This discussion paper was discussed at the February 2007 meeting. It is one of a series of papers prepared to aid the Council in its decisions about policy options in organ procurement, transplantation, and allocation. Each paper in the series is designed to facilitate and inform Council discussions and does not represent the official views of the Council or of the U.S. government.

The Ethics of Organ Allocation: Policy Questions Concerning Geography, Age, and Net Benefit

Staff Discussion Paper

By F. Daniel Davis, PhD

Introduction: The laws and regulations governing organ transplantation in the United States mandate that organs be allocated to achieve two moral ideals: efficiency and equity. The criteria in each organ-specific allocation algorithm reflect an effort to balance the often divergent demands for the best use (i.e., utility or efficiency) and a fair distribution (i.e., justice or equity) of these scarce, precious resources. They also reflect certain historical as well as clinical realities and are subject to an ongoing process of review and revision, especially in light of emerging data on such key outcomes as graft and patient survival.

This process of policy formation occurs within a context distinguished by several salient features. First is the chronic shortage of organs in the United States -especially of kidneys. Second is the persistence of geographic and racial/ethnic disparities in organ allocation. Third are certain trends in demography and morbidity: the aging of the American population and the looming burden of chronic and end stage renal disease. In such a context, the challenge of realizing the moral ideals of efficiency and equity is formidable. Too much emphasis on the best use of organs may exacerbate persistent inequities. Too much emphasis on equity may generate inefficiencies and thus waste in the distribution of a resource for which the supply is limited and the demand growing.

To one degree or the other, this tension between the demands for the best use and a fair distribution of organs is present in each of the following allocation policy questions:

I. In deference to equity , should the significance of geography in organ allocation be further mitigated?

II. In deference to both equity and efficiency , should age be an explicit criterion in organ allocation?

III. In deference to efficiency , should calculations of net benefit be included as a criterion in the allocation of kidneys, as well as other organs?

In addressing each of these questions, the Council has a range of options, including the option of simply providing an ethical analysis of the issue at hand without taking a stand or making a specific recommendation. It is important, however, that the Council be mindful of its potential as a force in determining the course of ongoing debate and policy formation in organ procurement and allocation. Difficult but necessary choices are to be made in reckoning with the challenges of an organ shortage, of determining how best to distribute human organs among those in need, and of deciding the scope and the limits of government engagement in an "enterprise" of contemporary medicine that invites both wonder and disquiet. And it is important, as well, that the Council be mindful of the fact that the difficulty of such choices is only compounded by their implications for such enduring questions as: How are we to understand the ultimate ends of medicine? How are we to live out our lives in the face of the inevitable-that is, in the face of morbidity and mortality as marks of our very humanity? How are we to decide among competing human needs for cure, care, and healing and the differing means of satisfying those needs? And, in determining whose needs most demand our earnest response, how do we weigh the significance of familial bonds and responsibility, of competing notions of the relevant "moral community," and of the human dignity to which every individual has claim?

I. The Role of Geography in UNOS Organ Allocation Algorithms

Background: In the United States , procuring and allocating organs originated as local practices, shaped by and directed to the needs and interests of local and later regional communities. In 1984, the passage of the National Organ Transplantation Act by Congress signaled a new phase in the evolution of allocation policy: organ transplantation was embraced as a medical innovation of national-rather than local or regional-significance, as was the need for a more ordered, principled approach to securing and distributing the precious resource of human organs. Subsequent legislative and regulatory initiatives, by the U.S. Congress and the U.S. Department of Health and Human Services, have served to articulate and to buttress three ethically relevant norms: first, in organ allocation, the operative sense of community should be the national-rather than the local or regional-community; second, organs should be allocated in ways that achieve their best, most efficient usage; third, in addition to effective usage, the most important criterion in allocation should be patient need.

In recent years, there has been laudable progress in the effort to bring the system of allocation into conformity with these norms. Reforms in the allocation algorithms for livers and lungs have tilted the balance of criteria toward urgency of patient need; as a result, there are now fewer deaths on the waiting list for these organs and geographic disparities have been diminished. Nonetheless, geography remains a pivotal criterion in organ allocation and where a transplant candidate is registered remains a potent factor in determining whether he or she ultimately receives an organ-such that candidates often register with multiple centers in disparate locales in the hopes of capitalizing on significant, geographic differences in waiting times. Thus, it is still the case that as a general rule (subject to well-defined, organ-specific exceptions), candidates in the local area of the organ procurement organization (OPO) stand in line ahead of comparable and often arguably needier patients in the region and beyond the region, the nation.

Policy Options for Council Consideration and Possible Action: In light of this state of affairs, the question before the Council is whether the significance of geography in organ allocation should be further mitigated with the aim of more fully realizing the moral ideal of equity. Given this question, the Council has a range of options, including:

Option One: The Council could respond in the affirmative to this question and urge the United Network for Organ Sharing and the U.S. Department of Health and Human Services to intensify efforts to explore and institute reforms that would ensure that allocation policies are primarily responsive to patient need, unfettered by considerations of geography unrelated to efficient usage.

In effect, by responding in this fashion, the Council would endorse the movement toward a national waiting list-which is, arguably, the trajectory of federal law and regulation since the 1984 passage of the National Organ Transplantation Act. In so doing, the Council could appeal, as well, to the argument that in organ allocation the ethically legitimate and operative moral community is the nation at large, rather than the region or the local area in which a given organ is procured. After all, the bulk of the funding for transplantation, especially kidney transplantation, is provided by a national program, Medicare.

Option Two: The Council could respond in the negative to this question and base this response on one or more of several reasons. First , the Council could argue that allocation policy as it now stands represents the best achievable balance between the demands of efficient and equitable allocation of organs. Second , the Council could appeal to the argument that geographic priorities are an inducement to organ donation -i.e., the inhabitants of a particular locality are more likely to donate organs to their fellow citizens within that locality. The lack of any empirical evidence for this claim should be kept in mind, however. There is some intuitive appeal to the psychology of motivation undergirding this alleged linkage between allocation and donation, that is, people are more likely to donate if they know that members of their own local community are more likely to benefit from the gift of their organs. Third , extending this second rationale a bit further, the Council could appeal to a more geographically restricted sense of moral community and argue that local priorities and preferences in organ allocation are legitimate within this "sphere of justice"; after all, it could be argued that this concept of differing spheres of justice is at play in the fact that organ allocation policies currently permit individuals to direct organs to loves ones, rather than to transplant candidates whose needs may be more urgent. This policy recognizes limits to the reach of equity. Fourth , the Council could base such a response on the insistent concern voiced by smaller organ procurement organizations (OPOs), transplant centers, and transplant programs that a mandate to allocate organs over wider geographic areas would disadvantage and ultimately close them, while larger, urban-based OPOs, centers, and programs would profit handsomely from resulting increases in organs procured, patients transplanted, and revenues accrued.

II. The Role of Age in UNOS Organ Allocation Algorithms

Background: In the early history of organ transplantation, when this "solution" to the problem of organ failure was still considered experimental, patients in their 50s and 60s were considered beyond the operable age range and thus ineligible for transplant. Advances in surgical techniques, immunosuppressive drug therapy, and post-operative care have significantly extended this range such that older age alone is no longer a barrier to transplant.

Data from the Organ Procurement and Transplantation Network (OPTN) illustrate the age-related demographics of transplant recipients and candidates, with a focus on those who are 50 years of age or older:

•  From January 1, 1988 to September 30, 2006, a grand total of 386,559 transplants were performed in the United States . Of this total, 26,841 (approximately 7 percent) have been performed in patients 65 years or older and 134,496 (approximately 35 percent) in patients 50 to 64 years of age.

•  More telling, however, are these data: in 1988, 265 of the 12,618 transplants for that year (2.1 percent) were performed in patients 65 years or older and 3,246 (or 25.7 percent) were performed in patients 50 to 64 years of age; seventeen years later, in 2005, 2,561 of the 22,017 transplants (or 11.6 percent) were performed with patients 65 years or older and 9,190 or 41.7 percent were for patients 50 to 64 years of age.

•  Of the 94,256 patients on the waiting list as of December 29, 2006, 13, 472 (14.3 percent) are 65 years of age or older, and 42,050 (44.6 percent) are 50 to 64 years of age.

Certain demographic trends should also be kept in mind in posing and responding to the question at hand, i.e., should age-particularly, older age-be an explicit criterion in organ allocation? According to the U.S. Census Bureau, Americans in the 65 to 84 years of age range constituted 10.9 percent of the population in 2000; by 2050, they are projected to make up 15.7 percent. In 2000, those 85 years and older were 1.5 percent of the population; by 2050, they will make up 5 percent of the population. Moreover, individuals 65 years of age and older are the majority in the population of patients with end stage renal disease and the fastest growing age group of patients with ESRD are 70 years of age and older. As one observer has recently put it: "The snowball effect of aging 'baby boomers' on health care resources in general, and kidney transplantation in particular, may soon become an avalanche."

