© 2013 John Wiley & Sons A/S.
Clin Transplant 2013: 27 (Suppl. 25): 34–39 DOI: 10.1111/ctr.12154
Liver allocation: urgency of need or prospect of success? Ethical considerations Bobbert M, Ganten TM. Liver allocation: urgency of need or prospect of success? Ethical considerations.
Monika Bobberta and Tom M. Gantenb a
Abstract: In German legislation and in Eurotransplant’s practice of liver allocation, urgency of need is considered as the primary distribution criterion. However, at a certain stage, the “sickest-first” principle is regarded as counterproductive as the performance status of these patients receiving an organ is on average critical and mortality and morbidity after liver transplantation increase. Within the medical transplant community, the criterion of prospect for success is highly accepted. As clinicians having a certain scope in decision-making as “gatekeepers” in regard to which patient gets on the waiting list and at which stage a patient is defined as “not transplantable” and as transplantation centers aspire good success rates, the goal of high prospect for success might become more weighty than intended by legislation and professional guidelines. From an ethical point of view, it is submitted a so-called mediatory approach in between the two extremes “sickest-first” and “fittest-first.” Beyond that, it is argued for further development of a prognostic score for post-operative outcome after liver transplantation – as long as questions of social justice are borne in mind – to support “objective” decision-making.
Organ transplantation and liver allocation in Germany
The possibility of liver transplantation has revolutionized the treatment of patients with severe liver disease. Before the first liver transplant by Starzl in 1963, these patients could not be treated causally and died. The possibility of liver transplantation gives these patients the opportunity to survive an otherwise deadly liver disease. Nevertheless, the increasing number of patients on the waiting list on the one hand, and the pronounced shortage of organs on the other hand, requires a selection process weighing urgency of need and the prospect of success (1). The process of organ allocation must be performed thoroughly and transparently to ensure on the one hand justice between patients and on the other hand appropriate use of the donated organs in respect of the donors. The clinical practice of taking patients onto the waiting list for organ transplantation and organ distribution is subject to legal requirements, professional, and ethical standards. However, despite legal and semi-legal framework and medical standards, there still remains a certain scope of discretion for physicians. Medical guidelines and
34
Faculty of Medicine, Institute for History and Ethics of Medicine, University of Heidelberg and bDepartment of Gastroenterology and Hepatology, University Hospital Heidelberg, Heidelberg, Germany Key words: allocation – ethics – liver – MELD score – transplantation Corresponding author: Prof. apl. Dr. Monika Bobbert, Dipl.-Psych, Institute for History and Ethics of Medicine, Im Neuenheimer Feld 327 – 1. OG, Heidelberg D-69120, Germany. Tel.: +49 6221 545458; fax: +49 6221 545457; e-mail: [email protected] Conflict of interest: None. Accepted for publication 2 April 2013
routines and the scope of discretion increasingly have to withstand the critical observation of different psychological, ethical, legal, and medical aspects (2). Therefore, an interdisciplinary discourse is required due to our responsibility to the individual, to the group of patients who need an organ and to the public. The organ allocation in Germany is organized by Eurotransplant, since December 2006, the organ allocation is priorized by the Model for End Stage Liver Disease (MELD) score (3). The MELD score is calculated from three medical parameters (creatinine, bilirubin, and INR) and makes a valid statement about the three-month mortality of patients on the waiting list for liver transplantation. The MELD score is generally objective, although it is possible to manipulate the MELD score of any individual patient through clinical actions and thereby increase the chance of organ allocation: for example, by forced dehydration, hemodialysis or other therapy which is not clinically indicated for the patient, but designed to alter the MELD score (4). Before the introduction of the MELD score, the organ procurement was performed with a greater emphasis on waiting time. The present organ
Ethics of liver allocation allocation according to the “sickest-first” principle has led to a decrease in mortality on the waiting list. On the other hand, due to this regulation, in view of the organ shortage, the performance status of patients receiving an organ is on average getting worse. This has led to an increase in mortality, but also of morbidity after liver transplantation in all German centers (5). The MELD score makes a strong statement about the urgency of need for a liver transplant, but the prospect of success is not adequately addressed. This raises, however, new medical issues, and there is a need for a thorough ethical debate on how to balance urgency, chances of success (morbidity/mortality), and latency in the light of equal opportunities for all patients. It is precisely the sickest patient who most urgently needs the organ and often has the worst prospect of success. On the other hand, these are also recipients who have in some cases the largest benefit of the transplantation (6). Finding a balance between the greatest possible individual benefit and maximum benefit for all is, therefore, still an unmet challenge (7). Thus, the development of guidelines, which both reflect the individual patient’s benefit, but also his risks and prospects of success in the view of all patients on the waiting list, is essential. But the care for the individual patient must not be compromised by the physician’s responsibility to the whole community of patients listed for transplantation. Therefore, this article will focus on regulations and decision-making processes which accomplish these tension-filled goals.
Necessity of ethical reflection in transplantation medicine Moral intuition, professional ethos, and medical ethics
Physicians’ decisions and regulations must be based on moral grounds and arguments, which are reasonable to accept, that is, clinical, authoritative, or pragmatic reasoning alone is insufficient. In discourse, the persuasive power of the better ethical argument is decisive. The necessity for such arguments is also evident considering divergent moral intuitions of clinicians, discussions in expert circles, and questions from patients and the public. In medicine, one must differentiate between medical ethics, a particular professional ethos, and moral intuitions. Medical ethics as a discipline of practical philosophy deals with questions that are controversial to assess in moral terms. In these cases, the medical profession does not per se have a particular assessment competence. The professional ethos in medicine draws back on internal convic-
tions of the profession that are limited thereto. The moral intuitions of attending physicians take effect when there is a leeway in decision-making or in unregulated fields. They, however, have to be open to further moral reflection if the decisions and actions of others are concerned. This is the case with organ transplantation. It is therefore necessary to provide arguments for regulations and courses of action, which can be reasonably accepted. Scope of decision-making in post-mortal liver allocation
In Germany, the organs of brain dead patients are distributed in accordance with the criteria developed by Eurotransplant and the guidelines of the German Medical Association (German: Bundes€ arztekammer). Physicians, however, have a certain scope in decision-making, for example, they are “gatekeepers,” when deciding on including or excluding a patient from the waiting list or when deciding on whether a patient is “transplantable” or not.
