6
Beyond the Biomedical Response

OVERVIEW

An influenza pandemic will likely spawn a plethora of legal and ethical dilemmas and political and economic consequences, and its impact will depend to a large extent on the public’s perception of and reaction to the crisis. This chapter presents a variety of social perspectives on the coming pandemic: economic, legal, and ethical implications of various response options; opportunities for collaboration between public and private sectors; and public communication strategies to address both interpandemic and pandemic influenza.

The chapter opens with a description of an economic model, based on the notion of preparation as an “insurance policy” against the next influenza pandemic, to calculate the investment necessary to prepare for a range of pandemic scenarios and responses. These calculations indicate the mutual exclusivity of two key goals of pandemic planning, minimizing overall mortality and minimizing economic impact, thus highlighting the need for a system by which to make such difficult choices and explain them to the public.

Focusing on the important role in mitigating pandemic influenza of both annual immunization (to build demand for flu vaccine, and therefore supply in the event of a crisis) and prompt vaccination against a pandemic strain, the chapter continues with a consideration of strategies to increase immunization uptake before and during a pandemic. In a pandemic—or even a severe annual flu season, as occurred in late 2003—public health officials face the difficult task of encouraging people with high priority to receive vaccine while persuading others to wait calmly and use nonmedical



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The Threat of Pandemic Influenza: Are We Ready? - Workshop Summary 6 Beyond the Biomedical Response OVERVIEW An influenza pandemic will likely spawn a plethora of legal and ethical dilemmas and political and economic consequences, and its impact will depend to a large extent on the public’s perception of and reaction to the crisis. This chapter presents a variety of social perspectives on the coming pandemic: economic, legal, and ethical implications of various response options; opportunities for collaboration between public and private sectors; and public communication strategies to address both interpandemic and pandemic influenza. The chapter opens with a description of an economic model, based on the notion of preparation as an “insurance policy” against the next influenza pandemic, to calculate the investment necessary to prepare for a range of pandemic scenarios and responses. These calculations indicate the mutual exclusivity of two key goals of pandemic planning, minimizing overall mortality and minimizing economic impact, thus highlighting the need for a system by which to make such difficult choices and explain them to the public. Focusing on the important role in mitigating pandemic influenza of both annual immunization (to build demand for flu vaccine, and therefore supply in the event of a crisis) and prompt vaccination against a pandemic strain, the chapter continues with a consideration of strategies to increase immunization uptake before and during a pandemic. In a pandemic—or even a severe annual flu season, as occurred in late 2003—public health officials face the difficult task of encouraging people with high priority to receive vaccine while persuading others to wait calmly and use nonmedical

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The Threat of Pandemic Influenza: Are We Ready? - Workshop Summary measures to reduce their exposure to infection. Limited research indicates that public officials can avoid losing their credibility in such situations by sharing the dilemmas of disease control with the public in a productive and effective way. Current understanding about the influence and causes of panic in public crises and how to remedy its effects has been advanced through recent efforts to prepare society to deal productively with terrorism. Both the September 11, 2001, terrorist attacks and subsequent anthrax assaults in the United States demonstrated that open and informative relationships among citizens, government, and public health and safety authorities are fundamental to a population’s ability to cope with unconventional health threats. In her contribution to this chapter, Monica Schoch-Spana describes a series of findings by study and research focus groups convened by the Center for Biosecurity of the University of Pittsburgh Medical Center in collaboration with Johns Hopkins University to examine governance dilemmas in bioterrorism response. These groups characterized the unique governing dilemmas posed by a major infectious outbreak and produced guidelines by which decision makers can identify opportunities to enlist public trust and cooperation in such emergencies. Legal authority must be brought to bear on nearly every facet of pandemic preparedness, from measures designed to reduce the risk of animal-to-human transmission of disease; to surveillance and detection procedures; to medical interventions to prevent or control the spread of infection; to the imposition of voluntary or mandatory quarantine and/or isolation measures; to travel limitations, trade restrictions, and border closures. This chapter continues with an examination of the legal and ethical questions attached to major public health interventions for preventing or ameliorating pandemic influenza; it also summarizes ethical values that can inform public health practice in an emergency. THE ECONOMIC IMPACT OF PANDEMIC INFLUENZA IN THE UNITED STATES: PRIORITIES FOR INTERVENTION Martin I. Meltzer, Nancy J. Cox, and Keiji Fukuda1 Centers for Disease Control and Prevention, Atlanta, Georgia, USA Reprinted from Emerging Infectious Diseases, CDC, 2003 1   Address for correspondence: Martin Meltzer, National Center for Infectious Diseases, Centers for Disease Control and Prevention, Clifton Road, Mail Stop C12, Atlanta, GA 30333; fax: 404–639–3039; e-mail: qzm4@cdc.gov.

