FROM THE CANADIAN PAEDIATRIC SOCIETY SOCIETE CANADIENNE DE PEDIATRIE COMMUNIQUE
Transplantation of organs from newborns with anencephaly
Bioethics Committee,* Canadian Paediatric Society T he successful transplantation in 1987 of a heart from Baby Gabriel into another Canadian, Baby Paul, at Loma Linda, Calif., provoked both interest and controversy in the possibility that infants born with anencephaly might act as organ donors. Although transplantation of kidneys and other organs from anencephalic donors had previously been performed in Europe and North America, this case raised the possibility of providing life-saving therapy for previously fatal cardiac anomalies in newborns and at the same time offering meaning and benefit for the donor's family in what was otherwise a terrible tragedy. Many questions have been raised: Should infants with anencephaly be regarded as people? Are they potential donors of organs? If so, under what circumstances? Should the definition of death or of brain death be changed? Should aggressive life support be used for infants with anencephaly in anticipation of brain death? How should priorities be determined in neonatal units with limited resources?
Organ transplantation in newborns The criteria and ethical principles that apply to organ transplantation involving children and adults also apply to the newborn, as either recipient or
potential donor. The stakes for recipients and their families are high; therefore, there is considerable obligation to ensure that the family understands the limited medical knowledge about both the risks and benefits of the procedure. Given that transplantation in newborns is innovative, that our knowledge of the intermediate results is limited and that the long-term results have yet to be evaluated, physicians performing such transplantations must evaluate the benefits, problems and costs to the infants, their families and society; the evaluation should include the families of "successful" and "unsuccessful" potential donors and of recipients. Ethical and legal principles require that the donor be pronounced dead by at least one physician who is not associated with the potential recipient or his or her family. Death may be pronounced on the basis of conventional grounds or grounds of brain death. The currently acceptable definition of brain death in Canada is that described by the CMA.' The definition refers to whole-brain death - death of both the forebrain (the "thinking brain") and the hindbrain (the "automatic brain").
Organ donation from anencephalic newborns Anencephaly is the congenital absence of the
*Members: Drs. Roland Leclerc (director responsible), Department of Pediatrics, h6pital de l'Enfant Jesus, Ste-Foy, PQ; John L. Watts (principal author and chairman), Department of Pediatrics, McMaster University Health Sciences Centre, Hamilton, Ont.; Syed Kaiser Ali, Department of Pediatrics, Janeway Child Health Centre, St. John's; Douglas Biggar, director ofpediatrics, Hugh MacMillan Medical Centre, Toronto; Graham Chance, Neonatal-Perinatal Medicine, St. Joseph's Health Centre, London, Ont.; Nuala P. Kenny, chairman, Department of Pediatrics, Dalhousie University, Halifax; and Serge Melancon, Service de genetique, h6pital Sainte-Justine, Montreal. Consultants: Drs. John U. Crichton, Department of Neurology, British Columbia's Children's Hospital, Vancouver; Bernard Dickens, professor of law, University of Toronto; Abbyann Lynch, director, Westminster Institute for Ethics and Human Values, London, Ont.; and Sydney Segal, professor emeritus ofpediatrics, University of British Columbia, Vancouver. Reprint requests to: Bioethics Committee, Canadian Paediatric Society, Children's Hospital of Eastern Ontario, 401 Smyth Rd., Ottawa, Ont. KJH 8LI CAN MED ASSOC J 1990; 142 (7)
715
skull, the scalp and the forebrain. The hindbrain is present, and there is usually some rudimentary or disorganized forebrain tissue. An excellent review has been provided by Shewmon.2 An infant with anencephaly is a human being, albeit severely malformed, and therefore must be treated in the same way as any other human being. As with all newborns the criteria and ethical principles that apply in organ transplantation involving other children and adults also apply if an infant with anencephaly is the potential donor. Physicians who accept the responsibility of caring for such an infant must have the interests of that patient as their primary consideration in decision-making and be bound by the same moral and ethical judgements as those used in caring for any other patient. Organs from an anencephalic infant cannot be considered for transplantation until the infant is declared dead on the basis of the medical or legal definition of death or brain death that applies to other human beings. However, two