8

Ethical and Societal Issues

[D]ramatic, “big ticket” treatments like kidney dialysis and transplantation—or the implantation of an artificial heart at the University of Utah Medical Center in late 1982—are not yet the major strains on the health care budget, but they do crystallize the ethical issues posed by limitations on society's resources. The Commission concluded that these issues cannot be avoided by the sort of response—” give everyone all they need”—that was used for kidney failure. Instead, the Commission turned to the ethical principle of equity. This principle is always a hard one to know how to apply . . .

President's Commission1

THIS CHAPTER IS ARRANGED in three sections, each addressing aspects of ethical and societal issues in future decisions by the National Heart, Lung, and Blood Institute (NHLBI) about research and development funding allocations in the artificial heart program. The first section provides background on the societal issues of justice that are raised by those complex medical technologies designed to sustain life that are here characterized as “incomplete.” These technologies reduce the effects of a disease but neither cure nor totally resolve the underlying condition. Because many of these technologies are in wide use and no longer under development as is the fully implantable total artificial heart (TAH), experience with them can shed light on the ethical and societal issues raised by the TAH.

The second area of concern is ethical issues that the TAH specifically raises for NHLBI and society. Epidemiologically, heart disease is the primary cause of death in the industrialized world. Physiologically, the heart is perhaps more immediately critical than other major organs; the functions performed by the heart are necessary on a minute-by-minute basis. Finally, the heart is an organ with great emotional, symbolic, or religious meaning for most people. For all these reasons, in study after study and commentary

1  

Page 74, President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research (1983).



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The Artificial Heart: Prototypes, Policies, and Patients 8 Ethical and Societal Issues [D]ramatic, “big ticket” treatments like kidney dialysis and transplantation—or the implantation of an artificial heart at the University of Utah Medical Center in late 1982—are not yet the major strains on the health care budget, but they do crystallize the ethical issues posed by limitations on society's resources. The Commission concluded that these issues cannot be avoided by the sort of response—” give everyone all they need”—that was used for kidney failure. Instead, the Commission turned to the ethical principle of equity. This principle is always a hard one to know how to apply . . . President's Commission1 THIS CHAPTER IS ARRANGED in three sections, each addressing aspects of ethical and societal issues in future decisions by the National Heart, Lung, and Blood Institute (NHLBI) about research and development funding allocations in the artificial heart program. The first section provides background on the societal issues of justice that are raised by those complex medical technologies designed to sustain life that are here characterized as “incomplete.” These technologies reduce the effects of a disease but neither cure nor totally resolve the underlying condition. Because many of these technologies are in wide use and no longer under development as is the fully implantable total artificial heart (TAH), experience with them can shed light on the ethical and societal issues raised by the TAH. The second area of concern is ethical issues that the TAH specifically raises for NHLBI and society. Epidemiologically, heart disease is the primary cause of death in the industrialized world. Physiologically, the heart is perhaps more immediately critical than other major organs; the functions performed by the heart are necessary on a minute-by-minute basis. Finally, the heart is an organ with great emotional, symbolic, or religious meaning for most people. For all these reasons, in study after study and commentary 1   Page 74, President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research (1983).

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The Artificial Heart: Prototypes, Policies, and Patients after commentary, terms such as “alluring” are used to describe this technology's potential to reduce suffering and death from heart disease. Because many patients cannot be helped by any technology other than a TAH, the questions of who should and who can have access to the device become critical. The second section of the chapter addresses issues directly pertinent to the TAH such as ethically determining and providing access to care, and developing criteria for use in clinical trials and routine medical practice. In the final section, methods of protecting individual patients' autonomy are considered in the context of clinical trials and routine use. These issues include the informed consent process, use of advance directives, and NHLBI funding as a means of promoting appropriate clinical investigation and use of new mechanical circulatory support systems (MCSSs). Although this chapter specifically refers to the TAH, most of the ethical principles discussed, such as the equitable allocation of resources and required informed consent, also apply to long-term ventricular assist devices (VADs). Ethical issues concerned with temporary or bridge use of MCSSs, however, such as their effect on the distribution of donor hearts for transplantation, are not considered. These issues have been examined in detail in other contexts (Annas, 1985; Robertson, 1987; Miles et al., 1988) and are likely to disappear if long-term devices are proven effective and become available for general clinical use. ISSUES RAISED BY INCOMPLETE TECHNOLOGIES Health care technologies differ in many ways such as purpose, necessity, ease of use, stage of development, cost, and effectiveness in improving patient longevity and quality of life. One approach to differentiation within a taxonomy of health care technologies is to consider the subset of “incomplete” measures that partially treat or palliate critical medical problems in individuals.2 The focus here is on those incomplete technologies—ranging from cardiac pacemakers to bone marrow and other types of transplantation to dialysis for end-stage renal disease—whose costs, given finite national resources for health care, raise particular questions about their appropriate and equitable use. Under this category of equitable and appropriate use are decisions about the distribution of benefits and costs, as well as questions about the procedures or mechanisms for ensuring access to the benefits. Whether, how, and in what fashion to make such technologies available 2   Complete technologies, in contrast, satisfactorily resolve a disease state. An illustration of a complete technology is gallbladder removal, which restores full function to the patient, whereas an incomplete technology might relieve suffering from the disease once it becomes evident.

