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Health Care Ethics USA Is Non-Heart-Beating Organ Donation Too Aggressive? Health care and government leaders are constantly seeking ways to increase the number of organs donated for transplantation. Nevertheless, it is commonly feared that some strategies for increasing the donor pool might actually reduce the number of organs donated, because they might harm public trust in the transplant community. Thus, supporters and critics of organ donation alike worry when organ procurement policies appear too "aggressive." Policies are deemed too aggressive when they seem to emphasize increasing the donor pool without sufficiently considering safeguards to organ donors. The US has already considered and rejected several organ donation policies because they appear to do just this. For example, even though some European nations have increased donation rates by implementing "presumed consent" policies, in the US we have avoided such policies in order to better protect the donor's right to provide informed consent. Similarly, while some have argued that "financial incentives" might increase organ donation, we have resisted such policies because they risk coercing the poor and "commodifying" donor bodies. Principles This year, the Institute of Medicine reiterated its support for non-heart-beating donation (NHBD).1 Non-heart-beating donation differs from traditional organ donation in that the organ donor is declared dead using circulatory-respiratory criteria, rather than brain-death criteria. A typical scenario involves a comatose, ventilator-dependent patient whose proxy has decided to discontinue life support because such treatment is either overly burdensome or fails to meet the patient's therapeutic goals. The ventilator is removed, death is declared a few minutes after cardiac arrest, and organ procurement begins almost immediately thereafter. Non-heart-beating donation presents us with many ethical issues. This essay will address only three issues - issues related to the charge that it is too aggressive. Specifically, some have charged that in the interest of procuring more organs, NHBD protocols are being implemented which risk the following: (1) permitting organ procurement to begin before the donor is really dead; (2) hastening the death of the donor by using anticoagulants prior to death; and (3) creating an environment that alienates families from patients at the very end of life. To address these three concerns, it is necessary to consider three ethical principles in the context of our discussion: (1) respecting life, (2) the principle of double effect, and (3) fostering family involvement. Discussion 1. Are Non-Heart-Beating Donors Really Dead When Procurement Begins? The principle of respecting life is embodied in legal and ethical norms against homicide. These norms dictate that organ donors must not be killed in the process of donating organs. For this reason, both brain-death and NHBD organ donation protocols require that patients be declared dead before organ procurement begins. Nevertheless, some fear that the declaration of death in NHBD protocols is premature. There are two reasons why people have alleged this. Both reasons relate to the Uniform Determination of Death Act (UDDA). The UDDA states that death may be declared when the individual sustains "either (1) irreversible cessation of circulatory and respiratory function, or (2) irreversible cessation of all functions of the entire brain, including the brain stem." The first reason why some allege that the declaration of the death is premature in NHBD protocols is that we would have to wait at least 9-10 minutes after circulation is lost in order to ensure that the patient meets brain death criteria. However, this approach to declaring death is based on a mistaken reading of the UDDA. NHBD protocols use circulatory-respiratory criteria, not neurological criteria, to declare death. Our laws permit death to be declared using either set of criteria; they do not require the use of both criteria. This bifurcated approach to declaring death is nevertheless consistent with the fact that death is just one, unified phenomenon: with the loss of circulation and respiration, integrated unity is lost, the brain shuts down and consciousness is lost within seconds. Moreover, brain functions will never again be restored (unless circulation and respiration are restored). The second reason why some object to the declaration of death recommended in NHBD protocols stems from the UDDA's circulatory-respiratory criteria. Specifically, the UDDA requires that the loss of circulation and respiration be irreversible. Some have argued that NHBD protocol cannot possibly satisfy this requirement, because with aggressive CPR the heart might regain circulatory function even after it has arrested for 2-5 minutes. So how is it that the Institute of Medicine has recommended the use of NHBD protocols? First, all evidence to-date suggests that by waiting one or two minutes after the loss of cardiac function we can safely rule out autoresuscitation. Second, all NHBD protocols require that the patient or his or her proxy has made a valid decision to withdraw treatment and to declare