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That doesn't mean the FDA has declared Redux to be entirely safe. As a condition of approval, the agency is requiring Wyeth-Ayerst to do follow-up testing. "We're concerned," says Bilstad, "that there could be subtle effects that you can pick up only in a clinical study." Among the possibilities: troubling changes in mood, like depression and aggressiveness, that might derive from a serotonin deficit.
The FDA's conditional approval, though, is based on the assumption that Redux will be doled out by well-informed physicians and will be used as intended--by the truly obese, for a limited time, in conjunction with a diet and exercise program. That seems rather naive, considering the history of fen/phen. In the four years since the older treatment has been on the market, clinics have sprung up all over the U.S., especially in the Los Angeles area, to distribute Redux to eager customers. One chain alone, California Weight Loss Medical Associates, has 19 centers and a catchy toll-free number (1-888-4FEN-FEN) that it advertises in the Los Angeles Times, the Los Angeles Daily News and on Howard Stern's syndicated radio show. Some places offer discounts for customers who buy in bulk. Many, says Dr. Michael Myers, an obesity expert in Los Alamitos, California, hand out prescriptions for fen/phen "like cheap Halloween candy."
Predictably, they have started to do the same with Redux. "In Europe," says Dr. Stuart Rich, a cardiologist at Chicago's Rush-Presbyterian-St. Luke's Medical Center and a co-author of the recent New England Journal study, "the majority of people who have taken Redux were looking to lose 10 lbs. to 20 lbs. You can just imagine how popular this medication is going to be here."
If general practitioners and weight-reduction chains get into the act, the problem of inappropriate use could get even worse. Says Dr. Brian A. Joseph, a Naperville, Illinois, physician who is chairman of the ethics committee of the American Society of Bariatric (obesity) Physicians: "These are legitimate medications when used in a responsible manner, as an adjunct to a weight-loss program, by trained physicians." But in the hands of nonspecialists, Joseph fears, these drugs could be misprescribed.
Some general practitioners are certainly enthusiastic. Culver City, California, doctor Ben Krentzman, a family physician, came out of retirement in 1993 to spread the gospel about fen/phen. He now treats some 300 patients--and so far has tallied 63,000 visitors to his Science of Obesity and Weight Control Website. Krentzman's contrarian advice, based on several months of library work and an ongoing experiment begun last year: take the pills instead of worrying about diet and exercise. Says Krentzman: "Dieting and exercise without fen/phen don't keep people slender, so why should they work with fen/phen?"
Most weight-loss experts insist that the reason diet and exercise don't work is that people don't stick with them. But because fen/phen and Redux can be dangerous if they're used too long, and they lose their effectiveness after a few months anyway, patients will eventually have to take up regular exercise and change their eating habits. Neither fen/phen nor Redux alone can "cure" obesity.