Scientist blasts FDA over Vioxx, says other drugs pose similar risks.

Publication: Knight Ridder Washington Bureau (Washington) (via Knight-Ridder/Tribune Business News)

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COPYRIGHT 2004 Knight Ridder Washington Bureau

Byline: Tony Pugh

Nov. 19--WASHINGTON -- The recently withdrawn painkiller Vioxx may have caused as many as 139,000 heart attacks, strokes and deaths, a government drug-safety scientist told lawmakers on Thursday. He said the U.S. Food and Drug Administration is "virtually defenseless" against a similar future catastrophe with another drug.

Dr. David Graham, the associate director for Science and Medicine at the FDA's Office of Drug Safety, made the charges in a scathing assessment of the FDA's reviews of drugs already approved and marketed.

Graham told the Senate Finance Committee that his agency's earlier projection that Vioxx may have caused roughly 28,000 heart attacks or sudden cardiac deaths was "an extremely conservative estimate." Graham said Thursday that the number of deaths alone may have been as many as 55,000.

Graham blamed the Vioxx deaths on the FDA's decision in 1999 to approve Merck & Co.'s sale of the drug, despite data that suggested the arthritis medication was linked to...

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