The popular U.S. drug Xarelto has been the cause of controversy for quite some time now, with over 5,000 lawsuits nationwide, and 500 patient deaths allegedly tied to the drug. More recently, a document emerged, alleging that two major pharmaceutical companies misled medical journals by leaving out critical data on the drug.
USRecallNews.com previously reported on this. See http://www.usrecallnews.com/document-claims-drug-makers-deceived-top-medical-journal/. Now this deception has reached the courts.
A brief recently filed in federal court claims that a letter published in The New England Journal of Medicine, primarily written by researchers at Duke University, left out critical data regarding laboratory results. The brief goes on to claim that the manufacturers of the drug, Bayer and Johnson & Johnson, aided in deceiving the editors by remaining silent while providing the same data to regulators in the U.S. and Europe.
The newly found data revealed that during trials testing the safety and effectiveness of Xarelto, in comparison to Warfarin, an older blood thinner, the blood-testing devices that were used had been recalled. USRecallNews.com also reported on this. See http://www.usrecallnews.com/defective-device-used-in-xarelto-trial/.
Researchers responsible for leading the original study have determined that use of the recalled device had no impact on the results; however, choosing to leave out such information is still considered to be an ethical problem.
The European Medicine Agency has concluded that the device was highly inaccurate, but most likely didn’t affect the outcome of the trials. The Food and Drug Administration is currently looking into whether or not the drug would have received approval knowing that a faulty blood-testing device was used.