The furor over Avandia is, by no means, confined to criticism of the FDA and Glaxo. In an editorial this week, The Lancet urged calm and chastised media coverage. So Medscape asked a few prominent docs what they think of all this and, not surprisingly, a couple of harsh remarks were made.

The most provocative came from Steve Haffner of the University of Texas Health Science Center in San Antonio, who was involved in Glaxo’s ADOPT study of Avandia. He said the results of Steve Nissen’s analysis in the New England Journal of Medicine weren’t a surprise, as the two large studies conducted, ADOPT and DREAM, suggested some increased cardiovascular risk.

“The FDA was well aware of the cardiovascular data with (Avandia). The cardiorenal advisory board has a calm and sedate head, unlike Steve Nissen. They would have come to the right decision to put a black-box warning on the label, which is what they will still do, in my view. They are not going to pull it from the market. So, the data would have come out anyway, but without so many fireworks. I don’t think throwing Molotov cocktails is the way to go about these things.”

Haffner goes on to say that Nissen’s paper needed to be published, but should have undergone a more extensive review, and there should have been a different editorial with more emphasis on the flaws of the study.

“The NEJM was irresponsible to go to (Bruce) Psaty and (Curt) Furberg for the editorial - they were always going to emphasize concerns about drug safety; that’s what they do,” Haffner fumes. “But I’m not surprised this paper was published like this. The three major medical journals are becoming more like British tabloid newspapers - all they lack is a bare-chested woman on page 3.”

Medscape didn’t point out, however, that Haffner has received speaking fees from Glaxo and other drugmakers. (Although Bill Childs of the Torts Prof Blog reminds us that Psaty and Furberg, who wrote the NEJM editorial, have served as expert witnesses for plaintiffs’ lawyers in trials involving pharmaceuticals).

For more comments, see Medscape.

Hat tips to PharmaGossip and KevinMD[tags]Avandia, GlaxoSmithKline, Steven Haffner[/tags]