The gift in donations A bioethical perspective
Giovanni Spitale, M.A. Visiting Research Fellow Institute for Medical Ethics and History of Medicine I Ruhr-Universität Bochum INTRODUCTION
Methodological approach
Bioethics: a participated discipline Philosophy “with a foot on the ground” A self-reflective science
2 The gift in donations. A bioethical perspective HISTORY AND STATUS QUAESTIONIS
Historical overview Regulatory framework Current situation Problems and solutions
The healing of deacon Giustiniano, Beato Angelico, 1443 saints Cosmas and Damian operate the «black leg miracle».
3 The gift in donations. A bioethical perspective Blood transfusion «Gladios veteremque haurite crurorem,ut repleam vacuas iuvenali sanguine venas!» Publius Ovidius Naso, Metamorphoses, VII – 333
Historical overview
Girolamo Cardano describes direct transfusion (De rerum varietate, 1558) William Harvey describes the functioning of the cardiocirculatory system (1628) Jean Denys and Guglielmo Riva experiment direct blood transfusion with random success (1667)
4 The gift in donations. A bioethical perspective Blood transfusion Historical overview
William Aveling performs the first clinical direct blood transfusion (1873) Karl Landsteiner discovers the AB0 system (1901) Landsteiner and Alexander Wiener discover the Rh factor (1940) Introduction of the ACD solution – acid, citrate, dextrose (1943)
Bellevue Hospital, New York The first photograph of a direct blood transfusion, ca. 1870
5 The gift in donations. A bioethical perspective Blood transfusion The Italian situation (2015)
1.690.426 donors 3.03.306 donations 3.400.693 transfusions (9317 per day)
6 The gift in donations. A bioethical perspective Organs and Tissue «Recordari memento!» Commemorative formula for praying the Lares
Technical innovations
The first experiments: Giuseppe Tagliacozzi and his noses (1545) Alexis Carrel and surgical anastomosis (1912) The matching problem: 10.418.468 possible HLA types Comprehending graft rejection: Snell, Benacerraf, Dausset (40s – 70s, Nobel in 1980) Tackling graft rejection: from total body X ray irradiation to ciclosporin
7 The gift in donations. A bioethical perspective Organs and Tissue Historical overview
The first effective human organ transplant: Murray and the Herrick twins (1954) Liver transplantation: Starzl’s first attempts (1963) and Calne’s success (1979) Lung transplantation: Hardy’s first attempt (1963) and Cooper’s success (1983) Pancreas transplantation: Lillehei (1966) Heart transplantation: Carrel and Guthrie (1905); Hardy’s xenotransplantation (1964), Barnaard (1967). Intestine transplantation: Lillehei’s first attempts (1958) and Starzl’s success (1989)
8 The gift in donations. A bioethical perspective Organs and Tissue The Italian Situation (2015)
Waiting Tx Deceased Dismissed Waiting time (y) Kidney 8700 1500 133 360 3,1 Liver 2245 1244 149 98 1,9 Lung 576 141 63 12 2 Pancreas 276 58 7 10 3 Heart 1009 219 62 32 2,8
From 2001 to 2011 in Italy just 59 intestine transplants have been performed, therefore there is no statistically significant data available.
9 The gift in donations. A bioethical perspective Haematopoietic Stem Cells Historical overview
First human clinical trial: sternum to sternum transplantation for AA patient, Morrison and Samwick (1940) Second human clinical trial: HSC transplantation for irradiated nuclear workers, Mathé (1959) Don Thomas: twenty years at Fred Hutchinson Cancer Research Centre (1950 – 1970)
10 The gift in donations. A bioethical perspective Haematopoietic Stem Cells The Italian Situation (2015)
Waiting Total tx Iliac crest Apheresis Cord blood
CSE 1527 749 235 458 56 In Italy there are 342.508 potential bone marrow donors, registered in a national database created in 1989. In Germany the DKMS registry counts 3,4 million potential donors.
