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Monday, March 30, 2009

Was Your Medical Device Approved by Dr. Dog? As in a Four-pawed "Doctor"?


5 Nissan 5769

Sorry for the late blogpost. I spent time verifying the news below.

Click on these links to
prepare yourself
for a frightening reality and
today's blogpost:

I read the news sites cited above and gasped. The lesson to be learned is a sad one, especially for people who rely on medical practitioners and their tools: Triple-check the integrity of any device, medication and therapy used in your care.

I know from personal experience
that life-threatening illness does
not afford much (if any) free time.

proposed medical care
is essential.

Coax friends and loved ones
to help you with that task.

Here's why:

In a Government Accountability Office (GAO) sting, investigators were able to invent and register a fictitious review board with the Department of Health and Human Services (HHS), complete with a fictitious panel of doctors and a canine president named "Truper Dawg" (named after a real pet dog that had long since passed away).

Names of other board members on the fictitious organization approved by the Department of Health and Human Services included "April Phuls" and "Timothy Wittless." These names apparently did not raise any suspicions at the HHS (did the U.S. government believe that the review board was being run by a group of badly-named rappers?).

Things get worse: To check out the credibility of the allegedly legitimate Independent Review Boards (IRBs), the GAO invented a fictitious medical product called Adhesiabloc -- an adhesive gel used as a kind of "stomach superglue" following surgery. A proposal to begin a clinical trial of this adhesive gel on humans was submitted to an FDA-recognized IRB company. The fake company approved it even though the clinical trial called for pouring one liter of this adhesive gel into patient's stomaches.

The ethical bankruptcy of the situation
begs comprehension!

The IRB that fell for the ruse was Coast IRB, LLC of Colorado Springs. Coast IRB was caught in the fraudulent act, and then blamed the GAO investigators for violating federal law by misrepresenting themselves by submitting false credentials to the review company.

Medical review companies are supposed to notice and prevent such malpractice. That's the purpose they're supposed to serve! But Coast IRB apparently proceeds by trusting everything they're told by any person or company applying for review. The efficacy and safety of the medical products to be tested seem to be irrelevant to Coast IRB.

Coast IRB is one of 6,300 IRBs (Independent Review Boards) certifying pharmaceutical trials and medical device trials for consideration by the FDA. So be forewarned.

As you consider using "FDA-approved" medical devices or drugs, remember: In
America, the Department of Health and Human Services once certified a fictitious review company headed by a dead dog!

If the GAO can pull this off after running the sting on just 3 companies, the potential for fraud by the 6,300 IRBs is huge: they could potentially certify dangerous and/or deadly
medical devices and pharmaceuticals right now!

Even the Ivy League isn't immune to the problem:

Harvard Researchers Subpoenaed

Medical professionals and their patients can't simply rely on the present medical device oversight system in America today. Paperwork prepared by cunning individuals could lead to review board approval for almost any sort of medical device.

Since HHS accepts the credentials of fictitious review boards, it is frighteningly apparent that the overseers of the review boards are incompetent. The credibility of the system remains suspect. And with instances of corruption at the FDA, we have to be on guard, wondering "how safe are the medical devices and pharmaceuticals being used by over a hundred million Americans and foreign recipients?"

The matter is a criminal,
ethical nightmare
threatening lives.

Ask your medical professionals to be careful with you. They might not realize how they could be misled.

And pray hard. Often. To your good health,

Yocheved Golani
Coping with a Medical Crisis?
Make the Changes You Need in Your Life

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