Results released today show a controversial experimental artificial blood product given to accident victims without their consent resulted in higher rates of mortality and side effects than among control patients who received standard treatment.
According to the results released by Northfield Labs, the maker of Polyheme, 11.1 percent of patients given Polyheme died, compared to 9.1 percent of patients who received the standard treatment of saline solution in the field and real blood in the hospital. In addition, 40 percent of Polyheme patients suffered serious adverse events, including shock, pneumonia, and respiratory failure, versus 35 percent in the control group.
The Northfield trial had been highly criticized by doctors and medical ethicists because Polyheme was given to seriously injured accident victims in 27 cities across the U.S. without their knowledge. The only way out of the experiment was to wear a blue bracelet provided by the company.
Pastor Paul Burleson of a Denver church alliance said the experiment turned test subjects into human guinea pigs.
"If I'm in an accident and I just don't happen to have this particular wristband, that I'd be a guinea pig is unconscionable," he said.
Northfield has maintained the unusual trial design was the only way to test such a product and that a viable blood substitute product would have revolutionary benefits for emergency medical care.
Northfield CEO Steven Gould said, "We continue to believe there is a potential benefit to using Polyheme in patients with delayed access to blood."
Past efforts to develop a viable blood substitute have met with failure because such products have been shown to cause a greater incidence of heart attacks. The Northfield results released today showed that seven percent of Polyheme patients suffered cardiac serious adverse events versus four percent of control patients.