- FROM BIOETHICS BRIEFINGS
Framing the Issue
Every day about 22 people in the United States die waiting for organ transplants. The deaths are especially tragic since many might be prevented if more organs were available. Every day very hard choices have to be made about who will live and who will die. With more than 100,000 people on waiting lists for kidneys, hearts, livers, lungs, intestines, and other organs, the pressure to distribute scarce organs fairly and to find ways to increase their supply is enormous.
The pressure is getting worse because waiting lists are growing faster than the supply of organs. And if transplant centers were to relax their standards to include more people—such as those who lack insurance, have severe intellectual disabilities, older persons, prisoners, undocumented immigrants, and foreigners who cannot get transplants in their own countries—then the lists of those waiting could easily triple or quadruple.
To close this gap, policy-makers will have to consider new options for inducing people to donate organs, and organ transplant centers may have to rethink their criteria for determining who is allowed on their waiting lists and who has priority. These decisions involve many ethical and legal issues, including:
- Who on the waiting lists should get transplants first: patients in the greatest need or those most likely to benefit?
- Should certain people, like undocumented immigrants, foreigners, and people with a history of addiction or a criminal record, be denied a place on waiting lists?
- Should people be paid to make their organs available when they die?
- Should federal law be changed to permit living people to sell organs?
- Should efforts be made to extend the opportunity to donate organs to those who die outside hospitals?
Distributing Organs: What Is Just and Fair?
Rationing is unavoidable in organ transplantation, so the system for allocating organs must be just and fair. Justice requires some rule or policy that ensures that the supply of donated organs is used wisely and consistently with what donors and their families would wish, such as giving priority to saving children’s lives, or to American citizens. Fairness demands that like cases be treated alike and that the allocation system be transparent, so that all who wait know why some are selected and some are not.
There are valid questions about the justice and fairness of the current system. Transplant centers are the gatekeepers who decide whom they will and will not admit as transplant candidates. Their policies vary. Many nonmedical values shape their decisions, and it can be argued that some centers invoke these values in ways that are not truly just. Here are some examples:
- Many transplant centers will not accept people without insurance.
- Transplant teams rarely consider anyone over 75 years of age.
- Some centers exclude patients with moderate mental retardation, mental health challenges, HIV, a history of addiction, or a long criminal record.
- Though American transplant centers can list foreigners, they can make up no more than 5% of any center’s list. Most non–U.S. citizens listed have substantial financial resources and pay in cash.
- Some transplant programs will admit undocumented immigrants, but most of those are children. Some transplant centers have caused controversy by refusing to retransplant organs in undocumented immigrants whose initial organs, received at the same hospital during childhood, have failed.
- Some hospitals do not accept persons who use marijuana, including medical marijuana.
Value judgments can also influence the process of matching cadaver organs with patients on the waiting lists. The United Network for Organ Sharing (UNOS), a national network based in Richmond, Va., bears this responsibility. At present, its driving considerations are matching a donor and a recipient by blood type, tissue type, and organ size. Some weight is also given to the urgency or need for a transplant as reflected by time on the waiting list and the person’s physical condition. There has been some push in recent years to steer organs toward those who are less seriously ill in order to maximize the chances for successful transplantation. This has resulted in some allocation systems using a “net transplant benefit” calculation, which considers both predicted survival while waiting for an organ and likelihood of post-transplant survival. UNOS used to have to allocate organs locally, but recently it has moved to a more regional distribution, as organ preservation techniques have improved.
Debates are growing louder about the criteria that UNOS should use—should it be the urgency of a patient’s medical need? Or should it be efficacy? In recent years, there has been a shift toward efficacy.
Under current UNOS rules patients can increase their chances of getting a transplant by enrolling at more than one transplant center—a practice known as multiple listing. About 10% of the current waiting list consists of persons who are listed at more than one center. Critics of multiple listing say that it is unjust because it gives an advantage to people with the resources to pay for more than one evaluation and listing. Each evaluation can cost tens of thousands of dollars.
Increasing the Supply
A number of steps have been taken over the years to try to increase the supply of organs (see box). The first attempt was from state laws permitting the use of organ donor cards or family consent to donate a deceased relative’s organs. Then, states began requiring hospitals to ask all patients’ families about organ donation. State laws also require hospitals to honor a patient’s donor card even when the family opposes donation, but when family members get vocal about opposition, hospitals usually acquiesce. There has also been a recent push to increase donor registration through state-operated online registries, which now account for close to half of all registered donors, but total numbers have not gone up significantly as a result.
None of these policies has significantly increased the supply of organs. Therefore, some people now argue for a shift away from a reliance on voluntary altruism in organ donation toward either a paid market or presumed consent.
Two basic strategies have been proposed to provide incentives for people to sell their organs upon their death. One strategy is simply to permit organ sales by changing the National Organ Transplant Act (NOTA), the federal law that bans them. Then, individuals would be free to broker contracts with persons interested in selling at prices mutually agreed upon by both parties. Markets already exist on the internet between potential live sellers and people in need of organs, but these transactions are illegal. The other strategy is a regulated market in which the government would act as the purchaser of organs—setting a fixed price and enforcing conditions of sale. Both proposals have drawn heated ethical criticism.
