Avandia drug company GlaxoSmithKline defends its popular diabetes drug in a 30-page “white paper” released February 24 rejecting a recent Senate Report stating that GSK downplayed the safety risks of their diabetes treatment Avandia. The prescription drug maker attacks the Senate Finance Committee’s January 2010 report on Avandia, claiming it is inaccurate, unbalanced and gives an incomplete complete view of the Avandia information currently available. GlaxoSmithKline denies allegations that it had hid and withheld important Avandia safety information.
Following on the heels of a February 20 press release rejecting the Senate Report conclusion that Avandia was unsafe, the lengthy “white paper” is Glaxo’s official response. Glaxo called criticisms of Avandia by FDA official David Graham “flawed and unreliable and, most importantly, do not represent the formal opinion of the FDA”. The prescription drug company claims “glaring omissions” in the Senate report include a discussion of the final results of clinical trials assessed by FDA advisors who voted against an Avandia recall.
“Full consideration of the extensive measures GSK undertook to study Avandia prior to marketing approval, and FDA’s determination that the risk-benefit profile of Avandia is favorable, demonstrates that Avandia is an appropriate treatment option for physicians and patients in the treatment of type 2 diabetes.”