Cadveric Organ Donors: What is the author's argument and what is he/she doing with it? Why?

Delimiting the Donor

by J O H N A . R O B E R T S O N

The scarcity of vital organs has prompted several calls to

either modify the dead donor rule or interpret it more

broadly. Given its symbolic importance, however, the

rule should be changed only cautiously.

A lthough living persons donate /t--j\ kidneys, cadaveric donors are

JL IV. the main source of solid or- gans for transplantation. Yet cadaver- ic donations have never been suffi- cient to meet the needs of persons with end-stage organ disease. One factor among many that limits the availability of cadaveric organs is the dead donor rule—the ethical and legal rule that requires that donors not be killed in order to obtain their organs.

Laws and norms against homicide forbid killings done for any purpose, including killings done to obtain or- gans to save the life of others. These laws and norms apply even if the per- son is unconscious, extremely debili- tated, or very near death. The effect is to create the dead donor rtile—the rule that states that organ retrieval it- self cannot cause death. Removal of organs necessary for life prior to demise would violate the dead donor rule regardless of the condition or consent of the donor because re- moval of those organs would kill the donor. Removal of nonvital organs prior to death would not violate the rule, though it would implicate other laws and ethical norms.

John A. Robertson, "The Dead Donor Rule,' Hasting Center Report 1^, no. 6 (1999): 6-14.

Laws and norms against killing are most clearly applicable when the person killed has not consented to the killing. But they also apply when a person requests death, whether to avoid suffering or to provide organs for transplant. The dead donor rule would thus prevent a person from committing suicide in order to pro- vide organs to his family or others. In the short run the rule is deontologic rather than utilitarian, for it prevents the killing of one person for organs that would save the three or more lives that can be saved by a single ca- daveric donor.

The dead donor rule is a center- piece of the social order's commit- ment to respect for persons and human life. It is also the ethical linchpin of a voluntary system of organ donation, and helps maintain public trust in the organ procure- ment system. Although it is possible that some changes in the dead donor rule could be adopted without a major reduction in protection of per- sons and public trust, changes in the rule should be measured by their ef- fect on both those fiinctions.

Several recent proposals to in- crease the supply of cadaveric organs would create exceptions to the dead donor rule to allow donation when the donor lacks an upper brain and will imminently die (anencephalic

infants) or will be executed (death row prisoners).' These proposals do not challenge the rule's core function of protecting persons against un- wanted demise. They do not, for ex- ample, propose a "survival lottery" in which persons are picked by chance to be killed to provide organs to sev- eral others.-̂ Nor would they permit competent persons to choose suicide by organ retrieval in order to save others. Instead, they would modify the rule at the margins of human life.

Proposals to permit donation from anencephalic infants or con- demned prisoners aim to maintain respect for the core values underlying the dead donor rtile while conclud- ing that the benefits of relaxing the rule in these marginal cases outweigh the loss in respect for life and trust in the transplant system that might re- stilt. In contrast, proposals to retrieve organs from non-heart-beating do- nors claim to respect the dead donor rule as such by permitting organ re- trieval only after the donor has been pronounced dead on cardiopulmon- ary grounds. Ethical controversy aris- es there, however, because uncertain- ties in determining cardioptilmonary death create a risk that the donor will not be dead when organ retrieval oc- curs, but will die as a result of the re- trieval itself

A closely related question con- cerns whether it is ethically accept- able for physicians to implement pro- posals that violate the dead donor rule in these marginal cases. From the time of Hippocrates, codes of med- ical ethics have condemned killing by physicians. This tradition continues strongly today in medical, ethical, and legal opposition to active eu- thanasia, physician-assisted suicide, and the participation of physicians in capital punishment and torture.' If the dead donor rule is relaxed to fa- cilitate organ procurement in these marginal cases, it will require a con- comitant relaxation in prohibitions against physicians killing. Many per- sons would count such a change as an additional reason for opposing ex- ceptions to the dead donor rule.

® HASTINGS CENTER REPORT November-December 1999

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The dead donor rule limits onlyorgan retrieval that causes death. It says nothing about situations in which organ retrieval itself would not cause death. Removing nonessential organs or tissue from incompetent persons on the basis of substituted consent—for example, retrieving kid- neys from retarded individuals or from those in persistent vegetative states—would not violate the dead donor rule because organ or tissue retrieval in those cases would not cause death. Retrieval of nonessential organs would, however, implicate concerns about showing proper re- spect for the dignity and well-being of incompetent persons, for example, not treating them as mere means to the ends of others. Although it would not violate the dead donor rule, re- trieval in such cases still could not occur unless applicable ethical and legal requirements for consent by the donor or family had been met.

Some persons have mistakenly viewed the dead donor rule as also prohibiting retrieval of nonessential organs from comatose or incompe- tent persons prior to their death be- cause ordinarily such organs are re- moved only after death has occurred. The fact that organ and tissue re- trieval usually occurs after death, however, does not mean that retrieval cannot occur before death if ethical and legal norms for what may be done to persons prior to their death are observed.

