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FDA Accuses Sanofi of Fraud in Ketek Trials

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A former clinical research associate who worked on the clinical trials for the antibiotic, Ketek, said that researchers and Sanofi-Aventis worked together to defraud the FDA. Ketek has been linked to liver problems and according to allegations by the FDA the manufacturer, Sanofi-Aventis, made deliberate efforts to conceal evidence that would be harmful to the drug during the post marketing clinical trial known as study 3014. When reviewing the data of study 3014 the FDA discovered several investigators that worked on the project violated FDA protocol.

Much of the focus on fraud revolves around Dr. Anne Kirkman-Campbell, a Sanofi-Aventis investigator who was accused of falsifying consent forms and convicted of fraud and sentences to 57 months in prison. Kirkman Campbell was also fined over half a million dollars and ordered to repay the company over nine hundred thousand dollars.

Ann Marie Cisneros was speaking as a witness at the hearing on the adequacy of the FDA to assure the safety of the drug supply, before the House Committee on Energy and Commerce members.

In her testimony, she said that both her former employer PPD and Aventis knew that there were discrepancies in the clinical trial data included in study 3014 and there were also problems at the site but said neither of the companies took any action.

Cisneros testified that Dr. Kirkman-Campbell engaged in fraud, but Sanofi-Aventis was not the victim of the fraud but rather a willing participant.

Since approval in 2004 over five million prescriptions for Ketek have been filled. The drug now carries a warning for liver risk and is no longer recommended to treat a full gamut of illnesses but rather specifically pneumonia. At least 14 patients have experienced liver failure, after taking Ketek, with four of them resulting in death.