July 27, 2015 — Bloomberg reports that the FDA delayed approving Eliquis for nine months after finding evidence of major fraud and other problems at a Chinese clinical trial site.
China is becoming a popular country for large clinical trials because there are a lot of people and costs are lower. However, questions remain about the integrity of data.
In Shanghai, the ARISTOTLE clinical trial was supposed to compare deaths among patients on Eliquis versus warfarin. However, one death went unreported and other “serious adverse events” were concealed, documents from the FDA show.
There were also many problems indicating poor overall quality-control. For example, several patients were lost during follow-up, and some patients who were assigned to receive Eliquis received warfarin instead.
The FDA also said records were changed, falsified, or disappeared after the agency announced that it planned on inspecting the clinical trial site — reportedly on the order of a Chinese-based employee of Bristol-Myers Squibb, according to the Wall Street Journal.
A growing number of lawsuits accuse drug-makers of failing to adequately test Eliquis or warn about the risk of uncontrollable bleeding. Unlike warfarin, which can be reversed with a dose of Vitamin K, Eliquis was introduced without a reversal agent. This is a serious problem because bleeding is the most common side effect of Eliquis. Without a reversal agent, patients who start bleeding can potentially bleed to death.
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