GlaxoSmith And FDA: Will Avandia Get A Clean Bill of Health?
I think I just killed a tree. This morning I printed out the GlaxoSmithKline and FDA documents that were posted on the agency's Web site ahead of the advisory committee meeting on Avandia safety next Monday. About 700 pages! Nearly as many pages as the new "Harry Potter" book, but not nearly as entertaining.
Actually, I bought the 'Potter' book on CD and haven't started listening to it yet (The narrator, Broadway veteran Jim Dale, by the way, is incredible. Don't know how he does it, but he slips from one character's voice into the next.) I digress. Contained within the documents are the results of a new GSK study (I wonder how much it cost) of the health insurance records of 400,000 diabetics that apparently show Avandia carries no greater heart attack risk than other diabetes drugs. We'll find out on Monday how much weight that carries with the huge panel.
The FDA has put nearly two dozen voting members on the committee for this meeting. The typical panel usually has around eight or 10. Now that the makeup of the committee is public, analysts will be busy checking out each member and trying to predict which way they might vote. At least a couple of senators claim the group is stacked in GSK's favor. The FDA staff's documents say the agency has "considerable concern" about the potential heart attack risk with Avandia, but adds that there are "somewhat inconsistent findings" regarding that risk.
The panel will hear from both sides Monday and then in the late afternoon vote on recommendations that could possibly result in a severe safety warning being put on the Avandia label or maybe even the drug being ordered off the market.
If you want some good bedtime reading go to www.fda.gov. Click on Advisory Committees, then Drugs and then on the Endocrinologic and Metabolic Drugs "Go" tab and you, too, can wipe out a forest.