FDA

Feds reject complaints of FDA misconduct in medical device approvals

Saturday, November 13, 2010 by: Jonathan Benson, staff writer
Tags: FDA, misconduct, health news

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(NaturalNews) At least nine current and former scientists at the U.S. Food and Drug Administration's (FDA) medical device unit have filed complaints against the agency for harassment and intimidation over their concerns about the safety of FDA-approved medical devices. But for the second time this year, federal officials have rejected those complaints without even conducting a legitimate investigation.

According to reports, FDA scientists went public with concerns about the safety of new medical imaging devices that inflict a heavy load of harmful radiation on patients. Of particular concern are new computed tomography (CT) scanning machines being used on otherwise healthy individuals to screen for prostate cancer, which the same scientists say exposes individuals to needlessly high levels of radiation. And these are the same devices implicated in hundreds of radiation overdoses throughout this past year.

The scientists say their FDA overseers pressured them to approve the devices despite the health concerns, and even threatened to retaliate against them if they failed to cooperate. These same managers actually overrode the scientists' decisions, but without documenting a valid reason for doing so as is required by law. And according to a recent Associated Press release, three of the "whistleblowers" had their contracts terminated after finally bringing their concerns before Congress.

But worst of all is the fact that the office of inspector general at the Department of Health and Human Services (HHS) did not even perform a real investigation into the matter before outright dismissing it. According to Dr. Julian Nicholas, an Oxford-trained intestinal specialist that had his contract at the FDA annulled for filing a complaint, the office did not even interview any of the scientists to hear their side of the story.

"It's hard for me to believe this was a bona fide investigation when they haven't even contacted the people who reported these violations," Nicholas stated in an interview. "Such a huge amount of money is at stake and so many people are affected, that for the (office of inspector general) not to conduct a credible investigation is criminal in itself."

Meanwhile, the FDA continues to insist that the new imaging devices are safe when used according to proper guidelines.

Sources for this story include:

http://www.google.com/hostednews/ap/article/...

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