January 26, 2005

FDA whistleblower creates more waves regarding Vioxx

Dr. David Graham, an FDA scientist and whistleblower, said he was firmly discouraged from publishing his data questioning the safety of Vioxx, which was recalled last September.

The paper suggested while Vioxx was on the market from 1999 to September 2004, it caused up to 140,000 serious injuries or deaths. A leading international medical journal, The Lancet, was supposed to publish Graham's paper on November 17, but has just released it online.

Graham called The Lancet asking for the paper to be withdrawn from publication because he said he was pressured and firmly discouraged from releasing data questioning the safety of Vioxx. Dr. Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research, contacted The Lancet before the originally scheduled publication date questioning Graham's analysis and the science and integrity of the research process.

Lancet editor Richard Horton said Galson had contacted him by telephone and email to criticize the paper. In an email to Horton, Galson wrote, "Some of the questions involve basic data integrity. (Graham) has declined to address these issues, and we think it's important that your readers know this."

When Horton contacted Graham directly, he said resolution to all the concerns, which he considered minor, was quickly reached. He said he discovered Galson had not even contacted Graham to discuss the points raised.

Earlier this month, the FDA said despite its concerns it would publish Graham's findings on its website. With an upcoming congressional investigation on Vioxx that the FDA must appear, Graham said he believed the agency's actions were in response to political pressure.

For more information on Vioxx safety, please contact us to confer with a Vioxx Recall Lawyer and learn your legal rights and options.

 

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