Two ethical approaches in discourse: urgency of need or prospect of success as primary distribution criteria Right-based (deontological) approach – urgency of need
In health care, the moral obligation to save life has a very high priority regardless of the fact that doing so might only have a limited prospect of success. This ethical norm is the main argument for the priority of urgency of need (respectively “sickest-first”) in liver transplantation. Only the individual patient’s potential suffering by transplantation would be the obstacle to transfer an organ (8). Every human being has the same value, regardless of attributes such as race, sex, or social status (9). This in turn means that one life cannot be weighed against the other. No human life is worth more than another, also not in terms of estimated remaining life expectancy. This argues against the approach that one should save the largest possible amount of human lives and that the death of many people was much worse than the death of few. It is strengthened that if one person of a group of five dies, the loss for them is no greater because four other people happen to die as well (10). In objection to this argument, in transplantation medicine it is frequently stated that needy, multimorbid patients who receive transplants often die post-surgery, resulting in the loss of the organ. Thus, this organ would also be lost for other patients.
35
Bobbert and Ganten Utilitarian (teleological) approach – prospect of success
A utilitarian approach, focusing on maximizing net benefits, is based on the norm that such actions are to be taken that are the most beneficial to the largest number of affected parties (11–13). One or a few humans’ lives may be sacrificed if a large number of lives can be saved as a consequence. Partly in favor of this argument, it is often claimed that in transplantation medicine, there is only a limited number of organs from brain dead patients and that this scarce and valuable resource should be used as advantageous as possible, for example, to maximize the total amount of life years. This means that a patient who would almost certainly live longer should be favored over a patient whose life expectancy is not as high (14). It is frequently argued that the moral obligation to help all patients to an equal extent is undermined by this approach. Mediatory approach
A “moderate” deontological approach could mediate between the two extremes. A right-based approach is needed, which is not blind to the consequences of actions and regulations in transplantation medicine, that is, an approach that under certain conditions incorporates prospect of success in the ethical deliberation. To this end, “success” and which measure of success is to be used in organ allocation must be discussed and defined. Indicators for success in transplantation medicine and ethically relevant value judgments
In looking at possible indicators for success and considering who the “affected parties” are and whose success is to be maximized, it is obvious that any attempt to define success contains value judgments. A descriptive statements or a certain focus of selection is ethically relevant, when particular moral norms or values are presupposed. Thus, possible valuations need to be made explicit and need to be based on solid argumentation. Different “affected parties” and indicators for success
First of all, it must be defined whose success is to be considered or maximized: for example, that of the individual patient, who needs a lifesaving organ, that of a collective of patients, that of surgeons or internists in transplantation medicine, that of a transplantation center, that of the national healthcare system? Furthermore, a defini-
36
tion is needed from an ethical point of view as to what qualifies as success or “quality.” In clinical practice and in medical literature, a variety of target criteria can be found, for example, a painfree end of life phase, no death during surgery, no post-operative complications, no organ rejection, three-month, one-yr, and three-yr survival or posttransplant quality of life. However, maximizing different criteria of success to some extent also means treating different groups of patients. On the one hand, as predictions of success in medicine are not deterministic but merely probabilistic, scoring systems such as the MELD score and expert medical estimations on post-transplant life expectancy and long-term survival must be questioned as to their validity, reliability, and thus, predictive value. On the other hand, it must be taken into consideration that statistical correlations found in empirical studies do not allow any predictions for the case of an individual patient. Probability prognoses relating to patient groups and their “application” to individual patients must be assessed from an ethical point of view, as it contains a value judgment whether a 50% or 80% probability of success is sufficient to justify a transplantation. Value judgments and controversial decision-making bodies
From an ethical point of view, it is controversial when a center’s transplant physicians, expert circles, or institutions of quality assurance define indicators and probabilities of success and thereby decide which patients qualify for transplantation. In Germany, the quality of transplant centers is assessed via a national analysis report since 2005 (15, 16). For liver transplantations, a variety of so-called quality indicators are specified, for example, “death due to surgical complications,” “in-hospital lethality,” “post-operative complications” (using length of stay as a surrogate parameter), and one-yr, threeyr, and five-yr survival. Transplantation centers compete with each other to a certain degree, and a national quality database requires them to maintain a specified performance level. In case of larger deviations, they are required to make a statement. Perioperative death can in part be attributed to operative care and should indeed be avoided. However, in addition to quality of care, there are other factors related to the individual patient that contribute to in-hospital lethality and complication and lethality rates, namely previous overall condition, co-morbidities, infections or side effects of immunosuppression, and the quality of the transplanted organ. When transplantation centers aim for one-yr survival rates of approximately
