A trawl of internal documents held by the US Food and Drug Administration (FDA) has revealed official action due to “significant departures from good clinical practice” against a total of 57 clinical trials, including 22 affected by “falsification” – yet a parallel search of the published study reports finds no mention of these grave concerns being made public.

Share on Pinterest Serious violations in clinical trials of drugs and other interventions included false results and under-reporting of potential side-effects.

The documents about FDA action triggered by bad practice at clinical trial sites were uncovered by freedom of information requests to the US regulator made by Charles Seife, a professor at the Arthur L. Carter Institute of Journalism at New York University.

The researcher and his students cross-referenced the FDA official actions against all the available peer-reviewed studies on the clinical trials affected, and the results are collated in a journal of the American Medical Association, the latest online issue of JAMA Internal Medicine.

“Official action indicated” (OAI) is reserved by the FDA for the most severe forms of clinical trial violation found during the regulator’s site inspections: “objectionable conditions or practices” that warrant compulsory regulatory action, as opposed to “voluntary action indicated” for lesser violations.

The bad practices ranged from falsification of results to poor record-keeping in the 57 trials found to have received action between 1998 and 2013.

In the 2013 fiscal year alone, the author says, about 2% of the 644 inspections by the FDA at trial sites were classified for OAI.

One of the studies, published in 2012, gives positive claims about a stem cell treatment for all the 26 patients with severe loss of blood circulation to their legs, stating “major clinical improvements” for all – while making no mention that one of the patients in fact needed amputation of their leg 2 weeks after having the treatment for severe limb ischemia.

The FDA had to take action over this omission, yet no correction or retraction of the published results was found by Prof. Seife’s search of the medical literature.