BMJ  2004;329 (27 November), doi:10.1136/bmj.329.7477.0-g

Editor's choice

Is drug regulation failing?

The first 150 words of the full text of this article appear below.

Something is rotten at the heart of the FDA. The United States Food and Drug Administration, mired in controversy over the last 12 months, now faces an extraordinary charge of attempting to discredit a whistleblower. As this week's issue reveals, David Graham, the FDA's associate director of drug safety, was so bothered about the difficulties of presenting his data on rofecoxib (Vioxx) in the Lancet that he took his case to the Government Accountability Group, a public interest group that protects whistleblowers. What was extraordinary, reports Jeanne Lenzer on p 1255, was that an FDA manager then called the accountability group to rubbish Graham's account and accuse him of scientific misconduct. In a quandary, the accountability group checked both sides of the story, and found that Graham's version was perfectly credible, while the FDA agent's version failed every test of credibility. It says something of the turmoil within the . . . [Full text of this article]

Kamran Abbasi, acting editor

(kabbasi@bmj.com)


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