NEJM Reviewer Leaked Avandia Study To Glaxo

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steven-haffner.jpgEver wonder how Glaxo was able to respond so quickly and authoritatively to the controversial meta-analysis published last May in The New England Journal of Medicine? This was the study linking the Avandia diabetes pill to a 43 percent increased risk in heart attacks and strokes. Well, it turns out that a peer reviewer for the journal broke confidentiality and leaked the damaging analysis to Glaxo ahead of publication, according to Nature (subscription required).

Exactly 17 days earlier, Steven Haffner of the University of Texas Health Science Center at San Antonio faxed his copy of the article to Alexander Cobitz, a Glaxo employee who Haffner knew from working on an earlier Avandia clinical trial. “Why I sent it is a mystery,” Haffner told Nature. “I don’t really understand it. I wasn’t feeling well. It was bad judgement.” He adds that Cobitz didn’t ask to see the draft and was “probably a bystander.”

A Glaxo spokeswoman, Nancy Pekarek, tells Nature the drugmaker didn’t offer any input to Haffner about the NEJM analysis, and that she wasn’t aware of anyone at Glaxo informing the journal of the confidentiality breach. Haffner, Nature writes, had earlier served on the steering committee of a Glaxo- sponsored Avandia trial. He says that he’s given many talks for Glaxo, but declined to say how much he was paid. “I’ve got a considerable amount of money,” he tells the mag. “I didn’t do it to raise my income or anything like that.”

Meanwhile, Chuck Grassley, the Republican from Iowa who sits on the Senate Finance Committee and probes drugmakers, has sent this letter to Glaxo to learn what Glaxo did with the leaked info.

Glaxo, of course, strongly contested the study’s methodology and “strongly disagreed” with its conclusions, Nature notes. Then, on June 5, Glaxo-sponsored researchers published in the journal’s online edition an interim analysis of the drugmaker’s own Record trial, a prospective study launched in 2001 to monitor adverse cardiac events. The June report referenced the May study and maintained the new data Record data “were insufficient” to determine whether Avandia increased the risk of a heart attack, Nature writes.

As Nature points out, the interim Record analysis was published just 15 days after the NEJM analysis. Pekarek says Glaxo’s advance knowledge of the NEJM study “added an additional sense of urgency” that prompted the fast publication. Karen Pederson, an NEJM spokeswoman, tells Nature that the journal doesn’t discuss specific peer reviewers, but adds that any reviewer who breaks confidentiality is banned from future reviewing and from contributing editorials and review articles.

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  1. Good to hear that Steve is not strapped for cash!

    I was planning a whip-round!

    LOL

  2. Involuntary leaking…..? Ambien fugue state?

    Life is complicated. It’s indeed possible he was just lonely. Perhaps hoping for a GSK teddy bear or something.

  3. It’d be interesting to know if Haffner was an NEJM peer reviewer for the RECORD article as well.

  4. Heathen! Haffner knows better than to do something like this! What in the world was he thinking? Or wasn’t he thinking? Sounds like he became too “chummy” with one of his handlers. When will the academics (aka key opinion leaders or KOls) realize that they are simply putty in the hands of Big Pharma? They lose their integrity and then their reputation. Steven is just another case in a long line - he’s not the first to have a major lapse in judgement and he certainly won’t be the last.

    I hope that he’s tenured. Then again, he brings so much money in for the university, he may not even be at risk. And don’t let him kid you, he’s been very, very, very well compensated for giving talks and being an “expert” in his field! It will be very interesting if he has to come clean on who’s paid him how much and when. Bad decisions.

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