Controversies in the ethics of organ transplantation

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Controversies in the ethics of organ transplantation




Introduction




• Clinical transplantation remains a relatively young field, yet it has created considerable ethical debate. Development of clinical programmes has required the rapid parallel development of ethical frameworks to justify the steps taken in the name of patient benefit.


• In many ways, the rate of technological advance has exceeded the development of the ethical, cultural and legal framework within which transplantation takes place. This has resulted in a variety of fascinating ethical debates but also represents a barrier to fully realising the potential of transplantation.


• All transplant professionals have a responsibility to be aware of the many ethical issues that surround transplantation and organ donation. It is also desirable for such professionals to be familiar with the terminology used to describe and discuss the ethics of transplantation.


• Good ethical practice should always be integral to efforts made to advance the science of transplantation. Interaction with stakeholders, lawmakers and those who determine public policy will be essential to the development of optimal future programmes.



Key terminology




Other terms




Deontology From the Greek ‘deon’ meaning obligation or duty. The ethical position which judges the morality of an action or belief on its adherence to a rule, e.g. ‘do no harm’ or ‘always strive to save a life’.


Consequentialism Contrasts with deontology; judging the morality of actions according to their consequences.


Utilitarianism The ethical position that the value of a particular course of action is determined by how much ‘good’ or happiness results, the total ‘good’ usually referring to the world as a whole.


Altruism In a transplant context, the voluntary wish of the individual to make the ‘gift’ of donation of their organs (or equivalent) without expectation of reward.


Dignity A complex and difficult term to define but, in this context, one reflecting the unique and precious status of the human being and the ethical requirement not to treat the individual disrespectfully or harmfully in both life and death.


Futility A concept that relates to a patient who has reached a point when there is no realistic prospect of a successful outcome, whatever their medical care.


Equity The concept of fairness/justice often used in connection with the way organs are allocated and utilised. Also applied to access to transplant for different individuals.



Death, organ donation, patient autonomy and the choice to donate


While living donation has been integral to kidney transplantation for decades, deceased donors have always constituted the majority of transplant activity. Death and its diagnosis seemed a simple and easily understandable concept until complex modern intensive methods and care of transplantation forced society to question it in more detail.


If doctors are striving to save the life of a patient, and yet there exists a possibility that the patient must die and donate their organs (so that other patients may be helped), there may be a perceived conflict of interest for the responsible physician. To avoid this, a clear separation between medical care in life and the facilitation of deceased donation has been established. The pivotal component of this is the establishment of death.



When does death occur?


Substantial ethical debate surrounds the exact definition of death and this is reflected in the variability of definition between societies.1,2


Standard clinical tests for the certification of death include the absence of circulation, respiration, any response to pain or pupillary response to light. However, these tests require a valid setting and need to be confirmed over a sufficient length of time in order to ensure no reasonable possibility of spontaneous reversal. Brain stem death3 allowed certification of death based on irreversible loss of brain stem function. This complex and intensively scrutinised mechanism for individuals to be declared legally dead has allowed organ donation even when the donor has a beating heart and viable organs maintained via mechanical ventilation.


The key ethical principle is that donation should proceed only after death has been established and no prospect of spontaneous autoresuscitation exists.4


Similarly, the decision to cease attempts at life- preserving treatments should be taken in a manner independent of considerations relating to organ donation and be based purely on the concept of patient benefit.


The idea of brain death remains a focus for ethical debate despite its long enshrinement in law. Initially the term ‘brain dead’ was applied, yet the demonstration of viable neuronal tissue was cited as a refutation of this as a valid state of death. This led to a change of terminology, with ‘brain stem dead’ being the currently accepted expression.5


The management of patients to facilitate organ donation either through the donation-after-brain stem-death (DBD) pathway or the alternative donation-after-circulatory-death (DCD) pathway remains one of the biggest ethical debating points of 21st century transplantation and intensive care medicine.


Guidance on the determination and diagnosis of death can be found in the Academy of Royal Colleges Code of Practice for the Diagnosis and Confirmation of Death (2008);6 however, there remains no statutory definition of death in the UK and the working definition, ‘the irreversible loss of the capacity for consciousness combined with irreversible loss of the capacity to breathe’, put forward by the Department of Health, seems both practicable and socially acceptable. However, further clarification of this definition may be of benefit to all stakeholders.



