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David Rodríguez-Arias - X seminario de bioética

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David Rodríguez-Arias - X seminario de bioética

  1. 1. ¿Cuándo el fin no justifica los medios? Límites éticos de los trasplantes de órganos X Seminario de Bioética Universidad de Salamanca
  2. 2. Esquema <ul><li>Papel de los trasplantes de órganos en la sociedad y el problema de la escasez </li></ul><ul><li>2. Marco legal de los trasplantes de órganos </li></ul><ul><li>3. Los trasplantes de órganos en la bioética: </li></ul><ul><li>- Problemas prácticos y de legitimación derivados </li></ul><ul><li>4. Bases para una mejor justificación </li></ul>
  3. 3. Escasez de órganos y diversificación de las fuentes de órganos <ul><li>Muerte cerebral </li></ul><ul><li>(Riñones, hígado, pulmón, páncreas, corazón, intestino, tejidos) </li></ul>Donantes a corazón parado (Riñones, hígado, pulmón, páncreas, corazón, tejidos) Donantes vivos (riñones, porciones de hígado) Bebés anencefálicos Xenotrasplantes EVP
  4. 4. Los trasplantes en la sociedad <ul><ul><li>El interés de los trasplantes </li></ul></ul><ul><ul><li>El problema de la escasez </li></ul></ul><ul><ul><li>Aceptabilidad social </li></ul></ul><ul><ul><ul><li>Altruismo </li></ul></ul></ul><ul><ul><ul><li>Beneficencia </li></ul></ul></ul><ul><ul><ul><li>Justicia </li></ul></ul></ul>
  5. 5. Marco legal . Principios reguladores (I) ( Real Decreto 2070/1999, de 30 de diciembre, por el que se regulan las actividades de obtención y utilización clínica de órganos humanos y la coordinación territorial en materia de donación y trasplante de órganos y tejidos ) <ul><li>Confidencialidad : “Los familiares del donante no podrán conocer la identidad del receptor, ni el receptor o sus familiares de la del donante ” (art.5) </li></ul><ul><li>Altruismo . “ La promoción de la donación u obtención de órganos o tejidos humanos se realizará siempre de forma general y señalando su carácter voluntario, altruista y desinteresado.” (art. 7) </li></ul><ul><li>Gratuidad. “ No se podrá percibir gratificación alguna por la donación de órganos humanos por el donante, ni por cualquier otra persona física o jurídica. ” (art. 8) </li></ul>
  6. 6. <ul><li>Consentimiento </li></ul><ul><ul><li>Donante vivo: otorgado de forma previa, “expresa, libre, consciente y desinteresada”, tras ser informado (art. 9). Se excluyen los menores e incapaces (salvo para tejidos regenerables  se solicita consentimiento al tutor legal). </li></ul></ul><ul><ul><li>Donante fallecido: “que no haya dejado constancia expresa de su oposición” (art.8). Obligación de verificar si el interesado hizo patente su voluntad. (art. 9) </li></ul></ul><ul><li>Respeto del donante (fallecido) </li></ul><ul><ul><li>“ La extracción de órganos de fallecidos sólo podrá hacerse previa comprobación y certificación de la muerte realizadas” (art. 10.2) </li></ul></ul><ul><ul><li>No interferencia entre el equipo de diagnóstico de la muerte y el equipo de trasplante : “ médicos (...), distintos de aquellos médicos que hayan de intervenir en la extracción o el trasplante y no estarán sujetos a las instrucciones de éstos.” </li></ul></ul><ul><ul><li>“ La muerte del individuo podrá certificarse tras la confirmación del cese irreversible de las funciones cardiorrespiratorias o del cese irreversible de las funciones encefálicas”. </li></ul></ul><ul><ul><li>Restauración y restitución del cuerpo a la familia (art. 12) </li></ul></ul><ul><li>Equidad en la distribución de órganos . “ Asimismo, se garantizará la equidad en la selección y acceso al trasplante de los posibles receptores (...)” (art.2) </li></ul>Marco legal. Principios reguladores (II) ( Real Decreto 2070/1999, de 30 de diciembre )
  7. 7. Los trasplantes de órganos en la bioética <ul><ul><li>La ética de los trasplantes </li></ul></ul><ul><ul><li>Un tema secundario en la agenda de la bioética </li></ul></ul><ul><ul><li>Tensión entre fines y medios </li></ul></ul><ul><ul><ul><li>Casos problemáticos </li></ul></ul></ul>
  8. 8. Casos problemáticos <ul><ul><ul><li>Donación de vivo </li></ul></ul></ul><ul><ul><ul><li>Consentimiento presunto </li></ul></ul></ul><ul><ul><ul><li>Conflictos de intereses </li></ul></ul></ul><ul><ul><ul><li>trato con los familiares </li></ul></ul></ul><ul><ul><ul><li>Protocolos de donación en asistolia: </li></ul></ul></ul><ul><ul><li>Riesgo: crisis de confianza. ( Legitimación frente a crisis de confianza ) </li></ul></ul>O' Neill , Onora. Autonomy and Trust in Bioethics . : Theoretical Medicine, Volume 24, Number 3, 2003 , pp. 261-269(9) ...
  9. 9. Donación de vivo: desequilibrio de género <ul><li>Desequilibrio de género entre las donantes vivas de riñón y los receptores. </li></ul><ul><li>Necesidad de una mayor transparencia en las estadísticas. </li></ul>Biller-Andorno (2008) López de la Vieja (2008)
  10. 10. Donación de vivo: el riesgo del mercado y del tráfico de órganos <ul><li>¿Cómo evitar todo intercambio económico si la donación de órganos entre personas no emparentadas está permitida? </li></ul><ul><li>El caso de IRÁN </li></ul>
