A Scowcroft Institute of International Affairs White Paper - "The Growing Threat of Pandemics: Enhancing Domestic and International Biosecurity." ...

 
A Scowcroft Institute of International Affairs White Paper - "The Growing Threat of Pandemics: Enhancing Domestic and International Biosecurity." ...
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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