The Ethics of Organ Allocation

A Staff Working and Discussion Paper

Prepared for the Twenty-Sixth Meeting of the President's Council on Bioethics, September 7-8, 2006

by Dan Davis, Ph.D., with Rebecca Wolitz

Outline

Introduction:            Compelling Questions in the Ethics of Organ Allocation

Part I:                         The Current System of Organ Allocation

A.        The Process of Procurement, Allocation, and     Transplantation:  An Overview

B.         Basic Definitions for Organ -Specific Allocation

C.        The Allocation of Organs:  Organ-Specific Criteria

1.         Kidneys

2.         Pancreata

3.         Livers

4.         Thoracic Organs

5.         Intestines

Part II:                        The Legal and Ethical Framework for Organ Allocation in the                                               United States

A.        Law and Regulation

B.         UNOS and OPTN

C.        Utility and Equity as Moral Ideals

D.        Utility and Equity in Practice

Part III:                      The Ethics of Allocation:  Criticisms and Controversies

A.        The Moral Relevance and Weight of Geography

B.         The Moral Quandaries Presented by Directed Donation and              Preferred Status

C.        Transplant Center Discretion and the Potential for        Manipulation

Part IV:                      Suggestions for Focusing Council Inquiry and Discussion:  The                                            Ethics of Organ Allocation

A.        The Moral Relevance and Weight of Geography in Organ                  Allocation

B.         Directed Donation and Preferred Status

C.        Discretion and Prudence in Organ Allocation

Appendix                  Chart/Comparison of Organ-Specific Algorithms and the Different                                      Moral Weights of Different Criteria

The Ethics of Organ Allocation

A Staff Working and Discussion Paper

Prepared for the Twenty-Sixth Meeting of the President's Council on Bioethics, September 7-8, 2006

Introduction:  Compelling Questions in the Ethics of Organ Allocation

About the current state of organ transplantation in America, several facts are well known, two of which are illustrated by the chart below and at right:  in each of the last ten years, the demand for organs in the United States has exceeded the supply and the rate of growth in demand has outstripped the rate of growth in supply.  Short of drastic changes in the law and ethics of organ procurement, there are, as well, limits to the available methods of increasing the supply of organs.  And finally, one of the more sobering of these well-known facts:  although we are helping more people every year with organ transplants, a growing number of transplant candidates suffer and die waiting for life-enhancing or life-saving organs that never come.   In the somber light of these and other factual considerations, certain questions seem urgent and unavoidable:  How are organs allocated? How should organs be allocated? That is, in accordance with what ethical theory, precept or principle should this scarce, life-saving therapy be distributed among the growing numbers of those who need it? 

Asking these questions is not unlike attempting to isolate a single strand in an intricately entangled ball of yarn:  this question is entwined with that question, which is knotted up with yet another question, and so on and so on.  Questions about the "how" of allocation are inseparable from questions about the "who":  for example, who should determine the criteria for organ allocation?  Individuals?  The community?  Which community?  The transplant community?  Or "the community" more broadly defined?  If the answer is "the community 'more broadly defined'," then how, exactly, should "the community" be so defined?  As the local community?  As the state?  As a region encompassing multiple states and/or localities?  As the nation?  Do our answers to these questions hold for organs from both deceased and living donors?  Or, does the difference in source-i.e., deceased vs. living donors-yield a difference for ethics and policy making?   Is there a viable ethical argument for the claim, made by some, that living donors have some degree of authority to allocate their organs as they see fit, but the organs of deceased donors are community resources that must be allocated within an altogether different ethical framework?  Or is the ethical and policy difference rooted in the fact that living donors usually decide to donate to help a particular recipient, whereas deceased donors often become donors unexpectedly, without a particular loved one in need to whom they might otherwise justly will their organs?   These focused questions about organ allocation lead inevitably to questions of a different, but related sort-questions posed from the perspective of philosophical anthropology:  How are we to reckon with the claim, implicit in these ethical arguments about living donation, that one owns one's body and one's organs?   To what extent does the word "ownership" capture the lived experience of being a body?    Does-or should-death mark a moral boundary, beyond which one no longer has interests, especially interests in the disposition of one's body or bodily organs?

Moreover, and again with respect to differing geographical notions of "community," should members of the local community-versus the regional or the national community-be given first priority in the allocation of a locally procured organ?    Are organs, in some primary sense, resources of the local community in which they are procured?  Or, in the context of organ transplantation, should the operative concept of community be the nation, with the result that organs are treated as a national resource (within the constraints of logistics, organ viability, etc.)?    Unavoidably, questions about the ethics of allocation cannot be completely disentangled from questions about the ethics of procurement.  Consider yet another question illustrating this point:  Should individuals who agree to donate their organs after death be given preferred status on the waiting list for organs in the event that they later develop the need for a transplant?    In other words, in the interests of stimulating organ donation, should organ "givers," as they are called by some, be given an edge as potential organ "takers," and if so, to what degree should this factor play a role in allocation decisions?    How we engage and how we respond to the challenges presented by these questions are matters of profound import, according to the testimony of two individuals who have been instrumental in shaping current policy for organ procurement and allocation, James Childress, ethicist and chair of the recent Institute of Medicine panel on organ transplantation, and James Burdick, director of the federal Division of Transplantation.  Underscoring the mutually implicate character of the relationship between procurement and allocation, Childress argues that "the success of policies of organ procurement may reduce scarcity and hence obviate some of the difficulties of organ allocation . [but] distrust is a major reason for the public's reluctance to donate organs, and policies of organ procurement may be ineffective if the public perceives the policies of organ allocation as unfair and thus untrustworthy."   To throw into relief the uniqueness of organ allocation within medicine and the point that particular allocation decisions have ripple effects throughout the national system-that micro-allocations reverberate at the macro-level-Burdick asserts that "[B]ecause there are not enough donated organs, all patients and practitioners are bound together by a community of medicine principle:  whenever a patient receives a transplant, it diminishes the chance that other potential recipients will be able to receive this gift of life in time to save them."

In the last decade or so, the intensity of public and scholarly debate over the ethics of organ allocation has ebbed and flowed, often with the waxing and waning of interest in specific events, sometimes sensationalized in the media.  Yet the core questions remain.  Questions remain about geographic inequity and about the moral relevance and weight of geography in organ allocation.   Questions remain about racial and ethnic inequity.  Questions remain about the moral relevance and weight of waiting time, about the ethics of directed donation to individuals and groups, and about the overarching ethical framework within which organs should be allocated.   In light of these remaining-these compelling-questions, it is not only appropriate that the President's Council on Bioethics turns its attention to the ethics of organ allocation:  it is inevitable and mandatory. 

This staff working and discussion paper has four parts.  The focus of Part I is the basic process and current system of organ allocation. It provides an overview of the sequence of events initiated by the procuring and offering of a donor organ and, with the aid of some basic definitions, describes the organ-specific algorithms used for allocating kidneys, pancreata, livers, thoracic organs (i.e., hearts and lungs), and intestinal organs.  Part II is an account of the legal and ethical framework within which organ allocation occurs in the United States:  in addition to identifying the loci of authority and accountability for allocation decisions at the macro- and micro-levels, Part II explicates the two ethical principles-equity and utility-that, by federal law and regulation, govern the allocation system.  Part III summarizes the criticisms that have been leveled against the current allocation system.  Part IV is intended to focus and guide Council deliberation and debate on certain remaining, compelling questions in the ethics of organ allocation.

