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XENOTRANSPLANTS
Bioethical considerations Ancy Foppiani
The term xenotransplantation (from the Greek ξένος, which means "foreign")
means the transplantation of organs, tissues or cells between organisms of
two different species.
 One of the most promising approaches for the treatment of
serious diseases in humans (cancer, diabetes, liver failure and
Parkinson's disease).
 The transplants of organs and tissues from animals to humans
could in fact eliminate the serious problem of donor shortages.
A worldwide shortage of organs for clinical implantation causes
approximately 20-35% of patients in need of replacement organs
to die on the waiting list.
 In addition to scientific problems (rejection, health risk),
xenotransplantation also raises other questions that require
theological, anthropological, psychological and ethical nature.
 Use of animals to improve human survival or health
Can we ethically justify the use of animals for xenotransplantation purposes?
Deciding whether animals are a simple tool and means aimed at the interest and well-being of man or animals are living beings with
interests, needs and desires and therefore must be considered and respected.
Do we also recognize the dignity of the animal?
Some argue that animals have similar rights to those deemed appropriate for humans. Animal protection has a legal status in
many countries.
 Consequentialists may consider the suffering and death of an animal acceptable for the
betterment of a human patient, as they would judge the morality of an action primarily by its
end result. They would argue that the potential benefits and improved human welfare
from xenotransplantation may justify the loss of animal life.
 However, this will never satisfy animal rights supporters; especially since while minimizing
the risk of acquired infections, animals must undergo greater suffering in the form of
isolation, monitoring and investigation. Furthermore, genetic modification can have both
immediate and long-term side effects on animals.
RELIGIOUS PERSPECTIVE
From a religious point of view, it is imperative to protect and preserve human life as a fundamental value.
Both Islam and Judaism prohibit the consumption of pork, but accept xenotransplantation on the basis that humans have
a higher place in the world and therefore have the right to use animals for their well-being as long as animals are treated
with respect.
Religions such as Hindu or Buddhist faiths allow the individual to make a choice.
The theme of xenotransplants could have a profound impact on religious communities that
perceive the self as sacred and the human being as separate from other animals.
The position of the Catholic Church on xenotransplantation was clarified and formalized in
the document entitled "The perspective of xenotransplantation, scientific aspects and ethical
considerations" in 2001. The Vatican considers xenotransplantation lawful as a therapeutic
operation in respect of the rights of the individual and the protection of society.
Christian, Jewish and Islamic religions have agreed that xenotransplantation does not
contravene the order of Creation and that the use of animals for the benefit of man is
acceptable.
 Health risk
Xenotransplantation raises alarm: although a therapy of this kind is justified as a life-
saving procedure, we are obliged to be cautious, because we do not know the risks and
side effects.
«Retroviruses and prions of animal origin transmitted by xenotransplants can cause
diseases which, if spread to other individuals, risk causing large pandemics. It is therefore
advisable to evaluate the health risk that is run in relation to the alleged advantages of
xenotransplants and find solutions to prevent any risk that could threaten public health»
-Council of Europe, Recommendation 1399 (1999) on xenotransplantation
Xenozoonosis: transmission of infectious agents from one species to another.
Pigs contain sequences in
their DNA that encode
retroviruses (PERVs -
Porcine Endogenous
RetroViruses)
Over sixty pig infectious agents have been identified with the potential to cause disease in
humans.
 Precautionary principle
 Libertarian principle
Not all organs of the human body are equally an expression of the identity of the person:
- Some are purely functional
- Others add a strong symbolic charge to the function, connected with the subjectivity of the individual
- Other organs have an inseparable relationship with the personal identity of the subject, regardless of their
symbolic value: brain (neuropsychic structures of conscientious identity) and gonads (structures intended to
transmit the genetic traits of their own identity to the progeny).
There is the subjective aspect of accepting the use of animal organs, which is a question of a
cultural and psychological nature. Transplant medicine has shown that there are repercussions of
varying intensity on those who have received human organ transplants, especially if they are
symbolically significant organs (heart).
