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Module 12: Transplant Ethics

Upon completion of this module, the resident should be able to:

  1. Describe the historical evolution of organ transplantation.
  2. Describe the current dynamics of organ demand and supply.
  3. Describe the current legal and regulatory framework in the United States for organ procurement, transplantation, and allocation.
  4. Identify and describe the moral or ethical ideals governing organ allocation.
  5. Identify the governing principles in the present ethical framework for organ procurement, allocation and transplantation.
  6. Describe the allocation algorithm for kidneys.

Module: 12 / Transplant Ethics

Contents

  1. Framing the Challenges: Clinical Scenarios
  2. Historial, Legal, and Ethical Background
  3. Transplant Ethics: Current Controversies
  4. Case
  5. Questions for Discussion, Analysis and Reflection

Framing the Challenges: Clinical Scenarios

John Collins is a 27-year old male, beginning evaluation as a potential living donor for his 40-year old brother, Phil, whose physicians have determined that he needs a kidney transplant. John’s behavior suggests that he is more than ambivalent about the prospect of donating a kidney; indeed, toward the end of the evaluation, John confesses that he does not want to donate his kidney to his brother, but feels pressured to do so.

Alejandro Cortez is a 23-year old Hispanic male who has had a car accident and suffered head trauma—and, as a result, serious neurological impairments. He does not meet the neurological criteria (whole brain) for the determination of death. His prognosis is poor and his family has been advised of this judgment and now wishes to proceed with the withdrawal of life-sustaining treatment, that is, the respirator he has been on since admission to the intensive care unit. Alejandro’s youth and other factors make him an ideal organ donor, at least potentially.

Cheryl Toms is a 65-year old Caucasian female. She has been on dialysis for the last 6 years and has recently asked to be placed on the waiting list for kidneys. The wait for kidneys in her locality tends to be quite long so Cheryl decides to seek multiple registrations in different locales to improve her chances of getting a kidney soon.

Carol Aims is a 17-year old African-American female who has been killed in a car accident. Her family has agreed to organ donation and her kidneys are about to be transplanted into Esther Smith, a 77 year old African-American female.

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Historial, Legal, and Ethical Background

Introduction: Organ transplantation is, without a doubt, one of medicine’s modern miracles—albeit a miracle that, by its very nature, engenders ethical questions and, not infrequently, ethical dilemmas. The reasons for this state of affairs are multiple. First, the necessary resources cannot be manufactured de novo and, instead, are derived from deceased as well as living human donors: these facts alone impose important ethical (as well as logistical) constraints on the procurement of organs. Second, because the resources are organic in nature, they must be handled with systematic care and in ways that avoid wasting and inefficient use. Third, there are, arguably, inherent limits on the supply of these scarce, precious resources—limits that yield substantive challenges in their allocation and distribution. In the United States as well as throughout the world, these challenges are acute, due in large measure to the growing demand and limited supply of organs. These conditions create significant pressures, on transplant physicians and surgeons, organ procurement organizations, national networks and systems for organ procurement and allocation, and, of course, patients and their families—pressures that have led to proposals for major changes in the ethical framework that now governs organ procurement and allocation in the United States.

This module on transplantation ethics will introduce residents in urology to: (1) the history of organ transplantation in the United States; (2) the legal and regulatory framework for organ procurement and allocation; (3) the dynamics of supply and demand; (4) the current ethical framework for organ procurement and allocation in the United States; (5) the allocation of kidneys; and (6) current controversies in transplantation ethics.

Organ Transplantation—Historical Overview: Prior to the mid-20th century, the dream of transplanting organs and tissues animated the experimental and clinical efforts of medical pioneers throughout the world. The earliest records date back to 400 BC, to the accounts of the Indian author, Sushruta, who described the use of cheek skin grafts to reconstruct noses and ear lobes. In the 17th century, the first recorded, successful xenotransplant was performed in Russia, using the bones of a dog to repair the skull of a soldier. Experimental transplants in animals were launched in the mid-18th century leading up to the first successful experimental kidney transplant in a dog in 1902. Four years later, the French surgeon, Mathieu Jaboulay grafted a pig kidney onto the arm of his patient, who lived for one hour after this xenotransplant. In 1920, a French surgeon transplanted the testicles of a monkey into a male human being, inaugurating a technique that had expanded to 500 men by the early 1930s.

In 1951, an unsuccessful kidney transplant was performed in the United States; two years later, a living related donor provided the kidney for a transplant in Paris, France. What is often regarded as the “breakthrough” event in the history of human organ transplantation occurred in 1954, when Joseph Murray, Hartwell Harrison, David Hume and John Merril performed the first successful living donor kidney transplant—between identical twins—at Peter Bent Brigham Hospital in Boston. In 1980, Murray was awarded the Nobel Prize for Physiology and Medicine in recognition of his discoveries in organ transplantation. In the following year, 1955, the first heart valve transplant was performed, followed the next year by the first bone marrow transplant using a related donor. Human leukocyte antigens were discovered in 1958.

