Congressmen Fault FDA, Aventis, IRB in Ketek Study

-FDA News

02/14/2008 - The FDA, Aventis, a contract research organization and an institutional review board (IRB) all failed to report or investigate fraud committed in a clinical trial of Aventis’ antibiotic Ketek, a House subcommittee charged.

The House Oversight and Investigations Subcommittee hearing focused on Study 3014 of Ketek (telithromycin) and the fraud committed by clinical investigator Anne Kirkman-Campbell, who is serving a 57-month prison sentence for falsifying study data.

Three FDA criminal investigators testified in detail about their investigation of Kirkman-Campbell’s site. One investigator said he had asked for support from the Center for Drug Evaluation and Research and the FDA’s Division of Scientific Investigations but did not receive the backing he needed.

When the FDA was preparing to audit Kirkman-Campbell’s site, Ann Marie Cisneros, a former clinical research associate at contract research organization Pharmaceutical Product Development (PPD), said, “I was told by a trusted and distressed former colleague at PPD that Nadine Grethe, project manager at Aventis, coached Dr. Kirkman-Campbell on how to explain away some of the site irregularities. I was called on two occasions by PPD lawyers who reminded me of the confidentiality agreement I signed and advised me not to speak with the FDA without Aventis’ approval and PPD attorneys present.”