Debate over GSK's Avandia rages as FDA gears up for panel meeting
This article was originally published in Scrip
Executive Summary
Controversy surrounding GlaxoSmithKline's blockbuster diabetes drug, Avandia (rosiglitazone), has reached fever pitch just days before a US FDA advisory panel review of the drug is set to begin on 13 July. GSK has found itself once again defending against attacks from the FDA's drug safety official Dr David Graham and Dr Steven Nissen of the Cleveland Clinic. Both are staunch Avandia critics, who have just had separate publications in major journals in conjunction with the recent American Diabetes Association (ADA) meeting. Now, US lawmakers are also calling for the FDA to justify its reasons for keeping the drug on the market.