Food and Drug Administration

Sanofi-Aventis - Fraudulent 'Study 3014' and the drug 'Ketek'

In 2006, the U.S. Senate Committee on Finance (Committee) contacted the Food and Drug Administration (FDA) regarding concerns over the Sanofi-Aventis drug Ketek.

A pivitol study commissioned by Sanofi-Aventis (known as 'Study 3014') which has been used, and continues to be used, as evidence of the safety of the drug was found to be 'marred by fraud' in late 2003/early 2004. One of the investigators involved in the study lost his medical license and another investigator (Anne Campbell) was indicted for falsifying study data. She pleaded guilty in October 2003 and in 2004 was sentenced to 57 months in jail.

Yet the fraudulent nature of the Study was not disclosed to the Anti-Effective Drugs Advisory Committee (AIDAC) who were responsible for approving the drug for use by adults in 2004. It was found that Ketek can cause serious liver damage and failure and there has been many recorded instances of the death of patients through the use of this drug.

In 2006, it is reported that Sanofi-Aventis are conducting trials to test Ketek as a treatment for ear infections and tonsillitis in nearly 4,000 infants and children in more than a dozen countries. Sanofi-Aventis has three ongoing trials in children as young as 6 months old and a fourth trial involving adolescents 13 years of age and older. The Committee voices concern that the parents of these children are unlikley to know of the risks their children are being exposed to and have called on the FDA to 'consider forcing Sanofi-Aventis to withdraw Ketek from the market, severely restrict its uses, even in adults, or add a prominent warning to its label about potentially fatal side effects’.

The Committee also voice concern at the ‘FDA’s complicity with the drug maker and subsequent failure to ensure the integrity of a pivotal study about the benefits and risks of this drug’.

“The allegations of misconduct in this case are as bad as I’ve heard yet,” Grassley (the investigating officer) said. “It looks like the FDA caught the drug company red handed and let them get away with it. On top of that, the FDA failed to set the record straight and, in fact, continues to cite a discredited safety study as a principal reason to feel okay about using this drug.”

See Sanofi-Aventis Group - Fraudulent Activities for further details.