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Blood trial could omit consent form
Doctors seek community consensus to test a blood substitute on trauma patients who may not be conscious
Tuesday, March 08, 2005 ANDY DWORKIN
How would you feel knowing that a doctor could experiment on you, without your permission, while you were unconscious?
What if that experiment could help save your life and test a possible treatment for wounded soldiers or car crash victims?
Doctors want Portland-area residents to ponder those questions as they move toward joining a study of a blood substitute called PolyHeme. Trauma medics with Legacy Health System, Oregon Health & Science University and local ambulance companies would take part in a national trial comparing PolyHeme with the salt-water solution now carried on ambulances and the blood banked in hospitals.
This is no ordinary research project. In most trials, scientists must tell each potential participant about the possible risks and rewards before getting their agreement to participate, a process called "informed consent." But PolyHeme would go to people unconscious from blood loss when treatment starts.
A seldom-used and ethically controversial 1996 Food and Drug Administration regulation lets researchers waive informed consent to test potential life-saving treatments when there is no other way to conduct the research.
Instead of individual consent, the FDA says researchers must teach local residents about the trial and gauge their feelings. So Legacy and OHSU workers are mailing letters to local officials and holding three public meetings to explain the trial and ask for feedback.
"This is not a sure thing that the study will happen," said Lise Harwin, a Legacy communications coordinator who helped plan the public education. "What we're trying to do now is get feedback to determine if it will."
Portland researchers have spent more than a year planning the trial, and both hospitals' research-review boards have approved the idea. But those boards won't give their final approval until they consider public reaction.
Scientists have spent decades searching for a blood substitute, which trauma doctors say is desperately needed. Donated blood is too delicate and has too short a shelf life to carry on ambulances. Instead, paramedics use durable saline solution. But saline can't carry oxygen through the body; blood and PolyHeme do. PolyHeme, which is made from expired blood donations, has a longer shelf life than blood and can be administered to a person of any blood type.
Other blood treatments have caused problems in research trials, including a substitute tested in Portland and elsewhere under the FDA consent-waiver process.
In early animal and human tests, PolyHeme has seemed better than saline but also showed signs it may be better than blood: Repeated blood transfusions may weaken a person's immune system and help cause organ failure, said Dr. Steven Gould, chief executive of Illinois-based Northfield Labs, which makes PolyHeme and is sponsoring the study.
So far, at least 250 people have been enrolled in 14 cities. Half get PolyHeme, and the rest get normal treatment with saline solution and blood. While researchers won't discuss results, a committee regularly reviews the progress. As of October, data on the first 120 participants showed that PolyHeme's "safety profile (was) at least as good" as saline, said Dr. Dean Gubler, the lead Legacy researcher.
"Most of us believe this product will save lives," Gubler said. "But nobody is confident one way or another."
Gould said the trial is scheduled to continue until 720 people have been enrolled. He expects final results sometime next year.
In the Portland area, researchers estimate that 20 people a year may fall into the trial's eligible category: trauma victims 18 and older who lose a lot of blood and go into shock. Medics would not enroll pregnant women or anyone with a severe head wound, cardiac arrest or an injury that seems too severe for the patient to survive.
Paramedics will not try to get consent from a victim or family members at a trauma scene, Gubler said. Research boards decided that could slow treatment, he said. Doctors will try to explain the trial to patients or family after trauma victims have reached the hospital and ask for consent to continue. Gubler said doctors will not argue with or give less care to anyone who chooses to withdraw from the study.
Local research boards decided not to pass out cards or bracelets to people who do not want to take part in the trial, as other cities have done. Portland research board members decided that time spent looking for bracelets or cards might "interfere or delay the EMS people" from starting care, said Maggie Allee, co-chairwoman of OHSU's board and a former member of Legacy's.
Allee said local research boards worked through several other concerns about the study. One is that the trial would let doctors give PolyHeme even after patients have arrived at a hospital where blood is available -- up to six units of PolyHeme over 12 hours.
A Boston University research board decided not to join the study partly because members "believed that once blood was available, the patient should be given that blood," according to Kristen Perfetuo, a Boston University Medical Center communications officer.
But Allee said Portland board members decided hospital PolyHeme use was scientifically justified to test whether the substitute is safer than repeated blood transfusions.
Local research boards "haven't established a particular percent or number" of negative responses from the community that would cause them to stop the trial, Allee said. One reason is that researchers assume people worried about the process are more likely to comment than those who support it.
Andy Dworkin: 503-221-8239;
andydworkin@news.oregonian.com
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