A controversial drug experiment, involving artificial blood given to accident victims without their consent, resulted in a 40 percent higher death rate than the standard treatment given to a control group.
Preliminary trial results released yesterday revealed that 46 subjects died after receiving the experimental blood substitute, Polyheme. There were 35 deaths among patients in the control group who received the standard care of saline solution in the field and real blood in the hospital.
An ABC News investigation this year raised questions about the propriety of administering the experimental product to subjects without their consent.
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The results were termed "devastating" by Dr. Peter Laurie of the watchdog group Public Citizen, which criticized the ethics of giving an experimental drug to patients without their consent. He said Polyheme itself is now on "life support, and needs a transfusion of real blood."
Shares in the company that makes Polyheme, Northfield Labs of Evanston, Ill., have fallen more than 50 percent since the test results were made public late yesterday.
Northfield said it will re-analyze the results because of what it termed "discrepancies" in the data.
Dr. Stephen Gould, Northfield's Chairman and CEO, said the company will push ahead with its efforts to get Polyheme approved by the FDA for public use. According to Dr. Gould, "We continue to move forward to submission of a Biologics License Application, and will review the data and submit to the FDA once we receive the final results."