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Has the Food and Drug Administration painted itself into a corner when it comes to bisphenol A (BPA)? This chemical is found in hard, clear plastic. It also used to line metal cans (soda, beer and food). Dentists use BPA-containing plastic to seal teeth and protect them from cavities.

Unlike Canadian regulators, who consider BPA a toxic chemical, American watchdogs have concluded that BPA is safe. This is a position that the FDA has held for years. A draft report that the agency released in August concluded that the amounts of BPA that leach out of containers into foods or beverages pose no threat to humans and no action is required to reduce exposure.

An article in the Journal of the American Medical Association (JAMA, Sept. 17, 2008) concludes “…that higher urinary concentrations of BPA were associated with an increased prevalence of cardiovascular disease, diabetes, and liver-enzyme abnormalities.”

An accompanying editorial in the JAMA acknowledges that this association does not prove that BPA is to blame, but it cites animal research showing that low levels of BPA can result in insulin resistance (a feature of type 2 diabetes). The authors also express concern that babies may be more susceptible to the estrogenic effects of BPA, a known endocrine disruptor.

With the JAMA article and a growing consensus from the scientific community that BPA during development may pose significant risks for humans, the FDA’s position that all is well is becoming more difficult to defend. A panel of experts for the FDA has criticized the agency for its handling of the BPA review. The independent scientists said on October 29th that the FDA ignored too many studies when it reached its earlier conclusions about safety.

We hope that the FDA isn’t so wedded to defending its original position that it is willing to put the health of American babies at risk. Safe until proven dangerous should not be the FDA’s motto. We prefer the “precautionary principle” which holds that chemicals should be proven safe before massive exposure.

For more details on BPA listen to our podcast of radio show # 670.

A story that was virtually ignored by the mainstream press and disappeared almost without a trace has to do with serious allegations against Ranbaxy Laboratories, an Indian drug company. Ranbaxy is not just any drug company. It is the largest pharmaceutical company in India, by sales. The company has huge sales around the world, thanks in large measure to its dominance in the generic drug arena. Not surprisingly, Ranbaxy sells a LOT of meds in the U.S.

According to reports, Justice Department investigators are concerned that Ranbaxy may have submitted false claims, fabricated documents and committed fraud in drug submissions to the FDA.

Congress is getting into the act. Leaders of the House Committee on Energy and Commerce have put the FDA on the hot seat, raising questions about what FDA staffers knew about this and when they knew it. There are court documents suggesting that FDA has been aware of trouble at Ranbaxy for at least 18 months. FDA apparently did nothing to warn physicians, patients or pharmacists of the suspected problems.

If Ranbaxy fabricated evidence for its generic drug applications to the FDA and concealed violations of manufacturing practices, this is a big deal. We have been questioning the ability of the FDA to monitor the quality of generic drugs for several years. (Read some of the reports on this site for frightening examples of apparent generic shortcomings.) We suspected that some companies in China and India may have taken short cuts. If the Ranbaxy mess proves true, we will know that our fears were justified. We wonder how many other problems may not have been detected by the FDA.

OK, I admit it: I am somewhat nervous about exposure to EMF (electromagnetic field) radiation. My interest predates the cell phone and cancer controversy.

It all started during the late 1960s because I was working in a neuropharmacology laboratory at the New Jersey Neuropsychiatric Institute. We were studying brain physiology. Specifically, we were measuring the quantitative electrical activity (EEG) in the brains of rats and rabbits exposed to a variety of medications and experimental compounds.

One area of particular interest was free radicals. These highly reactive chemicals were known to cause all sorts of mischief in the body. We tested a variety of free-radical compounds in our animals and discovered “EEG arousal and behavioral changes indicative of brain excitation.” [Polis, Wyeth, Goldstein, and Graedon. Proceedings of the National Academy of Sciences U S A. 1969 Oct;64(2):755-62.]

Around that time it was discovered that the American embassy in Moscow was being bombarded by microwaves. No one knew why the Russians were beaming microwaves at the embassy. Some speculated that the EMF radiation was being used to activate electronic eavesdropping equipment (bugs) within the embassy. Others thought the waves were intended to affect the nervous systems of embassy staffers.

Our lab got involved with this research because the Navy wanted to know whether EMF radiation could affect the brain waves of our rats and rabbits. I left the lab to attend graduate school at the University of Michigan, but later heard that the experiments did indeed demonstrate that low levels of microwave radiation could produce measurable effects on brain waves.

I pretty much forgot about this research until 1979. That was when a report was published linking exposure to EMF generated by high-tension electric power lines to childhood leukemia. [Wertheimer and Leeper; American Journal of Epidemiology, 1979 March;109(3):273-284]

That study created a huge controversy that exists to this day. Not only have researchers looked at EMF generated by power lines, they have also investigated the effects of low-frequency magnetic fields generated by electric blankets, old-fashioned cathode-ray computer screens and electric appliances. Electrical workers and military personnel exposed to radar have also been tracked. Epidemiologists have also looked at cell phone use and its relationship to brain tumors and salivary gland cancers. (http://aje.oxfordjournals.org/cgi/content/abstract/167/4/457)

After nearly 30 years of research the scientists still do not know what, if any, risk exists from exposure to electromagnetic field radiation. Childhood leukemia has not disappeared as a concern. Analysis of all the various studies suggests that a relationship still holds. There are also whispers about a risk of ALS (Lou Gehrig’s disease) linked to occupational EMF exposure. A comprehensive review published in 2001 concluded that the risks of “Breast cancer, cardiovascular disease, and suicide and depression remain unresolved.” [Environmental Health Perspectives; 2001 Dec;109(6):911-933]

Another resource comes from the BioIniative Working Group in August 2007. If you are interested in this topic, check out this overview of electromagnetic radiation: http://www.bioinitiative.org/report/index.htm.