I.     The Current System of Organ Allocation

The process of organ allocation occurs within a complicated legal, regulatory, and organizational matrix.  The several elements of this matrix-which overlap and, at times, seemingly conflict or, at the very least, fail to mesh-include: 

federal law and regulations

the organ procurement and allocation policies promulgated by the federally established Organ Procurement and Transplantation Network (OPTN) and the United Network for Organ Sharing (UNOS), which operates OPTN under contract with the federal government; these policies define the algorithms utilized in organ allocation throughout the United States on an organ by organ basis

state law and regulations

the nationwide network of 58 organ procurement organizations (OPOs), which occupy the "front lines" of the process, from procurement to allocation, along with the transplant centers and their organ-specific programs

transplant professionals, i.e., the physicians who evaluate and place patients on the waiting list for organs and who perform transplant surgery

In the control that it exerts over particular processes and decisions, i.e., the procurement of an organ (or organs) from a particular donor and the allocation of the organ(s) to a particular patient, this matrix is neither rigid nor "airtight."  Key decisions-whether a patient is added to or removed from the list, whether an organ is accepted for transplant, and, in some cases, whether a patient's need for an organ is medically urgent-are left to the prudential, clinical judgment of individual clinicians.  Transplant centers enjoy considerable latitude in establishing select standards, making cooperative arrangements, etc. With relative independence from UNOS allocation criteria, certain directed donations of organs are effected.  For some critics of the UNOS system, these variations from center to center are not just concessions to exceptional circumstances or wise allowances for discretion but inadequacies of the system that threaten to subvert rather than advance the achievement of its guiding ethical principles.  (Part II describes in greater detail how each element of the matrix functions, legally and ethically, in the UNOS system.)

A.        The Process of Procurement, Allocation, and Transplantation:  An Overview

The catalyzing event for the eventual transplantation of an organ is the donation of an organ from a donor, either deceased or living.   Most living donors donate to someone in particular-usually a family member or friend. The recipient thus receives an organ based not upon her level of medical need or urgency compared to other potential recipients, but because her need for an organ is felt as urgent by the potential donor, who willingly gives up an organ to help or save (only) the ailing person he loves. For deceased donors, who typically die without an intended recipient, the public system of organ allocation typically governs, which aims precisely to determine which potential recipient has the strongest claim to the particular organ that is available. Thus while many of the basic physiological procedures for classifying potentially usable organs are the same for living and deceased donors, the process of allocation is not. These two systems of allocation-directed donation by living donors and non-directed donation by deceased donors-exist on distinct but related tracks. At various points and in various cases, these tracks converge, as we will also explore below. But unless noted specifically, the discussion that follows will focus on the allocation of non-directed organs from deceased donors-precisely that place where the community needs to decide, as a whole, which moral principles and protocols should govern the use of this scarce resource.

When a potentially transplantable organ becomes available, the donated organ is first "typed":  the blood and tissue types of the donor, the size and condition of the organ, and other data relevant to the matching process are specified and entered into a UNOS-maintained database by the OPO that is managing the donor.  The UNOS database generates a list of potential recipients with medical and biological profiles that are compatible with the donated organ; the potential recipients are ranked on the list in accordance with organ-specific criteria for ranking.  The degree to which the recipient's need for an organ is urgent is pivotal in prioritizing recipients of livers, hearts, lungs, and intestines.  With kidneys, waiting time is often the most important criterion.  The list is also geographically segmented:  local potential recipients are ranked ahead of regional potential recipients, who are ranked ahead of national potential recipients.  The transplant team for the first-ranked patient has one hour to make the decision as to whether to accept or reject the organ for the potential recipient, utilizing such criteria as organ condition, patient condition, staff availability, and logistics of organ transport to the transplant center.  If the organ is accepted, it is transported to the transplant center; if the organ is rejected, it is then offered to the second ranked patient on the potential recipient list and then to the next ranked individual and so on.

B.        Basic Definitions for Organ-Specific Allocation

The organ-specific formulae or algorithms developed by UNOS and used in allocation are comprised of (point-based) variables or criteria.  Each criterion has an ethical correlate, a principle or precept justifying its moral relevance in the allocation of a particular type of organ-and the moral weight that criterion has in allocation decisions.  For the lay reader, it is helpful to keep in mind some basic definitions of key medical and biological factors (and processes) that figure prominently in these criteria, along with some indices of their significance for the efficient, as well as equitable allocation of organs.

Blood type:  Blood type is a key factor in the process of "tissue typing" both organ donors and potential recipients.  There are four major types-A, B, AB, and O-and each major type may contain the rhesus factor (Rh), in which case it is Rh positive; otherwise, it is Rh negative.  Blood type is significant in the organ transplantation process, which depends upon compatibility between recipient and donor blood types.  (See the chart at right.)    Potential recipients with blood type O can receive organs only from donors with type O blood.  Organs from donors with blood type O, however, can be transplanted into patients of any blood type.   Through these facts of human biology, we can begin to glimpse the role that medical utility (or, alternatively, efficiency) plays in the ethics of allocation:  transplantation involving incompatible donors and recipients would waste the scarce resource of human organs.  We can also discern the moral significance and moral conundrums of seeking equity:  compared with recipients of other blood types, those with blood type O have fewer chances for matching with suitable donors because they can only receive blood type O organs; and blood type O (along with blood type B) is more common among certain racial minorities, i.e., more common among African-Americans than Caucasians.  Thus, in some organ-specific algorithms, blood type O recipients are given a relative degree of priority over recipients of other blood types to compensate, in effect, for this biologically-based diminishment of their opportunities for transplant.

Human leukocyte antigen (HLA) system or major histocompatibility complex:  In the human immune system, HLAs play a critical role in differentiating cells that belong to the self from cells that are foreign.  These antigens, which are inherited from one's parents, are found on the surface of all nucleated cells of the body and characterize an individual as biologically unique.  In organ transplantation, HLAs are a critical measure of tissue compatibility between a donor and a potential recipient.   In kidney transplantation, for example, six different HLAs are typed and matched for a given donor and potential recipients; the results of this process are usually expressed in terms of the number of mismatches between donor and potential recipient HLAs with zero (0) mismatches indicating a high degree of compatibility and six (6) mismatches indicating complete incompatibility.    Histocompatibility testing is important in kidney and pancreas allocation, but plays virtually no role in liver, lung, and heart allocation.

Panel reactive antibodies (PRAs):  Antibodies are protein molecules produced by the immune system in response to a foreign body-for example, a virus or an allograft, i.e., transplanted organ.  PRA values are laboratory measures of a patient's level of "sensitization" to human leukocyte antigens.  Evaluating this antibody-antigen reaction between a given patient and a given donor entails cross-matching:  a negative cross-match is an indicator for transplant because the likelihood of rejection is low; a positive cross-match is a contraindication because the likelihood is high.  A patient in need of an organ may become "sensitized" through a previous transplant, a blood transfusion or pregnancy.   The patient's blood serum is screened in order to assess the degree of sensitization, which is expressed as a percentage of PRA:  such a percentage can range from 0 percent   (non-sensitized) to 80-100 percent   (highly sensitized).  High levels of PRAs are associated with a greater risk of graft rejection and failure.    For example, the likelihood of finding cross-match negative kidney donors for patients with high PRA values is low; hence, such patients may wait much longer and perhaps never receive a kidney.  Out of concern for equity, such patients are given a relative advantage over patients with low PRA values:  as with blood type O recipients, the aim is to improve their opportunities for transplant, which are encumbered by a biologically-based disadvantage.  Thus, PRA levels are very significant in the allocation of kidneys and pancreata, but only somewhat significant with heart allocation; a patient's degree of sensitization is of little import in the allocation of livers and intestines.

Tissue typing:  In tissue typing, organ donor-recipient compatibility for HLA and blood type (ABO) and PRA levels are assessed.   Tissue typing involves cross matching, i.e., testing patient antibodies against donor antigens.  With positive cross-matches, donors and recipients are incompatible; with negative cross-matches, donors and recipients are compatible.  Positive cross-matches are thus are a contraindication for transplantation, especially with kidneys and hearts; liver transplants tend to be more resistant to antibody-mediated rejection.  Cross-matching is routine for kidney and pancreas transplants.  

