October 4, 2016 — Investigators with the British Medical Journal say Janssen Pharmaceuticals withheld concerns about a defective blood-monitoring device during a major clinical trial for Xarelto.
The study — ROCKET-AF — concluded that Xarelto and warfarin had similar rates of bleeding. The device — Alere INRatio PT/INR Monitor — was recalled in July 2016 because it produces inaccurately low readings that could cause a patient to overdose on warfarin and bleed to death.
Janssen became concerned about the accuracy of the INRatio device and implemented a “safety recheck” program in 2008. Those concerns were not shared with the study’s safety monitors or the FDA.
This may have put patients at unnecessary risk, according to the BMJ. It may have also skewed results of the study by causing more bleeding in patients on warfarin.
Janssen and Bayer are now facing around 10,000 lawsuits from people who experienced severe bleeding after taking Xarelto. The drug-makers are accused of downplaying the risk.
In fact, low readings on INRatio devices were known before ROCKET-AF enrolled its first patient in December 2006. The FDA issued warnings to its manufacturer in 2005 and 2006 for ignoring complaints about low readings.
European health officials have already concluded that defective INRatio device readings would not change the overall conclusions of ROCKET-AF.
The FDA is also reviewing the problem, but there is a major conflict of interest — ROCKET-AF was run by Dr. Robert Califf, who was appointed as commissioner of the FDA soon after the study ended.
ROCKET-AF was run at Dr. Califf’s $200 million research institute at Duke University, which receives 60% of its funding from pharmaceutical companies. He was also paid salary and consulting fees from dozens of drug-makers, including Janssen and Bayer.
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