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.
Covering:
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.
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