Word: braine
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Dates: during 1990-1999
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FARRAH FAWCETT Foggy at 50. Buns of steel, but brain of Jell...
...several dozen neuroscientists blasting the agency for not opening up the post-approval monitoring process more fully. The FDA, these doctors charge, continues to ignore animal tests that suggest prolonged use of Redux can destroy nerve tissue. "Laboratories around the world have found that the drug has serious brain toxicity," says Dr. Mark Molliver of the Johns Hopkins Medical School. "It has the potential for producing brain damage...
...some respects Redux has been a victim of its own early success. The first new antiobesity medication in more than 20 years, the drug enjoyed one of the fastest launches in pharmaceutical history. Both the FDA and Wyeth-Ayerst Laboratories, which markets Redux, knew about the possibility of brain damage at high doses. But they also knew people who are morbidly obese--individuals who weigh 30% more than average--face even greater risks that they will die young from heart disease, diabetes or stroke. "We made the decision that the benefits outweigh the risks, at least for the population...
...that they put too much faith in the pill to make them thin without their having to eat less or exercise more. But Joseph also suspects a biochemical explanation. Redux, like "fen/phen" before it, boosts the levels of serotonin, a neurochemical that, among other things, signals the brain that the body has had enough food. "If a lack of serotonin is the reason patients are overeating, then Redux should work beautifully," Joseph says. "But if they are overeating for some other reason, then it probably won't do any good. The question no one has answered is, What percentage...
Meanwhile, competition is heating up. Last month an FDA advisory panel recommended approval of a drug called orlistat that works on the gut instead of the brain--reducing caloric intake by blocking the body's ability to absorb fat. Orlistat has its problems--its side effects include intestinal leakage. That doesn't mean orlistat will not be a big seller, at least at first. But if folks buy it expecting weight-loss miracles, they are bound to be as disappointed next year as Redux users are today...