Ethical issues in nephrology.PA Morrin
Department of Medicine, Queen's University, Kingston, Ontario, Canada., Canada
Keywords: Ethical Theory, Ethics, Medical, Human, Nephrology, standards,Patient Selection, Personal Autonomy, Resource Allocation,
My comments today will deal with ethical issues in nephrology from the perspective of Western medicine, because this is the area with which I am familiar. I recognize that India has rich ethical traditions as illustrated by this extract from the Oath of Initiation for the medical trainee taken from the Charaka Samhita, which predated the Hippocratic Oath by two centuries.
I also recognize that the medical and economic problems here ate quite different from those in Canada where I practice. I hope, during my brief visit here to learn from your culture and traditions, which I am sure have much to say to our over-indulgent and wasteful western societies, and 1 specifically do not wish to appear as a messenger of what has been called American ethical imperialism. It should be recognized however, that despite widely different cultures and traditions, there is far more common ground in medical ethics than there are differences, and I hope, today, to clarify some of the ethical thinking which has evolved in the practice of Western nephrology and to underline some of the problems which we currently confront and which you and your colleagues in Indian nephrology, will share to greater or lesser degrees.
Western medical ethics have been based primarily on the Hippocratic Tradition, which required the physician to do what he considered necessary for the patients' best interests.
The Hippocratic Oath was modified by Christian and Judaic influences and became widely accepted in medieval Europe. It formed the basis of the Declaration of Geneva in 1948, and has greatly influenced the British, American and Canadian traditions of medical practice and is still the dominant tradition in worldwide medicine.
Up until 30 years ago, medical ethics were not a highly visible component of medical practice. Medicine was regulated in accordance with the rules and laws of individual countries and professional practices were regulated by medical associations, which promulgated codes of ethics which were largely based on the Hippocratic Tradition. Following World War II, the Nazi war crimes shocked the world into recognizing the need to define rules of ethical behaviour for medical research on human subjects. These rules were promulgated in the Nuremberg Code and were designed primarily to protect the subjects. During the 60's there was a major cultural revolution in the Western world, characterized by an increasing willingness to challenge authority and accepted practices. People were becoming more educated, medical information was being more widely disseminated, and medical technology was offering enormous new powers over life and death. These developments together with a number of major scandals in medical research gave rise to the demand for increased critical evaluation of ethical practices in Western and especially in US medicine. This questioning was concurrently re-enforced by numerous lawsuits which, over the years, have defined the rights in law, of patients to informed consent and refusal of medical treatments and have clarified, to some extent, legal processes concerning withholding and withdrawing treatment, the diagnosis of death and the obligations of care givers to provide treatment. The public debate has been extensive, and contentious, and has included not only physicians, but lawyers, philosophers, theologians, religious leaders, sociologists, economists, psychologists and almost anybody who wished to participate in it. As a consequence, medical ethics is now considered an important component of both the undergraduate and graduate medical curriculum. More and more hospitals are establishing Ethics Committees to review policies and procedures and provide consultation in different cases. All research must be approved by some form of Ethics Review Board. National and international granting bodies demand appropriate ethical review before considering research proposals and medical journals refuse to publish work which they feel does not meet appropriate ethical standards.
North American society is looking to ethicists to solve many of the vexatious political, economic and medical problems which it confronts, but this trust and confidence in professional ethicists is misplaced and will lead to great disappointment because there is no longer any common ground from which by rational argument, the right solutions can be reached. We have moved into a post-religious. Multi-cultural world, where our laws specifically exclude religious tenets as acceptable grounds for policy decisions, so that issues such as abortion and euthanasia must be debated on a secular level, and a position based solely on a religious teaching will no longer be accepted in our society. In such an environment, dispute resolution becomes impossible, if each party is using different ethical theories to justify his or her position. Those involved in ethical discourse, however, have learned that despite having different fundamental ethical theories, when faced with individual cases, they can frequently achieve a consensus on the right course of action and, even if a consensus cannot be reached, they can usually agree on the tight process to follow in trying to resolve a dispute.
