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  | *This staff working paper was discussed at the Council's September             2006 meeting. It was prepared by staff solely to aid discussion,             and does not represent the official views of the Council or of the             United States Government.*        A Staff Working and Discussion Paper      The Ethics of Organ Allocation          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 CriteriaThe Ethics of Organ Allocation      
**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."1�� 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."2

 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.3� 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.      

              Donor Blood Type            

              Recipient Blood Type            
              O            

              O            

              A or O            

              A            

              B or O            

              B            

              A, B, AB, or O            

              AB            

**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.4� 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.5� 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 1.56; 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.7�      

        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.8� 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.9� 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.10�      

        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.11 �� 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.12�      

        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.13� 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,14 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.15� 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.16

**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.17� 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.18� � 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 17,093.19� 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. 20

        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.21�� 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, 2006.22� 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. 23�� 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 innovation24, 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,25 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. 26�

        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.27�

        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.28�� 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.29�� 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**30**: �** � 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.31 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.32� 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.33 � 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).34 ���

        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.35� 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.36�        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. 37�� 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.38 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."39� "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.40� 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.41� 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        that the reforms would, in effect, require transplant physicians to        provide transplantation to patients whose severity of illness made them        unsuitable candidates-that, if enacted, these reforms would lead to        *disutilities*, or inefficiencies, in organ transplantation.�        Finally, the claim was made that by creating a single, national waiting        list, these reforms would result in the deaths of more patients and in        longer waiting times for everyone on the list.� Before considering the        "fallout" of this controversy, it is important to be clear on the        relevant provisions of the then-proposed-and now adopted-final rule.�        As Shalala herself emphasized, the rule did not and does not issue in a        new allocation policy *per se*; rather, it directs UNOS to revise        its current policies to reduce geographic inequities.� Nor does it        mandate the development of a single, national list.

        The controversy over the final rule and its implications for the moral        relevance and weight of geography in allocation elicited a fairly        immediate reaction on the part of state legislatures, a number of which        began to enact "hoarding laws" restricting the out-of-state transfer of        organs procured within the state.� Louisiana, South Carolina,        Wisconsin, Oklahoma, Texas, Arizona and Florida were among the first;        today, fifteen states have passed laws expressly intended to counter        the drive for a national system of allocation, free of geographical        barriers to equity.� UNOS also responded by modifying the most        contentious allocation policy, the policy for livers by adjusting the        relative weights of urgency and geography and by instituting the        MELD/PELD scoring system. Implemented in 2002, 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.�� This is where the dispute over        geography now stands-at a stalemate.

        As Part II showed, geography continues to be a significant        co-determinant of priority in every organ-specific algorithm and        "accidents of geography" still tend to generate allegedly deep        disparities across the country.� A June 11, 2006 article in *The Los        Angeles Times* tells the story of Jonathan Van Vlack, a resident of        New York, where more than 2,000 patients populated the waiting list for        livers last year.� After waiting more than a decade, and never        receiving a transplant, Van Vlack died in December 2005.� The article,        entitled "Death by Geography," also juxtaposes Van Vlack's story with        that of Frank Evanac, who was also on the New York list for four        years-until, that is, he moved to Florida where, fourteen days later,        he received a new liver.� According to an analysis by the *Times*        of Van Vlack's MELD scores and national transplant data, 1,800 of the        6,121 livers transplanted in 2005 went to patients who were healthier        than Van Vlack.42

        It is not altogether clear why the UNOS system continues to endow        geography with such moral relevance and weight.� The claim is often        made, albeit not very convincingly, that giving preference to patients        in a restricted geographical area is good for procurement within that        area.� Such a claim rests, in turn, on an appeal to the psychology of        motivation:� people will be more likely to donate if they know that        members of their own community are more likely to benefit from the gift        of their organs.� There is little in the way of empirical evidence for        the appeal or the claim.� This is not to say or conclude that geography        is unquestionably, irrevocably illegitimate as a criterion for        allocation.� It might be possible to construct a rationale as follows.�        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.43        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-�-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.�� Whether this rationale, once complete, can        withstand intense scrutiny is a question to which we will return in        Part IV.

*B.������� The moral quandaries presented by directed donation and        preferred status:�* Previous note has been made of the provisions of        the Uniform Anatomical Gift Act that permit the directed donation of        organs:� before as well as after death, one's organs may be designated        for transplant to a particular individual, as long as this act of        donation entails no discrimination "against a person or class of        persons on the basis of race, national origin, religion, gender or        similar characteristics" and no "valuable consideration." � Directed        donations to family members have been ethically justified on the twin        bases of the respect owed to a donor's capacity for self-determination        and of the value and intuitive intelligibility of such giving in the        context of close familial or emotional bonds.� By contrast, organ        donations directed beyond these "spheres" of intimacy-that is, to        unrelated strangers or classes of individuals have been subject to        moral suspicion and critique, especially when donations to unrelated        strangers have followed public solicitation campaigns.

        Consider the following examples.� In the late summer of 2004, a Texas        man suffering from liver cancer mounted a media campaign in a desperate        effort to secure his only remaining chance for survival, a new liver.�        Using billboards strategically placed on the busiest highways in        Houston and a web site, 32-year old Todd Krampitz eventually succeeded        in securing an organ, directed specifically and only to him by the        family of a deceased donor.� Krampitz died eight months after the        transplantation.� Capitalizing on the potential of the world-wide web        for such public solicitations of organs, MatchingDonors.com is an        internet-based "venue where patients and potential donors can meet and        communicate, and hopefully expedite a donor agreeing to give a patient        a much needed organ."44�        Potential organ recipients pay a fee for registering, although a large        percentage of the listed patients have had the fee waived, according to        MatchingDonors.com officials.� Since its launch in February 2004, the        web site has facilitated the pairing of 30 living donors and        recipients; 12 transplantations, all involving kidneys, have        occurred.��� Media accounts have publicized numerous other directed        donations, from individuals of a particular faith to candidates of the        same faith, as well as from individuals who wish to ensure that a        member of some group or class of individuals does *or does not*        receive their organs:� in 1994, for example, the family of a deceased        member of the Ku Klux Klan wanted to ensure that his organs would be        allocated to whites only.45

