Coast IRB Tells Congressional Committee GAO's Sting Operation Was Illegal, Unnecessarily Harmful.

WASHINGTON -- Daniel S. Dueber, CEO of Coast Independent Review Board (IRB), testified today before the Subcommittee on Oversight and Investigations of the House Energy and Commerce Committee in the Rayburn House Office Building. Dueber testified that Coast IRB was targeted by the Government Accountability Office (GAO) in a clandestine sting operation at the request of the Committee. "Coast was singled out despite the absence of proof that Coast had committed any crime. No crime was unearthed from the sting. Never before had Coast been the victim of fraud from an actual clinical trial sponsor, and no patients in clinical trials reviewed by Coast have ever suffered serious physical harm," states Dueber.

The sting is an apparent effort by the Committee to prove that neither the FDA nor the private IRBs it regulates have sufficient checks to confirm the truthfulness of representations made in drug sponsor submissions. "It appears that The Committee asked GAO to pose as a legitimate clinical trial organization and induce Coast to authorize review of a bogus trial. To cause Coast to believe the clinical trial organization legitimate, the GAO engaged in extensive mail and wire fraud," continued Dueber. "GAO falsified professional credentials, and submitted a fake medical device protocol. It created a fake medical device, Adhesiabloc, said to be substantially equivalent to another medical device already given market approval by FDA. It submitted fake FDA 510(k) number and fake Federal Wide Assurance number for the device. It engaged in misleading telephone calls and emails. In violation of Virginia law it forged a Commonwealth of Virginia medical license in response to Coast's request for proof that the clinical trial's principal investigator was duly licensed."

Dueber described the fraud as an "elaborate scheme" that worked, at first. Coast IRB approved the clinical trial for review. Then after receipt of a request for production of documents from the Committee, Dueber looked behind the representations made and discovered the fraud, some four months after the trial had been approved.

In his opening statement, Dueber told the Committee that if its "objective . . . was to demonstrate that IRBs need to do more checking and verification . . . we will do that, and we have changed our SOPs to do just that . . .Coast unnecessarily suffered significant harm to its business and business reputation". "[Y]ou need to understand the effects of this charade .... My company spent over $100,000 defending itself ... we have had to lay off at least 5 people. A better approach would have been for you to call a conference together of key industry leaders to identify what needs to be fixed. No one would have had to be harassed as Coast has with this sting."

For a copy of Dueber's Opening Statement, report from Thomas Kupiec, Ph.D. and Analytical Research Laboratories, please contact B&B Media.