A medical research contractor is expected to have some drug makers scrambling. Following two 2010 inspections, an internal probe, and a third-party audit, the Cetero Researchâ€™s Houston, Texas facility was found to have â€œsignificant instances of misconduct and violations,â€ said the U.S. Food and Drug Administration (FDA), wrote Reuters.
Drug companies use Cetero Research, located in Cary, North Carolina, to test medications and evaluate results. Those results may require reevaluation, warns the FDA, which said Cetero had been â€œfaking documents and manipulating samples.” The contractor conducts early phase clinical research as well as bioanalytics for drug makers, which then use those studies to support data included in drug approval applications with the FDA, explained Reuters.
“The pattern of misconduct was serious enough to raise concerns about the integrity of the data Cetero generated during the five-year time frame,” wrote the FDA. The agency is warning drug makers that Cetero studies included with supporting data for applications to the FDA from April 2005 and June 2010 might have to be repeated or confirmed, Reuters reported.
The FDA is asking drug makers to identify if and when Cetero was used when applying for regulatory drug approvals since it is not clear what drugs and drug approvals have been impacted, noted Reuters. The agency did say the request is precautionary and drug safety and efficacy for drugs on the market should not be affected.
The agencyâ€™s May and December 2010 Cetero inspections revealed the contractor issued falsified study records; about 1,900 instances taking place between April 2005 and June 2009, wrote Reuters. In those cases, laboratory technicians indicated that they conducted specific studies that could not have been conducted at Cetero locations at that time, said the FDA in its initial report. The FDA also wrote that, during that time, itâ€™s possible that Cetero might have â€œfixedâ€ studies to either receive the needed result or that it excluded failed results in its findings, said Reuters.
“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 agency said, reported Reuters, which added that Cetero was not immediately available for comment.
No reason for the alleged fraud was given; however, the manipulation of research documents is not new. For instance, we just wrote that GlaxoSmithKline (GSK) was, again, accused of employing ghostwriters to pen articles about its antidepressant drug, Paxil. In 2009, we wrote that Paxil medical journal articles written by GSK consultants were prepared using a sophisticated ghostwriting program that allowed doctors to take credit for the work. In this new case, a University of Pennsylvania professor, Jay Amsterdam, accused 5 psychiatristsâ€”one a Harvard Medical School professorâ€”of allowing their names to be used on journal articles whose content was controlled by SmithKline Beecham, a part of drug giant GSK, said Fierce Pharma.
The Wall Street Journal previously reported that drug industry group PhRMA banned medical ghostwriting as part of new, voluntary clinical trial guidelines approved by PhRMAâ€™s board, which includes officials from most of the larger drug companies.