        Defenders of directed donations to strangers in need usually appeal to        the ethics of autonomy *and* the ethics of utility.� Decisions        about who is to benefit from the gift of my organs, whether I am living        or dead, should be respected as autonomous exercises in        self-determination.� After all, such respect serves to encourage me and        others to donate-and thus has a measurable, advantageous impact on the        supply of organs.� To the extent that directed donation in these        circumstances yields actual transplantations, the direct benefits to        the transplanted candidates have a ripple effect of indirect benefits        for others on the waiting list:� the removal of one candidate from the        list moves everyone behind the candidate up a place on the list-or so        goes the argument from the perspective of utility.46 In some cases, those living donors who        give their organs in response to a particular solicitation may not have        donated otherwise, meaning that an additional organ becomes available        that would not have been available otherwise. Thus, no one is hurt, and        everyone who moves up on the waiting list benefits. In addition,        concerns about public solicitation are shaped by a misunderstanding of        the complex motivations "behind" acts of organ giving:� it is within        our human capacity to be moved by narratives of need and pending        tragedy to act altruistically in response to that need.� This capacity        should be nurtured rather than cut off from actualization by a proposed        prohibition on public solicitation.47�

        Critics of directed donations marshal various arguments in rejecting        these practices outright or restricting them within clearly delineated        limits, but most take their stand on the common ground of equity:�        directed donation skews the ethics of allocation by displacing patient        need as the fundamental consideration.� Even if directed donations        generate benefits for the system overall, to the extent that these        practices enable individuals to "cut in line,"48 to use the advantages of socioeconomic status        to reap the additional advantage of publicity, they should be condemned        as inherently unfair.�� With the aim of limiting directed donation,        some argue that it is permissible within the moral sphere constituted        by our closest relationships, i.e., with family members and friends;        beyond that sphere, it is not morally permissible.49� � Others would impose limits on        directed donation by employing the "natural" boundary between life and        death:� directed donation is morally permissible for living donors, who        are due a measure of respect for the profoundly personal choices        involved in giving the gift of life; upon death, however, a deceased        donor's organs become public resources that should be allocated on the        basis of utility and equity alone.50 �� As for the contention that public solicitation enables        strangers to become morally engaged with the plight of patients in dire        need, others have argued that the ensuing relationship between        altruistic donor and needy patient should not count as a morally        significant relationship and does not provide grounds for partiality.51

        The issue of directed donation intersects with the issue of "preferred        status" in one particular "movement": the notion of giving one's organs        to other registered organ donors only or, at least, preferentially.        Already, as we have seen, the idea of preferred status has found        limited realization in the kidney allocation formula, which awards four        points to a transplant candidate who has already been a living organ        donor.� The DHHS Secretary's Advisory Committee on Organ        Transplantation has recommended that organ donors receive such enhanced        priority in every organ-specific algorithm.52� The LifeSharers movement would expand this        principle of preferred status even further, by giving priority not only        to former donors but to those who agree prospectively to donate their        organs at death.� Founded in 2002 by David Undis, LifeSharers is a        non-profit organization with a membership open to anyone-anyone, that        is, who is willing, one, to donate his or her organs upon death and,        two, to promise to direct these donated organs to other members of        LifeSharers.� As of June 30, 2006, 5,610 individuals have joined        LifeSharers, which does not, as a matter of policy, discriminate on the        basis of race, color, religion, sex, sexual orientation, national        origin, age, physical handicap, health status, marital status or        economic status.� "LifeSharers welcomes everyone, and turns no one        away."53� The founding        proposition for LifeSharers appears to enjoy some measure of public        support:� in a national telephone survey, 53 percent of 1,014 adult        respondents agreed that those who agree to donate their organs        posthumously should be granted priority in receiving deceased donor        organs over those unwilling to donate.54

        Against his detractors, Undis has vigorously defended LifeSharers by        citing the potential contributions of such a venture to the nationwide        problem of scarcity.� This claim, however, awaits empirical        justification.� Of more interest is his appeal to a concept of justice        as reciprocity:� "someone who would throw away his organs rather than        save his neighbor's life has no moral claim to a life-saving organ from        his neighbor."55� In        other words, those who are willing to give organs should, as a matter        of reciprocity and fairness, be given priority in the event that they        need these scarce resources; to allocate organs to those who are not        willing, who are content to be organ "takers" and not organ "givers,"        is unfair.�� Even if motivated by enlightened self-interest, if        individuals, in increasing numbers, find the logic of reciprocity        compelling, the system-and everyone within it-will benefit from the        resulting, enhanced sense of solidarity.� What each may need, each        should be willing to give.� �

        There is another feature of preferred status that its admirers and its        detractors alike recognize:� it would have equal appeal to rich and        poor alike.� As the ethics committee of UNOS put the matter:� "Because        the life-giving organ represents a benefit that transcends money, its        value is the same to a very poor disadvantaged person as to a wealthy        one, unlike a monetary consideration."56�� The committee goes on to underscore the        benefits of preferred status for the poor:� "It would be hoped that the        disadvantaged, now particularly likely to view organ donation and        transplantation with suspicion, might realize a sense of democracy in        their rightful access to the same option (that of preferred status) as        any other citizen.� This could be particularly important in the case of        kidneys for Blacks, who have a particular need at present, in view of        their higher incidence of kidney failure, since it would encourage        donation by this segment of the population that is particularly likely        to also need the availability of a transplant."57

