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Research Misconduct Involving Xarelto Goes Unreported

xarelto pill bottleJAMA Internal Medicine recently published a study by Charles Seife that highlights a profound flaw in how consumers obtain information about clinical drug trials. According to the New York University professor, only 4 percent of questionable practices or violations discovered by health regulators during pharmaceutical trials ever reaches the public.

Numerous drug companies, who are charged with proving the safety and efficacy of their products prior to receiving FDA approval, were found to have deviated from proper trial protocols during site visits by the FDA. Common violations included inaccurate record keeping, submission of false data and failure to protect the safety of trial participants. Seife concluded that although the FDA frequently encounters examples of research misconduct and departures from good clinical practice during these site visits, those discoveries are rarely seen in peer-reviewed literature.

Seife questions why the FDA, whose mission it is to protect the health of the public, would withhold evidence of serious drug trial misconduct from the scientific and medical communities. Most medications in the documents he reviewed were blacked out, with the exception of Xarelto (rivaroxaban).

Out of more than a dozen FDA inspections of Xarelto trial sites, signs of deceitful and objectionable behavior were uncovered during eight occasions. These included unauthorized unblinding, submission of falsified data and the discarding of medical records, among other serious issues.

Questionable drug research practices go unreported

“Only 3 of the 78 publications (4%) that resulted from trials in which the FDA found significant violations mentioned the objectionable conditions or practices found during the inspection,” said Seife in his report. “No corrections, retractions, expressions of concern, or other comments acknowledging the key issues identified by the inspection were subsequently published.”

According to Seife’s research, the Xarelto study known as RECORD 4 was found to be completely unreliable by health regulators, yet the results were later published with no indication of misconduct or problems. Seife urges respected medical journals to take more initiative in ensuring the integrity of their published studies, including information on FDA protocol violations.

Medications like Xarelto have already been associated with life-threatening side effects, the extent of which are now becoming clearer. Just after the blood thinner was launched in 2011, an estimated 350 “serious, disabling or fatal” injuries were reported to the FDA. Most of these involved pulmonary, venous, and other forms of thromboembolism, though Xarelto has also been blamed for uncontrolled bleeding events, since there is no approved antidote.

Litigation filed over Xarelto bleeding problems

Throughout the United States, patients who were prescribed Xarelto for their irregular heartbeat have suffered cerebral hemorrhages, gastrointestinal bleeds and other events that have sometimes proved fatal. Unlike Warfarin, which uses therapeutic doses of Vitamin K to stop bleeding, Xarelto bleeds are challenging to stabilize, since no reversal agent has been developed.

Bayer Pharmaceuticals and Janssen are being sued by dozens of plaintiffs who argue that deceptive advertising was employed and that defendants failed to sufficiently warn about Xarelto bleeding problems.

If the outcome of Pradaxa litigation ($650 million settlement) has any bearing on current and future Xarelto lawsuits, plaintiffs may witness similar recourse. Compensation is being sought to account for all related medical bills, lost income, pain and emotional suffering, diminished earnings and, in some cases, wrongful death.

  1. JAMA Internal Medicine, Research Misconduct Identified by the US Food and Drug Administration
  2. FDA, Xarelto medication guide