C.        The Allocation of Organs:  Organ-Specific Criteria

Organ allocation is profoundly complicated.   The criteria for allocation are organ-specific:  the allocation of each type of solid organ is governed by a somewhat unique set of criteria developed through an ongoing process of deliberation involving ethical reflection, informed by empirical evidence (of a scientific, clinical, and sociologic nature).    Despite the complexity of the system overall, and of each set of organ-specific criteria, some generalizations can be made.    The "universe" of factors, deemed relevant to the ethical aims of utility and equity, includes the following:

The match between blood types of donor and potential recipient, i.e. are the blood types identical, compatible, or incompatible?

Histocompatibility, i.e., the degree of mismatch (or match) between donor HLA and recipient HLA

The degree to which a recipient is "sensitized," i.e., his or her PRA percentage or level

The size and condition of the donor organ

The age of the donor

Whether the donor's need for organ transplant is classified as "medically urgent"

The length of time the potential recipient has spent on the waiting list

The distance between the potential recipient's location and the donor organ's geographical origin

Whether the recipient has been an organ donor, i.e., of a kidney or segment of liver or lung

With the exception of the final factor (i.e., whether the recipient has been an organ donor), each factor plays a role in the allocation criteria for more than one type of organ; only in kidney allocation does status as a previous organ donor confer a relative advantage on a potential recipient.  

The complexity of allocation is a function, in part, of the differing ways in which each factor is weighted from set to set of organ-specific criteria.  Several examples are illustrative.  Medical urgency plays a relatively minor role in kidney allocation, but it is decisive in liver, heart, and intestine allocation.    The logistics of organ viability (which include distance and thus travel time from the point of organ procurement to the location of a potential recipient) are basic to all allocation decisions, regardless of organ type, as are blood type, body size, and tissue type.  In combination with other factors, geography in another sense can be decisive as well.  With the exception of thoracic organs, most organs are first allocated locally, then regionally, and finally nationally.  With hearts and lungs, geographical priority is assigned to potential recipients depending on their registration site within one of four zones radiating in concentric circles from the source of procurement:  a potential heart recipient within 500 miles of the donor organ will enjoy an advantage over an otherwise similar potential recipient who is 1,000 miles away from the donor organ.   In kidney allocation, however, geographically-based priority can be trumped by a potential recipient with a zero-mismatch for HLA, even if that patient resides thousands of miles from the donor organ; in liver allocation, medical urgency can supersede geography in the process of prioritizing potential recipients.   In several sets of organ-specific criteria, time on the waiting list functions as a tie-breaker between potential recipients with an otherwise equal priority based, for example, on tissue matching, immune status, geography, and medical urgency.   In the following, each set of organ-specific criteria is described, some with the aid of charts to illustrate how factors are employed in combination to assign relative degrees of priority for transplant to potential recipients.  The chart in the appendix provides an overview and comparison of organ-by-organ allocation criteria.  This chart also offers a graphic illustration of the ethical correlates for a particular criterion within a given set of organ-specific allocation criteria. We explore these allocation criteria in richer ethical terms below; here, we aim simply to describe how the current system works.

1.         Kidneys:  At present, there are 92,486 patients on the national waiting list for organs.  Of these, 67,258 are in the lengthening line for kidney transplantation.   For anyone awaiting a kidney, organ supply and transplantation trends over the last decade can be daunting, if not downright discouraging:  although living donation has been an expanding supply source for donor kidneys, it has not been sufficient to close the ever-widening gap between the need for and the availability of transplantable organs.   The result is a situation that some would characterize as both chronic and acute:  chronic in terms of duration and acute in terms of the burden of suffering.  Dialysis offers an alternative to transplantation for those who wait for a kidney to become available; however, the health of those on dialysis tends to degenerate over an extended period of time. Many patients are less healthy by the time they receive a kidney transplant, while others die waiting, whether of renal failure or some other health problem. Criteria for the allocation of kidneys function within-and are, in some sense, products of-this context.

For deceased donor kidneys, there are two sets of allocation criteria:  one for so-called "standard" donors and another for "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.  Kidneys from "expanded criteria" donors may not function as well or as long as kidneys from standard donors but they may, nonetheless, be a viable option for patients who cannot tolerate extended periods of dialysis or whose risk of serious complications or death increases the longer they wait for transplant. 

In general, waiting time is the key factor that prioritizes potential kidney recipients, yet it does so within a ranking determined by the physiological match between donor and potential recipient and the geographical proximity of donor and potential recipient. Specifically, blood type O kidneys must be transplanted into blood type O recipients only-unless the potential recipient has a zero HLA mismatch with the donor organ, in which case the potential recipient may be of any blood type (remember:  an organ from a donor with blood type O can be transplanted into a potential recipient of any blood type).  Blood type B kidneys must also be transplanted into blood type B recipients, although here, too, the exception for a potential recipient with a zero HLA mismatch holds as well. 

If there are multiple candidates with a zero antigen mismatch for the donor organ, those in the local area with a blood type identical to that of the donor are prioritized, but they themselves are ranked according to their respective points-which, for a standard donor, are allocated based on a range of factors (see below.  With an expanded criteria donor, waiting time is the only determinant of this ranking.  If there are no local candidates who meet these criteria, then the standard donor kidney is offered to a candidate drawn from a pool of candidates defined, at this point in the process, by the fact that all are highly sensitized (i.e., they have 80 percent or higher PRA); this pool, however, is also geographically segmented.  Within this pool of candidates, those on the waiting list of certain OPOs (i.e., those that have shared kidneys with the procuring OPO in the past) receive offers before candidates on the regional waiting, who receive offers before candidates on the national waiting list.   If there is still no success in securing a match, the organ is allocated to a succession of candidates whose relative degree of priority is co-determined by immune status, age, and geography:  that is, it goes to candidates who have less than 80 percent   PRA and are less than 18 years of age and, within this candidate pool, first to those on the waiting list of select OPOs (again, those that have shared kidneys with the procuring OPO in the past), then to candidates on the regional waiting list and finally to those on the national waiting list.  The chart above illustrates these priority sequences.

Keep in mind the significance of the type of donor:  with standard donors, candidates in any one segment are ranked within that segment in accordance with the points they have by virtue of the determining as well as other criteria; with expanded criteria donors, candidates within any one segment are distinguished and ranked by waiting time alone.

As noted but not yet fully explained, candidates for kidney transplant are ranked (e.g., within the geographically defined subgroups described above) according to points accumulated for various criteria.   Consider waiting time.  The points for waiting time are not assigned until candidates are grouped by blood type:  if 10 candidates with blood type O are waiting for the same donor organ, the individual who has been waiting the longest receives 1 point, while the other 9 will receive fractions of 1 point according to their respective waiting times-e.g., 9/10 of a point to the individual who has been waiting the next longest time, 8/10 of a point to the next longest waiting individual, and so on.  For every full year of waiting time accrued, a candidate receives 1 point.  As we have seen, candidates with a zero antigen mismatch for a kidney are immediately prioritized for receipt of that organ; if a candidate has no antigen mismatches at a particular locus on HLA (i.e., the DR locus), he or she receives 2 points and if there is one mismatch at that locus, the candidate receives only 1 point. 

Four points are awarded to highly sensitized candidates with PRA levels of 80 percent or above: the logic here is that due to their immune status and their high risk of graft rejection, these patients face an uphill battle in receiving a suitable organ and merit a relative boost in their chances.    In general, candidates for kidney transplant receive no points for medical urgency.  The availability of a life-extending and life-saving alternative, dialysis, provides the rationale for this exclusion of medical urgency from general consideration.  There are patients, however, for whom dialysis is not a viable alternative due to the lack or loss of the required vascular access:  for them, the need for a kidney transplant can be or become medically urgent.   The policy stipulates two ways in which points for urgency can be assigned to such a patient.  If there is only one renal transplant center in the local area, a patient's physician may assign points for urgency based on his or her clinical judgment.  If there is more than one transplant center, then all local centers must make a cooperative decision as to whether or not points for medical urgency will be assigned to a patient. 

