Reminder: Ketek Clinical Fraud Hearing Today
The House Energy and Commerce committee’s subcommittee on oversight and investigations will hold a hearing at 11 a.m. EST to explore what Sanofi-Aventis knew about the problems with clinical trials for its Ketek antibiotic. Last February, the FDA withdrew approval for two of three uses for the drug, and issued a Black Box warning for use in treating community-acquired pneumonia, which was issued issued in the wake of numerous Ketek patients suffering 93 adverse events, including 12 deaths.
Among the witnesses will be Chuck Grassley, the US Senator from Iowa, and Ann Marie Cisneros served as a clinical research associate for PPDI, a contract research organization that conducts clinical trials on behalf of drug sponsors. Last February, Cisneros appeared at a hearing held by the same committee focusing on the FDA’s failure to ensure safe prescription drugs. Cisneros testified that Aventis knew of fraudulent clinical trial data involving Ketek, but that the company chose to ignore it. Other witnesses include a Sanofi-Aventis exec and FDA criminal investigators.