The bottom line is that we still do not truly understand the impact of electromagnetic radiation on the human body. Some studies suggest that there is a risk. Others do not. After all this time there is still a lot of uncertainty. That’s scary, since we are all exposed to varying levels of EMF every day. In a sense we are all part of a huge unplanned experiment.

What does all this have to do with hybrid automobiles? Several years ago a good friend proudly showed off his new Prius. He was an early adopter and he bragged about the great gas mileage this first-generation hybrid could achieve. On a whim I got out my EMF meter and discovered that the electrical wiring appeared to produce a substantial amount of electromagnetic field radiation, especially in the back seat behind the driver. He didn’t seem alarmed so I just forgot about it.

A few years later we ourselves were in the market for a new car. We wanted something with good gas mileage and took a look at the next-generation Prius, hoping that Toyota might have shielded the wiring to cut down on the EMF leakage. To our disappointment, the levels still seemed quite high. We passed on the Prius.

We are exposed to EMF radiation every time we turn on a small appliance. Your hair dryer, for example, almost assuredly puts out a lot of invisible waves. So do your toaster and your microwave oven. Your electric toothbrush probably does too. I don’t worry about those EMFs because the exposure is related to how close you are to the appliance and is relatively short. But if you commute 40 minutes to work or are constantly taking the kids to activities, the chances are pretty good that you and the family are being exposed for longer periods of time. That’s because the electrical energy from the batteries is transferred to the front of the car through cables that run under or along the seats.

A very interesting article on EMF in hybrids appears on the New York Times Web page (April 27, 2008). It is titled “Fear, but Few Facts, on Hybrid Risk,” by Jim Motavalli.


Based on our EMF readings and those of others, the amount of radiation detected in certain hybrids is disconcerting. Some experts believe that sustained exposure to levels over 3 mG (milliGaus) pose a potential problem. Whether there is a real danger remains to be determined. I certainly hope that people who are trying to be kind to the planet and save money on gasoline are not harming themselves or their children.

Joe Graedon 

Melinda Beck of the Wall Street Journal has written about the generic drug controversy. You can read it at: Health Journal.

Years ago, we loved generic drugs and encouraged patients to request that their doctors prescribe generically whenever possible. The savings were phenomenal, even 20 years ago.

 The savings are even better today. A $4 generic prescription for a 30-day supply of fluoxetine at a discount pharmacy chain is certainly much cheaper than a month’s worth of Prozac, which can cost as much as $175.

The only problem with this otherwise rosy picture is that everything depends upon the FDA’s vigilance to ensure that all generic drugs are indeed identical to their brand-name counterparts. Over the last several years, we have begun to doubt the government’s ability to do this job adequately.

Put aside for a moment the whole issue of medications imported from countries like China and India. The heparin horror highlights questions about how well such ingredients are monitored for quality control.

We thought that the FDA required every generic drug to be tested for equivalence before it could be approved and sold. Now that the FDA has published the report of its investigation, we know that is not the case. Budeprion XL 300 (a generic formulation of bupropion, meant as a substitute for Wellbutrin XL 300) was not subjected to bioequivalence testing. Instead, the FDA allowed the company to submit data for a pill containing half the dose (Budeprion XL 150).

Although the FDA says Budeprion XL 300 is good enough, its own report regarding the time to maximum blood levels (Tmax) suggests that the 150 mg pill behaves differently in the body: “The bupropion Tmax was faster for Teva’s XL product (2-3 hours) than Wellbutrin XL (5-6 hours).”

This could account for the experiences people have described on this Web site about side effects and depression, such as this one from BK:

“In March of 2007, my insurance company switched my Wellbutrin XL 300 to the generic-Budeprion. Within six weeks, my depression had returned full force.

“In May, my doctor put me back on Wellbutrin and within 2 to 3 weeks, I was fine again.

“Obviously, in my case and in many others, Budeprion does not work. In many cases, [people report] it has even done harm.”

Melinda Beck of the Wall Street Journal has summarized the controversy extremely well. You can read it at: Health Journal.

 This is a demonstration of how e-patients can inform each other and influence policy.

The Food and Drug Administration has one overarching mandate from Congress: Make sure that all drugs are safe and effective.

Sounds simple, but it’s far trickier than it seems. For one thing, there is no such thing as a drug that is effective for everyone. For another, all medicines have side effects and therefore are unsafe for some people.

The real issue, however, is how FDA finds out about such side effects and alerts doctors to them. Some complications show up in clinical trials, and those get listed in the approved prescribing information. But clinical trials only include a few thousand subjects at most. Often, the studies are short, lasting a few weeks or months. As a result, serious side effects may only be discovered years after a medicine has been marketed.

One need look no further than Vioxx for arthritis, Avandia for diabetes or HRT for preventing heart disease in women to find examples of serious problems that became apparent much later.

Part of the problem is that doctors frequently don’t recognize drug-induced symptoms. A study in the medical journal Drug Safety (August 2007) showed that doctors frequently dismissed patients’ complaints of muscle problems, memory impairment or nerve pain as unrelated to the statin-type cholesterol-lowering drugs they were taking. It is disappointing that some doctors blew off side effects that have been well reported in the medical literature. The authors conclude that if doctors don’t recognize these issues as side effects, they are not likely to report them to FDA. They suggest that side-effect reports from patients would be a valuable addition to the system.