Ethics of liver allocation 80% to 90% due to so-called quality figures, this pragmatic or economically motivated regulatory function leads to implicit moral decisions, concerning which patient receives an organ transplantation (2, 5). As a result, there is a strong incentive for the centers to use the existing scope to choose patients based on prospect of success. This could lead to a shift toward more low-risk transplantations. Transplantation centers could favor healthier patients with a greater likelihood of survival for transplantation over needy patients in a very bad overall condition or with other aggravating factors, who as a result have a lower life expectancy. However, this implicit regulatory function by “quality” assessment must undergo critical consideration, because this could lead to a practice which is detrimental to the overall goals. In addition, it is ethically controversial that liver transplants from brain dead patients are distributed to the transplantation centers via Eurotransplant’s standard European allocation procedure, but approximately 30 up to 50% of the transplants are rejected (2). This is in part the case because physicians worry that the suboptimal quality of a transplant might not lead to the desired success with the patient at the top of Eurotransplant’s (computer generated) match list, often because the patient’s high MELD score means that he is in an overall bad health condition. If two centers reject an organ because of its poor quality (in view to a patient in bad health condition), it is assigned to a regional transplantation center in an accelerated placement procedure (a so-called rescue allocation) (17, 18). With this center-based allocation, physicians and transplantation centers have greater discretionary decisions and can choose a patient for transplantation regardless of their MELD score. In this procedure, it is problematic that not only medical factors but also a wide range of other factors can play a role. Although the basis for the decision must be documented, the doctor–patient relationship could compromise an impartial transplant allocation. In addition, urgency of need as a decisive factor could be forced into the background. This procedure could be potentially problematic if a large proportion of liver transplants are allocated that way thereby converting the exception into a second “standard procedure” without, at the same time, guaranteeing the socially accepted and transparent distribution criteria of Eurotransplant. Ethically relevant facts and judgments
Whose success is to be measured and who defines which criteria are to be met for success are questions that cannot be answered from a mere prag-
matic or medical point of view. It is ethically relevant whether a transplant physician or a transplant center aims for “survival of the sickest” or “survival of the fittest.” It is equally relevant from an ethical point of view whether doctors, patients, lobby groups, or representatives with democratic legitimization define success criteria. Establishing success margins using statistics for quality assurance or the competition between transplantation centers can implicitly override ethically wellfounded allocation criteria. This should not occur without analyzing and critically discussing the effective distribution criteria.
Profile and conclusions of a mediatory approach Survival and well-being of individual patients as primary goal
In an ethical approach that attempts to mediate between the urgency of need and prospect of success, “benefit” and “success,” respectively, must take into consideration the individual patient and not the benefit for society or an abstract benefit, for example, the amount of life years gained. In addition, physicians must, to the best of their knowledge, aim to save as many of the “sickest” patients as possible. Good transplantation statistics are not an indicator of success and of ethical rightness per se. The definition of a statistically acceptable mortality rate, estimated by a score, is a difficult decision, because it would ultimately regulate to which extent critically ill patients who need a liver transplant are given a chance of survival. The mediatory approach – presented as follows – starts with a right-based approach which is based on individual moral rights according to the ethical theory of Alan Gewirth (9). This approach strengthens the right of an individual patient to get medical help in the case of a life-threatening situation. Foremost, the duty of a physician emerges as “passive” respective “negative”: He must refrain from inflicting basic harms to the patient. This means at least that the chance to benefit from organ transplantation should be higher than the chance to benefit from “conventional” medical or no therapy at all (e.g., “watch and wait”). Thus, first of all, physicians are asked to do their very best to estimate the surgery’s outcome and to compare this treatment option with treatment alternatives in regard to potential individual risks and benefits. Secondly, physicians have the “positive” duty to help in a life-threatening situation as long as they have measures to overcome such a health crisis. As in transplantation medicine, there is permanent
37
Bobbert and Ganten
shortage of means – in this case, organs – a physician cannot be sure to have an organ at his command to save a patient’s life. Thus, taking his task to save lives seriously, the physician should try to “keep” a liver transplant for patients who will not die soon after transplantation. Beyond that, it will be argued in the following why physicians may be allowed to take into account some potential consequences of measures of medical support. More precisely, in liver transplantation, physicians are allowed to take into account whether the potential survival of a patient will supposedly be only for a very short time (e.g., some days or just a few weeks – so to speak an organ transplantation being a “death-prolonging” measure) or whether a patient has a “more or less good” chance to prolong his life in the sense of overcoming a life-threatening crisis of health. As physicians do not know beforehand what will happen to an individual patient, they try an approximate estimate as clinician or they estimate more “objectively” by a score. It must be mentioned that post-operative scores only manage to give rough estimates for three-month periods; thus, there are pragmatic limitations of predictions of high quality. As scores deliver probabilities, they express chances to survive or to die, but they are not able to predict what will happen to the individual patient. Furthermore, it is not possible to give reasons in detail for at what point life prolongation can merely be regarded as delaying death and at what point it can be regarded as gaining life. Reference to a mediating rule of proportionality can be justified because other patients on the waiting list are also in a life-threatening situation. According to Gewirth’s theory, it can be argued that physicians have the duty to help an individual patient if there are effective means, if the means are under one’s proximate control, and if the physician can give assistance at no comparable cost to himself. By “comparable” cost is primarily meant that the physician is not required to risk his own life or other basic goods (9). It might be argued additionally to Gewirth’s theory that in regard to organ transplantation not the individual physician, but other patients on the waiting list would have even more than “comparable” costs if a patient would get a liver transplant just for “death-prolonging” goals – whereas another patient’s life could be saved. For not resulting in “incomparable” costs for other patients who could be saved from a lifethreatening crisis, the introduction of a mediating rule of proportion in the sense, that the goal of survival should not just mean survival for a few more days or several weeks, might be introduced into organ distribution deliberation.
