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Doubts about Death: The Silence of the Institute of Medicine

Published online by Cambridge University Press:  01 January 2021

Jerry Menikoff
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Traditionally, organ retrieval from cadavers has taken place only in cases where the declaration of death has occurred using “brain death” criteria. Under these criteria, specific tests are performed to demonstrate directly a lack of brain activity. Recently, as a result of efforts to increase organ procurement, attention has been directed at the use of so-called “non-heart-beating” donors (NHBDs): individuals who are declared dead not as a result of direct measurements of brain function, but rather as a result of the cessation of heart and respiratory functions. Attempts to obtain organs from such individuals have recently resulted in substantial negative publicity. Claims were made that the deaths of patients were being accelerated in order to get organs, and that sometimes organs were being removed from patients who were not yet dead.

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Article
Information
Journal of Law, Medicine & Ethics , Volume 26 , Issue 2 , Summer 1998 , pp. 157 - 165
Copyright
Copyright © American Society of Law, Medicine and Ethics 1998

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References

The tests involve checking specifically for the absence of various reflexes that would otherwise exist if the person's brain was still functioning. See, for example, Report of the Medical Consultants on the Diagnosis of Death to the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, “Guidelines for the Determination of Death,” JAMA, 246 (1981): 2184–86 [hereinafter Report of the Medical Consultants].Google Scholar
See, for example, Cho, Y.W., “Transplantation of Kidneys from Donors Whose Hearts Have Stopped Beating,” N. Engl. J. Med., 338 (1998): 221–25.CrossRefGoogle Scholar
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The use of non-heart-beating donors (NHBDs) could have a major impact on the number of organs available for transplantation. For example, it has been suggested that the use of such donors could increase the supply of kidneys by a factor of 2 to 4.5. See Koostra, G., “The Asystolic, or Non-heartbeating, Donor,” Transplantation, 63 (1997): 917–21, as cited in Cho et al., supra note 2. Thus, strong incentives exist to interpret the legal and ethical issues in a way that permits use of such organs.CrossRefGoogle Scholar
Institute of Medicine, Non-Heart-Beating Organ Transplantation: Medical and Ethical Issues in Procurement (Washington, D.C.: National Academy Press, 1997): At 73 [hereinafter IOM Report].Google Scholar
The Institute of Medicine (IOM) described its mandate as being to determine the “alternative medical procedures that can be used to increase the availability of organs and at the same time ensure the ethically and medically sound treatment of donor patients before and after death.” It also paraphrased this request to be “in essence, … how can the United States have a good organ donor and transplantation program?” Id. at 2.Google Scholar
See, for example, Weiss, R., “Some Hospitals Use Questionable Methods to Get Organs for Transplant, Panel Says,” Washington Post, Dec. 19, 1997, at A27; and Sternberg, S., “Kidneys OK for Transplant Even After Heart Stops,” USA Today, Jan. 22, 1998, at 10D.Google Scholar
The Kennedy Institute of Ethics Journal has published an article by the principal investigator and others involved in producing the IOM report. See Herdman, R. Beauchamp, T.L. Potts, J.T. Jr., “The Institute of Medicine's Report on Non-Heart-Beating Organ Transplantation,” Kennedy Institute of Ethics Journal, 8 (1998): 83-90. That journal had previously devoted an entire issue to what has remained the most extensive evaluation of the use of NHBDs. See Kennedy Institute of Ethics Journal, 3, no. 2 (1993), subsequently reissued as R.M. Arnold et al., eds., Procuring Organs for Transplant: The Debate Over Non-Heart-Beating Cadaver Protocols (Baltimore: Johns Hopkins University Press, 1995).Google Scholar
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This should be contrasted with what would be required explicitly to declare John “brain dead,” which would involve numerous tests designed directly to demonstrate that his brain is not functioning. See Report of the Medical Consultants, supra note 1.Google Scholar
Uniform Determination of Death Act, § 1, 12 U.L.A. 340 (Supp. 1991).Google Scholar
See, for example, Lynn, J., “Are the Patients Who Become Organ Donors under the Pittsburgh Protocol for ‘Non-Heart-Beating Donors’ Really Dead?,” Kennedy Institute of Ethics Journal, 3 (1993): 167-78; and Cole, D., “Statutory Definitions of Death and the Management of Terminally Ill Patients Who May Become Organ Donors After Death,” Kennedy Institute of Ethics Journal, 3 (1993): 145–55.Google Scholar
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To some extent, there must be an element of real-world practicality in determining whether something is not capable of being reversed. Thus, for example, the theoretical possibility of a heart transplant would not alter a determination of irreversibility, absent some demonstration that the patient did in fact have access to an available heart. Issues such as this lead some to question the very use of “irreversibility” in the context of cardiopulmonary function, as opposed to determining brain function, where there is currently no way to reverse the damage to a brain that has suffered from loss of oxygen for a sufficient period of time. See, for example, Cole, , supra note 15.Google Scholar
