[House Hearing, 109 Congress]
[From the U.S. Government Publishing Office]
ARE YOU READY? IMPLEMENTING THE NATIONAL STRATEGY FOR PANDEMIC
INFLUENZA
=======================================================================
FULL HEARING
before the
COMMITTEE ON HOMELAND SECURITY
HOUSE OF REPRESENTATIVES
ONE HUNDRED NINTH CONGRESS
SECOND SESSION
__________
MAY 16, 2006
__________
Serial No. 109-77
__________
Printed for the use of the Committee on Homeland Security
[GRAPHIC] [TIFF OMITTED] TONGRESS.#13
Available via the World Wide Web: http://www.gpoaccess.gov/congress/
index.html
__________
U.S. GOVERNMENT PRINTING OFFICE
37-063 WASHINGTON : 2007
_____________________________________________________________________________
For Sale by the Superintendent of Documents, U.S. Government Printing Office
Internet: bookstore.gpo.gov Phone: toll free (866) 512-1800; (202) 512�091800
Fax: (202) 512�092104 Mail: Stop IDCC, Washington, DC 20402�0900012007
COMMITTEE ON HOMELAND SECURITY
Peter T. King, New York, Chairman
Don Young, Alaska Bennie G. Thompson, Mississippi
Lamar S. Smith, Texas Loretta Sanchez, California
Curt Weldon, Pennsylvania Edward J. Markey, Massachusetts
Christopher Shays, Connecticut Norman D. Dicks, Washington
John Linder, Georgia Jane Harman, California
Mark E. Souder, Indiana Peter A. DeFazio, Oregon
Tom Davis, Virginia Nita M. Lowey, New York
Daniel E. Lungren, California Eleanor Holmes Norton, District of
Jim Gibbons, Nevada Columbia
Rob Simmons, Connecticut Zoe Lofgren, California
Mike Rogers, Alabama Sheila Jackson-Lee, Texas
Stevan Pearce, New Mexico Bill Pascrell, Jr., New Jersey
Katherine Harris, Florida Donna M. Christensen, U.S. Virgin
Bobby Jindal, Louisiana Islands
Dave G. Reichert, Washington Bob Etheridge, North Carolina
Michael T. McCaul, Texas James R. Langevin, Rhode Island
Charlie Dent, Pennsylvania Kendrick B. Meek, Florida
Ginny Brown-Waite, Florida
(II)
C O N T E N T S
----------
Page
STATEMENTS
The Honorable Peter T. King, a Representative in Congress From
the State of New York, Chairman, Committee on Homeland Security 34
The Honorable Donna M. Christensen, a Delegate in Congress From
the U.S. Virgin Islands........................................ 35
The Honorable Peter A. DeFazio, a Representative in Congress From
the States of California....................................... 32
The Honorable Norman D. Dicks, a Representative in Congress From
the State of Washington........................................ 2
The Honorable Bob Etheridge, a Representative in Congress From
the State of North Carolian.................................... 38
The Honorable John Linder, a Representative in Congress From the
State if Georgia............................................... 1
The Honorable Eleanor Holmes-Norton, a Delegate in Congress From
the District of Columbia....................................... 51
The Honorable Mike Rogers, a Representative in Congress From the
State of Alabama............................................... 42
The Honorable Rob Simmons, a Representative in Congress From the
State of Connecticut........................................... 37
WITNESSES
The Honorable John Agwonubi, Assistant Secretary for Health,
Department of Health and Human Services:
Oral Statement................................................. 9
Prepared Statement............................................. 10
The Honorable John Clifford, Deputy Administrator for Veterinary
Services, Animal and Plant Health Inspection Service,
Department of Agriculture:
Oral Statement................................................. 15
Prepared Statement............................................. 16
The Honorable Jeffrey W. Runge, Acting Undersecretary, Science
and Technology and Chief Medial Officer, Department of Homeland
Security:
Oral Statement................................................. 3
Prepared Statement............................................. 5
The Honorable Peter F. Verga, Deputy Assistant Secretary of
Defense for Homeland Defense, Department of Defense:
Oral Statement................................................. 22
Prepared Statement............................................. 24
ARE WE READY? IMPLEMENTING
THE NATIONAL STRATEGY OR
PANDEMIC INFLUENZA
----------
Tuesday, May 16, 2006
U.S. House of Representatives,
Committee on Homeland Security,
Washington, DC.
The committee met, pursuant to call, at 2:00 p.m., in Room
345, Cannon House Office Building, Hon. John Linder presiding.
Present: Representatives King, Linder, Simmons, Rogers,
Dicks, DeFazio, Norton, Christensen, and Etheridge.
Mr. Linder. The hearing ``Are We Ready? Implementing the
National Strategy for Pandemic Influenza,'' will come to order.
I would like to thank all of our distinguished panel witnesses
for appearing today in this hearing for the Committee on
Homeland Security. We are here today to examine the long-
awaited implementation plan for the President's national
strategy on pandemic influenza and assess our state of
readiness should a pandemic become reality.
ABC movies should not be the only source of information on
this topic. The leaders we have in the room here today must
separate fact from fiction for the American people. Sensational
portrayals in the media risk creating unnecessary panic and
must be balanced by solid and consistent information from
government leaders. We must provide a meaningful guide for all
Americans who ask, what should I be doing to prepare for
pandemic flu?
In February, the Subcommittee for Prevention of Nuclear and
Biological Attack, which I chair, and the Subcommittee on
Emergency Preparedness, Science and Technology held a joint
hearing examining the nature of the pandemic threat as
perceived through the eyes of those on the ground who will be
called upon to respond. It was clear that they were looking for
more universal guidance from the Federal level. Although the
possibility of when the next pandemic may occur is unknown,
what is clear is that, based on history, we are overdue for an
influenza pandemic.
As the pandemic of 1918 showed, the effects could be
dramatic. The United States, like most of the rest of the
world, was gripped with a horrific pandemic of Spanish
influenza, but that was nearly 90 years ago. Our medical and
public health system were rudimentary when compared to today.
There was no vaccine for influenza. There were no antibiotics
to counter the effects of flu.
Today, we have an advanced medical system and a stronger
public health system and pharmacological treatments
unimaginable in 1918, but we still have to do more. We need to
make sure that every American can answer the question: I know
what to do if and when influenza strikes. We need the
government leaders to be able to answer that same question.
Does each government agency know what to do if and when
influenza strikes? The Federal Government needs to be able to
definitively answer the question, who is in charge? We need to
be able to answer questions such as, who will the American
people turn to for guidance? Who will get vaccinated first? And
the inevitable question, what should I do if I get sick?
The effects of a pandemic could be devastating on our
economy. A recent release from HHS stated that up to 40 percent
of a business organization's workforce could be out sick or
taking care of sick family members. We need to make sure that
the Federal Government is providing real world guidance to our
business community as well.
The pillars that are laid out in the President's
implementation plan are a good start. We need to ensure plans
are being made for a potential pandemic everywhere, and what
every American should be doing, and how the Federal Government
will help them. Communication of rules and responsibility is
very important. We need to have the most effective surveillance
tools to detect possible outbreaks, and we must be able to
quickly respond and hopefully contain the spread of any
outbreak.
I look forward to the testimony of our witnesses as they
lay out their respective roles for preparing for potential
pandemic. We need to be able to separate fact from fiction and
make the public more confident that we will be ready in the
case of a influenza pandemic. I now turn to my friend from
Washington, Mr. Dicks, for the purpose of making an opening
statement.
Mr. Dicks. Thank you, Mr. Chairman.
I would like to welcome our witnesses today, and I look
forward to hearing their testimony. I am very pleased that the
committee is holding a hearing on the important issue of
pandemic flu preparedness and response. The witness before us
today represents the key Federal agencies that will be involved
in responding to a pandemic flu outbreak. In a full-scale
pandemic situation, Federal, State, local and private entities
will all need to cooperate effectively for a response to be
successful. The thousands of State and local health departments
are working hard to plan for pandemic flu, but they are
struggling with a lack of money and guidance from the Federal
Government.
In the President's National Strategy for Pandemic
Influenza, the bulk of Federal funding is for vaccine and drug
research. The President requested only $100 million for State
and local preparedness. While Congress appropriated $350
million in the emergency appropriations this past December, it
pales in comparison to the $6 billion that the President
requested for vaccines and antivirals.
I believe that the best way to handle the flu is to
strengthen our hospitals and other health care facilities, and
I don't think enough funding or aid is being offered to State
and localities. I am also concerned that the flu response plan
that we will discuss today might not complement the National
Response Plan, which is supposed to be the plan used to manage
domestic emergencies.
We have many questions to answer. Who is in charge of
response operations at Federal, State and local levels? Who
gets vaccinated first? When should we urge citizens to wear
masks or to stay home? When should we close schools? How will
hospitals manage the surge of patients?
As I have spoken in recent months to local physicians,
hospitals administrators and public health officials and first
responders, it has become clear to me that we do not yet have
the answers to some of these questions. I hope this hearing
will help us begin to answer them.
We cannot be certain how long we have before a full-scale
outbreak of avian flu may occur. In that time, we must ensure
that a coherent nationwide response is ready, and that it will
be properly executed when needed.
Thank you, Mr. Chairman.
Mr. Linder. Thank you, we are pleased to have before us a
distinguished panel of witnesses on this important topic. Let
me remind the witnesses that their entire written statement
will appear in the record. We would ask, however, that all
witnesses make an effort to limit their testimony to no more
than 5 minutes.
Mr. Linder. First up is Dr. Jeff Runge. Dr. Runge is the
Acting Undersecretary for Science and Technology and is DHS's
Chief Medical Officer. He is a punt person at the DHS for
pandemic flu preparedness planning.
Admiral John Agwunobi, Dr. John Agwunobi, is the Assistant
Secretary of Health for the Department of Health and Human
Services. He is an experienced practitioner in public health
and is a former State health officer in Florida.
From the Department of Agriculture, we have Dr. John
Clifford. Dr. Clifford is the chief veterinarian for USDA and
has extensive experience in the veterinary medicine field,
including being the area veterinarian in charge of Ohio, West
Virginia, Michigan and Indiana.
Mr. Peter Verga from DOD is the Principal Deputy Assistant
Secretary for Homeland Defense. He is a retired U.S. Army
officer with 26 years of experience and has held a variety of
senior level positions at the Department of Defense.
Dr. Runge, you may begin.
STATEMENT OF HON. JEFFREY W. RUNGE, ACTING UNDERSECRETARY,
SCIENCE AND TECHNOLOGY, AND CHIEF MEDICAL OFFICER, DEPARTMENT
OF HOMELAND SECURITY
Dr. Runge. Thank you, Chairman Linder, Congressman Dicks
and members of the committee. My name is Jeff Runge. I serve as
Chief Medical Officer for the Department of Homeland Security.
I am pleased to be here with my colleagues to discuss the role
of DHS as the overall incident manager and coordinator of the
Federal response in the event of a influenza pandemic.
We are working closely with our Federal partners,
especially at HHS, USDA and the Department of Veterans Affairs
and the Department of Defense and the Homeland Security Council
to assure that we are fully coordinated in our response to a
pandemic. We are all in agreement about our roles in managing
an outbreak of disease, whether it is an outbreak confined to
the bird population or in the event of a full-scale human
pandemic.
Even though we recognize the need to be ready at the
Federal level, preparedness for an incident such as this must
be defined at the local level. We have stood shoulder to
shoulder with our colleagues from HHS and USDA in nearly 50
State pandemic sessions discussing the need to work together
with State and local governments, nongovernmental organizations
and the private sector to ensure a condition of readiness.
As you know, the mechanism for coordination of any broad
Federal response is the National Response Plan. The NRP
supports the concept that incidents are handled at the lowest
jurisdictional level, even as it provides the mechanism for a
concerted national effort.
In the event we are faced with a pandemic, Secretary
Chertoff would activate a national planning element composed of
senior officials of Federal relevant agencies who have already
been identified to coordinate strategic level national planning
and operations. The Secretary would also likely establish as
many as five regional joint field offices with a deputy PFO in
charge of each regional joint field office to work directly
with State and local entities.
Now this framework provides a coordinated response for all
levels of government, nongovernment and volunteer organizations
and the private sector. It also affords full coordination
between the regional joint field offices and any military joint
task forces that might be established.
Obviously, a close synchronous working relationship with
HHS is essential. Our national public health and medical
resources will unquestionably be taxed, probably beyond
capacity, and DHS will do everything in its power to support
HHS with its mission.
As the DHS Chief Medical Officer, I am and will be the
primary point of interface with HHS, as well as being Secretary
Chertoff's advisor on all medical issues. The implementation
plan contains over 300 action items with very aggressive
timelines. DHS has the lead in 58 of those actions and
participates with other departments in another 84.
We are currently prioritizing these actions and are
searching for the resources that we need to carry them out. As
the committee understands, the Department has many competing
priorities right now, but we are fully engaged in making sure
we are as prepared as we can be for a pandemic.
In addition to our job as the overall incident manager, DHS
has some areas of unique responsibility, and in particular, to
maintain the function of our nation's critical infrastructures,
for border management and for the continuity of DHS operations.
We are also working on identifying and managing the economic
consequences to our Nation from a pandemic with a special focus
on the transportation industry, the flow of trade within and
across borders and a supply chain for food and other goods.
Mr. Chairman, with any illness, prevention is by far the
most effective method for managing this disease. President Bush
and HHS are on the mark in their efforts to improve our
domestic vaccine production and to stimulate transformational
change in vaccine technology. We also need to reinforce the
capacity of State and local public health organizations and
educate the public on good public health practices.
Mr. Chairman, I would also like to make the point that the
best way to prepare for a catastrophic event of any nature is
to strengthen the institutions that we use every day; namely,
public health, medical and emergency services. The collateral
benefits that provides will improve our Nation's quality of
life as well as our preparedness for what we all fear, a
biologic attack of any consequence, of any source.
Mr. Chairman, you have my written remarks for the record. I
thank you.
[The statement of Dr. Runge follows:]
Prepared Statement of Hon. Jeffrey W. Runge, MD
Good afternoon Chairman King, Congressman Thompson and Members of
the Committee on Homeland Security.n I am pleased to have this
opportunity to appear before you today to discuss the current threat
from Avian Influenza and how the Department of Homeland Security (DHS)
will coordinate the Federal response if an influenza pandemic were to
occur in the United States.
Like members of this Committee, the Department of Homeland Security
and our Federal partners recognize that an influenza pandemic in the
United States could trigger severe public health and economic
consequences, catastrophic loss of life, and disrupt our nation's
critical infrastructures. DHS is working closely with its Federal
partners, especially the Department of Health and Human Services (HHS),
the U.S. Department of Agriculture (USDA), the Veterans Administration
(VA), the Department of Defense (DOD), and the Homeland Security
Council to prepare and to ensure that we are coordinated in our
response.
The Role of DHS
As we coordinate, we recognize that each Department has
responsibilities that are unique as well as some responsibilities that
overlap. The DHS responsibilities are clear, pursuant to the Homeland
Security Act of 2002 and Homeland Security Presidential Directive-5
(HSPD-5). As the domestic incident manager, the Secretary of DHS will
coordinate the overall Federal response to a pandemic in order to
ensure the continuity of our government, maintain civil order, preserve
the functioning of society and mitigate the consequences of a pandemic.
The Secretary of DHS serves as the principal Federal official for
overall domestic incident management. In this role, during a pandemic
outbreak, the Secretary of Homeland Security is responsible for the
coordination of Federal operations and/or resources, establishment of
reporting requirements, and conduct of ongoing communications with
Federal, State, local, tribal, private sector, and nongovernmental
organizations.
Our Federal partners are also quite capable of fulfilling their
respective roles in managing outbreaks of avian influenza, from well
confined outbreaks in birds to a full-scale pandemic, and we are fully
coordinated with them. The USDA, working with its state agriculture
counterparts, has ample experience in managing an outbreak in the bird
population. HHS has the responsibility and expertise to plan public
health and medical preparedness. We all recognize that there is still
significant work to be done to ensure the Nation is adequately prepared
to respond to an outbreak in humans. As the National Strategy for
Pandemic Influenza says, ``Preparing for a pandemic requires the
leveraging of all instruments of national power, and coordinated action
by all segments of government and society.'' This need for coordination
of our National instruments is part of the reason that DHS exists. A
pandemic could threaten the ability of the health and medical sector to
manage all the consequences, which could likewise threaten the
functioning of society and the Nation's economy. It is the
responsibility of DHS to coordinate the Federal response to manage
those risks.
The NRP is the primary mechanism for coordination of the U.S.
Government response to terrorist attacks, major disasters and other
emergencies, and will form the basis of the Federal pandemic response.
If a pandemic influenza were to present grave social and economic
problems for the United States, the Secretary would--in consultation
with other cabinet members and the President--likely declare an
Incident of National Significance and ensure implementation of the
appropriate NRP coordinating mechanisms to ensure a coordinated Federal
response.
The NRP supports the concept that incidents are handled at the
lowest jurisdictional level. However, a pandemic will ultimately
require a concerted national effort. Under the National Strategy and
the NRP, Federal departments and agencies have assigned roles and
responsibilities to support all incidents to include a biological
incident.
The Secretary will consider the following four criteria set forth
in HSPD-5 when making the determination to declare an Incident of
National Significance; however, he will not be limited to these
thresholds and may base his decision on other applicable factors:
A Federal department or agency acting under its own
authority has requested the assistance of the Secretary of
Homeland Security
The resources of State and local authorities are
overwhelmed and Federal assistance has been requested by the
appropriate State and local authorities
More than one Federal department or agency has become
substantially involved in responding to an incident, and
The Secretary of Homeland Security has been directed
to assume responsibility for managing a domestic incident by
the President.
DHS will work collectively with the interagency to establish the
appropriate multi-agency coordinating structures when the situation
warrants, even before a full scale outbreak. The Secretary may consider
activating elements of the national response, including designating a
Principal Federal Official, standing up the Joint Information Center
and Joint Field Offices. The Secretary has already identified a
candidate to become the national PFO for pandemic influenza. This
individual will be intimately involved in the planning and exercising
of our contingency plans.
The Secretary would also set up a national planning element
composed of senior officials of relevant Federal agencies to coordinate
strategic-level national planning. The Secretary would also likely
establish as many as five Regional Joint Field Offices that would be
staffed and resourced with a Deputy PFO in charge of each Regional JFO
to work directly with state & local entities. This framework provides a
coordinated response for all level of government, non-government and
volunteer organizations (NGOs), and the private sector. This system
also affords full coordination between the regional joint field offices
and military joint task forces that may be established. Last month,
Secretary Chertoff asked his fellow Cabinet members to identify senior
officials to coordinate planning and operations among the Federal
departments before a pandemic would strike. The list has been compiled,
and we look forward to working with these individuals as we plan and
train together with our pre-designated PFO and Deputy PFOs.
In the event of a pandemic, a close, synchronous working
relationship with HHS is essential. Our national Public Health and
medical resources will unquestionably be taxed, probably beyond
capacity, and DHS will do everything in its power to assist HHS with
its mission to prevent illness and mitigate the consequences of the
anticipated widespread morbidity and mortality. The DHS Chief Medical
Officer is the primary point of interface with HHS and is responsible
for advising the Secretary of DHS on all medical issues, including
avian influenza. The DHS Chief Medical Officer is also responsible for
directing and overseeing the planning, policy, training, and operations
to protect the health of the DHS workforce in the event of a pandemic
in order to maintain critical DHS operations. We are taking advantage
of assets across the Department to accomplish this goal, especially the
expertise of the U.S. Coast Guard medical officers.
Federal Preparedness for Pandemic Influenza
The National Strategy for Pandemic Influenza, issued by President
Bush on November 1, 2005, provides the framework for the Federal
government's response to the influenza pandemic threat. It presents a
high-level overview of the Federal government's approach to an
influenza pandemic, emphasizes the importance of the full participation
of State Local, and Tribal Governments, the private sector and critical
infrastructure components, the public, and the international community
to prepare for, prevent, and contain influenza.
The National Strategy makes it clear that while the Federal
government will pursue all avenues available to it to thwart an
influenza pandemic, it is essential for the States and communities be
fully informed and engaged as well. The resources of the Federal
government alone may not be sufficient to prevent the spread of an
influenza pandemic across the nation. Preventing, minimizing and
mitigating the consequences of an influenza pandemic requires a
coordinated and integrated national effort that includes the full
participation of all levels of government and all segments of society.
The Implementation Plan for the National Strategy announced last
week contains over 300 action items with very aggressive implementation
timelines. DHS has the lead in 58 of these actions and participates
with other departments in 84 additional items. The Department is
currently prioritizing these actions and is attempting to identify
resources to carry them out. The department has many competing
priorities, but is fully engaged in planning efforts for our own
departmental plans as well as fulfilling our responsibilities
enumerated in the Implementation Plan.
While the Plan directs that departments and agencies undertake a
series of action in support of the Strategy, it does not describe the
operational details of how the departments will accomplish these
objectives. Each department will devise its own planning documents that
will operationalize the Implementation Plan and will address additional
planning considerations that may be unique to each department.
The DHS Pandemic Influenza Implementation Plan
The DHS Pandemic Influenza Plan is structured around the three
pillars of the National Strategy: Preparedness and Communication,
Surveillance and Detection, Response and Containment. In order to
support these pillars, the DHS plan focuses on the overall Federal
incident management of a pandemic, as well as our unique
responsibilities to manage our borders, protect our Nation's critical
infrastructures, ensure the health and safety of the DHS workforce, and
find ways to mitigate the overall economic impact tour Nation.
Since December, DHS work groups comprised of representatives from
across all components of the Department have been working to accomplish
these goals and have been developing contingency planning documents.
The DHS Office of Infrastructure Protection has developed plans and
exercises to maintain the function of the 17 critical infrastructures,
working closely with the private sector and our Federal partners. In
conjunction with its interagency partners, the Department will release
a Critical Infrastructure and Key Resource Pandemic Influenza
Preparedness, Response and Recovery Guide. This guide will assist the
private sector in business continuity planning efforts to cope with
business disruption and high rates of employee absenteeism that would
accompany a pandemic. Our overall incident management workgroup is
developing playbooks with the directorates and components of DHS, and
has focused efforts on synchronizing operation centers from across
Federal and State governments and developing a common operating picture
methodology so that real-time communications are optimized. The
workgroup on Entry and Exit Policy and Border Management has been
working very closely with our Federal partners and the Homeland
Security Council to determine the best policy to delay and limit the
introduction of a pandemic into the U.S. through effective screening of
passengers, travel restrictions and border controls, supporting the
CDC's quarantine stations at our major point of entries, and providing
training to our front line workforce. The Workforce Assurance workgroup
has been working closely with the CDC and the Occupational Safety &
Health Administration to devise scientifically sound policies for
personal protective equipment and training protocols to minimize
disruption to our workforce. They have also been developing contingency
planning for Continuity of Government and Continuity of Operations to
deal with disruptions in our workforce due to absenteeism or caring for
loved ones. The Economic Consequences workgroup has been working with
Federal partners and the National Laboratories to identify and
inventory the economic modeling capacity in order to drive policy
decisions that would minimize economic disruption to our nation during
a pandemic. Examples are policies related to transportation industry,
the flow of trade within and across borders, and maintenance of the
supply chain for food and other goods.