An example that nicely illustrates the distinction between the dead donor rule and rules for respecting incompetent persons would arise in a situation in which a family member, say the father, would like to donate a kidney to his daughter who suffers from end-stage kidney disease and who is not tolerating dialysis well. Medical examination shows that he has a serious heart condition that rules him out as a live donor. Soon after, he suffers a massive cardiac ar-

rest that leaves him in a permanent coma in which he can be maintained indefinitely."* At this point, removal of a kidney from him for transplanta- tion to his daughter would not vio- late the dead donor rule because it would not cause his death. Whether it is ethically and legally acceptable, however, would depend on whether removal is consistent with laws and norms for respecting the interests of incompetent persons. In this case, based on his prior expressed wishes to donate to his daughter and the ab- sence of harm to him from the dona- tion, a plausible claim can be made that removal of the kidney is ethically and legally acceptable. If this option were not acceptable to the family, they could request that he be treated as a non-heart-beating donor, that is, have life support stopped, and then retrieve his kidney after he has been pronounced dead.

Akey factor in observing the dead. donor rule is the determination of death. The United States and most European countries now accept that death can be determined by tests that show irreversible cessation of circula- tory and respiratory function or irre- versible cessation of all functions of the entire brain.' The latter tests— tests for whole-brain death—are nec- essary when the irreversible cessation of cardiopulmonary functions in a mechanically assisted patient cannot be independendy established.

Determining death by tests for total brain death does not contradict or violate the dead donor rule be- cause whole-brain death ("permanent cessation of the clinical functions of the entire brain," including the brain stem) is the criterion that indicates that death ("the permanent cessation of critical functions of the organism as a whole") has occurred.''

Critics argue that brain death tests for death lead to violations of the dead donor rule because studies have shown the presence of residual spon-

taneous electroencephalographic ac- tivity in some brain dead patients.'' But as James Bernat argues, the rudi- mentary and random elecroencephal- ographic activity found in these stud- ies "represents merely the isolated physiologic activity of a few surviving neurons and does not represent the systematic integrating function of the kind necessary to achieve classifica- tion as a clinical fiinction."* Thus the continued functioning of some neu- rons after declaration of whole-brain death does not mean that the person is still alive because such electric ac- tivity does not show that the critical integrative functions of life produced by the brain still exist. If they have otherwise suffered the permanent loss of all clinical functions of the brain (whole-brain death), such persons are dead and organs can be removed without violating the dead donor rule.

Although the needs of organ transplantation have driven the devel- opment of brain death, whole-brain criteria for death should not be viewed as a subterfuge for the judg- ment that brain-dead persons are in fact alive but because of severe mental impairment may be killed for their organs. Persons who argue that whole- brain death is not an indication that death of the individual has occurred must either disagree about what criti- cal loss counts as death or what tests count as adequate evidence that such critical loss has occurred. Although some misunderstanding and confu- sion about brain death continues to exist, even among physicians and op- erating room nurses, it is now well settled that brain death determina- tions of death do not violate the dead donor rule, but rather provide an ad- ditional set of tests for determining whether death has occurred.'

One proposal to change the deaddonor rule would allow the re- trieval of vital organs from anenceph- alic infants before they have suffered whole-brain death. Because few chil- dren die in circumstances where

November-December 1999 HASTINGS CENTER REPORT

brain death is pronounced, organs for pediatric transplant, where organ size is a crucial factor, are in very short supply. Faced with the shortage of pediatric hearts, one center tried un- successfully to transplant a heart from a baboon to an infant with hypoplas- tic heart disease.'" Because of medical and ethical opposition to further use of xenografts, the center then pro- posed with parental consent to use organs from anencephalic newborns who had expired after treatment was withdrawn." When it was found that viable organs could not be obtained from anencephalic infants after death, consideration turned to removing or- gans before brain stem activity had ceased.

Such an alternative, however, is blocked by the dead donor rule. Al- though anencephalics lack an upper brain, they do have brain stem func- tion, and thus are legally alive under existing criteria and tests for whole- brain death. Removing hearts and liv- ers from anencephalic infants prior to total brain death would thus violate the dead donor rule and could be punishable as homicide. If anen- cephalics were to be a viable source of organs for pediatric transplant, an ex- ception to the dead donor rule would have to be enacted into law and in- corporated into ethical norms.

An ethical argument in favor of re- laxing the rule in the case of anen- cephaly can be made on the ground of beneficence to the potential recipi- ents and the families who wish to do- nate and the absence of harm to the anencephalic donors. Because anen- cephalic infants have only a brain stem, they clearly lack consciousness or interests.'^ They will not survive for long, even with aggressive treat- ment, and there is no ethical or legal obligation to treat them aggressive- ly—even to treat them at all.'' Par- ents faced with this personal tragedy welcome the opportunity to donate organs, and may even initiate the re- quest to take vital organs before brain stem activity has ceased. Many chil- dren desperately await transplanta- tion. They and their families would

greatly benefit by the organs that became available from anencephalic donors under the proposed excep- tion. Because anencephalics are born without any upper brain, a narrow exception to the dead donor rule could be written without also extend- ing the exception to persons in per- sistent vegetative states or other con- ditions of consciousness who were born with an upper brain and were once competent.'"*

Strong arguments also exist against recognizing an exception. A primary one is the need to keep a bright line against killing individuals who are alive. Opponents also cite the diffi- culties in diagnosing anencephaly and the corresponding risk of mis- taken diagnoses, the small number of children who would benefit, and the risk that this exception would make it much more likely that additional exceptions to the dead donor rule would be enacted for those in persis- tent vegetative states or with severe, irreversible mental illnesses." An ex- ception might also reinforce public fears that the interests of organ donors would be sacrificed to obtain organs, and violate symbolic concerns for showing respect for human life by not killing. Finally, physicians would, in the very act of retrieving vital organs, be killing the anence- phalic patient.

The arguments against recogniz- ing an exception to the dead donor rule for anencephalic infants have carried the day. For example, the fa- vorable 1992 opinion of the Council on Ethical and Judicial Affairs of the American Medical Association was withdrawn in the face of wide oppo- sition and never reissued."^ Nor have legislative proposals to permit such retrievals been enacted. In a 1991 case the Supreme Court of Florida re- flised to add "brain absent" as an ex- ception to the brain dead or homi- cide laws despite the request of par- ents who wished to donate their in- fant's organs, noting that such a major change would have to come from the legislature not the courts.'''

An additional factor conserving

the dead donor rule in the case of anencephalic infants is the necessity for the government openly to autho- rize a change in the definition of death or in the law of homicide to allow killing by organ retrieval of anencephalic infants. Even if legal immunity from prosecution were provided, medical opposition to phy- sicians removing organs that cause an anencephalic child's death might still continue. Indeed, transplant physi- cians might refuse to retrieve or use organs from anencephalics to prevent erosion of public trust in the organ donation and transplant system.

Although hearts and livers could not be taken from anencephalic chil- dren without a relaxation of the dead donor rule, parents could consent to have their anencephalic child serve as a living kidney or tissue donor with- out violating the dead donor rule.

Interestingly, however, few such uses have occurred, just as persons in persistent vegetative states have rarely been used as the source of nonessen- tial organs and tissues, even though they would not be directly harmed by such use. Persons who oppose such use would likely argue that taking nonvital organs prior to death de- grades or disrespects the anencephalic newborn or vegetative person because it so deliberately treats them as a means for the good of others.

Proponents would contest the ac- curacy of the claim that anencephalic or vegetative donors in such cases are degraded by being used as a source of organs or tissue for others on the ground that ethical concerns about using people as mere means do not apply to persons who due to absence of cortical function lack interests al- together. They might also argue that the situation offers them the oppor- tunity, through proxy consent, to participate in the very human act of helping other humans to survive. Still, there has been little movement to use anencephalic newborns or veg- etative patients as donors even in sit- uations that would not violate the dead donor rule or otherwise direcdy harm the donors.

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With over 3,200 persons nowawaiting execution in the United States and some forty to sev- enty-five prisoners executed each year, proposals to retrieve organs for transplant from capital punishment have surfaced in recent years.'* The idea gained slight momentum in the early 1990s when a condemned pris- oner in Ceorgia offered to donate or- gans as part of his execution and sued unsuccessfully for the opportunity." Bills to permit organ retrievals from executions have been introduced in a few state legislatures (pp. 432-33).

In considering proposals to use the organs of condemned prisoners, we must distinguish procuring organs from executed prisoners after their death or during their lives from procuring organs from them as a form of execution. There is no ethical or legal objection to removing organs or tissue from executed bodies after death, if consent of the deceased or next of kin has been obtained. Al- though most methods of execution would render organs unacceptable for transplant, the unclaimed bodies of executed inmates are routinely given to medical schools for anatomical study.̂ ^ Nor is there any ethical bar to a condemned prisoner serving as a living donor of a kidney or tissue, as long as the prisoner freely consents. Indeed, Texas and other capital pun- ishment states permit live donations from condemned prisoners.^'

The question of execution by organ retrieval is quite diflFerent. To avoid the damaging effects on organs from execution by lethal injection, electrocution, hanging, gas, or firing squad, organ retrieval itself would become the method of execution. The condemned prisoner would request this method five to seven days before the execution date.̂ ^ At the time se- lected for execution, the prisoner would be taken from death row to the prison hospital and strapped on a gurney as in preparation for execu- tion by lethal injection. Witnesses to

the execution, including the victim's family, could view the insertion of in- travenous lines and administration of anesthetic outside of the operating room. When the prisoner became unconscious, he would be moved to an operating room where the trans- plant team would then remove all his

rule. The state in any case will be ex- ecuting the prisoner, and the excep- tion would permit the state to kill an- other in a way that salvages his or- gans. In addition, an exception for execution by organ retrieval has the salutary effect of respecting and pre- serving the lives of recipients at the

A mode of execution that protects organs would not

harm the prisoner or deprive him of continued life.

and thus would not infringe or deny the core values

underlying the dead donor rule.

organs. When organ removal was completed, ventilatory or other me- chanical assistance would be termi- nated, as occurs in retrieval from brain-dead, heart-beating cadavers. Death would be pronounced as hav- ing occurred either at the time that the heart and lungs were removed, or when mechanical assistance was ter- minated. The retrieved organs would then be distributed to consenting re- cipients in accordance with existing rules for distributing organs.

Such a procedure would clearly violate the dead donor rule. Retrieval of vital organs itself would be the cause of death because once heart, lungs, and liver are removed one would soon have to turn off the heart-lung bypass machines that are sustaining function during removal of vital organs. Physicians retrieving organs would thus also be executing the prisoner. For such a procedure to be acceptable, an exception to the dead donor rule in the case of execu- tions would have to be recognized.

