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.