38
Another aspect – which is not so much the idea of Gewirth’s theory, but in the logic of the norm to save life – is that for the sake of realization of the norm’s goal, it makes no sense to follow the norm “blindly.” But taking into account the consequences of strictly following a moral right means to save as many patients who are in an acute lifethreatening situation as possible at the one hand does not mean to maximize life years per se on the other hand. Therefore, the latter would not be in the sense of a right-based approach nor the proposed mediatory approach. In view of shortage of organs, not only the individual physician but also the healthcare system is restricted in the capability to give assistance in case of organ failure. Taking into account this situation, a mediatory ethical approach will strengthen: The medical means of organ transplantation should not be used as another technical and pharmaceutical means of an intensive care unit to prolong life although dying is presumed to be close. Instead, organ transplantation as means should be seen as a lifesaving measure – with lifesaving of more than just a few days or several weeks. The intermediate moral rule of proportion would say that providing a liver transplant should happen with a certain probability of success to live longer by this intervention. But a mediatory approach with its focus on individual moral rights only implies to save other patients who are in an acute life-threatening situation. And this approach cannot deliver a precise cutting point for the minimum probability of survival. Development of prognostic scores for post-operative outcome and aspects of social justice
One instrument to help physicians to approximate more objectively and also impartially the chance of a patient to be saved for a relatively longer period of time than “only” a short, “death-postponing” time might be the development of a statistically based prognostic score of the post-operative survival. Different scores are discussed including the SALT score (5), D-MELD estimating the postoperative outcome based on MELD and donor criteria (19, 20), and the SOFT score which predicts the probability that the patient will survive the first three month after liver transplantation (6). The SOFT score includes 13 recipient-related factors (among others BMI, age, and cardiovascular comorbidities of the recipient), four donor-related factors (among others the age of the donor), and two surgery-based factors (among others cold ischemia time) (6). Unfortunately, none of these scores can predict post-operative outcome good enough to be
Ethics of liver allocation a solid base from which a “futility” score could be routinely used. Nevertheless, physicians are looking for an optimization of prognostic post-operative scores supporting individual clinical judgments to become more objective – also in the sense to support clinicians to be impartial in the face of caring for individual patients. In regard to developing prognostic scores for post-operative outcome, questions of justice arise if “causes” respective – precisely speaking – correlations indicating multiple factors of social inequality would be multiplied by usage of a score. From an ethical point of view, it must be questioned if correlation factors such as sex, ethnic group, education level, or income should be used for prognoses. The SOFT score, for example, contains sex and race as predictors (5), some SOFA score-based models for predicting mortality in the intensive care unit contain education level or income (21), some rating scales, for example, TERS, for evaluating organ transplant candidates contain prior psychiatric history, health behaviors, family support, and prior history of coping (22). Thus, before developing and adjusting a prognostic score for the probability of post-operative survival a critical reflection about the items of such scores should take place – from a medical, but also from an ethical point of view. Finally, it would be left the question which chance of a three-month post-operative survival would be the decisive point to allow a patient to undergo an organ transplantation. Ethical argumentation can give good reasons for some “corner pillars” of distributive justice but ethical argumentation will supposedly not be able to give reasons for a certain decisive cutting point. Thus, this question should be passed over to democratic decision-making – also with regard to the question if transplantation medicine should have high or lowered priority in health care.
3.
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6.
7.
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9. 10. 11. 12. 13. 14.
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17. 18.
Acknowledgements We thank the Heidelberg University Marsilius-Kolleg – this article is the result of an interdisciplinary fellowship of the Marsilius-Kolleg. We thank our cooperation partner, Prof. Dr. iur. Gerhard Dannecker, Heidelberg, and Dr. med. Sylvia Brost for inspiring discussions.
References 1. BAHRA M, NEUHAUS P. Liver transplantation in the high MELD era: a fair chance for everyone? Langenbecks Arch Surg 2011: 396: 461. 2. SCHLITT HJ, LOSS M, SCHERER MN et al. [Current developments in liver transplantation in Germany: MELD-based
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organ allocation and incentives for transplant centres]. Z Gastroenterol 2011: 49: 30. WIESNER R, EDWARDS E, FREEMAN R et al. Model for endstage liver disease (MELD) and allocation of donor livers. Gastroenterology 2003: 124: 91. SIEGMUND-SCHULTZE N. Transplantationsskandal: zentren €berpr€ sollen regelm€ aßig u uft werden. Dtsch Arztebl 2012: 109: 1958. WEISMULLER TJ, FIKATAS P, SCHMIDT J et al. Multicentric evaluation of model for end-stage liver disease-based allocation and survival after liver transplantation in Germany – limitations of the ‘sickest first’-concept. Transpl Int 2010: 24: 91. RANA A, HARDY MA, HALAZUN KJ et al. Survival outcomes following liver transplantation (SOFT) score: a novel method to predict patient survival following liver transplantation. Am J Transplant 2008: 8: 2537. BROWN RS Jr, LAKE JR. The survival impact of liver transplantation in the MELD era, and the future for organ allocation and distribution. Am J Transplant 2005: 5: 203. GUTMANN T, FATEH-MOGHADAM B. Verfassungsrechtliche Vorgaben f€ ur die Verteilung knapper medizinischer G€ uter am Beispiel der Organallokation. In: GUTMANN T, SCHNEE€ A, LAND W, WIND KA, SCHROTH U, SCHMIDT VH, ELSASSER HILLEBRAND GF eds. Grundlagen einer gerechten Organverteilung. Berlin: Springer, 2003: 59. GEWIRTH A. Reason and Morality. Chicago: University Press, 1978. TAUREK JM. Should numbers count? Philos Public Aff 1979: 7: 293. BENTHAM J. An Introduction to the Principles of Morals and Legislation. London, 1789. HARRIS J. The survival lottery. Philosophy 1975: 50: 81. PARFIT D. Innumerate ethics. Philos Public Aff 1978: 7: 285. BIRNBACHER D. Allokation und Rationierung im Gesundheitswesen. Eine utilitaristische Perspektive. In: GUTMANN T, SCHMIDT VH eds. Rationierung und Allokation im Gesundheitswesen. Weilerswist: Velbr€ uck Wissenschaft, 2002: 91. Bundes€ arztekammer. Richtlinie zur Organtransplantation gem€ aß §16 Transplantationsgesetz: Anforderungen an die im Zusammenhang mit einer Organentnahme und -€ ubertragung erforderlichen Maßnahmen zur Qualit€ atssicherung. Deutsches Aerzteblatt, Sonderdruck, 20. April 2001. Unabh€ angige Bundesstelle f€ ur Qualit€ atssicherung (BQS) Bundesauswertung D€ usseldorf/Hamburg bzw. des AQUA-Instituts G€ ottingen zum Leistungsbereich Lebertransplantation. Bundes€ arztekammer. Richtlinien zur Organtransplantation gem€ aß §16 TPG. Dtsch Aerztebl 2008: 104: B1261 Eurotransplant Leiden, Official letter to heads of liver transplant programs in Germany, 26/4/2012. AVOLIO AW, AGNES S, CILLO U et al. http://www.D-MELD. com, The Italian survival calculator to optimize donor to recipient matching and to identify the unsustainable matches in liver transplantation. Transpl Int 2012: 25: 294. HALLDORSON JB, BAKTHAVATSALAM R, FIX O, REYES JD, PERKINS JD. D-MELD, a simple predictor of post liver transplant mortality for optimization of donor/recipient matching. Am J Transplant 2009: 9: 318. MINNE L, ABU-HANNA A, DE JONGE E. Evaluation of SOFA-based models for predicting mortality in the ICU: a systematic review. Crit Care 2008: 12: R161. TWILLMAN RK, MANETTE C, WELLISCH DK, WOLCOTT DL. The transplant evaluation rating scale. A revision of the psychosocial levels system for evaluating organ transplant candidates. Psychosomatics 1993: 34: 144.
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Clin Transplant 2013: 27 (Suppl. 25): 34–39 DOI: 10.1111/ctr.12154
Liver allocation: urgency of need or prospect of success? Ethical considerations Bobbert M, Ganten TM. Liver allocation: urgency of need or prospect of success? Ethical considerations.
Monika Bobberta and Tom M. Gantenb a
Abstract: In German legislation and in Eurotransplant’s practice of liver allocation, urgency of need is considered as the primary distribution criterion. However, at a certain stage, the “sickest-first” principle is regarded as counterproductive as the performance status of these patients receiving an organ is on average critical and mortality and morbidity after liver transplantation increase. Within the medical transplant community, the criterion of prospect for success is highly accepted. As clinicians having a certain scope in decision-making as “gatekeepers” in regard to which patient gets on the waiting list and at which stage a patient is defined as “not transplantable” and as transplantation centers aspire good success rates, the goal of high prospect for success might become more weighty than intended by legislation and professional guidelines. From an ethical point of view, it is submitted a so-called mediatory approach in between the two extremes “sickest-first” and “fittest-first.” Beyond that, it is argued for further development of a prognostic score for post-operative outcome after liver transplantation – as long as questions of social justice are borne in mind – to support “objective” decision-making.
Organ transplantation and liver allocation in Germany
The possibility of liver transplantation has revolutionized the treatment of patients with severe liver disease. Before the first liver transplant by Starzl in 1963, these patients could not be treated causally and died. The possibility of liver transplantation gives these patients the opportunity to survive an otherwise deadly liver disease. Nevertheless, the increasing number of patients on the waiting list on the one hand, and the pronounced shortage of organs on the other hand, requires a selection process weighing urgency of need and the prospect of success (1). The process of organ allocation must be performed thoroughly and transparently to ensure on the one hand justice between patients and on the other hand appropriate use of the donated organs in respect of the donors. The clinical practice of taking patients onto the waiting list for organ transplantation and organ distribution is subject to legal requirements, professional, and ethical standards. However, despite legal and semi-legal framework and medical standards, there still remains a certain scope of discretion for physicians. Medical guidelines and
34
Faculty of Medicine, Institute for History and Ethics of Medicine, University of Heidelberg and bDepartment of Gastroenterology and Hepatology, University Hospital Heidelberg, Heidelberg, Germany Key words: allocation – ethics – liver – MELD score – transplantation Corresponding author: Prof. apl. Dr. Monika Bobbert, Dipl.-Psych, Institute for History and Ethics of Medicine, Im Neuenheimer Feld 327 – 1. OG, Heidelberg D-69120, Germany. Tel.: +49 6221 545458; fax: +49 6221 545457; e-mail: [email protected] Conflict of interest: None. Accepted for publication 2 April 2013
routines and the scope of discretion increasingly have to withstand the critical observation of different psychological, ethical, legal, and medical aspects (2). Therefore, an interdisciplinary discourse is required due to our responsibility to the individual, to the group of patients who need an organ and to the public. The organ allocation in Germany is organized by Eurotransplant, since December 2006, the organ allocation is priorized by the Model for End Stage Liver Disease (MELD) score (3). The MELD score is calculated from three medical parameters (creatinine, bilirubin, and INR) and makes a valid statement about the three-month mortality of patients on the waiting list for liver transplantation. The MELD score is generally objective, although it is possible to manipulate the MELD score of any individual patient through clinical actions and thereby increase the chance of organ allocation: for example, by forced dehydration, hemodialysis or other therapy which is not clinically indicated for the patient, but designed to alter the MELD score (4). Before the introduction of the MELD score, the organ procurement was performed with a greater emphasis on waiting time. The present organ
Ethics of liver allocation allocation according to the “sickest-first” principle has led to a decrease in mortality on the waiting list. On the other hand, due to this regulation, in view of the organ shortage, the performance status of patients receiving an organ is on average getting worse. This has led to an increase in mortality, but also of morbidity after liver transplantation in all German centers (5). The MELD score makes a strong statement about the urgency of need for a liver transplant, but the prospect of success is not adequately addressed. This raises, however, new medical issues, and there is a need for a thorough ethical debate on how to balance urgency, chances of success (morbidity/mortality), and latency in the light of equal opportunities for all patients. It is precisely the sickest patient who most urgently needs the organ and often has the worst prospect of success. On the other hand, these are also recipients who have in some cases the largest benefit of the transplantation (6). Finding a balance between the greatest possible individual benefit and maximum benefit for all is, therefore, still an unmet challenge (7). Thus, the development of guidelines, which both reflect the individual patient’s benefit, but also his risks and prospects of success in the view of all patients on the waiting list, is essential. But the care for the individual patient must not be compromised by the physician’s responsibility to the whole community of patients listed for transplantation. Therefore, this article will focus on regulations and decision-making processes which accomplish these tension-filled goals.
