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Raisons du succès et problèmes éthiques du modèle espagnol de don d'organes

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Raisons du succès et problèmes éthiques du modèle espagnol de don d'organes

  1. 1. Raisons du succès et problèmes éthiques du Modèle Espagnol de don d’organes David Rodríguez-Arias, Linda Wright, David Paredes [email_address]
  2. 2. Résumé <ul><li>Le don d’organes dans un contexte global de pénurie. Quelques stratégies pour la combattre que l’Espagne n’a pas adopté. </li></ul><ul><li>Le Canada et l’Espagne: quelques données comparatives </li></ul><ul><li>Les choix de l’Espagne pour augmenter le don d’organes: “Mythes”, “Lumières” et “Ombres” du Modèle Espagnol </li></ul><ul><li>Discussion: Qu’est-ce que l’on pourrait copier de l’Espagne, et qu’est-ce qu’on ne pourrait pas copier? </li></ul>
  3. 3. Some international strategies to face organ shortage
  4. 4. 1. Don du vivant “ First do not harm” Cohercion? Altruism? The risk of black market of organs
  5. 5. 2. Marché régulé d’organes en Iran Larijani B, Zahedi F, Taheri E. Ethical and legal aspects of organ transplantation in Iran. Transplant Proc 2004;36(5):1241-4. 83% of kidneys from living donors Donors: 30/40 year old 84% poor 16% middle class Related morbidity risk: 20% Risk of death: 0.03%. Recipients: 50% poor 36% middle class
  6. 6. 3. Don à coeur arrêté contrôlé NEJM ; 2008;359(7):709-14. Hastings Center Report 2010(may-june):24-30
  7. 7. 4. Conscription d’organes Spital A. Am J Transplant 2005;5(5):1170-1.
  8. 8. 4. Don après euthanasie
  9. 9. 5. Xenotransplantation
  10. 10. <ul><li>AREA: 504,030 km2 / 195,364 sq mi </li></ul><ul><li>DEMOGRAPHICS ( 2009) </li></ul><ul><li>46,7 million population </li></ul><ul><li>12% immigrants (romanian, maroccan, latin-americans) </li></ul><ul><li>16,7 % over 65 years old </li></ul><ul><li>Density: 91.2/km2 ; 231/sq mi </li></ul>Espagne et Canada: démographie <ul><li>AREA: 9,984,670 km2 / 3,854,085 sq m </li></ul><ul><li>DEMOGRAPHICS (2009) </li></ul><ul><li>34 million population </li></ul><ul><li>1/5 are foreign born (Toronto) </li></ul><ul><li>13,8 % over 65 years old </li></ul><ul><li>Median Age: 39.5 </li></ul><ul><li>Density: 3.41/km2 ;   8.3/sq mi </li></ul>
  11. 11. Évolution des chiffres de don en Espagne
  12. 12. Chiffres de don en Espagne et dans d’autres pays 2009: 34.4 pmp 2010: 32 pmp
  13. 13. 22% of increase of living kidney donation 60 candidates for anonymous donation Exchange programmes
  14. 16. Résultats de Tx: Espagne et Canada (2008) www.ont.es , 2009; CIHI, 2009 http://secure.cihi.ca/cihiweb/products/corr_annual_report_2010_e.pdf SPAIN CANADA Temps dans la liste d’attente <ul><li>Kidney (months) </li></ul>30 (OCATT) 43 for DD / 11-18 for LD <ul><li>Liver (days) </li></ul>170; 2.4 urgency -- <ul><li>Heart (days) </li></ul>135; <96h urg -- <ul><li>Lung (days) </li></ul>205 -- Décès sur la liste: number of deaths/total of patients on the WL (%) <ul><li>Kidney </li></ul>-- -- <ul><li>Liver </li></ul>158/2144 (7.4%) 92/587 (15.6%) <ul><li>Heart </li></ul>29/453(6.2%) 14/131 (10.6%) <ul><li>Lung </li></ul>19/413 (4.6%) 44/282 (15.6%) Dépendence des donneurs vivants: living donors/total transplants (%) <ul><li>Kidney </li></ul>235/2328 (10%) 763/1243 (39%) <ul><li>Liver </li></ul>29/1099 (2.6%) 68/453 (15%)
  15. 17. Des questions importantes: <ul><li>Quels moyens l’Espagne a mise en oeuvre pour avoir ces résultats? </li></ul><ul><li>Les bons résultats justifient-ils les moyens utilisés? L’Espagne est-elle en train de payer un “prix éthique” pour son succès impréssionant? </li></ul><ul><li>Devraient les autres pays –comme le Canada- suivre l’exemple de l’Espagne? </li></ul>