But will FDA pay attention? The agency collects information about drug complications through MedWatch. Doctors are encouraged to submit reports about serious side effects to MedWatch, but that happens infrequently. Patients are permitted to do so as well, but there is a perception at the agency that patient reports are less reliable.

In truth, MedWatch is understaffed and has difficulty responding to side effect reports regardless of where they come from. What the FDA does with those that are submitted remains mysterious. Sometimes it seems that the agency is far more dedicated to downplaying drug dangers than to warning physicians and patients about them.

It’s worse than we imagined.

For the last five years or so we have been sounding an alarm about generic drugs. That’s because we’ve been hearing from readers and listeners that sometimes their generic medicine has not worked as expected. In other cases they have experienced unpleasant or even dangerous side effects.

For almost 30 years we championed generics as a wonderful way for consumers to save money. We believed that the FDA was protecting consumers from poor quality medications.

Within the last decade, however, there has been a tremendous shift in the source of medications. Both raw ingredients and finished generic drugs are increasingly coming from countries like India and China.

There is an article in the Washington Post (June 17, 2007) by Marc Kaufman titled “FDA Scrutiny Scant in India, China as Drugs Pour into the U.S.” http://www.washingtonpost.com/wp-dyn/content/article/2007/06/16/AR2007061601295.html

It reveals that over the last seven years FDA has made 200 inspections of plants in both countries compared to 1222 quality insurance inspections in the U.S. last year. There is no possible way for FDA to inspect all the plants in China and India that are producing pharmaceuticals that land on American drugstore shelves.

The intense competition among generic drug makers and their search for the cheapest raw materials has driven the huge increase of imports. The same motivation drove pet food manufacturers to purchase wheat gluten contaminated with melamine from China. We worry that the FDA cannot guarantee the safety of these inexpensive pharmaceutical products any more than they could protect our pets.

If you have experienced a problem with a generic drug you can add your comment on the home page of this Web site: http://www.peoplespharmacy.com/archives/generic_drug_problems/report_generic_drug_problem.asp

 

We interview a lot of medical experts on our syndicated radio show but we don’t usually test their advice ourselves. We just had an opportunity to do that, though.

We recently interviewed patients-rights advocate Janet Lynn Mitchell and Pierce Scranton, MD, for a forthcoming radio show on avoiding medical errors. They talked about how patients can protect themselves from mistakes and misadventures.

We found ourselves striving to remember Dr. Scranton’s “questions to ask first” when emergency room providers told us that Terry’s belly pain was appendicitis and that it was going to require surgery…right away. No time for homework, not even on the Web.

We asked the chief resident who was planning to do the surgery how many of these operations he had done, and he responded that he had done over a hundred. That sounded pretty good, but maybe not quite good enough if the appendix was as nasty as the radiologist suggested. We asked about potential complications and how they might be handled. We asked how long he had been on call and who, exactly, would be doing the surgery. And we asked to speak to the attending surgeon who would be supervising, since a resident, even a chief resident, is a learner who needs supervision.

We were glad we did. We were also glad we asked to speak with the anesthesiologist, so we could explain that after a previous surgery, Terry had taken an exceptionally long time to start breathing on her own again. The anesthesiologist assured us that he and the nurse anesthetist would be paying close attention so that she would be given smaller amounts of several different kinds of anesthesia to minimize post-surgical breathing problems.

As a result, though the surgery to remove the inflamed appendix laparoscopically (through a small “port” above the belly-button rather than through a large incision) took longer than expected, the recovery was far easier than with the previous surgery. When the attending surgeon came by for the post-op check the following day, he mentioned that it had been a more complicated procedure than they’d envisioned, but we had the clear impression that he had done it himself. We suspect that if we had not asked to speak with the attending surgeon, the chief resident would have done the surgery. It might have gone just as well, but he has far less experience than the attending and might not have known quite what to do when he discovered there was a lot of inflammation around the appendix.

We certainly are glad we spoke up and grateful we had had time to think about asking questions before we were faced with a crisis. Here are Dr. Scranton’s questions for you to ask your doctor:  

Dr. Pierce Scranton’s questions:
 
1)    How long have you been in practice?
2)    What is your experience in treating this condition?
3)    What are the treatment options, and what other options are available that you or the health plan are not offering? If you don’t understand the doctor’s basic explanation of your condition and treatment, then by all means ask him or her for more information.
4)    What are the possible complications of the proposed medical treatments or surgeries?
5)    If there are any complications, how will you correct the problem?
6)    Aside from your own partners, who would you go to for medical treatment if you had this condition?
7)    Are you personally going to perform the surgery?
8)    Will others assist and participate, in a major way, in this medical treatment?
9)    Can I ask your bookkeeper what my financial responsibility will be? You need to know in advance…and don’t be afraid to negotiate!
From http://seniorliving.about.com/od/doctorshospitals/a/medicaltreatmen.htm

Americans love being #1. Just watch any sporting event—high school, college or pro—and you will see team members and fans flashing the big #1 sign with their forefinger whenever the camera zooms past them.

Obviously, not every team in the country can be #1 at the same time. In fact, there is only one #1 at any given time. But Americans aspire to be #1 in almost all arenas.

Take health care, for example. We often hear repeated, almost like a mantra, that Americans enjoy the best health care system in the world. Never mind that 47 million of us have no health insurance and thus can’t take advantage of it.

But let’s dig a little deeper. Are we really #1 in health care or is this just an urban myth?

There seems to be no question that we have the most expensive health care system in the world. We spent more than $6,000 per person in 2005 on health care. Just for comparison, Germany spent about $3000 per person, as did Canada. The average Briton costs the government $2500 for health care and a Kiwi (New Zealander) comes in at about $2,100.