The 1960s brought a number of advances, including the introduction of imuran for immunosuppression (in 1962), the first successful kidney transplant using a deceased donor (also in 1962), the first (unsuccessful) liver transplant and the first lung transplant (in 1963), the first heart transplant using a chimpanzee as the donor (in 1964), the first pancreas transplant (in 1966), the first successful liver transplant (in 1967), and the first successful heart transplant (in 1968). The decade ended with one of the more profound discoveries in the field, that is, the discovery of the fungus from which cyclosporine is derived; by 1977, the immunosuppressive properties of cyclosporine were clearly elucidated, initiating a series of pharmacologic advances that would culminate in 1980, in the synthesis of this compound. In 1983, the U.S. Food and Drug Administration (FDA) approved cyclosporine for use, with profound benefits for the practice of transplantation and for transplant recipients.

Several other key advances occurred in the 1980s, including the first successful liver-bowel transplant (in 1988), the first fetal cell transplants (also in 1988), the first successful living related donor liver transplant (in 1989), the first combination heart/liver/kidney transplant (also in 1989), and the first living related donor lung transplant in 1990. More recently, in 2000, the first reported womb transplant was performed. The last few years have seen transplant techniques extended to jawbones, tongues, ankles, male genitalia, and the face.

The legal and regulatory framework for organ procurement and allocation in the United States: The processes of organ procurement, allocation, and transplantation occur within a complex legal and regulatory framework of which there are four main dimensions: (1) state laws; (2) federal laws; (3) federal regulations; and (4) the policies of the United Network for Organ Sharing (UNOS). State laws address the organ donation process and, in the main, define criteria for declaring death and donor consent requirements. In 1968, the National Conference of Commissioners on Uniform State Laws (NCCUSL) disseminated the Uniform Anatomical Gift Act. Among other provisions, the model 1968 Act stipulates that any eighteen years old, of sound mind and body, may donate his or her body after death and that the donated body may be used for medical research or as a source of transplantable tissues and organs. The Act also defines the priority list of those who might donate the body, in the event that the deceased did not, prior to death, declare a preference for or against donation. By 1972, all fifty states and the District of Columbia had adopted the 1968 Act. In 1987, with the express aim of enhancing the potential for organ donation, the NCCUSL revised the 1968 model Act by removing the required witnesses to a decision to donate, removing the required co-consent of a spouse or family member for deceased individuals who have documented their own consent to donate organs prior to death, and instituting “routine inquiry,” that is, the requirement that hospital personnel ask patients, upon admission, if they would consider being organ donors. In addition, the 1987 model Act states that hospital or medical personnel are required to ask a deceased individual’s relatives or surrogates if they would consent to donation of the deceased’s organs, in the event that that individual has not declared a preference regarding organ donation prior to death. The Act also sanctions the removal of organs from a deceased donor in the absence of consent from that donor or from the donor’s relatives or surrogates, provided a “reasonable effort” has been made to obtain such consent. Finally, the 1987 model Act reiterates the provision in the 1984 National Organ Transplantation Act prohibiting the buying and selling of human organs. Twenty-four states have adopted the 1987 model Act thus far.

Every state now recognizes the driver’s license as sufficient documentation of the intention to donate organs. Every state identifies two sources of consent: the potential donor and the potential donor’s family. Every state permits individuals eighteen years of age and older to donate without parental permission. And most states sanction the same ways of determining death: either by cardiac or neurological criteria (in accord with the definitions articulated in NCCUSL’s Uniform Determination of Death Act of 1980). Thus, state laws focus on the donation process, especially the consent requirements for donation and the criteria for determining death.

Federal laws also govern the process of organ procurement, in addition to allocation and transplantation, primarily through the establishment of the Organ Procurement and Transplantation Network (OPTN) (which is operated by UNOS) and through the enunciation of guidelines for organ procurement organizations (OPOs). OPTN is the nationwide organization that coordinates and monitors the system of organ transplantation in the United States. OPOs are local or regional organizations responsible for retrieving organs and notifying potential recipients; there are 58 OPOs in the country. In addition, the federal law, through the 1984 Organ Transplantation Act, establishes certain boundaries within which the process of organ procurement and allocation is to occur: that is, it prohibits “valuable consideration” in the transfer of organs—organ sales or organ vending.

