Summary and Assessment1

Most infectious disease experts believe that the world stands on the verge of an influenza pandemic (Chen et al., 2004; WHO, 2004a; Webby and Webster, 2003). Yet despite the legacy of the 1918 “Spanish flu,” estimated to have killed at least 20 million people,2 and the additional deaths, social disruption, and economic losses that resulted from pandemics in 1957 and 1968, the general public appears relatively unconcerned about the next “killer flu.” Considerably more attention has been focused on protecting the public from terrorist attacks than from the far more likely and pervasive threat of pandemic influenza—an event conservatively expected to cause between 2 and 8 million deaths (WHO, 2004a).

Meanwhile, the danger mounts as the world’s capacity to produce vaccines shrinks and H5N1 reaches endemic levels in poultry in many parts of Asia. A recent expert consultation convened by the World Health Organization (WHO) concluded that “the unpredictability of influenza viruses and the speed with which transmissibility can improve means that the time for preparedness planning is now” (WHO, 2004a).

To address these urgent concerns, the Institute of Medicine’s (IOM) Forum on Microbial Threats convened the workshop Pandemic Influenza:

1  

The assessments contained in the summary are based on the presentations and discussion periods of the workshop. They reflect the assessments of individuals and the editors and cannot be construed as the deliberations, consensus, or recommendations of a formally constituted study committee of the Institute of Medicine.

2  

For a more detailed description of how estimates have been determined for the numbers of deaths caused by the 1918 influenza outbreak, see Barry’s section in Chapter 1.



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The Threat of Pandemic Influenza: Are We Ready? - Workshop Summary Summary and Assessment1 Most infectious disease experts believe that the world stands on the verge of an influenza pandemic (Chen et al., 2004; WHO, 2004a; Webby and Webster, 2003). Yet despite the legacy of the 1918 “Spanish flu,” estimated to have killed at least 20 million people,2 and the additional deaths, social disruption, and economic losses that resulted from pandemics in 1957 and 1968, the general public appears relatively unconcerned about the next “killer flu.” Considerably more attention has been focused on protecting the public from terrorist attacks than from the far more likely and pervasive threat of pandemic influenza—an event conservatively expected to cause between 2 and 8 million deaths (WHO, 2004a). Meanwhile, the danger mounts as the world’s capacity to produce vaccines shrinks and H5N1 reaches endemic levels in poultry in many parts of Asia. A recent expert consultation convened by the World Health Organization (WHO) concluded that “the unpredictability of influenza viruses and the speed with which transmissibility can improve means that the time for preparedness planning is now” (WHO, 2004a). To address these urgent concerns, the Institute of Medicine’s (IOM) Forum on Microbial Threats convened the workshop Pandemic Influenza: 1   The assessments contained in the summary are based on the presentations and discussion periods of the workshop. They reflect the assessments of individuals and the editors and cannot be construed as the deliberations, consensus, or recommendations of a formally constituted study committee of the Institute of Medicine. 2   For a more detailed description of how estimates have been determined for the numbers of deaths caused by the 1918 influenza outbreak, see Barry’s section in Chapter 1.

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The Threat of Pandemic Influenza: Are We Ready? - Workshop Summary Assessing Capabilities for Prevention and Response on June 16 and 17, 2004. Participants discussed the history of influenza pandemics and the potentially valuable lessons it holds; the 2003–2004 H5N1 avian influenza outbreak in Asia and its implications for human health; ongoing pandemic influenza preparedness planning at global, regional, national, state, and local levels; strategies for preventing and controlling avian influenza and its transmission within bird and animal populations; and a broad range of medical, technical, social, economic and political opportunities for pandemic preparedness, as well as the many obstacles that stand in the way of this goal. ORGANIZATION OF WORKSHOP SUMMARY This workshop summary report is prepared for the Forum membership in the name of the editors as a collection of individually authored papers and commentary. Sections of the workshop summary not specifically attributed to an individual reflect the views of the editors and not those of the Forum on Microbial Threats, its sponsors, or the Institute of Medicine. The contents of the unattributed sections are based on the presentations and discussions that took place during the workshop. The workshop summary is organized within chapters as a topic-by-topic description of the presentations and discussions. Its purpose is to present lessons from relevant experience, delineate a range of pivotal issues and their respective problems, and put forth some potential responses as described by the workshop participants. Although this workshop summary provides an account of the individual presentations, it also reflects an important aspect of the Forum philosophy. The workshop functions as a dialogue among representatives from different sectors and presents their beliefs on which areas may merit further attention. However, the reader should be aware that the material presented here expresses the views and opinions of the individuals participating in the workshop and not the deliberations of a formally constituted IOM study committee. These proceedings summarize only what participants stated in the workshop and are not intended to be an exhaustive exploration of the subject matter or a representation of consensus evaluation. SECURING THE FUTURE Over the course of 2 days of wide-ranging, intense, and detailed discussion, several themes recurred and were elaborated upon from multiple perspectives. By the end of the proceedings, many of these ideas were surrounded by considerable clarity and a sense of urgency. These pervasive observations, described below, are grouped according to their ability to be

