4
Ethical Issues in Pandemic Planning and Response

OVERVIEW

Many of the conferences, meetings, and workshops convened in anticipation of an H5N1 influenza pandemic have focused on the specific strategies that can be used in fighting such a pandemic. The contributors to this chapter take a different tack and consider the creation of ethical guidelines for governments, health-care systems, and clinicians to be used in planning for and responding to a pandemic. The authors identify a set of ethical principles that should serve as a foundation for such guidelines; they also discuss the importance of public engagement in the development of the guidelines and the need for clear communication of the guidelines once they are done.

In the first contribution to this chapter, Alexander Capron of the University of Southern California examines a variety of ethical approaches to pandemic planning, noting that ethics may be applied to both the content of policies and the processes by which they are established and implemented. Returning to the central ethical considerations identified by his former World Health Organization (WHO) colleague, David Heymann (see page 33), Capron specifically addresses the implications of pandemic influenza for human rights, access to health care, obligations of and to health-care workers, and obligations of countries and intergovernmental organizations. He then explores how ethical principles can be applied in policy making to address these issues. Capron’s observation that all dilemmas faced by pandemic planners can be reduced to “the classic struggle between individual and group” echoes Victoria Sutton’s conception of a “pandemic flu ethic,” which she defined in her remarks at the workshop as “a limitation on the freedom of action or the imposition of a duty to act in the pursuit of the continued existence



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Ethical and Legal Considerations in Mitigating Pandemic Disease: Workshop Summary 4 Ethical Issues in Pandemic Planning and Response OVERVIEW Many of the conferences, meetings, and workshops convened in anticipation of an H5N1 influenza pandemic have focused on the specific strategies that can be used in fighting such a pandemic. The contributors to this chapter take a different tack and consider the creation of ethical guidelines for governments, health-care systems, and clinicians to be used in planning for and responding to a pandemic. The authors identify a set of ethical principles that should serve as a foundation for such guidelines; they also discuss the importance of public engagement in the development of the guidelines and the need for clear communication of the guidelines once they are done. In the first contribution to this chapter, Alexander Capron of the University of Southern California examines a variety of ethical approaches to pandemic planning, noting that ethics may be applied to both the content of policies and the processes by which they are established and implemented. Returning to the central ethical considerations identified by his former World Health Organization (WHO) colleague, David Heymann (see page 33), Capron specifically addresses the implications of pandemic influenza for human rights, access to health care, obligations of and to health-care workers, and obligations of countries and intergovernmental organizations. He then explores how ethical principles can be applied in policy making to address these issues. Capron’s observation that all dilemmas faced by pandemic planners can be reduced to “the classic struggle between individual and group” echoes Victoria Sutton’s conception of a “pandemic flu ethic,” which she defined in her remarks at the workshop as “a limitation on the freedom of action or the imposition of a duty to act in the pursuit of the continued existence

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Ethical and Legal Considerations in Mitigating Pandemic Disease: Workshop Summary of life and order.” Sutton, who has taken a similar approach to defining an ethic of biodefense and bioterrorism (Sutton, 2005) views ethics as a precursor to law (see also Chapter 3 and the Summary and Assessment), while Capron portrays ethics as integral to public health policy. Capron’s essay also features “straightforward, practical suggestions” for pandemic preparations that are supported by ethical principles. At the national level he advocates advanced planning, communication, and public involvement in order to realize an “ethically responsible and appropriate response.” At the international level, he calls on governments of wealthier nations to announce support for poor, early-affected countries out of both ethical responsibility and self-interest. Even if public debate results in differences in pandemic policies among communities and countries, Capron contends, civic engagement will promote the understanding and acceptance of necessarily imperfect—but beneficial—public health measures. Focusing on the disproportionate burden that a pandemic is likely to place on the world’s poorest people and countries, Ruth Faden of Johns Hopkins University asserts in her contribution to this chapter that “the greatest moral challenge posed by a pandemic is how to respect commitments to social justice in the face of the overwhelming and entrenched inequalities.” Such inequalities result from efforts to control avian influenza that disproportionately burden poor countries and benefit wealthy ones, and they are also likely to result from an exacerbation of social injustice within the U.S. and other wealthy countries in the response to a pandemic. Therefore, Faden argues, governments bear a moral responsibility to identify where social injustices are likely to occur as the result of a pandemic and to take reasonable steps to prevent or reduce the worst among them. In order to support this effort, Faden and fellow members of the Bellagio Group have developed a set of principles that are intended to uphold the rights and interests of disadvantaged groups in pandemic planning and response as well as a set of checklists to guide the incorporation of these principles into pandemic planning and response. In her essay, Faden describes these principles, the rationale behind them, and their significance to public health policy and practice. As noted in the Summary and Assessment, several workshop participants raised concerns regarding the lack of clear authority for decision-making in public health emergencies. Sutton has described the history and consequences of the longstanding conflict between federal and state claims to public health authority and has suggested a potential resolution through a system of “cooperative federalism” in which the federal government establishes standards for pandemic measures that are subsequently administered by state government and implemented at the local level (Sutton, 2001). This model of federal leadership is endorsed and expanded upon in the chapter’s third essay, by speaker Shelley Hearne of Johns Hopkins University, who argues that “from an ethical standpoint, federal health agencies should play a more directive role in establishing standards and critical requirements for state and local jurisdictions in order to ensure equal

