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Damage Control: How Far Will the FDA Go?

Last Friday, I told you about my newest hero, Dr. David Graham, who blew the whistle on the FDA during his recent testimony on Capitol Hill about the Vioxx recall. It seems the FDA's shaky image may have taken another public relations hit due to Dr. Graham.

According to a series of e-mails obtained by USA Today, the FDA may have wanted to head off further problems by contacting the editor of The Lancet to question the "scientific integrity" of Dr. Graham's study on the dangers of Vioxx. Although the agency claims they made no attempt to block the publication of Dr. Graham's paper, FDA official Steven Galson contacted The Lancet to inform them the report had been submitted before it had been cleared by his agency. Soon afterward, Graham pulled the paper for fear of losing his job.

The bone of contention as the FDA sees it: A Nov. 12 e-mail that alleged discrepancies between the article Dr. Graham submitted to The Lancet and an abstract presented at a scientific conference in May in an internal FDA review. However, that internal report had already been forwarded to The Lancet by Graham and discrepanicies in some calculations had been corrected for future meetings later in the year.

Two days later, Lancet editor Richard Horton sent Galson an e-mail admitting his surprise about the FDA official's "unusual" call in the middle of the review and publication process of a scientific manuscript.

The most telling quote from Horton's e-mail response to Galson: "One could read such an allegation as an attempt to introduce doubt into our minds about the honesty of the authors -- doubt that might be sufficient to delay or stop publication of research that was clearly of serious public interest."

Folks, you be the judge...

USA Today November 29, 2004

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