        LifeSharers' detractors remain skeptical on multiple grounds.� For one,        there is no guarantee that organs eventually donated by members will be        suitable for transplant:� some members may not have been suitable        donors while living or, due to the cause of their death or to problems        with the procurement process, the organs may be rendered unsuitable.58� � For another, preferred        status in this form may actually inhibit, rather than stimulate, organ        donation:� to those drawn by the appeal to altruism, preferred status        undermines the nature of organs as "gifts of life" and may, as a        result, inhibit rather than induce donation.59� Yet the most common arguments against        preferred status *in this form* turn on concerns about equity and        altruism.� With allocation in the LifeSharers' scheme, preferred status        has a determinative weight insofar as it alone can outweigh other        considerations, save basic need.� It is precisely this possibility that        critics of preferred status in this form condemn:� Robert Veatch, for        example, flatly asserts that "there is no justification for allowing        willingness to donate to trump all other considerations in an        allocation scheme."60�        Keep in mind how each criterion within the organ-specific algorithms        utilized by UNOS has a *relative* rather than absolute weight,        such that particular allocation decisions reflect an attempt to achieve        some balance among differently weighted criteria.� Preferred status in        the form advocated by LifeSharers would thwart such praiseworthy        attempts at finding a prudent balance among competing claims.�        Moreover, in the eyes of some critics, preferred status in this form is        a "Trojan horse" that serves to smuggle the morally dubious criterion        of "social worth" into an allocation system that has been kept free of        this and other ways of illegitimately measuring the value of        transplants in particular individuals-i.e., the value to them as well        as to others, including society at large.�� "[I]t would be disingenuous        to argue," writes the UNOS ethics committee, "that there is not an        imprimatur of worth connected to the concept of preferred status.� If        one factor, preferred status, were to be instituted, might that start        the system down a slippery slope of increasing calculations of worth        that have so far been avoided?"61� If pride of place is to be given to one particular        criterion over others, it should be patient need-and patient need        alone.� At a minimum, equity demands this much.

        An alternative form of preferred status would grant *relative*        weight, not determinative weight, in allocation decisions.� Individuals        who agree to donate their organs upon death would be awarded "bonus        points" in the applicable allocation formula; thus preferred status        would be factored into the decision process, *along with* urgency        of need, blood type compatibility, etc.� As such, it could make a        difference, but not necessarily the decisive difference, in whether a        given candidate becomes a transplant recipient.� Advocates of this        system cite the anticipated increases in donated organs and the        communal virtues of reciprocal altruism.� But even among its advocates,        there remains a disturbed wariness about any modification in the ethics        of allocation that has the potential to skew decisions in ways unmarked        by equity and utility.62�        Accordingly, the ethics committee of UNOS has recommended further        public deliberation on the ethics of preferred status before proceeding        with any change in policy.

**C.������� Transplant center and clinician discretion and the        potential for manipulation:**� In the summer of 2003, the federal        government and the state of Illinois filed suit against the transplant        centers at three highly respected institutions in the Chicago area:�        the University of Illinois, the University of Chicago, and Northwestern        University.� The allegation was damning:� at each of these centers, the        health status of transplant candidates had been falsified, not to        improve their chances for transplantation (by declaring them urgently        in need when actually they were not) but rather to improve the centers'        statistics, revenue, and profits.63� This is but one of many similar accounts of alleged        misdeeds by the individuals and organizations that stand between        patients and the possibility of transplant-and with transplant, the        possibility of enhanced life and perhaps survival itself.� It is not an        exaggeration to say that in the face of these accounts, there is        widespread concern about the possibility for abuse clothed as        discretion.� We have already seen how this concern is woven throughout        the performance indicators that the final rule establishes as        yardsticks for measuring the system's fulfillment of the ethical        desiderata of utility and equity:� the rule mandates the development        and use of objective criteria for adding patients to the list (or        conversely, withholding them from the list), for deciding whether a        given patient should undergo transplant with a given organ, and for        predicting the likely success of transplant in enabling a patient to        survive and live.� There is fear, too, that this concern feeds the        distrust of the system that many potential donors experience, along        with many long-waiting patients.� As long as individuals and        institutions have the discretionary space to operate at some remove        from strict objectivity, the system will be vulnerable to manipulation.

        It is eminently reasonable to condemn deception of any sort, especially        under the cover of clinical discretion and prudential judgment.�        Deception impairs the trust on which fiduciary relationships depend,        including relationships between patients, on the one hand, and        transplant clinicians and centers on the other.� It is at odds with the        natural bent of the virtuous toward truth. And it is at odds with the        respect owed not only to individuals but also to communities and the        public at large.� In organ transplantation, deception can be        systemically pernicious:� the deception in misrepresenting the health        of patients "warps a system designed to strike a balance between those        in critical need and other factors, such as time spent waiting for an        organ."64 �� It is        reasonable, as well, to ensure that the benefits of scientific        research-increasingly objective knowledge and thus criteria for        judgment that are more objective as well -are available at the level of        microallocation decisions.� In this key respect, the thrust of the        final rule's performance indicators is praiseworthy and well targeted.

        Difficulties, however, persist.� Prudential judgments depend, yes, on        objective knowledge and on objective criteria, but how is objective        knowledge-how are objective criteria-brought to bear on decisions about        *this* patient?�� Are such criteria to be rigidly, mechanically        "applied" to this patient such that the particulars of his case are        given no special weight?� Or do these criteria function in another        way:� could it be that they serve to illuminate the experienced        particulars of the patients, to enable the clinician to make practical        judgments informed by the objective but exquisitely responsive to this        patient and to those aspects of patient need that cannot be        comprehended by available objective measures?� In this concept of        prudential judgment, the somewhat spectral presence of the Hippocratic        ethic is nonetheless discernible:� by vocation, the transplant        clinician (even more so than the institution) is committed to the best        interests of the individual patient, first and foremost, and decisions        about what to do about and for this patient are decisions within the        sphere of a particular kind of justice, i.e., commutative justice.�        Commutative justice is about rendering unto this patient what is his or        her due, in this case, what he or she needs; it is distinguished from        distributive justice, which is about how benefits are distributed in a        group or groups of patients.�

        Of course, blatant abuse by clinicians to get their patients on the        waiting list early or moved forward in the line should be criticized or        condemned. But can we blame a doctor who interprets the evidence in a        way that is most advantageous to the individual patient he has pledged        to serve, so long as his interpretation is a justifiable one? Is this        not what commutative justice requires? Yet from the perspective of        distributive justice, every decision or judgment about an individual is        a decision or judgment with implications for the group.� Although it is        often argued that medical decision making in the patient-physician        relationship should occur in relative freedom from the demands of        distributive justice, organ transplantation is, according to many        commentators, different:� amid persistent conditions of scarcity and        rising need, every decision about this candidate unavoidably affects        this and then that and then another candidate, in a domino-like series        of effects.� In the relationship between a given transplant candidate        and a given transplant physician, decisions must serve commutative and        distributive justice, especially in the context of a crisis.� This        raises a difficult and fundamental question: Does the gap between organ        supply and organ demand constitute a *crisis*, justifying the        intrusion of distributive justice into the once-protected sphere of the        patient-physician relationship?�� And if so, how should the demands of        distributive justice change the way a given doctor serves a given        patient?