Age already functions as a determinative criterion in the transplant process in multiple ways, some of which are matters of explicit UNOS policy and others of which are more ad hoc and "localized" in nature. In deciding whether to place a patient on the waiting list or whether to proceed with transplant, physicians/surgeons may integrate age-related considerations in such processes of clinical judgment. As for explicit UNOS policy:

•  In the current allocation algorithm for kidneys, pediatric candidates have priority over older candidates in the allocation of kidneys from donors less than 35 years of age.

•  In the allocation of livers from pediatric donors, local pediatric candidates who have the highest degree of medical urgency (i.e., classified as status 1A) also have the highest priority, followed by local status 1A adults.

•  In the allocation of lungs, a potential recipient's age is one among several variables in the scoring formula implemented in 2003.

Policy Options for Council Consideration and Possible Action: Should age-particularly older age-be an explicit criterion in organ allocation and, if so, how would age as a criterion work in practice?

Option One: The Council could respond in the negative to this question and base such a response on the equity-related argument that the only ethically valid criterion in allocation is patient need. Whether a candidate is 35 years of age or 65 years of age is immaterial: if both are equally sick, it would be unfair to allocate an organ to the younger candidate simply because he or she is younger. To do so would constitute unethical, unfair treatment of older individuals.

Option Two: The Council could respond in the affirmative to this question and endorse the use of older age as an explicit criterion in organ allocation. It could base such a response on the concept of a natural life span, developed and advocated by Daniel Callahan. Although there is considerable variation from individual to individual, human beings have a natural span of life; the use of high-cost, intensive medical interventions-like organ transplantation-to extend that span indefinitely is an exercise in hubris and a foolhardy effort to postpone the fate that awaits us all. And, in a context of scarcity, organ transplantation in the old ultimately deprives the young of a resource that many will need simply to attain and enjoy a natural span of life. Indeed, one could argue that the old have a stake in the flourishing of the young and that youthful preferences in organ allocation are but one of many ways to support such flourishing.

In effect, an argument such as this asserts that equity requires limits on transplantation in the old. It is encumbered, however, by conceptual and practical problems, the principal one being the problem of establishing the age at which limits on transplantation would be imposed.

Option Three: The Council could respond in the affirmative and advocate the explicit integration of an age-related factor in organ allocation. Formulated and advocated by Robert Veatch, this proposal is rooted in an "over-a-lifetime" perspective on patient need for organs-a perspective that others have dubbed the "fair innings" argument. One equity-based argument holds that patient need at a given moment-in-time, regardless of patient age, is the only fair criterion for distributing. Another equity-based argument, however, views need in the context of one's whole life. From the moment-in-time perspective, there is little or no difference between the 35-year old and the 65-year old in need of an organ. From the perspective of their whole lives, however, one could argue that the 65-year old is better off than the 35-year old, simply because the former has made it to this point in life, while the latter has not- and may not without a transplant of the needed organ.

As for the practical application of this "over-a-lifetime" perspective, Veatch argues for a formula that would take age into account without absolutizing its significance (in the way that Callahan's natural span of life concept would, if it were applied in organ allocation). Assuming the now current practice of assigning points for particular criteria in, for example, kidney allocation, such a revised formula would correlate point-values and age such that as one ages, one's age-related points decrease: one's age would be inversely proportional to the value of this particular criterion in the algorithm or formula.

Option Four: The Council could circumvent a direct response to the question at hand by endorsing the practice of age-matching donor organs and transplant candidates-that is, of allocating organs with a lower expected length of functioning (ELF) to candidates with a lower expected life span (ELS). This practice derives moral support from both equity- and efficiency-based arguments: it does not neglect the need of the old for organ transplantation and, in deference to efficiency, it correlates donor organs and transplant candidates on apparently rational grounds. There are critics of this practice, however, who cite data indicating poor graft functioning results with organs that have a lower expected life of functioning. Many of these organs are procured from expanded criteria donors.