11 The gift in donations. A bioethical perspective Regulatory framework Blood
DM 13/12/1937: “professional givers” and donors Law 592/1967: states the gratuity of the blood for receivers, but “professional givers” continue to exist Law 107/1990: elimination of “professional givers”, recognition of the «civic and social function and of the human solidaristic values expressed in free and anonymous blood donation» Current regulation – law 219/2005
Protection of donors and receivers
Self-sufficiency
Creation of the National Blood Centre
Good use of blood
Gratuity and anonymity of the donation
12 The gift in donations. A bioethical perspective Regulatory framework Organs and tissue
Law 235/1957: “white list approach” (eye tissue, MST, blood vessels, nerves, skin, bone marrow, dura mater); the donation is gratuitous; opt-out criteria, explantation possible from unclaimed bodies Law 644/1975: non-strumentality of the declaration of death, sanctions for organ selling, introduction of the notion of “donating subject”, creation of the regional transplantation centres Current regulation – law 91/1999
Allocation of organs considering only urgency and matching
Silence-consent principle and related problems
Protection of “weak categories” (entrusted children, people with cognitive disability, unborn)
Gratuity and anonymity
13 The gift in donations. A bioethical perspective Regulatory framework HSC
Current regulation – Law 52/2001:
Recognition of Galliera hospital’s register Organization of regional typization centres Gratuity Right and duty to donor’s anonymity
14 The gift in donations. A bioethical perspective Regulatory framework European Regulation
The Oviedo Convention (1997)
First international treaty regarding bioethics Aims to protect human rights, fundamental freedoms and human dignity Ethical primacy of the person, equity, justice Residuality of living organ donation Obligatoriness of the consent Protection of “weak categories” (persons not legally able to consent) Gratuity
15 The gift in donations. A bioethical perspective Regulatory framework European Regulation
Strasbourg’s Protocol (2001)
Necessity to increase in an ethically acceptable way the donors’ pool Necessity to avoid the creation of a market for human bodies and parts Transparency and equity in assignation Impartiality and independence of the medical commission that diagnoses the death of the donor Admissibility of both opt-in and opt-out criteria Gratuity
16 The gift in donations. A bioethical perspective A problem, some solutions The lack of donors
The main issue of transplantation is the lack of donors
Moral cost in terms of human lives/reduced quality of life 3162 persons still waiting an organ after one year (414 deceased in the meanwhile) 778 persons not able to receive a bone marrow transplantation Financial cost: a patient with a kidney transplantation costs 66.696€ per three years, a dialyzed one 109.923€
Xenotransplantation Artificial organs Regenerative medicine Illegal organ market
17 The gift in donations. A bioethical perspective ETHICAL ISSUES
Living donors Justice and allocation Consent retrieval
The sweet spot, Giovanni Spitale, 2015
18 The gift in donations. A bioethical perspective Donations from living donor Overview
Low impact: blood, HSCs By-product: MST, blood vessels, amniotic membrane High impact: kidney, split-liver, pulmonary lobe, pancreatic section, intestine section The ethical complexity raises with the death/injury risk for the donor Balance of goods between three moral subjects: donor, receiver, medical team
19 The gift in donations. A bioethical perspective Donations from living donor Two theoretical models
Impartial model: unconditional, anonymous and free donation Partial model: conditional donation – directed to a specific person
Main issues: modality and conditions of consent retrieval, verification of the donor’s motivations, acceptance of the risks by the donor, acceptance to expose the donor to these risks
20 The gift in donations. A bioethical perspective Receiving a transplantation Fairness with a short blanket
There are different theories of justice that from the same formal principle (treat equally equal things) express different material principles
The Italian allocation system has a six-lists priority scheme: urgencies pediatric patients restitutions anticipations standard allocation surplus The allocation inside the list considers the best matching The Italian system is both egalitarian (priority to severe or pediatric patients) and communitarian (fair distribution of the resources)
21 The gift in donations. A bioethical perspective Consent retrieval From forced explant to market
Forced explant: the Chinese praxis Opt-in and opt-out systems: utilitarian perspectives and moral assumptions for presumed consent Non economical incentives: post-mortem largesse benefitting others Legal market: if I can sell my labor, why not selling its means?