Futility, the patient’s best interests, and the decision to withdraw life-sustaining treatments


In a situation where organ donation may be feasible, what constitutes a potential donor’s best interests? Before organ donation and transplantation, it was accepted that when a stage of futility was deemed to have been reached, further life-prolonging interventions were not in a dying patient’s best interests. This was observed in the early days of transplantation, when continuing intervention was seen as unethical as these interventions were not designed for the benefit of the potential donor. This debate was particularly fierce around the issue of elective ventilation, with a historical conclusion that this was not an ethically desirable course of action.7


However, the nature of futility itself may have been changed by the very existence of the possibility for organ donation. Few citizens in the developed world are unaware that donation of organs after death is a possibility. In the UK, originally through the organ donor card system and more recently through the organ donor register (ODR), the opportunity to document one’s wishes relating to organ donation has become increasingly accessible. This opt-in system has donor autonomy at its heart. In states like Spain, however, opt-out is the legal norm,8 when the individual must record a wish to opt out of organ donation or it will be assumed that the wish is to go ahead with this action. Other options such as mandated choice come somewhere in between, and the desirability and likely effect on donation rates of each system are widely debated.9 What is certain, though, is that the stated, informed and autonomous wish of a competent, living person to donate their organs can be regarded as a form of mandate to advance organ donation, even if this action may include interventions traditionally considered futile and therefore unethical.


In this context, what we mean by ‘best interests’ is less clear-cut. Many – including these authors – would regard it as unethical for a medical practitioner to withhold interventions designed to facilitate the successful donation of an individual who had expressed a clear wish to donate. However, this is not a simple argument. In the context of a highly pressured national intensive care service, efforts to facilitate organ donation from the dead or for those who will inevitably become dead may compete directly for human and material resources, in caring for the living. This argument is made doubly complex by the fact that third-party patients whose lives may be saved by the organs of the former group die on a daily basis. This ethical standpoint is dynamic across the healthcare professional spectrum and regular review will be beneficial to the working practices of the health service and to society as a whole.



Donor pain, distress and individuals’ rights after death


Invasive but potentially life-saving interventions such as intubation and cardiopulmonary resuscitation have the capacity to cause pain and distress to an individual. Administering measures like these in attempting to save an individual’s life is clearly ethically justifiable. But if the measures are contemplated in a patient who is deemed to be irreversibly dying in order to maintain tissue perfusion to facilitate organ donation, the ethics are not so straightforward.


In the UK, the Human Tissue Act (2004) and Human Tissue (Scotland) Act (2006) legally sanction ‘the minimum’ necessary steps to preserve organs in a state that allows successful donation.10,11 The principles of non-maleficence and individual dignity suggest that ethically only the least invasive methods and steps should be taken to preserve organs after death. It must be recognised that advancing technology may redefine and perhaps increase the ‘minimum’ necessary steps. Additionally, the overall process of donation should also respect the individual’s right to continuity of care, particularly with reference to access for relatives and communication/explanation of events.


Beyond the isolated concept of elective ventilation, perhaps the central ethical conundrum surrounding deceased donor transplantation is whether facilitation of a stated wish to donate provides ethical justification for interventions that may be considered futile in live-saving terms. The autonomy of the individual who has described a wish to donate would support interventions – even if theoretically painful or undignified – in order to fulfil their stated desire. The widely expressed view that death denies the individual ‘rights’ in the legal sense is at odds with the way in which we handle an individual’s last will and testament, and in purely ethical terms it must be seen as reasonable to go to some lengths to honour an individual’s wishes after death.



The conflict between donation and dignity in death


In the context of DBD, organ retrieval occurs in an operating theatre after confirmation of death has been carried out following the performance of brain stem tests.


Hypnotics and muscle relaxant medications are frequently employed. Controlled donation after circulatory death follows a period during which supportive treatments, often mechanical ventilation and inotropic cardiac support, are withdrawn. During this period there is an ‘agonal’ phase during which respiratory distress, movements consistent with discomfort, etc. may be observed. These findings may be detected whether or not the individual goes on to be an organ donor but this situation is ethically complex. The following considerations are germane and need to be weighed against each other:



Clinical protocols and individual conduct have evolved – and continue to evolve – to reflect a balance between these factors.



