Navigation Links
Coast IRB Tells Congressional Committee Sting Operation Was Illegal, Unnecessarily Harmful

WASHINGTON, March 26 /PRNewswire/ -- 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. 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.

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. 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. 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.

    Diane Morrow
    800-927-1517 or cell 817-319-9805

Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Streamline Health to Deliver Hosted Document Workflow Solution to Leading West Coast University-Affiliated Surgery Department
2. Southern California Dentist First on the West Coast to Perform Concentrated Stem Cell Transplant for Dental Implant Procedure
3. Clinical Trial Fraud Exposed by Coast IRB
4. First Coast Service Options Announces Start-up of New Medicare Contract in Puerto Rico
5. First Coast Service Options Announces Start-up of New Medicare Contract in the U.S. Virgin Islands
6. First Coast Service Options Announces Start up of New Medicare Contract
7. Women in Coastal Areas Have Higher Mercury Levels
8. Gulf Coast Veterinary Specialists to Expand Comprehensive Eklin Digital Practice(R) Solutions
9. Gold Coast, Queensland Cosmetic Plastic Surgeon Using Video to Give Virtual Tours of his Practice
10. Ambulatory Services of America, Inc. Announces Joint Venture with Gulf Coast Cancer Centers
11. Packard Childrens Opens West Coasts Most Advanced Pediatric Surgery Center
Post Your Comments:
(Date:6/25/2016)... , ... June 25, 2016 , ... "With 30 hand-drawn ... specific project," said Christina Austin - CEO of Pixel Film Studios. , ProHand ... all within Final Cut Pro X . Simply select a ProHand generator and ...
(Date:6/25/2016)... ... June 25, 2016 , ... On Friday, June 10, Van ... Wellness at Work award to iHire in recognition of their exemplary accomplishments in worksite ... 7th annual Maryland Workplace Health & Wellness Symposium at the BWI Marriott in Linthicum ...
(Date:6/24/2016)... Marne, Michigan (PRWEB) , ... June 24, 2016 , ... ... awareness about the dangers associated with chronic pain and the benefits of holistic treatments, ... for individuals who are suffering with Sickle Cell Disease. , Sickle Cell Disease (SCD) ...
(Date:6/24/2016)... ... June 24, 2016 , ... ... micro-osteoperforation for accelerated orthodontic treatment. Dr. Cheng has extensive experience with all areas ... , AcceleDent, and accelerated osteogenic orthodontics. , Micro-osteoperforation is a revolutionary adjunct ...
(Date:6/24/2016)... , ... June 24, 2016 , ... ... at the Clinical Decision Making in Emergency Medicine conference in Ponte Vedra Beach, ... journal articles published in Emergency Medicine Practice and Pediatric Emergency Medicine ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... and SAN CLEMENTE, Calif. , June 24, ... -based mobile pulmonary function testing company, is now able to perform ... developed by ndd Medical Technologies , Inc. ... in hospital-based labs.  Thanks to ndd,s EasyOne PRO ® , ARL ... can get any needed testing done in the comfort of her ...
(Date:6/24/2016)... Belgium , June 24, 2016 ... the appointment of Dr. Edward Futcher ... Non-Executive Director, effective June 23, 2016.Dr. Futcher was ... Nominations and Governance Committees.  As a non-executive member ... independent expertise and strategic counsel to VolitionRx in ...
(Date:6/23/2016)... 23, 2016 Any dentist who has made an ... current process. Many of them do not even offer this ... and high laboratory costs involved. And those who ARE able ... such a high cost that the majority of today,s patients ... Parsa Zadeh , founder of Dental Evolutions Inc. and ...
Breaking Medicine Technology: