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6 The Challenges to Post-Eradication Outbreaks OVERVIEW As the United States enters the post-eradication era, it is critical that we develop thoughtful institutional strategies to meet the challenges of poten- tial reintroduction or re-emergence of disease. The waning of surveillance and laboratory diagnostic capability, reduced medical awareness, lack of vaccine supply and production capacity, limiter! institutional response ca- pacity, decreased immunity in the population at large, and increased threats of bioterrorism all leave the non-immunized populace highly vulnerable to a post-eradication outbreak. Planning for the post-eradication era will likely warrant consideration of major outbreak scenarios and the requires! capac- ity for response. Hospitals serve as a major hub in the U.S. health care system ant! can and should play a major role in an outbreak response. However, they have neither the capacity nor infrastructure to handle such a crisis, and there are no financial incentives or mandates in place to encourage them to devote efforts to anticipate potential outbreak scenarios. There is an enormous amount of work to be done to prepare hospitals for the post-eradication era. Because of the increasing threat of bioterrorism, especially with regard to smallpox, planning for potential outbreaks in a post-eradication era should involve consideration of national security implications in addition to public health considerations. Although health care workers would be the sentinels of any outbreak response, no matter what the security implica- 141

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142 CONSIDERATIONS FOR VIRAL DISEASE ERADICATION tions, a bioterrorist act may require the involvement of other communities, such as intelligence and defense and arms control, that may not typically be involved in outbreak response. The appropriate agencies and institutions must be prepared to offer a swift and effective collaborative response. Preparing for unexpected disease outbreaks also requires a flexible and adaptive post-eradication vaccine program involving continued vaccine pro- duction, research, and development. Vaccine manufacture must keep up with changing regulatory requirements (e.g., safety issues concerning the threat of prior-mediated diseases from animal protein components of vac- cines), new scientific challenges (e.g., alterations to the virus), and changes in the manufacturing process. Institutions must be prepared to deal with the psychological challenges expected to surface during a post-eradication outbreak, namely, fear and panic. Well-traineci responder staff, effective communication regarding the risks of infection and exposure, and a swift, well-coordinated public health response will be key in promoting a healthy public reaction. Although U.S. institutions may be starting to take some steps in prepa- ration for a post-eradication era, much of the developing world lags far behind. Many countries are not only still struggling with early eradication initiatives for example, immunizing all children and developing effective communications networks they are doing so in the face of adversity. Many developing countries lack not only immunization services but basic health care services as well, and are in the midst of conflict situations where vaccinators are being killed in the field. This issue of equity has increasingly become a component of global health concerns. Access to limited quantities of vaccines has been debated as a human rights issue. Within the United States, this focus has been on the uninsured and underserved populations. More broadly, in developing coun- tries where the ability to pay for vaccines and maintain appropriate infra- structure for vaccine delivery remains quite limited- the responsibilities of international organizations, national governments, development banks, and private-sector suppliers are raised as a challenging ethical question. i: READY OR NOT: THE U.S. HEALTH CARE SYSTEM AND EMERGING INFECTIONS Kenneth D. Bloem, M.P.Ho Senior Fellow, The Johns Hopkins University Center for Biodefense Studies, Baltimore, MD, and Former CEO, Georgetown University Medical Center, Washington, DC The preparedness of the U.S. health care system to respond to future

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THE CHALLENGES TO POST-ERADICATION OUTBREAKS 143 disease outbreaks accidental or intentional- deserves careful consider- ation. A caveat may be in order here, however, as this topic will force us to descend from the Olympian heights of scientific discourse to the arid plains of bureaucracies, institutions, and politics. This presentation will focus on hospitals, clinics, and home care agencies what is commonly termed the "U.S. health care system" as opposed to the public health system, whose readiness is addressed elsewhere in this report. To the question, "Are we prepared?" the answer, in my opinion, is emphatically negative. This lack of readiness is characterized by: lack of capacity and infrastructure, lack of incentives and mandates, absence of networks of collaborating institutions, and unresolved staffing and legal policy issues. It is worth noting that there may be legitimate conflicting perspectives on what role the U.S. health care delivery system should play in response to an epidemic that constitutes a major public health threat. This paper sup- ports the notion that the acute health care system can and ought to play a very important, but delimited, role in helping the nation respond to future outbreaks. Following is an assessment of the four problems listed above. Their solutions are critical to an effective health care system response. Capacity and InEastructure Issues In order for the health care system to respond effectively to a potential disease outbreak, the health system must be operating reasonably effec- tively prior to the outbreak. That is, a certain amount of basic functionality, organizational infrastructure strength, and extra capacity (i.e., availability of drugs, equipment, supplies, and personnel) will be a sine qua non of an effective response. If hospitals and physicians are already struggling to handle day-to-day operations due to a lack of staff, equipment, and other core capacities, it will be impossible for them to respond effectively to a . ... . . s~gn~cant crisis. Unfortunately, U.S. hospitals are currently experiencing tremendous economic pressures. One-third of all hospitals are losing money. Of the two-thirds that are still profitable, their margins declined by a third be- tween 1998 and 1999. Their profitability is only 4.7/O, which is only slightly above the medical Consumer Price Index (CPI). In addition to the Balanced Budget Act of 1997, which reduced aggregate hospitals' Medicare payments by more than Congress intended, hospitals face a host of new regulatory demands including HIPAA (Health Insurance Portability Act), which industry analysts estimate will cost the sector more than did Y2K

