Ethical and Legal Considerations in Mitigating Pandemic Disease Workshop Summary (2007) / Chapter Skim
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4 Ethical Issues in Pandemic Planning and Response
4 Ethical Issues in Pandemic Planning and Response
Pages 154-202
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From page 154... ...
, 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.
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From page 155... ...
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.
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contacts that the vaccination program was premature and unfeasible, leading that network to conclude that the vaccination program was being launched solely for political reasons. Given the potential to create similarly influential and divisive messages in the face of pandemic influenza, experts should think carefully about their roles and respon
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From page 157... ...
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.
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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)
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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.
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Finally, there should be mechanisms to ensure that these criteria are actually fulfilled. The Values Em�edded 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.
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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.
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. Four Realms of Influenza Preparedness Planning and Action At WHO the ethical issues we have been dealing with concerning influenza preparedness planning and action can be divided into four groups or areas of
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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.
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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?
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(The 2 In our pandemic influenza work at WHO, each of these four topics is being addressed by a working group, which met once together (in May 2006) but which mostly have been operating separately as virtual committees.
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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.
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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 Issues 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®.
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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.
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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?
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0 ETHICAL AND LEGAL CONSIDERATIONS IN MITIGATING PANDEMIC DISEASE 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.
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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.
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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.
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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)
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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.
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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.
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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.
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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)
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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.
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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.
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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.
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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.
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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)
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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. 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.
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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.
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From page 185... ...
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.
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. In times of heightened medical threats, if the nation's health agencies are to exhibit national leadership, they must have more rapid response mechanisms.
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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)
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. 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.
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Broader Approaches for Standard Setting: Accrediting Health Departments In The Future of the Pu�lic's Health in the st 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.
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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 construct -- 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.
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. Similarly, health agencies have effectively used public reporting of restaurant grades as a mechanism for achieving improved sanitary conditions.
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. If this happens, many people in respiratory failure who need mechanical ventilation in order to survive will not receive it.
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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)
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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.
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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.
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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.
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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.
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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.
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2006b. Checklists for Aian and Pandemic Influenza Preparedness and Response.
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2004. Pandemic influenza: Public health preparedness for the next global health emer gency.
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2004. Accreditation of Pu�lic Health Agencies.
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