Recently, the British Medical Journal (BMJ) published a report regarding a clinical trial that resulted in FDA approval of the anticoagulant medication Xarelto (rivaroxaban). It involved the use of a device known as the INRatio, a meter designed to monitor the levels of such medications in a patient’s blood. That device was found to provide false low readings and was recalled by the FDA in 2014. As it turns out, that device was used during the clinical trial of Xarelto – the results of which led to FDA approval of the “blood thinner” in 2011.
The study at the center of the controversy, known as ROCKET-AF, was itself questionable. The purpose of that study was to compare the effectiveness of Xarelto, a “new generation” anticoagulant, with that of the old standby, warfarin (a form of rat poison that was first used for medical purposes in the 1950s). ROCKET-AF was funded by Bayer and Johnson & Johnson subsidiary, Janssen Pharmaceutical – the former of which manufactures the drug and the latter of which handles marketing.
Not surprisingly, the ROCKET-AF trial “found” that Xarelto was no different than warfarin when it came to preventing blood clots. The fact that the study was funded by the companies that made and marketed the drug itself should have indicated the strong potential for a conflict of interest, but it gets worse: it turns out that Janssen’s parent company, J&J, was aware of problems with the Alere device, but said nothing to regulators. Supposedly, Janssen cross checked the ROCKET-AF results through a confirmation system known as Covance, but apparently failed to inform its partners at Bayer – as Janssen was largely responsible for supervising the study.
According to the BMJ report, an independent check of ROCKET-AF itself didn’t uncover any impact caused by the INRatio monitor, but stated that such a re-analysis of those results might have provided skewed results. The FDA concurs on the issue of the INRatio. Nonetheless, the fact that Janssen may have been aware of the INRatio defect could mean a rise in the number of INRatio lawsuits associated with legal action against Xarelto’s makers.
Xarelto was touted as a “wonder drug” for patients at risk for blood clots due to hip and joint replacement as well as those suffering from atrial fibrillation (irregular heartbeat). Patients taking Xarelto require less monitoring and have fewer dietary restrictions to deal with than those taking warfarin. Unfortunately, there is currently no antidote for uncontrolled bleeding that may result. A San Francisco biotech firm, Portola, has been working on such an antidote, but that medication has yet to win FDA approval.