Why are Americans dying to be thin?Sep 9, 2003 | NewJournalOnline
Millions of Americans are considered obese to the point where it's become an epidemic. That's why the notion of a pill that can magically melt away the pounds is so alluring.
The public's hunger for weight-loss drugs makes them wildly profitable. But the same demand should increase the diligence of the U.S. Food and Drug Administration in making sure those "magic pills" are safe. Unfortunately, that's never been the case and now the FDA has another diet-pill scandal on its hands.
In 1998, Knoll Pharmaceuticals launched an aggressive, $50 million campaign for a new weight-loss aid called Meridia. The campaign showed smiling, active people, dinner plates with food left on them and a voice-over promising that the drug would help in the quest to eat less and lose weight. "You do your part," the voice-over crooned. "We'll do ours."
Even as the ads aired, however, Knoll Pharmaceuticals and the FDA knew that Meridia was potentially dangerous. In 1996, an FDA advisory committee charged with reviewing Meridia's safety voted 5-4 against approval, finding that it sharply increased blood pressure, leading to a risk of heart attack or stroke. That was particularly disturbing in a diet drug, since obese people already face increased blood-pressure risks.
For these risks, the payoff was relatively small: Weight loss among Meridia users averaged less than seven pounds.
The warnings are proving true. Since 1998, 49 Meridia users many of them young have died from cardiovascular disease, according to health watchdog Public Citizen, which requested FDA records through the Freedom of Information Act. An additional 124 people have been hospitalized for similar problems, and there have been nearly 400 reports of "serious adverse reactions." The drug has also been tied to a small number of birth defects in babies born to women who took Meridia.
Knoll Pharmaceuticals was also invesgated for under-reporting incidents associated with the drug including eight deaths and signed a multi-million consent decree with the FDA in 1999. The same year, the company was ordered to pull the TV and print advertisements that extolled the virtues of the drug, saying they didn't present a fair picture of the dangerous side effects.
The history of this drug raises disturbing questions about the FDA's approval process. Why is Meridia still available? Why was it ever approved in the first place? How much damage is being done by other drugs that should have been reviewed more carefully, and weren't?
The FDA seems to be hoping that the furor will go away or at least, go unnoticed. But pressure continues to increase. Last week, Public Citizen renewed its demand that the drug be banned.
The petition should be granted. But beyond that, the FDA must conduct a serious examination of how these dangerous drugs make it to market in the first place and do a better job of stopping them.