In JAMA Internal Medicine this week there’s an article that is especially newsworthy: “Research Misconduct Identified by the US Food and Drug Administration: Out of Sight, Out of Mind, Out of the Peer-Reviewed Literature.” Excerpts:
Every year, the US Food and Drug Administration (FDA) inspects several hundred clinical sites performing biomedical research on human participants and occasionally finds evidence of substantial departures from good clinical practice and research misconduct. However, the FDA has no systematic method of communicating these findings to the scientific community, leaving open the possibility that research misconduct detected by a government agency goes unremarked in the peer-reviewed literature.
Results Fifty-seven published clinical trials were identified for which an FDA inspection of a trial site had found significant evidence of 1 or more of the following problems: falsification or submission of false information, 22 trials (39%); problems with adverse events reporting, 14 trials (25%); protocol violations, 42 trials (74%); inadequate or inaccurate recordkeeping, 35 trials (61%); failure to protect the safety of patients and/or issues with oversight or informed consent, 30 trials (53%); and violations not otherwise categorized, 20 trials (35%). Only 3 of the 78 publications (4%) that resulted from trials in which the FDA found significant violations mentioned the objectionable conditions or practices found during the inspection. No corrections, retractions, expressions of concern, or other comments acknowledging the key issues identified by the inspection were subsequently published.
Conclusions and Relevance 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.
But what makes it even more newsworthy is that, while the author is Charles Seife of NYU’s Arthur L. Carter Journalism Institute, you’ll see deep down in the acknowledgements:
Graduate students from New York University’s Science, Health, and Environmental Reporting and Business and Economic Reporting programs assisted with data collection and analysis: Lydia Anderson, MA, Rebecca Cudmore, MA, Kathryn Free, MA, Chelsea Harvey, MA, Joshua Krisch, MA, Jamie Lee, MA, Sarah Lewin, MA, Claire Maldarelli, MA, Elizabeth Newbern, MA, Hannah Newman, MA, Amy Nordrum, MA, Alexandra Ossola, MA, Neel Patel, MA, Krystnell Storr, MA, and Manasi Vaidya MA. Rob Garver and Tom Detzel of ProPublica contributed to useful discussions.
And one of them, Joshua A, Krisch, wrote about it: “The Fraud Behind Some of The Most Common Prescription Drugs: It’s remarkably easy to find blatant dishonesty in the research that supports some popular treatments.” Excerpt:
That was the vague and intimidating order from my journalism school professor—and, actually, our very first homework assignment. I expected to spend my weekend digging through old FDA databases, hopefully managing to pull one example of real fraud from a mess of redacted, spurious warning letters.
But as it turned out, it was almost too easy.
The problem wasn’t finding fraud—it was deciding which heinous act of straight-up medical chicanery to use. Blatant dishonesty had tainted thousands of medical studies. I found clinical trials with fake patients, doctors who never bothered obtaining consent, forgeries and cover-ups galore. The FDA database was a veritable “who’s who” of dirty researchers.
And Krisch outlines three of his personal favorites of all the “dirtiest cases” they found:
A little light reading as one ponders what science journalism academics and students can contribute.
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