Word: fda
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Dates: during 2000-2009
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...however, the flurry of activity has done little to mollify critics both outside the agency and within. "I think the FDA is beginning to admit, in sort of a halting and hesitating fashion, that it hasn't done a good job with drug safety," says Dr. David Graham, the associate director for science and medicine in the agency's Office of Drug Safety and its chief whistle-blower. Graham calls the latest changes "cosmetic." An FDA official counters, saying they are "significant" and promise to have "a profound impact...
Democrats in Congress argue that the latest dustups show that the FDA needs more regulatory power and a bigger budget to stand up to the pharmaceutical industry. But the most aggressive attacks have come from a Republican, Iowa Senator Chuck Grassley, 71, chairman of the Senate Finance Committee. Normally the FDA would be the province of the Senate Health Committee, which usually has to approve any changes at the agency. But Grassley, whose state has many elderly constituents, has focused on the FDA for a year--ever since he learned that the agency held close to its chest worrisome data...
...once considered the world's gold standard of drug safety, especially after 1960, when it refused to approve thalidomide for use in the U.S. until it had more data and thus spared Americans the birth defects that plagued newborns in Europe and South America. In some ways, the FDA's recent troubles can be traced back to a pair of reforms that were made in the 1990s and hailed at the time as great innovations. Responding to complaints from AIDS activists and the pharmaceutical industry that drug approval was taking too long, the agency in 1992 announced a "fast track...
Then, in 1997, the FDA--this time under pressure from drug manufacturers and their friends in Congress--loosened the rules on direct-to-consumer advertising of prescription medications. Soon the airwaves were saturated with pharmaceutical messages, complete with big-budget videos and catchy jingles. Side effects received scant play, and most viewers assumed that if the drugs were FDA approved, the risks were probably minimal. Patients bombarded their doctors with requests for the new drugs. Harried physicians often acquiesced so they could address what they thought were more pressing needs. Demand for heavily promoted blockbuster drugs quickly soared...
...late 1998, when the first of the COX-2 inhibitors won FDA approval, the stage was set for a debacle. The easiest side effects to detect, once a drug is used by large numbers of people, turn out to be the rare ones. Most doctors don't see very many cases of liver failure, for example. So they notice right away if more and more of their patients get hospitalized for it. The problem with COX-2 inhibitors like Vioxx is that they increase the risk of two very common ailments: heart attacks and strokes. It's much harder...