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The Threat of Pandemic Influenza: Are We Ready? - Workshop Summary We estimated the possible effects of the next influenza pandemic in the United States and analyzed the economic impact of vaccine-based interventions. Using death rates, hospitalization data, and outpatient visits, we estimated 89,000 to 207,000 deaths; 314,000 to 734,000 hospitalizations; 18 to 42 million outpatient visits; and 20 to 47 million additional illnesses. Patients at high risk (15% of the population) would account for approximately 84% of all deaths. The estimated economic impact would be US$71.3 to $166.5 billion, excluding disruptions to commerce and society. At $21 per vaccinee, we project a net savings to society if persons in all age groups are vaccinated. At $62 per vaccinee and at gross attack rates of 25%, we project net losses if persons not at high risk for complications are vaccinated. Vaccinating 60% of the population would generate the highest economic returns but may not be possible within the time required for vaccine effectiveness, especially if two doses of vaccine are required. Influenza pandemics have occurred for centuries, three times (1918, 1957, and 1968) in the 20th century alone. Another pandemic is highly likely, if not inevitable (Patriarca and Cox, 1997). In the 1918 influenza pandemic, more than 20 million people died (Simonsen et al., 1998). Improvements in medical care and technology since the last pandemic may reduce the impact of the next. When planning for the next pandemic, however, decision makers need to examine the following questions: Would it make economic sense to vaccinate the entire U.S. population if 15% were to become clinically ill? What if 25% were to become ill? To answer such questions, we conducted economic analyses of potential intervention scenarios. Although many studies have examined or reviewed the economics of influenza vaccination (Campbell and Rumley, 1997; Carrat and Valleron, 1995; Jefferson and Demicheli, 1998; Kavet, 1977; Office of Technology Assessment, 1981; Patriarca et al., 1987; Riddiough et al., 1983; Schoenbaum, 1987), only one study (Schoenbaum et al., 1976), published in 1976, examined the economics of a vaccine-based intervention aimed at reducing the impact of an influenza epidemic in the United States. Our study examines the possible economic effects of the next influenza pandemic in the United States, analyzes these effects, and uses the results to estimate the costs, benefits, and policy implications of several possible vaccine-based interventions. These estimates can be used in developing national and state plans to respond to an influenza pandemic.2 Unlike the 2   A complete plan detailing a response to an influenza pandemic should include definition of a pandemic, points that will initiate various steps in the response plan, and details about deploying the intervention. While a U.S. federal influenza pandemic plan is being developed, a guide to aid state and territorial health officials in developing plans for their jurisdictions is available at http://www.cdc.gov/od/nvpo/pandemicflu.htm. Printed copies can be obtained from the author.

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The Threat of Pandemic Influenza: Are We Ready? - Workshop Summary 1976 study, ours examined the effect of varying the values of a number of key input variables. Specific objectives were to provide a range of estimates regarding the number of deaths, hospitalizations, outpatient visits, and those ill persons not seeking medical care in the next influenza pandemic; provide a cost estimate of health outcomes; estimate the potential net value of possible vaccination strategies;3 evaluate the effect of using different criteria (e.g., death rates, economic returns due to vaccination) to set vaccination priorities; assess the economic impact of administering various doses of vaccine and of administering vaccine to different age groups and groups at risk; and calculate an insurance premium that could reasonably be spent each year for planning, preparedness, and practice. Methods The Model Building a mathematical model of the spread of influenza is difficult largely because of differences in virus transmission and virulence, lack of understanding of the primary factors affecting the spread of influenza, and shortage of population-based data (Cliff and Haggett, 1993). Because of the difficulties in calculating realistic estimates of the numbers of cases in the next influenza pandemic, we used a Monte Carlo mathematical simulation model (Critchfield and Willard, 1986; Dittus et al., 1989; Dobilet et al., 1985), which uses predefined probability distributions of key input variables to calculate the number of illnesses and deaths that could result from an influenza pandemic. Some of the most important probability distributions we used describe the population-based rates of illness and death. These rates are based on illness and death rates reported in earlier influenza pandemics and epidemics. The model produces a range of estimated effects rather than a single point estimate. The model is not epidemiologic and thus does not describe the spread of the disease through a population. Many details of the model are presented below and in Appendix I; a more detailed explanation and a complete list of all the variables used and the values assigned to the variables are available at Appendix II. For interventions to contain and reduce the impact of an influenza pandemic, we used a societal perspective, which takes into account all benefits and all costs regardless of who receives and who pays. 3   We limited our examination of possible interventions to those involving influenza vaccines. We did not consider the use of antiviral drugs for influenza prophylaxis because there may not be adequate supplies; first priority for such drugs may be for treatment; and the side effects from the drugs, particularly amantadine, make them unsuitable for long-term prophylaxis for many workers, such as drivers or heavy construction operators.

