A Scowcroft Institute of International Affairs White Paper - "The Growing Threat of Pandemics: Enhancing Domestic and International Biosecurity." ...
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A Scowcroft Institute of International Affairs White Paper “The Growing Threat of Pandemics: Enhancing Domestic and International Biosecurity.” March 2017
The views expressed and opinions presented in this paper are those of the Scowcroft Institute of International Affairs and do not necessarily reflect the po- sitions of the Bush School of Government and Public Service or Texas A&M University.
The Growing Threat of Pandemics: Enhancing Domestic and International Biosecurity Scowcroft Institute of International Affairs The Bush School of Government and Public Service Executive Summary The threat posed by pandemics grows along- with built-in accountability to ensure decen- side increased globalization and technologi- tralized action. We also call for the reprioriti- cal innovation. Distant cultures can now be zation of national and international pandemic connected in a day’s time, and international preparedness and response exercises. trade links global health and economic pros- perity. In this report, the Scowcroft Institute 2. International Response: We should re- of International Affairs at the Bush School of evaluate pandemic response plans—in partic- Government and Public Service at Texas ular, the need to adopt the World Health Or- A&M University details nine priority areas ganization’s (WHO) reforms: WHO estab- and accompanying action items that will help lished an advisory group in 2015 to determine to address current pandemic response prob- ways to improve its response to disease out- lems. breaks and emergencies following an ineffec- tive response to the Ebola outbreak in 2014. 1. Leadership: Strong leadership in biode- We endorse the recommendations for reform fense and pandemic preparedness and re- provided by the advisory group and urge pri- sponse is the first area identified as needing ority action for reform implementation. We improvement. Following the recommenda- also recommend that WHO Regional Office tions made by the Blue Ribbon Panel on Bio- directors no longer be independent from defense (2015), we recommend that United WHO Headquarters, but report directly to the States leadership in biodefense be centralized Director-General. Independence of the re- in the White House, specifically within the gional offices makes a unified WHO re- Vice President’s office. Also in line with rec- sponse difficult and can impede efficient ommendations made by the Biodefense communication and organization during pan- Panel, we recommend that a Biodefense demic response. Council, overseen by the Vice President, be established. Additional action items include 3. The Anti-vaccine Movement: The in- the establishment of a new and overarching creasing influence of the anti-vaccine move- National Biodefense and Pandemic Prepared- ment in the United States is another growing ness Strategy. Beyond the panel’s findings, threat. Leaders of the movement spread mis- we recommend a detailed implementation information to parents with questions or anx- plan, tied to a unified and integrated budget, iety over the safety of vaccines. Many within The views expressed and opinons presented in this paper are those of the Scowcroft Institute of International Affairs and do not necessarily reflect the positions of the Bush School of Government and Public Service or Texas A&M University.
THE GROWING THREAT OF PANDEMICS: ENHANCING DOMESTIC AND INTERNATIONAL BIOSECURITY the anti-vaccine movement incorrectly be- professionals and researchers with the goal of lieve that vaccines cause autism, and the developing an interdisciplinary strategy for number of individuals seeking nonmedical animal, human, and environmental health; in- exemptions to the vaccination requirements creased disease surveillance along wild- of schools is on the rise. In some states, like life/livestock boundaries; and education and Washington and Texas, this puts public training for individuals who live or work in school populations dangerously close to fall- high-risk areas. ing below the threshold for “herd immunity,” which refers to the percentage of a population 5. Uniform Health Screening: There should that needs to be vaccinated in order to provide be uniform health screenings for individuals protection to those who are unvaccinated. seeking permanent or extended temporary Dropping below herd immunity puts individ- residence in the United States. Immigrants uals who cannot get vaccinated—those that and refugees are a vital part of American so- are either too young or immunocompro- ciety. The United States must continue to mised—at great risk. We recommend that welcome them, but there are currently, dis- public health authorities initiate education crepancies between the vaccination require- campaigns to communicate the risk that vac- ments for immigrants and the vaccination re- cine-preventable disease poses to unvac- quirements for refugees, which should be cinated individuals. Additionally, we made uniform. Immigrants are required to strongly recommend that states re-evaluate have all their vaccinations before entering the their acceptance of personal belief or philo- country, whereas refugees are only strongly sophical exemptions. These should be re- recommended to do so. There are also limited moved as exemption options. health screening requirements for individuals who are not seeking permanent residence in 4. Animal and Human Health: Next we ad- the United States. It may not always be pos- dress the need to bridge the gap between ani- sible for refugees to receive their vaccina- mal and human health. The majority of tions overseas, so we suggest requiring im- emerging diseases are zoonotic. Whether due munizations upon entry and requiring health to living in close proximity with animals, de- screenings for anyone staying in the US more struction and encroachment of habitats, or than three months. We also recommend im- lack of vaccinations, diseases originating in plementing more risk-based infectious dis- animals are increasingly making the jump ease screenings that reflect the individual’s into the human population. Some of our rec- country of origin. ommendations for bridging the gaps in this area include the following: expanded animal 6. Public Health and Health Care Infra- vaccination programs; institutionalization of structure: In many developing countries, One Health, a program that creates collabora- there are insufficient infrastructure, exper- tion between human and animal health care tise, and supplies to adequately provide for 2
