Concerns have risen that one of the giants of the pharmaceutical world, Johnson & Johnson (J&J), withheld information about a defective blood testing device used during in a key trial testing of a popular anti-clotting drug. Janssen executives were aware early on in the trial testing of concerns about device malfunction and implemented a safety program called Covance Recheck to monitor the accuracy and reliability of blood test readings against laboratory results. J&J kept the data concerning the defective equipment during approval of their extremely popular anticoagulant rivaroxaban, sold as Xarelto, from the U.S. Food and Drug Administration (FDA)
In an investigation published by the British Medical Journal (BMJ) it was revealed that J&J also neglected to share this information with the test trial’s data safety monitoring board, Bayer, the co-developer of rivaroxaban. The trial was known as the ROCKET AF trial and was published in the New England Journal of Medicine in 2011. The Xarelto test trial compared rivaroxaban with the older, established anti-clotting drug warfarin. Xarelto and Warfarin are both used to prevent strokes in patients with irregular heartbeat, or atrial fibrillation, reports inews.co.uk.
Rivaroxaban, a “new generation” of oral anticoagulant, works by preventing blood from clotting and is marketed as a better option to the widely-used warfarin because patients do not need regular blood testing and the somewhat strict diet regimen as is required with warfarin.
The BMJ raised concerns about the ROCKET AF trial results in February 2016 after the blood testing device was recalled for giving falsely low readings. Requests were made by doctors and researchers for the data to be independently checked, but Janssen and Bayer said an “independent reanalysis” showed the device had not affected trial outcomes, according to inews.co.uk.
Both European Medicines Agency and the FDA have not altered their recommendations regarding the use of Xarelto, although the FDA said it is “investigating.” Carl Heneghan, a professor at Oxford University, believes patients in the trial may have been put at undue risk of harm. He told the BMJ that the INR device errors “are worrying” as there is “a near exponential increase in bleeding risk with increasing INR.” International normalized ratio (INR) is a calculation used to monitor individuals who are being treated with blood-thinning medication.