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Xenotransplantation: ETHICAL, SOCIAL AND ECONOMIC CONSIDERATIONS

Xenotransplantation is potentially a reliable, long term so­lution to the current donor shortage for allotransplanta- tion. At the same time, it presents a number of complex ethical, social and economic issues that must be resolved before it can be fully implemented. Unlike other areas of clinical medicine, xenotransplantation raises a variety of ethical issues that have not been formally discussed or agreed upon in the public arena. The general public must play a role in defining ethical policies regarding xenotrans- plantation, and it is the duty of the medical and scientific communities to provide as much information as possible to them, so that public policies can be formulated in an in­formed manner.

The clinical application of xenotransplantation is predi­cated on the assumption that the use of animals in medical research and therapy is morally acceptable. Even if this de­batable principle is accepted, the use of animals in xeno- transplantation, particularly nonhuman primates, raises additional issues. That these animals may need to be ge­netically altered to overcome certain immunological obsta­cles further complicates their use as experimental subjects. As a minimum requirement, the use of source animals for xenotransplantation have to comply with the Canadian Council on Animal Care’s Guide to the Care and Use of Experimental Animals.

The issue of informed consent in xenotransplantation, as in any other area of medicine, requires that the subject be made aware of its potential benefits and risks. In the case of xenotransplantation, there are additional consid­erations that may violate some of the principles of in­formed consent. Early recipients of xenografts typically have poor rates of survival, so treatment of these subjects in experimental protocols may raise serious ethical con­cerns. While the potential benefits and risks of rejection may be estimated, the risk of xenozoonoses cannot reliably be predicted, particularly when DNA from different spe­cies is mixed, and may result in new and unpredictable in­fectious agents. For example, it was only recently determined that porcine endogenous retroviruses can in­fect human cells. The transplant recipient has to agree to the requirement for strict postoperative monitor­ing, which may result in quarantine or other physical con­straints should the recipient develop an infection potentially communicable to the community. This re­quirement may also extend to household members and other close contacts, and would violate another proviso of informed consent – the right to withdraw from the experi­ment at any time. Hence, in the clinical application of xenotransplantation, ‘informed consent’ may need to be replaced with a more binding ‘contract’ between doctor and patient.

For xenotransplantation to become a clinical reality, substantial financial resources have to be invested to es­tablish facilities for rearing and monitoring source ani­mals, developing laboratory tests, training staff, monitoring recipients and close contacts, and establishing infection control measures. Use of these resources in the development of xenotransplantation technology might re­sult in fewer dollars being available for other equally im­portant medical interventions. If, in the long term, the cost of xenotransplantation drops sufficiently to justify its widespread introduction, there would be additional cost implications for an already cash-strapped Canadian health care system.
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