On March 1, 2016, The New York Times put out an article questioning whether or not two major pharmaceutical companies deceived a top medical journal in order to protect their drug.
The two companies, Johnson & Johnson and Bayer, are said to have misled editors at The New England Journal of Medicine in regards to their anticlotting drug, Xarelto. The claim that was filed in a New Orleans federal court stated that the published letter in the journal, written by researchers at Duke University, had left out critical lab data.
Xarelto, a best selling drug in a new category of drugs which seek to replace the blood thinner Warfarin, is considered to be a best selling drug with nearly $2 billion in sales last year in the United States.
Lawyers in the case have asked for documents associated with more than 5,000 lawsuits filed by patients and their loved ones after being harmed by Xarelto to be unsealed. Of those lawsuits, 500 cases involved death of the patient.
The two companies in question had hired the Duke Clinical Research Institute to run a three-year clinical trial, leading to the approval of Xarelto by regulators. However, since September, the results of the clinical trial have come under scrutiny after the companies’ notified regulators about the malfunction of a blood-testing device during the study.
The trial compared the number of bleeding events and strokes that were experienced by patients taking Xarelto to those using Warfarin. The concern lies in the possibility that the faulty results may have led doctors to give patients the wrong dose of Warfarin, which may have favored Xarelto.
According to The Times, Duke researchers “published an analysis” in The New England Journal of Medicine concluding that the results of the trial were not impacted by the malfunctioning device in question.