Doubt Surfaces about Clinical Trials as Xarelto Cases MountAug 8, 2016
It is still several months before evidence is to be presented in court against the manufacturers of Xarelto. As of July 2016, the number of lawsuits involving the anticoagulant approaches the 6,000 mark. But, the question that lawyers will potentially want answered is, if Bayer and Janssen Pharmaceuticals, a Johnson & Johnson (J&J) subsidiary, failed to sufficiently inform users of potential risks linked to Xarelto.
The climate of scrutiny began in September 2015 when the two companies informed regulators that one of the blood-testing devices used in an ongoing three-year study was faulty. The potentially incorrect data was submitted to the New England Journal of Medicine (NEJM), which led to a positive report and, as a result, U.S. Food and Drug Administration (FDA) clearance. This information led some to view the trial results as questionable.
A disturbing thought was raised in a legal brief filed in federal court recently. Did Bayer and Johnson & Johnson know about the potentially erroneous data before the FDA approval? It’s difficult to determine if a line was crossed as specifics seem to be somewhat fuzzy, the New York Times reported. There was some control data at an independent laboratory that could possibly have shown the inaccuracy of the blood-testing device, but this information was not given to the NEJM.
In a 2013 article in the Journal of the American College of Cardiology (JACC), a number of issues and inconsistencies were revealed with data from a Phase III study. The revelations included “an unanticipated high rate of missing data” and a “divergent impact” between the cardiovascular risks of the low dose and the high dose, that ultimately cast doubt on the efficacy and safety of the drug.
The painkiller Vioxx, was at the center of controversy in 2005 when the NEJM discovered that researchers had deleted data from a trial manuscript before submitting it to the journal. Such practices hint that pharmaceutical companies may be putting financial interests before patients’ health.
It remains to be seen how the trials play out, but anyone currently taking Xarelto should consider the drug’s potential risks and its troublesome history.