The Only Numbers That Count
While there was great deal of discussion over data and the merits of meta-analysis, in the end the only data that really mattered was how the panel voted.
Question One: Do the available data support a conclusion that Avandia increases cardiac ischemic risk in type 2 diabetes?
Yes 20 No 3
Question Two: Does the overall risk-benefit profile support its continued marketing in the US?
Yes 22 No 1
Unfortunately the panel could not reach a consensus on what to do next, about the only thing we know for sure is there will be some type of label change for Avandia. Just how serious a label change, no one knows for sure. Diabetic Investor is still betting on a Black Box warning when the FDA issues a final decision.
A few interesting/disturbing notes:
1. 1. Actos appears safer than Avandia but the FDA dropped the ball when it came to having sufficient data to back up this claim.
2. 2. The panel was less than impressed with GlaxoSmithKline’s (NYSE:GSK) explanation which had everything in it but the kitchen sink.
3. 3. David Graham, M.D., M.P.H. FDA/CDER Associate Director for Science and Medicine Office Surveillance and Epidemiology who’s presentation made headlines early in the day, really didn’t have the evidence to recommend Avandia be pulled from the market.
While Clifford J Risen, M.D. acting chair of the committee did a commendable job of keeping the meeting on track and allowing all points of view to be heard, today’s meeting was a prime example of just how broken the system is. After all the pontificating, debates of meta-analysis and an endless amount of data patients and the physicians who treat them have no clear guidance on what to do. Although the vote was overwhelming on increasing cardiac ischemic risk, the vote was equally in favor of keeping the drug on the market. Worst of all with no clear consensus on just what to do next, patients and physicians are once again left twisting in the wind.
So after all this, nothing has really changed since Dr. Nissen published his meta-analysis. Actos, Januvia, Byetta and insulin will pick up share and Avandia sales will continue to sink. The question has to be asked; Did anyone learn anything here? Or was this just one huge waste of time and taxpayers money? Given the meeting was held within minutes of our nation’s capital it’s only fitting the result was typical Washington DC- lots of hot air and very little substance. As Diabetic Investor pointed out very early in this whole process there are no winners here only losers.