The main argument for an excep- tion in this case is that the prisoner will in any case be executed. An ex- ception to the rule to permit a mode of execution that protects organs would not harm the prisoner or de- prive him of continued life, and thus would not infringe or deny the core values underlying the dead donor

very moment that the condemned person's life is taken as punishment for his having previously taken the life of others.

Supporters of such an exception might require that several other con- ditions be met for execution by organ retrieval to be acceptable: Organ re- trieval executions might be permitted only at the request of the condemned prisoner made at a specified time in advance of the execution. The per- mission of the victim's family might also be required. Potential recipients would be free to reject organs from this source. Most important, the in- mate's request for execution by organ retrieval should not influence prior decisions about guilt and punish- ment, or later decisions for clemency.

For persons opposed to capital punishment, execution by organ re- trieval is as objectionable as execution by other means. They may also doubt that the prospect of organ donation by execution would not influence the willingness to impose capital punish- ment at earlier stages of the process, or that condemned prisoners would voluntarily choose such an option. Persons who believe that capital pun- ishment is morally and legally justi- fied might also oppose such execu- tions. They might fear that such a practice could weaken public accep- tance of capital punishment by mak-

November-Decemberl999 HASTINGS CENTER REPORT

ing executed criminals who donate look altruistic and thus deserving of a reprieve, or tainting all executions by associating them with allegations of Chinese practices of executing pris- oners to obtain organs to sell on the international market. Finally, many persons would oppose execution by organ retrieval in order to maintain strict adherence to the dead donor rule and strict separation of doctors and killing.̂ 3

The opponents of execution by organ retrieval have prevailed, and are likely to prevail for some time to come. The great aversion to an excep- tion to the dead donor rule in the case of lawful executions is not ade- quately explained by the values un- derlying the dead donor rule. If state employees may legally kill a con- demned criminal by drug, gas, or more violent means, it should not matter that execution occurs by re- moval of vital organs. This would not constitute an unconstitutional "cruel or unusual" punishment because there is nothing crueler about this method of execution, chosen by the prisoner, than other methods.

A stronger ground for opposition is the role that transplant physicians and nurses would necessarily play in a system of execution by organ re- trieval. Execution by organ retrieval could not be carried out by non- physician executioners as now occurs with execution by lethal injection and other methods. Even if some trans- plant doctors and nurses who accept the moral validity of capital punish- ment might be willing to participate in organ retrieval executions, their participation would violate medical ethical pronouncements against the participation of physicians in execu- tions. The execution would also have to occur in the operating room of a hospital. If the prison hospital lacked adequate facilities, a hospital willing to allow organ retrieval executions on its premises would have to be found—and it is likely that few trans- plant teams or hospitals would be willing to participate.

Opposition to such an exception also arises from the need to keep the death penalty separate from other so- cial institutions. The death penalty is highly problematic morally, legally, and socially in those states that allow it; it would become even more so if it also served as a method of organ pro- curement. Interjecting transplanta- tion into the controversy over capital punishment could also taint public perceptions of the beneficence of transplantation. Members of the public might come to view organ procurement teams as "killers" who harvest organs before or after death. Such a perception could reduce the willingness of families to donate, and thus impair the prospects of persons awaiting transplants. The purpose and effect of capital punishment is to end the life of a person who has him- self taken life. Trying at the same time to preserve other lives through execu- tion by organ retrieval only confuses the situation. It is best for organ transplantation and capital punish- ment to go their separate ways.

A nother proposal to increase the 2y^ supply of cadaveric organs for transplant focusing attention on the dead donor rule is the use of non- heart-beating cadavers as organ do- nors. The first cadaveric organ donors were persons declared dead on car- diopulmonary criteria, who either suffered cardiac arrest in the hospital or who arrived there dead.-̂ '* With the acceptance of whole-brain criteria of death, organ procurement shifted to heart-beating cadaveric donors— those persons who were found to be brain-dead while cardiopulmonary functions were mechanically sus- tained. The shortage of brain-dead heart-beating donors has now refo- cused attention on the use of non- heart-beating donors (NHBDs).

The use of NHBDs that impli- cates the dead donor rule involves those cases that are planned or con- trolled, as opposed to those persons who are brought to the hospital dead.

These protocols developed out of family requests to donate organs in situations in which it was unlikely that death would be pronounced on brain death grounds, thus preventing solid organ donation from occurring. Organ donation is a significant posi- tive experience for those facing the death of a loved one; if these families are to have that positive experience, organ donation would have to occur immediately after death has been de- clared subsequent to withdrawal of life support—the non-heart-beating donor situation.

In controlled NHBD cases a fam- ily requests that treatment be with- drawn from a loved one who is termi- nally ill but not brain dead and that his or her organs then be donated for transplant. To minimize warm is- chemic time damaging to organs, ventilatory assistance to the patient may be withdrawn in the operating room, where the family may choose to be present. After withdrawal of life support, the patient's attending physician, who is not part of the or- gan recovery team, determines wheth- er the heart and respiration have stopped. The physician will then pro- nounce the patient dead or, to pro- vide an additional margin of safety, in some cases will wait an additional two to five minutes after cardiac function has stopped before pro- nouncing death. At this point the physician and any family that is pre- sent would withdraw, and the trans- plant team, which has been prepped and waiting in an adjoining room, will enter and retrieve organs from the recently dead cadaver. Studies have shown that organs retrieved in this way sufFer little damage and are viable for transplant.

