So an interim analysis of an ongoing Glaxo study was
published online this afternoon by The New England Journal of Medicine, and here are the conclusions: Avandia was associated with an increased heart-failure rate, although there didn't appear to be an increased in deaths due to heart attacks or strokes. But the results were also "inconclusive" and "insufficient" to disprove fears.
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."
2 Comments
All fair enough critique, to be sure. It must be said that the Nissen meta-analysis was treated as definitive evidence by the press and by the investment community - and this was wrong. This analysis from the RECORD trial holds far less statistical uncertainty than Nissen's meta-analysis (simply on the basis of clinical trial design/analysis and staticitcal principles), and yet it is quickly bashed and marginalized, when in truth this is what happen to the Nissen analysis. Scientists like Buse and Nathan, while being no doubt nice guys and good doctors, are human - what do you expect them to do, retract all their previous critical statements??? Not gonna happen folks. Again, I cringe at the fact that Avandia is being singled-out as "special" in this case, when all one needs to do also read studies like PROactive, CHICAGO, and FIELD, and you'll know this to not be true! All PPAR agonists have positive effects as intended, but they all also have unintended toxicities that may negate any positives.....Wake up America!! Takeda and Abbott need to be called on the carpet as well. Especially Takeda, whose new Rx for Actos have skyrocketed since the bad news on Avandia.
Ahh...Duh.....