DHS Expenditures: Pandemic Preparedness
As part of the President's supplemental appropriations request to
fund the National Strategy for Pandemic Influenza, DHS received $47.3
million to increase the readiness and response capabilities of the
department in the event of an influenza pandemic. The Supplemental
Funding Plan allocates funds in six key categories that include:
Preparedness Planning: The Plan targets $12 million in
funding for preparedness planning. This effort is aimed at
preparing for the significant implications that a pandemic
influenza would have on the economy, national security and the
basic functioning of society. It includes developing the
capability to anticipate the impact of the disease on
absenteeism across multiple sectors and how this will affect
the continuity of essential functions in support of the Federal
response. Conducting modeling and simulation to predict the
impact of pandemic flu on critical infrastructure; engaging in
international negotiations for screening protocols, procedures
and quarantine authorities; and participating exercises to test
readiness are part of this effort.
Training Development and Deployment: The Plan calls
for $10.7 million to be allocated for the protection of border
and domestic air and maritime travel. These funds will be used
for readiness assessments of high risk airports and ports and
training related to the use of quarantine stations and the
isolation, handling, and transportation of potentially infected
individuals. The experience of HHS and CDC training exercises
will add value to DHS training activities, which will involve
personnel of the U.S. Coast Guard, Immigration and Customs
Enforcement, Transportation Security Administration, and
Customs and Border Protection.
Personal Protective Equipment (PPE): The Plan sets
aside $16 million for the acquisition of PPE for approximately
145,000 high risk and mission critical personnel. DHS will
develop the requirements to provide these personnel with
appropriate PPE and establish respiratory protection programs,
which include respiratory fit testing, medical clearance and
PPE related training.
Rapid Influenza Assay Study: The Plan provides $1.5
million to support system studies and define operational
requirements for a rapid diagnostic tests, working in
coordination with HHS. This test could provide more effective
screening prior to departure and entry, especially in
situations when infected persons may require isolation. This
could have broader applications in the transportation sector,
the workplace, or for continuity of government purposes.
Isolation Systems: The Plan dedicates $4.4 million to
support infrastructure changes and construction of isolation
systems at ports of entry or other major transportation hubs.
Currently the CDC has only 18 quarantine stations among over
320 ports of entry, few of which have adequate facilities for
isolation and containment of infected travelers.
Program Support: The Plan allocates $2.7 million for
technical, management, financial, and integration functions
relating to the implementation of the Plan. This includes the
coordination of requirements from DHS components for workforce
protection, environment, training, staffing restrictions and
protocols as well as documentation and tracking of requirements
and plans.
Conclusion
Since the reorganization of DHS under Secretary Chertoff's 2nd
Stage Review and the formation of the Office of the Chief Medical
Officer, a tremendous amount of our focus has been on pandemic
influenza planning, supplemental budget development and coordination,
coordinating with other Federal agencies on policy matters, and
participating in the writing of the Implementation Plan. DHS senior
officials have been present with HHS at nearly every one of the 50
State Pandemic Summits.
The Department of Homeland Security is in the process of making
recommendations to further clarify the National Response Plan to better
fulfill its incident management role. In collaboration with our
international partners, we are developing screening and containment
procedures to decrease the likelihood of disease spread should
sustained human-to-human transmission occur. We have been working with
our federal government and private sector colleagues to provide
business continuity guidance and recommendations, especially for
critical infrastructure and key resources. Our own plan addresses
workforce protection and continuity of operations.
The challenge to complete an effective contingency plan for DHS and
realize an appropriate response to such a catastrophic incident is
formidable. Carrying out the hundreds of actions in the Implementation
Plan will require significant amounts of time, human resources, and
budgetary resources. Even with the challenges, this effort will be
worth it for the sake of our Nation's biodefense. It has become
apparent that the newly found coordination among State, local and
tribal governments, HHS, DHS, USDA, VA, and DoD, NGOs and the private
sector will put our Nation in much better shape to deal with biological
threats, regardless of whether they are natural or man made. The
collateral benefits of pandemic planning are undeniable and are worth
our department's best efforts and full engagement.
As with any illness, prevention is by far the most cost effective
method for dealing with this disease. We fully support the efforts of
President Bush and the Department of Health and Human Services to
reinvigorate our domestic vaccine production, to stimulate
transformational change in vaccine technology, reinforce the capacity
of State and Local public health organizations and educate the public
on good public health and ways to keep every individual and family
safe.
The best way to prepare for and prevent a pandemic or any major
catastrophic event is to strengthen the institutions that we use every
day, namely public health, medical, and emergency services, as well as
the support of medical science for new vaccines and therapeutics. They
are also avenues to enhancing the quality of health care and the
quality of life in our communities on a daily basis. We look forward to
working with Congress as well as our State and local counterparts to
ensure that the response is as efficient and effective as it can be.
Mr. Linder. Thank you, Dr. Runge.
Dr. Agwunobi.
STATEMENT OF HON. JOHN AGWUNOBI, ASSISTANT SECRETARY FOR HEALTH
AND HUMAN SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES
Dr. Agwunobi. Thank you, Mr. Chairman, and members of the
committee for this opportunity to speak to you on what is a
critically important subject, pandemic influenza preparedness.
Pandemics are a fact of life. They have occurred numerous times
in the past, and they will likely occur in the future.
Our ultimate goal must therefore be to achieve a constant
yet flexible state of national preparedness, an enduring
national ethic of readiness for any and all hazards. If the
next pandemic is anything like the one that we saw in 1918, I
know of no nation that can credibly claim to be ready today.
Much work remains to be done.
Fortunately, some recent modeling shows that with
aggressive nationwide preparedness, exercised readiness and
unhesitant leadership when the alarm sounds, we can manage our
way through a pandemic and greatly reduce its negative impact
on individuals and our community. We will continue to
strengthen our plans as we learn more as science provides us
with information into the future.
In November of 2005, the President released the National
Strategy for Pandemic Influenza and requested $7.1 billion to
fund that strategy; $3.8 billion has already been appropriated,
so improvements to our preparedness are well under way. This
month, the administration released a detailed implementation
plan which delineates 300 specific critical preparedness tasks
for government and the private sector. That implementation plan
identifies HHS very clearly as lead for public health and
medical aspects of preparedness and response in a pandemic. We
will work very closely with our colleagues in DHS in that
regard.
Our efforts to date include stockpiling vaccines, building
additional capacity and researching the vast technology for
vaccine development and manufacturing. Similarly, we are
stockpiling antiviral drugs and searching for new and improved
antiviral alternatives. We are working to further the search
for rapid, accurate, yet portable diagnostic tests, and we are
stockpiling other necessary medical supplies.
But, Mr. Chairman, vaccines and antiviral countermeasures
don't in and of themselves equal preparedness. Our goal to
achieve true readiness must include and does include intra- and
interagency collaboration across this panel and other agencies,
our horizontal and vertical coordination across public health
and medical communities around the Nation, and the continued
strengthening of search capacity across the Nation.
We are also working to enhance surveillance capabilities,
the preparation of families and individuals, the development of
clear and open risk communication strategies, the improvement
of State and local planning and regular exercising of those
plans. At the global level, our efforts include the
strengthening of international public health partnerships and
cooperation, the strengthening of global surveillance for
pandemics and the enhancement of the international ability to
rapidly respond and its capacity.
In conclusion, Mr. Chairman, preparedness is not an
accomplishment. It is a constant endeavor. It consists of
Federal, State and local leaders working in partnership
nationwide. Every sector of society, every individual and every
community must do their part for us to stand as a Nation
prepared.
Pandemic preparedness makes the Nation better prepared for
any and all hazards, it is not just about pandemic influenza.
It will help in both manmade and natural events.
We are better prepared today than we were yesterday, that
is for sure, and we will be better prepared tomorrow than we
are today.
Thank you, Mr. Chairman.
[The statement of Dr. Agwunobi follows:]
Prepared Statement of John O. Agwunobi, M.D.
Mr. Chairman and members of the Committee, I am honored to be here
today to describe for you how the Department of Health and Human
Services (HHS) is working to improve the nation's preparedness for a
potential human influenza pandemic. Thank you for the invitation to
testify on this issue, which is one of our highest priorities at
HHS.Strategy and Threat Assessment
On November 1, 2005, President Bush released the National Strategy
for Pandemic Influenza, which outlines the roles of the Federal
government and sets expectations for State, local, and tribal
governments, private and international partners, and individual
citizens in preparing for and responding to an influenza pandemic. The
following day, Secretary Leavitt announced the HHS Pandemic Influenza
Plan-a blueprint for all HHS pandemic influenza preparedness and
response planning. The HHS Plan provides guidance to national, State,
and local policy makers and health departments with the goal of
achieving national readiness and the ability to respond quickly and
effectively to a pandemic. The HHS plan also includes an outline of key
HHS roles and responsibilities during a pandemic. In the event of a
pandemic, under the National Response Plan, HHS will lead the public
health and medical response with the Department of Homeland Security
carrying out its responsibility for overall domestic incident
management and Federal coordination. However, ultimately, the center of
gravity for such a response will be at the state and local level.
As you know, the President requested $7.1 billion in emergency
funding for the National Strategy for Pandemic Influenza, of which $6.7
billion was requested for HHS. Congress appropriated $3.8 billion as
the first installment of the President's request to begin these
priority activities, and of this amount, $3.3 billion was provided to
HHS. We appreciate the action of Congress on this appropriation as it
takes us an essential step forward to becoming the first generation in
history to be prepared for a possible pandemic.
We must also continue to prepare against a possible pandemic
influenza outbreak. The President's Budget includes $2.3 billion in
funding for the 2007 portion of the emergency funding request to
fulfill the next phase of the Strategy. It is vital that this funding
be allocated in the most effective manner possible to achieve our
preparedness goals, including producing pandemic influenza vaccine for
every American within six months of detection of sustained human-to-
human transmission of bird flu virus; ensuring access to enough
antiviral treatment courses sufficient for 25 percent of the U.S.
population; and enhancing Federal, state and local as well as
international public health infrastructure and preparedness.
The President's FY 2007 budget also requests more than $350 million
for important ongoing pandemic influenza activities at HHS such as
safeguarding the Nation's food supply (FDA), global disease
surveillance (CDC), and accelerating the development of vaccines,
drugs, and diagnostics (NIH).
Pandemics are not new. There were three in the 20th century, the
worst of which was the Spanish flu epidemic in 1918-1919 that is
estimated to have killed over one half million people in the U.S. and
50 million worldwide. While we are focusing today on the impact of the
H5N1 avian flu virus from a strain currently circulating in birds in
many parts of Asia and Europe, many of the policy issues and
preparedness measures that arise for this strain of influenza apply as
well to pandemics of other types of influenza, other emerging
infectious disease outbreaks and public health emergencies. For
example, pandemic preparedness offers tangible benefits in the fight
against seasonal influenza which causes an average of 36,000 deaths
each year.
Scientists cannot accurately predict the severity and impact of an
influenza pandemic, whether from the H5N1 virus or the emergence of
another influenza virus of pandemic potential. However, it is still
useful to model possible scenarios based on analysis of past pandemics.
In a report released in December 2005, the Congressional Budget Office
presented the results of modeling a severe pandemic scenario similar to
the 1918 Spanish flu outbreak and a more moderate outbreak resembling
the flu pandemics of 1957 and 1968. In the severe scenario, roughly 90
million people become ill and 2 million die in the United States and
the impact on the real Gross Domestic Product [GDP] is about a 5
percent reduction in the year following the outbreak. While there is
substantial uncertainty associated with these estimates, they
illustrate the enormous public health threat of an influenza pandemic
and the need for effective access to vaccines, treatments, and a robust
public health infrastructure to meet the challenge.
There are several important points to note about an influenza
pandemic:
A pandemic could occur anytime during the year and is
unlikely to behave like a typical seasonal influenza. Rather,
past pandemics have occurred in multiple "waves" of infection
and could persist in the world for over a year.