Current interest in the use of con- trolled NHBDs arose from a 1992 protocol at the University of Pitts- burgh Medical Center.^' The proto- col developed out of family requests, and intensivists, transplant physi- cians, nurses, and others developed a protocol responsive to identified con- cerns and presented it to the hospi- tal's ethics committee. Aft:er approval

"fl® HASTINGS CENTER REPORT November-December 1999

by the ethics committee, the issues were examined at a bioethics confer- ence in Pittsburgh and in scholarly publications.^"^ Many in the trans- plant field see NHBDs as a key source to meet the growing demand for organs, and many other NHBD pro- tocols have been proposed. Twenty- eight organ procurement organiza- tions now have active NHBD pro- grams, though many others do not.^''

The ethical and legal questions raised by controlled NHBDs received national attention in April 1997 when a bioethicist charged that a pro- posal at the Cleveland Clinic to re- trieve organs from NHBDs amount- ed to killing patients for their organs, and brought the protocol to the at- tention of the district attorney's of- fice.̂ ^ A 60 Minutes story on the Cleveland situation gave the impres- sion that there were serious violations of the dead donor rule occurring at institutions that used NHBDs.

As a result of the growing contro- versy. Secretary of Health and Human Services Donna Shalala in 1997 requested that the Institute of Medicine (IOM) examine the med- ical, ethical, and legal aspects of NHBDs. In its final report, the IOM recommended much greater use of NHBDs, in accordance with publicly adopted protocols that followed guidelines it identified.^' Its provision of a uniform protocol for the practice has now encouraged other programs to begin using NHBDs.

Ethical and legal controversy sur- rounds the use of controlled NHBDs because of the fear that retrieval of or- gans in the controlled setting could violate the dead donor rule, '̂' in ei- ther of two ways. One was that the drugs administered prior to death in N H B D protocols—anticoagulants (heparin) and vasodilators (regitine) to minimize the efiFects of warm is- chemia on organ viability—could hasten or even cause death.3' This was a key issue in the Cleveland con- troversy.̂ -̂ Whether the drugs used in NHBD protocols cause or only hasten death, in either case the dead donor rule would have been violated.

The doctrine of double effect would not shield an unintended death from these drugs from moral and legal dis- approval because the intended benefit is for persons other than the patient.^^

Transplant physicians with experi- ence with these drugs deny that they are administered to hasten death or that they are given in such doses that they could have that effect, and the IOM found that administer- ing heparin and regit- ine prior to death to preserve organs gener- ally does not harm the donor and are justifi- able as part of routine preparation for organ retrieval.̂ '̂ However, it noted that "in the occasional NHBD with ongoing intracranial bleeding or de- ficiencies in blood volume" the ad- ministration of such agents "is not indicated because it could actively cause death" (p. 52). Accordingly, it recommended "case-by-case deci- sions on the use of anticoagulants and vasodilators, and consideration of additional safeguards such as in- volvement of the patient's attending physician in prescribing decisions" (p. 52). Carefiil attention to whether such drugs need to be administered to the near-death patient to preserve organs and whether the dosages used are contraindicated because of the patient's condition should minimize the risk that efforts to preserve or- gans prior to death will inadvertent- ly violate the dead donor rule.

A second way in which NHBD protocols are said to violate the dead donor rule is that they allow retrieval of organs before cessation of pul- monary function is irreversible. The risk is that death will be pronounced so quickly after the removal of life support and induction of cardiac ar- rest that the person will not have irre- versibly lost cardiac fijnction and thus will still be alive when organs are re- moved. That is, the person will ap- pear to be dead, but might actually, if given longer time to breathe on his own or if̂ immediately resuscitated, regain spontaneous respiration and

circulation. If organ retrieval has al- ready begun in such patients, retrieval will then be the cause of death, thus violating the dead donor rule.

To guard against such mistakes, NHBD programs have traditionally waited a few minutes after determin- ing that cardiopulmonary function has ceased before pronouncing death

Do new proposals amount to

killing patients for their organs?

and beginning organ retrieval. The IOM, for example, recommended a wait of at least five minutes together with electrocardiographic monitor- ing. NHBD programs in Pittsburgh and the University of Wisconsin wait two minutes. Yet some have argued that no additional wait after cardiac arrest should be required before pro- nouncing death because no addition- al wait is required for pronouncing death in the case of cardiac arrest in ICUs or other situations in which donation is not planned.^'

Although very few studies have been done, no data suggest that au- toresuscitation five minutes after car- diac arrest is a serious risk, and there is no reason to think that further studies would reveal a different re- sult.^'' A more difficult problem concerns whether non-heart-beating donors pronounced dead after car- diac arrest and a two-to-five minute wait have irreversibly lost all car- diopulmonary fijnction. The loss of function must be "irreversible" to sat- isfy the criteria for death under the laws of every state.