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144 CONSIDERATIONS FOR VIRAL DISEASE ERADICATION preparedness efforts. Other regulatory pressures include ergonomic regula- tions, patient safety regulations, and major seismic upgrades (for California hospitals), to cite just a few. The problems hospitals currently face are not only financial. The most acute operational issues relate to staff shortages- including nurses, tech- nologists, pharmacists, technicians, nurses' aides, housekeepers, medical records coders, and others. Current staff levels are insufficient for hospitals to cope even with the small and entirely predictable seasonal influenza epidemics. To cite a few examples: In December 1999, during the flu season, three-quarters of the Los Angeles emergency rooms were so full that, for 10 days, they had to reroute ambulances to other hospitals. In Maryland, the amount of time that hospitals are on "emergency by-pass" has doubled each year for the past three years. . In San Antonio, the city's Emergency Medical Services physician- director was quoted in a New York Times article by C. Goldberg, "Emer- gency Crews Wary as Hospitals Say, 'No Vacancy,' " December 17, 2000, as saying "We're dying; I got called nine times yesterday to divert my ambulances and that wasn't an unusual day. We've got an epidemic of the nonavailability of acute care beds, and the epidemic is becoming a pan- demic." Because the population is aging and academic enrollments in key health care professions have declined, most observers are worried that these infra- structure problems will only become worse. In the same New York Times article mentioned above, the director of a suburban Boston ER, for ex- ample, likened ERs to canaries in the coal mine: "We are basically the canary that's telling the story that the whole system is in trouble, its capac- ity is inadequate to meet the peak demands." In addition to chronic infrastructure deficiencies, hospitals lack the capacity to handle "surges" of new patients. For example, a 1998 survey of ~ . ~ ~ ~ ~ ~ . medical resources for the state ot Minnesota revealed that only 60 of 144 acute care hospitals only 465 beds state-wide had negative air pressure rooms, which are critical tools for managing patients with highly conta- gious diseases (Osterholm and Schwartz, 2000~. As another example, a recent fire in a downtown high-rise motivated the Maryland Secretary of Health to commission a study which revealed that the city of Baltimore, home to two major meclical centers and medical schools, could not handle a situation involving only 100 casualties needing overnight ventilators (O'Toole, 2000~. After two decades of hospital reimbursement policies based exclusively on market principles, hospitals now operate on a " just in time just what's

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THE CHALLENGES TO POST-ERADICATION OUTBREAKS 145 required" basis which governs the availability of drugs, supplies, equip- ment, and staffing. In the process, we have lost sight of the historic concept of the hospital as a community resource that is always ready in the event of disease outbreak. Incentives and Mandates Among the range of issues with which hospital executives deal on a daily basis, a potential disease outbreak whether accidental or as a result of bioterrorism- is a low-probability event that competes for attention with more pressing, and more certain, matters. Currently, hospitals have neither incentives, such as funding, to prepare for future outbreaks, nor a legal mandate to do so. Since the Reagan administration, the United States' policies governing hospital reimbursement have been fundamentally free-market-based. This has led to economic competition among hospitals within a community, as well as the notion that hospitals that support "issues of the commons" (e.g., care for the poor, medical education, biomedical research) without receiv- ing full reimbursement are doing something "economically irrational." Spending significant dollars preparing for bioterrorism, or a similar event on behalf of the community, would trigger a red flag to a hospital's man- age`1 care payers, who would think they were overpaying (Bentley, 20001. This does not imply that hospitals would not respond in the event of a crisis. In fact, American hospitals have a record of extraordinary response when disaster strikes. The point is that, without preparedness funding, it is economically irrational to expect or hope for preparatory efforts on the part of any individual health care organization. In addition to a lack of incentive for hospitals' preparatory efforts, there is no mandate requiring such activity. Currently, the closest thing to a hospital mandate is a Joint Commission on the Accreditation of Health Care Organizations (TCAHO) requirement that every hospital have emer- gency plans and drills in place to cover a broad range of potential disasters. Legal mandates and financial incentives will likely be required to cata- lyze hospital response on this issue. At least four types of financial protec- tion will be necessary: Funds to help hospitals address fundamental capacity and infra- structure deficiencies, Funds for outbreak response planning and preparedness, Compensation for direct patient care in the event of an outbreak, combined with a loosening of the usual requirements for detailed corrobo- rating documentation, and Reimbursement for extraordinary institutional costs.

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146 CONSIDERATIONS FOR VIRAL DISEASE ERADICATION In addition, immunity from liability will be necessary in the context of actions that outbreak management typically entails: triage decisions, deal- ing with immuno-suppressed populations, mandatory vaccination, and quarantine. Regional Collaborative Networks An effective community response to an outbreak will require that mul- tiple health organizations and the public and private sectors respond in a highly integrated fashion. This collaboration must bridge at least three distinct health communitiespublic health, emergency management/first responders, and medical care deliveryeach of which has its own culture, language, and clecision-making processes. All three communities will need to be linked with local and state elected and government authorities, law and order institutions, state laboratories, military hospitals, the Centers for Disease Control and Prevention (CDC), and other agencies. However, substantial communications and knowledge barriers exist within anal among all of these various health agencies. For example, a recent TOPOFF exercise, named for its engagement of top officials of the U.S. government, was held in Denver in spring 2000. It tested the readiness of government officials and agencies to respond to a bioweapons event. In an assessment of TOPOFF, a number of the participants noted that differ- ent professions practiced different decision-making processes. One observer commented that, "In public health, most decision-making is through demo- cratic processes and consensus-building, but for some decisions, this cannot work." Another observer remarked, "The time frame that public health is accustomed to dealing with is not what is needed for bioterrorism. In this type of crisis, one needs to make decisions quickly. You don't have the luxury of time to do more research." One public health official noted a widespread lack of familiarity with termssuch as a lIC ~ loins Information Center), a fOC (joint Operations Center), or DMORTs (Disaster Mortuary Assistance Teams) used by the emergency management community (Inglesby et al., 2001~. As another example of a communications barrier, during the West Nile outbreak in New York City in 1999, an infectious disease physician from one of the boroughs notified the New York City Department of Health about two suspected cases of encephalitis. In the meantime, 20 other pa- tients with encephalitis had already been admitted to other NYC hospitals. Although encephalitis is clearly recognizable and is considered a legally reportable disease in New York, none of those other 20 cases had been called in (O'Toole, 2000~. Even if these cases had been called in, the capac- ity of the health agency to respond adequately is uncertain. Dr. John Bartlett, Chief of Infectious Disease at Johns Hopkins University School of Medi-

