot afford to spend February in Hawaii, what else can you do to cope with SAD? There are actually a number of strategies to beat back the winter doldrums.

Exercise is crucial. Spending half an hour outside walking vigorously during the middle of the day can be especially helpful. Even when it is overcast, the ultraviolet light that filters through the clouds is enough to help brighten the mood. Swimming, cycling or cross-country skiing can all help conquer the blues. Studies have shown that exercise can be almost as effective as antidepressant medication for some people.

For those who cannot make it outside because the weather is too awful or their schedules don't permit, a light box can provide ultraviolet exposure. These artificial rays mimic the sun and reset the body's hormonal balance. They can ease depression for those who are vulnerable to SAD.

Light boxes are available online from reputable manufacturers such as Apollo (www.apollolight.com) , Enviro Med (www.bio-light.com) and Northern Light Technologies (www.northernlight-tech.com). You may also want to check a distributor, Amjo Corp (www.sadlight.com).

A light box won't supply vitamin D, however. This crucial nutrient is essential not only for strong bones, but also for emotional wellbeing. In northern areas like New England, a third or more of the population may be vitamin D deficient by the end of the winter.

For those who get no sun, pills that supply about 1000 IU of vitamin D are advisable. Other supplements may also be helpful in fighting SAD.

Adding fish oil has been shown to help those who do not respond adequately to ordinary antidepressants. SAMe can also be useful in boosting the effectiveness of an antidepressant like Paxil or Prozac.

Although such drugs can be lifesavers for some, others may not be able to tolerate side effects such as insomnia, anxiety or sexual dysfunction.

For those with mild to moderate depression, St. John's wort in a standardized extract may help. It should not be combined with antidepressant drugs,

however, and may interact with many other medications.

Counseling is also crucial for depression. Not only can it offer psychological support, it is important for anyone who is seriously depressed to be in touch with a professional who can evaluate progress and recommend further treatment.

There may be several more months of winter. But with appropriate therapy, no one should have to suffer winter blues till spring.

For 70 million arthritis sufferers, the last few months have been a nightmare. The medicines they rely on to ease their aches and pains have come under fire. First, Merck withdrew its popular arthritis drug Vioxx because it increased the risk of heart attacks and strokes.

Then the FDA required a black-box warning about serious skin reactions and cardiovascular risks associated with the prescription pain reliever Bextra.

Next, the National Cancer Institute stopped a clinical trial of Celebrex prematurely because patients taking this medicine had a higher rate of heart attacks and strokes.

There was even bad news about over-the-counter naproxen (Aleve). The National Institutes of Health stopped an Alzheimer's prevention trial early because patients on naproxen had a higher incidence of heart attacks and strokes.

Celebrex, Bextra and Vioxx were supposed to be safer than older nonsteroidal anti-inflammatory drugs (NSAIDs). People taking medicines like aspirin, ibuprofen, naproxen, diclofenac or sulindac are at greater risk of serious digestive tract reactions. Experts estimate that more than 100,000 people are hospitalized every year with ulcers and more than 16,000 die from complications.

That's why doctors and patients were excited about COX-2 inhibitors like Celebrex and Vioxx. These drugs were supposed to spare the GI tract. But now an FDA safety officer estimates that as many as 139,000 people may have suffered heart attacks as a consequence of these drugs.

What's an arthritis patient to do? Many people are considering non-drug approaches to relieve their stiff joints. Although glucosamine and chondroitin have never received FDA approval, there are a number of studies suggesting that these dietary supplements can help some people.

The problem is that the FDA does not regulate dietary supplements for quality or dose, so it is difficult to choose a supplement that's worth the money. We suggest checking the Web site www.consumerlab.com to see which ones passed the tests this organization put them through. Another online source for information on glucosamine and chondroitin is www.drtheo.com.

We recommend that people planning to try glucosamine and chondroitin get their cholesterol measured before starting and measured again after 6 months. No studies have shown that these compounds raise cholesterol, but some readers of this column report that reaction.

Other non-drug approaches include herbs such as turmeric and ginger, as well as home remedies like grape juice and Certo or gin-drenched raisins. We have prepared for readers of this column a new Guide to Alternatives for Arthritis with more information on these non-drug approaches. Anyone who would like a copy, please send $3 in check or money order with a long (no. 10) stamped (60 cents), self-addressed envelope: Graedons' People's Pharmacy, No. AA-2, P. O. Box 52027, Durham, NC 27717-2027.