But who determines "irreversibil- ity," and under what circumstances? Two understandings of irreversibility are relevant here. A strong under- standing of the term would hold that patients who have suffered cardiac arrest have not irreversibly lost car- diac function and thus are not dead if they could have been resuscitated. Under this view of irreversibility

November-December 1999 HASTINGS CENTER REPORT "B "D

NHBDs who are pronounced dead five minutes after cardiac arrest are not dead because persons have been resuscitated—restored to respiratory and cardiac function—for up to ten minutes after cardiac arrest.

A second view of irreversibility would hold that "a function is irre- versibly lost if a morally defensible decision has been made not to reverse the loss" (p. 6). Because the patient had issued a prior directive against resuscitation or his family had law- fully requested a do not resuscitate order, no resuscitation after cardiac arrest would be morally and legally acceptable in situations of potential non-heart-beating donation. There- fore, the patient may legitimately be viewed as having irreversibly lost all cardiopulmonary function when death is pronounced on cardiopul- monary grounds.

Whether N H B D protocols ob- serve or respect the dead donor rule thus will depend upon which mean- ing of the inherently ambiguous term "irreversible" one adopts. Civen the strong protection now given to the right of patients and their families to reject resuscitation after cardiac arrest in situations very close to death, there is a very strong argument that the second construal of irreversible— whether a morally defensible decision against resuscitation has occurred—is the appropriate one in these cases. If so, NHBD protocols would involve no violation of the dead donor rule.

Because patients and their families have strong legal and moral rights to reject life support and resuscitation after cardiac arrest, it is difficult to see why one should adopt a construal of irreversibility that ignores whether the patient could in fact legally or morally be resuscitated. And because a severely debilitated patient with a do not resuscitate order who has suf- fered cardiac arrest after withdrawal of life support will not be resuscitated even if it were technically feasible to do so, there is no good reason why the stricter construal of irreversibility should be adopted over a construal of reversibility that focuses on whether

resuscitation after cardiac arrest has ethically and legally been rejected.

A decisional view of irreversibility reflects commonsense views of death, for the person is not now breathing and never will again. Not to regard her then as dead because she might have been resuscitated in a situation in which she never will be resuscitat- ed is counterintuitive to common un- derstandings of death held by the general public, families, health care providers, and most ethicists, philoso- phers, and lawyers who study these issues.

Ethical and legal issues beyond the question of irreversibility also arise with NHBD protocols, but they do not implicate the dead donor rule. The practice of administering he- parin or regitine prior to withdrawal of life support in order to minimize warm ischemic time in carefully se- lected cases does, however, raise the question whether administration of drugs not for the patient's benefit is respectful of the incompetent patient. This question should be resolved on the basis of whether the drugs harm the patient and whether the patient or the proxy have lawfiiUy consented to them. If no harm is shown and there is lawfiil consent, the mere fact that something is being done to the patient not for his benefit would not in itself make administration of the drugs unlawful or unethical. A simi- lar analysis would apply to cannuliza- tion of the patient prior to death so that cold perfusion to preserve organs after death has been pronounced can be administered rapidly. If the patient will not be harmed by the cannuliza- tion and there is proper consent, it is ethically acceptable prior to death.

The debate over the use of NHBDs shows that their use in ac- cordance with guidelines such as those recommended by the IOM does comply with the dead donor rule. Unlike the case of anencephaly, where the donor is clearly alive under whole-brain criteria of death when vital organs are taken, the use of NHBDs involves no violation of the dead donor rule and requires no

public alteration or exception to it. Nevertheless, it is important that NHBDs are used only according to publicly announced protocols that contain clear procedures for minimiz- ing the risk of any such violations. Such protocols should require that death is pronounced according to the attending physician's judgment with- out pressure from transplant person- nel, that tests and waiting periods are used that are reasonably certain to correctly ascertain cardiopulmonary death, and that administration of an- ticoagulants or vasodilators does not occur in circumstances that might hasten death or harm patients.

amidl

*" II ''he dead donor rule plays an im- -IL portant role in protecting per-

sons and engendering trust in a vol- untary system of organ donation. Any change in the rule to increase organ supply requires convincing evi- dence that more benefit than harm to persons and the transplant system would result from such a change. Even then, strong resistance to modi- fying the rule would exist based on the prudential and symbolic advan- tages of strict maintenance of a rule against death by organ retrieval.

It is thus no surprise that none of the proposals for explicit exceptions to the dead donor rule have been adopted. Removing vital organs from anencephalic infants requires public recognition that such lives are so di- minished or lacking in value that they may be killed for their organs. Al- though these newborns will immi- nendy die and will suffer no harm from retrieval of vital organs, the symbolic costs of relaxing the dead donor rule appear to be too great to be tolerated. Similarly, organ retrieval executions have little support, despite their attempt to wring some good from society's deliberate taking of life.

The use of NHBDs, on the other hand, is morally and legally accept- able because of their careful attempt to respect the dead donor rule. The

112 HASTINGS GENTER REPORT November-December 1999

debate over the use of NHBDs, how- ever, illustrates the strong opposition that probably would exist if vital or- gans were taken from non-heart-beat- ing donors who were not dead or if drugs administered to preserve organs also caused death. Despite the brief- ness and poor quality of the life re- maining to such donors, violation of the dead donor rule would most like- ly be as strongly opposed here as it is with anencephalic infants.