important issues are raised. First, the clinical criteria of brain death cannot usually be applied to infants less than 7 days old since their value in predicting nonrecovery at this time is uncertain, although it can reasonably be argued that their predictive value is much more certain in the presence of anencephaly. Second, by the time brain death is declared the donor organs may have been damaged and thus are unusable for transplantation. In the anencephalic infant, although the forebrain is absent the hindbrain exists and is usually functioning normally at birth. Death of the hindbrain is slow, and other organs may die in the meantime. Anecdotal evidence suggests that only under the most exceptional circumstances does an infant with anencephaly reach a stage of clinical brain death (i.e., total unresponsiveness, loss of all reflex activity and absence of spontaneous respiration) and maintain a reasonably normal cardiac output. Thus, organ donation from anencephalic infants is likely to be feasible in only a very few cases, if at all. An alternative approach that has been suggested would be to allow the removal of organs before the anencephalic infant reaches a stage equivalent to conventional brain death. However, we strongly oppose this proposal on the following grounds. * It might be extended to other groups of "near-dead" patients, including those in a persistent vegetative state, those with other major abnormalities of the central nervous system and those who are chronically comatose. * It would lead to negative effects on people's confidence and trust in physicians in general and pediatricians in intensive care units in particular. * It would have negative effects on staff otherwise committed to caring for these patients. 716
(AN MED ASSOC J 1990: 142 (7)
* It would be a further step toward the consideration of anencephalic infants simply as a means to an end. In addition to the very low likelihood that such infants would reach a stage at which organs could be donated, there is a continuing decline in the incidence of liveborn anencephalic infants, partly because of early diagnosis through screening in pregnancy (with subsequent abortion of affected fetuses) and also because of a secular trend, possibly related to improvements in nutrition. The practice of providing aggressive life support, including mechanical ventilation, in anticipation of brain death and subsequent organ removal is flawed from both medical and ethical aspects. Anecdotal experience suggests that this practice does not lead to early death but, rather, prolongs survival and therefore prolongs dying; this is ethically unacceptable. There is also evidence of distress among the parents and the staff during such attempts.
Competing resources Neonatal intensive care units are heavily used, expensive and frequently overcrowded. It is clearly unethical to transfer the resources needed for neonatal intensive care (a well-established system of proven benefit) to an experimental, unproven project such as the maintenance of infants with anencephaly for the purposes of organ donation.
Recommendations * Any program involving organ donation from anencephalic infants should be reviewed by the institution's research ethics committee and, if present, its clinical ethics committee. In addition, we strongly encourage external review of such protocols, especially if the institution has no research or clinical ethics committee. * The families of donors and recipients must be made aware of the investigative nature of these programs and of the likelihood that the number of babies with anencephaly who become successful donors will be very small. * The short-term and long-term outcomes of transplantation programs involving newborns should be evaluated with regard to the effects on the donors, the recipients and their respective families.
* After brain death has been declared, the use of extraordinary supportive measures such as mechanical ventilation and total intravenous feeding to prolong organ viability should be limited to a finite period (to be defined by each centre). * There should be no modification of the criteria for establishing whole-brain death. The absence of the forebrain should not be considered
equivalent to whole-brain death. The definition of brain death should not be specific to or specifically modified for any group of patients, including anencephalic infants. * The provision of aggressive life support in the anticipation of brain death should be discouraged. * Potential recipients and donors who are in the same hospital should be managed in separate units by separate professional teams. * Basic research and animal studies are needed
to determine and prevent the effects of hypoxia and ischemia on the viability and functioning of organs before and after transplantation.