Two other "conditions" can earn a kidney transplant candidate additional points.  The first has to do with age:  pediatric candidates, i.e., those less than 18 years of age, can be awarded points as follows:  candidates who fall in the age range from 11 years up to 18 years and have a zero antigen mismatch with the donor receive 3 points; candidates below the age of 11 years with a zero antigen mismatch receive 4 points.  Although the policies governing kidney allocation to pediatric candidates have additional stipulations, especially with regard to kidneys from donors less than 35 years of age, what is of key import here is the rationale for conferring a degree of priority on younger patients, a rationale that appeals to a fact of human biology:  impaired renal function has a pervasively deleterious effect on child and adolescent development in general.

Donation status is the other remaining "condition" that can earn additional points for a patient in need of a kidney:  if the patient has donated, within the United States, a kidney or a segment of her liver, lung, pancreas, or small bowel, she receives 4 additional points.  It is worth noting that donation status is a criterion for the allocation of kidneys only and plays no role, whatsoever, in the allocation of any other type of solid organ. 

Under the rubric of kidney allocation, we should note that the number of kidneys derived from living donors is rising, year after year, stimulated, in part, by relatively low-risk laparoscopic nephrectomy (compared with more invasive techniques) and good outcomes.  The first transplantation of any organ in this country, in 1954, was made possible by a living donor who donated to his twin brother.  Since then, kidney transplants involving living donors have become routine, for related as well as unrelated recipients:  more than a fourth of the kidneys from living donors are now allocated to unrelated recipients.    Despite the priority assigned to zero antigen mismatches in kidney allocation, outcomes data indicate that HLA mismatching is not as much a barrier as, say, blood type incompatibility and cross match reactivity.   These latter barriers, however, can be surmounted with so-called "paired kidney exchanges."  Such exchanges have the basic form illustrated above:  Donor 1, who is incompatible with intended Recipient 1, gives a kidney to compatible recipient 2, while Recipient 1 receives a compatible kidney from Donor 2, who wished to donate Recipient 2.    When both donors are living donors, allocation is relatively straightforward within the specialized "niche" that directed donation enjoys within the overall system. 

A more complicated case involves so-called paired "donor-list" exchanges, in which Donor 1, who is incompatible with intended Recipient 1, gives an organ to the most eligible person on the public waiting list, and in exchange, intended Recipient 1 receives the next available cadaveric organ for which he is medically compatible.

2.         Pancreata:  The national waiting list for pancreata now numbers 1,738 candidates; 2,442 additional candidates are in line for combined kidney-pancreata transplants.  The allocation algorithms for kidneys and pancreata are similar:  both confer priority on candidates with a zero-antigen mismatch with a given donor, regardless of the potential recipient's location (be it local, regional, or national), as well as on highly sensitized candidates (i.e., those with a PRA of 80 percent and above).  And as with kidneys, in pancreas allocation, geography can be a key determinant of priority:   local candidates stand in line ahead of regional candidates who are ahead of all candidates who are situated beyond the boundaries of the region, but within the boundaries of the nation.    Patients grouped by blood type, geography, and other criteria are ranked, in addition, by waiting time.

3.         Livers:  The waiting list for liver transplants now numbers 17,093.   For patients with liver failure, there are no alternatives:  no mechanical devices or procedures (e.g., comparable to a ventilator, artificial heart, pacemaker, dialysis, or intravenous nutrition) and no pharmacotherapies (e.g., comparable to vasopressors or insulin) to sustain the functions of a failing liver.  Thus liver transplants are not only life-enhancing or extending:  they are life-saving.  It is this clinical reality that undergirds the crucial significance of medical urgency in the allocation of livers.  Patients with acute liver failure and a life expectancy of a few hours to a few days-without transplant-are categorized as Status 1A or Status 1B.  A patient classified as Status 1A has "fulminant" liver failure with a life expectancy, lacking transplant, of less than seven days, even if they reside in the region, rather than the local area within which procurement occurs:  thus medically urgent candidates in a region can be placed ahead of local patients whose need for transplantation is not as urgent.  Others on the waiting list for livers are prioritized on the basis of their respective scores on one of two batteries of tests, that is, either their scores on MELD (Model of End Stage Liver Disease), if they are 12 years or older, or their scores on PELD (Pediatric End Stage Liver Disease) if they are 11 years of age or younger.  The formulae for MELD and PELD are summarized in the chart above.

UNOS revised its liver allocation policies in 2002, due, in part, to pressures generated by conflicts over the moral relevance and the moral weight of geography versus that of medical urgency.  The aim of the revision was to reduce the inequities that tended to privilege local recipients, regardless of the degree to which their need for transplant was urgent.  The resulting MELD/PELD calculations were developed on the basis of extensive study of liver disease and transplantation and yield an accurate predictor of the urgency of patient need for transplant-that is, of the risk of death in the absence of transplantation.  The calculations are rigorously objective and have restricted the opportunities for subject bias in the clinical judgment of physicians who evaluate patients for placement on the list.  Still, concerns about geographical inequity remain:  local and regional candidates whose need is less medically urgent precede national candidates whose need is more medically urgent.  Patients on the list are prioritized according to their respective MELD or PELD scores, which may range from 6 (less ill) to 40 (gravely ill) and function as an index of how urgently they need transplant within the next three months.   Thus, the probability of death looms large in liver allocation.  The charts on the preceding page and this page illustrate adult and pediatric donor liver allocation.

In allocating livers, waiting time functions as a "tie-breaker" and is used only in the event that two potential recipients with identical blood types have the same MELD/PELD score.  Waiting time is then introduced to determine which candidate has priority over the other.    Organ source and size are also the basis for yet another means of prioritizing candidates:  a liver from a pediatric donor is allocated to a pediatric patient first and then to adult candidates.

4.         Thoracic Organs:  As of August 8, 2006, there were 2,862 patients on the national waiting list for hearts; 2,925 were awaiting lungs; and 153 were in line for combined heart-lung transplants.  Medical urgency is decisive-to a degree bounded, again, by geography-in the allocation of hearts, lungs, and heart-lung combinations, as the chart at right shows.  Medically urgent adult candidates for hearts (i.e., 18 years of age or older) are classified as Status 1A (the highest degree of urgency) or Status 1B (the next highest degree of urgency):  Status 1A patients are hospitalized and require mechanical circulatory support, mechanical circulatory support with complications (e.g., infection, device failure, or arrhythmias), mechanical ventilation, or continuous infusion of medications to sustain cardiac function.  Status 1B candidates require implanted devices to sustain cardiac function or continual infusion.  Patients who do not meet the criteria for either Status 1A or Status 1B are classified as Status 2.

To determine severity of illness and thus, in a sense, urgency of need, lung allocation employs a scoring system for candidates 12 years of age and older.   The lung allocation score for a given candidate is calculated on the basis of the results of several tests, including forced vital capacity, pulmonary artery pressure, oxygen at rest, and pulmonary capillary wedge pressure; the potential recipient's age, body mass index, functional status, and diagnoses (e.g., does the candidate have diabetes, what type of lung disease does the candidate have, does the candidate require ventilatory support?).   The resulting score can range from 0 to 100:  the higher the score, the higher the priority a candidate has when suitable donor organs become available.   For pediatric patients less than 12 years of age, waiting time is the principal factor employed in prioritizing candidates.  In addition, organs from pediatric and adolescent donors are offered first to pediatric and adolescent transplant candidates and then to adult candidates.

