Ethicists
Criticize Medical Study over Lack of Consent
But principals of study say it is conducted within FDA rules and is
vitally important
CHICAGO
March 3, 2006
Associated Press
Medical ethicists are criticizing a study that involves giving trauma
victims a blood substitute without their knowledge.
The Associated Press reported that the debate over the product known as
PolyHeme was re-ignited last week after the Wall Street Journal
reported that in a previous study involving heart surgery, several
PolyHeme patients suffered heart attacks while those receiving real
blood did not, and that the study was abruptly curtailed.
Polyheme manufacturer Northfield Laboratories denied any link to the
heart attacks and maintained that the first study did not end abruptly,
but was halted because of low participation, according to the AP and a
statement from the company.
Now the same substance is being used by paramedics and other emergency
medical personnel in a nationwide study involving 30 trauma centers.
Patients or their families are not informed that the blood substitute
has been used until they have been transported to the hospital.
In an article scheduled to be released in the American Journal of
Bioethics, medical ethicists contend that real blood should not be
withheld from people without their consent, a "serious flaw in this
complicated and novel study," according to the medical website
Healthcentral.com.
While medical personnel participating in the study do not specifically
ask for a patient's permission when they first respond to the scene,
U.S. Food and Drug Administration (FDA) guidelines do permit the use of
the experimental substance without consent in emergency situations.
At various experimental sites across the country, doctors are sometimes
sharply divided over the ethical propriety of the study. While some
maintain that it is unethical to subject patients to risk without total
informed consent, others, such as San Antonio emergency physician
Ronald Stewart, a principal investigator in the PolyHeme study, say the
tests should continue because so much is at stake.
"We don't know whether it will work or not or whether it would even be
harmful," Stewart told the San Antonio Express-News. "But the bottom
line is if we don't study it in this way, we will never know. As a
matter of fact, I think it would be unethical to stop the trial now."
Another emergency study is under way in Washington County, Tenn., where
Dr. Julie Dunn, a physician in charge of the study site there, told the
Kingsport Times-News that the promise of drug is so compelling -- it
can be transported easily and given to any blood type -- that the study
is worth the risk.
"This is something that's been ongoing in this country for 50 years, to
come up with a blood substitute," Dunn told the Times-News. "Some
people think it's possible, and other people think it's not possible.
But who would have thought the microchip was possible?"