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Feature Investigation

Manufacturer failed to disclose faulty device in rivaroxaban trial

BMJ 2016; 354 doi: (Published 28 September 2016) Cite this as: BMJ 2016;354:i5131
  1. Deborah Cohen, associate editor, The BMJ, London, UK
  1. dcohen{at}

An investigation by The BMJ finds that companies were aware of concerns about a faulty device in a regulatory trial and reveals data that suggests participants were put at unnecessary risk. Deborah Cohen reports

A drug manufacturer knew about problems with a blood testing device but did not share data before the crucial approval process, an investigation by The BMJ has found.

Janssen, the pharmaceutical arm of Johnson and Johnson, withheld data from the Food and Drug Administration about problems with the INRatio device, which was used in the phase III trial (ROCKET AF) of the blockbuster anticoagulant.

The company generated these data in a safety programme (called the Covance recheck programme) set up after trial investigators became concerned, shortly after the study began, about the accuracy and reliability of the point-of-care device used to monitor patients receiving warfarin.

Janssen also failed to share these data with the safety monitoring board of the trial.

Executives from Bayer—which codeveloped rivaroxaban and markets it outside the United States—were also aware about concerns about the device used in the trial. However, the German company did not know about the existence of the recheck programme until this year.

Patients in the US are suing Janssen and Bayer for allegedly misleading users about the safety and efficacy of rivaroxaban (Xarelto).

In legal testimony, a Bayer official has alleged that Janssen, which had responsibility for conducting and managing the trial, withheld the programme from the company.

When asked by The BMJ, Bayer stated that it “Expressly contradicts with the allegation that Bayer would have withheld safety data from drug regulators and the safety monitoring board of the ROCKET AF trial.”

Pivotal trial comes under scrutiny

Published in the New England Journal of Medicine (NEJM) in 2011, the trial included over 14 000 patients and concluded that rivaroxaban was “similar to warfarin …

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