Relatives’ right to veto the act of organ donation


As noted above, different legislatures across the globe have approached the individual’s right to request organ donation by framing laws that are generally based on one of two principles. ‘Opt-in’ requires that the individual somehow records or comments, during life, that they would wish to be a potential organ donor. The opt-out system assumes that the individual does want to be a donor, given the appropriate circumstances at the time of their death, unless they have specifically opted out of the state organ donation system. Nuances apply in different countries. For instance, in Scotland, which has a slightly different law to the rest of the UK, the Human Tissue (Scotland) Act 200611 enshrines the concept of authorisation for donation that does not insist upon full informed consent but accepts that an individual may wish to indicate their advance directive towards organ donation. In such circumstances, the registration of a citizen on an organ donor register has much greater legal force and, at least in theory, carries legal primacy over the wishes of the next of kin. However, over a 5-year period from 2005 to 2010, 7.1% of all cases of potential deceased donation in the UK had a full or partial caveat placed on the organ donation process by relatives. No organ donation/transplant clinician would directly countermand the views of relatives in this difficult situation and it is, of course, quite possible that an individual might have rescinded their views, expressed on something such as an organ donor register, and it would then be expected that the next of kin would be the conduit for such a change of view coming to light. However, the likelihood is that the family member is countermanding the views of their loved one for a whole host of different reasons, including their own understanding of organ retrieval and donation. Even in countries with an opt-out system, it would be highly unusual for donation to proceed in the face of strong objection from a next of kin.12


Once again, this aspect of deceased donation brings an ethical tension between individual autonomy (the right of the citizen to decide what happens to their organs following death), non-maleficence to the family who might experience further extreme distress should their views not be taken into account and the utilitarian view that organs should be removed in all such circumstances for the greater benefit of society. Each country has achieved a reasonable compromise based on societal and cultural beliefs but it is acknowledged that such levels of compromise may need to be revisited from time to time as a change in societal view or need for organ donation evolves further.



The paradigm of uncontrolled DCD donation – still with ethical challenges


In any discussion with the general public concerning organ donation, it is commonly assumed that in circumstances where an individual is involved in an accident, is then taken to hospital and attempts are made for resuscitation but that resuscitation is unsuccessful, then the possibility of organ donation may be carried out. However, the truth remains that perhaps the largest group of missed potential organ donors are those who might potentially donate through an uncontrolled donation after circulatory death programme, as occurs in Spain, the Netherlands and parts of the USA.


Uncontrolled DCD donation includes a number of additional components that raise important ethical questions. The majority of this potential donor group either suffer sudden cardiac arrest in the community and are brought into hospital whilst undergoing cardiopulmonary resuscitation or suddenly arrest inside the hospital. This situation evolves far more rapidly than the majority of donations after brain death or controlled donations after circulatory death.



Early approach to the bereaved


The rapid approach to relatives that is required to obtain consent or authorisation is challenging. There is a moral balance to be struck – whilst it is important to respect the autonomy and altruism of a person who may have discussed or documented their wish to donate, it is important to be sensitive to the additional distress that may be caused by approaching newly bereaved next of kin.


The experience and expertise of the UK Specialist Nurse in Organ Donation (SNOD) network is central to the successful negotiation of this difficult situation. Evidence suggests that the approach regarding donation to relatives following death of their loved one is actually most often a comfort and rarely the cause of additional distress.12,13 This is clearly the case in the Netherlands and Spain, where uncontrolled DCD is well established.14 The cultural acceptability of this donation pathway in the UK remains to be confirmed on a large scale.



Pre-consent preservation measures


Uncontrolled DCD cannot proceed successfully without employing external preservation measures designed to maintain organ quality. These include external mechanical chest compression, in situ peritoneal cooling or, more recently, in situ perfusion of organs via a femoral cannula.15 These interventions must be instigated rapidly, frequently before the next of kin can be consulted. The Organ Donor Register provides a valuable resource in the context of uncontrolled DCD. If an individual has documented their desire to donate, pre-consent preservative measures can be ethically justified as the patient’s autonomy will have been respected.


If the deceased’s wishes were unknown at the time of presentation, it could be argued (less robustly perhaps) that the instigation of pre-consent organ preservation measures protects the right of the individual to donate until the next of kin can be consulted. The legal requirement for ‘minimum’ preservative steps is equally ethically applicable in this situation and must also be withheld until death is certified.



