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Document Suggests Bayer and JJ Misled Top Medical Journal

Mar 17, 2016

Plaintiffs' attorneys in Xarelto litigation point to a document that allegedly shows Bayer and Johnson & Johnson deceived the editors of a top medical journal. According to the New York Times, the issue stems from a letter published by Duke University researchers last month in The New England Journal of Medicine. The letter, which concerns clinical trial findings over Xarelto, failed to include important laboratory data. Attorneys say the drug companies were complicit in deceiving journal editors by staying silent on the issue while presenting the same data to regulators in the US and Europe.

Xarelto is part of a newer class of blood thinners marketed as a replacement for warfarin, which has been on the market for decades. Warfarin requires regular blood testing and dietary restrictions. Xarelto and other similar drugs in its class do not have these limitations, but some have expressed concerns about the risk of uncontrollable bleeding.

The FDA approved Xarelto based on a three-year, 14,000 patient clinical trial conducted by Duke Clinical Research Institute, who was hired by Bayer and J&J. However, it turns out that the device used during the trial was faulty, possibly calling Xarelto's approval into question. 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.

Last month, Duke researchers published an analysis in NEJM showing that the faulty device did not affect the outcome of the trial. For some, however, this was insufficient. 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."

Top editors at NEJM said they were unaware of separate lab data until they were contacted by a reporter last week, NYT reports. They say the analysis is credible and that the data is irrelevant. But some contend that the situation is reminder of earlier times, when pharma had a large influence on medical journal findings. 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?"

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