Crucial Drug Data Are Missing from Label

When smart consumers want to buy a new car, a refrigerator or a computer, they often turn to an objective source such as Consumer Reports. They get ratings of various products and recommendations about the “best buy” for the money.
Too bad doctors and patients can’t do the same thing when it comes to medications. Unfortunately, the information that they need to make critical decisions that can affect health may not be readily available.
That’s what two experts on drug safety concluded in the New England Journal of Medicine (Oct. 29, 2009). Lisa Schwartz, MD, and Steven Woloshin, MD, point out that doctors rely on the drug “label” to learn about effectiveness and safety. This official prescribing information is “written by drug companies, then negotiated and approved by the FDA.”
What many people don’t realize is that these drug labels may leave a lot of crucial information out. Perhaps that why Drs. Schwartz and Woloshin titled their perspective “Lost in Transmission–FDA Drug Information That Never Reaches Clinicians.”
Imagine trying to decide which washing machine to buy without knowing any comparative data about various brands and their efficiency or repair record. It would be next to impossible to make an informed choice.
Doctors are in a similar situation when they try to choose which sleeping pill to prescribe, for example. The article discusses Lunesta, a highly advertised prescription sleeping pill. Its television commercials feature a Luna moth flitting in through an open window to bring sleep to restless insomniacs.
Those ads and other promotions cost the manufacturer of Lunesta $750,000 a day in 2007, but the expense really paid off. In 2008, sales of Lunesta were nearly $800 million.
With sales like that, you might conclude that Lunesta works really well. The label says only that the drug is better than placebo. How much better? In the biggest, longest clinical trial, Lunesta helped insomniacs fall asleep about 15 minutes faster (on average) than those on placebo. They slept a bit more than half an hour longer. According to data the FDA has, there was “no clinically meaningful improvement in next-day alertness or functioning,” but you won’t find that statement anywhere in the drug label.
Another prescription sleeping pill, Rozerem, was no more impressive. As Schwartz and Woloshin note, “there were no subjective improvements in total sleep time, sleep quality, or the time it took to fall asleep.” An FDA review before approval concluded that the drug had “marginal clinical significance.” In other words, Rozerem just barely made it through the FDA approval process, but the label did not reflect this. Television commercials (many involving Abe Lincoln and a badger) implied that Rozerem was a new advance for fighting insomnia.
Some side effect information may also be lacking in the official label. That means doctors may not know about certain serious adverse reactions before prescribing a new drug.
Perhaps it’s time to get as much information about our prospective medicines as we can about a new TV. Doctors and patients deserve an easy-to-read summary of the true benefits and risks of prescription medications.