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The Threat of Pandemic Influenza: Are We Ready? - Workshop Summary accomplished in the near term or, following additional research or resolution, in the future. What can be said and was echoed throughout the discussions—if the question is: “Are we ready for a pandemic influenza?,” the answer is “no.” Addressing Unmet Needs Close Gaps in Global Surveillance3 Many countries lack infectious disease surveillance capabilities. Disturbingly, some of the most glaring gaps in surveillance occur in Asia, where H5N1 avian influenza has infected and killed scores of people since 1997. Developed countries’ interests would be well served by funding improved influenza surveillance in such flu “hot spots.” In addition to increasing surveillance capacity, replacing the current economic disincentives to early reporting of disease with incentives for surveillance, timely disease detection, and access to vaccines and antivirals will greatly increase the chance of catching and containing an emerging pandemic strain before or soon after it emerges. U.S. data on severe illness and death from influenza are also inadequate. Improved data would more effectively inform priorities for prevention and treatment investments and strategies made at the local, state, regional, and national levels (e.g., immunization and preparedness planning). Importantly, improved real-time surveillance and disease reporting could provide an early warning for an emerging pandemic outbreak. Integrate Animal and Public Health Communities4 Influenza surveillance, research, and pandemic response planning should reflect the zoonotic nature of the disease. Improved communication and the development of professional relationships among veterinary and medical researchers and agriculture and public health officials would encourage a greater appreciation in both communities for the implications of animal diseases in human populations, and for human practices that promote or prevent zoonoses. Current lack of integrated funding for influenza surveillance within the animal and human populations collectively now 3   Buranathai (2004); Cox (2004); Gellin (2004); Gostin (2004a); Meltzer (2004); Stöhr (2004); Webster (2004a). 4   Cardona (2004); Nguyen (2004); Sibartie (2004); Stöhr (2004); Swayne (2004); Webster (2004a).

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The Threat of Pandemic Influenza: Are We Ready? - Workshop Summary works against such integration. Better coordination between public and private funders of research and disease surveillance will be necessary. Explore Compensation for Preemptive Culling of Animals5 As is the case with surveillance, encouraging farmers (or even entire countries) to curtail or prevent a human pandemic by sacrificing their poultry or livestock is in the interests of global public health. A variety of options should be explored to support this outcome in a variety of settings, from individual farmers in low-resource settings to industrial poultry and livestock producers in wealthy countries. Promote the Use of Rapid, Inexpensive Influenza Diagnostics6 Cheap, simple diagnostic tests would improve influenza surveillance in animals and humans. Polymerase chain reaction (PCR) testing is the best current option, but the international veterinary community has yet to adopt PCR. As a result, the first farm to be culled in the recent H7N7 outbreak in The Netherlands was delayed 4 days as officials waited for virus isolation results. Increased use and improved diagnostics for influenza will also promote more prudent and effective use of both vaccines and antiviral drugs. Increase Demand for Annual Influenza Immunization and Antiviral Therapy and Prophylaxis7 Demand for influenza vaccine drives supply. After last year’s severe flu season and this year’s unanticipated vaccine shortages, the public may respond well to a pro-immunization campaign, perhaps one that introduces the hazards of pandemic influenza. It will be important to include in that message the distinction between the protective effect of an antiviral influenza vaccine and additional vaccination that would be necessary to respond to a pandemic strain. A similar argument can be made for increasing interpandemic demand for antiviral drugs, which to date have low demand. More interpandemic use of antivirals means the greater production and greater supply of them for use in an outbreak situation. Moreover, increasing physician experience with and public awareness of antiviral medications should support their effective use in responding to a pandemic. 5   Buranathai (2004); Meltzer (2004); Soebandrio (2004); Webster (2004a). 6   Koch (2004); Nguyen (2004); Swayne (2004); Webster (2004a); see Perdue in Chapter 5. 7   Brown (2004); Fedson (2004a); Gellin (2004); Hosbach (2004); Nowak (2004).

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The Threat of Pandemic Influenza: Are We Ready? - Workshop Summary Create International Stockpiles of Antiviral Drugs and Vaccines8 A dedicated supply of vaccines and antiviral drugs is necessary for a rapid response to the first cases of a potential pandemic influenza strain (e.g., through ring immunization and/or targeted antiviral prophylaxis). This plan would probably require a smaller investment, and possibly offers greater benefit in relation to cost, than the aforementioned strategy of compensating farmers for preemptive culling of poultry or livestock in areas affected by avian influenza. However, this strategy is unlikely to work unless an international agreement to create such stockpiles is in place when the next pandemic arrives; otherwise, stockpiles and production of vaccines and antiviral drugs are expected to be nationalized. Additionally, these antiviral stockpiles need to be placed in geographically high-volume points of care (e.g., outpatient clinics, emergency rooms, occupational health sites, student health facilities, nursing homes, pharmacies) for rapid access to therapy that does not rely on a visit to a physician for an effective pandemic response. If stockpiles of vaccines are to be developed and relied upon, it is clear that the range of factors contributing to the recent crises in seasonal influenza production and deployment will need to be overcome. Establish Protocols for Research During a Pandemic9 When the next influenza pandemic emerges, it will be essential to gain a greater understanding of the clinical, epidemiological, and biological nature of influenza—but this will only be possible if research protocols and the laboratory networks to pursue them are established before a pandemic strikes. As Klaus Stöhr of WHO observed, “We have to invest more into planning research, into having protocols ready, and having networks of scientists in place and eager to contribute before the next pandemic virus emerges.” For example, protocols to estimate vaccine efficacy could be implemented immediately upon the commencement of immunization in response to a pandemic, and could even be conducted during the annual flu season. Goals for Research Determine the Molecular Basis of Influenza Pathogenesis10 Much remains to be understood about the molecular basis of influenza pathogenesis, host immune response, immune protection, immune enhance- 8   Brown (2004); Gellin (2004); Hosbach (2004); Longini (2004a); Stohr (2004). 9   Grundy (2004); see Hayden in Chapter 3. 10   Taubenberger (2004); Webster (2004a).

