As follow up on previous discussion of ethics, blood and money (isn't that a Warren Zevon song?), three medical ethics professors formally protest the Northfield Laboratories blood substitute study.
WSJ.com - Use of Substitution For Blood Draws Ethics Challenge
Three medical-ethics professors, in an open letter to research boards at hospitals where a blood substitute is being studied without patients' consent, said the research “fails to meet ethical and regulatory standards.”
The medical ethicists called on the hospitals to at least sharply alter the details of the study of the Northfield Laboratories Inc. blood substitute.
They wrote that any litigation over the blood-substitute study “would likely do damage to Northfield, to the hospitals and universities that are running what we believe to be an ethically flawed study” and to “the credibility of” the Food and Drug Administration, which approved the research.
This new challenge to the study, which is under way at 31 hospitals around the U.S., emerges as the Securities and Exchange Commission begins an investigation into Northfield and its research into the blood substitute. Northfield said late last week that it plans to comply with the SEC's request for documents about clinical research into the blood substitute, called PolyHeme.
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The open letter to the hospitals' “institutional review boards” supervising clinical research, and to those considering participating in the study, is slated to be published in a coming issue of The American Journal of Bioethics. Its authors are Robert M. Nelson, a physician specializing in critical care and anesthesia at the University of Pennsylvania School of Medicine; Nancy M.P. King, social-medicine professor at the University of North Carolina School of Medicine, and Ken Kipnis, a medical-ethics professor at the University of Hawaii.Their focus is on the study, in 720 badly hemorrhaging trauma patients in 18 states, of the Northfield blood substitute. Half the patients are to receive PolyHeme both in the ambulance and the hospital, while the other half get standard therapy -- saline solution in the ambulance followed by donor blood in the hospital. It is the hospital portion of the study that has drawn the greatest fire. This is because blood, the standard of care for badly hemorrhaging trauma victims, can be withheld from half the patients -- without their consent -- under terms of the study.
I still don't understand how Northfield expected to avoid controversy with such a hare-brained scheme.
update 7-11-06
more here