 Xenotransplant and identity of the recipient
Body dimensions have a dramatic relevance in defining personal identity.
A serious issue is the protection of the identity of the human subject who receives an organ
of animal origin, in the doubt that the plant could objectively change the identity of the person.
 Social and economic aspects
 Xenotransplantation represents a form of possible therapy with a very high use of
health and economic resources.
 Doubts about the reasonableness of the huge investments in xenotransplants
research, no one can yet say with certainty that they will become an ordinary and safe
surgical practice. The need to wisely allocate the available resources so as not to
penalize the development of other promising therapies. Relationship between research
costs and benefits.
 Social justice. Protection of the right of pharmaceutical companies to have a return on
huge investments, a fundamental right of every person to have access to health care,
without discrimination or impediments due to excessive costs.
 Ethical and legal debate on the patentability of life. Patentability of genetically
modified animal organisms to make them compatible with humans. Border between
discovery and invention. Under current European legislation, there are no legal
obstacles to the patentability of engineered animal organs intended for transplantation.
In January 2004, the Executive Council of the World Health Organization (WHO) published the draft
resolution EB113.R5 concerning "human organ and tissue transplantation", which contains guidelines
relating to xenotransplants and which has been subsequently accepted by all member states.
Xenotransplants, added with studies on biomechanical organs and stem cells,
represent an unfounded hope for the future of many patients.
Investing resources and hopes in this new
therapeutic perspective, in light of the
scientific uncertainties still present and the
urgent need to increase the availability of
organs to be transplanted. A serious ethical
commitment on the part of scientists
should also not neglect to explore
alternative therapeutic ways to
xenotransplantation, as many recent
discoveries in the field of genetics seem to
promise, as well as, in a longer perspective,
the therapeutic use of somatic stem cells.
Artificial organ transplantation
Organ printing
Science 22 Sep 2017
Bibliography
• Anderson M., Xenotransplantation: a bioethical evaluation. J Med Ethics. 2006 Apr; PMID: 16574873
• Bach F.H., Xenotransplantation: problems and prospects, Annu.Rev.Med.1998, 49:301-10
• Wachholtz Amy B., Bioethics of xenotransplantation: Three religious perspectives. University of Massachusetts Medical
School.
• Sautermeister Jochen, Mathieu Richard, Bogner Veronika, Xenotransplantation—theological–ethical considerations in an
interdisciplinary symposium. Official Journal of the International Xenotransplantation Association.
• Mons. Elio Sgreccia, Emanuele Cozzi, Maurizio P. Faggioni, Marialuisa Lavitrano – Conferenza stampa di presentazione del
nuovo documento “La prospettiva degli xenotrapianti. Aspetti scientifici e considerazioni etiche”
• Onions D., Cooper D.K., Alexander T.J., et al., An approach to the control of disease transmission in pig-to-human
xenotransplantation, Xenotransplantation 2000; 7:143-155.
• Patience C, Takeuchi Y, Weiss RA, 1997, Infection of human cells by an endogenous retrovirus of pigs. Nature Med 3:282-
286.
• Crafen J., Rodin G.M., Psychiatric Aspects of Organ Transplantation, New York: Oxford Medical Publications, 1992.
• Kress J.M., Xenotransplantation: ethics and economics, Food Drug Law Journal 1998, 53 (2):353-384; Urruela Mora A.,
Workshop on the ethical, sociologic, economic and legal aspects of xenotransplantation, Law Hum Genome Rev 2000 Jan-
Jun.
• Shaer, Matthew (May 2015). "Soon, Your Doctor Could Print a Human Organ on Demand". Smithsonian Magazine. Retrieved
2020-04-02.
• Ventola, C. Lee (October 2014). "Medical Applications for 3D Printing: Current and Projected Uses". Pharmacy and
Therapeutics.
• Dong Niu, Hong-Jiang Wei, Lin Lin, Haydy George, Tao Wang, Hsiu Lee, Hong-Ye Zhao, Inactivation of porcine endogenous
retrovirus in pigs using CRISPR-Cas9; Science 22 Sep 2017.

