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)... (PRWEB) , ... June 24, 2016 , ... Those who ... with these feelings, many turn to unhealthy avenues, such as drug or alcohol abuse, ... Marne, Michigan, has released tools for healthy coping following a traumatic event. , Trauma ...
(Date:6/24/2016)... , ... June 24, 2016 , ... Marcy was in a crisis. Her son James, ... out at his family verbally and physically. , “When something upset him, he couldn’t control ... use it. He would throw rocks at my other children and say he was going ...
(Date:6/24/2016)... ... June 24, 2016 , ... Global law firm Greenberg Traurig, P.A. announced that ... chosen by their peers for this recognition are considered among the top 2 percent ... special honors as members of this year’s Legal Elite Hall of Fame: Miami ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... Comfort Keepers® ... American Cancer Society and the Road To Recovery® program to drive cancer patients to ... and other adults to ensure the highest quality of life and ongoing independence. ...
(Date:6/24/2016)... ... ... People across the U.S. are sharpening their pencils and honing their writing skills ... patients and their families pay tribute to a genetic counselor by nominating him or ... Counselors (NSGC) Annual Education Conference (AEC) this September. , In April, Genome magazine ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... Mass. , June 24, 2016   Pulmatrix, ... pharmaceutical company developing innovative inhaled drugs, announced today that ... Russell Investments reconstituted its comprehensive set of ... "This is an important milestone for Pulmatrix," ... will increase shareholder awareness of our progress in developing ...
(Date:6/23/2016)... , June 23, 2016  MedSource announced today ... its e-clinical software solution of choice.  This latest ... possible value to their clients by offering a ... preferred relationship establishes nowEDC as the EDC platform ... MedSource,s full-service clients.  "nowEDC has long been a ...
(Date:6/23/2016)... June 23, 2016 Research and ... Excipients Market by Type (Organic Chemical (Sugar, Petrochemical, Glycerin), ... Topical, Coating, Parenteral) - Global Forecast to 2021" ... The global pharmaceutical excipients market is projected ... CAGR of 6.1% in the forecast period 2016 to ...
Breaking Medicine Technology: