Lawmakers skewered the Food and Drug Administration last week over its lax post-market surveillance of the diabetes drug Avandia, which independent studies indicate can increase the risk of heart attack in patients even while it effectively lowers their blood sugar levels.
Approved in 1999, GlaxoSmithKlines Avandia is taken by almost a million Type II diabetics daily. But concerns about the drug were raised last month by a study in the New England Journal of Medicine, which said using Avandia increased the risk of heart attack by 43% and cardiac-related death by 64%.
House Oversight and Government Reform Committee Chairman Henry Waxman (D-Calif.), who called last weeks hearing, said the Avandia case is just the latest resulting from a flawed federal oversight process that can cause fatal results. It is not Congress role to adjudicate these medical issues, Waxman said in his opening statement. But it is our role to ensure that the (FDA) is taking these concerns seriously, and providing doctors and patients with the guidance they need to make informed decisions.
But FDA Commissioner Andrew von Eschenbach defended the agency, saying it approves drugs based on comprehensive, rigorous, disciplined analysis of all the science and data that bear on the evidence. About the Journal study, von Eschenbach warned that the researchers based it on one piece of information in a large portfolio that we have at the FDA.