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THE CHALLENGES TO POST-ERADICATION OUTBREAKS 147 cine, conducted an experiment two years ago in the Hopkins emergency department, during which he simulated a patient with a case of inhalational anthrax. During this exercise, which occurred during a summer weekend, no one he contacted either inside or outside the Hopkins hospital was certain about which telephone number to use or which state official to notify (Osterhoim and Schwartz, 2000~. Finally, a call was made to the state public health officer and an urgent message left on an answering machine. Due to a lack of beepers in the public health department, the call was not answered until three days later. Although the federal government has initiated efforts to create linkages among the emergency management and public health services in 50 to 60 cities nationwide, no region has yet truly integrated emergency manage- ment, public health, and medical services. An effective regional network requires adequate funding, designation of an in-charge organization and individual, and development of a regional response plan that would need to be rehearsed, critiqued, and modified as appropriate. Among the many challenges to overcome are the climate of competition among hospitals, distrust across the public-/private-sector divide, and communications and cultural obstacles among the multiple health communities. Staffing and Legal/Policy Issues Several groups of hospital executives have assembled over the past year under the auspices of the Johns Hopkins Center for Civilian Biodefense and the American Hospital Association (supported by the Department of Health and Human Services [DHHS ~ Office of Emergency Preparedness). Their objective has been to identify issues and barriers to hospitals response to bioterrorism. One set of concerns pertains to hospital staffing, specifically: Staff shortages, which cut across multiple professional and non- professional categories, are national in scope (in the case of nursing, inter- national) and, given declines in academic enrollments for some professions, will [likely be long-lasting. For many health care professions (including physicians, nurses, and pharmacists), licensing restrictions prohibit individuals from practicing across state borders. If unaddressed, this will act as a barrier to importing physicians and nurses from outside crisis areas. Seventy to eighty percent of hospital staff are female, the majority of whom are heads of households or are responsible for the care of family members. In the event of a major epidemic, which could last for weeks or months, the issue of family support becomes critical (Bentley, 2000~. Personal protection in the form of immunizations and access to antibiotics for staff and their families is a critical issue. It is unclear how

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148 CONSIDERATIONS FOR VIRAL DISEASE ERADICATION health care staff will respond to future outbreaks, though it may be instruc- tive to look back at workers' and professionals' concerns during the early days of the AIDS epidemic. A second set of concerns pertains to legal issues. For example, the Emergency Medical Treatment and Labor Act (EMTALA) was designed to prohibit hospitals from refusing treatment to uninsured patients and send- ing them to other hospitals. The legislation requires each hospital to screen and stabilize every patient, even during a disease outbreak when it is likely that a hospital's emergency room may be closed for containment purposes. Also, different hospitals may have different roles in a public health emer- gency; for example, some may be used solely for quarantine, others for triage, and still others for specialized treatment. Thus, during an outbreak, not all hospitals may be capable of screening and stabilizing every patient. The EMTALA was not designed with an era of emerging infections in mind (Bentley, 20001. EMTALA may be just the tip of the iceberg of unresolved legal and public policy issues, many of which relate to the fragmented U.S. legal system. For example, the legal powers that authorize response in a public health emergency are divided between the national and local levels. Inter- estingly, legal power may depend on whether an epidemic is deemed to be natural or intentional; national security law might apply in the case of the latter (Fidler, 2000~. A legal system that emphasizes protection of individual rights, while restricting government powers from impinging on such rights, creates addi- tional potential barriers to an effective public health response. For example, citizens might ignore government orders, such as travel bans, quarantine, or compulsory treatment directives, which could, in turn, increase the likeli- hood that military intervention would be necessary to enforce public health (Fidler, 20001. Conclusion It would be inappropriate to conclude without putting into a larger context the challenge of preparing our health care system to respond to future epidemics. As previously mentioned, there may be legitimate con- flicting perspectives on what role the health care system should assume in the event of a major public health crisis. These perspectives are buttressed by age-old differences in skill sets and attitudes between the medical and public health disciplines, and by large cultural gaps between triage and treatment, containment and continuous quality improvement, and isolation and architectural openness. A Stanford University Hospital analysis found that the routine hospitalized patient encounters over 30 different hospital