The conservative posture that now exists toward maintaining the dead donor rule is likely to continue for some time, but not because of logical necessity. One could imagine that the question of how strictly the dead donor rule should be adhered to in order to maintain respect for persons and trust in the organ procurement system might be answered differently as medical, ethical, and social condi- tions and perceptions change. We might, for example, come to accept that persons who have only brain stem function or who are permanent- ly unconsciousness are so close to being dead that we are willing to take their vital organs when clear benefits to others could be shown.̂ ^ Oppo- nents or proponents of capital pun- ishment might come to accept the need to save lives even as executions occur, and support execution by organ retrieval. Only a slight shift in attitude would then be needed to view the transplant team's role in ex- ecutions as life-affirming, just as it is in organ retrievals from brain-dead, heart-beating cadavers whose cardio- pulmonary functions are ended by organ retrieval. Such shifts in the strictness of the dead donor rule could occur without impairing respect for human life generally or diluting per- ceptions of physicians as healers, be- cause the life at stake in these cases is so marginal in quality or expectancy and the resulting preservation of life in recipients is so significant.

Yet it is highly unlikely that such changes in perception or practice will soon occur. The symbolic importance of the dead donor rule is so great that even the slightest explicit deviation

from it confronts a very high pre- sumption of unacceptability. An im- portant factor in strictly maintaining the rule is the small number of lives that would be saved as a result. With roughly fifty executions and fifty anencephalic births occurring each year, and only a portion of these pris- oners or families likely to opt for organ donation, relatively few lives would be saved at the price of cross- ing an important symbolic threshold. Of course, any additional contribu- tion to the pool of donor organs is welcome. Each cadaveric donor made possible by changes in the dead donor rule could save or extend the lives of three or more existing indi- viduals. But saving the lives of others, as the dead donor rule itself shows, has never been a uniformly privileged activity. Efforts to increase organ sup- ply would be more fruitfully directed to increasing acceptance of NHBDs and the desirability of donating or- gans generally than to changing the dead donor rule.

The author is grateful to Mitchell Berman for helpful comments on an earlier draft.

IRe1?eireinices

1. American Medical Association, Coun- cil on Ethical and Judicial Affairs, "The Use of Anencephalic Infants as Organ Donors: A Critique," JAMA 273 (1995): 1614-18; Laura-Hill M. Patton, "A Call for Common Sense: Organ Donation and the Executed Prisoner," Virginia Journal of Social Policy dr Law 3 (1996): 387-434; Stuart J. Youngner and Robert M. Arnold, "Ethical, Psycho- logical, and Public Policy Implications of Procuring Organs from Non-Heart-Beating Donors,"/XAM 269 (1993): 2769-74.

2. John Harris, "Survival Lottery," Phi- feo/-^^ 50 (1995): 81-87.

3. William J. Curran and Ward Casscells, "The Ethics of Medical Participation in Capital Punishment by Intravenous Drug Injection," NEJM 302 (1980): 226-30; American Medical Association, Council on Ethical and Judicial Affairs, "Physician Par- ticipation in Capital Punishment," JAMA 270 (1993): 365-68; Robert D. Truog and Troyen A. Brennan, "Participation of Physi- cians in Capital Punishment," NEJM 329 (1993): 1346-50; American College of Physicians, Breach of Trust: Physician Par-

ticipation in Executions in the United States (Philadelphia: American College of Physi- cians, 1994).

4. Stuart J. Youngner, personal commu- nication.

5. President's Commission for the Study of Ethical Problems in Medicine and Bio- medical and Behavioral Research, Defining Death (Washington, D . C : U.S. Govern- ment Printing Office, 1981); James L. Bernat, "A Defense of the Whole-Brain Concept of Death," Hastings Center Report 28, no. 2 (1998): 14-23.

6. Bernat, "A Defense," p. 17. 7. Amir Halevy and Baruch Brody,

"Brain Death: Reconciling Defintions, Cri- teria, and Tests," Annals of Internal Medicine 119 (1993): 519-25.

8. Bernat, "A Defense," p. 18. 9. Stuart J. Youngner, Martha Allen,

Edward T. Bardett et al., "Psychological and Ethical Implications of Organ Retrieval," Af£/A/313 (1985): 321-23.

10. Arthur L. Caplan, "Is Xenografting Morally Wrong?" Transplant Proceedings 24 (1992): 722-27.

11. "Anencephalic Infants: A Source of Controversy" [Symposium], Hasting Center Report 18, no. 4 (1988): 5-34.

12. Medical Task Force on Anencephaly, "The Infant with Anencephaly," NEJM'522 (1990): 669-74.

13. Child Abuse Amendments of 1984, codified at 42 U.S.CA. 5102, 5106, 5111- 5113, 5115 (West Supp. 1998).

14. John A. Fletcher, Michael R. Harri- son, and John A. Robertson, "Primates and Anencephalic Infents as Sources for Pedi- atric Organ Transplants,' Fetal Therapy 1 (1996): 150-64.

15- D. Alan Shewmon, Alexander M. Capron, Warwick J. Peacock, Barbara L. Schulman, "The Use of Anencephalic In- fants: A Critique," JAMA 261 (1989): 1773-81.

16. Diane M. Giannelli, "Ethics Coun- cil Reverses Stand on Anencephalic Organ Donors," American Medical News, 25 De- cember 1995, p. 3.