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The Threat of Pandemic Influenza: Are We Ready? - Workshop Summary TABLE 6-1 Estimate of Age Distribution of Cases and Percentage of Population at High Risk Used to Examine the Impact of Pandemic Influenza in the United States Age Group (yrs)     Percentage of All Casesa 0–19 40.0 20–64 53.1 65+ 6.8 Totalsb 100.0   Percentage at High Riskc 0–19 6.4 20–64 14.4 65+ 40.0 U.S. averaged 15.4 aThe actual number of cases will depend upon the assumed gross attack rate. The distribution of cases was based on lower and upper estimates of age-specific attack rates from the 1918, 1928–29, and 1957 epidemics and pandemics (Glezen, 1996). bTotals do not add to exactly 100% because of rounding. cPersons are categorized at high risk if they have a preexisting medical condition that makes them more susceptible to influenza-related complications. The percentages of age groups at high risk were obtained from the Working Group on Influenza Pandemic Preparedness and Emergency Response (GrIPPE, unpub. data). The Advisory Committee on Immunization Practices estimates that 27 to 31 million persons aged <65 years are at high risk for influenza-associated complications (Centers for Disease Control and Prevention, 1998). dAverage is an age-weighted average, using each age group’s proportion of the total U.S. population. Age Distribution and Persons at High-Risk Since the age distribution of patients in the next pandemic is unknown, we assumed a distribution (Table 6-1) among the three age groups (0 to 19 years, 20 to 64 years, and 65 years and older).4 Further, each age group was divided into those at high risk (persons with a preexisting medical condition making them more susceptible to complications from influenza) and those not at high risk (Table 6-1).5 Age by itself was not considered a 4   This article presents the results for one distribution of cases by age and risk group. The background paper in Appendix II, however, contains additional results obtained by using a different distribution. 5   The Advisory Committee on Immunization Practices estimates that 27 to 31 million people ages <65 years are at high risk for influenza-associated complications (CDC, 1998). ACIP

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The Threat of Pandemic Influenza: Are We Ready? - Workshop Summary risk factor; persons 65 years and older were assumed to have higher rates of illness and death than the rest of the population (Table 6-2). Gross Attack Rates In the model, we used gross attack rates (percentage of clinical influenza illness cases per population) of 15% to 35%, in steps of 5%. Infected persons who continued to work were not considered to have a clinical case of influenza, and were not included. Illnesses and Deaths The rates of adverse effects (outpatient visits, hospitalizations, deaths, and illnesses for which no medical care was sought), by age and risk group, were used to determine the number of persons in each category (Table 6-2) (Appendix II). Net Returns of Vaccinating against an Influenza Pandemic Vaccinating predefined segments of the population will be one of the major strategies for reducing the impact of pandemic influenza, and the net return, in dollars, from vaccination is an important economic measure of the costs and benefits associated with vaccination. We calculated the net return by using the following formula for each age and risk group: The savings from illnesses and deaths averted and the cost of vaccinations are described in Appendix I. Some input variables are described below and in Appendix II.     also classifies all 32 million people ≥65 years as being at elevated risk for influenza-related complications (CDC, 1998). Further, the working group on influenza pandemic preparedness and emergency response has assumed that approximately 19 million household members of persons at high risk should also be vaccinated to reduce the probability of transmission to those at high risk (GrIPPE, unpub. data, 1997).

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The Threat of Pandemic Influenza: Are We Ready? - Workshop Summary TABLE 6-2 Variables Used to Define Distribution of Disease Outcomes of Those with Clinical Casesa of Influenza Variable Rates per 1,000 personsb Lower Most likely Upper Outpatient visits   Not at high risk   0–19 yrs old 165   230 20–64 yrs old 40   85 65+ yrs old 45   74 High risk   0–19 yrs old 289   403 20–64 yrs old 70   149 65+ yrs old 79   130 Hospitalizations   Not at high risk   0–19 yrs old 0.2 0.5 2.9 20–64 yrs old 0.18   2.75 65+ yrs old 1.5   3.0 High risk   0–19 yrs old 2.1 2.9 9.0 20–64 yrs old 0.83   5.14 65+ yrs old 4.0   13 Deaths   Not at high risk   0–19 yrs old 0.014 0.024 0.125 20–64 yrs old 0.025 0.037 0.09 65+ yrs old 0.28 0.42 0.54 High risk   0–19 yrs old 0.126 0.22 7.65 20–64 yrs old 0.1   5.72 65+ yrs old 2.76   5.63 aClinical cases are defined as cases in persons with illness sufficient to cause an economic impact. The number of persons who will be ill but will not seek medical care, are calculated as follows: Number illage = (Populationage × gross attack rate) − (deathsage + hospitalizationsage + outpatientsage). The number of deaths, hospitalizations, and outpatients are calculated by using the rates presented in this table. bFor Monte Carlo simulations, rates are presented as lower and upper for uniform distributions, and lower, most likely, and upper for triangular distributions (Evans et al., 1993). SOURCES: Office of Technology Assessment, 1981; Carrat and Valleron, 1995; Schoenbaum et al., 1976; Glezen, 1996; Mullooly and Barker, 1982; Barker and Mullooly, 1980; Simonsen et al., 1997; Fox et al., 1982; Glezen et al., 1987; Serfling et al., 1967; Barker and Mulooly, 1982; Glezen et al., 1982; McBean et al., 1993; Barker, 1986, and Appendix II.

