Any drug company that had medicines tested by contractor Cetero Research may well have a serious safety problem. U.S. regulators issued a warning after Cetero Research was found faking documents and manipulating samples. According to the Food and Drug Administration, two 2010 inspections, an internal company investigation and a third-party audit uncovered “significant instances of misconduct and violations” at a Cetero facility in Houston. The Cary, N.C.-based firm does early-phase clinical research and bioanalytics for a number of drugmakers. The pharmaceutical companies can then use those studies as supporting evidence in drug approval applications to the FDA. That’s a scary thought!
The FDA found a “pattern of misconduct” to be serious enough to raise concerns about the “integrity of the data Cetero generated during the five-year time frame.” Drugmakers were warned by the FDA they might have to repeat or confirm any studies Cetero did in support of their applications between April 2005 and June 2010. At press time, we weren’t sure which drugmakers have used Cetero’s services to apply for regulatory approvals. That information is needed and the FDA is asking companies to identify such instances. The regulatory agency said the measure is precautionary and the safety and efficacy of drugs already on the market are unlikely to be affected. Hopefully, the FDA is correct in that assessment. But I have to wonder how at this stage they would know that with any certainty.
The FDA inspected Cetero in May and December last year and found falsified records about studies. In at least 1,900 instances between April 2005 and June 2009, laboratory technicians identified as conducting certain studies were not actually present at Cetero facilities at that time, according to the FDA May report. The FDA also said at the time Cetero might have “fixed” studies to get the desired result, or did not include failed results in their report. FDA staff had this to say:
Cetero’s May 2010 and December 2010 responses are inadequate because the scope of their internal investigation was far too narrow to identify and adequately address the root cause of these systemic failures.
The FDA should make sure that testing facilities are providing accurate information when they do testing for drug manufacturers. Obviously, safety hazards and tremendous safety risks are created by faulty testing.
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