In the absence of effective vaccines and antivirals,
the capacity to prevent or control transmission of the virus
once it gains the ability to be efficiently transmitted from
person to person will be limited.
Right now, the H5N1 avian influenza strain that is
circulating in Asia and Europe among birds is a significant
concern, but there is no way to know whether this virus will in
fact lead to a human pandemic. Whether of not the H5N1 adapts
itself to the human host, we know that influenza viruses are
constantly evolving, and it is possible that this strain or
another influenza virus, which could originate anywhere in the
world, could cause the next pandemic. This uncertainty is one
of the reasons why we need to maintain year-round surveillance
of influenza viruses to be able to determine if there are
genetic changes that may signal a potential pandemic, to
develop reference viruses that can be used to develop pandemic
vaccines, and to assess whether influenza viruses have
developed resistance to antiviral drugs. As is the case with
the H5N1 that is currently in birds around the world, pandemic
influenza viruses often emerge in animals. Like other viruses,
they tend to remain within a species. However, as we have seen
already in the more than 200 documented cases of human
infection of H5N1 confirmed by the World Health Organization,
they do have the ability to infect humans who have been exposed
to infected birds. Of greatest concern for human health is the
question of whether the viruses will develop the ability to
readily infect people and whether these viruses will be able to
transmit efficiently from person to person as is the case with
seasonal flu. For all of these reasons, it is critical to
maintain constant surveillance of viruses worldwide affecting
animal populations and that can potentially be transmitted to
humans.
We often look to history in an effort to understand
the impact that a new pandemic might have, and how to intervene
most effectively. However, there have been many changes in
society since the ``great influenza'' of 1918, including
dramatic changes in population and social structures, medical
and technological advances, and a significant increase in
international travel. Some of these changes have increased our
ability to plan for and respond to pandemics, but other changes
may have made us more vulnerable.
HHS Preparations for Pandemic Influenza
As you know, the President announced the Implementation Plan for
the National Strategy for Pandemic Influenza on May 3, 2006. The
purpose of this plan is to ensure that the efforts and resources of the
Federal government and State, local and tribal governments and the
private sector will be brought to bear in a coordinated manner against
the pandemic threat. The Plan describes more than 300 critical actions,
many of which have already been initiated, to address the threat of
pandemic influenza. The Implementation Plan for the National Strategy
for Pandemic Influenza confirms HHS' role as the lead federal agency
for the public health and medical preparation and planning for and
response to a pandemic. The Secretary of HHS will lead the Federal
health and medical response efforts, serve as the primary Federal
spokesperson for pandemic health issues, and coordinate the actions of
other departments and agencies in the overall public health and medical
emergency response efforts. The Secretary of the Department of Homeland
Security (DHS) will provide broader overall incident management for the
Federal response, will ensure necessary support to HHS to coordinate
the public health response, and coordinate with HHS and other Federal,
State, and tribal agencies in providing non-medical support.The timing
of the release of this Plan does not signal that a pandemic is
imminent. The Plan is the result of much work in many Federal
Departments and agencies to further prepare the government for a
pandemic, whenever it might occur. It is important to note that the
H5N1 avian influenza is a disease of birds, the virus has not yet
appeared in the U.S., and there is no influenza pandemic in the world
at this time.
HHS has been working with many Federal agencies, including the U.S.
Department of Agriculture, the Departments of Homeland Security, State
and others, in drafting the public health and medical aspects of the
Implementation Plan for the National Strategy. The Plan spells out over
199 specific tasks that HHS will take the lead in or play a supporting
role in to accomplish the human health aspects of the strategy. It is
important to note that HHS has already started to make progress on many
of the tasks delineated in the plan.
The Department's key tasks outlined in the plan include:
Building stockpiles of pre-pandemic vaccine adequate
to immunize 20 million persons against influenza strains that
present a pandemic threat;
Expanding domestic influenza vaccine manufacturing
surge capacity for the production of pandemic vaccines for the
entire U.S. population within 6 months of a pandemic
declaration;
Building stockpiles of antivirals adequate to treat
25% of the U.S. population, divided between Federal and State
stockpiles;
Building a Federal stockpile of 6 million treatment
courses reserved for domestic containment efforts.
Developing clear guidelines and decision criteria to
assist State, local, and tribal governments and the private
sector in defining groups that should receive priority access
to existing limited supplies of vaccine and antiviral
medications and other critical medical care.
Working with State and tribal entities to develop and
exercise influenza countermeasure distribution plans and to
include the necessary logistical support of such plans,
including security provisions.
Establishing a strategy for deploying Federal medical
providers from across the USG, including expanding and
enhancing programs such as the Medical Reserve Corps and
supporting the transformation of the Commissioned Corps of the
Public Health Service.
Creating plans to rapidly credential, organize, and
incorporate volunteer health and medical providers as part of
the medical response in areas that are facing workforce
shortages.
Supporting local and national efforts to:
establish ``real-time'' clinical surveillance
in domestic acute care settings such as emergency
departments, intensive care units, and laboratories;
link hospital and acute care health
information systems with local public health
departments; and
advance the development of the analytical
tools necessary to interpret and act upon these data
streams in real time.
Establishing a single interagency hub for infectious
disease modeling efforts, and ensuring that this effort
integrates related modeling efforts for transportation
decisions, border interventions, economic impact, etc. HHS will
also work to ensure that this modeling can be used in real time
as information about the characteristics of a pandemic virus
and its impact become available.
Providing guidance to all levels of government on a
range of options for infection control and containment,
including those circumstances where social distancing measures,
limitations on gatherings, or quarantine authority may be an
appropriate public health intervention.
Current HHS Progress
In December 2005, Congress appropriated $3.8 billion to help the
Nation prepare for pandemic influenza preparedness activities. Of that
total, Congress allocated $3.3 billion to HHS for the first year of
funding of the HHS Pandemic Influenza Plan. HHS will use these
emergency funds to help achieve five primary objectives:
1. Monitoring disease spread to support rapid response;
2. Developing vaccines and vaccine production capacity;
3. Stockpiling antivirals and other countermeasures;
4. Coordinating Federal, State and local preparation; and
5. Enhancing outreach and communications planning.
HHS is working both domestically and internationally to monitor the
spread of H5N1 and other possible pandemic viruses. On the
international front, HHS is spending $125 million of its FY 06
allowance to promote international pandemic preparedness and planning
and augment existing capabilities in areas such as international
surveillance, epidemiological investigation, and diagnosis of illness.
Through collaborations with the World Health Organization (WHO), the
United Nations Food and Agriculture Organization, the World
Organization for Animal Health, and numerous national governments, HHS
is working to build capacity in other countries to detect outbreaks
early and to contain the spread of the virus. HHS has signed Memoranda
of Understanding (MOUs) on influenza and other emerging infectious
diseases with Institute Pasteur (IP); the Gorgas Institute and the
Ministry of Health of Panama; and most recently, the International
Center for Diarrheal Disease Research, Bangladesh (ICDDR,B). HHS
experts have participated in WHO-led investigations into human cases of
avian influenza in Indonesia, China, and Turkey and are providing
substantial technical assistance for influenza containment activities
to many other countries on an as needed basis. Overall, HHS is
supporting influenza activities in approximately 40 countries and has
assigned influenza staff to the World Health Organization (WHO)
Secretariat, Regional, and country offices in Europe and Southeast
Asia.
On the domestic front, CDC is devoting $50 million to strengthen
local laboratory capacity and capability and $35 million to accelerate
the implementation of the national BioSense program to enhance our
ability to detect an outbreak early. On January 1, 2006, BioSense RT
(Real-Time) was launched in 10 select cities and 32 healthcare
institutions across the country. Real-time transmission of existing
clinical diagnostic and health information is being sent to CDC and
analyzed. In April 2006, CDC launched a new data visualization and
analysis tool for the use of all jurisdictional levels of public health
(hospital, city, county, state, national). The BioSense implementation
timeline is to link up to several hundred hospitals in over 30 cities
by the end of 2006.
In the event of a pandemic, infection control practices and social
distancing measures (such as school closures, cancellation of public
gatherings, etc), and antiviral drugs will be the first line of defense
before a vaccine is available and could limit and delay the spread of
the pandemic. Currently, the Strategic National Stockpile (SNS) has
over 5 million treatment courses of antiviral drugs on hand. On March
22, Secretary Leavitt announced the purchase of additional antiviral
drugs that could be used in the event of a potential influenza
pandemic. With these purchases, the SNS will have 26 million treatment
courses of antiviral drugs that will be available to the States when an
influenza pandemic is imminent. HHS' strategy is to federally procure
an additional 24 million treatment courses of antiviral drugs through
FY 07 and FY 08 funds and to offer a 25 percent federal subsidy for
state purchase of another 31 million treatments courses. Thus,
additional money will be needed to meet our goal to have enough
antivirals for 25 percent of the population during a pandemic.
Congressional support of $2.3 billion for the second year of the
President's Pandemic Influenza plan will be critical to meet this goal.
The cornerstone of the HHS Pandemic Influenza Plan is to create
domestic manufacturing capacity sufficient to produce 300 million
vaccine courses within 6 months of the onset of a pandemic outbreak,
and to maintain a stockpile of pre-pandemic vaccine. We currently have
approximately 4 million courses of pre-pandemic vaccine against a clade
1 H5N1 avian influenza strain. Plans and procedures are also underway
to manufacture pre-pandemic vaccine against a clade 2 H5N1 avian
influenza strain that is currently circulating the globe.
On May 4, 2006 Secretary Leavitt announced the award of $1 billion
for five contracts to support the development of advanced techniques
using a new cell-based, rather than an egg-based, approach to producing
influenza vaccines. Using a cell culture approach to producing
influenza vaccine is a promising technology and offers a number of
benefits. Vaccine manufacturers can bypass the step needed to adapt the
virus strains to grow in eggs. In addition, cell culture-based
influenza vaccines will help meet surge capacity needs in the event of
a shortage or pandemic, since cells may be frozen in advance and large
volumes grown quickly. U.S. licensure and manufacture of influenza
vaccines produced in cell culture also will provide security against
risks associated with egg-based production, such as the potential for
egg supplies to be contaminated by various poultry-based diseases,
including pandemic influenza strains. Finally, the new cell-based
influenza vaccines will provide an option for people who are allergic
to eggs and therefore unable to receive the currently licensed
vaccines.
A total of $1.7 billion in FY 2006 funding is allocated for vaccine
development to increase vaccine production capacity by accelerating
cell-based manufacturing technology, increasing egg-based vaccine
production capacity, and supporting the advanced development for
antigen sparing technologies that could extend the vaccine supply by
decreasing the amount of antigen needed to protect each individual.
Progress has also been made in the SNS purchase of medical supplies
and equipment essential to pandemic readiness. HHS has purchased over
150 million N95 respirators and surgical masks with approximately $50
million of FY06 funds. Other planned procurements include personal
protective equipment (PPE), ventilators, IV antibiotics, and other
medical supplies. Advanced development for rapid diagnostic tests also
continues through the use of FY06 funds. A request for information
(RFI) was issued for a point-of-care diagnostic on March 30, 2006 and a
request for proposal (RFP) will be issued soon.
State and Local Preparedness
Pandemic influenza preparedness requires the active planning and
participation of States and local communities. If a pandemic were to
occur in the U.S., it would likely affect thousands of communities at
the same time over the course of many weeks. The Federal Government is
working to provide guidance regarding how state, local, and tribal
governments can develop pandemic preparedness plans and respond in the
event of a pandemic. As part of the Administration's effort to enhance
State and local pandemic preparedness, HHS has held pandemic influenza
summits in 47 States and the District of Columbia so far. These summits
have brought together State and local officials, public health,
schools, businesses, and other stakeholders to discuss pandemic
preparedness. With the FY 2006 emergency funding, HHS has awarded $100
million of the $350 million allocated for State preparedness for
pandemic influenza preparedness planning activities. The remaining
portion of these funds will be awarded based on benchmarks that will
measure States' progress.