Federal laws governing organ transplantation are found, in the main, in Title 42 of the U.S. Code dealing with “The Public Health and Welfare.” Section 273 of Title 42 sets out guidelines for OPOs. To be eligible for federal funding, an OPO must be a nonprofit entity, have an agreement with the Secretary of the U.S. Department of Health and Human Services for reimbursement of the costs of procuring kidneys, have methods to receive payment for non-renal organs provided to transplant centers, have a defined service area that assures effective procurement and equitable allocation, and have met federal regulation performance standards. The OPO should also have agreements with most of the hospitals in its area to identify potential donors, arrange for the acquisition and the preservation of organs, have a system to allocate the organs in an equitable manner, and participate in the OPTN. Section 274 of Title 42 establishes the OPTN. The OPTN serves as primary national organization governing the procurement, allocation, and transplantation of organs in the United States. OPTN is a private nonprofit organization with a board of directors. It establishes and maintains the national waiting list of people needing organs and the national system for matching donated organs and transplant candidates on the list. Since the enactment of this law, the United Network for Organ Sharing (UNOS) has had the contract for the operation of OPTN. In addition a subsection of Section 274 establishes the scientific registry, a national database on organ transplantation, including national transplant statistics, transplant center-specific reports, and transplant research resources.

Another, key subsection of Section 274 contains the prohibition on the buying and selling of human organs. The subsection states that “It shall be unlawful for any person to knowingly acquire, receive, or otherwise transfer any human organ for valuable consideration for use in human transplantation if the transfer affects interstate commerce” and it spells out the penalties for violation of the law: “Any person who violates … this section shall be fined not more than $50,000 or imprisoned not more than five years, or both.” The subsection goes onto to clarify the meaning of “valuable consideration”: “The term ‘valuable consideration’ does not include the reasonable payments associated with the removal, transportation, implantation, processing, preservation, quality control, and storage of a human organ or the expenses of travel, housing, and lost wages incurred by the donor of a human organ in connection with the donation of the organ.”

Federal regulations bring specificity to the relevant federal laws by stipulating how OPTN, OPOs, and transplant hospitals are to function and coordinate their activities. These regulations are found in Title 42 of the Code of Federal Regulation. Part 121 of Title 42 describes the regulations of the OPTN—that is, the regulations that comprise what is usually called the “Final Rule,” implemented on October 21, 1999. It describes the policies that the OPTN Board of Directors is responsible for developing, implementing and monitoring: policies for the just distribution of cadaveric organs, policies for the testing of donors to avoid the spread of infectious diseases, policies that diminish allocation inequities caused by socioeconomic status, and policies regarding the training of transplant surgeons and physicians. The rules that OPTN members must abide by are also specified here: member hospitals may list transplant candidates for designated programs only, must assure that candidates for transplant are, indeed, listed, and must pay a registration fee to OPTN for every person listed. Another section spells out the criteria for determining the suitability of donated organs: the retrieving organization must guarantee that all necessary laboratory and clinical examinations of potential donors and their organs are conducted to ensure safe transfer and receipt of the organs; transplant programs must establish and communicate their criteria for accepting and rejecting offered organs; tests to avoid the transmission of HIV must also be performed.

Key provisions describe the mandate to UNOS’ Board of Directors to develop allocation policies to guarantee that they are both efficient and just, and allocation performance goals to ensure the best possible use and most equitable allocation of organs. The policies must be based on sound medical judgment. They must preserve the transplant program’s right to decline an organ. They must be organ specific. And they must avoid wasting organs. A few performance goals aimed at ensuring equitable allocation include: the standardization of the criteria for determining the suitability of candidates, the setting of priority rankings expressed through objective and measurable medical criteria, and the allocation of organs over as large a geographic area as possible.

UNOS rules and policies further define the functions of OPTN and describe the conditions of membership in OPTN for OPOs and transplant hospitals/centers. As previously noted, UNOS is the organization that administers the OPTN through a contract with the U.S. Department of Health and Human Services. Although UNOS and the OPTN are legally distinct, they are, in practice, the same. They have the same Board of Directors and the same policies. UNOS has four principal functions: (1) it facilitates the transplantation process by ensuring that organs are procured and allocated as quickly and as fairly as possible; (2) UNOS collects, maintains, and disseminates information on organ transplantation, acquiring and analyzing data on every transplantation that is performed in the United States; (3) UNOS develops policies for the OPTN, which must be approved by the Board of Directors and, in some cases, submitted to the Secretary of the U.S. Department of Health and Human Services; and (4) the UNOS Evaluation and Quality Department monitors OPTN members to ensure their compliance with UNOS/OPTN policies. Some UNOS policies become official regulations, while others are promulgated on a “voluntary” basis. Three types of organizations are eligible for membership in UNOS/OPTN: OPOs, transplant hospitals, and histocompatibility centers; each type of member type has its own laws, regulations, and rules. The members also belong to a specific region, which is based on the members’ geographic location. There are now eleven regions in the United States.

