The clinical trials that are submitted to the U.S. Food and Drug Administration for drug approvals may not be as accurate as commonly believed, according to a recent study recently published in the Journal of the American Medical Association. One drug, Xarelto Lawyers, was approved despite what is now being called a study filled with errors and deemed unreliable by the FDA.
The FDA, as part of its prescription drug approval process, inspects several hundred clinical sites performing biomedical research on human participants every year, and occasionally they find evidence of “substantial departures from good clinical practice and research misconduct,” according to the report in JAMA. But the FDA has no established method of communicating these findings to the scientific community, and they are never reported in the journals in which the studies are published.
According to the JAMA study:
- A total of 57 published clinical trials had evidence of one or more problems.
- Problems included falsification or submission of false information, problems with adverse events reporting, protocol violations, inadequate or flawed record keeping, and failure to protect the safety of the patients involved in the research.
- Only four percent of the publications arising from these trials mentioned the issues found during the inspections.
- No corrections, retractions, concerns, or comments about these problems were ever included in the published studies.
Xarelto Study a Departure from Good Clinical Practice?
One of the studies (RECORD 4) that showed Xarelto to be an effective and safe anti-coagulant was filled with departures from good clinical practice, according to the JAMA report. Although the study appeared to indicate that Xarelto Injuries is effective for preventing blood clots after knee replacement surgery, the FDA actually found that researchers falsified some of the data and destroyed medical records.
The FDA found RECORD 4 unreliable, yet approved Xarelto anyway, based on other trials with fewer issues. Some patients who took Xarelto have in turn suffered from serious side effects, including uncontrolled gastrointestinal bleeding.
Our Attorneys can Help with Your Potential Xarelto Case
If you or a loved one has suffered serious, uncontrollable bleeding while on Xarelto, you should speak with Childers, Schlueter & Smith today about seeking compensation. It may be the only way to alleviate the financial hardship that has been placed upon you.
Consultations are free and without obligation.