Geography is also a key determinant in the allocation of thoracic organs:  in general, hearts and lungs go to local candidates first.  Lacking suitable local candidates, thoracic organs are then allocated, sequentially, to candidates in zones that radiate from the source of procurement in concentric circles:  Zone A covers transplant centers that are not local but are within 500 miles of the source of procurement; Zone B extends from at least 500 miles to no more than 1,000 miles; Zone C, from 1,000 to 1,500 miles; and Zone D, beyond 1,500 miles from the donor.  Candidates within each zone are further segmented and prioritized by blood type:  those with blood types identical to donor organs are ranked ahead of those with blood types that are compatible but not identical.   Thus, the degree of medical urgency, blood type, and location are three co-determinants of a given candidate's place on the waiting list for thoracic organs.  A fourth is waiting time:  candidates grouped by degree of urgency, blood type, and location are further ranked, if need be, by the respective lengths of their times on the list. 

5.         Intestines:    The national waiting list includes a relatively small number of patients in need of intestinal organs, i.e., stomachs, large or small intestines, or segments of the gastrointestinal tract-just 225, as of August 8, 2006.  Here, too, the degree to which a patient's need is medically urgent is crucial.  Patients who are classified as Status 1 have developed life-threatening liver abnormalities or they can no longer receive intravenous feedings because of the lack or loss of the required vascular access.  Patients who do not meet these criteria are classified as Status 2.    Other variables in the algorithm for intestinal organ allocation are organ size, blood type, geography, and waiting time.   A given organ will go first to size-compatible patients of identical blood type and next to patients with a compatible blood type.   As with the allocation of other organs, geographical distinctions "overlay" these considerations of urgency, size, and blood type and waiting time is used to prioritize candidates within the rankings produced by the combination of these considerations. 

II.        The Legal and Ethical Framework for Organ Allocation in the United States

As previously noted, organ allocation in the United States is conducted within a complicated legal, regulatory, and organizational matrix, governed by federal law and regulation, the UNOS system with its member entities (i.e., organ procurement organizations and transplant centers and programs, which are organized geographically by regions), state law and regulation, and individual transplant clinicians.  Collectively, these laws, regulations, and institutions are directed to the achievement of two overriding moral ideals: utility (i.e., getting the most benefit from the organs we have) and equity (i.e., ensuring that the organs we have are allocated fairly to those who need them). This section describes, in greater detail, the legal and institutional matrix for (procurement and) allocation, and then turns to a consideration of the ethical rationales that purportedly undergird and inform this intricate system. 

A.        Law and Regulation:  The watershed event in the evolution of the relevant federal laws and regulations occurred in 1984, when Congress-motivated by arguments for a national initiative to advance and bring order to organ procurement, allocation, and transplantation-passed the National Organ Transplantation Act (NOTA).  Among the key provisions of NOTA were:  (1) the authorization of a grant system to fund the establishment and operation of organ procurement organizations (OPOs); (2) a mandate to develop and implement a system for allocating organs on the basis of established medical criteria; and (3) the creation of the Organ Procurement and Transplantation Network (OPTN).  Another well-known and increasingly controversial provision of NOTA, that having to do with "valuable consideration," prohibits the sale or the purchase of organs.  The intent of this provision was-and remains-to enshrine in the law the ethic of gift-giving, of altruism as the ethic governing procurement.

In 1988, in response to continuing concern about the influence of large transplant centers and individual transplant clinicians, Congress amended NOTA and clarified the sphere in which the equitable allocation of organs is to occur-that is, among transplant patients only and not among transplant centers and their patients:  patient need, rather than the allegedly conflict-prone interests of transplant hospitals and professionals, should determine allocation.    Other amendments stipulated that transplant centers and OPOs must be members of OPTN and must abide by its policies.  Two years later, in 1990, NOTA was amended yet again: spurred by continuous growth in the national waiting list for organs, Congress directed OPTN to give even greater priority to the problem of organ supply and, with the aim of ratcheting up the level of oversight, required OPTN to submit to the U.S. Department of Health and Human Services data revealing trends in procurement, allocation, and transplantation at the level of individual transplant centers.  NOTA and its amendments are the principal federal laws that we need to be concerned with in this inquiry into the ethics of organ allocation; before turning to federal regulation and, specifically, the "final rule," it is important to consider briefly state law and specifically the Uniformed Anatomical Gift Act.

Organ donation is a process that has, by tradition, been regulated by the states via anatomical gift laws.  In 1968, the National Conference of Commissioners on Uniform State Laws adopted the Uniform Anatomical Gift Act (UAGA), which was subsequently adopted by the 50 states and the District of Columbia.  The Act broke new ground by enabling individuals to donate their organs or bodies-to a hospital, physician, or organ procurement organization for scientific, medical, educational, research, or transplantation purposes; to a health professional school for educational purposes; to a designated recipient in need of transplantation; or to no specific individual or organization at all, i.e., without designating a donee.  In 1987, nearly twenty years after the initial act, years distinguished by a succession of triumphs in the science and practice of transplantation and by growth in the demand for this medical innovation, the National Conference formulated a revised UAGA with the aim of further facilitating organ donation.  Under the revised UAGA, witnesses are no longer needed to attest to a donor's signature on a document of gift.   "Routine inquiry" is required, i.e., upon admission to a hospital, patients must be asked to consider organ donation.   "Required request" is mandated as well, i.e., when patients die in a hospital, hospital personnel must discuss the option of organ donation with the next of kin and in the absence of a document of gift, ask that the deceased's organs be donated.  After the failure of reasonable attempts to locate the next of kin, a medical examiner is authorized, upon request, to remove organs.   Note should also be made of the revised act's inclusion of a provision banning the sale or purchase of organs for the purposes of transplantation.  Twenty five states and territories have adopted the revised UAGA thus far.

This brief review of federal and state law suggests how responsive the instruments of the law and regulation have been to the forces for change.  Among those forces has been mounting concern, within and beyond the transplant community, over the tragic paradox in organ transplantation:  therapeutic success coupled with growing, unmet need-and death.  As the dimensions of this paradox have come into sharper focus, attention has been riveted on the controversial meaning of "equitable allocation" and on such related questions as: How should equity and utility be balanced in allocating organs? and Who has dispositional authority over donated organs?   These concerns reached an unprecedented crescendo in 1998, when the U.S. Department of Health and Human Services (DHHS) issued a "final rule" with several provisions that soon proved to be divisive.  The intent of the rule was clear: to advance the cause of equity by restricting the opportunities for various forms of bias:

bias in the clinical judgments by which transplant professionals determine patient need and suitability for transplant and thus control access to the waiting list for organs;

bias in the policies and guidelines utilized by transplant centers and programs in evaluating urgency of patient need;

and specifically, geographic bias, which privileges local candidates over often medically needier regional or national candidates. 

To address these concerns, the final rule directed UNOS to define objective medical criteria for waiting list decisions, to promulgate objective measures of urgency and make medical urgency the driving criterion of allocation, and to ensure that "neither place of residence nor place of listing" is a "major determinant of access to a transplant."   If the results of UNOS's efforts to comply with these directives were not satisfactory in the eyes of the Secretary of DHHS, the final rule authorizes the Secretary to instruct UNOS to develop policies that do so comply. 

B.        UNOS and OPTN:  Mention has already been made of OPTN's establishment with the passage of NOTA in 1984.  Since 1988, in accordance with other NOTA provisions, the United Network for Organ Sharing (UNOS) has maintained OPTN, under contract with the federal government-specifically, the U.S. Department of Health and Human Services (DHHS).   OPTN is a private, not-for-profit entity, as is UNOS.  Public-private partnerships are relatively common vehicles for developing and implementing federally mandated policies, but the triangular relationship that brings together UNOS, OPTN, and DHHS is unique insofar as its primary purpose is to regulate access to a resource that can mean, for many, the difference between life and death.  