Conferences
June 12-15, 1990: Canadian Hospital Association Annual Conference: Caring for Medicare Centennial Auditorium and Holiday Inn, Saskatoon Conferences, Canadian Hospital Association, 100- 17 York St., Ottawa, Ont. KIN 9J6; (613) 238-8005, FAX (613) 238-6924
continuedfrom page 714 June 1-3, 1990: Nerves, Muscles and Joints: Chicken or the Egg - Bridging the Gap Between Research and Clinical Practice (sponsored by the Physical Medicine Research Foundation in cooperation with the Canadian Association of Orthopaedic Medicine) University of British Columbia, Vancouver Dr. John Fuller, Physical Medicine Research Foundation, 510-207 West Hastings St., Vancouver, BC V6B 1H7; (604) 684-4148, FAX (604) 684-6247 June 3-6, 1990: Canadian Dietetic Association Annual Conference: "Dare to Grow" Ottawa Congress Centre Joan Wyatt, chair, Conference Planning Committee, Royal Ottawa Rehabilitation Centre, 505 Smyth Rd., Ottawa, Ont. K1H 8M2; (613) 737-7350, ext. 544 June 3-6, 1990: Choices: Long-Term Care in the 90s - a Decade of Change (sponsored by the Alberta Long Term Care Association and the Canadian Long Term Care Association) Calgary Convention Centre Alberta Long Term Care Association, 1010 CN Tower, 10004-104 Ave., Edmonton, Alta. T5J OKI; (403) 421-1137, FAX (403) 426-0479 June 4-8, 1990: Ontario Medical Association 110th Annual Meeting Inn on the Park Hotel, Toronto Mrs. Ema Walker, annual meeting coordinator, 600-250 Bloor St. E, Toronto, Ont. M4W 3P8; (416) 963-9383 or 1-800-268-7215, FAX (416) 963-8819 June 7-9, 1990: American Society for Bariatric Surgery 7th Annual Meeting Royal York Hotel, Toronto Dr. Thomas J. Blommers, executive manager, American Society for Bariatric Surgery, Box 639, 633 Post St., San Francisco, CA 94109 June 12-15, 1990: Canadian Health Record Association 48th Annual Conference: "Strategies 2000" Inn on the Park, Toronto Canadian Health Record Association, 250 Ferrand Dr., Don Mills, Ont. M3C 3G8; (416) 429-5835
References 1. Guidelines for the diagnosis of brain death. Can Med Assoc J 1987; 136: 200A-200B 2. Shewmon DA: Anencephaly: selected medical aspects. Hastings Cent Rep 1988; 18: 11-19
June 15-19, 1990: Canadian Anaesthetists' Society 47th Annual Meeting Hyatt Regency Hotel, Vancouver Ann Andrews, executive director, Canadian Anaesthetists' Society, 187 Gerrard St. E, Toronto, Ont. MSA 2E5; (416) 923-1449 June 17-22, 1990: Canadian Society of Laboratory Technologists Congress: Technology in the 90s Centennial Auditorium and Holiday Inn, Saskatoon Shirley Pierce, CSLT National Congress 1990, Histology Laboratory, Saskatoon City Hospital, Saskatoon, Sask. S7K OM7 June 23-24, 1990: 5th Conference on Health Problems Related to the Chinese in North America Four Seasons Hotel, Toronto Dr. John Chiu, conference chairman, 50 Michael Dr., Willowdale, Ont. M2H 2A5; (416) 635-2550, FAX (416) 250-7395 June 24-27, 1990: Canadian Nurses Association Annual Meeting and Biennial Convention Calgary Convention Centre Linda O'Rourke, corporate affairs manager, Canadian Nurses Association, 50 The Driveway, Ottawa, Ont. K2P 1E2; (613) 237-2133, FAX (613) 237-3520 June 24-27, 1990: Canadian Ophthalmological Society 53rd Annual Meeting Quebec Municipal Convention Centre, Quebec City Paul Le Bel, executive director, Canadian
Ophthalmological Society, 610-1525 Carling Ave., Ottawa, Ont. K1Z 8R9; (613) 729-6779, FAX (613) 729-7209 June 24-27, 1990: Canadian Society of Otolaryngology 44th Annual General Meeting - Head & Neck Surgery Bonaventure Hotel, Montreal Canadian Society of Otolaryngology - Head & Neck Surgery, 103-4953 Dundas St. W, Islington, Ont. M9A 1 B6; (416) 233-6034, FAX (416) 239-8220
continued on page 740 CAN MED ASSOC J 1990; 142 (7)
717
Transplantation of organs from newborns with anencephaly
Bioethics Committee,* Canadian Paediatric Society T he successful transplantation in 1987 of a heart from Baby Gabriel into another Canadian, Baby Paul, at Loma Linda, Calif., provoked both interest and controversy in the possibility that infants born with anencephaly might act as organ donors. Although transplantation of kidneys and other organs from anencephalic donors had previously been performed in Europe and North America, this case raised the possibility of providing life-saving therapy for previously fatal cardiac anomalies in newborns and at the same time offering meaning and benefit for the donor's family in what was otherwise a terrible tragedy. Many questions have been raised: Should infants with anencephaly be regarded as people? Are they potential donors of organs? If so, under what circumstances? Should the definition of death or of brain death be changed? Should aggressive life support be used for infants with anencephaly in anticipation of brain death? How should priorities be determined in neonatal units with limited resources?