The current dynamics of demand and supply: As of early March 2007, there are nearly 95,000 transplant candidates on the national waiting list for organs maintained by OPTN:

  • 70,238 are candidates for kidney transplant
  • 16,959 are candidates for liver transplant
  • 1,742 are candidates for pancreas transplant
  • 2,380 are candidates for combined kidney/pancreas transplant
  • 2,818 are candidates for lung transplant
  • 133 are candidates for combined heart/lung transplant
  • 234 are candidates for intestine transplant

With respect to the gender and ethnicity of the 70,238 kidney transplant candidates:

  • 40,815 are male
  • 29,463 are female
  • 27, 647 are white
  • 24,371 are African-American
  • 12,238 are Hispanic
  • 4,574 are Asian
  • 761 are American Indian/Alaska Natives
  • 461 are Pacific Islanders
  • 466 are multiracial
  • 4 are of unknown ethnicity

As for the ages of the kidney transplant candidates: the largest number—29,292—are 50 to 64 years of age, followed by 21,070 candidates in the age range of 35 to 49 years of age. Candidates 65 years of age and older number 11,056, while those who are 18 to 34 years of age number 8.097. Pediatric candidates, ranging in age from less than 1 year old up to 17 years of age, total 741. Another key attribute of this group of candidates is blood type: more than half—36,858—are type O; 19,882 are type A; 11,495 are type B; and 2,003 are type AB. The final attribute (as well as a controversial one) is waiting time. Of the more than 70,000 kidney transplant candidates, 7,674 have waited 5 years or more; 10,840 have waited 3 to 5 years; 11,380 have waited 2 to 3 years; 16,485 have been on the list for 1 to 2 years. The remainder have waited less than one year; 2,770 were added to the list in the last month.

With respect to donors, in 2006 there were 13,582 donors: 7,386 were deceased donors and 6,196 were living donors. Using 1988 as the beginning benchmark, the number of deceased donors peaked in 2005 at 7,539, rising steadily, year to year, from the initial total of 4,077 in 1988. In that same year, there were only 1,824 living donors, but from 2001 to 2003, the number of living donors exceeded the number of deceased donors. With particular reference to donors of kidneys: in 2006, 6,612 were deceased donors and 5,915 were living donors. These statistics alone, in the light of waiting list statistics, illustrate the growing gap between the demand and supply of human organs—especially of kidneys. (Please note: current statistics on the waiting list, transplants performed, living and deceased donors, and other aspects of organ transplantation are available and updated daily on the OPTN website, http://optn.transplant.hrsa.gov.)

The current ethical framework for organ procurement and allocation in the United States: The state and federal laws and regulations described in the preceding sections articulate and establish not only a legal and regulatory framework for organ procurement, allocation, and transplantation: they also put into place an ethical framework for these processes. Several governing principles are integral to this ethical framework:

  • Organ transplantation is a human good that serves the cause of human health and prevents premature death; for these reasons, the processes of procurement, allocation and transplantation should be facilitated by sound public policies.
  • Becoming an organ donor is a personal decision, dependent upon voluntary consent—a consent that cannot be presumed.
  • Families of the newly deceased should have their needs and wishes respected, especially during the final moments of a loved one’s life and in the first moments of grieving and mourning.
  • Physicians, surgeons, and health care institutions are a duty to take every reasonable measure to ensure that organ donation is safe, free from coercion, and with respect to deceased donors, begins if and only when the donor is declared dead in the ways specified by the relevant state laws.
  • Transplant candidates on the waiting list for human organs should be treated with fairness and respect; organs allocated to these candidates should be distributed according to criteria that balance the demands of equity (justice) and utility (efficiency)—criteria that apply to everyone on the list.
  • Organ donors are—and should remain—donors, providing organs as gifts of the body to those whose bodies are failing. The dignity of the human being is a dignity that “resides” in every dimension of the human being, including the body and its constituent organs. In deference to this dignity, organs should never be sold or purchased, as one would sell or purchase a commodity.