It is important to note that HHS funding to enhance State and local
preparedness for public health emergencies, including pandemic
influenza, has existed since 2001. Principally through CDC and HRSA
funds have been provided to States and localities to upgrade infectious
disease surveillance and investigation, enhance the readiness of
hospitals and the health care system to deal with large numbers of
casualties, expand public health laboratory and communications
capacities and improve connectivity between hospitals, and city, local
and state health departments to enhance disease reporting.
First, CDC provides preparedness funding annually to public health
departments of all the States, certain major metropolitan areas, and
other eligible entities through cooperative agreements. Second, HRSA
employs complementary cooperative agreements to provide preparedness
funding annually within States for investment primarily in hospitals
and other healthcare entities. HHS collaborates with DHS toward
ensuring that the guidance associated with the CDC and HRSA awards is
coordinated with the guidance associated with those DHS awards that
address other aspects of State and local preparedness, such as
emergency management and law enforcement. Including the funding we have
requested for FY07, CDC and HRSA's total investments in State and local
preparedness since 2001 will total almost $8 billion.
In addition, the ability to quickly increase the number of health
care workers available is a critical component of State and local
public health emergency response capacity. HRSA has supported efforts
to improve personnel surge capacity. Funds are used to allow
jurisdictions to develop or enhance Emergency Systems for Advance
Registration of Volunteer Health Professionals (ESAR-VHP), authorized
under the Public Health Security and Bioterrorism Preparedness and
Response Act. ESAR-VHP is designed to help States develop registries of
volunteer health professionals whose credentials have been verified in
advance of an emergency so that they can be quickly called on and
utilized in an emergency. In addition to the FY07 budget request of $8
million to continue HRSA's registration system, the budget also
proposes development of a web-based portal that would create the means
for integrating the state ESAR-VHP systems into a National system,
thereby promoting a more coordinated national deployment of personnel.
The portal is intended to not only integrate existing state ESAR-VHP
systems, but to also provide a credentialing service that could assist
states with the development of their ESAR-VHP databases. The budget
also proposes to fund a Mass Casualty Initiative, including the Medical
Reserve Corps and Healthcare Provider Credentialing and the
Commissioned Corps Transformation initiatives.
Lastly, effective communications and outreach are essential to
pandemic preparedness at the Federal, State and local levels. President
Bush called for the development of a single, comprehensive web site to
be the official Federal source of pandemic and avian influenza
information. This web site, www.PandemicFlu.gov, includes a wide range
of information on pandemic influenza and preparedness activities. In
addition, HHS has developed a series of checklists intended to aid
preparation for a pandemic in a coordinated and consistent manner
across all segments of society. Thus far, ten checklists have been
released and are aimed at State and local governments, the business
community, the education sector, the health sector, community
organizations, and individuals and families.
Conclusion
Thank you for the opportunity to share this information with you.
Although much has been accomplished, continued vigilance and
preparation are needed for us to be ready for a pandemic. I am happy to
answer any questions at this time.
Mr. Linder. Thank, Dr. Agwunobi.
Dr. Clifford.
STATEMENT OF HON. JOHN CLIFFORD, DEPUTY ADMINISTRATOR FOR
VETERINARY SERVICES, ANIMAL AND PLANT HEALTH INSPECTION
SERVICE, DEPARTMENT OF AGRICULTURE
Dr. Clifford. Chairman Linder, Congressman Dicks, members
of the committee, thank you for the opportunity to testify
before the committee today. The implementation plan for the
National Strategy for Pandemic Influenza takes major components
of the President's National Strategy for Pandemic Influenza and
breaks them down into more than 300 critical actions.
As the primary agency for dealing with the disease in
poultry, the implementation plan directs USDA to play either a
leadership or coordinating role in 98 critical actions.
Examples include continuing our support of efforts overseas to
slow the spread of the disease in poultry, expanding our
domestic surveillance and early warning systems, and ensuring
we have a strong plan in place to respond to protection of high
pathogenic H5N1 in U.S. poultry.
The last department emergency supplemental bill for
pandemic influenza preparedness included $91.35 million for
USDA. We have since been working to ensure that our plans for
using these funds are strategically sound and coordinated with
our many cooperators. We are using approximately $20 million to
help affected countries overseas in collaboration with
international organizations such as the FAO, the World Health
Organization and the OIE, which is the World Organization for
Animal Health.
Domestically, we are using approximately $72 million for a
variety of efforts, including antismuggling programs, continued
research, strengthening wild bird and domestic poultry
surveillance efforts and increases to the current animal
vaccine stockpile.
I would like to focus my remaining time on APHIS's newly
drafted avian influenza response plan. This draft response plan
supports one of USDA's major mandates in the President's
implementation plan, the control and eradication and the
introduction into the United States of highly pathogenic avian
influenza. This plan would guide the steps taken by the USDA
and our State and industry partners following the detection of
high path H5N1 in domestic poultry.
USDA has in place a robust emergency response program
designed to complement all of our surveillance efforts. In
conjunction with our colleagues, APHIS maintains State level
emergency response teams. These teams would typically be on
site within 24 hours of the initial examination and diagnosis
or presumptive diagnosis of avian influenza or any other
significant foreign animal disease.
Destruction of the affected flocks would be our primary
concern and course of action. The response plan also provides
guidelines as to how APHIS would work with States to quarantine
affected premises and clean and disinfect those premises after
birds have been depopulated and disposed.
Surveillance testing would also be conducted in the
quarantine zone and surrounding area to be sure that the virus
is completely eradicated. The response plan focuses on quickly
containing and eradicating the virus before it has a chance to
spread further in poultry population. It draws on our real
world experience in handling avian influenza viruses, as well
as our ongoing partnerships with Federal agencies, State
agricultural departments, State veterinarians, the poultry
industry and the conservation and wildlife communities. The
plan is designed to be flexible and does not supersede any
State response plans. The response plan will be an evolving
document and takes into consideration the latest scientific
information and approaches to emergency preparedness and
response.
I would like to close by offering a few important thoughts.
First, just like in people, there are many strains of
influenza that affect birds with varying degrees of impact and
importance.
Second, the detection of high path H5N1 virus circulating
overseas in birds found here in the U.S. would not indicate a
start of a human pandemic.
Third, a detection in wild birds does not mean the virus
will reach a commercial poultry operation. We are certainly
preparing as if it will. But the U.S. poultry industry employs
a very sophisticated program of firewalls to protect the safety
of their product.
Fourth, even if a virus reaches a commercial poultry
operation, there is no reason for consumers to be concerned
about the safety of poultry that they purchase and eat.
Finally, when it comes to food safety, consumers have the
power to protect themselves. Proper handling and cooking of
poultry kills a virus as well as other foodborne pathogens.
Properly prepared poultry is safe.
Thank you again for the opportunity to testify before the
committee today.
[The statement of Dr. Clifford follows:]
Prepared Statement of Dr. John Clifford
Chairman King, Ranking Member Thompson, thank you for the
opportunity to testify before the Committee this afternoon. My name is
Dr. John Clifford and I am the Deputy Administrator for Veterinary
Services with the Department of Agriculture's (USDA) Animal and Plant
Health Inspection Service (APHIS). In this position, I also serve as
USDA's Chief Veterinary Officer.
USDA appreciates your interest in our efforts to ensure that
preparedness for a potential introduction of highly pathogenic H5N1
avian influenza virus into the U.S. poultry population remains high. I
also welcome the opportunity to provide you with information on our
roles and responsibilities under the Implementation Plan for the
National Strategy for Pandemic Influenza.
National Implementation Plan for Pandemic Influenza
On May 3, 2006, President Bush announced his Implementation Plan
for the National Strategy for Pandemic Influenza. The focus of the
Implementation Plan is to ensure that the efforts and resources of the
Federal government are being brought to bear in a coordinated manner
against the pandemic threat.
The Implementation Plan takes the major components of the
President's National Strategy for Pandemic Influenza and breaks them
down into more than 300 critical actions--many of which have already
been initiated. The Plan directs involved Federal agencies to carry out
these critical actions within prescribed amounts of time. The Plan is
helping to ensure that the Federal government, along with our State and
local partners and industry, continues to take appropriate steps in
preparation for a possible influenza pandemic in the country.
I want to stress that this disease, first and foremost, continues
to affect birds. However, we know it has caused acute illness in people
who have had direct contact with sick or infected birds, with about
half of these human cases resulting in death. We know that the virus,
through mutation, could present a much greater risk to human health
worldwide. So, there are both animal health and human health aspects of
the Federal government?s preparations.
As the President's Implementation Plan makes clear, these
preparations are being closely coordinated among several departments,
as well as with State and local governments and industry. USDA is the
primary agency in terms of dealing with the disease in poultry. The
Implementation Plan directs USDA to play either a leadership or
coordinating role in 98 critical actions. These include initiatives
such as continuing our support of the coordinated efforts overseas to
slow the spread of the disease in poultry and expanding our domestic
surveillance and early warning systems while ensuring we have a strong
plan in place to guide, along with our partners, the swift, decisive
response to any eventual detection of highly pathogenic H5N1 avian
influenza in poultry here in our country.
A few examples of USDA's critical actions under the Implementation
Plan include:
Supporting the testing of all broiler flocks in the
United States for avian influenza and, more broadly,
strengthening surveillance across the board for the disease in
other segments of the poultry industry, as well as migratory
birds.
USDA's National Veterinary Stockpile is strategically
storing ``strike packs'' containing personal protective
equipment supplies designed to protect response personnel from
influenza viruses. These strike packs can be deployed within 24
hours to the site of an outbreak in the United States.
USDA recently posted to its avian influenza website a
draft summary of the National Avian Influenza Response Plan.
Once finalized, this plan will comprehensively guide the
aggressive steps that will be taken by USDA and our State and
industry partners following a detection of highly pathogenic
H5N1 avian influenza in domestic poultry.
Providing expertise and funding to assist the United
Nation's Food and Agriculture Organization (FAO) with a new
Crisis Management Center to enhance the coordinated response to
detections of highly pathogenic H5N1 avian influenza worldwide.
USDA training has been provided on incident command system
structures, communications, and deployment procedures. We
expect that the command center will be operational in the very
near future.
I will touch more on these and other USDA critical actions in a few
moments. But first I would like to stress that as we work to complete
these efforts in the coming weeks and months, USDA will continue to use
a four-pronged approach to combating avian influenza. First, we are
focused on slowing the spread of this disease offshore by supporting
other nations affected with this virus through robust support to the
International Partnership on Avian and Pandemic Influenza and by
adopting a coordinated approach to work with affected countries through
the FAO and the World Organization for Animal Health (OIE). Second, we
are conducting a proactive messaging campaign designed to educate the
American public and poultry owners on this animal disease. We want to
inform while not alarming. A third pillar of our doctrine is an
aggressive surveillance program that focuses on four key areas: wild
bird surveillance; commercial poultry operations; live bird markets;
and backyard flocks. The fourth and final pillar of our doctrine is,
when necessary, to execute our response and containment plans. USDA has
a long and successful history of dealing with foreign animal diseases
and, in particular, handling avian influenza. These successful efforts
are due in large part to the high degree of cooperation we have
undertaken with our State animal health colleagues, industry, and other
Federal agencies.
I want to emphasize to the Committee that in taking this multi-
faceted approach, we are not waiting for the virus to reach our shores
before we begin coordinating our preparedness and response efforts with
our partners. We know that the threat is real and that the virus could
potentially arrive in our country via migratory birds. Therefore, many
important planning and coordination efforts are already well underway.
Our strategy, again, is that we are preparing as if the virus will
reach U.S. poultry, while taking measures where possible to slow its
spread overseas and, where and when we can, prevent its entry through
pathways that we can address. I believe this approach is the right one
to take, and will pay off greatly in the event this highly pathogenic
H5N1, or another serious avian influenza virus, reaches our country.