We’re paying for the Mercedes Benz level of health care, but the Germans, who make those quality automobiles, pay half as much and get a bigger bang for their buck. Our broken-down heap provides poor quality on almost every objective measure.

The Commonwealth Fund recently reviewed accepted measures of public health like infant mortality rates (IMR). [http://www.cmwf.org/] According to a commentary published in the Journal of the American Medical Association (May 16, 2007), “The US infant mortality rate is 6.37 per 1000 live births, higher than almost all other developed countries, as well as Cuba.”

Here’s another way to assess what we get for our money. The Hoover Institution is not a fuzzy-headed liberal think tank. Nonetheless, its Web site points out that “the United States spends about 16 percent of its GDP [Gross Domestic Product] on health care but has a much higher IMR than Iceland, Sweden, and Japan, which spent 10 percent, 9 percent, and 8 percent of their GDP, respectively, on health care.” [http://www.hoover.org/research/factsonpolicy/facts/7088621.html]

Let’s look at a practical measure that almost everyone can relate to. Say you need to deal with an emergency on a weekend. Chances are you will wait for hours and hours…and hours in the emergency room. If you were in Germany you would be seen much more quickly, perhaps even by your own doctor. Fewer Americans report having their own primary care physician than people in Australia, Canada, Germany, New Zealand or the U.K.

We fall down on another important metric as well. Although Americans love to think of themselves as technologically savvy, our doctors are less likely to be wired than health professionals in other industrialized countries. Information systems in Germany, New Zealand and the U.K. help doctors monitor electronic records so they can better manage patients with chronic conditions. They can also print medication lists for patients and nurses can help because they too have access to electronic records.

Most of these countries that pay less and deliver more have universal health care coverage. That means everyone has some level of access and care is more equitably distributed. Experience a catastrophic illness in America, and you could go bankrupt.

America is not #1 in health. We do not have the best health care system in the world. Our system is badly broken and it’s high time Americans wake up to that fact and demand that it be fixed!

The FDA has a mandate to make sure all drugs (prescription and OTCs) are “safe and effective.” This is the law. The only trouble is that FDA’s definition of ‘safe’ is hard to get a handle on.

The feds routinely approve drugs that have life-threatening side effects. This is completely understandable in the case of a drug that might cure a deadly cancer. It is inexcusable when it comes to a condition like arthritis, high blood pressure or diabetes.

Avandia is just the latest in a long list of FDA disappointments. The FDA has been slow to discover serious problems with medications and often drags its feet even when the warning bells are clanging.

PPA (phenylpropanolamine), for example, was a decongestant and diet aid that was found in both prescription and over-the-counter products. It was introduced in 1962. Over the years, a number of experts warned that this drug might predispose people to heart attacks and strokes. Still, it took the FDA until 2000 to ban it. Countless people suffered and died because of FDA’s delay.

There are so many other examples we don’t know where to start. The non-sedating antihistamine Seldane was introduced in 1985. Even though doctors reported that some patients suffered sudden cardiac arrest when they took Seldane in combination with certain other drugs, it took the FDA until 1998 to ask the manufacturer to take this allergy medicine off the market. The agency waited until the manufacturer had a replacement product, Allegra, ready for sale.

Vioxx got a lot of ink when its manufacturer admitted that the drug could increase the risk of heart attacks and strokes. Again the FDA was late to the show. We asked an officer of the agency why they didn’t discover this serious side effect themselves and were shocked to learn that the FDA has a very hard time detecting “common” complications such as heart attacks or strokes.  

Now we are told that one of the most popular diabetes drugs (6 million people are taking it worldwide) can also increase the risk of heart attacks and premature deaths from cardiovascular causes. Avandia has been on the market since 1999. It is only because of the persistence of Steven Nissen, MD, (Chairman of the Cleveland Clinic Department of Cardiovascular Medicine) that we learned about this problem.

Dr. Nissen is a bulldog. When he suspected that there was trouble with Avandia, he tracked down studies to assess cardiovascular risks. Why didn’t the FDA figure this out itself and warn physicians sooner?

People taking Avandia should NOT stop taking their medicine. If the risk is real, problems rarely develop overnight. It is a long-term process. Nevertheless, it would be prudent to schedule an appointment with the doctor who prescribed Avandia to discuss other options for diabetes control.

We deserve safe and effective medicine, just as the law says. To get there, though, FDA will have to do a much better job designing drug studies and monitoring medications once they are approved for sale. Until the FDA really protects us, we the public will have to be more vigilant, more skeptical and slower to accept prescriptions for the newest, most popular drugs.

 Have you ever bought a car? Did you pay full sticker price or did you bargain with the dealer? Most people realize that the price is negotiable. If you drive a hard bargain, you can often save thousands of dollars off the listed price. Only a chump would pay the full asking price.

If you have to go to a hospital, the price of almost everything is marked up way more than a new car. An aspirin pill that costs a few pennies in the drugstore could cost anywhere from $5 to $20 per dose depending on the hospital.

Most people never notice such inflated prices because they never look at the itemized bill. That’s because an insurance company pays the lion’s share first. The patient may be responsible only for a modest co-pay.

Insurance companies and the government (think Medicare or Medicaid) arm-wrestle hospitals over costs. These big players have enough clout to negotiate a steep discount on the “list price.” Research published in the journal Health Affairs (May/June 2007) spills the beans [http://content.healthaffairs.org/cgi/content/abstract/26/3/780]. In 2004, Medicare paid only a third the amount hospitals charged individuals paying out of their own pockets. Insurance companies get almost as much of a discount.

