Influenza Pandemic
Challenges Remain in Preparedness Gao ID: GAO-05-760T May 26, 2005Vaccine shortages and distribution problems during the 2004-2005 influenza season raised concerns about the nation's ability to respond to a worldwide influenza epidemic--or influenza pandemic--which many experts believe to be inevitable. Some experts believe that the next pandemic could be spawned by the recurring avian influenza in Asia. If avian influenza strains directly infect humans and acquire the ability to be readily transmitted between people, a pandemic could occur. Modeling studies suggest that its effect in the United States could be severe, with one estimate from the Centers for Disease Control and Prevention (CDC) ranging from 89,000 to 207,000 deaths and from 38 million to 89 million illnesses. GAO was asked to discuss surveillance systems in place to identify and monitor an influenza pandemic and concerns about preparedness for and response to an influenza pandemic. This testimony is based on GAO's 2004 report on disease surveillance; reports and testimony on influenza outbreaks, influenza vaccine supply, and pandemic planning that GAO has issued since October 2000; and work GAO has done in May 2005 to update key information.
Federal public health officials plan to rely on the nation's existing influenza surveillance system and enhancements to identify an influenza pandemic. CDC currently collaborates with multiple public health partners, including the World Health Organization (WHO), to obtain data that provide national and international pictures of influenza activity. Federal public health officials and health care organizations have undertaken several initiatives that are intended to enhance influenza surveillance capabilities. While some of these initiatives are focused more generally on increasing preparedness for bioterrorism and other emerging infectious disease health threats, others have been undertaken in preparation for an influenza pandemic. For example, in response to concerns over the past few years about the potential for avian influenza to become the next influenza pandemic, CDC implemented an initiative in cooperation with WHO to improve influenza surveillance in Asia. CDC has also implemented initiatives to improve the communications systems it uses to collect and disseminate surveillance information. In addition, CDC, the Department of Agriculture, and the Food and Drug Administration have made efforts to enhance their coordination of surveillance efforts for diseases that arise in animals and can be transferred to humans, such as SARS and certain strains of influenza with the potential to become pandemic. While public health officials have undertaken several initiatives to enhance influenza surveillance capabilities, challenges remain with regard to other aspects of preparedness for and response to an influenza pandemic. In particular, the Department of Health and Human Services (HHS) has not finalized planning for an influenza pandemic. In 2000, GAO recommended that HHS complete the national plan for responding to an influenza pandemic, but the plan has been in draft format since August 2004. Absent a completed federal plan, key questions about the federal role in the purchase, distribution, and administration of vaccines and antiviral drugs during a pandemic remain unanswered. Other challenges with regard to preparedness for and response to an influenza pandemic exist across the public and private sectors, including challenges in ensuring an adequate and timely influenza vaccine and antiviral supply; addressing regulatory, privacy, and procedural issues surrounding measures to control the spread of disease, for example, across national borders; and resolving issues related to an insufficient hospital and health workforce capacity for responding to a large-scale outbreak such as an influenza pandemic.
GAO-05-760T, Influenza Pandemic: Challenges Remain in Preparedness
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Testimony:
Before the Subcommittee on Health, Committee on Energy and Commerce,
House of Representatives:
United States Government Accountability Office:
GAO:
For Release on Delivery Expected at 10:00 a.m. EDT:
Thursday, May 26, 2005:
Influenza Pandemic:
Challenges Remain in Preparedness:
Statement of Marcia Crosse:
Director, Health Care:
GAO-05-760T:
GAO Highlights:
Highlights of GAO-05-760T, a testimony before the Subcommittee on
Health, Committee on Energy and Commerce, House of Representatives:
Why GAO Did This Study:
Vaccine shortages and distribution problems during the 2004-2005
influenza season raised concerns about the nation‘s ability to respond
to a worldwide influenza epidemic”or influenza pandemic”which many
experts believe to be inevitable. Some experts believe that the next
pandemic could be spawned by the recurring avian influenza in Asia. If
avian influenza strains directly infect humans and acquire the ability
to be readily transmitted between people, a pandemic could occur.
Modeling studies suggest that its effect in the United States could be
severe, with one estimate from the Centers for Disease Control and
Prevention (CDC) ranging from 89,000 to 207,000 deaths and from 38
million to 89 million illnesses.
GAO was asked to discuss surveillance systems in place to identify and
monitor an influenza pandemic and concerns about preparedness for and
response to an influenza pandemic. This testimony is based on GAO‘s
2004 report on disease surveillance; reports and testimony on influenza
outbreaks, influenza vaccine supply, and pandemic planning that GAO has
issued since October 2000; and work GAO has done in May 2005 to update
key information.
What GAO Found:
Federal public health officials plan to rely on the nation‘s existing
influenza surveillance system and enhancements to identify an influenza
pandemic. CDC currently collaborates with multiple public health
partners, including the World Health Organization (WHO), to obtain data
that provide national and international pictures of influenza activity.
Federal public health officials and health care organizations have
undertaken several initiatives that are intended to enhance influenza
surveillance capabilities. While some of these initiatives are focused
more generally on increasing preparedness for bioterrorism and other
emerging infectious disease health threats, others have been undertaken
in preparation for an influenza pandemic. For example, in response to
concerns over the past few years about the potential for avian
influenza to become the next influenza pandemic, CDC implemented an
initiative in cooperation with WHO to improve influenza surveillance in
Asia. CDC has also implemented initiatives to improve the
communications systems it uses to collect and disseminate surveillance
information. In addition, CDC, the Department of Agriculture, and the
Food and Drug Administration have made efforts to enhance their
coordination of surveillance efforts for diseases that arise in animals
and can be transferred to humans, such as SARS and certain strains of
influenza with the potential to become pandemic.
