Researchers who worked with pharma companies Johnson & Johnson (J&J) and Bayer withheld data when submitting research about their blood-thinning drug Xarelto, say lawyers who are suing the companies. The plaintiffs contend that J&J and Bayer withheld data in an attempt to mislead the New England Journal of Medicine (NEJM) about the Xarelto trial.
Xarelto Is the US’s Best-Selling Blood Thinner
Xarelto is a popular blood-thinning medication that was approved for use in the United States in 2011. Xarelto’s popularity has displaced the previous generation of blood-thinners like warfarin, earning nearly $2 billion last year in the US alone.
Xarelto Trial Research Had Faulty Equipment
In February this year, BMJ, a British medical journal, published the results of its investigation into the FDA regulatory approval trial for Xarelto. The journal’s investigation found that a crucial measuring device used in the study was faulty.
The malfunctioning device gave readings that resulted in researchers over-medicating some of the trial’s subjects, causing increased bleeding in the drugs competing with Xarelto – namely warfarin. The BMJ called for further investigation into whether the device significantly impacted the results of the Xarelto trial.
Xarelto Researchers Defend Their Findings
The researchers who worked with J&J and Bayer in conducting the FDA-approval Xarelto trial responded to the BMJ’s questions in late February with a letter to the NEJM. Although the letter concluded that the faulty measuring device didn’t have a significant impact on the ultimate outcome of the trial, it failed to provide lab data to the research community.
Possible Interference by Big Pharma Companies?
Typically, lab data is provided on published studies so that peers of those who worked on the studies can run their own verifications or other analyses on the study’s raw data. However, no lab data accompanied the NEJM letter.
As a result, some researchers are suggesting that J&J and Bayer may have pressured the NEJM or the researchers into not sharing their data set so that outside analysis couldn’t refute the results of their Xarelto trial. For its part, the NEJM says that neither J&J or Bayer had contacted the publication.
Former FDA Panelist Disparages Xarelto Study
Perhaps the most compelling quote on data flap comes from Dr. Steven Nissen, who voted against Xarelto’s approval while on the FDA’s advisory panel in 2011: “Given the fact that the device was inaccurate, there is no way anybody can tell you what would have happened in the trial.”
If you or a loved one has experienced abnormal or severe bleeding as a side effect of taking Xarelto, contact our legal team. You could be entitled to reimbursement for medical costs, lost wages, and more.