OPTN is governed by a board of directors whose membership, in terms of represented constituencies, is mandated by law:  half of the board members are drawn from the ranks of transplant clinicians; one fourth are candidates, recipients, donors or family members, i.e., individuals whose personal lives have been or will be significantly affected by transplantation; and the remaining members are representatives of OPOs, transplant hospitals, other transplant organizations, and the general public. 

OPTN's member organizations are the fifty-eight OPOs in the country, all transplant centers and hospitals participating in Medicare and Medicaid, and other individuals and organizations at work in the field.  For the purposes of procurement and allocation (as well as education and other objectives), these member organizations are organized by regions (see the chart on the preceding page).     The preceding review of the organ-specific algorithms illustrated the role that this regional organization plays in organ allocation:  although almost every generality about organ allocation must be qualified, in general, candidates in a given region come after local candidates but before candidates beyond that region in the waiting line for organ transplantation.

Although incomplete, this review of highlights in the legislative and regulatory history of organ transplantation illuminates a noteworthy movement in allocation-related ethics and policy-a movement from broad, somewhat vague mandates to increasingly specific directives.  Whereas NOTA stipulated that allocation be based on "established medical criteria," the final rule, now incorporated in the Code of Federal Regulations, charges OPTN with the task of developing "policies for the equitable allocation of cadaveric organs . that reduce inequities resulting from socioeconomic status" and that are not enforceable unless approved by the Secretary of DHHS.   The rule goes on to mandate that organ allocation "be equitable"; "based on sound medical judgment"; "seek to achieve the best use of the organs"; "be specific for each organ type"; "be designed to avoid wasting of organs, to avoid futile transplants, to promote patient access to transplantation, and to promote the efficient management of organ placement"; and, "not be based on the candidate's place of residence or place of listing," except to the extent that geographical considerations serve the purpose of avoiding waste and managing organs efficiently.   Thus, the final rule represents an attempt to define, with more precision, the respective meanings of utility and equity in organ allocation, although, as we shall soon see, this effort has been plagued by frustration, persistent ambiguity, and controversy. 

Another ongoing source of controversy is the relationship between where organs come from and to whom they belong. The guiding principle of the UAGA is that individuals, both living and once dead, have the right to donate their organs; although they are not private property per se, organs are subject to the dispositional authority of the donor, or of the surviving family in the event of the donor's death. This right to donate implies the right to donate to someone in particular, and in the case of living organ donation, the donor typically chooses the recipient. This recipient is the most eligible recipient precisely because he is chosen, not because he is the most needy or most worthy by any objective, universal criteria. In this sense, organ allocation, from individual to individual, is to some degree a private act.

With a deceased donor, whose status as a donor usually comes unexpectedly and without an intended recipient, the available organs become, in a sense, a public resource, to be allocated (one presumes) to the most worthy recipients in the fairest possible way-hence the questions:  which public rightly controls the allocation of available organs, which community has first claim on this scarce public resource, and by what authority are competing claims adjudicated? As we have seen, this public resource is treated as a national trust, with DHHS acting in some sense as a trustee. But this national trust governs a system of overlapping localities and regions, each with unique claims to the organs that become available in their designated area. Alongside the moral meaning of equity and utility, the meaning of geography-and, more deeply, the meaning of our overlapping communities-persists as a matter of moral controversy with significant policy implications.

We now turn to consider these moral matters more fully, beginning with the meaning of utility and equity as moral ideals.

C.        Utility and Equity as Moral Ideals:     In theory and practice, the ethics of organ allocation is rich in ambiguities surrounding the meaning of such key concepts as "benefit," "efficiency," and "equitable."  At this juncture, one could pause to catalog and sort through the range of meanings attached to these words in medical contexts, but we will adopt a more focused strategy.  We will explicate how these concepts have been implicitly defined in UNOS policy and, along the way, indicate how some concepts remain resistant to precise definition and rife with inherent conflicts. The laws and regulations governing allocation make explicit reference, as we have seen, to the "best" use of organs, to "avoiding the waste" of organs, and to allocating organs "based on sound medical judgment." In other words, they mandate efficiency in allocation.  Efficient allocation is crucial to the aim of maximizing the benefits of these scarce resources: that is, to deriving the most good for the most people from organ transplantation, knowing that the allocation of benefits is limited because the demand for organs far outstrips the supply. This moral aim-"best use"-is the aim of utility. 

Yet even with utility alone as our moral guide, it is not clear how much relative weight to give each kind of benefit when we allocate organs, assuming our goal is to maximize the sum total of benefits of the whole system.  For example: Should we privilege those individuals whose lives hang in the balance if they do not receive an organ now, or those who stand to get the most long-term use from a given organ, even if they do not need it urgently to stay alive? Does utility mean maximizing the number of years lived post-transplantation, or the amount of suffering ameliorated by transplantation, or the number of lives saved by transplantation? One could prioritize any of these aims in the name of utility. The principle of utility, by itself, cannot adjudicate among all the rival claims of utility.

The moral picture gets even more complicated when we recognize that utility alone is not the only moral aim or principle that ought to guide us.  The laws and regulations also require that organ allocation "be equitable." This commitment to equity means that how benefits are distributed matters-and sometimes may trump-the maximization of the benefits that are actually distributed. It suggests that it is more important, or just as important, to treat everyone fairly as individuals than to help the most people possible within society as a whole.  Yet here, too, we face complicated internal tensions about what equity itself means in the context of organ allocation:  Does equity mean treating everyone equally regardless of age, or giving the young special priority so that they might have an equal chance to grow older? Does it mean treating everyone fairly based on waiting time, or treating everyone fairly when the moment of medical urgency arrives? Does it mean treating every blood type according to the same rules, or giving greater preference to those whose blood or HLA types leave them biologically disadvantaged by the blind inequities of nature? Like utility, the principle of equity alone cannot adjudicate all the rival claims to allocation.

In the ethical justification for the current system of organ allocation, the goals of utility and equity conflict and converge:  that is, the criteria that function as relevant variables in the organ-specific algorithms set forth in UNOS policy (e.g., waiting time, medical urgency, age, etc.) all reflect, in different ways, the relative value given to the different meanings of utility and equity, both in themselves and in relation to one another. Each organ-specific algorithm reflects an effort to balance these moral and practical demands in the decision to allocate a particular organ to a particular candidate for transplant.  The inclusion of a given criterion within any organ-specific algorithm represents a judgment that the criterion has moral relevance, i.e., it serves the aims of utility or equity (or both).  The degree of significance that the same criterion has in the algorithm represents a judgment that the criterion has a specific moral weight in any allocation decision.   The controversies and conundra spawned by the current system of allocation arise, in part, from the difficulties inherent in determining the moral relevance and the moral weight of a given criterion and from conflicts within and between the ideals of utility and equity.  In addition, the current allocation system also serves, to a more limited but nonetheless ethically significant degree, the demands of autonomy:  living and deceased donors are permitted to direct their organs to designated individuals and thus to determine the beneficiaries of their altruism-as long as these acts of self-determination do not involve illegitimate forms of discrimination against individuals.

Utility and equity are both concerned with benefits-that is, with some good or goods, in this case the goods derived from the practice of organ transplantation. And like the goods of medicine more generally, the benefits of organ transplantation are varied and multiple: the preservation of life, the extension of life, the promotion of health, the relief of suffering, the cure of disease, and the improvement of the quality of life, to name the most prominent. For the utilitarian, the proponent of efficiency, the central question will be how overall benefit-in one or more of these senses of benefit-can be maximized; focusing on society as a whole, the utilitarian will be worried about the individual only to the extent that the choice of individual is critical to the project of maximization.  For the egalitarian, the proponent of equity, the question of whether a given individual has benefited, fairly or unfairly, from allocation will be paramount.  The difficulty here is deciding what counts most as a benefit-a saved life, a longer life, a better life, a healthy life-and it is a controversial difficulty for both utilitarians and egalitarians.