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Ethical and Legal Considerations in Mitigating Pandemic Disease: Workshop Summary levels of preparedness for all citizens.” She presents a detailed strategy for building emergency-response capacity that will protect all U.S. citizens equally and, in much the same way that the federal government ensures that each state meets certain minimal environmental standards, will enforce basic requirements for public health in pandemic preparations and response. The chapter concludes by shifting from the big picture of government action in a pandemic to the smaller scale of the clinic, where the personal agony of ethical dilemmas comes into focus. Speaker Bernard Lo of the University of California, San Francisco, and co-author Douglas White confront the need for specific criteria to triage patients with respiratory failure in the likely event of a shortage of respirators during a pandemic as well as the need for guidelines and procedures to address the practical problems that will arise when such policies are implemented. The authors stress that public participation in the crafting of such guidelines and procedures will be important in creating popular acceptance of the difficult choices that must be made during a pandemic. While recognizing the ideal of public participation in pandemic planning, workshop participants agreed that public health professionals must expect that most people will be entirely unprepared when the next pandemic strikes. In order to mount an effective response, public health authorities will need to act rapidly and authoritatively on the basis of incomplete knowledge. To the biomedical experts who would inform these decisions, Institute of Medicine (IOM) president Harvey Fineberg posed a series of rhetorical questions: Are experts bound to frame evidence, based on their knowledge, so that politicians reach “correct” conclusions regarding a threatened pandemic? Should experts refrain from making conclusions, but merely answer questions? Should experts speak directly to the media about their concerns? Rather than offering answers, Fineberg described how various experts approached these dilemmas in the course of reacting to the appearance of swine flu in 1976 and how those reactions—and their treatment in the media—shaped the nation’s response to a threatened pandemic. One television network, NBC, provided coverage that was sympathetic to the federal program of mass vaccination against swine flu, while another network, CBS, offered skepticism and criticism of the government’s actions, Fineberg recalled. Such a contrast in interpretation was rare in the media at that time, he said, and it originated in the distinct pool of experts that each network consulted on the story. When White House contacts told NBC reporters that the program was being carried out despite its disadvantage to President Ford, who was up for reelection, the network concluded that the President was being forced to do the bidding of scientific experts. At the same time, CBS reporters heard from their Centers for Disease Control and Prevention (CDC) contacts that the vaccination program was premature and unfeasible, leading that network to conclude that the vaccination program was being launched solely for political reasons. Given the potential to create similarly influential and divisive messages in the face of pandemic influenza, experts should think carefully about their roles and respon-

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Ethical and Legal Considerations in Mitigating Pandemic Disease: Workshop Summary sibilities in portraying their convictions, understandings, and beliefs to the media, Fineberg advised. But no matter what choices are made to address a threatened pandemic, there will be skepticism, criticism, and differences of opinion, Fineberg concluded. Because “there is no way to avoid the dilemmas posed by acting without full scientific knowledge,” as Gostin has observed, “the only safeguard is the adoption of ethical values in formulating and implementing public health decisions” (Gostin, 2004). ETHICAL CONSIDERATIONS IN INTERNATIONAL PREPAREDNESS PLANNING EFFORTS Alexander Morgan Capron University of Southern California1 Earlier papers have detailed the public health history of past epidemics, from polio to SARS, and have described how health-care professionals, particularly in public health, are organized to respond to existing and emerging communicable diseases. With this background we can now move to a discussion of the ethical considerations in preparedness planning efforts. The first question we encounter when thinking about these ethical considerations is, where exactly does ethics fit into international preparedness planning efforts? Not surprisingly, my view is that it must lie at the heart of the process because it helps us see what the right thing is to do under a particular set of circumstances. But in doing so ethical analysis must examine both the substance and the consequences of alternative policies and practices and the processes by which they are developed and selected. In this essay I will introduce some of the ethical considerations relevant to pandemic influenza planning but will not attempt to cover them all. In particular, I will leave some of the ethical issues raised by disease mitigation and resource allocation to be addressed when those topics are specifically discussed. But before talking about how ethics can be applied to pandemic planning, it seems advisable to say a few words about what “ethics” consists of. 1 These remarks grow out of work on which I was engaged (until August 2006) as Director, Department of Ethics, Trade, Human Rights and Health Law, at WHO. These efforts are being carried forward in the department by Dr. Andreas Reis, in collaboration with our colleagues in the Department of Epidemic and Pandemic Alert and Response, especially the pandemic influenza team leader, Dr. Keiji Fukuda, and department director, Dr. Mike Ryan, as well as the Acting Assistant Director-General for the Communicable Diseases Cluster, Dr. David Heymann. In these remarks, however, I write only for myself and not for WHO.

