The science behind the drug Xarelto® is again under scrutiny.
A re-analysis of Xarelto® done out of Duke University and later published in the New England Medical Journal of Medicine was missing information pertinent to the effects of the drug. Duke Clinical Research Institute
was hired by Johnson & Johnson and Bayer, the two companies behind Xarelto® in the US and the EU respectively, to conduct a three year study involving more than 14,000 patients. The study was published in the New England Medical Journal of Medicine and failed to disclose the information that one of the machines used for blood testing had malfunctioned. This device was particularly important because the data from it was used in comparison with study participants using warfarin.
Beyond the omission of the device malfunction, there are questions of the ethics behind the study as this case is reminiscent of the study behind the drug Vioxx, which had data deleted from the manuscript just days before the study was published in The New England Journal of Medicine in 2005. The Xarelto® study was supposed to have been independent of Johnson & Johnson and Bayer, but Bayer submitted an analysis to the European Medicines Agency that was nearly identical to the Duke study in its approach. A Johnson & Johnson employee sits on the trial’s executive committee but said he recused himself and took no part in the “re-analysis, the drafting of the research letter, and provided no feedback before it was submitted.”
We can help.
Dr. Steven Nissen, who voted against Xarelto® in 2011 when he was on the FDA advisory panel, said of the faulty device “there is no way anybody can tell you what would have happened in the trial.” Johnson & Johnson and Bayer through Duke University are playing fast and loose with the health of millions of Americans. While Xarelto® is an effective blood thinner, the risks may outweigh the benefits. Many doctors will prescribe Xarelto® over warfarin because of the easy medication schedule, but the effects of Xarelto® are hard to counter which make it dangerous. If you’ve been affected by the dangerous drug Xarelto®, please allow our attorneys to research your case today. Call 1-800-701-3672 for a free Xarelto lawsuit review.