February 10, 2015 — When the FDA finds evidence of scientific misconduct in clinical trials, that information is routinely omitted from published studies, according to an investigation published in JAMA.
Those omissions protect confidential commercial information, but leave doctors and the public in the dark when seriously flawed studies are published in peer-reviewed journals.
The problem is that the FDA has no systematic method of communicating these findings to the scientific community. As a result, the FDA’s findings are rarely reflected when the study is published.
An investigation by researchers at New York University looked at 57 clinical trials where significant evidence of scientific misconduct was identified by the FDA — such as failing to report adverse events, making up data, or manipulating the methods of the study to skew the results.
The 57 trials resulted in 78 studies published in peer-reviewed journals, but in only 3 cases (4%) was there any mention of violations cited by the FDA.
For example, one stem cell study in 26 people with ischemia in their foot reported that all of the patients had “major clinical improvements.” However, in reality, one patient had to have their foot amputated two weeks after receiving the stem cell treatment. Despite a warning from the FDA, the study was published with no corrections.
The FDA is supposed to protect public safety, but researchers warned about legal and ethical questions:
“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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