According to a recent report on clinical trial misconduct, there may have been problems with at least one early study on the safety of the new-generation anticoagulant drug Xarelto, including indications that Xarelto safety data may have been falsified and destroyed. This report sheds light on the alleged dangers of Xarelto, which has been linked to potentially life-threatening complications like uncontrollable bleeds. If you took Xarelto in the past, and you have since experienced severe side effects like uncontrollable bleeding, our consumer advocates at the Consumer Justice Foundation can help. We are committed to protecting the rights of consumers harmed by allegedly dangerous medications, and can help put you in touch with an experienced Xarelto attorney today.
In the report, published last month in JAMA Internal Medicine, Charles Seife of the Arthur F. Carter Institute of Journalism at New York University indicates that, while the U.S. Food and Drug Administration (FDA) often identifies clinical trial misconduct and discrepancies in studies conducted by drug manufacturing companies, that information is rarely reported to the medical journals that run the studies. The result is that these medication studies are published in credible medical journals, with no indication that the FDA uncovered problems like unsafe practices, falsified data and a disregard for scientific protocols.
During his research, Seife found that nearly all of the FDA’s clinical trial inspection records included sections in which the name of the medication, the manufacturing company and the researchers involved were removed or blacked out, making it nearly impossible to tell which clinical trials had problems. However, Seife did find an early Xarelto study, called RECORD 4, which was so poorly conducted, and so full of scientific misconduct and improper behavior, that the FDA rejected the report outright when considering whether to approve the new-generation blood thinner several years ago.
Despite the FDA’s findings of falsified data, purposely destroyed medical records and other alarming problems with RECORD 4, researchers were still able to publish the Xarelto study in The Lancet medical journal in May 2009. In the study, researchers suggest that Xarelto is safe and effective for the prevention of pulmonary embolism and deep vein thrombosis following knee replacement surgery, but the research does not disclose the FDA’s findings that the researchers involved in the study allegedly destroyed important medical records and falsified some of the data, actions that hint at an effort to hide questionable practices.
When the FDA was considering approval for Xarelto in 2011, the agency indicated that inspections at five clinical trial sites revealed that researchers involved in RECORD 4 failed to maintain adequate medical records, failed to report adverse events affecting patients, and failed to report unanticipated risks to human subjects. Today, Xarelto has been found to put patients at risk for serious bleeding risks, with large numbers of patients and medical professionals reporting incidents of uncontrollable bleeds that often result in serious injury or death. If you believe you have been harmed by side effects of Xarelto, contact a skilled Xarelto lawyer today for legal help.
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