This paper was prepared solely to aid discussion
for the September
2006 meeting, and does not represent the official views of the
Council or of the United States Government.
Staff Discussion Paper
Living Donors: Process, Outcomes, and Ethical Questions
Ginger A. Gruters, M.A.*
* With special thanks for the collaboration of my colleagues, Eric
Cohen and Dan Davis, Ph.D.
Outline
I. Some General Background
II. Organ by Organ: Donation Process and Health Outcomes
- Kidney
- Liver
- Lung
- Pancreas
- Intestine
- Conclusion
III. Some Ethical Questions
- The Moral Obligation of Doctors
- Acceptable versus Unacceptable Risk
- The Moral Meaning of "Who Donates?" and "Why?"
Appendix 1: Living Kidney Donor Evaluation
Guidelines
Appendix 2: Living Liver Donor Evaluation Guidelines
Living Donors: Process, Outcomes, and Ethical Questions
The contemporary practice of organ transplantation began in 1954 with a
kidney transplant from a living donor to his identical twin brother.1 Since then, much has
changed: the field of organ transplantation has grown tremendously,
saving, improving, or extending thousands of lives. Thanks to advances
in immunosuppressive medications, it is no longer necessary to be a
close genetic relative to be a living donor; and thanks to improvements
in surgical techniques, the recovery time for living donors has
decreased for many procedures, while graft survival has improved. This
success has heightened interest in expanding the pool of living organ
donors, especially in light of the growing demand and need for
transplantation and the limited supply of deceased donors.
Certain crucial facts remain, however. Removing organs from living
donors still involves performing surgery on a healthy patient for
reasons that have nothing to do with his or her physical health, and
with genuine risk of physical harm. Thus, living donation, by its very
nature, presents us with a unique ethical dilemma in the practice of
medicine, which has long been guided by the ethical maxim: "First, do
no harm." Although there are accumulating data on the perioperative
risks of being a living donor, there remains a dearth of data on the
longer-term outcomes for living donors.
The aim of this working paper is to provide background on the process
of living organ donation, with particular attention to what we know
about the health outcomes for living donors, and especially the
significantly different risks between kidney donation and liver or lung
donation, the three most common types. Part I provides some basic
information on the state of organ donation from living donors. Part II
surveys the donation process and health outcome data organ by organ.
Part III raises some of the relevant ethical questions, which the
Council might discuss in light of the empirical information presented
here.
I. Some General Background
A living donation takes place when an individual willingly allows the
removal of an organ (or part of an organ) for the purpose of
transplanting it into another. Most living donors are family members or
friends of the intended recipient, but there is also a growing number
of so-called anonymous altruistic donors. Prior to living donation,
potential donors must undergo rigorous evaluations of their physical
and psychological health, must be informed of the risks of living
donation, and must voluntarily consent to donation. OPTN/UNOS has not
issued specific policies to govern the process of living donation, but
two consensus statements have been developed by the transplant
community to ensure greater uniformity in the selection and pre- and
post-operative care of living donors: the Ethics Statement of the
Vancouver Forum on the Live Lung, Liver, Pancreas, and Intestine Donor
and the Consensus Statement of the Amsterdam Forum on the Care of the
Live Kidney Donor.2 Both
consensus statements emphasize the process of informed consent and the
opportunity for refusal.
Although "the OPTN/UNOS Board of Directors has recommended the
development of a standardized tool to inform potential living donors
and recipients about the living donation process, a nationally
standardized informed consent process does not currently exist."3 It is thus within the
purview of the transplant center to establish its own procedures for
informing donors and recipients about the following kinds of issues:
-
The fact that communication between the donor and the transplant
center will remain confidential
-
The evaluation process
-
The surgical procedure
-
The availability of alternative treatments for the transplant
recipient
-
The potential medical or psychosocial risks to the donor
-
The national and transplant center-specific outcomes for both donors
and recipients
-
The possibility that future health problems related to the donation
may not be covered by the donor's insurance and that the donor's
ability to obtain health, disability, or life insurance may be
affected
-
The donor's right to opt out of donation at any time during the
donation process4
In addition, the HHS Advisory Committee on Organ Transplantation (ACOT)
recommends that the following ethical principles and informed consent
standards be implemented, such that all living donors are:
-
competent, that is, they possess decision-making capacity;
-
willing to donate;
-
free from coercion;
-
medically and psychosocially suitable;
-
fully informed of the risks and benefits of donating; and
-
fully informed of the risks, benefits, and alternative treatment
available to the recipient.