  16. 18. <ul><li>(“Soft”) Presumed consent (Opt-out) (Ley 30/1979, de 27 de octubre, sobre extracción y trasplante de órganos, Art. 5.3; (Real Decreto 2070/1999, art. 10.1) </li></ul><ul><li>The “softness” of the presumed consent: two rare but significant settings </li></ul><ul><li>- when the proxies are not available </li></ul><ul><li>- when they refuse the explicit consent of the donor </li></ul><ul><li>Altruism (Real Decreto 2070/1999, art. 8) </li></ul><ul><li>Separation between diagnostic and transplant teams (Real Decreto 2070/1999, a rt. 10.2) </li></ul>Official legal and moral framework
  17. 19. Myths and misconceptions
  18. 20. “ Succes of Spanish Model is due to a high rate of traffic accidents ”
  19. 21. “ Succes of Spanish Model is due to the Spanish culture ”
  20. 22. Success of Spanish system is due to its Opt out model? ” Opt-in Opt-out Under discussion Undef./not known
  21. 23. “ Consentement” présumé: sous quelles conditions peut-il être considéré une sorte de consentement? <ul><li>Les espagnols connaissent-ils la loi sur le consentement présumé? </li></ul><ul><li>Sont-ils d’accord? </li></ul>25% 75% Conesa Bernal C, et al. [Population attitude toward presumed consent legislation to cadaveric organ donation]. Med Clin (Barc). 2004 Jan 24;122(2):67-9.
  22. 24. Raisons du succès <ul><li>Medicales: </li></ul><ul><ul><li>ICU beds; ICU doctors (potential donors admission, evaluation, maintenance) </li></ul></ul><ul><ul><li>Transplant coordinator (family interview, 17% of family refusal) </li></ul></ul><ul><li>Légales </li></ul><ul><ul><li>Presumed consent </li></ul></ul><ul><li>Formation des professionnels </li></ul><ul><ul><li>Training: donor detection, brain death diagnosis, family approach…, </li></ul></ul><ul><li>De communication </li></ul><ul><ul><li>Mass media </li></ul></ul>
  23. 25. Raisons Médicales <ul><li>Deux moments très importants </li></ul><ul><ul><li>Détection des donneurs potentiels </li></ul></ul><ul><ul><li>Entretien avec les familles </li></ul></ul>
  24. 26. Donor detection <ul><li>“ The first stage where potential donors are lost is the detection of people who can be diagnosed as brain dead” (B. Miranda) </li></ul><ul><li>“ La causa número uno de pérdida de donantes en todo el mundo, y la que realmente marca las diferencias entre países y hospitales, es la no detección de donantes potenciales (…) . Cualquier porcentaje posterior de pérdida por causas médicas o legales, negativas familiares o cualquier otra, queda sobradamente compensado por una detección adecuada” (R. Matesanz) </li></ul><ul><li>Audits on brain death </li></ul>Miranda B, Fernandez Lucas M, Matesanz R. The potential organ donor pool: international figures. Transplantation Proceedings . 1997 Feb-Mar;29(1-2):1604-6 Matesanz R. El milagro de los trasplantes . Madrid: La esfera de los libros; 2006, 107
  25. 27. The cornerstone of organ generation in Spain: the transplant coordinator <ul><li>Coordinator’s profile </li></ul><ul><li>At least one in every each hospital </li></ul><ul><li>ICU physician </li></ul><ul><li>Part time </li></ul><ul><li>Leadership </li></ul><ul><li>Authority </li></ul><ul><li>Diplomacy </li></ul><ul><li>In 2008, there were 158 teams composed by </li></ul><ul><ul><li>199 physicians (79% of them intensivists or anesthesiologists) </li></ul></ul><ul><ul><li>- 129 nurses </li></ul></ul>Matesanz R. El modelo español de donación y trasplante de órganos: la ONT. In: Matesanz R, editor. El modelo español de coordinación y trasplantes . 2 ed. Madrid: Aula Médica; 2008. p. 11-26.
  26. 28. Family Refusal Spain 19% (France: 31%)
  27. 29. 54% of families initially reluctant, finally accept donation REVERSED REFUSALS GOMEZ MARINERO, P. y SANTIAGO GUERVOS, C. (1995). &quot;La negativa familiar. Causas y estrategias&quot; Revista española de trasplantes 4(5): 334-337. % of total refusals Reason given % Reversed 40.7% Refusal of the donor 23% 24% Refusal of family 55% 7.7% Problems with the hospital’s system 46% 5.8% Problems with brain death 76% 4.8% Image of the donor 73% 3.8% Ignore the wish of the donor 86% 3.8% Social problems 69% 3.8% Religious problems 20% 2.9% “ Assertive” 0% 1.9% Want to have the donor at home 33%
  28. 30. Educational factors Specific courses for all types of professionals involved in transplantation on: - donor detection - brain death diagnosis - donor management - family approach (bad news, grief, “relation of help”, management of refusals, cultural issues, communication) - organ allocation - approach to the media - legal issues Source: www.tpm.org
  29. 31. Communication Factors <ul><li>“ much attention should be dedicated to mass media, including times for management of this information and the best way to pay attention to them. Regular meetings with reporters, communication courses to coordinators, and responding rapidly to adverse publicity and crisis situations have constituted throughout these years important elements for achieving a positive feeling towards organ donation”. </li></ul>Translated from: http://www.ont.es
  30. 32. Shadows <ul><li>Non acknowledged </li></ul><ul><li>Donation after cardiac death </li></ul><ul><li>Economic issues </li></ul><ul><li>End of life policies </li></ul><ul><li>Reported </li></ul><ul><li>Expanded criteria </li></ul><ul><li>Presumed consent </li></ul>
  31. 33. Expanded criteria. Spain vs Canada <ul><li>Canada (2008) </li></ul><ul><li>The mean age of deceased donors is 44.3 </li></ul><ul><li>62% were older than 40 </li></ul><ul><li>44% were older than 50 </li></ul><ul><li>20% were older than 60 </li></ul><ul><li>Spain (2008) : </li></ul><ul><li>The mean age of deceased donors is 54.2 </li></ul><ul><li>73% were older than 45 </li></ul><ul><li>44% were older than 60 </li></ul><ul><li>23% were older than 70 </li></ul>
  32. 34. Evolution of Spanish donors’ age En 2010, 79% de tous les donneurs sont agés de plus de 45 ans, et 46,6% de plus de 60 ans
  33. 35. Spanish Model is not the most efficient one EFFICIENCY Roels L, Cohen B, Gachet C. Am J Transplant . 2007 Cuende et al. Am J Transplant . 2007 PROCURED KIDNEYS from Deceased donors THAT COULD NOT BE TRANSPLANTED (% of total Kidneys procured) NON-USEFUL DONORS
  34. 36. End-of-life policies and the “induction” of Brain Death The Dutch protocol : “Starting or continuing mechanical ventilation in patients who are not brain dead, but who are beyond hope of meaningful survival, with the sole intent of awaiting brain death and the possibility of organ donation bears some risk that the patient will not die but remain alive in a persistent vegetative state. ( Erwin J.O. Kompanje, 2006 ) The Spanish Protocol : “In the name of the principle of justice, it is considered that these patients must be hospitalized in the ICU. It is considered ethically acceptable that, even though some of them become in PVS because of an aggressive treatment in the ICU, and even though it violates the non-maleficience principle, the social benefice that organ donation entails is a priority. A clear information to the proxies on these procedures and its probabilities must be given. The State should assume the social costs that follow the perpetuation of those PVS patients (Mercedes Lara ) http://www.uninet.edu/cin2000/conferences/MLara/mlara1/index.htm
  35. 37. <ul><li>Option b) Withdrawing life support to enable controlled DCD </li></ul><ul><li>Avoids futility, instrumentalization </li></ul><ul><li>Respects family wishes regarding EOL options </li></ul><ul><li>Loss of organs </li></ul><ul><li>Lack of explicit consent </li></ul><ul><li>Major conflicts of interest </li></ul>Dilemma. Pros and cons <ul><li>Option a) Maintaining life support to enable donation after brain death </li></ul><ul><li>Maximizes the # of organs </li></ul><ul><li>Accepted practice </li></ul><ul><li>Deceiving families about the aim of maintaining life support involves futile, expensive interventions and uncertainty of results (f. refusals) </li></ul><ul><li>Alternatively, transparency obliges to discuss with families the donation options before patients are dead, which subordinates the treatment received to the willingness to donate and may involve undue inducement </li></ul>Mini-Oral – Ethical, legal and psychoscial aspects of transplantation
  36. 38. Donation after uncontrolled cardiac death Manipulation of the place and timing for the determination of death Preserving techniques without patient or family explicit consent  Hardening of the initially “soft” presumed consent Lack of information to the families Unclear if donor brain dead Is this utilitarian policy ethically acceptable?