Necessity of ethical reflection in transplantation medicine Moral intuition, professional ethos, and medical ethics
Physicians’ decisions and regulations must be based on moral grounds and arguments, which are reasonable to accept, that is, clinical, authoritative, or pragmatic reasoning alone is insufficient. In discourse, the persuasive power of the better ethical argument is decisive. The necessity for such arguments is also evident considering divergent moral intuitions of clinicians, discussions in expert circles, and questions from patients and the public. In medicine, one must differentiate between medical ethics, a particular professional ethos, and moral intuitions. Medical ethics as a discipline of practical philosophy deals with questions that are controversial to assess in moral terms. In these cases, the medical profession does not per se have a particular assessment competence. The professional ethos in medicine draws back on internal convic-
tions of the profession that are limited thereto. The moral intuitions of attending physicians take effect when there is a leeway in decision-making or in unregulated fields. They, however, have to be open to further moral reflection if the decisions and actions of others are concerned. This is the case with organ transplantation. It is therefore necessary to provide arguments for regulations and courses of action, which can be reasonably accepted. Scope of decision-making in post-mortal liver allocation
In Germany, the organs of brain dead patients are distributed in accordance with the criteria developed by Eurotransplant and the guidelines of the German Medical Association (German: Bundes€ arztekammer). Physicians, however, have a certain scope in decision-making, for example, they are “gatekeepers,” when deciding on including or excluding a patient from the waiting list or when deciding on whether a patient is “transplantable” or not.
Two ethical approaches in discourse: urgency of need or prospect of success as primary distribution criteria Right-based (deontological) approach – urgency of need
In health care, the moral obligation to save life has a very high priority regardless of the fact that doing so might only have a limited prospect of success. This ethical norm is the main argument for the priority of urgency of need (respectively “sickest-first”) in liver transplantation. Only the individual patient’s potential suffering by transplantation would be the obstacle to transfer an organ (8). Every human being has the same value, regardless of attributes such as race, sex, or social status (9). This in turn means that one life cannot be weighed against the other. No human life is worth more than another, also not in terms of estimated remaining life expectancy. This argues against the approach that one should save the largest possible amount of human lives and that the death of many people was much worse than the death of few. It is strengthened that if one person of a group of five dies, the loss for them is no greater because four other people happen to die as well (10). In objection to this argument, in transplantation medicine it is frequently stated that needy, multimorbid patients who receive transplants often die post-surgery, resulting in the loss of the organ. Thus, this organ would also be lost for other patients.
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Bobbert and Ganten Utilitarian (teleological) approach – prospect of success
A utilitarian approach, focusing on maximizing net benefits, is based on the norm that such actions are to be taken that are the most beneficial to the largest number of affected parties (11–13). One or a few humans’ lives may be sacrificed if a large number of lives can be saved as a consequence. Partly in favor of this argument, it is often claimed that in transplantation medicine, there is only a limited number of organs from brain dead patients and that this scarce and valuable resource should be used as advantageous as possible, for example, to maximize the total amount of life years. This means that a patient who would almost certainly live longer should be favored over a patient whose life expectancy is not as high (14). It is frequently argued that the moral obligation to help all patients to an equal extent is undermined by this approach. Mediatory approach
A “moderate” deontological approach could mediate between the two extremes. A right-based approach is needed, which is not blind to the consequences of actions and regulations in transplantation medicine, that is, an approach that under certain conditions incorporates prospect of success in the ethical deliberation. To this end, “success” and which measure of success is to be used in organ allocation must be discussed and defined. Indicators for success in transplantation medicine and ethically relevant value judgments
In looking at possible indicators for success and considering who the “affected parties” are and whose success is to be maximized, it is obvious that any attempt to define success contains value judgments. A descriptive statements or a certain focus of selection is ethically relevant, when particular moral norms or values are presupposed. Thus, possible valuations need to be made explicit and need to be based on solid argumentation. Different “affected parties” and indicators for success
First of all, it must be defined whose success is to be considered or maximized: for example, that of the individual patient, who needs a lifesaving organ, that of a collective of patients, that of surgeons or internists in transplantation medicine, that of a transplantation center, that of the national healthcare system? Furthermore, a defini-
36
