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11/19/2004

Dr. David Graham Blows Whistle on FDA

Dr. David J. Graham, "a 20-year FDA veteran who is the associate director for science at its Office of Drug Safety," claimed before the Senate Finance Committee that "26,000 to 55,600 patients might have died as a result of taking Vioxx," and that "the FDA, as currently configured, is incapable of protecting America against another Vioxx." He pointed to five other currently on-market drugs that present similar risks.

Since 1996, multiple studies have indicated that taking Vioxx seriously increases (by as much as 3x) risks of heart failure and strokes by disabling natural anti-clotting agents in the blood. Merck, the pharmaceutical producer of Vioxx, has always explained away the studies, and the FDA has, until now, bought the rationalizations. The pharmaceutical producers of each of the other five drugs identified by Dr. Graham claimed that there was no scientific evidence of safety problems.

Coming on the heels of the FDA's negligent handling of bacterial contamination at the British flu vaccine plant, we have an agency in crisis (see also: Waxman's report). Its regulatory practices need a complete overhaul, and its scientific oversight needs major strengthening against industry corruption. Republicans will no doubt take this opportunity to push through more of their "peer-review" proposals that apply only to the risks of drugs.

Dr. Graham's study is available on the FDA website (PDF). The FDA's reaction to Dr. Graham's report as described by the AP on October 7:

"Dr. Graham described an environment where he was 'ostracized,' 'subjected to veiled threats' and 'intimidation,'" Sen. Chuck Grassley, R-Iowa, said in a statement after Finance Committee investigators interviewed the researcher Thursday.

Graham told The Associated Press that Grassley's characterization was accurate. Raising safety concerns within the agency is "extremely difficult," the 20-year employee said, declining further comment.

In a prepared statement, the FDA said it "values open discussion and frank exchange about scientific and medical issues" and subjects its scientists to "more rigorous" scrutiny than typical scientific peer reviews.

The Government Accountability Office, an investigative arm of Congress, already has been asked to look into whether the FDA muzzled another staffer who linked antidepressants to raising the odds of children suffering suicidal tendencies. When Merck voluntarily pulled Vioxx from the market on Sept. 30, the GAO was asked to roll the FDA's handling of that controversy into its inquiry.

That report is not expected for months. Grassley's committee is one of three in Congress also scrutinizing the FDA's actions.

A "picture is emerging of an agency that can't see the forest for the trees," Grassley said. "Merck knew it had trouble on its hands and took action. At the same time, instead of acting as a public watchdog, the Food and Drug Administration was busy challenging its own expert and calling his work 'scientific rumor.'"
Update, 11/19/04, 1:18 PM EST: See also, NYT; WP; USAT; Seattle PI.

Graham's testimony has hurt stock values (we're talking billions of dollars). FDA spokespeople are "categorically rejecting" Graham's comments.

 

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