Becker and Elias, 2007: Compensation of the risk of death (annual income*life expectancy*risk of death) Compensation of the time lost with surgery and rehabilitation (monthly income*lost months) Compensation of the risk of decreased life quality (arbitrary)
22 The gift in donations. A bioethical perspective Consent retrieval From forced explant to market
Una scelta in Comune: a new system for registering wills at civil registries Increase of the donors: in 2.5 years Perugia and Terni (experimenting municipalities) passed from 2300 to 10162 registered donors Extension of the procedure to dozen of municipalities Organ donation as an identity trait
Città del Dono: extending the procedure to other donations Experimenting at the municipality of Bassano del Grappa Act of the Senate n. 2465
23 The gift in donations. A bioethical perspective FROM DONATIONS TO “GIFT”
Apparent irreducibility The horizons of gift A new theoretical model
Illustration for the cover of “il dono nelle donazioni”, Angela Bonato, 2015
24 The gift in donations. A bioethical perspective Apparent irreducibility Differences and similarities
Great objective differences: ex mortuo, ex vivo “from by- product”, low impact ex vivo, high impact ex vivo Great differences in ethical problematicity and in regulation frameworks A fragmented horizon, but each practice refers to the idea of “gift”
25 The gift in donations. A bioethical perspective The horizons of “gift” Overview
Mauss and the circular gift: a theoretical model for the gift as a tie. Nexum, wadium, xenìa The vertical or absolute gift as an horizon for gratuity: old and new testament Absolute gift as figure of the impossible: Derrida’s reflection
26 The gift in donations. A bioethical perspective The horizons of “gift” Three unsuitable models
The circular model lays on relationality and translates gift in profit The biblical model lays on a total ontological alterity (giving to someone who structurally cant reciprocate). It sacrifices relationality and emerges as a prescription (imitatio dei) The derridian model is overtly impossible: «giving with the awareness that you are not donating»
27 The gift in donations. A bioethical perspective The horizons of “gift” Outline of a different model
It is possible to build a theoretical model of donation ethically acceptable and compatible with anatomical donations
Gratuity (second formulation of Kant’s categorical imperative) Ontological alterity (non-reciprocability) is guaranteed by the offer of something that is not a thing, but a part of the self Relationality as element-set connection
28 The gift in donations. A bioethical perspective A new theoretical model The gift in donations
This model of gift allows an ethical unitary perspective on the objective plurality of anatomical donations
Avoids utilitarianism and reification Offers an authentic relationality and a morally valuable perspective Can be effectively used in communicating donation Allows proposing a «tout court donation» Can become a useful instrument for resolving the donor shortage issue and for saving human lives
29 The gift in donations. A bioethical perspective Case discussion Consent and cognitive disability
30 The gift in donations. A bioethical perspective Case discussion Consent and cognitive disability
Desire to be a donor Current regulation: “it is not possible to manifest the will about organ donation for the unborn, for persons without the legal capacity to act, for entrusted children.”
Cautionary/paternalistic approach of the Italian law Conflict with the desire of a person actually able to understand the meaning of the choice he wants to do Necessity to prevent the possibility of exploiting vulnerable persons
Gradual regulation Discretionality of the GP Sorites paradox Paternalism
31 The gift in donations. A bioethical perspective Thanks for your attention To download this presentation scan the QR code or visit www.giovannispitale.net/gift
32 The gift in donations. A bioethical perspective Bibliography HISTORY AND STATUS QUAESTIONIS:
• Abiomed, AbioCor Frequently Asked Questions, 2014. • R. E. Bienstock, Tales from the organ trade, HBO. • G. Castelnuovo, R. Menici, M. Fedi (a cura di), La donazione in Italia. Situazioni e prospettive della donazione di sangue, organi, tessuti, cellule e midollo osseo. Springer, 2011. • Censis, Il valore del Trapianto. Un'analisi empirica dei consumi sanitari e dei costi dei trapiantati di rene in Italia, 2013. • Centro Nazionale Trapianti, Attività di donazione al 31 dicembre 2013. • Centro Nazionale Trapianti, Attività di donazione e trapianto tessuti in Italia 2013. • Centro Nazionale Trapianti, Documento informativo sul programma di donazione di rene da donatore vivente. • Centro Nazionale Trapianti, Statistiche, 2016. < https://trapianti.sanita.it/statistiche/ > [consulted on 01/05/2017]. • Centro Nazionale Trapianti, Valutazione di qualità dell'attività del trapianto di Cuore 2000 – 2011. • Centro Nazionale Trapianti, Valutazione di qualità dell'attività del trapianto di Fegato 2000 – 2011. • Centro Nazionale Trapianti, Valutazione di qualità dell'attività del trapianto di Polmone 2000 – 2009. • Centro Nazionale Trapianti, Valutazione di qualità dell'attività del trapianto di Rene 2000 – 2011. • D. K. C. Cooper, C. G. Groth, I. F. C. McKenzie, Xenotransplantation: this new form of treatment might benefit millions, in British Medical Journal, n° 340 2010. • Council of Europe, Additional Protocol to the Convention on Human Rights and Biomedicine concerning Transplantation of Organs and Tissues of Human Origin, 2002.