17. In reT.k.C.V., 609 So.2d 588 (Fla. 1992).

18. George Lardner, "74 Executions This Year: The Most Since 1995," Seattle Times, 15 December 1997. Jack Kevorkian, the former pathologist who has challenged laws against assisted suicide, first proposed the idea in 1985. See Jack Kevorkian, "Medicine, Ethics, and Execution by Lethal Injection," Medicine dr Law 4 {\9850: 307- 312.

19. Patton, "A Call for Common Sense." 20. Vernon's Ann. Texas Code Criminal

Procedure Art. 43.25 (West, 1998).

November-December 1999 HASTINGS GENTER REPORT "0 3

21. "Condemned Man Is Hoping to Save the Lives of Others; He Seeks to Do- nate His Organs for Transplant after Execu- tion," Dallas Morning News 25 October 1993.

22. Patton, "A Call for Common Sense." 23. Curran and Cascells, "The Ethics of

Medical Participation in Capital Punish- ment"; American Medical Association, "Physician Participation in Capital Punish- ment"; Truog and Brenan, "Participation of Physicians in Capital Punishment"; Ameri- can College of Physicians, Breach ofTrtist.

24. Institute of Medicine, Non-Heart- Beating Organ Transplantation: Medical and Ethical Issues in Procurement (Washington, D.C.: National Academy of Sciences, 1997), p. 20.

25. Institute of Medicine, Non-Heart- Beating Organ Transplantation; University of Pittsburgh Medical Center, "Policy for the Management of Terminally 111 Patients Who May Become Organ Donors after Death."

2 April 1992, Pittsburgh, Pennsylvania. 26. Conference on Ethical, Psychosocial,

and Public Policy Implications of Recover- ing Organs from NHBCDs, 10 October 1992, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania; "Non- Heart-Beating Donor Protocols to Increase Organ Donation" [Special Issue], Kennedy Institute of Ethics foumal 25 (1993): 1-262.

27. Institute of Medicine, Non-Heart- Beating Organ Transplantation.

28. Gina Kolata, "Controversy Erupts over Organ Removals," New York Times, 13 April 1997.

29. Institute of Medicine, Non-Heart- Beating Organ Transplantation.

30. Youngner and Arnold, "Ethical, Psy- chological, and Public Policy Implications"; Institute of Medicine, Non-Heart-Beating Organ Transplantation.

31. Institute of Medicine, Non-Heart- Beating Organ Transplantation; James E Childress, "Non-Heart-Beating Donors of

Organs: Are the Distinctions between Di- rect and Indirect Effects and between Killing and Letting Die Relevant and Help- ful?" Kennedy Institute of Ethics foumal 3 (1993): 203-216.

32. Kolata, "Controversy Erupts." 33. Childress, "Non-Hean-Beating Donors

of Organs," p. 211. 34. Institute of Medicine, Non-Heart-

Beating Organ Transplantation, p. 52. 35. Stuart J. Youngner, Robert M.

Arnold, Michael DeVita, "Issues in Deter- mination of Death in Non-Heart-Beating Donor Protocols." Unpublished manuscript prepared for the Institute of Medicine Committee on Non-Heart-Beating Organ Donation.

36. Youngner, Arnold, DeVita, "Issues in Determination of Death."

37. Robert M. Veatch, "The Impending Collapse of the Whole-Brain Definition of Death," Hastings Center Report 23, no. 4 (1993): 18-24.

When Is "Dead"? by S T U A R T J. Y O U N G N E R ,

ROBERT M. A R N O L D , and

M I C H A E L A. D e V I T A

One way of increasing the supply of vital organs without

violating the dead donor rule is to declare death on

cardiopulmonary criteria after withdrawing life support.

The question then is how quickly death may be declared.

TTn 1996, 60 Minutes ran a story about the ethical issues associated

J_Lwith procuring organs from indi- viduals who have been declared dead using cardiopulmonary criteria—so- called "non-heart-beating donors"

Stuart J. Youngner, Robert M. Arnold, and Michaei A. Devita, "When Is Dead?" Hastings Center Report 2^, no. 6 (1999): 14-21.

(NHBDs). They raised questions about the ethical appropriateness of the procedure, intimating that pa- tients were being given drugs that would shorten their life in order to improve organ quality. The story was quickly picked up by newspapers around the country that ran head- lines such as "Murder She Wrote."' In response, in 1997 the U.S. De-

partment of Health and Human Ser- vices asked the Institute of Medicine to "explore the medical and ethical balance between steps to ensure the availability of as many organs in the best condition for the transplant and the rights of patients who may be- come donors to the highest quality of care separate from extraneous condi- tions such as donor organ supply."^ The IOM's report found a great deal of variability in how different trans- plant centers procured NHBDs. In an effort to set standards, the report also presented recommendations for NHBD protocols.

One of the more controversial topics the IOM faced was the timing of death in controlled NHBD proto- cols. Because of the need to reduce warm ischemia, organs must be taken as quickly as possible after death is pronounced. There are no clear clini- cal guidelines upon which to make such a declaration. The question is, when, in the course of ascertaining death, is the patient dead, so that the organs can be taken?^ There is a ten- sion between making certain that the

HASTINGS CENTER REPORT November-December 1999