Preservation measures and the potential to restore cerebral circulation


Ethical concerns exist regarding the potential for preservative measures to restore cerebral circulation. Such restoration can create a grey area in which the status of the potential donor as truly dead may be in question.16 This returns us to the problem of the definition of death. DBD donors may have excellent cerebral blood supply but are deemed to be unequivocally dead, so cerebral perfusion per se is clearly not ethically incompatible with death and donation. This area of controversy must be further clarified to allow protocols that ensure unambiguity of the state of death and that ensure that ethical concerns regarding cerebral reperfusion are adequately considered. Of course, the problem may be with the preservation method and not the definition of death.



The extremes of deceased donation


In certain societies, the routine use of organs from executed prisoners has been documented.17 The majority of transplant professionals would regard this as morally highly dubious; less extreme examples of potential donors and their ethical acceptability continue to provoke debate. In certain European societies, assisted suicide is legal and it has been possible for such individuals to become organ donors.18 Assisted suicide is illegal in the UK but this may not always be the case and changes in law around the care of individuals at the end of life often have significant implications for transplantation.


The term ‘persistent vegetative state’ (PVS) is a concept that falls outside the current legal definition of brain stem death, yet is a state of such severe cerebral injury that its nature provokes debate around the definition of death. Some would argue that to remove organs from such individuals would constitute murder. Others argue that life is defined by the capability of the individual to interact with the wider world and that, given individuals in a PVS are incapable of this, they should be regarded as dead and therefore as potential deceased donors.19 These extreme examples are currently the province of the philosophical world. If clinical transplantation has proved anything in its short lifetime, it is that what seems purely abstract and philosophical can very quickly become material to everyday decisions.



Allocation of organs


The concept that the organs of someone who has died can be preserved and transplanted into another person was initially unproblematic in ethical terms. The pioneers of transplantation identified specific recipients on the basis of urgent need and directly allocated a suitable organ when it became available without a specific process. This, despite frequent local objections, was accepted. The current situation could not be more different. Thousands of people wait for an organ from a limited pool of donors. This situation has forced societies to consider how organs should be allocated and to develop ethically and legally approved systems of organ allocation.


This remains an area of substantial controversy. The UK organ allocation systems are subject to regular review, recognising that the parameters must regularly be re-evaluated in the context of society as a whole.


Urgent clinical need remains the most unambiguous parameter and this is accurately reflected in the UK’s systems of allocation for liver and heart transplants. In these cases, the potential recipient must be certain to die without a suitable graft and their clinical status defines their priority as ‘super urgent’ and above all other potential recipients who have more physiological reserve. This category may provoke ethical controversy if applied to slightly less urgent cases, since status may rest on physiological parameters that are modifiable, meaning actions to improve the recipient’s clinical status may alter their status score (e.g. MELD/UKELD in liver transplantation) and have implications for priority of transplant allocation.


However, most organs are not allocated in this way. In the case of the most frequently transplanted organ, the kidney, patients are invariable clinically stable and often in receipt of life-preserving treatment in the form of dialysis. Renal transplantation is therefore not immediately life-saving but is life-prolonging and associated with an improved quality of life.


So to which of the several thousand deserving patients on the waiting list should a given kidney be allocated? Clinicians would not agree, nor would there be universal agreement between any section of society or indeed key stakeholders such as the patients on the waiting list.


Many factors must be considered in making the allocation decision, but the key parameters are outlined below.



Benefit (utility)


Organs should be allocated to ‘do maximum good’ in terms of providing the best outcomes for patients. This may not equate to optimising the outcomes for an individual transplanting centre.


‘Maximum good’ should refer to the greatest benefit for the whole cohort of patients on the National Transplant Waiting List for that organ and is probably best – if imperfectly defined – in terms of the number and quality of life-years gained for the intended recipient.


This concept has important implications for the decision to list patients or to remove them from the active waiting list. Ethically, it is essential that efforts are made to define a threshold at which transplantation of a given organ ceases to be sufficiently beneficial and that this is regularly applied to all potential recipients. It must be accepted that the level of scientific evidence relevant to this area leaves something to be desired. Furthermore, constant re-evaluation is necessary in the light of a dynamic balance between organ supply and demand and the changing technology of transplantation as a whole, which has forced us to regularly redefine the limits of its benefit.

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Jul 23, 2016 | Posted by in Aesthetic plastic surgery | Comments Off on Controversies in the ethics of organ transplantation

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