Stretching Across International Borders

In spring 2009, a new type of influenza appeared in Mexico and quickly spread to the United States and around the world. Its cause: a mutated strain of swine flu virus—labeled H1N1 influenza A by scientists. Thousands of people fell seriously ill, and though most recovered, some did not.

The outbreak underscores the message that health threats recognize no political or geographic borders. Indeed, given today’s increasingly interconnected world, new or reemerging diseases are no more than an airplane ride—or even a car ride—away. Moreover, global events, ranging from climate disruption to poverty and violence, threaten public health as well.

In this era of globalization, the United States has a key role to play in maintaining health and mitigating risk. The Institute of Medicine (IOM) examines different aspects of this responsibility. The IOM looks at how the nation can best protect its own residents from global health threats and also at how the nation can help other countries with limited resources to tackle health problems within their own borders.

Meeting the global need for U.S. commitment

In 2008, the IOM—with the support of four federal agencies and five private foundations—formed an independent committee to examine the nation’s current and future role in global health. The committee issued a report in two installments, the first specifically targeting recommendations to government and the second offering recommendations for the public and private sectors as well. The report as a whole revisits the IOM’s 1997 study America’s Vital Interest in Global Health, which argued that a firm commit-



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Stretching Across International Borders In spring 2009, a new type of influenza appeared in Mexico and quickly spread to the United States and around the world. Its cause: a mutated strain of swine flu virus—labeled H1N1 influenza A by scientists. Thousands of people fell seriously ill, and though most recovered, some did not. The outbreak underscores the message that health threats recognize no political or geographic borders. Indeed, given today’s increasingly inter- connected world, new or reemerging diseases are no more than an airplane ride—or even a car ride—away. Moreover, global events, ranging from cli- mate disruption to poverty and violence, threaten public health as well. In this era of globalization, the United States has a key role to play in maintaining health and mitigating risk. The Institute of Medicine (IOM) examines different aspects of this responsibility. The IOM looks at how the nation can best protect its own residents from global health threats and also at how the nation can help other countries with limited resources to tackle health problems within their own borders. Meeting the global need for u.S. commitment In 2008, the IOM—with the support of four federal agencies and five private foundations—formed an independent committee to examine the nation’s current and future role in global health. The committee issued a report in two installments, the first specifically targeting recommendations to government and the second offering recommendations for the public and private sectors as well. The report as a whole revisits the IOM’s 1997 study America’s Vital Interest in Global Health, which argued that a firm commit- 

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4 INforMINg THe fuTure: Critical Issues in Health ment by the United States to promote health around the world serves not only the international population, but also the American people. The U.S. Commitment to Global Health: Recommendations for the New Administration (2008), the first installment of the new report, calls for highlighting health as a pillar of U.S. foreign policy and backing this up with significant funding increases for global health efforts over the next 4 years. It lays out a broad path for how the President and administration can demonstrate their commitment to global health: •  Expanding and rebalancing the federal government’s aid portfolio, particularly by increasing funding for chronic, noncommunicable diseases, which account for more than half of all deaths in low- and middle-income countries. •  Creating a White House Interagency Committee on Global Health, composed of heads of major federal departments and agencies involved in global health, and designating a senior administration official as its leader. •  Improving evaluation in order to determine which interventions are working and which are not. •  Developing and implementing an expanded research agenda— supporting, in particular, new research targeting health problems specific to poor populations—that could yield new tools, such as a vaccine for malaria, for use in global health programs. •  Ensuring that health improvements will be sustainable by working with pivotal international groups, such as the World Health Orga- nization; partnering with other national govern- ments; and strengthening local health systems and workforces. The U.S. Commitment to Global Health: Rec - ommendations for the Public and Private Sectors (2009), the second installment, provides a more detailed action plan that requires the participation of every sector of the U.S. global health enterprise. It calls on U.S.-based commercial entities, founda- tions, universities, and other nonprofit organiza- tions to join with the government in taking action in five key areas:

