WIKIMEDIA, TOM VARCOUS Food and Drug Administration (FDA) approval for the blood-thinning drug Eliquis was delayed for 9 months due to errors and misconduct at sites in China where clinical trials were performed, reported Bloomberg. Documents published by the FDA reveal that during trials overseen by Bristol-Myers Squibb (BMS), which developed the drug in partnership with Pfizer, some patients were given the wrong drug, records were badly kept and secretly manipulated to cover up good-practice violations, and “serious adverse reactions” went unreported.
The news raises questions about the reliability of clinical trials carried out in China, which has become a hotspot for such research because of the huge pool of potential subjects and the low costs, which can be as little as half of those in the U.S., according to the Tufts Center for the Study of Drug Development.
Thomas Marciniak, an FDA medical team leader who wasn’t directly involved in the Eliquis application process but reviewed the trial independently, told Bloomberg that problems with data collection and misconduct will continue as long as drug manufacturers keep doing trials in places like China without providing better oversight. “What we need is high-quality trials,” said Marciniak, who emphasized he was not speaking on behalf of the FDA. “If ...