Summary of Pandemic Influenza Supplemental Funding for USDA
Last December, Congress approved, and President Bush signed into
law, an emergency supplemental funding bill for pandemic influenza
preparedness that included $91.35 million for USDA. Since that time, we
have been working expeditiously to ensure that our plans for using
these funds are strategically sound and fully coordinated with our many
international, Federal, State, local, and industry cooperators. We have
taken these responsibilities so seriously, in fact, that we have
utilized USDA's and APHIS' emergency operations centers to coordinate
our efforts. Our animal health officials have also worked under an
incident command structure to maximize their communications, planning,
and logistical capabilities.
Let me quickly summarize the international and domestic initiatives
funded by supplemental appropriations, all of which are also included
as critical actions in the Implementation Plan.
On the international front, we are using approximately $20 million
to help affected countries overseas in collaboration with international
organizations. Again, we are participating in a coordinated effort by
the various interested U.S. Government agencies, led by the Department
of State, to work with affected countries through the Food and
Agriculture Organization of the United Nations (FAO), the World Health
Organization (WHO), and the World Organization for Animal Health (OIE).
We have developed a coordinated approach to work with affected
countries through the FAO and the OIE. This plan calls for the OIE to
lead and coordinate robust, consistent assessments of veterinary
service capacity in developing countries reporting cases of the H5N1
virus. This would also entail evaluating H5N1 eradication and control
plans in affected and at-risk countries. These assessments will form
the basis for carefully planned attempts to improve animal health
services capacity, using a range of support mechanisms including
international financial assistance and technical and other support from
the private and public sectors. Countries, like the United States, with
proven expertise in these areas would also provide personnel for
assessment teams that will travel to countries and provide on-the-
ground recommendations and assistance. Then, ultimately, a prioritized
list of needs for specific regions of the world would be produced to
further direct program coordination and resources to the most at-risk
areas. The FAO will coordinate these infrastructure improvements
efforts globally, regionally, and in affected countries with local
authorities.
On the domestic front, we are utilizing approximately $72 million
from the emergency supplemental appropriation, in part, to:
Enhance smuggling interdiction and trade compliance
($9 million);
Continue research and development of improved tools
like vaccines, genome sequencing; environmental surveillance
and biosecurity measures ($7 million);
Enhance surveillance of wildlife/bird flyways ($18
million);
Strengthen other domestic surveillance and diagnostics
(about $18 million);
Increase the current animal vaccine stockpile and
stock other response supplies ($10 million);
Enhance planning, equipment, and preparedness
training, and the development of simulation models ($9
million); and
Improve a variety of other preparedness activities ($1
million)
USDA has been engaged in avian influenza response efforts for
decades. We have much real-world experience dealing with the disease--
both the low pathogenic and highly pathogenic forms. Based on that
experience, we are focusing our resources where they are most needed.
Surveillance and Detection
A 1983 outbreak of highly pathogenic avian influenza was the
largest incident of the disease in this country, ultimately resulting
in the destruction of 17 million birds in Pennsylvania and Virginia to
eradicate the virus. By contrast, a 2004 outbreak in Texas was quickly
isolated to a flock of 6,600 birds and eradicated.
The disease detection in Texas underscores just how critical
effective biosecurity measures, stringent surveillance, timely
reporting, and swift control, eradication, and disinfection are to an
effective emergency response. We are striving to bolster all of these
capabilities through our plan for using the emergency supplemental
funding, as well as by meeting our requirements under the Pandemic
Influenza Implementation Plan.
I believe we are in an excellent position to accomplish this goal
today because of the partnerships we have forged with State animal
health officials and the poultry industry over the years. Several
programs are helping to foster close relations with States and
industry. One of them is the longstanding National Poultry Improvement
Plan (NPIP), a cooperative Federal-State-industry program designed to
enhance the health and marketability of commercial U.S. poultry. The
other is our new low-pathogenic avian influenza program, designed to
increase surveillance efforts for the low-pathogenic H5 and H7 strains
of the disease in commercial flocks and the live bird marketing system.
These strains, if left unaddressed, have the potential to mutate into a
more virulent disease. Both of these programs are serving as
springboards as we enhance surveillance efforts, enter into additional
cooperative agreements with States, and tighten our emergency response
plans.
We are using approximately $5.9 million for the NPIP cooperative
effort to enhance the testing of commercial flocks--broilers, layers,
turkeys, and their respective breeding flocks--for avian influenza
viruses of concern. The supplemental also includes $2.9 million for
surveillance by USDA's National Veterinary Services Laboratories
(NVSL). This funding will allow NVSL to provide support to approved
laboratories for the processing of samples. This includes all segments
of the surveillance program for H5N1, including samples collected from
wildlife, commercial poultry, and the live bird marketing system in the
United States.
This funding will also allow NVSL to develop and contract out the
production of agar gel immunodiffusion (AGID) testing reagents to be
distributed at no charge to laboratories approved to participate in the
surveillance effort. In this way, we will meet the poultry industry's
desire to test all broiler flocks in the United States for avian
influenza and, more broadly, surveillance across the board will be
strengthened.
Migratory Bird Surveillance
Another area where we have taken steps to obtain better information
regarding any potential disease threat to U.S. poultry is migratory
bird surveillance. Wild birds, in particular certain species of
waterfowl and shorebirds, are considered to be the natural reservoirs
for many common, relatively harmless strains of avian influenza. We
also know that migratory birds have been implicated, to some degree, in
the spread of the disease overseas.
On March 20, 2006, the Departments of Agriculture, the Interior,
and Health and Human Services released an inter-agency strategic plan
that expands the monitoring of migratory birds in the United States for
the highly pathogenic H5N1 virus and establishes common protocols for
testing birds and tracking the data.
``An Early Detection System for H5N1 Highly Pathogenic Avian
Influenza in Wild Migratory Birds--U.S. Interagency Strategic Plan''
reflects the best possible scientific information on the highly
pathogenic H5N1 virus and the migratory patterns of wild birds. In
addition, the plan draws on ongoing partnerships with State and private
wildlife experts, animal health experts, as well as public health
officials.
The plan targets bird species in North America that have the
highest risk of being exposed to, or infected with, highly pathogenic
H5N1 because of their migratory movement patterns. Key species of
interest include ducks, geese, and shorebirds.
Personnel from USDA, Department of the Interior, State wildlife
agencies, and other cooperators will work closely to obtain samples and
test them for avian influenza viruses of concern.
Under the new enhanced surveillance program for migratory birds,
APHIS officials began sampling efforts in Alaska in late April. I would
note here that between 1998 and 2005, USDA's Agricultural Research
Service and the University of Alaska partnered to test some 12,000
samples taken from wild migratory birds in Alaska for avian influenza
viruses of concern. All these samples were negative for these viruses
of concern to us.
In other areas under the enhanced migratory bird surveillance plan,
APHIS has also begun sampling Eastern wild turkeys in collaboration
with the Vermont Fish and Wildlife Department. And just last week, our
National Wildlife Research Center began processing environmental water
and fecal samples collected from areas of Alaska that harbor high-risk
waterfowl and shorebirds. Other states will begin collecting similar
high-risk environmental samples in June based on migration patterns.
Import Restrictions and Anti-Smuggling Efforts
There are other important efforts USDA has employed to keep the
H5N1 virus and others out of the United States. As a primary safeguard,
APHIS maintains trade restrictions on the importation of live poultry,
birds, and unprocessed poultry products from all affected countries.
Heat-treated poultry meat and eggs from countries with highly
pathogenic avian influenza are considered eligible for importation from
countries with equivalent meat inspection systems. Imports of live
birds, poultry and unprocessed poultry products may resume after APHIS
has completed a regionalization analysis that identifies the entire
country or zone within the affected-country as disease-free. Import
permits must accompany properly sanitized products, such as feathers.
APHIS' Smuggling, Interdiction, and Trade Compliance (SITC) teams,
as well as our colleagues with the Department of Homeland Security's
Customs and Border Protection, have been alerted and are vigilantly on
the lookout for any poultry or poultry products that might be smuggled
into the United States from any of the affected countries. In the
coming weeks, APHIS port veterinarians will make presentations to CBP
officials at numerous high-traffic U.S. ports of entry to ensure that
inspectors are reminded of the protocols for handling live birds they
intercept, as well as have accurate contact information for any related
questions or concerns. Additionally, USDA quarantines and tests
imported live birds from countries (excluding Canada) not known to have
cases of infection to make sure that pet birds and other fowl do not
inadvertently introduce disease into the United States.
I'd like to point out that APHIS' SITC program is responsible for
intelligence gathering and other anti-smuggling activities, such as
secondary market and warehouse inspections, that help prevent animal
and plant pests and diseases from entering the United States. As I
said, SITC has increased its targeting of illegal shipments of birds or
bird products that could potentially carry the highly pathogenic H5N1
avian influenza virus, as well as its partnering with other Federal
agencies and law enforcement personnel. Thus far in fiscal year 2006,
SITC has already contributed to 63 separate seizures of prohibited
products from countries reporting detections of the highly pathogenic
H5N1 virus. These seizures total more than 135,000 pounds of prohibited
poultry products that, again, could pose a risk of harboring the H5N1
virus, or other serious poultry diseases.
The Draft National Avian Influenza Response Plan
Now that I have touched on our plans to slow the spread of the
highly pathogenic H5N1 virus overseas, exclude its entry into the
United States through trade restrictions and anti-smuggling programs,
and bolster domestic surveillance, I'd like to update you on our plans
for responding to a detection of any highly pathogenic avian influenza
in commercial poultry.
Again, our ability to respond swiftly is linked directly to the
strong cooperative efforts APHIS is engaged in with States and industry
relative to avian influenza. The U.S. Poultry and Egg Association
convened an industry-wide meeting in Atlanta, Georgia, on April 27, to
facilitate dialogue with State and USDA officials regarding the many
operational, policy, and communications issues related to our
cooperative avian influenza preparedness efforts. Many of APHIS' senior
animal health staff attended the meeting, which was, I believe,
extremely beneficial to all who attended.
Prior to the poultry industry meeting in Atlanta, APHIS posted to
its website a draft summary of the National Avian Influenza Response
Plan. This draft response plan supports one of USDA's major mandates in
the President's Implementation Plan--the control and eradication of an
introduction into the United States of highly pathogenic avian
influenza.
The draft response plan would guide the steps taken by USDA and our
State and industry partners following a detection of highly pathogenic
H5N1 avian influenza in domestic poultry. It reflects USDA's scientific
expertise on highly pathogenic avian influenza viruses, as well as our
real world experience in planning for, and responding to, incursions of
significant animal diseases into the United States.
In addition, the plan draws on our ongoing partnerships with other
Federal agencies, State Agriculture Departments, State Veterinarians,
the poultry industry, and the conservation and wildlife communities. In
this way, the plan is designed to be flexible and does not supersede
any State response plans. Rather, it complements such plans already in
existence, or under development.
As a result of tabletop exercises and numerous meetings and
discussions with our partners, the response plan incorporates much
positive feedback. In releasing a summary of the draft document and
posting it online, we fully expect further review and comment by
stakeholders. In this way, we intend for the response plan to be an
evolving document that takes into account the latest scientific
information and approaches to emergency preparedness and response.
Let me elaborate a bit further on the Response Plan. USDA has in
place a robust emergency response program designed to complement all of
our surveillance efforts. When we have unexpected poultry, or for that
matter livestock, illnesses or deaths on a farm, we immediately conduct
a foreign animal disease investigation. We have a cadre of specially
trained veterinarians who can be on site within four hours to conduct
an initial examination and submit samples for additional laboratory
testing. Also, the Departments of Health and Human Services and Labor
are providing occupational health guidance on the use of personal
protective equipment and antiviral prophylaxis treatments to USDA and
other departments that have personnel in direct contact with live
infected or dead poultry.
In conjunction with our State colleagues, APHIS maintains State-
level emergency response teams on standby. These teams will typically
be on site within 24 hours of the initial examination and diagnosis of
a presumptive diagnosis of avian influenza or any other significant
foreign animal disease. Destruction of the affected flocks would be our
primary concern and course of action. We would also work with States or
tribes to possibly impose State-level quarantines and movement
restrictions.
For highly pathogenic avian influenza as well as for low pathogenic
H5 and H7 subtypes, the Response Plan provides guidelines as to how
APHIS would work with States to quarantine affected premises and clean
and disinfect those premises after the birds have been depopulated and
disposed. Surveillance testing would also be conducted in the
quarantine zone and surrounding area to ensure that the virus has been
completely eradicated.
I would like to note here that APHIS also maintains a bank of avian
influenza vaccines for animals in the event that the vaccine would be a
potential course of action in any outbreak situation. Funding included
in the emergency request will augment the current animal vaccine bank
by an additional 40 million doses. This expansion of the animal vaccine
bank to approximately 100 million doses of avian influenza vaccine will
be critical in the event of a large-scale avian influenza situation in
the United States.
I need to stress here, however, that wide-scale vaccination of
poultry is not our primary strategy against avian influenza. Rather,
poultry vaccination could be used in response to widespread detection
of the disease in the United States to create barriers against further
spread and assist with our overall control and eradication measures.
The Response Plan's focus, first and foremost, is on quickly
containing and eradicating this virus before it has the chance to
spread further in the poultry population.
Communications
I also want to emphasize that for the last several years APHIS has
conducted a major outreach campaign called ``Biosecurity for the
Birds.'' The campaign places informational materials directly into the
hands of commercial poultry producers, as well as those raising poultry
in their backyards. All of the brochures and fact sheets are available
in several languages and emphasize the need for good biosecurity and
disease surveillance programs to reduce the possibility of bringing any
disease, not just avian influenza, on the farm or into their backyard.
The campaign also encourages producers to report sick birds, thereby
increasing surveillance opportunities for avian influenza.
We also recognize that an essential part of a successful emergency
response program is effective communication with the media and the
public. This is especially important given the concern right now
regarding avian influenza and potential risks to human health. To be
prepared in the event of a detection, USDA has been coordinating
closely with its counterparts at other Federal agencies, State
Agriculture Departments, and industry organizations to ensure, when the
time comes, consistent messages regarding the strain of the disease
found, the steps being taken in response, and the potential effects to
poultry and, if appropriate, human health. USDA officials have also
participated in numerous government-wide tabletop exercises with a
focus on avian influenza. Coordination will be vital to our ability to
deliver important information, while maintaining public confidence in,
among other things, the food supply and public health system. Our draft
National Avian Influenza Response Plan includes a detailed
communications plan that will guide our efforts in these areas.
Conclusion
Allow me to close by offering a couple of thoughts that I believe
are absolutely central to our discussion today. These points are also a
critical part of understanding the broader context in which I believe
avian influenza should be viewed.
First, just like in people, there are many strains of influenza
that affect birds, with varying degrees of impact and importance.
Second, a detection of the highly pathogenic H5N1 avian influenza
virus circulating overseas in birds here in the United States does not
signal the start of a human pandemic. This virus is not easily
transmitted from person to person. As I said, almost all of the human
illnesses overseas were the result of direct contact with sick or dead
birds.
Third, a detection in wild birds does not mean the virus will reach
a commercial poultry operation. We are certainly preparing as if it
will, but the U.S. poultry industry employs a very sophisticated system
of firewalls to protect the safety of their product. In addition, the
wild migratory bird surveillance plan is serving as an early warning
system for commercial poultry operations.
Fourth, even if the virus reaches a commercial poultry operation,
there is no reason for consumers to be concerned about the safety of
the poultry that they purchase and eat, as long as the poultry is
properly handled and cooked. Again, I believe that our state of
readiness for a detection in commercial poultry is high, and our
Response Plan would guide a swift, comprehensive response designed to
minimize further spread of the disease.
Finally, I want to stress again that when it comes to food safety,
consumers have the power to protect themselves. Proper handling and
cooking of poultry, quite simply, kills this virus and other food-borne
pathogens. Properly prepared poultry is safe. To reinforce this message
in the event of an outbreak in domestic poultry, the Federal government
will provide supplemental guidance on food preparation and public
health protection through a robust communications plan.
Thank you again for the opportunity to testify before the Committee
today. I will be happy to answer your questions.
Mr. Linder. Thank you, Dr. Clifford.
Mr. Verga.
STATEMENT OF HON. PETER F. VERGA, DEPUTY ASSISTANT SECRETARY OF
DEFENSE FOR HOMELAND DEFENSE, DEPARTMENT OF DEFENSE.
Mr. Verga. Mr. Chairman, distinguished members of the
committee. I will also thank you for the opportunity to address
you today regarding Department of Defense's role in preparing
for and responding to a possible outbreak of a pandemic
influenza. I am joined today by Ms. Ellen Embry, who is our
Deputy Assistant Secretary of Defense for Force Health
Protection and Lieutenant Colonel Antonio Aragon of the Joint
Staff.
On Monday, March 11, 1918, as the United States continued
to mobilize for the war in Europe, an Army private named Albert
Gitchell reported to the camp hospital at Fort Riley, Kansas
complaining of a fever, sore throat and a headache. By noon
that same day, the camp's hospital had seen well over 100
soldiers with similar symptoms, and by week's end, the number
had jumped to 500. The pandemic influenza of 1918, which killed
some 675,000 people in the United States and over 40 million
worldwide, had begun.
The effects of the 1918 influenza pandemic on the U.S.
military were devastating. Of all the U.S. servicemen who died
in Europe during World War I, approximately half of them, about
43,000, fell to the influenza virus and not the enemy. As the
servicemen gathered together to train for war, they unknowingly
spread the virus that would eventually take so many lives.
Entire units already shipping out to Europe were already
showing the effects of the virus, while servicemen on the front
became too sick to fight. The flu eventually devastated both
sides of the conflict, and some believe that the virus killed
more servicemen than weapons of war.
The lessons of the 1918 worldwide influenza pandemic figure
predominantly in global planning efforts made in preparation
for the potential threat from an avian influenza pandemic.
As noted, the National Strategy for Pandemic Influenza was
published, and additionally, on May 3, 2006, the Federal
Government published an implementation plan for that national
strategy which details Federal Government preparedness and
response efforts. These documents provide a blueprint for a
coordinated national response to an influenza pandemic.
Today I will focus on the Department of Defense's
preparations for and response to a potential outbreak, which
could have consequences similar to those of the catastrophic
1918 pandemic. I will also address ongoing preparations within
DOD to respond more broadly to a pandemic outbreak and not just
the threat of an H5N1 strain.
That national strategy was developed to guide our
preparedness and response to a pandemic with the intent of
stopping, slowing or otherwise limiting the spread, limiting
the spread of the pandemic and mitigating disease, suffering
and death, and sustaining infrastructure and mitigating impact
of the economy and the functioning of society.
The strategy has three pillars, preparedness and
communication activities that should be undertaken before a
pandemic; surveillance and detection of domestic and
international systems to provide continuous situational
awareness; and response and containment, actions to limit the
spread of the outbreak among humans and to mitigate the health,
national security, social and economic impacts.
Preparing for and responding to pandemic influenza or any
other threat, requires an active layered defense to integrate
seamlessly U.S. government capabilities in the forward regions
of the world, the approaches to U.S. territory, and within the
United States. The effort will also include assisting partner
countries to prepare for and detect an outbreak, respond should
an outbreak occur, and manage the key second order of effects.
There are four planning priorities in the implementation
plan: protection of the health and safety of personnel;
determination of essential functions and services and
maintenance of those; support of the Federal response to a
pandemic; and effective communications. The DOD implementation
plan addresses each of these planning priorities in alignment
with the pillars of the national strategy.
The top priority within the Department is maintaining
operational capability by protecting DOD forces. We must do
this in order to execute our primary mission of defense of the
homeland. In addition, DOD has a large supporting role in the
national and international response to a pandemic influenza.
The national strategy directs the Department, along with other
departments and agencies, to examine ways to support the
government-wide response.
DOD has identified 19 critical tasks that the Department
will perform to provide protection of personnel, mission
assurance and the support to civil authorities, both foreign
and domestic. These tasks include, among others,
biosurveillance, disease detection, interagency planning
support, communications support, the maintenance of civil
order, continuity of operations in government and the support
of international allies and nongovernmental organizations. Our
five geographic combatant commanders around the world are also
developing more detailed plans in their areas of
responsibilities.
In a very unique and tragic way, Army Private Albert
Gitchell continues to significantly influence DOD's efforts to
respond to pandemic influenza. By understanding the effect of
the 1918 influenza pandemic on the U.S. military, we can better
forecast the potential effects on our current operations and
take prudent steps to minimize the potential impact on our
fighting force as well as our Nation.
Mr. Chairman, the efforts that are under way to prevent an
outbreak of pandemic influenza are a testament to the
leadership at the Federal level and superb coordination and
cooperation among Federal, State, local, tribal and
nongovernmental organizations and international organizations,
including our allies.
The Department of Defense is prepared to both combat the
spread of a potentially catastrophic flu pandemic within the
United States military and provide support to national and
international organizations in their efforts to fight this
disease.
I thank you for your leadership on this issue and for the
opportunity to appear before you today. I welcome any questions
you may have.
[The statement of Mr. Verga follows:]
Prepared Statement of Peter F. Verga
Introduction
Chairman King, Ranking Member Thompson, and distinguished members
of the subcommittee: thank you for the opportunity to address you today
regarding the Department of Defense's role in preparing for, and
responding to, a possible outbreak of pandemic influenza.
On Monday, March 11, 1918, as the United States continued to
mobilize for war in Europe, Army Private Albert Gitchell reported to
the camp hospital at Fort Riley, Kansas, complaining of fever, sore
throat, and a headache. By noon that same day, the camp's hospital had
seen well over 100 soldiers with similar symptoms. By week's end, that
number had jumped to 500. The influenza pandemic of 1918, which killed
675,000 people in the United States and 40 million people worldwide,
had begun.
The effects of the 1918 influenza pandemic on the U.S. military
were devastating. Of all the U.S. servicemen who died in Europe during
World War I, approximately half of them, an estimated 43,000
servicemen, fell to the influenza virus and not to the enemy. As the
servicemen gathered together to train for war, they unknowingly spread
the virus that would eventually take so many lives. Entire units
shipping out to Europe were already showing the effects of the virus
while servicemen on the front became too sick to fight. The flu
eventually devastated both sides of the conflict--some believe the
virus killed more servicemen than the weapons of war.
The lessons from the 1918 worldwide influenza pandemic figure
prominently in the extraordinary global planning efforts made in
preparation for the potential threat from an avian influenza pandemic.
On November 1, 2005, President Bush announced the publication of the
National Strategy for Pandemic Influenza. Additionally, on May 3, 2006,
the Federal government published the Implementation Plan for the
National Strategy for Pandemic Influenza, which details the Federal
government's preparedness and response efforts for a pandemic influenza
scenario. These documents provide a blueprint for a coordinated
national response to an influenza pandemic.
My testimony today will focus on the Department of Defense's
preparations for and response to a potential outbreak of avian
influenza, which could have consequences similar to those of the
catastrophic 1918 pandemic. I will also address ongoing preparations
within DoD to respond more broadly to a pandemic influenza outbreak,
and not just the current threat posed by the H5N1 strain of the avian
influenza.
