NHBD: non-heart-beating organ donation.

The first heart transplant was performed in 1968. In the same year, the Harvard Ad Hoc Committee declared that a person who was in irreversible coma was, for all practical purposes, though not in reality, dead. That self-contradictory notion of death was immediately adopted by those who promoted organ harvesting and transplantation, and has been used ever since then in an attempt morally to justify these procedures despite the fact that there is still no agreement that the argument is valid.

Criticism in the relevant literature has included the following observations:

1. That the theory is highly controversial and can be used for purely utilitarian purposes. (1)

2. That there is no consensus on diagnostic criteria. (2,3)

3. That there is evidence of poor compliance with accepted guidelines of 'brain death'. (4)

4. Shewmon has shown that 'brain death' does not lead to the total loss of somatic integrated unity of the bodily functions, the criterion for the death of a person given by Pope John Paul 11. (5,6)

'Cardiopulmonary death'

In essence 'brain dead' patients, before their organs are harvested, are assigned the moral status of "heart-beating cadavers". They have become the main source of organs for transplantation over the years. However, the demand for organs increasingly exceeds the supply, so that the number of American patients still in need of organ transplants was more than three times higher than the number of people receiving transplants in the year 2000. This problem of supply and demand has produced pressure from the very beginning in 1968 to find new sources of organs.

In recent years, the fiction of 'brain death' has largely been abandoned. Doctors in Calgary suggested that as well as using organs from those who are 'brain dead', organs should also be harvested from patients who are not yet 'brain dead', but in whom the heart has stopped beating. (7)

Already in 1993, a novel way for categorizing patients as dead was conceived. The University of Pittsburgh had developed a protocol, strangely similar in principle to the previous Harvard protocol, which purported to allow patients or their surrogates to offer organs for donation even though the patients were not brain dead. According to the Pittsburgh protocol, if a patient was declared to have suffered irreversible loss of circulatory and respiratory function, he or she was deemed also to have suffered irreversible loss of all brain function, that is to be 'brain dead'. The Institute of Medicine (IOM) found that in so-called "controlled non-heart-beating donation" (NHBD), such a patient would be typically 5 to 55 years old; would have suffered from a severe head injury, but not be 'brain dead'; would not be a drug user or HIV positive; and would be free from hypertension, sepsis or cancer. In other words, this candidate for organ retrieval would, apart from the severe head injury, be young and perfectly well. This patient would also typically be in the emergency department of a hospital and on a ventilator. The decision to declare the patient 'suitable' to donate organs would be made either after, or even before, the withdrawal of life support (ventilation). Discussion between the physicians responsible for the care of the patient and the transplant surgeons would take place before withdrawal of ventilation and, in the majority of cases, before the actual decision to donate organs. Next the ventilation would be withdrawn. The physicians then waited for the heart to stop beating. If the patient was still breathing, they would not wait longer than one hour because, by then, lack of oxygen might have damaged the organs. After an hour the patient would be allowed to die, without treatment being resumed. (8)

In some cases, once the decision to withdraw treatment is made, blood thinners and vessel dilators are given to the patient to help preserve the organs to be transplanted. NHBD promoters say this does not harm the potential donor, but even accidental administration of such medications to an ordinary patient would be a serious error in treatment. (9) If the heart stops beating within an hour of the withdrawal of ventilation, the transplant team usually counts two minutes of pulselessness, and then waits five minutes before removing organs. However, the IOM found that some teams allowed no time to elapse after the last heart beat or that the time involved was left to the physician's discretion.

The ethical debate

The above NHBD procedures are now routinely followed despite the fact that there is no scientific evidence that proves how long after the last heartbeat the heart will no longer be able to start beating again and restore circulation. These procedures are followed also despite the fact that animal studies and cardiopulmonary experience itself show that even complete recovery of consciousness is possible after several minutes if resuscitative efforts are successful. (10) It should be noted that ventilation is treatment that is usually temporary and can be withdrawn after a short period of time when the patient has recovered the ability to breathe without assistance. Traditional ethics allows withdrawal or withholding of treatment which is futile in relation to the survival of the patient, or is excessively burdensome to him or her. It does not allow the withdrawal of ventilation where patient recovery may be possible.

Note also that there are no scientific data to support the notion that a patient has suffered brain death after two minutes of cessation of the heartbeat. What it comes down to is that the transplant team relies on an "expert medical opinion" as to whether the patient has "died". That opinion depends on evidence that the loss of heartbeat was long enough to ensure that the "probability of return of circulatory function is vanishingly small." This time interval, the IOM admits, is not relevant to the determination of death, but will "in a donor with normal body temperature produce irreversible brain damage." (11) That NHBD supporters define death in inconsistent and non-objective terms is demonstrated in a 1999 study of 108 patients. In this study, a potential donor in an intensive care unit who refused resuscitation, was declared "dead" five minutes after cardiopulmonary arrest, according to many NHBD protocols. According to these same protocols, a patient who was willing to undergo resuscitation and was not a donor was not "dead" five minutes after the arrest.

