Академический Документы
Профессиональный Документы
Культура Документы
Introductory article
Article Contents
. Introduction . Present Policies Regarding Organ Procurement Are Inadequate . Why Has Encouraged Voluntarism Fallen Short? . A Viable Policy Alternative: Presuming Consent . Organ Donation Charity or Obligation? . Equity in Transplantation . Is It Fair to Give Everyone in Need an Equal Chance to Get a Transplant? . Who Gets a Transplant? . What Are the Referral Criteria for Transplant? . What are Some of the Policies, Principles and Values at Work at Different Stages in the Process of Allocating Organs? . Justice in Organ Transplantation
Introduction
As the ability to transplant organs and tissues has grown, the demand for these procedures has increased as well to the point where it far exceeds the available supply. The gap between supply and demand, while large, is not adequately reected by the number of persons actually on waiting lists to receive an organ or tissue. Many potential recipients are not even placed on waiting lists. They are deemed too old, not of the right nationality, not appropriate for transplant as a result of severe mental impairment or criminal history or simply because they do not have access to a physician who can quickly refer them to a transplant programme. There are also impressive nancial obstacles to access to transplant waiting lists in the United States. There are severe limits on the availability of transplant services in many underdeveloped nations. While the demand for organs now exceeds the supply the size of waiting lists would quickly expand by ve to ten times their present size were there to suddenly be an equally large expansion in the number of organs available for transplantation. Physicians are well aware of this gap in supply and demand. They cope with the shortage by denying access to transplant centres on the grounds that some potential recipients are medically unsuitable. This scientic judgement is based upon a hodge-podge of physical, economic and psychosocial factors. The reality is that the waiting lists for cadaver organs have grown so long that a quiet form of triage takes place every day to prevent raising false hopes among those dying of organ failure. For infants and children, the shortage is so severe that for many organs the only viable source of transplant appears to be living donors or xenografts or genetically engineered organs.
ENCYCLOPEDIA OF LIFE SCIENCES / & 2002 Macmillan Publishers Ltd, Nature Publishing Group / www.els.net
might be expected are many. Many people still do not carry a donor card or other written directive specifying the disposition of their bodies when they die. Rates of donation among the poor and minorities are especially low. Some experts estimate that as few as 3% of all those who serve as organ donors are actually carrying a donor card at the time they are pronounced dead. In one sense this is not surprising. While it is all well and good to promote public education and awareness, organ donation is a subject intrinsically lacking in appeal to the general population. Many people are loath to contemplate their own death, much less make plans for the disposition of their bodies. This means that many people are not going to ll out a donor card just as they are not going to make out a will, buy a funeral plot or complete an advance directive concerning the kind of medical care they would like to have if they become incompetent. Fear of death and reluctance to think of it are not the only reasons for the low percentage of those who carry written directives of some sort about organ donation. The fact that health care has in recent years become increasingly centralized in large and impersonal institutions undermines trust between patients and healthcare providers. It is very dicult to trust in the good intentions of strangers. Many people are afraid that if they carry a donor card they may not receive aggressive medical care if they need it so that others can receive their organs. The failure to secure high rates of compliance with respect to written directives and the mistrust of hospitals and healthcare providers are, however, only part of the explanation for low rates of organ procurement. The reality in the United States is that when the subject of donation is raised it is often done with the presumption that the family of the deceased must decide to opt into donation. It may be possible to obtain a higher rate of donation simply by changing the philosophy underlying requests to donate from an opt in approach to an opt out approach.
remains that the level of public altruism is high at least in theory. The problem is that encouraged voluntarism using donor cards does not seem to be able to tap this powerful sentiment. This has led some to argue that more organs could be obtained by schemes to pay donors or their next of kin. Such a policy has been legislated in the state of Pennsylvania where a fund was created to reimburse donor families who asked the costs of funerals. But the governor decided not to implement this policy for fear that it would violate a federal law prohibiting the sale of organs and tissues. Paying for organs is not likely to become public policy anywhere in the world any time soon. Major religious traditions oppose payment on the grounds that persons do not own but are, rather, the stewards of their bodies. Payment also introduces risks concerning the quality of organs obtained. And payment may give persons an inducement to kill or take organs from others to pay debts. There is another way of modifying existing practice that would respect the dignity and value of individual choice while at the same time holding out the prospect of greatly increasing the number of organs and tissues obtained from cadaver sources. It requires a shift in the ethical presumptions that prevail about organ donation. If each hospital and procurement programme were to modify its approach to donation to presume that people do want to be donors and that families do want donation to occur, this might have a major impact on donation rates. Some maintain that the only way to move toward a presumed consent policy of this sort is by a change in state, federal or national law. And indeed some nations, such as France, Austria, Belgium and Spain, have legislated versions of presumed consent with a consequent positive impact on their cadaver donor rates. But a change in the law is neither necessary nor even important. There is nothing to prohibit hospital personnel or Organ Procurement Organization (OPO) ocials from making the presumption that donation will occur. This can be the presumption that undergirds the initial approach to families. And there is nothing to prevent society from shifting its moral expectation away from the view of organ donation as a heroic act to one that is simply expected as the reasonable and decent thing to do. A practice of presuming consent at the time of death addresses many of the failings of the current approach to cadaver organ procurement. It maximizes the opportunity to make a donation by way of a donor card or written directive since it ensures that some eort will be made by health professionals and family members to nd and act on a donor card if one exists. When no card exists, this form of approach allows families and guardians to feel far more comfortable with donation while still permitting a family member to raise an objection should they wish to do so.