This is the most unfair system ever devised. People who cannot afford health insurance and are not eligible for Medicare or Medicaid must pay way more than anyone else.

Think of it this way. A small businessman, say a painter or a garage mechanic, who cannot afford $500 a month for health insurance premiums, suddenly develops a life-threatening heart valve problem that requires surgery. Medicare would pay roughly $38,000 for this hospitalization. But our hypothetical middle-class tradesman could be charged $115,000 for the same care. Where is he going to find that kind of dough?

Those without insurance who must pay out of their own pocket get stuck with the biggest bills. Does that make any sense at all? Some hospitals will negotiate small discounts, but they may not go out of their way to inform prospective patients that this is an option. Very few will offer individuals the same kind of deal they routinely give big insurance companies.

How would you feel if you discovered that people who worked for IBM only paid $12,000 for a Toyota Camry that you had to pay $36,000 for? A car is not a matter of life and death. But a heart valve replacement is not optional.

Nearly 50 million Americans have no health insurance. There is something very wrong with a system that charges these folks so much more than everyone else.
 

It’s all about greed. Pet food manufacturers figured out that they could save money by buying ingredients from China. The Chinese figured out that they could get a higher price for wheat gluten if they added melamine.

That’s because this chemical, used in making plastic and fertilizer, has a lot of nitrogen. Quick and easy tests for protein content measure nitrogen, so adulterated gluten looks protein-rich on such tests.

Everyone makes money except the consumer. When a pet gets sick, vet bills skyrocket. Even worse, the dog or cat may die.

The FDA did not discover the pet food problem. Rather, Menu Foods initiated a recall after pet owners complained about kidney problems in dogs and cats. Since then, more than 100 brands of pet food from various manufacturers have been recalled.

According to the FDA: “As of April 26, 2007, FDA had received over 17,000 consumer complaints relating to this outbreak, and those complaints included reports of approximately 1950 deaths of cats and 2200 deaths of dogs.”

No one knows how complete the FDA’s numbers are. When it comes to human adverse drug reactions, the agency admits that it collects only a small fraction of true events. The Pet Connection http://www.petconnection.com/blog/category/2007-food-recall/
reports that as of April 30, 2007, pet owners have reported 14,228 problems to its Web site database. http://www.petconnection.com/recall/
Total deaths reported in cats reached 2,334 and in dogs 2,249.

Although the Chinese pet food manufacturers insist that there is no problem with melamine, it is an illegal additive in the U.S. That makes you wonder how effective FDA oversight is for pet food or other animal feed. There are preliminary reports that both chickens and hogs have also been fed melamine-contaminated food.

If the FDA couldn’t catch the melamine mess, we wonder what else it is missing. More and more, pharmaceuticals or their ingredients are coming from countries like China and India. Labor costs are lower and therefore the raw materials in medicines often cost less than those manufactured in France, Germany or the U.S. How well does the FDA monitor quality in offshore manufacturing facilities?

A pharmaceutical industry insider expressed concern that some generic companies buying these raw materials don’t inspect the plants and may not even take the time to fully test the resulting pills. Nor does the FDA. In fact, the agency relies too much on the honor system. As pet owners have painfully learned, the honor system may not be adequate to protect health.

FDA has posted a list of all the pet foods that have been recalled: http://www.accessdata.fda.gov/scripts/petfoodrecall/

Remember when you were a kid and you told your mother that everybody else was doing something you wanted to do too? For most moms that excuse never worked!

That’s why we’re so surprised to see the latest Celebrex ads. The first paragraph says it all:

“When it comes to relieving arthritis pain, you may think some prescription NSAID pain relievers, like ibuprofen and naproxen, don’t have any cardiovascular risks. But based on the available research, that’s not clear. And if you look closer, the FDA requires all these NSAID pain relievers, including Celebrex, to have the same cardiovascular warning.”

Read between the lines and what they’re saying is that all these anti-inflammatory drugs have the same risks. Gee, what a great excuse! How about it, mom? Why not take Celebrex since all these drugs may increase the risk for heart attacks and strokes?

In some respects, Pfizer’s candor is refreshing. The ad states unequivocally that “Any prescription NSAID, including Celebrex, may increase the chance of heart attack or stroke, which can lead to death.” The next paragraph reinforces the message, “All NSAIDs, including Celebrex, also increase the chance of stomach and intestine problems, such as bleeding and ulcers, which can occur without warning and may cause death.”

Such clear warnings should give people pause. Most of us would prefer to avoid things that “may cause death.” On the other hand, drug companies have figured out that many people ignore such dire messages. (Take a look at a pack of cigarettes if you need verification.) And if someone were to experience a stroke or heart attack, the drug company is likely off the hook. After all, they told you so! It’s your own damn fault if you die prematurely.

There may be a place for Celebrex and other NSAIDs. But the research shows that such drugs are not miracles against arthritis pain. Given the risks that Pfizer lays out so clearly, we’re sticking with home remedies, fish oil and aspirin.
 

Millions of cat and dog owners have been horrified to learn that pet food has been contaminated and could be harming or even killing their companion animals. We now know that wheat gluten, used in a variety of pet foods and dog treats, was tainted with melamine. This chemical is highly toxic to pets, causing kidney damage or death.

Melamine is used in the manufacture of plastic. It is also used as a fertilizer in Asia, but no one knows exactly how it got into the wheat gluten that has caused so much harm. The current belief is that a Chinese supplier of wheat gluten provided a contaminated supply to North American pet food manufacturers.

It may comes as a shock to many people to learn that key ingredients in familiar and trusted pet foods come from sources overseas and may not be inspected as carefully as they should be upon arrival in North America. Unfortunately, there is no good way for the consumer to tell if the pet food on the shelf is safe or not.