While public health officials have undertaken several initiatives to
enhance influenza surveillance capabilities, challenges remain with
regard to other aspects of preparedness for and response to an
influenza pandemic. In particular, the Department of Health and Human
Services (HHS) has not finalized planning for an influenza pandemic. In
2000, GAO recommended that HHS complete the national plan for
responding to an influenza pandemic, but the plan has been in draft
format since August 2004. Absent a completed federal plan, key
questions about the federal role in the purchase, distribution, and
administration of vaccines and antiviral drugs during a pandemic remain
unanswered. Other challenges with regard to preparedness for and
response to an influenza pandemic exist across the public and private
sectors, including challenges in ensuring an adequate and timely
influenza vaccine and antiviral supply; addressing regulatory, privacy,
and procedural issues surrounding measures to control the spread of
disease, for example, across national borders; and resolving issues
related to an insufficient hospital and health workforce capacity for
responding to a large-scale outbreak such as an influenza pandemic.
www.gao.gov/cgi-bin/getrpt?GAO-05-760T.
To view the full product, including the scope and methodology, click on
the link above. For more information, contact Marcia Crosse at (202)
512-7119.
[End of section]
Mr. Chairman and Members of the Subcommittee:
I am pleased to be here today as you discuss issues regarding the
nation's preparedness to respond to a worldwide influenza epidemic, or
influenza pandemic.[Footnote 1] The emergence of new diseases such as
severe acute respiratory syndrome (SARS) has raised concerns about our
ability to respond to other infectious disease outbreaks such as an
influenza pandemic,[Footnote 2] which many experts believe to be
inevitable. Vaccine shortages and distribution problems during the 2004-
2005 influenza season add to these concerns.
Influenza pandemics arise periodically but unpredictably from a major
genetic change in the virus that results in a new strain.[Footnote 3]
Some experts believe that the next pandemic could be spawned by the
recurring avian influenza in Asia. As of May 19, 2005, 97 people,
mostly young and otherwise healthy, have been confirmed by the World
Health Organization (WHO) to have been infected with avian influenza
since 2003, and 53 of them have died. Recent studies suggest that avian
influenza strains are increasingly capable of causing severe disease in
humans and suggest that these strains have become endemic in some wild
birds. If these avian influenza strains directly infect humans and
acquire the ability to be readily transmitted between people, a
pandemic could occur.
While the severity of the next pandemic cannot be predicted, modeling
studies suggest that its effect in the United States could be severe.
The Centers for Disease Control and Prevention (CDC) estimates that if
a "medium-level" influenza pandemic were to occur in the United States,
in the absence of any control measures (e.g., vaccination and drugs),
it could cause 89,000 to 207,000 deaths, 314,000 to 734,000
hospitalizations, 18 million to 42 million outpatient visits, and
another 20 million to 47 million cases of the illness.[Footnote 4] From
15 percent to 35 percent of the U.S. population could be affected by an
influenza pandemic, with associated costs ranging from $71 billion to
$167 billion.
You asked us to provide our perspective on the nation's ability to
conduct disease surveillance[Footnote 5] for an influenza pandemic, as
well as the public health system's preparedness for an influenza
pandemic. In this testimony, I will discuss (1) surveillance systems in
place to identify and monitor an influenza pandemic and (2) challenges
in preparedness and response to an influenza pandemic.
My testimony today is based largely on our 2004 report on disease
surveillance[Footnote 6] as well as reports and testimony on influenza
outbreaks, influenza vaccine supply, pandemic planning, and the SARS
outbreak that we have issued since October 2000[Footnote 7] and work we
have conducted to update key information. Our prior work on disease
surveillance and influenza pandemics included analysis of information
provided by multiple federal departments and agencies, including the
Department of Health and Human Services (HHS)--specifically from CDC
and the Food and Drug Administration (FDA)--and the Departments of
Agriculture, Defense, and Homeland Security, as well as interviews with
officials of those departments and agencies. We also interviewed public
health department officials from 11 states,[Footnote 8] vaccine
manufacturers, and vaccine distributors and surveyed physician group
practices. To learn about pandemic planning efforts, we interviewed HHS
officials in the National Vaccine Program Office and reviewed HHS's
August 2004 draft "Pandemic Influenza Preparedness and Response Plan."
Our prior work on the SARS outbreak included analysis of information
provided by U.S. agencies, WHO, and Asian governments, as well as
interviews with officials from those entities. We also conducted
fieldwork on SARS in Beijing; Hong Kong; Guangdong Province, China; and
Taipei, Taiwan. In May 2005, we updated our information to include
issues that arose during the 2004-2005 influenza season and to verify
the current status of HHS efforts on surveillance, planning, and
preparedness activities. We conducted all of our work in accordance
with generally accepted government auditing standards.
In summary, federal public health officials plan to rely on the
nation's existing influenza surveillance system and enhancements to
identify an influenza pandemic. CDC currently collaborates with
multiple public health partners, including WHO, to obtain data that
provide national and international pictures of influenza activity.
Federal public health officials and health care organizations have
undertaken several initiatives that are intended to enhance influenza
surveillance capabilities. While some of these initiatives are focused
more generally on increasing preparedness for bioterrorism and other
emerging infectious disease health threats, others were undertaken in
preparation for an influenza pandemic. For example, in response to
concerns over the past few years about the potential for avian
influenza to become the next influenza pandemic, CDC implemented an
initiative in cooperation with WHO to improve influenza surveillance in
Asia. CDC has also implemented initiatives to improve the
communications systems it uses to collect and disseminate surveillance
information. In addition, CDC, USDA, and FDA have made efforts to
enhance their coordination of surveillance efforts for diseases that
arise in animals and can be transferred to humans, such as SARS and
certain strains of influenza with the potential to become pandemic.