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THE CHALLENGES TO POST-ERADICATION OUTBREAKS 149 employees during an average 24-hour period hardly an ideal environment from which to try to contain an epidemic. Nonetheless, hospitals can and should play a major role in outbreak response: The population will undoubtedly continue to seek hospital care for diagnosis, treatment, and prophylaxis. The absence of treatment facilities could contribute to public panic. Hospitals are socially and geographically well-established arsenals within their communities, constituting well-known loci where profession- als, equipment, supplies, and information technology come together in the service of local communities. . < ~ However, it is remarkable how quickly local hospital capacity is over- whelmed in many, if not all, epidemic-response scenarios. There is a need for sophisticated modeling of a range of hypothetical outbreaks, using current hospital capacity data. More importantly, we should explore all reasonable mechanisms to help hospitals substantially expand their capaci- ties to handle mass surges of people (by incremental hundreds or even thousands) in the event of a major epidemic. One option, for example, might be to create expandable big-containment units, which would be self- contained but placed adjacent to hospitals. Such units might enable the use of the existing hospitals' organizational infrastructures, supplies, and per- sonnel, while providing a simple but epidemiologically sound setting for the triage and treatment of far more individuals than the institutions' emer- gency rooms or clinics could safely handle. Similarly, we might explore the feasibility of training a cadre of hospital-based epidemiologists, current EMS physicians, and new staff. These suggestions and speculations are offered as a point of departure for future discussions on how best to help America's health care system prepare for inevitable disease outbreaks. VACCINES FOR POST-ELIMINATION CONTINGENCIES Thomas P. Monath, M.D. Vice President, Research and Medical Affairs Acambis Inc., Cambridge, MA Vaccines have been by far the most efficient means to prevent and control infectious diseases. Smallpox eradication was achieved through vac- cination, and the eradication of poliovirus and measles will be achieved when the prevalence of artificial immunity is sufficiently high to preclude interhuman transmission. The benefits of disease eradication achieved through vaccination include life years gained; savings to patients, families,

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150 CONSIDERATIONS FOR VIRAL DISEASE ERADICATION and society due to reduced morbidity and mortality; avoidance of costs for treatment and continued vaccination; indirect cost savings due to increased productivity; and the freeing-up of health care resources for other interven- tions. Following successful eradication, a responsible policy must include provisions for vaccine reserves and contingency planning in case the disease re-emerges; surveillance and diagnostic activities; and research on and de- velopment of new vaccines and therapeutic drugs. Rationale for Vaccine Reserves Because surveillance and case-finding may be difficult, particularly in medically underserved regions, disease eradication may be uncertain for several years after the last reported case. During this period of watchful- ness, rumors of disease and case and outbreak investigations will continue, and vaccine must be available in the event of re-emergence. The means by which a disease could be reintroduced after presumptive elimination are listed in Table 6-1. For smallpox and other diseases under consideration for potential eliminationpolio, measles, and rubella no enzootic or non- human reservoir has been identified as a source of reintroduction; thus, the principal risks are human factors, inadvertent escape of laboratory stocks, and intentional release (bioterrorism or biowarfare). The consequences of reintroduction become increasingly grave over time clue to the decline of herd immunity, susceptibility of the population to a pandemic, senescence of surveillance and laboratory diagnostic capability, and reduced medical awareness. Smallpox as a Case Study When smallpox was eradicated in 1979, re-emergence was dismissed as highly unlikely for several reasons: TABLE 6-1 Sources of Disease Re-Emergence After Eradication Chronic infection and reactivation (e.g., immunosuppressed hosts) Natural reservoir or zoonotic cycle Closely-related agent fills niche of original virus Vaccine manufacturer's seed viruses Research laboratory stocks Stored diagnostic specimens . . . releases Cross-contaminated or mislabeled laboratory materials Environmental sources, fomites, human remains (e.g., permafrost) Biological weapons, surreptitious stocks, accidents, weapons tests, intentional

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THE CHALLENGES TO POST-ERADICATION OUTBREAKS 151 There was no enzootic reservoir; monkeypox and other zoonotic poxviruses related to the smallpox virus were not considered a significant source for the reintroduction of human pox virus. There were only a limited number of laboratories working with smallpox, and confidence was high that all laboratory stocks had been identified and destroyed. Reference materials were deposited in only two laboratories, one in the United States and the other in the Soviet Union. There was no evidence that smallpox virus could persist or be reactivated in previously infected humans. There was a high degree of confidence that vaccine reserves (ap- proximately 200 million doses deposited at WHO) were adequate for any contingency and vaccine manufacture could be reinstated if necessary. There was lithe concern about any threat posed by biowarfare (BW). In the United States, vaccine manufacture ceased in 1982, and immuni- zation of soldiers ceased in 1989 (Table 6-2~. Smallpox was dismissed as a bioweapon in part because all countries, including the USSR, had participated actively in eradication of the disease. It was, therefore, a surprise to {earn that the Soviet Union, a nation engaged in the eradication effort, would simultaneously engage in surreptitious, state-sanctioned activities that could result in disease reintroduction. More- over, smallpox has undesirable features as a bioweapon for several reasons: the disease is easily diagnosed; attribution of an attack would be obvious; the virus is transmissible and could backfire on non-target populations; the incubation period is long and its effect on a target population delayed; and a vaccine is available and routinely used to protect military forces. The fallacy of these conclusions was not apparent until the early l990s, after a defector from the former USSR revealed that smallpox was consid- ered a strategic (not tactical) weapon. Development of smallpox as a BW TABLE 6-2 Smallpox Vaccination History, United States 1949 Last indigenous cases of smallpox (Texas) 1969-1970 Studies emphasize high incidence of vaccine-related adverse events 1971-1972 Routine vaccination of children ceases 1976 Vaccination of medical workers ceases 1979 Eradication certified by WHO 1982 Wyeth ceases vaccine manufacture 1989 U.S. military ceases vaccination of soldiers 2000 Over half the U.S. population unvaccinated Vulnerability to pandemic spread if reintroduced