Organ transplantation in newborns The criteria and ethical principles that apply to organ transplantation involving children and adults also apply to the newborn, as either recipient or
potential donor. The stakes for recipients and their families are high; therefore, there is considerable obligation to ensure that the family understands the limited medical knowledge about both the risks and benefits of the procedure. Given that transplantation in newborns is innovative, that our knowledge of the intermediate results is limited and that the long-term results have yet to be evaluated, physicians performing such transplantations must evaluate the benefits, problems and costs to the infants, their families and society; the evaluation should include the families of "successful" and "unsuccessful" potential donors and of recipients. Ethical and legal principles require that the donor be pronounced dead by at least one physician who is not associated with the potential recipient or his or her family. Death may be pronounced on the basis of conventional grounds or grounds of brain death. The currently acceptable definition of brain death in Canada is that described by the CMA.' The definition refers to whole-brain death - death of both the forebrain (the "thinking brain") and the hindbrain (the "automatic brain").
Organ donation from anencephalic newborns Anencephaly is the congenital absence of the
*Members: Drs. Roland Leclerc (director responsible), Department of Pediatrics, h6pital de l'Enfant Jesus, Ste-Foy, PQ; John L. Watts (principal author and chairman), Department of Pediatrics, McMaster University Health Sciences Centre, Hamilton, Ont.; Syed Kaiser Ali, Department of Pediatrics, Janeway Child Health Centre, St. John's; Douglas Biggar, director ofpediatrics, Hugh MacMillan Medical Centre, Toronto; Graham Chance, Neonatal-Perinatal Medicine, St. Joseph's Health Centre, London, Ont.; Nuala P. Kenny, chairman, Department of Pediatrics, Dalhousie University, Halifax; and Serge Melancon, Service de genetique, h6pital Sainte-Justine, Montreal. Consultants: Drs. John U. Crichton, Department of Neurology, British Columbia's Children's Hospital, Vancouver; Bernard Dickens, professor of law, University of Toronto; Abbyann Lynch, director, Westminster Institute for Ethics and Human Values, London, Ont.; and Sydney Segal, professor emeritus ofpediatrics, University of British Columbia, Vancouver. Reprint requests to: Bioethics Committee, Canadian Paediatric Society, Children's Hospital of Eastern Ontario, 401 Smyth Rd., Ottawa, Ont. KJH 8LI CAN MED ASSOC J 1990; 142 (7)
715
skull, the scalp and the forebrain. The hindbrain is present, and there is usually some rudimentary or disorganized forebrain tissue. An excellent review has been provided by Shewmon.2 An infant with anencephaly is a human being, albeit severely malformed, and therefore must be treated in the same way as any other human being. As with all newborns the criteria and ethical principles that apply in organ transplantation involving other children and adults also apply if an infant with anencephaly is the potential donor. Physicians who accept the responsibility of caring for such an infant must have the interests of that patient as their primary consideration in decision-making and be bound by the same moral and ethical judgements as those used in caring for any other patient. Organs from an anencephalic infant cannot be considered for transplantation until the infant is declared dead on the basis of the medical or legal definition of death or brain death that applies to other human beings. However, two important issues are raised. First, the clinical criteria of brain death cannot usually be applied to infants less than 7 days old since their value in predicting nonrecovery at this time is uncertain, although it can reasonably be argued that their predictive value is much more certain in the presence of anencephaly. Second, by the time brain death is declared the donor organs may have been damaged and thus are unusable for transplantation. In the anencephalic infant, although the forebrain is absent the hindbrain exists and is usually functioning normally at birth. Death of the hindbrain is