THE GROWING THREAT OF PANDEMICS: ENHANCING DOMESTIC AND INTERNATIONAL BIOSECURITY even basic day-to-day health care, let alone to We further recommend that the new national detect, report, and respond to infectious dis- biodefense and pandemic preparedness strat- ease outbreaks and other threats as required egy affirm OFDA’s role as the lead coordina- by WHO's International Health Regulations tor of the United States’ international re- (IHR). Even the US, which has greater exper- sponse for pandemic emergencies, similar to tise and higher investment in healthcare, its lead role for all other international disaster struggles with adequate surge capacity in the responses. case of a high-impact infectious disease out- break or other emergencies. In this section, 8. Cultural Competency: Ebola demon- we recommend investment in host country strated that disease control protocols and cul- institutions and restructuring hiring systems tural rituals can collide with devastating re- for health care professionals in developing sults. In this report, we suggest that cultural countries. In addition, enhanced diplomacy anthropologists and crisis communicators be and commitment to the Global Health Secu- consulted and included in US public health rity Agenda will help support implementation missions to other countries. of the International Health Regulations. We 9. Academic Collaborations: Academic in- also recommend enhanced foreign aid invest- stitutions situated in developing countries ments in global health, specifically for pan- have pre-established relationships with the demic prevention and preparedness, as they affected people in their local communities are essential to international security and US and regions and will be around long after the national security. acute response phase has ended. There are 7. Effective Outbreak Response: The US is also growing global academic and scientific often caught unprepared when an outbreak university-based collaborations between fac- with pandemic potential strikes. Valuable ulty and students in developed and underde- time is wasted in the existing, cumbersome veloped countries. We suggest building uni- process of identifying the disease, predicting versity-based public health extension pro- risk, and acquiring emergency appropriations grams designed to work within local commu- to respond. To help create a more effective nities and communicate disease research to a response, we recommend that Congress make nonacademic audience as well as incorporat- funding for diagnostics and biosurveillance a ing host country universities and their estab- high-priority budget item. In addition, the lished, global academic collaborations into United States should use the USAID Office the overall disease response. of Foreign Disaster Assistance’s (OFDA) fi- nancial authorities and resources, which are not earmarked, as an international pandemic emergency response fund to reduce the need for supplemental emergency appropriations. 3
THE GROWING THREAT OF PANDEMICS: ENHANCING DOMESTIC AND INTERNATIONAL BIOSECURITY Introduction The world is experiencing accelerated levels gress and other donors for the massive fund- of change. Massive expansion of global ing required. This has the effect of creating a travel; economic interdependence; global slower than necessary response as organiza- supply chains; climate change; urbanization; tions are waiting for funds to be allocated be- deforestation; technological advancement; fore they take action. Once the funds are ap- and the expansion of mechanized, scientific propriated, the money must then be spent commercial food production are just a hand- quickly in an attempt to control the epidemic ful of the changes that have occurred globally after it is already out of control. in the last fifty to seventy years. Remote vil- The Department of Health and Human Ser- lages in Africa are not as disconnected from vices (HHS) and other supporting public the US population as they once were, and health officials need emergency funding au- people are coming in increasingly close con- thorities and appropriations, similar to the tact with wildlife populations around the Stafford Act, which is designated for the Fed- world. Armed conflict is causing an unprece- eral Emergency Management Agency dented migration of people, and, in fact, the (FEMA) and other emergency management United Nations High Commission for Refu- activities. We support the establishment of gees (UNHCR) reports that there are cur- emergency funding authority but emphasize rently 65 million internally displaced people that establishing the emergency fund should and refugees—the largest number in history. not cause a reduction in funding for infec- Air travel allows a person to move around the tious disease preparedness more broadly. world in a day. All of these elements play a role in the increasing number of emerging The 2014 Ebola outbreak in West Africa cost and re-emerging infectious diseases through- the United States government $2.4 billion in out the world. response operations. The United States and the rest of the international community spend Preparing for and responding to diseases with billions of dollars responding to epidemics pandemic potential is one of the greatest chal- and pandemics that occur with greater and lenges modern society faces. These outbreaks greater frequency. This reactive method of cause loss of life, loss in personal and na- disease response is not sustainable and does tional income, and foreign policy challenges. little to prevent the emergence of infectious The United States government’s current re- diseases at their source. Organizational and sponse approach relies too heavily on supple- funding changes must be made at a domestic mental emergency appropriations from Con and international level to avoid the exponen- tial loss of resources, personnel, economic 4
THE GROWING THREAT OF PANDEMICS: ENHANCING DOMESTIC AND INTERNATIONAL BIOSECURITY development, and human life caused by dis- Recognizing that we face the threat of pan- ease outbreaks. We cannot continue to rely on demics is the first step. Taking action to cor- a reactive strategy. rect or minimize the threat is the second. This white paper outlines the major obstacles The importance of preparing for a pandemic standing in the way of optimal pandemic pre- cannot be overstated. At the same time, the vention, preparedness, and response—many importance of educated predictions and com- of which were discussed during the 2nd An- munication, rather than “crying wolf” every nual Pandemic Policy Summit hosted by the time there is a possible threat, also cannot be Scowcroft Institute of International Affairs. overstated. Expressing certainty of a threat There are nine problem topics this white pa- that doesn’t materialize hurts the credibility per will cover. These areas are the need for of the government—and more specifically, effective, centralized leadership and collabo- the Centers for Disease Control and Preven- ration and better use of available resources; tion’s (CDC) reputation—making it less improved international system response; to likely that citizens will take future threats se- counter the anti-vaccine movement and stress riously. A prime example of this is the 1976 the threat from vaccine-preventable diseases; swine flu outbreak, a virus said to be a direct to bridge the gap between animal and human descendant of the 1918 flu. A massive, na- health; implementation of more uniform tionwide vaccination campaign was launched health screenings and travel education; im- in preparation for the outbreak. The outbreak proved and sustained public health institu- America so greatly feared never materialized tions and infrastructure; to respond effec- and, instead, an increased risk of Guillain- tively and in a timely way to disease out- Barre