An important contribution to this process was made by Beauchamp and Childress, who emphasized what they called, four middle level principles mentioned below which are widely accepted.
These principles are beneficence, non-maleficence, autonomy and justice. They are insufficient in themselves to provide an adequate ethical framework for problem resolution, but they are very useful in clarifying thinking and contribute significantly to ethical discourse.
Let us now consider some of the ethical issues related to dialysis, which involve the application of these principles.
When Scribner showed that it was possible to keep patients alive by repeated dialysis, the immediate problem arose that resources to do so were not available on anything except the most limited scale. Somebody had to decide who would live and who would die. This involved trying to do the most good (beneficence), avoiding doing harm (non-maleficence) and being fair (justice). The Seattle group approached the problem by establishing a committee of lay people to decide who would be accepted for dialysis
This committee assessed patients, in terms of age, sex, marital status, number of dependents, net worth, emotional stability education, past performance, future potential and personal preferences. The results of the committee’s deliberations were that most of the candidates who were selected tended to be white, upper class, middle-aged males and the work of the committee has been severely criticized as showing a selection bias against women, blacks and under-previliged individuals. When we started dialysis we also had a selection committee and I am sure we could have been accused of bias but we did the best, we could under difficult circumstances.
The question of how much of the health care budget should be devoted to dialysis depends on the amount of money available and the national priorities. There is a linear relationship between the GNP of a country and its health care expenditures and consequently chronic dialysis is generally limited to the wealthier nations. In 1972, the US government passed a bill providing dialysis treatment to essentially all Americans and concurrently, other Western countries, including Canada, were accepting liability for providing dialysis to their citizens. In Britain, dialysis was controlled by allocating a set budget to regional health centres, whereas in the United States, the process was open-ended. In Canada, allocation was theoretically open-ended, but the resources were always marginal to meet the demand and that is still the case at the present time, although chronic dialysis is a legislative entitlement of all Canadian citizens. During the 1980's, in North America, Dr. Scribner claimed that there was a negative selection process, or In other words, that people who were entitled to dialysis, and should have been offered it were not. This was also true in Canada, and over the years, we have increasingly expanded our criteria for who should be accepted into dialysis programs, so that in my own institution, the current policy is that anyone who can have meaningful life prolongation by dialysis, and who wishes to have it, will be given it. This type of policy has meant a progressive annual increment in our dialysis population, ranging between 10 and 15 per cent per year, and it is not at all clear to me that government will continue to fund an open-minded policy for dialysis as resources for other health care needs are declining. Such decisions are based on multiple considerations apart from, ethics and John Wax has listed 18 possible factors, which can influence health care allocations. These are:
The widespread availability of dialysis in Canada raises ethical questions when a physician decides not to provide this treatment to somebody who could theoretically benefit from it. In the early days, we did not provide ill to patients over 45, but this age barrier quickly collapsed, because it was arbitrary and riot defensible on medical grounds. We now have no age barrier and our oldest patient was 92. For a number of years, we refused to accept diabetics, on the grounds that they had severe comorbidity and a relatively short life expectation. This prognosis still true today and the outlook for end stage Type I diabetics, on dialysis, is extremely poor, but in North America, they are almost universally accepted, so that 30% of the dialysis population in our unit are diabetics. We have also had to deal with the question of whether mentally disabled people should be accepted. Our Society does not permit discrimination against the disabled and. unless we can show that they would not benefit medically from treatment, or would be too mentally incapacitated to cooperate with it, we provide dialysis to them. I must say that I have been surprised how well some of these severely retarded patients have done, in contrast to my initial assessment, but the societal burden in caring for them is multiplied several-fold when they go on dialysis.
This open-ended practice, which has been followed in most of the western world, but particularly in Canada and the United States, has lead to many patients with severe multi system disease being placed on dialysis, often with marginal benefit and sometimes with an unwarranted prolongation of the dying process. In a society, which considers dialysis as a right, it is very difficult to withhold treatment if the technology is available and the patient wishes to have it, no matter how poor the quality of life may appear to be to the nephrologists. In this respect, it should be noted that physicians and nurses consistently weigh the quality of patients' lives at a lower level than the patients themselves, and ethically it is generally considered unacceptable to use a quality of life scale based only on the physician's assessment.
