FDA is Aware of Fraudulent Clinical Trials Hidden from PublicFeb 17, 2015
The U.S. Food and Drug Administration (FDA) is aware of faulty clinical trials, but a recent investigative report shows that this information was never made public. Charles Seife, a professor at the Arthur L. Carter Institute of Journalism at New York University uncovered documents about FDA action prompted by bad clinical practice through freedom of information requests to the agency. According to Medical News Today, Seife and his students found that in 57 clinical trials, there was official action due to "significant departures from good clinical practice"; "falsification" was a factor in 22 of them. The concerning part is that none of these serious concerns were found in a parallel search of the published study reports. Seife's findings were published in the online issue of JAMA Internal Medicine.
Between 1998 and 2013, 57 trials resulted in an "official action indicated" (OAI). The FDA uses an OAI for the most serious type of clinical trial violations, "objectionable conditions or practices" that mandate regulatory action rather than "voluntary action indicated" for less severe violations. The violations discovered in the report ranged from falsification of results to poor record-keeping. Seife and his students found that 2 percent of the 644 FDA inspections at trials sites were classified for OAI in 2013 fiscal year alone.
For example, one study study published in 2012 presented a stem cell treatment in a positive light. The authors said they found "major clinical improvements" for all 26 patients who had severe loss of blood circulation to their legs. Meanwhile, there was no mention of one patient who suffered severe limb ischemia and underwent amputation of the leg 2 weeks after treatment. Seife's search found that the FDA had to take action over this omission but the published results were never corrected.
According to Medical News Today, Seife's investigation found the following violations:
- Fraudulent ("falsification or submission of false information") - 39% (22 trials)
- Problems with the reporting of adverse events - 25% (14 trials)
- Protocol violations - 74% (42 trials)
- "Inadequate or inaccurate" recordkeeping - 61% (35 trials)
- "Failure to protect the safety of patients" and/or issues with oversight or informed consent - 53% (30 trials)
- Other violations not categorized - 35% (20 trials).
However, Medical News Today reports, only 3 out of 78 published reports mentioned anything about the misconduct discovered by the FDA. "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." Seife stated.