We enjoy hearing from readers who have had success with one or more of these approaches: "Turmeric, pectin and glucosamine work great on my arthritis. I forgot to take it for two days because I was tired from being active again for the first time in years. I've learned my lesson and will take it every day."

Millions of Americans have figured out a way to save big bucks on prescription drugs. A click of a computer mouse allows access to Canadian online pharmacies with prices that run 30 to 50 percent lower than in the U.S.

A number of municipalities and even some states have also taken advantage of lower prices in Canada for their employee health plans. That's because high drug bills have been straining city and state health care budgets for years.

Canada has a highly regulated drug approval and distribution system. As a result, prescription drugs in Canada are at least as safe as those in the U.S., despite their lower cost. As in most other countries, except the U.S., drug approval in Canada also entails establishing the price at which a medication can be sold.

The pharmaceutical industry hates the idea of Americans saving money by shopping online in Canada. Drug companies maintain that research and development of new medications depend upon the profits generated by free-market pricing in the U.S.

The FDA is also strongly opposed to importation. The agency maintains that it is not safe to purchase drugs from Canada.

According to FDA regulations, it is illegal for citizens to import prescription drugs. Despite the law, though, the FDA and the U.S. Customs Service have been reluctant to bust grannies trying to save money on cholesterol medicine or high blood pressure pills. Congress has even considered legalizing the practice. It was a hot-button issue during the past election.

Even if U.S. lawmakers were to make importation easier for Americans, the Canadian government is preparing to shut the trade down. After President Bush visited Canada, the health authorities there proposed changes that would make it virtually impossible for Americans to buy their drugs online from Canada.

People who wanted to buy medicine north of the border would have to travel to

Canada, see a physician and take the prescription in person to a Canadian pharmacy. Obviously, any savings would be eliminated. Such a change in Canadian policy would please the FDA and the pharmaceutical industry.

What can Americans who cannot afford their medicines do to save money? Until the regulations are enacted, it is still possible to shop online from reputable Canadian pharmacies.

The trick is in locating such firms. There are many bogus operators on the Web claiming to be Canadian, but actually located elsewhere. Always look for the Provincial pharmacy license number on the Web site and a physical address in Canada. The pharmacy must require a doctor's prescription.

We have prepared a Guide to Saving Money on Medicines with tips on economizing on prescription drugs and a list of licensed online Canadian pharmacies. Anyone who would like a copy, please send $2 in check or money order with a long (no. 10) stamped (60 cents), self-addressed envelope: Graedons' People's Pharmacy, No. CA-99, P. O. Box 52027, Durham, NC 27717-2027.

If Canada closes the border to online drug sales, Americans who are used to buying medicine from the Web may turn to other countries. This would be a shame, as few others practice the kind of careful control of prescription drugs that Canada does.

What Is A Safe Drug?

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"There is no such thing as a safe drug. Each medication is a double-edged sword, with a good side and a bad side."

We wrote those words thirty years ago in the first edition of our book The People's Pharmacy. They are as true today as they were three decades ago.

We went on to say that "Successful treatment is a careful balance between the beneficial and harmful effects, hopefully weighted in favor of the beneficial.

Unfortunately, just the opposite is often the case. The original disease may be less of a problem than the reaction to treatment, and the old dictum 'The cure was worse than the disease' has frequently been all too true.'"

In 2005, it is quite possible that we are less safe from medication mishaps today than in 1975. It's not that medications have become more toxic, but our attitudes have changed. Americans have become far more cavalier about the pills we pop.

Part of that is due to advertising. If you watch a 30 second commercial on TV for Viagra, Lipitor or Nexium (the Purple Pill) you may start to think of potent prescription drugs as if they were consumer products like shampoo or beer.

Recent experience with Vioxx and Celebrex, however, suggests that patients, physicians and drug regulators are not being cautious enough. Someone who took Vioxx to relieve knee pain or tennis elbow and ended up having a heart attack might well conclude the cure was worse than the original problem.

How can patients protect themselves from drug disasters? The first thing to recognize is that the FDA cannot guarantee that your medicine is safe. Although the law requires all medications be proved "safe and effective" before approval, these are relative terms.

The agency routinely approves medications that cause serious side effects for some people. They even allow products on the market that occasionally cause life-threatening reactions. The FDA relies on precautions and warnings in the labeling to alert prescribers to these hazards.

All health professionals-doctors, nurses, pharmacists and others-realize that drugs are double-edged swords. But many do not share that awareness with their patients.