While withholding treatment has created major ethical problems for nephrologists, the withdrawing of treatment has produced equally difficult decisions. Our Society attaches great importance to the Principle of Autonomy and patients have an absolute legal and moral right to refuse any medical treatment, and this right has been reinforced repeatedly by legal decisions. Consequently, if a patient decides that they wish to discontinue dialysis treatment, we must respect this decision if we believe they are acting autonomously.
Deciding whether a patient is functioning autonomously is not as easy as the lawyers and ethicists would have us believe. Nephrologists in the audience will be very familiar with the impaired mental thinking which uraemia imposes on patients, and how the patients' mental state may fluctuate from day to day. Furthermore, they may be subject to unrecognized pressures from family and care givers, who are tired of looking after them or standing to benefit financially from their death. Because of this, we should be very cautious about withdrawing treatment, and in my institution, we ensure to the best of our ability, that the request is sustained and that the patient is mentally competent, but if these criteria are met, we accept the decision and will try to provide as much supportive, terminal care as possible. Many institutions, particularly in the United States, will seek the help of an ethics committee in such situations, but our practice has been to make these decisions ourselves after appropriate consultation with colleagues, the nursing staff and other caregivers. Although we have an ethics committee and a hospital ethicist available to us, I am not convinced that ethics committees are always the best way to resolve these questions, and certainly, in .the United States, many of them serve as risk management committees to try and reduce the chances of a lawsuit. The situation is more difficult in the case of incompetent patients, who cannot express their own wishes, and if we discontinue treatment in such cases, we have to be sure that there is no value in continuing the treatment or that the burdens of doing so are greater than any of the benefits, which can be achieved. Dis-continuation of dialysis is a common event in chronic dialysis programs in North America, and Kjellstrand has stated that withdrawal from dialysis is the second commonest cause of death in the United States and the third commonest in Canada for these patients.
The history of Chronic dialysis therapy in the West has been one of starting with limited resources to meet an excessive need, and gradually increasing those resources to a state where all who need dialysis can now receive it, but as I mentioned earlier, the demand for dialysis continues to grow and it has been suggested that equilibrium between the rate of acquisition of new patients and the rate of death, may not be achieved until somewhere around 2020. In Canada, as in most countries, the health care budget is finite, and currently our economy is in trouble. Government revenues have fallen, so that less money is available for health care than previously. This is forcing a reallocation of resources on a macro economic scale and it would be surprising if expenditures on renal disease were spared from the cutbacks which other areas are experiencing. The government's response has been to delay the initiation of new dialysis facilities, so that all units are operating at capacity with marginal reserve. Further cutbacks will, I believe, force us to reconsider our open-ended allocation system. Two approaches could be used. One to limit the intake of patients based on predetermined criteria such as age, estimated benefit, estimated longevity, extensive comorbidity or other factors, each one of which might be subject to ethical criticism.
The second approach would be to reduce the quality of dialysis, so that more patients could benefit. This could be done by shortening the dialysis time from 4 hours to 3 hours, or by extending the interval between dialyses. The second approach would only be a short-term gain, because ultimately, continued growth in the patient population would force us to deal with the allocation decision.
The final question, that must be asked, is should patients have the right to buy dialysis if the state system will not provide it? I suspect that most people in the audience consider that a rather silly question, and would say, of course they should, but in my country, it would be difficult to do, because the Canadian government has taken the position that there should be no two-tier health care system, where wealthy people can buy better care than those who are less fortunate. This, of course, is quite a hypocritical position, because the very wealthy go to the United States for health care, which they cannot get readily in Canada.
What then can ethics tell us about these tough allocation decisions? The most important underlying principle involved is Justice.