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 Stretching Across International Borders 40% 36% 33% 32% 30% U.S. % of Donor Total 23% 21% 20% 19% 18% 17% Average (16%) 15% 15% 14% 13% 11% 11% 10% 10% 10% 10% 7% 7% 5% 5% 3% 0% xe dom n n a ly Ze l i a g Fi ia C ce ce N ust s es he m k nd Sw ay en d Be en Po ny d itz al d pa A nd ai ad te our ar an Ita an r d lan iu ew r a Sw rtug an e at la w st a Sp ed m Ja rla an re lg Lu ing m al or nl St Au er U mb ni Ire Fr G er N K d D G et te ni N U 5xf.eps Allocable aid for health (2006). SOURCE: The U.S. Commitment to Global Health: Recommendations for the Public and Private Sectors, p. 134. 0.98 1.0 0.92 0.88 0.9 0.82 0.80 0.8 0.7 0.58 0.6 As % of GNI Millennium Development Goals (0.54) 0.47 0.5 Average Country Effort (0.47) 0.43 0.43 0.43 0.42 0.41 0.39 0.38 U.S. 0.4 0.34 0.32 0.30 0.27 0.3 0.20 0.20 0.18 0.18 0.2 0.1 0.0 en g ay k Ir e s Be nd Fi m d n m i t z t r ia Fr d er e y lia Ze d a Po d G al e ly St n es an ar nd ur ai n an te p a an c ec Ita g iu do ra w at an la ew n a ed la Sp r tu m Sw us bo m lg rla re ni Ja nl al or er st ng N Ca Sw en A m N Au he Ki d G D xe et d Lu N te U ni U Net official development assistance (2008). 5xg.eps SOURCE: The U.S. Commitment to Global Health: Recommendations for the Public and Private Sectors, p. 135.

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 INforMINg THe fuTure: Critical Issues in Health 1. Scaling up proven interventions for improving health outcomes and reducing poverty, a known contributor to health problems, in low- and middle-income countries. Numerous interventions are available, but many nations lack the infrastructure or resources to take suffi- cient action on their own. 2. Generating and sharing knowledge that serves the global commu- nity. Typically, the United States and other wealthy countries focus their health research on conditions that affect their own people. This situation too often means that the tools to prevent and treat many diseases in resource-limited countries are either inadequate or not fully used because there is insufficient understanding of how best to apply them in such settings. 3. Investing in capacity building with global partners. Many countries face critical health workforce deficits that directly affect efforts at combating disease and death. U.S. institutions should establish long- term partnerships with universities, research centers, and health care systems in resource-limited countries to help them build a cadre of capable local leaders and researchers who can identify effective solu- tions to health problems that are sustainable in their own countries. 4. Increasing financial commitments to global health. Although the U.S. government has made record commitments to global health, its over- all commitment to overseas development assistance falls below the efforts of other developed countries. The government also should consider novel approaches, such as results-based financing, to deliv- ering aid that is effective. 5. Setting an example by engaging in respectful partnerships. To ensure that countries retain ownership and accountability for the health of their people, the United States should support resource-limited countries in developing results-focused, country-led agreements that rally all development partners around one health plan, one monitor- ing and evaluation framework, and one review process. International aid focusing on global health is a longstanding tradition in the United States, and the White House increased its commitments under President George W. Bush. On July 30, 2008, President Bush signed into law a reauthorization of the President’s Emergency Plan for AIDS Relief (PEPFAR), originally launched in 2003, providing $15 billion in relief. The new law expanded funding more than threefold, to $48 billion, to treat not