In particular, waiting for that additional period of time would make the heart unusable for transplant. The heart is one of the organs for which NHBDs are viewed as a possible source. See, for example, Cope, J.T., “Intravenous Phenylephrine Preconditioning of Cardiac Grafts from Non-Heart-Beating Donors,” Annals of Thoracic Surgery, 63 (1997): 1664–68. Indeed, in 1993 and 1994, the hearts were removed from 4.7 and 8.5 percent, respectively, of the NHBDs in each year. See IOM Report, supra note 5, at 27. It is curious that supporters of this practice see no inconsistency, on the one hand, in declaring a person dead as the result of the irreversible failure of that person's heart, and, on the other, in successfully using that very heart to replace the malfunctioning heart of another person.Google Scholar
See Capron, A.M. Kass, L.R., “A Statutory Definition of the Standards for Determining Human Death: An Appraisal and a Proposal,” University of Pennsylvania Law Review, 121 (1972): At 89. Oddly, the medical literature is silent with regard to these traditional criteria. Thus, a 1968 article observed that, in a sample of fifty texts of physical diagnosis published within the prior half century, only one—published in 1926—discussed the methods and techniques for diagnosing death. See Arnold, J.D. Zimmerman, T.F. Martin, D.C., “Public Attitudes and the Diagnosis of Death,” JAMA, 206 (1968): 1949-54. A more informal survey of the library shelves of Kansas University Medical Center produced a similar result: Although the criteria for declaring a patient “brain dead” are frequently discussed, rarely is there a discussion of the more traditional criteria. Indeed, the only text to discuss such criteria made a point of commenting on that fact: “Edwin V. Motto, M.D., a resident on our service, called the authors' attention to the dearth of instructions on this subject in books on diagnosis.” DeGowin, E.L. DeGowin, R.L., Bedside Diagnostic Examination (New York: Macmillan, 4th ed., 1981): At 843. It bears noting that the “Death Examination (for Most Patients)” provided in this text involved not just tests for “cardiac activity” and “respiratory activity,” but also tests for “neurologic function,” such as checking for the “fixed dilated pupils of death.” Id.Google Scholar
See, for example, Iserson, K.V., Death to Dust: What Happens to Dead Bodies? (Tucson: Galen Press, 1994): 34–38 (discussing various tests for death, including making surgical incisions into bodies, touching the bodies with hot irons, and putting devices in coffins for signaling whether the body begins to move); and President's Commission, supra note 12, at 13–15.Google Scholar
See Report of the Ad Hoc Committee of the Harvard Medical School to Examine the Definition of Brain Death, “A Definition of Irreversible Coma,” JAMA, 205 (1968): 337–40.Google Scholar
Henry K. Beecher, the chair of the Ad Hoc Committee, was even more explicit in observing that whether our ancestors recognized the special role of the brain, “there is [now] a need to move death to the site of an individual's consciousness.” Beecher, H.K., “Definitions of ‘Life’ and ‘Death’ for Medical Science and Practice,” Annals of the New York Academy of Sciences, 169 (1969): At 474. Beecher did not confine his comments to those declared dead under the newly proposed criteria for brain death.Google Scholar
See Report of the Ad Hoc Committee, supra note 22, at 339.Google Scholar
See, for example, President's Commission, supra note 12, at 62–63.Google Scholar
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Id. at 109–10. As Alexander Capron and Leon Kass further note,Google Scholar
One hopes that the form the statute takes does not reflect a conclusion on the part of the Kansas legislature that death occurs at two distinct points during the process of dying. Yet this inference can be derived from the [Kansas Act], leaving open the prospect “that X at a certain stage in the process of dying can be pronounced dead, whereas Y, having arrived at the same point, is not said to be dead.”Google Scholar
Id. at 110. It is interesting that Capron and Kass were presumably worried that a person might be declared dead sooner under the brain death definition than under the cardiopulmonary definition, no doubt as a result of the pressures created by the need for transplantable organs. Somewhat paradoxically, the NHBD controversy has created the same issue, but flipped: The desire to get organs has created a reading of the cardiopulmonary definition that would allegedly allow these persons to be declared dead at a time when they clearly could not be declared dead under the brain death definition.Google Scholar
Id. at 112 (emphasis added).Google Scholar
Id. at 113–14.Google Scholar
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The director of the President's Commission was an active participant in the drafting of what would become the Uniform Definition of Death Act (UDDA). See President's Commission, supra note 12, at 9.Google Scholar