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Presentation of Bioethics - Xenotransplants.pptx

  • 2. The term xenotransplantation (from the Greek ξένος, which means "foreign") means the transplantation of organs, tissues or cells between organisms of two different species.  One of the most promising approaches for the treatment of serious diseases in humans (cancer, diabetes, liver failure and Parkinson's disease).  The transplants of organs and tissues from animals to humans could in fact eliminate the serious problem of donor shortages. A worldwide shortage of organs for clinical implantation causes approximately 20-35% of patients in need of replacement organs to die on the waiting list.  In addition to scientific problems (rejection, health risk), xenotransplantation also raises other questions that require theological, anthropological, psychological and ethical nature.
  • 3.  Use of animals to improve human survival or health Can we ethically justify the use of animals for xenotransplantation purposes? Deciding whether animals are a simple tool and means aimed at the interest and well-being of man or animals are living beings with interests, needs and desires and therefore must be considered and respected. Do we also recognize the dignity of the animal? Some argue that animals have similar rights to those deemed appropriate for humans. Animal protection has a legal status in many countries.  Consequentialists may consider the suffering and death of an animal acceptable for the betterment of a human patient, as they would judge the morality of an action primarily by its end result. They would argue that the potential benefits and improved human welfare from xenotransplantation may justify the loss of animal life.  However, this will never satisfy animal rights supporters; especially since while minimizing the risk of acquired infections, animals must undergo greater suffering in the form of isolation, monitoring and investigation. Furthermore, genetic modification can have both immediate and long-term side effects on animals.
  • 4. RELIGIOUS PERSPECTIVE From a religious point of view, it is imperative to protect and preserve human life as a fundamental value. Both Islam and Judaism prohibit the consumption of pork, but accept xenotransplantation on the basis that humans have a higher place in the world and therefore have the right to use animals for their well-being as long as animals are treated with respect. Religions such as Hindu or Buddhist faiths allow the individual to make a choice. The theme of xenotransplants could have a profound impact on religious communities that perceive the self as sacred and the human being as separate from other animals. The position of the Catholic Church on xenotransplantation was clarified and formalized in the document entitled "The perspective of xenotransplantation, scientific aspects and ethical considerations" in 2001. The Vatican considers xenotransplantation lawful as a therapeutic operation in respect of the rights of the individual and the protection of society. Christian, Jewish and Islamic religions have agreed that xenotransplantation does not contravene the order of Creation and that the use of animals for the benefit of man is acceptable.
  • 5.  Health risk Xenotransplantation raises alarm: although a therapy of this kind is justified as a life- saving procedure, we are obliged to be cautious, because we do not know the risks and side effects. «Retroviruses and prions of animal origin transmitted by xenotransplants can cause diseases which, if spread to other individuals, risk causing large pandemics. It is therefore advisable to evaluate the health risk that is run in relation to the alleged advantages of xenotransplants and find solutions to prevent any risk that could threaten public health» -Council of Europe, Recommendation 1399 (1999) on xenotransplantation Xenozoonosis: transmission of infectious agents from one species to another. Pigs contain sequences in their DNA that encode retroviruses (PERVs - Porcine Endogenous RetroViruses) Over sixty pig infectious agents have been identified with the potential to cause disease in humans.  Precautionary principle  Libertarian principle
  • 6. Not all organs of the human body are equally an expression of the identity of the person: - Some are purely functional - Others add a strong symbolic charge to the function, connected with the subjectivity of the individual - Other organs have an inseparable relationship with the personal identity of the subject, regardless of their symbolic value: brain (neuropsychic structures of conscientious identity) and gonads (structures intended to transmit the genetic traits of their own identity to the progeny). There is the subjective aspect of accepting the use of animal organs, which is a question of a cultural and psychological nature. Transplant medicine has shown that there are repercussions of varying intensity on those who have received human organ transplants, especially if they are symbolically significant organs (heart).  Xenotransplant and identity of the recipient Body dimensions have a dramatic relevance in defining personal identity. A serious issue is the protection of the identity of the human subject who receives an organ of animal origin, in the doubt that the plant could objectively change the identity of the person.
