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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)

User Comments

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It is alleged that Directed Energy Weapons (electromagnetic, laser, acoustic, infrasound, radio frequency) are being used experimentally on unwilling, non-consenting American citizens in actions that amount to torture and leave the body destroyed and in pain. Would ABC News be interested in investigating and writing about this problem of Directed Energy Weapons

Posted by: Nomi | Sep 8, 2006 1:18:06 PM

The last three posts from Bridget, Bev and Carolyn sound like plants to discredit the rest of the legitimate complaints.

Wake up people! The government is not your friend!

This is what happens when society looks to government to solve all their problems. Now the government IS our problem.

Burn in hell FDA, you facist, greedy corporate pigs!

Posted by: Michael Cole | Sep 8, 2006 9:21:24 PM

pigeonpoop... the regulation was passed in 1996 ... who was president then or dont you remember?

Posted by: John in Georgia | Sep 10, 2006 4:58:13 PM

My mother was involved in a situation in which while she was sedated for and balloon angioplasty, she had a heart attack on the table. This was in 1989, and the procedure known as the atherectomy had been developed but had not been used in live humans before. The doctors were pretty sure that my mother was going to die on the table, untill they choose to do an atherectomy with out consent (she was offically the first live human being to have it performed) she did live through the procedure, but the next day her femoral artery ruptured, she was bleeding out terribly quickly. They did have her sign some papers after they did the procedure basically aknowledging that they had performed it. She almost died that day, but she got a complete blood transfusion, ended up septic, she lived with the complications of this untill 2001 when she had metal stents put in, after that she had horrible back pain went to the hospital but they just told her it was side effects of the procedure and sent her home, she collapsed in our kitchen paralyzed for the waist down. There had been an abscess on her spinal cord, she then lived a bed ridden existance untill her body finally caved and shut down in november 05. I understand the need to make sure that a procedure will work on a living human before you can use it to treat things, but want to know what, they learned to use a smaller catheter so you dont "stretch" the artery out as much. And also learned that it opened her body up for a world of trouble, so I feel that doing experimental procedures while I do understand the necessity, should not be done with out consent ever.(although it is a tough call , even though my mother went through hell, if she hadnt had the atherectomy without consent,she would have died on the table in 1989 when I was 14, and never would have met her grandchildren)

Posted by: Jen B | Sep 10, 2006 10:49:49 PM

Medical experimentation without consent? Torture? Secret going-ons without oversight? Black ops? Budgetary indiscretions? Not in America!!! Or is it?

Posted by: Wordsmith | Sep 11, 2006 1:41:24 AM


.... without consent.. Hummm..I guess we have forgotten the Tuskegee Experiment of some 50 years ago. Let's ask the surviving widows of the men injected how they feel about "consent".

C'mon folks ... wake up.....

Posted by: dreek | Sep 11, 2006 1:36:32 PM

There is much evidence that electromagnetic (or directed energy) weapons are being used on innocent and patriotic US citizens. This technology can simulate every kind of physical illess/pain, as well as simulated mental illness. Our tax money is being used to torture us! Write to your congresspersons, your newspapers, and your activist organizations to have electromagnetic weaponry banned.

Posted by: Annyce Arntzen | Sep 25, 2006 4:36:13 PM

Hello,

I am a target of the electromagnetic energy beams. They are being directed at me by my next door neighbors. I am under a constant barrage. I don't have the strength to type out the whole story. Does anyone have any suggestions for me. What should I do.

Posted by: Paul Maxwell | Dec 27, 2006 2:07:40 PM

if people know about it that's one thing, but to not have consent is wrong to use experimental medicines. Stop the Tuskegee experiments

Posted by: guest | Apr 30, 2008 1:19:24 AM

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