Potentially Faulty Xarelto Study Data Hid By J&J, Bayer: Report
According to documents produced during the discovery process in lawsuits filed over the side effects of Xarelto, reports suggest that a major medical journal was misled about the existence of data that may have made it clear whether controversial clinical trial results were accurate.
A recent New York Times report indicates that Bayer, Johnson & Johnson and those who ran clinical trials at Duke University that eventually led to the FDA approval of the blood thinner, may have lied to editors at the New England Journal of Medicine.
At issue is a device that measured the levels of blood thinner in patients involved in the study, due to concerns that the device was defective and that those running the clinical trial knew it, but failed to reveal that information.
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The New York Times reports that documents produced by the drug makers during pending Xarelto lawsuits filed on behalf of individuals who suffered severe bleeding complications after receiving the drug suggest that those running the clinical trial were asked if there were lab tests that confirmed the accuracy of the device. The editors were told there was not, when in actuality there were such tests.
The issue is part of an investigation into the Xarelto studies underway by the FDA, which is focusing on the measurement of the levels of the older blood thinner warfarin in test subjects’ blood. It is now believed that the device was defective and may have compromised the approval process for Xarelto, which has since been promoted as a superior alternative to warfarin.
The Xarelto blood testing problems in the clinical trial were first reported in the medical journal The BMJ in December, with researchers warning that the device may have led to an underestimation of the rate of Xarelto bleeding complications in comparison to warfarin.
The ROCKET-AF clinical trials compared the rate of bleeding events between Xarelto (rivaroxaban) and Coumadin (warfarin). The potentially defective blood testing device, known as the INRatio by Alere, was used to measure the levels of warfarin in patients’ blood and was used to adjust their dosage. However, an INRatio recall has since been issued after it was discovered that the device may return results that were falsely low. The recall came after Alere received nearly 19,000 reports of malfunctions, 14 of which resulted in serious injuries.
The recall could affect the ROCKET-AF results, because falsely low readings may have resulted in warfarin patients being given too high a dose, increasing their risk of bleeding. If the device caused excessive bleeding among warfarin patients, it could have given the false impression that Xarelto had a lower rate of bleeding problems.
Researchers reportedly said that the best way to evaluate whether the device was working properly would be a comparison of the device’s readings with tests conducted at a central laboratory. That happened twice in the clinical trials, involving samples from 5,000 patients given warfarin at 12 weeks and 24 weeks in the clinical trial.
Editors with the New England Journal of Medicine indicate that they were never shown or told about the results, even though the Xarelto clinical trial researchers were asked directly about it by a peer reviewer.
The clinical trials, led by Dr. Robert Califf, who is now the FDA commissioner, have come under intense criticism for a variety of reasons since Xarelto was approved, as the drug has been linked to a surprising number of adverse event reports involving severe and uncontrollable bleeding problems. Due to a lack of a reversal agent for Xarelto, doctors have often been unable to stop bleeding problems that occur among users of the drug, increasing the risk of severe injury or death.
Xarelto Lawsuits Over Bleeding Problems
Xarelto (rivaroxaban) is part of a new class of blood thinners introduced in recent years as a replacement for warfarin, which had been the go-to anticoagulation treatment for decades. Since it was approved in 2011, this new-generation treatment has been commonly prescribed instead of warfarin for reduction of the risk of blood clots and strokes among patients with atrial fibrillation, or following hip or knee replacement surgery.
Amid allegations that the drug makers failed to adequately warn about the risk of bleeding on Xarelto, more than 4,000 lawsuits are currently pending in courts throughout the U.S., alleging that plaintiffs suffered severe and often fatal injuries due to uncontrollable bleeding while on the medication.
While users of warfarin can be given a dose of vitamin K to reduce the blood thinning effects of the medication, there were no similar reversal agents available for Xarelto at the time it was introduced, placing doctors in a position where they were unable to control many bleeding problems.
Lawsuits also allege that the drug makers provided false and misleading information about the importance of blood monitoring on Xarelto, marketing the drug as easier to use and indicating that it does not require close testing like warfarin. However, independent studies published after the medication was introduced have suggested that Xarelto monitoring may help identify patients at greater risk of bleeds.
As part of the coordinated proceedings in the federal Xarelto litigation, a small group of “bellwether” cases are being prepared for early trial dates, which are expected to begin early next year to help gauge how juries may respond to certain evidence that has been obtained during the discovery process.
While the outcome of these early bellwether trials will not be binding in other cases, they may facilitate Xarelto settlement negotiations that will avoid the need for hundreds of individual cases to go to trial nationwide.
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