Today, organs are retrieved under four different sets of circumstances.

• From a living donor, e.g. a single kidney or part of a liver. This presents no moral problem provided there is properly informed consent and there is no major risk to the life or health of the donor

• From a person who is declared dead using the older criteria of loss of respiration and cardiac function along with rigor mortis. Tissues such as bone marrow, corneas, heart valves and skin may be removed. This procedure is morally acceptable

• After the patient has been declared ‘brain dead’

• After the patient has been declared to have suffered ‘cardiac death’. The moral status of both ‘brain death’ and’ cardiac death is questionable.

Theory and Practice

            Organs are obtained from an unconscious patient after he or she has been called ‘brain dead’ using clinical and technologically acquired information, regarded as diagnostic of true death.. The public in general is not aware of the following serious criticisms of   organ harvesting. The theory of brain death is highly controversial and can be used for utilitarian purposes⁴.  The Pontifical Academy of Sciences declared brain death to be “the true criterion for death” in 1985, and again, in 1989. In February of 2005, Pope John Paul II called for more precise means of establishing that the donor is dead before vital organs are removed. Organ transplants, he continued, are acceptable only when they are conducted in a manner “so as to guarantee respect for life and for the human person.”⁵ The concept that whole brain death (irreversible loss of function of the cerebrum, cerebellum, and brain stem), indicates the loss of integrated organic unity in a human being has been subjected to a powerful critique by neurologist, Alan Shewmon.⁶ Some physicians question whether we can be sure the entire brain is really dead in patients declared dead in the U.S. by ‘whole brain’, or in the U.K. by ‘brain stem’ criteria.⁷ Neurological criteria are not sufficient for declaration of death when an intact cardio-respiratory system is functioning. These criteria test for the absence of some specific brain reflexes. Functions of the brain that are not considered are - temperature control, and control of blood pressure, cardiac rate, and salt and water balance. When a patient is declared brain dead these functions are not only still present, but also frequently, active.

            There is no consensus on diagnostic criteria for brain death. They are the subject of intense international debate. Various sets of neurological criteria for the diagnosis of brain death are used. A person could be diagnosed as brain dead if one set is used, and not be diagnosed as brain dead if another is used.^8,9,10,11  A diagnosis of death by neurological criteria is based on  theory, not on scientific fact. Also, complete irreversibility of neurological function, is an arbitrary prognosis, not a medically observable fact. There is also evidence of poor compliance with accepted guidelines of brain death.¹²

Utilitarian Rationale

            Brain death can be used for purely utilitarian purposes. In 2005, Dr. Robert Spaemann, a former philosopher at the University of Munich, told the Pontifical Academy of Sciences that the brain death approach to defining death reflects a new set of priorities.  The first priority is no longer the interest of the dying, to avoid being declared ‘dead’ prematurely, but the community’s interest in declaring a dying person dead as soon as possible. Two reasons are given, 1) Guaranteeing legal immunity for discontinuing life-prolonging measures that would constitute a financial and personal burden for family members and society alike and 2) Collecting vital organs for the purpose of saving the lives of other human beings by transplantation.¹³ The goal is to move to a society where people see organ donation as a social responsibility and where donating organs would be accepted as a normal part of dying, and that in cases where a person chose to withhold recording a specific choice about donating his or her organs, the surviving family members would  agree to donation.¹⁴ In the U.S., Federal regulations require institutions to contact local organ procurement organizations concerning death, or impending death, to insure that the family will be approached at the appropriate time by a professional skilled in presenting the proposal of organ donation.

Vatican Debate

            Bishop Fabian Bruskewitz of Lincoln, Nebraska, told the Pontifical Academy of The Sciences at its 2005 meeting that “no respectable, learned, and accepted, moral Catholic theologian has said that the words of Jesus regarding laying down one’s life for one’s friends (John 15:13) is a command or even a license for suicidal consent for the benefit of another’s continuation of earthly life.” The bishop then observed that current technology enables doctors to monitor brain activity “in the outer one or two centimeters of the brain.” He asked, “Do we have then, moral certitude in any way that can be called apodictic regarding even the existence, much less the cessation of brain activity?”¹⁵

             In 2006, the Pontifical Academy of the Sciences published a statement titled, “Why the Concept of Brain Death is Valid as a Definition of Death.” Breaking protocol, several participants in a 2005 Vatican sponsored conference on the ethics of declaring someone brain dead, have published the papers they delivered at the debate. The publication of those papers, which the Vatican had decided not to publish, is evidence of strong feelings about brain death by a minority of members of the Pontifical Academy. Roberto De Mattei, vice president of the National Research Council of Italy, told Catholic News Service. April 20, 2007, that “The concern of many is that the Vatican has not taken the appropriate position when doubts exist about the end of human life ... The moment of separation of the soul from the body is shrouded in mystery, just as the moment when a soul enters a person is.”

