The Food and Drug Administration (FDA) is warning pharmaceutical companies that they may have to take a second look at any drugs tested by Cetero Research, since it was recently discovered that the research firm was faking test results.
Two independent investigations in 2010 corroborated “significant instances of misconduct and violations” at North Carolina-based Cetero Research. The drug research firm often does clinical research for a number of large drug companies in the early phases of new drugs. The results of the research are then used to support the applications seeking FDA approval.
A significant number of falsified records were uncovered in the investigation. According to the FDA, in at least 1,900 studies conducted between April 2005 and June 2009 the laboratory technicians named as conducting the studies were not actually present at the time of the study. The FDA believes that Cetero may have “fixed” those studies in order to get the results that support the drug companies’ agendas.
The concerns raised by the investigation are so substantial that the FDA has actually told drug manufacturers that they may need to confirm results of any studies completed by Cetero between April 2005 and June 2010. Depending on the “true” results of these drug studies, some drugs may be found to be defective and have to be removed from the market.
Source: Reuters.com, “FDA finds drug research firm faked samples, documents,” 27 July 2011.