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The Threat of Pandemic Influenza: Are We Ready? - Workshop Summary Input Variables The direct medical costs (i.e., those reimbursed by third-party payers such as health insurance companies) associated with hospitalizations, outpatient visits, and drug purchases were obtained from a proprietary database containing health insurance claims data from approximately 4 million insured persons (The MEDSTAT Group, Ann Arbor, MI) (Table 6-3). Following the methods used by McBean et al. (1993), we extracted the data for outpatient visits from the database with codes from the International Classification of Diseases, Ninth Revision (ICD-9) for pneumonia and bronchitis (ICD-9:480–487.8), acute bronchitis (ICD-9:466–466.1), and chronic respiratory disease (ICD-9:490–496). Costs for inpatient care were extracted with the same codes, when recorded as the principal diagnosis and when recorded as any of the diagnoses in a patient’s chart. Further, because influenza can cause patients with preexisting medical conditions to seek inpatient care, data were extracted for the inpatient costs of treating heart-related conditions (common preexisting conditions that place a person at high risk for influenza-related illness or death). Hospital costs attributed to pneumonia and bronchitis, acute bronchitis, chronic respiratory disease, and the identified heart conditions were then estimated as weighted averages (Appendix II). The principal indirect cost was lost productivity, which was valued by using an age- and gender-weighted average wage (Table 6-3) (Haddix et al., 1996). The economic cost of a death was valued at the present net value of the average expected future lifetime earnings, weighted for gender and age (Haddix et al., 1996). All costs were standardized to 1995 US$ values. The cost of fully vaccinating a person (i.e., administering the number of doses necessary to protect against disease) was modeled with two assumed values, approximately $21 and $62 per person fully vaccinated (Table 6-4). These costs include the cost of the vaccine, as well as its distribution and administration (health-care worker time, supplies); patient travel; time lost from work and other activities; and cost of side effects (including Guillain-Barré syndrome) (Table 6-4) (Appendix II). Vaccine Effectiveness The assumed levels of vaccine effectiveness used to estimate the savings gained due to a vaccine-based intervention are described in Appendix I; the equation defining savings from outcomes averted contains the rate of compliance multiplied by the assumed vaccine effectiveness. In cases requiring two doses of vaccine to satisfactorily protect against influenza-related illness and death, a person was considered compliant only after both doses.

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The Threat of Pandemic Influenza: Are We Ready? - Workshop Summary Net Returns of Vaccination: Sensitivity Analyses To illustrate the importance of the death rate in determining economic outcomes, we conducted further sensitivity analyses in which the death rates for persons not at high risk were one quarter or half of those used in the main analyses (Table 6-2). Insurance Premiums To determine how much should be spent each year to plan, prepare, and practice to ensure that mass vaccinations can take place if needed, we considered the funding of those activities as an annual insurance premium (Kaufmann et al., 1997). The premium would be used to pay for improving surveillance systems, ensuring sufficient supply of vaccine for high-priority groups (and possibly the entire U.S. population), conducting research to improve detection of new influenza subtypes, and developing emergency preparedness plans to ensure adequate medical care and maintenance of essential community services (Kaufmann et al., 1997). We calculated the premium as follows (Robinson and Barry, 1987): annual insurance premium = net returns from an intervention × the annual probability of a pandemic. Vaccination Priorities and Distribution During the early stages of a pandemic, the supply of influenza vaccine will likely be limited. Even if sufficient vaccine is produced to vaccinate the entire U.S. population, it will take time to administer the vaccine to all, especially if two doses are required. Because a pandemic will be caused by a new subtype of influenza, two doses of vaccine may be required. Who should receive priority for vaccination until vaccine supplies are more plentiful? To illustrate the use of the model in estimating the impact of different priorities, we created sample priority lists by using three different criteria: total deaths, risk for death, and maximizing net returns due to vaccination. In choosing the criteria for priorities, society must debate the main goal of a pandemic vaccination plan: prevent deaths, regardless of age and position in society; prevent deaths among those at greatest risk (i.e., 65 years of age); or minimize the social disruption. If the last is the goal of society, the net return due to vaccination should be used to set priorities. The model can also be used to compare the economic consequences of plans that specify which target populations are vaccinated. To illustrate this capability, we constructed four options for prioritizing vaccine distribution. For Option A, the target population is similar to current Advisory Committee on Immunization Practices (ACIP) recommendations, with production and use of vaccine similar to current, intrapandemic recommendations (Centers for Disease Control and Prevention, 1998). We assumed 77.4

