A study of internal documents from the Food and Drug Administration (FDA) reveals that though the agency has taken action against clinical trials for “significant departures from good clinical practice” and even falsifications, there is no mention of such problems in the published studies.
The documents were uncovered through freedom-of-information requests from Charles Seife, a professor at the Arthur L. Carter Institute of Journalism at New York University. Seife and his students cross-referenced FDA’s actions against available published peer-reviewed studies. Their results are published in the most recent online issue of JAMA Internal Medicine, Medical News Today reports.
The group found bad practices ranging from falsification of results to poor record keeping in the 57 trials that received action between 1998 and 2013. “Official action indicated” (OAI) is the FDA’s most severe form of clinical trial violation. In the 2013 fiscal year, Seife reports, about 2 percent of the FDA’s 644 inspections at trial sites were classified OAI. A study published in 2012, for example, makes positive claims about a stem cell treatment for 26 patients with severe loss of blood circulation to their legs. The study cited “major clinical improvements” for all, but did not mention that one patient had the leg amputated two weeks after the treatment. The FDA took action but Seife found no correction or retraction of the published results. In another case, the FDA deemed an entire study unreliable but the study was published with no mention of the issue, according to Medical News Today.
An editorial accompanying Seife’s article called such examples “disturbing.” Dr. Robert Steinbrook and Dr. Rita Redberg say a “central responsibility of medical journals is maintaining and improving trust in the medical literature.” Investigators and sponsors of clinical trials should notify journals of substantial findings from regulatory agency inspections, and “modify their reports of clinical trials as needed, either before or after publication,” Medical News Today reports.
Seife concluded that significant FDA findings are seldom revealed in peer-reviewed literature, even when there is “evidence of data fabrication or other forms of research misconduct.” The FDA does not typically notify journals when a clinical trial site receives an OAI inspection, nor does it generally alert the public about the research misconduct it finds. Heavy redaction of released FDA documents makes it “very difficult, or even impossible, to determine which published clinical trials are implicated by the FDA’s allegations of research misconduct,” according to Medical News Today.