F.D.A. Panel Rejects Drug for Obesity
A drug once viewed as a possible magic bullet against obesity was rejected yesterday by a federal advisory panel because of worries that it causes neurological and psychiatric problems and increases the risk of suicide.
Although the drug, rimonabant, is already marketed in 37 countries, it is now unlikely that the Food and Drug Administration will approve its sale in the United States without additional safety data.
The advisory panel voted unanimously, 14 to 0, against recommending the drug, saying there was inadequate evidence of its safety. The F.D.A. is not required to follow the advice of such panels, but it typically does.
The drug, which the company had planned to call Zimulti in the United States, works on the brain’s endocannabinoid system. The system was discovered through research into marijuana, which works on brain receptors to give users the “munchies.”
By suppressing those receptors, Zimulti curbs hunger. Clinical studies revealed that patients taking it lost about 5 percent of their weight.
But the same brain system also modulates depression, phobias, anxiety and post-traumatic stress disorder. Testimony before the panel yesterday in Silver Spring, Md., suggested that tampering with the endocannabinoid system also increased such psychiatric symptoms, including suicidal thoughts.
Dr. Hirsch of Rockefeller University said Zimulti’s effects on weight were similar to those of other drugs already marketed — a 5 percent loss followed by a regain of weight.
“The problem I see with this whole thing is that the number of people who are going to lose weight is very small,” Dr. Hirsch said. “You’re telling a 220-pound woman that she has a one in four chance of getting down to 200 pounds if she sticks with the program. That’s not going to make anyone very happy.”
The New York Times, 14th June, 2007
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