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:10/13/2015)... ... October 13, 2015 , ... ... first commercially-available next-generation sequencing laboratory test for bacterial vaginosis- a significant women's ... in Vancouver, BC, Canada. , In a presentation entitled: "The Microbiome ...
(Date:10/12/2015)... ... October 13, 2015 , ... Career Step, ... the release of its new Professional Medical Coding and Billing with Applied PCS ... ICD-10-CM and ICD-10-PCS code sets, earn the Certified Professional Coder (CPC) and Certified ...
(Date:10/12/2015)... ... 12, 2015 , ... According to an article from ... particularly in the area of track and field, are at a significantly higher ... peers in the same age group. Dr. Steven Meier of Meier Orthopedic Sports ...
(Date:10/12/2015)... ... 12, 2015 , ... According to an article published by Texas ... Texas recommended that any high-rises in the city limits that do not have fire ... article explains that it wasn’t until 1982 that the city started requiring fire sprinklers ...
(Date:10/12/2015)... ... October 12, 2015 , ... AcousticSheep LLC, creators of the ... honor of Breast Cancer Awareness Month. During the month of October, for ... SleepPhones® Classic product to a breast cancer patient at the Cleveland Clinic. , ...
Breaking Medicine News(10 mins):
(Date:10/12/2015)... -- Use this report to: - Learn ... the medical membrane devices market. - Analyze the present ... medical membrane devices market including hemodialyzers, membrane oxygenators, intravenous ... devices. - Gain information on newly approved products, recalls ... Use this report to: - Learn about the performance, ...
(Date:10/12/2015)... and CRANBURY, N.J. , Oct. ... LLP announces that a securities fraud class ... for the District of New Jersey.  The complaint alleges ... FOLD) violated the Securities Exchange Act of 1934 between ... materially false and misleading statements about Amicus Therapeutics, business ...
(Date:10/12/2015)... , Oct. 12, 2015  MiMedx Group, Inc. ... utilizing human amniotic tissue and patent-protected processes to develop ... Care, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic, and the ... results for the third quarter of 2015, its guidance ... Company has secured a $50 million Senior Secured Credit ...
Breaking Medicine Technology: