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Bogus Medical Products and Human Testing
[By Darrell K. Pruitt; DDS]
On March 27, 2009, I found the following Associated Press article about a Government Accounting Office (GAO) sting operation. For dentists who are awaiting the final rules from the FDA on the toxicity of amalgam, expect emotional-capricious and expensive. Forget about science, or even logic. For physicians awaiting HHS-supported usability in eMRs … well, good luck.
The HHS – Institutional Review Board
Recently, the GAO successfully gained approval from an HHS-registered institutional review board (IRB) for a bogus and dangerous medical product to be used in human testing. An independent IRB member called pouring a liter of the mystery product into the stomach of a woman following surgery the “riskiest thing I’ve ever seen on this board.”
Daniel Dueber Responds
So what did Daniel Dueber, CEO of the careless IRB, have to say in defense of his company? Since there is no defense, what could he say? According to the AP article, he chose to attack the GAO instead:
“The review board that fell for the GAO ruse, Coast IRB LLC, of Colorado Springs, charged that the GAO violated federal and state criminal laws by falsely representing itself to be a medical device company and forging a medical license. ‘We got hoodwinked,’ said Daniel Dueber, Coast IRB’s chief executive.”
Bart Stupak Responds
Representative Bart Stupak, a Michigan Democrat and chairman of the House Energy and Commerce Committee’s oversight and investigations panel, replied,
“You didn’t get hoodwinked. You took the bait – hook, line, and sinker.”
That’s not all. For those who hoped for rational and well-considered decisions from the Department of Health and Human Services in the Obama administration, it might disappoint some to learn that the GAO was also successful in registering a fictitious IRB.
Assessment
The president of the fake board is a dog named Trooper. If we end up with a Cabinet Secretary at HHS who is a dog-lover as well as a tax-payer, will he or she protect and feed Trooper?
Link:
Conclusion
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Filed under: Alerts Sign-Up, Breaking News, Career Development, Ethics, Information Technology, Managed Care, Practice Management, Research & Development | Tagged: Bart Stupak, Daniel Dueber, Darrel Pruitt, dentists, FDA, GAO, Government Accounting Office, HHS, House Energy and Commerce Committee, Institutional Review Board, IRB | 4 Comments »
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