Johnson & Johnson failed to inform FDA over faulty blood testing device in Phase III trial

pharmafile | September 29, 2016 | News story | Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing Bayer, Johnson & Johnson, Xarelto, phase III, warfarin 

The British Medical Journal, after its own investigation, found that Janssen knew early into the Phase III trial, known as the ROCKET AF trial, that the blood testing device used to test an anti-clotting drug was not working correctly. The trial was for the blockbuster drug Xarelto (rivaroxaban), which was pitted in the trial against warfarin.

It was known early into the trial that concerns had been raised about the reliability of the device used to monitor patients who were taking warfarin. Janssen reacted by initiating a safety programme, called Covance recheck, to monitor the accuracy and reliability of blood test readings against laboratory results.

Carl Heneghan is quoted by The British Medical Journal as saying that the INR device errors “are worrying” as there is “a near exponential increase in bleeding risk with increasing INR.” The suggestion being that the patients who were monitored by the fault device were potentially put at risk of harm during the trial. The journal states that the information was not passed onto the trial’s data safety monitoring board, the co-developer of rivaroxaban, Bayer, and the FDA prior to drug approval.

Both Bayer and Janssen have since launched a robust defence of the clinical trial. A Janssen spokeswoman said: “Janssen and our development partner Bayer will continue to ensure that health authorities receive all required and accurate information regarding past and ongoing clinical trials.

“The companies have disclosed safety data to regulators and the safety monitoring board of the ROCKET AF trial and deny the central premise of BMJ’s report.

“The data in question represent fewer than one-twentieth of one percent of the 366,000 measurements taken during the ROCKET AF trial and they could not have had any impact on the conclusions of the trial.”

A spokewoman for Bayer also commented that “Janssen and Bayer have ensured and will continue to ensure that health authorities receive all required and accurate information regarding past and ongoing clinical trials.”

Ben Hargreaves

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