While public health officials have undertaken several initiatives to
enhance influenza surveillance capabilities, challenges remain with
regard to other aspects of preparedness for and response to an
influenza pandemic. In particular, HHS has not finalized planning for
an influenza pandemic. In 2000, we recommended that HHS complete the
national plan for responding to an influenza pandemic, but the plan has
been in draft format since August 2004. Absent a completed federal
plan, key questions about the federal role in the purchase,
distribution, and administration of vaccines and antiviral drugs during
a pandemic remain unanswered. Other challenges with regard to
preparedness for and response to an influenza pandemic exist across the
public and private sectors, including challenges in ensuring an
adequate and timely influenza vaccine and antiviral supply; addressing
regulatory, privacy, and procedural issues surrounding measures to
control the spread of disease, for example, across national borders;
and resolving issues related to an insufficient hospital and health
workforce capacity for responding to a large-scale outbreak such as an
influenza pandemic.
Background:
To be prepared for major public health threats such as an influenza
pandemic, public health agencies need several basic capabilities,
including disease surveillance systems. Specifically, to detect cases
of pandemic influenza, especially before they develop into widespread
outbreaks, local, state, and federal public health officials as well as
international organizations collect, analyze, and share information
related to cases of the disease. When effective, surveillance can
facilitate timely action to control outbreaks and promote informed
allocation of resources to meet changing disease conditions.
Influenza:
Influenza is more severe than some other viral respiratory infections,
such as the common cold. Most people who get influenza recover
completely in 1 to 2 weeks, but some develop serious and potentially
life-threatening medical complications, such as pneumonia. People aged
65 and older, people of any age with chronic medical conditions,
children younger than 2 years, and pregnant women are more likely than
other people to develop severe complications from influenza. Influenza
and pneumonia rank as the fifth leading cause of death among persons
aged 65 and older.
Influenza viruses undergo minor but continuous genetic changes from
year to year. Almost every year, an influenza virus causes acute
respiratory disease in epidemic proportions somewhere in the world.
Vaccination is the primary method for preventing influenza and its more
severe complications. Influenza vaccine is produced and administered
annually to provide protection against particular influenza strains
expected to be prevalent that year. Influenza vaccine takes several
months to produce. Deciding which viral strains to include in the
annual influenza vaccine depends on data collected from domestic and
international surveillance systems that identify prevalent strains and
characterize their effect on human health. FDA decides which strains to
include in the vaccine and also licenses and regulates the
manufacturers that produce the vaccine.[Footnote 9] HHS has limited
authority, however, to directly control influenza vaccine production
and distribution.[Footnote 10]
FDA has approved four antiviral medications (amantadine, rimantadine,
oseltamivir, and zanamivir) for prevention and treatment of influenza.
However, influenza virus strains can become resistant to one or more of
these drugs, and so they may not always be effective.
Disease Surveillance and Response:
In the United States, responsibility for disease surveillance is
shared--involving health care providers; more than 3,000 local health
departments, including county, city, and tribal health departments; 59
state and territorial health departments; more than 180,000 public and
private laboratories; and public health officials from multiple federal
departments and agencies.
States, through the use of their state and local health departments,
have principal responsibility for protecting the public's health and
therefore take the lead in conducting disease surveillance and
supporting response efforts. According to the Institute of Medicine
(IOM), most states require health care providers to report any unusual
illnesses or deaths--especially those for which a cause cannot be
readily established.[Footnote 11] Generally, local health departments
are responsible for conducting initial investigations into reports of
infectious diseases. Laboratory personnel test clinical and
environmental samples for possible exposures and identification of
illnesses. Epidemiologists in health departments use disease
surveillance systems to detect clusters of suspicious symptoms or
diseases in order to facilitate early detection and treatment. Local
and state health departments monitor disease trends. Local health
departments are also responsible for sharing information they obtain
from providers or other sources with their state departments of health.
State health departments are responsible for collecting surveillance
information--which they share on a voluntary basis with CDC and others-
-from across their state and for coordinating investigations and
response efforts. Public health officials provide needed information to
the clinical community and the public.
At the federal level, several departments and agencies are involved in
disease surveillance and response. For example,
* HHS has primary responsibility for coordinating the nation's response
to public health emergencies. As part of its mission, the department
has a role in planning to prepare for and respond to an influenza
pandemic. One action the department has taken is the development of a
draft national pandemic influenza plan, titled "Pandemic Influenza
Preparedness and Response Plan.":
* CDC is charged with protecting the nation's public health by
directing efforts to prevent and control diseases and responding to
public health emergencies. It has primary responsibility for conducting
national disease surveillance and developing epidemiological and
laboratory tools to enhance disease surveillance. CDC also provides an
array of technical and financial support for state infectious disease
surveillance efforts. In addition, CDC participates in international
disease and laboratory surveillance sponsored by WHO.
* FDA is responsible for ensuring that new vaccines and drugs are safe
and effective and for conducting research on diagnostic tools and
treatment of disease outbreaks. The agency also regulates and licenses
vaccines and antiviral agents through the Center for Biologics
Evaluation and Research and the Center for Drug Evaluation and
Research, respectively. FDA also develops influenza viral reference
strains and reagents and makes them available to manufacturers for
vaccine development and evaluation.
* The Department of Defense (DOD) contributes to global disease
surveillance, training, research, and response to emerging infectious
disease threats. DOD maintains the DOD Influenza Surveillance Program,
a laboratory-based surveillance program. DOD maintains multiple sites
throughout the world that serve as sentinels for disease outbreaks,
where it collects and analyzes viral specimens.
* The Department of Agriculture (USDA) is responsible for protecting
and improving the health and marketability of animals and animal
products by preventing, controlling, and eliminating animal diseases.
USDA undertakes disease surveillance and response activities to protect
U.S. livestock, ensure the safety of international trade, and
contribute to the national zoonotic disease[Footnote 12] surveillance
effort.
The United States is a member of WHO, which is responsible for
coordinating international disease surveillance and response efforts.
An agency of the United Nations, WHO administers the International
Health Regulations, which outline WHO's role and the responsibility of
member countries and regions in preventing the global spread of
infectious diseases. WHO also helps marshal resources from its members
to control outbreaks within individual countries or regions. In
addition, WHO works with national governments to improve their
surveillance capacities through--for example--assessing and redesigning
national surveillance strategies, offering training in epidemiologic
and laboratory techniques, and emphasizing more efficient communication
systems.
Existing Influenza Surveillance System and Enhancements Would Be Used
to Identify an Influenza Pandemic:
Surveillance is a key component in planning for an influenza pandemic,
and federal public health officials plan to rely on the nation's
existing annual influenza surveillance system and enhancements to
identify an influenza pandemic. Federal public health officials have
undertaken several initiatives that are intended to enhance influenza
surveillance capabilities. These initiatives have been undertaken both
through programs specific to influenza as well as through programs
focused more generally on increasing preparedness for bioterrorism and
other emerging infectious disease health threats. Federal officials
have implemented and expanded syndromic surveillance systems[Footnote
13] in order to detect outbreaks more quickly, but there are concerns
that these systems are costly to run and still largely untested.
Federal officials have also implemented initiatives designed to improve
public health communications and have undertaken initiatives intended
to improve the coordination of zoonotic surveillance efforts.
Systems Are in Place to Routinely Monitor for Influenza:
Current U.S. surveillance for identifying annual influenza outbreaks as
well as an influenza pandemic involves multiple public health partners
at all levels of government and relies on several data sources. At the
federal level, CDC's Influenza Branch leads the national influenza
surveillance effort, monitoring disease and viral trends using data
submitted each week from October through May. These surveillance data
are collected at the local and state levels and voluntarily submitted
to CDC. Data submitted on influenza activity in the United States
include data from more than 120 laboratories and 2,000 health care
providers and mortality reports from 122 cities. In addition, influenza
data are collected from all 50 state health departments and the health
departments in the District of Columbia and New York City. CDC also
receives data that are specifically focused on influenza in pediatric
patients. When the data are used collectively, they provide a national
picture of influenza activity. Specifically, they allow CDC to (1)
identify when and where influenza activity is occurring, (2) determine
what strains of the influenza virus are in circulation, (3) detect
changes in the influenza virus, (4) monitor influenza-related
illnesses, and (5) measure the impact influenza is having on deaths in
the United States.
DOD also plays a role in national and international influenza
surveillance. Specifically, DOD's Influenza Surveillance Program, under
the direction of the Air Force, collects viral specimens from its
active duty personnel and their dependents at military facilities
around the world. DOD's program also sends specimens to CDC for further
analysis and contributes to the determination of which viral strains
FDA includes in the nation's annual influenza vaccine. Internationally,
DOD provides viral specimens to WHO and assists in identifying emerging
influenza strains.
In countries throughout the world, infectious disease surveillance is a
national responsibility, but WHO assists its members' efforts through
its Global Influenza Surveillance Network. WHO's Network is composed of
112 institutions, called National Influenza Centres, from 83 countries.
Collectively, these Centres monitor influenza activity and annually
gather more than 175,000 viral specimens for analysis from patients
with influenza-like illnesses throughout the world. Selected influenza
isolates--an estimated 2,000 viruses--may also be sent to one of four
WHO Collaborating Centres[Footnote 14] for further, more specific
genetic analysis. The additional analysis conducted by the WHO
Collaborating Centers is used for the annual WHO recommendations on
which strains to include in the influenza vaccine for the northern and
southern hemispheres. In addition to making recommendations on the
components of the influenza vaccine, this Global Influenza Surveillance
Network also serves as a global alert mechanism for the emergence of
influenza viruses with pandemic potential.
Federal Agencies Have Undertaken Initiatives to Enhance Influenza
Surveillance:
CDC has undertaken several initiatives that are intended to enhance
influenza surveillance capabilities in preparation for an influenza
pandemic. CDC works with its international partners to improve global
surveillance for influenza. For example, CDC participates in
international disease and laboratory surveillance sponsored by WHO.
Also, when concerns were raised over recent influenza seasons that the
avian influenza A (H5N1) could become the next influenza pandemic, CDC
led a variety of efforts with its international partners to plan for
and address threats of increased influenza activity worldwide. For
example, CDC worked collaboratively with WHO to conduct investigations
of avian influenza A in Vietnam and to provide laboratory testing. CDC
also provided training assistance and has implemented an initiative to
improve influenza surveillance in Asia.
CDC also supports several domestic initiatives to improve surveillance
capabilities for influenza. For example, CDC supports enhanced
influenza surveillance activities through its Epidemiology and
Laboratory Capacity (ELC) Grants. Established in 1997, this program
provides funding to state and local influenza programs. Grants have
steadily increased from the first awards in 1997, when less than
$100,000 was provided to five states through August 2004, with funding
totaling more than $2 million being given to about 47 states or major
metropolitan areas. States and cities receiving ELC-influenza funding
are encouraged to achieve three highlighted influenza epidemiology and
laboratory surveillance capacities: sentinel physician surveillance,
viral isolation and subtyping, and year-round surveillance. Each state
targets funding to meet one or more of these three priorities and uses
funding for support of improvements that include the assignment or
hiring of an influenza coordinator, recruitment of sentinel physicians
to collect influenza specimens and report influenza-like illness to the
state, laboratory infrastructure enhancements to increase influenza
testing capabilities for viral isolation and subtyping, and expansion
of influenza surveillance activities to year-round.
In an effort to enhance the ability to detect infectious disease
outbreaks, particularly in their early stages, federal funding has
supported state efforts to implement numerous syndromic surveillance
systems. These systems collect information on syndromes from a variety
of sources. For example, the National Retail Data Monitor (NRDM)
collects data from retail sources instead of hospitals. As of February
2004, NRDM collected sales data from about 19,000 stores, including
pharmacies, in order to monitor sales patterns in such items as over-
the-counter influenza medications for signs of a developing infectious
disease outbreak.