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The Threat of Pandemic Influenza: Are We Ready? - Workshop Summary TABLE 6-3 Input Variables Used to Calculate the Economic Impact (Direct and Indirect Costs) of Health Outcomes Due to an Influenza Pandemic in the United States (in 1995 US$) Outcome Category Iitem Age Group (yrs) Type of Cost 0–19 20–64 65+ Sources Deaths   Average age (years)   9 35 74 Assumed PV earnings lost ($)a Indirect 1,016,101 1,037,673 65,837 16, 30 Most likely ± min or max hospital costs ($)b Direct 3,435 ± 2,632 7,605 ± 3,888 8,309 + 3,692 Marketscan Database; 31 Subtotal ($)c   1,019,536 1,045,278 74,146   Hospitalizations   Most likely ± min or max hospital costs ($)b Direct 2,936 ± 2,099 6,016 ± 2,086 6,856 ±3,200 Marketscan Database; 31 Most likely ± min or max net pay for outpatient visits ($)d Direct 74 ± 40 94 ± 70 102 ± 60 Marketscan Database; 31 Avg. copayment for outpatients visit ($) Direct 5 4 4 Marketscan Database Most likely ± min or max net payment for drug claims($)e Direct 26 ± 9 42 ± 30 41 ± 10 Marketscan Database Most likely ± min or max days lostf Indirect 5 ± 2.7 8 ± 4.8 10 ± 5.4 Marketscan Database; 31 Value 1 day lost ($)g Indirect 65 100 or 65 65 30 Subtotal ($)c   3,366 6,842 7,653  

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The Threat of Pandemic Influenza: Are We Ready? - Workshop Summary Outpatient visits   Avg. no. visitsh Direct 1.52 1.52 1.52 Marketscan Database Most likely ± min or max net payment per visit($)i Direct 49 ± 13 38 ± 12 50 ± 16 Marketscan Database Avg. copayment for outpatient visit ($) Direct 5 4 4 Marketscan Database Most likely ± min or max net payment per prescription($)j Direct 25 ± 18 36 ± 27 36 ± 22 Marketscan Database Avg. prescriptions per visit Direct 0.9 1.8 1.4 Marketscan Database Avg. copayment per prescription ($) Direct 3 3 3 Marketscan Database Days lost Indirect 3 2 5 4,5 Value 1 day lost ($)g Indirect 65 100 65 30 Subtotal ($)c   300 330 458   Ill, no medical care sought   Days lost Indirect 3 2 5 4,5 Value 1 day lost ($)g Indirect 65 100 65 30 Over-the-counter drugs ($) Direct 2 2 2 Assumed Subtotal ($)c   197 202 327  

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The Threat of Pandemic Influenza: Are We Ready? - Workshop Summary strain will inevitably raise questions about the appropriate scope of government surveillance and its effects on privacy. Surveillance needs to take place, therefore, with privacy safeguards firmly in place. Case Contact Investigations Case contact investigation is a classical form of surveillance. It involves identifying infected or exposed persons and following their recent contacts. This provides an opportunity to interrupt the spread of infection (see Table 6-10). Persons exposed or infected can be offered antiviral therapy as a prophylaxis or treatment. Those who are infectious or potentially infectious can be separated from the healthy population. Case contact investigation is ostensibly voluntary because the “index case” is under no formal obligation to reveal his or her contacts. Nevertheless, its use in sexually transmitted infections and HIV/AIDS has proved highly controversial (Bayer and Toomey, 1992). The index case may feel coerced into giving information, investigations inherently pose privacy risks, and individuals may experience stigma and discrimination. These investigations, therefore, need to be conducted with sensitivity and respect for individuals and their family, friends, or associates. Vaccination and Medical Treatment The dominant strategy for seasonal influenza is to use vaccinations and antiviral therapy (see Table 6-10). Recommended vaccination of high-risk populations (e.g., children and the elderly) has become standard in developed countries, and mass vaccination could be recommended in the event of a more severe outbreak. Antiviral therapy, although not as effective as vaccination, can be used for prophylaxis, alleviation of symptoms, and reduction of infectiousness (Longini et al., 2004). Therapeutic interventions raise distinct ethical and legal concerns. Although mandating competent adults to be vaccinated or treated for their own protection is a difficult notion to espouse, the law permits a reasonable interference with bodily integrity to prevent harm to the community (Jacobson v. Massachusetts, 197 U.S. 11 [1905]). Although officials have the legal authority to compel vaccination or treatment to protect the public, the political and ethical dimensions of doing so are complex. There is a long history of opposition to vaccinations among certain sections of the population (Spier, 2001). Anti-vaccination sentiments are not always irrational because immunizations can pose risks, as well as confer benefits. Mass vaccination to avert an influenza epidemic can go horribly wrong, as occurred with swine flu in 1976: The CDC campaign to immunize the American population cost $134 million and