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 Stretching Across International Borders only AIDS, but also tuberculosis and malaria. The reauthorization elimi- nated a previous requirement that one-third of all prevention funding must go to abstinence and fidelity programs, as well as other earmarks to allow local implementers to allocate funds based on the needs of at-risk popula- tions. These modifications, along with an increased focus placed on women and girls, were recommended in the 2007 IOM report PEPFAR Implemen- tation: Progress and Promise, a congressionally mandated evaluation of the program. Yet the reach of global health goes far beyond worldwide disease pre- vention and international relations. It is an interdisciplinary field that also incorporates economics, epidemiology, and public health, among others. One area that tends to be overlooked is violence, which may include inter- personal and self-directed violence, violence in society, violence in the fam- ily, and violence against women and children, among others. Such violence, comprising both suicidal behavior and interpersonal violence, is among the leading causes of death and disability worldwide. In 2000 alone, the latest year for data, violence claimed an estimated 1.6 million lives globally—more than 1.5 times the number of deaths from malaria. The devastating impact of violence also extends far beyond immediate death, resulting in injuries that are often lifelong, hospitalizations, political instability, and stagnation of economic growth for families, communities, and nations. Although it strikes everywhere, violence overwhelmingly and disproportionately affects low- and middle-income countries, which often lack the resources to invest in prevention and to respond to the consequences of violence. The IOM, together with the nonprofit group Global Violence Prevention Advocacy, convened a workshop to examine how a public health approach might be applied in lessening the pressing dangers. Among their goals, workshop participants—drawn from an array of fields related to health, criminal justice, public policy, and economic development— set out to discuss specific opportunities for the U.S. government and other public and private groups with resources to more effectively support programs aimed at preventing the many forms of violence that occur. Violence Prevention in Low- and Middle-Income Countries: Finding a Place on the Global Agenda: Workshop

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 INforMINg THe fuTure: Critical Issues in Health Summary (2008) highlights the need for the timely development of an inte- grated, science-based agenda to support research, clinical practice, pro- gram development, policy analysis, and advocacy for violence prevention. One central message is that the cur- rent state of science in violence prevention In 000 alone, the latest year reveals progress, promise, and a number for data, iolence claimed of remaining challenges. Most of what is an estimated . million known about effective violence prevention lies globally—more than comes from studies in developed coun- . times the number of tries, but improved collaboration could help deaths from malaria. developing countries apply these lessons to their own circumstances. Promising, effective interventions are currently being implemented in and by developing countries, but they have not been rigorously evaluated for scaling up to regional and national levels. Both government and private efforts are needed to span this knowledge gap. Top 0 Causes of Death, Ages -44 Years, Both Sexes, 00 rank -4 Years - Years 0-44 Years 1 Childhood cluster HIV/AIDS HIV/AIDS 200,139 855,406 855,406 2 Road traffic injuries Road traffic injuries Tuberculosis 118,212 354,692 368,501 3 Drowning Tuberculosis Road traffic injuries 113,614 238,021 354,692 4 Respiratory infections Self-inflicted injuries Ischemic heart disease 112,739 216,661 224,986 5 Diarrheal diseases Interpersonal violence Self-inflicted injuries 88,430 188,451 215,263 6 Malaria War injuries Interpersonal violence 76,257 95,015 146,751 7 HIV/AIDS Drowning Cerebrovascular disease 46,022 78,639 145,965 8 War injuries Respiratory infections Cirrhosis of the liver 43,671 65,153 135,072 9 Tuberculosis Poisonings Respiratory infections 36,362 61,865 102,431 10 Tropical diseases Fires Liver cancer 31,845 61,341 84,279 NOTE: Bold, italic figures highlight deaths or disability due to violence. SOURCE: Violence Prevention in Low- and Middle-Income Countries: Finding a Place on the Global Agenda: Workshop Summary, p. 25.