33 The gift in donations. A bioethical perspective Bibliography HISTORY AND STATUS QUAESTIONIS:
• Council of Europe, Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, 1997. • Council of Europe, Explanatory Report: Additional Protocol to the Convention on Human Rights and Biomedicine concerning Transplantation of Organs and Tissues of Human Origin, 2002. • B. Culliton, Marrow grafting holds promise, in Science News, n° 16 1959. • R. Del Bello, Rene portatile, ecco WAK, la dialisi è una cintura, in la Repubblica, 1/12/2009. • R. Dionigi (a cura di), Chirurgia. Chirurgia specialistica, Elsevier, 2011. • Editorial, Bone marrow transfusions. New attack on Leukemia, in Science News Letter, n°21 1940. • Gazzetta Ufficiale della Repubblica Italiana, n° 292 2013. • W. Gilks, Tissue Matching and Matchability in Kidney Transplantation, in Journal of the Royal Statistical Society, n° 2 1991. • E. Goldman, Xenotransplantation: public risk must not be dismissed, in British Medical Journal, n° 320 2000. • International Society for Heart and Lung Transplant, Transplant Registry Quaterly Report, 2014. < http://www.ishlt.org/registries/quarterlyDataReport.asp > [consulted on 29/10/2014]. • International Society of Nephrology, The Transplantation Society, The Declaration of Istanbul on Organ Trafficking and Transplant Tourism, 2008. • Leading article, Roots of plastic surgery, in British Medical Journal, n° 2 1966. • C. Machado, J. Kerein, Y. Ferrer, L. Portela, M. de la C. García, J. M. Manero, The concept of brain death did not evolve to benefit organ transplants, in Journal of Medical Ethics, n° 4 2007.
34 The gift in donations. A bioethical perspective Bibliography HISTORY AND STATUS QUAESTIONIS:
• V. R. Potter, Bioethics, bridge to the future, Prentice-Hall Biological Science Series, 1971. • Registro Italiano Donatori di Midollo Osseo, Report di attività, 2016. • J. Savulescu, Should we clone human beings? Cloning as a source of tissue for transplantation, in Journal of Medical Ethics, n° 2 1999. • R. L. Soutar, D. King, Bone marrow transplantation, in British Medical Journal, n° 6971 1995. • T. E. Starzl, C. W. Putnam, Experience in hepatic transplantation, Saunders Company, 1969. • T. E. Starzl, J. Fung, A. Tzakis, S. Todo, A. J. Demetris, I. R. Marino, H. Doyle, A. Zeevi, V. Warty, M. Michaels, S. Kusne, W. A. Rudert, M. Trucco, Baboon-to-human liver transplantation, in Lancet, n° 341 1993. • T. E. Starzl, T. L. Marchioro, G. N. Peters, C. H. Kirkpatrick, W. E. C. Wilson, K. A. Porter, D. Rifkind, D. A. Ogden, C. R. Hitchcock, W. R. Waddell, Renal heterotransplantation from baboon to man: experience with 6 cases, in Transplantation, n° 6 1964. • H. Y. Vanderpool, Xenotransplantation: progress and promise, in British Medical Journal, n° 19 1999 • J. a Voragine, Legenda Aurea, Librariae Arnoldianae, 1850. • A. Watts, Bit of an animal, in British Medical Journal, n° 340 2010. • World Health Organization, Constitution of the World Health Organization as adopted by the International Health Conference, 1946. • World Health Organization, Second Global Consultation on Regulatory Requirements for Xenotransplantation Clinic Trials, 2011. • World Health Organization, The Changsha Communiqué, 2008.
