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Government to Review Rules Allowing Human Testing Without Consent

September 05, 2006 3:07 PM

Polyheme_nr_3The 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. 

Click here to read ABC News report on Polyheme trials.

Read Brian Ross' 20/20 script on the Polyheme trials.

Click here to read FDA regulation allowing testing without consent. (Enter 21 CFR 50.24)

September 5, 2006 | Permalink | User Comments (29)

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The issue of CONTINUING to permit experimental emergency medicine research is an issue that should be decided by American citizens via the local and/or national voting process rather than being decided by the members of a hand picked FDA Advisory Committee scheduled to conduct the majority of the upcoming meeting BEHIND CLOSED DOORS!

The current leadership of the FDA has proven time and again that they simply cannot be entrusted with decisions of this magnitude that have the potential of affecting the safety and health of all American citizens and visitors who travel to America for short term and long term visits.

Level I Trauma Centers in the United States of America should not be permitted to continue to evolve into Level I Experimental Emergency Medicine Research Centers.


Posted by: Mercedes | Sep 6, 2006 10:24:46 AM

How very interesting that the bush admin critics are called facists, nazis, and slave owners.

Yet the same administraion is conducting itself as facists, nazis and slave owners.

What's next? re-education camps? Soilent Green?

How can ABC just report this and not find it disturbing? Oh, Right, nevermind. I forgot you are the mouth piece of the bushies.

Go to hell

Posted by: PigeonPoop | Sep 6, 2006 3:44:32 PM

The introduction of ANY experimental medical treatment or procedure without the patients informed consent should be strictly prohibited unless the patient is unconscious, in which case the consent of the next of kin would be required before the administration of any experimental service or procedure.

This current practice sounds like nothing more that a "dressed up" version of the syphilis experimentation conducted on unsuspecting black citizens many years ago.

What comes next? The testing of nerve gas counteragents AFTER first having exposed an unsuspecting citizen to the gas?

If the Government cannot get the volunteers it needs the experimental practices should be unlawful UNTIL they have volunteers available. PERIOD!

Posted by: Chuck Bahr | Sep 6, 2006 4:23:42 PM

What in the world is there to review? There should NEVER be experimentation on people without their explicit consent.

Performing experiments on people without their knowledge or consent puts these "doctors" in the same class as Dr. Mengele of the Nazi era.

If the potential treatment really shows promise, then they should have absolutely no qualms about ASKING the patient if he/she would be willing to try it. Otherwise they are reducing the patient to slave status.

Perhaps we should see if the doctors themselves would like to try out the new treatments, or perhaps the FDA board members would be willing to undergo the new experimental procedures? After all, if it is good enoough to try on unwitting patients, it is good enough to try on them.

Posted by: Henry | Sep 6, 2006 4:56:41 PM

The weather modification experiments under U.S. SENATE BILL 517 & U.S. HOUSE BILL 2995 support programs which are being tested all across the United States, especially in the Southwest, Florida and Pennsylvania. Heavy sprays of chemically created cloud cover are surreptiously unleashed on a near daily basis. These artificial clouds are shown to contain barium stearete, aluminum oxide, ethylene dibromide and other toxic chemicals.
This is a secretive program of experimentation on all living things, without their knowledge or consent. A crime of major proportions which must be stopped immediately! How about investigating this story?

Posted by: Operation Bluesky | Sep 6, 2006 5:03:54 PM

If they want to practice experimental crap on us without our consent, then these people need to make it so that our medical is free. Period.

Posted by: WelcomeToHell | Sep 6, 2006 5:24:19 PM

Well, what can be said.

Not the first time this has happened.

Posted by: Robert Duncan O'Finioan | Sep 6, 2006 5:38:01 PM

Quoting from the report: On the 10-year anniversary of the regulation, the FDA says it will take "a close look" at how it is being used.... It is appropriate that we review the regulation and get the perspectives of those who participated...

Well golly gee whiz. I feel privileged that my government is willing to reconsider after only 10 years. Just how do you anticipate gaining the perspectives of those who died?

