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There is a powerful "Perspective" in the New England Journal of Medicine titled "Lost in Transmission--FDA Drug Information That Never Reaches Clinicians" (JAMA, Oct. 29, 2009). It is written by Lisa Schwartz, MD, and Steven Woloshin, MD, from the Dartmouth Institute for Health Policy and Clinical Practice.
What the researchers found was that "Much critical information that the Food and Drug Administration (FDA) has at the time of approval may fail to make its way into the drug label and relevant journal articles." This is pretty damning. It means that neither physicians nor patients are given the full story, and that makes it hard to use modern medicines wisely.
A few examples are cited: Lunesta is a highly advertised prescription sleeping pill. Perhaps you have seen the TV commercials that feature a luna moth flitting in through an open window to magically transform insomniacs into peaceful sleepers. According to the NEJM article, the manufacturer of Lunesta spent $750,000 a day in 2007 to promote this sleeping pill. And it paid off! Last year sales of Lunesta approached $800 million.
How good is Lunesta? Well, the label says that the drug is better than placebo. How much better? In the biggest and longest clinical trial Lunesta helped insomniacs fall asleep about 15 minutes faster (on average) than those on placebo and they slept a little more than half an hour longer. Not mentioned in the prescribing information was that there was "no clinically meaningful improvement in next-day alertness or functioning."
Another prescription sleeping pill, Rozerem, didn't perform all that well, either. The NEJM article notes that, "there were no subjective improvements in total sleep time, sleep quality, or the time it took to fall asleep." An FDA review concluded that the drug had "marginal clinical significance." In other words, it just squeaked through the FDA approval process. The label did not reflect this and the TV commercials (often involving Abe Lincoln and a badger) implied that Rozerem was a wonderful new advance for fighting insomnia.
Bottom line: You can't always trust the official prescribing information to tell you how effective or risky a medication may be.
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As a nurse, we had easy access to the PDR and used it frequently. Side effects were clearly and lengthily printed. I learned to be very wary of medications then. Now, as soon as a new potion hits the market and makes it big due to deceptive TV advertising, another company cranks out its competitive formula! Usually the newest concoction has more side effects than the first one because company B can't infringe on company A's formula rights. Why are pills sold whose side effects read "MAY CAUSE DEATH"?!!!
The unsuspecting public is no better off now than they were 100 years ago when the snake oil man sold adulterated alcohol from a horse drawn wagon. I got so I hated to carry in a cup full of pills to the patients I had taken an oath to protect. I knew many of the drugs were not helpful and were used instead of good diagnostic, but time consuming, practice.
I'm old enough to remember hospitals and doctors before medicare made them all very, very rich. That began the change in the reasons that men and woman went to medical school.
Bring on socialized medicine! Let Drs. be salaried. Pay for med school so they don't have outrageous bills when they graduate. Teach them nutrition and pharmacy!!! Forget inorganic chemistry! Take prescriptions med adds off TV!!!! Cut out drug lobbyists. No Dr. office drug reps. Maybe medicine will go back to being an art without the harmful drugs and quick fix surgery. Thanks for listening and being such a help to so many.
A lot of things "may cause death" like not treating your high blood pressure.
We are doing better than 100 years ago. Always beware of money. The newest product is NOT the best.
Talk to your pharmacist more often when you have medication questions -- your pharmacist has the answers, so why not ask them. Sorry everyone, your physician (aka: doctor, pharmacists are often doctors now, too) went to school to learn how to diagnose people and how to treatment too, but they cover medications in about 3 months of school. Pharmacists know their medications because we spend about 24 months just studying medications.
I think you can trick a MD if you are talking about medications just as you might fool a pharmacist when talking about diseases. So leave the medications to the pharmacists and the diseases to the MD's.
I think you and I agree on a lot, but use me -- Ask a Pharmacist!!
I am a complementary health care provider and choose to use herbs when I can over Western meds. During my mother's illness I became very stressed and had many nights of insomnia where skullcap, baths etc wasn't helping... I was given some samples of Lunesta to try. I woke up the three times I took it with a horrible metallic taste in my mouth, felt very groggy and had brain fog until I had some Black tea which helped clear my head.
I did not feel rested.!! Since then I take daily adaptogenic herbs (Siberian ginseng...Holy Basil) and my sleep has improved!
But some pharmacist are just like some doctors. Abrupt, and with poor bedside manners. You have to read the side effects too!! We continue to have to do home work through out life.
I've got to agree with Greg K: pharmacists are taught and expected to know what the benefit of the medications are. We discussed Lunesta in our classes for a whole hour as we reviewed the primary literature.
Likewise, we discussed that Aricept and other medications for Alzheimer's show no difference in many quality of life measures, cognitive tests etc.--that the only statistically significant difference was in reduced amount of time required of their care-taker to assist them. Granted this can be significant if Grandma now can assist in dressing herself or can go to the bathroom on her own.
What I like about the above discussion is that several of the suggestions have been adopted by other countries & specific health-systems, so we have a proxy for how those systems might work:
1. Most other countries do not allow advertising about medications on TV. In fact, officially these advertisements are still being shown on a probationary basis in the US. So if you don't like them complain to the FDA or support movements like http://www.commercialfreechildhood.org/ (I am sure they can connect you with similar movements.
2. The Veterans Affairs hospitals (VA) does not allow gifts to be given to MDs or PharmDs from drug reps. In addition their formulary changes are created centrally, so Pharma influence is minimal.
3. In Britain, pre-medical education is a 2 yr process not a 4 yr degree--while I am sure general chemistry is taught they might avoid further increasing their debt by having less schooling. I believe it is also in Britain where physicians' education is very much subsidized--their post-secondary education on a whole is inexpensive.
4. There are usually many other therapies to try before using medications--so I agree with jb & dp (don't need 15 pills...Lunesta is not always the answer). A recent article in JAMA (google JAMA zolpidem--its the first link or go here: http://bit.ly/JAMA-sleep) concluded it was helpful to have Lunesta or Ambien for sleep but mostly to positively reinforce good sleeping habits--after those habits were learned thanks to thorough counseling, or after 6 weeks, patients were no better off to take sleeping pills.
Many people also stand by herbal supplements that improve sleep quality, unfortunately Siberian ginseng does not have evidence behind it besides people using it historically--on the other hand melatonin has been in scores of scientific studies with most showing efficacy. Its important to hold supplements to the same standards as we do medicine, especially when some are clearly proven while others are not. Its also important to get the word out there--drug companies will certainly not be funding those advertisements however.
Ask my Pharmacist???? I think not. The Pharmacist at the local drugstore in Temple Hills, switched my Brand name prescription (yes, my Dentist had written "Do not substitute") to a generic, and had billed me the same cost as the Brand name. I noticed the pills looked a bit different... but thought it was "just one of those things."
After taking the drug for 3 days and having all kinds of side effects I'd never had before, I called my Dentist. She asked me what the drug looked like. She realized I'd been given the generic. She called the Drugstore and had them deliver the correct prescription.