U.S. FDA's Graham Says He Was `Forced' to Become Whistleblower

November 26, 2004

SSRI-Research@

Wed, 24 Nov 2004 21:30:58 -0500

U.S. FDA's Graham Says He Was `Forced' to Become Whistleblower

Nov. 23 (Bloomberg) -- U.S. Food and Drug Administration doctor David

Graham said circumstances at the agency ``forced'' him to become a

whistleblower to protect consumers from dangerous drugs.

Less than a week after Graham told a Senate Finance Committee of his

concerns about the FDA, he appeared on ABC's ``Nightline'' program.

Graham told the Senate panel that his research has led him to estimate

that Merck & Co.'s Vioxx hurt 88,000 to 139,000 Americans, with 30

percent to 40 percent of them dying.

The Vioxx withdrawal, the biggest for a prescription drug, is leading

Congress to take a closer look at the FDA. The House Energy and

Commerce Committee today said it will examine the agency's monitoring

of Vioxx. The committee, which oversees the FDA, already was examining

whether the agency delayed telling the public about risks of

antidepressants.

``We have a system that is biased toward approving drugs almost

regardless of the safety risks,'' Graham said in his ``Nightline''

interview. ``Any reason will be looked for to approve a drug, unless

there's an overwhelming safety reason not to approve a drug.''

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