Id. at 1, 57.Google Scholar
Although the President's Commission begins the chapter discussing these issues with the observation that “these views all yield interpretations consistent with the recommended statute,” id. at 31, subsequent discussion in the report makes it very clear that the Commission rejected the higher brain and nonbrain views. With regard to the view that it is the destruction of the higher brain—the portions of the brain that deal with consciousness, thought, and feelings—that determines whether a person is dead, the Commission noted that “the adoption of a higher brain ‘definition’ would depart radically from the traditional standards.” Id. at 40–41. And with regard to the nonbrain view of death, the Commission very explicitly noted that the “concept of death based upon the flow of bodily fluids cannot be completely reconciled with the proposed statute.” Id. at 42.Google Scholar
Id. at 36. It is also the case that, among philosophers, there is “nearly a consensus” that one must look to brain function to determine death. See Furrow, , supra note 30, at 1037.Google Scholar
President's Commission, supra note 12, at 37.Google Scholar
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Id. It is noteworthy that IOM's report fails to comment on whether any evidence suggests that a person would always lack pupillary light responses at the point in time five minutes after the heart has stopped beating. As the President's Commission notes, the examination of such pupillary responses has classically been a routine test for death under the traditional cardiopulmonary criteria, thus demonstrating that even those criteria did not fully ignore the functioning of the brain. See DeGowin, DeGowin, , supra note 20, at 843.Google Scholar
President's Commission, supra note 12, at 37 (emphasis added).Google Scholar
The President's Commission also considered it important that death not be viewed “as a process,” but as a specific event that “separates the process of dying from the process of disintegration.” Id. at 77. Thus, at the time a person would be declared dead, he would be declared dead because his status is at that time consistent with the concept of death being adopted, and not because he might merely in the near future have the desired status, whether or not his progression to that status was inevitable. In other words, “dying” is different from “being dead.” Presumably, if the status of the person's brain was the relevant concept, then the condition of that brain—for example, being irreversibly nonfunctional—should exist at the time death is declared.Google Scholar
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See, for example, Veatch, R.M., “The Impending Collapse of the Whole-Brain Definition of Death,” Hastings Center Report, 23, no. 4 (1993): At 18 (“The President's Commission … made clear, however, that circulatory and respiratory function loss are important only as indirect indicators that the brain has been permanently destroyed.” (emphasis added)); and Arras, J.D. Steinbock, B., eds., Ethical Issues in Modern Medicine (Mountain View: Mayfield, 4th ed., 1997): At 130 (making similar comments in discussion of the writings of Karen Gervais).Google Scholar
IOM's report contains several references to articles generated by a conference that examined in detail the University of Pittsburgh NHBD protocol. A number of those articles raised issues discussed herein. See, for example, Cole, , supra note 15, at 152–53; Tomlinson, T., “The Irreversibility of Death: A Reply to Cole,” Kennedy Institute of Ethics Journal, 3 (1993): 163-64; and Veatch, R.M., “Consent for Perfusion and Other Dilemmas with Organ Procurement from Non-Heart-Beating Cadavers,” in Arnold, R.M., supra note 8, at 198. Although the number of pages devoted to this issue are relatively few, it is highlighted in the conference's introductory essay. See Arnold, R.M. Youngner, S.J., “Back to the Future: Obtaining Organs from Non-Heart Beating Cadavers,” Kennedy Institute of Ethics Journal, 3 (1993): At 106–07:Google Scholar
Cole, Tomlinson, and Lynn all note that the Pittsburgh protocol's sole emphasis on cardiopulmonary criteria for death poses unexpected questions regarding the concept of death. When the “brain death” criteria were introduced, its supporters argued it did not entail a new conception of death, but simply supplemented the traditional cardiopulmonary criteria…. According to this argument, both criteria serve as clinical tests for a unitary definition of death—the loss of integrative functioning of the whole brain. However, there are no clear empirical data proving that a patient who meets the Pittsburgh protocol's criteria for cardiopulmonary death, two minutes of pulselessness, also meets neurologic criteria for death, irreversible loss of all brain function.Google Scholar
The importance of this issue has clearly increased in the context of IOM's report. Although the discussants of the Pittsburgh protocol could assume empirical data may ultimately resolve whether there is irreversible loss of all brain function at the time death is declared, IOM acknowledges it is unlikely that there is such loss of function at the time it approves for the declaration of death, and acknowledges it does not even care about the existence of such function. See IOM Report, supra note 5, at 59.Google Scholar
