Clinical xenotransplantation seems close: Ethical issues persist

Abstract

Scientific barriers that have prevented successful xenotransplantation are being breached, yet many ethical issues remain. Some are broad issues that accompany the adoption of novel and expensive technologies, and some are unique to xenotransplantation. Major ethical questions include areas such as: viral transmission; zoonoses and lifetime surveillance; interfering with nature; efficacy, access, and expense; treatment of animals; regulation and oversight.

Current Status of Cardiac Xenotransplantation: Report of a Workshop of the German Heart Transplant Centers, Martinsried, March 3, 2023

“…As a novel treatment strategy, xenotransplantation (XT) raises several ethical issues [82][83][84][85] which require thorough scrutiny before entering a first clinical trial. The ethical assessment should proceed in a transparent and structured manner 86 .…”

In defense of xenotransplantation research: Because of, not in spite of, animal welfare concerns

“…Bernard Rollins observes that, although their welfare will be better than most other pigs, their living situation will “be equally deficient in accommodating the animals’ biological and psychological natures” (p. 4) 47 . Entwistle and colleagues note the chronic care, isolation, and sterile lab environment “could be emotionally harmful” (p. 992) 48 for transgenic pigs. Johnson is more explicit:

These pigs are genetically modified and cloned, and must be bred and housed using infection‐control measures like artificial insemination, embryo transfer, Caesarian births, and isolation in sterile environments without contact with other animals, preventing the expression of their natural behaviors.

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Bioethics and xenotransplantation from pig to human

“…Clinical application of innovation such as xenotransplantation raises questions concerning the balance between beneficence, individual autonomy and the recognition of possible damage to society and the environment. 18 , 19 The problems of autonomy in xenotransplantation are related to the difficulty of composing the free and informed consent form, since the risks and benefits for the recipient, given the complexity of the situation, are still unknown. Furthermore, some of the greatest risks of this procedure, zoonosis, is associated with the possibility of its success.…”

“…Therefore, the recipient's notion of being able to withdraw from participating in the research at any time must be very well clarified before proceeding with the xenotransplantation, if there is a predictable chance of survival for a long period. 18 , 19 …”

“…However, according to Dr. Entwistle from Thomas Jefferson University (Philadelphia, USA), confinement, social isolation (to avoid infections), and repeated procedures such as blood collections, which are part of the protocol for producing these animals, violate guidelines for the care and use of laboratory animals and deserves, at the very least, discussion and open public debate. 18 …”