**IV.������ Suggestions for Focusing Council Inquiry and Discussion:� The Ethics of Organ Allocation**
        What should a national forum in public bioethics do or say about the        ethics of organ allocation?� To be more precise:� what, if anything,        should *this* Council do or say about this particular domain of a        medical innovation that has achieved stunning success, albeit success        marred by the mounting toll of patients in need?� How should the weight        of this suffering and death on organ waiting lists be measured?� And        how is the weight of suffering and death from the failure of vital,        i.e., life-giving transplantable organs, to be balanced against the        weight of suffering and death due to other causes, to other        afflictions, be they biologic (e.g., infection) or natural (e.g.,        hurricanes)?� These are not questions that lend themselves to quick        resolution.� Here, too, we encounter the now familiar pattern of        questions begetting more (and often more vexing) questions.

        More specifically, we might ask: What should a *federal* advisory        commission do or say about the ethics of organ allocation?� For the        word *federal* is a clue to the sorts of issues that are ripe for        deliberation by a diverse group of individuals, appointed on the basis        of their capacity to contribute to public dialogue in bioethics and of        their ability to give voice to a *plurality* of perspectives:�        science, clinical medicine, political theory, law, philosophy, and the        humanities. This plurality of perspectives is essential to the        Council's accomplishment of its mission, which is to inquire into        bioethical questions whose significance transcends the boundaries of        time and space-questions of long lineage in the annals of human thought        intertwined with emergent questions about the meaning of "advances" in        biomedical science and technology for the experience of being human.��        In the event that its inquiries encounter bioethical questions that        bear on the political organization of the United States, a federation        of states bound together by a national government, it seems reasonable        to suggest that the Council, as a *federal* body, should take up        these questions for focused deliberation, although always with the aim        of elucidating what is at stake, ethically, in the effort to address        these questions richly and wisely.�� And it should do so by grappling        with a challenge central to federalism:� how is the power of government        to be apportioned among, on the one hand, the governments of the 50        states and the District of Columbia, and on the other hand, the        national-that is, the federal-government?� For a presidential council        on bioethics, the ethical significance and implications of this        political question and of any proposed answer to this question are        arguably paramount.�� In organ allocation, is equity an ethical ideal        that is only achievable in a system that permits the imperative of        urgency to triumph, ultimately, over claims of community-that is,        "community" in the sense of local communities, states, and regions?�        And what is at stake in these claims of community?� Americans are a        people of multiple identities in the geographic sense, and display        strong tendencies to experience identity as bound up with the multiple        communities in which they have been raised and live:� the community of        one's family and friends; the community of one's block or village or        one's town or city; the community of one's state; and yes, the        community of people who, regardless of locality or state, call        themselves Americans.� It is likely, then, that these claims of        community will yield conflicts, depending on how broadly, in the        geographical sense, one draws the spatial boundaries in which equity-or        for that matter, utility or autonomy-will be sought.� A national forum        on public bioethics is uniquely situated, by nature and mission, to        explore the relevance and weight of these claims and the relative force        and particular meaning that equity, utility, and autonomy should have        in procuring, allocating, and transplanting organs.

        The question of organ allocation, rightly understood, raises many of        the profound questions about human dignity and human equality that the        Council has puzzled over in the past-questions about the meaning and        experience of being human; about equality, particularly equality of        moral status; about the ethical quandaries spawned by morbidity and        mortality, by the ontological facts that human beings get sick and        eventually die, and by the question of what can and should be done        about these facts of human embodiment.� Taking up these considerations        once again, but now in the specific context of organ allocation, is a        means toward the ever-present goal of further explicating, refining,        and clarifying the ontological, the philosophical-anthropological, the        ethical, and yes, the political significance of human dignity.�� For        example, how should considerations of human dignity shape our thinking        about the human body in the context of organ transplantation?� From the        intuitive sense that this body that I *am* is also in some sense        *mine*, rather than *yours* or *ours*, can we derive a        claim to ownership, and on that basis, a right to dispose of one's body        and one's bodily organs as one sees fit-whether by giving or even        selling one's organs?� And what role, if any, should the distinction        between life and death have in these considerations?� Alive, am I free        to give or sell my organs to whomever or whatever I wish?� After death,        do my organs still belong to me or do they belong, instead, to my        family, to my local community, to my state, or perhaps to the nation?�        Indeed, how adequate are notions that organs are *owned by* or        *belong to* individuals or communities-adequate, that is, as        insights into the experience of being human and as expressions of human        dignity?

        In any fundamental inquiry into organ transplantation, it would be        virtually impossible to avoid an encounter with these deeper human        considerations. On varying levels, most every professional society and        organization that has addressed the ethics of organ procurement,        allocation, and transplantation has appealed to some concept of        dignity, equity, and utility in defending its recommendations, as is        evident in the recent report by the Institute of Medicine as well as in        the recommendations of the Secretary of Health and Human Services'        Advisory Committee on Organ Transplantation.65� The former, however, is focused almost        entirely on the ethics of organ procurement. The latter, although broad        in scope in bringing together recommendations ranging over procurement,        allocation, and transplantation, is rather limited in its treatment of        these deeper ethical considerations, particularly those of an        ontological or philosophical-anthropological bent.� � There are, to be        sure, excellent works of academic scholarship on organ transplantation        in sociology, ethics, and the law-works that meet the demands of both        breadth and depth.� But no group operating in the sphere of public        bioethics has done so:� no national forum for public bioethics has        sought to bring the resources of a plurality of diverse perspectives to        bear on the twin questions of *how* certain concepts of being        human inform and are reflected in our practices of procurement,        allocation, and transplantation, and *which* concepts should        animate our thinking and doing as individuals and as collectives.� A        fundamental, far-reaching inquiry into the ethics of procuring,        allocating, and transplanting organs, undertaken by this Council with        transparency and rigor, could illuminate, further, the manifold meaning        of being human and meet this need in the sphere of public bioethics.

