In early March of this year, the New England Journal of Medicine (NEJM) published a report that involved the blood thinning drug, Xarelto (rivaroxaban). The report brings into question whether or not Xarelto can be considered safer than the traditionally used blood-thinner Coumadin (warfarin).
It was found that a malfunctioning blood test device was used in the trial. As a result, those participating in the studies that were in the Coumadin group may have received higher doses of Coumadin than would have been optimal. This had the potential of an increased risk of serious bleeding in those patients. Complaints by patients with the device date as far back as 2002 and ultimately in 2014 led to its complete recall by the FDA.
The NEJM and other similar medical journals which publish the results of clinical trials of drugs and medical devices, says that it requires that authors make the data used in their study publicly available within six months of publication.
The authors of the Xarelto trial published a letter in the NEJM on February 25 in order to allay any concerns regarding the blood test device. What was not included, however, was blood test data may help more accurately make a comparison between Xarelto and more traditional drugs used to treat blood clots in patients.
Editors of the NEJM claim they were unaware that the data existed. A similar issue has arisen in the past involving the drug, Vioxx and its clinical trials.
According to The Wall Street Journal, medical journals such as the NEJM make money off of studies such as this and that the journal sold some 900,000 reprints of the Vioxx study, which brought in an estimated $697,000. Most of those were purchased by the company selling the drug (Merck).
It is likely that the makers of Xarelto similarly purchased a number of reprints from NEJM. Some feel that this represents a clear conflict of interest and creates a publication bias to produce studies with positive outcomes and rejecting those studies which show negative outcomes.
Can studies published in medical journals be trusted when such a conflict of interest has arisen? Many feel that such conflicts of interest should be stated at the outset so that those utilizing such studies published in medical journals can take the information into consideration. It can help doctors and patients better determine if taking a medication is the best choice.
Many patients that took the blood thinner, Xarelto thought it was the best choice available on the advice of their doctor. If a doctor read a report without knowing of any bias or conflict of interest, it could cause a patient to suffer needlessly because they didn’t have all of the information.
Class action lawsuits have been brought against the makers of Xarelto on behalf of patients who have suffered after being prescribed the drug for their condition of potential stroke due to blood clotting. Many of the lawsuits allege that the makers of Xarelto did know about the risk of prolonged bleeding but were negligent in failing to warn doctors and their patients about these risks. One of the risks is that there is no antidote to uncontrolled bleeding for those patients on the drug.
If you or someone you love has suffered after having taken the drug Xarelto, it is possible that you are entitled to compensation. To find out if you have a case, contact the law offices of John Foy & Associates. Call the “Strong Arm” attorneys in Atlanta at (404) 800-4635 to schedule a free consultation and legal analysis. There are no upfront fees to worry about. Contact us today.