Two related ethical principles that ACOT endorses are:
-
The benefits to both the donor and the recipient must outweigh the
risks associated with the donation and transplantation of the live
donor organ; and
-
A clear statement that the potential donor's participation must be
completely voluntary, and may be withdrawn at any time.5
Ensuring that the decision to donate is voluntary and uncoerced is a
challenge considered in greater depth in the final section of this
paper.
By far, the most common organ to be donated by living donors is the
kidney (about 95% of all living donations), but it is also possible to
donate all or part of the liver, lung, pancreas, intestine, and
heart.6 7 At this time, there are "no absolute age
limits to organ donation," but "individuals considered for living
donation are usually between the ages of 18-60 years of age."8 9 Additionally, UNOS reports, "a handful of medical
conditions will rule out organ donation, such as HIV-positive status,
actively spreading cancer (except for primary brain tumors that have
not spread beyond the brain stem), or certain severe, current
infections. However, for most other diseases or chronic medical
conditions, organ donation remains possible."10 In the process of clinical evaluation,
potential living donors generally undergo the following tests: blood
test, tissue typing, crossmatching, antibody screen, urine tests,
X-rays, arteriogram, psychiatric and/or psychological evaluation,
gynecological examination, and a final blood test.11
In 1988, the effort to compile various types of data on living donation
was launched in the United States, and since then there have been
80,516 living donors in the U.S., with the percent of living donor
transplants compared to cadaveric donor transplants rising in the last
decade.12 In 1995, living
donation accounted for 35.1% of all transplants; in 2005, living
donation accounted for 47.6% of all transplants.
II. Organ by Organ: Donation Process and Health Outcomes
Although it is possible to generalize about certain features of living
donation per se, it is important to analyze this increasingly
significant source of human organs on an organ by organ basis, to
review briefly the history of the relevant procedures, to look more
closely at donor evaluation, and, especially, to survey what is known
about perioperative and long-term risks to donors. After reviewing the
available statistics on morbidity and mortality associated with living
donation, the transplant community's recommendations for improved
tracking and response to longer-term health outcomes of living donation
will be discussed. Most of the information and data concern living
donation of kidneys, livers, and lungs; for the other organs and parts
of organs, living donation is relatively rare and significant data do
not exist.
A. Kidney
Living Donors:
1995: 3,392
2005: 6,564
To date (from January 1, 1988-April 30, 2006): 76,29713
Nephrectomy, the surgical removal of a kidney, was apparently first
performed by the German surgeon Gustav Simon on August 2, 1869. This
proved that a human being could still live with only one functional
kidney-the first step toward the age of living donor kidney donation.
At present, "potential kidney transplant candidates constitute
approximately 70% of the individuals on the entire Organ Procurement
and Transplantation Network (OPTN)/United Network for Organ Sharing
(UNOS) waiting list," while, as said above, kidney donation constitutes
roughly 95% of all donation from living donors.14
For recipients of kidneys from living donation, the evidence is
encouraging. The survival rate for recipients of living donor kidneys
is measurably better than that of deceased donor kidneys: at one year,
research shows a 97.9% survival rate for living-donor kidneys versus a
94.6% survival rate for deceased-donor kidneys; at five years, the
living-donor kidney survival rate is 90.2% versus 81.1% for
deceased-donor kidneys.15 The National Kidney Foundation also notes certain additional advantages
with living donor kidneys:
A kidney from a living donor usually functions immediately, making it
easier to monitor. Some nonliving donor kidneys do not function
immediately and, as a result, the patient may require dialysis until
the kidney starts to function.
