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FDA Buries Evidence of Fraud


Stephen Luntz

Stephen has a science degree with a major in physics, an arts degree with majors in English Literature and History and Philosophy of Science and a Graduate Diploma in Science Communication.

Freelance Writer

954 FDA Buries Evidence of Fraud
Anyaivanova/Shutterstock. Clinical trials are not always as transparent as they should be

The U.S. Food and Drug Administration (FDA) is letting scientists get away with fraud, a paper in the Journal of the American Medical Association claims.

The Internet is littered with baseless conspiracy theories that scientists are covering up the dangers of foods, vaccines, pharmaceuticals and even windmills. Such slurs make it even more important that real fraud gets exposed when its discovered.


However, according to New York University's Professor Charles Seife, that is not what the FDA is doing. "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,” writes Seife. Around 2% of their investigations in 2013 found breaches severe enough to earn an “official action indicated” (OAI) classification.

“However, the FDA has no systematic method of communicating these findings to the scientific community,” Seife notes. “Leaving open the possibility that research misconduct detected by a government agency goes unremarked in the peer-reviewed literature."

Scientific fraud is hardly unknown, but the expectation that work can be replicated keeps it in check. However, when the risk of exposure is low, the chance of fraud rises dramatically, and Seife alleges the FDA is allowing this to occur.

Using Freedom of Information requests, Seife identified 57 examples of research misconduct over 15 years of OAI-rated clinical trials. Of these, 22 trials involved “falsification or submission of false information” and 35 were described as having “inadequate or inaccurate record keeping.” In other cases, the consequences were most severe for the subjects—30 trials were cited with a “failure to protect the safety of patients and/or issues with oversight or informed consent.” Even if the results of those studies were not a threat to the wider community, there is a strong case that those running the trials should have been named and shamed.


Yet in only three cases were the FDA-identified violations reported in peer-reviewed papers, even though many of the trials led to more than one paper. None had corrections or retractions published thereafter.

Seife provides examples where the FDA found deeply disturbing activities that might be expected to have been included in any published paper and yet were left out, apparently with impunity. In one trial, a researcher was sentenced to 71 months in jail for misbehavior leading to the death of a patient undergoing a chemotherapy trial, yet this didn't get mentioned in the peer-reviewed literature. He expands on these examples in terrifying detail in Slate, with primary documents on his own site.

“Failing to notify the medical or scientific communities about allegations of serious research misconduct in clinical trials is incompatible with the FDA’s mission to protect the public health,” Seife argues, proposing a website listing all OAI-rated inspections.

H/T io9


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