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Ethical and Legal Considerations in Mitigating Pandemic Disease: Workshop Summary The Range of Ethical Theories Ethical Theories Relevant to Policies and Practice 1. Deontology and principilism. How does ethics provide a guide to right action? Many ethical theories are used in medicine and public health, including deontology (in which decisions are based mainly on a consideration of one’s duties), casuistry, consequentialism, virtue ethics, and rights-based theories. Of these, the first is probably the most familiar to people working in health care—and has been since the time of Hippocrates. His oft-repeated oath and his many other injunctions, such as “First, do no harm” (familiar to generations of physicians in its Latin version, “Primum non nocere”), form the basis for a set of professional obligations which consists primarily of doctors’ duties toward their patients. Another, more contemporary statement of the principles that should guide health professionals was set forth in the Belmont Report, produced in 1978 as the capstone of the work of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Afterwards, the principles were elaborated on by Tom Beauchamp, who had been the principal consultant on the Belmont Report, and his colleague Jim Childress in Principles of Biomedical Ethics, now in its fifth edition (Beauchamp and Childress, 2001). The two ethicists set fourth four principles—beneficence, non-maleficence, respect for persons, and justice—that have been used so widely in discussions regarding health-related topics that they may sometimes be mistaken as all that bioethics has to say on the subject. Indeed, they are invoked so formulaically in so many settings that they are sometimes mocked as “the Georgetown mantra” (referring to Georgetown University, at whose Kennedy Institute of Ethics both Beauchamp and Childress were teaching when they wrote their book). These four principles are indeed often useful, but they ought not to be substituted for careful ethical analysis, both because the principle most relevant to public health actions—namely justice—is the least fully discussed in the literature applying the principles to medical practice and biomedical research and also because the list of the four principles itself does not provide guidance on how to give more weight to one than the other when they are in conflict. The Belmont Report and its kin are a form of principilism, or making ethical decisions based on a set of principles. Principilism is one way of approaching professional deontology, particularly in the case of health-care clinicians and researchers. Although experience indicates that these principles are indeed useful as a guide for individual physicians and researchers in thinking about their obligations to individual patients and subjects and in understanding the rules that appear in many codes of ethics or in determining when further rules are needed, we should keep in mind that this is only one set of principles among many. Rights-based ethics, for example, is an alternative formulation that involves a larger number of principles and is addressed more to the actions of institutions

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Ethical and Legal Considerations in Mitigating Pandemic Disease: Workshop Summary and governments. An example of rights-based ethics is the Universal Declaration on Bioethics and Human Rights, adopted by the General Conference of the United Nations Educational, Scientific and Cultural Organization (UNESCO) in October 2005. As suggested by its name, rights-based ethics attempts to ground its principles not in philosophic or medical tradition but in human rights, particularly those that have been agreed upon in international conventions. People in the human-rights field point out that these are not vague ethical obligations but rather are binding legal rights. Like all matters that arise out of intergovernmental debate and consensus, the principles in UNESCO’s bioethics declarations are written with a great deal of imprecision (in order to get countries with markedly different views to agree to them), and, like the Belmont Report, they also are not particularly helpful in those inevitable situations where principles collide or, sometimes, even point in opposite directions. 2. Consequentialism and “the greatest good.” Of the alternatives to principilism, the ethical approach of greatest relevance for public health actions is probably consequentialism, the most influential example of which is utilitarianism. Whereas a deontologist says that people should act so as to fulfill their duties to others, a consequentialist says that a person should act in the way that produces the best outcome. Of course, what counts as the best outcome varies among ethical viewpoints. For a utilitarian, at least a utilitarian of a Benthamite stripe, the right action is that which produces the greatest sum of pleasure in the relevant population, or more generally that which maximizes human welfare or well-being. A related approach, “rule utilitarianism,” looks at the consequences of general rules instead of the consequences of individual acts. For a rule utilitarian, the question is not whether a particular act will produce the greatest good but instead whether a particular rule—say, “Do not lie”—as a general matter will produce the greatest good even if there may be situations in which not following the rule (e.g., by lying) would produce a better outcome. By reasoning in this way, obligations can be generated on consequentialist grounds. Even when people agree on the “facts” about a set of policies or practices, they may reach differing conclusions about whether the policies are ethically justifiable, and often the reason for the different conclusions is that the people are applying different ethical approaches. Consider, for example, a decision to allocate limited supplies of antiviral medicines to hospitalized patients who were already very sick before they contracted influenza instead of providing the medicines to people in their homes who were found by community nurses to be showing early signs of influenza. Such a decision might seem appropriate to a deontologist who believes that the duty of beneficence attaches to all existing physician-patient relationships and who therefore reasons that it is the physician’s duty to help the infected patients fight the influenza. On the other hand, the decision might seem wrong to a utilitarian who calculated that many more lives would be saved by treating otherwise healthy outpatients who were just developing