Posted by: Steve | Sep 6, 2006 5:48:42 PM

This is only the tip of this health crisis. The Medical Community in America LIES about Borrelia, lyme disease, too. There is such a thing and it is a spirochete people. Like syphillis, remember Tuskegee.... so when the NC Medical Board jerks a doctor's license.... and human beings are DENIED HEALTHCARE IN AMERICA IN 2006, there is BIG SMELLY RAT lurking the CDC< FDA< and the BIG OLE WHITE HOUSE FOR * allowing it*

Posted by: liz | Sep 6, 2006 8:54:11 PM

Yeah, let's ask those who were in the studies....(which medium will we use to talk with those who died in the studies?)

The NAZI'S got away with this crap!
How do you feel ,that you might go into a trauma care unit. say, after an auto accident, and they decide to try some new junk out on you?

You might die, becuase you were not consulted- but hey, they did discontiunue tyhe use of some the stuff.
I guess too amny people died!

Posted by: ernest cann | Sep 6, 2006 9:13:03 PM

Between stuff like this, the policy of doing medical experimentation on convicts, the 5,000% increase in the number of children with autism due to the Thimoseral (mercury) in vaccines, the immense dangers of drugs for lowering cholesterol, and the FDA's new ruling that nobody can sue the pharmaceutical manufacturers anymore, no matter what harm they've done... why in the heck would anyone trust any drug-pushing doctor or consider taking any pharmaceuticals or vaccines? It is pretty obvious the government is trying to kill us!

Posted by: RevSuzanne | Sep 7, 2006 12:37:12 AM

What idiot cooked up THIS little doozy? How many of these politicians, board members, doctors and other conspirators would allow their family members or other loved ones to be experimented upon without their consent? I would wager NONE. I certainly could not imagine a circumstance when I would.

Lets use our heads here folks, if you wouldn't do it unto yourself, don't try to do it unto me!! How about a published list of who the responsible people are in this gruesome scheme!?

Posted by: Roger | Sep 7, 2006 1:42:26 AM

Considering they blew up the twin towers, this isn't suprising at all.

Posted by: Thinker | Sep 7, 2006 4:26:03 AM

They are doctors and they are always right. Next you will suggest that the government is bad and that there is a new world order agenda devoted to enslaving mankind in a matrix of consumption and false beliefs. Yea, sure, right...

Posted by: ponzi | Sep 7, 2006 7:48:40 AM

HOW MUCH MORE WILL AMERICA TAKE? THIS COUNTRY IS RUN ON DECIET FOR BIG BIZ. NOTHING BUT CORRUPTION. PEOPLE SHOULD ALSO KNOW ABOUT CODEX. CODEX IS COMING SOON. CODEX MAKES ALL OVER THE COUNTER MEDICINES, HERBAL REMEDIES AND VITAMINS BY PRESCRIPTION ONLY. YOU WILL NOT BE ABLE TO GET AN ASPIRIN WITHOUT A DOCTORS SCRIPT.
BUSH HAS MANDATED MENTAL HEALTH SCREENING FOR ALL AMERICANS AS WELL. THEY PLAN TO START WITH THE SCHOOL CHILDREN AND THEN TEACHERS AND THEN YOU! THEY ARE ALREADY MENTAL HEALTH SCREENING PREGNANT WOMEN AND THEIR CHILDREN IN ILLINOIS AND THE NORTHWEST. PEOPLE--YOU NEED TO START READING. LEARN WHAT IS IN STORE FOR YOU IN THE VERY NEAR FUTURE. I STRONGLY URGE YOU ALL TO START RESEARCHING. FIND OUT WHAT YOUR GOVERNMENT IS UP TO BEFORE IT IS TOO LATE. IF YOU JUST READ NEW LAWS, YOU WILL UNDERSTAND THAT THINGS DO NOT LOOK GOOD FOR THE RANK AND FILE AMERICAN.