Potential donors can be tested ahead of time to find the donor who is
most compatible with the recipient. The transplant can take place at a
time convenient for both donor and recipient.16
Thus, with living donor kidney donation, the outcome for recipients is
generally better, and due to progress in preventing immune rejection
complications, the outcome for recipients of living unrelated donors is
equivalent to that of related donors.17 In addition, laparoscopic nephrectomy is an option today,
where "smaller incisions make for faster recovery time and less pain"
for the donor (though, as we will see, not necessarily better long-term
outcomes).18 Nonetheless, all of these advantages exist alongside a major
comparative disadvantage: "a living donor . is required to have a major
operative procedure that is associated with morbidity, mortality and
the potential for adverse long-term consequences of living with a
single kidney."19
Donor Evaluation
The OPTN/UNOS Ad Hoc Living Donor Committee has offered potential
Living Kidney Donor Evaluation Guidelines, and although they are not
current OPTN/UNOS policy, it is possible that these guidelines could
become the standard for practice in living kidney donor evaluation (see
Appendix 1).20 At this
time, however, the precise procedures and process are within the
purview of the transplant center.
The process of evaluating a potential living donor begins with
educating the donor about the donation process and reviewing the
donor's health history. The donor's blood type is determined early on,
so as to determine the potential donor's compatibility with the
recipient.21 The
importance of full disclosure is central to the whole process of
eliciting the potential donor's consent or refusal to donate, including
discussion of "the impact of donation on their social and financial
well-being, short-term morbidity and mortality directly related to the
surgery, future risk for renal insufficiency and failure, risk for de
novo medical problems with renal and overall health (i.e.,
hypertension, diabetes), and risk for allograft failure in the
recipient because of rejection, technical problems, recurrent disease,
and/or comorbid medical problems."22 The more detailed health evaluation consists of myriad
tests to assess the following: "donor hypertension, body mass index,
dyslipidemia, renal function, malignancy, and a history or current
presence of infectious diseases such as tuberculosis or hepatitis."23 In addition, the
potential donor's age, amount of proteinuria, degree of hematuria, and
the evaluation performed in those with a history of nephrolithiasis and
a strong family history of diabetes are taken into account.24 25 26 27 28 This is necessary, as factors
such as obesity, hypertension, type II diabetes, and infectious
diseases have potentially detrimental effects to the donor, in
addition to making the donor candidate's organs potentially ineligible
for transplant.
Perioperative Risk and Long-Term Risk
One study of the kidney donation process notes the following: "the risk
of donating a kidney includes both the short-term perioperative risk,
including pain and discomfort, and the long-term risk of having only
one kidney. Exactly what information potential donors are told about
the risks involved in renal donation appears to vary substantially from
center to center."29 30 Moreover, with living
kidney donation, "information on perioperative risk comes from three
sources: published data on the risk of any major surgery, published
data on the specific risk of donor nephrectomy, and the personal
experiences of the transplant team."31
In living kidney donation, the donor may opt for one of two types of
surgery: an open nephrectomy or a laparoscopic nephrectomy. The open
nephrectomy involves making an incision of several inches (6-10
inches) in the donor's abdomen area, and it requires the removal of all
(or part of) a rib, in order to allow removal of the kidney.32 33 The laparoscopic nephrectomy requires
3 to 5 small incisions (1-inch or less) to be made in the donor's
abdomen, and this procedure is characterized by its use of a
laparoscope, a telescopic device which is inserted into the incisions
in order to provide viewing capabilities for the surgeon.34 35 Surgical instruments are then inserted into
the incisions as well, and with the help of the laparoscope, the
removal of the kidney is made possible. In the end, the incisions
require cutting through three layers of muscle, and the kidney is then
removed through the largest incision (about 2.5 inches).36 Studies to date have shown
that laparoscopic procedures usually result in less pain, shorter
hospital stays, and faster recovery, yet there is also evidence of a
higher relative incidence of complications.37
For an open nephrectomy, hospital stays average 6 days; with
laparoscopic nephrectomy, hospital stays average 4.1 days. Those who
have the open procedure typically return to work in about 12 weeks,
while those who have the laparoscopic procedure typically return in 5
weeks. After open surgery, one can drive a car after 6 weeks; with
laparoscopic surgery, the wait is 2 weeks. One can exercise after 11
weeks with open surgery and after 4 weeks with laparoscopic surgery.38 Due to this greater ease
of recovery, laparoscopic nephrectomy is now the more common surgical
procedure used with living kidney donation today. 39 40 41 42 Yet the laparoscopic procedure
is also relatively new, first conducted in 1995 at Johns Hopkins
