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HARD CHOICES IN DIFFICULT SITUATIONS: ETHICAL ISSUES IN PUBLIC HEALTH EMERGENCIES

Bernard Lo, M.D.69

University of California, San Francisco


During the past decade, the destruction of the World Trade Center, bioterrorism using inhalational anthrax, severe acute respiratory syndrome (SARS), and natural disasters such as Hurricane Katrina have dramatized the importance of effective responses to public health emergencies. Currently, preparedness for the 2009-H1N1 influenza A pandemic is a public health priority.

Public health emergencies differ markedly from ordinary clinical care in several ways. First, essential services may be threatened. Basic necessities such as safety, shelter, food, sanitation, and electricity may not be available to large sections of society. After Hurricane Katrina, essential services such as police protection, transportation, and medical care broke down in New Orleans. These disruptions fell most heavily on poor, primarily African American persons who could not evacuate because they did not have automobiles. Second, during a public health emergency there may be critical shortages of medical resources that far exceed surge capacity. In the 2009-H1N1 influenza A pandemic, vaccines may be in short supply because of production constraints. If the pandemic becomes severe, the number of people with respiratory failure, who require mechanical ventilation to survive, is projected to far exceed the available number of ventilators, critical care beds, personnel, and surge capacity of hospitals. Persons with respiratory failure who are not able to receive mechanical ventilation during a severe pandemic will almost certainly die. Such identifiable deaths, which might have been prevented, will distress families, health care workers, and the general public. Because the allocation of scarce resources during a public health emergency may have life-and-death consequences, the ethical rationale for these policies will be closely scrutinized and will need to be carefully justified.

This paper first analyzes the ethical principles that should guide public health policies during a declared public health emergency. Second, it analyzes how physicians should respond when patients challenge allocation priorities and request interventions for which they have low priority. Third, it discusss the importance of conducting research during a public health emergency and suggest steps to facilitate such research. Finally, this paper analyzes why some members of the public may be suspicious of emergency public health guidelines and suggests how public health officials can address such concerns.

69

Professor of medicine and director of the program in medical ethics. Dr. Lo is also the national program director for the Greenwall Faculty Scholars Program in Bioethics.



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248 IMPACTS OF THE 2009-H1N1 INFLUENZA A PANDEMIC A8 HARD CHOICES IN DIFFICULT SITUATIONS: ETHICAL ISSUES IN PUBLIC HEALTH EMERGENCIES Bernard Lo, M.D.69 University of California, San Francisco During the past decade, the destruction of the World Trade Center, bio - terrorism using inhalational anthrax, severe acute respiratory syndrome (SARS), and natural disasters such as Hurricane Katrina have dramatized the importance of effective responses to public health emergencies. Currently, preparedness for the 2009-H1N1 influenza A pandemic is a public health priority. Public health emergencies differ markedly from ordinary clinical care in several ways. First, essential services may be threatened. Basic necessities such as safety, shelter, food, sanitation, and electricity may not be available to large sections of society. After Hurricane Katrina, essential services such as police protection, transportation, and medical care broke down in New Orleans. These disruptions fell most heavily on poor, primarily African American persons who could not evacuate because they did not have automobiles. Second, during a pub- lic health emergency there may be critical shortages of medical resources that far exceed surge capacity. In the 2009-H1N1 influenza A pandemic, vaccines may be in short supply because of production constraints. If the pandemic becomes severe, the number of people with respiratory failure, who require mechanical ventilation to survive, is projected to far exceed the available number of ventila- tors, critical care beds, personnel, and surge capacity of hospitals. Persons with respiratory failure who are not able to receive mechanical ventilation during a severe pandemic will almost certainly die. Such identifiable deaths, which might have been prevented, will distress families, health care workers, and the general public. Because the allocation of scarce resources during a public health emer- gency may have life-and-death consequences, the ethical rationale for these poli- cies will be closely scrutinized and will need to be carefully justified. This paper first analyzes the ethical principles that should guide public health policies during a declared public health emergency. Second, it analyzes how phy- sicians should respond when patients challenge allocation priorities and request interventions for which they have low priority. Third, it discusss the importance of conducting research during a public health emergency and suggest steps to facilitate such research. Finally, this paper analyzes why some members of the public may be suspicious of emergency public health guidelines and suggests how public health officials can address such concerns. 69 Professor of medicine and director of the program in medical ethics. Dr. Lo is also the national program director for the Greenwall Faculty Scholars Program in Bioethics.

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249 APPENDIX A Ethical Principles During a Public Health Emergency The goal of public health is to improve the health of a population or com- munity rather than the well-being of an individual patient (Childress et al., 2002; Gostin, 2008; Gostin et al., 2003). Public health is utilitarian, seeking to improve aggregate measures of community health. During the 2009-H1N1 influenza A pandemic, the mission of public health is to prevent mortality and morbidity caused by influenza and to maintain essential societal functions. Because of this focus on population outcomes, public health officials may adopt measures that are not in the best interests of individual citizens and may restrict liberties. This section specifies the goals of public health during this pandemic, then discusses how to balance public health powers with individual liberty and fairness. Next, it analyzes how ethical principles for a declared public health emergency should be specified and balanced. When ethical principles are overridden, they are not ignored or voided but must be observed to the extent that is possible under the circumstances, consistent with the public health goals. Finally, this section illus- trates how ethical principles have been invoked—either implicitly or explicitly— in federal guidelines to allocate vaccines, antiviral drugs, and ventilators during the 2009-H1N1 influenza A pandemic. The Goals of Public Health Emergency Policies When responding to an H1N1 pandemic, the public health system aims to pre- vent or reduce harms resulting from the pandemic. This goal is community-oriented and inherently utilitarian (IOM, 2009), seeking to minimize aggregate harms to society. “Utility” can be specified in many ways: for example, maximizing total lives saved, maximizing total number of life-years saved, minimizing new instances of infection, or minimizing societal harm by maintaining public functions. To be operationalized, public health goals need to be specified in more detail. This speci- fication will depend on the particular public health intervention being considered. One goal would be to prevent deaths from 2009-H1N1 influenza A; in other words, to save the most lives (IOM, 2009). This goal would be appropriate when allocating ventilators and other life-sustaining technologies during a severe pan- demic. More broadly, the public health goal might focus on morbidity as well as mortality. The goal might be to prevent cases of severe influenza in order to reduce the aggregate morbidity and burden of disease. This goal would be appro- priate if antivirals and vaccine were in short supply and needed to be allocated. An even broader goal would be to minimize the total number of cases of influenza, including mild as well as severe cases. This would be an appropriate goal if there were no shortfall of vaccine, but a priority system still needs to be established in order to deliver the vaccine to the population. During a severe pandemic, another goal might be to maintain essential func- tions of society. The image of basic services such as shelter and public safety

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250 IMPACTS OF THE 2009-H1N1 INFLUENZA A PANDEMIC breaking down in New Orleans after Hurricane Katrina has been seared into public memory. In a wave of a severe pandemic, a goal of public health efforts might be to ensure that police and fire departments continued to function, and that services such as housing sanitation, food, electricity, and communications were provided. Finally, because a pandemic is global, the geographical scope of public health goals needs to be considered. Federal and state governments in the United States are developing national and state responses to the pandemic. Plans are under way to purchase and distribute vaccine and antivirals. Critics in developing countries charge that the available supply of vaccine is being rapidly purchased by developed nations, leaving inadequate supply to other countries (Bertozzi et al., 2009). Furthermore, many nations cannot afford to purchase vaccines for all citizens at increased risk for severe 2009-H1N1 influenza A infection. The world is interconnected, and the United States and other developed countries are affected by the course of the pandemic in less-developed countries. A large num- ber of cases worldwide may increase the chances that the virus will mutate to a lethal variant. Moreover, the United States benefits from other countries sharing surveillance data and virus samples. However, resource-poor countries may be reluctant to engage in such scientific cooperation if they do not receive assistance with their public health efforts in return (Bertozzi et al., 2009). Balancing Public Health Powers with Liberty and Fairness Traditional public health laws, promulgated in the late nineteenth and early twentieth centuries, gave great deference to the “police powers” of the state to act in the common good (Colgrove and Bayer, 2005). During a declared public health emergency, public health officials have the authority take actions that would not be permissible in ordinary clinical care, including mandatory examination, isola- tion, and quarantine. These measures compel individual citizens to forego their basic rights. In the late twentieth century, greater concern for civil rights was the back- ground for attention to individual liberty during the AIDS epidemic. Mandatory public health measures were recognized as placing heavy burdens on individuals, restricting their liberty, causing economic losses, and sometimes leading to stig- matization (Fidler et al., 2007). Agreement developed that individual liberty may be restricted by public health officials only when several ethical requirements are met (Childress et al., 2002; Gostin, 2008; Gostin et al., 2002, 2003): • The threat to public health must be serious and likely. • The intervention should be effective in addressing the threat. • The intervention should be the least restrictive alternative that addresses the threat. • The burdens on those whose freedom is restricted must be acceptable.

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251 APPENDIX A • Procedural due process should be available to persons deprived of their freedom and autonomy. • Policies are implemented equitably. Even the perception that some groups are being treated unfairly may undermine public support for compulsory measures (Lo and Katz, 2005). These standards for mandatory public health interventions struck a balance between protecting the public health and respecting the rights of individuals. If the AIDS epidemic focused attention on individual rights, Hurricane Katrina riveted attention on how public health policies affect different groups within society. The public health response to Hurricane Katrina had an over- whelmingly disparate impact on social, economic, and racial groups. The poor, who were disproportionately African American, were unable to evacuate. Evacu- ation plans failed to anticipate that many people had no access to cars to leave the city. This discrepancy focused even more attention on the importance of fairness and protection of vulnerable groups during a public health emergency. In particular, these groups need to be engaged in the development of emergency plans, so that problems with implementation and access to services can be identi- fied and ameliorated. General and Specific Ethical Principles Three recent national consensus reports have proposed ethical principles to guide public health policy during public health emergencies generally or, more specifically, during the 2009-H1N1 influenza A pandemic (Table A8-1). Table A8-1 groups these principles under several broad headings: goals of public health policy during an emergency, balancing individual liberty with pub- lic health goals, fairness, the policy formation process, and the responsibility of public health officials and healthcare professionals. The three reports have similarities and differences that can be characterized as a family resemblance. There is no set of principles that is common to all the reports, yet each report shares numerous features with the others. The reports all have something to say about each of the broad headings, although they differ in how they specify and balance principles. Each report also contains some prin- ciples that are not contained in the other reports. Table A8-1 suggests that there is general agreement on many common ethi- cal considerations regarding public health emergencies. This consensus includes the need to balance individual liberty with public health goals, the importance of fairness, and appropriate procedures for developing and implementing policies. These ideas provide a good starting point for discussions of ethical issues in the influenza pandemic. Ethical principles are usually stated in a general manner, so that they apply to a broad range of situations. However, in order for principles to guide public

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252 IMPACTS OF THE 2009-H1N1 INFLUENZA A PANDEMIC TABLE A8-1 Ethical Considerations During a Declared Public Health Emergency Report CDC, Ethical Guidance CDC, Ethical IOM, Guidance for for Public Health Guideline for Establishing Standards Ethical Emergency Preparedness Pandemic Influenza of Care in Disaster and Response (2009)a (2007)b Situations (2009)c consideration Goals of public Protect public safety, Minimize serious Duty to steward resources health policy health, and well-being influenza-associated complications Preserve the Utilitarian goal of saving functioning of the greatest possible society number of lives Balance Equal liberty and human Balance individual Proportionality—public individual rights. Respect the equal liberty and and individual liberty with liberty, autonomy, and community interests requirements must be public health dignity of all persons commensurate with the goals scale of the emergency and degree of scarce resources Distributive justiced Fairness Maintaining the trust of patients and the community Process Public accountability and Commitment to Standards recognized as of policy transparency transparency fair by all those affected formation by them Public engagement Transparency and involvement Consistency Accountability Procedural justicee Community and provider engagement, education, and communication Responsibility Recognize the special Responsibility Standards evidence based of public health obligations of some public to maximize and responsive to specific and healthcare health professionals, and preparedness needs of individuals and professionals promote competency of the population and coordination among these professionals Base guidelines on Duty of compassion and the best available care scientific evidence

