Investigations conducted by the Food and Drug Administration (FDA) have renewed suspicions that the Xarelto clinical trial may be inaccurate. Legal documents indicate that the Rocket AF trial, which led to the approval of a billion-dollar blood thinner, may have been mismanaged.
Xarelto (rivaroxaban) is an anticoagulant used to prevent blood clots. The blood thinner, which has been prescribed to millions of people, is linked to an extreme bleeding side effect that has no existing antidote.
Xarelto Clinical Trial
Manufactured by Johnson & Johnson, Xarelto was approved in 2011. The Rocket AF trial, which included 14,000 participants and took place from 2006 to 2010, yielded the safety results that allowed the drug to enter the market. The trial also compared Xarelto to an industry-standard blood thinner known as Warfarin.
The FDA has been investigating a number of issues related to the trial, including:
- Improper doses of Warfarin were given to patients, distorting the results
- INRatio blood monitors may have malfunctioned during testing
- Trial leaders potentially knew that results could have been inaccurate
In 2011, the FDA questioned whether or not the trial participants were mismanaged, raising concerns about the legitimacy of the results. In 2014, the INRatio device was recalled for underestimating the severity of the side effect. But after journalists and the FDA started investigating, it was discovered that suspicions about the defectiveness of the INRatio were sparked in 2006 when the Rocket AF trial began.
Legal documents show that Johnson & Johnson may have known about the device’s potential failures, though no concerns were reported to the FDA. The manufacturers enacted an undisclosed investigative program dedicated to the discovering more about the device’s malfunctions.
Two groups of researchers, the Duke Clinical Research Institute and the European Medicines Agency, found that the device did not alter the results of the trial. However, the New York Times reported that the investigations have only raised additional questions about the trial conduct.
The Rocket AF trial was led by Dr. Robert M. Califf, a lead researcher at Duke Clinical Research Institute. Califf is now nominated to take a place as the head of the FDA, which has led to additional concerns.
According to Johnson & Johnson’s files, Xarelto garnered $1.9 billion in U.S. sales in 2015. The legal battle has exposed the fact that doctors were questioning the device, which led to the approval of a drug that injured thousands with an extreme bleeding side effect. No reversal agent currently exists.