Influenza Pandemic
Efforts to Forestall Onset Are Under Way; Identifying Countries at Greatest Risk Entails Challenges Gao ID: GAO-07-604 June 20, 2007Since 2003, a global epidemic of avian influenza has raised concern about the risk of an influenza pandemic among humans, which could cause millions of deaths. The United States and its international partners have begun implementing a strategy to forestall (prevent or delay) a pandemic and prepare to cope should one occur. Disease experts generally agree that the risk of a pandemic strain emerging from avian influenza in a given country varies with (1) environmental factors, such as disease presence and certain high-risk farming practices, and (2) preparedness factors, such as a country's capacity to control outbreaks. This report describes (1) U.S. and international efforts to assess pandemic risk by country and prioritize countries for assistance and (2) steps that the United States and international partners have taken to improve the ability to forestall a pandemic. To address these objectives, we interviewed officials and analyzed data from U.S. agencies, international organizations, and nongovernmental experts. The U.S. and international agencies whose efforts we describe reviewed a draft of this report. In general, they concurred with our findings. Several provided technical comments, which we incorporated as appropriate.
Assessments by U.S. agencies and international organizations have identified widespread risks of the emergence of pandemic influenza and the United States has identified priority countries for assistance, but information gaps limit the capacity for comprehensive comparisons of risk levels by country. Several assessments we examined, which have considered environmental or preparedness-related risks or both, illustrate these gaps. For example, a U.S. Agency for International Development (USAID) assessment categorized countries according to the level of environmental risk--considering factors such as disease presence and the likelihood of transmission from nearby countries, but factors such as limited understanding of the role of poultry trade or wild birds constrain the reliability of the conclusions. Further, USAID, the State Department, and the United Nations have administered questionnaires to assess country preparedness and World Bank-led missions have gathered detailed information in some countries, but these efforts do not provide a basis for making comprehensive global comparisons. Efforts to get better information are under way but will take time. The U.S. Homeland Security Council has designated priority countries for assistance, and agencies have further identified several countries as meriting the most extensive efforts, but officials acknowledge that these designations are based on limited information. The United States has played a prominent role in global efforts to improve avian and pandemic influenza preparedness, committing the greatest share of funds and creating a framework for managing its efforts. Through 2006, the United States had committed about $377 million, 27 percent of the $1.4 billion committed by all donors. USAID and the Department of Health and Human Services have provided most of these funds for a range of efforts, including stockpiles of protective equipment and training foreign health professionals in outbreak response. The State Department coordinates international efforts and the Homeland Security Council monitors progress. More than a third of U.S. and overall donor commitments have gone to individual countries, with more than 70 percent of those going to U.S. priority countries. The U.S. National Strategy for Pandemic Influenza Implementation Plan provides a framework for U.S. international efforts, assigning agencies specific action items and specifying performance measures and time frames for completion. The Homeland Security Council reported in December 2006 that all international actions due to be completed by November had been completed, and provided evidence of timely completion for the majority of those items.
GAO-07-604, Influenza Pandemic: Efforts to Forestall Onset Are Under Way; Identifying Countries at Greatest Risk Entails Challenges
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Report to Congressional Requesters:
United States Government Accountability Office:
GAO:
June 2007:
Influenza Pandemic:
Efforts to Forestall Onset Are Under Way; Identifying Countries at
Greatest Risk Entails Challenges:
GAO-07-604:
GAO Highlights:
Highlights of GAO-07-604, a report to congressional requesters
Why GAO Did This Study:
Since 2003, a global epidemic of avian influenza has raised concern
about the risk of an influenza pandemic among humans, which could cause
millions of deaths. The United States and its international partners
have begun implementing a strategy to forestall (prevent or delay) a
pandemic and prepare to cope should one occur. Disease experts
generally agree that the risk of a pandemic strain emerging from avian
influenza in a given country varies with (1) environmental factors,
such as disease presence and certain high-risk farming practices, and
(2) preparedness factors, such as a country‘s capacity to control
outbreaks.
This report describes (1) U.S. and international efforts to assess
pandemic risk by country and prioritize countries for assistance and
(2) steps that the United States and international partners have taken
to improve the ability to forestall a pandemic.
To address these objectives, we interviewed officials and analyzed data
from U.S. agencies, international organizations, and nongovernmental
experts.
The U.S. and international agencies whose efforts we describe reviewed
a draft of this report. In general, they concurred with our findings.
Several provided technical comments, which we incorporated as
appropriate.
What GAO Found:
Assessments by U.S. agencies and international organizations have
identified widespread risks of the emergence of pandemic influenza and
the United States has identified priority countries for assistance, but
information gaps limit the capacity for comprehensive comparisons of
risk levels by country. Several assessments we examined, which have
considered environmental or preparedness-related risks or both,
illustrate these gaps. For example, a U.S. Agency for International
Development (USAID) assessment categorized countries according to the
level of environmental risk”considering factors such as disease
presence and the likelihood of transmission from nearby countries, but
factors such as limited understanding of the role of poultry trade or
wild birds constrain the reliability of the conclusions. Further,
USAID, the State Department, and the United Nations have administered
questionnaires to assess country preparedness and World Bank-led
missions have gathered detailed information in some countries, but
these efforts do not provide a basis for making comprehensive global
comparisons. Efforts to get better information are under way but will
take time. The U.S. Homeland Security Council has designated priority
countries for assistance, and agencies have further identified several
countries as meriting the most extensive efforts, but officials
acknowledge that these designations are based on limited information.
The United States has played a prominent role in global efforts to
improve avian and pandemic influenza preparedness, committing the
greatest share of funds and creating a framework for managing its
efforts. Through 2006, the United States had committed about $377
million, 27 percent of the $1.4 billion committed by all donors. USAID
and the Department of Health and Human Services have provided most of
these funds for a range of efforts, including stockpiles of protective
equipment and training foreign health professionals in outbreak
response. The State Department coordinates international efforts and
the Homeland Security Council monitors progress. More than a third of
U.S. and overall donor commitments have gone to individual countries,
with more than 70 percent of those going to U.S. priority countries.
The U.S. National Strategy for Pandemic Influenza Implementation Plan
provides a framework for U.S. international efforts, assigning agencies
specific action items and specifying performance measures and time
frames for completion. The Homeland Security Council reported in
December 2006 that all international actions due to be completed by
November had been completed, and provided evidence of timely completion
for the majority of those items.
[Hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-07-604].
To view the full product, including scope and methodology, click on the
link above. For more information, contact D. Gootnick at (202) 512-3149
or gootnickd@gao.gov or M. Crosse at (202) 512-7114 or crossem@gao.gov.
[End of section]
Contents:
Letter:
Results in Brief:
Background:
Information Gaps Hinder Assessments of Comparative Risk and
Identification of Priority Countries:
The United States Has Played a Prominent Role in Global Efforts to
Improve Preparedness:
Concluding Observations:
Agency Comments and Our Evaluation:
Appendix I: Scope and Methodology:
Appendix II: Comments from the U.S. Agency for International
Development:
Appendix III: Comments from the Department of Health and Human
Services:
Appendix IV: Comments from the Department of Agriculture:
Appendix V: Analysis of Selected USAID and State Department Rapid
Assessments of Avian Influenza Preparedness:
Appendix VI: Assistance to Regional and Global Organizations:
Appendix VII: U.S. Agency Obligations Funding by Pillar:
Appendix VIII: Distribution of USAID Personal Protective Equipment
Kits:
Appendix IX: GAO Contacts and Staff Acknowledgments:
Related GAO Products:
Tables:
Table 1: Confirmed Human H5N1 Cases by Country, 2003 through 2006:
Table 2: U.S. Planned Funding for International Avian and Pandemic
Influenza Assistance by Agency and by Pillar/Activity:
Table 3: Regional Recipients of Donor Assistance for International
Avian and Pandemic Influenza Preparedness as of December 2006:
Table 4: U.S. Obligations for International Avian and Pandemic
Influenza Assistance by Agency and by Pillar/Activity:
Figures:
Figure 1: Locations of Reported H5N1 Infection in Poultry, Wild Birds,
or Both and in Humans through December 2006:
Figure 2: Global Response to the Spread of H5N1 through December 2006:
Figure 3: USAID Assessment of Country-by-Country Risk of H5N1
Outbreaks:
Figure 4: UN Summary of Country Preparedness, December 2006 -
Bangladesh:
Figure 5: Pledges and Commitments for International Avian and Pandemic
Influenza Assistance by Donor, as of December 2006:
Figure 6: Allocation of U.S. and Global Commitments for International
Avian and Pandemic Influenza Assistance, as of December 2006:
Figure 7: Top 15 Recipients of Committed, Country-Specific
International Avian and Pandemic Influenza Funding as of December 2006:
Figure 8: U.S. Planned Funding for International Avian and Pandemic
Influenza Assistance by Agency:
Figure 9: Selected Action Item for Preparedness and Communications--
Creating Emergency Stockpiles:
Figure 10: Selected Action Item for Surveillance and Detection--
Training Foreign Health Professionals:
Figure 11: Selected Action Item for Response and Containment--
Developing Rapid Response Teams:
Figure 12: Avian Influenza Preparedness--Analysis of Selected
Indicators and Countries from USAID and State Department Rapid
Assessments (October/November 2005):
Figure 13: Global Organization Recipients of Donor Commitments for
International Avian and Pandemic Influenza Preparedness as of December
2006:
Figure 14: Distribution of USAID PPE Kits as of October 2006:
Abbreviations:
CDC: Centers for Disease Control and Prevention of the Department of
Health and Human Services:
DOD: Department of Defense:
FAO: United Nations Food and Agriculture Organization:
HHS: Department of Health and Human Services:
OIE: World Organization for Animal Health (Office International des
Epizooties):
PPE: personal protective equipment:
UN: United Nations:
USAID: U.S. Agency for International Development:
USDA: Department of Agriculture:
WHO: United Nations World Health Organization:
United States Government Accountability Office:
Washington, DC 20548:
June 20, 2007:
The Honorable Edward M. Kennedy:
Chairman:
Committee on Health, Education, Labor, and Pensions:
United States Senate:
The Honorable Daniel Akaka:
Chairman:
Subcommittee on Oversight of Government Management, the Federal
Workforce, and the District of Columbia:
Committee on Homeland Security and Governmental Affairs:
United States Senate:
Since the end of 2003, a global epidemic of avian influenza[Footnote 1]
among poultry has raised concern about the risk of a global influenza
epidemic--a pandemic--occurring among humans. Though initially confined
to Southeast Asia, since mid-2005, this epidemic has spread to the
Middle East, Europe, and Africa and has caused the deaths of more than
250 million poultry, either directly or as a result of culling programs
designed to stop its spread. While thus posing a serious threat to
farmer livelihoods, the H5N1 strain of influenza that is causing this
epidemic has also demonstrated the ability to infect and kill humans.
From 2003 through 2006, more than 260 humans contracted the H5N1 strain
and more than half of them died.[Footnote 2] Nearly all of these cases
resulted from contact with infected poultry. However, if H5N1 develops
the ability to pass easily among humans, an influenza pandemic could
ensue. In contrast to the more moderate health threat presented by
annual outbreaks of seasonal influenza,[Footnote 3] pandemic influenza
poses a grave threat to global public health. Scientists estimate that
the pandemic of 1918 to 1919 killed more than 50 million humans,
including an estimated 675,000 Americans, although the last two
pandemics (in 1957 and 1968) were milder.
Disease experts caution that it is not possible to predict when or
where the next influenza pandemic will begin--or whether it will
involve H5N1. Nonetheless, concern that H5N1 may spark a pandemic has
increased as the virus has spread among countries with comparatively
high levels of environmental and preparedness-related risk--that is,
countries where:
* the virus is already present, or is present in a neighboring country,
and a range of conditions, such as high-risk poultry farming practices,
are conducive to H5N1 spreading in poultry and infecting humans
(environmental risk)[Footnote 4] and:
* animal and human health systems are relatively unprepared to detect
or respond appropriately to this virus (preparedness risk).
The United Nations World Health Organization (WHO) has concluded that
the H5N1 epidemic in poultry has brought the world closer to an
influenza pandemic than at any time in the last 40 years. Concern about
this threat has prompted the United States and its international
partners to launch efforts aimed at improving global preparedness to
both forestall (prevent or at least delay) the onset of an influenza
pandemic and cope with a pandemic should one occur. As agreed with your
offices, we focused on U.S. and international efforts to forestall a
pandemic. This report addresses (1) the extent to which U.S. agencies
and their international partners have assessed the country-by-country
risk of H5N1 sparking a pandemic and prioritized countries for
international assistance and (2) the steps that U.S. agencies and their
international partners have taken to improve global preparedness to
forestall a pandemic.
In related work, we are examining constraints on the use of vaccines
and antiviral drugs to help in forestalling a pandemic and efforts that
are under way to overcome these constraints. Our analysis of these
issues will be published in a separate report.
To address our objectives, we reviewed relevant Department of
Agriculture (USDA), Department of Health and Human Services (HHS),
Department of Defense (DOD), Department of State, and U.S. Agency for
International Development (USAID) planning, funding, and reporting
documents for avian and pandemic influenza programs and discussed them
with agency officials. We examined and analyzed documents such as
country risk and preparedness assessments, operational plans, and
budget spreadsheets. We also analyzed the U.S government's strategy and
plan for addressing pandemic influenza and associated reports on
progress through December 2006.[Footnote 5] In addition, we studied
relevant documents from the United Nations (UN) and other international
organizations, including WHO, the United Nations Food and Agriculture
Organization (FAO), the World Bank, and the World Organization for
Animal Health (OIE).[Footnote 6] Finally, we consulted with
nongovernmental and academic experts on avian and pandemic influenza.
We determined that the data provided to us were sufficiently reliable
for the purposes of this report. We conducted our work from January
2006 through March 2007 in accordance with generally accepted
government auditing standards. Appendix I provides a detailed
description of our scope and methodology. A list of other GAO reports
on pandemic preparedness, influenza vaccine development, and related
topics is included at the end of this report.
Results in Brief:
Assessments by U.S. agencies and international organizations have
identified widespread environmental and preparedness-related risks in
many countries and the United States has designated priority countries
for assistance, but gaps in available information limit the capacity
for comprehensive, well-informed comparisons of risk levels by country.
Assessment efforts we examined, carried out by U.S. and international
agencies, illustrate these gaps. For example, a USAID assessment
categorized countries according to level of environmental risk,
considering disease presence and the likelihood of transmission from
nearby countries, but factors such as poor understanding of the role
poultry trade and wild birds play in transmitting the disease
constrained the reliability of USAID's conclusions. USAID, the State
Department, and the UN have administered questionnaires aimed at
assessing country preparedness in areas ranging from national planning
to the availability of antiviral drugs. The information collected has
proven useful in planning for projects but has not been sufficiently
detailed or complete to permit well-informed country comparisons.
Similarly, World Bank-led missions have gathered more detailed
information in a limited number of countries, but these efforts do not
provide a basis for making complete or comprehensive global
comparisons. Efforts to assemble better information are under way, but
will take time to produce results. Despite these limitations, the U.S.
Homeland Security Council has used available information to designate
about 20 priority countries for U.S. assistance.[Footnote 7] In
addition, U.S. agency officials stated that certain of these priority
countries have emerged as being of especially high concern, and federal
agencies are preparing interagency operating plans for these countries.
The United States has played a prominent role in global efforts to
improve avian and pandemic influenza preparedness, committing the
greatest share of funds and creating a framework for managing its
efforts. Through 2006, the United States had committed about $377
million to improve global preparedness for pandemic influenza, about 27
percent of the $1.4 billion committed by all donors.[Footnote 8] U.S.
agencies and other donors have reported committing funds to recipients
at the global, regional, and country-specific levels, with more than 70
percent of country-specific funds going to U.S. priority countries.
USAID and HHS have provided more than 90 percent of U.S. funding, while
the State Department coordinates agency efforts. Specific efforts
funded to date include, for example, stockpiling personal protective
equipment kits and other commodities for outbreak investigations and
response and training foreign health professionals to detect and
respond to disease outbreaks. The U.S. National Strategy for Pandemic
Influenza Implementation Plan provides a framework for implementing
U.S. international efforts, assigning agencies responsibility for
completing specific actions, and in most cases specifying performance
measures and time frames for determining whether the action items have
been completed. The Homeland Security Council monitors agency efforts
to implement the plan. It reported in December 2006 that all
international action items due to be completed by November had been
completed, and provided evidence of timely completion for the majority
of these items.
USAID, HHS, and USDA provided written comments on a draft of this
report, and the Department of the Treasury (Treasury) provided oral
comments. These agencies generally concurred with our findings. USAID
briefly reviewed progress to date in improving global preparedness, and
emphasized that in the coming months the agency will be focusing in
particular on developing more effective approaches to controlling the
spread of H5N1 in small-scale "backyard farms" where high-risk
agricultural practices are common.[Footnote 9] While acknowledging the
information gaps that limit country-by-country risk assessment, HHS
emphasized its support for targeting resources to priority countries as
identified by the Homeland Security Council. In this context, HHS
stressed the importance of improving information sharing among
countries. USDA stated that it found the report accurate in its
description of USDA's role and involvement in global efforts to improve
preparedness. In its oral comments, Treasury described its efforts to
encourage and support efforts by the World Bank and other international
financial institutions to address the threats discussed in this report,
and emphasized that in addition to providing funds, these international
institutions have contributed to the global response in other ways,
such as tracking and reporting on donor commitments and helping
countries develop national strategies. In addition, we received
technical comments from HHS and Treasury, as well as the Department of
State, DOD, WHO, the United Nations System Influenza Coordinator, FAO,
OIE, and the World Bank. We incorporated these comments in the report
as appropriate.
Background:
H5N1 has spread to infect poultry and wild birds over a wide geographic
area. After appearing in southeastern China and Hong Kong in 1996 and
1997, the virus reappeared in late 2003 and early 2004 in a number of
other Southeast Asian countries. In 2005 and 2006, it spread rapidly to
countries in other parts of Asia and to Europe and Africa. Through
December 2006, H5N1 had been detected in poultry and wild birds in
nearly 60 countries. Figure 1 shows the progression of the disease
across countries and also notes which of those countries have
experienced human cases.
Figure 1: Figure 1: Locations of Reported H5N1 Infection in Poultry,
Wild Birds, or Both and in Humans through December 2006:
[See PDF for image]
Source: GAO based on data and map assembled by the UN World Food
Program.
Note: No new countries reported outbreaks among birds from July through
December 2006. However, during the first 3 months of 2007 two
additional countries--Bangladesh and Saudi Arabia--reported such
outbreaks for the first time.
[End of figure]
H5N1 has infected increasing numbers of humans. WHO confirmed only 4
cases of H5N1 infection among humans in 2003, and 3 of these occurred
in one country, Vietnam. In contrast, WHO confirmed 115 human cases in
2006, in nine different countries. Table 1 shows how the number and
distribution of human cases grew from 2003 through 2006. The largest
numbers of human cases occurred in Southeast Asian countries where the
virus is well established in wild and domestic birds.
Table 1: Confirmed Human H5N1 Cases by Country, 2003 through 2006:
Countries by group: Southeast Asian countries;
Vietnam;
2003: 3;
2004: 29;
2005: 61; 2006: --;
Total: 93.
Countries by group: Southeast Asian countries;
Indonesia;
2003: --;
2004: --;
2005: 20;
2006: 55;
Total: 75.
Countries by group: Southeast Asian countries;
Thailand;
2003: --;
2004: 17;
2005: 5;
2006: 3;
Total: 25.
Countries by group: Southeast Asian countries;
China;
2003: 1;
2004: --;
2005: 8;
2006: 13;
Total: 22.
Countries by group: Southeast Asian countries;
Cambodia;
2003: --;
2004: --;
2005: 4;
2006: 2;
Total: 6.
Countries by Group: Other countries;
Egypt;
2003: --;
2004: --;
2005: --;
2006: 18;
Total: 18.
Countries by Group: Other countries;
Turkey;
2003: --;
2004: --;
2005: --;
2006: 12;
Total: 12.
Countries by Group: Other countries;
Azerbaijan;
2003: --;
2004: --;
2005: --;
2006: 8;
Total: 8.
Countries by Group: Other countries;
Iraq;
2003: --;
2004: --;
2005: --;
2006: 3;
Total: 3.
Countries by Group: Other countries;
Djibouti;
2003: --;
2004: --;
2005: --;
2006: 1;
Total: 1.
All countries;
2003: 4;
2004: 46;
2005: 98;
2006: 115;
Total: 263.
Source: WHO.
Note: Through June 12, 2007 WHO confirmed an additional 49 cases in six
different countries. Of these cases, 24 occurred in Indonesia and 18
occurred in Egypt. The remainder occurred in Cambodia and in China, and
in two countries that had not previously reported human case--Nigeria
and Laos.
[End of table]
Pandemics can occur when influenza strains emerge that have never
circulated among humans but can cause serious illness in them and can
pass easily from one person to the next. H5N1 has shown that it can
cause serious illness in humans, and could spark a pandemic if it
evolves into a strain that has the ability to pass easily from one
human to the next.[Footnote 10]
H5N1 may evolve into such a strain gradually, through accumulation of a
number of small mutations, or suddenly, through the introduction of
genetic material from another influenza virus. Influenza A viruses,
which cause both avian influenza outbreaks and human influenza
pandemics, occur naturally in wild birds and can also infect pigs,
humans, and other mammals. The various subtypes, including H5N1, mutate
as they reproduce in their avian or mammal hosts. These small mutations
continually produce new strains with slightly different
characteristics. More rarely, when an animal or human is infected with
two different subtypes, an entirely new subtype can emerge. Scientists
believe that the 1957 and 1968 pandemics began when subtypes
circulating in birds and humans simultaneously infected and combined
into new subtypes in other host animals, most likely pigs.[Footnote 11]
Pandemic Risk Varies with Environmental Conditions and Preparedness:
Disease experts caution that there are significant gaps in our
understanding of the H5N1 virus in wild and domestic birds and in
humans, and it is not possible to quantify the pandemic risk presented
by this strain. However, they generally agree that the level of risk
that H5N1 will spark a pandemic varies with (1) environmental factors,
defined as the extent to which a country or region has already become
infected with the virus--or may become infected from a neighboring
country--and provides conditions in which the virus can spread in
poultry and infect humans, and (2) preparedness factors, defined as the
extent to which the country or region is prepared to detect the virus
in poultry and humans and respond appropriately.
Taking both environmental and preparedness factors into consideration,
the risk of a pandemic emerging from the current H5N1 epidemic in
poultry is considered higher in countries or regions where:
* the virus is well-established among domestic poultry;
* there is substantial risk that wild birds or unregulated trade in
poultry and other birds will introduce the virus from neighboring
infected countries;
* large numbers of poultry are raised in heavily populated areas;
* high-risk agricultural practices (such as allowing poultry
unrestricted access to family homes and selling them in "wet
markets"[Footnote 12]) are common;
* local authorities have little ability to detect, diagnose, and report
H5N1 cases or outbreaks in either poultry or humans; or:
* local authorities have little ability to respond (apply control
measures) and contain outbreaks when they occur.
In such conditions, outbreaks among humans or poultry are more likely
to occur and to persist for prolonged periods before they are detected
or investigated. This increases the potential for mutations, and thus
the emergence of a pandemic strain.
Different Systems and Approaches Are Used to Control Influenza in
Animals and Humans:
The global community maintains separate systems for addressing
influenza and other infectious diseases in animals and humans. At the
country level, agricultural agencies are responsible for addressing
disease threats to animals, while public health agencies are
responsible for addressing disease threats to humans. International
organizations support and coordinate these national efforts. In
particular, OIE and FAO share lead responsibility for addressing
infectious disease threats to animal health, while WHO leads efforts to
safeguard humans. National agencies with technical expertise, such as
USDA and HHS, assist in these efforts.
The animal and human health systems have traditionally approached
influenza in different ways. The animal health system has emphasized
measures to protect flocks from exposure to influenza--for example, by
reducing contact with wild birds--and, when outbreaks nonetheless
occur, taking action to contain them and eradicate threatening strains.
Outbreak control measures include (1) identifying and isolating
infected zones, (2) "stamping out" the virus by culling (killing) all
poultry within these zones, and (3) cleaning and disinfecting
facilities before reintroducing poultry. Vaccines that prevent clinical
illness in poultry--and decrease the risk of transmission to both other
poultry and humans--are available. However, these vaccines do not
completely prevent influenza viruses from infecting and replicating in
apparently healthy poultry and veterinary authorities recommend their
use only in conjunction with other disease control measures.[Footnote
13] No effective antiviral drugs are available for poultry and thus
animal health agencies do not recommend their use.
The human health system's approach to both seasonal and pandemic
influenza has traditionally emphasized development and application of
vaccines to limit spread and protect individuals.[Footnote 14] However,
while vaccines are likely to play a key role in mitigating the impact
of the next pandemic, they are likely to play little role in
forestalling its onset, barring major changes in technology. Prior to a
strain being identified, the pharmaceutical industry cannot currently
produce vaccines that are certain to be effective against it. Rather,
when a new strain is identified, 6 months or more are required to
develop and reach full production capacity for new vaccines. Therefore,
a pandemic will likely be well under way before a vaccine that is
specifically formulated to counteract the pandemic strain becomes
available.[Footnote 15] Antiviral drugs are also used to treat and
prevent seasonal influenza in humans and could be used in the event of
a pandemic to contain or slow the spread of the virus.[Footnote 16] In
contrast to the approach used with poultry, the human public health
community has not generally attempted to contain an initial outbreak of
a pandemic-potential strain or to eradicate it while it is still
confined to a limited area.[Footnote 17]
The United States and International Partners Have Adopted an Overall
Response Strategy:
The U.S. government has developed a national strategy for addressing
the threats presented by H5N1, and has also worked with its
international partners to develop an overall global strategy that is
compatible with the U.S. approach. In November 2005 the Homeland
Security Council published an interagency National Strategy for
Pandemic Influenza, followed in May 2006 by an Implementation Plan that
assigns responsibilities to specific U.S. agencies. The U.S. strategy,
in addition to outlining U.S. plans for coping with a pandemic within
its own territory, states that the United States will work to "stop,
slow, or otherwise limit" a pandemic beginning outside its own
territory. The strategy has three pillars that provide a framework for
its implementation: (1) preparedness and communications, (2)
surveillance and detection, and (3) response and containment. The
United States has also worked with UN agencies, OIE, and other
governments to develop an overall international strategy. Figure 2
shows key steps in the development of this international strategy in
relation to the spread of the H5N1 virus. These steps included the
appointment of a UN System Influenza Coordinator and periodic global
conferences to review progress and refine the strategy. The most recent
global conference was held in Bamako, Mali, in early December 2006.
Figure 2: Figure 2: Global Response to the Spread of H5N1 through
December 2006:
[See PDF for image]
Source: GAO.
[A] FAO and OIE, in collaboration with WHO, A Global Strategy for the
Progressive Control of Highly Pathogenic Avian Influenza (November
2005).
[B] See UN System Influenza Coordinator and World Bank, Responses to
Avian and Human Influenza Threats: Progress, Analysis and
Recommendations January-June 2006.
[C] See UN System Influenza Coordinator and World Bank, Responses to
Avian and Human Influenza Threats: Progress, Analysis and
Recommendations July-December 2006 (January 2007).
[End of figure]
At the global level, according to the UN coordinator, the overall
strategic goal of avian and pandemic influenza-related efforts is to
create conditions that enable all countries to (1) control avian
influenza in poultry, and thus reduce the risk that it poses for
humans; (2) watch for sustained human-to-human transmission of the
disease (through improved surveillance) and be ready to contain
it;[Footnote 18] and (3) if containment is not successful, mitigate the
impact of a pandemic. To guide efforts to improve capacity for
performing these tasks, the UN System Influenza Coordinator has
identified seven broad objectives. Four of these focus in large measure
on improving capacity to forestall a pandemic:[Footnote 19]
* Improve animal health practices and the performance of veterinary
services.
* Sustain livelihoods of poorer farmers whose animals may be affected
by illness or by control measures, including culling programs.
* Strengthen public health services in their ability to protect against
newly emerging infections.
* Provide public information to encourage behavioral changes that will
reduce pandemic risks.
Information Gaps Hinder Assessments of Comparative Risk and
Identification of Priority Countries:
Although U.S. and international assessments have identified serious and
widespread environmental and preparedness-related risks in many
countries, gaps in the available information on both types of risk have
hindered comprehensive, well-informed comparisons of risk levels by
country. Assessment efforts that we examined, carried out by U.S. and
international agencies from late 2005 through late 2006, illustrate
these gaps.[Footnote 20] Efforts to assemble more comprehensive
information are under way, but will take time to produce results.
Despite these limitations, the Homeland Security Council has used
available information to designate about 20 priority countries for U.S.
assistance, and U.S. officials have determined that the United States
should focus, in particular, on certain of these countries where
pandemic risk levels appear comparatively high, including Indonesia,
Nigeria, and Egypt.
USAID Environmental Risk Assessment Illustrated Information Shortfalls:
A global analysis based on environmental factors that USAID originally
conducted during 2005[Footnote 21] identified areas at greater risk for
outbreaks but revealed gaps in available information. USAID considered
two factors in its analysis: (1) the extent to which H5N1 was already
present in animals and (2) the likelihood that the virus will be
introduced from another country through factors such as trade in
poultry and other birds and bird migration. USAID undertook this
assessment to inform its decisions about spending priorities in the
initial phase of heightened concern about human pandemic risk from
H5N1, when very little risk information was available, according to
USAID officials. USAID used OIE data on reported animal cases. For
countries that had not yet reported cases, USAID estimated the risk of
introduction based on proximity to affected countries and available
information on poultry trade and bird migration patterns. USAID
concluded that the countries at highest risk for new or recurring H5N1
outbreaks, or both, were those in Southeast Asia where the disease was
well-established, with widespread and recurring infections in animals
since 2003 (see fig. 3). Countries that were comparatively distant from
those that had already reported cases were deemed at lowest
risk.[Footnote 22]
Figure 3: USAID Assessment of Country-by-Country Risk of H5N1
Outbreaks:
[See PDF for image]
Source: GAO, based on USAID data; map (Map Resources).