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The Threat of Pandemic Influenza: Are We Ready? - Workshop Summary caused Guillain-Barré syndrome in some vaccine recipients (Neustadt and Fineberg, 1983). When used appropriately, vaccination or treatment can confer considerable benefit to the individual and ultimately to a population. Pandemic influenza would likely result in a paucity of vaccines and antiviral medications, raising the hard problem of fair allocation of scarce resources. What ethical values should guide rationing decisions: private need (treatment of the sick); public need (prevention among vulnerable populations); maintenance of essential services (health care workers and “first responders”); or political influence (priority for those with political connections)? Justice may require that therapeutic interventions be used to benefit the most people possible, irrespective of their power or influence. This would militate toward the use of “public need” as the principal ethical value. Therapeutics, therefore, would be used primarily for prevention and targeted to those who pose the greatest risk of transmission. The ethical value of “public need” might also require use of therapeutics for emergency workers to ensure maintenance of essential services and ongoing assistance to the public. This would place private need and political influence lower on the priority scale. The global reality is that rich countries will have much less scarcity than poor countries. The ethical question then arises as to whether developed countries would be expected to forego some of their precious stockpile of vaccines and antiviral medications for the sake of poorer countries experiencing a higher burden of morbidity and mortality from influenza. One might argue that it is in the richer country’s self-interest to do so because infectious disease can and does travel across the globe. Ethical analysis would prove difficult—do developed countries have an obligation to reduce the burden of disease in developing countries? If all human life has the same worth, then it may be ethically desirable to devote therapeutic resources to poor regions experiencing higher burdens of disease. This allocation of resources is likely to have the maximum beneficial effect on morbidity and premature mortality. Community Hygiene One of the most valuable means of infection control is also the least intrusive. Health education to promote safer behaviors such as hand washing, disinfection, masks, ventilation, and avoidance of contacts can be highly effective (see Table 6-10). Community hygiene, although largely uncontroversial, can impose costs (e.g., purchasing and distributing equipment) and cause social unrest (e.g., exaggerated concerns about health risks). Hygiene measures are also culturally sensitive—notice the difference in mask-wearing habits in Asia as compared to North America and Europe.

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The Threat of Pandemic Influenza: Are We Ready? - Workshop Summary Under what circumstances should public health authorities issue a national recommendation for aggressive hygiene measures given the costs and cultural expectations? Probably the most important concern would be the cost effectiveness of the hygiene measure. If a hygiene measure is clearly cost effective, then the public has the right to know how to adopt that measure in a safe way. Vulnerable members of the community may also need economic and technical assistance to ensure equitable access to essential hygiene measures. If a measure is not cost effective, then public health authorities have an obligation to inform the public about the lack of effectiveness and the risks. In some cases, such as the use of masks, the evidence for, or against, effectiveness may be unclear. In such instances, the principle of transparency may suggest that public health officials should state honestly the lack of conclusive evidence, leaving the judgment to the individual. Travel and Border Controls One of the first instincts in the face of infectious disease threats is to protect national borders (see Table 6-10). Consequently, international or national health agencies may issue travel advisories, establish border restrictions, or regulate conveyances such as airplanes, ships, and trains. They might similarly use “stop-lists” to prevent specified individuals or groups from traveling. The IHR afford WHO considerable authority to regulate international travel and control borders. Travelers legitimately claim the right to know health risks, but restrictions significantly affect tourism and trade. Consequently, travel advisories can be politically charged, as were WHO advisories concerning SARS in Ontario, Canada (Krauss, 2003). A delicate balance exists between trade and health. Indeed, the draft revised IHR directs WHO to “provide security against the international spread of disease while avoiding unnecessary interference with international traffic” (WHO, 2004b). When faced with a hard tradeoff between maximization of health or of trade, which should prevail and why? Arguably, health should take precedence over trade because of the fundamental value of human functioning and life itself. Despite the effects on tourism and trade, the public has a legitimate interest in knowing if there are health hazards in regions where they intend to travel. National and international public health agencies have an obligation to take steps that are necessary to prevent the spread of infection across borders. Thus, it would be legitimate to prevent travel of a person who poses a significant risk of transmission. What public health authorities may not do is use infectious disease control as a pretext for discrimination by targeting individuals based on their nationality, race, religion, or other status.

