A National Institutes of Health researcher who is a leader in government efforts to combat obesity says she would prefer that the U.S. Food and Drug Administration "have studies that take a longer look at the safety issues" before approving a new weight-loss drug like Acomplia (rimonabant).

Dr. Denise Simons-Morton, Director of the Clinical Applications and Prevention Program, Division of Epidemiology and Clinical Applications at the U.S. National Heart, Lung, and Blood Institute, expressed concern in the current issue of the Journal of the American Medical Association over "possible Acomplia side-effects in light of its only modest effects on weight-loss."

She said the two-year trials of Acomplia that have been presented to the FDA by the drug's developer, Sanofi-Aventis, showed a 2.7-fold higher rate of psychiatric disorders among those receiving the 20-mg dose of Acomplia compared with those receiving placebo (6.2% vs 2.3%)."

"I really think we should be cautious in approving new drugs – especially new classes of drugs – before they are put on the market," Simons-Morton said in an interview. "I would prefer that they have studies that take a longer look the safety issues."

Asked how long new drugs should be studied before being made available, Simons-Morton said: "We have done lifestyle weight-loss studies for at least four years. Weight-loss medications should have to be tested as least as long. I do think we may see side effects we wouldn't have known about."

Simons-Morton expressed concern that if Acomplia was prematurely approved, "there might be a clamor for it, and doctors might be inclined to use it prematurely. The whole weight loss drug area worries me because 65 percent of Americans are obese or overweight. Can you imagine putting all of those people on medication?

"I know that people want new drugs, but I really feel that we should be cautious," Simons-Morton added. "For some reason, people think there is going to be a magic pill. I don’t think one exists, and I don’t think one ever will."