        With this larger end in mind, let us reconsider, briefly, the three        particular issues previously explored in Part III:� (A) the moral        relevance and weight accorded to geography, (B) directed donation and        preferred status, and (C) the discretionary scope of individual and        institutional prudence in deciding who needs organ transplantation and        when.� In focusing on these practices and their associated conflicts,        which are systemic rather than marginal in their scope, the Council        will be concerned with the very integrity of the system itself, and        thus, inevitably, with the more fundamental human questions that stand        behind all our practical dilemmas.

*A.������� The moral relevance and weight of geography in organ        allocation:***�** � There is a range of possible positions on the moral        relevance and weight that geography should have in organ allocation.�        At one extreme, while acknowledging that geography is appropriately        significant in more utilitarian concerns about organ viability and        organ waste, one could otherwise reject geography as morally irrelevant        in a *national* system of allocation purportedly driven by the        desire to respond with *equity* to the medical needs of patients.�        In terms of need, a patient with fulminant liver failure in New Jersey        is no different from a patient, in the same dire straits, in West        Virginia.�

        Alternatively, one could attempt to bring geography and equity together        and achieve some "balance" between the claims of community and the        medical needs of patients.� This seems to be the aim of the current        system-at least the aim that UNOS has in its policy making for the        current system, although the rationale for the moral relevance and the        moral weight that it has assigned to geography is unclear.�� 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.�

        At another extreme, one could argue that in the procurement and        allocation of organs, all ethics is local:� in deference to the bonds        of community, organs procured from donors within a local area should be        allocated to needy patients in that same local area, even if this form        of geographical priority entails blindness to patient needs beyond the        boundaries of this area-that is, even if it means giving organs to a        less needy patient *here* rather than a more needy patient        *elsewhere*.      

*B.������� Directed donation and preferred status:�***�** As explained        in Part III, "directed donation" is a rubric for several practices        defined by their shared aim of directing a specific donor organ to a        specific individual, group, or institution:� my kidney to my        genetically-related brother, or to my best friend, this hospital, this        medical school, or this group of potential recipients-or perhaps, to a        stranger.� In UNOS policy, some of these practices are condemned        outright:� directed donation involving bias toward or against a group        on the grounds of race, sex, age, and other dimensions of identity        offends the cause of equity.� Others are generally accepted, albeit        with a degree of unease by some:� such is the case with living directed        donation to a family member or close friend.� This now rather common        practice, which puts the donor at risk without any specifically medical        benefits *for the donor* herself, is justified, it seems, by the        benefits that flow from the giving of the gift.� One such benefit is        the strengthening of familial solidarity and the cultivation of a        capacity for mutual care in its members, or the strengthening of that        special bond of fidelity between long-time friends, or perhaps even        between fellow members of a particular community of mutual concern,        like a church or synagogue.���

        Other practices-some actual, some proposed-are more controversial        because they throw into sharp relief the unavoidable conflict between        and among the claims of autonomy, equity, and utility.�� With one such        practice, some degree of preference is given to candidates who have        themselves agreed to be organ donors (live donation) or to become organ        donors after death (deceased donation).�� As we have seen, a relative        degree of priority (in relation to other prioritizing criteria) is        already given to organ donor status in the allocation of kidneys.� The        form of directed donation advocated by LifeSharers expands the reach of        preference:� those who agree to become organ donors would gain some        *absolute* advantage, should they need *any* organ.�� It also        injects considerations of reciprocity-by promising to give, one has        enhanced opportunities for receiving-into our thinking about the ethics        of procurement as well as allocation.� Reciprocity of this sort could        induce more people to declare themselves organ donors, which is a        legitimate goal of the system; in the context of community, reciprocity        could also strengthen the bonds of mutuality between and among        community members.� Judgments about the effects of reciprocity as an        inducement to individual donation (and as a stimulant to the growth of        organ supply), and judgments about the benefits of reciprocity for        solidarity, could be made but only on the basis of experience.�� If in        experience, such benefits were actually realized, that fact alone would        probably suffice for an endorsement of this form of directed donation        by a utilitarian.

        For others, the reciprocity in this form of directed donation is        morally corrosive, for it transforms what is and should be a        *gift* into an *item of exchange*:� it is redolent, that is,        with the moral qualms that surround "valuable consideration."� Directed        donation, in this form, also allegedly diminishes the autonomy with        which the gift of organs should be given:� rather than being untainted        benefits that should simply be placed alongside risks and burdens, the        expectation of preferred status could be coercive in the individual's        weighing of a decision about organ donation.� It is important to note        here, however, that autonomy-arguments have also been marshaled in the        defense of directed donation in any form:� to the extent that this body        that I am is also mine, I should enjoy unfettered freedom in deciding        to whom it will be given-or perhaps even sold.� In addition, some        object to preferred status and directed donation on egalitarian        grounds:� preferred status smuggles considerations of social worth into        a system anchored in an ethics of equity.� The only defensibly        *central* criterion for allocation is patient need (within the        limits imposed by legitimate concerns about efficiency and utility).���

*C.������� Discretion and prudence in organ allocation:* In the        HHS final rule (and other elements of the allocation system), the        emphasis on objective determinants of medical need is driven by the        desire to restrict the scope of discretion within which transplant        clinicians and institutions make decisions about access and allocation.        Yet should there be limits on this desire to set limits on discretion?        Is there a place for *prudential* judgment about the needs of        particular patients that cannot be easily quantified?

        Candidates for transplantation necessarily enter into        *relationships* with individual clinicians and particular        institutions, and it is within those relationships *and only within        those relationships* that the giving and receiving of organs occur.�        Traditionally, such relationships have been distinguished from their        larger contexts (i.e., of community or of society) by their concerns        with *commutative* rather than *distributive* justice:�        individual clinicians and particular institutions are morally obligated        to give *their* patients their due, to be responsive to the needs        of *this* patient rather than to the needs of this patient *in        light of* the needs of others.� Objective criteria may be useful in        screening patients for need, deciding that this patient rather than        that patient needs a transplant now, that this patient would benefit        most from transplantation, and that the benefit outweighs the risks and        burdens for this patient.� This decision, however, turns, in decisive        ways, on the clinician's (and the institution's) *knowledge and        experience* of this patient.� In this crucial sense, organ        transplantation is no different from any other therapeutic        intervention:� considerations of commutative justice should dominate        the most immediate relationships-the physician-patient relationship and        institution-patient relationship-in which the fruits of medical advance        are provided to those who need them.�� As separable spheres of justice,        these relationships give pride of place to commutative rather than        distributive justice.

