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Congressional 'Sting' Operation Uncovered By Coast IRB

WASHINGTON, March 12 /PRNewswire/ -- The following is being issued by Coast IRB: In a press release issued on March 10, 2009, Coast IRB informed the public that it had discovered what appeared to be a fraudulent clinical trial submitted to that Independent review board for evaluation. Coast IRB has since learned that the fraudulent trial was apparently commenced as part of a congressional "sting" operation. Apparently at the behest of the U.S. House Subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce, agents submitted false credentials and clinical trial data to Coast IRB and possibly other IRBs to induce them to perform reviews. Evidence of the progress of the trials could then form the basis for arguments critical of the FDA and in favor of greater regulatory oversight. Unless pursuant to a court order or under the auspices of the Department of Justice, the sting could be illegal, violating wire fraud, mail fraud, and state laws against fraud and false credentialing.

Coast IRB CEO Daniel Dueber had been asked by subcommittee staff to submit to an informal interview prior to giving testimony before the committee on March 19. Following notice from Coast IRB that the fraud had been detected, committee staff informed Coast that the hearing would be postponed until March 26, 2009 and that the chairman of Coast IRB and possibly another Coast official would now have to appear for a "transcribed interview" with committee staff. "We are doing our level best to ensure protection for subjects of clinical trials under our review, an objective we share with the Food and Drug Administration," said Daniel Dueber, CEO of Coast IRB.

On Friday, March 6, 2009, Coast IRB, an Independent review board, discovered that a protocol submitted to it for review of a medical device called Adhesiabloc by a Device Med Systems of Clifton, Virginia, was in fact fraudulent in violation of federal and state law. Upon receipt of proof of the fraud, Coast IRB and its CEO, Daniel Dueber, ordered the immediate termination of the clinical trial, referred evidence to federal and state authorities for investigation and prosecution, and instituted measures to prevent a recurrence.

Coast IRB is one of the largest independently owned IRB's and was founded in 2002. It is located in Colorado Springs, Colorado.

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