A former staff member of the Pharmaceutical Product Development (PPD) has claimed that Aventis and PPD – the contract research organization (CRO) hired by Aventis- both knew of fraudulent data in a postmarketing trial for the antibiotic drug during a testimony before a US Congressional subcommittee last week.

The postmarketing study was carried out between November 2001 and March 2002 on behalf of Aventis by PPD, after the FDA required more safety information on Ketek following concerns that it could cause liver problems.

The study was allegedly riddled with fraud, including unscrupulous patient recruitment by some of the enrolling doctors and significant under reporting of adverse events.

To read more about CRO fraud and how it can result in a violation of the False Claims Act, click here.