Ethical Issues in Pandemic Planning and Response
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
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
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-
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.
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
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
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
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
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
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
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
needs of people in other countries than they were for the very people for whose welfare they were responsible. (Complicating all of this is yet another consideration: that sending the scarce treatments to low-resource countries at the epicenter of a pandemic could well be a very prudent move, in the sense that sending the treatments might contain or substantially slow down the pandemic, which in turn could end up saving more lives in the donor country—and perhaps overall—than holding back would have done.)
Recognizing Relevant Ethical Principles
Discussions on these four topics by WHO and its consultants2 have produced agreement on several basic principles that should underlie planning for and responses to a pandemic. The first is the principle of utility, that is, acting so as to produce the greatest good. One standard criticism of this criterion is that it can lead to a preference for a program that brings very great good to a small number of people, even if that good is not fairly distributed, over a program that brings a much smaller good to a much larger group of people who are well distributed across a society.
A second principle is efficiency, which calls for minimizing the resources needed to produce a particular result or maximizing the result that can be produced from a particular set of resources. The third principle is the principle of fairness, which is usually formulated in a formal manner as treating like cases alike. In this case, I would think that the principle of fairness should deal specifically with the risk of unfair discrimination, that is, discrimination based on irrelevant or illegitimate characteristics of a person or a group.
Finally, there is the principle of liberty, which holds that one should impose the least burden on personal self-determination that is necessary to achieve a legitimate goal—or, in other words, one should not trade all freedom for security.
Additionally, there is a set of principles concerned with the procedures by which decisions are made. The first of these principles is often referred to these days as transparency. It states that information about the processes and bases of decisions should be made available to the affected population. But it isn’t enough that things be transparent. There is also a principle of participation—that is, that the stakeholders should be involved, through appropriate institutions and means, in the processes of formulating the objectives and adopting the policies. (The
efforts of the Pan American Health Organization toward that sort of participatory policy formulation were described in Chapter 2.)
Then there is the principle of review and revisability. Stakeholders should have a way to appeal policies after they have been adopted, and processes should be in place that allow policies and plans to be reviewed and revised in light of experience.
Finally, the principle of effectiveness states that there must be ways to translate the other principles into practice. Otherwise, the principles will have no relevance, and the whole exercise of judging the ethics of pandemic preparation and response becomes irrelevant.
Now, if these eight principles strike you as straightforward and commonsensical, I concur. Indeed, whenever the public is involved in a process, it is important to have some sort of guidelines like these that are readily accessible, that coincide with people’s general sense about the way their lives should be lived, that guarantee people an opportunity to participate, and that affirm to people that they will be treated fairly and with respect. In sum, these eight principles in some sense summarize people’s general expectations of how government should respond to problems, including problems facing public health authorities. And it is significant that the relevant principles do not apply just to professionals in the private sector but also encompass public health actions involving governments.
Ethical Issues in Access to Health-Care Services
Returning to the four areas of ethical concern, we will now examine some of the specific issues that arise in each of the four areas and see how the above ethical principles apply.
Let us begin with the issue of access to health-care services. The central problem here is how to fairly distribute health-care resources that are not going to be adequate to provide for everyone in need—even in rich countries—if an influenza pandemic occurs anytime soon. Whether it is the United States not yet having anywhere near an adequate stock of Tamiflu, the inability of many countries—even countries of the North—to rapidly supply adequate amounts of vaccine, or the absence in poor countries of even the basic rudiments of “health for all,” every country will face a pronounced scarcity of what may be essential, life-saving resources. And it is important to keep in mind that, as has been mentioned already, the scarcity will encompass not just the antiviral drugs and vaccines needed to battle the pandemic but also supplies for day-to-day health care, including emergency and routine surgery, intensive care, and primary care.
In countries where the health-care system is hanging on by its fingertips, if at all, the notion of spending a lot of time on planning for pandemic influenza itself raises ethical problems. Such preparations are probably important, but choosing to undertake them means that a country is immediately facing a trade-off, as specialists will be drawn away from activities that are necessary for care and
planning that is immediately relevant today to plan for a contingency that may not occur for quite some time, if ever.
At the heart of all of these considerations is the question: What counts as a fair distribution? The answer to this question in turn rests on what one thinks about two questions regarding justice.
The first question is: What sort of justice is being sought? If we are looking for compensatory justice, that means we believe it is important to make up for any special burdens that a person has suffered. The burdens in question could arise as part of a pandemic response in a number of different ways—for example, when a poor subsistence farmer is forced to get rid of his small number of chickens because somewhere within a few kilometers a case of avian influenza has been detected.
Another approach is generally referred to as distributive justice. Among people in a society there are those who are generally worse off than others, and some believe that any time a government undertakes efforts to improve society— as, for example, through public health activities—it should try to make people in the disadvantaged group relatively better off. This is an idea that is often associated with the philosopher John Rawls, who thought it important to attend first to the needs of those who are worst off in society. That statement, of course, raises yet another question: Worse off in what respect? Worse off in terms of health, in terms of income, or just what should we be looking at?
Then there is procedural justice. Philosophers such as Norman Daniels have written a good deal about the characteristics of fair process, which is an aspect of justice that is particularly relevant in situations where it is difficult to achieve wide social agreement on the substantive implications. In such circumstances, if the process used to reach a decision is perceived as being fair in the way that it treats the interests and views of people, then the results should be seen as more justified than if the process was not seen as a fair one. And, as a practical matter, the results of such a decision may also be more widely acceptable even if the decision itself is not popular with many people.
The second basic question regarding justice is: What is the basis of comparison? Again, I have already spoken to the issue: Are we looking overall for the maximization of well-being? Is it important to us that the effects on well-being are comparable among different members of society? Are we concerned only with lives saved? Are we concerned with achieving justice in terms of economic and social costs? To see how these various principles might play out in the face of pandemic influenza, in the next section we analyze in more detail what happens to society in the course of such a pandemic.
The health-care access issue with the highest visibility in terms of the attention that it has gotten in the press is, I believe, access to Tamiflu©. In particular,
the issue of prioritization raises a number of difficult questions: Should the Tamiflu© go first to health-care workers, and, if so, does that mean just to the professionals or also to others working in the hospitals, perhaps even including the cleaning staff? Should it go to other first-responders preferentially and others who provide public services? And which services? Should preference be given to those whose service involves maintaining safety in society, such as police officers and soldiers? How about those who provide educational services? How about those who deliver everything from medical supplies to groceries? If truck drivers are going to be too sick to drive across the George Washington Bridge or go through the Holland Tunnel, how quickly will the stores of Manhattan run out of food?
Should priority be given to those most likely to be stricken and to die? Those most likely to survive if treated? Those most likely to spread the disease if not treated? Should all lives be valued equally, or should there be a preference for saving those most productive for society, which would generally imply young to middle-aged workers? Or should there be a preference for the youngest based on an argument sometimes referred to as “fair innings,” namely that older persons—say 65 years and older—have already had their fair share of opportunities and that persons of 15 or 25 deserve a chance to have theirs.
To illustrate how these factors might actually play out, let me share with you an exercise developed for the Massachusetts Health Department by some of my colleagues at the Harvard schools of medicine and public health, principally Professor Dan Brock. Assume that for the past several months there has been sustained human-to-human transmission of a novel strain of avian influenza A with genetic components of human influenza in several countries around the world. Your community was first affected three weeks ago, and, since then, there have been over 500 cases and 50 deaths.
Tamiflu is the only drug that may effectively reduce mortality of ill patients and limit infection of exposed persons. However, supplies are limited, and hospitals across the country are independently making decisions about how to govern the allocation of such antivirals within their own institution. In your community, the four major medical centers have recently established four different protocols regarding prioritization of access to care:
Hospital A, recognizing the importance of protecting its work force in order to minimize absenteeism and ensure continuous response capacity, has decided to use its remaining cache of Tamiflu® for prophylaxis of staff who are exposed while caring for influenza patients.
Hospital B, in an effort to save its very ill patients, has decided to reserve its remaining Tamiflu® for treatment of the sickest influenza patients. This approach is consistent with the usual practice of providers at hospital B, who are accustomed to focusing primarily on treatment. Hospital B is relying on airborne-infection isolation and personal protective equipment—namely, N95
respirators, gloves, and gowns—to protect its staff, and is not using Tamiflu® for prophylaxis.
Hospital C, in order to maximize survival rates, has decided to reserve its remaining Tamiflu® for treatment of those patients most likely to benefit, namely, those who come to the hospital within 48 hours of disease onset. As this prioritization plan will result in faster depletion of the antivirals, hospital C is relying on airborne infection isolation and personal protective equipment to protect its staff and is not using Tamiflu® for prophylaxis.
Hospital D, assuming that its cache of Tamiflu® will soon be depleted regardless of its distribution strategy, is using the antiviral for prophylaxis of exposed staff and treatment of all probable and confirmed cases, regardless of severity. This is the most comprehensive approach, and hospital D will reach the limits of its available Tamiflu® stock most quickly.
Professor Brock has provided a set of five questions with which to analyze the different strategies:
Is each hospital's plan independently something that would be fair and reasonable? Viewed in the context of the community, what are some potential challenges that may arise as the result of different institutions using these different strategies?
Are these strategies publicly announced? If so, it will not only give each hospital a reputation as to what its ethical orientation is, but it will obviously lead everyone in the community, from hospital workers (if they are able to work at more than one place) to the very sick and to recently exposed patients, to choose one hospital or another based on how their own perceived needs fit with the announced policy.
Which of the options should be employed when prioritizing the allocation of limited resources?
What factors should govern this decision? Should this decision be made by leaders within the individual hospitals, by local government, by public health officials, by the state department of public health, or perhaps by the national government? Should there be one uniform policy for all?
What are some prospective actions the community could take to avoid reaching this point? Who should be involved in this process? Who should make the decisions? Should the state department of public health mandate that hospitals unify their actions?
Another allocation issue involves the distribution of risks rather than benefits. This issue arises, for instance, regarding the subjects in the clinical trials of new vaccines or drugs. Suppose there is a push to accelerate the technical and ethical review process, not simply to get the regular process done more quickly but maybe to omit certain time-consuming items because they do not seem to impor-
tant enough to worry about in the face of an impending pandemic. The issue also arises when considering which clinical interventions to use to fight a pandemic. Is it acceptable to approve interventions under interpretations of standards that differ from the usual interpretations, when doing so increases the risk of lack of efficacy or, worse, of actual harm for people taking the approved product? Consider, for example, the case of an adjuvant that is not usually approved in the United States for use in vaccines. Would it be acceptable to use that adjuvant in a vaccine if that would increase number of doses, assuming that doing so would not involve at most a modest increase in risk of harm or reduced efficacy?
A third issue of risk-allocation is whether health-care workers are obliged to accept vaccination. There are at least two arguments for why the answer should be yes. One of them parallels the argument used to justify members of combat divisions being made to undergo mandatory vaccination against possible agents of biowarfare so as to keep them fit for battle, even when the vaccines are newly developed or perhaps experimental. A second argument goes beyond that and focuses on the need to protect the patients with whom health-care workers come into contact. And this, of course, takes us back to the reciprocal issue, namely, the providing of benefits to frontline workers because they run a disproportionate share of risks.
Arriving at Ethical Policies for a Pandemic on Access to Health Care
What conclusions might one reach about how treatments should be allocated during a pandemic? First, it is very clear from the above four-hospital example that the fairness of the process will be crucial in producing allocation decisions that are defensible. After all, none of the alternatives adopted by the hypothetical hospitals A, B, C, or D is prima facie unreasonable, and no one choice is clearly the correct one, so the legitimacy of the process is going to be very important. This means that information, participation, transparency and revisability will be key to the decision-making process: How are the priorities being set, and who has a say in that process? The standards need to be publicly articulated, debated, and justified in light of objectives that are either agreed upon or are themselves at least openly debated.
My suspicion is that the greatest cause of skepticism about the fairness of the process will be policy-setting processes that are opaque and exclusionary. This would be true in the United States, but it will be particularly the case in countries with a history of discrimination against certain ethnic or religious groups and in countries where there are tribal differences and where there are suspicions that the government acts on behalf of one group at the expense of another. Ironically, the decision-makers who try to impose their own agenda by excluding others from the process will be the least likely to achieve the goals that they want because policies in this arena are going to be very dependent on community acceptance for their success.
Ethical and Legal Issues in Public Health Interventions
The second area of ethical concern involves public health interventions, such as the quarantine of exposed persons, isolation of infected persons, social distancing among the general population, border control, personal hygiene, and so forth. One of the ethical questions that has to be asked is whether we actually know how to measure the benefits that will come from any of these interventions. This is a particularly important issue if one is seeking to balance limitations on personal freedom against the value of achieving a legitimate public goal that cannot be achieved in any less intrusive or less burdensome way. If we cannot measure the expected benefits—that is, if we do not have a data-based model showing that performing a particular action will save this many lives or prevent this many illnesses or save this much money that can be used for other purposes, or whatever the benefit might be—then imposing on people’s right of self-determination would not fit within the ethical framework that I articulated earlier.
It is clear that the specific decision-making process is going to be very important here, perhaps even more so than in the allocation area. As interventions and burdens are imposed on the public, it will become very important that the process by which people’s freedom is limited has been publicly laid out, so that people can participate in that process if they choose. Just as different groups may make different allocation choices, different communities and different people may have different levels of risk aversion and may put varying weights on the value of preserving liberty. There is an intersection here with the allocation issue discussed above because one of the limitations on liberty could be the imposition of public control over drugs and vaccines to meet whatever plan has been decided upon to maximize public benefit, rather than leaving choices about drugs and vaccines to individuals. In selecting a public health intervention, one should always seek the least restrictive alternative, as chosen by people with authority to act on solid evidence.
Obligations of and to Health-Care Workers
As I have already suggested, the unique skills of health-care workers create certain prima facie obligations on them to provide needed care based on one (or both) of two arguments: first, that persons who enjoy a privileged position are obligated to respond when the society that bestowed those privileges is in great need; and, second, that health-care skills are established and judged by self-governing professionals, and this status has long been understood to carry with it certain ethical obligations toward patients and the community, as recognized in the Hippocratic Oath and other professional codes.
The question remains, however: What are the limits of this obligation? The level of risk that individuals are willing to accept is a matter of personal choice, but choices that depart from recognized obligations may be subject to sanctions.
A number of factors are important here, including how the disease is actually spread—and, in particular, whether health-care workers are at heightened risk— and the obligations that health-care workers have to their families and significant others. The issues are always what obligations these people have and how they compare with the obligations of non-professionals who may also be placed at increased risk.
Linked to this are society’s obligations to health-care workers if it turns out that the disease is not being passed simply by community exposure, where everybody is at equal risk, but instead its spread is closer to that of SARS or Ebola, where the activities that health-care workers, including public health officials, undertake place them at higher risk than other members of the community. If providing care increases risk for health-care workers, there is a legitimate reason to provide them with preferential access to prophylaxis and treatment on the grounds that are narrower than simply rewarding general social utility—that is, using scarce medical resources on health-care workers would be directly associated with the continued ability of the health-care system to provide these interventions to everybody else. This is not true of many other people who provide social benefit to society, but it may well be true of some people who are not usually described as health-care workers (e.g., people who deliver health-care supplies).
There are two ways of looking at this. The first is that if there is added risk, the choice to take it on should be, at first, a voluntary choice. Choosing the risk is therefore a superogatory—and hence particularly praiseworthy—act. The alternative approach—in my mind, less preferable, though it may be necessary—would be for health-care workers to be obligated to act because their conduct is mandated by the profession or by the state.
Planners need to work with local and national professional associations in advance—right now—to obtain agreement within these groups about what professional ethics implies about the actions that will be expected from a particular professional in the case of a pandemic. These statements should be developed and agreed upon through a process that is transparent, and there should be opportunities for professionals to hear from the general community about its expectations. In particular, if any sanctions will be applied, that must be clear in advance.
Ethical Aspects of International and Intergovernmental Obligations
National and international issues are clearly interrelated, not the least because the principal international response is going to come from national governments. The impact of a pandemic will be global, so international action will be needed. International disease surveillance is being organized under the new International Health Regulations (IHR), which WHO member states are already implementing voluntarily in advance of the June 2007 deadline when the IHR will formally come into effect. Furthermore, expert advice from WHO on various standards—
including ethical standards—is providing a framework for an internationally coordinated response.
A central purpose of the United Nations, including its specialized agencies such as WHO, is to achieve international cooperation in solving international problems of a humanitarian character. The Universal Declaration of Human Rights guarantees respect for economic, social, and cultural rights, which include matters of health that are indispensable for human dignity, and it proclaims that these rights should be realized through national effort and international cooperation. The International Covenant on Economic, Social and Cultural Rights (to which not all countries are signatories, though I need not mention which ones) commits each state to taking steps—individually and through international assistance and cooperation, especially economic and technical, to the maximum of its available resources—that are aimed at achieving the full realization of the rights set forth in the covenant, which include the promotion of health and the prevention, treatment, and control of epidemics (Article XII). Similar commitments were reaffirmed more recently in the Millennium Declaration.
Despite these international agreements, difficulties arise regarding all of these commitments. The agreements offer laudable goals rather than the precise steps that need to be taken. They are vague on how they are to be implemented. They are focused on long-term development and on the progressive realization of rights, not on concrete, rapid response to emergencies. They provide no criteria for judging how a state should assess the extent of its obligations or to whom such obligations attach. Obviously, governments are more likely to act if others are acting, so there are always questions of coordination and initiative: Who gets the ball rolling and how is it moved toward the goal?
Of particular concern when implementing human rights obligations is keeping the focus on those persons who are especially vulnerable. This vulnerability is partly determined by biology, but it may also be determined by political circumstances. That is, if you are a citizen of a country that does not have the ability to mount a well-organized response to a pandemic, you are at greater risk than a person in a country in which the virus is equally prevalent but which is better prepared to respond.
Those countries that are considering providing medical supplies, personnel, and other support will naturally be more inclined to do so if the recipient country has in place a plan that makes it likely the donations will be used both efficiently and fairly: Don’t ask us for aid if you’re just going to take care of the elite, the well-connected, or the armed forces. Yet the obligations that countries have to people in other countries—under human rights conventions and, for that matter, simply on moral grounds—are not primarily obligations to other governments. They are obligations to the people at risk. Although such obligations are typically met by supporting the governments that represent these vulnerable populations, if those governments are unable to act or unwilling to take the needed steps, the humanitarian obligation should, if possible, be met by other means.
Perhaps this situation may provide an additional impetus for countries with the greatest need for assistance in responding to a pandemic to take the necessary steps in planning for a pandemic now. For all societies, the ability to respond appropriately will depend upon being aware of the problem and the threat that it poses, possessing the knowledge, expertise, and technology to control the problem, and having the financial, logistical and administrative capacity to act effectively. (When I speak of the ability of the society, I mean all its components, including voluntary, community, and professional bodies, not merely central or regional governments, though they may take the lead in stimulating and directing the planning activities.)
In turn, the obligation of potential donor states—those that have the ability to respond to the threat of a pandemic with needed medical supplies, personnel, funds, and the like—depends on several factors: first, the extent to which their own capacity exceeds a reasonable projection of their own population’s needs; second, the existence of an organized international response; and third, the existence in potential recipient countries of plans to use the aid in an effective and equitable manner. Because aid activities are often undertaken in service of donor countries’ political or prudential aims, these activities have often been carried out without regard for whether they support a well-planned and ethically defensible response in the recipient country. But when scarce public health resources are being taken from domestic use for the benefit of people elsewhere, it is imperative that these resources be allocated to those places that will use them efficiently and ethically. A country that has that capacity is in a much better position to argue for scarce aid than a country that does not, not only on the grounds that it has done its planning ethically and has organized itself in a fair way, but also on the grounds that the resources spent there will be more likely to have a beneficial effect.
A Few Concluding Remarks
Having discussed some ethical theories and the different models of pandemic preparedness they might lead to, let me underline some straightforward, practical suggestions that I think most ethicists would agree with. First, the key to an ethically responsible and appropriate response is advanced planning, including communication. Part of the communication is openly acknowledging the unavoidable reality of scarcity of life-preserving resources and thus the resulting need both for collective action and for personal responsibility.
As a practical matter, the likelihood of being able to carry out any pandemic response plan will be greatly enhanced if the general population is aware of and, to the greatest extent possible, involved in the planning process in advance of a crisis. This is particularly true when, as will certainly be the case in a pandemic, success depends not only on acceptance by the public but on their cooperating with requirements that will demand their forbearance or self-denial. If I may draw an analogy, I would suggest that planners need to engage the public in something
that, about 50 years ago, Irving Janis termed “the work of worrying.” Physicians who are reluctant to have frank conversations with their patients about the problems that may arise in a course of treatment or surgery often express concern that doing so will only makes a patient very anxious, perhaps for nothing since the problems may not actually arise, or worse, that it will induce symptoms precisely because patients are worried about them. Janis’s findings about the value of psychological rehearsal of possible problems countered this concern. He found that the work of worrying made people stronger and more capable of dealing with the problems that did occur, while the imagined problems that did not occur produce no long-lasting effects. Likewise, I would argue that public health leaders should be prepared to lead people through the work of worrying about the effects of a pandemic on their lives. It is very difficult to get people to focus on future difficulties that remain merely possibilities, so when the occasion arises to engage people in some needed worrying about what difficulties they will face should a pandemic strike—realistic planning efforts that involve simulations of disasters, for example, or some other event that can seize the public’s attention—I believe the occasion should be exploited.
An ethical conclusion related to the international picture is that it is important to recognize the full meaning of “solidarity.” We often think of solidarity as most relevant when poor countries make pleas to rich countries for emergency assistance. Yet it is also relevant in the situation when a mutated influenza virus, capable of sustained human-to-human transmission, first appears. The countries first affected are likely to be relatively poor countries, and their governments are expected under international agreements, especially the IHR, to act responsibly by carrying out surveillance, reporting outbreaks to the international community, and supply samples of the infectious agent to the appropriate agency. The correlate of this is that the governments with greater resources ought to make clear in advance—as they have begun to, through pledging funds to the international preparations—how these essential activities will be rewarded through efforts to help the first-affected countries deal with their own health problems and contain the spread of the virus as long as possible (including fair access to vaccines), as well as through financial aid to mitigate harm caused by disruption of trade, loss of tourism, and the like. If widespread culling of poultry—which could perhaps destroy a major sector of the economy—is needed to keep avian influenza from moving into the human population, what reciprocal duties fall on those countries that stand to benefit from this measure? Likewise, what if air travel or shipping must be suspended? The countries that benefit from such efforts have an obligation to help compensate the frontline countries.
As this set of issues illustrates, our entire topic can be seen through an ethical lens as the need to resolve the classic struggle between individual and group. Here we have, for example, the interests of country A versus the interests of the community of nations. We have the interests of one person in obtaining scarce resources to protect or treat himself or herself (or family)—resources for which
the person may be willing and able to pay—versus the interests of others in having those resources distributed according to established priorities. We have the interest of a subject in a clinical trial to have that trial conducted cautiously versus the interests of people who are waiting to receive needed drugs or vaccines and wish to have them tested and approved as quickly as possible. We have the interests of physicians and other health-care workers in being able to protect themselves from influenza competing with the needs of the group to have functional health-care services respond as fully as possible to a pandemic. And we have the interests of an individual to move freely and to decide about his or her own treatment versus the interests of the community in isolating or treating or vaccinating people who could spread a deadly disease.
All of these ethical dilemmas are dilemmas precisely because they involve choices between one good and another good. Unlike many human-rights situations, they do not involve choosing between doing the right thing, on the one hand, and clearly violating people’s rights, on the other. They are difficult because both choices are good ones, and they seem particularly difficult because of our emphasis—in Western societies generally and in health care particularly—on respect for individual choices. The collective interests embodied in traditional public health measures are less often acknowledged despite their clear and strong history.
So it becomes very important for ethical as well as practical reasons that the decision-making processes involve open public debate. Even if this leads to different outcomes in different communities—and it will certainly lead to different outcomes in different countries—it can provide a basis for ethically justifiable decisions, and the decisions will be ethically justifiable not because they are incontrovertible but because a process involving public communication and participation promotes understanding and acceptance and, therefore, a greater ability to cope with public health measures that are inevitably going to be imperfect. Regrettably, the countries least inclined to engage in such processes and least capable of doing so may be precisely those where the need is the greatest. And so for ethical as well as prudential reasons, part of the U.S. response to the threat of pandemic influenza should be to find means of helping people in other countries, as well as those here at home, to engage in the work of worrying that is an essential part of our individual and collective pandemic preparations.
SOCIAL JUSTICE AND PANDEMIC PLANNING AND RESPONSE
Ruth Faden, Ph.D., M.P.H.3
Johns Hopkins Berman Institute of Bioethics
It is reasonable to expect that the health, economic, and social burdens of a pandemic influenza will fall disproportionately on the poorest countries of the world and on the poor and otherwise systematically disadvantaged within the world’s rich countries. Arguably, 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 in health, well-being, and resources that will constitute the backdrop for, and the harsh realities of, any global outbreak of devastating disease.
As Madison Powers and I argue in our recent book, Social Justice, at least three moral tasks are required to address this challenge (Powers and Faden, 2006). The first task is to identify which of the likely inequalities in burden are the most morally egregious. Not all the ways in which some will suffer less and others will suffer more are ethically problematic to the same degree, so it is important to identify which of these inequalities are the most unjust.
The second task is to determine, among the more egregious inequalities, which are the most easily prevented or at least mitigated. Although, tragically, there may be neither the political will nor the economic capability to address some of the likely egregious injustices, by focusing on those that are the most plausible candidates for public policy interventions or technological fixes, it may be possible to at least blunt or narrow some of the worst injustices that might occur.
The third task is to implement whatever changes in policy and practice are necessary to reduce those inequalities that are amenable to prevention or mitigation.
In this paper I set the stage for the first of these three tasks by raising some relevant concerns for the United States as well as from a global standpoint. I close by briefly describing a recent effort to address the third of these tasks by the Bellagio Group. The Bellagio Group is advocating that international institutions and national governments adopt a series of principles and action steps to protect the interests of systematically disadvantaged groups in pandemic planning and response.
Social Justice in the Global Context
Recent work is beginning to provide a formal evidence base supporting the assumption that the burden of disease from a pandemic influenza will fall disproportionately on the developing world (Murray et al., 2006; Cummings, in press). Even without the formal evidence base, however, the case for this claim, as well as for the broader assumption that economic and social burdens will be far greater in the developing world, would seem obvious. There is simply no reason to think that the global impact of a pandemic influenza will be distributed any differently than the burdens of other infectious diseases, such as HIV/AIDS, which have uniformly taken a much greater toll on the poor nations of the world.
What should be emphasized most perhaps is the magnitude of the disparity that can be anticipated. Historical data suggest that in 1918 the mortality rate from influenza in the United States and the United Kingdom was in the order of 4 per 1,000 (Collins et al., 1930; Registrar General of the United Kingdom, 1920). By contrast, the mortality rate is estimated to have been between 32 and 55 per 1,000 in India (Mills, 1986) and between 19 and 51 per 1,000 in South Africa (Phillips, 1990). There is little reason to think that this dramatic gap in disease burden will be any smaller in the next pandemic. Disparities in life expectancy and access to primary medical care between the wealthy and poor nations of the world have, if anything, increased in the years since 1918. Although vaccines, antivirals, ventilators, and other advances in medical technology may be able to reduce the burdens of a twenty-first-century pandemic in the world’s wealthier nations, it is likely that many people living in the world’s poorest regions will have little or no access to these interventions, and thus that the gap in burden of disease may be even greater in a new pandemic than it was in 1918.
Elsewhere I have argued that it is difficult to conceive of a more egregious injustice than the extraordinary gap in life expectancy and well-being that continues to persist between the world’s desperately poor and the rest of us (Powers and Faden, 2006). In some respects, the additional hit that the world’s poorest will likely receive from a new pandemic is simply more of the same. How directing global resources to narrow the gap in impact of a potential influenza pandemic compares with other strategies to improve the well-being of the world’s poorest people is an open—and important—question. In particular, whether pandemic influenza’s claim for our moral attention is greater or lesser than the claims of other factors that contribute to the horrible conditions and reduced life prospects of the world’s poor depends largely on causal claims about the relative impacts of the different factors and on technical claims about the prospects of successfully intervening in a pandemic.
There are, however, at least two sets of arguments that suggest there may be something morally special about a pandemic influenza. The first set of arguments has to do with some particular features that are not unique to pandemics but that may have particular moral resonance. An influenza pandemic is a discrete threat
that is foreseen, rather than an existing state of affairs with a complicated and contested history. Every country and every individual in the world is vulnerable to this threat. Indeed, the term pandemic is used only because it is expected that the disease will be a global phenomenon. This universal threat has rightly prompted a significant response from almost all of the major global institutions, with a high (if not high enough) degree of international cooperation. In the face of this remarkable amount of anticipatory planning and international cooperative action, a failure by the global order to take steps to mitigate the completely foreseeable, disproportionate impact on the world’s poor would be a singular moral failing. The global order would be responding to a discrete, highly consequential threat to well-being, to which all peoples of the world were vulnerable, by knowingly taking actions that disproportionately protected those of us who already were relatively advantaged.
A second set of reasons has to do with the fact that the burdens of efforts to prevent or contain a human pandemic, mainly through control of avian disease and surveillance of human disease, are currently falling primarily on the poor countries of the world, while the benefits of these efforts are likely to be experienced mostly by the world’s wealthier nations. This imbalance introduces another moral dimension that argues even more strongly that social justice demands a global response to narrow the gap in the burden of disease and in well-being more broadly.
There is increasing evidence that interventions to contain avian disease, particularly through the culling of poultry, are placing a significant and disproportionate burden not just on developing countries but particularly on the poor and low-income people within those countries. While industrial-scale poultry producers are also sustaining losses, they are well positioned to adjust their production practices to changing market conditions. By contrast, small-scale poultry farmers who are just beginning to move up the development ladder have in some cases lost their livelihoods and been plunged back into poverty when their birds have been culled. In some parts of the world, household chickens represent the only source of independent income for poor women and children. When chickens in these villages are culled, the most dependent and vulnerable members of the community become even more dependent and vulnerable. Families and individuals who have been implicated in avian disease outbreaks or in suspected human outbreaks have suffered extreme social stigma and isolation, and there have been reports of suicides and disappearances. Although some of the negative consequences of avian disease control and human surveillance actions could be prevented by better practices, poorer countries—and the poorest within these countries—will continue to suffer the most from containment efforts. Yet if these efforts fail, they again will suffer the most, this time from the pandemic itself.
Social Justice Within the United States
Social justice will not only be the biggest moral challenge of a pandemic across nations, but it will also be the biggest moral challenge within countries. All nations, from the most resource-poor to the wealthiest, are making policies and taking actions that have profound implications for social justice within their boundaries. Whether the rights and interests of the poor, of ethnic and political minorities, of women, and of other disadvantaged groups are adequately taken into account and respected in pandemic planning and response is a central, but ofttimes neglected, question.
Within the Unites States as well as globally, it is reasonable to expect that the health, economic, and social burdens of pandemic influenza will fall disproportionately on the most disadvantaged people. Limited historical data suggest that in 1918 those at the bottom of the American economic ladder suffered the most. For example, in one study of ten locations in the United States, the mortality rate for people classified as “well to do” was 3.8 per 1,000, compared to 10 per 1,000 among those classified as “very poor” (Sydenstricker, 1931). The association between poverty, lowered life expectancy, and increased burden of disease continues to persist in the United States, and there is little reason to think that a new pandemic would defy this pattern. Indeed, insofar as medical countermeasures such as antivirals, vaccines, and ventilators end up mitigating the toll of a twenty-first-century pandemic, it is possible that those at the bottom will have an even greater relative disadvantage than they did in 1918, when these measures were not available. Moreover, it is likely that the poor in our country as well as people who are otherwise substantially disadvantaged will have more difficulty not only in accessing medical countermeasures but also in implementing—and thus in benefiting from—traditional public health measures. In addition, it is likely that the burdens of complying with these measures will be greater for those in our society who already have the least (Blendon et al., 2006).
Consider, for example, the prospect of school closings. While this would be a hardship for many families, for those children for whom school is the safest and most nurturing environment they experience, conditions will be particularly bleak. There will be, at best, no books, no access to the Internet, and no home-based learning. At worst, there will be overcrowding, increased exposure to violence, little adult supervision, and reduced access to healthy foods, if not outright malnutrition.
Consider also the implications of community confinement, isolation, or sheltering in place. People who live paycheck to paycheck could lose what little economic stability they have by the resultant loss of income. Some would have no wherewithal to stockpile food. People who are in and out of housing would have no place in which to shelter.
It is predicted that in the next pandemic influenza there will be an acute shortage of hospital beds. How will those who are profoundly disadvantaged
even before a pandemic strikes provide adequate care at home to sick loved ones? Families are not equally positioned to be able to take care of a seriously ill person. Even accessing medical advice in one’s home through the Internet or by phone will be more difficult, if not impossible, for some families.
The difficulties that the poor and other disadvantaged groups face in putting public health recommendations into action and the increased burdens that some of these recommendations will impose on them have deeply troubling implications for social justice. Arguably, the moral authority of the government to make such recommendations carries with it the reciprocal moral responsibility to identify where social injustices with respect to these recommendations are likely to occur and to take reasonable steps to reduce, if not prevent, at least the most egregious injustices among them. A pandemic will produce suffering, and suffering is itself sufficient cause for moral concern. But from a moral point of view, of even deeper concern is the suffering associated with an injustice that could have been anticipated and ameliorated.
Similar concerns about social justice apply to medical countermeasures as well. Imagine, for instance, that local governments have vaccine to distribute. In order to effect an efficient distribution of the vaccine, the population is asked to remain calm in their homes and await notice about when to appear at a particular location for vaccination. But in the aftermath of Katrina, why should people who belong to systematically disadvantaged groups trust that the government will distribute vaccine as quickly and in the same quantity in their neighborhoods as in the neighborhoods of more advantaged Americans? It is in the interests of public health and public order, as well as of justice, that disadvantaged groups not be further disadvantaged by how medical countermeasures are distributed and also that these groups do not perceive themselves as being treated unjustly. Reducing perceptions of injustice may be as difficult to do as reducing injustice itself. Most would agree that the worst injustices would involve having only the powerful, the elite, or the affluent receive—or else be the first to receive—whatever is in short supply, whether vaccines, antivirals, intensive care unit (ICU) beds, respirators, or admissions to hospital. Such an outcome would constitute an egregious inequality that should be avoided at all costs. At the same time, it will be difficult to make priority decisions that do not give the reasonable appearance of unjustly favoring the privileged at the expense of the systematically disadvantaged. Consider two examples.
Many universities with sizable undergraduate programs also operate hospitals located in impoverished, inner-city neighborhoods. In the event of a pandemic, undergraduates may be asked, or told, to remain in their dormitories. It is likely that some of these undergraduates will become ill. University officials may feel—and indeed may have—a special moral obligation to care for the young people in their charge. Certainly parents will have a reasonable expectation that the university will use the medical resources at its disposal to assist their desperately ill child when they cannot. It is an open moral question whether, in
a context of extreme scarcity, university leaders should prioritize the students in their care over others, including other young people who live in the surrounding neighborhoods to whom the university also has an obligation. But even if such a priority is morally acceptable, or even if it is morally required, it will be difficult to persuade poor parents of color that the bypassing of their children in favor of university students is not a grievous injustice in which the lives of the privileged are valued more than the lives of the disadvantaged.
Turning from the university hospital to public policy, on the subject of access to medical countermeasures many current national planning documents as well as many state and local plans give priority to those people who are deemed essential to maintaining the infrastructures for national defense, public safety, governance, communications, and commerce as well as for public health and medical care. Although there is considerable disagreement about who exactly should be considered essential in each of these sectors, there is widespread agreement that such a prioritization is in the public interest and is morally justified. The problem from the standpoint of people who are at the bottom of society, however, is that they are likely to be underrepresented in the ranks of occupations deemed critical to essential infrastructures. Although the critical workforce will no doubt be more diverse in social class and ethnicity than traditional political or economic elites, it may still be reasonable for those who are most disadvantaged to conclude that their interests and rights are being disregarded in egregiously unjust ways.
The Bellagio Principles
In an intensive meeting held in Bellagio, Italy, in July 2006, twenty-four officials, scientists, and public health and policy experts from eleven countries discussed the rights and interests of systematically disadvantaged groups in pandemic planning and response. This group, which I helped convene with my colleague Ruth Karron, concluded that international institutions and nation-states must bring these rights and interests to the forefront of consideration in efforts to prevent a pandemic, in responses during a pandemic, and in efforts to redress economic and health burdens in the post-pandemic period. The Bellagio Group did not conclude that the rights and interests of disadvantaged groups should always be given priority, but instead that they should always be taken into account as part of a serious commitment to social justice. The Bellagio Group is advocating the adoption of its Statement of Principles (Bellagio Group, 2006a), which is intended to guide institutions and governments wishing to support this commitment. The Statement of Principles addresses the need to reduce the technology gap that currently exists between poor and wealthy nations with respect not only to biomedical research and development but also to relevant socioeconomic analysis. Most of the research that has been conducted so far has focused on the implications of alternative containment strategies for the developed world (Ferguson et al., 2006), including studies projecting the implications of efforts
to prevent animal or human disease in Asian Rim countries (Ferguson et al., 2005; Longini et al., 2005). While wealthy nations thus can take advantage of an increasing body of relevant modeling and epidemiological analyses in revising their national plans, poor countries have almost no such research on which to rely.
The Statement of Principles also calls on countries and regions to explicitly identify how disadvantaged groups in their societies will fare under proposed pandemic plans, with respect to both the prospects for benefit and the burdens and secondary harms that pandemic planning and response produces. Whether in tabletop exercises, community exercises, or mathematical modeling, we will not uncover what is likely to happen to those who are already the most disadvantaged unless we make it a priority to find out. Similarly, the Principles call for ensuring that special efforts are made in communications and public engagement to involve disadvantaged groups. These groups are frequently underrepresented in political and civic processes and may doubt the credibility and trustworthiness of those responsible for pandemic planning.
To facilitate the translation of the Statement of Principles into policy and practice, the Bellagio Group developed a series of checklists intended to guide the actions of government officials in developing and revising pandemic-response plans and of animal health and public health practitioners in responding to suspected outbreaks of animal and human disease (Bellagio Group, 2006b). These checklists are being adopted for use in various settings throughout the world. It remains an open question whether they will contribute in any way to reducing at least the most egregious social injustices that are currently occurring in attempts to prevent a pandemic and that will occur should a pandemic take place. There is no question that concerted efforts are urgently needed, both globally and within the United States, to address social justice concerns in pandemic planning and response.
REDUCING STATE VARIABILITY IN HEALTH EMERGENCY PREPAREDNESS THROUGH FEDERAL STANDARDS, ENFORCEMENT, AND PUBLIC ACCOUNTABILITY: LESSONS FROM THE ENVIRONMENTAL FIELD
Shelley A. Hearne, Dr.P.H.4
Johns Hopkins University
Against the background of the 2001 anthrax attacks, Hurricane Katrina, and the looming threat of an influenza pandemic, the public health field is wrestling with how to improve its preparedness for a major health emergency in the most effective and ethical manner. The challenge is not new, however: public health
faced fundamentally similar issues 30 years ago with the emergence of environmental health threats.
For the majority of the last century, health agencies were responsible for environmental management and regulation. By the end of the late 1960s a series of high-profile events, ranging from Ohio’s Cuyahoga River catching on fire to heated Congressional debates about lead in consumer products, raised questions about the public health services’ ability to protect citizens from emerging environmental threats. As a result, these responsibilities were predominately shifted from federal and state health agencies to newly formed environmental regulatory agencies (Burke et al., 1997). The U.S. Environmental Protection Agency (EPA) began establishing national standards, rules, and regulations as well as extensive public accountability and engagement with the goal of ensuring that all states provided their citizens with equal protections from toxic contaminants in water, air, foods, and communities.
We are at an eerily similar crossroads with emerging bioterrorism and pandemic threats, which once again raise questions about the ability of the public health field to adequately respond. The insights gained several decades ago from the environmental agencies’ efforts to ensure fair and equal protections from exogenous threats can help inform federal health agencies today about ways that they can more ethically and effectively address pandemic threats. In particular, without strengthened oversight and transparency in health emergency preparedness, some responsibilities might be shifted to emergency management or homeland security agencies, just as occurred when environmental threat management was transferred away from public health agencies.
The Landscape: Geographic Variability in Health Emergency Preparedness
With substantial federal investments in public health infrastructure, progress has been achieved in strengthening the nation’s ability to respond to a biological, chemical, or radiologic attack. Still, numerous national studies have found wide variations from one state to the next in their capabilities to respond to a major health crisis, such as an influenza pandemic. Concerns include the following (Trust for America’s Health, 2006):
CDC reports that only 56 percent of states have tested their state-wide pandemic plan in the last 12 months;
Only fifteen states and two cities have received CDC’s highest rating for preparedness to receive the country’s Strategic National Stockpile, the emergency medical supplies delivered in a major catastrophe;
Eleven states and the District of Columbia lack sufficient BSL-3 laboratories to test biological agents, according to a survey by the Association of Public Health Laboratories (Trust for America’s Health, 2006); and
Only seven states and three metropolitan areas are part of the nation’s
active surveillance system for food-borne diseases, which monitors trends and determines specific foods associated with poisoning incidents (CDC, 2007).
This variation in the states’ ability to plan, monitor, and respond to medical or biological emergencies could leave citizens with different levels of protection based on geographic location.
The Need to Ensure Equal Levels of Preparedness for All Citizens
One of the greatest challenges in pandemic preparation is that the public health system is not a single entity but rather a loosely affiliated network of approximately 3,000 federal, state, and local health agencies. Through their police powers, state and local governments have primary responsibility for the health of their citizens (Gostin, 2002). According to the IOM, the federal government “plays a crucial role in protecting and improving the health of the population by providing leadership in setting health goals, policies, and standards, especially through its regulatory powers” (IOM, 2002).
The U.S. Department of Health and Human Services (HHS) is the primary federal health authority. As one of its principal tasks, HHS administers Medicaid, a health insurance program that provides coverage for over 50 million Americans. States are given federal support and guidance and are allowed flexibility in implementing the programs, based on their population’s needs and on market opportunities. HHS ensures appropriate state implementation through an extensive structure of rules, regulations, and standards. Some HHS public health agencies, like the Food and Drug Administration, conduct regulatory activities.
The CDC is HHS’s lead agency for ensuring the national capacity to respond to health emergencies and for overseeing disease-prevention efforts. The agency’s standard approach is to work with state health agencies as equal partners, allowing the states to determine priorities and implement strategies through federally funded initiatives. Often, important decisions about health policy are determined through outside consensus-based organizations. Despite being a significant financial and technical resource for state and local health agencies, the CDC rarely, if ever, directly establishes national standards or public-accountability mechanisms for a state’s health-protections efforts.
An Example: The Disease Surveillance Challenge
CDC is the lead agency nationally for collecting and disseminating disease surveillance data. Despite collecting information on four out of every five American deaths, the agency has not established national standards for tracking most chronic diseases (Environmental Health Tracking Project Team, 2000). For example, CDC, through its broad authority and the Birth Defects Prevention Act of 1998, provides funding for some state birth-defect surveillance systems, but it
does not provide national reporting guidelines (Erickson, 2000). Because of a lack of standards and sufficient funding, there are wide variations in states’ reporting systems which create gaps in timeliness, comparability, and consistency and which compromise investigative capabilities (Trust for America’s Health, 2005).
Similar challenges exist for emerging infectious diseases. The federal government has made substantial investments in building and fortifying state and local public health preparedness, including communications, laboratories, and surveillance activities, and this in turn has improved capabilities for tracking infectious diseases. But CDC has been limited in its leadership role in directing the system’s ability to respond rapidly to emerging infectious diseases.
For example, in 2003, the nation faced an annual influenza season that appeared highly lethal to children. As the CDC director noted in the heat of the crisis:
It was difficult to say if this year’s childhood death toll from the flu was higher than average, because they don’t have detailed, accurate information on the number of children who die every year from influenza specifically because it hasn’t been a reportable illness (CDC, 2003).
State disease surveillance is mandated through state legislation or regulations and is submitted to CDC on a voluntary basis. As such, states may vary in their disease reporting. In the midst of the 2003 influenza crisis, which had led to an enormous public demand for information, CDC requested a professional association—the Council on State and Territorial Epidemiologists (CSTE)—to consider recommending pediatric deaths due to influenza as a nationally reportable condition (CDC, 2004). CSTE has the responsibility of providing an annual evaluation of the national reportable conditions list through its state health officer members, with CDC input. As of October, 2004, CSTE established influenza-associated pediatric mortality as a nationally notifiable disease that states are voluntarily requested to report to CDC (Jajosky, 2006). Similarly, after the nation’s experts had worried for years about the emergence of novel human influenza strains, in January 2007 CSTE finally issued an interim policy calling on CDC to establish national reporting for novel type A influenza virus infections (CSTE, 2007a).
In times of heightened medical threats, if the nation’s health agencies are to exhibit national leadership, they must have more rapid response mechanisms. They can still draw on the advice and counsel of key scientist and constituency groups, but the authority for quick, directive action on nationwide disease reporting should exist on the national level. Such a capability could also help the development of coordinated and compatible syndrome surveillance systems and other related terrorism-preparedness programs that are now being devised by the states.
In contrast to the current state of affairs in disease surveillance, in the environmental area the EPA establishes guidance, standards, and reporting systems as part of its standard operating procedures. State agencies and other interested par-
ties can become involved in these efforts through public commenting processes and advisory councils, but the final determination belongs to the EPA.
Status of Measurable, Verifiable, and Publicly Accountable Standard-Setting for Health Agencies
In emergency response, lack of national leadership can lead to an enormous variability among different geographic regions and subpopulations. Variability in turn can cause unequal and sometimes inadequate protection for citizens during a medical crisis. Unfortunately, HHS and its agencies have taken minimal steps to ensure that states are meeting preparedness expectations.
The CDC Public Health Emergency Preparedness cooperative agreement and the Health Resources Services and Services Administration’s (HRSA) National Bioterrorism Hospital Preparedness program have established draft performance standards for states and cities. The various jurisdictions provide CDC and HRSA with self-reported data on progress toward achieving these benchmarks, but neither agency has a system to verify or calibrate these city and state reports. The federal agencies have documented nationwide performance on each benchmark, but they have not produced individual state assessments. In fact, there are no review criteria, penalties, or incentives associated with gauging state performance; states have lost funds only for insufficient expenditures. Agencies will not release performance standard data, including outcomes from plan exercises, on a state-by-state basis.
The federal government has required all states to develop pandemic influenza operational plans as a condition of receiving funding through CDC’s public health preparedness cooperative agreement. To date all states have, at a minimum, assembled their draft pandemic plans (CSTE, 2007b). In March 2007 all state plans must be submitted to CDC for review and approval (CDC, 2006). However, the agency has not yet established procedures for reviewing or approving these plans. Most likely, if plans are inadequate, states will be asked to modify them rather than face penalties. In December 2006, the Pandemic and All-Hazards Preparedness Act was signed into law with a mandate for CDC to review and approve plans with options for penalty provisions.
Consequently, jurisdiction performance standards and plans lack any form of verification, enforcement, or public accountability.
Limited Public Engagement
Reflecting lessons they have learned from years of intense environmental conflicts and public distrust, such as accompanied the Love Canal or Times Beach incidents, environmental regulatory agencies have taken significant steps to engage, involve, and communicate with the public more actively (Covello and Sandman, 2001). As part of building public trust and support, agencies routinely
include the public in standard setting, advisory boards, and risk communication and also provide broad access to data, including information on decision making and agency activities, such as rates of inspections, enforcements, and permits.
As federal and state health agencies states have initiated preparedness efforts, the level of public engagement has varied widely from place to place. In state pandemic preparedness planning, for instance, some jurisdictions actively sought public comments and participation, while others treated the process and documents as “state secrets.” In one state, fewer than twenty-five copies were distributed to partner organizations because of concerns that terrorists might obtain sensitive information (Uhlman, 2005), which in turn sparked a barrage of hearings and newspaper articles about the lack of transparency in the process.
Recent investigations have found that greater public involvement is needed in emergency planning for health crises. In 2004 a New York Academy of Medicine (NYAM) study of 2,500 people found that citizens would not respond to government instructions during a major health crisis, such as a radiologic or biologic attack, because the plans did not reflect their individual interests, health, or family needs (Lasker, 2004). These researchers believe that the lack of involvement of the public in planning is a fundamental flaw in emergency preparedness (Lasker, 2006). A RAND study found that public health officials had less engagement with the public than their counterparts in law enforcement (Lurie et al., 2004). The NYAM study concluded that “people are more likely to follow official instructions when they have a lot of trust in what officials tell them to do and are confident that their community is prepared to meet their needs if a terrorist attack occurs” (Lasker, 2004).
To date, federal health agencies have not required public participation in federal or state planning, in evaluation and standard setting efforts for bioterrorism, or in preparedness initiatives for pandemics or other health emergencies.
Evolutions in Health Agency Standards
CDC’s Strategic National Stockpile (SNS) program is the most advanced model within the agency for ensuring that all jurisdictions are meeting preparedness requirements. The SNS is a national repository of vital pharmaceutical and medical equipment, such as antibiotics and respiratory ventilators, which in response to emergencies that threaten mass casualties can be delivered to states within 12 hours. Through cooperative agreements, CDC provides states with funding, technical guidance, and checklists on performance standards.
States’ SNS programs are inspected by federal teams who evaluate states’ self-assessment of their performance standards. Based on total performance, an overall score is awarded using a traffic-light color-coding scheme. As a program once jointly managed with the Department of Homeland Security, the green/ amber/red code (with plus and minus variations) indicates a state’s overall readiness to effectively manage the SNS (see Table 4-1). Green indicates the highest
TABLE 4-1 CDC Determination of States’ Readiness to Receive and Distribute the Strategic National Stockpile as of October 2006
“Stop Light” Readiness Indicator
Number of States in Category
SOURCE: Trust for America’s Health (2006).
level of readiness; red the lowest. Starting in 2007, states will be measured on a 100-point scale instead of the color-coding system. Regardless of score, all states will receive the SNS in an emergency if approved by HHS/CDC. The scores are used to stimulate states to be optimally prepared.
While CDC has established measurable and verifiable performance standards, states are given flexibility on how to best achieve operational goals.
Broader Approaches for Standard Setting: Accrediting Health Departments
In The Future of the Public’s Health in the 21st Century, the IOM determined that “greater accountability is needed on the part of state and local public health agencies with regard to the performance of the core public health functions of assessment, assurance, and policy development and the essential public health service” (IOM, p. 157). Building on these recommendations, public health associations have launched an initiative for creating a voluntary national accreditation program with the goal to “improve and protect the health of the public by advancing the quality and performance of state and local public health departments” (Exploring Accreditation Project, 2006). As currently envisioned, state and local health departments may conduct self-evaluations using national standards, which will then be validated by site visits of peers and public members, who in turn will inform an independent board’s accreditation decision. The exploratory group believes that accreditation will lead toward continuous quality improvements as well as enhanced credibility, accountability, and public trust in public health agencies (Lasker, 2004).
Recognizing the need for improved accountability, credibility, and consistency in services and capacity, several states have been conducting accreditation-like efforts for years. A Robert Wood Johnson Foundation report found that there are several leadership states with mandatory accreditation or standard-setting
programs for their local health agencies that have data verified by independent review teams and that, in some instances, link funding to performance (Theilen, 2004).
Increased Federalism to Encourage and Ensure All Citizens Are Equally and Adequately Protected
From an ethical standpoint, so as to ensure equal levels of preparedness for all citizens, federal health agencies should play a more directive role in establishing standards and critical requirements for state and local jurisdictions. At a minimum the federal government should set
measurable standards that are verifiable, impact-oriented, publicly available, and performed on an annual basis;
requirements for systematic public participation in the pandemic preparedness process, including planning, exercise evaluations, and standard setting; and
provisions for encouraging state and local health agencies to continuously improve, along with penalties, funding incentives, and public-accountability methods.
If the public health field begins to evolve toward a more federalist con-struct—with national standards, inspection, enforcement, and accountability measures as part of the strategy options—then we will need to start considering how to take the next steps toward ensuring that standards are met. Again, the environmental field offers lessons that could inform and influence public health’s evolution toward federalism. In particular, a number of federalism strategies and powers that have been used to encourage equal protection of the public’s health and welfare in the environmental area might also have application for pandemic preparedness. These include:
Funding Penalties or Incentives
The federal government can set conditions on state block grants or cooperative agreements to encourage states to adopt federal regulatory standards (Gostin, 2002). This technique has been used to advance various public health protections, as when the federal government required states to set automobile emission standards as a condition for receiving federal highway transportation funds. In a similar way, achieving pandemic-preparedness standards could be made an explicit requirement for cooperative agreements or other state health programs, such as health-care insurance funding. The preparedness standards could require such things as inspections, public participation, and transparent accountability.
Federal Oversight and Preemption
In the Clean Water Act, the EPA is charged with establishing effluent and water standards for waterways. States can be delegated the authority to administer, permit, and enforce parts of the law, but the EPA still retains oversight responsibilities. Should a state fail to meet federal performance standards, the EPA can remove these responsibilities and take over the state’s clean-water regulatory activities. Establishing such structured oversight and responsibilities in the case of pandemic preparedness would require legislative action and could be considered in future preparedness laws.
Public Right to Know
Information can be a powerful persuasive force and has been widely used in the environmental field to encourage state and industrial actions. For instance, the EPA provides the public with standardized data on public water systems and their violations of EPA drinking water regulations (EPA, 2007). Similarly, health agencies have effectively used public reporting of restaurant grades as a mechanism for achieving improved sanitary conditions. The federal government could have national reporting requirements for standardized, quantifiable measures on state preparedness performance and on the status of public health infrastructure (such as laboratory capabilities and capacities, workforce, and communications). This information should be collected, assessed, and made available to the public annually, on a state-by-state basis, as a condition of federal funding. As a matter of ethics, taxpayers in each state have a right to know how well their health and safety is being protected.
A wide variety of tools to facilitate enforcement of water standards were included in the Clean Water Act, such as provisions that gave citizens the right to sue to force enforcement of federal and state permits and also the right to sue EPA for failure to perform nondiscretionary regulatory duties. In the case of preparedness planning, citizens currently have no such mechanisms available to them, such as the ability to sue the CDC, and provisions for such mechanisms would have to be specifically legislated into public health laws.
Just as was the case with environmental pollutants, influenza pandemics and other emerging biological threats know no state boundaries. As the nation acknowledges that federal and state governments are underprepared for dealing with a major health disaster, there is an urgent need for nationwide leadership to
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
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-
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
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
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.
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?
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.
This work was supported in part by the Greenwall Foundation and by NIH grant Roadmap K12 HD049077.
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