FDA cites fakes results in Sanofi study

-Business Week

10/25/2007 -  Government investigators say drug maker Sanofi-Aventis ignored misconduct by doctors who helped test an antibiotic that was later linked to several deaths.

The Food and Drug Administration sent a letter to Sanofi this week outlining numerous problems with its 2002 patient study of Ketek. A series of Congressional hearings were held last year after several users of the drug developed serious liver problems and died.

FDA said even after Sanofi identified problems with multiple physicians in the study, "violations persisted."

The government said one physician who worked on the Sanofi patient study fabricated data and in one case fabricated a patient's existence. Even after raising concerns about the researcher with Sanofi, government investigators said the company did not discipline or fire the physician.

FDA limited use of Ketek earlier this year to pneumonia and said it should not be used to treat less serious illnesses. Previously, the drug was prescribed to treat bronchitis and sinus infections.

Calls to Sanofi were not immediately returned.

Shares of Sanofi-Aventis rose 25 cents Thursday to $42.46 in morning trading.

If you or a loved one have experienced liver damage, liver failure, or Stevens Johnson Syndrome as a result of Ketek side effects contact the Ketek attorneys of Ennis & Ennis today for a free confidential case evaluation. Our on staff nurse and attorneys are standing by to answer any questions you may have regarding Ketek side effects, a possible Ketek class action lawsuit, or any other type of Ketek litigation.