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The Artificial Heart: Prototypes, Policies, and Patients has raised basic questions about the just distribution of finite benefits and inevitable burdens within a community. How does a nation ethically distribute benefits and burdens? In its conscious efforts, the United States uses a democratic process (Bellah et al., 1985; Engelhardt and Wildes, 1991). Through mechanisms ranging from established procedures (e.g., legislation, congressional representation, executive decision) to the accumulated precedent of specific decisions, a national consensus or status quo is reached. Such actions are usually influenced by a range of ethical principles such as the desires to avoid doing harm (nonmaleficence) and to do good (beneficence), the just distribution of benefits and burdens, and respect for individual autonomy, as well as by other concerns that can be based on national, individual, or special-group interests.3 Overall questions of societal priorities, such as the portions of government resources devoted to health care, education, support of the arts, or interstate highways, are not considered here. These are most appropriately determined or influenced by the national political process, and they are beyond the purview of NHLBI or the Institute of Medicine (IOM). Ideally, decisions about allocating federal funds for health care would start with a unified process for determining the proportions of funding for general societal benefits, such as those provided through community-based health measures, and for individual needs, such as those met with incomplete technologies. Currently no such national priority setting is used. The charge to the IOM committee was to help NHLBI determine whether, and in what amounts, funds should be allocated to continuing the development of TAHs. In determining the appropriate level of federal R&D funding for TAHs, it became necessary to go beyond the issue of resource allocation and consider the societal issues that will arise should TAHs be developed and become available to the public. The NHLBI artificial heart program has been evaluated six times since its inception; it is, perhaps, the most persistently scrutinized program of the National Institutes of Health (NIH). In part, the impetus behind the long-standing discomfort with the NHLBI artificial heart program can be attributed to the recognition that some planning for, and control over, the use of this technology is needed. Such 3   Four principles—nonmaleficence, beneficence, justice, and autonomy—are recognized as general guidelines for moral action. They also identify several approaches to the issue of justice. The egalitarian philosophyemphasizes equal access to those goods that all rational people desire; this philosophy therefore focuses on procedural guarantees of access. Libertarian and Marxist theoriesboth emphasize the rights of individuals, with libertarianism focusing on the individual's contribution or merit and Marxist approaches focusing on the individual's needs. Utilitarianismapplies a mix of criteria so as to maximize public and private utility (Beauchamp and Childress, 1979).

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The Artificial Heart: Prototypes, Policies, and Patients concerns are included in these deliberations, as they were in previous expert assessments of the artificial heart program, because they were significant enough to directly impinge on the committee's ability to address the question of funding allocations. Specifically, the committee felt unease at the lack of mechanisms for considering the appropriate use of approved TAHs. Health priorities cannot be effectively or reasonably set if the issue under consideration is limited to R&D funding allocation decisions; this is, however, the level at which decisions to continue or halt development are made. As economic constraints become increasingly urgent, gaps in the existing decision-making processes may lead to the use of R& D funding decisions, such as the one under consideration by the committee, as a “last-secure-stopping-point” (Blumenthal and Zeckhauser, 1984). A decision of this nature would limit development and use of the TAH not on the basis of its value, but in an attempt to determine or safeguard national health priorities. An extreme option considered by the committee was to recommend a halt to NHLBI funding for any TAHs or VADs, on the ground that they are simply too costly to society. Such a decision would indicate that, as a matter of public policy, it is preferable that people die of heart disease than that federal funds be applied to artificially sustaining them at so high a cost. This option, however, raises troubling questions about justice and national priorities for health care. Given its relative lack of ethical expertise, the committee did not feel comfortable making, without a clear national mandate to do so, a recommendation that would potentially affect national policy and thousands of lives. There was, moreover, some question about the acceptability of such a recommendation given “the rule of rescue, ” a societal tendency to demand that the utmost be done for identifiable individuals who are in critical need (Jonsen, 1986a). Lester Thurow describes the current dilemma faced by the health care system in allocating expensive incomplete technologies as a very high stakes game of Old Maid, where everybody wants to shuffle the deck in such a way that they don't have to tell the patient the bad news. The bad news is, there's something that might be done to help them but we can't, as a society, afford to give it to them. Everybody wants to be in a position to force somebody else to . . . deliver that nasty message. He continues by pointing out that, far from being simply considerations of economic concerns, these are “ethical questions constrained by economics” (Thurow, 1988, p. 71). For technologies with great potential impact on national priorities and spending, the balance of individual and societal interests must be considered if we are to avoid proceeding blindly or halting the development and use of viable, useful technologies. Health care pri-