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Ethical and Legal Considerations in Mitigating Pandemic Disease: Workshop Summary influenza rather than inpatients with co-morbidities who might not survive even if the influenza treatments were successful. The difference of opinion arises not from any disagreement over what the outcomes of the two choices would be but rather from a disagreement about which factors are important in judging ethical actions or about the weights that should be accorded to the various factors. A principilist, for example, might ask which outcome is more important, achieving justice or respecting persons, while a utilitarian might want to know which changes would do the most to increase total welfare. Sometimes it is possible to apply more than one ethical system to a set of policies and thereby meet the concerns of people with different views of what is right—for example, to select among policies that have all passed muster on utilitarian grounds, the one policy that is fairest or that best promotes self-determination by patients. Ethical Standards for the Process Besides evaluating the content of pandemic preparations and response plans, one can also examine the process by which such policies are established. Again, such an evaluation can rely on duty-oriented considerations, outcomes-based considerations, or both. It is now widely agreed, both on philosophical grounds (e.g., what Prof. Norman Daniels calls “fair process”) and on human-rights grounds (e.g., the obligations of governments to resident populations), that the process by which these policies are decided should conform to certain standards. Perhaps the most important is that the people who will be affected by the policies should be kept informed and be allowed to participate in deliberations about the policies through processes in which the reasons, principles, and evidence that they regard as relevant are considered. Furthermore, the decision-making process should allow for revisiting and revising policies in light of new evidence and arguments as well as for formal appeals of the policies. Finally, there should be mechanisms to ensure that these criteria are actually fulfilled. The Values Embedded in Policies In their analyses of the moral reasons for formulating a policy or taking an action, ethicists are not limited to looking at the ethical principles that were included explicitly in the process; they can also point out values that were included implicitly in what might otherwise seem to be purely technical decisions. At WHO, for example, the processes for developing and promulgating standards typically involve consultations with experts as well as approval by WHO’s governing bodies, but until recently the processes have not also overtly included any ethical analyses. Nonetheless, it has always been the case that whenever WHO developed guidance in any of the many areas where it sets technical norms, it was also implicitly importing value preferences and adopting ethical norms. The same is true for WHO’s member states and for other major actors, such

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Ethical and Legal Considerations in Mitigating Pandemic Disease: Workshop Summary as health-related nongovernmental organizations. Accordingly, one of the things we have done at WHO is to look at the pandemic preparedness plans that are being produced by countries around the world to see what value assumptions they reveal. Few of these plans identify the particular ethical considerations used in their formulations, so we have had to try to unpack the values revealed by the specific policy choices that were made. Consider, for instance, a pandemic program plan that gives its goal as saving the most lives. This might seem so straightforward as to be beyond ethical dispute—after all, it is a goal shared with most medical institutions and public health authorities. Yet in the context of a particular health system, such an objective might translate into a preference for treating particular groups of patients. To illustrate this, consider an example from another arena, namely the choices facing countries participating in the so-called 3-by-5 Initiative of the Joint United Nations Programme on AIDS (UNAIDS) and WHO: If treatment programs had targeted the patients who were the easiest to treat, it would have been possible to make much more progress toward the initiative’s aim of having three million AIDS patients in developing countries on antiretroviral (ARV) treatment by the end of 2005. But targeting those easiest to reach might result in focusing the initiative’s resources on those who were already privileged in various ways: those who have good access to health care (because they live near a major medical center capable of operating ARV treatment programs and they have sufficient funds to obtain care there); those who are best informed about HIV/AIDS in general and about how to obtain treatment; those who are otherwise healthiest and hence find it easiest to seek care; or those who are best protected against the negative consequences of a positive HIV diagnosis (such as loss of job, family rejection, etc.) and hence most likely to have sought out and received an HIV test and therefore have discovered that they needed treatment. If utility—measured simply in terms of lives saved—is the principal or sole measure of how ethical a policy is, then using limited resources to successfully treat the largest number of patients possible would seem justified even if that meant preferring those with other advantages. After all, treating such patients would likely cost the least per life saved and therefore make it possible to save the most people. But there are other good reasons—turning on fairness rather than utility—why a government ought not simply devote its treatment resources to those who already had the best care, who were already the healthiest, who were already close to hospitals with ARV clinics, who had the means to partially pay for their treatments, or who knew the most about their need for treatment. In particular, focusing solely on utility would seriously disadvantage poor, rural, female, and socially marginalized populations, and considerations of justice would imply that at least some of the government’s treatment budget should be spent on reaching out to remote or socially isolated populations by providing community education, creating clinics, or perhaps even building basic infrastructure, such as roads to remote villages. The result would be to modify the goal of

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Ethical and Legal Considerations in Mitigating Pandemic Disease: Workshop Summary saving the most lives with the “side constraint” of treating all people with equal need in an equal fashion. No matter what balance of objectives is ultimately chosen, a process that explicitly recognizes these considerations is likely to be more justifiable than one that pretends that value choices are not being made and that produces a plan based only on “technical” considerations. In both our work on HIV (see Guidance on Ethics and Equitable Access to HIV Treatment and Care [UNAIDS/WHO, 2004]) and our work with pandemic influenza, our ethics team has insisted on working in tandem with the departments that are involved in the technical work, which, in the latter case, is principally the Department of Epidemic and Pandemic Alert and Response. The idea is that ethical guidance and analysis should not stand on its own, but rather it should be incorporated into and shape the processes by which the technical norms and standards for treatment, prophylaxis, and other influenza-related public health measures are developed, both by WHO and by WHO’s member states. In this way ethical guidance is explicitly and deeply embedded in advice that might otherwise be regarded as being merely technical. Ethics and Prudence While we may speak of our duties to ourselves (“You owe yourself a break— you’ve been working too hard!”), and while choices that affect us can also be framed in terms of our obligations to other people (“You shouldn’t take risks like that or you’ll leave your children as orphans”) or to the deity (“It would be wrong to take your own life, which is a gift from God”), most ethical duties are framed in terms of what effects our behavior can have for others. Sometimes, however, doing something to benefit others is framed not as something we should do because we have agreed to do so (for example, in a human rights convention) or because doing so is inherent in our role (for example, a Hippocratic duty) or even because doing so would maximize overall human welfare, but rather because it would be the smart thing to do to achieve benefits for ourselves. Of course, a single act can serve multiple aims—the Marshall Plan, for instance, was a great humanitarian effort that responded to the desperate conditions in a ravaged continent after the Second World War, but it also served to build a strategic buffer against the expansion of Soviet power. Such a mixture of aims can complicate analysis, but it is always important to distinguish an argument that we should do something because it will be to our material benefit (which is a prudential claim) from arguments based on something being the morally necessary or morally desirable thing to do (which is an ethical claim). Four Realms of Influenza Preparedness Planning and Action At WHO the ethical issues we have been dealing with concerning influenza preparedness planning and action can be divided into four groups or areas of