  • 7.  Social and economic aspects  Xenotransplantation represents a form of possible therapy with a very high use of health and economic resources.  Doubts about the reasonableness of the huge investments in xenotransplants research, no one can yet say with certainty that they will become an ordinary and safe surgical practice. The need to wisely allocate the available resources so as not to penalize the development of other promising therapies. Relationship between research costs and benefits.  Social justice. Protection of the right of pharmaceutical companies to have a return on huge investments, a fundamental right of every person to have access to health care, without discrimination or impediments due to excessive costs.  Ethical and legal debate on the patentability of life. Patentability of genetically modified animal organisms to make them compatible with humans. Border between discovery and invention. Under current European legislation, there are no legal obstacles to the patentability of engineered animal organs intended for transplantation.
  • 8. In January 2004, the Executive Council of the World Health Organization (WHO) published the draft resolution EB113.R5 concerning "human organ and tissue transplantation", which contains guidelines relating to xenotransplants and which has been subsequently accepted by all member states. Xenotransplants, added with studies on biomechanical organs and stem cells, represent an unfounded hope for the future of many patients. Investing resources and hopes in this new therapeutic perspective, in light of the scientific uncertainties still present and the urgent need to increase the availability of organs to be transplanted. A serious ethical commitment on the part of scientists should also not neglect to explore alternative therapeutic ways to xenotransplantation, as many recent discoveries in the field of genetics seem to promise, as well as, in a longer perspective, the therapeutic use of somatic stem cells. Artificial organ transplantation Organ printing Science 22 Sep 2017
  • 9. Bibliography • Anderson M., Xenotransplantation: a bioethical evaluation. J Med Ethics. 2006 Apr; PMID: 16574873 • Bach F.H., Xenotransplantation: problems and prospects, Annu.Rev.Med.1998, 49:301-10 • Wachholtz Amy B., Bioethics of xenotransplantation: Three religious perspectives. University of Massachusetts Medical School. • Sautermeister Jochen, Mathieu Richard, Bogner Veronika, Xenotransplantation—theological–ethical considerations in an interdisciplinary symposium. Official Journal of the International Xenotransplantation Association. • Mons. Elio Sgreccia, Emanuele Cozzi, Maurizio P. Faggioni, Marialuisa Lavitrano – Conferenza stampa di presentazione del nuovo documento “La prospettiva degli xenotrapianti. Aspetti scientifici e considerazioni etiche” • Onions D., Cooper D.K., Alexander T.J., et al., An approach to the control of disease transmission in pig-to-human xenotransplantation, Xenotransplantation 2000; 7:143-155. • Patience C, Takeuchi Y, Weiss RA, 1997, Infection of human cells by an endogenous retrovirus of pigs. Nature Med 3:282- 286. • Crafen J., Rodin G.M., Psychiatric Aspects of Organ Transplantation, New York: Oxford Medical Publications, 1992. • Kress J.M., Xenotransplantation: ethics and economics, Food Drug Law Journal 1998, 53 (2):353-384; Urruela Mora A., Workshop on the ethical, sociologic, economic and legal aspects of xenotransplantation, Law Hum Genome Rev 2000 Jan- Jun. • Shaer, Matthew (May 2015). "Soon, Your Doctor Could Print a Human Organ on Demand". Smithsonian Magazine. Retrieved 2020-04-02. • Ventola, C. Lee (October 2014). "Medical Applications for 3D Printing: Current and Projected Uses". Pharmacy and Therapeutics. • Dong Niu, Hong-Jiang Wei, Lin Lin, Haydy George, Tao Wang, Hsiu Lee, Hong-Ye Zhao, Inactivation of porcine endogenous retrovirus in pigs using CRISPR-Cas9; Science 22 Sep 2017.