Congress accuses HHS and FDA of contempt in Ketek case

-PharmaTimes

02/13/2008 - The latest instalment in the US Congress’ investigation into the handling of data regarding the controversial antibiotic Ketek has put pressure on the drug’s maker, Sanofi-Aventis and seen government officials and drug regulators stand accused of contempt.

The Committee on Energy and Commerce of the US Congress is continuing its year-long probe into Ketek (telithromycin) which claims that the US Food and Drug Administration approved the drug in 2004 despite knowing that a key safety study contained fraudulent data. Less than a month ago, the Committee subpoenaed documents from members of the US government and the FDA but has had no joy.

Now, John Dingell (Democrat), chairman of the Committee on Energy and Commerce, has launched a broadside against Health and Human Services Secretary Michael Leavitt after the latter refused to turn over the aforementioned documents which were used to prepare FDA Commissioner Andrew von Eschenbach for his appearance before Congress last year.

Rep Dingell said that Secretary Leavitt’s arguments for ignoring the subpoenas are at best specious but “at worse, they border on contempt of Congress. If anything, his refusal to cooperate causes me to wonder what he is trying to hide.” The chairman then asked: “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?

Commissioner von Eschenbach’s lack of cooperation was also criticised and the Committee heard from three FDA criminal investigators who had to be subpoenaed because the agency refused to let them testify voluntarily. One of them, Robert West, said he tried to get permission in 2002 to probe whether Aventis (as the drugmaker was called before its merger with Sanofi-Synthelabo) was aware of fraudulent data when it submitted the study but his request was blocked by senior FDA officials, though he said he didn't know which ones.

Another investigator, Douglas Loveland, described the French drugmaker’s handling of the study as "a catastrophic failure", saying that the decision-making process it used “to investigate these problems was illogical and ineffective and it could have led them to come to the wrong conclusion."


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