Every year the US Federal Drug Administration inspects several hundred clinical sites performing biomedical research on humans. They classify their inspections mostly as “no action indicated” but occasionally discover a severe problem they label as “official action indicated” or OAI.
The worst of these OAI’s could include submission of false information and/or failure to report adverse events.
The author of this paper is a profession or journalism from NYU with a special interest in research misconduct. With much of his graduate students doing the leg work, he attempted to find the OAI’s, describe the violations and determine whether subsequent published articles acknowledged the FDA’s findings. One would think that the FDA had ethical and or legal obligations to make these serious infractions public.
Without going in to too many specifics, they found it quite difficult to even find the OAI’s as there is no public repository for this information. In addition, the FDA reports they discovered were highly redacted. This made it hard to determine what infractions were related to actual articles in the peer reviewed literature. Nevertheless they found 78 publications that resulted from trials in which the FDA found significant violations. How many of these papers mentioned the FDA’s concerns? Only 4%.
There are numerous examples of transgressions listed in the paper. My favourite was a researcher who pled guilty to fraud and criminally negligent homicide in the conduct of a trial. She was sentenced to 71 months in prison. Although this was clearly documented by the FDA, there is no mention of any of this in the published studies based on her trial.
How could all of this happen? It turns out the FDA does not officially make OAI’s public. They don’t tell journal editors nor do they link their discovered information back to clinicaltrials.gov. The author of this paper makes some very sensible suggestions on how the FDA might improve their processes. Fortunately it looks like they might be listening.
All of this might sound a bit like a conspiracy theory. But fraud in medical research is a real entity and very easy to execute. There are strong incentives in our “publish or perish” climate to resort to devious means of research. This says nothing of bias, spin and the billions of dollars that pharmaceutical industry stand to profit from research that goes their way.
What are we to take home from all of this? At the core of biomedical research lurks a perverse incentive encouraging fraud and it happens more than we like to know. Be sceptical of studies that look to good to be true. Sorry, but sometimes data is simply made up.
Hopefully the FDA will change their ways.
Seife C. Research Misconduct Identified by the US Food and Drug Administration; Out of Sight, Out of Mind, Out of the Peer-Reviewed Literature. JAMA Intern Med 2015 Apr 1; 175(4):567-77.