A footnote discovered by The New York Times in a federal legal documents suggests Johnson & Johnson subsidiary Janssen Pharmaceuticals and Bayer, manufacturers of the blood thinner Xarelto, may have mislead medical journal editors about the medication in order to protect their profits. The footnote seems to suggest the drugmakers left out critical laboratory data when a peer reviewer at the New England Journal of Medicine requested it in order to confirm the accuracy of the data.
Lawyers representing individuals suing over bleeding risks linked to Xarelto, including lawyers from our firm, have raised alarming questions about whether the drug company left out key research information that may have skewed clinical trial results that were later used to approve the drug in the United States and abroad. Frankly, this sort of thing from a drug manufacturer is not really surprising.
Xarelto is the leader in a new class of blood thinners taking aim at the long-used warfarin for the prevention of strokes in atrial fibrillation patients, the prevention and treatment of deep vein thrombosis and pulmonary embolism, and the prevention of blood clots in patients who recently underwent knee or hip replacement surgery. Our firm is heavily involved in the Xarelto multidistrict litigation (MDL) and Andy Birchfield is co-lead of the Plaintiffs Steering Committee.
Xarelto has been linked to gastrointestinal bleeds, brain bleeds and bleeding deaths, and, unlike warfarin, there is currently no antidote to reverse the blood thinning qualities of Xarelto in the event of a bleeding emergency. Xarelto has generated nearly $2 billion in revenue since it was approved in 2011.
This is an additional red flag raised about the validity of Xarelto testing information. Johnson & Johnson, Janssen and Bayer hired Duke Clinical Research Institute to run a three-year clinical trial involving more than 14,000 patients. The clinical trial compared the number of strokes and bleeding events in patients taking Xarelto compared to those taking warfarin.
Earlier, it was discovered that a device used to measure the blood’s clotting ability during the trial was later found to be defective and ultimately it was recalled. The concern is that the malfunctioning device may have caused doctors to give patients the wrong dose of warfarin, ultimately favoring Xarelto. Duke researchers reviewed the issue and determined that the device issue did not affect the trial’s results. But some researchers said that a more accurate way of evaluating the device would be to compare the device’s readings with those done at a central laboratory. This was done two times during the trial – at 12 weeks and at 24 weeks – during which blood was drawn from 5,000 patients taking warfarin.
Duke researchers had never mentioned this lab data, and the Journal editors said they didn’t know about the data until they were contacted by a reporter with The New York Times. I hope that is an accurate statement. However, it certainly appears that this information should have been made available to the Journal.
Sources: New York Times and Business Insider
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