Senate investigates clinical trial of diabetes drug Avandia and risk of heart failure

Senate Finance Committee members, Max Baucus and Chuck Grassley, have issued a report regarding the FDA’s handling of the diabetes drug Avandia.

Avandia, manufactured by GlaxoSmithKline (GSK), is an oral treatment for type-2 diabetes. Thousands of patients rely on this drug, which acts by making their cells more sensitive to insulin, thus reducing their blood sugar.

In 2007, Dr. Steven Nissen, professor of cardiology at the Cleveland Clinic, published a study of Avandia in the New England Journal of Medicine. This study revealed that patients taking Avandia were at an increased risk for heart failure. A debate within the FDA ensued over what actions to take to ensure patient safety. The FDA requested that GSK perform a clinical trial comparing Avandia and a competing drug Actos, manufactured by Takeda, which has not been implicated in heart failure.

Since 2007, the Senate committee has examined internal GSK documents and they now believe that GSK was aware of the risks of Avandia long before the 2007 study. Instead of warning patients of these risks, GSK chose to minimize the findings. The Senate committee has asked what actions the FDA will be taking to protect patients still enrolled in the Avandia clinical trial.