February 13, 2015

Does the FDA Hide Evidence of Clinical Fraud?

FDA approvedBy Marlene Koury

The FDA protects the public health and assures all drugs are proven safe and effective by reputable scientific trials before they are licensed for sale.  Or do they?  An investigative reporting class at NYU found evidence showing when the FDA finds scientific fraud or misconduct, it does not notify the public, doctors, or the scientific community.  Rather, the FDA “has shown a pattern of burying the details of misconduct.”

NYU journalism professor Charles Seifeat and his students dug through FDA documents relating to roughly 600 clinical trials in which one of the researchers running the trial failed an FDA inspection.  They were looking to see if they could determine which study, which drug, and which pharmaceutical company were involved.  To do this, the researchers reviewed hundreds of form 483s, or Establishment Inspection Reports, where information on failed clinical trials is documented.  What they found is, most of the time, key portions of the documents are blacked out, including information describing the drug, the name of the study, and how the misconduct affected the quality of the data.  In only roughly 100 cases were the researchers able to determine which study, which drug, and which pharmaceutical company were involved.

An article written by Mr. Seifeat discussing the findings was published in Slate magazine earlier this week.  As one of many examples in the article, Mr. Seifeat discussed the fiasco a decade ago over a newly approved antibiotic named Ketek.  In that case, FDA inspectors had found extensive problems, including fraud, affecting key clinical trials of the drug.  Nevertheless, the FDA hid the problems from the public, doctors, and even its most trusted advisors.  David Ross, the FDA official in charge of reviewing the drug’s safety confirmed that “FDA managers hid the evidence of fraud and misconduct from the advisory committee, which was fooled into voting for approval.”  As Mr. Seifeat and his team concluded, the FDA seems to be “spending an awful lot of effort protecting the perpetrators of bogus science from the public.”

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