CDC is taking steps to enhance its two public health communications
systems, the Health Alert Network (HAN)[Footnote 15] and the Epidemic
Information Exchange (Epi-X),[Footnote 16] which are used in disease
surveillance and response efforts. For example, CDC is working to
increase the number of HAN participants who receive assistance with
their communication capacities. In addition, following reports of human
deaths from avian influenza A in Vietnam in August 2004, CDC issued a
HAN message reiterating criteria for domestic surveillance, diagnostic
evaluation, and infection control precautions. CDC also issued detailed
laboratory testing procedures for avian influenza through HAN.
Similarly, CDC has expanded Epi-X by giving officials at other federal
agencies and departments, such as DOD, the ability to use the system.
CDC is also adding users to Epi-X from local health departments, giving
access to CDC staff in other countries, and making the system available
to Field Epidemiology Training Programs (FETP) located in 21
countries.[Footnote 17] Finally, CDC is facilitating Epi-X's interface
with other data sources by allowing users to access the Global Public
Health Intelligence Network (GPHIN), the system that searches Web-based
media for information on infectious disease outbreaks worldwide.
In addition to the efforts to enhance communication systems, federal
public health officials also have enhanced federal coordination for
zoonotic disease surveillance and expanded training programs. According
to CDC, nearly 70 percent of emerging infectious disease episodes
during the past 10 years have been zoonotic diseases. Moreover, recent
outbreaks of human disease caused by avian influenza strains in Asia
and Europe highlight the potential for new strains to be introduced
into the population. Surveillance for zoonotic diseases requires
collaboration between animal and human disease specialists. CDC, USDA,
and FDA have made efforts to enhance their coordination of zoonotic
disease surveillance. For example, CDC and UDSA are working with two
national laboratory associations to add veterinary diagnostic
laboratories to the Laboratory Response Network (LRN).[Footnote 18] As
of May 2004, 10 veterinary laboratories had been added to LRN, and CDC
officials told us that they had plans to add more veterinary
laboratories in the future. In addition, CDC officials told us the
agency has appointed a staff person whose responsibility, in part, is
to assist in finding ways to enhance zoonotic disease coordination
efforts among federal agencies and departments and with other
organizations. This person is helping CDC develop a working group of
officials from CDC, USDA, and FDA to coordinate zoonotic disease
surveillance.[Footnote 19] According to CDC officials, the goal of this
working group is to explore ways to link existing surveillance systems
to better coordinate and integrate surveillance for wildlife, domestic
animal, and human diseases. CDC officials also said that the agency is
exploring the feasibility of a pilot project to demonstrate this
proposed integrated zoonotic disease surveillance system. In addition,
USDA officials told us that they hired 23 wildlife biologists in fall
2003 to coordinate disease surveillance, monitoring, and management
activities among USDA, CDC, states, and other federal agencies. While
each of these initiatives is intended to enhance the surveillance of
zoonotic diseases, each is still in the planning stage or the very
early stages of implementation.
USDA also conducts influenza surveillance in domestic animals.
Coordination with USDA is important because a pandemic strain is likely
to arise from genetic mixing of animal and human influenza viruses.
Recent outbreaks in domestic poultry in Asia and Europe associated with
cases of human disease highlight the importance of coordinating
surveillance activities. Surveillance for influenza viruses in poultry
in the United States has increased substantially since the outbreak of
highly pathogenic avian influenza (HPAI) in Pennsylvania and
surrounding states in 1983 and 1984. However, individual states are
generally responsible for the development and implementation of
surveillance programs that are consistent with the size and complexity
of the resident poultry industry.
Despite Efforts by Federal Officials, Challenges Remain regarding
Preparedness for and Response to an Influenza Pandemic:
Challenges regarding the nation's preparedness for and response to an
influenza pandemic remain. Specifically, our prior work has found that
although CDC participated in an interagency working group that
developed the U.S. plan for pandemic preparedness that was posted for
public comment in August 2004, as of May 23, 2005, the plan had not
been finalized. Further, we found that the draft plan does not address
certain critical issues, including how vaccine for an influenza
pandemic will be purchased, distributed, and administered; how
population groups will be prioritized for vaccination; what quarantine
authorities or travel restrictions may need to be invoked; and how
federal resources should be deployed. At the state level, we found that
most hospitals across the country lack the capacity to respond to large-
scale infectious disease outbreaks.
HHS's Pandemic Influenza Plan Remains in Draft and Leaves Many
Important Issues Unresolved:
In August 2004, HHS released its national pandemic influenza plan for
comment. The draft "Pandemic Influenza Preparedness and Response Plan"
describes HHS's role in coordinating a national response to an
influenza pandemic and provides guidance and tools to promote pandemic
preparedness planning and coordination at the federal, state, and local
levels, including both the public and the private sectors. However, as
of May 23, 2005, this document remained in draft form. Further,
although the plan is comprehensive in scope, it leaves many important
decisions unresolved about the purchase, distribution, and
administration of vaccines. For example, some decisions yet to be made
include determining the public-versus private-sector roles in the
purchase and distribution of pandemic influenza vaccines; the division
of responsibility between the federal government and the states for
vaccine distribution; and how population groups will be prioritized and
targeted to receive limited supplies of vaccines. Until these key
decisions are made, public health officials at all levels may find it
difficult to plan for an influenza pandemic, and the timeliness and
adequacy of response efforts may be compromised.
The draft plan does not establish a definitive federal role in the
purchase and distribution of vaccines during an influenza pandemic.
Instead, HHS provides options for vaccine purchase and distribution
that include public-sector purchase and distribution of all pandemic
influenza vaccine; a mixed public-private system where public-sector
supply may be targeted to specific priority groups; and maintenance of
the current largely private system. In its draft plan, HHS does not
recommend a specific alternative.
