Xarelto: Did Drugmakers Hide Information?

Boston, MAThe makers of Xarelto face accusations from plaintiffs’ attorneys that they hid information from editors at The New England Journal of Medicine. The New York Times (3/1/16) published an article reporting that a letter, which was written by researchers at Duke University and published by The New England Journal of Medicine, left out vital laboratory data. Lawyers involved in Xarelto lawsuits say that information may have misled editors as to Xarelto’s safety and/or effectiveness.

The letter was published in February, and involved the Alere INRatio Monitor System. That system was used as part of the ROCKET AF trial (Rivaroxaban Once Daily Oral Direct Factor XA Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation) comparing rivaroxaban (the generic version of Xarelto) with warfarin. In 2014, the Alere INRatio Monitor System was recalled because of abnormal readings. Those abnormal readings could have resulted in warfarin patients having their doses unnecessarily increased, which would have also increased their risk of bleeding events.

The ROCKET AF trial found that although there was no significant difference between rivaroxaban and warfarin when it came to the risk of a major bleeding event, rivaroxaban was associated with a decreased risk of bleeding in the brain and fatal bleeding events.

In their letter to The New England Journal of Medicine, researchers at Duke University said they reviewed data and found that possible issues with the Alere INRatio Monitor System did not significantly affect the outcome of the trial.

“These results are consistent with the overall trial findings and indicate that possible malfunction of the point-of-care device used for INR measurement in the ROCKET AF trial…did not have any significant clinical effect on the primary efficacy and safety outcomes in the trial,” researchers wrote in their analysis.

But according to the New York Times article, that analysis failed to include vital laboratory data. And while it was the researchers who wrote the letter, lawyers argue the drug companies stayed silent on the issue. Specifically, critics say the researchers’ method of reviewing their findings involved them guessing which patients might have been affected by the device, rather than comparing device readings with results from a different, central laboratory. In their letter to The New England Journal of Medicine, researchers omitted information about test results from the central laboratory.

At one point, a peer reviewer (an independent reviewer who checks the study design and methodology) asked about lab data to compare INR readings, but no information from the central laboratory was provided.

For their part, editors at The New England Journal of Medicine told the New York Times that they were not aware of additional data, but that they stood by the analysis they published. A spokesperson for Johnson & Johnson told the newspaper that the study was conducted separately from the company.

The US Food and Drug Administration (FDA) has reportedly said it would review data concerning the INRatio Monitor system. Meanwhile, the European Medicines Agency has issued a news release on its website that the recalled device did not affect the outcome of the ROCKET AF trial.

As of March 15, 2016, there are 4,585 lawsuits consolidated for pretrial proceedings in MDL 2592, In Re: Xarelto (Rivaroxaban) Products Liability Litigation.