Tags: MidPoint | Charles Seife | FDA | new drugs | fraud

Journalist: FDA Buries Fraud, Misconduct in Clinical Trials

By    |   Thursday, 19 Feb 2015 04:52 PM

The U.S. Food and Drug Administration is concealing the errors, misconduct and sometimes fatal medical fraud uncovered by the agency's own auditors in their inspections of clinical trials of new drugs and treatments, the author of an investigation into the FDA's suspect reporting procedures tells Newsmax TV.

The agency entrusted with protecting patients from unsafe and untested medicines has instead been annexed by the industries it's supposed to police, New York University journalism professor Charles Seife told "MidPoint" host Ed Berliner on Thursday.

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"There' s a broad idea called 'regulatory capture,' which is well known, that an agency which regulates an industry winds up being drawn into the orbit of that industry over time," said Seife, "and I don't think the FDA is any different."

Seife and his graduate students at NYU's Arthur L. Carter Institute of Journalism scoured the FDA's clinical trial records and published their findings in the latest issue of a leading medical journal, Jama Internal Medicine.

Their analysis found that between 1998 and 2013, severe problems in dozens of clinical trials flagged by FDA auditors were not publicized, and never mentioned in scores of peer-reviewed medical journal articles that presented data based on the faulty, sometimes fraudulent trials.

"In one trial they were looking at the effect of a medication on people's retinas and it turns out that the retinal scans were just fake — they were duplicated from other patients," said Seife. "So it was just fake data."

Seife and his students found that the FDA was aware of, but didn't report, faked x-rays, doctored patient entry forms and sometimes "gruesome" medical mishaps in testing of new drugs and cutting-edge treatments.

"In one case a patient who was undergoing a stem cell therapy had a foot amputated and that amputation never wound up being reported," he said. "So it looks like, if you look at the [published] paper, that the stem cell therapy was working, when in fact there's good evidence that it was not."

Seife noted that doctors rely on those medical journal articles for good information on new products and treatments for their parents.

Seife said that FDA auditors find most clinical trials are conducted diligently, ethically and without errors, and that most trials pass muster for their clinical practices, patient safety measures, record keeping, informed patient consent procedures and other areas that come under FDA review.

"But about 2 percent of the time, give or take, they find serious, serious problems including fraud," he said.

Seife said the agency has been less than forthcoming with him and his students.

For starters, the stacks of FDA paperwork they received at the outset were riddled with "heavy, heavy, heavy redactions to prevent us from figuring out which trials were affected," he said.

The FDA also refused to make anyone available to him for an interview, "which doesn't speak well to their transparency," he said. "The direct questions I asked them were universally dodged. I can point to specific things on FDA-approved labels that are false, and they've never responded to them."

Siefe said his study's findings should give pause but not cause panic. He said it's a long distance from "showing that there's problems with the study" to "saying that a drug is not safe or ineffective."

"Just because I'm finding flaws with these studies that aren't being publicized does not necessarily mean you have to go out and panic and worry about your medications," he said. "But it does mean that physicians, the doctors who are prescribing things for you, are often working on inaccurate information."

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The U.S. Food and Drug Administration is concealing the errors, misconduct and sometimes fatal medical fraud, the author of an investigation into the FDA's suspect reporting procedures tells Newsmax TV.
Charles Seife, FDA, new drugs, fraud
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2015-52-19
Thursday, 19 Feb 2015 04:52 PM
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