The principle of formal justice, which was first enunciated by Aristotle, states that equals should be treated equally and unequals, unequally. This means that, it we are going to provide a therapy to one group of individuals and not to another we must be able to show that there are legitimate differences between the two groups which make them unequal with respect to the treatment in question. For instance, it has been claimed that there was discrimination against women in selection for transplantation, because fewer women were receiving transplants, if this discrimination was based on sex alone, and society said that sexes should be treated equally, then an injustice was being done to women. However, it was shown that the reason fewer women were accepted for transplantation was because they were more likely to have high levels of pre-formed antibodies, which made it harder to find kidneys for them, then the difference would be due to an inequality between men and women, in terms of antibody status, and not discrimination based on sex. There are different forms of justice, but for purposes of allocation, we are concerned with distributive justice, and there are a number of principles of distributive justice.
These include the principle of giving to each an equal share, which may be appropriate if one is rationing food or gasoline, but is not very helpful in deciding how to allocate dialysis slots or organs for transplantation. To each, according to individual need, how health care is normally allocated, in most national systems, but this requires defining what is meant by need. Individual effort, contribution and merit are sometimes used in a negative way to limit treatment to those who are not willing to cooperate or who continue to follow destructive life styles. In the early days of dialysis, ability to follow a strict diet and comply with the limitations of the program, was an essential part of the selection process.
Nephrologists in the United States, and particularly New York, have a large number of patients with drug - induced nephropathy and concerns have been raised whether such patients should be accepted for chronic in the United States the current ethical view is that patients should not be discriminated against on their life-styles, but this opinion is not, necessarily, widely shared by the general population.
The material principles of justice make us locus on what particular principle we should choose in allocation decisions, but having done that, we must then decide what factors are relevant in individual cases.
For instance, the colour of a patient's skin should not be a relevant factor in accepting a patient for dialysis treatment, as occurred in South Africa, but in patients with AIDS nephropathy, the rapidly fatal prognosis would be a legitimate reason for refusing a patient.
Some philosophers have used the concept of 1air opportunity" and state that properties over which we have no control, should not be considered relevant in deciding how to allocate health care. Such properties include sex, race and intelligence, and unless it can be shown that these characteristics are relevant to the decision-making, they should not be considered in the allocation process. Sometimes however, they may be highly relevant as for instance, the case of a severely retarded individual, who might not understand the reasons for chronic dialysis, and would regard each treatment session as a form of torture. We have had several such patients whom we have excluded on these grounds, but the exclusion was based on the patient's inability to understand the treatment and not because they were mentally handicapped. If a society accepts the fair opportunity principle, it accepts an obligation to try and provide everyone with an equal opportunity, and this means giving more resources to the least favoured, as for instance, providing special schools for handicapped children. It is a principle, which can only have a significant impact in a wealthy society and it can have little meaning unless all the basic needs of the population have been met.
Allocation decisions become increasingly complex the more resources there are available to distribute, and they involve economists, social scientists, politicians and other specialists as well as physicians. The ethical component is often lost in the complexity of the decision, and it is always possible to claim that resources should be switched from one area to another, such as military spending, to health care, or that more resources could be made available by higher levels of taxation, or by improving national productivity These arguments are much less applicable when we consider allocation with respect to organs for transplantation.
There are a number of ethical issues related to transplantation, but I would like to focus on who should be accepted as a recipient and how the organ should be allocated. The principles of distributive justice apply much more specifically to questions of organ allocation than to provision of dialysis. The number of cadaver organs available for transplantation is finite, and even the most aggressive retrieval programs have not been able to achieve a rate better than 50/million kidneys. Almost no programs are this successful, and in my province, we at one point, achieved a rate of 30/million but the most recent figures show that it is now down to 17/million. The rate of acceptance of patients into dialysis programs is approaching 100/million in Canada so that, there will always be insufficient cadaver organs available for transplantation. The first question that must be asked is, should a country put resources into a transplant program? If the country has decided to provide dialysis, the economic answer must definitely be yes. Because transplants are highly cost effective compared with dialysis. If we accept that a cadaver transplant program should be established, then we have an obligation in justice to see that those who can benefit from a renal transplant will have a fair opportunity of receiving one. Prior to the establishment of UNOS, the American program was criticized for giving kidneys, which were obtained from the American population by public donation, to wealthy foreigners. In establishing a program the transplant units must be fairly distributed, and the distribution should be based on need, unlike the situation found in the United States, and even in Canada, where one city might have three transplant centres competing with each other, whereas another might have none. Secondly, the support and funding for such units should be fair, so that if one unit is given more resources than another, there are legitimate grounds for the discrepancy. Thirdly, we must consider how the organs are allocated to the potential recipients. The same principles of justice apply to the allocation of organs, as they do to other resources, but it is easier to be more focused. First, we must recognize that there has to be a balance between efficiency and fairness.