III. The Role of Net Benefit in Organ Allocation

Background: The final rule promulgated by the U.S. Department of Health and Human Services in 2000 clarified the aims of allocation policy in the United States . Allocation policy, the rule states, should (1) "seek to achieve the best use of donated organs"; (2) be "designed to avoid wasting organs"; and (3) with respect to patients needing and waiting for organs, establish "priority rankings expressed, to the extent possible, through objective and measurable medical criteria." With these aims in mind, a UNOS policy formation group, the Kidney Allocation Review Subcommittee (KARS), has been working to revise the allocation algorithm for kidneys, the organs for which the demand is greatest. KARS is expected to finalize and unveil, for public comment, its proposed revisions in February 2007. Despite the currently incomplete status of the subcommittee's work, it is well known that "net lifetime survival benefit" will be the centerpiece of its recommendations for change in the criteria for allocating kidneys from standard criteria donors.

In its most basic form, net lifetime survival benefit (NLSB) is a calculation of the projected years of life that a patient will enjoy as a result of transplantation minus the projected years of life that he or she will have in the absence of transplantation. In the likely policy revision to be proposed by KARS, calculations of NLSB will also incorporate an empirically based estimate of the quality of life that transplant recipients enjoy in contrast to the qualify of life they may have on dialysis. Studies comparing the two patient populations-transplant recipients and dialysis patients-have yielded evidence that transplantation significantly improves the transplant recipient's quality of life. The consulted studies document a range of differences between the measures of post-transplant quality of life and of on-dialysis quality of life, but KARS has reportedly settled on the following quantification of this quality of life differential: in terms of quality, one year of life with transplant (1.0) is "equivalent" to eight tenths of a year of life on dialysis (0.8). The benefit metric that will likely become a pivotal criterion in kidney allocation is, accordingly, referred to as Net Lifetime Survival Benefit modified for Quality of Life (NLSB-QoL).

The central, overriding goal of the new kidney allocation formula is to maximize overall recipient benefit from deceased donor kidney transplantation. According to advocates of the new formula, achieving this goal will realize other subsidiary gains or outcomes. For example, transplant candidates who are expected to enjoy lengthy survival post-transplant will receive organs that are also expected to function over the long term and the need for re-transplantation will be diminished and thus, so, too, will the demand for deceased donor kidneys. If the new formula works as expected, KARS believes that the achievement of this goal and the realization of these outcomes will be fully responsive to the Final Rule's imperative to make the "best use of donated organs."

Policy Options for Council Consideration and Possible Action: There are two options before the Council with respect to the question of whether calculations of net benefit should be included as a criterion in the allocation of kidneys, as well as other organs.

Option One: The Council could lend its support and endorsement to the proposal that is likely to emanate from KARS and, perhaps, be approved by the UNOS Board of Directors. In so doing, it could appeal to efficiency, which arguably assumes greater import in light of the enormous and mounting pressures of growing demand on the limited supply of organs, particularly of kidneys.

Option Two: The Council could decline to support and endorse the KARS proposal for one or more of several reasons. First, some critics argue that the KARS proposal, if implemented, would produce too radical a shift from considerations of individual efficiency (e.g., is this organ compatible with this candidate?) to an emphasis on group efficiency and benefit. Simply put: the proposal is resolutely utilitarian and for that reason alone, morally dubious. Second, other critics cite the likely impact of an implemented KARS proposal on key populations. Because calculations of net benefit are likely to skew allocation toward relatively healthy, young Caucasian and Asian males and diabetics (because the latter do so poorly on dialysis), certain ethnic and racial disparities in organ allocation will be worsened. Third, for many, the whole concept of quantifying-and predicting-quality of life is irremediably complex and ethically suspect. Multiple factors impinge on how any one individual defines, much less experiences the "quality" of his or her life; the attempt to objectify this experience both fails to capture its specificity and harms the individual for whom the experience is just that-his or her experience.

For a detailed analysis of the legal, regulatory and ethical framework for organ allocation in the United States , see the staff discussion paper prepared by Dan Davis, Ph.D. for the September 2006 Council meeting.

In 2002, UNOS implemented a significant change in one of the more contentious allocation algorithms, i.e., the algorithm for livers. With the change, which adjusted the relative weights of urgency and geography, the MELD/PELD scoring system was instituted. The amended policy still gives local patients with a medically urgent need an advantage over similarly needy regional patients; similarly needy patients beyond the region come after local and regional patients who are less needy. The aim of the MELD/PELD scoring system is to bring greater objectivity to clinical judgments about need and urgency. In 2003, with the same aim in mind, UNOS also implemented a revision in the allocation policy for lungs and launched a comparable scoring system for objectively distinguishing patients on the basis of severity of illness and thus need.

The Board of Directors of the United Network for Organ Sharing has considered proposals to limit or prohibit the practice of multiple registrations, but has not taken decisive action as yet; thus, the practice continues to be permitted.

