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Raisons du succès et problèmes éthiques du Modèle Espagnol de don d’organes   David Rodríguez-Arias,  Linda Wright, David Paredes [email_address]
Résumé ,[object Object],[object Object],[object Object],[object Object]
Some international strategies to face organ shortage
1. Don du vivant “ First do not harm” Cohercion? Altruism? The risk of black market of organs
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
3. Don à coeur arrêté contrôlé NEJM  ; 2008;359(7):709-14. Hastings Center Report   2010(may-june):24-30
4. Conscription d’organes Spital A.  Am J Transplant  2005;5(5):1170-1.
4. Don après euthanasie
5. Xenotransplantation
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Espagne et Canada: démographie ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Évolution des chiffres de don en Espagne
Chiffres de don en Espagne et dans d’autres pays 2009: 34.4 pmp 2010: 32 pmp
22% of increase of living kidney donation 60 candidates for anonymous donation Exchange programmes
 
 
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 ,[object Object],30 (OCATT) 43 for DD / 11-18 for LD ,[object Object],170; 2.4 urgency  -- ,[object Object],135; <96h urg -- ,[object Object],205  -- Décès sur la liste:  number of deaths/total of patients on the WL (%) ,[object Object],-- -- ,[object Object],158/2144 (7.4%)  92/587 (15.6%) ,[object Object],29/453(6.2%) 14/131 (10.6%) ,[object Object],19/413 (4.6%) 44/282 (15.6%) Dépendence des donneurs vivants:  living donors/total transplants  (%) ,[object Object],235/2328 (10%) 763/1243 (39%) ,[object Object],29/1099 (2.6%) 68/453 (15%)
Des questions importantes: ,[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Official legal and moral framework
Myths and misconceptions
“ Succes of Spanish Model is due to  a high rate of traffic accidents ”
“ Succes of Spanish Model is due to the  Spanish culture ”
Success of Spanish system is due to its  Opt out model? ” Opt-in Opt-out Under discussion Undef./not known
“ Consentement” présumé: sous quelles conditions peut-il être considéré une sorte de consentement?  ,[object Object],[object Object],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.
Raisons du succès ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Raisons Médicales ,[object Object],[object Object],[object Object]
Donor detection ,[object Object],[object Object],[object Object],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
The cornerstone of organ generation in Spain: the transplant coordinator ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],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.
Family Refusal Spain 19%  (France: 31%)
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%
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
Communication Factors ,[object Object],Translated from:  http://www.ont.es
Shadows ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Expanded criteria. Spain vs Canada ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
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
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
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
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Dilemma.  Pros  and  cons   ,[object Object],[object Object],[object Object],[object Object],[object Object],Mini-Oral – Ethical, legal and psychoscial aspects of transplantation
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?
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?
[object Object],[object Object],[object Object],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 )
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
[object Object],[object Object],[object Object],[object Object],Current and future challenges Much to learn from Canada
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Spain: kidney transplant from Living donors and DCD (uncontrolled)
Conclusions : the  Lights ... ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
... and shadows ,[object Object],[object Object],[object Object]
Debate ,[object Object],[object Object]
 
Thank you David Rodríguez-Arias Vailhen, PhD [email_address] Merci

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

  • 1. Raisons du succès et problèmes éthiques du Modèle Espagnol de don d’organes David Rodríguez-Arias, Linda Wright, David Paredes [email_address]
  • 2.
  • 3. Some international strategies to face organ shortage
  • 4. 1. Don du vivant “ First do not harm” Cohercion? Altruism? The risk of black market of organs
  • 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. 3. Don à coeur arrêté contrôlé NEJM ; 2008;359(7):709-14. Hastings Center Report 2010(may-june):24-30
  • 7. 4. Conscription d’organes Spital A. Am J Transplant 2005;5(5):1170-1.
  • 8. 4. Don après euthanasie
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  • 11. Évolution des chiffres de don en Espagne
  • 12. Chiffres de don en Espagne et dans d’autres pays 2009: 34.4 pmp 2010: 32 pmp
  • 13. 22% of increase of living kidney donation 60 candidates for anonymous donation Exchange programmes
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  • 20. “ Succes of Spanish Model is due to a high rate of traffic accidents ”
  • 21. “ Succes of Spanish Model is due to the Spanish culture ”
  • 22. Success of Spanish system is due to its Opt out model? ” Opt-in Opt-out Under discussion Undef./not known
  • 23.
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  • 28. Family Refusal Spain 19% (France: 31%)
  • 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%
  • 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
  • 31.
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  • 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
  • 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
  • 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
  • 37.
  • 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?
  • 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?
  • 40.
  • 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
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  • 48. Thank you David Rodríguez-Arias Vailhen, PhD [email_address] Merci

