Ketek Probe Snares FDA Chief

In a stunning turn of events, the Congressional probe into Sanofi-Aventis’ drug Ketek has snared the head of the FDA, Andrew von Eschenbach, M.D. The FDA chief is now under investigation for perjury in light of his testimony concerning Ketek. The FDA approved Ketek in 2004 to treat respiratory tract infections, bronchitis, sinusitis and community-acquired pneumonia. Soon thereafter, reports concerning liver damage began surfacing in those who used Ketek. During the Congressional probe of Ketek, the committee learned that Dr. Eschenbach’s testimony was not entirely truthful. Now, the FDA is stonewalling and refusing to hand over documents related to Eschenbach’s written testimony concerning the safety of Ketek and its subsequent approval. On February 12, 2008 the committee heard testimony from Douglas Loveland, a special agent at the FDA´s criminal-investigation office, told the committee that Aventis should have known there was fraud and there was a “catastrophic failure” of their clinical trial systems. They ignored “red flags” about the bogus data, “they were loud signals…they were bright signals.” Congressman Dingell responded by asking, “What is in those briefing books that he does not want either my Republican colleagues or our side to see? Is there evidence of perjury? Are there statements embarrassing to the administration?” He went on to say that “Neither Chairman Stupak nor I will tolerate such a perversion of Congressional powers to investigate and probe.” Dr. David Ross, the FDA’s chief examiner of Ketek was concerned about problems with Ketek and that the clinical trials contained information that was blatantly fraudulent. When he attempted to turn his findings over to the FDA advisory panel he was blocked.