March 2, 2016
By Alex Keown, BioSpace.com Breaking News Staff
NEW YORK -- In the ongoing legal concerns surrounding the anticlotting drug Xarelto developed by Janssen Pharmaceuticals, a Johnson & Johnson company, and marketed by Bayer , a new wrinkle surfaced in a legal brief filed last week in federal court in New Orleans claiming the two companies mislead editors at the New England Journal of Medicine over the safety of the drug, the New York Times reported this morning.
Lawsuits filed against Janssen, the maker of Xarelto, and Bayer, the drug’s co-marketer, claim the companies failed to warn patients and physicians of increased risks of fatal internal bleeding when using the drug. In the latest legal maneuver, the Times said plaintiffs argue that researchers at Duke University left out “critical laboratory data” about the drug in an article they published in the prestigious medical journal. They also claim the two pharmaceutical companies were complicit by remaining silent during the regulatory process in the United States and Europe, the Times said.
Xarelto, a popular drug being used in place of the older blood-thinner, warfarin, earned $2 billion in the United States alone last year. Xarelto was approved by the U.S. Food and Drug Administration in 2011.
The Duke researchers were hired to run a three-year clinical trial that involved more than 14,000 patients. The trial results lead to regulatory approval of the drug. However, there have been concerns over a possible defective blood-clotting test device affected the trial. The study compared Xarelto with warfarin for the prevention of stroke and systemic embolisms in patients with a type of irregular heartbeat that is common among the elderly. The malfunctioning device may have caused doctors to administer the wrong dose of warfarin, causing favorability for Xarelto. In February, Duke researchers published a letter in the New England Journal of Medicine arguing that issues with the device did not impact the results of the trial, the Times reported. That letter failed to mention lab data, which the editors of the New England Journal of Medicine claimed they did not know existed until the New York Times reached out to them.
The Duke study was done independently of Janssen and Bayer, however, the Times noted Bayer’s regulatory filing with the European Medicines Agency was nearly identical to the Duke research.
Although the medical journal’s editorial staff have disputed claims they were misled by the Duke researchers, Dr. Jeffrey Drazen, editor in chief of The New England Journal of Medicine, told the Times that the Duke researchers have agreed to conduct an analysis of the lab data.
Critics have suggested the lack of the lab data in the report are “reminiscent of other instances in which drug companies concealed or altered drug-trial data in medical journals,” the Times reported.
There have been more than 5,000 lawsuits filed by patients and their families claiming harm from taking Xarelto. Of those lawsuits, 500 involved patient deaths, the Times said.
