Ethicists pen commentary on organ transplantation
Ethicists pen commentary on organ transplantation
Group calls for opt-in/opt-out
Ethicists primarily at the University of Pennsylvania in Philadelphia came together to pen a commentary appearing in June 26, 2008, issue of The New England Journal of Medicine calling for organ transplantation policies that would require potential organ recipients to opt-in or opt-out at the time they are listed for organs as to whether they would accept so-called "non-standard" organs.
Without such a policy, the ethicists say, and, for example, following a policy whereby the recipient gets to choose whether to accept an organ on a case-by-case basis after being informed of risks that may be associated with a particular organ, the organ donation process becomes vulnerable to personal biases that result in inequitable distribution and inefficiencies in the system.
As one of the commentary authors, Scott D. Halpern, MD, PhD, told Medical Ethics Advisor, the group decided to offer a public opinion of their thoughts on organ transplantation policy following a case that occurred in Chicago in late 2007.
In that case, four organ recipients of organs from one donor ultimately became infected with the HIV virus, as well as Hepatitis C, both of which infections were traced back to the donor.
That case alone prompted "a good bit of debate," Halpern said, and prompted the governing body for organ transplantation, UNOS (acronym stands for) in Richmond, VA, on the need to inform potential recipients of risks.
"This case, although incredibly unique…is [occurring] within a broader context of realizing that there are a variety of risks of organ transplantation, [that] often, recipients aren't informed of and many times they are not even risks that doctors could foresee," Halpern tells MEA.
In the NEJM article, the authors note that "Donors with behavioral risk factors are not barred from contributing to the organ supply, as they are from contributing to the blood supply, because scarcity is a much more salient feature of the organ supply. Indeed, approximately 10% of all patients on the waiting list for solid-organ transplantation die each year without receiving an organ."
The authors suggest that including donors with "behavioral risk factors" is one way to "narrow the growing gap between the supply of and demand for transplantable organs."
No organ transplantation is without risk, Halpern said.
"Because the risk could never be zero, there is a right among potential recipients to be informed not only of all foreseeable risks, but also the fact that there may be some risks that could not be foreseeable," Halpern told MEA, although the overall risk of disease transmission is "exceedingly rare" in organ transplantation.
The Penn ethicists, after an evaluation including the local hospital and their region's organ procurement organization, realized that there was variability even within the various transplantation programs at that institution. They decided on a policy whereby potential recipients of organs would be notified of risks.
"In doing so, we realized that not only was there tremendous variability within our region regarding how informed consent for organ transplantation was being obtained, but there was tremendous variability within our own hospital," he said.
UNOS, he says, has certain policies designed to "guide transplant programs in relaying information about specific risks, but there is not general guideline and no sort of ethical framework for why a particular strategy is better than another," he says.
So, the group decided that if there is variability in programs at Penn and within their region, they felt that they could be "quite confident" that variability existed through the country.
The biggest problem with what Halpern sees as a lack of an ethical framework is that "variability has important consequences for recipients, not only because it means that recipients somewhere will be told of things they might want to know about, whereas recipients elsewhere won't, but it's also important because it — by giving people information and allowing them to make choices to accept or decline an organ based on that information.
"Those decisions have implications for how organs get allocated," Halpern said.
Halpern says organ transplantation recipients can be described as those who are "risk averse" and those who are "risk accepting." Most people who are at the point of being listed as donor recipients are very ill, and without an organ, "their time is short."
So, those who are risk averse might refuse an organ that was thought to have some risk associated with it, and then that organ would be offered to the next person on the list.
"Unfortunately, when allocating any scarce public good, of which transplantable organs are perhaps the most paradigmatic example, the choices of individuals have intricable consequences for society," Halpern says. "So, any choice that an individual makes to accept or decline an organ affects the availability in number and type of organs that would be available to others.
Therein lies what Halpern calls a "justice problem."
According to Halpern, UNOS has taken the positions that risks should be disclosed to potential organ recipients at the time that a specific organ becomes available. That question of when to inform a potential organ recipient of both foreseeable and unforeseeable risks is the crux of his group's argument, i.e., suggesting that potential organ recipients be informed of all possible knowable and unforeseen risks at the time they become listed.
Unforeseeable risks are important, because as Halpern points out, "it's an inevitable problem with the organ transplantation system, which is we can't always know everything we'd like to know about donors. They are often unable to communicate at a time when they become potential donors, and even the best available tests for infectious agents are not perfect."
UNOS, while not a federal agency, does have the power to enact federal policy, and make adherence to that policy a condition of being a member of its network.
"Unfortunately, in our view, [UNOS has] responded to the Chicago case by saying that people should be told about the risks associated with a specific organ at the time that it's offered, but…that's a problematic view for reasons of equity, efficiency and failure to actually help people make better decisions."
By allowing potential donor recipients to choose an organ on a case-by-case basis would perhaps allow social biases to enter into the selection process, Halpern suggests.
And the UNOS solution is problematic "because it raises tremendous potential for inequity in how organs get allocated, because it allows patients to cherry-pick those that best serve their own interest."
"It also creates the potential for patients to make judgments on accepting or declining an organ based on their own personal biases [such as] regarding whether homosexual men or an intravenous drug user or any other type of donor is someone that they wanted to be associated with," Halpern says. "It would be wrong to allow such biases to represent a means of allocating a public good, like transplantable organs are."
Risk inherent in organ transplantation
The current policy of UNOS, based in Richmond, VA, is such that patients who are organ donors who meet the criteria of being high risk for transmitting HIV as defined by the public health service's in 1994 in MMWR., recipients of those organs are made aware "that they are about to receive [such] an organ and they are provided with whatever questions and answers they may have related to the level of information that the transplant center has gotten from the donor."
So says Michael G. Ison, assistant professor, divisions of infectious diseases and organ transplantation at Northwestern University in Chicago and chair of the Disease Transmission Advisory Committee for UNOS.
The criteria are "generally behavioral based," he said.
Ison agreed with Halpern, who suggests that there is always the possibility of unforeseen risks associated with receiving a donated organ.
"The reality is . . .if people knew that there was an infection or a malignancy in a potential donor that could be transplanted to the recipient, we, in general, would not use those organs," Ison said.
Ison said that testing capability simply does not allow for screening for pathogens that is always reliable.
Unfortunately, he said, " . . .there's always going to be — even if we dichotomize [donor organs] — as was recommended in the opinion piece, there's still going to be a risk of acquiring an infection, a malignancy or having an adverse outcome that is unexpected."
- Halpern, Scott D., et al. Informing Candidates for Solid-Organ Transplantation about Donor Risk Factors. N Engl J Med 358;26, pp. 2832-2837.
For more information, contact:
- Scott D. Halpern, MD, PhD, Center for Bioethics, University of Pennsylvania School of Medicine, Philadelphia. E-mail: [email protected].
- Michael G. Ison, MD, MS, assistant professor, Divisions of Infectious Diseases and Organ Transplantation, Northwestern University Feinberg School of Medicine, Chicago. Phone: (312) 695-4994. E-mail: [email protected].
Subscribe Now for Access
You have reached your article limit for the month. We hope you found our articles both enjoyable and insightful. For information on new subscriptions, product trials, alternative billing arrangements or group and site discounts please call 800-688-2421. We look forward to having you as a long-term member of the Relias Media community.