ENCYCLOPEDIA OF LIFE SCIENCES / & 2002 Macmillan Publishers Ltd, Nature Publishing Group / www.els.net
is it correct to describe a decision to donate as a gift that is praiseworthy if oered but not blameworthy if withheld or, as an obligation that is both? For this discussion to come about, both healthcare providers and other citizens will have to make every eort to reassure the general public that organs are distributed fairly and eciently. While it is true that allocation criteria are closely tied both to the availability of organs and to the system used to obtain them, it is also true that the connection between the ethics of procurement and allocation is reciprocal. Few people will feel obligated to help those in need if they perceive inequities in the system used to designate exactly who is most in need and most deserving.
Equity in Transplantation
The trust that is essential for public support is a product of a key ethical value equity. The values of altruism and autonomy the foundations of organ procurement rest on the presumption that organs, which are given freely, voluntarily and altruistically, will be distributed in a fair and impartial manner to those in need. Any policies, practices or activities that suggest otherwise imperil the entire enterprise of organ donation and, thus, transplantation. There is sucient evidence of inequity in the allocation of organs to raise doubts about the fairness of the existing system. The ever-present news stories of families desperately seeking funds, begging for money to pay for transplants, leave an especially bitter taste in the mouths of a public that expects altruism. If organs are requested from the rich and poor alike but, given primarily to the rich, how long can we expect the public to support transplantation with either organs or public funds? An impressive number of papers have appeared in the past few years in professional journals maintaining that women, the elderly, the disabled, the retarded and minorities are not represented in the ranks of those receiving transplants to the extent that they could and should be. Policies that give priority of access to patients on articial heart assist devices, or to those who require multiple organ transplants or re-transplantation, leave plenty of room for doubt about what values are being used to allocate scarce organs. The tolerance of multiple listing by those who can aord to seek admission at more than one transplant centre and thus gain access to a larger share of the organ donor pool is blatantly unfair. Explicit policies at some centres which exclude some categories of patients from the prospective recipient pool because they have a history of drug abuse, crime or simply because they have a mental illness or disability give further reason for doubt about equity in the allocation of organs.
3
ENCYCLOPEDIA OF LIFE SCIENCES / & 2002 Macmillan Publishers Ltd, Nature Publishing Group / www.els.net
Even seemingly objective medical criteria such as antigen matching can produce inequities in who can and cannot obtain a transplant. The emphasis on tissue matching means that, de facto, minority groups are at a disadvantage in receiving transplants due to their underrepresentation in the donor pool and the diculty of doing rapid accurate tissue typing for rare antigens. In addition, the fact that so many hospitals and medical centres have rushed into the transplant eld raises legitimate doubts about the fairness of the system for distributing organs and tissues. The competition between transplant centres to secure organs is certainly not in the public interest. The impression that the allocation of organs is based on bias, prejudice, favouritism, greed, geography or publicity is enough to weaken public condence that the system is equitable. Flat or falling rates of organ donation may reect scepticism about the fairness of the current system.
getting a transplant. Fairness will also depend upon the degree to which the public has been given a chance to review existing policies and to hold those who formulate and implement them accountable.