One criticism is that only the poor and desperate will want to sell their body parts. If you need money, you might sell your kidney to try and feed your family or to pay back a debt. This may be a “rational” decision, but that does not make it a matter of free choice. Watching your child go hungry when you have no job and a wealthy person waves a wad of bills in your face is not exactly a scenario that inspires confidence in the fairness of a ‘free’ market for body parts. Talk of individual rights and autonomy is hollow if those with no options must “choose” to sell their organs to purchase life’s necessities. This scenario has manifested in Iran, where the sale of organs is legal. In that country there is virtually no waiting list, yet it appears some individuals compete to sell their organs at low prices to feed their families. Coercion is rampant, including instances in which the organ “buyer” lowers the offer at the last minute, and the “seller” must choose between accepting the new terms and the ability to provide for their family a little longer. Choice requires information, options, and some degree of freedom, as well as the ability to reason.
It is hard to imagine many people in wealthy countries eager to sell their organs upon their death. In fact, even if compensation is relatively high, few will agree to sell. That has been the experience with markets in human eggs for research purposes and with paid surrogacy in the U.S.—prices have escalated, but there are still relatively few sellers. Some maintain that selling organs, even in a tightly regulated market, violates the ethics of medicine. The doctor must harm the patient for no end other than a sale to another party. The core ethical norm of the medical profession is the principle, “Do no harm.” The only way that removing an organ from someone seems morally defensible is if the donor chooses to undergo the harm of surgery solely to help another, and if there is sufficient medical benefit to the recipient.
The creation of a market puts medicine in the position of removing body parts from people solely to abet their interest in securing compensation. A market in human organs has a model in the existing market for human eggs for assisted reproduction and research purposes, but that practice is highly controversial. Is this a role that the health professions can ethically countenance? In a market—even a regulated one—doctors and nurses still would be using their skills to help people harm themselves solely for money. The resulting distrust and loss of professional standards may be too high a price to pay to gamble on the hope that a market may secure more organs for those in need.
There is another option for increasing the organ supply that has not been tried in the U.S. but is practiced abroad. Spain, Italy, Austria, Belgium, Hungary, Croatia, and many other European countries have enacted laws that create presumed consent, or what we prefer to call “default to donation.” In such a system, the presumption is that you want to be an organ donor upon your death—the default to donation. People who don’t want to be organ donors have to say so by registering this wish on a computer, carrying a card, or telling their loved ones. With default to donation, no one’s rights are taken away—voluntary altruism remains the moral foundation for making organs available, and, therefore, procuring organs is consistent with medical ethics. Based on the European experience, there is a good chance many regions in America could get a significant jump in the supply of organs by shifting to a default-to-donation policy. Donation rates in some European countries with presumed consent are about 25% higher than in other European nations.
Default to donation proposals have been submitted in several states over recent decades, but they have yet to be adopted anywhere in the U.S. As of 2015, Wales became the first nation in the U.K. to adopt presumed consent, with about 86,000 people (3% of the population) opting out shortly after implementation of the law. If Welsh families know that the deceased did not want to donate, despite lack of documentation, their expression to this effect will prevent procurement. Scotland and Iceland are instituting presumed consent as well. If these policies are successful, they may provide momentum for trying default to donation elsewhere in the U.K. and in the U.S.
There are important issues to consider before moving to default to donation. For millions of people who are used to actively deciding for or against donation when registering at the DMV or online, a shift to presumed consent could be unsettling. To preserve fairness and trust, an education campaign designed to reach everyone affected must accompany the legislation. The role of the family would also need to be clear: Should families have no say, or should they be able to veto default to donation of a deceased relative based on knowing the person’s unwritten wishes? Or, since the family has to keep living knowing a loved one’s organs are in a new person—and might find that knowledge distressing–should they have unqualified veto power? These questions also bring to bear the fact that in nearly all countries with presumed consent laws, donation professionals almost always still seek family consent as if they were in an opt in system.
The main ethical objection to presumed consent is the perceived loss of patient autonomy–that it is wrong to take someone’s organs without that person’s explicit consent. In addition, some people believe that presumed consent violates the 5th Amendment prohibition against taking private property without due process and compensation. Critics are also concerned about mistakes in which there is the presumption that someone consented when, in fact, either the individual meant to indicate opposition but had failed to do so or the record of that opposition was lost.
Vascularized Composite Allografts
A new form of transplantation called vascularized composite allograft (VCA) has, to date, enabled approximately 30 face transplants for people with severe facial trauma, around 70 hand transplants for amputees, a small number of uterus transplants for women without uteruses or with uterus malformations, one successful penis transplant for a man injured by an adult ritual circumcision, and another penis transplant too recent to gauge success. While not life-saving, VCAs have the potential to make life worth living for people with injuries that hinder basic human functions and prevent comfortable operation in society. Instead of using prosthetics or grafts, replacing “like with like” promises greater achievement of form and function.