Further, in many intensive care units, a patient who refused resuscitation but was not a potential donor, would be certified "dead" after much less than two minutes, after observation of two or three EKG screens which showed no pulse (about 15-20 seconds). Ambiguity in regard to the terms "irreversible cessation of cardiopulmonary function" was admitted. If "irreversible" means that the heart cannot be restarted no matter what intervention is done, observation for loss of heartbeat, breathing and unresponsiveness must be much longer than a few minutes. (12,13)

It is evident from the above that the definition of 'death' is not based on objective, scientifically established criteria, but on a variety of protocols, policies, and 'expert medical opinion'. The IOM also admits that a major concern in allowing NHBD is the question as to whether the cardiopulmonary resuscitation of a potential donor has been vigorous or sustained enough. Proponents of the procedure argue that allowing NHBD could increase organ donation by 25%, and go so far as to say that it would also enable patients to determine the point at which they would be declared dead "instead of forcing them to meet brain death criteria. For those who wish to donate organs, but will never meet whole brain death criteria, this also gives meaning to their death." (14)

Critics argue that such protocols would give physicians a perverse incentive to minimize the quality of care given to patients in the hope of harvesting organs, and that the rush to harvest organs shows that physicians are worried that the patient is not really dead; that he or she could regain consciousness during the procedure. Reports and articles supporting NHBD deny that withdrawing ventilation is an ethical problem because the decision to do so is presumed to have been made before the decision to donate is made and independently of it. The dilemma for the patient's physician remains: shall I treat my patient or declare him or her dead and thus benefit some other person by harvesting the organs? The stark reality remains that, as the IOM reported, "controlled non-heart-beating organ donation cannot take place unless life-sustaining treatment is stopped." (13)

A follow-up IOM report in the year 2000 found that almost none of its recommendations made about NHBD were being followed universally, and that the participants in the report could not even reach a consensus on such basic issues as to whether conscious people on ventilators should be allowed to donate organs using NHBD. Decisions to withdraw ventilators "are routinely being made because of potential quality of life concerns rather than ability to survive." NHBD proponents nonetheless insist that withdrawal of ventilators is legally and ethically allowable because such patients are regarded as being, in their terms, 'hopeless.' (16)

It will not be surprising if NHBD proponents will push for changes in the law which would allow that death will not be necessary before organ procurement, or for a change in the law that would allow non-heart-beating patients to be defined as 'dead'. Doctors Greg Knoll and John Mahoney have recently encouraged the harvesting of organs by NHBD. They declare that there is an obligation for our health care system in Canada to provide organs and recommend that the use and success of NHBD transplantation "be disseminated to physicians and nurses working in emergency departments, operating rooms, and intensive care units." Patients in those areas of a hospital are presumably regarded as a prime source of organs suitable for transplant. (17)

Comment

The laudable purpose of saving lives does not justify the donation of an organ whose removal could cause the death of the donor. The fact is that neither "brain death" criteria nor "non-heart-beating death" criteria definitely indicate that a patient has actually died. As Nancy Valko has pointed out, it is virtually impossible at the beginning of treatment accurately to predict whether a patient will die or what level of recovery he or she may eventually attain. (18) These criteria for defining death are currently being morally defended by a strictly pragmatic and utilitarian ethics, in which the dignity of a human life depends only on the value of its use.

A doubt about the fact concerning the life of a human being, his existence here and now, is a dubium facti. As such "it creates the same obligation as certainty". (19) The question as to when a person dies is also a dubium facti, and likewise creates the same obligation as certainty. Pope John Paul 11 has stated that death "occurs when the spiritual principle which ensures the unity of the individual, can no longer exercise its functions in and upon the organism, whose elements left to themselves, disintegrate." (20) The biologist is the only person competent to say when a human being ceases to exist, and this task has not yet been accomplished.

Organ retrieval based on NHBD criteria is not a boon to humanity, but is yet a further hazard for any critically ill patient, especially if he or she is young and otherwise healthy, who happens to have to cross the threshold of our emergency departments, our operating rooms, or the intensive care units of our hospitals.

References

(1.) Capron A.M., "Brain Death--Well Settled Yet Still Unresolved" New England Journal of Medicine, April 19, 2001, vol. 344 (16).

(2.) Wijdicks E.F., Neurology, 2002, Jan.8;58 (1): 20--5.

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

(4.) Wang M.Y, Wallace P., Gruen J.P., Neurosurgery, 2002, Sep; 51(3): 751--5.

(5.) Shewmon D.A., "Chronic 'brain death': meta-analysis and conceptual consequences", Neurology, i998, Dec; 51 (6): 1538--45.

(6.) Pope John Paul II, "Address to the XVIII International Congress of the Transplantation Society," Aug. 29, 2000.

(7.) Canadian Medical Association Journal, June 1,1999.

(8.) Institute of Medicine, "Non-Heart-Beating Organ Transplantation--Medical and Ethical Issues of Procurement," 1997, National Academy Press, Washington, D.C.

(9.) Nancy Valko R.N., "Ethical Implications of Non-Heart-Beating Organ Donation", Voices--Michaelmas, 2002, vol. XVII, No. 3.

(10.) Ibid.

(11.) See reference 8 above.

(12.) Younger S., Arnold R., De Vita M., "When is death?" Hastings Center Report, 1999; 29:14--21.

(13.) Ethics Committee of the Society for Critical Care Medicine, Critical Care Medicine, vol. 29; No. 9: Sept. 2001. Special article. Lippincott Williams and Wilkins.

(14.) Corinne Levy, "Organ Donors: Wanted 'Dead' or 'Alive,'" Dec.20, 2001. www.bioethics.net

(15.) Institute of Medicine, "Non-Heart-Beating Organ Transplantation: Practice and Protocols (2000). National Academy Press, p. 20.

(16.) See Valko, reference 9, above.

(17.) Greg A. Knoll, John E. Mahoney, "Commentary. Non-heart-beating organ donation in Canada: Time to proceed?" Canadian Medical Association Journal, Aug. 19, 2003; 169 (6).

(18.) See Valko, reference 9, above.

(19.) 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 Del Vaticano.

(20.) Ibid.

Dr. John B. Shea is a retired diagnostic radiologists and fellow of the Royal College of Canada. He lives in Toronto.