tion is needed from an ethical point of view as to what qualifies as success or “quality.” In clinical practice and in medical literature, a variety of target criteria can be found, for example, a painfree end of life phase, no death during surgery, no post-operative complications, no organ rejection, three-month, one-yr, and three-yr survival or posttransplant quality of life. However, maximizing different criteria of success to some extent also means treating different groups of patients. On the one hand, as predictions of success in medicine are not deterministic but merely probabilistic, scoring systems such as the MELD score and expert medical estimations on post-transplant life expectancy and long-term survival must be questioned as to their validity, reliability, and thus, predictive value. On the other hand, it must be taken into consideration that statistical correlations found in empirical studies do not allow any predictions for the case of an individual patient. Probability prognoses relating to patient groups and their “application” to individual patients must be assessed from an ethical point of view, as it contains a value judgment whether a 50% or 80% probability of success is sufficient to justify a transplantation. Value judgments and controversial decision-making bodies
From an ethical point of view, it is controversial when a center’s transplant physicians, expert circles, or institutions of quality assurance define indicators and probabilities of success and thereby decide which patients qualify for transplantation. In Germany, the quality of transplant centers is assessed via a national analysis report since 2005 (15, 16). For liver transplantations, a variety of so-called quality indicators are specified, for example, “death due to surgical complications,” “in-hospital lethality,” “post-operative complications” (using length of stay as a surrogate parameter), and one-yr, threeyr, and five-yr survival. Transplantation centers compete with each other to a certain degree, and a national quality database requires them to maintain a specified performance level. In case of larger deviations, they are required to make a statement. Perioperative death can in part be attributed to operative care and should indeed be avoided. However, in addition to quality of care, there are other factors related to the individual patient that contribute to in-hospital lethality and complication and lethality rates, namely previous overall condition, co-morbidities, infections or side effects of immunosuppression, and the quality of the transplanted organ. When transplantation centers aim for one-yr survival rates of approximately
Ethics of liver allocation 80% to 90% due to so-called quality figures, this pragmatic or economically motivated regulatory function leads to implicit moral decisions, concerning which patient receives an organ transplantation (2, 5). As a result, there is a strong incentive for the centers to use the existing scope to choose patients based on prospect of success. This could lead to a shift toward more low-risk transplantations. Transplantation centers could favor healthier patients with a greater likelihood of survival for transplantation over needy patients in a very bad overall condition or with other aggravating factors, who as a result have a lower life expectancy. However, this implicit regulatory function by “quality” assessment must undergo critical consideration, because this could lead to a practice which is detrimental to the overall goals. In addition, it is ethically controversial that liver transplants from brain dead patients are distributed to the transplantation centers via Eurotransplant’s standard European allocation procedure, but approximately 30 up to 50% of the transplants are rejected (2). This is in part the case because physicians worry that the suboptimal quality of a transplant might not lead to the desired success with the patient at the top of Eurotransplant’s (computer generated) match list, often because the patient’s high MELD score means that he is in an overall bad health condition. If two centers reject an organ because of its poor quality (in view to a patient in bad health condition), it is assigned to a regional transplantation center in an accelerated placement procedure (a so-called rescue allocation) (17, 18). With this center-based allocation, physicians and transplantation centers have greater discretionary decisions and can choose a patient for transplantation regardless of their MELD score. In this procedure, it is problematic that not only medical factors but also a wide range of other factors can play a role. Although the basis for the decision must be documented, the doctor–patient relationship could compromise an impartial transplant allocation. In addition, urgency of need as a decisive factor could be forced into the background. This procedure could be potentially problematic if a large proportion of liver transplants are allocated that way thereby converting the exception into a second “standard procedure” without, at the same time, guaranteeing the socially accepted and transparent distribution criteria of Eurotransplant. Ethically relevant facts and judgments
Whose success is to be measured and who defines which criteria are to be met for success are questions that cannot be answered from a mere prag-
matic or medical point of view. It is ethically relevant whether a transplant physician or a transplant center aims for “survival of the sickest” or “survival of the fittest.” It is equally relevant from an ethical point of view whether doctors, patients, lobby groups, or representatives with democratic legitimization define success criteria. Establishing success margins using statistics for quality assurance or the competition between transplantation centers can implicitly override ethically wellfounded allocation criteria. This should not occur without analyzing and critically discussing the effective distribution criteria.
