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While July 2016 has seen the total number of Xarelto lawsuits approach the 6,000 mark, it will still be several months before evidence against the drug’s manufacturers is presented in court.  But what’s quickly becoming evident is that lawyers will call into question the depth and quality of the clinical trials, as they argue that Bayer and Janssen Pharmaceuticals, a Johnson and Johnson subsidiary, failed to adequately inform users of the potential risks associated with the drug.

The recent controversy over the blood clot preventative started in September 2015 when the two companies informed regulators that one of the blood-testing devices used in an ongoing 3-year study was found to be faulty. The thought that potentially erroneous data was submitted to the New England Journal of Medicine (NEJM), which led to a positive assessment by the institution and subsequently to an FDA approval, has caused some to question the validity of the trials.

In response, Duke University researchers followed up with a letter to the NEJM in February 2016 claiming that, upon re-analysis, the incorrect data did not impact the study’s conclusions. Yet, according to the New York Times, the situation escalated when a foreshadowing footnote in a legal brief filed in federal court recently raised the rather ugly question—did Bayer and Johnson and Johnson know about the unreliable data before FDA approval? The Times reported that it’s hard to determine if a line was crossed because the details appear to be rather blurry. First, there was some control data collected at an independent laboratory that could potentially have shown the inaccuracy of the device, but this information was not shared with the NEJM. Then, it seems there was a peer reviewer of the Duke letter who asked about the existence of any comparative data, and the university researchers answered “no.” Later, their response was justified by claiming an editor had rephrased the reviewer’s question in a way that asked if such control data had been available throughout the study, when in actuality it was only done twice during the 6-month trial.

And this is not the only time that Xarelto trials have been scrutinized. In a 2013 article in the Journal of the American College of Cardiology (JACC), published two years after FDA approval of the drug, numerous issues and inconsistencies were noted with data from a phase III study, including “an unanticipated high rate of missing data and a “divergent impact” between the cardiovascular risks of the low dose and the high dose—ultimately casting doubt on the overall efficacy and safety of the drug.

For some, this is reminiscent of a dubious drug-marketing era thought past. In 2005, the NEJM discovered that researchers for the painkiller Vioxx had deleted data from the trial manuscript before submitting to the journal—just one of several controversies that led to authors being required to reveal the role that drug manufacturers played in an article’s publication. Such actions hint that pharmaceutical companies might potentially be putting business interests before patient health, a stance that should be viewed as unacceptable. We will have to wait and see how this all plays out in the courtroom, but anyone taking the drug should be fair warned of the drug’s possible risks and its problematic trial history.

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