Interpreting the FDA Advisory Panel Vote on Avandia
Three days ago, I wrote about the diabetes drug Avandia and the allegations in The New York Times that its manufacturer GlaxoSmithKline (GSK) hid test results indicating the increased risk of heart attacks from using the drug. At the time of that post, a Food and Drug Administration (FDA) advisory panel was scheduled to meet and discuss Avandia.
Well, the advisory panel has met. The results of that meeting can be "spun" by both sides of the debate. What is clear is that a significant majority of the panel voted that Avandia does increase heart risks. Yet, the panel did not vote to remove the product from the market. How can the results be interpreted concerning Avandia's future?
Harlan Krumholz is a physician who is also a Professor of Medicine and Epidemiology at Yale. Yesterday, he wrote a column in Forbes providing his interpretation of the panel's vote. In his column, he aptly stated: "This is a drug with a cloud hanging over it." Although the panel did not vote to remove the product from the market, a clear majority voted either to remove the product or restrict its marketing. His article provides some excellent opinion concerning how to interpret the panel's vote. Interestingly, on the same day as the panel meeting, GSK apparently agreed to settle a large majority of the lawsuits currently pending against it as a result of Avandia, for the sum of $460 million.