  11. 11. Consentimiento presunto “débil” Real Decreto 2070 1999, Art 10 “ que no haya dejado constancia expresa de su oposición” Are donor’s previous wishes respected? Do the Spaniards know the current legal framework on presumed consent? Do they agree? “ Siempre que las circunstancias no lo impidan, se deberá facilitar a los familiares presentes en el centro sanitario información sobre la necesidad, naturaleza y circunstancias de la extracción ...” The “softness” of the presumed consent: two rare but significant settings - when the proxies are not available - when they refuse the explicit consent of the donor
  12. 12. Aceptación del consentimiento presunto <ul><li>Spanish policy on soft presumed consent could be against the opinion of: </li></ul><ul><ul><li>75% of Spaniards </li></ul></ul><ul><ul><li>a large majority who thinks that their will must prevale over their proxies one. </li></ul></ul><ul><li>- from theory to practice: the need to preserve public trust </li></ul>75% 25% 96% : se debe pedir permiso a la familia -72% debe prevalecer la opinión del difunto si se conoce - 18%, debe prevalecer la opinión de la familia. Conesa Bernal et al. (2004)
  13. 13. CPR and the “Production” of Brain Death Severely damaged patients, in coma The Dutch or American 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 Ambiguity of the objectives of CPR: saving the patient or his/her organs? Both? A culture against withdrawal of LST or in favor to organ donation? Both? Is this utilitarianism unethical?
  14. 14. Dinero de por medio <ul><li>Retribución por actividad a los equipos de trasplante </li></ul><ul><ul><li>¿El dinero ensucia las manos del médico trasplantador? </li></ul></ul><ul><ul><li>qué consecuencias tiene este conflicto de intereses </li></ul></ul><ul><li>“ Compensación” a los familiares de los donantes </li></ul><ul><ul><li>¿El dinero ensucia las manos del altruismo? </li></ul></ul><ul><ul><li>¿Qué consecuencia se seguiría del conocimiento de este fenómeno por parte del público? </li></ul></ul><ul><ul><li>¿Es esto legal? ¿Es compatible con el principio proclamado del altruismo? </li></ul></ul>
  15. 15. Ética de la extracción de órganos : consideraciones generales <ul><li>PRINCIPIOS ( prima facie ) </li></ul><ul><li>No maleficencia : </li></ul><ul><li>- Ausencia de conflicto de intereses: la extracción no debe comprometer los cuidados debidos al paciente ni sus intereses. Regla del donante fallecido : “no se puede matar para extraer órganos”. Todo donante de órganos impares debe estar muerto. </li></ul><ul><li>- Donantes vivos: riesgo asumible y balance beneficio / riesgo aceptable. </li></ul><ul><li>Autonomía: </li></ul><ul><li>- Consentimiento del paciente. Dos modelos : Explícito (vivos) y presunto (fallecidos). </li></ul><ul><li>Beneficencia: </li></ul><ul><li>- Consideración de los deseos de la familia. Respeto al cadáver. ¿Compensaciones? </li></ul><ul><li>- Cuidado y comprensión del sufrimiento del donante (vivo), de la familia del donante (fallecido) y de los equipos de trasplante. </li></ul><ul><li>Justicia : </li></ul><ul><li>- Equidad, no discriminación en la selección de los receptores. </li></ul>CONSECUENCIAS Beneficio de los receptores  Preservar al máximo la calidad de los órganos extraídos para salvar vidas y mejorar la calidad de vida de los enfermos (menor tiempo de isquemia posible) Preservación de la confianza de la sociedad en el sistema de trasplantes  transparencia, atención a la publicidad negativa, respeto condicionado de los principios
  16. 16. Donación en asistolia (a corazón parado) <ul><li>Controlled cardiac arrest. (withdrawal of LST). (Maastricht III) </li></ul><ul><ul><li>Cardiac arrest after withdrawal, from a conscient patient with a severe illness, who refuses lst, (or who express his/her refusal by ADs, or surrogates) USA (Pittsburgh), UK, Netherlands </li></ul></ul><ul><li>Uncontrolled cardiac arrest . (Maastricht I, II y IV) </li></ul><ul><ul><li>Cardiac arrest after unsuccesful cpr USA (Illinois), Spain (Madrid, Coruña, Barcelona, Sevilla), Francia. </li></ul></ul>Arnold, Youngner, Schapiro, Spicer, 1995
  17. 17. Donation after cardiac death Intentionated ambiguity concerning the vital status of the patient-potential donor? Manipulation of the place and the moment for the determination of death Respect of the presumably consenting donor’s body when the preserving technics are applied Hardening of the initially “soft” presumed consent Precarious information to proxies Is this utilitarianism unethical?
  18. 18. PRAGMATISMO Flexibilidad en la aplicación de los principios: Respeto de principios en la teoría, atención a las consecuencias en la práctica ¿Coherencia?
  19. 19. Propuesta de justificación <ul><li>Utilitarismo limitado (de la regla) : El fin de salvar vidas no justifica el empleo de todos los medios posibles. Ciertas reglas y principios generales deben ser respetados por el interés de los trasplantes a largo plazo. </li></ul>Confianza del público   autorregulación
  20. 20. gobernanza <ul><li>Gobernanza : </li></ul><ul><li>- Participación ciudadana: estrategias sometidas a la discusión pública </li></ul><ul><li>- Transparencia </li></ul><ul><li>- Autonomía: No es sólo una cuestión de expertos </li></ul><ul><li>“ Sólo si nos aseguramos de que la ciencia se somete al examen y la deliberación públicos la ciencia puede contribuir al bien común” </li></ul>

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