the patient DNR. Thus, it would be illegal and unethical to resuscitate such patients. Given these facts, when the patient is declared dead using NHBD criteria, we do know that circulatory and respiratory functions have been irreversibly lost. 2. Is Death Intentionally Hastened? NHBD protocols often recommend that a large dose of Heparin or a similar anticoagulant be administered in order to prevent blood clotting and to permit a better "flush" of organs after they have been procured. This is an important step in preserving organs so that they remain suitable for transplantation. However, many of the patients who become donors using NHBD protocols are severely head injured. Thus, the use of anti-coagulants is typically contraindicated, because there is a risk that the brain might hemorrhage. Using Heparin thus risks hastening the death of the donor (though the actual extent of the risk is unknown). Is the use of Heparin before death unethical? Certainly, the intention in using Heparin is good, not evil: it is meant simply to aid the preservation of organ for transplantation, not to hasten death. Thus, it might be that the principle of double effect can be invoked: the risk of a negative effect is foreseen, but it is not intended. However, the proper use of the principle of double effect requires that other criteria be met as well. In this case, it is fair to say that the risk of causing death is not a means of achieving the good that is aimed at (i.e., thinning the blood). It is also fair to say that the risk is likely proportionate to the good at stake for the simple reason that it is assumed that the patient is in the process of dying after the ventilator has been removed. The biggest challenge in applying the principle of double effect is the following: ordinarily, the person who endures the foreseen negative effect also benefits from the intended positive effects. In this case, it would seem that the organ recipient is the primary beneficiary. However, in many cases it would be wrong to deny that organ donation also benefits the organ donor. We often speak of organ donation as a way of providing a "gift of life" and many people find this deeply meaningful. Many donor families experience organ donation as healing, as a way of finding meaning in what sometimes appears to be a meaningless tragedy. If this is true, then it would seem that - if consent is properly given - organ donation can be viewed as a good also for the donor, and the principle of double effect might be applied legitimately. Not everyone accepts this line of argumentation. But fortunately, refusing to use Heparin in cases in which it is normally contraindicated need not be devastating to the use of NHBD protocols. First, the Institute of Medicine actually recommends that the decision whether to use Heparin should be made on a case-by-case basis. (It also rightly recommends that consent be obtained for the use of any medications that are not directly of benefit to the donor). Second, some organ procurement organizations are currently experimenting with the administration of Heparin post-mortem, and perhaps time will show that these organs too are suitable for transplantation. 3. Does NHBD Alienate Families From Dying Patients? Because organ procurement must begin shortly after death is declared, from a medical point of view, the best place to withdraw ventilation and to declare death is in the operating room. This is not the environment that most people would choose to die in. Moreover, because death is followed by procurement surgery, families are encouraged to leave the room soon after death is declared. With these facts in mind, some have charged that NHBD alienates families from dying patients and that it provides an inhumane context for death. Some protocols address these concerns by declaring death in a room near the OR, rather than in the OR. They also invite families to remain with the patient until death is declared. Nevertheless, it cannot be denied that NHBD does not provide an ideal setting for death. But two things must be borne in mind. NHBD only occurs when a decision has been made to remove ventilation from a critically ill patient. Such scenarios already deviate from the ideals of dying peacefully in one's sleep or (especially in the case of comatose patients) of dying at home after making one's peace with family and God. Secondly, donation is often instigated by donor families. As mentioned above, donation is typically not perceived by families as a tragedy added onto a tragedy, but as a way of finding meaning in tragedy. Conclusion Non-heart-beating organ donation presents a number of ethical challenges. This essay did not address the need to avoid conflicts of interest, the need to protect the interests of organ recipients, or the process of developing protocols. However, it has attempted to show that NHBD protocols are not desperate attempts to increase the number of organs for transplantation at the expense of organ donors. Well-designed NHBD protocols protect donor interests while enabling them to make a life-prolonging gift at the very end of their own life.
James M. DuBois, Ph.D., D.Sc. Questions for Discussion
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