Harvard’s Oxymoron

            The 1968 Harvard Ad Hoc Committee for Irreversible Coma published criteria that held that any organ that no longer functions, or has the possibility of functioning again, is, for all practical purposes, if not in reality, dead. They then describe the criteria for the diagnosis of irreversible coma and its concomitantly permanent nonfunctioning brain. They equate the state of coma with brain death and then declare the patient brain dead. They imply that brain death should be regarded as death because it inevitably leads to death, and that the person in irreversible coma, is, for all practical purposes, if not in reality, dead. Untold semantic confusion has followed this oxy-moronic notion.¹⁶

The Deadly Apnea Test

            Every set of criteria for ‘brain death’ includes an apnea test, considered the most important step in the diagnosis of brain death. The ventilator is discontinued. ‘Apnea’ is the absence of breathing. The only purpose of this test is to determine if the patient is unable to breath on his/her own, in order to declare ‘brain death’. It aggravates the patient’s condition and is commonly done without the knowledge or consent of family members. The ventilator is turned off for up to 10 minutes, carbon dioxide increases in the blood, and the blood pressure may drop indicating that cardiac arrest has occurred. The test significantly impairs the possibility of recovery and can lead to the death of the patient through a heart attack or irreversible brain damage. Dr. Yoshio Watenabe, a cardiologist from Natoya, Japan, stated that if patients were not subjected to the apnea test they could have a 60% chance of recovery to normal life if treated with timely therapeutic hypothermia (cooling). Note the similarity to cardiac death, later described.¹⁷

            In August of 2007, Dr. K.G. Karakatsanis of the Medical School, Aristotle University of Thessaloniki, Greece, published an article in which he evaluated criteria and confirmatory tests for the diagnosis of brain death. He concluded that they do not satisfy the requirements for a diagnosis of irreversible cessation of all functions of the entire brain.¹⁸

            Some form of anaesthesia is needed to prevent the donor from moving during removal of the organs. The donor’s blood pressure may rise during surgical removal. Similar changes take place during ordinary surgical procedures only if the depth of anaesthesia is inadequate. Body movement and a rise in blood pressure are due to the skin incision and surgical procedure if the donor is not anaesthetized. Is it not reasonable to consider that the donor may feel pain? In some cases, drugs to paralyze muscle contraction are given to prevent the donor from moving during removal of the organs. Yet sometimes no anaesthesia is administered to the donor. Movement by the donor is distressing to doctors and nurses. Perhaps this is another reason why anaesthesia and drugs to paralyze the muscles are usually given.

Organ Harvesting After ‘Cardiac Death’

            Brain death has been used as a means of the morally validating the retrieval of vital human organs for transplant since the late 1960s, and ‘brain dead’ patients have been the main source of organs over the years ever since. However, demand for organs has increasingly exceeded supply. In 1993, a new way for categorizing patients as ‘dead’ was conceived. According to a protocol developed at the University of Pittsburgh, a patient could be declared dead, even though not ‘brain dead’ if he or she was declared to have suffered “irreversible loss of circulatory and respiratory function.” The Institute of Medicine found that in so-called “controlled non-heart-beating donation”, a typical candidate for organ donation would be 5 to 55 years old, would have suffered from severe head injury, would not be brain dead, would not be a drug user or HIV positive, and would be free from cancer or sepsis. This patient would frequently be unconscious as a result of a car crash.

            Typically, the patient would be in an emergency department, in coma, and on a ventilator. If the physician decided that treatment was futile,[an arbitrary decision] , he  or she would ask the relatives’ permission to withdraw ventilation and then would  ask for their permission to remove organs if the patient’s heart stopped beating. Ventilation  would  then be withdrawn. If the heart stopped beating within an hour, the surgeon would wait 2 to 5 minutes before taking out the organs. If the heart had not stopped beating within an hour, the patient would be returned to a hospital bed to die without any further treatment. Note that the patient’s physician has a conflict of interest. The longer he waits, the less suitable the organs are for transplant due to damage from lack of oxygenation. The sooner the doctor declares treatment futile, the less chance the patient has of spontaneous recovery.¹⁹