slow, and other organs may die in the meantime. Anecdotal evidence suggests that only under the most exceptional circumstances does an infant with anencephaly reach a stage of clinical brain death (i.e., total unresponsiveness, loss of all reflex activity and absence of spontaneous respiration) and maintain a reasonably normal cardiac output. Thus, organ donation from anencephalic infants is likely to be feasible in only a very few cases, if at all. An alternative approach that has been suggested would be to allow the removal of organs before the anencephalic infant reaches a stage equivalent to conventional brain death. However, we strongly oppose this proposal on the following grounds. * It might be extended to other groups of "near-dead" patients, including those in a persistent vegetative state, those with other major abnormalities of the central nervous system and those who are chronically comatose. * It would lead to negative effects on people's confidence and trust in physicians in general and pediatricians in intensive care units in particular. * It would have negative effects on staff otherwise committed to caring for these patients. 716
(AN MED ASSOC J 1990: 142 (7)
* It would be a further step toward the consideration of anencephalic infants simply as a means to an end. In addition to the very low likelihood that such infants would reach a stage at which organs could be donated, there is a continuing decline in the incidence of liveborn anencephalic infants, partly because of early diagnosis through screening in pregnancy (with subsequent abortion of affected fetuses) and also because of a secular trend, possibly related to improvements in nutrition. The practice of providing aggressive life support, including mechanical ventilation, in anticipation of brain death and subsequent organ removal is flawed from both medical and ethical aspects. Anecdotal experience suggests that this practice does not lead to early death but, rather, prolongs survival and therefore prolongs dying; this is ethically unacceptable. There is also evidence of distress among the parents and the staff during such attempts.
Competing resources Neonatal intensive care units are heavily used, expensive and frequently overcrowded. It is clearly unethical to transfer the resources needed for neonatal intensive care (a well-established system of proven benefit) to an experimental, unproven project such as the maintenance of infants with anencephaly for the purposes of organ donation.
Recommendations * Any program involving organ donation from anencephalic infants should be reviewed by the institution's research ethics committee and, if present, its clinical ethics committee. In addition, we strongly encourage external review of such protocols, especially if the institution has no research or clinical ethics committee. * The families of donors and recipients must be made aware of the investigative nature of these programs and of the likelihood that the number of babies with anencephaly who become successful donors will be very small. * The short-term and long-term outcomes of transplantation programs involving newborns should be evaluated with regard to the effects on the donors, the recipients and their respective families.
* After brain death has been declared, the use of extraordinary supportive measures such as mechanical ventilation and total intravenous feeding to prolong organ viability should be limited to a finite period (to be defined by each centre). * There should be no modification of the criteria for establishing whole-brain death. The absence of the forebrain should not be considered
equivalent to whole-brain death. The definition of brain death should not be specific to or specifically modified for any group of patients, including anencephalic infants. * The provision of aggressive life support in the anticipation of brain death should be discouraged. * Potential recipients and donors who are in the same hospital should be managed in separate units by separate professional teams. * Basic research and animal studies are needed
to determine and prevent the effects of hypoxia and ischemia on the viability and functioning of organs before and after transplantation.
