Lawmakers investigating the defective drug Ketek have been forced to subpoena current and former Food & Drug Administration (FDA) officials. 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.
At the same time, the FDA updated the Ketek label to include information about reports of fatal worsening of the neuromuscular condition, myasthenia gravis. At the time of the label change, the FDA knew of three reported deaths in myasthenia gravis patients taking Ketek.
Many Ketek critics say the dangerous antibiotic should never have been approved for use because of the widespread fraud committed by doctors involved in the drug’s clinical trials. 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.
In October, the FDA sent a Warning Letter to Sanofi-Aventis, outlining various instances of misconduct by doctors involved in the Ketek clinical trial, and criticizing the drug maker for ignoring those issues. But it appears the FDA ignored the fraud as well, because it still approved Ketek in spite of the irregularities found in the clinical trials.
The congressional subcommittee has been trying to figure out why the FDA went ahead and did so. But the FDA hasn’t been very cooperative, so the subcommittee was forced to take the drastic action of issuing subpoenas. “Unfortunately, the FDA has been less than forthcoming with either witness or document production in connection with our drug safety investigations,” said Rep. Bart Stupak, the Democratic chairman of the subcommittee on oversight and investigations.
Yesterday, the subcommittee voted 12-0 to issue a subpoena 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 FDA and HHS have refused to provide those documents in the past.
The panel 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 lawmakers want to question the witnesses about “their knowledge of whether Aventis was aware of substantial data integrity problems in Study 3014 at the time of submission to FDA.
The subcommittee will hold a third hearing into the Ketek debacle on February 12.
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