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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.
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 giseng...Holy Basil) and my sleep has improved!