syndrome was later linked to the 1976 breaks; to establish cultural competency in flu vaccine (CDC, 2015b). This incident re- pandemic response; and to establish and ex- sulted in the firing of the CDC director and pand the unique role of universities. Each embarrassment for the federal government as problem outlined in this paper is coupled with well as laying the groundwork for the distrust action items that will help close the gaps in of flu vaccines we see today. Despite all of disease preparedness and response. this, the 1976 incident does not diminish the danger posed by infectious diseases, nor does This paper aims to create a realistic and ef- it take away from the importance of preparing fective plan for reducing the threat of pan- for disease outbreaks. Thoughtful, deliberate, demics throughout the world. The plan also near real-time surveillance and epidemiolog- helps to mitigate the need for large, recurring, ical analysis, diagnostics, and communica- supplemental emergency appropriations to tion are critically important in responding to respond to outbreaks after they are already pandemic risk. Prematurely or incorrectly an- beyond control. Many of the intellectual and nouncing disease threats can cause backlash organizational structures necessary to accom- and a lack of trust among the public. plish pandemic prevention and preparedness 5
THE GROWING THREAT OF PANDEMICS: ENHANCING DOMESTIC AND INTERNATIONAL BIOSECURITY objectives are already in place. However, we nature of pandemics, there are often many must maximize available authorities, budg- government authorities and nongovernment ets, and resources, and the current approach organizations (NGOs) involved in prepared- does not do so. The action items put forth be- ness, response, and recovery. While the con- low will address major gaps in both US na- tribution from various areas of international tional security and international health secu- and domestic government can be beneficial rity. in terms of resources, it often complicates the actual response process through confused As the new administration and Congress re- lines of authority, a lack of ability to effec- focus priorities on defense and security for tively integrate resources, and communica- the United States, the Scowcroft Institute tion obstacles. maintains not only that enhanced global health foreign aid and other related invest- At the international level, WHO serves as the ments targeted at pandemic prevention are in main authority in public health. WHO was our national security interest but moreover established in 1948 as an entity of the United that subtle efforts/investments toward pre- Nations (UN) and includes more than 190 vention will be much less costly than the re- member states. WHO’s mission is to provide active strategy we find ourselves in today. leadership on health matters, guide the global health research agenda, provide technical Problem Topic 1: Leadership, Col- support, monitor health trends, and develop laboration, and Accountability ethical and evidence-based policies. Alt- hough the organization was originally estab- Problem Statement: lished to tackle global infectious diseases, WHO has expanded its scope and today pur- Fragmentation and a lack of coordination, sues a comprehensive health agenda. WHO integration, and communication within plays a primarily supportive role but has also multilateral international organizations and assumed an emergency response leadership domestic government agencies tasked with role to support member states and emergency pandemic preparedness and control pose a responses involving cross-border and multi- threat to rapid and efficient disease re- ple-state needs. Most member states, other sponse. multilateral organizations, and NGOs look to WHO for leadership during epidemics and Background: pandemics. Emerging infectious diseases with pandemic potential can have a global effect and are The WHO enterprise includes the headquar- spread more easily by the travel and trade ters located in Geneva and regional offices. structures that serve as the backbone for The Regional Office for Africa; the Regional global commerce. Due to the international Office for the Americas, which is also the 6
THE GROWING THREAT OF PANDEMICS: ENHANCING DOMESTIC AND INTERNATIONAL BIOSECURITY Pan-American Health Organization (PAHO); countries, but it also serves as a regional of- the Regional Office for Southeast Asia; the fice for WHO. One of the most important Regional Office for Europe; the Regional Of- roles of PAHO is to help set the health agenda fice for the Eastern Mediterranean; and the for the Americas and to provide technical as- Regional Office for the Western Pacific pro- sistance for health issues. vide WHO presence on six of the seven con- tinents. The role of these offices is to address The last two international organizations of health issues that may be specific to the re- consequence to pandemics are the World Or- gion, and they are the first point of contact ganisation for Animal Health (OIE) and the when there is a suspected infectious disease Food and Agricultural Organization of the within their region. One of the challenges that United Nations (FAO). OIE was imple- WHO faces, however, is that it relies heavily mented by an international agreement in on information and cooperation from its re- 1924 and is tasked with controlling animal gional offices and the member states it disease at a global level. FAO is an entity of serves. WHO deploys personnel and can the UN with the purpose of eradicating hun- make recommendations for action, but, ulti- ger and food insecurity. The role of FAO in mately, disease detection, reporting, and re- pandemic preparedness and response may not sponse are the responsibility of the affected be quite as obvious as the other organiza- WHO member states. tions, but the natural and bioterrorist threat to agriculture presents a food security challenge Several after-action reports regarding the that would likely fall under its purview. The Ebola 2014 incident, including WHO’s own majority of emerging infectious diseases with report, were highly critical of WHO’s re- pandemic potential are zoonotic. The grow- sponse to the outbreak. Shortcomings and ing recognition for the need to apply One needed reforms have been identified that re- Health approaches—which integrate all as- quire priority attention, as the global commu- pects of animal, human, and environmental nity needs effective WHO participation and health care through worldwide, interdiscipli- leadership going forward. nary collaboration—to controlling high-im- pact emerging infectious diseases makes In addition to WHO, there are three other in- close collaboration between WHO, OIE, and ternational health organizations of conse- FAO critical. quence. The first of these is the Pan-Ameri- can Health Organization (PAHO), which op- In the US, there are many organizations and erates much like WHO but only extends its government officials involved in preparing authority to North, Central, and South Amer- and responding to pandemics at federal, state, ican countries. It operates independently, local, and tribal levels. At the federal level providing health leadership to almost fifty alone, there are at least ten departments and 7