In addition to being incredibly complex and expensive (health insurance will not cover VCA operation cost until proven safe and effective), these procedures have significant implications for personal identity. Unlike lungs or a kidney, faces and hands exhibit public histories of their owners, reflecting and reinforcing personality. What happens when these histories are transferred to new owners? Anecdotes from some of the first medically successful VCAs indicate a range of outcomes. Many recipients appear to be re-integrating well into their lives and careers. Some have suffered serious identity crises leading to compromised relationships, procedure reversal, and in very few instances suicide. The mental and emotional strain make standardized psychosocial screening and support a moral necessity for the field of VCA. Potential recipients and their family members should undergo extensive evaluation to ensure they are stable enough for the challenge, and long term psychotherapy should be built into the expected procedure costs.
Despite hands, faces, and penises having a different moral valence than solid organs, the Organ Procurement and Transplantation Network has rolled VCAs into the definition of organs for purposes of donation and transplantation. So when a person provides general consent to donation, all their parts are up for procurement. However, no online or DMV registry makes it clear that everyone has the right to opt out of VCA donation. They also do not explain that these transplants are still experimental. This information might be necessary to build an informed VCA donor pool, and to prevent some people from giving up on donating any kind of organ.
Should the Definition of Death Be Changed?
Most donated organs now come from people declared dead on the basis of neurological criteria—the absence of brain activity. Brain death typically occurs after cardiopulmonary death, the cessation of a heartbeat and breathing. One way to expand the pool of deceased donors is to include those declared dead by cardiopulmonary criteria. This recommendation was made in 2006 by a panel of the Institute of Medicine chaired by Hastings Center fellow James F. Childress and including Hastings fellow Mary Ann Baily.
Donation after circulatory determination of death (DCDD) has become more common around the world, but the practice is controversial. For one thing, it is medically more complex than donation after brain death because of the risk of organs being harmed by oxygen deprivation. In addition, there is ethical concern that DCDD will lead to substandard health care at the end of life—for example, inadequate morphine in the effort to avoid harming the organs. The Institute of Medicine report recommends ethical guidelines already used in Europe, such as preventing the organ recovery team from being the ones to decide when to discontinue cardiopulmonary resuscitation.
An extension of DCDD is the procurement of organs from people who die unexpectedly, often not in a hospital, which is called “uncontrolled donation after circulatory determination of death” (uDCDD). Teams in Spain and France have shown that uDCDD can contribute to improved transplantation rates with good outcomes. Progress in organ containment and transportation methods help protect against lengthy time without oxygen, a risk in uncontrolled settings, such as the scene of a motor vehicle accident. Some fear that uDCDD would lead to reduced efforts to save lives in favor of procuring organs, or that death would not be accurately confirmed prior to procurement. These concerns might be assuaged by policies such as one proposed in New York City that would require 30 minutes of vigorous resuscitation effort by trained EMTs, which would terminate only after futility standards have been met (including impossibility of restarting cardiac and respiratory function, and spontaneous circulation). After termination, the patient would be declared dead and then permission would be sought to transfer the body to a hospital so that organ donation could be considered. Under such a two-step protocol, those responsible for determining death would be completely separate from those assessing feasibility of donation, and there would be time for the deceased’s prior consent to donate to be verified.
On the Horizon
The need for organ transplantation may eventually be reduced by stem cell therapies. Scientists hope to repair or even replace damaged organs with new cells grown from adult or embryonic stem cells. In 2008, researchers at the University of Minnesota reported that they had built a beating heart in a laboratory with stem cells from neonatal and fetal rats. And scientists are undertaking clinical trials that attempt to repair the hearts of heart attack patients by injecting them with stem cells, and creating “heart patches” by combining stem-cells with other biomaterial. Patient-specific heart valves have been created by a method called “electrospinning” and implanted with apparent success. Another method called perfusion decellularization has enabled the creation of organ scaffolds into which individual-specific cells are seeded leading to structures that function very much like a heart, liver, vein, kidney, and bladder. In the near future, high resolution micro-imaging could create computer models of an individual’s ideal organ, which would dictate information to a bioprinter that would accurately place components like differentiated cells and growth factors, leading to a faithfully-reproduced fully-functional patient-specific organ. There is also increasing interest in using gene editing to create animals whose organs might be used in transplantation.
To reach these goals it will be necessary to decide when animal studies are successful enough to justify human trials, and who would be eligible for trials, such as those precluded from transplant listing due to insurance status or mental health issues, those closest to death, highest or lowest on the waiting list, with greatest probability of survival, or some other factors.
Arthur Caplan, PhD, a Hastings Center Fellow, is the founder of the Division of Medical Ethics at NYU Langone Medical Center.
Brendan Parent, JD, is director of applied bioethics at New York University’s School of Professional Studies.