Still, the results are "reassuring" to Ron Krall, Glaxo's chief medical officer, who's endured the heat generated by last week's publication of a meta-analysis in the NEJM, which suggested Avandia may increase heart risks by 43 percent. Krall also tells the Wall Street Journal that Avandia's safety profile is similar to other type 2 diabetes meds.
And in a statement, Moncef Slaoui, Glaxo's R&D chief, argues: "The interim findings do not show evidence of a significant difference in cardiovascular death and heart attack between Avandia and the control groups, and therefore do not confirm the hypothesis generated by the recently published meta-analysis in the NEJM that raised concerns about these events with Avandia."
Of course, this is just so much spin. The interim analysis is released, of course, one day before a Congressional hearing into the way Glaxo and the FDA handled Avandia data. And a quick read of the accompanying editorials in the NEJM makes clear that Glaxo has done anything but prove its case.
From the editorial by Bruce Psaty of the University of Washington and Curt Furbert of Wake Forest University: "Even with the findings from the RECORD trial included, the possibility of a benefit in terms of the risk of myocardial infarction remains remote, and there is still significant evidence of harm."
From the editorial by David Nathan of the Diabetes Center at Massachusetts General Hospital and Harvard Medical School: "The interim results of the RECORD trial do not provide any assurance of the safety of treatment with (Avandia)."
And what's the headline for the editorial by the NEJM editors? "Continued Uncertainty Over Safety."