        There are those, however, who argue that organ transplantation is        different, and that this difference is due to its combination of        success and failure.�� There is a crisis in organ transplantation        generated by escalating need and persistent scarcity:� in such a        context, arguments about spheres of justice and about the scope and        limits of commutative versus distributive justice are oblivious to the        potential for tragedy that inflects every decision about access and        allocation:� at least that seems to be the case, if we follow Burdick        and agree that "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."66�� In other words, in organ allocation demands for        distributive justice cannot ultimately be excluded from the        patient-physician or patient-institution relationship:� decisions under        the aegis of commutative justice are unavoidably decisions in        distributive justice.� The logic of this conclusion seems inexorable in        a context of "crisis" and that, according to many observers, is what we        have:� a "looming organ-shortage crisis." 67�

        We would do well, in closing, to reflect on the meaning of crisis and        on the reasons for describing the current state of organ        transplantation as a crisis.� We might begin by clarifying the meaning        of the word.� In the *Oxford English Dictionary*, a crisis is        defined as "a time of intense difficulty or danger" and, within a        specifically clinical context, as "the turning point of a disease, when        it becomes clear whether the patient will recover or not."��        Intriguingly, the English word is from the Greek *krisis*, meaning        "decision," and *krinein*, meaning "to decide."68�� For many, if not most, patients on the        list, waiting is, or could easily become, a crisis in their lives as        well as those of their intimates; especially among the sickest, waiting        is intensely difficult and, yes, dangerous in light of the possibility        of dying while waiting.� And among those who care for patients before        and after transplantation, among transplant physicians, programs, and        centers, there seems to be a strong, widely shared conviction that        organ transplantation is "in crisis":� they witness, at close range,        the morbid effects of organ failure in their patients and struggle to        help them "make do" until a suitable organ comes along; they        experience, daily, the frustration of knowing the life-saving benefits        of transplant for those who get organs and the all-too-real danger of        death for those who do not.� Although it is risky to make sweeping        generalizations about the national government's view of the matter,        there is, nonetheless, ample evidence that DHHS and the U.S. Congress        have, in effect, defined the current state of organ transplantation as        a crisis.�

        We might also think of other "problems" that have been classified as        "crises"-particularly as *national* crises.� The Cuban missile        "crisis" of 1962 is a more distant example, while the aftermath of        Katrina is a more ready one-as is 9/11, whereupon the nation (not just        a city or a region) seemed to enter a chronic state of crisis from        which we have yet to emerge.� In the realm of human health and disease,        the HIV epidemic and AIDS come to mind, as do the epidemics of        influenza and other infectious diseases (polio) that have swept the        country at intervals.� (Faced with a possible pandemic of avian flu, we        could perhaps be said to be in a "pre-crisis" mode, preparing, one        would hope, for the coming time of "intense difficulty and danger.")�        In recent accounts of another national "epidemic," obesity, the steady,        year to year, increase in the number of overweight children and adults        is often described as having reached a state of "crisis."� Perhaps the        most prominent example is the American health care "system" itself:�        citing the rising number of uninsured Americans, the steadily        increasing costs, the problems of medical error and malpractice, and        the fragmentation of the "system," the Institute of Medicine issued a        report declaring that the system is in "crisis."��� It may, as well,        prove instructive to contrast these examples of crisis with problems in        health care that tend not to be identified as crises.� Consider the        problem of cancer:� although public awareness and public and private        investment have spawned the establishment of a wide array of        scientific, government, and philanthropic forces to "combat" its many        types, the incidence of cancer does not tend to be described as a        "crisis."�� The same is true of the high infant mortality rate in this        country or the incidence of multiple sclerosis and other        neurodegenerative diseases.�

        Although this analysis could go on at considerable length, it seems        obvious even now that we are unlikely to identify purely objective        criteria for sorting through all of the examples of difficulty and        danger that do or do not qualify as crises.� The definition of organ        transplantation as a crisis, however, does seem to rest, in part, on an        assumption (whether implicit or explicit) that allocating human organs        is a *unique* problem in distributive justice and health care,        with distinguishing features that set it apart from other problems in        allocation.� Certainly, in some respects, human organs are comparable        to other therapeutic interventions in that they can be life-enhancing        (like, say, knee replacements) and life-saving (like, for example,        cardiopulmonary resuscitation).� Like other surgical        procedures-coronary bypass, for example-transplantations entail        considerable expense, as does post-transplant care.� And, organ        transplantation is not unique insofar as the resource supply is        insufficient to meet the demand.� In no other instance, however, do we        obtain the much needed but scarce resource from *ourselves* - from        our bodily selves.� With comparative ease, albeit great expense, we can        manufacture more dialysis machines and we can divert monies from one        source to another to pay for the additional production to meet demand.�        No such possibility exists with human organ transplantation:� here, the        availability of the resource depends upon thousands of individual        decisions, made with varying degrees of autonomy and altruism-by        individuals before they die, often by family members once they do, and        by those who consider donation while living.� Decisions like this        unavoidably become enmeshed in our ambivalences about death and the        human body and our beliefs and convictions about the care of the living        and the dead. This is the all the more reason why a fundamental inquiry        into organ transplantation must ask about these beliefs and questions,        must examine the uniqueness of organ allocation as a problem in        distributive justice and its classification as a crisis, and must        ultimately wrestle with the question, *how are we to take the measure        of suffering and death caused by organ failure and of the undeniable        benefits of organ transplant, and weigh them against the other ways in        which human beings experience morbidity and mortality and the other        ways in which we attempt to mitigate the impact of the inevitable?*

_______________________ 
ENDNOTES
1. James F. Childress, "Putting Patients First in Organ Allocation:� An Ethical Analysis of          the U.S. Debate" in *Cambridge Quarterly of Healthcare Ethics* (2001), 10, 365-376/366.�          
2.  James Burdick, "Responses to 'A Critique of UNOS Liver Allocation Policy' by Kenneth          Einar Himma," *Cambridge Quarterly of Healthcare Ethics* (2000),          9, 275-283/275.          