ENCYCLOPEDIA OF LIFE SCIENCES / & 2002 Macmillan Publishers Ltd, Nature Publishing Group / www.els.net
Admissibility
Age, geography, ability to pay, patient, family and referring doctor perseverance, whether someone is an interesting or unusual case, whether someone has the disease qualications to enter into an ongoing research study, the presence of disability or mental illness, the availability of a supportive family, and having a good psychosocial prole including the right (positive and, once in a while, grateful!) attitude all play important roles in why patients get into centres. There is no consistent set of standards for admission to organ or tissue transplant programmes. Each centre is free to make up its own selection criteria. Those who are referred but turned down may continue to shop for a centre that will accept them. While there are sound reasons for some of the variations in admissions standards, variability in who gets in and who does not at particular hospitals gives the impression that the pettiness or arrogance of providers can be decisive in determining who gains admission to a programme. Personal resources play a role too, since it is still possible for those in need to try and seek admission to more than one transplant centre. It is not clear how many would-be recipients pursue what can be a very expensive strategy, but some do. Multiple listing at dierent transplant centres is advantageous because centres follow dierent allocation standards, and many attempt to place organs they procure with patients on their own waiting lists before oering them to other centres. The ability to pursue multiple listing is not only expensive, it is inherently unfair: only those with the resources to visit more than one centre can gain the advantages conferred by being placed on more than one list. The gatekeepers who make admission decisions have many identities. Many centres and hospitals operate with teams who regularly assess potential patients referred to them for suitability. Such teams often include social workers, transplant coordinators, psychologists, and psychiatrists. These teams each have their own medical criteria for admission. But there is more involved in the decision to admit than a medical diagnosis and evaluation. Representatives of the business oce, boards of trustees, institutional review boards (IRBs), ethics committees, local legislators, Federal ocials and third-party payers all have some say about who should or should not be taken into a particular transplant programme. Federal programmes such as the Veterans Administration may only permit certain transplant centres to be used by their enrollees. Private insurers may restrict their payments to certain centres only. Government ocials may insist that a foreign citizen gain entry to a transplant centre as a matter of national security or maintaining good foreign relations. Medical evaluations are sometimes re-cast for the purpose of persuading payers or a business oce that a prospective patient really needs a transplant. An operation that is described as experimental when described at a professional
conference may be termed therapeutic for the purposes of securing third-party payment and thus admission for the person in need. Admission decisions are closely tied to the experience of the transplant centre and transplant team. The established centres pride themselves on taking on the hard cases, and often they do. However, the hardest cases sometimes wind up at the newest programmes because these programmes are competing against established programmes and cannot attract referrals from physicians who prefer to send their patients to more established programmes. The most ethically fraught decisions in transplant are not who gets an organ on a given day from a transplant centres waiting list. They are who is actually on a waiting list and who is not on any given day.
Distribution
Once a potential recipient of a transplant has been entered on at least one waiting list, the process of allocation is then governed by two sets of distribution rules; those that exist in the particular hospital and those set by the United Network for Organ Sharing (UNOS). This is not true for tissues where decisions are often made by individual doctors negotiating with individual tissue banks and forprot companies that handle and distribute some tissues. In the case of organs there are systems in place in Europe and the United States and Canada to distribute organs to those on waiting lists. In the USA the semi-private United Network for Organ Sharing (UNOS) handles this. UNOS has not claimed and probably cannot yet secure total authority in the distribution of organs among those on waiting lists at various transplant centres. Individual centres, despite the existence of UNOS, frequently claim rst rights over organs they procure in their geographic area. Too many transplant programmes in many parts of the country still view organs they procure as theirs, even if other centres might be able to make better use of them. This distribution policy has the advantage of giving individual centres an incentive to aggressively pursue organ donations. But, it is a practice that fails to ensure that those who might be best suited to receive a particular organ actually receive it.
Selection
It is only when eligibility, admissibility and distribution have been settled that a person actually becomes a candidate for transplant. The criteria and policies used in selection, the nal stage in the process, are determined by individual surgeons. The criterion that most surgeons and transplant teams have followed for decades is that of treating the sickest patients rst when allowed to do so by the biology of the available donor organ. This principle comes from the earliest days of transplant when surgeons
5
ENCYCLOPEDIA OF LIFE SCIENCES / & 2002 Macmillan Publishers Ltd, Nature Publishing Group / www.els.net
knew that a transplant might do as much harm to a patient as benet. In order to do no harm they took the sickest patients, possibly knowing that if the transplant failed they had not made the patient worse o. But exceptions to this criterion abound. The sickest patient in a pancreas transplant programme may be so sick that only the best surgeon could hope to succeed with the case. But if that surgeon is sick, on vacation, or too tired from a previous operation, then, even if a well-matched organ of the right size is available, the sickest patient may not get the transplant a situation that is unfortunate but not unfair. The allocation of organs moves through a process that involves four stages eligibility, admissibility, distribution, and selection. Any assessment of the fairness of the current system for distributing organs must not simply look at the pattern of organ distribution among those getting transplants, but also examine the values and principles that prevail at each of these stages in the allocation process.
What are Some of the Policies, Principles and Values at Work at Different Stages in the Process of Allocating Organs?