For patients to use medicine safely, then, they must become better informed themselves. Here are some key points to remember:

  • Be slow to jump on the bandwagon with a new drug. Our experience with Vioxx, Bextra and Celebrex shows that it can take a lot of time to learn about serious adverse reactions.

  • Find out about side effects. Every drug has them. Some are common and some can be life threatening.

  • Learn which symptoms should trigger a call to the doctor or a trip to the ER.

To help you organize this information, we offer readers of this column a Drug Safety Questionnaire and Medical History form. It will assist you and your physicians in organizing crucial drug data and alerting you to key side effects, drug and food interactions. It is free with a long (no. 10) self-addressed stamped envelope: Graedons' People's Pharmacy, No. QH-3, P. O. Box 52027, Durham, NC 27717-2027.

Although there are no 100 percent safe drugs, there can be safer patients. Information is your best defense against dangerous drug reactions.

First it was Vioxx. Then Bextra and Celebrex were tarnished. Even the over-the-counter arthritis drug Aleve (naproxen) has been linked to cardiovascular complications.

Several weeks ago a safety expert for the FDA estimated that as many as 160,000 Americans may have suffered a heart attack or a stroke as a side effect of Vioxx. With Bextra and Celebrex added to the list, goodness knows how many drug-induced heart attacks may have occurred.

Ironically, these pricey prescriptions (more than $3 a pill) were supposed to be safer than old-fashioned arthritis medicines. We're now learning that the hype was way out of line.

The oldest arthritis medicine, aspirin, may turn out to be the unsung hero after all. At just pennies per pill, aspirin remains the best deal in the pharmacy. No other arthritis drug has ever been shown to be superior to aspirin for relieving pain or inflammation.

Aspirin has an added benefit. Unlike the medicines now under scrutiny, aspirin actually lowers the risk for heart attacks and thrombotic (clotting) strokes. Dozens of studies involving thousands of subjects over several decades have concluded that aspirin is a life saver.

In one of the largest studies of its kind, the Physicians' Health Study followed 22,000 men for many years. Aspirin lowered the risk of a heart attack by 44 percent in healthy men. Those at high risk for heart disease doubled their benefit. The results were so good the investigators stopped the study early because they felt it would be unethical to deprive the physicians on placebo of the benefits of aspirin.

In contrast, the Vioxx and Celebrex studies were halted prematurely because the results were so alarming. People on the medications developed a significantly higher risk of heart attack.

Aspirin can even reduce the risk of complications from coronary artery bypass surgery. In one study, (New England Journal of Medicine, Oct. 24, 2002) post-surgical strokes, heart attacks, kidney problems and intestinal damage were much less common than expected in the patients on low-dose aspirin. Aspirin can cause bleeding, but even this side effect was less common than anticipated.

An added bonus to aspirin is its apparent ability to reduce the risk of cancer. Regular aspirin users seem to develop fewer tumors of the prostate, lung, breast, ovaries, pancreas or colon. In two separate studies, people taking aspirin were less likely to develop pre-cancerous colon polyps than those on placebo (New England Journal of Medicine, March 6, 2003).

Despite all this good news about aspirin, the drug is not without risk. People can develop ulcers, even bleeding ulcers that are life threatening. Some people are allergic to aspirin and others take medications that are incompatible.

We have collected information about the pros and cons of this hundred-year-old wonder drug in our Guide to Key Aspirin Information. Anyone who would like a copy, please send $1 in check or money order with a long (no. 10) stamped (60 cents), self-addressed envelope: Graedons' People's Pharmacy, No. A-12, P. O. Box 52027, Durham, NC 27717-2027.

Arthritis sufferers who can tolerate aspirin may want to discuss it with their doctors. Used with caution, aspirin offers more than pain relief.

SEX! From the beginning of human history sex has been a topic of compelling interest. And people can't seem to get enough. They have been trying to concoct aphrodisiacs for thousands of years.

Truffles, oysters, artichokes and crocodile kidneys all seemed exotic enough to stimulate sexual desire. Rhinoceros horn and ginseng have been popular in east Asia for centuries. But despite a lot of wishful thinking, there is no evidence that such products actually work as love potions.

Although Viagra, Levitra and Cialis allow many men to achieve a satisfactory erection, they are not aphrodisiacs. But the idea of better performance is enough to increase some men's interest in sexual activity.

What about their partners, though? The popularity of drugs for ED has revealed a surprising number of women who just aren't very interested in sex. Many of them have lost their libido, in part because of postmenopausal hormonal changes.

An FDA panel just recommended against approving the only medication that has been shown to increase women's sex drive. The medicine is testosterone.

