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 Criteria
The 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 Ideals30: 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-à-vis the source of donation: to one degree or the other,
the donor and recipient can be said to inhabit the same moral space,
the space of community. 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.
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.
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 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.
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.
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,
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accessed on May 23, 2006.
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