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(NaturalNews) Just how trustworthy are medical review boards that review and approve medical devices? In a Government Accountability Office (GAO) sting, investigators were able to invent and register a fictitious review board with the Department of Health and Human Services (HHS), complete with a fictitious panel of doctors and a canine president named "Truper Dawg" (named after a real pet dog that had long since passed away).
Names of other board members on the fictitious organization approved by the Department of Health and Human Services included "April Phuls" and "Timothy Wittless." These names apparently did not raise any suspicions at the HHS. (Perhaps the U.S. government thought the review board was being run by a group of badly-named rappers?)
But that's not all: To check out the credibility of existing Independent Review Boards (IRBs), the GAO invented a fictitious medical product called Adhesiabloc -- an adhesive gel used as a kind of "stomach superglue" following surgery. A proposal to begin a clinical trial of this adhesive gel on humans was submitted to an FDA-recognized IRB company, and the company approved it! This, despite the fact that the clinical trial called for pouring one liter of this adhesive gel into the stomach of patients.
Misleading the misleadersThe IRB that fell for the ruse was Coast IRB, LLC of Colorado Springs, which after being caught, charged that the GAO investigators violated federal law by misrepresenting themselves when they submitted false credentials to the review company.
But isn't this exactly what a medical review company is supposed to notice and prevent in the first place? This company seems to think they can trust everything they're told by any person or company applying for review, regardless of whether the medical products in question make any sense at all.
Coast IRB is one of 6,300 IRBs (Independent Review Boards) that certify pharmaceutical trials and medical device trials for consideration by the FDA.
The next time you considering using an "FDA-approved" medical device or pharmaceutical, remember this simple truth: In America, the Department of Health and Human Services will certify a fictitious review company headed by a dog!
If the GAO can pull this off after running the sting on just 3 companies, imagine how many of the 6,300 IRBs are certifying fraudulent, dangerous or outright deadly medical devices and pharmaceuticals right now!
What this fiasco really shows is that the medical device oversight system in America today is a complete joke. With the right paperwork, a medical device company could get review board approval for practically anything. And with the HHS accepting the credentials of fictitious review boards, the overseers of the review boards are so incompetent in their own jobs that the credibility of the whole system must be called into question.
Combine this with the corruption at the FDA, and you have to really wonder: Just how safe are the medical devices and pharmaceuticals being used by over a hundred million Americans right now? The answer, of course, is that many of them may have simply been rubber-stamped by dishonest or incompetent review board companies and HHS bureaucrats who have now been utterly exposed as either criminally dishonest or shockingly incompetent.
Sources for this story include:
Wall Street Journal: http://online.wsj.com/article/SB123...
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Sunday, March 29, 2009
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