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Government to Review Rules Allowing Human Testing Without Consent

 
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User ID: 138939
United Kingdom
09/06/2006 03:08 PM
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Government to Review Rules Allowing Human Testing Without Consent
ahhh gasp ahhh

*** Government to Review Rules Allowing Human Testing Without Consent ***

By: Joseph Rhee - (September 05, 2006)

The federal government said it will now reconsider a controversial loophole that allows human medical experiments without the subjects' consent.

The decision comes in the wake of a highly-criticized experiment involving a blood substitute product, Polyheme, which was given to trauma patients in 27 U.S. cities without their knowledge. Our 20/20 report on the Polyheme trials detailed how the FDA had come under fire for allowing the experiment to proceed despite heavy criticism from many in the medical community.

The regulation, approved in 1996, allows experimental testing without consent in the field of emergency medicine research. The first trial under the new rules involved another experimental blood substitute product called HemAssist, which was also tested on trauma patients without consent. That trial was halted after far more patients died who were given HemAssist than those who received standard care. Development of the product was ultimately discontinued.

On the 10-year anniversary of the regulation, the FDA says it will take "a close look" at how it is being used. According to Dr. Janet Woodcock, FDA Deputy Commissioner for Operations, "It is appropriate that we review the regulation and get the perspectives of those who participated in such studies to make sure that emergency research is being carried out in a scientifically sound and ethical manner."

The FDA has released a draft of revised guidelines on non-consent trials that "broaden the discussion of community consultation and public disclosure" and "clarify terminology used in regulations that have been difficult to interpret." A public hearing on the issue is scheduled for Oct. 11, at the University of Maryland Shady Grove Center.

ARTICLE:
[link to blogs.abcnews.com]

(ABC News report on Polyheme trials)
[link to blogs.abcnews.com]

(Read Brian Ross' 20/20 script on the Polyheme trials)
[link to abcnews.go.com]

(Click here to read FDA regulation allowing testing without consent) (Enter 21 CFR 50.24)
[link to www.accessdata.fda.gov]
Anonymous Coward
User ID: 140348
United States
09/06/2006 07:05 PM
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Re: Government to Review Rules Allowing Human Testing Without Consent
"...a highly-criticized experiment involving a blood substitute product, Polyheme, which was given to trauma patients in 27 U.S. cities without their knowledge."

"...new rules involved another experimental blood substitute product called HemAssist, which was also tested on trauma patients without consent."

Shades of Mengele! It's Germany all over again. May the heads of CONgresscritters, FDA, and others of their ilk suffer trauma and be given either Polyheme or HemAssist. It won't matter which one because it's only a test to see if they die.
.
Anonymous Coward
User ID: 76936
United States
09/06/2006 07:14 PM
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Re: Government to Review Rules Allowing Human Testing Without Consent
That's absolutely evil. What the hell is wrong with people these days? More and more bizarre crap happening every day. It's scary.
Anonymous Coward
User ID: 140456
Puerto Rico
09/06/2006 10:17 PM
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Re: Government to Review Rules Allowing Human Testing Without Consent
FDA, owned and control completly by big pharm and agro companies.
Anonymous Coward
User ID: 140454
Canada
09/06/2006 10:21 PM
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Re: Government to Review Rules Allowing Human Testing Without Consent
We're the guinea pigs.

seal <----- Where can I get one?
Anonymous Coward
User ID: 139676
United States
09/06/2006 10:39 PM
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Re: Government to Review Rules Allowing Human Testing Without Consent
Wow...

What's the point of medical insurance anymore?

Either (a) you're stuck with a chronic condition, and become just another revenue stream for the medical-industrial complex or

(b) you get in a car accident, and either the doctor gives you synthetic blood or else... steals your organs for the lucrative transplant market.
Ningishiddza

User ID: 124957
United States
09/06/2006 10:49 PM
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Re: Government to Review Rules Allowing Human Testing Without Consent
What's the point of medical insurance anymore?
 Quoting: Anonymous Coward 139676


It proves just how dumb, stupid, ignorant and uneducated Amerians really are.

Either (a) you're stuck with a chronic condition, and become just another revenue stream for the medical-industrial complex or
 Quoting: Anonymous Coward 139676


Gosh, golly gee whiz, chronic conditions used to be covered under what used to be known as "catastrophic health insurance" until dumb, stupid, ignorant and uneducated Americans decided that having a middle-man, whom they didn't even know, arbitrarily make decisions about their health care was much better than having an intimate relationship with their doctors, and at the same time, Amerians decided that they wanted to voluntarily pay 1600% more for their health care than it really costs.

(b) you get in a car accident, and either the doctor gives you synthetic blood or else... steals your organs for the lucrative transplant market.
 Quoting: Anonymous Coward 139676


Never sign a donor organ card.

If you feel that strongly about giving up your organs (I would not without compensation), then make a living will/trust and empower someone responsible to make that decision when the time comes. You'll live longer.
Americanii-s de vina futu-i in gura sa-i fut

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