The allocation of kidneys: UNOS has developed formulae or algorithms for the allocation of kidneys, hearts, lungs, pancreata, livers, and intestines. 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 (human leukocyte antigens) and recipient HLA
  • The degree to which a recipient is “sensitized,” i.e., his or her PRA percentage or level
  • The size and condition of the donor organ
  • The age of the donor
  • Whether the donor’s need for organ transplant is classified as “medically urgent”
  • The length of time the potential recipient has spent on the waiting list
  • The distance between the potential recipient’s location and the donor organ’s geographical origin
  • Whether the recipient has been an organ donor, i.e., of a kidney or segment of liver or lung

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

The complexity of allocation is a function, in part, of the differing ways in which each factor is weighted from set to set of organ-specific criteria. Several examples are illustrative. Medical urgency plays a relatively minor role in kidney allocation, but it is decisive in liver, heart, and intestine allocation. The logistics of organ viability (which include distance and thus travel time from the point of organ procurement to the location of a potential recipient) are basic to all allocation decisions, regardless of organ type, as are blood type, body size, and tissue type. In combination with other factors, geography in another sense can be decisive as well. With the exception of thoracic organs, most organs are first allocated locally, then regionally, and finally nationally. With hearts and lungs, geographical priority is assigned to potential recipients depending on their registration site within one of four zones radiating in concentric circles from the source of procurement: a potential heart recipient within 500 miles of the donor organ will enjoy an advantage over an otherwise similar potential recipient who is 1,000 miles away from the donor organ. In kidney allocation, however, geographically-based priority can be trumped by a potential recipient with a zero-mismatch for HLA, even if that patient resides thousands of miles from the donor organ; in liver allocation, medical urgency can supersede geography in the process of prioritizing potential recipients. In several sets of organ-specific criteria, time on the waiting list functions as a tie-breaker between potential recipients with an otherwise equal priority based, for example, on tissue matching, immune status, geography, and medical urgency.

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

For deceased donor kidneys, there are two sets of allocation criteria: one for so-called “standard” donors and another for “expanded criteria” donors. Expanded criteria donors are either 60 years of age or older or between the ages of 50 and 59 with two of the following three conditions: a history of high blood pressure; a creatinine level greater than 1.5; or, cerebrovascular accident (e.g., a stroke or aneurysm) as the cause of death. Kidneys from “expanded criteria” donors may not function as well or as long as kidneys from standard donors but they may, nonetheless, be a viable option for patients who cannot tolerate extended periods of dialysis or whose risk of serious complications or death increases the longer they wait for transplant.

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

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

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

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

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

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

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

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

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

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).

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Transplant Ethics: Current Controversies

The separate but interrelated processes of procuring, allocating, and transplanting human organs are rife with ethical questions and dilemmas. Within the scope of this on-line curriculum, all of these questions and dilemmas cannot be adequately or justly addressed. The focus of the following is on controversies in: (1) consent to donate; (2) criteria for the determination of death; (3) rewards and incentives for organ donation or provision; (4) allocation.

Consent: As previously noted, most of the 50 states have first-person consent laws, stipulating that the individual adult has the sole authority to choose whether or not to donate his or her organs; legally, neither the family nor the state can overturn an individual’s decision to donate or not donate. There is, however, a significant difference between the law and practice: in the case of a living individual who wishes to donate a “non-essential” organ, the legality of first person consent is typically upheld, so long as the consenting individual is deemed to understand the risks and benefits of donation and is determined to be medically eligible to donate. In the case of donation after death, however, the situation is somewhat more complicated from the perspective of consent. When a declared donor dies, most procurement teams still consult the surviving family members and do not procure the decedent’s organs if the family objects. In those cases in which the deceased person is not a declared donor, surrogates must decide on his or her behalf—whether by seeking to discern what they believe the deceased person would have wanted, or by doing what they believe themselves to be right. The most complicated cases involve situations in which it is unclear who speaks for the deceased, or when there seem to be no family members or surrogates at all to speak for the deceased. In the latter case, some states will not procure organs without explicit family consent; other states have the option to proceed with procurement after making a reasonable effort to get consent. Some observers argue that the prevailing practice should be enshrined and validated in the law in the form of family consent laws.

The increasingly “acute” shortage of organs has prompted some to advocate significant revisions in the policies and practices by which consent for organ donation is obtained in the United States. One such proposed revision is termed mandatory choice: mandatory choice policies or laws would dictate that citizens explicitly make choices regarding their preferences for or against organ donation. Combined with “opt-in” provisions, such a law would classify individuals who do not or fail to make these choices as potential organ donors. It is clear that the enactment of such a law in the United States would remove the option not to choose for individuals. Another proposed reform is presumed consent: as the name implies, such a revision would put into law the explicit assumption that every citizen agrees to donate organs unless that individual or that individual’s family explicitly withholds consent. As the previous review of state law suggested, there is already within the American system of procurement a limited form of presumed consent, insofar as the 1987 Uniform Anatomical Gift Act permits medical personnel to remove organs from deceased individuals if they are unable to locate a family member or surrogate to provide consent. The most radical proposed revision is to move to a policy of organ conscription: such a policy would mandate that all available, suitable organs be removed from a deceased individual, regardless of the wishes or the individual or the individual’s family or surrogates.

