U.S. regulators chastize Sanofi for failing to monitor study

WASHINGTON A unit of Sanofi-Aventis SA failed to properly watch over researchers in a clinical study of its antibiotic Ketek in 2001 and 2002.

The unit failed to “adequately investigate” reports that Maria “Anne” Kirkman-Campbell falsified data and enrolled ineligible patients. Another researcher worked with a suspended medical license and a third signed up patients without written consent.

The drug has been prohibited from being used to treat sinusitis and bronchitis, but is still used to treat pneumonia. Kirkman-Campbell was sentenced to 57 months in prison in 2004, when she plead guilty to mail fraud.

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