February 10, 2015 — An investigation published in JAMA has found that that FDA routinely fails to report evidence of fraud and scientific misconduct when it investigates clinical trials, leaving doctors and the public in the dark when less-than-credible studies are published.
As part of the drug approval process, the FDA inspects clinical trial sites to make sure scientists are conforming to good clinical practice. When inspectors find problems, they can issue citations or warning letters for violations.
Researchers at New York University looked at 57 clinical trials where the FDA found significant evidence of scientific misconduct, including falsified data and under-reporting of adverse events. These trials resulted in 78 articles published in peer-reviewed journals, but only 3 (4%) included any mention of FDA inspection violations.
In one case, a stem cell study in 26 patients with ischemia in their leg stated that all of the patients who were treated with stem cells had “major clinical improvements.” However, one patient actually had a foot amputated 2 weeks after administration of stem cells.
The study was published without a correction or retraction, despite a warning from the FDA.
The findings of the investigation raise legal as well as ethical questions. The researchers warn:
“When the agency withholds the identity of a clinical trial affected by scientific misconduct, it does so because it considers the identity to be confidential commercial information, which it feels bound to protect. However, 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.”
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