Criteria for the Determination of Death: Nearly every state (with the exception of New Jersey), sanctions two standards for declaring someone dead: a neurological standard (death of the whole brain, including the whole brain stem) and a cardiopulmonary standard (permanent cessation of heart and lung functions). Although these standards have been “on the books” for some time now, they have, all along, generated some degree of controversy, which has escalated of late as the pressures to find “new” sources of donor organs has increased. Some critics argue that death be declared by cardiopulmonary criteria along, due to alleged uncertainties surrounding those who are “brain dead.” Other critics argue that individuals who have lost higher brain (cortically based) functions should be declared dead because they have lost those functions that make us distinctly human; thus, a revision of this sort would permit patients in persistent vegetative states to be declared dead and thus eligible for organ donation. Still other reformers propose that, in light of the biological and moral ambiguities surrounding this issue, individuals should be able to establish, by means of a living will, the criteria or standards of death that they wish to have applied to them.

Rewards or Incentives for Organ Donation or Provision: Here, too, the increasing demand and limited supply of organs shape the ideas and proposals of those who believe some degree of change in the current legal, regulatory and ethical framework is needed to address a pressing problem. A whole range of policy options centers on the creation of new incentives or rewards for organ donation. While disincentives are the costs that originate with the act of donation, incentives are the rewards offered to those who donate. These potential incentives vary significantly in type, and include: (1) public honors or medals for organ donors and/or their families; (2) gifts to charity in the name of the donor; (3) preferred status as a potential donor recipient; (4) health insurance coverage for living donors or insurance premium reductions for those who agree to donate their organs after death; (5) life and disability insurance for living donors; (6) payment of a deceased donor’s funeral expenses.

A seventh incentive is cash payment for organs, with either fixed prices set and paid by the government or a true organ market with prices set by the laws of supply and demand. In light of the current legal, regulatory, and ethical framework, this is the most controversial proposal. The proposal to provide monetary incentives to individuals (that is, to living individuals or to the families of deceased individuals) assumes many forms. Such a system of payment could involve living donors who agree to sell their organs in the present, deceased donors whose appointed surrogates are paid at the time of organ procurement, or potential donors who sell the future rights to their organs if and when they become available at death. Some believe cash payment should only be permitted for deceased donors, where the possibility for harm is more limited. Others believe that cash payment would have the greatest impact, by far, in increasing the supply of organs from living donors turned vendors, by giving them a monetary reason to supply their organs that would not exist otherwise. One specific proposal is for the federal government or state governments to pay organ vendors directly. This could involve either paying a fixed price for each individual organ (most relevant to living donors, who might sell a kidney, part of a liver, or part of a lung) or paying a fixed price for the right to procure all available organs (relevant only to deceased donors). Defenders of “fixed price, public payer” compensation proposals seek to distinguish them from true organ markets: they argue that the compensation would be public, not private, and thus would represent the appreciation of the entire community rather than a private contract between parties. Moreover, a public compensation system for increasing organ procurement could be kept separate from the system of organ allocation so as not to endanger the equity of organ allocation, whereas the right to sell one's organs in the open market would likely give special advantages to wealthy prospective buyer-recipients. Of course, the government could also set prices for organs without being the payer; or it could create hybrid arrangements, such as giving private insurance companies rebates and tax incentives for buying organs on behalf of their clients.

A different proposal would permit and promote the buying and selling of organs in the open market, with prices and practices set by supply and demand, just as with other valuable commodities. Most likely, such a system would give rise to organ brokers who act as middle-men, matching prospective buyers with potential sellers, and matching both suppliers and recipients with a medical facility that can perform the procurement and transplantation. It would likely include both “spot markets,” where living individuals or relatives of the deceased could sell their organs now; and “futures markets,” where living individuals could sell the rights to their organs if and when they die in a manner that makes organ recovery possible. The highest prices would likely be paid for living organs from healthy donors, who provide not a potential future commodity but an actual present commodity. The future rights to one’s organs would likely command a far lower market price because most people do not die in such a way that organ retrieval is actually possible. There already exists a black market for living organ donors, suggesting that the most likely organ sellers would be the very poor at home and especially abroad, who see their organs as a valuable economic asset, and who judge that selling them is a way to improve their quality of life.

A truly free market in organs would affect not only organ procurement but organ allocation: the wealthiest individuals would have readiest access not only to the most organs but to the best organs. Most likely, a two-tier system would evolve, with the wealthy securing their organs from living donors in the private market and the less affluent joining the public waiting list for organs from the deceased that are donated rather than sold. Some seek to develop a system that would permit organ selling in the free market while preserving a system of organ allocation that is dictated by moral and medical criteria rather than market criteria. But others believe that such a division between procurement and allocation is problematic, since it would prohibit the creation of a motivated buyer pool (i.e., those who need organs for themselves or their loved ones) and thus would prevent supply and demand from setting prices.

