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Blood Transfusion «Gladios Veteremque Haurite Crurorem,Ut Repleam Vacuas Iuvenali Sanguine Venas!» Publius Ovidius Naso, Metamorphoses, VII – 333

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Blood Transfusion «Gladios Veteremque Haurite Crurorem,Ut Repleam Vacuas Iuvenali Sanguine Venas!» Publius Ovidius Naso, Metamorphoses, VII – 333 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
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