THE GROWING THREAT OF PANDEMICS: ENHANCING DOMESTIC AND INTERNATIONAL BIOSECURITY agencies and over fifty presidentially ap- Within HHS, the Centers for Disease Control pointed, senate-confirmed individuals that and Prevention is the major operational divi- have biodefense responsibilities (Larsen et sion for public health preparedness and re- al., 2015). sponse. Its role includes conducting the ma- jority of human infectious disease surveil- The Pandemic Influenza Implementation lance, maintaining public health laboratory Plan identifies two departments with more capabilities, and supporting state and local significant leadership roles in pandemic re- public health for preparedness planning and sponse: the Department of Health and Human response activities. Several other staff and Services (HHS) is the lead for federal medi- operating divisions in HHS also have signifi- cal and public health response, and the De- cant roles, including the Centers for Medicaid partment of Homeland Security (DHS) is the Services, the National Institutes of Health, lead in overall domestic incident manage- the Federal Food and Drug Administration, ment and federal coordination. the Assistant Secretary of Health, the Sur- geon General, and others. As such, the Secretary of HHS is the lead for federal public health and medical response The Secretary of Homeland Security serves during a domestic infectious disease out- as the principal federal official for domestic break. The Assistant Secretary for Prepared- incident management and coordinates the ness and Response (ASPR) was created by overall federal response, assuring the full the Pandemic and All Hazards Preparedness function of the nation’s critical infrastructure. Act (PAHPA) in 2006 and serves as the Sec- The Secretary is also responsible for setting retary’s principal advisor on all matters re- reporting requirements and communicating lated to public health, medical preparedness, with all entities involved in the response. and response for public health emergencies. Within DHS, however, there are many organ- Although some argue that Congress intended izations that are involved in a pandemic re- for the ASPR to lead all federal interagency sponse. These include the Federal Emer- biodefense efforts, including pandemic re- gency Management Agency (FEMA), US sponse, that mandate is not authorized by leg- Customs and Border Protection, the Trans- islation or executive action. The ASPR did portation Security Authority (TSA), the Of- establish the Public Health Medical Counter- fice of Public Affairs, and the US Coast measures Enterprise (PHEMC) to coordinate Guard. Each of these organizations plays a medical countermeasure preparedness and separate role in the response, including response activities across HHS, including ac- screening of potentially sick individuals and tivities of the Department of Homeland Secu- referring people to public health quarantine rity (DHS), United States Department of Ag- authorities. DHS also has a responsibility to riculture (USDA), Department of Defense mitigate the entry of contaminated products (DOD), and Veterans Affairs (VA). into the country by screening vessels, trucks, 8
THE GROWING THREAT OF PANDEMICS: ENHANCING DOMESTIC AND INTERNATIONAL BIOSECURITY aircraft, and other forms of commerce when US/internationally for an infectious disease they reach the border or port of entry. outbreak. The United States Department of Agriculture The military and DOD have a long history of (USDA) is responsible for inspecting all ani- distinguished accomplishments in infectious mals and plants entering the United States, disease research and public health for US but it is also the main agency tasked with re- military personnel, in collaboration with our sponding to animal disease outbreaks. strategic allies. DOD has world-class re- Though USDA is often overlooked when dis- search centers and biocontainment laborato- cussing issues of human health, its surveil- ries working on defense and the control of lance of animal health can be an important high impact infectious diseases, including the tool in preventing zoonotic outbreaks. Unfor- United States Army Medical Research Insti- tunately, the links between animal and human tute of Infectious Diseases and the Walter surveillance are extremely limited, and wild- Reed Army Institute of Research. The latter life surveillance is in a different department includes a network of international research altogether (Department of the Interior). There laboratories that are strategically located in is also a significant funding disparity be- areas of the world to enable international tween animal and human health at a time public health collaboration, disease surveil- when a One Health approach has become in- lance, and local response, as well as further creasingly important to pandemic prevention. regional diplomacy. The Department of Defense is another major Several other departments at the federal level stakeholder in pandemic preparedness and bi- have significant responsibilities, including odefense. Pandemic preparedness is critical Department of State, Department of Labor, for DOD to ensure that force projection, Department of Education, Department of which is the ability to project national power Transportation, Federal Aviation Admin- through military operations, is not impeded in istration, and Department of the Interior. The the event of a severe infectious disease out- United States Agency for International De- break. DOD is also responsible for protecting velopment has unique authorities and lead re- service members and their families world- sponsibilities for coordinating the United wide. DOD has unique planning logistics, States’ response to international humanitar- and command and control capabilities can be ian and other disasters, along with a Global called upon to support humanitarian relief as Health Bureau that deals with infectious dis- well as global and domestic natural disaster ease and public health programs from a de- response. The 2014 Ebola outbreak in West velopment perspective. Africa was the first time that major DOD lo- gistical, engineering, and command/control capabilities were deployed outside of the 9