The argument for financial incentives is rooted primarily in the desire to increase the organ supply and thus ameliorate the current suffering and potential death of those on organ waiting lists. Advocates argue that organs should be treated like any other commodity, where the free market effectively brings supply and demand into balance, and that we already permit the buying and selling of blood, sperm, and human oocytes. They see concerns about the “commodification of the body” as vague and unconvincing, especially when they stand in the way of the concrete good of saving lives by potentially expanding the organ supply, and especially when there are wealthy people desperate to buy organs and poor people desperate to sell them, an exchange that mutually benefits both parties.

A second, related argument for permitting organ selling is the desire to expand the scope of human freedom. Advocates argue that free choice should dictate the provision of organs; that those individuals who believe selling a “redundant organ” could improve the quality of their life should be permitted to do so; and that it is condescending to protect the poor (or anyone else) against the rational choices they might make for themselves, including the decision to sell part of their body. They note, quite correctly, that everyone else involved in the organ transplantation business—the doctors, the health insurance companies, those working for organ procurement organizations, and so on—profits in some way from the practice of organ transplantation, except for those who supply the most valuable asset: the organs themselves. They further argue that permitting individuals to sell their organs would not prevent anyone from giving their organs; vending and gifting could co-exist, allowing everyone to act on the values they hold dear.

The most common objection to payment for organs is that such monetary incentives would exploit the poor, who would bring harm to themselves motivated only by money. Of course, to defenders of organ markets, the freedom to sell their organs extends opportunity to the poor, who stand to benefit the most from this new freedom and expanded ownership over their own bodies. They would not be coerced to sell their organs; they would merely be given the option to do what many poor people want to do anyway (and in some cases are doing already); and they would be lifted up from the dangerous underground market, where the health of the donor is a low priority, to a regulated system of compensation, in which all exchanges are legal and provide adequate safeguards for donor health. Yet critics of organ selling believe that in a wealthy society like our own, we do not really benefit the poor by encouraging them to believe that the only way or best way to make ends meet is to sell their body parts—that is, to sell “assets” that require no work, no skills, and no possibility for long-term self-improvement. They argue that, in fact, we consign the poor to hopelessness if the only hope we extend them is the one-time sale of a kidney. And while it is true that everyone else in the business of organ transplantation is paid for their services, they are paid because of their professional skills, not for selling their bodies.

When it comes to deceased donors, critics of cash payment fear that adding money into the mix would only disrupt the already difficult period of mourning. It could lead to new tensions among surviving family members who disagree about the propriety of taking money for organs; it could tempt surrogates to alter the course of care in order to get paid; it could (in the case of “futures markets”) give a third party a commercial claim on the body that trumps the interests of the surviving family, whose wishes and needs as mourners might violate the business arrangement entered into years ago by the deceased.

Yet perhaps the strongest objection to organ selling is that some people believe it would invite us to see the body as a mere thing, like any other commodity or natural resource. The market works efficiently by making things generic and therefore interchangeable; the price system is effective because it can put a price on anything, with little regard for what the thing is. In many cases, this reduction of things to comparable quantities is desirable, since it allows different commodities to be traded, and thus allows a multitude of different producers and consumers to obtain what they need and dispose of the valuable things they wish to sell. But in some cases, as with the human body, the market’s blindness to what a thing is arguably debases those who trade in it. The very efficiency that would come from depersonalizing the source of organs—by treating them as mere resources, not as parts of this embodied person—makes the whole enterprise, in the eyes of some, morally compromised. Even if a market in dead bodies were to increase the organ supply—which many opponents of organ sales readily admit—they believe that the cost of putting so explicit, so impersonal a price on the body is too high for society as a whole.

These worries about commodification are especially significant, some people believe, when we consider buying organs from living (and probably mostly poor) donors. Living donors necessarily expose themselves to some harm, an exposure that makes greatest moral sense when done to benefit a family member or friend as an act of love. It makes less moral sense, they argue, as an act of commerce. True, the motive to sell one’s organs might still be love: namely, the desire to benefit one’s family with the proceeds of one’s sale. And the poor, merely by being poor, are no doubt already exposed to a variety of risks comparable to, or greater than the risks associated with giving up a kidney. But even if this is so, some argue, it does not justify the act of organ removal by physicians, whose willingness to put a healthy donor at risk is rooted in the direct connection between the donor’s sacrifice and the donor’s desire to see a particular person benefit from the organ he has given.

