Xenotransplantation - Nuffield Council on Bioethics

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Animal-to-Human Transplants : the ethics of xenotransplantation 7.11 As set out above, the initial trials to xenotransplant organs will be major and risky procedures. This suggests that it would be justifiable to offer organ xenotransplantation only to patients for whom there is no alternative form of effective treatment. This would apply to many heart patients, whose lives are at risk and for whom the shortage of human organs is acute. The lives of most kidney patients can be maintained, albeit uncomfortably, on dialysis. For some people with renal failure, however, accessing the vascular system becomes extremely difficult and, eventually, dialysis may no longer be possible. The potential, albeit small, risk that xenotransplantation will transmit new infectious diseases to the population at large must also be considered (paragraphs 6.16 - 6.19). It would be hard to justify posing any potential public health risk unless the first xenografts were used to save the lives of people with no alternative possibilities of treatment. 7.12 Another issue is whether it would be unethical to transplant certain types of animal organ or tissues into human beings. One respondent drew a distinction between material “of a ‘mechanical’ (for example, heart muscle) rather than ‘personal’ (for example, neural material) character”. 9 <strong>Xenotransplantation</strong> of neural tissue has been proposed as a possible treatment for Parkinson’s disease. In the US, four Parkinson’s disease sufferers have already received xenografts of pig fetal neural cells. 10 It is hoped that the cells of the xenograft will produce the neurotransmitter dopamine that is deficient in Parkinson’s sufferers. If successful, this would cause a very specific pharmacological change in the brain. Consequently, the Working Party considers that neural tissue xenografts should be regarded in the same way as any other xenograft intended to restore the body’s physical function. <strong>Xenotransplantation</strong> with the intention of changing aspects of someone’s personality is almost certain to remain technically impossible, and would certainly be ethically unacceptable. 11 The unlikely prospect of attempts to alter the germline by xenotransplantation would be equally unacceptable. 12 7.13 If xenotransplantation of neural tissue were to be successful, it might reduce or eliminate the current use of human fetal neural tissue for transplantation. This material comes from aborted human fetuses and many would see a reduction in its use as desirable. In this respect, some would argue that xenotransplantation would reduce the ethical difficulties associated with neural transplantation. As set out in Chapter 4, however, there is a contrary view that using animals to treat human beings is equally, if not more, unacceptable (paragraph 4.13). 9 A point made by Professor John Polkinghorne in his submission to the Working Party. 10 Parkinson’s pig cure. The Times, 15 December 1995. 11 A view expressed in several submissions to the Working Party including those from the Christian Medical Fellowship, the Church of England and the Methodist Church. 12 A view expressed in submissions from the Joint Ethico-Medical Committee of The Catholic Union of Great Britain and Guild of Catholic Doctors, the Methodist Church, the Royal College of Obstetricians and Gynaecologists. 86
Early patients Consent considerations 7.14 It will be ethically acceptable to offer xenotransplantation to individual patients only when it has been decided, by the procedures set out above, that the results using animal recipients merit starting human trials. At this stage, the question becomes how best to protect early patients’ welfare and interests. The principal problems that may arise with the early use of xenografts in human beings include: possible suffering for perhaps limited, if any, therapeutic benefit; the raising of unjustified expectations even when every effort is made to explain honestly the low likelihood of success in early cases; poor quality of life that might follow only a semi-successful use of xenografts; the possibilities of disease transfer across species, which would be an unknowable risk for early patients; and the consequences of the need for health monitoring for those who are recipients. It is likely that the first xenografts will be offered only to those with little chance of surviving without it. But these people, who are facing death, require particular protection from over-optimistic or reckless experiments. 7.15 It is a paramount principle of contemporary medicine that patients should give properly informed consent to any treatment or therapeutic research, and that human volunteers should give properly informed consent to participation in research. People should be in a position to make a decision on the basis of proper information and without pressure, so that participation can truly be said to be voluntary. Where possible, people should make decisions for themselves. Alternative safeguards to protect people who are not considered capable of consenting on their own behalf are considered below (paragraphs 7.22 - 7.26). The Department of Health’s 1990 circular, A guide to consent for examination or treatment, defines the patient’s right to information in the following way: “Patients are entitled to receive sufficient information in a way that they can understand about the proposed treatments, the possible alternatives and any substantial risks, so that they can make a balanced judgement. Patients must be allowed to decide whether they will agree to the treatment, and they may refuse or withdraw consent at any time.” 13 7.16 As with any other procedure, it is of the utmost importance that potential patients give free and properly informed consent to participation in the first xenotransplantation trials. The Working Party foresees the following problems with regard to consent to xenotransplantation. First, the risk/benefit ratio of the procedure will be hard to assess in the early stages, because of its novelty. There may be good reason to believe on the basis of experiments using animal recipients that using transgenic animal organs will allow successful xenotransplantation. But 13 NHS Management Executive (1990) A guide to consent for examination or treatment. London: Department of Health. p 2. 87
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Preface Preface Since the N
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Working Party on Xenografts Working
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Xenotransplantation</strong
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Xenotransplantation - Nuffield Council on Bioethics

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