3. UNOS/OPTN Policy 3.4.1          on Time Limit for Acceptance 

 4. UNOS/OPTN Policy 3.4.5          on National Distribution of Organs          

 5. As of August 8, 2006,          according to the OPTN website found at http://www.optn.org.          

 6. Creatinine levels are          measures of kidney function; the normal range is 0.8 to 1.4.          
7. UNOS/OPTN policy 3.5.2          concerning ABO "O" Kidneys into ABO "O" Recipients and ABO "B"          Kidneys into ABO "B" Recipients. 

8. UNOS/OPTN policy          3.5.3.3.1          

 UNOS/OPTN policy          3.5.11.1.1 on Time of Waiting Points          
9. UNOS/OPTN policy          3.5.11.2 on Quality of Antigen Mismatch          

 10. UNOS/OPTN policy          3.5.11.3 on Panel Reactive Antibody          
11. UNOS/OPTN policy          3.5.11.4 on Medical Urgency          

 12. UNOS/OPTN Policy          3.5.11.5 on Pediatric Kidney Transplant Candidates          
 13. UNOS/OPTN Policy          3.5.11.5.1 on Pediatric Kidney Transplant Candidates Priority for          Kidneys from Donors Aged Less than 35 Years          
 14. UNOS/OPTN Policy          3.5.11.6 on Donation Status          
15. This case raises          myriad complicated ethical issues beyond the scope of the current          paper. On the one hand, it allows an organ to become available from          Donor 1 that might not be available otherwise. Without the exchange,          only one recipient-the person at the top of the waiting list, who          would get the next available cadaevric organ-would receive a          transplant. With the exchange, two recipients-intended Recipient 1          (who gets an organ from a deceased donor) and the person at the top          of the waiting list (who gets an organ from living Donor 1)-receive          transplants. From the perspective of utility, everyone wins. Yet such          exchanges may also raise problems from the perspective of equity:          Intended Recipient 1, because he has a living donor willing to give          an organ on his behalf even if he cannot give it to him directly,          effectively moves up the list. Moreover, those at the top of the list          are potentially affected by being "moved down," especially if the          next cadaveric organ to become available is a blood type O: that is,          if a blood type O organ goes to intended Recipient 1 (who may or may          not be type O himself), then the blood type O person at the top of          the list is adversely affected. All we can do here is suggest the          complexity of such a case-indeed, the paradigmatic case when the two          systems or tracks of organ allocation converge: directed donation by          the living and non-directed donation by the deceased. 

16. As of August 8,          2006, according to the OPTN website.�          

 17. UNOS/OPTN Policy          3.8.1 on Pancreas Organ Allocation          
 18. As of August 8,          2006, according to the OPTN website.          

 19. UNOS/OPTN Policy          3.7.3 Adult Patient Status/Allocation of Thoracic Organs.          
 20. See *Answers to          Your Questions about Lung Allocation Policy*, a patient education          pamphlet published by UNOS.          
 21. According to the          UNOS/OPTN website.          

 22. UNOS/OPTN Policy          3.11.1 on Degree of Medical Urgency for Intestinal Organ Allocation          
23. For example, in          1968, the first successful pancreas transplant and the first          successful heart transplant were performed.� In 1974, the first          heterotropic piggyback heart transplant was undertaken.� The year          1981 witnessed the first heart-lung transplant followed two years          later by the first single lung transplant and five years later by the          first double lung transplant.�          
24. 42 CFR 121.3          

25. Martin A. Strosberg          and Ron W. Gimbel, "The Public Administration of Organ Allocation:�          Maintaining the Public-Private Partnership," in *Public          Administration and Management:� An Interactive Journal*, 7, 3,          2002, pp.229-249/233.          
 26. 42 CFR Sec. 121.3          
 27. 42 CFR Sec. 121.4          
 28. 42 CFR Sec. 121.8          
 29. In developing this          section of the paper, the writings of Robert Veatch and James          Childress were especially helpful as lucid guides to the complexities          of allocation ethics-particularly, Veatch's *Transplantation          Ethics* and Childress' "Putting Patients First in Organ          Allocation:� An Ethical Analysis of the U.S. Debate" in *Cambridge          Quarterly of Healthcare Ethics* (2001), 10, 365-376.          

 30. Robert M. Veatch,          *The Basics of Bioethics*, second edition, Upper Saddle River,          New Jersey:� Prentice Hall, 2003, p. 54. 
 31. Robert M. Veatch,          *Transplantation Ethics*, Washington, D.C.:� Georgetown          University Press, 2000, pp. 288-289. 
32. The concept of "fair          equality of opportunity" is central to the egalitarian theory of          distributive justice developed by Norman Daniels in his *Just          Health Care* (Cambridge:� Cambridge University Press, 1985). 

 33. One might argue that          waiting time, in fact, sometimes functions as a form of          age-prioritization, because older patients have a greater likelihood          of suffering health declines while waiting for organs that make them          ineligible to be organ recipients.          
 34. Maryam Valapour, "Changing Our Priorities in Organ Distribution," in *Bioethics          Examiner:� A University of Minnesota Publication Exploring Issues in          Bioethics*, Spring 2003, Volume 7, Issue 1, p. 2.          

 35. Advisory Committee          on Organ Transplantation, U.S. Department of Health and Human          Services, *Summary Recommendations to the Secretary*,          Recommendation 5, at http://www.organdonor.gov/acotrecsbrief.html,          accessed on May 23, 2006.          
 36. Robert Veatch and          James Childress, two prominent transplant ethicists, give voice to          this position on the efficacy and ethics of the UNOS system.� Lloyd          Cohen and Richard Epstein are (often vociferous) critics of UNOS;          both are also articulate proponents of organ markets from a          libertarian perspective. 
 37. Indeed, the issues          of voluntary risk, of racial and ethnic disparities, and of the role          of age are such that each could be the focus of extended          treatment-and eventually must be as this aspect of the Council's          inquiry moves forward. 