Testosterone is normally thought of as a male sex hormone, but women make it too. With age, levels can drop in both men and women.

Research dating to 2000 showed that a testosterone patch or sublingual (under the tongue) tablet could increase sexual fantasies and arousal in women significantly more than placebo.

Why did the expert committee balk at a testosterone patch (Intrinsa) for women? For one thing, increased desire is harder to measure than improved erections. The panel was not convinced that the patch was so much better than placebo that it deserved approval.

The experts also suggested that there are concerns about long term safety. Fears were expressed that testosterone might carry cardiovascular risks or even increase the danger of breast cancer. Memories of the HRT scandal may have influenced the panel.

Some women who testified that testosterone gave them back their sexuality might have wondered whether the FDA experts were applying a double standard. Testosterone has been available for prescription use in men for years. There are no long-term studies of its risks, but that does not seem to have bothered the FDA.

The drug Estratest, which combines estrogen and methyltestosterone, has been available for years for postmenopausal women. The FDA has looked the other way on off-label use of testosterone by women wishing to improve libido and sexual enjoyment. It is estimated that 20 percent of the prescriptions written for testosterone are for women. Compounding pharmacists have also been creating a variety of testosterone products for women.

Even if the FDA doesn't approve the Intrinsa testosterone patch, women may continue to take testosterone without much oversight. This might pose unexpected problems.

For more information on the benefits and risks of testosterone and other sexual issues, we offer readers of this column our Guides to Female Sexuality and Sexual Dysfunction. Anyone who would like copies, please send $3 in check or money order with a long (no. 10) stamped (60 cents), self-addressed envelope: Graedons' People's Pharmacy, No. PZ-9, P. O. Box 52027, Durham, NC 27717-2027.

When visitors from another country turn on the TV in the U.S., they are often shocked to see commercials for prescription drugs. The only other place in the world where this is permitted is New Zealand, and efforts are underway to prohibit the practice there.

Since the FDA opened the floodgates several years ago, prescription drug ads have proliferated. It's hard to watch the evening news without seeing a commercial for drugs to lower cholesterol or relieve arthritis pain.

Heavy TV advertising helped make Vioxx so successful. Hundreds of millions were spent suggesting that this arthritis drug could make life more enjoyable.

In early commercials, Olympic figure skater Dorothy Hamill was featured gliding over the ice in a picture-perfect mountain setting. The message: "Ask your doctor about Vioxx, a prescription medicine from Merck. And find out if Vioxx is right for you."

With 20/20 hindsight, experts are complaining that the direct-to-consumer advertising for Vioxx created unjustified enthusiasm. People badgered their doctors for a prescription for the drug instead of relying on over-the-counter pain relievers such as ibuprofen (Advil, Motrin, etc) or naproxen (Aleve). It turns out these inexpensive products may have been about as effective as Vioxx and a lot safer.

Since prescription drug commercials must include information on side effects, it's surprising they work so well. In most ads, an authoritative voice describes a litany of side effects. While you watch people having a wonderful time, you hear about potentially serious reactions like headache, blurred vision, kidney failure, heart attack, liver disease and pneumonia. Why would anyone beg a doctor for something that can cause so much misery?

The reason appears to be that people disregard the warnings. The time devoted to side effects in TV commercials can be measured in a few seconds. In addition, commercials often diminish the seriousness of such warnings with exciting, uplifting images that distract the TV viewer from the voice-over describing disease and death. An appealing visual image trumps scary words every time.

Repetition is also a key to success. The pharmaceutical industry spends almost $4 billion on these ads so that the television audience will get a lot of exposure. With that kind of promotion, it's hardly any wonder that products like Lipitor, Levitra, Zoloft and Viagra have become household names.

Occasionally the FDA cracks down on a TV ad. In one Viagra commercial, a man and woman are strolling along a street. A lingerie display in a store window catches his eye, and part of the Viagra logo becomes glowing devil horns on his head.

The FDA found this ad objectionable because it does not inform consumers what the product is for or what the side effects might be. Pfizer was told to take the commercial off the air because of a lack of information about risks. So the Viagra devil has disappeared from the screen, although print ads still feature him.

Proponents of TV ads for prescription drugs claim they serve a valuable educational function. But in the wake of the Vioxx fiasco, the FDA should reconsider its rules on such commercials to make sure the public really learns about the risks.

Is Chocolate Good For You?

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The Mayan Indians of Central America recognized the power of chocolate more than 3000 years ag