A document brought up in Xarelto litigation is raising questions about whether Bayer and Johnson & Johnson intentionally misled the editors of a top medical journal. Xarelto is a blockbuster blood thinner marketed as a replacement for warfarin, a decades-old medication that requires blood testing and dietary restrictions. Xarelto is part of a newer class of anti-coagulants that does not have these limitations, but is not without its own risks; the drug has raised safety concerns because it lacks an antidote to reverse any bleeding that may occur.
A number of lawsuits have been filed over Xarelto alleging the drug is blame for injuries.
According to the New York Times, plaintiffs’ attorneys are citing a letter published in The New England Journal of Medicine, authored mostly by researchers at Duke University, that leaves out crucial laboratory data. Allegedly, the pharmaceutical companies helped deceive the editors by failing to take action on the omission. Meanwhile, they presented the same data to regulators in the US and Europe. Duke and J&J say they did not work together.
According to NYT, top editors at NEJM said they were unaware of separate lab data until they were contacted by a reporter last week. Regardless, they say the analysis is valid and that the data is irrelevant. For some, however, the situation is reminiscent of an earlier period when pharmaceutical companies had more sway and crucial data was left out of journal articles. Dr. Lisa Schwartz, a professor of medicine at Dartmouth commented on the failure to include lab data, saying “It just feels like it’s a real ethical breach,” to NYT. “If you know the direct answer to this question, then how can you not provide it to be able to give insight?”
J&J and Bayer hired Duke Clinical Research Institute to conduct a three-year, 14,000 patient clinical trial that ultimately led to Xarelto’s approval. The approval is now being questioned, in light of the fact that a blood-testing device used in the trials was defective. Some are worried that the malfunctioning device could have caused doctors to give patients the wrong dose of warfarin, skewing the results in favor of Xarelto.
Duke researchers published an analysis in NEJM last month showing that the faulty device did not affect the outcome of the trial. Instead of quelling concerns, however, it raised more questions among members of the medical community. Some researchers criticized their method of analysis, which basically guessed which groups of patients would be most affected by the device. Other scientists say the device readings should have been compared with results conducted at a central laboratory, which was done at two points during the trial. This data was not mentioned in the letter, and journal editors say they were unaware of its existence. “At the time we published the letter, we didn’t know that it existed,” said Dr. Jeffrey M. Drazen, editor in chief of The New England Journal of Medicine.
Plaintiffs’ attorneys in the Xarelto litigation pointed out in a footnote that a peer reviewer had asked about the existence of lab data that would allow comparison with the device’s readings. “Despite being provided this opportunity to respond to the peer reviewers,” attorneys said, according to NYT “defendants remained silent on this point, thereby misleading the NEJM.”