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See Furrow, , supra note 30, at 1032–38.Google Scholar
The use of the word “prolonged” in this statute presumably highlights the need to wait long enough so that one can be confident that brain function has irreversibly ended.Google Scholar
President's Commission, supra note 12, at 74. The President's Commission was referring to a statute proposed by a Canadian law reform commission. For subsequent discussion of this Canadian proposal, see Bernat, J.L. Culver, C.M. Gert, B., “Defining Death in Theory and Practice,” Hastings Center Report, 12, no. 1 (1982): 5–9.CrossRefGoogle Scholar
Capron would appear to agree with this characterization of the dispute, because he had previously discussed exactly this issue under the heading “Disagreements Over Form,” as opposed to “Disagreements Over Substance,” which related to whether the entire brain, or just the “higher brain centers,” had to be destroyed in order for a person to be declared dead. See Capron, A.M., “Legal Definition of Death,” Annals of the New York Academy of Sciences, 315 (1978): At 354–55.Google Scholar
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See Areen, J., Law, Science and Medicine (Westbury: Foundation Press, 2nd ed., 1996). Capron, who played a major role in the series of events that led to the UDDA, is one of the five co-authors of this text.Google Scholar
Areen, J., Teacher's Manual for Law, Science and Medicine (Westbury: Foundation Press, 2nd ed., 1996): At 124–25 (emphasis added).Google Scholar
The apparent acceptability of deceiving the public in order to increase organ donation was affirmed by the comments I received from an anonymous reviewer:Google Scholar
The author insists that “ethical behavior demands that we not shade the truth….” If the author had found a way to facilitate the use of non-heart-beating donors without shading the truth, the paper would constitute a substantial step forward. For the reasons given, I do not believe that the author accomplishes this. As stated, I do agree that the IOM report shades the truth. What is to be done?… In the end, we would have more candor, but organs would be denied to desperately ill patients…. The IOM is not alone in wrestling with this moral issue.Google Scholar
Peer Review, at 3 (emphasis added) (on file with author).Google Scholar
See President's Commission, supra note 12.Google Scholar
See Cho, , supra note 2.Google Scholar
One recent report, for example, concludes that the time period during which the liver receives no blood flow prior to the beginning of the preservation process should not exceed ninety minutes. See Platz, K.-P., “Influence of Warm Ischemia Time on Initial Graft Function in Human Liver Transplantation,” Transplantation Proceedings, 29 (1997): 3458–59. One can readily contemplate that improved techniques will eventually shave at least ten minutes off a period of that length.Google Scholar
IOM Report, supra note 5, at 3.Google Scholar
Id. at 8.Google Scholar
See President's Commission, supra note 12. Under the interpretation of the UDDA I recommend, the person's entire brain would be irreversibly nonfunctional after such a period, thus allowing death to be declared even under clause (1) of the Act.Google Scholar
This statement would, of course, require validation, presumably initially by appropriate studies in animals. Nonetheless, basic principles of physiology would appear to suggest that once blood flow has stopped, thus depriving all of the person's brain cells from not only the supply of oxygen, but also from the effects of hormones and other chemical factors that might somehow influence their viability, the removal of the other organs is unlikely to influence substantially negatively the condition of the now-dying brain cells. It should be assumed that appropriate anesthesia has been given to the patient, so that no pain is experienced during the organ removal, thus eliminating pain signals as a stress factor. Note that under this proposal, giving anesthesia is perfectly acceptable, as compared with the protocol recommended by IOM, wherein under exactly the same conditions, the patient would have already been declared dead, and thus presumably never need anesthesia. See, for example, Veatch, , supra note 42, at 198 (“In fact, much of the literature advocating such death pronouncements really does not even present firm evidence that the patient is unconscious.”).Google Scholar
These arguments are similar to those made by advocates for the strict version of the dead donor rule, under which organs should not be removed from a living person, whether or not the removal causes or hastens the person's death. See Arnold, R.M. Youngner, S.J., “The Dead Donor Rule: Should We Stretch It, Bend It, or Abandon It?,” Kennedy Institute of Ethics Journal, 3 (1993): At 265.CrossRefGoogle Scholar
Even this argument loses much of its force under IOM's interpretation of irreversibility, because the major element of that determination is the patient's intent that no actions be taken to reverse their condition. See supra note 14 and accompanying text. Thus, the irreversibility is largely illusory, and the fear of doctors hastening death to get organs would still exist.Google Scholar
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Id. at 73.Google Scholar
Id. at 49.Google Scholar