35 The gift in donations. A bioethical perspective Bibliography ETHICAL ISSUES:
• Ad Hoc Committee of the Harvard Medical School to Examine the Definition of Brain Death, A definition of Irreversible Coma, in Journal of American Medical Association, n°6 1968. • G. S. Becker, J. J Elias, Introducing incentives in the market for live and cadaveric organ donations, in The Journal of Economic Perspectives, n° 3 2007. • T. L. Beuchamp, J. F. Childress, Principles of Biomedical Ethics – seventh edition, Oxford University Press, 2013. • N. Biller – Andorno, H. Schauenburg, It's only love? Some pitfalls in emotionally related organ donation, in Journal of Medical Ethics, n°3 2001. • Centro Nazionale Trapianti, Determinazione di morte con standard neurologico. Elementi informativi essenziali, 2008. • Centro Nazionale Trapianti, Documento informativo sul programma di donazione di rene da donatore vivente. • F. Chabalewski, M. K. G. Norris, The gift of life: talking to families about organ and tissue donation, in The American Journal of Nursing, n° 6 1994. • Comitato Nazionale di Bioetica, Definizione e accertamento della morte nell'uomo, 1991. • Comitato Nazionale di Bioetica, I criteri di accertamento della morte, 2010. • A. J. Cronin, J. Harris, Authorisation, altruism and compulsion in the organ donation debate, in Journal of Medical Ethics, n° 10 2010. • C. A. Erin, J. Harris, An ethical market in human organs, in Journal of Medical Ethics, n° 3 2003. • A. J. Ghods, S. Savaj, Iranian model of paid and regulated living-unrelated kidney donation, in Clinical Journal of the American Society of Nephrology, n° 1 2006.
36 The gift in donations. A bioethical perspective Bibliography ETHICAL ISSUES:
• G. Haddow, “Because you're worth it?” The taking and selling of transplantable organs, in Journal of Medical Ethics, n° 6 2006. • J. Harvey, Paying organ donors, in Journal of Medical Ethics, n°3 1990. • M. Heidegger, Essere e tempo, Longanesi, 2009. • M. T. Hilhorst, “Living apart together”: moral frictions between two coexisting organ transplantation schemes, in Journal of Medical Ethics, n° 6 2008. • C. Ikels, Ethical issues in organ procurement in chinese societies, in The China Journal, n° 38 1997. • R. Jarvis, Join the club: a modest proposal to increase availability of donor organs, in Journal of Medical Ethics, n° 21 1995. • H. Jonas, Dalla fede antica all'uomo tecnologico. Saggi filosofici. Il Mulino, 1991. • R. R. Kishore, Human organs, scarcities, and sale: morality revisited, in Journal of Medical Ethics, n° 6 2005. • Lega Nazionale Contro la Predazione degli Organi e la Morte a Cuore Battente, < http://www.antipredazione.org > [consulted on 18/12/2014]. • LifeShares Members, < http://www.lifesharers.org/ > [consultato il 29/11/2014]. • C. Machado, J. Korein, Y. Ferrer, L. Portela, M. de la C. Garcia, Y. Machado, J. M. Manero, The Declaration of Sydney on human death, in Journal of Medical Ethics, n° 33/2007. • C. Machado, J. Korein, Y. Ferrer, L. Portela, M. de la C. García, J. M. Manero, The concept of brain death did not evolve to benefit organ transplants, in Journal of Medical Ethics, n° 4 2007. • N. H. Maple, V. Hadjianastassiou, R. Jones, N. Mamode, Understanding risk in living donor nephrectomy, in Journal of Medical Ethics, n° 3 2010.