Profile and conclusions of a mediatory approach Survival and well-being of individual patients as primary goal
In an ethical approach that attempts to mediate between the urgency of need and prospect of success, “benefit” and “success,” respectively, must take into consideration the individual patient and not the benefit for society or an abstract benefit, for example, the amount of life years gained. In addition, physicians must, to the best of their knowledge, aim to save as many of the “sickest” patients as possible. Good transplantation statistics are not an indicator of success and of ethical rightness per se. The definition of a statistically acceptable mortality rate, estimated by a score, is a difficult decision, because it would ultimately regulate to which extent critically ill patients who need a liver transplant are given a chance of survival. The mediatory approach – presented as follows – starts with a right-based approach which is based on individual moral rights according to the ethical theory of Alan Gewirth (9). This approach strengthens the right of an individual patient to get medical help in the case of a life-threatening situation. Foremost, the duty of a physician emerges as “passive” respective “negative”: He must refrain from inflicting basic harms to the patient. This means at least that the chance to benefit from organ transplantation should be higher than the chance to benefit from “conventional” medical or no therapy at all (e.g., “watch and wait”). Thus, first of all, physicians are asked to do their very best to estimate the surgery’s outcome and to compare this treatment option with treatment alternatives in regard to potential individual risks and benefits. Secondly, physicians have the “positive” duty to help in a life-threatening situation as long as they have measures to overcome such a health crisis. As in transplantation medicine, there is permanent
37
Bobbert and Ganten
shortage of means – in this case, organs – a physician cannot be sure to have an organ at his command to save a patient’s life. Thus, taking his task to save lives seriously, the physician should try to “keep” a liver transplant for patients who will not die soon after transplantation. Beyond that, it will be argued in the following why physicians may be allowed to take into account some potential consequences of measures of medical support. More precisely, in liver transplantation, physicians are allowed to take into account whether the potential survival of a patient will supposedly be only for a very short time (e.g., some days or just a few weeks – so to speak an organ transplantation being a “death-prolonging” measure) or whether a patient has a “more or less good” chance to prolong his life in the sense of overcoming a life-threatening crisis of health. As physicians do not know beforehand what will happen to an individual patient, they try an approximate estimate as clinician or they estimate more “objectively” by a score. It must be mentioned that post-operative scores only manage to give rough estimates for three-month periods; thus, there are pragmatic limitations of predictions of high quality. As scores deliver probabilities, they express chances to survive or to die, but they are not able to predict what will happen to the individual patient. Furthermore, it is not possible to give reasons in detail for at what point life prolongation can merely be regarded as delaying death and at what point it can be regarded as gaining life. Reference to a mediating rule of proportionality can be justified because other patients on the waiting list are also in a life-threatening situation. According to Gewirth’s theory, it can be argued that physicians have the duty to help an individual patient if there are effective means, if the means are under one’s proximate control, and if the physician can give assistance at no comparable cost to himself. By “comparable” cost is primarily meant that the physician is not required to risk his own life or other basic goods (9). It might be argued additionally to Gewirth’s theory that in regard to organ transplantation not the individual physician, but other patients on the waiting list would have even more than “comparable” costs if a patient would get a liver transplant just for “death-prolonging” goals – whereas another patient’s life could be saved. For not resulting in “incomparable” costs for other patients who could be saved from a lifethreatening crisis, the introduction of a mediating rule of proportion in the sense, that the goal of survival should not just mean survival for a few more days or several weeks, might be introduced into organ distribution deliberation.
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Another aspect – which is not so much the idea of Gewirth’s theory, but in the logic of the norm to save life – is that for the sake of realization of the norm’s goal, it makes no sense to follow the norm “blindly.” But taking into account the consequences of strictly following a moral right means to save as many patients who are in an acute lifethreatening situation as possible at the one hand does not mean to maximize life years per se on the other hand. Therefore, the latter would not be in the sense of a right-based approach nor the proposed mediatory approach. In view of shortage of organs, not only the individual physician but also the healthcare system is restricted in the capability to give assistance in case of organ failure. Taking into account this situation, a mediatory ethical approach will strengthen: The medical means of organ transplantation should not be used as another technical and pharmaceutical means of an intensive care unit to prolong life although dying is presumed to be close. Instead, organ transplantation as means should be seen as a lifesaving measure – with lifesaving of more than just a few days or several weeks. The intermediate moral rule of proportion would say that providing a liver transplant should happen with a certain probability of success to live longer by this intervention. But a mediatory approach with its focus on individual moral rights only implies to save other patients who are in an acute life-threatening situation. And this approach cannot deliver a precise cutting point for the minimum probability of survival. Development of prognostic scores for post-operative outcome and aspects of social justice
One instrument to help physicians to approximate more objectively and also impartially the chance of a patient to be saved for a relatively longer period of time than “only” a short, “death-postponing” time might be the development of a statistically based prognostic score of the post-operative survival. Different scores are discussed including the SALT score (5), D-MELD estimating the postoperative outcome based on MELD and donor criteria (19, 20), and the SOFT score which predicts the probability that the patient will survive the first three month after liver transplantation (6). The SOFT score includes 13 recipient-related factors (among others BMI, age, and cardiovascular comorbidities of the recipient), four donor-related factors (among others the age of the donor), and two surgery-based factors (among others cold ischemia time) (6). Unfortunately, none of these scores can predict post-operative outcome good enough to be
Ethics of liver allocation a solid base from which a “futility” score could be routinely used. Nevertheless, physicians are looking for an optimization of prognostic post-operative scores supporting individual clinical judgments to become more objective – also in the sense to support clinicians to be impartial in the face of caring for individual patients. In regard to developing prognostic scores for post-operative outcome, questions of justice arise if “causes” respective – precisely speaking – correlations indicating multiple factors of social inequality would be multiplied by usage of a score. From an ethical point of view, it must be questioned if correlation factors such as sex, ethnic group, education level, or income should be used for prognoses. The SOFT score, for example, contains sex and race as predictors (5), some SOFA score-based models for predicting mortality in the intensive care unit contain education level or income (21), some rating scales, for example, TERS, for evaluating organ transplant candidates contain prior psychiatric history, health behaviors, family support, and prior history of coping (22). Thus, before developing and adjusting a prognostic score for the probability of post-operative survival a critical reflection about the items of such scores should take place – from a medical, but also from an ethical point of view. Finally, it would be left the question which chance of a three-month post-operative survival would be the decisive point to allow a patient to undergo an organ transplantation. Ethical argumentation can give good reasons for some “corner pillars” of distributive justice but ethical argumentation will supposedly not be able to give reasons for a certain decisive cutting point. Thus, this question should be passed over to democratic decision-making – also with regard to the question if transplantation medicine should have high or lowered priority in health care.
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Acknowledgements We thank the Heidelberg University Marsilius-Kolleg – this article is the result of an interdisciplinary fellowship of the Marsilius-Kolleg. We thank our cooperation partner, Prof. Dr. iur. Gerhard Dannecker, Heidelberg, and Dr. med. Sylvia Brost for inspiring discussions.
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