            These procedures are performed despite animal studies and clinical experience that shows that even complete recovery of consciousness is possible several minutes after the heart stops if resuscitative efforts succeed. This kind of resuscitation has been reported after more than 10 minutes of cardiac electric asystole in humans.²⁰ The fact that the heart stops beating due to ventricular fibrillation, as occurs in a heart attack, does not indicate irreversible cessation of cardiac activity.²¹ The application of criteria for organ donation after “cardiac death” also becomes questionable since artificial circulatory and ventilatory support is sometimes resumed after “death” in order to maintain the viability of abdominal and thoracic organs in potential donors.²² Extra-corporeal circulatory support can lead to return of neurological function in people who were neurologically intact before “cardiac death.”^23,24

            Finally, it is now widely known that a patient whose heart has stopped beating for 15 minutes after a heart attack can recover if they are treated by cooling the body to 33 degrees C., by using cardio-pulmonary by-pass, by cardioplegia, that is, stopping the heart beat chemically, and a slow increase in oxygenation for 24 hours. Up to 80% of these patients can be discharged from hospital, 55% having a good neurological outcome. Clearly, the assumption made by physicians that a patient is dead five minutes after the heart has stopped beating is incorrect.²⁵

            The case for considering “brain death” as equivalent to true death has undergone further trenchant scientific and philosophical critique.^26,27,28, The notion of irreversible loss of circulatory and respiratory function as a criterion for determining death has also been seriously challenged. This notion means either that the heart cannot be restarted spontaneously (a weaker definition), or that the heart cannot be started despite standard cardio-pulmonary resuscitation (a stronger definition.) The stronger definition of irreversibility, as meaning “can never be done”, implies that at no time can organ procurement be permissible because future possibilities of resuscitation can never be ruled out. The weaker definition, in practice, considers the patient dead based on the patient’s moral choice to forego resuscitative interventions. The problem is that first, the issue is not whether to resuscitate a person, but is the person truly dead? Secondly, that resuscitative interventions are performed during the procurement process to keep organs viable for transplantation after cessation of vital functions, e.g. the use of cardio-pulmonary bypass machines etc. This can result in a return of heart and brain function and even a return to consciousness.²⁹ The application of criteria for irreversible cessation of neurological, circulatory, and respiratory functions requires a waiting time well in excess of ten minutes to give more precision to the determination of death for organ procurement.^{30,31,32,33,34,35}

            One medical group has removed the heart from newborn infants as early a 75 seconds after the heart stopped beating.³⁶ On August 14, 2008, Robert Truog and Franklin Miller, after giving reasons why brain death and cardiac death should not be considered valid, went so far as to advocate vital organ donation in terms of valid informed consent and under the condition of devastating neurological injury.³⁷

            An ominous and disturbing development concerns palliative care givers in the donation process. Those caregivers are said to provide “... skills and principles applicable to donation after cardiac death.” In effect, they are to act as the agents of a soft-sell program to make the family “feel comfortable and supported during this extremely difficult time.” This movement is in keeping with the Institute of Medicine Report Brief, 2006, on Organ Donation: Opportunities for Action.

            The IOM goal is “to move toward a society where people see organ donation as a social responsibility” and where “... donating organs would be accepted as a normal part of dying, and in cases where a patient “died” without recording a specific choice about donation of his or her organs, the surviving family members would be comfortable giving permission.”³⁸

            In 2006, research done by Dr. Gerald Buckberg, a cardio-thoracic surgeon and UCLA expert, demonstrated that a person can survive cardiac arrest for an average of 72 minutes if given the following treatment: cardio-pulmonary resuscitation, the use of a heart-lung machine to keep blood and oxygen circulation, and gradual restoration of blood and oxygen flow.

            This research was done at hospitals in Alabama and Ann Arbor, Michigan, and also in Germany. Of 34 patients, seven died, only two had permanent neurological changes and 25 recovered completely. One patient had been in cardiac arrest for two and a half days. Similar results were obtained by research in Japan, Taiwan, and elsewhere in Asia.