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 Stretching Across International Borders Confronting infectious diseases In recent decades, most of the emerging infectious disease events in humans have been caused by zoonotic pathogens—those infectious agents that are transmitted from animals to humans. Noteworthy changes in the patterns of human and animal contact in recent years make conditions ripe for global outbreaks of zoonotic diseases, the 2009 swine flu outbreak among them. Some of these diseases, including AIDS, severe acute respira- tory syndrome (SARS), and West Nile virus infection, have already caused global health and economic crises. With an estimated billion people cross- ing international borders every year, the shipment of animals and animal products over great distances to reach their final destinations, and rampant population growth in countries where poverty rates are high and people by necessity live in close proximity to animals, new outbreaks could emerge with devastating health, economic, environmental, agricultural, and socio- political results. The IOM and the National Research Council jointly convened a work- shop to examine how well the United States and the world are prepared to deal with the threats of zoonotic diseases over the long term. Achiev- ing Sustainable Global Capacity for Surveillance and Response to Emerging Diseases of Zoonotic Origin: Workshop Summary (2008) outlines what is known about the transmission of zoonotic disease and explores the current global capacity for zoonotic disease surveillance. In particular, the report discusses methods of disease surveillance as a way of detecting outbreaks of diseases in animals, spotting outbreaks of zoonotic disease in humans, and using these data to inform public health responses to outbreaks or per- haps prevent them in the future. It also describes components of a research plan to explore many of the questions that remain about how best to protect humans worldwide from the transfer and spread of diseases from animals. Changing climatic conditions also have contributed to a shift in the global spread of disease. Climatic change has long been known to influence the appearance and spread of epidemic diseases, but evidence is mounting that Earth’s climate is changing at a faster rate than previously appreciated and that this change likely will be accompanied by more frequent occur- rences of extreme weather events, such as droughts and hurricanes. This awareness is leading researchers to view the relationships between climate and disease with a new urgency and from a global perspective. The IOM explored various aspects of this climate–health link at a workshop convened by its Forum on Microbial Threats. Global Climate

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0 INforMINg THe fuTure: Critical Issues in Health Change and Extreme Weather Events: Understanding the Contributions to Infectious Disease Emergence: Workshop Summary (2008) notes that the projected impacts of climate change and extreme weather events are pre- dominately negative. Impacts are expected to be most severe in low-income countries where the capacity to adapt is weakest, though developed countries also are vulnerable, as was demonstrated in 2003 when tens of thousands of Europeans died as a result of record-setting summer heat waves. The report discusses some of the scientific questions that must be answered in order to dis- cern—and, ultimately, to predict—the effects of a changing climate on specific infectious diseases, as well as to identify technical means to tackle these issues. For example, it will be critical to develop a greater understanding of the interaction of climate with other major factors, such as the globalization of travel and trade, population growth, urbanization, land-use patterns, and habitat destruction, that play a role in disease emergence and resurgence. Governments also will need to establish long-term monitoring programs to simultaneously track climate and infectious disease dynamics, and to opti- mize measurement instruments (many of which were designed for other purposes) for use in such programs. In addition, researchers must continue to develop and refine predictive models of climate and infectious disease as the basis for early warning and public health response systems, and gov- ernments should encourage more stakeholders to become involved in the operation of such systems. Assessing treatment of disease Malaria is a leading cause of death among children in the developing world. Of the more than 1 million people who die of malaria each year, more than 80 percent are young children in sub-Saharan Africa. One promising approach for reducing malaria’s toll is called intermittent preventive treatment, in which all infants, regardless of whether or not they are infected, are given a full therapeutic course of an antimalarial drug—typically sulfadoxine- pyrimethamine—at defined intervals, usually in conjunction with regularly scheduled visits to health clinics. But questions have remained about the method’s effectiveness.

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 Stretching Across International Borders obsered Changes in North American extreme eents, Assessment of Human Influence for the obsered Changes, and Likelihood That the Changes Will Continue Through the Twenty-first Centurya Likelihood of Where and When Linkage of Continued Phenomenon These Changes Human Activity Future and Direction Occurred in to Observed Changes in of Change Past 50 Years Changes This Century Warmer and fewer Over most land Likely warmer Very likelyd cold days areas, the last 10 extreme cold and nights years had lower days and nights numbers of severe and fewer frostsb cold snaps than any other 10- year period Hotter and more Over most of Likely for Very likelyd frequent hot North America warmer nightsb days and nights More frequent Over most land Likely for certain Very likelyd heat waves and areas, most aspects, e.g., warm spells pronounced over night-time northwestern temperatures; two-thirds of and linkage North America to record high annual temperatureb More frequent Over many areas Linked indirectly Very likelyd and intense heavy through downpours and increased water higher proportion vapor, a critical of total rainfall in factor for heavy heavy precipitation precipitation events eventsc Increases in No overall average Likely, Southwest Likely in area affected change for North USA.c Evidence Southwest by drought America, but that 1930s and USA, parts of regional changes 1950s droughts Mexico, and are evident were linked to Carribeand natural patterns of sea surface temperature variability continued

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 INforMINg THe fuTure: Critical Issues in Health Continued Likelihood of Where and When Linkage of Continued Phenomenon These Changes Human Activity Future and Direction Occurred in to Observed Changes in of Change Past 50 Years Changes This Century More intense Substantial Linked indirectly Likelyd hurricanes increase in Atlantic through since 1970; increasing likely increase sea surface in Atlantic since temperature, a 1950s; increasing critical factor tendency in for intense W. Pacific and hurricanes;e decreasing a confident tendency in E. assessment Pacific (Mexico requires further West Coast) studyc since 1980e Based on frequently used family of Intergovernmental Panel on Climate Change emission a scenarios. Based on formal attribution studies and expert judgment. b Based on expert judgment. c Based on model projections and expert judgment. d As measured by the Power Dissipation Index (which combines storm intensity, duration, and e frequency). SOURCE: Global Climate Change and Extreme Weather Events: Understanding the Contributions to Infectious Disease Emergence, p. 7. At the request of the Bill & Melinda Gates Foundation, which is investing heavily in malaria treatment and prevention worldwide, the IOM convened an expert committee to examine the body of evidence about the technique’s effectiveness. The committee relied heavily on work con- ducted by the Intermittent Preventive Treatment in Infants Consortium, comprising 17 leading organizations involved in malaria research in Africa, Europe, and the United States. Assessment of the Role of Intermittent Pre- ventive Treatment for Malaria in Infants: Letter Report (2008) concludes that the method yields significant benefits. Some reported data, for exam- ple, showed that treated infants experienced approximately 20 to 30 per- cent fewer clinical malaria episodes than did untreated infants. Based on such findings, the report concludes that intermittent pre- ventive treatment is worthy of further investment as part of a public health

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 Stretching Across International Borders strategy to decrease morbidity from malaria infections among infants who are at high risk because they reside in malaria-endemic areas. The report also recommends, however, that if public health authorities elect to expand use of the method in sub-Saharan Africa, they should include monitoring efforts during the early stages to further assess their safety, effectiveness, cost effectiveness, acceptability, and sustainability at the community level. Because malaria kills so many people and is an enormous public health problem, health experts around the world are searching for new ways to fight the disease. While the recent IOM report discusses intermit- tent preventive treatment, that is only one option among many. In 2004, the IOM released Saving Lives, Buying Time: The Economics of Antimalarial Drugs, which recommended ways to make the new combination malaria treatments—called artemisinin-combination therapies, or ACTs—widely accessible despite their high cost. The report’s central recommendation came to pass in April 2009 with the announcement of a program called Affordable Medicines Facility for Malaria. Funded by international pub- lic health organizations and European governments, the program will be piloted in Cambodia and 10 African countries initially, and then evaluated after 2 years to determine its success and viability. Although it may not claim as many lives each year as malaria, influ- enza poses an even broader geographic sweep of health challenges. Dur- ing the early stages of an influenza pandemic, physicians and other public health workers may rely on two antiviral drugs, oseltamivir (sold as Tami- flu®) and zanamivir (sold as Relenza®), to treat illness and slow its spread during the several months it takes to develop a vaccine. But as the emer- gence of a new strain of flu virus in spring 2009 demonstrated, it is difficult to estimate in advance how severe the next pandemic will be and what mix of treatment and prophylaxis will be optimal. At the request of the U.S. Department of Health and Human Services (HHS), the IOM examined the nation’s strategies for coping with major new influenza outbreaks. Antivirals for Pandemic Influenza: Guidance on Developing a Distribution and Dispensing Program (2008) concludes that governments at all levels—federal, state, and local—currently lack a coordi- nated plan to get drugs fairly and efficiently to people who need them. The report calls for government officials to begin a national and public process of creating an ethical framework for allocating antivirals, and for the fed- eral government to appoint a science-based advisory body that can guide decision making during a pandemic.

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4 INforMINg THe fuTure: Critical Issues in Health Prioritized Strategies for Antiiral Drug use from Noember 00 HHS Draft Proposed guidance Estimated Number of Population to Receive Prophylaxis Antiviral Courses Needed } Initial pandemic outbreaks overseas and in the United States 6 million Exposed travelers entering the United States early in a pandemic Persons with pandemic influenza illness 79 million (outbreak and post-exposure) Health care and emergency services workers 103 million Outbreak control in closed settings 5 million (e.g., nursing homes) Immunocompromised and not 2 million candidates for vaccine Unique and specialized infrastructure workers 2 million Household contacts of cases 88 million The summary of the proposed guidance, dated November 20, 2008, revises the preliminary position on household prophylaxis: “No national recommendation is made at this time for PEP [post-exposure prophylaxis] of household contacts of an influenza case or for workers in sectors other than healthcare and emergency services.” Total estimated number of courses 285 million for treatment and prophylaxis Total excluding household post- 197 million exposure prophylaxis SOURCE: Antivirals for Pandemic Influenza: Guidance on Developing a Distribution and Dispensing Program, p. 29. In developing a strategic framework, officials should establish, among other things, a process for prioritizing which groups of people should first receive antiviral medications currently stored in federal and state stock- piles. In most instances, first priority should go to health care workers and emergency personnel who are likely to face repeated viral exposures, fol- lowed by other health care providers and emergency responders, and then people in households in which a member has been infected. The prioriti- zation process should be built to have enough flexibility to adjust for the

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 Stretching Across International Borders particular circumstances of an actual outbreak, including how quickly the virus spreads, which population groups it affects most severely, and how readily it responds to drugs. In addition to engaging the public in In most instances, first prioritization planning, government officials priority should go to health also should connect with the corporations care workers and emergency and other private entities that are build- personnel who are likely to ing stockpiles of antiviral drugs for their face repeated iral exposures, employees. Efforts to establish agreements followed by other health care and understanding between the public and proiders and emergency private sectors could lead to collaboration responders, and then people in an actual outbreak and reduce confusion in households in which a member has been infected. and inefficiencies during a pandemic. While malaria and influenza remain everyday threats to human health, in the late 20th century the global health community eradicated one of the most devastating diseases ever to plague humanity: smallpox. Today, all known stocks of the disease’s causative agent, variola virus, are stored in two repositories sanctioned by the World Health Organization—in the United States at the federal Centers for Dis- ease Control and Prevention, and in Russia at the State Centre for Research on Virology and Biotechnology. But debate has continued about whether to retain or destroy these stocks of live virus. In 1999, the Institute of Medicine explored this question, and its report, Assessment of Future Scientific Needs for Live Variola Virus, concluded that preserving live strains of the virus could help researchers in developing medical countermea- sures for smallpox. That same year, the World Health Assembly, the decision-making body of the World Health Organization, declared that given the important research remaining, a decision about retaining stocks of the live virus should be deferred until 2010. To help prepare for this decision, the HHS and the Centers for Disease Control and Preven- tion requested the IOM review the body of research that has accumulated over the past decade and determine what unmet needs still exist that require the use of live variola virus. Live Variola Virus:

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 INforMINg THe fuTure: Critical Issues in Health oeriew of essential Versus useful Scientific Needs for Lie Variola Virus Need Requires Use of Live Virus Does Not Require Live Virus •  Development of therapeutics •  Development of first- and Essential and assessment of resistance second-generation vaccines that produce a take •  Development of vaccines •  Development of methods that do not manifest a take for detection and diagnosis •  Functional genomics– •  Variola genome Useful based research sequence analysis •  Discovery research SOURCE: Live Variola Virus: Considerations for Continuing Research, p. 4. Considerations for Continuing Research (2009) finds that developing medi- cal countermeasures against this deadly pathogen remains an essential need because of the potential for an accidental or deliberate release, and that having access to stocks of live variola virus will critically aid research- ers in reaching their goals. The report singles out four areas for particular attention: development of improved therapeutics; development of new or improved vaccines; genomic analysis to improve the fundamental under- standing of the virus and identify new strategies for therapies; and “discov- ery research” that can yield fundamental insights about human biology as well as lessons on how to improve smallpox prevention and treatment.