  37. 39. Economic incentives 1. Professionals may be paid by the hospital according to the number of organs procured AND transplanted Compromising patients’ interests? 2. Families receive a compensation if they accept the donation. That includes - Funeral expenses - Repatriation of the corpse for foreign donors “ Unwelcomed irresistible offers”? (R. Veatch) Are these practices compatible with altruism?
  38. 40. <ul><li>(“Soft”) Presumed consent (Opt-out)? </li></ul><ul><li>Altruism? </li></ul><ul><li>Separation between teams? </li></ul>Actual framework Why do we care –or should care- about consistency between law and practice? “ Any too transgressed law is a bad one. The legislator should abrogate it or modify it so that the contempt in which this senseless law has fallen do not permeate fairer laws”. (M. Yourcenar, Memoirs of Hadrian )
  39. 41. Diagnostic and procurement teams are really separated? Conflicts of Interest When the coordinator is an intensivist who - treats the patient - participates in the identification and maintenance of potential donors - is likely to receive more income if the procurement is performed
  40. 42. <ul><li>Living donation </li></ul><ul><ul><li>Unrelated living donation </li></ul></ul><ul><li>Donation after Controlled DCD? </li></ul><ul><li>Transplant tourism </li></ul>Current and future challenges Much to learn from Canada
  41. 43. <ul><li>Living donation </li></ul><ul><li>(2008): 156/2229 (6.9%) </li></ul><ul><li>(2009): 235/2328 (10%) </li></ul><ul><li>(2010): 240/2225 (10.8) </li></ul><ul><li>DCD </li></ul><ul><li>(2008): 105/2229 (4.7%) </li></ul><ul><li>(2009): 148/2328 (6.3%) </li></ul><ul><li>(2010): 158/2225 (7.1%) </li></ul>Spain: kidney transplant from Living donors and DCD (uncontrolled)
  42. 44. Conclusions : the Lights ... <ul><ul><li>Resources </li></ul></ul><ul><ul><li>Coordinators </li></ul></ul><ul><ul><li>Audits on BD </li></ul></ul><ul><ul><li>HCW training </li></ul></ul><ul><ul><li>Presumed consent </li></ul></ul><ul><li>Are clear success factors which are a plausible explanation of Spanish success on organ procurement and transplantation </li></ul>
  43. 45. ... and shadows <ul><li>More transparency on some aspects of the Spanish model is needed </li></ul><ul><li>A public discussion on some ethically debatable aspects of the Spanish Model could be implemented, and enlightened by sound empirical data, not only for the respect and the dignity of the patient and his/her family, but above all for the goals of organ transplantation and its long-term success. </li></ul><ul><li>That could provide more lessons in success factors in organ donation </li></ul>
  44. 46. Debate <ul><li>Are Spanish policies in organ donation ethically acceptable, considering its good results and the pervasive threaten of organ shortage? </li></ul><ul><li>Should other countries, as Canada, partially or totally incorporate them? </li></ul>
  45. 48. Thank you David Rodríguez-Arias Vailhen, PhD [email_address] Merci

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