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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 |
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How Does the FDA Monitor Your Medical Implants?
[It Doesn’t – Really]
From eroding surgical mesh to rusting artificial hips, the past decade has seen many medical devices malfunction.
http://www.propublica.org/article/how-does-the-fda-monitor-your-medical-implants
But, did you know that the FDA doesn’t have a standardized national system to track and catch problems?
Zina
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HHS Propaganda
What did I tell you? HHS coupled with Ketchum Inc. is a propaganda machine.
“Spinning EHR Adoption Numbers? – Margalit Gur-Arie provides a compelling look into spinning EHR adoption numbers of office based physicians, hospital, and Meaningful Use reports from the HHS.”
http://www.hitconsultant.net/2013/06/20/spinning-ehr-adoption-numbers/
HHS also censors dentists’ concerns posted on the government website.
D. Kellus Pruitt DDS
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Government shutdown leaves HHS, ONC reeling
The government shutdown has dealt certain healthcare organizations tough blows.
http://www.medicalpracticeinsider.com/news/government-shutdown-leaves-hhs-onc-reeling
The Office of the National Coordinator for Health IT, for one, was hit particularly hard — of the total 184 on-board staffers at ONC, only 4 will be retained and charged with handling an orderly phase-down and suspension of operations.
Karma-eh!
Carmen
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Is it time to defy HHS, Doc?
Physician declares it’s time to defy the U. S. Department of Health and Human Services.
“So when do we say damn the mandates and requirements from bureaucrats who are not in the healing profession? When do we stand up and say we are not going to take it any more?” – Dr. Daniel F. Craviotto, a 58 year old orthopedic surgeon in Santa Barbara, California.
Sound familiar? For years, I’ve been (almost alone) openly encouraging dentists to rebel against the half-baked ideas of unaccountable, unresponsive healthcare IT stakeholders who don’t care for patients. Physicians are apparently less embarrassed to discuss the healing profession’s parasitic problems than most dentists, while hapless patients remain blissfully clueless about their doctors’ conflict of interest with federal HIT busywork.
Dr. Craviotto’s opinion appeared in the Wall Street Journal this week under the title: “A Doctor’s Declaration of Independence – It’s time to defy health-care mandates issued by bureaucrats not in the healing profession.”
http://online.wsj.com/news/articles/SB10001424052702304279904579518273176775310?mg=reno64-wsj&url=http%3A%2F%2Fonline.wsj.com%2Farticle%2FSB10001424052702304279904579518273176775310.html
Dr. Craviotto adds, “I don’t know about other physicians but I am tired—tired of the mandates, tired of outside interference, tired of anything that unnecessarily interferes with the way I practice medicine. No other profession would put up with this kind of scrutiny and coercion from outside forces. The legal profession would not. The labor unions would not. We as physicians continue to plod along and take care of our patients while those on the outside continue to intrude and interfere with the practice of medicine.”
Recently, I’ve been told by a few people, “You were right all along, Darrell.”
Thanks. That feeds the beast.
D. Kellus Pruitt DDS
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