Confidential studies by Food and Drug Administration officials recommend that GlaxoSmithKline’s Avandia, a diabetes medicine, get pulled from the market because it is linked to heart attacks.
The studies, released as part of a report on Avandia by staff of Senate Finance Committee members Chuck Grassley (R., Iowa) and Max Baucus (D., Mont.), also say any head-to-head trial where patients get Avandia and Takeda Pharmaceutical Co.’s diabetes medicine Actos would be “unethical and exploitative.” GlaxoSmithKline is currently sponsoring a study, called TIDE, where patients get either Avandia, Actos or other medicines.