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The Artificial Heart: Prototypes, Policies, and Patients orities that only become evident in retrospect still function as priorities; they have distributive consequences as substantive as any policy determined through more deliberate or conscious means. As a nation facing increasing economic constraints, we cannot continue to sacrifice optimized and ethical results for the comforts of a pay-as-you-go system. The inadequacies of the decision process for developing and using technologies such as the TAH mean that R&D allocation decisions inappropriately carry some of the weight of decisions about the technology's use. Either directly or indirectly, NHLBI's decisions about the allocation of public resources for TAH development will respond to the issue of national health priorities. It is therefore part of NHLBI's responsibility as a funding sponsor to encourage other health care policymakers to examine these questions. Maximizing Benefits in the Provision of Health Care Our objective is to use the available resources as efficiently as possible to maximize the health (measured in terms of length and quality of life) of our population. To achieve this objective, decisions about the development or use of a procedure must consider the extent to which the procedure contributes to that objective (its effectiveness), and how efficiently the procedure achieves the objective (its cost-effectiveness). . . . This fact creates a burden on anyone who attempts to set policies to guide the use of a procedure. The burden exists for any procedure, but is greater and more urgent for an expensive and potentially widely practiced procedure. . . . [T]he crucial question is whether there are other things that could be done with the resources that would yield greater benefit. (D. M. Eddy in NHLBI, 1985, p. 56) As stated above, maximum benefit from the use of resources is desired. But benefits differ and their assessed value is usually shaped by the specific criteria used. Cost-effectiveness as a criterion, for example, is not the only measurement for equitable or appropriate use of resources. In societies based on different ethics, options preferring certain groups such as the sick or poor might be based on effectiveness, without necessarily being based on cost. Measures of benefit alone and cost-effectiveness analysis of several options might result in ethically different and even contradictory conclusions. But criteria for measuring benefit are needed. Because cost-effectiveness is more objectively determined than benefit, and because it is an economic concept that can be applied in an ethical context, it offers NHLBI a quantitative approach to ethical questions that also uses units of evaluation—dollars—that are within NHLBI's area of responsibility. Despite the lack of answers to such larger ethical questions as the nation's priorities

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The Artificial Heart: Prototypes, Policies, and Patients for health care, NHLBI can appropriately apply cost-effectiveness analysis as a way of helping to address moral and ethical questions. Criteria other than cost-effectiveness are also relevant, however. This section of the chapter will suggest which criteria are most notable in specific situations. Leaving payment and reimbursement aside, among the often used criteria in health care are the urgency or immediacy of the need and concerns about equitable distribution and use of resources. These and other criteria are relevant to varying degrees, depending on specific goals. In the provision of care, urgent need is often separated from overall considerations of potential benefit; issues of finite resources or cost-effectiveness are seldom considered in individual cases. The result is an obscuring of both the need to consider multiple goals —helping specific people in immediate need and helping overall improvement of a population's health—and the question of how to maximize both goals. The difficulty of evaluating benefits can be demonstrated using the differences between incomplete technologies and public health interventions that have broad demographic results. Incomplete technologies offer treatment to individuals who can no longer, and in some cases never could, benefit from public health or preventive interventions. Furthermore, they help individuals who are dying now, whereas public health measures help people who do not appear to be in immediate need. Both approaches are necessary, for both improve health and neither can completely replace the need for the other. But the different “faces” of these approaches can create a disjunction in the perception of need or a lack of attention to criteria such as relative cost-effectiveness. Compared with the urgency of emergency room treatment or implantation of an MCSS in a dying patient, public health measures such as better sanitation, vaccinations, or smoking cessation programs may appear less immediately necessary. Nevertheless, it can be argued that general public health measures usually provide greater overall benefits to a population. 4 In addition to need and cost-effectiveness, overall substantive justice must be carefully considered. Recent research suggests that, among patients with ischemic heart disease, there are racial variations in the use of 4   With public health measures such as improved sanitation, the benefits to a population probably have a highly favorable cost-effectiveness value when compared with treatment of diseases. With preventive measures such as vaccination, screening for hypertension, and lifestyle changes, however, a comparison of cost-effectiveness ratios results in the conclusion that “sometimes prevention buys more health for the money; sometimes cure does” (Russell, 1986, p. 111). In general, Russell concludes that prevention provides additional health benefits at additional costs. Decisions should not, however, be based on the assumption that preventive measures are either free or a bargain but, she says, on whether they are the appropriate choice for a particular situation.

