It should be unthinkable that a medication prescribed to heal could do more harm than good. Drugs have always had side effects, but what patient would consent to take a drug for a relatively minor condition -- say, acne -- if he knew the medication could be fatal?At the very least, patients should know what they're taking, and what the possible dangers are. And at one time, they could have confidence that the Food and Drug Administration was the strictest drug safety agency in the world.
No more. Congress has slowly weaned the FDA off federal funding, to the point where drug companies pick up roughly half the bill for new drug review. In return, drug makers have pushed for a drastically accelerated safety-review time. For most drugs, the FDA has only 10 months to say yea or nay, and must say yes if it can't produce the evidence to support a regulatory refusal within that time.
While the agency plays beat-the-clock with new drugs, its record with established drugs worsens. It takes a virtual train wreck to turn the FDA's attention to problems with drugs that have already been approved.
In the case of acne drug isotretinoin -- marketed as Accutane -- reports of suicidal thoughts and depression among people taking the drug mounted at the FDA for 18 years before the agency took action. By 2001, 37 Accutane takers had committed suicide, and 110 had been hospitalized with depression. That year, the FDA required a stronger warning about potential psychological side effects.
The agency generated even more unwelcome attention with the outcry over the prescription painkiller Vioxx. During congressional hearings, it became clear that the FDA ignored warnings from its own scientists about an increased risk of cardiac problems -- a risk that was not disclosed to the public. As many as 139,000 patients took Vioxx before suffering cardiac "events," including heart attacks and strokes, according to a doctor once employed in the FDA's drug safety division.
Last week, the agency took an across-the-bow hit from the national Institute of Medicine, part of the national Academies of Science. In a report requested by the FDA itself, a 15-member panel of experts blasted the drug approval process from start to finish, focusing particularly on the safety record of already approved drugs.
The panel offered suggestions, including a ban on advertising new drugs immediately after they are approved -- giving doctors time to judge side effects before patients start bombarding them with requests for a specific drug. The experts also suggested that new drugs be labeled with a warning that unknown side effects might emerge.
The FDA offered a promising response, saying it would improve post-approval drug review. But the promises will be hollow if Congress doesn't give the agency the money it needs to monitor medications -- and make it clear that safety, not drug company profits, should be the agency's foremost concern.