D.        Utility and Equity in Practice:  The difficulties of maximizing utility or seeking equity are all too evident in the practical workings of the allocation system. Measuring utility in organ allocation is controversial because, as we have noted, there are different ways to define and then calculate the benefits to be maximized.  Measurements of social utility-of the benefits that accrue to society from decisions to provide or withhold transplantation to particular individuals-have been ostensibly excluded from the ethics of organ allocation in the United States:  thus, social worth, measured as one's actual or potential contribution to such social "goods" as economic productivity or the cohesion of a particular family, has been ruled out as an ethically justified criterion for organ allocation.  Instead, the focus has been on measurements of medical utility-for example, graft survival, patient survival, relief of suffering and enhancement of the quality of life, years added to life, healthy development of the young, and the availability of alternative therapies. The overriding concern has been to avoid the waste or the inefficient use of organs.    Thus, in every organ-specific algorithm, the match between blood types of the donor organ and its potential recipients has relevance and great weight, from the perspective of utility, because a transplanted organ will function effectively in identical or compatible blood types only.  In the allocation algorithms for kidneys and pancreata, the degree of HLA mismatch (or match) has relevance because it predicts graft survival:  the lesser the degree of mismatch, the greater the assurance of graft survival.  Indeed, with kidneys and pancreata, a zero mismatch has a determinative moral weight that trumps other criteria, including geography and waiting time.     Patient survival, a crucial measure of medical utility, can be problematic:  judgments that a patient not only needs but will likely survive transplantation are left to the clinician's prudential judgment (aided by objective criteria) and thus are not explicitly incorporated in any organ-specific algorithm.  The same is true about predictions of years added to life and of enhancements in the quality of the life lived, although accumulating data on transplant outcomes are available for making such prudential judgments.

Promoting equity in organ allocation is also controversial-again, in part, because of the number and types of possible variables or criteria.  As we have noted, an allocation system anchored in utilitarianism would judge itself by the overall sum of benefits it yields to society, benefits measured in terms of the number of lives saved, extended, and enhanced throughout the system and, in such judgments, it would not concern itself too much with patterns evident in the actual distribution of these benefits.    Such patterns of distribution, however, are of central concern to the advocates of equity, who see fair treatment as the central ideal for the system of allocation.  A system of organ allocation anchored in equity will strive to give individuals with a demonstrable medical need for organ transplantation an opportunity to be as healthy as other people, regardless of the other individuating characteristics that they may possess.   Obviously, this means never discriminating on the basis of race, or giving an undue advantage to those with superior socioeconomic resources. Yet the meaning of fairness as an obligation or an aspiration is sometimes far more ambiguous. Consider, for example, the relationship between urgency and age as morally relevant criteria for allocation. In some cases, a younger patient might have the greatest potential long-term benefit from a kidney transplant, since his life expectancy is long and his health is still otherwise strong except for his worsening renal failure. And it may be that the earlier the transplant, the better chance of a positive outcome-that is, the greater likelihood of maximizing years lived post-transplantation. From the perspective of fairness, the 30-year old patient would have a more equal chance to live a flourishing life until sixty and beyond. And yet, there might be a sixty-year old patient whose case is more urgent, for whom dialysis is becoming more burdensome, and who has waited longer than his 30-year old competitor for the only kidney now available. Is it fair to give the kidney to the 30-year old when the 60-year old needs it more urgently? Yet, is it fair to give the 60-year old the kidney, when he has lived the comparatively long, healthy life that the 30-year old rightly seeks? Even if we set aside rival arguments about utility, treating individuals fairly becomes a moral and practical conundrum, with no single system obviously superior to its alternatives.

Although pediatric patients are typically given a clear priority in receiving available organs, the justification for this preference is typically the healthy development of the young, not the prospects of living as normal a lifespan as possible. Beyond age 18, there is no explicit age discrimination or age advantage: the 25-year old and the 55-year old are treated the same, so long as they are equally eligible, from a health perspective, to be organ recipients. But one might argue that relative youth should be weighed preferentially-that the younger one is, the more priority points one should receive. And one could justify this argument either in terms of utility (i.e., maximizing the total benefit of organ use, measured as years lived with a transplanted organ) or in terms equity (i.e., giving the young an equal chance to grow old).    

In adding patients to the waiting list, transplant centers and clinicians are to base their decisions on evaluations of need, in accord with objective medical criteria although the application of these criteria to a given patient is a matter of prudential judgment on the part of the transplant physician or surgeon.  Urgency of need, in particular, has moral relevance and determinative weight in the allocation of livers, hearts, intestines, and, with qualification, lungs.  Patients in need of livers have no alternative therapies; those suffering from chronic liver failure will, usually sooner rather than later, need a transplant, while those in grip of acute failure need transplantation urgently if they are to escape certain death.  Patients in urgent need of hearts can be sustained with mechanical and pharmacologic interventions, but not indefinitely, especially in the presence of complications from these available but limited therapeutic modalities.  Candidates for the transplantation of intestinal organs become urgent when their conditions impair liver function or when lack of vascular access prevents intravenous nutrition.  With lungs, the allocation scoring system is designed to yield a measure of the severity of disease:  with scores ranging from 0 to 100, the system arranges patients along a continuum demarcated by degrees of severity such that those with scores approaching 100 are in conditions so grave that their need for transplantation is significantly more urgent than those with lower scores.   The MELD/PELD scores utilized in liver allocation serve a similar purpose.  Candidates are prioritized on the basis of objective measures of severity and likelihood of death:  increasing scores are reflective of increasing degrees of both severity of disease and risk of dying.

Concerns for equity in the sense of fairness of opportunity also inform the roles played by panel reactive antibodies (PRA) and blood type in certain organ-specific allocation algorithms.  As previously noted, the kidney allocation algorithm assigns four points to "highly sensitized" candidates, i.e., potential organ recipients with high percentages or levels of PRAs.  Thus, as a criterion for allocation, this immunologic factor has significant weight in kidney (and pancreas) allocation.  The rationale is that such candidates face formidable challenges in finding a suitable negative cross-match donor and their chances for transplantation are very limited; to compensate for this disadvantage and thus to boost their chances-to equalize their opportunity for transplant-patients with high PRA levels are given this relatively large number of points.  A similar logic is at work in the weight assigned to blood type in some organ-specific algorithms:  for example, a potential recipient with blood type O can receive an organ only from donors with blood type O; such a recipient is often prioritized on waiting lists to compensate for this biologically based disadvantage-when O blood type organs become available, O blood type recipients go to the head of the line, relatively speaking, so that they can capitalize on this good, but relatively infrequent fortune. 

One final criterion serves the interests of equity alone: waiting time.  "First come, first served" is, after all, a widely accepted principle of fairness in other moral contexts.  As waiting time grows, this criterion takes on greater relative weight, especially when it comes to kidneys, even though there is no utilitarian justification for valuing such a non-medical factor. Of course, for patients who, to some degree, suffer in need every day on the waiting list, this advantage may seem like an abstract benefit, especially if one's condition deteriorates so much that the benefits of receiving an organ actually diminish.  In addition, there are critics of this aspect of UNOS policy, some of whom argue, in a clearly egalitarian vein, that the moral relevance of waiting time is tainted or diminished by problems with fairness.  From transplant physician to transplant physician, judgments can vary about when to put someone on the list in the first place or when to move a candidate forward in the name of urgency. With their decisions about how to apply these pivotal criteria, transplant clinicians can open or close the gates of access to transplantation.  To be clear, "pivotal criteria" include those for declaring a patient, one, to be needful of transplant and, two, capable not only of surviving the procedure but also of living beyond it, for some time, with some improvement in the quality of that living, especially when compared with living before transplant.

