Word: wyeth
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...trigger problems much more serious than a dull sex life. Just 1 1/2 years after it approved Redux for treatment of obesity, the FDA issued a warning advising patients to stop taking it and its close chemical cousin fenfluramine immediately. At the same time, the drugs' manufacturers and distributors, Wyeth-Ayerst Laboratories, told physicians to stop prescribing them and took the dramatic step of pulling both medications from the market. The reason for such haste: new evidence had revealed that as many as 30% of Redux and fen/phen users could develop abnormalities in the shape of their heart valves--changes...
...works, an endless stream of flowers, landscapes, crosses and skulls that generated enormous attention and an O'Keeffe industry that rarely flagged. In 1987, a year after her death at age 98, 438,000 people visited her retrospective at the National Gallery of Art in Washington. (By comparison, Andrew Wyeth--perhaps postwar America's most cherished artist--drew 558,000 visitors to his retrospective at the National Gallery.) That same year O'Keeffe's Black Hollyhock with Blue Larkspur, 1929, was sold at auction for the artist's record of $1.98 million. In the decade since, her paintings have seen...
...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...
Still, the FDA was not entirely satisfied, and as a condition of approval it required that Wyeth-Ayerst conduct a follow-up study to determine whether Redux users were suffering any ill effects from the drug. Wyeth-Ayerst's critics say the company has been dragging its feet. Wyeth-Ayerst, for its part, says it is pleased with Redux's sales and is ready to start the tests, but that the FDA still has not decided how the study should be designed...
...meantime, the drug has become a magnet for bad press--most of it unwarranted, if not downright false. In February, after the FDA met behind closed doors with officials from Wyeth-Ayerst to iron out details of the follow-up study, critics cried "cover-up"--as if the FDA never granted drug companies private meetings in order to protect trade secrets. In April the Associated Press reported that a 38-year-old, 120-lb. woman had died after taking Redux for just a few days. It turned out that she weighed 220 lbs. and was in fact murdered--a turn...