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The Threat of Pandemic Influenza: Are We Ready? - Workshop Summary ment, virulence, and transmissibility. H5N1 variants provide an opportunity to study all of these phenomena. Breakthroughs in these areas of scientific understanding could rapidly lead to more effective and more easily produced countermeasures to an influenza pandemic. Predict Pandemic Potential of Influenza Isolates11 As knowledge of the molecular pathology of influenza expands, it should become possible to predict the threat posed by a particular strain by analyzing key sequences in its genome. While there has been one probable case of human-to-human transmission (ProMED-mail, 2004e) to date, the fact that H5N1 has not yet accomplished infectious human-to-human transmission begs the question, “why not?” Risk assessment tools based on influenza viral genomics may one day provide an answer—and perhaps prevent the unnecessary culling of poultry or livestock following outbreaks of avian influenza. Increase the Efficacy of Influenza Vaccines12 Limited supplies of vaccine could go further if their antigen content could be adjusted to provide the lowest effective dose to each recipient, and if they could be safely made more effective with an adjuvant. Several participants suggested the need for the United States and Europe to view this problem as a joint effort and work together to assure that the entire set of needs for improving influenza vaccines is addressed and shared. An atmosphere of 11th-hour urgency surrounded many of the workshop presentations and participant discussions. The potential for catastrophe is immense, but that potential has been evident, and largely ignored, since 1918. The power of vaccines to prevent influenza is well proven, but the capacity to produce them—as recent events confirm—is limited so as to put them out of reach of the vast majority of the global population. If the initial cases of an emerging human influenza strain are detected, and if antiviral drugs were quickly administered to the close contacts of index cases, transmission could be stifled—but those are big “ifs” in a world where early reporting of influenza carries dire economic consequences and where nations are expected to nationalize stockpiles and production of antiviral drugs and vaccines in response to a threatened pandemic. What should be done to prevent the loss of millions of lives, and the evidence for doing it, is quite clear. What is missing—as evidenced by the clarion calls of 11   Taubenberger (2004); Webster (2004a). 12   Epstein (2004); Fedson (2004a); Gellin (2004).

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The Threat of Pandemic Influenza: Are We Ready? - Workshop Summary workshop presenters—is the political will to support such efforts before the next pandemic renders them futile. However, developments during the writing of this report might suggest that the tide is changing. The World Health Organization has called for an unprecedented summit of national public health leaders, vaccine manufacturers, and leading researchers to expand the plans and possibilities for responding to a pandemic influenza threat—now a growing concern among many nations and leaders (see, http://www.who.int/en/) (Marchione, 2004). THE STORY OF INFLUENZA: 1918 AND BEYOND To expand on some of the key messages described above, the following text summarizes workshop presentations and discussions concerning preparedness for influenza outbreaks at every level of government and society and the prospects for preventing or mitigating the next pandemic. Although historical evidence of probable encounters with virulent influenza date back to the 16th century, chronicles of the disease often begin with the 1918 pandemic (see Barry in Chapter 1). By that time, science was sufficiently sophisticated to characterize the most lethal infectious outbreak in recorded history, and even to anticipate that such an event would occur. As a result of its staggering mortality, the brunt of which was borne by young adults, the 1918 influenza pandemic remains a focus of scientific inquiry; the origin of the virus remains to be determined. Most recently, the “source” of its exceptional virulence has been discovered, and these findings suggest it is due to the hemagglutinin (HA) gene (Kobasa et al., 2004). Workshop participants discussed progress to date in addressing these critical issues. They also considered the consequences of deeply flawed public and official responses to the 1918 flu and their implications for the management of future pandemics and other public health crises. Current estimates place the death toll from the approximately year-long 1918 pandemic at 50 to 100 million.13 A “herald wave” of influenza in the spring of that year produced a relatively mild disease, as described in Western medical journals (Taubenberger, 2004). The second pandemic wave struck violently in early autumn, spreading and killing with astounding rapidity. The unusually severe symptoms of this so-called Spanish flu included cyanosis, internal and external hemorrhage, and intense pain (see Barry in Chapter 1). Limited reliable mortality statistics from the United States show that the highest number of flu deaths occurred in people aged 25 to 29 years and that more than twice as many people aged 20 to 34 died 13   For a more detailed description of how estimates have been determined for the numbers of deaths caused by the 1918 influenza outbreak, see Barry’s section in Chapter 1.

