In a recent New York Times article, it was reported that Johnson & Johnson and Bayer, the makers of the anticlotting drug Xarelto, were complicit in staying silent in what is claimed to be an effort to protect the drug from criticism over its safety. Xarelto is sold in the U.S. by Johnson & Johnson and overseas by Bayer. Sales in the U.S. in 2015 were nearly $2 billion. Xarelto is said to be the best seller in a new category of drugs used to break up blood clots.
The claim of deception comes from what was a letter published in The New England Journal of Medicine and written primarily by researchers at Duke University that omitted laboratory data about Xarelto. Xarelto is widely used as a replacement to Warfarin, which is an older blood thinner. Johnson & Johnson and Bayer hired the Duke Clinical Research Institute to run a 3-year clinical trial involving more than 14,000 patients that led to Xarelto’s approval by federal regulators.
Those research results have come under scrutiny since Sept. 20, 2015, when the companies notified regulators that a blood-testing device used in the study had malfunctioned.