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The Artificial Heart: Prototypes, Policies, and Patients cardiovascular procedures such as coronary angiography and coronary artery bypass surgery (Wenneker and Epstein, 1989). If such inequities of access exist, applying only the criteria of cost-effectiveness and immediate presenting need ignores a critical concern. The various goals of providing health services—including cost-effectiveness, meeting individual needs, and the equitable provision of care—must be considered, along with their differing criteria and mechanisms for access, in a national decision that will balance health costs and benefits between (1) identified individuals with critical needs and (2) overall improvements in the health of the population. The committee was assembled to consider the costs and goals of a specific federal program, the NHLBI artificial heart program. In the process of answering this question, it calls attention to an issue beyond its scope of work or expertise: the need for developing national priorities for the allocation of resources within the health care system. Conceptualizing Access to Incomplete Technologies The different levels of benefit in health care elicit varied solutions to the problem of equitable and appropriate access to health technologies. One approach argues against investment in, or coverage for, extremely expensive new technologies on the grounds that the money might be more efficiently used in other areas of health care such as public health measures. Another perspective, noting the piecemeal, de facto nature of funding and reimbursement (Rosenthal, 1979), is that money is not necessarily fungible between the different levels of health care and that prioritizing and funding decisions should be made within categories of technologies with similar purposes. Given this second argument, the approach to the category of incomplete technologies has significant consequences for the questions of equity and access. On the one hand, if incomplete technologies are seen in a historical and legal framework, policymakers might consider it more important to be consistent and equitable than to weigh the effects of such individual decisions on total spending for expensive incomplete technologies. Such an approach is evident in the argument that TAHs should be available to all who need them because renal dialysis is available. This approach, however, does not recognize the fact that health care resources are, and will always be, limited. On the other hand, if incomplete technologies are seen as a necessarily limited segment of health care efforts and their costs—perhaps defined as a rough proportion of all funds spent on health care—then the most beneficial technologies within the category should be funded, with benefit measured using various indicators such as relative cost-effectiveness, need, and

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The Artificial Heart: Prototypes, Policies, and Patients existing inequities. This “limited resources” model would parallel the peerreview system for awarding NIH research grants where, as funds become available in a fiscal year, the most highly valued forms of research are financed until there is no more money.5 Proponents of the legal, individual-focused model would argue that, if dialysis and the TAH are within the same magnitude of costs and cost-effectiveness, TAHs should be available to patients with end-stage heart disease. Conversely, if the limited resources model is applied, current funding of the end-stage renal disease program might militate against the development and provision of TAHs, at least with federal funds, on the grounds that we cannot afford it at this time. Consideration of both models might lead to the establishment of options for reconciling them, such as a comprehensive nationwide or statewide position on access to selected incomplete technologies. In Habits of the Heart (1985), Bellah, Madsen, and colleagues argue that individualism, and not equality, is the preeminent value in American society. Our traditions encourage us to think of justice as a matter of guaranteeing equal opportunities and access for individuals through laws and political procedures, and as a consequence we have become knowledgeable about procedural and even distributive justice. They suggest, however, that such an approach does not guarantee substantive justice, which considers the overall societal effectiveness of procedural and distributive guarantees when resources are limited and there are competing valid demands. This committee was not constituted to resolve such major issues on the nation's health care agenda, but it does urge that attempts at their equitable resolution become a high-priority agenda item for the appropriate federal and state policymakers. 5   Although the NIH peer-review system could serve as an example for determining priority levels within the category of incomplete technologies, several immediate considerations come to mind. First, peer-review study sections concentrate on specific research disciplines. Multidisciplinary approaches would have to be developed for considering a range of technologies (IOM, 1990, pp. 92-100). Such ranking of a range of technologies according to criteria is currently being done, on the state level, in Oregon. Second, a review process for determining the appropriateness and merit of technologies would have to be based on stated national priorities. Setting these priorities would, perhaps, be best carried out by a standing national commission. Third, the category of “peers” would undoubtedly have to be expanded to include citizens other than physicians, researchers, and ethicists. National or state priorities should be set with adequate consultation of many sectors of the community, including at a minimum the elusive “average citizen, ” legislators, and most particularly those directly affected by the decisions. Involving representatives of these groups, particularly the last one, may be difficult; the Oregon initiative has experienced some difficulty with this and has had to set Medicaid priorities with only limited input from actual Medicaid recipients.

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The Artificial Heart: Prototypes, Policies, and Patients ISSUES RAISED BY THE TOTAL ARTIFICIAL HEART Access to Total Artificial Hearts If the overall consideration of incomplete technologies raises issues of substantive justice, the specific case of the TAH raises issues of procedural and distributive justice such as how, ethically, to define and assure adequate access to the device. The technology is the only possible life-sustaining treatment for certain end-stage heart disease patients, and most individuals will not be able to afford it without Medicare or other third-party coverage. Because the TAH is still in development, whether such coverage will be forthcoming has not been determined and the likelihood of adequate coverage is uncertain. A critical issue is whether developing the TAH is in the public interest if a substantial portion of the insured public will not have access to it. If access to the TAH is determined, either as a matter of national or state-level policy or through Medicare and other third-party coverage decisions, to be within the definition of adequate or basic care called for by the President's Commission (1983), another question remains: Should access to TAHs be provided to the more than 30 million citizens with no health insurance? If so, yet another question arises: Would adequate care include, for example, replacement of the device, which in initial clinical use would be needed every two to five years? Decisions on these types of questions will be made, either explicitly or indirectly, but the committee's conclusions about the allocation of NHLBI funds are not equivalent to conclusions about whether the artificial heart falls within the category of basic care. If basic or adequate care is defined to include access to the TAH for certain individuals in need—that is, ethical access is assured within categories of clinical appropriateness—or if funding of TAH development continues for other reasons, the interim period before routine availability of the TAH should be used to improve those individuals ' procedural access to health care and to facilitate more systematic and consistent third-party decision-making processes. Considerations would include equitable access and use across socioeconomic, ethnic, and racial categories for those with equivalent clinical indications for use, equitable geographic availability, and reduction of nonmonetary restraints on availability such as limited numbers of facilities and personnel able to provide such care. The case of the artificial heart offers a significant, previously unavailable opportunity: a test case for managing the application of a health care technology. Defining and controlling appropriate access to such a technology prior to its first clinical use has never been possible. Legislators and policymakers at state and federal levels should begin, now, to decide

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The Artificial Heart: Prototypes, Policies, and Patients about equitable access to MCSSs and other technologies by establishing commissions or other broadly based groups to aid in making those decisions. If access decisions are made on a state-by-state rather than national basis, then an adequately funded organization or mechanism should be established to provide information and assistance to such state decisionmaking processes. With the knowledge already accumulated about the TAH, and the 15 or so years before it is generally available, the TAH becomes an unprecedented potential case study. Criteria for Use Ensuring appropriate access includes the identification of research subjects and patients using an equitable process. Patient use criteria are necessary for investigational clinical trials, and the Stanford University heart transplantation program has established selective criteria that may be relevant for MCSS use (Christopherson, 1982). Criteria for routine MCSS use, however, will be more exclusionary than selective for two reasons. First, MCSSs are not a limited resource, like donor hearts. Rather than choose among potential recipients, as in a clinical trial, criteria for general clinical use will exclude those patients who clearly would not benefit from MCSSs (Jonsen, 1984; Parker et al., 1990). Second, routine MCSS use will be largely determined by third-party coverage. Health insurance coverage will therefore be a critical exclusionary criterion. Use of a strict upper age limit for determining eligibility for MCSS implantation is inappropriate unless such an age limit addresses only extreme cases; MCSS implantation in a 90-year-old patient, for instance, seems an extreme case. But on an ethical level, age should not be used to categorically define or regulate access to care. On a pragmatic level, chronological age may indicate relatively little about the potential benefits of an MCSS to an individual and may be far less significant than factors such as medical condition, comorbidities, and other available interventions. Appropriate and significant clinical benefit to the patient should be the overriding consideration in determining the appropriateness of individual MCSS use, and indications for use should be cooperatively developed by clinicians, third-party payers, and others, as discussed in Chapter 7. If MCSSs become available for routine clinical use, third-party payers rather than individual hospitals and physicians are likely to determine whether specific patients receive them. This identification of patient eligibility will be performed through the mechanism of prior review for each case. History tells us, however, that the availability of a health care option can be quickly transformed into a right without sufficient reference to clini-

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The Artificial Heart: Prototypes, Policies, and Patients cal appropriateness. This is particularly likely with the TAH, a life-saving technology of great symbolism and visibility. As noted by the President's Commission, the ethical imperative to provide adequate or basic care does not guarantee the provision of sufficient care. The committee reiterates the importance of using explicit clinical criteria to define appropriate use on an individual level, and using the goals of equitable and appropriate access and use to define overall access. Aggregate Societal Costs Because of its cost, the eventual levels of TAH use will be highly responsive to coverage and reimbursement decisions by Medicare and other third-party payers (see also Chapter 4). Depending on the clinical indications for use and third parties ' coverage criteria, adequate coverage for VADs and TAHs could add several billions of dollars annually to national health care expenditures. Such factors are not usually considered in R&D allocation decisions because they are most appropriately addressed at the federal level by Congress, the Department of Health and Human Services, or other policymaking bodies, or at the state level by legislatures and health departments. Another possible broad impact from the use of long-term VADs and TAHs is the potential cost to society of prolonging the lives of tens or even hundreds of thousands of individuals. This issue was reviewed by the National Heart and Lung Institute (NHLI) Artificial Heart Assessment Panel (NHLI, 1973). Consideration of the nation 's unemployment and underemployment levels is beyond the committee 's scope and expertise, but it must note that the prospect of MCSS recipients returning to the work force does not appear great, particularly if they were disabled by heart disease for some time before receiving the MCSS. In concluding this section on societal concerns, a final comment: Clarity about the various goals of TAH development and use is necessary when considering the issues surrounding access and appropriate use. In his addendum to the NHLI 1973 report on the TAH, Havighurst notes that “society's humanitarian [self-]image” is often served by providing highly visible benefits to identifiable individuals in order to preserve the “myth of life's infinite value” (NHLI, 1973, pp. 243-244). This “rule of rescue,” or impulse to save identified lives—which does not necessarily encompass concern about the quality of that life—will be a powerful factor in future decisions about MCSS use (Jonsen, 1986a; NHLI, 1973, pp. 231-247). The appropriateness of clinical use of the TAH to reinforce a symbolic valuation of human life should not go unquestioned in decisions about appropriate access and distributive justice.

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The Artificial Heart: Prototypes, Policies, and Patients PROTECTING THE INDIVIDUAL PATIENT Informed Consent and Advance Directives The issue of patient autonomy, both generally and in reference to the TAH, has been well addressed in the bioethical literature6 and in previous reports on the TAH. Informed consent is designed to ensure, as much as possible, that patient choices about treatment are autonomous, informed, and in accordance with their personal values. Although the concept of informed consent is supported and partially defined by the law, meeting the legal definition of informed consent is a starting point, not an assurance of having conducted the consent process in an ethical and complete fashion. In both clinical trials and routine TAH use, an individual's informed consent must result from a careful, explicit, and accountable process. Patients such as those considering a TAH are seriously ill and faced with difficult choices; their capacity for objective, considered consent will be impaired. Consent should be obtained through a series of discussions, over time, to assure adequate understanding of alternative and palliative therapies, risks and benefits, and long-term effects of treatment, as well as clarification and communication of the patient 's preferences and values. The patient's preferences about discontinuing use of the TAH should be explicitly examined and, as well, recorded in an advance directive. The specific, personal considerations associated with such a decision (including clinical condition, prognosis, and procedures to be performed) should be clear for the patient, health care providers, and a proxy or surrogate decision maker. This advance directive will ensure future treatment in accordance with the patient's preferences and will reduce emotional distress and guilt for loved ones, close friends, and the medical professionals providing care (Engelhardt and Wildes, 1991). To further the likelihood that the patient's wishes will be carried out, each patient should also consider executing a durable power of attorney. “Durable” signifies that a trusted relative or representative is legally authorized to make treatment decisions in accordance with the patient's wishes, 6   “The most general idea of autonomy is that of being one's own person, without constraints either by another's action or by a psychological or physical limitation. . . . To respect autonomous agents is to recognize with due appreciation their own considered value judgments and outlooks even when it is believed that their judgments are mistaken. To respect them in this way is to acknowledge their right to their own views and the permissibility of their actions based on such beliefs. And to grant them this right is to say that they are entitled to such autonomous determination without limitations on their liberty being imposed by others.” (Beauchamp and Childress, 1979, pp. 57-58; see also Shaw, 1984)

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The Artificial Heart: Prototypes, Policies, and Patients should the patient be unable to do so.7 Any patient, and any person acting according to the patient's wishes through a power of attorney, should be able to make explicit choices about treatment, including termination of treatment (President 's Commission, 1983; Schiedermayer and Shapiro, 1989). In the context of informed consent, prior directives, and powers of attorney, issues of patient-physician interactions must be carefully considered. As examined by Katz (1984) and by Annas (1987) in the situation of the first experimental human uses of long-term MCSSs, the hopes and understandings of physicians and patients can become intertwined in a complex manner, amounting to a situational transference brought about by the risks, fears, hopes, and mutual dependencies of both the patient and the physician. Table 8.1 delineates, for patients, researchers, and physicians, considerations for decision making about MCSS use. Emotional transferences are always a consideration in the physician-patient dyad, particularly with the use of life-saving technologies, but they require particular scrutiny during experimental or investigational use when the researcher and the patient have somewhat divergent goals. As shown in the table, the purpose of investigational use is to evaluate the device by determining benefit under controlled conditions. This is, however, a statement of the goal shared by the researchers and patient. The patient has a prior, preemptive goal of improving survival or quality of life and is dependent on the researcher for care, continued survival, and hope. The researcher, by contrast, is dependent on the patient for continuation of the trial. The noncomplementary interdependencies of patient and researcher should be a constant consideration in the clinical trial consent process. All the above factors diminish the patient's ability to consider consent fully. A disinterested observer should therefore be involved throughout the presumably lengthy discussions before the granting or denying of consent and determining of advance directives. In the case of clinical trials, a mechanism to ensure ethical oversight is the hospital institutional review board. Such an entity should ensure that, even as a last resort in the treatment of seriously ill patients, investigational use of a device or a technique such as xenografting is not undertaken without a legitimate foundation for research, a clear, objective anticipation of benefits, and informed consent for each event in the process of medical care. 7   Various legal documents for creating a durable power of attorney exist; a recent collaborative effort in Massachusetts, for example, resulted in a single-sheet “health care proxy” form that meets all the requirements of Massachusetts law (Annas, 1991). Those interested in obtaining advance directive forms could consult their hospital's legal counsel or administration, which may have forms appropriate for that state or regional jurisdiction.

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The Artificial Heart: Prototypes, Policies, and Patients TABLE 8.1 Decision-Making Considerations for Patients, Physicians, and Researchers with Respect to MCSS Use Variables Investigational Use in Clinical Trials Routine Use in Treatment Purpose To evaluate the device by determining benefit under controlled conditions. To improve individual patients' health status as defined by mortality, quality of life, and morbidity. Patient Criteria A process of selection: Emphasis on choosing the best possible patient for the research protocol. This goal is complicated by the fact that patients cannot, ethically, be eligible for the clinical trial if an alternative treatment is likely to be more clinically beneficial (Parker et al., 1990). A process of exclusion: Emphasis on not choosing patients for whom the balance of risks and benefits of MCSS use is unfavorable or unreasonable. Informed Consent Few hard data on probable outcomes are available to be provided to patients. Much attention must be paid to the entire process of informed consent throughout both the trial and use of the device, including termination of use. Oversight by institutional review boards and less directly through the mechanism of NHLBI funding. Because benefits and risk are more clearly known, patients' personal preferences are important in determining use. Informed consent is still crucial but now approximates consent for the use of similar life-sustaining technologies. MCSS, mechanical circulatory support system; NHLBI, National Heart, Lung, and Blood Institute. A final form of patient protection is provided through NHLBI. Most probably, NHLBI does not consider its funding role to have any quasi-regulatory components. Nevertheless, continued federal funding through NHLBI can restrict the investigative use of MCSSs to those groups with the most expertise, experience, resources, and commitment. This regulatory influence can provide added protection for patients and further reduce the possibility of MCSS misuse in clinical investigations (Jonsen, 1986b). This influence is particularly relevant for future clinical trials of VADs, as discussed further in Chapter 10. CONCLUSIONS For both clinical trials and general use, regard for the individual patient's autonomy and concern about equitable access to TAHs will continue to be complex, serious issues. Decisions should be made in advance of the device's availability about its relative priority compared with other health care

