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FDA is incapable of protecting US “against another Vioxx”

BMJ 2004; 329 doi: (Published 25 November 2004) Cite this as: BMJ 2004;329:1253
  1. Jeanne Lenzer
  1. New York

    The approval of rofecoxib (Vioxx) by the US Food and Drug Administration has led to the “single greatest drug safety catastrophe in the history of this country or the history of the world,” charged one of the agency's own experts, Dr David Graham, in US Senate hearings last Thursday.

    Dr Graham, associate director in the FDA's Office of Drug Safety, said an estimated 88 000 to 139 000 Americans had heart attacks and strokes as a result of taking rofecoxib. The number, he said, far exceeds earlier disasters such as the 100 children killed in the United States by an elixir of sulfanilamide in the 1930s and the 5000 to 10 000 children born in the 1960s with birth defects related to thalidomide. Both events led to sweeping regulatory changes in the United States.

    Senator Charles Grassley, chairman of the Senate's finance committee, opened the hearings on the FDA and rofecoxib and its manufacturer, Merck, saying he hoped Congressional investigation would help shed “disinfecting sunlight” on the approval …

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