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FDA criticises sanofi-aventisí Ketek clinical trials fraud

The FDA criticises sanofi-aventis for failing to deal with fraud reports during clinical trials for its antibiotic Ketek and did not properly oversee the trial

The FDA has heavily criticised French pharmaceutical company sanofi-aventis (S-A) for failing to deal with fraud reports during clinical trials for its antibiotic Ketek (telithromycin) and did not properly oversee the trial's conduct.

The FDA sent a warning letter to the CEO of S-A's US subsidiary, Gregory Irace. The letter accused the company that it knowingly submitting clinical study data which was obtained by investigators who had committed "multiple and significant violations of FDA regulations that affected the integrity of data submitted".

The suspect data was collected as part of post-marketing study 3014, performed between 2001 and 2002 as a response to the FDA's safety concerns. The studies were carried out by Pharmaceutical Products Development (PPD) on behalf of Aventis, prior to its merger with Sanofi-Synthelabo.

In July 2002, Aventis submitted the results of the study to the FDA. Subsequent data validation inspections by the agency of several clinical investigators participating in the study raised concerns.

In January 2003, the FDA requested from Aventis extra information regarding its monitoring and auditing of clinical investigator sites for the trial. The company then provided this information to the FDA and a lengthy investigation followed.

The investigation is seen as a test case to support the FDA's Bioresearch Monitoring Programme, which was established to evaluate the conduct of research and protect the rights human subjects in clinical studies. The programme also ensures that data submitted in support of new drug applications (NDAs) are scientifically valid and reliable.

The FDA concluded: "Aventis did not adhere to the applicable statutory requirements and FDA regulations governing the conduct of clinical investigations. Aventis' own audits revealed serious protocol violations and regulatory non-compliance by multiple clinical investigators."

The agency added that it was "unable to find evidence" that the company had either solved the problems or had removed the errant doctors from the study. It also criticised Aventis for failing to make sure the study was properly conducted and for allowing unqualified investigators to participate in the trial.

The FDA detailed the case of Dr Anne Kirkman-Campbell, who in 2004 was convicted of fraud over the enrolment of patients and faking consent forms during the Ketek study. She was sentenced to 57 months in prison, fined USD 557,251 and ordered to pay Aventis USD 925,774.

Ketek, which has been linked to a risk of liver damage, was approved by the FDA in 2004, though the agency insists it did not rely on the questionable safety study in approving the drug.

In its defence, sanofi-aventis said it had conducted the study responsibly and would provide a detailed response to the FDA's letter, including remedial actions to prevent the problem occurring again. In 2006, the company added a warning to Ketek's label regarding the potential for liver damage.

Since 2004, five million prescriptions for Ketek have been written in the US. Fourteen patients have suffered liver failure, while at least four have died. Twenty-three more suffered serious liver injury. The majority of the adverse events reported involved healthy subjects.

30th September 2008

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