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The Threat of Pandemic Influenza: Are We Ready? - Workshop Summary than did people older than 50 (see Barry in Chapter 1). Pregnant women had the highest case fatality (the number of deaths among people with clinically diagnosed illness) of any group in this country, a phenomenon that has been reported in other influenza outbreaks (see Barry in Chapter 1). Local estimates of case fatality varied widely across the globe and in some circumstances (e.g., among populations never before challenged by influenza and troops stationed in close quarters) reportedly exceeded 20 percent. Patterns of Pandemic-Associated Mortality Despite the devastation caused by the 1918 virus, it produced what was in many ways a typical influenza pandemic (see Taubenberger in Chapter 1) (Taubenberger, 2004). Most pandemics arrive in waves, albeit generally separated by years, rather than months. In the United States, with an aggregate case fatality of 2.5 percent, more than 97 percent of people with clinically reported influenza recovered from the disease; serological studies, conducted in the 1930s on people alive during the pandemic, suggest that less than 1 percent of people exposed to the virus died of flu. Prior exposure to pandemics in the mid-1850s and around 1890 apparently provided protection against the 1918 virus, resulting in relatively low mortality in people aged 35 and older. Thus the crucial uniqueness of the 1918 pandemic lay not in its virulence, but in the disproportionate number of deaths it caused among young adults, as reflected in its famously “W-shaped” pattern of mortality (Figure S-1). Several workshop participants are studying this trend, described by presenter Jeffery Taubenberger as “the one issue that desperately needs to have a biological explanation before we can actually draw any lessons from 1918” (Taubenberger, 2004). Hypotheses under investigation include a genetic feature of the virus that targeted young adults; an intrinsic characteristic of their immune systems that produced a deadly response to viral infection; and—perhaps most likely—a deadly interaction between this virus and the young adult immune system. Epidemiological analyses of the 1918 pandemic further highlight the dramatic shift in age-adjusted mortality as compared with subsequent years in which influenza was epidemic (Simonsen, 2004). Such studies also show that the profound impact of the 1918 flu on young adults was not limited to the second, autumnal wave of the disease, but could be detected in the initial herald wave and in influenza seasons for several years after the pandemic’s peak. Similar age shifts in mortality also marked the two subsequent influenza pandemics in 1957 and 1968, which caused far fewer deaths than the 1918 flu.

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The Threat of Pandemic Influenza: Are We Ready? - Workshop Summary FIGURE S-1 Influenza and pneumonia mortality by age, United States. Influenza and pneumonia specific mortality by age, including an average of the inter-pandemic years 1911–1915 (dashed line) and the pandemic year 1918 (solid line). Specific death rate is per 100,000 of the population in each age division. SOURCES: Grove and Hetzel (1968); Linder and Grove (1943); U.S. Department of Commerce (1976). Clues to Lethality and Adaptation It remains unclear why the 1918 influenza virus was so deadly to otherwise healthy young adults. Historical data suggest its virulence was due in part to its novelty to people under the age of 30, who were not exposed to similar viral antigens during the apparent pandemics of the mid-and late 19th century. Children between the ages of 5 and 10 years were diagnosed with flu at higher than average rates, yet had the lowest mortality rates of any age group; that outcome may reflect a weak T-cell response to the virus, which is known to spare this age group from mortality due to measles (Taubenberger, 2004). By contrast, young adults may have mounted an unusual—and deadly—immune response to the 1918 virus. This possibility is supported by death records from Kentucky which, when analyzed on a year-by-year basis, reveal a precipitous rise to a peak in flu deaths beginning at age 17 and ending with a more gradual drop beginning around age 30 (Taubenberger, 2004). Researchers have also found epidemiological evidence that in the United States, people infected with tuberculosis (TB)—a relatively common infection in 1918, particularly among young males—

