Did Xarelto manufacturers purposefully withhold vital data from the New England Journal of Medicine?
That is a concern many injured patients have after reanalyzed results raised questions about the faulty drug. An article published in the New York Times, has revealed some startling accusations. Did two of the most major pharmaceutical companies mislead editors of a major medical journal, in order to protect their lucrative moneymaking drug?
Lawyers suing Johnson & Johnson and Bayer over the safety of Xarelto, their anticlotting wonder drug, say yes. They claim that the companies and researchers at Duke University left out critical laboratory data that would have affected clinical trials that compared Xarelto to older, established blood thinners, such as Warfarin. During the Xarelto clinical trial, a faulty device was used to test the effectiveness of the drug on blood clotting. This faulty device made Xarelto results look better when compared to older blood thinners. Yet, this device was faulty and later recalled.
The Duke Clinical Research Institute ran a three-year clinical trial on Xarelto and included more than 14,000 patients. They compared the number of stroke and bleeding events experienced by patients taking both Xarelto and those taking Warfarin. The results showed that Xarelto was more effective. This directly led to Xarelto receiving FDA approval followed by millions of dollars in advertising expenses to see the drug. Now, it appears that vital information was withheld that should have been published with the follow-up analysis – separate laboratory data.
At two points during the study, investigators drew blood from 5,000 patients who took Warfarin and sent it to a central laboratory for testing. Blood was taken at 12 weeks and 24 weeks after enrollment in the trials. But Duke researchers made no mention of these lab results in their letter to the New England Journal of Medicine.
Duke said it had conducted its research separately from Bayer and Johnson & Johnson, but many are beginning to wonder – especially since Bayer recently submitted an analysis to the European Medicines Agency that was nearly identical to the approach used by the Duke researchers.
Just How Profitable is Xarelto?
Bayer sells Xarelto internationally, while Johnson & Johnson sells Xarelto in the United States. This drug raked in nearly $2 billion in United States sales last year and is the best seller in a new category of drugs seeking to replace Warfarin, an older, established blood thinner. Since the FDA first approved it, more than 13 million Xarelto prescriptions have been written in the United States alone. This makes it the most prescribed blood thinner in its class.
Unfortunately, Xarelto was manufactured without a known antidote – unlike older blood thinners. This means that when someone begins to bleed uncontrollably, there is little doctors can do to reverse the effects of the drug. As a result, numerous patients have died and thousands more have been harmed after being prescribed Xarelto. To date, more than 3000 lawsuits have been filed on behalf of injured Xarelto patients.
Contact Our Xarelto Lawsuit Lawyers
If you have suffered medical complications, pain, or excessive bleeding after using Xarelto or another dangerous drug, your injuries may be the result of the drug manufacturer's negligence. You may be eligible to take part in national lawsuits. To learn more about your legal options or to schedule a free consultation call the Philadelphia dangerous drug lawyers at Golomb Legaltoday at 1-800-355-3300 or 1-215-985-9177 or fill out our confidential Contact Form.
The national dangerous drug lawyers at Golomb Legalhave successfully represented individuals in Philadelphia, Pennsylvania, New Jersey, and throughout the United States.