Notas del editor

  1.   1. To learn the main statistical data about the Spanish system of organ donation and transplantation   2. To understand the factors that contribute to successful rates of organ donation.   3. To identify and explore some aspects of the system which give rise to ethically debatable issues   4. To learn about the  lights and the  shadows of the &amp;quot;Spanish Model&amp;quot;
  2. Source: wikipedia April 19th 2010
  3. 10. 1. La obtención de órganos de donantes fallecidos para fines terapéuticos podrá realizarse si se cumplen las condiciones y requisitos siguientes: Que la persona fallecida, de la que se pretende extraer órganos, no haya dejado constancia expresa de su oposición a que después de su muerte se realice la extracción de órganos. Dicha oposición, así como su conformidad si la desea expresar, podrá referirse a todo tipo de órganos o solamente a alguno de ellos, y será respetada cualquiera que sea la forma en la que se haya expresado. Artículo 8. Gratuidad de las donaciones. 1. No se podrá percibir gratificación alguna por la donación de órganos humanos por el donante, ni por cualquier otra persona física o jurídica. 10. 2. La extracción de órganos de fallecidos sólo podrá hacerse previa comprobación y certificación de la muerte realizadas en la forma, con los requisitos y por profesionales cualificados, con arreglo a lo establecido en este Real Decreto y teniendo en cuenta los protocolos incluidos en el anexo I del presente Real Decreto , las exigencias éticas, los avances científicos en la materia y la práctica médica generalmente aceptada. Los citados profesionales deberán ser médicos con cualificación o especialización adecuadas para esta finalidad, distintos de aquellos médicos que hayan de intervenir en la extracción o el trasplante y no estarán sujetos a las instrucciones de éstos.
  4. El mundialmente conocido como «Spanish Model», punto de referencia internacional obligado a la hora de hablar de potenciar la donación de órganos desde un punto de vista científico, asienta sobre el papel y la función desempeñadas por estos profesionales que describiremos continuación. Fundamentalmente ellos, bajo la dirección funcional de la ONT han sido los responsables de que España constituya el único país que ha experimentado un incremento progresivo y continuado de las tasas de donación a lo largo de los últimos 18 años. (El modelo español, p. 14) El agente fundamental capaz de actuar sobre este proceso será por tanto un médico ubicado primariamente en las UVIs, que sea capaz de indicar de igual a igual a los otros médicos responsables de estas unidades, que un paciente por el que ya no puede hacerse más por conservarle con vida, todavía puede contribuir a salvar la de otros pacientes a través de la donación de órganos. Con todos los matices que se quieran, la base del modelo español es tan simple como ésta. Disponer en todos los hospitales de profesionales específicamente entrenados en la consecución de todos los pasos encaminados a potenciar la donación. “ (L)a necesidad de que haya al menos un médico (...)en el equipo de coordinación, tesis que personalmente he mantenido contra viento y marea, tiene un origen si se quiere clasista, pero real como la vida misma” “(...) la intervención de alguien jerárquicamente inferior, como sucedía con las enfermeras, pero también con los médicos residentes, difícilmente servía para controlar la situación.” (Matesanz, 2006)
  5. Durante el año 2008 se extrajeron 2.832 riñones para trasplante, de los que no se trasplantaron un total de 738, lo que supone un 26,1% de los generados. (Fig. 3.8). El porcentaje de riñones desechados se ha ido incrementado en los últimos años de forma paralela al incremento del número de donantes. Las causas por las que se desecharon la totalidad de los riñones durante el año 2008 fueron las siguientes: 1) en 225 riñones (30,5%) el motivo fueron las características del donante, 2) en 460 riñones (62,3%) fueron las características del injerto, 3) en otros 43 riñones (5,8%) hubo problemas con el receptor
  6. Leer art’iculo de Shemie, Critical care, 2002, pros and cons
  7. Historically, two requirements have served as moral support for cDCD: 1. The decision to withdraw life support is always prior to any consideration of OD, so that the latter cannot unduly interfere with the former, and 2. the protocol respects donors’ autonomy by honoring their formerly expressed wish to become organ donors. These two conditions contribute to the protection and respect of potential donors and limit the risk of health professionals’ conflicts of interest. Thus, these requirements also underpin public trust in organ transplantation policies. Although Spanish transplant coordinators generally apply the opt-out law in a soft manner – families are always consulted and can refuse the donation- there is no need for explicit manifestation of willingness to donate for any patient to become an organ donor. These circumstances not only increase the risk of disrespecting donors’ wishes but also the potential conflict of interest professionals may undergo, which could, in turn, negatively influence the social perception of the Spanish system of OD. Special care must be taken in Spain in order to avoid the conflicts of interest which may arise as a result of practicing cDCD without the donors’ explicit consent. In particular, in order to avoid the risk of compromising the donors’ interests, transplant coordinators should never participate in end-of-life decisions of potential cDCD donors. This especially applies when transplant coordinators have also a clinical role as intensivists.