According to the article, the U.S. Food and Drug Administration (FDA) uncovered potentially serious misconduct committed by researchers who published a study called “RECORD 4.” The study was sponsored by Bayer, a co-marketer of Xarelto. The article reported FDA investigators found evidence that data was falsified, and medical records of patients taking the drug were destroyed, in an effort to conceal evidence linking Xarelto with major bleeding events. JAMA Internal Medicine reported that half of the 16 clinical trial sites were reviewed as OAI – Official Action Indicated. This means that several troubling issues had been observed, including unsafe medical practices, a lack of regard to established protocols, and data that had been falsified.
Even though the FDA expressed serious concerns about the reliability of the RECORD 4 study, Bayer was still able to have the results of the study published in the British medical journal Lancet.
The article reported that the RECORD 4 study was completely rejected by the FDA while Xarelto was in the approval process, with the agency stating that the data was so unreliable it had to be thrown out. One of the FDA’s allegations was that RECORD 4 researchers did not properly report side effects that Xarelto patients had experienced. The FDA also alleged that RECORD 4 researchers failed to notify trial participants of the potential dangers of Xarelto and also failed to get the proper medical consent from trial subjects.
To put it mildly, this report raises eyebrows as to what Bayer and Janssen knew about the dangers of Xarelto before making it available to the public. The JAMA Internal Medicine article raises cloud of suspicion regarding the true motivations of those involved with the manufacture and marketing of this drug.