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BMJ Investigation Drug Makers Knew of Faulty Device During Xarelto Trials But Failed to Warn

Oct 6, 2016

A British Medical Journal (BMJ) investigation has found that the makers of Xarelto, an anticoagulant that has spurred a number of personal injury lawsuits, knew about safety concerns with a medical device used in Xarelto clinical trials but failed to disclose this information. The clinical trial in question is the ROCKET-AF, in which researchers compared adverse events in Xarelto users to warfarin users. A device used in the trial, called the INRatio, was used to measure the amount of warfarin in a patient’s blood. Later on, the blood monitoring device was recalled because it gave low readings.

The faulty device has raised questions about the integrity of clinical trial data, which was used to gain approval for Xarelto as an anticoagulant medication used to reduce the risk of blood clots. Now, a feature investigation published in the BMJ reports that Janssen, a subsidiary of Johnson & Johnson, knew that there were issues with the device but did not disclose this information to the U.S. Food and Drug Administration (FDA). BMJ’s Deborah Cohen reports that the company "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".

BMJ found that shortly after the trial began, investigators expressed concerns about whether the INRatio was accurate and reliable. In response, Janssen set up the Covance recheck programme, a safety program that collected this data. The company did not, however, share this data with the FDA or with the safety monitoring board of the trial.

According to BMJ, Bayer also had knowledge of safety concerns with the INRatio. However, the company did not know about the recheck safety program until 2016. Bayer has testified that Janssen, who was responsible for conducting the trial, failed to inform Bayer of the program. Bayer told BMJ 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."

The faulty INRatio device is a point of contention because if it gave low readings during the clinical trial, then patients may have received more warfarin than necessary. This may have made Xarelto seem safer than it actually is, experts say. The BMJ tackled this issue in December 2015, stating the data needed to be reanalyzed.

In 2016, the lead investigator in the ROCKET-AF trial published a letter in the New England Journal of Medicine stating that the recalled device did not affect overall findings. However, one of the BMJ authors said that the investigators should release all the data so other researchers can conduct an independent analysis.

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