People might be even more shocked to learn that this predicament could also apply to the prescription drugs they themselves take. For the past several years, many raw ingredients and even finished pills have been imported from India, China, or other countries. Prices are lower in these places, so the generic drug company saves money on materials. This may even help lower the price of generic medicines in the drugstore. But are there adequate safeguards?

When the FDA approves a new generic medicine, the pill must go through rigorous testing to demonstrate that its active ingredient is identical to that in the brand-name product it mimics. The tests must also show that people absorb the ingredient properly, so that an appropriate amount gets into a patient’s bloodstream. But once this careful approval process is finished, the FDA stops paying close attention. The agency does not routinely monitor the quality of generic drugs—or even brand-name medications. Drug manufacturers are essentially on the honor system.

According to our calculations (based on extensive interviews with FDA honchos), only about one out of 10,000,000 pill bottles is ever actually tested by the agency in the course of a year. This leaves a significant temptation for the unscrupulous.

Since no one is actually enforcing drug quality on the shelves, it is up to consumers to be vigilant. If you go back to our home page (www.peoplespharmacy.com) you will find a box where you can report any problems you may have experienced with generic drugs. We are constantly amazed at how many people find that their generic medicine does not work as well as the brand name they are used to.

Are you as sick and tired of drug ads on TV as I am? Have you had it with commercials for erectile dysfunction, overactive bladder or high cholesterol? Unfortunately, there is no relief in sight. The FDA is actually considering taking money from drug companies to speed up the approval process for drug ads to consumers.

The inside word is that the FDA and the pharmaceutical industry have cut a deal whereby the agency would get $40,000 to $50,000 for each prescription drug ad campaign. Given how many ads are aired on TV, that would amount to some big bucks for the FDA. And what will they do with the money? They will hire more staffers to review ads promptly (within 45 days of submission) so they can make it to your TV set even faster than before. Gee, thanks FDA!

A recent GAO (Government Accountability Office) report says that where we really need some speed is stopping misleading ads. The GAO is your watchdog at work. These folks make sure you get the biggest bang for your federal tax dollars and they are not happy with how the FDA is spending your money.

The FDA is supposed to shut down commercials that make exaggerated claims or do not adequately warn about side effects. The GAO report notes: “The 19 regulatory letters FDA issued in 2004 were issued an average of 8 months after the materials were first disseminated. By the time FDA issued these letters, companies had already discontinued use of more than half of the violative materials.”

No other country in the world (except tiny New Zealand) permits this kind of nonsense at all. You will not see Frenchmen smirking because of taking Viagra. Australians are not dashing to the bathroom because they have an overactive bladder. What’s next? Perhaps we will see actors simulating heart attacks or strokes and then popping a pink pill and looking cheerful and fully recovered.

The pharmaceutical manufacturers maintain that all these commercials are just a way of educating consumers about potential treatments and making them more knowledgeable. To my way of thinking, prescription drugs ads are to health education as Coke commercials are to nutrition education. They are designed to sell products! And they work. Last year drug companies spent over $4 billion on such ads and you can bet your bottom dollar that they paid off in increased sales.

Speaking of your dollars: Although drug companies may soon be paying user fees to the FDA to get their commercials on the tube faster, guess who will ultimately pay? Right! We will all end up paying because of higher prescription prices to cover the cost of the ads (and the user fees).

Direct to consumer (DTC) prescription drug advertising is a terrible idea. The FDA should not be expediting these commercials but slowing them down. Drugs are not like dish detergent, light beer or even SUVs. They affect our health, even our lives. It’s time to stop this craziness and get the U.S. to join the rest of the civilized world. Let’s provide real health education and not advertising.

When Congress passed the Medicare Part D prescription drug benefit for seniors, we thought that something smelled suspicious. The pharmaceutical industry has generally resisted government involvement in its business. Why, we wondered, did big Pharma seem pleased with this huge government program?

Now that we are approaching the first anniversary of Medicare Part D, the answers are becoming apparent. This was a massive benefit for the pharmaceutical industry.

First, it was a fantastic relief valve for all the negative publicity that had been building for years about skyrocketing drug prices. Remember when Congressmen used to take well-publicized bus trips to Canada with senior citizens who wanted to purchase less expensive drugs? Those days are long gone. All the negative press about older people having to eat dog food so they could afford their medicine is over.

But prices are still going up and up and up! According to the Wall Street Journal (Nov. 6, 2006), “Companies have raised prices on many top-selling medicines by 6 percent or more this year, double the overall inflation rate.�? Yet the media and the public seem oblivious. The outrage is gone because everyone figures that Medicare Part D has solved the senior citizen price problem. The trouble is that everyone under 65 who does not have insurance is stuck with escalating drug bills. And those with insurance will inevitably see premiums rise as companies pass along their rising prescription drug costs.

Profits at many drug companies are soaring. It’s not just because they have raised prices so substantially. There were a couple of amazing loopholes in the Part D program. For one thing, negotiating price is not allowed under this law. Even though Uncle Sam (your tax dollars at work) is the ultimate payer for Part D, the government cannot arm-wrestle drug companies over the price they charge. We are about the only country in the world that doesn’t use our muscle to control drug costs. (This is almost certainly why Americans pay more for drugs than anyone else.)

There is one other fascinating and overlooked loophole. Before Medicare Part D, really poor folks had their medicines covered under Medicaid. This government-supervised program required a mandatory 15 percent discount off standard prescription drug prices. In some instances the discount was substantially greater. This saved you, the taxpayer, a ton of money.