37 The gift in donations. A bioethical perspective Bibliography ETHICAL ISSUES:
• I. Marino, Market of organs is unethical under any circumstances, in British Medical Journal, n° 7368 2012. • F.G. Miller, R. D. Truog, Decapitation and the definition of death, in Journal of Medical Ethics, n° 10 2010. • B. Saunders, Normative consent and opt-out organ donation, in Journal of Medical Ethics, n° 2 2010. • J. Savulescu, Is the sale of body parts wrong?, in Journal of Medical Ethics, n° 3 2003. • J. Seifert, la morte cerebrale non è la morte di fatto. Argomentazioni filosofiche, in R. Barcaro, P. Becchi (a cura di), Questioni mortali. L'attuale dibattito sulla morte e il problema dei trapianti, Edizioni Scientifiche Italiane, 2004. • T. J. Shafer, Improving relative's consent to organ donation, in British Medical Journal, n° 7702 2009 • A. L. Simpkin, L. C. Robertson, V. S. Barber, J. D. Young, T. J. Shafer, Modifiable factors influencing relatives' decision to offer organ donation: systematic review, in British Medical Journal, n° 7702 2009. • R. Spaemann, La morte cerebrale è la morte dell'essere umano? Il dibattito in corso, in R. De Mattei, Finis vitae. Brain death is not true death, Life guardian foundation, 2010.
38 The gift in donations. A bioethical perspective Bibliography UNA SCELTA IN COMUNE:
• Centro Nazionale per la prevenzione ed il Controllo Malattie, guida alla redazione dei progetti CCM – allegato A, 2010. • Centro Nazionale Trapianti, Attività di donazione al 31 dicembre 2013. • Centro Nazionale Trapianti, Statistiche dichiarazioni di volontà < https://trapianti.sanita.it/statistiche/PEdich.asp > [consulted on 15/01/2015]. • Comitato Nazionale di Bioetica, Definizione e accertamento della morte nell'uomo, 1991. • R. Filippin, Modifica al testo unico delle leggi di pubblica sicurezza di cui al regio decreto 18 giugno 1931, n. 773, in materia di donazioni di organi e tessuti ex vivo, Act of the Senate 2465 < http://www.senato.it/leg/17/BGT/Schede/Ddliter/47111.htm > [consulted on 7/7/2016] • B. Gobbi, Come raddoppia il sì alla donazione, in Il Sole 24 Ore, n° 31/07/2012. • La donazione organi come tratto identitario, Linee guida per l'applicazione dell'art. 3, comma 8 bis del decreto legge 30 dicembre 2009, n.194, convertito dalla legge n. 25 del 26 febbraio 2010: inserimento della volontà o del diniego a donare gli organi sulla carta di identità, 2012. • La donazione organi come tratto identitario, Rapporto finale del progetto pilota “la donazione organi come tratto identitario”, 2012. • G. Manuali, Progetto CCM 2011 “La Donazione Organi come Tratto Identitario”, 2011. • Regione Umbria, Direzione Regionale salute, coesione sociale e società della conoscenza, Campagna di comunicazione. Progetto CCM “La Donazione Organi come Tratto Identitario”, 2011.
39 The gift in donations. A bioethical perspective Bibliography FROM DONATIONS TO “GIFT” :
• M. Aime, Eppur si dona, in M. Aime et al., Dono dunque siamo: otto buone ragioni per credere in una società più solidale. UTET, 2013. • L. Battaglia, Bioetica senza dogmi. Rubbettino, 2009 • Council of Europe, Additional Protocol to che Convention on Human Rights and Biomedicine concerning Transplantation of Organs and Tissues of Human Origin, 2002. • Council of Europe, Additional Protocol to the Convention on Human Rights and Biomedicine concerning Transplantation of Organs and Tissues of Human Origin, 2002. • Council of Europe, Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, 1997. • R. Dawkins, The selfish gene. Oxford University Press, 2006. • J. Derrida, Given time: 1. Counterfeit money. The University of Chicago Press, 1994. • C. Di Sante, Lo straniero nella Bibbia. Ospitalità e dono. San Paolo, 2012. • B. Giacomini, In cambio di nulla. Figure del dono. Il Poligrafo, 2006. • Homer, The Odissey. John Hopkins University Press, 2004. • I. Kant, groundwork of the metaphysics of Morals. Cambridge University Press, 1998. • M. Mauss, The gift; forms and functions of exchange in archaic societies. Cohen and West, 1966. • The Bible, Exodus 22, 21; Deuteronomy 14, 29; Deuteronomy 16, 11-14; Deuteronomy 26,13; Leviticus 19,2; Luke 6, 32-35; John 1, 16; Romans 5, 6-8. • S. Zanardo, Nelle trame del dono, forme di vita e legami sociali. EDB, 2013.
40 The gift in donations. A bioethical perspective