March 30, 2016 — San Diego,CA. Lawyers representing the thousands of people who have filed lawsuits against the makers of the blood-thinning medication Xarelto are alleging the companies purposely withheld trial data from a respected medical journal.
A recent article published in the New York Times reports the lawyers are accusing Johnson & Johnson and Bayer of misleading editors at the New England Journal of Medicine by leaving out critical data in a letter published in the journal earlier this month.
The letter addresses questions posed by the U.S. Food and Drug Administration (FDA) regarding faulty medical equipment used in the clinical trial that eventually led to the approval of Xarelto in 2011. The medical device, called an INRatio Monitor System, measures the effect of warfarin on clotting time and helps doctors know whether patients are receiving the correct dose of the medication.
The device was recalled by the FDA in 2014 because it could potentially give false readings in patients with certain medical conditions, including anemia, pneumonia, influenza, rheumatoid arthritis and Crohn’s disease.
The trial that helped get Xarelto approved for U.S. and European markets, called the Rocket AF trial, studied the effectiveness and safety of Xarelto in patients with nonvalvular atrial fibrillation compared to warfarin, a blood-thinning medication that has been on the market since the 1950s. Rocket AF used the INRatio device in the warfarin group to make sure patients received the correct dosage. When news of the faulty devices broke, questions arose about the accuracy of the trial’s results and whether inaccurate measurements skewed results in Xarelto’s favor.
Duke University’s Clinical Research Institute was hired to conduct the Rocket AF trial between 2006 and 2010 by Johnson & Johnson, which markets the drug in the U.S., and Bayer, which manufactures and markets the drug overseas. Xarelto reportedly reached nearly $2 billion in sales in 2015 and is the best seller of a new category of blood thinners called Factor Xa inhibitors.
In light of the INRatio controversy, Duke researchers published an analysis in the New England Journal of Medicine this month arguing that the device did not impact the results of the trial.
The analysis, however, failed to include test results of about 5,000 blood samples taken from patients on warfarin that were analyzed at a central laboratory.
According to the New York Times report, editors at the journal did not even know the data existed until they were asked about it by a reporter late last month. News of the lab data was apparently brought to light by a peer reviewer when lawyers were vetting Duke researchers’ letter. Yet the editor in chief of the journal reportedly denied that they had been “misled” about the data.
Still, the omission of data begs the question of whether Johnson & Johnson and Bayer were trying to hide something in doing so.
The results of the Rocket AF trial were originally published in the New England Journal of Medicine in September 2011. Xarelto was approved by the FDA in July 2011 to prevent deep vein thrombosis and pulmonary embolism in patients undergoing hip or knee replacement surgery. The drug was later approved to help reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation in November 2011.
Two years after its approval, the FDA issued a black box warning informing patients that stopping Xarelto prematurely could increase their risk of forming blood clots.
Several label revisions have also been made to warn patients of the increased risk for spinal or epidural hematoma—the buildup of blood in the spinal column or brain — and thrombocytopenia – a deficiency of platelets in the blood that can cause bleeding into the tissues, bruising and slow blood clotting after injury.
Peer-reviewed studies have indicated an increased risk for gastrointestinal and other bleeding in patients taking the new-generation drug. A 2012 study published in the BMJ (formerly British Medical Journal) concluded that new anticoagulants, including Xarelto, were generally associated with a higher bleeding tendency.
While there is an increased risk of excessive bleeding with all blood-thinning medication, there is no approved antidote to stop bleeding in patients taking Xarelto. In October 2015, the FDA approved an antidote for the blood-thinning drug Pradaxa, but antidotes for Xarelto are still under investigation.
The risks for increased or uncontrollable bleeding, along with other potentially life-threatening complications, have prompted lawsuits against the makers of Xarelto.
Thousands of lawsuits have already been filed across the United States by patients and their families who allege Xarelto caused serious and sometimes fatal side effects. If you or someone you love took Xarelto and suffered serious injury, you need to take action. Call the Hood National Law Group today at 1-800-214-1010 for a free case evaluation or use the form on the right-hand side of your screen.
New York Times article published March 1, 2016: http://www.nytimes.com/2016/03/02/business/document-claims-drug-makers-deceived-a-top-medical-journal.html