THE GROWING THREAT OF PANDEMICS: ENHANCING DOMESTIC AND INTERNATIONAL BIOSECURITY In the US, while several federal organizations decentralized execution across the biode- have authorities and oversight responsibili- fense enterprise for defense against biologi- ties for pandemic preparedness, state and lo- cal threats—whether natural, accidental, or cal authorities on the frontline are ultimately intentional. The Blue Ribbon Panel on Bio- “ … w e n e e d s t r o n g l e a d e r s h i p t o e n a b l e e f f e c t i v e decentral- ized execution across the biodefense enterprise…” responsible for an infectious disease response defense discussed this recommendation ex- in their communities. These include gover- tensively in the 2015 report. The need for ef- nors, mayors, tribal leaders, and their associ- fective leadership was more recently ad- ated government public health and emer- dressed by the President’s Council of Advi- gency management officials, as well as pri- sors on Science and Technology. The Biode- vate sector health care providers and busi- fense Panel recommended that leadership for nesses. The National Guard also has a local biodefense be centralized with the Vice Pres- or state level role in pandemic response if ac- ident of the United States and that a White tivated by a governor. House Biodefense Coordination Council to coordinate and integrate the work of all the Further, the Blue Ribbon Panel on Biode- agencies and departments working on biode- fense reported that there are at least twenty- fense and pandemic preparedness should be five policy documents (legislation, national established. The Panel further recommended strategies, and executive orders) covering bi- that the Vice President and a Biodefense Co- odefense and pandemic preparedness. We do ordination Council establish a new, overarch- not lack for policy documents, but we do suf- ing national biodefense strategy with clear fer from both competing and overlapping metrics and then hold departments/agencies strategies, which further complicate our re- accountable for achieving outcomes. Some sponse efforts. We need a new, overarching argue that improved biodefense and pan- national strategy coupled with an implemen- demic preparedness may not require substan- tation plan to provide focus on priority ac- tial new funding but rather refocus of priori- tions and accountability for all levels of gov- ties, accountability, and better use of availa- ernment and to provide better guidance to ble resources. The Scowcroft Institute con- nongovernment organizations. curs with the Panel’s leadership recommen- dations and the need to use available authori- To overcome the difficulties of diffuse and ties and resources more effectively. We ex- competing interagency organization and en- tend the Panel’s recommendation for a na- sure better utilization of available resources, tional strategy to include a detailed imple- we need strong leadership to enable effective mentation plan with clearly identified lead 10
THE GROWING THREAT OF PANDEMICS: ENHANCING DOMESTIC AND INTERNATIONAL BIOSECURITY and supporting roles for priority action items activities in a manner that allows the agency tied to a unified, integrated, and comprehen- to expand response into the realm of pandem- sive budget. ics. With existing legislative authorities, staffing, and a discretionary emergency re- Forming a biodefense council under the pur- sponse budget, USAID/OFDA is the best view of the Vice President will help to clarify equipped agency to lead and coordinate fed- who the response authority is at the domestic eral response efforts to global pandemics. level. The same must be done with regard to the United States government response to in- Making sure that international pandemic re- ternational disease outbreaks. The interna- sponse is rapid and effective will require tional arena can be even more complicated to more than just putting USAID/OFDA in navigate, making it more necessary to have charge, however. In addition to officially des- clear and established lines of authority prior ignating OFDA as the lead organization in re- to a pandemic response. The new national bi- sponse, clear lines of authority must be estab- odefense strategy and implementation plan lished between USAID/OFDA, DOD, HHS, should affirm USAID’s Office of Foreign the State Department, and any other federal Disaster Assistance (OFDA) as the lead in organizations that may be called upon. Sup- coordinating the United States’ response to porting agencies must know and understand pandemics overseas, just as it is the lead for their roles and responsibilities. We suggest United States government response to all the development of an International Re- other international disasters. sponse Framework, analogous to the Na- tional Response Framework for domestic re- While the OFDA office already responds to sponse, that outlines each organization’s role an average of sixty-five disasters per year, the in the response and clarifies lead and support- 2014 Ebola outbreak was the first time that ing responsibilities. USAID/OFDA Disaster Assistance Re- sponse Teams (DART) were deployed in re- Although centralized leadership in the United sponse to a pandemic (OFDA, 2017).. OFDA States is vital to developing effective pan- has the demonstrated experience, personnel, demic response, it is also important that col- and expertise to effectively lead future inter- laboration with the international community national pandemic response efforts. In FY be strengthened. Pandemic response requires 2015, USAID/OFDA provided over $1.6 bil- a unified effort by members of the interna- lion for disaster response activities, in addi- tional community, including a reformed tion to almost $90 million in community dis- WHO, the United States, other donor and re- aster preparation and mitigation (USAID, cipient members, and affected country gov- 2016). In coming years, Congress and the ernments. If these entities are not able to White House should continue to provide work together and communicate to the public funding for OFDA’s international response 11
THE GROWING THREAT OF PANDEMICS: ENHANCING DOMESTIC AND INTERNATIONAL BIOSECURITY with a unified, coherent message, the pan- could prove particularly useful at linking sci- demic response will be undermined. Having ence, policy, local communities, and affected centralized US leadership may make it easier individuals. to strengthen and clarify interactions with a reformed WHO, but this will need to be sup- Recommendations and Action Items: plemented by culturally appropriate commu- There are many US government departments nication and training regarding countries and agencies involved in pandemic planning likely to be affected by a pandemic in order and response, and the bureaucracies associ- to increase response effectiveness. ated with these departments and agencies re- sist ceding power or territory. The threat of Beyond government organizations, there are future pandemics and our vulnerabilities re- still barriers to effective collaboration and di- quire strong leadership paired with the ability visions among institutions and individuals. to better coordinate and integrate capabilities Researchers are working in a range of disci- across all levels of government (federal, plines, including infectious diseases, biology, state, local, and tribal) and the private sector chemistry, psychology, communication, po- with a sense of urgency, priority, and maxi- litical science, and anthropology. As pan- mization of available resources. Nationally, demics are interdisciplinary, these research- aside from the President and Vice President, ers should reach out to each other to address the private sector and academia have the the problem of pandemics more holistically. greatest ability to galvanize state, local, and Researchers whose work is applicable to ele- tribal authorities. The following action items ments that impact disease response must col- underscore the Blue Ribbon Panel’s first laborate in order for the United States to de- three recommendations. vise the best possible disease prevention, containment, and response policies and plans. 1. Establish strong, centralized leader- Unfortunately, these academic institutions ship at the highest level of the federal gov- and research institutes often have “silos”—or ernment. Biodefense and pandemic prepar- barriers to effective multidisciplinary collab- edness leadership must have the ability to oration. New models of collaboration, such transcend internal bureaucratic strife; allow as a One Health approach, can overcome new evidence-based approaches to have a fair these barriers and effectively bridge gaps debate; make difficult decisions; and, im- across traditional organizational boundaries portantly, develop an integrated biodefense in both government and nongovernment or- budget tied to a new national strategy. Lead- ganizations. Universities also have growing ership needs to be at a level in the White international faculty and student collabora- House that can influence and galvanize ac- tions that are an underutilized resource for tion by state, local, and tribal governments, as pandemic preparedness and response and that well as nongovernment organizations. The ultimate goal of strong centralized leadership 12
THE GROWING THREAT OF PANDEMICS: ENHANCING DOMESTIC AND INTERNATIONAL BIOSECURITY is to enable effective and focused decentral- best response because they give individuals ized implementation with better utilization of and organizations an opportunity to work to- available resources and existing authorities. gether in an outbreak scenario and help solid- ify/secure/develop/chains of command/au- 2. Establish a biodefense policy coordi- thority and lines of communication before a nation committee that focuses on prepared- real outbreak occurs. Simulations also allow ness and is not diluted by day-to-day exigen- officials to see what parts of the preparedness cies. The policy process must include the and response plans are working well and ability for state, local, and tribal govern- what areas need revision. It is important to ments, as well as nongovernment organiza- make the exercises as real-life as possible by tions to provide input into the deliberative creating short deadlines, uncertainty, and the and planning processes. need to coordinate multiple agencies in a 3. Establish a new and overarching high-stress environment. This will provide National Pandemic Preparedness Strategy, individuals participating in the exercise the followed by a detailed implementation plan greatest learning experience. that identifies lead and supporting roles and 5. Affirm USAID/OFDA as the lead US organizations and that is tied to a national, government international pandemic re- integrated pandemic preparedness budget, sponse. OFDA already has the pre-existing as a detailed line item in the President’s expertise, unique legal and acquisition au- budget request. The implementation plan thority, logistic capabilities, and staff to suc- should include milestones and metrics and ceed in this role. The United States govern- should hold departments and agencies ac- ment’s international pandemic response countable for action. The 2017 National De- needs a system in which White House leader- fense Authorizing Act requires DOD, HHS, ship can instill discipline in the response ef- DHS, and USDA to establish a new national fort and that works effectively with members biodefense strategy. The Scowcroft Institute of the international community throughout applauds Congress for enacting this require- the response. OFDA is the most readily ment, and recommends that Congress exer- equipped to fill this role. cise stringent oversight responsibilities to en- sure a sound strategy, including metrics for 6. The United States should support accountability, is established, implemented, WHO reforms that enable its effective lead- and monitored. ership in a new era of global health financ- ing at a time when WHO faces significant 4. Prioritize national and interna- criticism as a result of the delayed interna- tional-level pandemic preparedness and re- tional response to Ebola. This will require sponse exercises and “breath life” into sustained, if not enhanced, US government plans and exercises. Pandemic preparedness global engagement for effective pandemic exercises/simulations are key to ensuring the 13
THE GROWING THREAT OF PANDEMICS: ENHANCING DOMESTIC AND INTERNATIONAL BIOSECURITY preparedness planning and will help over- Margaret Chan called for reform and estab- come any challenges that jeopardize timely lished the Advisory Group on Reform to An- WHO reform. WHO’s structural, financial, alyze WHO’s Work in Outbreaks and Emer- management, and other organizational chal- gencies with Health and Humanitarian Con- lenges require major reform and priority ac- sequences. This advisory group began work tion. The Director-General has stated her shortly after it was established in summer commitment to implementing recommended 2015. reforms to improve emergency response, but implementation requires support by the entire To date, the advisory group has issued two WHO enterprise, including the United States. reports, the first released on November 16, As an action item under leadership, new 2015, and the second issued on January 18, White House and HHS leadership should 2016. Both reports recommend that WHO de- start working with WHO and other strategic velop a unified platform that draws on all or- international partners immediately to develop ganizational resources to fight disease out- better action plans for pandemic response and breaks. The report termed this platform the to identify how best to help WHO overcome Programme for Outbreaks and Emergencies challenges to reform. This should include and suggested the program be led by an Ex- communication guidelines to avoid contra- ecutive Director, who would report directly dictory messages from the two organizations. to the Director-General. Further, the platform should have “one budget, one workforce (re- Problem Topic 2: Restructuring the porting to the Executive Director); one line of International System Response managerial authority; consistent procedures for supporting operations across the organi- Problem Statement: zation; specifically designed processes for managing human resources, finances, pro- The current international response system curement, and logistics; and one set of perfor- for pandemics is dysfunctional and needs mance benchmarks to be applied across the reform. organization” (Second Report of the Advi- Background: sory Group on Reform of WHO’s Work in Outbreak and Emergencies, 2016). The pro- Following the 2014 Ebola outbreak in West gram is designed to correct WHO’s frag- Africa, WHO faced significant criticism for mented and slow response to Ebola. its management of the response, character- ized as slow, disorganized, and inadequate. The creation of the outbreak and emergencies Member states further criticized WHO for program was just the first major step toward being politicized and biased. Largely due to WHO reform. The advisory group also sug- the backlash after Ebola, Director-General gested that WHO work with local, national, and regional governments throughout their 14
THE GROWING THREAT OF PANDEMICS: ENHANCING DOMESTIC AND INTERNATIONAL BIOSECURITY “As it currently operates, WHO is not effective at meet- i n g t h e n e e d s o f a l l m e mb e r c o u n t r i e s w i t h r e g a r d t o p a n e mi c p r e p a r e d n e s s a n d e m e r g e n c y r e s p o n s e . ” member states to create more resilient health The advisory group also recommended that systems prior to a disease outbreak. Despite a WHO maximize its existing funding mecha- lack of extensive information about how this nisms—they provide the Central Emergency would be accomplished, there was mention of Response Fund, for example—and develop a training local health care workers to function contingency fund. The advisory group set the as first responders during an outbreak. We capitalization goal for this contingency fund also suggest that building up diagnostic capa- at $100 million, but, as of February 2017, the bilities and developing laboratory availability fund had only $32.65 million available are vital to effectively creating a resilient (WHO, 2017). In order for this contingency health system and member states’ Interna- fund to be effective, it needs to attract greater tional Health Regulation compliance. levels of funding that can make it effec- tive/useful in combatting future diseases. The advisory group report proposes an alter- Member states and the global community native method for establishing an emergency cannot ask WHO to do more without com- health care workforce that relies much more mensurate member state commitments to per- heavily on involvement from a variety of sec- form essential emergency outbreak response tors. This recommendation from the report functions. coincides with building resilience, as the ad- visory group believes that training the local Lastly, the advisory group on WHO reform workforce to respond to pandemics will pro- identified the need to accelerate research and vide an emergency health care workforce development with regard to disease outbreaks that is less dependent on a surge response and emergencies. They mention the im- from WHO and other member states. While portance of extending partnerships and look- this recommendation is valuable and training ing at different categories of donors, includ- the local health workforce to serve as part of ing the private sector. By extending partner- the emergency response is a good way to ex- ships, particularly in the private sector, the pand the emergency response team, it is also advisory board states that WHO will be able important to have scale-up capacity within to make real progress in increasing its ability the actual WHO response workforce. This is to respond appropriately and innovatively to not something that is included in WHO’s re- disease outbreaks. It should be noted, how- form recommendations. ever, that there is a great deal of bureaucratic inertia against the reforms across the WHO 15
THE GROWING THREAT OF PANDEMICS: ENHANCING DOMESTIC AND INTERNATIONAL BIOSECURITY enterprise, including from some member tions, such as through the United Nations Of- states. Despite the potential benefits of these fice of Coordinating Humanitarian Affairs. If changes, the desire to continue business as this shift becomes necessary, it should in- usual may be more powerful. The Scowcroft clude the reallocation of a portion of US fi- Institute stresses that this challenge to WHO nancial contributions normally directed to reform must be overcome. As it currently op- WHO. This reallocation should instead be erates, WHO is not effective at meeting the sent to a new United Nations structure for needs of all member countries with regard to pandemic emergency response. pandemic preparedness and emergency re- sponse. Without implementation of these re- 2. Regional offices should not be inde- forms, enhanced financing with demon- pendent and, instead, should report directly strated better use of available resources, and to the Director-General. While the advisory the support of all member states, inadequate group makes an attempt to streamline the responses will continue, generating frustra- work and communication between WHO tion among the global community. This could headquarters and its regional offices, the lead to the emergence of alternative struc- group still allows the regional offices to op- tures that would further fracture an already erate independently. If regional offices are al- shaky global health leadership landscape. lowed to maintain independence from head- quarters, challenges with communication and Recommendations and Action Items: response organization will continue. Instead, regional offices should operate as part of the 1. WHO must implement the advisory hierarchy of the main organization. Requir- group’s reform recommendations. Without ing regional directors to report to and imple- implementation of these reforms, WHO is not ment decisions from the Director-General able to meet the needs of its member states will help WHO have a more cohesive re- during outbreaks and emergencies. The 2014 sponse during disease outbreaks and emer- Ebola outbreak in West Africa demonstrated gencies. If the regional offices must report to exactly how badly these reforms are needed. WHO headquarters, there will be less delay By most accounts, WHO responded too late in response, as funding and physical support and in a fashion that provided little assistance typically must come from outside the re- to countries in need during Ebola. These fail- gional offices. This structure would allow ures must be corrected before the next major WHO headquarters to establish more strin- pandemic. If WHO is unable to implement gent reporting requirements for regional of- timely reforms, the United States, in coordi- fices in the hope of eliminating reporting and nation with strategic international partners, response delays. should explore alternative pandemic emer- gency response models under the United Na- 16
THE GROWING THREAT OF PANDEMICS: ENHANCING DOMESTIC AND INTERNATIONAL BIOSECURITY Problem Topic 3: The Anti-vaccine global immunization campaign. Polio, also Movement and the Re-emergence of feared for causing paralysis and death, has been eliminated in the United States and most Vaccine-Preventable Diseases of the world, with less than 100 cases re- Problem Statement: ported globally in 2015—also a result of a global immunization campaign. Similarly, Anti-vaccination activists contribute to the measles, mumps, rubella, pertussis, and other re-emergence of vaccine-preventable dis- diseases were once associated with signifi- eases, which has become a serious public cant morbidity and mortality until immuniza- health problem in the United States and tions decreased disease incidence by over 99 elsewhere. The anti-vaccine movement has percent in the United States. Unfortunately, the potential to impact biodefense and pan- many of these diseases have not been elimi- demic vaccine availability, which could nated globally and still threaten parts of the make life-saving vaccines unavailable as a developing world, where vaccine access is component of a future comprehensive pub- not prevalent. In addition to the international lic health response. impact, the US can be directly impacted when citizens travel abroad and infect their Background: local communities upon their return. Vaccines are one of the greatest public health Because vaccines and immunization cam- advances of the 20th century. During the early paigns have been so successful, parents today 1900s in the United States, childhood mortal- have not witnessed firsthand the epidemics ity was staggering, rivaling what we recog- these illness can become. They do not appre- nize today as third world suffering. Infectious ciate the serious and potentially catastrophic diseases, many of which are now preventable consequences vaccine-preventable diseases through vaccines, were at the top of the list of could have on their children, families, and childhood killers. The Centers for Disease communities if allowed to return unchecked. Control and Prevention estimated that the Similarly, many front-line health care provid- lives of 732,000 American children will be ers would not recognize or even consider saved, and 322 million cases of childhood ill- these diseases in their initial differential diag- nesses will be prevented due to vaccinations nosis due to their low frequency of occur- children received between 1994, at the start rence and their own unfamiliarity with these of the Vaccines for Children Program, and diseases that were once so common. 2013 (CDC, 2014). WHO similarly reports that vaccines prevent an estimated 2 to 3 mil- The adoption of widespread, population- lion child deaths (WHO, 2016e). Smallpox, based, mandatory immunization using safe feared for centuries, was declared eradicated and effective vaccines is largely responsible by the WHO in 1980 through an aggressive for this successful eradication. Mandatory 17
THE GROWING THREAT OF PANDEMICS: ENHANCING DOMESTIC AND INTERNATIONAL BIOSECURITY vaccination laws were first enacted in the rise. In fact, the frequency of parents devel- early 19th century to combat smallpox in oping a personal belief that vaccines are not Massachusetts. In 1905, the United States Su- safe has put some communities at a height- preme Court upheld the authority of states ened risk of community-level outbreaks. and municipalities to pass compulsory vac- cination laws that gave state and local public The last ten to twenty years have seen a re- health authorities prerogative over individual emergence of vaccine-preventable diseases choice to protect the public’s health and that coincides with the rise of nonmedical ex- safety in the event of communicable diseases emptions. Most recently, this has caused (Swendiman, 2011). Mandatory municipal high-profile, multistate outbreaks of measles, and state-based vaccination policies have pertussis, and mumps. subsequently been adopted by all states. To- What is causing this re-emergence of vac- day, modern childhood vaccination laws pre- cine-preventable diseases, and why is this a scribe specific vaccine requirements for entry relatively new phenomenon? A review of into schools, preschools, and child care facil- multiple studies exploring these phenomena ities. in detail points to decreasing vaccine uptake As with any vaccine or drug, there is always in communities as a major factor, but not the the possibility of adverse reactions as well as only factor, tied to the re-emergence of vac- medical contraindications for some individu- cine-preventable diseases (Phadke, Bednar- als. Because of this, every state allows vac- czk, Salmon, et al., 2011). For example, de- cination exemptions, with exemption allow- creased immunizations are largely responsi- ances varying by state. All states allow med- ble for increased measles outbreaks. Pertussis ical exemptions in the event a vaccine is con- outbreaks are also associated with decreased traindicated for a child that is immunocom- vaccination rates. But waning immunity is promised, allergic to a vaccine or its excipi- also a factor, as some don’t realize that the ents, or has other medical contraindications effectiveness of the vaccine decreases over to receiving a vaccine. All but three states time. Nonetheless, a clear pattern has also allow for nonmedical exemptions, emerged where parents, often from affluent though the types and enforcement of these communities, are electing to seek nonmedical nonmedical exemptions varies by state. Rea- exemptions to avoid immunizations for their sons for/types of nonmedical exemptions in- children. clude religious, philosophical, and personal Seemingly well intentioned but misguided beliefs. For example, some religions like Je- parents avoid vaccines because of their con- hovah’s Witnesses may avoid some modern cerns about vaccine safety. Through nonex- medical practices and science. The number of pert or falsified information, they are led to children not receiving vaccines due to non- medical personal belief exemptions is on the 18
THE GROWING THREAT OF PANDEMICS: ENHANCING DOMESTIC AND INTERNATIONAL BIOSECURITY believe there is a causal link between vac- (Wakefield, 1998). In that study, the author cines and autism. Well-organized, anti-vac- reported that twelve children who received cine activists are igniting this fear through the measles, mumps, and rubella (MMR) misinformation that is contrary to prevailing vaccine developed what, appeared to be au- scientific evidence, which shows no link be- tism—implying a causal link. The claims tween vaccines and autism. made in the article ignited fear in society at large about the safety of vaccinations. This Societal avoidance and resistance to vaccines fear led to decreased vaccination rates, fol- is not a new phenomenon. Vaccine resistance lowed by measles, mumps, and rubella out- dates back to soon after Edward Jenner dis- breaks in Europe and the United States. covered that inoculation of cowpox pustules induces protective immunity to smallpox. Subsequent investigations into the original Since the discovery of vaccines by Jenner, re- 1998 study revealed that the author had a sig- sistance movements have come and gone and nificant financial conflict of interest and had have, at times, become very emotional, lead- committed other ethical and scientific ing to irrational fears. breaches while conducting the research. The editorial board of The Lancet retracted the Today, vaccine research, development, man- publication twelve years later in 2010, and ufacturing, use, and post-marketing surveil- the UK body for medical examiners revoked lance are highly regulated by the FDA. Child- the author’s medical license that same year. hood vaccines have advanced tremendously In 2011, The British Medical Journal pub- over the last fifty years and are as safe and lished an editorial about the investigation into effective as ever. the 1998 Lancet paper in which they con- cluded the research was an elaborate fraud. The contemporary anti-vaccine resistance Unfortunately, the damage to public health, movement is, in some respects, similar to re- families, children, and communities had al- sistant movements that preceded it. Unlike ready been done, and the perception of a link previous movements, however, current ef- between MMR vaccines and autism persists. forts are based on fraudulent data accompa- nied by intensive misinformation campaigns. The use of personal belief and philosophical exemptions is reaching a crisis point and has serious implications for modern society and health security. The contemporary anti-vaccine movement stems from a widely debunked study pub- lished by a British physician/scientist in the journal The Lancet nineteen years ago 19
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