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The Artificial Heart: Prototypes, Policies, and Patients technologies. Based on such priorities, preparation should begin now for dealing with the procedural and substantive justice concerns that will be raised by the availability of an approved TAH. The question of access to TAHs must be addressed by the nation's health care policymakers before TAHs become available for general use. With such planning, it may be possible to achieve appropriate levels of benefit for both individual patients and society in exchange for understood, equitable, and acceptable levels of cost and burden. Progress on the question of access to TAHs will also provide, for the first time in the United States, a case study for defining and controlling access to a health technology. The committee was assembled to help NHLBI determine whether, and in what amounts, funds should be allocated to further development of TAHs; in the process of doing so, it became necessary to examine larger societal concerns raised by TAH development. The limited scope of this study, however, precludes recommendations on such national issues as substantive justice and national health priorities. The committee's recommendations on resource allocation for R&D should not be construed as responses to these larger national issues. REFERENCES Annas, G. J. 1985. No cheers for temporary artificial hearts. Hastings Center Report 15(10):27-28. Annas, G. J. 1987. Death and the magic machine: Informed consent to the artificial heart . Western New England Law Review 9:89-112. Annas, G. J. 1991. The health care proxy and the living will. New England Journal of Medicine 324:1210-1213. Beauchamp, T. L., and J. F. Childress. 1979. Principles of Biomedical Ethics. New York: Oxford University Press. Bellah, R. N., R. Madsen, W. M. Sullivan, A. Swidler, and S. M. Tipton. 1985. Habits of the Heart: Individualism and Commitment in American Life. Berkeley and Los Angeles: University of California Press. Blumenthal, D., and R. J. Zeckhauser. 1984. The artificial heart as an economic issue. In: M. W. Shaw, ed. After Barney Clark: Reflections on the Utah Artificial Heart Program. Austin: University of Texas Press, pp. 149-167. Christopherson, L. K. 1982. To mend the heart : Ethics and high technology. 2. Heart transplants. Hastings Center Report 12(1):18-21. Engelhardt, H. T., and K. W. Wildes. 1991. Beyond cost-effectiveness and cost-benefit analysis: A bioethical assessment of some issues associated with the development and use of mechanical circulatory support systems . Background paper prepared for the Institute of Medicine Committee to Evaluate the Artificial Heart Program of the National Heart, Lung, and Blood Institute . IOM (Institute of Medicine). 1990. Funding Health Sciences Research: A Strategy to Restore Balance. F. E. Bloom and M. A. Randolph, eds. Washington, D.C.: National Academy Press.

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The Artificial Heart: Prototypes, Policies, and Patients Jonsen, A. R. 1984. Patient autonomy and the process of informed consent. In: M. W. Shaw, ed. After Barney Clark: Reflections on the Utah Artificial Heart Program. Austin: University of Texas Press, pp. 5-10. Jonsen, A. R. 1986a. Bentham in a box: Technology assessment and the artificial heart. Western Journal of Medicine 145:685-686. Jonsen, A. R. 1986b. The artificial heart's threat to others. Hastings Center Report 16(2):9-11. Katz, J. 1984. The Silent World of Doctor and Patient. New York: Free Press. Miles, S. H., M. Siegler, D. L. Schiedermayer, J. D. Lantos, and J. La Puma. 1988. The total artificial heart: An ethics perspective on current clinical research and deployment. Chest 94:409-413. NHLBI (National Heart, Lung, and Blood Institute). 1985. Artificial Heart and Assist Devices: Directions, Needs, Costs, Societal, and Ethical Issues. Report of the Working Group on Mechanical Circulatory Support, National Heart, Lung, and Blood Institute. Rockville, Md.: NHLBI. NHLI (National Heart and Lung Institute). 1973. The Totally Implantable Artificial Heart: Economic, Ethical, Legal, Medical, Psychiatric, Social Implications. Report by the Artificial Heart Assessment Panel. DHEW Publication No. (NIH)74-191. Parker, L. S., R. M. Arnold, A. Meisel, L. A. Siminoff, and L. H. Roth. 1990. Ethical factors in the allocation of experimental medical therapies: The chronic left ventricular assist system. Clinical Research 38:537-544. President's Commission for the Study of Ethical Problems in Medicine and Bio-medical and Behavioral Research. 1983. Summing Up: Final Report on Studies of the Ethical and Legal Problems in Medicine and Biomedical and Behavioral Research. Washington, D.C.: U.S. Government Printing Office. Robertson, J. A. 1987. Supply and distribution of hearts for transplantation: Legal, ethical, and policy issues. Circulation 75:77-87. Rosenthal, G. 1979. Anticipating the costs and benefits of new technology: A typology for policy. In: S. H. Altman and R. Blendon, eds. Medical Technology: The Culprit Behind Health Care Costs? Proceedings of the 1977 Sun Valley Forum on National Health. Washington, D.C.: U.S. Government Printing Office, pp. 77-87. Russell, L. B. 1986. Is Prevention Better than Cure? Washington, D.C.: The Brookings Institution. Schiedermayer, D. L., and R. S. Shapiro. 1989. The artificial heart as a bridge to transplant: Ethical and legal issues at the bedside. Journal of Heart Transplantation 8:471-473. Shaw, M. W., ed. 1984. After Barney Clark: Reflections on the Utah Artificial Heart Program. Austin: University of Texas Press. Thurow, L. C. 1988. Can we afford the new medical technologies? IEEE Engineering in Medicine and Biology Magazine (June) pp. 70-73. Wenneker, M. B., and A. M. Epstein. 1989. Racial inequalities in the use of procedures for patients with ischemic heart disease in Massachusetts. Journal of the American Medical Association 261:253-257.