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The Threat of Pandemic Influenza: Are We Ready? - Workshop Summary Decreased Social Mixing/Increased Social Distance Most Americans take for granted the freedom to associate with others in a variety of social settings. Yet public health authorities could restrict social mixing and increase social distance to avert a serious infectious disease threat (see Table 6-10). This might involve closures of civic activities (e.g., schools, workplaces), meeting places or large gatherings (e.g., sports events, theatres, business meetings), and transportation systems (e.g., mass transit, airlines). The purpose behind restrictions on mixing is to prevent rapid spread of infection in settings where multiple people congregate. The U.S. Constitution affords individuals the freedom to associate, but courts would likely defer to reasonable regulation of congregate settings to prevent transmission of infection (New York v. New St. Mark’s Baths, 497 N.Y.S.2d 979 [1986]). As with other interventions, closures entail heavy costs in lost revenue as well as in diminished freedoms. When an infectious disease outbreak deeply affects a society’s everyday activities, public health authorities will have to cogently explain the justifications for the chosen intervention and gain the public’s confidence prior to implementation. Critical legal and logistical questions loom: Which authority has the power to close a venue; what criteria should be used to trigger a closure and when should the restriction be lifted; and how will services be delivered to vulnerable populations who may be at risk in an isolated residence or shelter? Civil Confinement The potential for a mass outbreak raises the specter of civil confinement to separate the infected or exposed from healthy individuals (see Table 6-10). This might entail isolation of infected persons, quarantine of exposed persons, or quarantine of a geographic area (cordon sanitaire). Civil confinements may take place in hospitals or other institutions or in a person’s home. New conceptions to separate the healthy from the infectious include “sheltering in place,” which public health authorities analogize to a “snow day.” Many states modernized their public health statutes in the aftermath of the terrorist attacks on September 11, 2001 (Gostin et al., 2002). Public health law reform is necessary to ensure that states and localities have the legal authority for isolation and quarantine (Gostin, 2002). In order to meet constitutional standards, state law must have clear criteria for the use of civil confinement and offer procedural due process (Greene v. Edwards, 263 S.E.2d 661 [W.Va. 1980]). Civil confinement, of course, raises powerful civil liberties concerns. Not only is isolation or quarantine a deprivation of liberty, but enforcement can sometimes be intrusive. For example, during the SARS outbreaks, some countries used electronic bracelets, web cameras, and police. It will

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The Threat of Pandemic Influenza: Are We Ready? - Workshop Summary also be important to ensure that judicial hearings are available, particularly in a mass outbreak. Isolation or quarantine will have to take place in a humane and habitable environment. Vulnerable persons will need to be protected against reexposure to infection, offered care and treatment, and ensured the necessities of life such as safe food and water (Barbera et al., 2001). There may also be the need to consider compensation for lost work. Individuals are confined for the good of the community and have to forego their livelihood and other essential activities. Above all, public health authorities need to maintain the public’s trust. To what extent would orders for civil confinement dissipate trust and reduce cooperation? Acting Under Conditions of Uncertainty: The Key Scientific and Social Questions Influenza pandemic preparedness requires careful consideration of the public health strategy as well as the legal and ethical implications. Several key scientific questions loom: Are specific interventions proven cost effective? What combination of measures is most cost effective? During what phase of the pandemic should interventions be implemented? When should public health measures be discontinued? Although the foregoing interventions have been widely used, many still lack adequate evidence of cost effectiveness. Even if individual interventions are known to be cost effective, public health authorities will have to form a judgment as to the combination of measures that will be maximally effective. They will need to decide when to initiate and when to end an intervention. The decision to intervene is a difficult one because public health authorities may be acting under conditions of scientific uncertainty. It may be unclear whether serologic tests are reliable, vaccines or treatments are safe and effective, and coercive interventions are acceptable to the population. To be effective, agencies may have to intervene at the earliest stages, before the threat level is clear. If interventions are well targeted and timed, then public health officials may prevent untold economic and human harm. However, if the interventions overreach, officials will be accused of disregarding essential economic interests and fundamental human rights. These scientific questions are important because public health interventions do not take place in a vacuum. They raise fundamental economic, political, and legal questions that need to be considered. Economics As mentioned earlier, public health interventions can have dire effects on the economy. They impede individual economic freedoms to travel and

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The Threat of Pandemic Influenza: Are We Ready? - Workshop Summary pursue a business or livelihood. They also affect local, national, and regional economies through the impacts on trade, travel, tourism, and agriculture. Countries may have built-in disincentives to conduct surveillance and response in an energetic and public way. Political Infectious disease outbreaks can have intense sociopolitical ramifications. Diseases affect a country’s prestige as well as its economy, and the electorate may hold politicians accountable. As a result, political leaders may try to deemphasize the threat or delay taking definitive action, which has occurred in numerous epidemics ranging from HIV/AIDS to SARS. Legal and Constitutional Infectious disease outbreaks take place in countries with vastly different legal and constitutional traditions. Public health planning may be undertaken within liberal democracies guaranteeing full protection of human rights or they may take place in less democratic, perhaps more authoritarian, societies. During the SARS outbreaks, for example, countries behaved very differently in their response to and protection of civil liberties (Sapsin et al., 2003). Infectious diseases tend to bring out the best and worst in societies. History demonstrates the potential for overreaction, stigma, and discrimination in the face of a severe epidemic (Gilman, 1999). Consequently, the legal and constitutional dimensions will be important in confronting a severe epidemic (Gostin, 2000). Ethical Values Underpinning Public Health Preparedness: The Cross-Cutting Issues Public health authorities have a mandate to protect the population’s health. It is crucial, however, that they act ethically. Ethical values are usually too broad to determine precisely whether a particular activity is morally appropriate. Nevertheless, it should be possible to articulate several ethical values that can inform public health practice, particularly in an emergency. Transparency The ethical value of transparency requires officials to make decisions in an open and fully accountable manner. Government officials must be willing to make clear the basis for public health measures. They should honestly and openly inform the public about what is known and not known;