Furthermore, the draft plan delegates to the states responsibility for
distribution of vaccine. The lack of a clearly defined federal role in
distribution complicates pandemic planning for the states. Furthermore,
among the current state pandemic influenza plans, there is no
consistency in terms of their procurement and distribution of vaccine
and the relative role of the federal government. Approximately half of
the states handle procurement and distribution of the annual influenza
vaccine through the state health agency. The remainder either operate
through a third-party contractor for distribution to providers or use a
combination of these two approaches.
Challenges Persist in Ensuring an Adequate and Timely Influenza Vaccine
Supply:
Challenges persist in ensuring an adequate and timely influenza vaccine
supply. The number of producers remains limited, and the potential for
manufacturing problems such as those experienced during the 2004-2005
influenza season is still present. When one manufacturer's production
is affected, providers who order vaccine from that manufacturer can
experience shortages, while providers who receive supplies from another
manufacturer may have all the vaccine they need. The allocation plan
CDC developed for this past season's shortage was dependent upon
voluntary compliance by the private sector and individuals to forgo
vaccination. Most annual influenza vaccine distribution and
administration are accomplished within the private sector, with
relatively small amounts of vaccine purchased and distributed by CDC or
by state and local health departments. In the United States, 85 percent
of vaccine doses are purchased by the private sector, such as private
physicians and pharmacies. HHS has not yet determined how influenza
vaccine will be distributed and administered during an influenza
pandemic.
There are many issues surrounding the production of influenza vaccine,
which will only become exacerbated during an influenza pandemic.
Vaccines, which are considered the first line of defense to prevent or
reduce influenza-related illness and death, may be unavailable or in
short supply. Producing the vaccine is a complex process that involves
growing viruses in millions of fertilized chicken eggs. Experience has
shown that the vaccine production cycle takes at least 6 to 8 months
after a virus strain has been identified, and vaccines for some
influenza strains have been difficult to mass-produce, causing further
delay. The lengthy process for developing a vaccine may mean that a
vaccine would not be available during the initial stages of a pandemic.
Vaccine shortages during the 2004-2005 influenza season have
highlighted the fragility of the influenza vaccine market and the need
for its expansion and stabilization. Currently, only two manufacturers
are licensed to sell their vaccine in the United States.[Footnote 20]
Maintaining an influenza vaccine supply is critically important for
protecting the public's health and improving our preparedness for an
influenza pandemic. As a result, according to CDC officials, the agency
plans to alleviate the impact of next year's influenza season by taking
aggressive steps to ensure an expanded influenza supply to protect the
nation. To this end, the agency's fiscal year 2006 budget request
includes an increase of $30 million for CDC to enter into guaranteed
purchase contracts with vaccine manufacturers to ensure the production
of bulk monovalent influenza vaccine. If supplies fall short, this bulk
product can be turned into a finished trivalent influenza vaccine
product for annual distribution. If supplies are sufficient, the bulk
vaccine can be held until the following year's influenza season and
developed into vaccines if the circulating strains remain the same. In
addition, according to CDC, this guarantee will help to expand the
influenza market by providing an incentive to manufacturers to expand
capacity and possibly encourage additional manufacturers to enter the
market. In addition, the fiscal year 2006 budget request includes an
increase of $20 million to support influenza vaccine purchase
activities.
Even if sufficient quantities of the vaccine are produced in time,
vaccines against various strains differ in their ability to produce the
immune response necessary to provide effective protection against the
disease. Studies show that it is uncertain how effective a vaccine will
be in preventing or controlling the spread of a pandemic influenza
virus.
Challenges Persist in Ensuring an Adequate Supply of Antiviral Drugs:
Early in an influenza pandemic, especially before a vaccine is
available or during a period of limited vaccine supply, use of
antiviral drugs may have a significant effect. Specifically, antiviral
drugs can help prevent or mitigate the number of influenza-related
deaths until an influenza vaccine becomes available. They can be used
against all strains of pandemic influenza and have immediate
availability as both a prophylactic to prevent illness and as a
treatment if administered within 48 hours of the onset of symptoms.
According to HHS, analysis is ongoing to define optimal antiviral use
strategies, potential health impacts, and cost-effectiveness of
antiviral drugs in the setting of a pandemic.
The United States has a limited supply of influenza antiviral
medications stored for an influenza pandemic. HHS officials expect the
amount produced will be below demand during a pandemic. This
assumption, supported by drug manufacturers, is based on the fact that
current production levels of antiviral drugs are set in response to
current demand, whereas demand in a pandemic is expected to increase
significantly if vaccines are unavailable. In addition, the production
of antiviral medications cannot be rapidly expanded and involves a long
production process. Moreover, sometimes influenza virus strains can
become resistant to one or more of the four approved influenza
antiviral drugs, and thus the drugs may not always work. For example,
the influenza A (H5N1) viruses identified in human patients in Asia in
2004 and 2005 have been resistant to two of the four antiviral drugs,
amantadine and rimantadine.
Implementation of Control Measures to Prevent Spread of Pandemic
Influenza Presents Difficulties:
Another challenge in responding to an influenza pandemic involves
implementing certain control measures to prevent the spread of the
disease. These control measures--case identification and contact
tracing, transmission control, and exposure management--are well-
established and have proved effective in both health care and community
settings.[Footnote 21] However, federal attempts to limit the spread of
SARS into the United States by advising passengers who traveled to
infected countries faced multiple obstacles. For example, due to
airline concerns over authority and privacy, as well as procedural
constraints, CDC was unable to obtain passenger contact information it
needed to trace travelers. Although HHS has statutory authority to
prevent the introduction, transmission, or spread of communicable
diseases from foreign countries into the United States,[Footnote 22]
HHS regulations implementing the statute do not specifically provide
for HHS to obtain passenger manifests or other passenger contact
information from airlines and shipping companies for disease outbreak
control purposes.[Footnote 23]
Most Hospitals Lack the Capacity to Respond to Large-Scale Infectious
Disease Outbreaks:
A challenge identified during the SARS outbreak that may also affect
response efforts during an influenza pandemic is lack of sufficient
hospital and workforce capacity. This lack could be exacerbated during
an influenza pandemic, compared to other natural disasters, such as a
tornado or hurricane, or an intentional release of a bioterrorist
agent, because it is likely that a pandemic would result in both
widespread and sustained effects.
Public health officials we spoke with said a large-scale outbreak, such
as an influenza pandemic, could strain the available capacity of
hospitals by requiring entire hospital sections (along with their
staff) to be used as isolation facilities. As we have reported earlier,
most states lack "surge capacity," that is, the capacity to respond to
the large influx of patients that could occur during a large public
health emergency.[Footnote 24] For example, few states reported that
they had the capacity to evaluate, diagnose, and treat 500 or more
patients involved in a single incident. In addition, few states
reported having the capacity to rapidly establish clinics to immunize
or provide treatment to large numbers of patients. Moreover, a shortage
in workforce could increase during an influenza pandemic because higher
disease rates could result in high rates of absenteeism among health
care workers who are likely to be at increased risk of exposure and
illness.
Concluding Observations:
There are a number of systems in place to identify influenza outbreaks
abroad, to alert us to a pandemic, and these systems generally appear
to be working well. HHS has taken important steps to enhance
surveillance and to fund initiatives for preparedness and response,
including steps to increase the vaccine supply.
However, important challenges remain in our preparedness to respond,
should an influenza pandemic occur in the United States. The steps HHS
is taking to address vaccine production capacity and stockpiling of
antiviral drugs may not be in place in time to fill the current gaps in
preparedness should an influenza pandemic occur in the next several
years. As we learned in the 2004-2005 influenza season, problems
affecting even a single manufacturer can produce major shortages. Once
a pandemic influenza strain is identified, a vaccine will take many
months to produce, and our current stockpile of antiviral drugs is
insufficient to meet the likely demand. Pandemic influenza would have
major impacts on the ability of communities to respond, businesses to
function, and public safety to be maintained when communities across
the country are simultaneously impacted and hospital capacity is
overwhelmed.
Since 2000, we have been urging the department to complete its pandemic
plan. A draft plan was issued in August 2004, with a 60-day period for
public comment, but as of this week, the plan had not been finalized.
It is important for the federal government and the states to work
through issues such as how vaccine will be purchased, distributed, and
administered, how population groups will be prioritized for
vaccination, what quarantine authorities or travel restrictions may
need to be invoked, and how federal resources should be deployed before
we are in a time of crisis.
Mr. Chairman, this concludes my prepared statement. I would be happy to
respond to any questions you or other Members of the Subcommittee may
have at this time.
Contact and Staff Acknowledgments:
For further information about this testimony, please contact Marcia
Crosse at (202) 512-7119. Gloria E. Taylor, Gay Hee Lee, Elizabeth T.
Morrison, and Roseanne Price made key contributions to this statement.
[End of section]
Related GAO Products:
Emerging Infectious Diseases: Review of State and Federal Disease
Surveillance Efforts. GAO-04-877. Washington, D.C.: September 30, 2004.
Infectious Disease Preparedness: Federal Challenges in Responding to
Influenza Outbreaks. GAO-04-1100T. Washington, D.C.: September 28,
2004.
Emerging Infectious Diseases: Asian SARS Outbreak Challenged
International and National Responses. GAO-04-564. Washington, D.C.:
April 28, 2004.
Public Health Preparedness: Response Capacity Improving, but Much
Remains to Be Accomplished. GAO-04-458T. Washington, D.C.: February 12,
2004.
Infectious Diseases: Gaps Remain in Surveillance Capabilities of State
and Local Agencies. GAO-03-1176T. Washington, D.C.: September 24, 2003.
Severe Acute Respiratory Syndrome: Established Infectious Disease
Control Measures Helped Contain Spread, But a Large-Scale Resurgence
May Pose Challenges. GAO-03-1058T. Washington, D.C.: July 30, 2003.
SARS Outbreak: Improvements to Public Health Capacity Are Needed for
Responding to Bioterrorism and Emerging Infectious Diseases. GAO-03-
769T. Washington, D.C.: May 7, 2003.
Infectious Disease Outbreaks: Bioterrorism Preparedness Efforts Have
Improved Public Health Response Capacity, but Gaps Remain. GAO-03-654T.
Washington, D.C.: April 9, 2003.
Global Health: Challenges in Improving Infectious Disease Surveillance
Systems. GAO-01-722. Washington, D.C.: August 31, 2001.
Flu Vaccine: Steps Are Needed to Better Prepare for Possible Future
Shortages. GAO-01-786T. Washington, D.C.: May 30, 2001.
Flu Vaccine: Supply Problems Heighten Need to Ensure Access for High-
Risk People. GAO-01-624. Washington, D.C.: May 15, 2001.
Influenza Pandemic: Plan Needed for Federal and State Response. GAO-01-
4. Washington, D.C.: October 27, 2000.
West Nile Virus Outbreak: Lessons for Public Health Preparedness. GAO/
HEHS-00-180. Washington, D.C.: September 11, 2000.
Global Health: Framework for Infectious Disease Surveillance. GAO/
NSIAD-00-205R. Washington, D.C.: July 20, 2000.
FOOTNOTES
[1] An influenza pandemic is defined by the emergence of a novel
influenza virus, to which much or all of the population is susceptible,
that is readily transmitted person-to-person and causes outbreaks in
multiple countries.
[2] See GAO, SARS Outbreak: Improvements to Public Health Capacity Are
Needed for Responding to Bioterrorism and Emerging Infectious Diseases,
GAO-03-769T (Washington, D.C.: May 7, 2003).
[3] Influenza pandemics can have successive "waves" of disease and last
for up to 3 years. Three pandemics occurred in the 20th century: the
"Spanish flu" of 1918, which killed 500,000 people in the United
States; the "Asian flu" of 1957, which caused 70,000 deaths in the
United States; and the "Hong Kong flu" of 1968, which caused 34,000
deaths in the United States.
[4] See CDC, Fact Sheet, Information about Influenza Pandemics, 3,
www.cdc.gov/flu, downloaded May 12, 2005.
[5] Disease surveillance is the process of reporting, collecting,
analyzing, and exchanging information related to cases of infectious
diseases.
[6] See GAO, Emerging Infectious Diseases: Review of State and Federal
Disease Surveillance Efforts, GAO-04-877 (Washington, D.C.: Sept. 30,
2004).
[7] See "Related GAO Products" at the end of this testimony for a list
of our earlier work related to emerging infectious diseases and
influenza pandemic planning.
[8] These states--California, Colorado, Indiana, Louisiana, Minnesota,
New York, Pennsylvania, Tennessee, Texas, Washington, and Wisconsin--
were selected based on their participation in CDC's Emerging Infections
Program, each state's most recent infectious disease outbreak, and
their geographic location.
[9] FDA decides which strains to include in the annual influenza
vaccine based on the recommendations of its Vaccines and Related
Biological Products Advisory Committee.
[10] Under the Federal Food, Drug, and Cosmetic Act, FDA ensures
compliance with good manufacturing practices and has limited authority
to regulate the resale of prescription drugs, including influenza
vaccine, that have been purchased by health care entities, such as
public or private hospitals. The term "health care entity" does not
include wholesale distributors. This authority would not extend to
resale of the vaccine for emergency medical reasons. CDC also has a
role in encouraging appropriate public health actions.
[11] The requirement to report clinically anomalous symptoms is
particularly important for the detection of emerging infectious
diseases, many of which may be unfamiliar to health care providers.
[12] Zoonotic diseases are those diseases that are transmitted from
animals to humans.
[13] Many syndromic surveillance systems currently in use in the United
States were developed in response to the September 11, 2001, attacks on
the World Trade Center and Pentagon and to the anthrax outbreaks that
occurred shortly afterwards. The fundamental objective of syndromic
surveillance is to identify illness clusters early, before diagnoses
are confirmed and reported to public health agencies.
[14] A WHO Collaborating Centre is a national institution designated by
WHO to form part of an international collaborative network that
contributes to implementing WHO's program priorities and to
strengthening institutional capacity in countries and regions.
Collaborating Centre activities include collection and dissemination of
information, education and training, and participation in collaborative
research developed under WHO's leadership. The four Collaborating
Centres that are part of WHO's Global Influenza Surveillance Network
are located in the United States, Australia, Japan, and the United
Kingdom.
[15] The Health Alert Network (HAN) is an early-warning and response
system operated by CDC that is designed to ensure that state and local
health departments as well as other federal agencies and departments
have timely access to emerging health information.
[16] The Epidemic Information Exchange (Epi-X) is a secure, Web-based
communication system operating in all 50 states. CDC uses this system
primarily to share information relevant to disease outbreaks with state
and local public health officials and with other federal officials. Epi-
X also serves as a forum for routine professional discussions and
nonemergency inquiries.
[17] In selected foreign locations, CDC operates international training
programs, such as FETP. Through FETP, each year CDC trains
approximately 50 to 60 physicians and social scientists in applied
public health, integrating disease surveillance, applied research,
prevention, and control activities. Graduates of the FETP program serve
in their native country and provide links between CDC and their
respective ministries of health. CDC officials said that trainees from
its international programs have frequently provided important
information on disease outbreaks.
[18] To strengthen the nation's capacity to rapidly detect biological
and chemical agents that could be used as a terrorist weapon, CDC, in
partnership with the Federal Bureau of Investigation and the
Association of Public Health Laboratories, created LRN in 1999.
According to CDC, LRN leverages the resources of 126 laboratories to
maintain an integrated national and international network of
laboratories that are fully equipped to respond quickly to acts of
chemical or biological terrorism, emerging infectious diseases, and
other public health threats and emergencies. The network includes
federal, state and local public health, military, and international
laboratories, as well as laboratories that specialize in food,
environmental, and veterinary testing. LRN laboratories have been used
in several public health emergencies. For example, in 2001, a Florida
LRN laboratory discovered the presence of Bacillus anthracis, the
pathogen that causes anthrax, in a clinical specimen it tested.
[19] This working group was created in response to a congressional
mandate that the Secretary of Health and Human Services, through FDA
and CDC, and USDA, coordinate the surveillance of zoonotic diseases.
Public Health Security and Bioterrorism Preparedness and Response Act
of 2002, Pub. L. No. 107-188, §313, 116 Stat. 594, 674 (2002).
[20] During the 2004-2005 influenza season, the license for a third
manufacturer was suspended by British regulatory authorities due to
safety concerns with the vaccine.
[21] In the United States, the Healthcare Infection Control Practices
Advisory Committee, a federal advisory committee made up of 14
infection control experts, develops recommendations and guidelines
regarding general infectious disease control measures for CDC. Expert
recommendations include (1) case identification and contact tracing,
which involves defining what symptoms, laboratory results, and medical
histories constitute a positive case in a patient and tracing and
tracking individuals who may have been exposed to these patients; (2)
transmission control, which involves controlling the transmission of
disease-producing microorganisms through use of proper hand hygiene and
personal protective equipment, such as masks, gowns, and gloves; and
(3) exposure management, which involves separating infected and
noninfected individuals.
[22] Section 361 of the Public Health Service Act, 42 U.S.C. § 264.
[23] See 42 C.F.R. pts 70 and 71; 21 C.F.R. pts 1240 and 1250.
[24] See GAO, Public Health Preparedness: Response Capacity Improving,
but Much Remains to be Accomplished, GAO-04-458T (Washington, D.C.:
Feb. 12, 2004).