            In 1997, the Pittsburgh Protocol declared that cardiac arrest lasting 2-5 minutes causes ‘cardiac death’ and that it is ethically acceptable to remove vital organs for transplantation if a patient is in cardiac arrest for 5 minutes. The evidence provided by Dr. Buckberg and others directly contradicts this. Cardiac death was accepted according to the Pittsburgh Protocol with fanfare and approbation in Canada on January 27, 2006. In December, 2002, Drs. M.L. Weisfeldt and L. Becker, demonstrated that resuscitation was possible up to 15 minutes after cardiac arrest. It is now clear that the use of cardiac arrest as a criterion of death is no longer tenable. Will Dr. Buckberg’s research be ignored by bioethicists, hospitals, and physicians and the hunt for transplant organs continue on its inexorable course? ³⁹

Comment

            Organ donation can be a moral good if the means used to obtain the organs is itself, morally good. The circumstances under which this holds true have been described. The critical question is whether a person is truly dead when declared ‘brain dead’ or to have suffered ‘cardiac death’. The answer, in light of the scientific evidence, is that it has not been established that cardiac or brain death criteria indicate the real death of a patient with certainty. Mauro Cozzoli, writing about the status of the embryo has stated ... “The uncertainty with regard to whether we are dealing with a human individual is not an abstract doubt, regarding a theory, principle, or doctrinal position (dubium uris). As such, it is a doubt about a fact concerning the life of a human being, his existence here and now (dubium facti).” As such, “... it creates the same obligations as certainty.”⁴⁰

            The object of the will is determined by both the agent’s motive (finis operantis) and by the physical character, the integral nature of the external act (finis operis). The physical and clinical realities of an action, whether actual or potential, must not be ignored or denied.⁴¹ Those caregivers in Catholic hospitals who administer levonorgestrel, an abortifacient, to a woman who has been raped, ignore or deny the fact that it is impossible to exclude the possibility that she has ovulated and may be pregnant. Those who harvest organs after brain death or cardiac death similarly ignore or deny the possibility that the “donor” may be alive. Professor Joseph Seifert from the International Academy of Philosophy in Lichtenstein, states that medical ethicists should invoke the traditional moral teaching of the Catholic Church that “... even if a small reasonable doubt exists that our acts kill a living human person, we must abstain from them.”⁴²

            The declaration of brain death and cardiac death do not appear to be sufficient to arrive at moral certainty that the donor is truly dead. That declaration also does not appear to be consistent with the teaching of Pope Benedict XVI, that the definition of death receive the consensus of the entire scientific community and does not give everyone certainty that the primary criterion is respect for the life of the donor and that the organs are removed from a dead body.

John B. Shea, MD FRCP

September 4,2009

References:

1. Address of the Holy Father, John Paul II, to the Eighteenth International Congress of the Transplantation Society, August 29, 2000.

2. Dr. Alan Shewmon and Elizabeth Seitz Shewmon, “The Semiotics of Death and Its Medical Implications”, Brain Death and Disorders of Consciousness. Edited by Machado and Shewmon. Kluwer Academic/Plenum publishers. New York, 2004, pp. 105-6.

3. Carol Glatz, Vatican resuscitates issue of whether brain death means total death. Vatican Letter, Catholic New Service. Sept. 15, 2006, backgrounder xxxi.

4. Capron A.M., “Brain Death – Well Settled Yet Still Unresolved,” New England Journal of Medicine, April 19, 2001, vol. 344 (16).

5. Pope John Paul II, Letter to the Pontifical Academy of Sciences. Feb. 3 2005.

6. D. Alan Shewmon, “Recovery from Brain Death. A Neurologist’s Apologia.” Linacre Quarterly, Feb. 1997, 30 – 96.

7. Donald W. Evans, Retired Physician, Queens College, Cambridge, Journal of Medical Ethics. April 11, 2007.

8. Wijdicks E.F., Neurology, 2002, Jan. 8; 58(1): 20-25.

9. Haupt W.F., Rudolf J. “European brain death codes: a comparison of national guidelines.” J. Neurol, 1999, June; 246(6): 432-7.

10. Evans D.W. and Potts M., Brain death, BMJ, 2002; 325:598.

11. David W. Evans, Open letter to Prof. E F M Wijdics, Dec. 11, 2001, www bmj.com.

12. Wang M.Y. et al, Neurosurgery, 2002, Sept; 51(3): 751-5.

13. Institute of Medicine, National Academy of Sciences, Report Brief, Organ Donation- Opportunities for Action, Committee on Increasing Role of Organ Donation, May, 2006.

14. D. Truog et al., Recommendations for End-of-Life Care in the Intensive Care Unit. The Ethics Committee of the Society of Critical Care, Crit. Care Med. 2001 vol.29. no. 12, pp. 2332-234

15. Paul A. Byrne et al., “Brain Death is Not Death!” Source: Essay – Meeting of the Political Academy of Sciences, in early February, Paul Byrne to the Compassionate Health Care Network, March 29, 2005, via e-mail.