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The Threat of Pandemic Influenza: Are We Ready? - Workshop Summary were more likely than others to die of influenza (Noymer and Garenne, 2000). However, contradictory evidence from 120 autopsy reports of influenza victims showed that none had evidence of TB in the lungs, leading to the speculation that TB could have had a protective effect (Taubenberger, 2004). Genetic features of the 1918 virus have also been examined for clues to its deadliness, but none of the mutations identified have been shown to correlate with virulence (see Taubenberger in Chapter 1). Such genomic studies are, however, revealing the genetic basis of viral adaptation to human infection and transmission. For example, research on the 1918 hemagglutinin gene and its product suggest that a single amino acid change allowed the avian-like virus to bind to a human receptor (Kobasa et al., 2004); it was speculated that a similar change in the avian H5 gene—now circulating among birds infected with pandemic H5N1 influenza—would make it easier for the avian virus to infect humans. Applying Lessons Learned from Past Pandemics There is particular pressure to recognize and heed the lessons of past pandemics in the shadow of the worrisome 2003–2004 flu season. At the time of this report’s release, 44 confirmed human cases of H5N1 avian influenza occurred in Thailand and Vietnam; 32 (72 percent) of these patients, mostly children and young adults, have died of the disease (ProMED-mail, 2004a; WHO, 2004d). Six of those confirmed deaths have occurred in Vietnam during a resurgence of the avian flu epidemic since July 2004, as this report was being prepared (ProMED-mail, 2004b,c). Concurrently, Thailand has confirmed four deaths since July 2004 (ProMED-mail, 2004d,v), with one case possibly having been transmitted from daughter to mother (ProMED-mail, 2004e).14,15 In addition, an early-onset, severe form of influenza A (H3N2) made headlines when it claimed the lives of many children in the United States in late 2003. As a result, stronger than usual demand for annual flu vaccine outstripped the vaccine supply, of which 10 to 20 percent typically goes unused (Hosbach, 2004). Because statistics on pediatric flu deaths had not been collected previously, it is unknown if the 2003–2004 season witnessed a significant change in mortality patterns. However, in response to these deaths, the Centers for Disease Control and Prevention’s (CDC’s) Advisory 14   Editor’s note: During the production process, further evidence suggests the daughter transmitted H5N1 to her mother and this report also suggests she transmitted H5N1 to her aunt (Ungchusak et al., 2005). 15   Editor’s note: It should be noted that during the production process of this report there were 12 additional deaths in Vietnam during January 2005 and the first case and death in Cambodia, bringing the total number of deaths to 45 (ProMED-mail, 2005).

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The Threat of Pandemic Influenza: Are We Ready? - Workshop Summary Committee on Immunization Practices now recommends that beginning in 2004–2005, children aged 6 to 23 months (and their close contacts) receive the annual flu vaccine (Harper et al., 2004). During the writing of this report, another vaccine shortage was making headlines. On October 5, 2004, British authorities suspended Chiron Corporation’s license for vaccine production due to contamination problems during the manufacturing process (ProMED-mail, 2004f). Currently one of only two suppliers of the influenza vaccine to the United States, Chiron was expected to provide approximately half of the supply of vaccines to the United States this flu season. As a result, the U.S. Department of Health and Human Services is urging healthy adults to forego the shot this year in an effort to conserve the remaining doses for the youngest, oldest, and sickest Americans, who are the most vulnerable to influenza (CDC, 2004b). However, problems with distribution of vaccine supply to providers well placed to serve the at-risk populations and the unwillingness of many healthy adults to sacrifice on behalf of these at-risk individuals continue to complicate this public health strategy. Difficulty finding the vaccines, long lines, and frustration have caused many to even cross the border into Canada to be immunized (Americans cross border for flu shots, 2004). Both of these shortages reveal the historic lack of adequate attention and preparedness to the threat of influenza and the complications presented by the vaccine development and production process. This continued crisis demonstrates how fragile the method of vaccine production is and has brought to light our lack of investments for alternative forms of vaccine production. Most importantly, these shortages raise questions about our ability to respond to an influenza crisis or pandemic if we cannot provide routine influenza vaccine in a typical influenza season. The outrage expressed and extreme measures taken recently by some individuals do not suggest that the population is adequately prepared to respond rationally to a future crisis. A series of recent avian influenza epidemics, discussed in detail below, can be seen to foreshadow pandemic human influenza in an age of globalization. In several cases, the virus has spread rapidly across entire countries, necessitating the destruction and disposal of millions of domestic birds. None of these viruses has proven readily transmissible among humans, but several workshop participants recognized that this development—a recipe for pandemic influenza—may be only a few mutations away (Figure S-4). It was also noted that although there is no historical precedent for an influenza pandemic spawned by highly pathogenic avian influenza virus in poultry, flu “does something different every time” (Taubenberger, 2004). To more reliably predict the threat posed by emerging avian influenza strains, the complex, and largely unknown, spectrum of genetic variability among these viruses must be better understood.

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The Threat of Pandemic Influenza: Are We Ready? - Workshop Summary any given year. Using a relatively simple, conservative model, presenter Martin Meltzer and colleagues determined the total costs of a moderate (15 percent attack rate) and severe (35 percent attack rate) influenza pandemic, then calculated annual “premiums” to be paid on preparations against these losses based on the cost of vaccination (Meltzer et al., 1999). The cost of vaccination, however, depends on the population segment that first receives the projected limited quantities of pandemic vaccine. Given the expected pattern of higher mortality in the elderly, it would be most cost effective to vaccinate high-risk people of working age, but more deaths would be prevented if the high-risk elderly are given priority (Meltzer et al., 1999). Only one of these outcomes can be maximized, so decision-makers must make the difficult choice among them. This requirement highlights the need for a system by which such a choice could be made, as well as a means to gain public understanding and support for the decision-making process (and thereby, for its outcome). Having chosen a goal, public health officials must be vigilant for changes in patterns of pandemic mortality, and be ready to adapt interventions to support the desired outcome. To make optimal use of funds set aside for pandemic preparedness, decision-makers were advised to invest in activities that both ensure a strong pandemic response and enhance the response to annual influenza (Meltzer, 2004). These include improvements in surveillance (including support for surveillance in low-resource countries where a pandemic strain is likely to emerge), increasing vaccination rate among high-risk individuals (and perhaps providing a financial incentive to do so), and conducting planning and preparedness exercises to strengthen the response to a broad range of possible public health emergencies. The Legal and Ethical Context Legal authority should 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 (see Gostin in Chapter 6) (Gostin, 2004b). Each of these interventions, while potentially beneficial to society, also imposes a burden on at least some of its members in the form of economic disadvantage, loss of political power, or sacrifice of human rights. Moreover, if these measures are to be effective, they should be imposed early in the course of a pandemic, before it can be scientifically ascertained whether they are actually warranted. Thus, it was argued, decision makers must undertake transpar-