Bayview Medical Center.43 Unlike open nephrectomy, laparoscopic nephrectomy is an intraperitoneal
operation (i.e., takes place within the area that holds the abdominal
organs), meaning that the risks of reoperation for hemorrhage or bowel
obstruction are typically higher.44 Matas and colleagues conducted a survey which "found some
differences between donation techniques in the rates of reoperation,
complications, and readmissions-all higher with laparoscopic
nephrectomy."45 It should
also be noted that there are surgical variations, such as
"hand-assisted laparoscopic" and "mini-open" nephrectomy that involve
characteristics of both laparoscopic and open nephrectomy, and if at
any time complications arise in the course of laparoscopic surgery, the
procedure can be changed to an open nephrectomy. 46 47
Perioperative risks include, but are not limited to, the following:
pneumothorax, small peritoneal damage, superficial wound infection,
deep wound infection, pneumonia, urinary tract infection, renovascular
injury, bowel injury, bowel obstruction, hernia, hematoma, pulmonary
embolism, transfusion, orchalgia, transient neuromuscular injury,
fever, liver bleeding, acute renal failure, bradycardia, hemorrhage,
anaphylactic reaction, or even re-operation.48 49 50 51 52
Along with the perioperative risks, the long-term health outcomes for
living kidney donors are a topic of great concern in the transplantation
community. One of the major long-term concerns for living kidney
donors "is whether having a unilateral nephrectomy predisposes to
the development of kidney disease and/or premature death."53
According to the statistics available, mortality after living kidney
donation is .03% and morbidity is less than 10%." 54
55 56
Yet, "of concern is the recent finding that mild renal dysfunction
or proteinuria correlates with cardiovascular risk. All donors
lose 20% renal function; and. proteinuria is not uncommon after
kidney donation."57 Thus, the effects
of proteinuria and mild renal dysfunction need further investigation,
in light of the association of these phenomena with risks to the
cardiovascular health of living kidney donors. All of these findings
suggest that additional, systematic follow-up, especially concerning
long-term outcomes or effects on the health of living kidney donors,
is needed. Arthur Matas, a transplant surgeon at the University
of Minnesota and an analyst of living donation, presents six pressing
questions in need of research:
-
Does kidney donation increase the long-term risk of developing End
Stage Renal Disease (ESRD)?
-
Is the mild increase in blood pressure seen in some donors
progressive, and is it a risk for ESRD or survival?
-
Does the incidence of protoeinuria increase after donation?
-
Do donors with increased BMI or a history of smoking have increased
risk for development of proteinuria and renal dysfunction?
-
Are donors who subsequently develop type II diabetes or hypertension
at increased risk for ESRD, and does ESRD develop more rapidly?
-
Does the mild renal impairment, increase in blood pressure, and
proteinuria associated with uninephrectomy increase cardiovascular
risk? 58
While "studies to date have suggested that there is not an increased
incidence of ESRD vs. the age-matched general population" with living
kidney donors, there are insufficient data to prove that living donors
are not at an increased risk.59 As the Amsterdam Forum states:
As in the general population, based upon age and other medical risk
factors (e.g., hypertension, proteinuria, hyperlipidemia, impaired
glucose tolerance test), kidney donors should undergo long-term
follow-up of body weight, blood pressure, blood sugar, serum
creatinine, and urinalysis. Abnormalities should be treated promptly
by either the local medical physician or the transplant nephrologist.
Long-term collaborative prospective studies and comprehensive national
registries should be established to determine whether the incidence of
medical risk factors and renal dysfunction is different from the
general population.60
B. Liver
Living Donors:
1995: 54
2005: 323
To date (since January 1, 1988-April 30, 2006): 3,066
On November 27, 1989, the first successful liver transplantation with
an organ from a living donor took place at the University of Chicago
Medical Center. The donor was 29-year old Teresa Smith, the mother of a
21 month-old daughter, Alyssa, who suffered from biliary atresia, a
congenital condition that can prove fatal if not treated. Alyssa
graduated high school on May 27, 2006. She is completely recovered,
leads a "normal" teenage life, and for the past three years has been
free of taking anti-rejection medications. The mother is also reported
to be doing well, and is very thankful for the success of the
transplant that took place years ago.61
Donor evaluation
A potential living liver donor must be in excellent physical and
psychological health, and is required to undergo extensive examinations
and testing, including a radiological imaging of the liver which
assesses the anatomy, liver volume, and size.62 It has been noted that "a liver biopsy may be
performed," but this practice is not mandated.63 64 The OPTN Ad Hoc Living Donor Committee has issued Living Liver
Donor Evaluation Guidelines, but these are not currently OPTN/UNOS
Policy (see Appendix 2).65 There is no national standard of evaluation for living liver
donors at this time, leaving each transplant center to make the final
decision regarding the suitability and health of the potential live
liver donor.
