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Mar 2, 2006 11:00 pm US/Eastern
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Health: Emergency Blood Substitute
by Stephanie Stahl
PHILADELPHIA (CBS 3) ―
Medical Reporter Stephanie Stahl reports hospitals are testing an experimental blood substitute that could be a huge medical breakthrough, but it's being tested on people without their consent.
Say you are in a horrible accident, have massive bleeding, and are unconscious, you can't give consent, but you get treated with an experimental blood substitute.
"I think it's wrong if they're not notified. I mean obviously people need to know what's going on," said Wendy Trach.
"If something's going be tried on me, I, you know, if it's experimental, I might be ok with it, but if they did it without me knowing about it I'd be extremely upset," said Earl Reed.
The blood alternative is called polyheme. Its maker halted an earlier study, in which 10 of 81 heart surgery patients had heart attacks, but the company says polyheme did not cause the heart attacks and is safe.
Finding a blood substitute would be revolutionary. In an emergency, it could be given quickly to people of any blood type, and it has a longer shelf life than the real thing.
"Blood is a precious resource," said Dr. Mark Cipolle.
Dr. Cipolle is with the Lehigh Valley Hospital, one of 31 hospitals nationally involved in the polyheme testing, which is being allowed by the F.D.A
.
While they're not giving it to any patients right now, they could resume at any time.
Dr. Cipolle says ten patients received it with no adverse reactions, but they weren't told until after receiving the experimental blood.
"To do a trial of this nature in trauma it would be pretty difficult to be able to do it with traditional informed consent procedures," he said.
Instead, hospitals testing polyheme are supposed to have a series of community meetings to inform the public, which Lehigh Valley did.
People are supposed to wear blue wrist bands if they don't want the blood substitute, but many people don't get that information
"I think a lot of people find it terrifying to think you mean somebody cold experiment on me without my permission," said bio-ethicist Dr. Art Kaplan of the University of Pennsylvania.
But despite that fear, Dr. Kaplan believes there is an upside to studying polyheme. It might be the difference between life and death
Two other area hospitals are also taking part in the study; St. Luke's in Lehigh County, and Christiana Hospital in Delaware.
For its part, the F.D.A. didn't get back to CBS 3 with a response, but has been reported as saying this study is important and there is a need to find an alternative to human blood in emergency situations.
(© MMVI, CBS Broadcasting Inc. All Rights Reserved.)