Controversial Artificial Blood Trials Completed

The makers of an artificial blood product called Polyheme say they have wrapped up a controversial clinical trial that was being conducted without the consent of test subjects.  Polyheme’s manufacturer, Northfield Labs, has announced that it has enrolled the 720 patients needed for the trial.  "We are pleased to have completed enrollment in this complex Phase III study — another key milestone in our progress toward bringing Polyheme to market," said Northfield’s CEO Dr. Steven Gould. The Northfield trial had been criticized by doctors and medical ethicists because Polyheme was given to seriously injured accident victims 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 that 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 that the unusual trial design is the only way to test such a product AND that a viable blood substitute product would have revolutionary benefits for emergency medical care. The federal Food and Drug Administration will now look at the test results to determine if Polyheme should be approved for widespread use.  Dr. Gould said, "We are eager to begin the data analysis, and look forward to reporting top-line results from the study in the fall."