[End of figure]
We identified three constraints on the reliability of these USAID
categorizations. First, global surveillance of the disease among
domestic animals has serious shortfalls. While OIE and FAO collaborate
to obtain and confirm information on suspected H5N1 cases, surveillance
capacity remains weak in many countries.[Footnote 23] Second, estimates
of risk for disease transmission from one country to another, as well
as among regions within countries, are difficult to make because of
uncertainties about how factors such as trade in poultry and other
birds and wild bird migration affect the movement of the disease.
Specifically, illegal trade in birds is largely undocumented and
movement of the virus through the wild bird population is poorly
understood. Finally, these categorizations did not take other elements
of environmental risk, such as high-risk agricultural practices, into
account.[Footnote 24]
USAID, State Department, and UN Data Collection Efforts Have Found
Widespread Preparedness Weaknesses but Have Not Resulted in Clear
Country Comparisons:
USAID, the State Department, and the UN System Influenza
Coordinator[Footnote 25] have each administered questionnaires to
assess country-by-country avian and pandemic influenza preparedness.
These efforts identified widespread preparedness weaknesses and
provided information for planning improvement efforts in individual
countries. However, the results did not provide information that was
sufficiently detailed or complete to permit clear categorization of
countries by level of preparedness.
USAID and State Department Data Collection on Country Preparedness:
During 2005, USAID and the State Department collected country-level
data that indicated widespread weaknesses in countries' ability to
detect and respond to avian and pandemic influenza, but did not provide
enough information to place the examined countries in preparedness
categories. USAID and the State Department sent separate questionnaires
to their respective missions around the world to obtain a quick
overview of avian and pandemic influenza preparedness by
country.[Footnote 26] The two agencies requested information on key
areas of concern, including surveillance, response, and communications
capacity, and stockpiles of drugs and other supplies. These efforts
identified widespread preparedness shortfalls. Our analysis of a
selection of the USAID and State Department results found, for example,
that many of the countries had not prepared stockpiles of antiviral
drugs or did not have plans for compensating farmers in the event that
culling becomes necessary. Missions in African countries reported the
greatest overall shortfalls. (See app. V for our analysis of the USAID
and State Department preparedness responses.)
USAID disease experts used this information to rate each country
according to a numerical "preparedness index," but decided against
using the results of the exercise to help establish U.S. assistance
priorities. According to USAID headquarters officials, the information
submitted by its missions provided insights on preparedness strengths
and weaknesses in the examined countries but was not sufficiently
complete or detailed to allow them to rate countries on a numerical
scale. The officials noted that they had difficulty interpreting the
largely qualitative information provided by their field missions and,
in some instances, found that the responses did not match their
experience in the relevant countries. In addition, the USAID exercise
did not include developed countries or developing countries where the
agency does not maintain a presence. The State Department did not use
the information it had collected to categorize countries by
preparedness level.
UN Data Collection and Analysis on Country Preparedness:
The UN System Influenza Coordinator, in collaboration with the World
Bank, has completed two data collection and analysis efforts that
provided useful information on country preparedness. However, this
information was not sufficiently complete or comprehensive to allow
clear country comparisons. These efforts, which surveyed UN mission
staff in countries, were conducted before the June and December 2006
global conferences on avian and pandemic influenza preparedness, to
inform discussion at the conferences. In collaboration with the World
Bank, UN staff have used the information, in addition to information
from government officials and the public domain, to summarize each
country's status with regard to seven "success factors." The staff also
analyzed the aggregate results for all countries and for specific
regions.[Footnote 27]
Similar to the USAID effort, this exercise identified widespread
shortcomings in country-level preparedness. For example, the UN found
that about one-third of the countries lacked the capacity to diagnose
avian influenza in humans. Figure 4 presents the UN's summary for a
representative country, Bangladesh. The information indicates, for
example, that programs were in place to strengthen Bangladesh's
surveillance and reporting for avian influenza in both animals and
humans, but capacity to detect outbreaks was still constrained.
Figure 4: Figure 4: UN Summary of Country Preparedness, December 2006 -
Bangladesh:
[See PDF for image]
Source: Reproduced from Responses to Avian and Human Influenza
Threats, July-December 2006, Part 2: Country Profiles (UN System
Influenza Coordinator and World Bank, January 2007).
Legend: AI = avian influenza; ADB = Asian Development Bank; AHI = avian
and human influenza; DFID = Department for International Development
(of the United Kingdom): GDP = gross domestic product; GNI/c at PPP =
gross national income per capita at purchasing power parity; HDI =
human development index; HPAI = highly pathogenic avian influenza; IDA
= International Development Association (of the World Bank); JICA =
Japan International Cooperation Agency; NGO = nongovernmental
organization.
[End of figure]
Like USAID, the UN data-gathering effort encountered obstacles that
preclude placing countries in preparedness categories. As shown in
figure 4, for example, the UN mission in Bangladesh could not provide a
clear response concerning the country's planning for farmer
compensation in the event that poultry culling becomes
necessary.[Footnote 28] In addition, the UN sought information from its
mission staff in about 200 countries, but obtained information on 141
of these in its first round of data gathering and 80 in its second. The
UN cautioned that there had been no independent validation of the
information obtained on individual countries, and that the information
could not be used to compare countries to one another or to make a
comprehensive evaluation of preparedness levels.
World Bank-Led Missions Have Provided Additional Information for Some
Countries but Have Not Provided Basis for Comprehensive Comparisons:
The World Bank has conducted more in-depth assessments of both
environmental and preparedness-related risk factors in some countries
(those that have expressed interest in World Bank assistance), but they
do not provide a basis for making complete or comprehensive global
comparisons.
The World Bank has developed guidance for its staff to apply in
generating the information needed to design avian and pandemic
influenza preparedness improvement projects in individual
countries.[Footnote 29] The guidance instructs bank staff charged with
preparing assistance projects to examine and take into account both
environmental and preparedness-related risk factors. In preparing their
projects, bank staff often work with officials from other organizations
with technical expertise, including U.S. agencies, WHO, and FAO, and
conduct fieldwork in the countries requesting bank assistance. As of
December 2006, the World Bank reported that it had completed or was
conducting assessments of national needs in more than 30
countries.[Footnote 30]
The following are examples of preparedness shortfalls in the human and
animal sectors identified by World Bank teams:
Laos:
* District-level staff responsible for human disease surveillance
typically are not qualified in epidemiology and lack the equipment
needed to report health events in a timely manner.[Footnote 31]
* Public health laboratories are not capable of diagnosing influenza in
humans.[Footnote 32]
* The human health care system has insufficient professional staff and
lacks essential drugs and needed equipment.
Nigeria:
* Veterinary services are inadequately equipped and trained to deal
with large-scale outbreaks.
* Most available laboratory facilities are outdated, with laboratory
staff needing substantial training.
Although the World Bank's assessment efforts generate information that
is useful in designing country-specific programs, they do not provide a
basis for making complete or comprehensive global comparisons of
pandemic risk levels. The World Bank performs such studies only in
countries that request bank assistance, and incorporates its findings
into project documents as needed. That is, bank staff members cite
assessment findings to support particular points in individual project
plans.[Footnote 33] The World Bank does not assess risk in countries
that have not requested bank assistance, nor does it publish its
assessment results in independent documents that employ a common
format, and thus could be readily employed to make country-by-country
comparisons.[Footnote 34]
Efforts to Assemble More Comprehensive Information on Country
Preparedness Are Under Way but Will Take Time to Produce Results:
U.S. government and international agencies have initiated several data-
gathering and analysis efforts to provide more complete information on
country preparedness levels. However, these efforts will take time to
produce substantial results.
First, HHS's Centers for Disease Control and Prevention (CDC) is
developing an assessment protocol or "scorecard" that the United States
could employ to obtain systematic, and therefore comparable,
information on pandemic preparedness levels by country. CDC officials
explained that no such assessment tool currently exists. CDC officials
are developing indicators that could be applied to rate core
capabilities in key areas, such as differentiating among influenza
strains and identifying clusters of human illness that may signal
emergence of a pandemic strain. According to CDC officials, creating
such a system would provide the United States with a basis for
comparing preparedness in different countries, identifying response
capabilities within countries that are particularly weak, and--over
time--gauging the impact of U.S. efforts to address these shortcomings.
CDC officials said that they hoped to begin testing these indicators
before the end of 2007. They stated that their efforts have so far been
limited to human public health functions, but they have discussed with
USDA and USAID opportunities to incorporate animal health functions
into this format once the prototype has been worked out for human
health capabilities.
Second, the UN System Influenza Coordinator's staff has indicated that
it is working with the World Bank to improve the quality of the UN's
country preparedness questionnaire and increase the response rate. The
goal is for their periodic efforts to assess global and country-level
preparedness to generate more useful information. The impact of these
efforts will not be clear until the staff publishes the results of its
third survey prior to the next major global conference on avian and
pandemic influenza, which is scheduled to take place in New Delhi in
December 2007.
Third, in 2006 OIE published an evaluation tool that can be used to
assess the capacity of national veterinary services.[Footnote 35] While
it has established standards for national veterinary services, the
organization had not previously developed a tool that could be used to
determine the extent to which national systems meet these standards.
With assistance from the United States and other donors, OIE reports
that it has trained over 70 people in how to apply its evaluation tool
and has initiated assessments of veterinary services in 15 countries. A
senior OIE official indicated that the organization intends to complete
assessments of over 100 countries over the next 3 years.[Footnote 36]
Finally, under the terms of a 2005 revision of the International Health
Regulations, WHO member countries have agreed to establish
international standards for "core capacity" in disease surveillance and
response systems and to assess the extent to which their national
systems meet these standards. However, guidance on how to conduct such
assessments is still being developed.[Footnote 37] Such assessments
would provide consistent information on preparedness in all
participating countries. WHO is required to support implementation of
these regulations in several ways, including supporting assessments of
national capacity. The UN System Influenza Coordinator has identified
development of national systems that comply with the new international
standards as a key objective of global efforts to improve pandemic
preparedness, and WHO has begun developing assessment tools. However,
while the regulations enter into force in June 2007, member states are
not required to assess their national capacities until 2009 and are not
required to come into compliance with the revised regulations until
2012.[Footnote 38]
The United States Has Prioritized Countries Based on Available
Information:
The United States has prioritized countries for U.S. assistance, with
the Homeland Security Council identifying about 20 "priority
countries," and agency officials have determined that the United States
should focus in particular on certain of these countries where pandemic
risk levels appear comparatively high.
In May 2006, the Homeland Security Council categorized countries, using
the limited information available on environmental and preparedness-
related risks from U.S. and international agencies, and also taking
U.S. foreign policy concerns into account. The council differentiated
among countries primarily according to available information on H5N1's
presence in these countries or their proximity to countries that have
reported the disease. According to agency officials and planning
documents, more detailed information on environmental risk factors and
country preparedness would have provided a more satisfactory basis for
differentiating among countries, but such information was not
available.
In May 2006 the council grouped 131 countries into four risk
categories:
* At-risk countries: Unaffected countries with insufficient medical,
public health, or veterinary capacity to prevent, detect, or contain
influenza with pandemic potential.
* High-risk countries: At-risk countries located in proximity to
affected countries, or in which a wildlife case of influenza with
pandemic potential has been detected.
* Affected countries: At-risk countries experiencing widespread and
recurring or isolated cases in humans or domestic animals of influenza
with human pandemic potential.
* Priority countries: High-risk or affected countries meriting special
attention because of the severity of their outbreaks, their strategic
importance, their regional role, or foreign policy priorities.
Through this process, the Homeland Security Council initially
identified 19 U.S. priority countries.[Footnote 39] They include
countries in Southeast Asia where H5N1 has become well-established
(such as Indonesia) as well as countries that:
* have experienced severe outbreaks (such as Egypt);
* have not yet experienced major outbreaks, but U.S. foreign policy
considerations mandate their identification as a priority (such as
Afghanistan); or:
* are playing an important regional role in responding to the H5N1
threat (such as Thailand).
The council has updated the country categorizations, according to State
Department officials, and there have been slight changes since the
original list was completed. According to these officials, the council
had designated 21 countries as priority countries as of March 2007.
In addition, U.S. agency officials stated that certain of these
priority countries have emerged as being of especially high concern,
and the State Department is coordinating preparation of interagency
operating plans for U.S. assistance to these countries. Based on
ongoing evaluation of both environmental and preparedness-related
factors, agency officials stated that Indonesia, Egypt, Nigeria, and a
small number of Southeast Asian countries present comparatively high
levels of pandemic risk and thus merit greatest attention. According to
the State Department, a plan for Indonesia has been completed and plans
are being prepared for Egypt, Nigeria, and three additional Southeast
Asian countries, as well as for U.S. assistance to international
organizations such as WHO. According to State Department officials,
each plan will provide information on a country's avian and pandemic
influenza preparedness strengths and weaknesses and lay out a U.S.
interagency strategy for addressing them, taking into account the
actions of the host governments and other donors. The country plans are
to be laid out according to the three pillars of the U.S. National
Strategy for Pandemic Influenza: preparedness and communications,
surveillance and detection, and response and containment.
The United States Has Played a Prominent Role in Global Efforts to
Improve Preparedness:
The United States has played a prominent role in global efforts to
improve avian and pandemic influenza preparedness, committing more
funds than any other donor country and creating a framework for
monitoring its efforts. According to data assembled by the World Bank,
U.S. commitments amounted to about 27 percent of overall donor
assistance as of December 2006. U.S. agencies and other donors are
supporting efforts to improve preparedness at the country-specific,
regional, and global levels, and the bulk of the country-specific
assistance has gone to U.S. priority countries. USAID and HHS have
provided most of the U.S. funds, while the State Department coordinates
the United States' international efforts. The U.S. National Strategy
for Pandemic Influenza Implementation Plan establishes a framework for
U.S. efforts to improve international (and domestic) preparedness,
listing specific action items, assigning agencies responsibility for
completing them, and specifying performance measures and time frames
for determining whether they have been completed. The Homeland Security
Council is responsible for monitoring the plan's implementation. The
council reported in December 2006 that all action items due to be
completed by November had been completed, and provided evidence of
timely completion for the majority of the items.
The United States Has Been a Leader in Financing Efforts to Improve
Global Preparedness:
As shown in figure 5, the United States has been a leader in financing
efforts to improve preparedness for pandemic influenza around the
world.[Footnote 40] Through December 2006, the United States had
committed about $377 million to improve global preparedness for avian
and pandemic influenza.[Footnote 41] This amounted to about 27 percent
of the $1.4 billion committed by all donors combined; exceeded the
amounts other individual donors, including the World Bank, the Asian
Development Bank, and Japan, had committed;[Footnote 42] and was also
greater than combined commitments by the European Commission and
European Union member countries.[Footnote 43] In terms of pledged
amounts, the United States has pledged $434 million, behind the World
Bank and the Asian Development Bank, which offer loans and grant
assistance.[Footnote 44]
Figure 5: Pledges and Commitments for International Avian and Pandemic
Influenza Assistance by Donor, as of December 2006:
[See PDF for image]
Source: GAO analysis of data from January 2007 report Responses to
Avian and Human Influenza Threats, July-December 2006, published by the
UN System Influenza Coordinator and World Bank.
Notes:
The World Bank defines a pledge as an indication of intent to mobilize
funds for which an approximate sum of contribution is indicated. The
World Bank defines a commitment as the result of an agreement between
the donor and recipient for designated purposes or a firm decision,
such as a legislative appropriation, that prevents the use of an
allocated amount for other purposes.
These data reflect amounts reported to the World Bank by member
countries, with some validation by the World Bank. Some U.S. activities
that also benefit international influenza preparedness, including
certain efforts that improve global response capacity for a range of
infectious diseases, are not included in the amounts the United States
reports.
The World Bank has provided nearly all of its funding in the form of
loans, sometimes at highly concessional rates, to individual countries.
Asian Development Bank financing has been more evenly divided between
loans and grants.
The pledge and commitment totals allocated to the World Bank in this
presentation do not include the Avian and Human Influenza Facility--a
World Bank-administered grant-making mechanism. Funds contributed to
this facility are reflected in the totals for the European Commission,
the United Kingdom, Australia, and other donors. The United States has
not contributed to the facility.
See app. I for additional information on these data.
[End of figure]
The United States and Other Donors Are Funding Efforts at Country,
Regional, and Global Levels:
The United States and other donors are supporting efforts to improve
preparedness at the country-specific, regional, and global levels (see
fig. 6). According to the World Bank, more than one-third of U.S. and
total global commitments have gone to assist individual countries.
Substantial shares of U.S. and global commitments also have been
directed to regionally focused programs, with primary emphasis on the
Asia-Pacific region, and to relevant global organizations, with primary
emphasis on WHO and FAO (see app. VI for additional detail). More than
half of U.S. funding in the "other" category has been used to stockpile
nonpharmaceutical equipment, such as protective suits for workers
involved in addressing outbreaks in birds or humans. The other category
also includes support for research, wild bird surveillance, and a
variety of other purposes.
Figure 6: Allocation of U.S. and Global Commitments for International
Avian and Pandemic Influenza Assistance, as of December 2006:
[See PDF for image]
Source: GAO analysis of data from January 2007 report Responses to
Avian and Human Influenza Threats, July-December 2006, published by the
UN system Influenza Coordinator and World Bank.
Notes: The World Bank defines a commitment as the result of an
agreement between the donor and recipient for designated purposes or a
firm decision, such as a legislative appropriation, that prevents the
use of an allocated amount for other purposes. See app. I for
additional information on these data.
[A] The World Bank-administered Avian and Human Influenza Facility can
support country-specific, regional, and global projects.
[End of figure]
Most Country-Specific Commitments Have Gone to U.S. Priority Countries:
The bulk of U.S. and other donors' country-specific commitments have
been to countries that the United States has designated as priorities,
with funding concentrated among certain of these countries (see fig.
7). Of the top 15 recipients of committed international funds, 11 are
U.S. priority countries. According to data compiled by the World Bank,
about 72 percent of U.S. country-specific commitments and about 76
percent of overall donor country-specific commitments through December
2006 were to U.S. priority countries.
Figure 7: Top 15 Recipients of Committed, Country-Specific
International Avian and Pandemic Influenza Funding as of December 2006:
[See PDF for image]
Source: GAO analysis of data from January 2007 report Responses to
Avian and Human Influenza Threats, July-December 2006, published by the
UN system Influenza Coordinator and World Bank.
Notes:
The World Bank defines a commitment as the result of an agreement
between the donor and recipient for designated purposes or a firm
decision, such as a legislative appropriation, that prevents the use of
an allocated amount for other purposes.
Totals include funds from donor countries, international organizations,
and the World Bank-administered Avian and Human Influenza Facility.
See app. I for additional information on these data.
[End of figure]
As figure 7 shows, Vietnam and Indonesia have been the leading
recipients of country-specific commitments from the United States and
from other donors. Indonesia, which U.S. officials have indicated is
their highest-priority country, has received the largest share of U.S.
country-specific commitments (about 18 percent), followed by Vietnam
and Cambodia.
USAID and HHS Implement Most U.S.-Funded Activities:
USAID, HHS, USDA, DOD, and the State Department carry out U.S.
international avian and pandemic influenza assistance programs, with
USAID and HHS playing the largest roles. According to funding data
provided by these agencies, USAID accounts for 51 percent of U.S.
planned spending, with funds going to provide technical assistance,
equipment, and financing for both animal and human health-related
activities.[Footnote 45] HHS accounts for about 40 percent of the
total, with the focus on technical assistance and financing to improve
human disease detection and response capacity.[Footnote 46] USDA
provides technical assistance and conducts training and research
programs, and DOD stockpiles protective equipment. The State Department
leads the federal government's international engagement on avian and
pandemic influenza and coordinates U.S. international assistance
activities through an interagency working group.[Footnote 47] Figure 8
shows planned funding levels by agency.
Figure 8: U.S. Planned Funding for International Avian and Pandemic
Influenza Assistance by Agency:
[See PDF for image]
Sources: DOD, HHS, State Department, USDA, and USAID.
Notes:
Planned funding levels indicate agency budget projections for planning
purposes. According to U.S. agency officials, such figures are roughly
equivalent to commitments as defined by the World Bank.
USAID and USDA provided planned funding levels through December 2006.
The remaining agencies provided information on planned funding through
September 2006. See app. I for additional information on these data.
[A] The DOD total does not include (1) $5 million in Overseas
Humanitarian, Disaster and Civic Aid programs to strengthen foreign
military capacity for responding to a potential pandemic or (2) $17
million in influenza-related support for DOD's Global Emerging
Infections Surveillance and Response System. The United States did not
include these funds in the information that it provided to the World
Bank.
[End of figure]
U.S. Implementation Plan Establishes a Framework for U.S. Action:
The U.S. National Strategy for Pandemic Influenza Implementation Plan,
adopted in May 2006, provides a framework for monitoring U.S. efforts
to improve both domestic and international preparedness. The plan
assigns agencies responsibility for completing specific action items
under the three pillars of the overall U.S. strategy (preparedness and
communications, surveillance and detection, and response and
containment) and, in most cases, specifies performance measures and
time frames for determining whether they have been completed. The
Homeland Security Council is responsible for monitoring the plan's
implementation.
In its international component, the Implementation Plan identifies 84
action items. It designates HHS as the lead or co-lead agency for 34 of
these, the State Department for 25, USAID for 19, USDA for 19, and DOD
for 11.[Footnote 48] Table 2 shows the distribution of planned funding
by agency within each of the three pillars in the strategy. Appendix
VII provides information on obligations by agency and pillar.
Table 2: U.S. Planned Funding for International Avian and Pandemic
Influenza Assistance by Agency and by Pillar/Activity:
Dollars in millions.
Pillar/activity: Preparedness and communications;
Agency: HHS[A]: 53;
Agency: USAID: 104;
Agency: DOD[B]: 10;
Agency: USDA: 9;
Agency: State: 5;
Agency: Total by pillar/activity: 181.
Pillar/activity: Surveillance and detection;
Agency: HHS[A]: 48;
Agency: USAID: 51;
Agency: DOD[B]: 0;
Agency: USDA: 5;
Agency: State: 0;
Agency: Total by pillar/ activity: 104.
Pillar/activity: Response and containment;
Agency: HHS[A]: 34;
Agency: USAID: 36;
Agency: DOD[B]: 0;
Agency: USDA: 6;
Agency: State: 0;
Agency: Total by pillar/ activity: 76.
Pillar/activity: Other;
Agency: HHS[A]: 15;
Agency: USAID: --;
Agency: DOD[B]: --;
Agency: USDA: --;
Agency: State: --;
Agency: Total by pillar/activity: 15.
Total by agency;
Agency: HHS[A]: 150;
Agency: USAID: 191;
Agency: DOD[B]: 10;
Agency: USDA: 20;
Agency: State: 5;
Agency: Total by pillar/activity: 376.
Sources: DOD, HHS, State Department, USDA, and USAID.
Notes:
Planned funding levels indicate agency budget projections for planning
purposes. According to U.S. agency officials, such figures are roughly
equivalent to commitments as defined by the World Bank.
USAID and USDA provided planned funding levels through December 2006.
The remaining agencies provided information on planned funding through
September 2006.
See app. I for additional information on these data.
[A] As the table shows, HHS did not designate a pillar for a portion of
its planned funds, including about $5 million to expand influenza-
related staffing levels in key global, regional, and country-level
facilities (such as WHO's regional offices for Africa and the Western
Pacific and regional surveillance and response facilities in Thailand
and Egypt), and about $10 million for HHS headquarters management of
its influenza-related initiatives.
[B] The DOD total does not include (1) $5 million in Overseas
Humanitarian, Disaster and Civic Aid programs to strengthen foreign
military capacity for responding to a potential pandemic or (2) $17
million in influenza-related support for DOD's Global Emerging
Infections Surveillance and Response System. The United States did not
include these funds in the information that it provided to the World
Bank.
[End of table]
Preparedness and Communications Actions Include Creating Emergency
Stockpiles:
Within the preparedness and communications pillar, the Implementation
Plan assigns U.S. agencies responsibility for action items that focus
on (1) planning for a pandemic; (2) communicating expectations and
responsibilities; (3) producing and stockpiling vaccines, antiviral
drugs, and other medical material; (4) establishing distribution plans
for such supplies; and (5) advancing scientific knowledge about
influenza viruses. For example, action item 4.1.5.2 assigns HHS and
USAID lead responsibility for setting up stockpiles of protective
equipment and essential commodities (other than vaccines and antiviral
drugs) with action to be completed within 9 months--that is, by
February 2007 (see fig. 9). Through fiscal year 2006, USAID reported
spending about $56 million to create a stockpile of personal protective
equipment (PPE) kits and other nonmedical commodities to facilitate
outbreak investigation and response.[Footnote 49] The USAID stockpile
consisted of 1.5 million PPE kits to be used by personnel investigating
or responding to outbreaks, 100 laboratory kits, and 15,000
decontamination kits.[Footnote 50] As of October 2006, USAID reported
having deployed approximately 193,000 PPE kits for immediate or near-
term use in more than 60 countries (see app. VIII).
Figure 9: Selected Action Item for Preparedness and Communications--
Creating Emergency Stockpiles:
[See PDF for image]
Source: GAO analysis of U.S. National Strategy for Pandemic Influenza
Implementation Plan.
[End of figure]
Surveillance and Detection Actions Include Training Foreign Health
Professionals:
To improve global surveillance and detection capacity, the
Implementation Plan assigns U.S. agencies responsibility for action
items that focus on (1) ensuring rapid reporting of outbreaks and (2)
using surveillance to limit their spread. For example, action item
4.2.2.4 assigns HHS lead responsiblity for training foreign health
professionals to detect and respond to infectious diseases such as
avian influenza with action to be completed within 12 months--that is,
by May 2007 (see fig. 10).[Footnote 51] In 2006, HHS established or
augmented five regional global disease detection and response centers
located in Egypt ($4.4 million), Guatemala ($2 million), Kenya ($4.5
million), Thailand ($6.5 million), and China ($3.9 million) to enhance
global disease surveillance and response capacity.[Footnote 52] Among
other things, these centers provide training in field epidemiology and
laboratory applications. For example, in July 2006, the Thailand center
conducted a workshop aimed at teaching public health officials what to
do when investigating a respiratory disease outbreak that may signal
the start of a pandemic. More than 100 participants from 14 countries
participated in this workshop, which was cosponsored by WHO and Thai
authorities.[Footnote 53]
Figure 10: Selected Action Item for Surveillance and Detection--
Training Foreign Health Professionals:
[See PDF for image]
Source: GAO analysis of U.S. National Strategy for Pandemic Influenza
Implementation Plan.
[End of figure]
Response and Containment Actions Include Development of Outbreak
Response Teams:
To improve global response and containment capacity, the Implementation
Plan assigns U.S. agencies responsibility for action items that focus
on (1) containing outbreaks; (2) leveraging international medical and
health surge capacity; (3) sustaining infrastructure, essential
services, and the economy; and (4) ensuring effective risk
communication. Action item 4.3.1.5, for example, assigns USDA and USAID
lead responsibility for supporting operational deployment of response
teams when outbreaks occur in poultry[Footnote 54] (see fig.
11).[Footnote 55] In 2006, USDA and USAID supported the creation of a
crisis management center at FAO to coordinate and respond to avian
influenza outbreaks globally. According to FAO, the center is able to
dispatch its experts to any location in the world in under 48 hours.
USAID and USDA have provided approximately $5 million in support to the
center.[Footnote 56] USDA detailed three veterinary specialists to the
center for headquarters operations as well as an official to serve as
its deputy director. USDA is also providing experts to respond to
outbreaks. USAID has directed its support toward enhancing coordination
with WHO on rapid deployment of joint animal health/human health teams
and facilitating operations in underresourced African countries.
Figure 11: Selected Action Item for Response and Containment--
Developing Rapid Response Teams:
[See PDF for image]
Source: GAO analysis of U.S. National Strategy for Pandemic Influenza
Implementation Plan.
[End of figure]
Homeland Security Council Reported Success on Action Items to Be
Completed by November 2006:
The Homeland Security Council's first progress report on U.S. pandemic
influenza-related efforts reported that agencies had completed all of
the 22 international action items scheduled for completion by November
2006. In December 2006, the council issued a compendium of the action
items in the Implementation Plan, with updates on the corresponding
performance measures.[Footnote 57] The council reported that all 22 of
the international action items in the Implementation Plan that agencies
were to complete by November 2006 had been completed.[Footnote 58] (The
84 action items in the international section of the Implementation Plan
have time frames for completion that range from 3 months to 2 years.)
The Homeland Security Council's report did not clearly indicate the
basis for determining completion in a number of cases, generally
because the report did not fully reflect agency efforts or the wording
of the performance measure made it difficult for agency staff to
respond. Our review of the progress report found that for 14 of the 22
action items, the report directly addressed the specified performance
measures and indicated that these measures had been addressed within
the specified time frames. However, for 8 of the action items, the
information in the progress report did not directly address the
performance measure or did not indicate that the completion deadline
had been met. Based on interviews and information we obtained from the
responsible agencies, we determined that the lack of clarity in these
cases was primarily because of omission of key facts on agency
activities or agency difficulties in reporting on poorly worded
performance measures.[Footnote 59] For example, 1 action item directed
DOD to prepare to limit the spread of a pandemic-potential strain by
controlling official military travel between affected areas and the
United States.[Footnote 60] The performance measure was designation of
military facilities that could serve as points of entry from affected
areas. The council's report described the department's preparedness for
controlling travelers' movements but did not state that DOD had
identified facilities that could serve as points of entry. Our review
of DOD documents indicated that the department had designated such
facilities. A second action item assigned the State Department lead
responsibility for developing plans to communicate U.S. avian and
pandemic influenza objectives to key stakeholders.[Footnote 61] The
performance measure was the "number and range of target audiences
reached" and the impact of relevant efforts on the public. The
council's report provided a rough estimate of the number of people
reached through U.S. government communication efforts to date. However,
State Department officials told us that the performance measure was
difficult to address because they did not have the means to accurately
estimate the effective reach or impact of their efforts.
Concluding Observations:
Difficulties in obtaining and applying accurate and complete
information present an overarching challenge to U.S. efforts to
identify countries at greatest risk and effectively target resources
against the threat presented by the H5N1 virus. In particular, although
country preparedness is a primary consideration in determining relative
risk levels, U.S. determinations on priority countries have relied
primarily on information about environmental risks, which is itself
incomplete. While the United States, the UN, and the World Bank, as
well as WHO and OIE, are refining and expanding their efforts to gather
useful information, substantial gaps remain in our understanding of
both environmental and preparedness-related risks in countries around
the world.
With strong leadership from the United States, the international
community has launched diverse efforts to increase global preparedness
to forestall an influenza pandemic. These efforts constitute a
substantial response to the threat presented by H5N1. They reflect
significant international cooperation, and the U.S. National Strategy
for Pandemic Influenza Implementation Plan provides a useful framework
for managing U.S. agencies' participation in these efforts. The
Homeland Security Council's first update on U.S. efforts and UN reports
on donor efforts in general suggest that U.S. and global efforts to
improve preparedness are producing results, but challenges remain in
accurately measuring their impact. Many countries remain relatively
unprepared to recognize or respond to highly pathogenic influenza in
poultry or humans, and sustained efforts will be required to overcome
these challenges.[Footnote 62]
Agency Comments and Our Evaluation:
USAID, HHS, and USDA provided written comments on a draft of this
report. These comments are reproduced in appendixes II, III and IV. In
addition, Treasury provided oral comments. HHS and Treasury also
provided technical comments, as did the Department of State, DOD, WHO,
the World Bank, and the United Nations System Influenza Coordinator.
The Coordinator's comments included comments from FAO and OIE, and the
latter organization also provided us with technical comments
independently. These agencies generally concurred with our findings,
and we incorporated their technical comments in the report as
appropriate.
USAID briefly reviewed progress in improving global preparedness,
citing, for example, reductions in outbreaks among poultry and humans
in Vietnam and Thailand. The agency observed, however, that the
practices employed in small-scale "backyard farms" continue to present
a major challenge to efforts to control the spread of H5N1. USAID will
therefore be paying particular attention to this challenge in the
coming months.[Footnote 63]
While acknowledging the information gaps that limit capacity for
comparing country-level risks, HHS emphasized its support for targeting
resources according to the Homeland Security Council's country
prioritization decisions. In this context, HHS stressed the importance
of improved information sharing among countries, as called for under
the revised International Health Regulations, and noted the particular
importance of sharing influenza virus samples and surveillance data. In
addition, HHS commented that limited human-to-human transmission of
H5N1 could not be ruled out in some clusters of cases in Indonesia, and
explained certain differences in the roles played by HHS, USDA and
USAID under the response and containment pillar of the U.S. National
Strategy for Pandemic Influenza. In response, we clarified the
information in the background section of this report on human-to-human
transmission and our presentation on the roles played by the HHS, USDA,
and USAID in responding to poultry and human outbreaks. In its
technical comments, HHS elaborated upon our concluding observation
regarding the need for sustained effort to overcome challenges in
improving global preparedness. We added a footnote to our concluding
observations to summarize the HHS comments in this area.
USDA stated that the report provides a comprehensive evaluation of
pandemic influenza and global efforts needed to improve avian and
pandemic influenza preparedness. USDA also stated that it found the
report accurate in its description of USDA's role and involvement in
global efforts to improve preparedness.
* In oral comments, Treasury stated that it has been actively engaged
in the U.S. government's efforts to respond to avian influenza and
increase readiness to address a potential influenza pandemic, both
internationally and within the United States. To coordinate the
department's activities, Treasury created an informal avian influenza
working group that includes staff from its domestic and internationally
focused offices. Among other things, the working group ensures that
Treasury is fully engaged in all Homeland Security Council-led
initiatives against avian and pandemic influenza. Treasury also stated
that, in coordination with U.S. executive directors at the various
international financial institutions (including the World Bank), it has
encouraged and supported these institutions in their efforts to develop
adequate responses to the threat of an influenza pandemic. However,
Treasury stated that its efforts in this area have been constrained by
U.S. legislation that requires the United States to vote against
multilateral development bank programs in cases where Burma might
receive support. According to Treasury, this has occurred two times
with respect to Asian Development Bank regionally-focused projects.
While these matters were largely outside the scope of our report, we
modified the text to acknowledge Treasury efforts to encourage and
support international financial institution efforts against avian and
pandemic influenza.
* Treasury also stated that, building on experiences drawn from the
2003 severe acute respiratory syndrome outbreak, the international
financial institutions (including the World Bank) have responded to the
H5N1 epidemic by providing financing, and also by helping countries
develop national strategies, providing relevant technical assistance
and training, serving as focal points for donor and regional
coordination, tracking and reporting on donor commitments, preparing
impact analyses, and hosting international conferences. Treasury
further noted that in addition to providing financing for individual
countries, the multilateral development banks have provided financial
and technical support to international and regional technical
organizations working in this area, including WHO and FAO.
We are sending copies of this report to the Secretaries of Agriculture,
Defense, Health and Human Services, State, and the Treasury; the
Administrator of the U.S. Agency for International Development;
appropriate congressional committees; and other interested parties. We
will also make copies available to others upon request. In addition,
the report will be available at no charge on GAO's Web site at
http://www.gao.gov.
If you or your staff have any questions, please contact David Gootnick
at (202) 512-3149 or gootnickd@gao.gov or Marcia Crosse at (202) 512-
7114 or crossem@gao.gov. Contact points for our Offices of
Congressional Relations and Public Affairs may be found on the last
page of this report. Key contributors to this report are listed in
appendix IX.
Signed by:
David Gootnick:
Director, International Affairs and Trade:
Signed by:
Marcia Crosse:
Director, Health Care:
[End of section]
Appendix I: Scope and Methodology:
We provided relevant background information on the spread of the H5N1
virus, factors that may affect the comparative risk that this virus
presents in different countries, methods that health systems
traditionally employ to respond to influenza in animals and humans, and
the overall strategy that the United States and its international
partners have developed to respond to the threats presented by H5N1. To
describe how H5N1 has spread internationally, we used country-specific
data on cases among humans assembled by the United Nations World Health
Organization (WHO), and on cases and outbreaks in humans and in wild
and domestic birds assembled by the United Nations (UN) World Food
Program. World Food Program officials told us their data on human cases
were provided by WHO, while their data on cases in birds were provided
by the World Organization for Animal Health (OIE) and the UN Food and
Agriculture Organization (FAO). WHO, OIE, and FAO have cautioned that
global surveillance is imperfect, and some human and animal cases and
outbreaks may go unrecorded. However, these organizations work with a
wide variety of global partners, including national governments, to
identify and verify outbreaks of this disease. We determined that these
data on human and animal outbreaks were sufficiently reliable for the
purposes of this report, which were to convey a general sense of the
manner in which the disease has spread across international boundaries
and the extent to which it has infected humans. However, these data
should not be relied upon to precisely identify countries where the
disease has occurred or to indicate with absolute certainty the number
of human cases that have occurred.
To identify and describe factors that affect the level of risk that
H5N1 presents in different countries and the methods that animal and
health systems generally employ against influenza, we interviewed
officials and consulted documents produced by avian and human disease
experts in relevant U.S. government agencies, international
organizations, academic institutions, and nongovernmental
organizations. To describe the overall strategy that the United States
and its international partners have developed to respond to the H5N1
epidemic, we interviewed and examined relevant documents from U.S. and
UN agencies, including the U.S. National Strategy for Pandemic
Influenza and strategy statements and progress reports produced by the
UN System Influenza Coordinator and the World Bank.
To examine the extent to which U.S. and international agencies have
been able to assess the pandemic risk that H5N1 presents in individual
countries and prioritize them for international assistance, we reviewed
and analyzed assessments of environmental risk and preparedness.
Specifically, we reviewed assessments prepared by the U.S. Agency for
International Development (USAID), the Department of State, the UN, and
the World Bank and spoke with cognizant officials at these agencies and
organizations about how they were conducted. These assessments
evaluated country-level pandemic risk deriving from environmental
conditions, country preparedness for responding to avian and pandemic
influenza, or both. We analyzed a sample of 17 country-specific avian
influenza preparedness assessments compiled by USAID and the State
Department to provide summary information on capacity in several
regions. (See app. V for a detailed description of the scope and
methodology for our analysis of sampled USAID and State Department
assessments.) We also reviewed the U.S. Homeland Security Council
Country Prioritization Matrix as of May 3, 2006, which designates
country priority levels for U.S. actions to address the avian and
pandemic influenza threat. We discussed this priority ranking with
officials from the State Department and USAID. We requested a meeting
with officials from the council, but the council declined, stating that
we could obtain needed information from other agencies and departments.
In addition, we reviewed analyses of environmental risk factors
prepared by U.S. intelligence community analysts during 2006 and early
2007 and discussed these analyses with U.S. agency officials. We also
reviewed assessments of risks in particular countries prepared by a
U.S. intelligence agency.[Footnote 64]
To determine the actions U.S. agencies and their international partners
took to address these risks, we examined funding, planning, and
reporting documents and spoke with cognizant officials. To determine
the overall level of financial support that the donor community is
providing for efforts to improve global avian and pandemic influenza
preparedness, we examined World Bank and UN documents detailing donor
pledges and commitments resulting from the international pledging
conferences on avian and pandemic influenza, including funding levels
by donor, by recipient, and by purpose. We also reviewed World Bank and
UN documents describing recipient countries, regions, and
organizations.
To describe the international activities of the U.S. government, we
reviewed the National Strategy for Pandemic Influenza and the National
Strategy for Pandemic Influenza Implementation Plan. We reviewed
pertinent planning, reporting, and funding documents for U.S.
international avian influenza control and pandemic preparedness
assistance programs. We also consulted cognizant officials from USAID
and from the Departments of Agriculture (USDA), Health and Human
Services (HHS), Defense (DOD), and State about their efforts. We
reviewed the international action items tasked to these U.S. agencies
and assessed by the Homeland Security Council in its 6-month status
report issued on December 18, 2006.[Footnote 65] We independently
compared the performance measures associated with each action item with
the agency responses to it. Finally, we visited the WHO, OIE, and FAO
headquarters in Geneva, Paris, and Rome, respectively.
To assess the reliability of the pledges and commitments data that
national governments and other donors submitted to the World Bank, we
spoke with World Bank officials responsible for maintaining these data
and reviewed supporting documentation. The pledges and commitments data
are self-reported by individual donor countries in response to a
standard request template. The World Bank staff responsible for this
data collection provided countries with standard definitions of key
terms, such as pledges, commitments, and in-kind and cash payments.
However, because countries' data reporting systems vary substantially,
World Bank staff conduct ongoing discussions with donor countries to
establish the correspondence between those systems and the World Bank
terms. World Bank staff also stated that the pledges and commitments
totals provided by countries may include funding not strictly related
to pandemic influenza and may therefore be somewhat overstated.
Therefore, based on our review, we use these data to identify general
levels of pledges and commitments made by particular countries or
organizations; they should not be relied upon to support precise
comparisons of funding by donor or recipient. Overall, we concluded
that the World Bank pledges and commitments data were sufficiently
reliable for the purposes of this report.
To obtain data on U.S. agency funding for international avian and
pandemic influenza preparedness by agency and by the three pillars of
the overall U.S. pandemic strategy, we requested separate submissions
from each of the five U.S. agencies, showing planned, obligated, and
expended funds by pillar. Two of the five agencies (USAID and USDA)
maintained funding data by pillar prior to our requesting these data.
Two others (DOD and the State Department) found it relatively easy to
comply with our request, since all of their reported activities fell
within the preparedness and communications pillar.[Footnote 66]
However, providing this information was comparatively complex for HHS.
The various units within that agency (for example, the Centers for
Disease Control and Prevention and the National Institutes of Health)
support a wide variety of relevant programs, many of which involve more
than one pillar. In addition, HHS can utilize other sources of funding
in addition to influenza-specific appropriations for many of these
programs. To respond to our request, the HHS Office of Global Health
Affairs collected data from relevant HHS units. The Director of the
Office of Global Health Affairs reviewed the final HHS submission for
accuracy before reporting back to GAO. The pillar-specific totals HHS
was able to provide were for planned funds and for obligated funds.
Thus, the funding information by agency that we provide is for these
two categories of funding data and not for expenditures.
We identified a number of limitations in the data that the agencies
provided. First, the data are not from consistent periods. USDA and
USAID provided information on planned funding levels and obligations
through December 2006. HHS, DOD, and the State Department provided data
through September 2006. In addition, DOD and the State Department
received funding for international avian and pandemic influenza
activities through appropriations in 2006 only; whereas, USAID, HHS,
and USDA received funding through 2005 and 2006 appropriations. Second,
the distribution of funds among the pillars is somewhat imprecise. When
programs addressed more than one pillar, agency officials employed
their professional judgment to decide which pillar was most
significant. This limitation was most pronounced in the HHS data. While
HHS decided how to allocate most of its funds, the agency did not
specify a pillar for about $15 million of its planned funds. This total
included about $5 million to expand staffing levels in key global,
regional, and country-level facilities, including the WHO regional
offices for Africa and the Western Pacific and surveillance and
response facilities in Thailand and Egypt, and about $10 million for
HHS headquarters management of its influenza-related initiatives.
Third, the total planned and obligated amounts are also somewhat
imprecise. Some of the agency funds come from programs that are not
dedicated specifically to avian or pandemic influenza. In such cases,
agency officials used professional judgment to decide what portion of
the funds should be designated as supporting avian or pandemic
influenza preparedness.
Despite these limitations, we determined that these data were
sufficiently reliable for the purpose of this report, which was to
provide information on general levels of agency planned and obligated
funding by pillar. However, we rounded the funding information that the
agencies provided to the nearest million dollars.
We conducted our work from January 2006 through March 2007 in
accordance with generally accepted government auditing standards.
[End of section]
Appendix II: Comments from the U.S. Agency for International
Development:
USAID:
From The American People:
Jun 11 2007:
Mr. David Gootnick:
Director:
International Affairs and Trade:
U.S. Government Accountability Office:
441 G Street, N. W.
Washington, D.C. 20548:
Dear Mr. Gootnick:
I am pleased to provide the U.S. Agency for International Development's
(USAID) formal response on the draft GAO report entitled Influenza
Pandemic: Efforts to Forestall Onset are Under Way; Identifying
Countries at Highest Risk Entails Challenges (GAO-07-604). We
appreciate the time and effort GAO has put into producing this report.
There are several points raised in the report on which we have enclosed
further discussion.
Thank you for the opportunity to respond to the GAO draft report and
for the courtesies extended by your staff in the conduct of this
review.
Sincerely,
Signed for:
Mosina H. Jordan:
Counselor to the Agency:
Enclosure: Agency Comments on GAO Report:
U.S. Agency for International Development:
1300 Pennsylvania Avenue, NW:
Washington, DC 20523:
www.usaid.gov:
Comments On GAO 07-604:
The re-emergence in late 2003 of H5N1 1 avian influenza as a highly
pathogenic virus capable of infecting both poultry and humans raised
immediate concerns about the threat of a global pandemic. Beginning in
late 2005, the virus swept out of its original focus in Southeast Asia
and across Eurasia, Europe, South Asia, the Near East, and Africa,
dramatically signaling the start of an even more dangerous phase in the
virus' evolution. It was at just this time that USAID received its
first appropriation to address the threat posed by avian influenza
(AI). The GAO document largely focuses on the challenges USAID and
other U.S. agencies faced in setting its country priorities in the face
of a rapidly evolving threat.
To date, animal outbreaks have been reported in 59 countries, with 12
countries having confirmed human cases. A total of 309 humans have been
infected since 2003. Of these, 61% have been fatal. Since its
emergence, the virus has continued to mutate and become increasingly
more pathogenic. The increase in outbreaks in highly pathogenic AI in
birds and humans since the beginning of 2007 has heightened concerns
about the emergence and spread of a viral mutation that could spark a
human pandemic.
In the face of these alarming developments, there has been notable
progress made since the beginning of 2006 in response to the AI threat.
Progress has been particularly significant in the case of Vietnam and
Thailand, two of the most affected countries. During the two-year span
between late 2003 and 2005, these two countries accounted for a total
of 3,319 reported outbreaks of AI among birds (88% of the global
total). In 2006, after introducing an aggressive package of control
measures, total animal outbreaks fell to 209 (29% of the global total).
On the human-health side, results are equally remarkable: During the
2003-2005 period Vietnam and Thailand recorded 115 cases (78% of the
global total), but in 2006 there were just three total human cases
(less than 3% of the worldwide total).
Even in the case of other countries infected in 2006, there has been
noted progress. Compared to a year ago, the current 2007 "influenza
season" has involved fewer outbreaks and infected far fewer poultry.
While there are many factors that may be contributing to this shift,
there has been tremendous progress, with U.S. assistance strengthening
"early-warning surveillance" and rapid response capacities in affected
countries over the past year.
As a result of USAID and other U.S. government agency efforts, we are
hearing about AI outbreaks sooner and are thus better able to launch
more effective and timely responses. In many places, the time lapse
between the onset of an outbreak and its being reported has been
reduced from typically three to five weeks to 48 hours. Similarly, we
are getting faster laboratory confirmation, which enables us to mount
more successful mitigation measures. Intensive communications campaigns
have also made communities more aware of the risks they face by
improper rearing or handling of poultry, leading to more appropriate
practices at the household level and earlier reports of outbreaks.
Collectively, these measures have played an important role in limiting
the size and spread of the outbreaks.
These successes have dramatically illustrated the effectiveness of the
"package" of interventions being used for controlling the spread of AI,
particularly in large-and medium-size commercial poultry farms. What
has emerged as the greatest single challenge to effective control of
the spread of the virus, however, is the more informal poultry setting
characterized as "backyard farms". In 2006, and so far in 2007, nearly
all newly reported outbreaks have been among these small holdings. From
Indonesia to Nigeria, it is the small poultry holdings of individual
families - which on average range from 12-50 birds - that account for
anywhere from 30% to 70% of the poultry in a country.
While economic self-interest and access to resources has proven
critical in motivating the larger commercial farms to take action, it
has proven far more difficult to transform the way small farm holders
rear their poultry. These small holders largely fall into the lowest
economic quintiles, with poultry rearing making significant
contributions to household nutrition and livelihood. A combination of
poverty, entrenched "traditional practices", and lack of clear
understanding about the risks posed by AI pose significant challenges
in applying an effective package of bio-security measures.
In 2007, we will be bringing particular attention to meeting this
challenge. In Indonesia, we have partnered with the U.N. Food and
Agriculture Organization and local non-governmental organizations
(NGOs) to develop a highly successful community-based model for
improving virus surveillance and the containment of the outbreaks. With
its focus on "backyard farmers", we anticipate this model will have a
significant role in protecting small poultry holdings in many of the
countries in which we are working.
In the coming year, we will also be placing much greater emphasis on
developing plans and capabilities to respond to a global human
influenza pandemic. Recent analysis of past global pandemics has led
international experts to predict that in the event of a pandemic
greater than 95% of the global death toll will occur in the developing
world. We are working closely with the U.N. and other U.S. government
partners to develop standard operating procedures and protocols for
addressing both the health and non-health aspects of a humanitarian
response. Special emphasis is being placed on building an international
network of NGOs, private-and public-sector providers, and international
donors that would be drawn upon to deliver a humanitarian response in
the event of a global pandemic.
As highlighted in the GAO document, responding to the threat posed by
AI has been very much "learning by doing". Over the past two years,
however, we have made significant progress in learning what works and
what does not. As we go forward in 2007, we are strongly guided by
these lessons learned both in setting priorities and in making
decisions about program actions. With the recently appropriated 2007
supplemental funds for AI, we expect to build on our past successes
over the coming year to reduce further the risks posed by AI.
[End of section]
Appendix III: Comments from the Department of Health and Human
Services:
Note: GAO comments supplementing those in the report text appear at the
end of this appendix.
Office of the Assistant Secretary foe Legislation:
Department Of Health & Human Services:
Washington, D.C. 20201:
Jun 11 2007:
Ms. Celia Thomas:
Assistant Director:
International Affairs and Trade:
U.S. Government Accountability Office:
Washington, DC 20548:
Dear Mr. Thomas:
Enclosed are the Department's comments on the U.S. Government
Accountability Office's (GAO) draft report entitled, "Influenza
Pandemic: Efforts to Forestall Onset are Under Way; Identifying
Countries at Greatest Risk Entails Challenges " (GAO-07-604).
The Department has provided several technical comments directly to your
staff.
The Department appreciates the opportunity to comment on this draft
before its publication.
Sincerely,
Signed by:
Vincent J. Ventimiglia:
Assistant Secretary for Legislation:
Comments From The U. S. Department Of Health And Human Services (HHS)
On The U.S. Government Accountability Office's (GAO) Draft Report:
Influenza Pandemic: Efforts To Forestall Onset Are Under Way,
Identifying Countries At Highest Risk Entails Challenges (GAO-07-604):
General Comments:
The U.S. Department of Health and Human Services (HHS) is grateful for
the opportunity to comment on the draft report from the Government
Accountability Office (GAO) entitled Influenza Pandemic: Efforts to
Forestall Onset are Under Way; Identifying Countries at Greatest Risk
Entails Challenges.
HHS agrees with the overall assessment of the GAO regarding the
challenges associated with identifying widespread environmental and
preparedness-related risks among countries, and acknowledges the
information gaps that limit the capacity for comprehensive comparative
risk by-country. Despite these limitations, HHS supports the U.S.
Government strategy of targeting resources and activities according to
the U. S. Homeland Security Council's prioritization of countries.
Furthermore, HHS contends that the allocation of funding to high-
priority countries is pivotal in the development of capacity to detect
influenza viruses.
Of equal importance to targeting resources, is complete and transparent
information-sharing among countries as codified in the revised
International Health Regulations (2005). This exchange of information
should include the sharing of influenza viruses and surveillance data
with the World Health Organization (WHO). We continue to call on
countries everywhere to share influenza samples openly and rapidly
without preconditions. HHS would like to emphasize that the early
sharing of virus samples is essential for the development of vaccine
candidates and for the accurate assessment of pandemic risk and
potential severity. Included in the 434 million the U.S. Government has
committed since 2005 to international efforts to contain the highly
pathogenic H5N1 strain of avian influenza and prepare for a possible
human pandemic are investments to help developing nations create the
laboratory and public health infrastructure to track influenza and
treat its victims, and to expand the number of manufactures of
influenza vaccines to give more people access to the products of the
WHO system.
HHS disagrees with the statement in this report that H5N1 has never
circulated among humans. It is more accurate to note that H5N1 has not
circulated widely among humans, but has shown that it can cause serious
illness in them. For example, limited human-to-human transmission among
a few clusters in Indonesia cannot be ruled out. Such viruses have not
shown any significant genetic mutations or re-assortment, but they
could spark a pandemic if they were to evolve into a strain that has
the ability to pass easily from one human to the next.
In reference to the deployment of "outbreak response teams" supported
by the U. S. Department of Agriculture (USDA) and the U. S. Agency for
International Development (USAID), HHS has several comments. Outbreak-
response teams supported by the USDA and USAID are veterinary (i.e.,
poultry-outbreak) response teams, and not public-health response teams.
HHS mediates the U.S. Government's assistance to countries with human
cases of disease. These efforts support Ministries of Health through
the training of rapid (public-health) response teams (RRTs) and often
provide on-site assistance when health officials suspect human H5N1
cases. For example, between January 2006 and March 2007, HHS staff from
the Centers for Disease Control and Prevention (CDC), Atlanta and the
Department's Global Disease Detection (GDD) Centers around the world
assisted with on-site H5N1 investigations in Turkey, Nigeria, Romania,
Djibouti, Indonesia, Kenya, China, Laos, Vietnam, and South Sudan.
Investigative assistance included laboratory diagnosis, the
identification of disease risk factors and the analysis of clusters of
disease to establish whether human-to-human (i.e., second-generation)
or human-to-human-to-human (i.e., third-generation) transmission was
occurring. For example, in Indonesia in 2006, an HHS/CDC epidemiologist
investigated a large family cluster of H5N1 cases in North Sumatra
(eight cases, seven deaths), in which limited, non-sustained human-to-
human-to-human transmission of H5N1 viruses likely occurred.
The following are GAO's comments on the Department of Health and Human
Services letter dated June 11, 2007.
GAO Comment:
1. HHS said that it is inaccurate to state, without qualification, that
H5N1 has never circulated among humans; limited human-to-human
transmission cannot be ruled out in a few clusters of cases in
Indonesia. We agreed with the need to qualify this statement. We
revised the background section of this report to acknowledge that
limited human-to-human transmission cannot be ruled out in these cases.
[End of section]
Appendix IV: Comments from the Department of Agriculture:
USDA:
United States Department of Agriculture:
Animal and Plant Health Inspection Service:
Washington, DC 20250:
Jun - 7 2007:
Dr. David Gootnick, Director:
International Affairs and Trade:
U.S. Government Accountability Office:
441 G Street, NW:
Washington, DC 20548:
Dear Dr. Gootnick:
The United States Department of Agriculture (USDA) has reviewed the
U.S. Government Accountability Office's (GAO) draft report, "Pandemic
Influenza: Efforts to Forestall Onset Are Under Way; Identifying
Countries at Greatest Risk Entails Challenges" (07-604). USDA
appreciates this GAO comprehensive evaluation of pandemic influenza
with a concentration on the global efforts needed to improve avian and
pandemic influenza preparedness. As the GAO report noted, USDA has
responsibility for a variety of actions and activities related to the
onset or containment of an occurrence of international avian and
pandemic influenza. USDA has devoted various resources and has obtained
funding to allow for readiness and preparedness.
While there were no recommendations for USDA, we appreciate the
opportunity to review the draft report. We found the report accurate in
its description of USDA's role and involvement in the global strategy.
And lastly, USDA appreciates the opportunity to work with GAO on the
evaluation of our efforts.
Sincerely,
Signed by:
W. Ron DeHaven:
Administrator:
Safeguarding American Agriculture:
APHIS is an agency of USDA's Marketing and Regulatory Programs:
[End of section]
Appendix V: Analysis of Selected USAID and State Department Rapid
Assessments of Avian Influenza Preparedness:
This appendix presents the results of our analysis of avian influenza
preparedness information submitted by USAID and State Department field
staff from 17 of more than 100 countries surveyed by USAID and State
Department headquarters during late 2005. These characterizations
reflect our analysis of information gathered through assessment efforts
at that time. For some countries, the assessments may not reflect
current capabilities. As figure 12 shows, the field staff charged with
providing information identified widespread shortcomings in national
preparedness. However, the figure also shows that field staff often
could not obtain sufficient information to provide clear or definitive
information on every topic.
Figure 12: Avian Influenza Preparedness--Analysis of Selected
Indicators and Countries from USAID and State Department Rapid
Assessments (October/November 2005):
[See PDF for image]
Source: GAO analysis of USAID and State DEpartment cables regarding
national preparedness for avian and pandemic influenza, from May
through November 2005.
Note: The categorizations in this figure reflect GAO analysis of
assessments done at a particular point in time. They do not necessarily
reflect current capability.
[End of figure]
The preparedness and communications section of the figure suggests that
most of the countries in our sample were aware of the need to position
themselves for effective action, 16 of the 17 were reported to have
made at least limited progress in preparing a national plan for
responding to the threats presented by avian influenza, and 14 of 15
countries for which data were available were reported to have
established national task forces to address these threats. However, the
remainder of the figure suggests that there were at the time of the
assessments widespread weaknesses in the elements of preparedness. For
example, only 9 of the 17 countries were reported to have made at least
limited efforts to educate the public about avian influenza. Only 4 of
the 12 countries for which data were available were reported to have
made at least limited progress toward preparing stockpiles of both
antiviral drugs and PPE kits that could be used by those responding to
poultry or human outbreaks. Most of the countries were found to be
conducting at least limited surveillance for avian influenza. However,
many countries were found to have gaps in their capacity to carry out
key outbreak response activities. For example, only 4 of the 15
countries for which data were available were reported to have plans for
compensating farmers in the event that culling became necessary.
The USAID and State Department officials who provided this information
reported shortcomings in each of the 17 countries we reviewed. The
officials identified multiple shortcomings in Cambodia, Indonesia, and
Vietnam, where H5N1 is well-established. In addition, the figure
illustrates why there is particular concern about weak capacity in
Africa. USAID and State Department officials recorded negative
responses in most categories for the 2 of the 3 African countries in
the table (Djibouti and Uganda). Additionally, officials recoded
limited or negative responses for 11 of 15 categories for Nigeria--the
remaining African country in our analysis.
The figure also demonstrates the data-gathering and analysis
difficulties that field and headquarters staff experienced in
completing this exercise. The information provided by field staff was
insufficient to allow us to arrive at definitive entries for about 15
percent (39 of 255) of the cells in the figure. Field staff had
particular difficulty in providing clear information on response and
containment measures, such as stockpile distribution and culling plans
and quarantine capacity. Staff in some countries (for example, Vietnam)
were able to provide comparatively clear information on all or nearly
all issues, while others (for example, India) were unable to provide
sufficient information on several matters.
Scope and Methodology:
The study population for our analysis included rapid country avian
influenza preparedness assessment reports prepared by USAID and State
Department overseas missions from October to November 2005. USAID
maintains country-specific missions in 80 developing countries and
regional offices in 6 such countries, and these missions provided USAID
headquarters with information on more than 100 countries. The State
Department maintains diplomatic missions in about 180 countries and
territories. From the population of USAID missions, we drew a
nonprobability sample of 17 countries. Of these countries, 14 had
reports from USAID and the State Department, 3 had USAID reports only,
and 1 had a State Department report only. State Department assessments
were missing from the following countries: India, Pakistan, and
Indonesia. USAID did not perform a country assessment on Thailand.
To select our sample, we took a variety of factors into account. To
ensure geographic diversity, we included countries from four regions:
Asia, Africa, Eurasia and the Near East, and the Americas. Based on
influenza experts' opinions and congressional interest, we chose to
oversample Asian countries and not represent North America or Europe.
We sought to include countries in a variety of situations with regard
to the presence of H5N1 in animals or humans, concentrations of poultry
and humans living in proximity to each other, exposure to migratory
patterns that could allow wild birds to transmit H5N1 into the country,
political stability, and strength of the public health infrastructure.
We did not include China in our table of countries because the relevant
reports were classified.
USAID and the State Department conducted their assessments by sending
out sets of questions to personnel at their respective missions. The
questions asked in the two instruments differed in their wording, and
as a consequence, our first step in developing our analysis was to
identify a set of broader dimensions, or indicators, encompassing data
from both sets of assessments. Through a review of these two sets of
questions, as well as survey questions recently developed by WHO and
the World Bank to assess country preparedness, we identified a set of
15 qualitative indicators covering a wide array of issues within the
topic areas of preparedness and communications, surveillance and
detection, and response and containment. These indicators then became
the dimensions along which we analyzed the data contained in the USAID
and State Department assessments.
We reviewed USAID rapid country assessments and State Department cables
assessing the level of country preparedness for avian influenza. The
analysis of the 17 USAID and State Department assessments was performed
by two GAO analysts, reviewing the reports separately and recording
answers, with justifications, in workpapers. To enhance inter-rater
reliability in our analysis of the USAID and State Department
assessments, we developed a code book to reflect the specific
characteristics needed for a country to be classified in one of three
categories for each indicator: yes, no, or limited. Subsequently, the
two analysts compared their answers and justifications, reconciled
their analyses when they diverged, and modified the code book as needed
to ensure consistent coding across indicators and countries. A
methodologist performed a final check on the consistency and accuracy
of the analysis.
The USAID and State Department instruments had a number of limitations.
First, the information provided in these assessments is limited by the
rapidly evolving dynamic of the H5N1 virus and ongoing efforts to
improve capacity. As a consequence the information provided in them is
already dated and should be understood as a snapshot of the countries
assessed at a particular point in time (fall 2005), rather than
directly reflecting the current status of country capacities. Second,
the purpose of these assessments was to rapidly assess country
capacities in this evolving environment, and as a result, the
instruments developed were limited in the design of the questions
asked, restricted primarily to open-ended questions that could be
interpreted and answered in multiple ways. Third, the instruments were
limited in the manner in which they were implemented. In particular,
the data reported reflect the individualized data-gathering and
assessment efforts of the point of contact at USAID or the State
Department rather than a standardized approach to data gathering and
assessment.
Fourth, while many respondents addressed the indicators we identified
for analysis, because the questions were open-ended, there is
inconsistency in the depth and coverage of responses. Furthermore, in
some cases, the response to a question was simply "yes" or "no" without
any details. When this occurred, we recorded the answer the respondent
gave. Fifth, some indicators had only one source of information (they
were addressed in one report but left blank in another), and we could
not compare them for consistency. Sixth, in some instances, respondents
did not answer questions sufficiently for us to make determinations or
left them blank. We could not determine the level of these indicators
based on available data and rated them as missing and left them blank
in those cases. Despite these limitations, we determined that the data
contained in these statements were sufficient for the purpose of our
report, which was to provide information broadly demonstrating the
limited capacities of countries at a particular point in time with
implications for the challenges posed in subsequent periods.
[End of section]
Appendix VI: Assistance to Regional and Global Organizations:
According to data submitted to the World Bank by the United States and
other donors, Asia-Pacific regional initiatives have received the
largest share of regionally focused funding from international donors,
including the United States (see table 3). Approximately 67 percent of
committed funds have gone to programs in this region. For example,
donors reported providing the Association of Southeast Asian Nations
about $50 million in committed funds, including about $47 million from
Japan to procure antiviral drugs, PPE kits, and influenza test kits.
Examples of support in other regions include HHS's provision of $3.3
million in committed funds to support the Gorgas Institute, a
laboratory network in Panama, and the European Commission's provision
of about $28 million to the African Union.
Table 3: Regional Recipients of Donor Assistance for International
Avian and Pandemic Influenza Preparedness as of December 2006:
Dollars in millions.
Region: Asia-Pacific.
Asia-Pacific Economic Cooperation;
Commitments (U.S.) --;
Commitments (All other donors): $7.6;
Total commitments: $7.6.
Asian Development Bank;
Commitments (U.S.) --;
Commitments (All other donors): 10.3;
Total commitments: $10.3.
Association of Southeast Asian Nations;
Commitments (U.S.) --;
Commitments (All other donors): 51.2;
Total commitments: $51.2.
U.S. Global Disease Detection Centers;
Commitments (U.S.) $14.9;
Commitments (All other donors): --;
Total commitments: $14.9.
Pacific Island Nations;
Commitments (U.S.) --;
Commitments (All other donors): 6.1;
Total commitments: $6.1.
Research in Southeast Asia;
Commitments (U.S.) 18.0;
Commitments (All other donors): --;
Total commitments: $18.0.
Other regional assistance;
Commitments (U.S.) 7.5;
Commitments (All other donors): 15.5;
Total commitments: $23.0.
Subtotal;
Commitments (U.S.) $40.4;
Commitments (All other donors): $90.7;
Total commitments: $131.1.
Region: Africa; .
African Union;
Commitments (U.S.) --;
Commitments (All other donors): $28.8;
Total commitments: $28.8.
Partnership for Livestock Development, Poverty Alleviation and
Sustainable Growth in Africa;
Commitments (U.S.) --;
Commitments (All other donors): 10.2;
Total commitments: $10.2.
U.S. Global Disease Detection Centers;
Commitments (U.S.) $8.9;
Commitments (All other donors): --;
Total commitments: $8.9.
Other regional assistance;
Commitments (U.S.) 2.5;
Commitments (All other donors): 0.1;
Total commitments: $2.6.
Subtotal;
Commitments (U.S.) $11.4;
Commitments (All other donors): $39.1;
Total commitments: $50.5.
Region: Americas.
U.S. Global Disease Detection Center;
Commitments (U.S.) $2.0;
Commitments (All other donors): --;
Total commitments: $2.0.
Gorgas Memorial Institute of Tropical and Preventive Medicine;
Commitments (U.S.) 3.3;
Commitments (All other donors): --;
Total commitments: $3.3.
Other regional assistance;
Commitments (U.S.) 3.5;
Commitments (All other donors): --;
Total commitments: $3.5.
Subtotal;
Commitments (U.S.) $8.8;
Commitments (All other donors): $0;
Total commitments: $8.8.
Region: Eastern Europe/Eurasia.
U.S. Government Regional Platform;
Commitments (U.S.) $1.1;
Commitments (All other donors): --;
Total commitments: $1.1.
Other regional assistance;
Commitments (U.S.) 2.9;
Commitments (All other donors): --;
Total commitments: $2.9.
Subtotal;
Commitments (U.S.) $4.0;
Commitments (All other donors): $0;
Total commitments: $4.0.
Total;
Commitments (U.S.) $64.6;
Commitments (All other donors): $129.8;
Total commitments: $194.4.
Source: GAO analysis of data from UN System Influenza Coordinator and
World Bank, Responses to Avian and Human Influenza Threats: Progress,
Analysis and Recommendations July-December 2006 (January 2007).
[End of table]
According to data submitted to the World Bank, WHO and FAO have
received the greatest shares of overall funding committed to global
organizations (see fig. 13). Of the $240 million in reported overall
donor commitments for global organizations, the WHO and FAO shares
constituted about 35 percent and 27 percent, respectively. U.S.
agencies are supporting WHO and FAO with funds, staff, equipment, and
technical assistance to improve these organizations' capacity to
support countries. For example, HHS has provided funding to all six WHO
regional offices. Some of this assistance is directed at improving
collaboration on human and animal components of the response.[Footnote
67] OIE, the UN Children's Fund, and the UN System Influenza
Coordinator (among others) share the remaining $91 million, with the
Children's Fund accounting for more than half of this amount--about $49
million from Japan, provided primarily to enhance communications on
avian and pandemic influenza risks.
Figure 13: Figure 13: Global Organization Recipients of Donor
Commitments for International Avian and Pandemic Influenza Preparedness
as of December 2006:
[See PDF for image]
Source: GAO analysis of data from January 2007 Responses to Avian and
Human Influenza Threats, July-December 2006 published by the UN System
Influenza Coordinator and World Bank.
[End of figure]
[End of section]
Appendix VII: U.S. Agency Obligations Funding by Pillar:
In response to our request, HHS, USAID, DOD, USDA, and the State
Department reported having obligated about 64 percent of their planned
funding for international avian and pandemic influenza-related
assistance. However, the data are not from consistent time periods.
HHS, DOD, and State Department data represent obligations through the
end of fiscal year 2006 (that is, through the end of September 2006).
USAID and USDA provided data on their obligations through December
2006. (See table 4.)
Table 4: U.S. Obligations for International Avian and Pandemic
Influenza Assistance by Agency and by Pillar/Activity:
Dollars in millions.
Pillar/activity: Preparedness and communications;
Agency: HHS[A]: 21;
Agency: USAID: 96;
Agency: DOD: 10;
Agency: USDA: 5;
Agency: State Department: 2;
Agency: Total by pillar/activity: 134.
Pillar/activity: Surveillance and detection;
Agency: HHS[A]: 25;
Agency: USAID: 38;
Agency: DOD: 0;
Agency: USDA: 1;
Agency: State Department: 0;
Agency: Total by pillar/activity: 64.
Pillar/activity: Response and containment;
Agency: HHS[A]: 15;
Agency: USAID: 22;
Agency: DOD: 0;
Agency: USDA: 3;
Agency: State Department: 0;
Agency: Total by pillar/activity: 40.
Pillar/activity: Other;
Agency: HHS[A]: 1;
Agency: USAID: --;
Agency: DOD: --;
Agency: USDA: --;
Agency: State Department: --;
Agency: Total by pillar/activity: 1.
Total by agency;
Agency: HHS[A]: 62;
Agency: USAID: 156;
Agency: DOD: 10;
Agency: USDA: 9;
Agency: State Department: 2;
Agency: Total by pillar/ activity: 239.
Sources: HHS, USAID, DOD, USDA, and the State Department.
Notes:
Obligations create a legal liability for payment. For example, an
agency incurs an obligation when it places an order, signs a contract,
or awards a grant. See app. I for additional information on these data.
USAID and USDA provided obligated funds through December 2006. The
remaining agencies provided information on obligated funds through
September 2006.
[A] As the table shows, HHS did not designate a pillar for a portion of
its obligations. These funds were devoted primarily to expanding
influenza-related staffing levels in regional surveillance and response
facilities in Thailand and Egypt.
[End of table]
[End of section]
Appendix VIII: Distribution of USAID Personal Protective Equipment
Kits:
Figure 14 shows USAID's distribution of PPE kits by country as of the
end of fiscal year 2006. As the figure shows, Indonesia accounted for
the majority of these kits. According to a USAID official,
approximately 193,000 PPE kits were distributed for immediate use in
surveillance and response activities in more than 60 countries.
Additionally, USAID had begun to create long-term stockpiles of PPE,
laboratory, and decontamination kits in 20 countries.[Footnote 68]
Figure 14: Distribution of USAID PPE Kits as of October 2006:
[See PDF for image]
Sources: GAO, based on USAID information; map (Map Resources).
[End of figure]
[End of section]
Appendix IX: GAO Contacts and Staff Acknowledgments:
GAO Contacts:
David Gootnick (202) 512-3149 or gootnickd@gao.gov:
Marcia Crosse (202) 512-7114 or crossem@gao.gov:
Staff Acknowledgements:
Key contributors to this report were Celia Thomas, Assistant Director;
Thomas Conahan, Assistant Director; Michael McAtee; Robert Copeland; R.
Gifford Howland; Syeda Uddin; David Fox; Jasleen Modi; David Dornisch;
Etana Finkler, Debbie Chung, Monica Brym, and Jena Sinkfield.
[End of section]
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FOOTNOTES
[1] In this report, we use the term avian influenza to refer to the
highly pathogenic form of this disease, which can cause nearly 100
percent mortality in infected poultry. The disease can also occur in
low pathogenic forms that cause only mild symptoms in infected birds.
[2] From December 2003 through the end of 2006, the World Health
Organization confirmed 263 cases of H5N1 in humans and 158 deaths.
[3] The World Health Organization estimates that annual epidemics of
seasonal influenza affect about 10 to 20 percent of the world's
population each year, causing 3 million to 5 million cases of severe
illness and 250,000 to 500,000 deaths.
[4] More specifically, we use the term environmental risk to include
risk from a range of factors, including known disease presence or
proximity (such as the H5N1 virus being well-established among domestic
poultry and the risk that the virus will be introduced from neighboring
countries by unregulated trade in poultry and other birds, or by wild
birds); large numbers of poultry being raised in heavily populated
areas; and high-risk agricultural practices, such as allowing poultry
unrestricted access to family homes and selling poultry in markets with
inadequate cleaning and disinfection.
[5] According to U.S. agency officials, the Homeland Security Council
is currently preparing a new report that provides updated information
on U.S. efforts to improve both domestic and international pandemic
influenza preparedness and response.
[6] OIE stands for Office International des Epizooties--the
organization's original name, adopted at its founding in 1924. In 2003,
the organization decided to begin using the name World Organization for
Animal Health while retaining the OIE acronym. OIE is a multilateral
organization but is not part of the UN system.
[7] The Homeland Security Council, with input from an interagency
process, identified 19 priority countries in May of 2006, considering
various risk and political factors; the list currently includes 21
countries, according to State Department officials.
[8] Data on commitments by donor, including the United States, were
obtained from the World Bank. U.S. data reflect amounts reported to the
World Bank by the United States. Some U.S. activities that also benefit
international influenza preparedness, such as DOD laboratories abroad
with significant diagnostic capacities, are not included in these
amounts. The World Bank monitors international financial flows for
influenza preparedness in terms of funds pledged, committed, and
disbursed. As defined by the bank, commitments are roughly equivalent
to U.S. agency planned funding levels--the budget projections that
agencies use for planning purposes.
[9] USAID also stated that it will be placing much greater emphasis on
developing plans and capabilities for responding to an influenza
pandemic--a matter that lies beyond the scope of this report.
[10] According to HHS and WHO, there have been a limited number of
human cases in which human-to-human transmission cannot be ruled out.
However, H5N1 has not yet demonstrated an ability to spread efficiently
and sustainably among humans.
[11] H5N1 has been reported among pigs. Disease experts have also
expressed concern about a pandemic virus emerging as a result of a
human becoming simultaneously infected with H5N1 and one of the
subtypes that commonly causes seasonal influenza.
[12] FAO and OIE define a wet market as a "a place, either fixed or
temporary, where members of the public go to buy small mammals and
birds that are (a) live and slaughtered there, (b) live and taken home
to be slaughtered, or (c) already slaughtered and sold as meat." Some
of these markets provide greater risks of disease transmission than
others. High-risk practices in some of these markets include stacking
cages on top of one another, inadequate cleaning and disinfection, and
returning unsold birds (which may have been exposed to the virus) to
the farms from which they came.
[13] In March 2007 an international scientific conference organized by
FAO and OIE, among other organizations, recommended that poultry be
vaccinated against avian influenza, particularly in countries where the
disease is well-established and where other control measures cannot
stop the disease from spreading. However, the conferees added that any
vaccination policy should include a strategy for eventually ending the
vaccinations so that countries do not rely on costly, long-term
vaccination campaigns, and recommended the use of tools to
differentiate infected from vaccinated animals. An OIE official
emphasized that the organization does not recommend across-the-board
preventive vaccination in countries not yet affected by H5N1.
[14] Vaccines can provide full or partial immunity to influenza and
thus help control the spread of the disease. Vaccines confer immunity
by causing the body to produce antibodies to fight off particular
strains. Vaccines that produce an adequate antibody response to a
particular strain may prevent illness from that strain in 70 to 90
percent of healthy adults under the age of 65, with lower effectiveness
among older adults.
[15] While specifically targeted vaccines cannot be produced until a
pandemic strain is identified, efforts are under way in the United
States and other countries to produce pre-pandemic vaccines--that is,
vaccines that are designed to provide protection against influenza
strains (such as H5N1 strains) that have caused isolated infections in
humans and have pandemic potential. Since such vaccines are prepared
prior to the emergence of a pandemic strain, they may be a good or poor
match (and thus provide greater or lesser protection) for the pandemic
strain that ultimately emerges. In April 2007 the U.S. Food and Drug
Administration approved the first such pre-pandemic vaccine for human
use in the United States against H5N1.
[16] Antiviral drugs can be used both to prevent illness and as a
treatment. Studies suggest that such drugs may be as effective as
vaccines in preventing influenza illness in healthy young adults and,
when used for treatment, to shorten its duration and severity.
[17] An exception was the U.S. government decision to mass vaccinate
the public against an outbreak of swine flu in New Jersey in 1976. That
effort was halted when a small apparent risk emerged of contracting
Guillain-Barre syndrome--an inflammatory disorder that can cause
paralysis--from the swine flu vaccine.
[18] WHO has developed a strategy for containing an initial outbreak of
pandemic influenza. For the most recent version of this strategy, see
WHO Interim Protocol: Rapid operations to contain the initial emergence
of pandemic influenza (May 2007).
[19] Two of the remaining three objectives focus on increasing
preparedness for managing under pandemic conditions. The final
objective focuses on coordinating national, regional, and international
stakeholders in both areas. According to the World Bank, effective
action against avian and pandemic influenza is multisectoral in nature
and must involve players from many areas, including human health,
agriculture, economics, and finance.
[20] WHO, FAO, and other international, U.S., and foreign country
agencies also have conducted a variety of assessment and assistance
missions in individual countries. For example, WHO reported carrying
out assessment missions in 29 countries during the first 6 months of
2006, often in collaboration with other agencies. Such missions provide
useful information for planning preparedness improvement efforts.
However, they have not been conducted in a comprehensive or uniform
manner.
[21] USAID last updated this assessment in May 2006.
[22] The World Bank conducted a similar risk assessment in December
2005, when H5N1 had been reported in fewer than 20 countries, mainly in
Eastern and Central Asia. The subsequent detection of the virus in more
than 30 additional countries, including several in Africa, rendered
this earlier assessment invalid, and the World Bank has not redone its
analysis.
[23] Similar weaknesses hamper surveillance among humans. For example,
one senior WHO official said that numerous "disease blind spots" around
the world hamper the organization's ability to identify H5N1 outbreaks.
[24] Analysts from the U.S. intelligence community have attempted to
provide a more thorough analysis of risk arising from environmental
factors. This work was initially conducted in late 2006 under the
auspices of the Department of State, focusing on Southeast Asia. The
intelligence community analysts subsequently extended this analysis to
cover other countries. They developed a statistical model for
identifying areas at greater risk, introducing corrections for disease
underreporting in areas known to have poor surveillance, and employing
data on four general factors significant to the spread of H5N1 in
animals: commerce, farming practices, terrain, and seasonality. (For
example, the model uses detailed data on proximity to roads, poultry
populations, terrain ruggedness, and monthly minimum and maximum
temperatures.) The analysis used statistical techniques to identify
areas at greater or lesser risk for future H5N1 outbreaks. According to
a State Department official, the model provides useful insights, but is
of limited value for predicting new outbreaks and is not sufficiently
robust to be relied upon as a basis for differentiating among countries
or allocating resources to those presenting the greatest risk.
[25] The UN effort was undertaken in collaboration with the World Bank.
[26] USAID maintains country-specific missions in 80 developing
countries and territories and regional offices in 6 such countries. The
State Department maintains 258 embassies, consulates, and diplomatic
missions in about 180 countries and territories.
[27] The country summaries and analyses of the combined results are
available at Hyperlink, http://www.undg.org/index.cfm?P=298.
[28] In commenting on a draft of this report, the State Department
stated that Bangladesh has had great difficulty in controlling the H5N1
outbreak that began in that country in February 2007. In addition, OIE
commented that the UN assessments about preparedness in Bangladesh in
table 4 are very optimistic. According to the State Department, like
many nations facing severe budget constraints and with inadequate
laboratory capacity and limited medical and animal health
infrastructure, Bangladesh has not succeeded in developing precise
plans for responding to avian influenza. According to the department,
the UN mission's inability to get a clear response regarding
compensation for culled birds reflected the fact that, despite
government assurances that such a plan was forthcoming, no plan had
been agreed upon and no compensation paid as of early May.
[29] See World Bank, "Annex 2d: Country Preparedness Assessment Tool
and Financing under the Adaptable Program Loan," Program Framework
Document for Proposed Loans/Credits/Grants in the Amount of US $500
Million Equivalent for a Global Program for Avian Influenza Control and
Human Pandemic Preparedness and Response (Washington, D.C: December
2005).
[30] As of the end of December, the World Bank reported having 17 avian
and pandemic influenza preparedness projects under way--in Zambia, the
West Bank and Gaza, Romania, Djibouti, Laos, Tajikistan, Albania,
Moldova, Armenia, Georgia, Turkey, Nigeria, the Kyrgyz Republic,
Vietnam, Azerbaijan, and the Middle East-North Africa region. According
to Treasury, the World Bank reported that it had another 15 projects in
preparation.
[31] According to the World Bank, Laos has 141 administrative
districts.
[32] According to HHS, this information is no longer accurate. With HHS
assistance, Laos has established a national influenza laboratory that
is capable of diagnosing H5N1 cases without outside assistance.
[33] See, for example, the technical annexes that describe the bank's
influenza preparedness projects in Laos and Nigeria, available through
the World Bank's Internet project information portal at Hyperlink,
http://web.worldbank.org/WBSITE/EXTERNAL/PROJECTS/0,,menuPK:115635~pageP
K:64020917~piPK:64021009~theSitePK:40941,00.html .
[34] The World Bank stated that the bank is prepared to work with
national or international agencies undertaking global risk assessments
by making relevant information from its project appraisal reports
available to them. The World Bank also noted that, over time,
implementation progress reports will become available from the World
Bank's regular supervision of influenza-related programs and
information from those reports will also be made available.
[35] This tool, Performance, Vision and Strategy for Veterinary
Services, can be viewed at Hyperlink,
http://www.oie.int/eng/oie/organisation/en_vet_eval_tool.htm?e1d2.
[36] The World Bank has indicated that it intends to rely upon this
tool to evaluate veterinary systems in countries that have requested
influenza-related assistance.
[37] Annex 1 of the revised regulations defines core capacity
requirements for national surveillance and response systems. For the
revised regulations and the regulations as they stood prior to this
revision, see Hyperlink, http://www.who.int/csr/ihr/en/.
[38] The revised regulations specify that each state party shall assess
its systems within 2 years of the regulations entering into force on
June 15, 2007. They also specify that each state party shall develop
systems that meet the new requirements as soon as possible, but no
later than 5 years from the date the regulations enter into force. In
certain circumstances, the revised regulations allow countries to
request an extension of up to 4 years to develop systems that meet the
requirements.
[39] According to U.S. officials, the list of priority countries has
not been made public because of the sensitivity of the categorizations
for some countries. With respect to the other three categories, the
Homeland Security Council initially identified 63 at-risk countries, 39
high-risk countries, and 10 affected countries. The council did not
categorize 62 countries that were viewed as not needing U.S.
assistance. This group was composed primarily of high-or upper-middle-
income countries and small island nations.
[40] Data on commitments by donor, including the United States, were
obtained from the World Bank. U.S. data reflect amounts reported to the
World Bank by the United States. Some U.S. activities that also benefit
international influenza preparedness, including certain efforts that
improve global response capacity for a range of infectious diseases,
are not included in the amounts the United States reports.
[41] Overall, Congress has appropriated about $6.1 billion for avian
and pandemic influenza-related preparedness, through the Emergency
Supplemental Appropriations Act for Defense, the Global War on Terror,
and Tsunami Relief, 2005 (Pub. L. No. 109-13); the Department of
Defense, Emergency Supplemental Appropriations to Address Hurricanes in
the Gulf of Mexico, and Pandemic Influenza Act, 2006 (Pub. L. No. 109-
148); and the Emergency Supplemental Appropriations Act for Defense,
the Global War on Terror, and Hurricane Recovery, 2006 (Pub. L. No. 109-
234). These appropriations provided funds for a variety of domestic and
international purposes, including (in addition to the types of
activities described in this report) support for developing vaccines
and antiviral drugs.
[42] As noted above, the World Bank is preparing a number of additional
projects that will substantially increase the total that the bank has
committed to avian and pandemic influenza preparedness.
[43] According to the World Bank, the total amount committed by the
European Commission and European Union member countries was about $360
million.
[44] The World Bank has provided nearly all of its funding in the form
of loans, sometimes at highly concessional rates, to individual
countries. Asian Development Bank financing has been more evenly
divided between loans and grants. These institutions have also provided
funds to concerned international organizations. For example, through
October 2006 the World Bank has committed $1 million to OIE, and the
Asian Development Bank has committed a total of nearly $19 million to
WHO and FAO.
[45] Planned funding levels indicate agency budget projections for
planning purposes. According to U.S. agency officials, such figures are
roughly equivalent to commitments as defined by the World Bank.
[46] According to HHS, the focus of technical assistance and financing
to improve surveillance in both humans and birds is to increase and
enhance early recognition and reporting of outbreaks and facilitate
sharing of virus samples.
[47] In addition to DOD, HHS, the State Department, USAID, and USDA,
representatives from the Department of Homeland Security, the National
Security Council, the Homeland Security Council, and U.S. intelligence
agencies attend working group meetings. Treasury has not been a regular
participant. However, Treasury officials stated that their department
has worked with U.S. executive directors at the World Bank, the Asian
Development Bank, and other international financial institutions to
encourage and support these institutions in their efforts to address
avian and pandemic influenza threats.
[48] The allocation of action items among agencies sums to more than 84
because in some cases the implementation plan assigns multiple agencies
lead responsibility for individual items.
[49] Approximately $40 million represents commodity purchases for this
stockpile, with the remainder for logistical needs, such as deployment
and storage.
[50] A PPE kit consists of items such as a mask, protective suit,
goggles, and hand sanitizer wipes. Laboratory kits include materials
and instructions to collect and ship specimens to national or
international reference laboratories for confirmation. A
decontamination kit includes a backpack sprayer, disinfectant powder,
and other items to clean affected equipment, vehicles, and so forth.
[51] In addition to training activities, HHS officials stressed that
development of effective surveillance and detection systems also
requires improvements in laboratory capacity and development of
effective rapid response protocols. The U.S. Implementation Plan
includes action items in both of these areas.
[52] According to State Department officials, this HHS funding to
strengthen or establish global disease detection centers does not
include additional funds provided through these centers to assist
individual countries.
[53] The goal of this course was to prepare participants to teach
additional courses in their own countries to further build
international capacity. In addition to the United States, participating
countries were Bangladesh, Burma, Cambodia, China, Egypt, Guatemala,
India, Indonesia, Kenya, Laos, South Africa, Thailand, and Vietnam.
(Source: U.S. Embassy, Bangkok, and WHO Press Release, July 13, 2006).
[54] Action item 4.3.1.3 assigns HHS lead responsibility for deploying
surveillance and response teams to investigate potential human
outbreaks, in coordination with other U.S. agencies and with WHO.
[55] The Implementation Plan did not specify a time frame for
completing this action.
[56] According to FAO, other major donors include Germany and the Asian
Development Bank.
[57] See the U.S. Pandemic Influenza Strategy Implementation Plan:
Summary of Progress, December 2006, available on the Internet at
Hyperlink,
http://www.pandemicflu.gov/plan/federal/stratergyimplementationplan.htm.
According to U.S. agency officials, a report providing updated
information on U.S. efforts to improve domestic and international
pandemic influenza preparedness and response is being prepared.
[58] The council's report added that while determinations that action
items had been completed meant that the indicated measure of
performance had been met, this did not necessarily mean that work had
ended. In many cases, the agencies were continuing their efforts.
[59] State Department, DOD, and Treasury officials responded to our
requests for information on the seven items for which they exercised
lead responsibility. HHS officials declined to provide information on
the remaining item, for which they held lead responsibility.
[60] Action item 4.3.2.2.
[61] Action Item 4.3.6.1.
[62] In its technical comments on a draft of this report, HHS stated,
in particular, that sustained financial and technical support for
priority countries is needed to maximize the return on U.S. investments
to date and to build sustainable laboratory and epidemiologic
surveillance systems.
[63] USAID also stated that it will be placing much greater emphasis on
developing plans and capabilities for responding to an influenza
pandemic--a matter that lies beyond the scope of this report.
[64] Some of these assessments contained classified information. We do
not discuss these assessments in this report so that our report remains
unclassified and because the classified documents we reviewed did not
lead to substantially different observations than the unclassified
assessments we examined.
[65] According to U.S. agency officials, a report providing updated
information on U.S. efforts to improve domestic and international
pandemic influenza preparedness and response is being prepared.
[66] The DOD total does not include (1) $5 million in Overseas
Humanitarian, Disaster and Civic Aid programs to strengthen foreign
military capacity for responding to a potential pandemic or (2) $17
million in influenza-related support for DOD's Global Emerging
Infections Surveillance and Response System. The United States did not
include these funds in the information that it provided to the World
Bank. For more information on the Global Emerging Infections
Surveillance and Response System, which includes units in Egypt,
Indonesia, Kenya, Peru, and Thailand, see Hyperlink,
http://www.geis.fhp.osd.mil.
[67] According to State Department officials, U.S. contributions to FAO
and WHO do not include funds provided to those organizations to carry
out programs in country or at the regional level. The United States
counts those funds as bilateral or regional assistance.
[68] USAID designated the following countries as having the greatest
need for forward deployment of PPE kits: Nigeria, Cameroon, Côte
d'Ivoire, Niger, Sudan, Democratic Republic of the Congo, Bulgaria,
Romania, Moldova, Ukraine, Georgia, Armenia, Azerbaijan, Jordan, Egypt,
Bangladesh, India, Nepal, Pakistan, and Indonesia. According to USAID,
the agency selected these countries because they were in regions where
outbreak risk remains high.
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