Guess what? Under the new law, low-income senior citizens have been switched from Medicaid to Medicare and the discount is gone. That means many drug companies are experiencing a huge windfall.

Some experts estimate that next year Medicare Part D will cost us $50 billion, or one fifth of the entire drug bill in America. Since it comes out of the public trough, few folks will complain that we may not be getting our money’s worth. But we should, since we are all paying for it.

Perhaps it is time to look abroad where other countries have been negotiating prices with the pharmaceutical industry for decades. You know the old saying—he who pays the piper calls the tune! Maybe a new Congress will stiffen its spine and demand a bigger bang for our bucks.

Turn on the evening news and you will inevitably see commercials for prescription drugs. It might be something for restless legs, overactive bladder, cholesterol control, osteoporosis or erectile dysfunction.

In most cases the actors are smiling and thrilled to tell you how a pill has made them better and better in every way. A voice-over briefly warns you that said medicine might cause all sorts of mischief, from liver damage to heart attacks, but the message goes by so fast and the people on the screen are having so much fun that most folks seemingly ignore the dire warnings. The pharmaceutical industry has apparently adopted the old motto of another industry—“better living through chemistry.�?

Now that drugs are marketed just like any other commodity—paper towels, shampoo or beer—we virtually take them for granted. Any risk of side effects seems so remote that we assume it will never happen to us. And many doctors have apparently decided that it is easier to write a prescription than to try to talk someone out of the latest and greatest highly advertised drug.

The trouble is that adverse reactions to drugs are not rare and are not something that happen to the other guy. Bad things happen to an amazing number of good people every year. A fascinating report in the Journal of the American Medical Association (Oct. 18, 2006) concludes that more than 700,000 patients are treated for adverse drug events each year in emergency rooms: http://jama.ama-assn.org/cgi/content/abstract/296/15/1858

Think about this for a moment. No one wants to go an emergency department. Unless you are having a heart attack or a stroke you are likely to wait for hours…and hours…and hours! And if you don’t have insurance it is incredibly expensive. Most folks will do just about anything to avoid a trip to the ER. We can assume that for every person who traveled to an emergency department because of drug side effects, a great many more toughed it out and waited till they could catch up with their physician during normal office hours.

One study published in the Archives of Internal Medicine (Jan. 24, 2005) revealed that more than one out of four patients experienced “medication-related symptoms.�? Then the authors dropped a bombshell: “Extrapolating to the 98.9 million annual visits to US internists by patients who received a medication or for whom a medication was prescribed during the visit, as many as 7.8 million ADEs [adverse drug events] could be prevented or ameliorated if patients and their physicians communicated better and if physicians acted more reliably to address medication symptoms.�?

Can you believe that? The very drugs that are supposed to help are hurting millions and millions of people each year. And far too often people are never warned in advance what symptoms to watch out for. A recent article in the Archives of Internal Medicine (Sept. 25, 2006) reports that roughly two-thirds of the physicians that were monitored did not mention side effects when prescribing drugs. http://archinte.ama-assn.org/cgi/content/abstract/166/17/1855

To my way of thinking, that is a little like asking someone to drive down a twisty mountain road blindfolded. There is real danger in your drugstore. Although medications save lives and relieve a lot of suffering, they can also cause permanent harm or even kill you. Next time you fill a prescription, please do your homework. Find out about side effects and be alert for early warning signs of problems.

Millions of Americans are just now entering the “donut hole�? of Plan D. This Medicare prescription drug benefit has been a hot political potato for years.

Faced with growing anger from senior citizens about the high cost of medicine, Congress fought about this legislation for years. Eventually in 2003 our legislators passed the Medicare Prescription Drug Improvement and Modernization Act and President Bush signed it into law on December 8th, 2003. There was a great deal of smiling and hand shaking and congratulating. Finally, the monkey was off the back of Congress.

At the time he signed this legislation President Bush offered that: “Our nation has the best health care system in the world. And we want our seniors to share in the benefits of that system. Our nation has made a promise, a solemn promise to America's seniors. We have pledged to help our citizens find affordable medical care in the later years of life… First and foremost, this new law will provide Medicare coverage for prescription drugs… Medicare will pay for prescription drugs, so that fewer seniors will get sick in the first place… Drug coverage under Medicare will allow seniors to replace more expensive surgeries and hospitalizations with less expensive prescription medicine. And even more important, drug coverage under Medicare will save our seniors from a lot of worry.�?

A lot of senior citizens breathed a sigh of relief when they heard about prescription drug coverage at long last. What they did not know was that a lot of arm wrestling and rule bending went on to make it happen. According to Louise M. Slaughter, M.P.H and member of the House of Representatives, “The political process used to pass Part D was the worst abuse of the legislative process I have ever seen during my 20 years in Congress.�? For the full account see her “perspective�? in the New England Journal of Medicine see this URL:

http://content.nejm.org/cgi/content/full/354/22/2314

Initially a lot of seniors were confused by all the various plans offered by insurance companies. But once they signed up and discovered that many drug bills were in fact 75 percent lower, there was genuine delight. There was just one problem.

Most seniors did not truly understand the intricacies of Part D. What they did not realize is that once their total medication outlay (including $1500 kicked in by Uncle Sam) reached $2250, they would be in the dastardly donut hole. From that point until the total drug bill reaches $5100, older people are responsible for 100 percent of their medication costs including their monthly insurance premium.

What that means in practice is that someone could go to the drugstore and pay $100 to $200 for five or six prescriptions one month and discover that the next month the bill has gone up to $400 or $500 for the same medicines. Millions are now entering this donut hole and will have to pay full freight until the end of the year when it all starts over again.

Not surprisingly, many pharmaceutical companies are smiling all the way to the bank. According to Wall Street analysts, drug sales are up because of increased drug dispensing. And pharmaceutical price increases have continued to outstrip inflation. You have probably heard that the new legislation means that pharmaceutical companies do not have to negotiate prices the way they do with the Veterans Administration.

The bottom line seems to be that the donut hole is hurting millions of seniors but many drug companies are licking their chops. The next few months are likely to produce some unexpectedly high prescription bills for a lot of people who thought Part D was going to end their worries.

Americans love to plug and play. We don’t want to waste a second reading manuals. We just want to plug in the new computer, turn it on and start surfing the Web.

That may be an OK strategy for computers or a new flat-screen television or even a microwave. The worst that can happen is that the device won’t work as expected, at least not until we break down and actually read the instruction booklet.

When it comes to pills, Americans are also popping and swallowing without a moment’s hesitation. The results can be disastrous.

At last count, 150 million of us take at least one prescription medicine each day. Older people and those with health problems frequently swallow a handful of pills daily without a moment’s thought. Many of the drugs are crucial for good health, but if patients do not know what side effects and interactions to be alert for this casual approach can be a prescription for disaster.

Sadly, too many doctors are enabling this plug and play pill mentality. An article in the Archives of Internal Medicine (Sept. 25, 2006) suggests that way too many physicians are cavalier in how they prescribe new medicine. Researchers at UCLA and UC-Davis performed a clever experiment. The “Physician Patient Communication Project�? involved patients who visited family physicians, internists and cardiologists in Sacremento, CA. Physicians were surveyed, patients were surveyed and audiotapes of the visits were analyzed.

The results of the study were shocking. Not only did doctors frequently fail to tell patients basic information about dosing or duration of use, they only mentioned potential side effects about a third of the time.

I knew there was a problem with patient-phsyician communication about pharmaceuticals, but I never imagined it was this bad. How can a physician send a patient out the door without some inkling of potential side effects? Every medicine has the ability to cause some adverse events for some patients. It is inconceivable to me that two-thirds of the new drugs prescribed in this study were accompanied by NO WARNINGS from the MD. It’s hardly any wonder that patients are popping their pills without a moment’s hesitation.

Perhaps these physicians hope that if they speak no evil, nothing bad will happen. That is magical thinking. It flies in the face of everything we have learned over the last 30 years. The Agency for Healthcare Research and Quality encourages patients to ask lots of questions about prescription medicines.

Until doctors start supplying answers, wise patients had better find other ways to learn about side effects and interactions.

Welcome to Joe's Blog. This is Number 1 and I sincerely hope that you will find my ramblings of interest and worthy of comment. I welcome your feedback.

Even before I started writing about drug-related issues 30 years ago, I was aware of the thalidomide scandal. In the 1950s thousands of babies were born with severely deformed limbs and other malformations. For years thalidomide represented the worst drug scandal in history. That the U.S. largely avoided the thalidomide tragedy was a point of pride for the FDA. The agency maintained that its rigorous testing and high standards protected the American public from this drug disaster.

Fifty years later the FDA is disgraced and in disarray. Over the intervening years we have watched as the agency was slow to recognize serious drug problems. Diet pills like Redux and phen-fen were allowed to linger on the market long after the handwriting was on the wall. The FDA dawdled over the herbal weight-loss and energy booster ephedra while gullible consumers experienced strokes or heart attacks. But all these misadventures pale in comparison to the FDA's latest screw-up.

The greatest drug disaster in history has occurred while our federal watchdog was asleep at the switch. In fact it wasn't the FDA that discovered the Vioxx disaster, but rather the manufacturer. When I asked one of the key FDA officials why the agency missed the iceberg that has nearly sunk his organization, he replied that the FDA is not very good at catching common things like heart attacks or strokes. They seem to be able to detect strange or rare complications like liver failure, but "common" problems frequently go undetected.

The FDA still to this day does not know how many people experienced heart attacks or strokes from Vioxx, Bextra or Celebrex and how many died. FDA safety officer, David Graham, MD, has estimated that it could be as many as 30,000 or 40,000 deaths, but that's just an educated guess. That would make Vioxx the greatest drug disaster in history, dwarfing thalidomide and fen-phen and all the other drug scandals combined.

What is even scarier, though, is that virtually all NSAIDs (nonsteroidal anti-inflammatory drugs) can do the same thing. For decades doctors have been prescribing drugs like ibuprofen (Motrin), diclofenac (Cataflam, Voltaren), indomethacin (Indocin), piroxicam (Feldene) and sulindac (Clinoril) to ease patients' arthritis pain or strained muscles. No one knows how many heart attacks and strokes may have resulted from the hundreds of millions of prescriptions that have been filled over the last 40 years. The number could be in the hundreds of thousands. And even though naproxen (Aleve) has been reported to be neutral for cardiovascular complications, it is not entirely clear that it is perfectly safe either. At the very least, it and all the other NSAIDs can cause stomach ulcers that in some cases may lead to hospitalization or even death.

The bottom line is that the FDA has let us down for decades. It has allowed these pain relievers to be marketed without recognizing that millions of people would be put at risk for heart attacks and strokes. Only in the last few years have we seen strong warning labels on prescription-strength NSAIDs. But I doubt that most Americans still to this day realize how dangerous these drugs may be. Perhaps even scarier, we don't know what other drug disasters the FDA continues to miss.

If there is a lesson to be learned from this sad chapter in American medicine, it is that the FDA is no longer capable of protecting you from dangers in the drugstore. Without adequate warning information, your doctor can't protect you either.

You're on your own. Good luck!