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 loo
'/>"/>

SOURCE Coast IRB
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2

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:5/29/2015)... May 29, 2015 Johnson & ... a confidential Risperdal lawsuit ( http://www.risperdallawsuit2014.com/ ) settlement ... due to his use of the antipsychotic medication. ... selected for the third bellwether trial to involve ... litigation underway in Pennsylvania’s Philadelphia Court of Common ...
(Date:5/29/2015)... California (PRWEB) May 29, 2015 A group ... and have joined the national effort to teach this “new ... in the U.S. have been “sickened” by the recent implementation ... love it or hate it, Common Core is now a ... of Columbia. Parents are now seeking ways to improve ...
(Date:5/29/2015)... May 29, 2015 Intermountain ... partnered with Stratus Video Interpreting ... facilitate better communication and timely care for ... hearing loss. Stratus’ video remote interpreting (VRI) ... enabling staff to quickly access qualified medical ...
(Date:5/29/2015)... The print component of “Skin Health” ... approximately 250,000 and an estimated readership of 750,000. The ... media strategy, and across a network of top news ... of the campaign, click here. , Lucy ... the actress, model and producer details her skin care ...
(Date:5/29/2015)... NY (PRWEB) May 29, 2015 Mediaplanet ... the “beauty of protection”. Skin Health is a ... Today within the markets of New York, Los Angeles, ... estimated 750,000 readers. Its digital counterpart will reach a ... hubs. To read more the Skin Health campaign and ...
Breaking Medicine News(10 mins):Health News:Risperdal Lawsuit Selected as Pennsylvania’s Third Bellwether Gynecomastia Case Settles Hours Before Trial 2Health News:Risperdal Lawsuit Selected as Pennsylvania’s Third Bellwether Gynecomastia Case Settles Hours Before Trial 3Health News:Doctors Discover a Cure for the Common Core 2Health News:Stratus Video Interpreting Partners With Intermountain Healthcare to Provide On-Demand Interpretation Services for Patients With Limited English Proficiency (LEP) 2Health News:Stratus Video Interpreting Partners With Intermountain Healthcare to Provide On-Demand Interpretation Services for Patients With Limited English Proficiency (LEP) 3Health News:Stratus Video Interpreting Partners With Intermountain Healthcare to Provide On-Demand Interpretation Services for Patients With Limited English Proficiency (LEP) 4Health News:Mediaplanet Launches “Skin Health” Campaign Featuring Colorescience 2
... Finding challenges conventional theory on how immune system responds ... -- Immune system T-cells don,t begin to multiply until ... that changes current thinking about how the immune system ... Institute in La Jolla, Calif., said this delay in ...
... More at Risk than Adults, OAKBROOK TERRACE, ... and administered to children in health care,facilities are ... errors,according to a Joint Commission alert issued today ... Sentinel Event Alert addresses pediatric,medication errors, and urges ...
... of doctors around the United States walk a tightrope stretched ... the risk of abetting illegal and life-destroying drug addiction and ... , They walk this tightrope every time a patient asks ... as Oxycontin or Vicodin. These drugs have eased the pain ...
... RENO, Nev., April 10 Microflex Corporation, a ... gloves, and a,subsidiary of Barrier Safe Solutions International, ... non-latex gloves -- Tranquility(TM), a white,examination glove that ... Tranquility(TM) gloves conform to the hand allowing ...
... new report from Packaged Facts,Pet Insurance in North America, ... pet insurance during the next five years,placing sales as ... consistent,with soaring revenues in the overall pet market due ... the health and wellness of their,beloved furry family members. ...
... Osteoporosis,Foundation (NOF) has partnered with CESLIE - The ... women - a dynamic mother-daughter trio -,for their ... prevention. Joan Rivers, Melissa Rivers, Jill Eikenberry,Janet Hubert, ... Ceslie,Armstrong will host the cocktail soiree and networking ...
Cached Medicine News:Health News:T-Cell Duplication Delayed Up to 3 Days After Infection 2Health News:Joint Commission Alert: Prevent Pediatric Medication Errors 2Health News:Joint Commission Alert: Prevent Pediatric Medication Errors 3Health News:Study shows doctor's offices can help stem abuse of Oxycontin, other narcotic painkillers 2Health News:Study shows doctor's offices can help stem abuse of Oxycontin, other narcotic painkillers 3Health News:Study shows doctor's offices can help stem abuse of Oxycontin, other narcotic painkillers 4Health News:Microflex Introduces Tranquility(TM) White Nitrile Gloves 2Health News:North America Primed for Pet Insurance Market Expansion and Expecting $1.1 Billion by 2012 2Health News:National Osteoporosis Foundation and CESLIE - The Women's Network Honor LeFrak Mother and Daughters for Commitment to Bone Health and New York Community 2
(Date:5/29/2015)... , May 28, 2015 Research and Markets ... "North America MRI Market - Growth, Trends And ... The North American MRI systems market is ... 2014 to $1.58 billion by 2020 with a CAGR ... of three types namely, the open system, closed system ...
(Date:5/29/2015)... 28, 2015 Research and Markets ( http://www.researchandmarkets.com/research/p37spr/north_america ... America Open System MRI Market - Growth, Trends And ... The key players in the industry are ... Healthcare and Toshiba Medical Systems ... CT because of its higher sensitivity and use of ...
(Date:5/29/2015)... , May 29, 2015  The annual customer satisfaction ... ranks Praxis EMR as #1 across all specialties. Every ... Research LLC conducts a poll of EHR users and ... results.    Praxis EMR topped 348 ... 18 performance based criteria used by Black Book. In ...
Breaking Medicine Technology:North America MRI Market - Growth, Trends And Forecasts 2014-2019 with GE, Hitachi Medical, Philips Healthcare, Siemens Healthcare & Toshiba Medical Systems Dominating 2North America Open System MRI Market 2014-2019 with GE, Hitachi Medical, Philips Healthcare, Siemens Healthcare and Toshiba Medical Dominating 2Praxis EMR Ranks #1 for Physician Satisfaction in Black Book's 2015 Survey of Solo and Small Practices 2
... 2012 Auxilium Pharmaceuticals, Inc. (Nasdaq: AUXL ... the BofAML 2012 Health Care Conference to be held ... in Las Vegas.  Mr. Adrian Adams, Chief Executive Officer ... the Company and its product pipeline at 11:20 a.m. ...
... May 11, 2012 Remedy Informatics, Inc. further ... science and translational research informatics today with its ... SpecimenTrack™ .  Remedy will offer demonstrations of SpecimenTrack ... Environmental Repositories (ISBER) 2012 Annual Meeting & Exhibit ...
Cached Medicine Technology:Auxilium Pharmaceuticals, Inc. to Present At The BofAML 2012 Health Care Conference 2Auxilium Pharmaceuticals, Inc. to Present At The BofAML 2012 Health Care Conference 3Auxilium Pharmaceuticals, Inc. to Present At The BofAML 2012 Health Care Conference 4Remedy Informatics to Debut SpecimenTrack, Next-Generation Biorepository Software at ISBER 2012 Annual Meeting 2Remedy Informatics to Debut SpecimenTrack, Next-Generation Biorepository Software at ISBER 2012 Annual Meeting 3
Inquire...
Inquire...
... EDTA K2 or EDTA K3 tubes. ... therefore blocks the coagulation cascade. Erythrocytes, ... anticoagulated blood sample are stable for ... are for the examination of whole ...
... the most powerful, productive ... and rich in features, ... a comprehensive authoring environment ... custom interactive multimedia content ...
Medicine Products: