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Ethical and Legal Considerations in Mitigating Pandemic Disease: Workshop Summary 3 Strategies for Disease Containment OVERVIEW Given limited supplies of vaccines, antiviral drugs, and ventilators, non-pharmaceutical interventions are likely to dominate the public health response to any pandemic, at least in the near term. The six papers that make up this chapter describe scientific approaches to maximizing the benefits of quarantine and other nonpharmaceutical strategies for containing infectious disease as well as the legal and ethical considerations that should be taken into account when adopting such strategies. The authors of the first three papers raise a variety of legal and ethical concerns associated with behavioral approaches to disease containment and mitigation that must be addressed in the course of pandemic planning, and the last three papers describe the use of computer modeling for crafting disease containment strategies. More specifically, the chapter’s first paper, by Lawrence Gostin and Benjamin Berkman of Georgetown University Law Center, presents an overview of the legal and ethical challenges that must be addressed in preparing for pandemic influenza. The authors observe that even interventions that are effective in a public health sense can have profound adverse consequences for civil liberties and economic status. They go on to identify several ethical and human rights concerns associated with behavioral interventions that would likely be used in a pandemic, and they discuss ways to minimize the social consequences of such interventions. The next essay argues that although laws give decision makers certain powers in a pandemic, those decision makers must inevitably apply ethical tenets to decide if and how to use those powers because “law cannot anticipate the specifics of each public health emergency.” Workshop panelist James LeDuc of
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Ethical and Legal Considerations in Mitigating Pandemic Disease: Workshop Summary the Centers for Disease Control and Prevention (CDC) and his co-authors present a set of ethical guidelines that should be employed in pandemic preparation and response. They also identify a range of legal issues relevant to social-distancing measures. If state and local governments are to reach an acceptable level of public health preparedness, the authors say, they must give systematic attention to the ethical and legal issues, and that preparedness should be tested, along with other public health measures, in pandemic preparation exercises. LeDuc’s fellow panelist Victoria Sutton of Texas Tech University also considered the intersection of law and ethics in public health emergencies in general and in the specific case of pandemic influenza. In particular, Sutton identified several “choke points”—particularly thorny ethical and legal issues—that present barriers to pandemic mitigation. In addition to the problem of leadership, which is addressed in the next chapter, these issues include the role of interdisciplinary and intersectoral approaches in decision-making; the tradeoffs between personal freedom and public good that are implicit in social-distancing measures; the global implications of quarantine and travel restrictions; the need for consistency among various disease-control policies; and the definition of appropriate, measurable “triggers” for when to impose each potential countermeasure. The third paper in this chapter considers quarantine, one of the most ethically and legally complex tactics used in combating pandemic disease. In this article, Martin Cetron of CDC and Julius Landwirth of Yale University describe the modern practice of quarantine and its potential implementation as outlined in the U.S. Department of Health and Human Services (HHS) plan for containing pandemic avian influenza. Whenever the possibility of using a quarantine is discussed, they observe, decision makers confront the central dilemma arising from the contrast between public health ethics, which emphasizes collective action for the good of the community, and therapeutic medicine, with its focus on the individual. The authors identify various means to address this tension and offer examples of how ethical considerations can be incorporated into pandemic preparedness plans. The chapter concludes with a three-part contribution by Joshua Epstein of the Brookings Institution: an informal discussion of the modeling process as it applies to infectious disease containment, followed by two publications in which such models are used to inform strategies for containing smallpox epidemics resulting from bioterrorism. Epstein and his group produce explicit models of disease, and, in the course of doing so, they examine and refine the assumptions upon which each model rests. Epstein observes that while models cannot replace human judgment, they can better inform our choices, and while they cannot eliminate uncertainty, models can identify crucial gaps in knowledge. To support these assertions, Epstein describes how his group collaborates with medical experts to produce disease scenarios and containment strategies (e.g., for smallpox) more robust than would be possible either through pure computation or through expert opinion alone. Responding to Epstein’s presentation, workshop panelist Timothy Germann,
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Ethical and Legal Considerations in Mitigating Pandemic Disease: Workshop Summary of Los Alamos National Laboratory, observed that models cannot address ethical and legal questions; instead models must be combined with ethical and legal judgments to make policy decisions. Epstein replied to that observation by pointing out the possibility that models of infectious disease containment could be shaped by legal and ethical considerations—introduced in the form of constraints—built into them, much as economic factors have been included in similar models. Moreover, he said, models sometimes provide information that can help resolve ethical dilemmas; for example, projections that reveal little difference in effectiveness between voluntary and mandatory quarantine. PREPARING FOR PANDEMIC INFLUENZA: LEGAL AND ETHICAL CHALLENGES1 Lawrence O. Gostin, J.D.2 Georgetown University Law Center Benjamin E. Berkman, J.D., M.P.H.3 Georgetown University Law Center Introduction Highly pathogenic influenza A (H5N1) has captured the close attention of policy makers who regard pandemic influenza as a national security threat. The virus is endemic in bird populations in Southeast Asia, with serious outbreaks also having now occurred in Africa, Europe, and the Middle East (WHO, 2006a, 2007a). Modeling4 suggests that the infection will eventually affect the 1 This is an expanded version of a two-part series: Gostin LO. 2006. Medical countermeasures for pandemic influenza: Ethics and the law. Journal of the American Medical Association 295(5): 554-556; and Gostin LO. 2006. Public health strategies for pandemic influenza: Ethics and the law. Journal of the American Medical Association 295(14):1700-1704. A longer version of this paper is published as Gostin LO, Berkman BE. 2007. Pandemic Influenza: Ethics, Law, and the Public’s Health. Administrative Law Review 59(1): 121-175. Additionally, some of this article is based on the authors’ work with the World Health Organization Project on Addressing Ethical Issues in Pandemic Influenza Planning. Professor Gostin and Mr. Berkman acknowledge the invaluable comments of their WHO working group, as well as the able assistance of Deborah Rubbens, L.L.M., and John Kraemer, JD Candidate, Georgetown University Law Center. 2 Associate Dean and Linda D. and Timothy T. O’Neill Chair in Global Health Law, Georgetown University Law Center; Professor of Public Health, the Johns Hopkins University; Faculty Director, O’Neill Institute for National and Global Health Law at the Georgetown University Law Center; Director, Center for Law and the Public’s Health, a Collaborating Center of the World Health Organization and Centers for Disease Control and Prevention. 3 Sloan Fellow in Biosecurity Law and Policy, Center for Law and the Public’s Health. 4 A good overview of the state of current influenza containment modeling can be found at Institute of Medicine. 2006. Modeling Community Containment for Pandemic Influenza. Washington, DC: The National Academies Press.
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Ethical and Legal Considerations in Mitigating Pandemic Disease: Workshop Summary entire globe through transmission mechanisms involving both birds and humans (Longini et al., 2005). The majority of avian outbreaks in Southeast Asia have been attributed to the movement of poultry and poultry products (Chen et al., 2006; Rosenthal, 2006). Similarly, international trade and travel will play a major role in transmission in human outbreaks, and frequent and widespread travel will make it difficult to contain any pandemic in humans. Even if trade and travel are severely restricted in order to limit human transmission, migratory birds will likely spread the disease by infecting birds on other continents (Normile, 2006). So far, however, the spread of the H5N1 strain has been confined mainly to animal populations. The virus is highly contagious among birds, and also highly pathogenic (Garrett, 2005), but because of a significant species barrier, the virus is still rare in humans (WHO, 2005b). The first confirmed cases of human infection were reported in 1997. As of May 16, 2007, 306 cases of the current wave of Influenza A (H5N1) have been reported, with 185 deaths (WHO, 2007b). Most cases are attributable to close contact with infected poultry or contaminated surfaces—e.g., poultry farms, markets, backyard pets, and cock-fighting venues (Thorson et al., 2006). A few cases of human-to-human transmission have occurred, principally involving intimate household contact, but the virus is of very limited transmission competence (WHO, 2006b). The virus appears highly pathogenic, with a reported death rate exceeding 50 percent (Wong and Yuen, 2006). However, because of the possibility of under-reporting, the exact prevalence, transmissibility, and fatality rates of H5N1 remain uncertain. Recent evidence that the 1918 pandemic was caused by an avian influenza virus lends credibility to the theory that the current strain could develop pandemic potential (Taubenberger et al., 2005; Tumpey et al., 2005). Historically, the number of deaths during a pandemic has varied greatly, depending on the number of people who become infected, the virulence of the virus, and the effectiveness of preventive measures (WHO, 2005c). Accurate predictions of mortality are thus difficult to establish, and estimates differ considerably. A mild pandemic, comparable to those in 1957 and 1968, is likely to cause the deaths of from 89,000 to 207,000 people in the United States (Garrett, 2005; Global Security, 2006) and 2 million to 7.4 million people globally (WHO, 2005d). One study that extrapolates from the severe 1918 pandemic finds that, in the absence of intervention, an influenza pandemic could lead to 1.9 million deaths in the United States and 180 million to 369 million deaths globally (Osterholm, 2005).5 A different study, also based on 1918 data, concludes that an estimated 62 million people will die globally, with 96 percent of these deaths occurring in the developing world (Murray et al., 2006). An influenza pandemic would also result in massive economic disruption. At present, the principal economic effects are being experi- 5 Notably, seasonal (interpandemic) influenza causes worldwide yearly epidemics resulting in 1 to 1.5 million infections.
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Ethical and Legal Considerations in Mitigating Pandemic Disease: Workshop Summary enced in the rural areas of Southeast Asian countries and are fairly limited. They are mostly related to losses of poultry and to governmental control measures such as the culling of birds. Economic losses would become much higher if sustained human-to-human transmissions develops. The two principal strategies for containing serious human outbreaks of influenza are therapeutic countermeasures (e.g., vaccines and antiviral medications) and public health interventions (e.g., infection control, social separation, and quarantine). Many of the barriers to effective interventions are technical and have been thoroughly discussed. This article focuses on the formidable legal and ethical challenges, which have yet to receive sufficient attention (Kotalik, 2005; Torda, 2006; Thomson et al., 2006; Kayman and Oblorh-Odjidja, 2006).6 Medical Countermeasures: Vaccines and Neuraminidase Inhibitors Industrialized countries place great emphasis on scientific solutions. Vaccination and, to a lesser extent, antiviral medication (in particular, the neuraminidase inhibitors oseltamivir [Tamiflu©] and zanamivir [Relenza©]) are perhaps the most important medical interventions for reducing morbidity and mortality associated with influenza (Germann et al., 2006; Iton, 2006; Stohr and Esveld, 2004). There is also recent evidence from primate models that the 1918 H1N1 influenza strain, unlike contemporary strains, can cause an exuberant immune response, which suggests that immunity suppressants might be another means of combating at least some strains of the virus (Kobasa et al., 2007). The United States plans to devote over 90 percent of pandemic influenza spending to medical countermeasures (U.S. Congressional Budget Office, 2006; Spotswood, 2005). Despite the promise of medical countermeasures, their use has been limited by a chronic mismatch between public health needs and private-sector control of production. Vaccine production, for example, has been unreliable even for seasonal influenza. The best way to ensure pandemic preparedness is to increase the baseline level of seasonal countermeasures. The World Health Organization (WHO) concluded that better use of vaccines for seasonal epidemics could help ensure that manufacturing capacity meets demand in a future pandemic (World Health Assembly, 2005; Gronvall and Borio, 2006). But even though this approach is good for the long-term, more immediate solutions are needed. Moreover, supply is difficult to increase because intellectual property concerns, regulatory hurdles, a lack of market incentives, limited production capacity, and fear of liability all act to curb entry into the market. 6 For an example of this lack of attention to law and ethics, see Department of Health and Human Services. 2006. Medical Offices and Clinics Pandemic Influenza Planning Checklist. [Online]. Available: http://www.pandemicflu.gov/plan/medical.html#3 [accessed January 30, 2007]. This document purports to be a “checklist to help medical offices and ambulatory clinics assess and improve their preparedness for responding to pandemic influenza.” However, it does not address the myriad legal and ethical issues that will arise.
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Ethical and Legal Considerations in Mitigating Pandemic Disease: Workshop Summary Even if these supply problems can be overcome, it is unlikely that sufficient medical countermeasures will be available to halt the spread of a pandemic. In particular, there will likely be a significant delay in the production of a vaccine. With current technology it will take at least 6 months from the onset of an outbreak, and possibly longer, for the first doses of vaccine to be available. Furthermore, there is no guarantee that medical countermeasures will be efficacious. Experimental H5N1 vaccines may not be effective against a novel human subtype, and the pathogen may become resistant to neuraminidase inhibitors. Public Health Countermeasures Given the limits of medical countermeasures, a broad range of public health would likely be employed against an influenza pandemic, from relatively innocuous techniques, such as disease surveillance and hygienic measures, to considerably more restrictive interventions, such as social distancing, travel restrictions, quarantine, and case isolation. There are reasons to believe that all of these will be effective to at least some degree (Markel et al., 2006), but evidence supporting their effectiveness is scarce (IOM, 2006). The hope is that public health interventions, while incapable of completely stopping the transmission of the virus, will be able to slow the pandemic. By reducing the rate of spread of the disease, public health countermeasures can buy time for the development of medical countermeasures while also helping to ensure that the health-care system does not become overwhelmed by a surge of patients (Cetron, 2006). Unfortunately, each type of public health intervention raises serious ethical and human rights concerns. Public Health Surveillance Surveillance is the backbone of public health, providing the data necessary to understand an epidemic threat and to inform the public, provide early warning, describe transmission characteristics and incidence and prevalence, and assist a targeted response. Surveillance strategies include rapid diagnosis, screening, reporting, case management reporting, contact investigations, and the monitoring of trends. It is clear that surveillance is necessary to quickly identify and respond to a pandemic influenza outbreak. The revised International Health Regulations (IHR) require member states to notify WHO of all events which may constitute a “public health emergency of international concern.” Consequently, once a country identifies a signal suggesting human-to-human transmission, the country is expected to begin investigations immediately and simultaneously to notify WHO of the event. Surveillance thus comprises a crucial element of the early response to a forming pandemic. But because governments must collect sensitive health information from patients, travellers, migrants, and other vulnerable populations, surveillance also
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Ethical and Legal Considerations in Mitigating Pandemic Disease: Workshop Summary poses privacy risks (Bayer and Fairchild, 2002). The IHR requires states to keep data “confidential and processed anonymously as required by national law,” but in a crisis it can sometimes be necessary to disclose certain information without any undue delay. In such a situation, when the immediate use of the information is necessary for an important public health purpose, disclosure can be warranted, but the identity of the affected person should be protected as much as possible. A breach of the right to privacy can result not only in economic harms, such us unemployment or loss of insurance or housing, but also in social and psychological harms. For that reason, if information is released outside of the public health system, it is particularly important to avoid the inclusion of any uniquely identifiable characteristics, such as names, government identification numbers, fingerprints, or phone numbers. Cases should stay anonymous or encrypted when reasonably feasible. In every situation the rights to privacy and personal autonomy require that only the minimum amount of information necessary to achieve the goal should be released and to as few people as possible. Dignity and respect for the person should be protected. Screening and testing can pose serious threats to a person’s privacy and bodily integrity. Ideally, public health officials should receive an individual’s informed consent before performing any medical tests, and education programs can help convince many people to agree to voluntary testing, but there may be rare times when mandatory testing is necessary to advance the public good. In such cases, interference with the right to bodily integrity and with the right to refuse testing may be permissible when the mandatory testing policy is clearly necessary and effective in protecting the public health, when it is performed by competent public health officials, and when the least intrusive means are used. At a minimum, compulsory testing should be limited to individuals known or at least suspected to be infected and should be done in a fair and nondiscriminatory way. The people whose privacy and autonomy are being infringed should be informed of the reasons for the infringement. And in all cases compulsion should be the last resort and used only if voluntary or less restrictive means are ineffective. Community Hygiene and Hospital Infection Control Hygienic measures to prevent the spread of respiratory infections are broadly accepted and have been widely used in both influenza pandemics (APHA, 1918) and also, although with uncertain benefits, the SARS outbreaks (WHO, 2003; CDC, 2005a). These hygienic methods include hand-washing, disinfection, the use of personal protective equipment (PPE) such as masks, gloves, gowns, and eye protection, and respiratory hygiene, such as the use of proper etiquette for coughs, sneezes, and spitting. It is important that the public be informed of the need for hygienic measures, and that accurate information, including the uncertainty of the effectiveness of the recommended interventions, be provided. In past epidemics misinformation
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Ethical and Legal Considerations in Mitigating Pandemic Disease: Workshop Summary has been rampant, and this has led to substantial public anxiety, to reliance on word of mouth for knowledge, and to the purchase of ineffective and expensive products (Rosling and Rosling, 2003). The situation raises issues of distributive justice because ineffective or inaccurate communications have the greatest effects on marginalized members of society, as they are the least likely to have access to alternative credible sources of information and are the people for whom wasting resources would have the greatest adverse effects (Gostin and Powers, 2006). Furthermore, a consideration for personal dignity implies that individuals should be provided with adequate information to make informed decisions about their own health. Public education campaigns should be grounded in the science of risk communication, as the acceptability of health measures is vital to community adherence. The information disseminated through public education campaigns should be accurate, clear, uncomplicated, not sensationalistic or alarmist, and as reassuring as possible (SARS Commission, 2006).7 Decreased Social Mixing/Increased Social Distance Past experience shows that one consistent response to epidemics has been to decrease social mixing and increase social distance by such means as community restrictions and voluntary social separation (WHO, 2005d; Stern and Markel, 2004). There is some limited evidence that school closings do reduce seasonal influenza transmission (Heymann et al., 2004), and it is assumed—although but not proven—that other limits on social mixing also slow the spread of respiratory disease (World Health Organization Writing Group, 2006). Thus societies faced with pandemics have often closed public places (schools,8 childcare, workplaces, mass transit) and cancelled public events (sports, arts, conferences). As fear rises,rises,, the public itself may shun public gatherings. Predicting the effect of policies to increase social distance is difficult, as infected persons and their contacts may be displaced into other settings, and individuals may voluntarily separate in response to perceived risk. For these reasons, additional research needs to be conducted on behavior during epidemics and the effects of social distancing on transmission. Social separation, particularly for long durations, can cause loneliness and emotional detachment, disrupt social and economic life, and infringe individual rights. Community restrictions raise profound questions about the government’s right to interfere in such areas as faith (by, for instance, limiting religious gatherings), family (with, for example, restrictions on funeral attendance), and pro- 7 The Canadian SARS Commission has evaluated crisis communication during that public health emergency. 8 A review of state law authorizing school closure can be found at Hodge JG. 2006 (December 11). Assessing Legal Preparedness for School Closure in Response to Pandemic Flu or Other Public Health Emergencies. [Online]. Available: http://www.newfluwiki2.com/upload/Hodge.ppt [accessed January 30, 2007].
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Ethical and Legal Considerations in Mitigating Pandemic Disease: Workshop Summary tection of the vulnerable (e.g., by making it more difficult to visit vulnerable individuals and provide them with food, water, clothing, or medical care). Undoubtedly, most judicial systems would uphold reasonable community restrictions, but legal and logistical questions loom: Who has the power and under what criteria to order closings, and for what period of time? What threshold of disease should trigger closings, and should thresholds be different for different entities? Under what circumstances should compensation for closings be paid? What should the penalties be for non-compliance? Such questions about enforcement and the assurance of population safety are critically important, but for the most part they have not been answered. One fear is that governments might put into effect restrictions on personal liberties that are unnecessary—implementing restrictions before they are needed, extending them past the end of the crisis, or enacting restrictions that do nothing to decrease influenza transmission. In such situations, closings would not meet the appropriate standards for either necessity or proportionality. Furthermore, it is important to remember that the cost of restrictive policies will be borne most heavily by those with the fewest resources, so errant social-distancing actions have distributive-justice implications. A final worry is that governments might use social distancing in a discriminatory fashion, scapegoating ethnic or religious minorities, or that governments might use social distancing as a pretext to crack down on dissidents who assemble to protest. Ideally, questions of government authority and accountability should be answered by policy decisions made in an open and transparent process that encourages input from all portions of society and that is carried out before a pandemic hits. Governments should explicitly define who has the power to order social distancing strategies and for what period of time. Governments should also clearly state the criteria under which such power is exercisable and delineate the legitimate bases for any differential treatment. Penalties should be proportional to offenses and not based on irrational fears or discriminatory beliefs. On the other hand, one must recognize that detailed pandemic influenza preparations will often not be the highest priorities for countries dealing with important and more immediate concerns. Furthermore, some countries lack the legal and governmental infrastructures to implement such an ideal plan as is outlined above. In such countries, completely determining issues of government authority and accountability prior to a pandemic may be extremely difficult. One should also note that pandemics are difficult to predict, and information acquired as a pandemic evolves may render some of what was previously believed about various social-distancing strategies obsolete. At the very least, though, governments should dedicate themselves to non-discrimination and transparency before an influenza pandemic occurs. It is important that governments implement social-distancing policies fairly and with as broad involvement in planning as possible. This will not only make it more likely that the appropriate ethical considerations have been taken into account, but it
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Ethical and Legal Considerations in Mitigating Pandemic Disease: Workshop Summary will also improve the likelihood that the public will accept social distancing as a means to slow disease transmission. And, since compliance with social-distancing instructions will be difficult to enforce, public acceptance will be critical to such a measure’s success. Workplace and School Closings Workplace and school closings present particularly difficult ethical issues. Apart from the uncertainty of their effectiveness, the most important issues center on the subject of distributive justice. Workplaces are vital to the livelihoods of both employers and employees, so closing them can cause severe financial hardships. In extreme cases, lost profits caused by closings may push companies to go out of business, leading to job losses and other economic hardships. Even for people who have an economic safety net, these problems can have a significant effect, but for people living at a subsistence level the effect of lost income can be far worse. If workplaces stay closed for a significant amount of time, such people may be unable to pay for shelter, food, or medicine. Similar issues are raised by school closings, which may require parents to stay at home in order to care for young children. Ideally, public health authorities should work cooperatively with businesses, schools, and communities prior to an emergency in an effort to establish mutually agreeable closure procedures. Though governments should retain the legal power to enforce closings if absolutely necessary, it would be preferable to subsidize lost profits and incomes as necessary in order to create incentives for complying with closure requests. The latter approach was used extensively in countries affected by SARS for people placed in quarantine (Rothstein et al., 2003). Practical constraints may sometimes make this approach impossible. The governments of many countries have more pressing needs than addressing a potential pandemic. Furthermore, some countries may be financially unable to provide compensation for closure. In 1918 each of the waves of the pandemic lasted for several months, and most locations were hit by multiple waves (Johnson and Mueller, 2002). The amount of resources needed to compensate for lost income or profits for this amount of time will be out of the reach of many of the world’s governments. In light of these constraints, governments should at least make a serious effort to weigh the risks to health and welfare from workplace closings and other social-distancing measures against those risks of disease transmission that the closings might mitigate. In different locations the balance of risks may be resolved differently, depending on resources and the number of people living at or below a subsistence level. Countries should consider tactical closures if necessary, such as closing only those entities that most facilitate transmission. For example, schools have been identified as a primary driver of seasonal influenza (Germann et al., 2006), and some believe that closing schools will slow the
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Ethical and Legal Considerations in Mitigating Pandemic Disease: Workshop Summary spread of a pandemic. Countries might also consider using closings as a means to buy time for other preparations; closings could be put in place until the level of disease in a community exceeds a predetermined level and then relaxed, with the hope of slowing the initial spread of disease through the community. Provision of Necessities If people are instructed to avoid public places, such as markets, stores, and pharmacies, or if those places are required to close, there will be a need for people to procure food, medicine, and other necessities in some other way. Similarly, shutting down mass transit may prevent people from being able to get to those facilities that do remain open, and it could prevent some people from being able to seek medical care. Such a situation also raises distributive-justice concerns since those people with the least resources will be least likely to be able to procure additional resources before closings occur. Ideally governments would set up networks for the distribution of necessary provisions to citizens’ homes, with a particular focus on those most in need. Such distribution should be consistent and reliable, and it should provide necessities such as food and medicine for the duration of social-distancing measures. It should also be conducted in such a manner as to minimize interaction with potentially infectious people, and those people responsible for distributing provisions should use infection-control precautions to decrease the likelihood that they will spread disease. Transportation for medical care should be provided as needed by personnel who are apprised of the risks involved in transporting potentially infectious people; these personnel should be provided with protective equipment that will allow them to guard themselves from the disease and to avoid spreading it to others. Similarly, a program should be put in place for the removal of bodies from homes in a safe and efficient manner. Resource constraints and logistical difficulties are likely to impede such a program in many areas. Many governments may lack the resources to provide food, medicine, and other necessities to its citizens during a pandemic. Even if the resources are available, the workforce needed to conduct distribution may be absent, especially at the height of a pandemic when a substantial number of people would be ill. Furthermore, there may not be enough people willing to interact closely with potentially infectious people to allow such a system to function. Shortages of personnel may be especially likely for medical transport and mortuary services. At the very least, governments should do what they can to facilitate the provision of resources before an area is hit by disease. To the extent possible governments should give advance warning of disease and make recommendations about what food, medicine, and other supplies should be stockpiled and in what quantities. If they are able, governments should provide such necessities for people unable to afford them on their own. Governments should provide access to
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Ethical and Legal Considerations in Mitigating Pandemic Disease: Workshop Summary Discussion The objective of this modeling exercise was to evaluate the potential effectiveness of epidemic control strategies that might be deployed in response to a bioterrorist attack. Our main finding is that contact tracing and vaccination of household, workplace, and school contacts, along with effective isolation of diagnosed cases, can control epidemics of smallpox. In our 6,000-person town model, we found that in scenario 3 (the combination of interventions most closely parallel to current U.S. governmental policies) the expected total number of smallpox cases that would ensue from ten simultaneous introductions would be 25–40 additional cases (CDC, 2002). Our findings in the 50,000-person town model were consistent with these estimates; under scenario 3,500 introductions into a population of 50,000 would give rise to approximately 1,100 new cases of smallpox. In both size versions of the model, reactive mass vaccination at the town level had additional value in bringing an epidemic under control. We estimate the number of reactive mass vaccinations required to incrementally reduce the epidemic by one case to be about 190 vaccinations in the 6,000-person town/10-attack-case model versions and about 35 vaccinations in the more intense 50,000-person town/500-attack-case model version. Although a good deal of variation in the size and other characteristics of the modeled epidemics is expected in a highly stochastic epidemic model, we were nonetheless surprised by some of our observations (Bailey, 1953; Whittle, 1955). In our epidemic simulation runs, 1) epidemics ranged dramatically in size and duration based on chance alone, 2) the epidemic impact of individual index (attack) cases ranged from no transmissions whatsoever to large and lengthy transmission chains, and 3) the epidemic reproductive rate varied substantially by clinical disease type and by epidemic generation and was dependent on the underlying social network configuration. These results suggest that the heterogeneity of our microscale, agent-based model has significantly impacted the resultant epidemics. Limitations It is possible that some important parameters may not have been considered in the development of this model. For example, age-specific differences in the pathogenicity and transmissibility of smallpox were not considered, other than as they relate to age older than 32 years and prior vaccination status as well as social contact processes (schools for children vs. workplace for adults). We did not explicitly include risks of smallpox vaccination as a source of adverse outcome in our model. The number of vaccinations used in each modeled response is given in the Results section and can be used to estimate adverse outcomes. Another potentially important biological variable unexamined in this exercise is the effect of seasonality on transmission of smallpox (Fenner et al., 1988).
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Ethical and Legal Considerations in Mitigating Pandemic Disease: Workshop Summary Perhaps the most important model parameters incompletely considered in this work are the social networks and contact processes that dictate disease transmission patterns. Clearly, there is a trade-off between the inclusion of a large degree of detail and heterogeneity in the social structure in a model and the complexity of the resultant model (Ferguson et al., 2003). We have included the level of social detail that we believed necessary to capture the transmission dynamics of smallpox. Although we explicitly modeled person-to-person contacts in hospitals, households, schools, and workplaces, our representations of these social units were admittedly crude. Although we addressed a range of model parameterizations and model structures, a larger sensitivity analysis may reveal surprising results. In future work, we will continue to examine the sensitivity of our results to specific model parameters. Another limitation of this work is not the model itself but its proper interpretation and use. We caution that the numbers of cases generated in various scenarios should not be taken as quantitative predictions, but instead as a basis for comparing and evaluating different intervention strategies. We also note that in this exercise we modeled only a single geographically confined attack on a relatively small discrete social unit (6,000- or 50,000-person town). In the event of a real smallpox attack, response strategies would have to consider larger social networks and possible repeated introductions over a wide geographic area. Conclusions Our simulation exercise revealed that contact tracing and vaccination of household, workplace, and school contacts, along with prompt reactive vaccination of hospital workers and isolation of diagnosed cases, could contain smallpox at both epidemic scales examined. Individual-based simulations of smallpox epidemics provide a valuable tool in crafting policy regarding outbreak response. REFERENCES Annas G. 2002. Bioterrorism, public health, and civil liberties. New England Journal of Medicine 346(17):1337-1342. APHA (American Public Health Association). 1918. Influenza: A report of the American Public Health Association. Journal of the American Medical Association 71:2068. Bailey NTJ. 1953. The total size of stochastic epidemic. Biometrika 40:177. Bayer R, Fairchild A. 2002. The limits of privacy: Surveillance and the control of disease. Health Care Analysis 10(1):19-35. Bell DM, World Health Organization Working Group on International and Community Transmission of SARS. 2004. Public health interventions and SARS spread. Emerging Infectious Diseases 10(11):1900-1906. Benenson AS, Ed. 1995. Control of Communicable Diseases Manual. Washington, DC: American Public Health Association.
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Ethical and Legal Considerations in Mitigating Pandemic Disease: Workshop Summary TABLE 3-4 Daily Transmission Probabilities, x,aAmong Children andAdults, by Mixing Group, and Group Sizes Contact group Mean size Children Adults Pre-school School Small playgroup Large daycare Elementary Middle High Small playgroupd 2.9 0.03000 Large day-care centers 15.8 0.02000 Elementary school 77.8 0.01000 Middle school 145.3 0.00800 0.00800 High school 113.7 Family 2.5 Child 0.03520 0.03520 0.03520 0.03520 0.03520 0.01240 Adult 0.01240 0.01240 0.01240 0.01240 0.01240 0.01510 Household social cluster 10.1 Child 0.03000 0.03000 0.03000 0.03000 0.03000 0.01000 Adult 0.01000 0.01000 0.01000 0.01000 0.01000 0.01000 Hospital Smallpox ward 133.0 Worker-worker 0.00200 Worker-visitor 0.00200 0.00200 0.00200 0.00200 0.00200 0.00200 Patient-worker 0.00010 0.00010 0.00010 0.00010 0.00010 0.00010 Patient-visitor 0.00010 0.00010 0.00010 0.00010 0.00010 0.00010 Other wards 533.0 0.00050 Workgroup 0.01000 Neighborhood 500.0 0.00004 0.00004 0.00005 0.00005 0.00005 0.00014 Community 2000.0 0.00001 0.00001 0.00001 0.00001 0.00001 0.00003 aThe probability that an infected person with ordinary smallpox, on the second day after the onset of fever, makes sufficient contact to infect an unvaccinated susceptible person in the mixing group being modeled.
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Ethical and Legal Considerations in Mitigating Pandemic Disease: Workshop Summary TABLE 3-11 Summary of Results of Epidemic Simulation Runs Showing the Effects of “No Response” Scenarios 1 and 2 and Response Scenarios 3-10 on Epidemics Initiated by the Introduction of Ten Smallpox Cases into 6,000-Person Towns Scenario Single Uniform Town Four Hub-and-Spoke Towns Ring of Six Towns Cases Deaths New Vaccina-tions Duration (days) Cases Deaths New Vaccina-tions Duration (days) Cases Deaths New Vaccina-tions Duration (days) Mean (SD) Mean (SD) Mean (SD) Mean (SD) Mean (SD) Mean (SD) Mean (SD) Mean (SD) Mean (SD) Mean (SD) Mean (SD) Mean (SD) No response 1 5,231.6 (46.5) 1,650.4 (34.7) NA (NA) 649.7 (124.4) 5,226.9 (58.3) 1,638.9 (40.0) NA (NA) 643.1 (146.1) 5,240.2 (47.5) 1638.7 (30.6) NA (NA) 629.1 (115.0) 2 2,981.3(623.2) 935.0 (198.3) NA (NA) 394.9 (82.2) 2,521.2 (583.0) 788.1 (181.5) NA (NA) 470.9 (125.5) 2,167.9 (996.3) 676.4 (313.0) NA (NA) 416.2 (125.3) Response 3 47.2(16.5) 11.3 (5.1) 355.7 (88.2) 76.9 (17.7) 35.5 (14.4) 9.5 (4.9) 295.0(78.4) 69.2 (15.1) 43.6 (14.8) 11.4 (4.9) 332.9 (68.8) 75.6 (16.5) 4 45.9(21.9) 11.4 (5.8) 351.6 (99.2) 73.0 (17.7) 39.9 (16.6) 9.3 (4.2) 309.7 (69.5) 70.5 (16.5) 34.8 (12.4) 8.9 (4.2) 306.8 (64.6) 68.5 (16.1) 5 35.9(12.7) 9.8 (4.2) 316.2 (62.0) 66.9 (12.6) 41.2 (11.8) 11.0 (3.7) 324.6 (60.2) 71.4 (13.2) 38.5 (17.7) 10.3 (5.0) 314.9 (75.9) 65.6 (10.4) 6 32.2(13.6) 8.4 (4.5) 2,373.1 (46.1) 59.7 (12.7) 28.9 (10.4) 7.0 (3.1) 2,359.8 (45.3) 57.9 (11.1) 24.2 (6.7) 6.8 (3.0) 2,357.9 (44.5) 54.8 (10.6) 7 25.1(8.6) 7.0 (3.5) 2,364.6 (49.7) 58.3 (13.8) 29.4 (8.9) 7.5 (2.6) 2,373.9 (42.4) 60.0 (9.9) 28.2 (10.70 7.8 (3.4) 2,363.0 (51.9) 58.3 (15.9) 8 22.2(10.1) 5.8 (2.9) 4,502.7 (28.9) 46.9 (6.4) 19.8 (7.2) 4.7 (2.6) 4,492.5 (31.3) 46.7 (10.2) 17.5 (4.0) 4.9 (1.9) 4,505.0 (29.5) 43.3 (7.4) 9 17.3(4.7) 4.3 (2.0) 4,505.7 (38.4) 45.2 (8.0) 19.9 (5.6) 5.9 (2.1) 4,501.8 (38.0) 46.7 (8.1) 18.6 (5.8) 5.1 (2.6) 4,504.1 (29.80) 45.2 (5.8) 10 44.2(21.1) 11.2 (5.5) 334.9 (94.0) 70.2 (18.3) 42.5 (17.9) 10.9 (5.3) 323.5 (82.4) 75.5 (19.5) 32.5 (10.2) 8.2 (3.9) 282.9 (46.5) 66.1 (10.0) Data from single uniform town, ring town, and hub-and-spoke town architectures are shown. For each scenario, the number of infected persons, number of deaths, number of vaccinations administered, and duration of the epidemic are shown.Totals include index generation (G0) cases along with subsequent cases.
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Ethical and Legal Considerations in Mitigating Pandemic Disease: Workshop Summary TABLE 3-12 Summary of Results of Epidemic Simulation Runs Showing the Effects of “No Response” Scenarios 1 and 2 and Response Scenarios 3–10 on Epidemics Initiated by the Introduction of 500 Smallpox Cases into 50,000-Person Towns Scenario Single Uniform Town Ring of Six Towns Cases Deaths NewVaccinations Duration (days) Cases Deaths New Vaccinations Duration (days) Mean (SD) Mean (SD) Mean (SD) Mean (SD) Mean (SD) Mean (SD) Mean (SD) Mean (SD) No response 1 46,474.6(109.3) 14,641.7 (117.9) NA (NA) 1,280.8 (159.6) 46,463.7 (100.0) 14,623.4 (66.2) NA (NA) 1,204.5 (139.3) 2 26,915.2(819.4) 8,435.3 (288.6) NA (NA) 453.2 (30.4) 27,103.0 (784.3) 8,476.0 (220.60 NA (NA) 531.7 (77.2) Response 3 1,609.5(90.2) 415.6 (29.6) 8,780.7 (445.2) 104.3 (13.1) 1,563.6 (95.4) 406.8 (28.9) 8,325.4 (407.7) 105.1 (16.6) 4 1,635.9(133.5) 429.9 (35.0) 8,945.1 (592.5) 109.2 (18.6) 1,500.2 (59.2) 400.5 (16.1) 8,114.5 (445.6) 107.3 (10.1) 5 1,657.3(88.0) 429.6 (22.5) 8,988.3 (371.2) 112.5 (9.7) 1,472.6 (126.7) 392.1 (37.1) 7,993.1 (618.2) 101.9 (11.8) 6 1,146.9(69.3) 305.1 (21.1) 22,023.1 (149.3) 87.1 (6.5) 1,101.2 (55.8) 299.4 (13.7) 21,723.2 (202.6) 81.4 (6.3) 7 1,160.2(52.5) 310.6 (20.6) 22,041.2 (206.0) 86.8 (6.2) 1,088.2 (43.2) 295.1 (15.3) 21,784.2 (202.6) 90.5 (11.5) 8 772.5(45.7) 216.4 (14.0) 37,516.9 (84.8) 66.0 (8.9) 775.0 (17.4) 219.9 (11.6) 37,529.3 (115.3) 65.6 (10.3) 9 780.5(25.6) 211.7 (12.1) 37,560.0 (59.6) 63.6 (7.4) 756.8 (32.1) 214.8 (10.5) 37,569.0 (117.8) 60.3 (5.0) 10 1,634.8(79.3) 428.2 (21.6) 8,928.2 (336.2) 116.0 (14.9) 1,512.6 (50.1) 398.3 (20.2) 8,018.1 (248.3) 104.5 (11.1) Data from simulations on the single uniform town and ring town architectures are shown (simulations on the hub-and-spoke town architecture were not performed for the 50,000-person town).
Representative terms from entire chapter: