Reframing Rights: Bioconstitutionalism in the Genetic Age

8. Risks and Rights in Xenotransplantation

8 Risks and Rights in Xenotransplantation Mariachiara Tallacchini I don’t think we are going to really feel comfortable . . . until we have done 1,000 patients or maybe even 10,000 patients, all the animal studies aside. We really just need to do patients. —D. Auchincloss (FDA 1997) Well, that is a tough one when you are saying, you know, the patient is going to die unless we do a xenotransplant. They will probably truly die with one. —H. Y. Vanderpool (FDA 1997) Started as a form of experimental surgery and advertised since the 1960s as a solution to the shortage of human organs, xenotransplantation (XT), the transplant of cells, tissues, or organs between different species, moved toward clinical application during the 1990s, when developments in genetic engineering made transgenic animals available for this purpose. The major technical obstacle to performing transplants from one species to another, the hyperacute rejection (HAR) of the transplanted organ or tissue—also existing, but in a weaker form, in human-to-human transplantation —was at least partially overcome when pig tissues and organs (the species of choice for this technology) became more compatible with humans through genetic engineering. But the ups and downs of xenotransplants as an acceptable therapeutic approach have depended more on factors other than mere feasibility. The most controversial and still unresolved point concerns the ethical use of animals, both pigs and nonhuman primates used as recipients in preclinical trials (Nuffield Council on Bioethics 1996). Numerous national and international documents addressing the issue have invariably agreed on the acceptability of using pigs and for increasing restrictions in experimenting with nonhuman primates. Besides the scientific and ethical barriers relating to animal use, XT raises concerns about both individual and collective rights, especially in 170 Chapter 8 the conduct of clinical trials. Because of the potential risk of infections transmitted from the animal source to the human recipient, XT breaks the common rules of individual informed consent. On the one hand, the lack of adequate information makes informed consent inconceivable and lays the basis for additional constraints to which patients have to consent; on the other hand, threats to collective safety from the possibility that novel or known infectious agents (so-called xenogeneic infections) (Chapman et al. 1995) may spread to the population at large not only require new ways of thinking about individual and collective rights, but also represent a challenge for bioethics in individually oriented liberal democratic societies. At the beginning of the twenty-first century, as conditions for the delicate passage from preclinical to clinical trials seemed near, different regulatory frameworks were developed to normalize XT, primarily by mitigating the potential risks of infections while protecting involved subjects . This paper explores four legal and policy approaches to XT framed in that period. These are the U.S. (2001), the European (Council of Europe and European Union) (2003), the Canadian (2002), and the Australian regulations (2004) (the third and fourth as variants of the same model). Each uses a different strategy to build legitimacy for a technology whose implementation requires well-established rights to be reframed (Jasanoff 2004; Jasanoff 2005; Jasanoff, chapter 1, this volume). Each of these legal approaches had to adjust both science and norms to create an acceptable context for XT: although certain legal constraints were justified on technical grounds, specific scientific statements were adopted not because of their factual reliability but rather for their expected legal implications. Each set of adjustments has given rise to a particular scheme of cognitive and social order, new roles and identities for citizens, and new social relationships. Collectively, these models have opened up broader and more complex scenarios of legitimate government for controversial biomedical technologies. At stake in the U.S. regulatory model is the maintenance of a coherent, contractual, liberal vision of society. In the European Union (EU) and Council of Europe (COE) model, the paternalistic and vertical construction of Europe as a fully political entity, responsible for European citizens, represented the main challenge (see also Dratwa, chapter 12, this volume). In the cases of Canada and Australia an incomplete attempt was made to extend the concept of citizenship and so to integrate the realities of state and society. Historically, XT was often associated with the chimera (a mythological figure made of different animal parts). However, XT has constantly Risks and Rights in Xenotransplantation 171 changed its discursive identity. From relying on organ...