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EVANSTON, Ill. — A small number of the nation's hospitals are testing a promising blood substitute on patients, but they're performing the transfusions without getting consent.
The substitute is called PolyHeme (search) and it is made of salt water and the blood component hemoglobin.
"It is like blood in that it delivers oxygen to vital organs in an effort to avoid organ failure in patients that are bleeding,” said Steven Agoule, chairman of Northfield Laboratories (search).
When the blood substitute was tested on trauma patients who had lost a lot of blood, injury survival rates rose. Furthermore, the synthetic blood can be given to a person with any blood type and has a long shelf life. Unlike donated real blood, which lasts just six weeks, PolyHeme has a shelf life of one year.
The controversy over this promising treatment arises because about 20 hospitals are testing PolyHeme on trauma patients, most of whom are unconscious.
"The problem with the trial is simply that there is no consent by the subjects. That's a very big issue because medical experiments should never be done on human beings without their voluntary informed consent," said Vera Sharav of the Alliance for Human Research Protection (search).
The Food and Drug Administration (search) rarely allows experiments without consent, but agency officials refused to talk about its decision to green-light this one
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