16. See reference 6.

17. Ari R. Joffe, Critical Care Physician, Stollery Children’s Hospital, University of Alberta, e-letter to J.R. Cuo et al. Time dependent validity in the diagnosis of brain death using transcranial Doppler. J. Neurol Neurosurg Psychiatry, 2006; 77: 646-649.

18. Dr. K.G. Karakatsanis, Spinal Cord, 2007, Aug.14; 17700512(P,S,G,E,I,D).

19. Institute of Medicine, “Non-Heart-Beating Organ Transplantation – Medical and Ethical Issues of Procurement.” 1997, National Academy Press, Washington, D.C.

20. Adhiyaman V., Sundaram R., The Lazarus phenomenon, J. R. Coll. Physicians Edinb. 2002, 32: 9-13.

21. American Heart Association, Management of Cardiac Arrest. Circulation, 2005; 112:IV 58-IV66.

22. Institute of Medicine Committee on Non-Hearth-Beating Transplantation, The scientific and ethical basis for practice and protocols, Executive Summary. Washington, (D.C.): National Academy Press; 2000.

23. Magliocca J. F. et al, Extracorporeal support for organ donation after cardiac death effectively expands the donor pool. J Trauma, 2005; 58:1095-1201.

24. Younger J.G. et al, Extracorporeal resuscitation of cardiac arrest. Acad Emerg Med, 1999: 6: 700-7.

25. Weisfeldt M.L., Becker L., “Resuscitation After Cardiac Arrest” A 3 – phase Time-Sensitive Model, JAMA, Dec. 18, 2002, vol. 288, no. 23, pp. 3035-8.

26. Potts M., Byrne P.A., Nilges R.G., Beyond brain death: the case against brain based criteria for human death. Dordecht: Kluwer Academic Publishers; 2000.

27. Shewmon D.A., “Brain body disconnection: implications for the theoretical basis of ‘brain death’.” In De Mattia R., Finis Vitae – is brain death still life? 211-50. Roma:Consiglio Nazionale della Richerche; 2006.

28. Truog R.D., “Brain death – too flawed to endure, too ingrained to abandon.”        J Law Med. Eth. 2007: 35(2): 273-81.

29. Verheijde J.L., Rady M.Y., McGregor J., “Recovery of transplantable organs after cardiac or circulatory death: transforming the paradigm of the ethics of organ donation.” Philosophy, Ethics and Humanities in Medicine, 2007, 2:8. http://www/pch.med.com/content/2/1/8

30. Koostra G: The asystolic or non-heart beating donor. Transplantation, 1997, 63(7): 917-21.

31. Weber M. et al., Kidney Transplantation from Donors Without a Heartbeat. N. Eng J Med., 2002, 347 (4): 248-255.

32. Daar A.S: Non heart-beating donation: ten evidence-based ethical recommendations. Transplant Proceed, 2004, 26: 1885-1887.

33. Wijdics E.F., Diringer M. N: Electro-cardiographic activityafter terminal cardiac arrest in neurocatastrophies. Neurology, 2004, 62(4): 673-674.

34. Bos M.A: Ethical and legal issues in non-heart beating organ donation. Transplantation, 2005, 79(9): 1143-1147.

35. Bell M., MD: Non-heart beating organ donation: clinical process and fundamental issues, Br J Anaesth., 2005, 94(4): 474-478.

36. Mark M. Boucek et al, N E J M, vol. 359: 709-714. Aug. 14, 2008. No.7. Pediatric Heart Transplantation After Declaration of Cardio-circulatory Death.

37. Robert D. Truog, MD., Franklin G. Miller, PhD. N E J M  vol. 359: 674-675. Aug. 14, 2008. No. 7.  The Dead Donor Rule and Transplantation. 

38. Catherine McVearry Kelso,MD et al. Journal of  Palliative Medicine, vol.10,no.11,207.

39. Prof. Mauro Cozzoli, The Human Embryo: Ethical and Normative Aspects. The Identity and Status of the Human Embryo. Proceedings of the Third Assembly of The Pontifical Academy for Life, Vatican City, Feb. 14-16, 1997. p. 271, Libreria Editrice Vaticana, 00120. Citta Dei Vaticano.

40. Lifeissues.net / ‘Cardiac Death’ allows one to Kill the Organ Donor.

41. Steven Long, Regarding the Nature of the Object of the Moral Act According to St. Thomas Aquinas, The Thomistic Institute, 2001, maritain.nd.edu/jiuc/ti01/long.htm

42. See reference 15.

John B. Shea, MD. FRCP(C)

June 11, 2007