Some of the factors involved are shown above. Patient need has been used in most transplant allocation decisions, but patient need has also been abused by physicians claiming that their patient will die unless he or she receives an organ immediately. Many such patients are so sick that they will die even if they receive the organ, and in terms of efficiency, should probably be excluded. In most transplant matching programs, need is considered, but it has to be strictly justified, and claims for great urgency should be audited. This is particularly true in heart transplants.
The quality of the match will have an impact on the long-term survival of the kidneys, but fairness suggests that patients who have been a long time on the waiting list, should not be rejected in favour of those who have just been placed on the list, even though the latter may have a better match. In Ontario we give priority to a very high quality match, but beyond that, we only use the match as one of the selection criteria. Time on the waiting list must also be critically assessed and it is important to record the time from the beginning of dialysis and not allow patients to be put on the cadaver waiting list before they need dialysis. It is well known, that first transplants of kidneys have more than an 80% chance of one year survival, whereas second transplants have a 50 to 60% chance of one year survival. Efficiency should dictate that scarce organs be given to first time recipients as a priority, and this is the policy which we follow in my own institution, but there are some situations where the first time recipient may be an elderly patient with multi-system disease and a relatively limited prognosis, whereas the second time recipient might be a young patient, in her 20's, with no co-morbidity. Efficiency would require that the life expectation of the recipient should be taken into account. The life expectation of the graft is harder to assess, but we assume that kidneys taken from older patients, with previous vascular disease, in general do not do as well as those taken from young, healthy individuals, and a case can be made for putting older kidneys into older recipients. This raises the questions whether all recipients are equal. Many ethicists would argue that once medical selection criteria have been applied, and patients have entered the recipient pool, that justice requires that they all be treated equally. I personally do not agree with this position, because I do not feel that all transplant recipients are medically equal in terms of - a) chances of a successful graft., and b) life expectation, and ideally, I believe there should be some stratification of recipients into more than one transplant pool, which is, in fact, what we are already doing with first and second transplants.
Finally, we must ask what strength should be given to the physician's loyalty to her patient. It is much easier to refuse a patient whom you don't know in another centre, than it is to turn down a patient with whom you have developed a strong doctor- patient relationship. This issue comes up more frequently with heart transplants where, for some reason, the initial heart transplant fails and the cardiac surgeons immediately try to find a second transplant, while maintaining the patient perhaps on an artificial heart. If the failure is due to some error on the part of the transplant team, it would seem that they have an even stronger obligation to try and get a second heart immediately, but if they do succeed in getting a second heart. it means that some other cardiac recipient will probably die without having had the chance of a first attempt. Most ethicists feel that loyalty to the patient commits the transplant team to try and complete the transplant procedure property, and would not object to the use of a second heart in the situation which I have described, but there is great debate, at this time, as to whether patients who have already received one heart should be given a second.
I would like to be able to tell you that a, knowledge of ethics and ethical theories can provide the answer to all these problems but I think you will realize, that this is a false hope. Which particular theory we use, may determine the outcome in the decision making process, and in a multicultural, secular society, the best that we can hope for, by the application of ethical theory to medical decisions, is to achieve a process which can be publicly scrutinized and defended on rational grounds.
[Table - 1], [Table - 2], [Table - 3], [Table - 4], [Table - 5], [Table - 6], [Table - 7], [Table - 8], [Table - 9], [Table - 10], [Table - 11], [Table - 12]