Administrators briefly suspended clinical trials of the blood substitute PolyHeme earlier this week in light of recent reports criticizing the safety of the substance.
Dr. Sandy Williams, dean of Duke University's School of Medicine and vice chancellor for academic affairs at Duke University Medical Center, stopped the trial Monday after the Feb. 22 edition of the Wall Street Journal published findings that Northfield Laboratories, Inc.-the company that produces PolyHeme-did not disclose safety information to the public.
"What became apparent from what was published in the Wall Street Journal was there was legitimate concern. We were sympathetic," Williams said. "We wanted to be sure that in making a decision that it was ethical to do that and that all of the proper procedures had been followed."
After further review, it was deemed that PolyHeme trials fulfilled ethical guidelines. The trials resumed Tuesday evening. "Certain senior administrators wanted to be sure that we did know all the facts," said Dr. Ross McKinney, vice dean of research for the School of Medicine. "The review was reassuring to the administrators that the appropriate steps had been taken to evaluate the product before starting again."
PolyHeme is the first oxygen-carrying blood-substitute to make it to clinical trials. If the trials are successful, PolyHeme will be used in trauma situations. Any adult in Durham County who is seriously injured and treated by emergency medical technicians is eligible for the study. McKinney said five patients from Durham so far have been enrolled in the study, which began in summer 2005.
Current medical guidelines require emergency officials to use a saline solution, which cannot carry the oxygen organs need in order to continue functioning. Ambulances do not transport blood because of the multitude of blood types and its short shelf-life. PolyHeme is compatible with all blood types and is usable for 12 months.
Ethicists have criticized the clinical trials of PolyHeme since its inception because patients are unable to give consent before taking part in the study. Williams said, however, that saline solution is not adequate, and any replacement would need to go through human trials before being approved by the Food and Drug Administration.
"In order to conduct human experimentation, [the study] must appeal to some higher value," Williams said. "In this case, the higher value is the societal need to improve care of patients with acute blood loss."
He added that Duke officials conducted eight community information sessions and constructed kiosks in local high-traffic areas. The study was also approved by the city.
According to a poll that Williams cited, 90 percent of the local community said the medical need outweighed the ethical implications. Patients can opt out from the study by contacting Duke Hospital and obtaining a bracelet, which a "few hundred people" have received, he said. "I am confident that not only have we followed the letter of the regulation but the spirit of trying to do the right thing," Williams said.
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