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The Threat of Pandemic Influenza: Are We Ready? - Workshop Summary openly acknowledge when new evidence warrants reconsideration of policies; and educate the public about the goals of intervention and the steps taken to safeguard individual rights. Protection of Vulnerable Populations Diseases that may differentially affect segments of the population have usually imposed the additional burden of social opprobrium. Public health officials may inadvertently amplify the process as they conduct their surveillance activities. Although they may not be able to prevent stigmatization completely, officials have an obligation to take steps to mitigate the suffering that may attend their efforts by underscoring the irrationality and inequity of ethnic stereotyping. Consultation with representatives of the communities most at risk will be important for both instrumental reasons and as an expression of social solidarity. Individuals should feel a sense of participation in crucial decisions affecting their lives and communities. People place their trust in political leaders and, in return, deserve due consideration of and respect for their health and human rights. Fair Treatment and Social Justice Justice requires that the benefits and burdens of public health action be fairly distributed, thus precluding the unjustified encumbering of already socially vulnerable populations. Equitable public health action is based on science and assures reasoned, population-based policies. Procedural justice requires a fair and independent hearing for individuals who are subjected to burdensome public health action. Due process requirements are inherently important because fair hearings affirm the dignity of the person; due process is also instrumentally important because it ensures accurate decision making. The Least Restrictive Alternative International human rights law is guided by the principle of proportionality: interventions should be necessary and proportional to the risk posed (Siracusa principles, 1985). Interventions should be the least restrictive alternative necessary to prevent or ameliorate the health threat. Requiring the least restrictive/intrusive alternative represents a means to impose limits on state interventions consistent with the traditions of privacy, freedom of association, and individual liberty. The standard does not require officials to utilize less-than-optimal interventions, but rather to select the least intrusive alternative that can best achieve the identified health objective.

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The Threat of Pandemic Influenza: Are We Ready? - Workshop Summary The Public Health Paradox There is no way to avoid the dilemmas posed by acting without full scientific knowledge. Failure to move aggressively in the early stages of pandemic influenza can have catastrophic consequences. Actions that prove to have been unnecessary will be viewed as draconian and based on hysteria. The only safeguard is the adoption of ethical values in formulating and implementing public health decisions. Public health policy will reflect in a profound way the manner in which humane societies both implicitly and explicitly balance the common good with respect for personal rights. REFERENCES Barbera J, Macintyre A, Gostin L, Inglesby T, O'Toole T, DeAtley C, Tonat K, Layton M. 2001. Large-scale quarantine following biological terrorism in the United States: Scientific examination, logistic and legal limits, and possible consequences. JAMA 286(21):2711–2717. Barker WH. 1986. Excess pneumonia and influenza associated hospitalization during influenza epidemics in the United States, 1970–78. Am J Public Health 76:761–765. Barker WH, Mullooly JP. 1980. Impact of epidemic type A influenza in a defined adult population. Am J Epidemiol 112:798–813. Barker WH, Mullooly JP. 1982. Pneumonia and influenza deaths during epidemics: Implications for prevention. Arch Intern Med 142:85–89. Barry JM. 2004. The Great Influenza: The Epic Story of the Deadliest Plague in History. 1st ed. New York: Viking. Bayer R, Toomey KE. 1992. HIV prevention and the two faces of partner notification. Am J Public Health 82:1158–1164. Blendon RJ, Benson JM, DesRoches, CM, Herrmann MJ. 2001. Harvard School of Public Health/Robert Wood Johnson Foundation Survey Project on Americans’ Response to Biological Terrorism, Study 2: National and Three Metropolitan Areas Affected by Anthrax, November 29–December 3, 2001. [Online]. Available: http://www.hsph.harvard.edu/press/releases/blendon/report2.pdf [accessed January 7, 2002]. Brunell PA, ed. 2004. Importance of vaccinating healthcare workers against influenza. CME monograph from Infectious Diseases in Children. Selected article: Piedra PA. Time has come to make vaccination mandatory. [Online]. Available: http://idinchildren.com/monograph/0402/article6.asp [accessed February 10, 2005]. Campbell DS, Rumley MA. 1997. Cost-effectiveness of the influenza vaccine in a healthy, working-age population. J Occup Environ Med 39:408–414. Carrat F, Valleron A-J. 1995. Influenza mortality among the elderly in France, 1980–90: How many deaths may have been avoided through vaccination? J Epidemiol Community Health 49:419–425. CDC (Centers for Disease Control and Prevention). 1998. Prevention and control of influenza: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 47(RR-6):1–26. CDC. 2002. Crisis and Emergency Risk Communication. Atlanta, GA: CDC. CDC. 2004a. Questions and Answers: The Disease. [Online]. Available: http://www.cdc.gov/flu/about/qa/disease.htm. CDC. 2004b. Outbreaks of avian influenza A (H5N1) in Asia and interim recommendations for evaluation and reporting of suspected cases—United States, 2004. MMWR 53(5):97–100.

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