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Avandia Study Results Were Leaked Early to Glaxo

The wall between a prestigious medical journal and a major drug company may have been shattered.

The company logo of GlaxoSmithKline, is seen on the headquarters building in London, Wednesday May 10, 2006. GlaxoSmithKline PLC said Wednesday it has been granted a High Court injunction against animal rights activists who sent threats to the drugmaker's shareholders, barring them from sending more letters or revealing private information about the investors. (AP Photo/Alastair Grant)
Alastair Grant
The company logo of GlaxoSmithKline, is seen on the headquarters building in London, Wednesday May 10, 2006. GlaxoSmithKline PLC said Wednesday it has been granted a High Court injunction against animal rights activists who sent threats to the drugmaker's shareholders, barring them from sending more letters or revealing private information about the investors. (AP Photo/Alastair Grant)

The scientific journal Nature reported today that a peer-reviewer for The New England Journal of Medicine leaked key study results on GlaxoSmithKline's diabetes drug Avandia to the company weeks before they were published.

Steven Haffner with the University of Texas Health Science Center in San Antonio faxed the study to a Glaxo employee he had worked with on an earlier Avandia study.

Haffner told Nature, "Why I sent it is a mystery. I don't really understand it. I wasn't feeling well. It was bad judgment. I've got a considerable amount of money. I didn't do it to raise my income or anything like that."

Today, Senator Chuck Grassley, the ranking member of the Senate Finance Committee, sent this letter inquiring about the leak to Glaxo's top U.S. executive.

The study in question--an analysis of many clinical trials--showed that Avandia may increase the risk of heart attacks. UK-based Glaxo's stock plummeted when the results were released May 21.

The Food and Drug Administration put a stiff warning on Avandia's label over the findings.

A Glaxo spokesperson told Nature that the inside knowledge that the company had about the study's pending publication "added an additional sense of urgency" to swiftly get the interim results of a more favorable Glaxo-sponsored study published in NEJM.

Peer-reviewers who break confidentiality rules are typically banned from doing future reviews and writing articles or editorials.

The Glaxo employee who received the fax is the senior director of the company's Metabolism Development Center. A Glaxo spokesperson said Haffner sent the study to the employee to get his take on it, but the company told Haffner it couldn't help him.

The spokesperson says the Glaxo executive "didn't do anything wrong."

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