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Ethical and Legal Considerations in Mitigating Pandemic Disease: Workshop Summary concern. These four areas were also apparent in David Heymann’s review of the history of public health responses to communicable disease outbreaks in Chapter 1, and, indeed, the history that Heymann describes provides a great deal of material with which to evaluate the ethical arguments for or against certain policies or actions. So let us begin by reviewing those four areas and then investigate how ethical considerations arise in each. Four Areas of Ethical Concern The first area of concern is equitable access to health care in a pandemic. A major issue here is how influenza vaccines, antivirals (Tamiflu), and hospital beds should be allocated for influenza patients. More broadly, the question is how health-care resources in general should be allocated, both before and during the pandemic, between the needs of the influenza effort and other health needs. A related, more specific question is whether it is appropriate to alter the standards for approval of vaccines or drugs for a pandemic because of the pressing public need. The second area of concern is the ethics of public health actions taken in response to a pandemic, such as the surveillance of outbreaks of animal and human pathogens and dissemination of outbreak information; measures to prevent animal-to-human transmission through culling of livestock and so forth; separation measures such as quarantine, isolation, and social distancing; and control of international travel and borders, partly in response to the new WHO International Health Regulations. The third area of ethical concern is the obligations of health-care workers during a pandemic and the obligations of society to them in return. As Dr. Heymann made clear, a notable feature of many of the outbreaks he reviewed was the danger to and mortality among the health-care professionals dealing with those outbreaks, including both those who were providing treatment and those who were simply monitoring the outbreak. One can assume that if health-care workers are at greater-than-ordinary risk for acquiring infections because of their jobs—which appeared to be the case with SARS and may or may not be the case with pandemic influenza—then their natural inclination to minimize their exposure would be in conflict with their professional obligations both to individual patients and perhaps to their communities as a whole. Their acceptance of this risk in the execution of their duties would engender reciprocal duties on the part of the community to them. When we speak of health-care professionals’ duties—perhaps most fully articulated in the case of physicians, but certainly recognized for other professionals as well—we need to ask whether such duties derive from their special training and their status as licensed, self-governing professions, or whether they reflect the fact that they possess a set of skills that are particularly needed under the circumstances. And if it is the latter, would this rationale not also extend beyond

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Ethical and Legal Considerations in Mitigating Pandemic Disease: Workshop Summary workers who fit the usual, narrow definition of professionals? If “possessing essential skills” is the criterion, then would this class not encompass other people who are central to the operation of the health-care system, especially in times of crisis, right down to the delivery drivers, the maintenance workers who keep facilities going and clean up patient rooms, and so forth? A further question here is whether the obligations of health-care workers are dependent upon their receiving any special protection from society. If the obligations are to be linked to special protection, it would imply a contractual/reciprocal model of their roles rather than a professional model, in which certain duties are inherently part of the job. Since various ethical issues concerning the role of health-care workers are disputed—both because of questions about the relevance of ancient precepts to modern practitioners and because of the many workers who are not professionals in the same sense as physicians—the social-contract model may prove useful in deciding whether to give these groups special status when allocating prophylaxis and treatment for pandemic influenza and, if so, why. Do these workers have any special claim? One might say no on the grounds that, just as soldiers who sign up in peacetime are obligated to serve during war, workers in health care go into the field knowing that it has some unavoidable risks. The justice of concluding that they should not get special treatment on the occasions when these risks actually arise is reinforced—at least as to physicians and, to a lesser extent, nurses—by their having received a very heavily subsidized education that put them in a very privileged position in society. The fourth area of ethical concern centers on obligations among countries and the obligations of intergovernmental organizations: How should governments balance their duties to their own populations versus duties to other countries and populations, and what role should international organizations such as WHO play in addressing the cross-border risks and obligations? The first of these questions is closely related to an issue raised in a workshop discussion of vaccine-allocation strategies (see Summary and Assessment): How should decision makers determine the appropriate point in time to release a particular portion of the preventive and curative medicines under their control? Here the question is whether it is appropriate for a country to release scarce supplies of vaccine or other treatment to a second country when that second country is experiencing a pandemic, instead of holding on to the supplies for possible use by its own population. If the answer is yes, then one must also ask at what point in time should the release be made. If the first country holds back and the epidemic is contained—particularly if this is due to the aid of still other countries—then the decision makers will be seen as not having responded as dictated by humanitarian principles and perhaps human rights obligations and thus being responsible for a loss of lives that could have been avoided. Conversely, if the decision makers ship off the supplies and then the pandemic arrives full force in their own country, they will later face legitimate questions about why they were more solicitous of the

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Ethical and Legal Considerations in Mitigating Pandemic Disease: Workshop Summary build a health emergency-response capacity that will provide equal protections to all citizens, no matter what state they live in. The federal government needs improved mechanisms for encouraging and ensuring the preparedness of different jurisdictions, including verifiable and enforceable state and federal performance standards that require public participation and public accountability. CDC must adopt a more directed federalist role so that, regardless of where one lives, citizens will trust that government plans and instructions can and will save lives. INTENSIVE CARE UNIT TRIAGE DURING AN INFLUENZA PANDEMIC: THE NEED FOR SPECIFIC CLINICAL GUIDELINES Bernard Lo, M.D.5 University of California, San Francisco Douglas B. White, M.D.6 University of California, San Francisco During a severe influenza pandemic, a dire shortage of breathing machines— mechanical ventilators—is projected. According to one estimate, a pandemic will require 198 percent of the current supply of ventilators (Bartlett, 2006). If this happens, many people in respiratory failure who need mechanical ventilation in order to survive will not receive it. This grave shortage of ventilators will raise unprecedented allocation dilemmas that ought be addressed before a pandemic strikes. In a pandemic a public health emergency would be declared, and decisions by individual physicians and patients would be subordinated to public health goals (Gostin, 2000). The objective would no longer be the health of individual citizens but the well-being of the community as a whole. Emergency-preparedness exercises have considered which groups should receive priority for scarce public health preventive resources, such as a vaccine or oseltamivir (Emanuel and Wertheimer, 2006; Gostin, 2006). Similarly, ventilators should be considered a scarce resource to be allocated according to public health guidelines rather than by the decisions of individual physicians and patients. Guidelines for allocating scarce medical resources during a pandemic will require several levels of specificity. At the broadest level, state public health laws express a general societal agreement that during a public health emergency the decisions of individual physicians and patients will be constrained by public health policies (Gostin, 2000). At the next level of specificity—the level of clinical care decisions—hospitals and physicians need criteria for triaging various patients who need mechanical ventilators when the demand greatly exceeds 5 Professor of Medicine and Director of the Program in Medical Ethics. 6 Assistant Adjunct Professor, Program in Medical Ethics.

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Ethical and Legal Considerations in Mitigating Pandemic Disease: Workshop Summary supply during a pandemic. To minimize overall loss of life during a pandemic, priority should be given to patients who require mechanical ventilation but who are highly likely to survive after only a few days on the ventilator. Finally, at the most specific level, frontline physicians need guidance in implementing these triage priorities in specific clinical cases. Current ICU Allocation Policies Shortages of ventilators and beds in the intensive care unit (ICU) currently occur sporadically in U.S. hospitals. When this occurs, beds are allocated on a first-come, first-served basis (Society of Critical Care Medicine Ethics Committee, 1994). Patients who are already in the ICU and who need continued ICU care remain there unless they or their surrogates decide to forego it. Patient autonomy is respected. Similarly, mechanical ventilation may be withdrawn without the agreement of the patient or surrogate only if it is futile. Otherwise, the withdrawal of beneficial care without the agreement of the patient would violate the ethical guidelines of beneficence and fidelity to patients, the latter of which requires physicians to put the best interests of current patients foremost, ahead of any obligations to other patients, future patients, or third parties (Lo, 2005; Beauchamp and Childress, 2001). The sporadic shortages of ICU beds typically stimulate short-term measures to increase ICU resources. For instance, hospitals close their emergency departments to divert ambulances to other hospitals in the city. In addition, hospitals cancel elective surgery and use post-operative rooms as temporary ICU beds. Furthermore, patients whose need for ICU services is lower may receive their care in general hospital beds—a patient recovering in the ICU may be transferred out of the ICU a day earlier than usual, for example. Such measures may not be feasible during an influenza pandemic, however. In the case of ventilators, for instance, during a pandemic it is likely that other hospitals in the same geographical area will also have shortages of ventilators. (For the sake of argument, this paper will assume that hospitals have already taken steps to maximize the availability of ventilators.) In other clinical situations, several general ethical principles have been used to decide how to allocate scarce resources (Veatch, 2005; Baker and Strosberg, 1992). As we have discussed, the current method for allocating ICU beds during sporadic shortages is first-come, first-served. A second approach gives priority to those who are sickest and therefore in greatest need. During the system of triage established in the Napoleonic army, for instance, soldiers who were “dangerously wounded” received care before the less severely wounded. The dying were left untreated. This approach is still used in modern emergency departments, where medical need determines which patients are seen first. The ethical guideline underlying both is to help those patients who are the worst off and who have the greatest need. Yet a third approach is to maximize health outcomes in the com-

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Ethical and Legal Considerations in Mitigating Pandemic Disease: Workshop Summary munity by granting priority to patients who can be most efficiently treated. This focus on population-based outcomes was first used by British physicians during typhoid epidemics in the eighteenth century. The U.S. military has also adopted this principle of maximizing the total number of lives saved during extreme battlefield situations (Repine et al., 2005). Because these broad allocation principles are contradictory, it is essential to forge agreement on which will be applied during a pandemic before such a dire shortage occurs. Ventilator Shortages During a Pandemic Suppose for the sake of a dramatic example that an ICU in the midst of a pandemic has only one available bed and ventilator. In the emergency department are several patients in respiratory failure, all of whom will die without mechanical ventilation. It is not feasible, given staff shortages, to keep these patients alive by manually squeezing a bag to drive air into the lungs. One patient is a 30-year-old whose only medical problem is respiratory failure, presumably from influenza. Another patient has not only respiratory failure from influenza but also hypotension and renal failure. The presence of these additional problems means that the second patient has a worse prognosis than the first (Graf and Janssens, 2005). Additionally, there are two other patients in the emergency department with respiratory failure who also will die without mechanical ventilation. One is a 22-year-old with an acute asthma attack who has no clinical evidence of influenza. Another is a 58-year-old who requires emergency coronary bypass surgery for continued myocardial ischemia despite optimal medical management. These latter two patients are expected to survive if they receive just a few days of mechanical ventilation. Thus the shortage of ventilators will affect not only patients with influenza but also those who have respiratory failure from other causes. This scenario dramatizes the dilemmas and tradeoffs that frontline physicians are likely to face during a pandemic. First, the goal of helping those most in need will clash with the goal of trying to minimize deaths. Among patients with respiratory failure, those with multi-organ failure and those whose condition deteriorates over the first few days of treatment have a poor prognosis, so they are most in need. But treating these patients will increase the total number of deaths: treating a patient with multi-organ failure, who will need to use a ventilator for many days, will preclude the treatment of other patients who are likely to need it for only a few days. A second dilemma concerns the distribution of benefits. Allocation policies that are neutral on their face, taking into account only medical prognosis, may in practice have disparate impact on different social groups. For instance, members of ethnic groups who historically have suffered discrimination are more likely to be poor or have poor access to medical care. They may have difficulty coming to the hospital and therefore may be sicker when they present. Thus an allocation policy based on evidence-based determinations of medical

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Ethical and Legal Considerations in Mitigating Pandemic Disease: Workshop Summary prognosis and administered in a fair manner may still result in treating disproportionately fewer patients from disadvantaged ethnic minority groups. Ethical Guidelines for Triage of Mechanical Ventilators During a Pandemic A scarcity of ventilators during a pandemic will require an allocation policy based on different ethical guidelines than those governing usual clinical care. The term triage is commonly applied to the process of sorting, classifying, and assigning priority to patients when available medical resources are not sufficient to provide care to all who need it. Although the term has been used to refer to a variety of clinical situations, we use it here rather than the term allocation because it carries the connotation of being used in disasters, such as deadly epidemics or battlefield situations, where the shortage is extreme and people die who might be saved if they had access to the level of medical care available in ordinary circumstances. The first ethical guideline for ventilator use during a pandemic is that increasing the number of lives saved may take priority over patient autonomy. Public health officials, working in concert with clinical experts and public representatives, should set guidelines for prioritizing patients who need mechanical ventilation. Individual physicians and patients must then make decisions that are consistent with these guidelines. The second guideline is that patients with a high likelihood of surviving after a few days of mechanical ventilation should receive the highest priority. Characterizing this group will be difficult, however, because data are incomplete and uncertain. The prognostic model that has been most thoroughly studied uses clinical data from the day of admission to the ICU (Knaus, 2002), but other studies suggest that patients who have a positive response to treatment in the first 24 to 48 hours have a better prognosis than patients who fail to show such a favorable early response (Graf and Janssens, 2005). There are no published studies that predict the duration of mechanical ventilation that will be needed. Furthermore, no studies have been carried out during a pandemic, so data will need to be extrapolated to this situation. In light of these gaps in the data, decisions will need to be based on consensus and expert judgments. Reaching such consensuses will require extensive discussions and will need to be done before a pandemic occurs. The third guideline is that during a public health emergency fairness and perceptions of fairness are crucial (Lo and Katz, 2005). Citizens will be more willing to subordinate their personal self-interest to the common good if they believe that the same rules apply to all. Conversely, people who believe that others are receiving special consideration are less likely to accept mandatory emergency measures. Even the perception that some persons are receiving favoritism may undermine willingness to sacrifice for the sake of the community. The fourth guideline is that transparency is essential during a public health

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Ethical and Legal Considerations in Mitigating Pandemic Disease: Workshop Summary emergency. The public needs to know how ventilators will be allocated in order to trust that the allocation is fair. Triage priorities and policies should be explicit. The public should have ready access to the triage guidelines, the data and the reasoning underlying them, and the process by which they were derived. Such information could be made available on the Internet, for example. From a practical point of view, the public needs a consistent message. Public health announcements through the media should prepare patients and families for individual discussions in the hospital regarding triage. Applying Triage Principles to Specific Cases Even if there is wide agreement on the triage principle of minimizing loss of life during a pandemic, hospitals and health-care workers will still face many difficult decisions when making triage decisions in specific cases. Before a pandemic occurs, it will be important to identify these dilemmas, analyze them, and reach some agreement on how to resolve them. During Triage, Should Patients Already on Ventilators Be Reassessed? We have framed the problem of allocating ventilators as “the last bed in the ICU.” In reality, the situation is more complex because patients already in the ICU on ventilators may have a worse prognosis than new patients with respiratory failure. Suppose, for example, that one of the ICU patients is a 38-year-old man with influenza who has developed multi-organ failure and whose condition has worsened during five days of intensive care. His prognosis now is worse than that of a new patient who presents with respiratory failure as her only medical problem, with no other organ failure. Or suppose that there is also a 68-year-old patient with chronic emphysema and respiratory failure who is gradually improving but who is likely to require several weeks of ventilator support as his lungs slowly improve. Keeping such current ICU patients on ventilators leaves fewer ventilators available to other patients in respiratory failure, who will die without them and who are likely to survive after receiving ventilation for only a few days. Therefore, allowing patients already in the ICU to remain on ventilators without regard to new patients with respiratory failure is likely to decrease the total number of lives saved. On the other hand, removing patients from ventilators who are not improving after several days would violate the usual ethical guideline that a physician should act in the best interests of patients and be faithful to them. Logically, there is no difference between stopping a ventilator and not starting it in the first place, as long as the justification is the same in both cases—in this case, following emergency public health regulations (Beauchamp and Childress, 2001; Lo, 2005). However, health-care workers and families may find it more difficult emotionally to withdraw a ventilator. These emotions need to be anticipated and addressed.