The following is an excerpt from the staff discussion paper on "The Ethics of Organ Allocation" prepared for the September 2006 meeting; it provides a more detailed account of the third rationale for a negative response by the Council to the question of whether the role of geography in allocation should be further mitigated. "One might begin by arguing that an allocation system, even one oriented to equity and utility, should take account of-and somehow, be responsive to-the more salient features of the moral life. One such feature is that we live this life in the company of others. Moreover, the more "tangible" these others are to me, the more likely I am to experience myself as bonded to them, by blood, by affection, and by the fact that we inhabit the same spheres of community-the street, the neighborhood, and beyond that, the city, the area, and the region. Those within our respective circles of family and friends are perhaps most tangible to us-hence, the directed donation of an organ to someone joined to us genetically or emotionally troubles us little (setting aside, for the time being, objections to living donation per se), even if the recipient is not necessarily the person most in need. Beyond these circles, those with whom I inhabit neighborhoods and cities and areas and regions are perhaps more tangible than others who live at a greater geographical remove from me, say, in another region of the country. Can we assign both relevance and weight to these increasing degrees of tangibility, which are functions of genetic, affective, and spatial proximity? In particular, can we assign a weight that can outweigh other criteria, like patient need? We do so, in effect, with directed donation from one member of a biological family to another or within relationships of affection, from one spouse or partner to another. Such relationships constitute what Michael Walzer would describe as a separable sphere of justice-separable, that is, from other spheres of justice, defined, in part, by the dominance of a particular ethic. Between family members or loved ones, directed donation can occur in relative freedom from the full force of the demand for equity. To be sure, the family member or loved one in need of an organ must, indeed, have a demonstrable, medically defensible need for transplantation and must pass muster for blood type and tissue compatibility; assuming these criteria are met, the recipient of a directly donated organ is the beneficiary of the respect given to the autonomous choices of the donor-and not of the overall arc of the system toward equity. Here we have a sphere of justice in which respect for autonomy and for the most intimate of our relationships is the dominant ethic. Beyond this sphere, another can be envisioned wherein geographical proximity to the source of the gift is important in determining who, among those with an established medical need and with physiological compatibility, is where in the line of potential recipients of the gift. Within this sphere, proximity between donor and recipient can outweigh urgency of need simply because the less urgent recipient is nonetheless more tangible vis-à-vis the source of donation: to one degree or the other, the donor and recipient can be said to inhabit the same moral space, the space of community. . Inspired by Walzer's vision of differing spheres of justice, an advocate of balancing geography and equity could argue that geography is instrumental and critical in setting the boundaries of these spheres, each with its own ethos and thus its own notion of justice. And such an advocate could argue as well that the more narrowly one construes the spatial reach of a particular sphere, the more likely one is to promote and realize the ethic of altruism infusing the conviction that organs are gifts of life-gifts given by particular people, bound by identity to particular places and, thereby, to other people in those particular places."

See, for example, JS Cameron, "Renal Transplantation in the Elderly," International Urology and Nephrology 32: 193-201, 2000.

It may be of interest to note that, for the period from January 1, 1988 through September 30, 2006, the grand total of deceased donors is 104,979; of these, 7,087 (6.8 percent) have been donors 65 years of age or older and 21,623 (20.6 percent) have been 50 to 64 years of age.

U.S. Census Bureau, 2004, "U.S. Interim Projections by Age, Sex, Race, and Hispanic Origin," http://www.census.gov/ipc/www/usinterimproj/ . Internet release date: March 18, 2004.

J.J. Curtis, "Ageism and Kidney Transplantation," American Journal of Transplantation 2006; 6: 1264-1266.

D. Callahan. Setting Limits: Medical Goals in an Aging Society . New York : Simon and Schuster, 1987.

R. Veatch. Transplantation Ethics . Washington , D.C. : Georgetown University Press, 2000.

See footnote 11 below for a definition of expanded criteria donors.

Standard criteria donors are deceased donors who have suffered brain, rather than cardiac death and who do not qualify as expanded criteria donors; expanded criteria donors are either 60 years of age or older or between the ages of 50 and 59 with two of the following three conditions: a history of high blood pressure; a creatinine level greater than 1.5; or, cerebrovascular accident (e.g., a stroke or aneurysm) as the cause of death.

The most important factors in this projection are, in order of importance: age, diagnosis, angina, previous transplant, time exposed to end stage renal disease, and ethnicity. Neither gender nor geographical locus was predictive according to the studies upon which the projection is based.