July 27, 2015 — The FDA delayed approval of the blood-thinner Eliquis for nine months after discovering fraud and other major problems with a clinical trial run in China, Bloomberg reports.
The purpose of the ARISTOTLE clinical trial was to study the rate of death in Eliquis users compared to Coumadin (warfarin). However, at least one death went unreported and records were secretly changed.
Other “serious adverse events” were concealed, the documents show. Subjects were “lost” during follow-up, and there were major dispensing errors indicating poor overall quality-control. For example, some patients were assigned to receive Eliquis, but received warfarin instead, and vice versa.
The FDA was also concerned that Chinese researchers changed and falsified records. When the researchers learned that the FDA planned on inspecting the clinical trial site, some records were altered or “disappeared,” reportedly on the order of a Shanghai employee of Bristol-Myers Squibb, according to the Wall Street Journal.
Pfizer and Bristol-Myers Squibb are facing a growing number of lawsuits from people who were severely injured by Eliquis. Like other new blood-thinners Xarelto and Pradaxa, Eliquis was introduced without a reversal agent. Many people have experienced uncontrollable bleeding or died from severe bleeding. In comparison, warfarin can be reversed with a simple dose of Vitamin K.