Perioperative Risks and Long-term Risks
Today, live liver donation is considered one of the most dangerous
living donations in terms of risks to the donor, even though the
donor's remaining liver segments have the ability to regenerate
themselves after donation and recover total function. It is necessary
to remove the gallbladder and in general to remove 25 to 65% of the
liver.66 The Vancouver
Forum maintained that live liver donation should take place "only if
deceased donor transplantation is not possible," and "after careful
analysis of the recipient risk to benefit ratio as it relates to
severity of liver failure, quality of life, and expected wait list time
for a deceased donor."67
Recipients of living liver donation are usually genetically or
emotionally related to the donor; non-directed living liver donation is
"unusual."68
The perioperative risks associated with living liver donation include:
infection (e.g. urinary tract infection), pneumonia, blood clotting,
allergic reaction to anesthesia, injury to the bile duct or other
surrounding organs or tissues (e.g. spleen or bowel), obstruction of
the intestine, liver failure, biliary strictures, and/or possible
death. 69 Additionally,
with a living liver donor, it is necessary to remove a portion of the
saphenous vein in the donor's leg to connect the donated liver to the
recipient.70 This
procedure usually takes from 5 to 8 hours, and the resultant hospital
stay usually lasts about 7 days. Barring complications, the donor then
may return to work or normal activity (if not overly physically
strenuous) in 4 to 6 weeks.
The Vancouver Forum reports that "the estimated risk of mortality and
morbidity currently associated with live donor right hepatectomy is
0.4% and 35% respectively."71 These risks are thus dramatically higher than the risks
associated with living kidney donation-more than 13 times higher for
mortality and 3.5 times higher for morbidity. In looking at worldwide
statistics, "right lobe liver donation is associated with an increased
morbidity and more severe complications than that associated with left
lobectomy or left lateral segmentectomy."72 Specifically, "mortality approaches 0.5% for
the right lobe donor in contrast to approximately 0.1% for left lobe
donation.73
It is recommended that a live liver donor's operative follow-up consist
of at least one year.74 Yet, there is concern in the literature that restrictions in donor
health insurance may influence the feasibility of such long-term
follow-up.75 The
Vancouver Liver Group maintains that "since the risk to the donor is
considerable, programs performing live donor liver transplantation
should institute procedures and protocols that insure that donor
mortality and morbidity is minimized."76 Given the high relative risks of this surgery
(compared to kidney transplantation involving living donors), ACOT has
recommended "that a process be established that would verify the
qualifications of a center to perform living donor liver (or lung)
transplantation."77
Another recommendation, from the Vancouver Forum's Liver Group, states
that a registry of live donor complications should be established and
that donor deaths should be reported to the registry.78
C. Lung
Living Donors:
1995:45
2005:2
To date (since January 1, 1988-April 30, 2006): 461
Live donor lung transplantation began in 1990, and this particular
transplantation "generally involves three simultaneous operations: two
donor lobectomies and a recipient bilateral pneumonectomy and lobar
implantation."79 In
other words, one donor gives the right lower lobe, the second donor
gives the left lower lobe.80 This living donation procedure thus "places two donors at risk
for each recipient."81
Donor evaluation
Donor selection entails identifying donors with good health, who have
adequate pulmonary reserve for lobar donation, and are free from
coercion in making the decision to donate.82 Potential living lung donors "receive a
series of exams and tests including chest radiography, pulmonary
function testing, ventilation-perfusion scanning and computed
tomography, and a cardiac stress test" in order to determine personal
health and their further suitability and compatibility with the
recipient.83 Additionally, the potential donors' lungs must be the correct size and
volume, so that there are sufficient lung capabilities for the
recipient. For adult recipients, "the donors should be at least as tall
as the recipient."84
Perioperative Risks and Long-Term Risks
The perioperative risks with living lung donation include, but are not
