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Ketek Investigation Could Yield Subpoenas

Jan 29, 2008 | Parker Waichman LLP

Ketek investigators at the Food & Drug Administration (FDA) could soon be subpoenaed by a congressional committee looking into the agency’s handling of the defective drug.   Ketek, approved in 2004 to treat respiratory tract infections, bronchitis, sinusitis and community-acquired pneumonia, has been linked to liver failure.  The FDA approved Ketek despite knowing that its clinical trials were rife with fraud.

Shortly after its approval, Ketek was linked to serious side effects, including sometimes fatal liver damage. The FDA eventually confirmed 53 cases of liver failure in patients using Ketek, including five deaths. This past February, the FDA finally added black box warnings to the Ketek label and severely restricted its use.

Congressman Bart Stupak and John Dingell, both Michigan Democrats, want to know why Ketek was able to be approved even though the FDA found instances of serious fraud in its clinical trials.  Doctors participating in those clinical trials were paid $400 by Aventis (now part of Sanofi-Aventis) for every patient they convinced to participate in the Ketek study.

That huge financial incentive was too much for some doctors to resist. When the FDA audited study participants, they found one family doctor in a small Alabama town had signed up 407 patients for the study. What else they found during the audit at Dr. Ann Campbell’s was shocking. The doctor’s entire staff was enrolled in the trail. It even appeared that some of the patient signatures on consent forms where forged. So gross were Dr. Campbell’s violations that she was eventually convicted of fraud and sentenced to prison. The FDA also visited several other sites with high numbers of participants, and found serious irregularities at every one.

This afternoon, the House Energy and Commerce Committee Subcommittee on Oversight and Investigation, headed up by Dingell and Stupak, is scheduled to vote on whether or not to subpoena several FDA officials who investigated Ketek trials.  The subpoenas are needed to compel the testimony of Ann Marie Cisneros, a clinical researcher who found fraudulent data in a Ketek study, two current FDA investigators, Robert West and Douglas Loveland, and one former investigator, Robert Ekey.

According to the Associated Press, the subcommittee will also consider issuing a subpoena for internal FDA documents connected with the investigators' work. Congressional aides were told the documents summarize the FDA's investigation of whether Sanofi-Aventis was aware of problems with one of its safety studies before it was submitted to an advisory committee. The document "may recommend prosecution of certain individual and/or entities for the fraudulent trials," according to a memo issued by the subcommittee.  

Stupak is also seeking to subpoena the briefing book for Commissioner Andrew C. von Eschenbach to determine whether he was misled in the preparation of his testimony dealing with Ketek.

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