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Gould says PolyHeme is made by extracting hemoglobin, the oxygen- carrying molecules in red blood cells, from expired whole blood.
In 2002, the Journal of the American College of Surgeons reported the results of Northfield's first controlled human trials. The study compared 171 trauma patients who received PolyHeme to statistics from an earlier, unrelated study in which, for religious reasons, 300 trauma patients did not receive any blood products.
Gould, who was proud of the results, anticipated criticism from the fact that he had to rely on a historical control group.
In order for doctors to compare patients who received PolyHeme to patients who didn't receive any blood or red blood cells, the researchers would have had to deny life-saving blood products to a control group. Because such denial would have been unethical, Gould relied on the historical data.
Ultimately, 18 of the 171 PolyHeme patients died (10.5 percent), compared to 48 deaths in the control group (16 percent). "None of the deaths was considered due to the PolyHeme," the study states, citing other factors, such as multiple organ failure.
Dr. Ronald Maier, a Seattle doctor, published a critical review of the study: "Unfortunately the use of historical controls raises significant concern for the reliability of the final comparisons .[I]t is unlikely that the difference is as great as is demonstrated using selected historical control groups," he wrote.
But based in part on the report, and after analysis by review boards at the UT Health Science Center, the study to transfuse PolyHeme without consent was granted.
Dr. Laurence McCullough, a medical ethicist at Baylor University, calls it a classic moral dilemma: the clash between two good, yet incompatible, ideas -- the fundamental right to informed consent versus the need to improve emergency medical care through means that cannot allow for that consent.
"Emergency medicine has developed by innovation, without confidence in all cases that the innovation is doing patients any good," McCullough says. "So if we can't do research to improve emergency medicine, then we're left with a real major ethical problem on our hands; we may be doing things to patients in emergency medicine that may not benefit them and, even worse, may harm them."
In 1996, the FDA began allowing waivers with the belief that, as McCullough says, "If you stick to an absolute requirement of consent, you may oblige doctors and nurses in places like emergency rooms or in ambulances to deliver care that is substandard."
The ultimate goal of medicine is to establish "evidence-based standards" of care, where factors such as geography -- how far away a person lives from a hospital -- would not affect the level of care for patients.
"The kind of medical care you get for a heart attack or for a stroke shouldn't be a function of where you live, right?" McCullough asks. "That's irrelevant. What's relevant is your medical diagnosis, and that's how you should be managed."
But in order to get there, researchers must be allowed to conduct trials where informed consent is difficult or impossible. Waivers are not issued lightly. Committees of medical experts and community members outside the medical field extensively reviewed UT's application.
Larry Scott, UT's assistant vice president for Human Subjects Research, called the proposal "a conundrum," adding that "on the one hand, research [was] needed to be done in these emergent life-threatening situations, but the usual kinds of safeguards that were put in place to protect research participants just weren't gonna work."
Marianne Fanning, a health care consultant who sat on one of the review committees, says she put herself "in the role of the patient or the patient's family members When they say, 'let's waive consent,' it's a fundamental right that you are waiving you take those real seriously as they come through."
(There is a provision where members of the general public can avoid becoming test subjects by calling the UT Health Science Center at 713-500-7277. Callers will receive bracelets exempting them from the possibility of receiving a blood substitute.)
To gauge community reaction, the UT committees also held meetings last summer with about ten churches and civic organizations, including the Metropolitan Community Church of the Resurrection and the Chinese Community Center.
Vicki Gibbs, pastor's assistant at Metropolitan, was among two dozen people who attended the August meeting. She supported the waiver.
"I would like informed consent, but I know that that's not always necessary -- and if you're trying to save a life, save the life," she says.
Theresa Hong Chen, the CCC's community services director, says 66 people attended their meeting in July. "They explained it very well, they were clear," she says of the university's committee members. She says the explanations were clear and she would have no problem receiving PolyHeme without consent.
"What you do when you want to sacrifice one good to achieve another," McCullough says, "is you set up very rigorous review processes to reach a judgment that the one good is worth sacrificing for the other. And you make people justify that."
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