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253 APPENDIX A TABLE A8-1 Continued Report CDC, Ethical Guidance CDC, Ethical IOM, Guidance for for Public Health Guideline for Establishing Standards Ethical Emergency Preparedness Pandemic Influenza of Care in Disaster and Response (2009)a (2007)b Situations (2009)c consideration Work with and learn Clinicians must not from preparedness abandon patients efforts globally Other Community strength and resiliency Responsible civic response aJennings and Arras (in review). bKinlaw and Levine (2007). cIOM (2009). dBenefits and burdens imposed on the population by the emergency response measures and mitiga- tions are shared equitably and fairly. eConsistency in applying standards across people and time (treating like cases alike). Decision makers who are impartial and neutral. Those affected by the decisions have a voice in decision making and agree in advance to the proposed process. Treat those affected with dignity and respect. Decisions are adequately reasoned and based on accurate information. Communications and processes that are clear, transparent, and without hidden agendas. Processes to revise or correct approaches to address new information. policy and individual actions, they need to be given more specificity. As we see in the following discussion, the manner in which principles are specified will lead to different policy emphases or recommendations. For instance, fairness or justice is an ethical principle that seems intuitively clear and appealing. No one advocates unfairness in public health emergency policies. However, fairness or justice has many dimensions, and the reports in Table A8-1 specify the idea of justice in various ways. Distributive justice requires us to distribute the benefits and burdens of the response to a public health emergency fairly or equitably across different groups in society. Public health emergency measures should not disproportionately dis- advantage subgroups that already are vulnerable or disadvantaged and should reduce or eliminate existing public health disparities. Vulnerable or disadvantaged subgroups may also need special attention or protection. Policies that are neutral on their face may have a disparate impact on racial, economic, or social groups when they are applied in real-world settings. For example, communities with little public health or healthcare infrastructure may lack access to influenza vaccines or antivirals unless steps are taken to improve access.

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254 IMPACTS OF THE 2009-H1N1 INFLUENZA A PANDEMIC Impartiality requires that policies be applied without favoritism, bias, or discrimination. Consistency requires us to treat in a similar manner people who are similar in all ethically pertinent characteristics. For each public health intervention and situation, it will need to be determined what characteristics are considered ethi- cally relevant. Procedural justice concerns the process by which public health policies in an emergency are developed and implemented. Decisions in public health emergencies are often contested because the evidence base is incomplete and uncertain and because people evaluate risks and burdens differently and have different values and priorities. Fair procedures help to establish the policies as legitimate. The term procedural justice is not always defined clearly or consistently. It refers to a cluster of ideas that typically include • Transparency. Literally, transparency refers to letting light through; not being opaque. Figuratively it means that decisions are made in the open: policies are available for all to see, together with the evidence and reasons supporting them and a description of the process by which they were developed. • Engagement of stakeholders, including the public. Determining the views of stakeholders before policies are finalized ensures that their views and concerns are taken into account. It will also improve the policies because stakeholders may point out problems that were not apparent previously. • Accountability. The root meaning is to count, enumerate, or calculate. An account is a reckoning or record of money received and spent. Thus, being accountable means that a person can be called upon to answer for conduct and responsibilities. Public health officials are accountable to the governor who appoints them and to the legislature, who may conduct hearings. Their decisions also can be appealed in the courts. These checks and balances increase accountability. Furthermore, good public health practice includes internal review and quality improvement procedures to try to improve policies and implementation. Reciprocity is a more controversial interpretation of justice. Some people have jobs that benefit society but place them at increased risk of 2009-H1N1 influenza A infection. Examples include doctors, nurses, emergency first responders, and janitorial staff in hospitals. There is wide agreement that society needs to protect such workers by providing appropriate protective gear and giving them priority for vaccination. The extent of such reciprocity, however, may be contested. Some argue that doctors and nurses deserve priority for mechanical ventilators if they develop respiratory failure. However, others argue that it would be unfair to give a ventilator to a healthcare worker who has an extremely poor prognosis even

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255 APPENDIX A with a ventilator as it will deprive another patient with a much better prognosis. Furthermore, it may seem self-serving for doctors writing guidelines to give themselves priority over others. These different dimensions of fairness have implications regarding specific policies and actions. An emphasis on procedural justice will lead to calls for public engagement and consultations with healthcare workers and health care institutions. An emphasis on distributive justice will lead attention to vulnerable populations and how they will be impacted by emergency policies. Actions result- ing from these different aspects of fairness often are interrelated. For example, one step toward reducing the disparate impact of policies is to engage vulnerable communities to better understand how they might be disproportionately affected by facially neutral policies. Differences and Continuity Between Clinical Practice and Public Health Emergencies The three reports in Table A8-1 differ in emphasizing the differences or similarities in the ethical principles that guide clinical care and responses to declared public health emergencies. During a public health emergency, public health officials and physicians have the authority to carry out actions that would not be permitted under ordinary circumstances, including mandatory examina- tion, isolation, quarantine, and allocation of scarce healthcare resources. The justification for these actions is of utmost importance in gaining the acceptance and trust of the public. The ethical basis for ordinary care is the best interests and autonomy of the individual patient. The competent, informed patient decides whether to accept or decline an intervention that the treating physician considers medically indi- cated. Best interests are determined according to the values and preferences of the individual patient, who may choose an option different than what the physician recommends. Ordinary care is centered on the individual patient, and patient autonomy is accorded great respect. The physician who disagrees with the patient’s decision should act in the patient’s best interest by educating and trying to persuade the patient (Lo, 2009a). However, the patient’s informed deci- sion is generally followed, unless the intervention is regarded as not medically indicated. Considerations of justice, including the allocation of healthcare dollars or the overall cost of care, ordinarily do not play a predominant role in decisions concerning ordinary care. In terms of ethical principles, patient autonomy and acting in the best interests of the individual patient are paramount, and justice is a subsidiary consideration. In articulating ethical considerations during a public health emergency, the Centers for Disease Control and Prevention (CDC) guidance for allocation of vac- cine, antiviral drugs, and nonpharmaceutical interventions emphasizes how these principles differ from the ethical principles governing clinical care:

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256 IMPACTS OF THE 2009-H1N1 INFLUENZA A PANDEMIC During the course of a pandemic, the functioning of society may be threatened. Our moral tradition embodies an understanding that it may be ethically accept- able (or perhaps even ethically mandatory) to suspend some (but not all) ordi- nary moral rules in such circumstances. (Kinlaw and Levine, 2007) The CDC report goes on to specify criteria that would justify such “suspensions of ordinary moral rules”: • Adopting the least restrictive practices that will allow the common good to be protected. • Ensuring that restrictions are necessary and proportional to the need for protection. • Attempting to ensure that those impacted by restrictions receive support from the community (Kinlaw and Levine, 2007). The Institute of Medicine (IOM) report (IOM, 2009), in contrast, emphasized the continuity between ethical norms in usual healthcare practice and during a disaster. “Ethical norms in medical care do not change during disasters—health care professionals are always obligated to provide the best care they can under given circumstances” (IOM, 2009). The IOM committee recognized that during a disaster there will be “a substantial change in usual health care operations and the level of care it is possible to deliver” (IOM, 2009). The committee acknowl- edged that “core ethical precepts in medicine permit some actions during crisis situations that would not be acceptable under ordinary circumstances, such as implementing resource allocation protocols that could preclude the use of certain resources on some patients when others would derive greater benefit from them” (IOM, 2009). However, the primary duty of a healthcare professional “to the patient in need of medical care” still holds during disasters. The IOM committee declared: Recognizing that scarce resources may restrict treatment choices, clinicians must not abandon, and patients should not fear abandonment, when an ethical framework informs healthcare disaster policy. It is important to try to reconcile these apparent disagreements over whether ethical principles differ during a public health emergency. Otherwise confusion and mistrust may result. Furthermore, analyzing these disagreements may lead to sounder policies for public health emergencies. Broad statements such as “suspending ordinary moral rules” and “ethi- cal norms in medical care do not change during disasters” may be misleading because of their high level of generality. It might be better to specify which particular moral rules do not change and which are suspended, under what cir- cumstances, and with what limits.

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257 APPENDIX A There are several ethical principles that physicians should follow. These dif- ferent principles may conflict, and the tension between them cannot be resolved according to some hierarchical ordering of principles. Rather, they must be specified and balanced in the context of a particular situation. Principles like “fairness” are usually formulated in very general terms and often do not provide guides to action in specific situations. To provide an action guide, principles need to be specified—it needs to be spelled out how, by whom, and under what circumstances an action is to be carried out (Beauchamp and Childress, 2008). When countervailing ethical principles apply to a decision or situation, they need to be balanced. That is, reasons need to be provided for why one principle should be given more weight than another in the circumstances under consideration (Beauchamp and Childress, 2008). The balance among principles may be struck differently in usual care and public health emergencies. The concept of “suspending” moral rules may also be misleading. It suggests that they are temporarily cancelled. A more helpful perspective may be that ethi- cal principles may be overridden in certain circumstances. Ethical principles are not absolute but prima facie binding; that is, they may be overridden, but only for good reasons. Those reasons will depend on the particular situation at hand; the acceptable reasons and their weight may differ in ordinary clinical care and during public health emergencies. When a prima facie principle is outweighed by a countervailing principle in a particular situation, it is overridden, not simply discarded or overruled (Beauchamp and Childress, 2008). When overridden, a principle is still followed to the greatest extent possible consistent with follow- ing the dispositive principle. Ethical principles that are overridden leave “moral traces”: physicians find it emotionally difficult not to follow them and regret that they cannot follow them in the situation at hand. Moreover, when overriding a moral principle, people have an obligation to mitigate the harm caused by violat- ing the principle (Beauchamp and Childress, 2008). Let us illustrate these ideas through the example of allocating ventilators dur- ing a severe influenza pandemic. Treating physicians will be constrained by pub- lic health emergency regulations to follow public health allocation policies. The ethical rationale is that during a public health emergency the aggregate benefit to society assumes paramount importance, and minimizing the number of avoidable deaths takes priority over the core ethical principles that underlie usual clinical care: respect for patient autonomy and the best interests of individual patients. However, beneficence in the sense of acting in the best interests of the individual patient is overridden, not neglected or discarded. This has several specific implications. Beneficence to the individual patient is still required in the sense of fidelity to patients and nonabandonment. For example, after Hurricane Katrina, some physicians and nurses did not report for duty, leaving hospitals severely understaffed, and hospitals allegedly did not make plans to evacuate patients. Physicians not only should not abandon patients, but they also retain positive duties to relieve patient symptoms and emotional distress to the greatest

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258 IMPACTS OF THE 2009-H1N1 INFLUENZA A PANDEMIC extent possible under the circumstances. Moreover, IOM (2009) drew a clear limit to overriding the best interests of the individual patient, declaring it would be unacceptable to administer drugs to intentionally cause or hasten a patient’s death. Furthermore, when basic ethical principles are overridden during a declared public health emergency, procedural safeguards and constraints should be observed in order to ensure that there are good reasons for overriding them and that the new balancing of principles is carried out in a fair manner. According to the IOM, these procedural safeguards should include acceptance by those affected by the crisis standards of care, transparency, consistency, proportionality, accountability, community and provider engagement, education, and communica- tion. The CDC reports refer to procedural justice. Although these reports differ in how they specify these procedural safeguards, they agree that safeguards are essential to gain public acceptance and trust. Finally, the idea that principles are overridden suggests specific ways to organize health care during a public health emergency. To maintain the treating physician’s fidelity to his or her patients, the decision as to whether a patient in respiratory failure would receive mechanical ventilation should be made by a designated triage officer, not by the treating physician. This separation of roles should help the treating physician better maintain his or her fiduciary role. Allocation of Scarce Resources During a severe pandemic, there may be shortages of key medical resources, and rules for allocation may be needed. In the case of 2009-H1N1 influenza A vaccine, shortages may be temporary, for example, when production of the 2009- H1N1 influenza A vaccine is scaling up and systems for delivering vaccination are set up. For ventilators, shortages cannot be avoided because during a severe pandemic the need is projected to far outstrip the supply; the cost of supplying enough ventilators and critical care beds for a worst-case scenario would be pro- hibitive, diverting resources from more basic public health emergency needs. For allocating scarce resources during a public health emergency, ethical principles will need to be specified—that is, explained in much greater detail with regard to particular public health interventions and circumstances. Another way to view what is needed is to develop second-order ethical principles, which are more specific than the first-order principles, such as fairness, which we have previously discussed. Shortages of ventilators in usual clinical care can be overcome by expand- ing surge capacity. Allocation of resources in this situation is commonly done according to several second-order principles or rules: first come, first served; and informed refusal by patients or their surrogates. In usual clinical care, no patient is denied access to mechanical ventilation who has a medical indication for it and consents to it. Furthermore, if there is a temporary shortage of ventilators or

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259 APPENDIX A critical care beds that cannot be addressed through surge capacity, the first-come, first-served principle is followed. Patients are not removed from the ventilator against their wishes to make way for a patient with a much better prognosis. During a dire shortage of a medical resource in a public health emergency, however, these second-order principles governing usual clinical care would not achieve the public health goals of minimizing avoidable deaths and maintaining essential societal functions. For example, an intensive care unit (ICU) patient with a very low probability of survival can often be kept alive for weeks on a ventilator, precluding the use of a ventilator for several patients with less severe, uncomplicated respiratory failure, who are highly likely to survive after only a few days of mechanical ventilation. What second-order ethical principles or rules should guide allocation decisions during a public health emergency? Several candidate rules allocating scarce resources during the 2009-H1N1 influenza A pandemic are discussed below, as well as an illustration of how they have influ- enced government guidelines. Giving priority to those with the greatest medical need This is an intuitively plausible rule, often characterized as the “rule of rescue.” In ordinary clinical care, this principle is used to triage patients in the emergency department. With regard to 2009-H1N1 influenza A, this principle has been cited in several federal recommendations. For vaccine allocation, pregnant women receive highest prior- ity because they comprise a disproportionately large percentage of cases of severe 2009-H1N1 influenza A infection. Infants are also given high priority because they are at increased risk but cannot receive vaccination. In another example, for postexposure prophylaxis with antivirals, high priority is given to persons with compromised immunity or who are living in a residential setting (such as skilled nursing facilities), who are at increased risk for infection. While this rule is plausible, in some circumstances it may undermine the goal of maximizing the total number of lives saved. In the case of mechanical ventila- tion during a severe pandemic, it would not make sense to allocate ventilators to patients who are so sick that they will have a very poor prognosis even if they receive the ventilator. More lives would be saved by the following rule. Giving priority to those who are most likely to benefit from the scarce medi- cal resource This rule would indeed maximize the number of lives saved. With regard to allocation of ventilators in a severe pandemic, this rule would give higher priority to those patients with respiratory failure who have the highest probability of survival if they receive mechanical ventilation. The utilitarian principle of maximizing the number of lives saved could be further refined. Rather than maximizing the number of lives saved, the aggregate utility might be characterized in other ways, for example maximizing the number of life-years saved. While theoretically attractive, however, it might be impractical to try to assess expected life-years when making allocation decisions in the emergency

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260 IMPACTS OF THE 2009-H1N1 INFLUENZA A PANDEMIC department. Still another refinement of the utilitarian public health goal might be to maximize the number of quality-adjusted life-years saved. However, in addi- tion to the practical difficulties in assessing quality of life in emergency settings, assessments of quality of life can be criticized as discriminatory. Giving priority to persons whose roles are vital for society as a whole This prioritization rule will help achieve the goal of preserving essential societal functions. For example, the Department of Health and Human Services (HHS) vaccine allocation policy gives priority to those needed in pandemic response and care (such as physicians, and first responders) and to those who provide essential services and security (such as police). It is important that these essential roles be specific for the type of intervention and emergency under consideration. Furthermore, this emergency- and intervention-specific prioritization should not be confused with general estimates of social worth, which have no place in public health emergency rules. Giving priority to healthcare workers makes sense for vaccinations, as they will subsequently be able to continue to provide medical care to patients who are sick with 2009-H1N1 influenza A. However, such priority makes less sense for mechanical ventilation, because healthcare workers who are so sick as to require mechanical ventilation are unlikely to recover their health in time to provide services to other patients during that wave of the pandemic. Give priority to the fair distribution of benefits A general criticism of utili- tarianism is that it ignores the distribution of benefits across society, which some consider to be important as well as the total amount of benefit to society. Sev- eral criteria have been proposed for distributing the benefits of scarce medical resources fairly. Equal access to interventions Whatever prioritization rule is selected, it may exacerbate health disparities because certain groups may lack access to the public health intervention. For instance, HHS guidelines for 2009-H1N1 influenza A vaccination give priority to pregnant women. However, pregnant women who are poor, have low health literacy, and lack private health insurance and a primary care physician may have steep barriers to accessing vaccination services. The concern about worsening disparities is particularly acute because such women disproportionately will be women of color. Thus, in implementing prioritization rules, it will be essential that barriers to access be identified and ameliorated. Life-cycle principle Some argue that everyone should have equal opportu- nity to live through all the stages of life (Emanuel and Wertheimer, 2006). Under this principle, children would have priority over elderly persons. This principle is consistent with the common belief that the death of a child or young adult is more tragic than the death of an elderly person who has already had the opportunity to have a family and career and grow old (Lo, 2009a).

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261 APPENDIX A Reciprocity Another allocation principle that invokes the distribution of benefits is giving priority to persons whose work is essential in the pandemic response but puts them at increased risk for 2009-H1N1 influenza A. This prior- ity might be viewed as reciprocity for assuming a duty to provide medical care and other services to infected persons. However, this principle may be regarded as self-serving, because physicians are drawing up priorities that put them at the head of the list. Fair opportunities A more radical critique of utilitarianism rejects the goal of maximizing aggregate benefit to society. If there are relatively small differences in expected survival between two prioritization groups, some argue that it is not fair to those in the lower priority group to have no chance to survive. Philosophers have proposed a weighted lottery system, in which people in the lower priority group receive some small but nonzero chance of receiving the intervention (Dan- iels and Sabin, 2002). During a public health emergency, there would be many difficult challenges to a weighted lottery to allocate ventilators. Information on prognosis and outcomes is incomplete and uncertain, and it would be difficult to set weights for the lottery in an understandable manner. Allegations of bias would likely be made if a wealthy or famous person in a lower priority group received a ventilator. Finally, even if a trustworthy weighted lottery could be set up, it would be difficult to implement during a public health emergency. Patient Challenges to Allocation Priorities During public health emergencies, physicians in clinical practice will encounter patients who request or demand a scarce intervention even though they fall outside public health priorities for receiving it. Physicians’ responses during a public health emergency will differ from their responses in usual clini- cal practice to patient requests for interventions that are not medically indicated. In usual practice, physicians generally attempt to persuade the patient that they are unnecessary. However, physicians often accede to such requests, as long as the intervention does not present undue medical risk to the patient (Lo, 2009a), is not futile in a strict sense, and does not deprive another identified patient who would benefit from the intervention. In contrast, during a public health emer- gency, it may not be appropriate or feasible to provide interventions that are in very short supply to persons who do not fit public health priorities (Lo, 2009a; Lo and Katz, 2005). During an outbreak of severe pandemic influenza, a healthy 43-year-old lawyer asks his primary care physician for vaccination. “We’ve just bought a new house, started a new business, and had our second baby. I can’t afford to get sick, and my family and employees can’t afford to lose me” (Lo, 2009a). Current public health guidelines for 2009-H1N1 influenza A vaccination give low priority to healthy people of this age. Because of vaccine shortages at the time, they are unlikely to be vaccinated.

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262 IMPACTS OF THE 2009-H1N1 INFLUENZA A PANDEMIC Impact on Others Unlike usual clinical care, during public health emergencies decisions for one patient regarding scarce interventions will likely have an impact on other patients. Public acceptance of priorities for allocating scarce resources during a public health emergency will be enhanced if the policies are perceived as fair. If many patients receive interventions even though they are not in high-priority groups, the press and Internet blogs are likely to report the story. In turn, people may believe that the guidelines are unfair or being unfairly implemented or that the magnitude of the threat is greater than officials acknowledge (Lo, 2009a). If some patients receive the vaccine even though they do not belong to a high- priority category, other patients in the low-priority categories will be less likely to accept the allocation plan. Act in the Best Interests of the Patient Physicians should maintain their usual role of acting in the best interests of the individual patient, insofar as it is possible while respecting emergency public health guidelines (Lo, 2009a). Elicit and address patient concerns and emotions Fear and a sense of loss of control are natural human reactions to public health emergencies, and they need to be acknowledged. Also physicians should acknowledge the uncertainty inherent in an emergency. Patients may be more willing to pay attention to public health after their own needs are acknowledged. Trying to reassure people by tell- ing them not to worry is unlikely to be effective during a declared public health emergency (Lo, 2009a). Use the doctor-patient relationship to benefit patients The physician can explain other measures the patient can take to reduce the risk of infection, such as social distancing, frequent hand-washing, and telecommuting. The physician should explain that in the case of 2009-H1N1 influenza A vaccine, it is likely that individuals in lower priority groups will receive the vaccine, only at a later date. Patients often could be reassured if they are informed that they could see the physician promptly if they develop symptoms (Maunder et al., 2003). Also patients may be reassured by knowing what warning signs to watch for. Advocate for appropriate exceptions to restrictions A particular case may be a justified exception to emergency public health policies or may show that a policy needs to be modified (Lo, 2009a). For example, a case could be made that, because of the number of reported cases of severe 2009-H1N1 influenza A influenza among young, healthy adults, they should receive higher priority for vaccination. Any exception should be fair in the sense that it would also apply to

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263 APPENDIX A all other patients in a similar clinical situation, not just the particular patient at hand. If such a widespread exception would not be feasible from a public health perspective, it is difficult to justify making an exception for an individual patient (Lo, 2009a). It would be preferable for treating physicians to contact public health officials to ask that the rules be changed, rather than making an ad hoc exception that would not be consistently applied by other caregivers. Research During a Public Health Emergency Because the current 2009-H1N1 influenza A pandemic is novel, research will be needed to provide up-to-date information about the pandemic on which to base public health policy. Public health officials have a legal responsibility to carry out surveillance and epidemiological studies during a public health emergency. This will require officials to collect information from patients, physicians, hospitals, and clinical laboratories and to investigate cases and outbreaks as needed. For such activi- ties, which are routine public health practice, generally institutional review board (IRB) approval and individual patient consent are not required. Beyond this, research will also be needed to determine what clinical strat- egies and treatment are optimal during this pandemic. For instance, several important questions about respiratory failure during a severe 2009-H1N1 influ- enza A pandemic need to be studied. One question is how best to assess the prognosis of patients with respiratory failure. The Sequential Organ Failure Assessment (SOFA) scoring system for patients in critical care units has not been prospectively validated in the setting of a 2009-H1N1 influenza A outbreak. As previously discussed, expected prognosis will be a key consideration in priori- tizing patients who require mechanical ventilation if there is a dire shortage of ventilators. A second question concerns treatment for patients with 2009-H1N1 influenza A infection and refractory respiratory failure. Some critical care units have used extracorporeal membrane oxygenation (ECMO) for patients whose respiratory failure does not respond to mechanical ventilation and other critical care. Case series suggest that ECMO may be of benefit in this situation (Bertozzi et al., 2009). However, the efficacy and safety of ECMO when added to standard critical care in this setting can only be rigorously determined in a randomized controlled clinical trial (RCT). Randomization is the best way to ensure that the group receiving ECMO and the group receiving standard critical care are similar at baseline and to reduce the possibility that any observed difference in outcome between the two groups was due to some factor other than ECMO. Because ECMO is a scarce, labor-intensive resource, it is important to rigorously evalu- ate its effectiveness and safety, so that clinical standards regarding its use will be based on sound evidence and to ensure that scarce resources are prudently allocated. Additional novel clinical questions undoubtedly will arise during a severe pandemic.

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264 IMPACTS OF THE 2009-H1N1 INFLUENZA A PANDEMIC Carrying out research during a public health emergency presents formidable challenges that are best addressed in advance. Public health personnel will be stretched thin carrying out their duties during a wave of a severe pandemic and may have little time to plan and organize research studies and obtain IRB approval for them if needed. Delays in IRB approval may make it impossible to carry out studies in a timely manner, particularly multicenter studies, for which many IRBs need to give approval. We offer several suggestions to facilitate research that will provide crucial information for setting public health policies and for clinical standards during a public health emergency: 1. The National Institutes of Health (NIH) and CDC should fund the prelimi- nary design of such crucial clinical research as part of preparedness for a severe pandemic. If the design and planning for such studies begins only if and when the pandemic becomes severe, valuable time will be lost. Some investment now in research planning will allow more timely research if a severe pandemic occurs and ultimately more efficient use of scarce public health resources. 2. Researchers should design studies that have strong confidentiality and data security provisions. Many investigators will be contributing to a central database and accessing the data. NIH or CDC should also establish a system of secure access to identifiable data on a strict need-to-know basis when deidentified data will not suffice. This system should have strong confidentiality and security protections for identifiable data, such as password protection, encryption, and a prohibition on downloading identifiable data to laptops or portable storage devices. 3. Local IRBs should give priority to the review of studies that will provide crucial data to guide public health policies and clinical standards during a public health emergency. For example, studies designated as such by an NIH or CDC panel should be placed at the head of the queue for IRB scheduling. 4. NIH or CDC should set up a central IRB review process to review multi - site 2009-H1N1 influenza A studies and encourage local IRBs at each site to defer to this centralized review instead of carrying out their own in-depth review. This centralized process should conduct coordinated scientific and ethics review. To facilitate review by individual sites and to gain public trust, the deliberations of this central IRB should be public. The transcript and minutes of this review should be publicly available on the Internet, so that local IRBs, investigators, and members of the public can readily access them. To facilitate acceptance of this central review by site IRBs, the central IRB should include IRB chairs from institutions that are expected to participate in these studies. The Centralized IRB estab- lished by the National Cancer Institute for multisite cancer clinical trials provides a model for such centralized review (Lo, 2009b).

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265 APPENDIX A Different studies pose different ethics and human subject concerns. A multi- center study to validate SOFA as a prognostic tool in a 2009-H1N1 influenza A pandemic will be relatively straightforward in terms of human subjects protec- tion, since it will use data that are already being collected for clinical and admin- istrative purposes. It will not involve invasive interventions carried out solely for research purposes. The challenges will be to plan the study, protect confidential- ity, and provide data security. It would be prudent to retain identifiers in order to allow long-term follow-up on participants. For example, long-term mortality could be readily determined through the National Death Registry, which requires identifying information on each participant. A multicenter RCT of ECMO would present complex scientific, design, and ethical challenges. A number of ethical issues would need to be addressed: • Is there scientific and clinical rationale for such a trial? If many institu - tions begin to offer ECMO, it may be desirable to study its effectiveness and safety in this setting to help set emergency standards of care even if the evidence supporting its use is weak. • Will ECMO be offered to patients at trial sites outside the clinical trial? • Investigators need to plan procedures for surrogate consent, because almost all eligible participants will be unable to consent themselves. • Investigators need to address conflicts of commitment between carrying out an RCT of ECMO and providing clinical care. During a severe pan- demic, it may be difficult to mobilize resources to carry out the trial, since key personnel will likely be needed for clinical duties. Thus, it would be preferable to carry out such a trial when the pandemic is of mild severity and there is no dire shortage of ICU personnel. Because these challenges would be difficult to address during a severe pan- demic, it might be desirable to discuss them now. Concerns About Emergency Public Health Policies During a declared public health emergency, public acceptance of and trust in emergency measures will be crucial. As part of public engagement and outreach, it would be prudent for public health officials to anticipate concerns that might be raised and to address them explicitly. Furthermore, officials should recognize that some concerns might not be voiced during formal public engagement activities, just as patients may not voice their underlying concerns to the treating physician during patient care. Because public health emergency powers are so broad, they may provoke distrust of government and scientists. Many Americans distrust government and seek to limit its power. They may view the federal government as infringing on their God-given and constitutionally protected liberty. Plans for mandatory mea- sures such as isolation, quarantine, and allocation of health care resources may be

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266 IMPACTS OF THE 2009-H1N1 INFLUENZA A PANDEMIC viewed as violating their freedom. Some critics may believe that the government cannot play a constructive role in protecting life; in their perspective, this should be left to individual initiative. Such critics may view government allocation of health resources as an unwarranted intrusion on the doctor-patient relationship, which they have voluntarily chosen, as well as a violation of their privacy. Further- more, some critics may view the government as incompetent and inefficient and therefore unable to provide effective services during an emergency. The inept response to Hurricane Katrina serves to strengthen this view. Finally, some critics may view the government as corrupt, favoring special interests rather than the common person. Thus, they may suspect emergency powers will serve to benefit only the well-connected and the well-to-do. These objections to emergency pre- paredness plans may be based not on the merits of particular provisions in the plans but instead on a political and social philosophy that is deeply critical of governmental power. Another sweeping objection to public health emergency powers may rest on distrust of scientists and scientific expertise. Again, there may be several strains to this objection. One criticism is that scientists are not objective. Scientists may be viewed as serving the interests of drug and vaccine manufacturers with whom they have lucrative consulting arrangements. In this view, guidelines that give priority to healthcare workers for scarce resources may be viewed as self- serving. A more fundamental objection concerns the scientific method. Some critics believe that scientists disregard or play down the risks of interventions that are obvious to a layperson. The scientific method is not viewed as objective and leading to a societal good, but rather as a means of asserting power over the ordinary person and promoting conclusions that defy common sense and the wisdom of the people. Again, these populist objections are manifest with regard to other public health measures. Some people continue to oppose childhood vaccination as causing serious adverse effects such as autism, despite a number of consensus, peer-reviewed panels that have concluded that there is no associa- tion. Furthermore, the debacle of swine flu vaccination in 1976 may be viewed as an example of ineptitude and arrogance by both government and scientists. The Internet allows such objections to public health measures to be rapidly and widely disseminated. What can be done to respond to these objections? First, these objections need to be acknowledged and addressed directly. In patient care it is helpful for the treating physician to listen to the patient’s con- cerns, acknowledge them, show that he or she understands them, and empathize with the underlying feeling that animates the concerns, even if he or she does not agree with them. Such acknowledgment of concerns legitimizes the underlying feelings and may be a helpful first step in finding common ground. Second, the highest-level public health officials should articulate to the public a vision of what kind of nation we aspire to be in a dire public health emer- gency. There should be an appeal to values we hold in common as human beings

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267 APPENDIX A and as Americans—such as helping others in great need, making sacrifices, and generosity. These values, which are widely shared among different faith tradi - tions and cultures, provide the grounding for more formal ethical principles like fairness and maximizing the number of lives saved. Furthermore, leaders need to articulate a vision of the proper role of government during a public health emer- gency. Acknowledging that people differ in how much power they believe gov- ernment should have during ordinary times, leaders need to make the case that, during extraordinary times such as public health emergencies, special powers are needed. Leaders should also reassure the public that emergency powers will be cancelled as soon as the emergency passes. In conclusion, ethical issues will be prominent in setting public health poli- cies during the influenza pandemic. Public health officials will need to articulate the ethical reasoning that supports their policies and to develop a process for setting policy that is regarded as fair and participatory. Officials will need to explain why during a declared public health emergency restrictions on liberty and allocation of scarce health resources is ethically appropriate. Acknowledgments This work was supported by The Greenwall Foundation. References Beauchamp, T. L., and J. F. Childress. 2008. Principles of biomedical Ethics. New York: Oxford University Press. Bertozzi, S., A. Kelso, M. Tashiro, V. Savy, J. Farrar, M. Osterholm, S. Jameel, and C. P. Muller. 2009. Pandemic flu: from the front lines. Interviewed by D. Butler. Nature 461(7260):20-21. Childress, J. F., R. R. Faden, R. D. Gaare, L. O. Gostin, J. Kahn, R. J. Bonnie, N. E. Kass, A. C. Mastroianni, J. D. Moreno, and P. Nieburg. 2002. Public health ethics: mapping the terrain. Journal of Law and Medical Ethics 30(2):170-178. Colgrove, J., and R. Bayer. 2005. Manifold restraints: liberty, public health, and the legacy of Jacobson v Massachusetts. American Journal of Public Health 95(4):571-576. Daniels, N., and J. Sabin. 2002. Setting limits fairly—can we learn to shared medical resources? New York: Oxford University Press. Emanuel, E. J., and A. Wertheimer. 2006. Who should get influenza vaccine when not all can? Science 312(5775):854-855. Fidler, D. P., L. O. Gostin, and H. Markel. 2007. Through the quarantine looking glass: drug-resistant tuberculosis and public health governance, law, and ethics. Journal of Law Medicine and Ethics 35(4):616-628, 512. Gostin, L. O. 2008. Public health law: power, duty, restraint, 2nd edition. Berkeley: University of California Press. Gostin, L. O., J. W. Sapsin, S. P. Teret, S. Burris, J. S. Mair, J. G. Hodge, Jr., and J. S. Vernick. 2002. The Model State Emergency Health Powers Act: planning for and response to bio terrorism and naturally occurring infectious diseases. Journal of the American Medical Association 288(5):622-628.

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268 IMPACTS OF THE 2009-H1N1 INFLUENZA A PANDEMIC Gostin, L. O., R. Bayer, and A. L. Fairchild. 2003. Ethical and legal challenges posed by severe acute respiratory syndrome: implications for the control of severe infectious disease threats. Journal of the American Medical Association 290(24):3229-3237. IOM (Institute of Medicine). 2009. Guidance for establishing crisis standards of care for use in disaster situations. Washington, DC: The National Academies Press. Jennings, B., and J. Arras. In review. Ethical guidance for public health emergency preparedness and response. Morbidity and Mortality Weekly Report. Kinlaw, K., and R. J. Levine. 2007. Ethical guidelines in pandemic influenza 2007. Recommendations of the Ethics Subcommittee of the Advisory Committee to the Director, Centers for Disease Control and Prevention, http://www.cdc.gov/od/science/phethics/panFlu_Ethic_Guidelines.pdf (accessed October 14, 2009). Lo, B. 2009a. Best interests. In Resolving ethical dilemmas: a guide for clinicians. Philadelphia: Lippincott Williams & Wilkins. ———. 2009b. IRB review of human participants research. In Ethical issues in clinical research: a practical guide. Philadelphia: Lippincott Williams & Wilkins. Lo, B., and M. H. Katz. 2005. Clinical decision making during public health emergencies: ethical considerations. Annals of Internal Medicine 143(7):493-498. Maunder, R., J. Hunter, L. Vincent, J. Bennett, N. Peladeau, M. Leszcz, J. Sadavoy, L. M. Verhaeghe, R. Steinberg, and T. Mazzulli. 2003. The immediate psychological and occupational impact of the 2003 SARS outbreak in a teaching hospital. Canadian Medical Association Journal 168(10):1245-1251.