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Ketek Warning Letter Issued By FDA Following Clinical Trial Fraud Investigation

Oct 25, 2007 | Parker Waichman Alonso LLP

A Ketek clinical trial was rife with irregularities including fraud, but the drug’s maker, Aventis never acted on reports about problems with the study.  Now, the Food & Drug Administration (FDA) has sent a Warning Letter to Sanofi-Aventis, the successor of Aventis, outlining various instances of misconduct by doctors involved in the Ketek clinical trial, and criticizing the drug maker for ignoring those issues.

Ketek, a powerful antibiotic, was approved by the FDA in 2004 to treat sinus infections.   This approval came despite serious concerns with the way clinical trails of Ketek had been conducted.  However, the FDA maintains that it did not rely on the Ketek study detailed in yesterday’s Warning Letter when it approved the drug.  Shortly after its approval, however, 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

Because cheaper antibiotics, like amoxicillin, were already doing a good job of treating sinus infections, the FDA required Aventis to design a study showing that Ketek would work at least as well as existing treatments before it could be approved. Aventis eventually signed up 1800 private physicians to participate in these clinical trails. These doctors were given $400 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.

In yesterday’s Warning Letter, the FDA said that Aventis’ own records showed that there were many instances of “serious protocol violations and regulatory noncompliance by clinical investigators” involved in the Ketek clinical trial.  According to the Warning Letter, the FDA found no evidence that Aventis did anything to correct the problems with the Ketek clinical trial, or remove doctors responsible for violations from the study.  The FDA also criticized the drug maker for failing to make sure the Ketek clinical trail was run properly and for allowing unqualified investigators to participate.

For its part, Sanofi-Aventis claims that it acted in good faith in conducting the Ketek clinical trail.   The company said it was working on a response to the FDA Warning Letter.