A May 1 article details Public Citizen’s, a consumer advocacy group, fight for the removal of Avandia from the market. Avandia, the type 2 diabetes drug, has been under fire by Public Citizen since October 2008 when it petitioned the FDA to remove Avandia from the market because of its risks for heart attack and heart failure, among other risks.
Dr. Sidney Wolfe, the spokesperson for Public Citizen, appeared before the House Agriculture-FDA Subcommittee, on April 28, and told the Subcommittee to stop the TIDE study. The TIDE study was requested by the FDA to compare Avandia and its type 2 diabetes competitor, Actos (made by Takeda). The study is composed of 16,000 participants in 14 countries. Wolfe’s appearance before the Subcommittee comes on the heels of a February report commissioned by the Senate Finance Committee that claimed GlaxoSmithKline (GSK) had been well aware of Avandia’s risks, but chose not to disclose the risks to the public or the FDA.
Johns Hopkins conducted a study of 40 randomized, controlled trials involving cardiac risks of older and newer diabetes drugs. The study, Dr. Wolfe explained, concluded that metformin hydrochloride was the only drug on the market that was associated with a decreased risk of cardiovascular mortality. Avandia has an increased cardiovascular risk of 1.68, just below statistical significance, while Actos, Avandia’s competitor, showed no increased or decreased cardiovascular risk.
Dr. Wolfe, referencing the TIDE study, said. “the price of such definitive proof [that Avandia increases the risk of heart attack and heart failure] will almost certainly be measured in the lives of study subjects who have been incompletely informed about the available evidence regarding the risks and benefits of participation.”
Sheller, P.C. is currently handling claims for those who have suffered or lost loved ones due to a heart attack or stroke while taking Avandia.