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Showing posts with label NEJM. Show all posts
Showing posts with label NEJM. Show all posts

Wednesday, 30 January 2008

Who's Sorry Now? Not Feeling So Good Edition

Posted on 09:50 by Unknown
Nature reports today that a peer reviewer for the New England Journal of Medicine leaked to GlaxoSmithKline that big old Avandia meta-analysis that has been the bane of their existence since it was released in May 2006. (Our coverage of the Avandia debacle can be found here.)

University of Texas Health Science Center professor of epidemiology Steven Haffner, MD, explained to Nature: "Why I sent it is a mystery. I don't really understand it. I wasn't feeling well. It was bad judgement."

Brian Vastag writes in Nature that Haffner faxed the article 17 days ahead of publication to GSK's Alexander Cobitz, whom he had worked with on an earlier trial of Avandia. What happens from there is unclear--though it's not like GSK effectively got out in front of the news, the 17-days head start may have helped them provide a relatively prompt interim analysis of its RECORD study, which was published in the NEJM in June to try to stop the bleeding.

We will likely have more on this later, once the dust settles. For now, we bring you another edition of "Who's Sorry Now?"
  • Steven Haffner to NEJM: Sorry I leaked the Avandia study, but i had a serious cold that day.

  • Senator Grassley's office to Nature: Sorry we broke your embargo on the Avandia news today, but we aren't feeling so hot today ourselves.

  • American Heart Association and American College of Cardiology to patients: sorry we forgot to disclose our potential financial ties to Merck and Schering-Plough, but there's a wicked flu going around the office.

  • Phillies to Mets: Sorry you're spending all that money on Santana, but you're still not winning the NL East this year. Cough.
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Posted in Avandia, NEJM, Vytorin | No comments

Thursday, 16 August 2007

Avandia and Rezulin Redux

Posted on 09:35 by Unknown
We told you about the dangerous parallels between GlaxoSmithKline's diabetes drug Avandia and Warner-Lambert's now-dead TZD Rezulin.

The New England Journal of Medicine has published a piece on making the same connection by Jerry Avorn, a Harvard Medical School professor. I think this quote from Avorn says it all on how he feels about FDA's advisory committee vote (almost unanimous) July 30 to keep Avandia on the market:
"The decision was more suggestive of Rezulin redux (and of Redux) than it was of resolve."
You all remember Redux don't you? To read the whole Avorn piece, click here. As always, your comments are welcome.
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Posted in Avandia, drug safety, NEJM | No comments
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