The Vioxx disaster

Before it was removed from the market in 2004, Vioxx may have hurt hundreds of thousands of patients, killing a third of them, a senior FDA investigator said at the time.

Dr. David Graham, in interviews and Congressional testimony, criticized his own agency’s approval process of the pain reliever.

Graham described the outcome of Vioxx as “a disaster,” one that is “unparalleled in the history of the United States” and that “constituted an unprecedented failure of the nation’s system of drug approval and oversight.”

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Vioxx is a good example of how badly wrong the FDA can get it and how slow it can be to change bad decisions. ABN

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