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The Threat of Pandemic Influenza: Are We Ready? - Workshop Summary ent and ethical deliberations in order to safeguard against the possibility of an unjustified and burdensome response to an apparent pandemic threat. But public health law at many levels is not sufficiently robust to meet this daunting challenge. At the international level, efforts to ensure strong surveillance and response to infectious disease outbreaks are hampered by the outdated International Health Regulations, which are currently undergoing revision (Gostin, 2004a). Strong national infrastructures for public health law also need to be developed to support the delivery of essential services, assign public health powers, and safeguard human rights; unfortunately, no such foundation currently exists, because most public health statutes have been enacted in response to a specific (and therefore limited) threat or crisis. In response to this need, model public health laws are currently being developed for the United States (Center for Law and the Public’s Health, 2001), and WHO is studying the development of a national public health law toolkit for worldwide distribution (Gostin, 2004b). In addition to this legal framework, workshop participants were also urged to evaluate the ethics of public health interventions against pandemic influenza. Compelling ethical considerations include the need for transparency, the importance of anticipating and addressing stigmatization, the pursuit of human rights and social justice, and the fair distribution of scarce resources. Coordinating Public and Private Sectors The example of the Department of Veterans Affairs (VA) was used to illustrate a variety of opportunities for public–private partnership in addressing pandemic influenza, including the guaranteed advanced purchase of vaccine, the establishment of coordinated risk communications, the delivery of prophylaxis and treatment in home-based and other non-medical settings, and the removal of disincentives to sheltering in place for ill and exposed workers. Health policy within the VA system focuses on the use of information systems and outcomes measurement in clinical decision-making. This paradigm also supports the collection of standardized data that, if replicated in hospitals nationwide, could be used to build a national health information database—a possibility that has come one step closer to reality with the recent launch of a 10-year federal initiative to develop electronic medical records for most Americans (DHHS, 2004c). Increasing Immunization Uptake The previously described confluence of events that led to exceptionally high demand for immunization during the 2003–2004 flu season can be likened to a worst case scenario in order to increase uptake: let the disease

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The Threat of Pandemic Influenza: Are We Ready? - Workshop Summary come early, at the beginning of immunization season; let it be severe, striking otherwise healthy people—even lethally, so that it makes headlines and causes medical experts to issue warnings of dire consequences. Unfortunately, a large component of this success depended on the timing and severity of the disease and so may not result in continued high immunization rates; however, this experience could also be seen as a dress rehearsal for communication during an influenza pandemic, with its attendant shortages of vaccine and dire media reports. Clear communication will be essential to obtaining adherence to mass vaccination campaigns during a pandemic, but it faces several challenges, particularly among people who consistently refuse annual flu shots. Mixed messages will be hard to avoid, particularly given the fact that only a minority (less than 40 percent) of health care workers are immunized each year. On the one hand, people with high priority to receive vaccine will need to be encouraged (and perhaps made afraid enough) to get it; others will need to be encouraged to wait calmly for their opportunity to receive vaccine while using non-medical measures to reduce their exposure to infection. Unless public messages are tailored to gain the attention of specific segments of our racially and culturally diverse society, they are likely to be ignored. The most effective way that public officials can avoid a damaging credibility problem in a pandemic, participants advised, is by sharing the dilemmas of pandemic control with the public in a productive and effective way—that is, by doing more than simply furnishing facts and figures. More research is needed to learn how to do this well; in the meantime, public health officials are advised to invest in targeted (as opposed to nuanced) and widely dispersed communications in order to sway as many “undecideds” as possible to the cause of influenza prevention and control (see Nowak in Chapter 6). Public Communication Strategies The history of public response to a variety of natural disasters demonstrates that people are capable of effective collective action in these circumstances, and conversely, that failure to involve the general public in crisis response can increase the likelihood of social disruption (Glass and Schoch-Spana, 2002). Although it is widely believed that public support for a pandemic response can only be won through good communication, it is important to recognize that “good communication” is perceived differently by the communicator, who wants public cooperation and understanding in a time of crisis, and members of the public, who want inclusion, consideration, respect, expert guidance, and proof that officials have justly consid-

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The Threat of Pandemic Influenza: Are We Ready? - Workshop Summary ered the public (see Schoch-Spana in Chapter 6). Risk communication,18 a key component of the WHO pandemic plan and several national plans, attempts to bridge this gap by providing individuals and communities with information that allows them to make the best possible decisions about their well-being. Systemic challenges make it difficult to get such messages out, however. Due to the multiplicity of contemporary media outlets, the significant decline in newspaper readership, and the lack of a public broadcast system (in the United States) public health messages should be broadly directed and more effectively coordinated among agencies and official channels that often compete for resources and notoriety. Although a more coordinated effort at the federal level is paramount, it was suggested that important information could be disseminated effectively through trusted sources in communities, such as physicians, neighborhood leaders, schools, or places of worship. It was also noted that official attitudes that equate overwhelming public requests for information with “panic” obscure an important opportunity for communication. Rather than view these demands as a distraction, communicators were advised to address the public’s increased need for information as part of an emergency response (Schoch-Spana, 2000). Both the quality and quantity of information available to the public should address the fears as well as the facts about disease spread, and are key to promoting public security as well as more effective public health. Chapter 6 (see Schoch-Spana) describes the development of analytical tools for decision-makers to help them forge collaborations with the public during health crises. REFERENCES Americans cross border for flu shots. 2004. CNN. [Online]. Available: http://www.cnn.com/2004/HEALTH/conditions/10/20/fluvaccine.canada.ap/ [accessed November 10, 2004]. ASTHO (Association of State and Territorial Health Officials). 2002. Nature’s Terrorist Attack: Pandemic Influenza; Preparedness Planning for State Health Officials. Washington, DC: ASTHO. Barclay WS, Zambon M. 2004. Pandemic risks from bird flu. BMJ 328(7434):238–239. Brown P. 2004 (June 16). Ensuring an Adequate Stockpile of Antivirals. Presentation at the Institute of Medicine Workshop on Pandemic Influenza: Assessing Capabilities for Prevention and Response. Washington, DC: Institute of Medicine Forum on Microbial Threats. 18   Defined by CDC as the attempt by science or public health professionals to provide information that allows individuals, stakeholders, or an entire community to make the best possible decisions about their well-being, under nearly impossible time constraints, and to communicate those decisions, while accepting the imperfect nature of their choices (source: http://www.cdc.gov/communication/emergency/ercoverview.htm).

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The Threat of Pandemic Influenza: Are We Ready? - Workshop Summary Meltzer MI, Cox NJ, Fukuda K. 1999. The economic impact of pandemic influenza in the United States: Priorities for intervention. Emerging Infectious Diseases 5(5):659–671. Millar JD. 1977 (June 27). The Swine Flu Program: An unprecedented venture in preventive medicine. Report to the Congress by the Comptroller General of the United States. HRD-77-115. Washington, DC: Department of Health, Education, and Welfare. Monto AS. 2003. The role of antivirals in the control of influenza. Vaccine 21(16):1796–1800. Nguyen TD. 2004 (June 17). Retrospection into Avian Influenza Outbreak in Vietnam during 2003-04. Presentation at the Institute of Medicine Workshop on Pandemic Influenza: Assessing Capabilities for Prevention and Response. Washington, DC: Institute of Medicine Forum on Microbial Threats. Nichol KL. 2003. The efficacy, effectiveness, and cost-effectiveness of inactivated influenza vaccines. Vaccine 2003:1769–1775. NISN (Neuraminidase Inhibitor Susceptibility Network). 2004 (August 13). Neuraminidase Inhibitor Susceptibility Network statement. Weekly Epidemiological Record 79:306–308. [Online]. Available: http://www.who.int/wer/2004/en/wer7933/en/ [accessed November 10, 2004]. Nowak G. 2004 (June 17). Increasing Awareness and Uptake of Influenza Immunization. Presentation at the Institute of Medicine Workshop on Pandemic Influenza: Assessing Capabilities for Prevention and Response. Washington, DC: Institute of Medicine Forum on Microbial Threats. Noymer A, Garenne M. 2000. The 1918 influenza epidemic’s effects on sex differentials in mortality in the United States. Population and Development Review 26(3):565–581. OIE (Office International des Epizooties). 2004. Disease Information. 17(36). [Online]. Available: http://www.oie.int/eng/info/hebdo/a_current.htm#Sec0 [accessed December 21, 2004]. Perrotta D. 2004 (June 16). Panel Discussion at the Institute of Medicine Workshop on Pandemic Influenza: Assessing Capabilities for Prevention and Response. Washington, DC: Institute of Medicine Forum on Microbial Threats. Petola VT, McCullers JA. 2004. Respiratory viruses predisposing to bacterial infections: Role of neuraminidase. Pediatr Infect Dis J 23:S87–S97. ProMED-mail. 2004a. PRO/AH/EDR> Avian influenza, human—East Asia (52): update. Published date: October 4, 2004. Archive number: 20041004.2738. Available at http://www.promedmail.org. ProMED-mail. 2004b (August 31). PRO/AD/EDR> Avian influenza, human—East Asia (38). Published date: August 31, 2004. Archive number: 20040813.2249. Available at http://www.promedmail.org. Source: WHO Outbreak News, 13 August 2004 [edited]: http://www.who.int/csr/don/2004_08_13/en/print.html. “Human cases of avian influenza: situation in Viet Nam.” ProMED-mail. 2004c (September 29). PRO/AH/EDR> Avian influenza, human—East Asia (49): Viet Nam. Archive number: 20040929.2692. Available at http://www.promedmail.org. ProMED-mail. 2004d. PRO/AH/EDR> Avian influenza—Eastern Asia (98): Viet Nam, Thailand. Published date: July 27, 2004. Archive number: 20040727.2058. Available at http://www.promedmail.org. ProMED-mail. 2004e. PRO/AH/EDR> Avian influenza, human—East Asia (46): Thailand, susp. Published date: September 25, 2004. Archive number: 20040925.2647. Available at http://www.promedmail.org. ProMED-mail. 2004f. PRO/AH/EDR> Influenza vaccine 2004/2005—N. hemisphere (02): supply. Published date: October 5, 2004. Archive number: 20041005.2742. Available at http://www.promedmail.org.

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The Threat of Pandemic Influenza: Are We Ready? - Workshop Summary ProMED-mail. 2004g. Avian influenza—eastern Asia (78): Thailand, cats. Published date: June 17, 2004. Archive number: 20040617.1614. Available at http://www.promedmail.org. Source: The Messybeast Cat Resource Archive: 16 June 2004 [edited]: http://www.messybeast.com/zoonoses.htm. “Asian Bird Flu.” Byline: Sarah Hartwell. ProMED-mail. 2004h. PRO/AH/EDR> Avian influenza—Eastern Asia (127): Thailand, tigers. Published date: Oct 19, 2004. Archive number: 20041019.2838. Available at http://www.promedmail.org. ProMED-mail. 2004i. PRO/AD/EDR> Avian influenza—Eastern Asia (128): Thailand, tigers. Published date: October 22, 2004. Archive number: 20041022.2862. Available at http://www.promedmail.org. ProMED-mail. 2004j. PRO/AD/EDR> Avian influenza, poultry vaccines (08). Published date: March 24, 2004. Archive number: 20040325.0829. Available at http://promedmail.org. Source: New Scientist, 24 Mar 04 [edited]: http://www.newscientist.com/news/news.jsp?id=ns99994810. “Bird vaccination could lead to new strains.” Byline: Debora MacKenzie. ProMED-mail. 2004k (July 16). PRO/AH/EDR> Avian influenza—Eastern Asia (92). Published date: July 16, 2004. Archive number: 20040716.1925. Available at http://www.promedmail.org. Source: The Jakarta Post, 16 July 2004 [edited]: http://www.thejakartapost.com/detailcity.asp?fileid=20040716.G04&i. “IPB, Japan to produce bird flu super vaccine.” Byline: Theresia Sufa. ProMED-mail. 2004l (July 16). PRO/AH/EDR> Avian influenza—Eastern Asia (92). Published date: July 16, 2004. Archive number: 20040716.1925. Available at http://www.promedmail.org. Source: ABC Online [Australia]: 16 July 2004 [edited]: http://www.abc.net.au/news/newsitems/200407/s1155030.htm. “More bird flu outbreaks in Viet Nam.” ProMED-mail. 2004m (July 2). PRO/AH/EDR> Avian influenza—Eastern Asia (83): Viet Nam. Published date: July 2, 2004. Archive number: 20040702.1771. Available at http://www.promedmail.org. Source: Taipei Times: http://www.taipeitimes.com/News/world/archives/2004/07/02/20031773. “Mekong bird flu may be spreading to nearby province.” ProMED-mail. 2004n (July 3). PRO/AH/EDR> Influenza activity update 2003/2004—worldwide. Published date: July 3, 2004. Archive number: 20040703.1776. Available at http://www.promedmail.org. ProMED-mail. 2004o (August 9). PRO/AH/EDR. Avian influenza—Eastern Asia (103): FAO. Published date: August 9, 2004. Archive number: 20040809.2196. Available at http://www.promedmail.org. ProMED-mail. 2004p. PRO/AH/EDR> Avian influenza—Belgium ex Thailand: smuggled birds (02): OIE. Published date: October 27, 2004. Archive number: 20041027.2907. Available at http://www.promedmail.org. ProMED-mail 2004q (July 30). PRO/AH/EDR> Avian influenza—Eastern Asia (100). Published date: July 30, 2004. Archive number: 20040730.2078. Available at http://www.promedmail.org. Source: WHO: http://www.who.int/csr/don/2004_07_30/en/. “Avian influenza—assessment of the current situation.” ProMED-mail. 2004r (July 29). PRO/AH/EDR> Avian influenza—Eastern Asia (99). Published date: July 29, 2004. Archive number: 20040729.2069. Available at http://www.promedmail.org. Source: Sapa-AFP via IOL South Africa, 28 July 2004 [edited]: http://www.iol.co.za/index.php?set_id=1&click_id=31&art_id=qw109099908550B221. “UN to recommend wider use of bird flu vaccine.” ProMED-mail. 2004s. PRO/AD/EDR> Avian influenza, poultry vaccines (08). Published date: March 24, 2004. Archive number: 20040325.0829. Available at http://promedmail.org. Source: New Scientist, 24 Mar 2004 [edited]: http://newscientest.com/news/news.jsp?id=ns99994810. “Bird flue vaccination could lead to new strains.”

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