Xarelto lawyers representing the patients suing the drug’s manufacturer have claimed Bayer and Johnson & Johnson failed to provide clinical trial data in a 2011 study. The legal representatives say the companies withheld key information that could have affected the results of a comparison of Xarelto to Warfarin (an older anticoagulant), staying silent in an effort to deceive editors of the New England Medical Journal of Medicine.
The trial compared the safety of the two drugs and showed that though the drugs had the same risk of bleeding, Xarelto showed fewer brain bleed and fatal bleeding events. The newer drug (Xarelto) is currently the most popular anticoagulant on the market, with an approximate 23 million annual prescriptions and annual sales in the billions.
Several doctors are troubled by these claims, feeling the amount of control drug manufacturers have on medical journal articles may be too high. In this particular case it seems as though a device used to measure the proper dosage of the drug warfarin had been recalled by the FDA in a class I recall – the most serious kind.
The devices could have delivered results lower in clinical uses than when used in a lab. As a result, the device could have made Xarelto seem safer than warfarin. This obviously calls the results of the study into question. Moreover, the lab results of the warfarin patients were not published and this was called into question by the Xarelto lawsuit plaintiffs’ lawyers. J&J’s Janssen Pharmaceuticals stated, however, that after a re-analysis the results and conclusions of the original study are confirmed.
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from RGM Original Post