Two other controversial criteria remain: "preferred status" for organ donors and the weight of geography.   As noted already, the allocation formula for kidneys is the only organ-specific algorithm that awards a relative advantage to previous organ donors.  The relevance and weight that preferred status is given   in kidney allocation, juxtaposed with its utter lack of relevance (and thus weight) in the allocation of livers, hearts, intestines, and lungs, reflects an inconsistency in ethical reasoning that the Secretary's Advisory Committee on Organ Transplantation has targeted for redress:  it recommends that candidates for any type of organ should be recognized and relatively advantaged for having donated an organ or part of an organ already-for having already given the gift of life, altruistically and autonomously.  Defenders of preferred status argue that it is supported by the legitimate aim of recognizing individuals whose past giving of an organ should be honored as an act of altruism, as a giving of oneself, worthy of this form of especially meaningful award:  an advantage in pursuing (and waiting for) "the gift of life" that one has given but now needs.  Critics argue that preferred status serves neither utility nor equity: one's status as a former donor has nothing to do with the urgency of one's present need compared to other potential recipients, even if the act of donation contributed to one's own organ failure. And to give preferred status to organ donors is arguably unfair to those who had neither the pressing occasion nor the biological capacity to be donors, but whose moral claim on available organs is no less diminished. Why not give preferred status to those who care for individuals with organ failure, or to those who do any number of good deeds? At most, one might argue from a utilitarian perspective that the promise of preferred status may be an effective inducement to increased donation, but this claim for now is unsubstantiated.  Thus, preferred status occupies an ill-founded niche within an allocation system purportedly mapped, as a whole, along the two ethical axes of utility and equity. It merits the closer scrutiny that we will give it in Parts III and IV.

Geography is last among the criteria for ethical analysis.  As a potent co-determinant of allocation in every algorithm, this one criterion has been the cause of controversies that have waxed and waned in intensity but remain largely unresolved.  Most people accept that geography is a legitimate consideration in a limited, somewhat utilitarian sense:  Organs have varying degrees of viability; some types can be maintained over longer distances, and thus over longer times, than other types.  Most reasonable people would agree that in the interests of viability and thus of avoiding waste, the practice of allocating a particular type of organ within geographically defined (and utilitarian-inspired) limits can be ethically defended and justified.  But what of geography as a driver of priority in an altogether different way?  What about the common use of geography to determine who gets priority for organs in ways untouched by concerns about waste and viability, ways that ultimately permit "accidents of geography," the mere locale of one's residence or registration, to outweigh medical urgency or other moral claims?  Consider, for example, the allocation of intestines:  in the waiting line, local status 2 patients living or registered in close proximity to the donor source precede more urgent status 1 patients beyond the locale but within the region of the source.  A similar bent of the allocation algorithm is characteristic of hearts, lungs, kidneys and pancreata:  geography prevails when less urgent candidates are advantaged by their proximity to the organ source over patients whose need is more urgent-and whose location is more distant from that source.  For egalitarian defenders and critics of the UNOS system, the possibility of such a subversion of equity is cause for concern; for the more stringent among these critics, the daily occurrence of such a subversion is cause for indictment-after all, geographical preference is a fundamental feature of the system's design and not just an "accident" in the otherwise logical working of an allocation algorithm.

Before turning to evaluations and critiques of the UNOS allocation system and criteria, let us summarize our steps thus far.   We considered the complicated meanings of the ideals of utility and equity that govern the organ allocation system, and then considered how these moral ideals operate and conflict in the allocation of particular organs and organ types. The chart in the appendix presents the results of this analysis by means of a comparison of the criteria in each organ-specific algorithm.  Clearly, utility and equity are predominant in a system that, nonetheless, permits decisions about allocation to be influenced by other considerations that have little or nothing to do with utility and equity.  Eventually, we will have to grapple with the possibility that the influence of these other considerations is, as some critics argue, pervasively corrosive of the system's ethical underpinnings-and not just marginally so.

  III.      The Ethics of Allocation:  Criticisms and Controversies

A review of the scholarly literature on the ethics of allocation suggests that, on the whole, the UNOS system is serving the federally mandated goals of equity and utility-although there are vocal dissenters from this view, especially among advocates for the repeal of the prohibition on valuable considerations and the institution of organ markets in one form or the other.    The operative phrase in this general statement is "on the whole":  for there are also vocal critics who argue that, despite recent progress, the system is inadequate. They argue that it is vulnerable to manipulation in ways that cripple the achievement of both utility and equity, and that, "on the whole," it remains unjust due to the persistence of geographical bias and inequity.    There are, as well, ongoing debates about such ethical questions as:  Should organs be allocated to patients who are "responsible" for the conditions-alcohol-related cirrhosis of the liver or smoking-related disease of the lungs-that generate their need for transplant?  Should organs be allocated to the incarcerated?  What role should age play in allocation decisions?  What about the persistence of racial disparities in organ transplantation?  All of these lingering questions, along with the myriad ethical dilemmas discussed above, merit careful attention and deliberation. At this juncture, however, we will focus primarily on three areas of concern:  (A) the moral relevance and weight of geography; (B) the moral quandaries presented by directed donation and preferred status for organ donors; and (C) the degree to which the discretion granted to transplant organizations and transplant clinicians renders the system vulnerable to manipulation, frustrating the achievement of equity and utility in allocation.

A.        The moral relevance and weight of geography:  On June 18, 1998, then-Secretary of DHHS, Donna E. Shalala appeared before a joint meeting of the U.S. Senate's Labor and Human Resources Committee and the U.S. House of Representatives' Committee on Commerce to testify on her department's proposed "final rule" for organ transplantation.  Shalala's message was unambiguous and clear:  the ethical aims embodied in the National Organ Transplantation Act of 1984, and clarified and reaffirmed in subsequent amendments to the Act, have not yet been realized:  "organ transplant policies are not yet fair to all Americans" because "where you live and where you list can determine whether you live or die."  "Non-medical criteria, such as geography, should not drive policy anymore than a person's wealth, celebrity or religion, ethnicity or race should be a factor," Shalala argued.  "The unfairness exists," she went on to say, "not only between different parts of the country, but even within States.  For example, the median waiting times for the two major liver transplant centers in the state of Kentucky are vastly different.  One recent report found that the median waiting times for livers at one of the centers was 38 days while it was 226 days at another.  In Louisiana, the median waiting time at one center was 18 days, while it was 262 days at a different center.  In Michigan, one center had a waiting time of 161 days while another major center in the state had a waiting time of 401 days.  And so it goes across the country, inequity within States, and unfairness from one State to another."  Data cited by others tended to substantiate the Secretary's argument:  for example, in the years from 1990 to 1992, patients on the waiting list in the region encompassing Alaska, Idaho, Montana, Oregon, and Washington waited a median of 31 days for a liver, whereas those in New York state (i.e., UNOS region 9) waited a median of 207 days: as a grim result of this widespread disparity, patients in some regions were two times as likely to die before liver transplantation as in other regions.  In the New York City metropolitan area, the median wait for a liver transplant for patients with blood type O was 511 days in New York City versus 56 days in adjacent cities in New Jersey.  Shalala sharpened her attack on the moral relevance of geography by citing evidence of the linkage between geographic-based inequity and racial disparity in transplantation:  minorities populate the long waiting lists at transplant centers in large urban areas and thus, in particular, African Americans tend to wait twice as long as white Americans for kidney transplants.

Defenders of the then-current system of allocation advanced several counterarguments to Shalala's critique.  Some argued that geographically-based preferences 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.  Other arguments were aimed at the allegedly likely effects of the reforms advocated by Shalala.  For example, according to one such argument, by mandating the distribution of organs over a wider geographic area, smaller OPOs and small transplant centers and programs would be disadvantaged, while large urban-based centers would profit handsomely from resulting increases in organs procured, patients transplanted-and revenues accrued.  (It was common knowledge that the large transplant center at the University of Pittsburgh had been a forceful proponent of the proposed final rule.)  Yet another argument advanced the allegation