Word: fda
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Dates: during 2000-2009
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...after reports that the risk of heart attack or stroke doubled among a group of Vioxx users. Vioxx was summarily yanked from the market and the tort lawyers immediately canceled lunch. Celebrex was also implicated because it's in the same drug class. It's still available, but the FDA has called for a black-box warning about the added danger...
While the state-of-the-art images have thrilled thousands of moms-to-be, the same isn't true for many of their doctors. Generally, ob-gyns make it a practice to avoid exposing fetuses to powerful sound waves any more than is necessary. Both the FDA and the American College of Obstetricians and Gynecologists (ACOG) have warned against the trivial use of sonograms. Yet several keepsake-ultrasound companies actually offer discounts to encourage repeat visits...
...FDA has issued several warnings over the past decade against the use of keepsake ultrasounds, and last year its consumer magazine went so far as to list an address readers could use to alert compliance officers whenever retail sonographers set up shop in their community. Since then, a few states, including California and Illinois, have proposed legislation banning such ultrasounds. In the meantime, says Copel, "physicians can do a fair amount to blunt the impact of these places." If provided with a blank videotape beforehand, his staff will happily pop it into the VCR and record the sonogram for posterity...
Beefing up the FDA's safety portfolio or farming it out to another agency are two ways to address that kind of failure. Another would be for manufacturers to design their drug trials so that more attention is paid to the effects on all patients who take them, not just the relatively healthy ones usually used in their studies. A fourth would be to force drug companies to publish all their clinical data, not just the data that show their product in the best light. Editors at several prominent research journals are calling for measures that would do just that...
...meantime, the FDA keeps plugging along. It's a small agency with a fine old tradition dwarfed in both budget and political power by the pharmaceutical giants it is being asked to police. It's going to take more than a three-day hearing to straighten that out. --Reported by Perry Bacon Jr. and Mark Thompson/Washington and Alice Park/New York