Word: fda
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Dates: during 1990-1999
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...Redux and fenfluramine are too powerful for the body to handle--a proposition not fully accepted by some doctors despite the FDA and manufacturers' action--research into serotonin-boosting drugs is hardly slowing down. If anything, the discovery of a new set of side effects will spur researchers to hone their pharmacological handiwork even more, to create medicines that will not just fine-tune the way serotonin is used in the brain but might target specific serotonin receptors as well or act on only specific parts of the brain and nervous system...
...finger pointing that followed last week's abrupt withdrawal of two of the country's favorite diet pills looked like a multiple-choice law-school torts exam, the similarity was hardly coincidental. Even before the FDA urged the recall of Redux (dexfenfluramine)--and Pondimin (fenfluramine), the front half of the fat-pill combo known as fen/phen--scores of lawyers across the nation had already started filing lawsuits. After the recall, the legal assault turned into a stampede. "Everyone saw money," says Jacoby & Meyers' Gail Koff...
Much of this legal furor is being vented against Wyeth-Ayerst Laboratories, a subsidiary of American Home Products, which makes fenfluramine and distributes dexfenfluramine, and Interneuron Pharmaceuticals, a small Lexington, Mass., firm founded by the M.I.T. neurologist who developed Redux. There's also talk of bringing action against the FDA--though federal law usually protects government officials from suits challenging routine performance of duties like approving drugs. Whatever the outcome of the legal battles, they leave unsettled larger societal questions--about Americans' infatuation with quick-fix remedies for whatever ails them, real or imagined, and their doctors' willingness to cater...
When fenfluramine was approved in 1973, the FDA declared it safe for short-term use. The assumption: that it would be prescribed for only severely obese patients who seemed impervious to other treatment--"not," as University of Pennsylvania cardiologist Frank Silvestry puts it, "to get into a bikini or wedding dress." But in 1992 all that changed. Studies showed that if fenfluramine was taken with a kindred drug, phentermine, the euphonious fen/phen duo would help dieters shed pounds not only faster but with few side effects. Although the drugs were never approved for combined use, doctors exercised their right...
These cautionary words were all but lost in the hype surrounding the FDA's approval of Redux in April 1996 (after a scientific advisory panel initially voted 5 to 3 against approval). By June, U.S. doctors had scribbled nearly 2.5 million prescriptions for Redux, and the number of people exposed to the drugs rose to an estimated 60 million worldwide...