The criteria that dominate decisions about allocation at the levels of eligibility and admissibility are heavily weighted toward nonmedical factors. Indeed, once the critical role of decision-making in determining the pool of candidates for transplants is understood, it is easy to see why nonmedical factors predominate. The criteria that prevail at the levels of distribution and actual patient selection are also heavily value-laden. Money plays a major role in determining admissibility to waiting lists at hospitals and transplant centres in the United States. The rich and those who have comprehensive medical insurance have a better chance of being referred and admitted to transplant programmes than do those who cannot demonstrate the ability to pay. Since health insurance is often provided in our society as a benet of employment, those who are unemployed, who do not qualify for Medicaid but have an income below the legal denition of poverty, who work part-time or who are selfemployed in other words, the poor, minorities, the chronically ill, the disabled, and women are at a signicant disadvantage in gaining access to transplant centres. Unless our society wants to argue that the rich are entitled to easier access to the pool of altruistically donated organs, the current under-representation of minorities, the poor, women, the elderly, and the handicapped in the recipient pool for transplants relative to their rates of
6
endstage organ failure is not an unfortunate or unlucky circumstance, it is unfair. The policies that have evolved to govern both distribution and patient selection are strongly weighted toward factors such as size of donor organ and recipient, blood and tissue matching, medical urgency, time on the waiting list, and logistics. Similar policies prevail at most centres for assigning priority to patients on waiting lists from week to week and day to day. There is no rm consensus within the transplant eld about the importance of tissue matching for the success or failure of various forms of transplantation. Many transplant teams believe that tissue type plays a crucial role in determining the chances for a successful transplant, especially with respect to kidneys. Others believe that minor tissue mismatches can easily be overcome through prudent immunosuppression. It is interesting to note that tissue typing has emerged as a critical variable for distributing kidneys that are oered to the national network. Arguments in favour of tissue typing focus on the implication of close matches for ecacy. Emphasizing tissue type has the advantage of allowing an objective standard to be invoked in allocating organs. It is a standard that is relatively easy to assess and monitor. Other factors such as the existence of co-morbid states or psychosocial complications are more dicult to track. Thus, the high priority given to tissue matching in current distribution policies may be more a function of the need to nd a clear, objective, and nearly indisputable standard than it is the result of a well-established association with successful outcomes. The cost of emphasizing tissue type in distributing kidneys in the national pool is to penalize those waiting for organs who have either rare tissue types or who are members of racial groups for whom there are few closely matched donors. If there is no empirical basis or only a very weak one for the importance of tissue matching in determining successful outcomes, then a distribution policy that emphasizes tissue type unfairly penalizes those with rare tissue types minorities. The other factor that drives patient selection is medical urgency. Both UNOS policies and those of individual transplant centres tend to give priority to persons in the greatest need of a transplant need being dened as the likelihood of the patient dying unless a transplant is done. Such a policy can be defended as fair since medical urgency is not known to correlate with any particular characteristic of those patients waiting for transplant. People with a failing vital organ can suddenly take a turn for the worse and nd themselves at deaths door. But is a policy fair, which gives priority to the sickest? Does it represent the most prudent use of scarce, life-saving resources? If one thinks of similar situations in which life-saving resources are in scarce supply, deciding whom to care for on the battleeld or who will receive food and water on a
ENCYCLOPEDIA OF LIFE SCIENCES / & 2002 Macmillan Publishers Ltd, Nature Publishing Group / www.els.net
lifeboat, a strong case can be made for considering principles of distribution other than who is most likely to die. Indeed, following policies that favour those most likely to die in these situations would be seen as both unfair and illogical.
resources whose eectiveness is uncertain, e.g. pancreas transplants or lung transplants. If a form of transplantation works then it would seem that ecacy in the saving of life should drive allocation. After all those who give organs say they do so to save lives. Those who transplant say they do so to save lives. And the reason organ transplantation has special status as a noncommodity in Western societies is that the goal of making the gift of an organ available is to save lives. If the goal is to save lives then giving organs to the sickest persons who need them is not necessarily the best way to achieve this goal. There must be more attention paid in the future in transplant allocation policies in the USA and other nations to outcomes as well as need and urgency.
Further Reading
Caplan AL (1998) Am I My Brothers Keeper?: The Ethical Frontiers of Biomedicine. Bloomington: Indiana University Press. Caplan AL and Coehlo DH (1998) The Ethics of Organ Transplants. New York: Prometheus. Cronin DC, Millis JM and Siegler M (2001) Transplantation of liver grafts from living donors into adults too much too soon. New England Journal of Medicine 344 (21): 16331637. Kaplan B and Polise K (2000) In defense of altruistic kidney donation by strangers. Pediatric Nephrology 14: 518522. Levine D (2000) Kidney vending. American Journal of Kidney Diseases 35: 10021018. Rothman DJ (1998) The international organ trac. New York Review of Books 45: 1417.
ENCYCLOPEDIA OF LIFE SCIENCES / & 2002 Macmillan Publishers Ltd, Nature Publishing Group / www.els.net