The US Food and Drug Administration (FDA) summarizes their purpose on their website as “Protecting and Promoting Your Health”. In addition to protecting the public they serve health professionals, researchers, and industry. One of the main responsibilities of the FDA is listed as: “ensuring that human and veterinary drugs, and vaccines and other biological products and medical devices intended for human use are safe and effective”.
Given this vital role, there has been much concern over Charles Seife’s February 9, 2015 article in the Journal of the American Medical Association: Internal Medicine, titled Research Misconduct Identified by the US Food and Drug Administration.
The conclusion of this article states: “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 the impact is better stated in the author’s article at the Slate where he states:
It’s not just the public that’s in the dark. It’s researchers, too. And your doctor. As I describe in the current issue of JAMA Internal Medicine, my students and I were able to track down some 78 scientific publications resulting from a tainted study—a clinical trial in which FDA inspectors found significant problems with the conduct of the trial, up to and including fraud. In only three cases did we find any hint in the peer-reviewed literature of problems found by the FDA inspection. The other publications were not retracted, corrected, or highlighted in any way. In other words, the FDA knows about dozens of scientific papers floating about whose data are questionable—and has said nothing, leaving physicians and medical researchers completely unaware. The silence is unbroken even when the FDA itself seems shocked at the degree of fraud and misconduct in a clinical trial.
Sources and further reading:
Slate: Are Your Medications Safe?
JAMA Internal Medicine: Research Misconduct Identified by the US Food and Drug Administration
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