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Ethical and Legal Considerations in Mitigating Pandemic Disease: Workshop Summary Who Should Make Triage Decisions Regarding Ventilators? Separating the roles of triage and clinical care allows physicians who are treating patients to remain loyal to those patients during a pandemic. A senior ICU physician in the hospital can be appointed to make triage decisions, so that treating physicians are not forced to decide to withhold or withdraw mechanical ventilation from patients who still desire it. This creates a situation where the triage officer is making decisions based on the overall outcomes for the population, while the treating physician is free to serve the best interests of the individual patient within the constraints of the public health emergency. But the role of triage officers needs to be specified in some detail. Questions to be addressed include: What training will they receive? What decision support and consultation will be available to them as difficult decisions arise? What emotional support will be available to them? What Other Considerations Should Be Taken into Account During Triage? We have identified a high likelihood of survival and a short-term need for mechanical ventilation as two criteria for giving high priority to patients with respiratory failure during a pandemic. If there is still a shortage of ventilators after these criteria have been applied, a number of other criteria might be considered. Such criteria might include the likely duration of life and the likely quality of life in a patient after treatment or the existence of personal behaviors that may have led to the respiratory failure, such as smoking or non-adherence with asthma medications. Judgments about quality of life and personal behaviors are more subjective that a strict medical prognosis and inevitably involve value judgments over which reasonable people may disagree. Because incorporating these considerations into triage decisions would heighten concerns about unfairness, they are best avoided during a public health emergency. How Will Disagreements by Family Members Be Managed? Civilians have no experience with triage, unlike military personnel who are familiar with the approach. Faced with the death of a relative which might be averted with mechanical ventilation, families might strongly object to foregoing the use of the ventilator. In light of this, several issues likely to face frontline physicians should be addressed before a pandemic strikes. Would it be feasible, for example, to create timely appeals mechanisms for decisions regarding ventilator use? During public health emergencies, governments have the police powers to enforce public health measures; will there be police in hospitals to enforce triage decisions about ventilators? And how can the risk of violence be minimized?

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Ethical and Legal Considerations in Mitigating Pandemic Disease: Workshop Summary How Should Patients in Respiratory Failure Be Managed if Ventilation Is Not Provided? Patients with respiratory failure who do not receive mechanical ventilation during a pandemic are expected to die. They should receive respectful and compassionate palliative care. Dying from respiratory failure can be agonizing; patients commonly describe it as suffocating, drowning, or fighting for breath. Administering sedatives and analgesics is ethically and clinically appropriate in this situation (Lo and Rubenfeld, 2005). Even doses that will cause unconsciousness are appropriate if lower doses fail to relieve symptoms. Although such palliative sedation has strong ethical and legal justification, health-care workers are often confused about the distinction between palliative sedation, which is intended to relieve suffering, and active euthanasia, which is intended to kill the patient. Thus emergency-preparedness plans should include provisions for training physicians and nurses about palliative sedation and for providing emotional and spiritual support to patients, families, and health-care workers. Furthermore, shortages of resources besides ventilators might occur during a pandemic, so there may not be enough trained nurses to increase the dose of sedation and analgesia if lower doses have failed to relieve the suffering of dying patients, and disruptions to hospital supply chains may cause shortages of medications needed to relieve symptoms. In summary, a number of general principles for protecting public health during a public health emergency have been articulated and, in some cases, enacted into state laws. Still, hospitals and frontline physicians need more specific criteria to triage patients with respiratory failure if a shortage of respirators develops. Furthermore, guidelines and procedures are needed to address the practical problems that will arise when putting triage priorities into practice. During a pandemic, it will not be feasible to carry out extensive discussions, so preparedness planning should anticipate the strong likelihood of a shortage of ventilators and develop explicit triage criteria and procedures ahead of time. Such discussions will need to involve the public in order to foster acceptance of the idea that during a pandemic some patients will die who might have been saved if they had received a ventilator. Acknowledgments This work was supported in part by the Greenwall Foundation and by NIH grant Roadmap K12 HD049077. REFERENCES Baker R, Strosberg M. 1992. Triage and equality: An historical reassessment of utilitarian analyses of triage. Kennedy Institute of Ethics Journal 2(2):103-123. Bartlett JG. 2006. Planning for avian influenza. Annals of Internal Medicine 145(2):141-144.

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