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Book Review
Xenotransplantation: Law and Ethics
Craig Fry
ISBN: 0-754623-79-3 2005 290 pages Ashgate
Sheila McLean
Laura Williamson
McLean and Williamson's Xenotransplantation: Law and Ethics is an impressive piece of scholarship on a complex issue in public health. Xenotransplantation is the animal-to-human transplantation of cells, tissues or organs for potential therapeutic benefits. It has developed in the context of the ongoing shortage in human organs and tissues available for transplantation.
The authors present nine chapters traversing much ground. Conclusion and summary sections in each chapter help to tie the main themes together and increase the utility of this work for students and established academics and practitioners alike. There are some formatting characteristics that make the book difficult to use as a quick reference. One of these is the lack of a stand-alone reference section. Instead, cited sources are listed as footnotes throughout the text.
Chapter one provides an overview of the current state of human organ transplantation. Why is society considering xenotransplantation? Live and cadaveric organ donation is discussed, along with procurement alternatives such as presumed consent, elective ventilation, a regulated human tissue market, artificial organs/tissue, stem cell research, and mandated donation. Evidence is presented to suggest that even with a number of successful strategies in place, the supply would still fail to meet potential demand. I learned several things about organ donation, which made me wonder whether wider public education strategies might raise the number of registered donors.
Xenotransplantation itself is introduced in chapter two. The primary objective of research in this area is therapeutic benefit: a key distinction ethically and for related evaluative questions. The authors highlight the divergence of definitions and the possible challenges this poses for international regulation since risks of infection is a global concern. The chapter gives a good historical overview, from the earliest accounts of sheep-to-human blood transfusions in 1628, to the later experimentation with primate kidneys, hearts, livers and the recent advances in cellular transplants. Clinical obstacles to success are also discussed (immunology, physiology, infectious disease risk). This chapter makes clear that xenotransplantation developed due to clinical urgency, but the authors do not ignore the wider socio-cultural questions. I suspect that many HSR readers would find much of interest in this work.
Chapters three and four provide a detailed description of the xenotransplantation regulatory environment in the United Kingdom. I admit to finding these (and the later chapters on legal issues) less interesting, however I was impressed by the way key reports were reviewed and critiqued. The authors acknowledge that in addition to the need for public debate about the ethics of xenotransplantation, there is at present still a range of scientific, psychological, practical and public health issues requiring further attention.
Chapter five reviews the national and international responses to xenotransplantation. Again, the work here is broad (but each section helpfully summarised), including international and European initiatives by WHO, OECD, the European Commission, the Council of Europe, and a review of the Australian response to xenotransplantation. The authors also describe clinical trials underway in the USA, Netherlands and Spain.
The ethical dimensions of xenotransplantation are discussed in chapter six. It focuses primarily on issues to do with the use and treatment of animals, and the possible impact (covering costs and benefits) of xenotransplantation on individuals and society. I would recommend this chapter to students interested in public health ethics generally. It gives a clear account of the role and nature of ethics, individual and social dimensions and (importantly) the relationship between empirical and ethical approaches.
Chapters seven and eight are devoted to outlining the legal issues associated with xenotransplantation, including a comprehensive account of predictable topics such as consent (medical, research), monitoring and surveillance, confidentiality, resource issues, human rights and international law, and legal liability. The final chapter considers the future for xenotransplantation. The authors warn that the ethical implications of scientific work in some jurisdictions are not being assessed thoroughly. They summarise the legal problems needing attention, including liability of industry and consent to xenotransplantation. The conclusion that McLean and Williamson arrive at is that ‘a public health ethic would support a moratorium on xenotransplantation clinical trials until more information is available on the procedure' (2005:262).
McLean and Williamson focus more on the legal regulatory than ethical issues surrounding xenotransplantation, perhaps because of the failure of applied ethics to deliver practical resources to guide decision-making in public health. This situation is changing with an increased focus on public health ethics over the last two decades. In public health we are seeing this space increasingly occupied by legal scholars.
This book is a fine example of the intersection of law and ethics in public health. The authors help to demonstrate what an applied public health ethics approach can look like in an increasingly evidence-based and regulated public health arena. They see the link between the empirical and ethical clearly: ‘To determine the ethical standing of different aspects of animal to human transplantation it is imperative that ethical work is based on the most up to date empirical information. This necessitates that the ethical analysis of xenotransplantation is a dynamic exercise' (2005:261).
Of special note to Australian readers will be the overview of the deliberations of the NHMRC Xenotransplantation Working Party. In 2004 the NHMRC recommended a five year moratorium on organ animal-to-human transplantation trials. Readers may also like to look at other available Australian sources (Carter 2002; Public Health Association of Australia 2004) to give this work greater local context. While Australia has amongst the highest transplantation success rates internationally, our organ donation rate currently falls below the internationally accepted benchmark of 15-20 donors per million population (Mathew and Chapman 2006; Opdam and Silvester 2006).
This book makes clear that several relevant human and system issues are poorly understood at present and require further investigation. These include public understanding, risks, barriers and incentives to human organ donation, and recipient identity issues.
McLean and Williamson's suggestion that ‘the potential of stem cell research may in fact overtake xenotransplantation as a treatment of choice for the future' (2005:269), may prove prophetic considering recent developments in Australia. But other options to address the therapeutic shortfall due to low rates of organ donation in this country should also be explored (eg presumed consent, regulated human tissue market, artificial organs/tissue, mandated donation). Xenotransplantation: Law and Ethics should be compulsory reading for anyone with an interest in organ transplantation and related issues.
References
Carter L (2002) The Ethics of Xenotransplantation Fact Sheet 7, Office of Public Policy and Ethics, University of Queensland. Available at: http://www.uq.edu.au/oppe/PDFS/Xenotransplantation.pdf
Mathew TH and Chapman JR (2006) Organ donation: A chance for Australia to do better. Medical Journal of Australia 185(5):245-246.
Opdam HI and Silvester W (2006) Potential for organ donation in Victoria: An audit of hospital deaths. Medical Journal of Australia 185(5):250-254.
Public Health Association of Australia (2004) Xenotransplantation PHAA Policy Statement, PHAA: Deakin, ACT. Available at:
http://www.phaa.net.au/policy/policy_statements/Section%2020/Xenotransplantation.pdf
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