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162 CONSIDERATIONS FOR VIRAL DISEASE ERADICATION the biowarfare potential of measles. Measles is transmitted by respiratory droplets and is highly contagious. It can remain infective in droplet form in air for several hours, especially in low relative humidity (CDC, 1992), and can be transmitted by airborne spread as aerosolized droplet nuclei. Under these conditions, it is possible that a biowarfare aerosol release of measles virus could result in infection in exposed, non-immune individuals. Measles causes significant morbidity and mortality in children and is even more severe in aclults. In one study, 30/O of aclult cases exhibited bacterial super- infection of the respiratory tract, 17% exhibited evidence of bronchospasm, and 3/O developed pneumonia requiring hospitalization (Gremillion and Crawford, 1981~. The biowarfare potential of measles would probably figure promi- nently into the defense community's assessment of measles elimination. Given the likelihood of significant complications in military-age popula- tions and the possibility of natural or other reservoirs, future DoD vaccina- tion policies would probably have to take into account possible post-eradi- cation outbreaks. Properly administered measles vaccine results in immunity lasting for at least 16 years (Markowitz and Katz, 1994), but possible security concerns may require further longitudinal studies evaluating the duration of vaccine- induced immunity. Even if civilian vaccine practices were curtailed or dis- continued, it may still be necessary to immunize the military or at least maintain a stockpile of measles vaccine, which would require planning and budgeting for an uninterrupted or standby surge production capacity. If the biowarfare threat from measles were deemed creclible, the efficacy of the current vaccine might have to be assessed in the context of aerosolized transmission, which would depend on identifying an appropriate animal model for human measles. If researchers found that the vaccine were not entirely protective, research into possible antiviral therapies may be war- ranted. Surveillance systems would have to be geared to meet a possible measles threat, and rapid clinical diagnostics and detector technologies may have to be researched and developed. These are only a few of the possible issues that may have to be addressed during a security-based review. Conclusion Incorporating a national security process into an eradication effort introduces a dimension not commonly encountered in public health de- bates. On the one hand, it involves activities that strengthen the objective and purpose of the eradication effort. On the other hand, it raises concerns that may be new to public health practitioners. Security reviews may alter the public health community's fundamental expectations for eradication,

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THE CHALLENGES TO POST-ERADICATION OUTBREAKS 163 and raise questions about traclitional assumptions concerning disease eradi- cation. For example, the conventional wisdom associating significant finan- cial savings with ending routine immunizations may be challenged. Money saved on immunizations may have to be spent on expanded surveillance and vaccine stockpiling programs, for example. As America enters the 21st century, cognizant of the revolutions in biotechnology and genetics and the prospect of biowarfare, the health and security communities must work together to ensure both public health and national security. Disease eradi- cation supports both imperatives, but the long-term consequences must be anticipated from the outset. UNDERSTANI)ING THE PUBLIC AND MEDIA RESPONSE TO AN OUTBREAK Ann E. Norwood, M.D. Colonel, U.S. Army Medical Corps Associate Professor and Associate Chair, Department of Psychiatry Uniformed Services University of the Health Sciences, Bethesda, MD A swift, well-coordinated, and effective public health response is the most powerful psychological intervention in a post-eradication outbreak. Through their actions and comments, political leaders, public health ex- perts, and other key figures at the local, state, and federal levels will shape individual and community expectations, beliefs, and behaviors. In particu- lar, the management of the outbreak in the first hours to days sets the tone for societal responses. Fear and the Public Reaction Infection by a microorganism taps into very deep-rooted fears of being invaded and destroyed by an invisible force. The lack of sensory cues asso- ciated with infection makes it impossible to discern whether or not one has been infected. Many organisms produce ubiquitous symptoms that can go undiagnosed until it is too late to save the victim. A delayed onset between exposure and illness produces tremendous anxiety and uncertainty in those fearing they have been infected. Moreover, much of the public does not have the scientific background with which to understand the outbreak. By definition, post-eradication outbreaks would produce diseases rarely seen in medical practice. There would be limited medical knowledge about diagnosis, treatment, and outcome in the general community. This poses considerable uncertainty for both physicians and patients. In many coun-

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164 . ventlons; CONSIDERATIONS FOR VIRAL DISEASE ERADICATION tries, an epidemic of a disease that produces a high acute mortality rate will be a new experience. While people can become accustomed to quite terrible circumstances, there is a great possibility of panic when they are exposed to an unfamiliar threat for the first time. For example, the first use of gas and the introduction of machine guns in war both produced panic in the troops. As soldiers became familiar with these weapons, however, panic dissipated. Exposure to the dead and disfigured also produces strong psychological responses and is a potent psychological stressor. Understanding which aspects of biological agents invoke terror can aid in developing intervention strategies. For example, unrealistic beliefs about microbes and viruses can be addressed through education. Informing people about what they can expect, thereby lessening surprise and affording them a sense of control through predictability, can alleviate uncertainty. Fear-producing aspects of outbreaks include: the potential for high numbers of casualties; a potentially limited availability of treatments; in some cases, uncertainty about the effectiveness of medical inter- the possibility of an epidemic involving person-to-person transmis- sion; and dispersion of the ill, which can erode the sense of safety in regions far from the original source of infection. Based on data gleaned from studies of disasters and observations of past outbreaks, there are certain elements of an outbreak that influence the public's reaction. How an outbreak has arisen has major implications for behaviors. An act of bioterrorism, for example, can be expected to provoke widespread rage which can be difficult to manage with respect to scapegoating. It could also result in ill-advised policy decisions made in the heat of the moment. Grotesqueness has been demonstrated to be a powerful predictor of strong emotional responses. Diseases like smallpox and hemor- rhagic fevers, such as Ebola, evoke terror in many people. The larger the outbreak, the more strain it places on the community. The disruption of basic community functions and normal activities adds secondary psycho- logical and behavioral stressors. The media will play a major role in determining how the public reacts following an outbreak. In a climate of uncertainty and fear, the public will thirst for information to help them gauge their personal risks. Radio, televi- sion, and the Internet should be used to provide accurate, non-sensational- ized information in order to control rumors and provide instructions on personal safety measures. Psychological responses to outbreaks of eradicated disease can include:

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THE CHALLENGES TO POST-ERADICATION OUTBREAKS 165 the attribution of somatic symptoms to intoxication and infection, scapegoating and stigmatization, and social isolation and paranoia, which contribute to the development of conspiracy theories and mistrust. As the outbreak continues, people may become demoralized and lose their faith in the institutions that are supposed to protect them. All of these responses are influenced by cultural and religious views about causality, cleath, and dy- ing. Therefore, it is very difficult to generalize findings across cultures and over time. The Nature of Panic The word "panic" is often used to describe psychological responses to disease outbreaks. Panic refers primarily to a group phenomenon in which intense, contagious fear causes individuals to think only of themselves. They become paralyzed by fear or seek to escape by any means necessary. Panic also refers to an individual response characterized by the loss of rational thought due to overwhelming terror. A major goal of preparation and response for a post-eradication outbreak is the prevention of panic and the preservation of individual, group, and community function. In examining historical responses to epidemics, Garrett (1994) has made the following observations: Panic does not always go hand in hand with epidemics, nor does its scale correlate with the general gravity of the situation. Indeed, history demon- strates that population responses to diseases are rarely predictable, open peculiar.... Where a hefter dose of public concern was warranted, as in the case of the 1918-19 [influenza] pandemic, an oddly common feature was nonchalance.... In contrast, public reaction to the 29 deaths in Philadelphia [Legionnaires' disease] was extraordinary.... Phrases like "explosive outbreak," "mysterious and terrifying disease," "Legionnaire killer," and "killer pneumonia" filled press accounts as well as the on- camera statements of Philadelphians and politicians. As this statement implies, the way the news is covered shapes the public response to an outbreak. Panic is rare following disasters. For example, panic did not occur following the Tokyo satin attack; although thousands of people sought medical care after the satin attack, they were orderly and obeyed instruc- tions, and first responders and hospital staff managed their responsibilities well. However, this may not happen during an epidemic. The risk factors tor panic are: surprise and novelty, the belief that there is only a small chance of escape, seeing oneself as high risk for becoming ill,

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166 CONSIDERATIONS FOR VIRAL DISEASE ERADICATION . available, but limited, resources in which there is a situation of "first come, first served," a perceived lack of effective management of the catastrophe, and loss of credibility of authorities. The government and medical community will play large roles in shap- ing the public's reaction. Medical responses will be scrutinized for efficacy and fairness. For example, political and medical decisions about what groups to vaccinate first, or which groups will be given highest priority for a limited supply of vaccine, may have a chilling effect. These decisions may also affect those responsible for providing medical care and other essential community services. For example, a question that frequently arises in the first responder community is, "In the event of a contagious agent, would our families be given high priority as well as us?" Policy makers must address how decisions in this area will be made and explained to the public. Protocols should be developed for these scenarios in order to mitigate panic and minimize the risk of poor decisions in the midst of a crisis. The provision of accurate knowledge is an important determinant in whether panic will occur. Even if the news is very bad, knowledge is prefer- able to uncertainty in which fantasies and rumors run rampant. Providing inaccurate news or lying to the public results in loss of credibility that cannot be regained, as was seen at Three Mile Island and in Surat, India. Untrained or mistrained responders can cause group breakdown and institutional panic, which would not be reassuring to the public if it oc- curred in a hospital, for example. There are several factors that could contribute to group disorganization and institutional breakdown: distrust prior to the event, a breakdown in communication failure of critical elements, poor leadership, and a perception that there is no effective response. Realistic simulation training maximizes the probability of people per- forming their roles well by identifying key personnel and facilitating the development of personal relationships. It minimizes panic by teaching deci- sion-making and problem-solving skills under calm conditions, rather than during the chaotic time of an actual response. While panic may not be evident during a crisis, there will likely be significant numbers of the "worried well" seeking medical evaluation. The signs and symptoms of anxiety are protean and ubiquitous. People who have been exposed to infection often worry that they are becoming ill when they experience anxiety symptoms. Following an outbreak, well-designed

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THE CHALLENGES TO POST-ERADICATION OUTBREAKS 167 risk communication can reassure low-risk citizens that they are not sick, thereby reducing the number of people seeking hospital evaluation. Now, despite having devoted so much time to a discussion of the multidimensional nature of panic, it may be wise to strike the word "panic" from our lexicons. Telling people not to panic may, in fact, reinforce the behaviors we are trying to prevent. Also, in terms of trying to understand and develop predictive models about how the public will behave, it is far more helpful to explicitly describe the behaviors rather than lumping them uncler the rubric of "panic." Historical Examples and Post-Outbreak Interventions Following the SCUD attacks on Israel during the Gulf War, for every ill or injured casualty seeking medical assistance, there were four non-ill be- havioral casualties seeking aid. This phenomenon has also been observed during disease outbreaks. Furthermore, medical and hospital support per- sonne! are not immune from fear-organized behaviors, such as absenteeism and decreased performance, especially in circumstances where emergency and health personnel are worried about their families. The 1994 outbreak of pneumonic plague in Surat, India, illustrates how fear-organized behaviors can dominate the public's response to an epidemic. This is true despite the fact that, in this case, the organism was susceptible to antibiotics. Stigma and social isolation had economic as well as psychological consequences, and fear of disease dissemination eroded feelings of safety in many parts of the world. Communicating the risks and managing fear, anger, and paranoia should be major intervention objectives in the wake of a post-eradication outbreak. Overdedication- people continuing to work despite suffering the ef- fects of fatigue from sleep deprivation and intense mental and physical activity is a common problem in crisis situations. There are scores of case examples in which exhausted leaders have made poor clecisions which have endangered others. Protocols need to specify plans for rotating all person- nel. This is especially critical in situations in which the outbreak may ex- tend from days to weeks to months. The tendency of the science community to debate and criticize as a way of seeking the truth will not reassure the public and may actually lead to the loss of credibility. A number of experts have emphasized the need for "one voice" to provide information to the public. While this is a laudable goal, it may be unreachable given the long-standing traditions of scientific dis- course. We need a better understanding of how the public should be trained to anticipate and cope with the diverse, and often conflicting, information that will be disseminated in the wake of an outbreak. For example, follow- ing the midwestern U.S. floods in 1997, there were discrepancies in the

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168 CONSIDERATIONS FOR VIRAL DISEASE ERADICATION amount of time residents were told to boil their water by different govern- ment agencies. In the face of this confusion, how did people decide what to clo? Discrepancies between what leaders and experts are telling people to do and what they, themselves, are doing, will not escape media notice and will undermine the credibility of the authorities. Recommendations Multiple research methodologies must be employed to address the psychological and behavioral consequences of a post-eradication outbreak. Policies on the distribution of limited resources, such as vaccine and antibiotics, should! be informed by behavioral research and ethical review. Planning for the behavioral and psychosocial aftermath of a post- eradication outbreak requires a multidisciplinary effort involving political, medical and mental health leaders, governmental and social institutions, ant! the citizenry. While developing outbreak policies, the emotional and physical impact of a major disease outbreak on leaders must be taken into account in order to ensure rational. informed decision-makin~ during the crisis. Research should be directed toward delineating how best to enlist media support in the management of outbreaks . . . . . . ~ . The behavioral and societal effects of past infectious disease out- breaks should be studied systematically and a taxonomy developed which can be used to identify the effects and course of responses to outbreaks. These studies should examine responses in individuals, families, small groups, hospitals, and communities. The review should! also examine the response to past uses of mass quarantine, evacuation, immunization, and isolation. Information gleaned from these studies can serve as the basis for hypotheses which can be tested in future outbreaks. Infectious disease specialists, risk communication experts, public officials, and members of the media should develop communication and information programs for each disease of concern. Effective risk communi- cation after an attack will be key in promoting healthy and constructive public behaviors and reducing fear-organized behaviors. These programs should designate who will inform the public, and they should delineate the specific actions recommended for citizens to minimize their possibility of falling ill. Messages must be specifically designed for each segment of the population, based on available information and input from credible com- munity leaders.

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THE CHALLENGES TO POST-ERADICATION OUTBREAKS POST-ERADICATION CHALLENGES IN THE DEVELOPING WORLD Ellyn W. Ogden, M.P.H. 169 Worldwide Polio Eradication Coordinator and Senior Technical Advisor for Health and Child Survival, Bureau for Global Programs U.S. Agency for International Development, Washington, D.C. The U.S. Agency for International Development (USAID) provides for- eign assistance to developing countries and maintains offices and ongoing programs in nearly every country of the developing world. Immunization has long been a hallmark of AID's child survival activities. In 1996, at the urging of Rotary International, Congress directed USAID to establish a global polio eradication program that would provide a minimum of $25 million per year for polio-specific activities. The rationale for this earmark was based on the success of the eradication efforts in the Americas, where USAID had been the largest external donor, and on the belief that savings would come once vaccination could stop. Annual estimated savings from vaccination costs alone ranged from $230 million per year in the United States to $1.5 billion globally, in perpetuity, once immunization ceased. Because of a complex budget structure and earmarks for USAID, much of the funding had to come out of existing resources, primarily routine immu- nization programs. Knowing the enormous challenge of immunizing chil- dren and establishing certification-standard surveillance in the most diffi- cult-to-reach areas of Africa and South Asia, often under conflict situations, as well as concerns regarding cessation of immunization, USAID entered into this commitment with skepticism. However, once engaged, the com- mitment has been strong and visible, with hopes that USAID, working closely with its partner organizations, would leave a long-term legacy behind. I have listened carefully to the presentations over the last few days and the doubts being raised about the feasibility of stopping polio immuniza- tion. If true, USAID is in a very difficult position. We have pledged to maintain political, financial, and technical involvement until the world is certified polio-free, even if the road is bumpier and longer than originally planned. Any lessening of the effort at this point in the eradication program would be a signal to other donors and to host country governments that they can retreat. This risks halting the momentum currently enjoyed by the program as well as setting the stage for polio cases to resurge to pre- eradication levels100 times what they are today. USAID does not want to send this signal without seriously considering all of the scientific data and