limited to, the following: allergic reaction to anesthesia, pneumonia,
urinary tract infection, pleural effusions, bronchial stump fistulas,
bilobectomy hemorrhage (necessitating blood transfusion), phrenic nerve
injury, atrial flutter, bronchial stricture, persistent air leaks,
pericarditis, arrhythmia, transient hypotension, atelectasis (lung
collapse), ileus, subcutaneous emphysema, loculated pleural effusions,
Clostridium difficile colitis, and infection.85 To date, there have been no reported
deaths from living lung donation, but "the perioperative morbidity is
high, with complication rates ranging from 20-50% of donors."86 Additionally, in some
long-term (>1 year) donor follow-ups, donor complaints included
chronic incision pain, dyspnea, pericarditis, and non-productive
cough.87 In response,
the Vancouver Lung Group has recommended that "comprehensive short-term
follow-up should be mandatory and long-term follow-up be strongly
encouraged and funded by government/insurance authorities."88
D. Pancreas
Living Donors:
1995: 7
2005: 2
To date (since January 1, 1988-April 30, 2006): 70
Living pancreatic donation requires a portion of the pancreas to be
removed, and even though the pancreas is unable to regenerate, it still
maintains the ability to function at a reduced size. The first
successful living-donor (segmental) pancreas transplant took place in
the United States in 1979, by Dr. David Sutherland of the University of
Minnesota in Minneapolis. Compared to other organs, living pancreas
donors are quite rare. Pancreas transplants are almost always performed
in conjunction with a simultaneous kidney transplant, typically from
the same donor.89
Post-operative hospitalization for a live pancreas donor usually
requires 5 to 7 days; although no donor deaths have been reported after
segmental pancreatectomy, 15% of donors may need a splenectomy
performed due to complications involving insufficient blood supply or
bleeding.90 This is a
rather serious complication, and merits further investigation. As with
other higher-risk areas of donation, the Vancouver Forum recommends
"the establishment of a pancreas donor registry and database for
lifelong follow-up."91
E. Intestine
Living Donors:
1995: 1
2005:7
To date (since January 1, 1988-April 30, 2006): 33
The first live donor intestinal transplant took place in 1989, as a
treatment for patients who are suffering with "life threatening
complications of intestinal failure."92 Without a transplant, the patient faces long-term
parenteral nutrition.
Live intestinal donation, as with all other living donations in the
United States, is to be done out of voluntary, altruistic motives (no
coercion).93 A donor
must be at the age of legal consent and should be a first or second
degree relative of the recipient, or else they should have close
emotional ties. 94 It is
reported that with this operative procedure, "it is essential to
preserve at least two-thirds of the small bowel length in the donor."95 Several problems can
occur early in the post-donation period, including small bowel
obstruction, diarrhea, weight loss, and dysvitaminosis. The risk of
perioperative death is 0.03%.96 According to the Vancouver Forum, the minimum follow-up
schedule should include postoperative visits at 2 and 4 weeks, and
donor teams need to be aware of B12 deficiency, as it must
be monitored at 6 months and annually for 3 years.97 Experience with intestinal living
donation is limited, and though live donor intestinal transplants are
not considered experimental, "this procedure should be regarded as an
innovative and an evolving technology." 98 99
F. Conclusion
From this brief survey of the process of organ donation from living
donors and the health outcomes for living donors, the following
preliminary conclusions can be drawn:
(1) By far, the most common and least risky form of living donation
occurs with kidneys. It is critical, nonetheless, to remember that
there are genuine risks of both morbidity and (rarely) mortality, and
there has been an inadequate follow-up study of the long-term health
effects of kidney donation on living donors.
(2) The second most common forms of donation from living donors involve
the donation of parts of livers or lungs. These procedures involve
significantly greater health risks compared with kidney donation, and
similarly lack adequate long-term follow-up study.
(3) Other types of donation from living donors-such as pancreas or
intestine donation-are so rare that it is difficult to generalize in
any way.
(4) Among the various groups that have examined current practices in
living donation, there is broad interest in developing binding policies
and protocols to ensure the health of living donors, or at least full
recognition of all the risks. To this end, ACOT recommends "that a
database of health outcomes for all live donors be established and
funded through and under the auspices of the U.S. Department of Health
and Human Services." 100 But, as of now, no such database exists, and its practical feasibility
remains a complicated question. In addition, ACOT recommends support
for "a consortium of investigators to conduct epidemiologic research on
the outcomes and health needs of live organ donors" that would focus on
"the medical and functional outcomes of individuals who have donated a
kidney or a lobe of a lung for transplantation."101
III. Some Ethical Questions
Living organ donation raises myriad complicated ethical questions-three
of which have been selected to guide the Council's discussion in this
area: (1) the moral obligations of physicians performing surgery on
living donors; (2) the moral distinction between acceptable and
unacceptable levels of risk for living donors; and (3) the moral
meaning of who donates.
A. The Moral Obligations of Doctors
Since the Hippocratic era, one of medicine's core ethical precepts has
been primum non nocere, "First, do no harm." With the removal of
organs from healthy, living donors, this ethical maxim is, in effect,
suspended: in the interests of benefiting a patient suffering or dying
from organ failure, a surgical procedure is performed on the donor, an
intervention in the body that cannot benefit the donor himself
physically but does hold the potential for bringing physical harm. In
the usual circumstances, patients present themselves to physicians as
patients, as sufferers of some malady that demands and needs the care
that only physicians can provide. In the circumstances of living
donors, such individuals only become patients through their
encounters with the transplant surgeons.
For most living donors, the physical risks of surgery are seen as
warranted by the desire to help another, usually a family member or
friend who is suffering or dying. Thus, the transplant physician can
help the living donor achieve some benefit, the benefit to be derived
from helping a loved one enjoy a better quality of life or even survive
through transplantation. In this non-bodily sense, the doctor does good
for the donor-patient by helping him do good for another. The physician
might serve the well-being of the donor as a whole, even if this
requires the donor to place his own physical health at risk. But we are
still left to ask: Is the doctor truly acting as a doctor by
achieving this sort of benefit for the donor, by serving this
non-bodily good? Or is the physician using a medical technique (e.g.,
kidney removal) to serve a non-medical end (e.g., the moral and
spiritual goal of helping another)?
Interestingly, the Institute of Medicine reported that in "a survey of
100 liver transplant surgeons, Cotler and colleagues (2003) found that
77 percent experienced a moral dilemma in placing a living donor at
risk. Nevertheless, 72 percent also agreed that transplant centers had
a duty to offer their patients the possibility of transplantation using
living donors."102 103
B. Acceptable versus Unacceptable Risk
The ethics of living donation turns, in critical ways, on the
assessment of acceptable vs. unacceptable risk. At the extreme, some
forms of living donation are clearly impermissible-such as a father who
wished to give his son a heart. Here, the risk of death is 100 percent.
The more complicated questions come in discerning how much risk (or how
much additional risk) of morbidity or mortality is morally
acceptable-both from the perspective of the physician who performs the
surgery and from the perspective of the donor who submits to it. As we
have seen, the risks of liver and lung donation are significantly
higher than the risks of kidney donation. The question is: Are they too
high? And conversely, on what grounds might a physician turn down a
potential donor who wants to help a loved one, knowing full well what
the risks are?
This points us to another major problem: to some degree, the risks are
unknown, especially the long-term risks of being an organ donor. As the
Institute of Medicine reports, "it is difficult for transplantation
teams, independent donor advocate teams, and prospective donors
themselves to perform their analysis and assessments of risks,
benefits, and risk-benefit ratios because of incomplete data about the
health outcomes of living donation."104 According to Robert Steiner, "centers may
justifiably reject certain donors because they feel that, try as they
might, the risk of donation cannot be estimated: that they have 'no
idea' of the risks taken by these donors."105
According to one study, most transplant professionals believe that "the
risk assumed by the donor depends on the benefit of donation to the
donor, i.e., how their life will be enhanced if they donate. For
instance, if a husband or wife donates to their spouse, their own
quality of life may improve; therefore, more risk is accepted for the
common benefit, whereas in the altruistic situation, there is no donor
benefit other than the sense of helping someone in need, and even
marginally increased medical personal health risk is especially
important if the prospective living donor is a minor."106 107 108
C. The Moral Meaning of "Who Donates" and "Why"
Some of the more complex ethical questions in living donation have to
do with who donates and why. It is well known that the majority of
living donors are close relatives or close friends, but there is also
an increasing number of so-called anonymous or non-directed living
donors, who give an organ (almost always a kidney) as an act of
altruism to a stranger. With donation to a loved one, the psychological
motivation is humanly intelligible and (in general) morally
praiseworthy, though the extent to which donation is voluntary or
coerced, subtly or explicitly, is still of concern. With non-directed
donation, anonymous donation, or donation to an individual whom one
does not intimately know, the psychology is more complicated. We must
evaluate: Does the donor understand fully what he or she is doing? Is
she doing it for the right reasons? Does she expect more than just the
psychic rewards of doing good for another? Might she believe that her
act of donation puts a claim on the recipient to repay her in some way,
or might she suffer post-donation troubles when her life returns to
normal, or when her normal life never returns due to unexpected health
problems from the donation? Of course every case is different. But the
increasing rate of anonymous/non-directed donation requires greater
attention to the procedures and regulations governing this practice.
Consequently, the Advisory Committee on Organ Transplantation has
recommended "that the Secretary of HHS direct the OPTN to develop
allocation policy pertaining to non-directed, living-donor organs."109
It is interesting to note that not too long ago, non-directed donation
was a rather unaccepted practice. In 1994, concerning living kidney
donation, a survey was conducted whose results "suggested that only 15%
of the transplant centers in the US would consider a non-directed
living kidney donor (NDLD)."110 Today, however, "the willingness to consider NDLD is
growing."111 The
OPTN/SRTR Annual Report 2005 stated that "there was a general consensus
that the growing number of living non-directed donors results from two
factors: (1) increased public awareness of the organ donor shortage,
and (2) a new willingness on the part of transplant centers and OPOs to
participate in these cases."112 In fact, one study noted that "a total of 24 of 25 (96%) of
transplant centers and 23 of 25 (92%) of OPOs surveyed reported that
they had received inquiries from people interested in serving as an
NDLD."113 However, there
is justified concern about the recent growth in non-directed living
donation because "although non-directed living donation is growing,
there are no unified policy guidelines agreed on and accepted by those
organizations practicing (or planning to practice) NDLD."114
Another set of ethical questions relating to who donates involves
potential disparities concerning the age and gender of living donors.
In living donation, there has consistently been a disproportionate
number of female living organ donors compared to males.115 In 2005, women constituted
59.1% of live organ donors.116 The underlying reasons for this significant disparity remain
unexplained. A British medical journal concluded that "instead of
congratulating women on their altruism, we need to ask about possible
reasons for the gender imbalance and check it for matters of fairness
and undue pressure on a vulnerable group."117
The data also suggest that living organ donors are often younger than
organ recipients. In 2004, 45.5% of living donors were between the ages
of 35 and 49 years old, while the next highest percentage were those
between the ages of 18 and 34 at 33.3%. By contrast, since 1998, the
majority of organ transplants were received by those between 50 and 64
years old (41% in 2005) and those between 35 and 49 years old (27.75%
in 2005), though the OPTN data does not distinguish between living
donors vs. deceased donors as the source of these received organs. This
leaves open an ethically significant question: Are we "using" the
younger generation as organ suppliers for a growing elderly
population? And should the young put themselves even at minimal risk
to help the generation above them?
APPENDIX 1
APPENDIX 2
_______________________
ENDNOTES
1. A 23-year old patient,
Richard Herrick, was suffering and dying from chronic kidney failure;
his identical twin brother, Ronald, agreed to donate one of his
kidneys. Dr. Joseph Murray, a trained plastic surgeon who had become
interested in transplants during World War II, performed the surgery
at the Peter Bent Brigham Hospital (now Brigham and Women's Hospital)
in Boston. The procedure lasted five and a half hours and was lauded
a tremendous success. Ronald gave his brother eight more years of
life by agreeing to be a living donor; more than fifty years later,
he is still living and promoting organ donation. In 1990, Dr. Murray
won the Nobel Prize in Medicine for introducing organ transplantation
to the world.
2. The Vancouver Forum, "The Care of the Live Organ Donor: Lung, Liver, Pancreas and
Intestine Data and Medical Guidelines," Transplantation 81,
no. 10 (2006): 1372-1387, and The Amsterdam Forum, "Care of the Live
Kidney Donor," Transplantation 79, no. 6 (2005): S51-S66.
3. United Network for
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5. The Advisory Committee
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6. Institute of Medicine
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7. Organ Procurement and
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