Posted by: mae | Sep 7, 2006 8:36:37 AM

HOW MUCH MORE WILL AMERICA TAKE? THIS COUNTRY IS RUN ON DECIET FOR BIG BIZ. NOTHING BUT CORRUPTION. PEOPLE SHOULD ALSO KNOW ABOUT CODEX. CODEX IS COMING SOON. CODEX MAKES ALL OVER THE COUNTER MEDICINES, HERBAL REMEDIES AND VITAMINS BY PRESCRIPTION ONLY. YOU WILL NOT BE ABLE TO GET AN ASPIRIN WITHOUT A DOCTORS SCRIPT.
BUSH HAS MANDATED MENTAL HEALTH SCREENING FOR ALL AMERICANS AS WELL. THEY PLAN TO START WITH THE SCHOOL CHILDREN AND THEN TEACHERS AND THEN YOU! THEY ARE ALREADY MENTAL HEALTH SCREENING PREGNANT WOMEN AND THEIR CHILDREN IN ILLINOIS AND THE NORTHWEST. PEOPLE--YOU NEED TO START READING. LEARN WHAT IS IN STORE FOR YOU IN THE VERY NEAR FUTURE. I STRONGLY URGE YOU ALL TO START RESEARCHING. FIND OUT WHAT YOUR GOVERNMENT IS UP TO BEFORE IT IS TOO LATE. IF YOU JUST READ NEW LAWS, YOU WILL UNDERSTAND THAT THINGS DO NOT LOOK GOOD FOR THE RANK AND FILE AMERICAN.

Posted by: mae | Sep 7, 2006 8:38:03 AM

The ends do not justify the means, with this, I personally would rather have the synthetic rather then real blood do to religous beliefs but it should just be posted or announced that it is being used.

Others in this comment section mention the Nazis and medical experimentation and what is more important is the finding that medicating people without their consent is against the Nuremberg trials, which leads me to my next point regarding flouridization of our water without our consent and this falls into the same catagory as to the blood replacement, they dump it in the water without our consent this to is illeagal

Posted by: anonymous | Sep 7, 2006 10:55:20 AM

Reply to Henry: Thank you.

RE: S517 and HR 2995

Yes, thousands of us would like to see which media will stand-up to protect the health of their families.
Bridget Conroy
Agriculture Defense Coalition

"The weather modification experiments under U.S. SENATE BILL 517 & U.S. HOUSE BILL 2995 support programs which are being tested all across the United States, especially in the Southwest, Florida and Pennsylvania."

Posted by: Bridget | Sep 7, 2006 3:50:13 PM

many I kknow have been victimized by other american citizens by electronic harassment. This may be allowed in prisons but not us citizens in our homes. This needs to be investigated. People have died & many other citizens have had medical & emotional damaage. Tthis is not a nice way to live & do not believe this is the american way, to harm the innocent. These are hate crimes ^ should be punishable by imprisonmentt. I have video & missing items. Also, emergency room visits due to shocks that set the heart into an irregular rhythm that is painful, burns on the skin, dissrupted sleep, etc----

Posted by: Bev | Sep 7, 2006 7:15:45 PM

I have been a victim of non-consensual electromagnetic torture for at least 16 years. I videotaped the plasma weapons that sends augmented reality pictures to my optic nerves. Turn on your speakers if you want to hear the sound (I could only capture SOME of the sound) that is transmitted to my ears along with that plasma. This is some kind of infrared, psychotronic plasma weapon that is coming from somewhere in the atmosphere or low-earth orbit. It has made me very physically ill.

American Torture.

The video is a slow-motion nightshot video shot in VERY low light. The original was so dark one could not really see what was happening. I lightened the video up just a little bit so you could see the action. I am looking into the dark and the camera was on a tripod. All reflective surfaces were covered with a non-reflecting cloth.

Torture in real-time folks. I am in contact with victims of this all over this country.

Posted by: Carolyn Palit | Sep 8, 2006 12:07:59 PM

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