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170 CONSIDERATIONS FOR VIRAL DISEASE ERADICATION opinions, how the public and Congress would perceive it, and what it would mean in terms of USAID's credibility. While many reputable scientists and virologists are firm in their belief that polio eradication is feasible and immunization can safely stop at some point in the near future, others, equally strongly, believe that polio immuni- zation may never cease. If the funds spent on eradication cannot be re- coupect, then how do we tell our constituentsthe children in developing countries that we have invested nearly $1.8 billion thus far, anal that this amount is increasing, for an activity that may never be stopped. In the meantime, in a district in Zambia, for example, it costs about $11 per capita to provide an essential package of basic health services, but currently available resources amount to only $5 per capita. Access by developing countries to limited supplies of vaccine stockpiles and costs to contain potential outbreaks in the post-eradication era, raise additional issues of equity and public health priority. This is a very serious issue. The need for eradication and anticipating post-eradication needs must be balanced with the general health needs of the children, while at the same time maintaining USAID's integrity and credibility in the eyes of the public, Congress, host countries, and other stakeho1ders. There are a number of other important issues that must also be ad- dressed while considering eradication. Eradication programs have conse- quences, both opportunities and threats, beyond wiping out a virus. First, the great need to provide every child with basic preventive health care, including immunization. House-to-house strategies are no longer enough for delivering polio vaccine, so USAID and its partners are now going child- to-child, which requires intensive effort looking for children in places where we have never looked before. Like the homeless here on the streets in Washington, D.C., it is easy to simply walk by them. But we cannot do this in the slums of Calcutta, for example. To achieve polio eradication we must find and immunize every child. Once we find them how can we ignore them for other services? How do we bring the same intensity of effort and find the resources to bring basic preventive services to them as well? Second, polio eradication is helping to build or revitalize many aspects of health infrastructure in developing countries. One example is the impor- tant area of communications. Most laboratories in developing countries did not have dedicated phone and fax lines until USAID helped pay for them in their effort to establish an effective laboratory network for acute flaccid paralysis (AFP) surveillance. With foresight and planning, the laboratory network will extend beyond AFP, but in order for this to happen, objectives need to be outlined from the beginning. Even if eradication efforts fail, the network is a legacy that must continue if we are ever to build a stronger system of health services. It is this type of global communication system

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THE CHALLENGES TO POST-ERADICATION OUTBREAKS 171 that will alert us to outbreaks of disease anti enable us to take corrective action. USAID considers this a good investment for polio eradication and for protecting the United States. Finally, convict situations are posing tremendous challenges in many developing countries. In the Eastern Congo, for example, administering vaccinations requires negotiating with the Congolese rebels to set aside certain days of peace- something I have personally done. Despite all good- faith negotiations, it is impossible to control all factions or undisciplined soldiers who shoot anybody they see. Everyone from volunteers, to health workers, to staff of U.N. organizations, to clonors, regularly demonstrate acts of courage and put themselves at risk in an effort to vaccinate children. Sometimes, these acts of bravery are a step toward peace-building. Some- times, vaccinators die while conducting eradication activities. CDC, to their credit, has established a Heroes Fund for the many vaccinators who have died since polio eradication started. We should not enter eradication efforts lightly without thinking of these people who are giving up their lives for the sake of eradication. USAID is proud of our involvement in polio eradication and our contri- bution to reducing the death, disability, and social stigma that accompanies the disease. The global program can be prouc! of the success so far; thou- sands of cases of polio have been prevented; children that might have been paralyzed are walking, will marry, be involved in economic activities, and be vital members of their communities. USAID leadership to maximize the benefits of polio eradication, to raise awareness of the health needs of children, and to seek peace will have provided a great service regardless of whether immunization can cease or not. REFERENCES Alibek K. 1999. Biohazard. New York: Random House. Bentley J. 2000. Hospital Preparedness, Presentation at the Second National Symposium on Medical and Public Health Response to Bioterrorism, Washington, D.C., November 28- 29, 2000. Centers for Disease Control and Prevention. 1992. Public sector vaccination efforts in re- sponse to the resurgence of measles among preschool-age childrenUnited States- 1989-1991. Morbidity and Mortality Weekly Report 41(29):522-525. Fidler D. 2000. Legal Issues Surrounding Public Health Emergencies, Presentation at the Second National Symposium on Medical and Public Health Response to Bioterrorism, Washington, D.C., November 28-29, 2000. Garrett L. 1994. Pp. 175-176 in The Coming Plague: Newly Emerging Diseases in a World Out of Balance. New York: Penguin Books. Gremillion DH and Crawford GE. 1981. Measles pneumonia in young adults: An analysis of 106 cases. American Journal of Medicine 71:539-542.

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172 CONSIDERATIONS FOR VIRAL DISEASE ERADICATION Henderson DA, Inglesby TV, Bartlett JG, Ascher MS, Eitzen E, Jahrling PB, Hauer I, Layton M, McDade J. Osterholm MT, O'Toole T. Parker G. Perl T. Russell PK, and Tonat K. 1999. Smallpox as a biological weapon: medical and public health management. Journal of the American Medical Association 281:2127-2137. Inglesby T. Grossman R. and O'Toole T. 2001. A plague on your city: Observations from TOPOFF. Clinical Infectious Diseases 32(3):436~45. LeDuc JW and Becher J. 1999. Current status of smallpox vaccine. Emerging Infectious Diseases 5:593-594. Markowitz LE and Katz SL. 1994. Measles vaccine In Plotkin, SA and Mortimer, EA, (eds.) Vaccines, p. 248. Philadelphia: SUB Saunders. Osterholm MT and Schwartz J. 2000. Living Terrors. New York: Delacourte Press. O'Toole T. 2000. Biological Weapons: National Security Threat and Public Health Emer- gency, CSIS Presentation, Washington, D.C., August 22, 2000, p. 10.