38. The Honorable Donna          E. Shalala, Testimony on Organ Allocation before the U.S. Senate          Committee on Labor and Human Resources and the U.S. House of          Representatives Committee on Commerce, June 18, 1998 at /www.hhs.gov/asl/testify/t980618a.html">http://www.hhs.gov/asl/testify/t980618a.html.          

39. A.C. Klassen, D.K.          Klassen, R. Brookmeyer, R.G. Frank, and K. Marconi, "Factors          influencing waiting time and successful receipt of cadaveric liver          transplant in the United States, 1990 to 1992" in *Medical Care*          1998; 36: 281-294.          

40. Martin A. Strosberg          and Ron W. Gimbel, "The Public Administration of Organ Allocation:�          Maintaining the Public-Private Partnership," in Public Administration          and Management:� An Interactive Journal, 7, 3, 2002, pp.229-249/231. 
 41.Alan Zarembo, "Death          by Geography" in *The Los Angeles Times*, June 11, 2006.          
42. Michael Walzer,          *Spheres of Justice: A Defense of Pluralism and Equality*, New          York:� Basic Books, 1983. 

43. /www.matchingdonor.com/">http://www.MatchingDonor.com.          
 44. Cited in Timothy F.          Murphy and Robert M. Veatch, "Members First:� The Ethics of Donating          Organs and Tissues to Groups," in *Cambridge Quarterly of          Healthcare Ethics* (2006), 15, 50-59/50.          
 45. Christopher          Robertson, "Who Is Really Hurt Anyway?� The Problem of Soliciting          Designated Organ Donations," in *The American Journal of          Bioethics,* July/August 2005, Volume 5, Number 4, pp. 16-17.          
 46. Ellen M. McGee, "Using Personal Narratives to Encourage Organ Donation," in *The          American Journal of Bioethics*, July/August 2005, Volume 5, Number          4, pp. 19-20.          
47. Arthur L. Caplan, "Cutting Line for Organ Transplants:� Texas Man's Efforts to Get          Liver Undermine the System," on bioethics.net at /www.bioethics.net/printer.php?aid=67">http://www.bioethics.net/printer.php?aid=67,          downloaded on June 7, 2006.          

 48. Sheldon Zink et al, "Examining the Potential Exploitation of UNOS Policies," in *The          American Journal of Bioethics*, 5(4): 6-10, 2005.          
 49. Robert D. Truog, "Are Organs Personal Property or a Societal Resource?" in *The          American Journal of Bioethics*, 5(4): 14-16, 2005.          
 50.Rachel A. Ankeny, "The Moral Status of Preferences for Directed Donation:� Who Should          Decide Who Gets Transplantable Organs?" in The Cambridge Quarterly of          Healthcare Ethics (2001), 10, 387-398/392. 
 51. Advisory Committee          on Organ Transplantation, U.S. Department of Health and Human          Services, *Summary Recommendations to the Secretary*,          Recommendation 5, at http://www.organdonor.gov/acotrecsbrief.html,          accessed on May 23, 2006.          
52. David Undis, "Escaping the System:� The Current System of Organ Allocation and the          Attempts to Survive It" at /www.lifesharers.org/amc20060315.htm">http://www.lifesharers.org/amc20060315.htm.          

53. Aaron Spital, "Should People Who Commit Themselves to Organ Donation Be Granted          Preferred Status to Receive Organ Transplants," in *Clinical          Transplantation*, 2005: 19: 269-272.          

54. David Undis, "LifeSharers:� Increasing Organ Supply Through Directed Donation," in *The American Journal of Bioethics*, July/August 2005, Volume 5,          Number 4, pp.22-24.          
 55. UNOS Ethics          Committee, "Preferred Status for Organ Donors:� A Report of the UNOS          Ethics Committee," June 30, 1993 at /www.optn.org/resources/bioethics.asp?index=5">http://www.optn.org/resources/bioethics.asp?index=5,          downloaded July 7, 2006.          
 56. Ibid.          
57. Timothy F. Murphy          and Robert M. Veatch, "Members First:� The Ethics of Donating Organs          and Tissues to Groups," in *Cambridge Quarterly of Healthcare          Ethics* (2006), 15, 50-59/54.          

58. UNOS Ethics          Committee, "Preferred Status for Organ Donors:� A Report of the UNOS          Ethics Committee," June 30, 1993 at /www.optn.org/resources/bioethics.asp?index=5">http://www.optn.org/resources/bioethics.asp?index=5,          downloaded July 7, 2006.          

59. Timothy F. Murphy          and Robert M. Veatch, "Members First:� The Ethics of Donating Organs          and Tissues to Groups," in *The Cambridge Quarterly of Healthcare          Ethics* (2006), 15, 50-59/58.          

 60. UNOS Ethics          Committee, "Preferred Status for Organ Donors:� A Report of the UNOS          Ethics Committee," June 30, 1993 at /www.optn.org/resources/bioethics.asp?index=5">http://www.optn.org/resources/bioethics.asp?index=5,          downloaded July 7, 2006.          
61. David Steinberg, "An          'Opting In' Paradigm for Kidney Transplantation," in *The American          Journal of Bioethics*, 4(4): 4-14.          

62. Timothy F. Murphy, "Gaming the Transplant System," in *The American Journal of          Bioethics* January 2004, Volume 4, Number 1:W28.          
 63. Ibid.          
 64. Institute of          Medicine Panel on Organ Donation, *Organ Donation*, Washington,          D.C.:� National Academies Press, 2006. 

 65. James Burdick, "Responses to 'A Critique of UNOS Liver Allocation Policy' by Kenneth          Einar Himma," in *The Cambridge Quarterly of Healthcare Ethics*          (2000), 9, 275-283/275.          
 66. Todd Zwillich, "USA          Confronts Looming Organ-Shortage Crisis," *The Lancet* Vol. 368,          August 12, 2006, 567-568.
*67. The Compact          Oxford English Dictionary*, available on-line at AskOxford.com,          definition found at /www.askoxford.com/concise_oed/crisis?view=uk">http://www.askoxford.com/concise_oed/crisis?view=uk,          accessed August 16, 2006.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     |