Conferences
June 12-15, 1990: Canadian Hospital Association Annual Conference: Caring for Medicare Centennial Auditorium and Holiday Inn, Saskatoon Conferences, Canadian Hospital Association, 100- 17 York St., Ottawa, Ont. KIN 9J6; (613) 238-8005, FAX (613) 238-6924
continuedfrom page 714 June 1-3, 1990: Nerves, Muscles and Joints: Chicken or the Egg - Bridging the Gap Between Research and Clinical Practice (sponsored by the Physical Medicine Research Foundation in cooperation with the Canadian Association of Orthopaedic Medicine) University of British Columbia, Vancouver Dr. John Fuller, Physical Medicine Research Foundation, 510-207 West Hastings St., Vancouver, BC V6B 1H7; (604) 684-4148, FAX (604) 684-6247 June 3-6, 1990: Canadian Dietetic Association Annual Conference: "Dare to Grow" Ottawa Congress Centre Joan Wyatt, chair, Conference Planning Committee, Royal Ottawa Rehabilitation Centre, 505 Smyth Rd., Ottawa, Ont. K1H 8M2; (613) 737-7350, ext. 544 June 3-6, 1990: Choices: Long-Term Care in the 90s - a Decade of Change (sponsored by the Alberta Long Term Care Association and the Canadian Long Term Care Association) Calgary Convention Centre Alberta Long Term Care Association, 1010 CN Tower, 10004-104 Ave., Edmonton, Alta. T5J OKI; (403) 421-1137, FAX (403) 426-0479 June 4-8, 1990: Ontario Medical Association 110th Annual Meeting Inn on the Park Hotel, Toronto Mrs. Ema Walker, annual meeting coordinator, 600-250 Bloor St. E, Toronto, Ont. M4W 3P8; (416) 963-9383 or 1-800-268-7215, FAX (416) 963-8819 June 7-9, 1990: American Society for Bariatric Surgery 7th Annual Meeting Royal York Hotel, Toronto Dr. Thomas J. Blommers, executive manager, American Society for Bariatric Surgery, Box 639, 633 Post St., San Francisco, CA 94109 June 12-15, 1990: Canadian Health Record Association 48th Annual Conference: "Strategies 2000" Inn on the Park, Toronto Canadian Health Record Association, 250 Ferrand Dr., Don Mills, Ont. M3C 3G8; (416) 429-5835
References 1. Guidelines for the diagnosis of brain death. Can Med Assoc J 1987; 136: 200A-200B 2. Shewmon DA: Anencephaly: selected medical aspects. Hastings Cent Rep 1988; 18: 11-19
June 15-19, 1990: Canadian Anaesthetists' Society 47th Annual Meeting Hyatt Regency Hotel, Vancouver Ann Andrews, executive director, Canadian Anaesthetists' Society, 187 Gerrard St. E, Toronto, Ont. MSA 2E5; (416) 923-1449 June 17-22, 1990: Canadian Society of Laboratory Technologists Congress: Technology in the 90s Centennial Auditorium and Holiday Inn, Saskatoon Shirley Pierce, CSLT National Congress 1990, Histology Laboratory, Saskatoon City Hospital, Saskatoon, Sask. S7K OM7 June 23-24, 1990: 5th Conference on Health Problems Related to the Chinese in North America Four Seasons Hotel, Toronto Dr. John Chiu, conference chairman, 50 Michael Dr., Willowdale, Ont. M2H 2A5; (416) 635-2550, FAX (416) 250-7395 June 24-27, 1990: Canadian Nurses Association Annual Meeting and Biennial Convention Calgary Convention Centre Linda O'Rourke, corporate affairs manager, Canadian Nurses Association, 50 The Driveway, Ottawa, Ont. K2P 1E2; (613) 237-2133, FAX (613) 237-3520 June 24-27, 1990: Canadian Ophthalmological Society 53rd Annual Meeting Quebec Municipal Convention Centre, Quebec City Paul Le Bel, executive director, Canadian
Ophthalmological Society, 610-1525 Carling Ave., Ottawa, Ont. K1Z 8R9; (613) 729-6779, FAX (613) 729-7209 June 24-27, 1990: Canadian Society of Otolaryngology 44th Annual General Meeting - Head & Neck Surgery Bonaventure Hotel, Montreal Canadian Society of Otolaryngology - Head & Neck Surgery, 103-4953 Dundas St. W, Islington, Ont. M9A 1 B6; (416) 233-6034, FAX (416) 239-8220
continued on page 740 CAN MED ASSOC J 1990; 142 (7)
717
