A footnote in a plaintiff's brief in a federal lawsuit against two major pharmaceutical companies has led the New York Times to pose an unsettling question: did Bayer and Johnson & Johnson mislead the editors of a leading medical journal in an effort to protect Xarelto, an anti-clotting drug that is a sales blockbuster for the two companies?
According to the legal brief, a letter published in the prestigious New England Journal of Medicine by researchers at Duke University did not include important laboratory data that was being provided to regulators in the U.S. and Europe at the same time. The plaintiffs claim that Bayer and J&J were complicit in helping to deceive NEJM editors.
Bayer and J&J hired the Duke Clinical Research Institute to administer a three-year clinical trial leading up to the drug's approval. That trial involved more than 14,000 patients and compared the number of strokes and bleeding incidents between patients on Xarelto and those on Warfarin.
The FDA has brought the results from that trial into question after it was revealed that a faulty blood monitor was used during the trial. The FDA is investigating whether the use of that device could have compromised the trial's results that led to Xarelto's approval. Specifically, investigators are trying to determine whether the faulty device may have led doctors to administer the wrong dosage of Warfarin to patients, giving Xarelto an advantage if the overdose led to increased bleeding incidents.
In a re-analysis of the trial in the NEJM, the Duke researchers stated that the faulty blood monitor did not change the results of the trial. However, according to the New York Times, the researchers never mentioned the existence of laboratory tests taken twice during the trial that could have shown that the faulty blood monitor's readings were inaccurate.
NEJM editors said that while they were unaware of the lab data at the time the letter was published, they did not feel it was relevant. However, the Times noted that some experts claim this case is similar to others where drug companies altered or concealed drug trial data in medical journals.
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