Allocation: As noted, the allocation algorithms employed by UNOS in distributing human organs reflect two moral or ethical ideals, equity and utility. The exact meaning of these two terms—and how that meaning is to find practical realization in a complex formula for determining the recipient of a given organ—have been matters of continuing controversy. Equity is now largely interpreted as patient need and, with respect to livers, lungs, and hearts, the urgency of patient need—that is, how likely is patient death in the event that a candidate does not receive an organ? Here, too, the difficult dynamics of demand and supply have exerted pressures on the current system of policies for organ allocation. Several questions have come to the fore. First, is it just, fair or equitable that geography continues to play the role that it does in organ allocation? Recall that, with some key exceptions, local candidates enjoy priority over regional candidates who, in turn, have preference over national candidates. It is arguably the case that the trajectory of the evolution of federal law and regulation is such that the operative “moral community” for organ procurement and allocation is the nation; however, organ procurement and allocation originated as localized practices that were gradually brought under the governing rubric of federal law and regulation; there remain strong sentiments in favor of local preference. Although there is little if any empirical evidence for this claim, some argue that local preferences are an inducement to organ donation: when an individual knows that someone within his or her local community will receive a donated organ, he or she is more likely to donate.

Another controversy centers on the role of age in organ allocation. Age already is a factor in some organ allocation algorithms: pediatric candidates are given preference for kidneys from young donors. The question, here, however, is whether individuals of younger ages should enjoy preference over individuals who are, for example, 65 years of age or older? Some make the case for an affirmative response to this question by pointing to considerations of utility or efficiency: an organ from a young donor transplanted into an individual 70 years of age will not have the degree of efficiency or utility that it would have if transplanted into an individual who is only 35 or 40 years of age (due to graft survival). Others make the same argument but from an equity or justice point of view: they contend that older individuals have already enjoyed their “share” of scarce health care resources and in fairness, such resources should be allocated to the young to enable them to reach the age of their elders.

Finally, there is a debate underway in the United States that centers on the question of whether calculations of net benefit should be factored into the allocation of kidneys. Indeed, it is likely the UNOS will adopt such a revision in the near future. Net benefit refers to the added years and quality of life that transplant yields to individuals in need of a kidney, compared with the years and quality of life afforded by dialysis. Proponents of this revision argue that it will yield a much more efficient use of all donated kidneys in the United States and ensure that the maximum number of life years is derived from transplantation. In support of their cause, they point to the waste involved in current practice, which sometimes permits the transplantation of a kidney from a deceased 18 year old donor into a candidate 75 or 80 years of age: such a donor kidney has a comparatively long life in terms of graft survival—probably longer than the anticipated survival of the recipient. Critics of this revision object to it on two principal grounds: first, such a calculation turns on estimates of quality of life—that is, on a highly subjective measure that varies from individual to individual and thus should not provide the basis for a reputedly objective determination of how best to allocate a scarce resource. Second, they argue that the current algorithm for kidney allocation reflects a very careful, delicate balance between the demands of equity and the demands of utility: calculations of net benefit would tip that balance in favor of utility and away from equity—and likely exacerbate existing racial and ethnic disparities in organ allocation.

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Case

Doris Callahan is a 27-year old Caucasian female whose religious convictions and commitments—especially to the performance of altruistic acts—have prompted her to contact your transplant center with the aim of becoming a living kidney donor. She does not wish to donate to a family member or friend in need, but wants, instead, to be an “altruistic stranger/donor” and, thus, to donate “to the list.”

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Questions for Discussion, Analysis and Reflection

  1. What criteria should be used in evaluating Ms. Callahan as a potential living donor?
  2. Do these criteria differ, in any way, from the criteria used to evaluate living related donors who give organs to family members of friends?
  3. How has practice evolved in the evaluation and use of living altruistic donors in the United States?
  4. Are there unique ethical concerns raised by living altruistic donation?
  5. If so, what are these concerns and what policies should be in place to address them?

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Additional Resources


The website for the United Network for Organ Sharing can be found at:  http://www.unos.org; the companion website for the Organ Procurement and Transplantation Network is accessible at:  http://www.optn.org.

The website for the American Society of Transplant Surgeons can be found at:  http://www.asts.org.

An excellent portal to a wide range of links for organ procurement, allocation, and transplantation is provided by the National Library of Medicine at:  http://www.nlm.nih.gov/medlineplus/organtransplantation.html.  Another, government-sponsored site is found at:  http://www.organdonor.gov/.  A third site is sponsored by NIH and is found at:  http://health.nih.gov/result.asp/484.

The Organ Donation Breakthrough Collaborative is an initiative to increase organ donation rates within the current legal and regulatory framework.  Its website can be found at:  http://www.organdonationnow.org/.

A comprehensive explanation of HLA typing is found at:  http://tpis.upmc.edu/tpis/immuno/wwwHLAtyping.htm.



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