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Volume 352:1063-1066 March 17, 2005 Number 11 Next

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Testifying before a spellbound audience in a Senate hearing room this past November, scientist and whistle-blower David J. Graham charged that his employer, the Food and Drug Administration (FDA), is incapable of protecting the public from dangerous prescription drugs. Graham, an epidemiologist who monitors drug safety, conducted a study that confirmed an increase in the risk of myocardial infarction among users of rofecoxib (Vioxx), Merck's blockbuster antiinflammatory medicine. When he informed his supervisors about his findings last summer, he said, they pressured him to change his conclusions because they were inconsistent with the FDA's position on the drug's safety. A . . . [Full Text of this Article]

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Dr. Okie is a contributing editor of the Journal.

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What Ails the FDA?
Gorelick K. J., Marcus D. M., Cohen F. J., Jenny-Avital E. R.
Extract | Full Text | PDF  
N Engl J Med 2005; 352:2553-2555, Jun 16, 2005. Correspondence

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