Navigation Links
Coast IRB Tells Congressional Committee Sting Operation Was Illegal, Unnecessarily Harmful
Date:3/26/2009

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.

    CONTACT:
    Diane Morrow    dmorrow@tbbmedia.com
    800-927-1517 or cell 817-319-9805


'/>"/>
SOURCE Coast IRB
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:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... Michigan (PRWEB) , ... June 24, 2016 , ... June ... about the dangers associated with chronic pain and the benefits of holistic treatments, ... individuals who are suffering with Sickle Cell Disease. , Sickle Cell Disease (SCD) is ...
(Date:6/24/2016)... ... , ... Global law firm Greenberg Traurig, P.A. announced that 20 Florida attorneys ... peers for this recognition are considered among the top 2 percent of lawyers practicing ... members of this year’s Legal Elite Hall of Fame: Miami Shareholders Mark D. ...
(Date:6/24/2016)... ... June 24, 2016 , ... Topical BioMedics, Inc, makers of Topricin and MyPainAway Pain Relief ... a minimum wage raise to $12 an hour by 2020 and then adjusting it yearly ... lost value of the minimum wage, assure the wage floor does not erode again, and ...
(Date:6/24/2016)... NY (PRWEB) , ... June 24, 2016 , ... ... Haute Living, is proud to recognize Dr. Barry M. Weintraub as a prominent ... “the most beautiful women in the world, and the most handsome men, look ...
(Date:6/24/2016)... ... ... National recruitment firm Slone Partners is pleased to announce the placement of ... President of North American Capital Sales at HTG Molecular . , ... the commercialization of the HTG EdgeSeq system and associated reagents in North America. , ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... , June 23, 2016 ... "Pharmaceutical Excipients Market by Type (Organic Chemical (Sugar, ... Formulation (Oral, Topical, Coating, Parenteral) - Global Forecast to ... The global pharmaceutical excipients market ... at a CAGR of 6.1% in the forecast period ...
(Date:6/23/2016)... , June 23, 2016 Roche (SIX: ... 510(k) clearance for its Elecsys BRAHMS PCT (procalcitonin) assay ... sepsis or septic shock. With this clearance, Roche is ... a fully integrated solution for sepsis risk assessment and ... with bacterial infection and PCT levels in blood can ...
(Date:6/23/2016)... 23, 2016 Capricor Therapeutics, ... a biotechnology company focused on the discovery, development ... patient enrollment in its ongoing randomized HOPE-Duchenne clinical ... 50% of its 24-patient target. Capricor expects the ... quarter of 2016, and to report top line ...
Breaking Medicine Technology: