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Eric T. Chaffin
Eric T. Chaffin
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Was Xarelto Approved Based on Faulty Data?

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Just how accurate are the clinical trials that are submitted to the FDA for drug approvals?

According to a recent study in JAMA Internal Medicine, there may be a number of errors, or “departures from good clinical practice” in these studies. These are seldom reported in peer-reviewed literature, leaving doctors and consumers in the dark. This could be particularly serious, as many of the clinical trials in the studies were those that formed the basis for later drug approvals.

One of those drugs—Xarelto—was approved despite what has now been called a study full of transgressions, a study that was deemed unreliable by the FDA.

FDA Regularly Inspects Clinical Study Sites

Unknown to most consumers of prescription drugs, the FDA, as part of its approval process, inspects several hundred clinical sites performing biomedical research on human participants every year. They do occasionally find “evidence of substantial departures from good clinical practice and research misconduct,” according to the study in JAMA.

The problem is the FDA has no established method of communicating these findings to the scientific community. That means that there is a chance that scientists, doctors, and consumers remain in the dark about them, as they are never reported in the journals in which the studies are published.

JAMA Study Shows Errors in Studies Never Reported

Researchers examined documents dated from January 1, 1998 to September 30, 2013. These documents described inspections of clinical trial sites at which the FDA found evidence of problems. The researchers then checked to see if the inspection documents could be linked to specific published clinical trials.

Results showed the following:

• A total of 57 published clinical trials were found to have evidence of one or more problems.
• These problems included falsification or submission of false information, problems with adverse events reporting, protocol violations, inadequate or inaccurate record keeping, failure to protect the safety of the patients, and other violations.
• Only four percent of the publications that resulted from these trials ever mentioned the problems found during the inspections.
• No corrections, retractions, expressions of concern, or other comments acknowledging these issues were ever included in the other published studies.

The researchers concluded that even when the FDA finds “significant departures from good clinical practice, those findings are seldom reflected in the peer-reviewed literature, even when there is evidence of data fabrication or other forms of research misconduct.”

One of the Studies Riddled with Problems was On Xarelto

Unfortunately, the research, conducted by Charles Seife of the Arthur L. Carter Institute of Journalism at New York University, gave few clues as to just which drugs were involved in these error-ridden clinical trials. The inspection records had redacted and blacked out sections that concealed the drugs and their manufacturers. There was one, however, that was not blacked out—Xarelto (rivaroxaban).

It turns out that one of the studies that supposedly showed Xarelto to be an effective and safe blood-thinner was full of departures from good clinical practice. So called “RECORD 4” (Regulation of Coagulation in Orthopedic Surgery to Prevent Deep-Venous Thrombosis and Pulmonary Embolism 4) was riddled with problems, including “systematic discarding of medical records,” according to Seife, falsification, and “concerns regarding improprieties in randomization.”

Yet despite all these issues, the study was published in the respected medical journal, Lancet, in May 2009—with none of the errors or problems reported. It seems to indicate that Xarelto is effective for preventing blood clots after knee replacement surgery, even though the FDA found that researchers faked some of the data and destroyed some medical records. Seife noted in his report that the FDA found RECORD 4 unreliable, yet they ended up approving Xarelto anyway, based on other trials that were found to have fewer problems.

Plaintiffs who took Xarelto and then suffered from serious side effects like severe gastrointestinal bleeding may be eligible to file a personal injury lawsuit.