Last week I promised to bring you specific instances where Duke is treating Durham residents in ways that may be racist or elitist. Today's installment's topic reflects both.
In March 2006, the Duke University Hospital resumed a controversial "waived consent" clinical trial of a blood substitute called PolyHeme. Under the trial's guidelines, paramedics will administer PolyHeme--without consent--to patients who are "critically injured, losing a large amount of blood and in shock." These trauma victims will continue to receive PolyHeme at the hospital--again, without having consented--for 12 more hours, despite the fact that real blood, which is the universal standard of care, is available.
PolyHeme, which is made from human blood, may be better than the saline given in the field because it contains oxygen-delivering cells; it is also compatible with all blood types, and it can be easily transported in an ambulance. PolyHeme is experimental, however, and researchers do not yet know if it works as well as real blood.
Indeed, there are two serious problems here. The first: PolyHeme may not be safe. The second: Duke Hospital's new ethical model, which considers "community consultation" an acceptable substitute for an individual's informed consent.
The Wall Street Journal recently published an article questioning why Northfield Laboratories, the maker of PolyHeme, withheld troubling results about the performance of its only product.
Click for previous column: O, brave new world
So how did the blood substitute perform when given to people recovering from heart problems? Of 71 patients who received PolyHeme, 10 had heart attacks and 2 died. Of 81 who got human blood, 0 had heart attacks. If you count other "adverse events" like pneumonia and arrhythmia, the results are even worse: 54 percent of PolyHeme recipients had these problems, versus 28 percent of the control group.
Consider, then, the objectivity of this pamphlet from the INOVA Health System, which is also testing PolyHeme, reassuring participants that "PolyHeme has demonstrated no clinically relevant adverse effects."
Whether or not PolyHeme ultimately proves safe and effective, the manner in which it is being tested is unprecedented. In fact, Duke initially had to suspend the study when it became clear that "community consultation" protocols were illegal under North Carolina law; the study only resumed after Duke had successfully lobbied the North Carolina General Assembly for an amendment to this state's Patient's Bill of Rights.
What's worse, an article in The American Journal of Bioethics recently asserted that the PolyHeme study is designed to artificially simulate "the circumstances of combat-wounded soldiers when evacuation to field hospitals is impossible." This explains why doctors are required to continue administering PolyHeme for 12 hours in the hospital, since "12-hour field evacuation delays" represent "well-known military constraints." Indeed, it is worth noting that the bioethicists writing the article ultimately conclude that the PolyHeme trials "cannot justify a possible departure from ethical principles governing research on non-consenting civilian human subjects."
Given the legacy of slavery, segregation and discrimination in this region-and in this hospital--it is particularly disheartening to consider the racial overtones of a "waived consent" clinical trial. Historically, physicians have shown an appalling disregard for the rights of racial and ethnic minorities, particularly when conducting experimental research. Given the importance of that cultural narrative to a county that is almost 40 percent black, Duke Hospital's decision to appropriate unconscious patients for use in this study reopens old wounds.
Indeed, PolyHeme's most serious "adverse effect" of all may be the damage it does to the bond between physician and patient, particularly in communities already inclined to distrust Western medical practice. After all, why should you trust a doctor who asserts his right to experiment on your body without consent, no matter how exceptional the circumstances?
I lived no more than 1,500 feet from an entrance to Duke Hospital for my entire sophomore year, and so I would like to assure bioethicists and administrators alike that my "community" was never "consulted" when this protocol was approved. In fact, I would be shocked if 2 percent of Duke students had ever heard of PolyHeme before today. Given that the "traumatic injuries" targeted by this study represent the number-one cause of death for our age group, this is completely unacceptable.
Of course, this column is ultimately about much more than a blood substitute, or even the dubious way in which it is being tested. This is also a conversation about institutional authority, and the ways in which we choose to wield it. Keeping in mind that many Durham residents interact with our campus primarily through treatment at the Duke Hospital, this community has a decision to make: if we do not want to be called racists or elitists, then will we address the latent indignities that invite those charges?
Kristin Butler is a Trinity junior. Her column runs every Friday.
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