Sunday, March 29, 2009

Department of Health and Human Services Approves Fictitious Medical Device Review

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http://www.naturalnews.com/025955.html


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 misleaders
The 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.