A Ketek probe in Congress is getting ugly, with one lawmaker threatening to hold federal officials in contempt of Congress for failing to turn over documents regarding the Food & Drug Administration’s (FDA) approval of the drug. A subcommittee of the House Energy and Commerce Committee is trying to figure out how Ketek, one of the most dangerous antibiotics on the market, obtained FDA approval even though an FDA audit of Ketek clinical trials found several instances of fraud.
Ketek was approved by the FDA in 2004 to treat respiratory tract infections, bronchitis, sinusitis and community-acquired pneumonia. Soon after its approval however, the FDA began to receive reports that Ketek was causing liver damage in some patients. This past February, the FDA added black box warnings about liver damage to the Ketek label. In total, the FDA had reports of at least 53 cases of liver damage linked to Ketek. At least five of those cases were fatal, and one required a liver transplant. The FDA also withdrew Ketek’s approval to treat sinusitis and bronchitis.Earlier this month, the subcommittee issued subpoenas to Health and Human Services (HHS) Secretary Michael Leavitt, asking him to produce unredacted records prepared for the FDA commissioner’s appearance at a March 2007 hearing on Ketek. Leavitt’s department oversees the FDA. The committee also approved subpoenas for two current FDA investigators, one former FDA investigator and a former employee of a company that monitored the fraudulent Ketek clinical trials. The subpoenas were necessary because the Bush Administration had refused to release the documents or allow any of the officials to testify.
Rep. John Dingell (D-Mich), chairman of the committee, said yesterday he would consider holding Leavitt in contempt after the HHS Secretary refused to turn over the FDA briefing documents subpoenaed by the committee. The documents were used to prepare FDA Commissioner Andrew von Eschenbach for his appearance before lawmakers last year.
The Ketek briefing documents might include information regarding a Sanofi-Aventis Ketek study that was rife with fraud. When the FDA audited Ketek study participants recruited by the drug’s maker Aventis (now Sanofi-Aventis) they found one family doctor in a small Alabama town had signed up 407 patients for the study. The doctor’s entire staff was enrolled in the trail, and it even appeared that some of the patient signatures on consent forms where forged. Eventually, that doctor was charged with fraud, and sentenced to prison. The FDA also visited several other sites with high numbers of participants, and found serious irregularities at every one.
That study prompted the FDA to issue Sanofi-Aventis a warning letter, but the fraud did not keep Ketek off the market. Last year, Von Eschenbach testified that the FDA did not use the flawed safety study to approve Ketek. Dingell and others on the committee say that statement may be untrue, and they need access to the briefing documents to make that determination.
At yesterday’s Ketek hearing, lawmakers heard from three government staffers who were also issued subpoenas. Robert West, an FDA agent who first investigated Ketek, said he tried to get permission in 2002 to look into whether Aventis was aware of fraudulent data when it submitted the study. West said his request was blocked by senior FDA officials, although he said he did not know which ones.
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