National Strategy for Pandemic Influenza and the Implementation Plan
for the National Strategy for Pandemic Influenza
The National Strategy for Pandemic Influenza was developed to
``guide our preparedness and response to an influenza pandemic with the
intent of (1) stopping, slowing or otherwise limiting the spread of a
pandemic to the United States; (2) limiting the spread of a pandemic
and mitigating disease, suffering, and death; and (3) sustaining
infrastructure and mitigating impact to the economy and the functioning
of society.'' The National Strategy uses three pillars to guide and
enhance preparedness and further directs the development of Federal
implementation plans in order to support the tenets of the National
Strategy.
The three pillars of the National Strategy are:
Pillar #1: Preparedness and Communication--These are
activities that should be undertaken before a pandemic to
ensure preparedness and the communication of roles and
responsibilities to all levels of government, segments of
society, and individuals.
Pillar #2: Surveillance and Detection-- These are the
domestic and international systems that provide continuous
``situational awareness'' to ensure the earliest warning
possible of outbreaks among animals and humans to protect the
population.
Pillar #3: Response and Containment--These are the
actions to limit the spread of the outbreak among humans and to
mitigate the health, national security, social, and economic
impacts of a pandemic.
In addition to the National Strategy, the Federal Government
recently released the Implementation Plan for the National Strategy for
Pandemic Influenza. This document provides a framework to the National
Strategy, assigns preparedness and response tasks to Federal
departments and agencies, and describes U.S. Government expectations of
non-Federal entities, including State, local, and tribal governments,
the private sector, international partners, and individuals. The
Implementation Plan translates the National Strategy into over 300
tasks to achieve the goals of the National Strategy.
DoD's Implementation of the National Strategy for Pandemic Influenza
Preparing for and responding to a pandemic or pandemic influenza,
or any other threat, requires an active, layered defense. This posture
is global in scope and seeks to integrate seamlessly U.S. government
capabilities in the forward regions of the world, in the approaches to
the U.S. territory, and within the United States. This effort will also
include assisting partner countries to prepare for and detect an
outbreak, to respond should an outbreak occur, and to manage the key
second-order effects that could lead to an array of challenges.
Under the Implementation Plan, Federal departments and agencies,
including DoD, focus on four Federal planning priorities: (1)
protection of the health and safety of personnel and resources; (2)
determination of essential functions and services and the maintenance
of each; (3) support the Federal Response to a Pandemic; and (4)
effective communications. DoD's Implementation Plan addresses each of
the planning priorities, in alignment with the three pillars of the
National Strategy.
The top priority within DoD is the protection of DoD forces, which
are composed of the uniformed military, DoD civilians, and contractors
performing critical roles, as well as the associated resources
necessary to maintain the readiness of the Total Force. Of equal
importance is our ability to execute our primary mission of the defense
of our homeland. Priority consideration is also given to protecting the
health of DoD beneficiaries and family members, who rely upon military
treatment facilities and on private health care providers.
In addition to the protection of DoD forces, DoD has a supporting
role in the national and international response to a pandemic
influenza. The National Strategy directs DoD, along with all other
Federal departments and agencies, to examine ways to support a
government-wide response to a pandemic. DoD is developing plans to
utilize its medical surveillance and laboratory testing facilities
abroad to provide early warning and tracking of a pandemic influenza.
Potentially, the military could provide transportation of essential
resources with its air and ground transportation assets. National Guard
units and members--to whom the Posse Comitatus Act does not apply when
in State Active Duty or Title 32 status--could provide security for the
protection and distribution of pharmaceuticals. Another potential
support role for DoD could be the provision of surge medical capability
such as health and medical care providers.
DoD has identified 19 critical tasks that the Department will
perform to provide protection for its personnel, mission assurance, and
support to civil authorities, both foreign and domestic, in response to
a pandemic influenza outbreak. These tasks are already driving the
shape and content of joint training, military exercises, and
coordination with interagency partners. These tasks include:
Medical intelligence
Force Protection (including Force Health Protection)
Biosurveillance, disease detection, and information
sharing
Interagency planning support
Surge medical capability to assist civil authorities
Medical care to U.S. forces
Patient transport and strategic airlift
Installation support to civilian agencies
Bulk transport of pharmaceutical/vaccines/commodities
Security in support of pharmaceutical/vaccine
production and distribution
Protect defense critical infrastructure
Communications support to civil authorities
Quarantine assistance to civil authorities
Military assistance for civil disturbances
Mission assurance: Defense Industrial Base
Mortuary affairs
Continuity of operations/government
Support to international allies and non-governmental
organizations
Public affairs support to civil authorities
Additionally, the five geographic combatant commanders (U.S.
Northern Command, U.S. Southern Command, U.S. Pacific Command, U.S.
Central Command, and U.S. European Command) are developing more
detailed plans to protect DoD personnel, ensure mission continuity,
support local or host-nation authorities, and interagency partners.
These commanders are synchronizing their plans at the regional level
with our international partners, as well as with other Federal, State,
and local authorities.
DoD's Pandemic Influenza Task Force
To better prepare for a potential pandemic, in November 2005, the
Deputy Secretary of Defense directed that a pandemic task force be
established within DoD. The Assistant Secretary of Defense for Homeland
Defense (ASD(HD)) was named as the lead for the Pandemic Influenza Task
Force (PITF). The Assistant Secretary of Defense for Health Affairs
(ASD(HA)) has supported the effort as the Department's lead for force
heath protection and health and medical response. Additionally, the
Office of the Assistant Secretary of Defense for Special Operations and
Low Intensity Conflict (ASD(SO/LIC)) has provided policy oversight of
the DoD pandemic influenza bilateral and multilateral international
partnership capacity building program.
The ASD(HD) serves as the principal civilian advisor to the Deputy
Secretary of Defense for all matters concerning pandemic influenza
preparedness and response, as well as the official who coordinates all
efforts of the Task force. These efforts include coordination of
pandemic influenza preparedness, mitigation, and response policy within
DoD and among appropriate interagency, international, governmental and
non-government agencies and host nation partners.
The Task Force is charged with the coordination and implementation
of policies and plans that will (1) prepare, prevent, and contain the
effects of a pandemic on military forces, DoD civilians, contractors,
family members, and beneficiaries; (2) ensure the Department protects
American interests at home and abroad; and (3) render appropriate
assistance to civilian authorities in the United States.
Conclusion
In a very unique and tragic way, Army Private Albert Gitchell
continues to significantly influence DoD's efforts to respond to
pandemic influenza. By understanding the effect of the 1918 influenza
pandemic on the U.S. military, we can forecast the potential effects on
our current operations and take prudent steps to minimize the potential
impact on our fighting force, as well as our Nation.
Mr. Chairman, the extraordinary efforts that are underway to
prevent an outbreak of pandemic influenza are a testament to superb
coordination and cooperation that is ongoing among Federal, State,
local, tribal, non-governmental organizations, international
organizations, and our allies. The Department of Defense is prepared to
both combat the spread of a potentially catastrophic influenza pandemic
within the U.S. military establishment, and to provide support to
national and international organizations in their efforts to fight this
disease.
Thank you once again for this opportunity to testify before you
today. I welcome any questions you may have.
Mr. Linder. Dr. Runge, at what point does a public health
event, such as the spreading of influenza, become an incident
of national significance and DHS takes over from HHS
coordinating the response?
Dr. Runge. Mr. Chairman, we anticipate that in the event
that this disease escapes simply the public health and medical
response role, which we think will happen very shortly after
human-to-human transmission is sufficient and sustained in the
U.S., it would escape the confines of public health and medical
and enter into severe economic consequences as well as the need
for possible security issues. I think the Secretary would be
very forward leaning in declaring such an incidence of
significance.
Just to remind the committee, the work of HHS goes on. The
work of HHS is one of coordination and support for the public
health and medical as well as our other medical
responsibilities.
Mr. Linder. Dr. Agwunobi, is HHS taking the
responsibilities for finding surge capacity for hospital beds,
sufficient numbers of ventilators and things such as that?
Dr. Agwunobi. HHS recognize that an important part of
pandemic preparedness is facilitating the development of
adequate surge capacity in communities. But we see it as
primarily a responsibility of local and State governments to
look to their specific needs and to build those needs into
their plans. We are stockpiling beds and ventilators within the
Federal national stockpile, in case that is needed. Ultimately,
we are also working with States and local governments to help
them develop the capacity and the strategies to manage through
the increase in surge that can be expected in a pandemic.
Mr. Linder. Mr. Verga, does the DOD consider itself part of
the surge problem?
Mr. Verga. Yes, sir, as far as the surge capability,
absolutely. Both National Guard and active duty medical
response personnel would be available for medical surge. That
is one of those 19 tasks that we identified.
Mr. Linder. Do you see your role in the United States,
after concerning yourself with the health of your troops and
the protection of the mission, do you see a role in the United
States more in terms of law and order or medical delivery or
what?
Mr. Verga. Sir, I think it is a combination, depending on
the situation. As I said, we identified those 19 tasks, which
run the gamut from assisting in the maintenance of public
order, which we always have that mission of doing, to providing
transportation, for example, the movement of critical, medical
equipment or supplies, should the public transportation system
not be adequate to handle it.
We see ourselves very much in the role of supporting our
Federal interagency partners in doing what they need to do to
meet the needs of the American people in this kind of an
emergency.
Mr. Linder. Dr. Clifford, there was a recent story in The
New York Times about a week ago that the migrating birds that
have returned from South Africa on their way to Europe had no
H5N1. What does that make you think about?
Dr. Clifford. Well, I think, from our standpoint, we are
enhancing the surveillance activities within the U.S., with
regard to migratory bird surveillance. The plans with USDA and
Department of Interior include sampling anywhere from 75,000 to
100,000 samples in the four flyways across the U.S., and we
have begun that effort in Alaska, as well as 50,000
environmental samples, so as far as I think we need to monitor
the flyways, as well as other potential avenues for
introduction, which would also look at the Euro-Asian flyways
as well. If we see a decrease of evidence of the virus in those
birds, I think that is a positive thing.
Mr. Linder. What are we doing about the millions of pounds
of smuggled chickens into Europe from China?
Dr. Clifford. I am not familiar with the millions of pounds
of smuggled product from Europe.
Mr. Linder. Into Europe.
Dr. Clifford. Into Europe from China. Obviously the
European Union or other European countries need to take action
with that. With regard to the U.S., we work very closely with
the Department of Homeland Security and our Customs and Border
Patrol at the major ports of entry, as well as within APHIS. We
have smuggling and interdiction teams that play a critical role
as a second line of defense for smuggling into the U.S. That
has been proven to be very beneficial in confiscation of
illegal product into the U.S. from some of these countries.
Mr. Linder. Are any of you prepared to say we are
comfortable with the reporting we are getting out of China.
Dr. Runge.
Dr. Runge. I must profess not to be an expert in whether
the veracity of their reports are sufficient or not, Mr.
Chairman. I do think that the level of transparency has
increased significantly, due to the good work of the folk
overseas, as well as at WHO. We are seeing improvements in that
area.
Mr. Linder. Dr. Agwunobi.
Dr. Agwunobi. I would concur. I think when we compare the
degree of openness that we see today with what we saw during
the SARS outbreak, it is pretty clear that they have come a
long way since then.
Mr. Linder. Dr. Clifford, do you agree?
Dr. Clifford. I agree that it is improved. I mean, there is
always more room for improvement, but it certainly has
improved.
Mr. Linder. Mr. Dicks is recognized for 5 minutes.
Mr. Dicks. There is still some question out here, I think.
I think it might be good to discuss this. The President has
released his National Strategy for Pandemic Influenza. But some
people feel that it is still not a plan, it is actually a plan
to develop more plans.
During the press conference announcing the release of the
National Strategy for Pandemic Influenza, the White House
Homeland Security Advisor Fran Townsend stated the plan
contains over 300 specific actions for Federal departments and
agencies, because we think it is important to measure and
demonstrate the effectiveness of our efforts. Every one of the
Federal actions included in the plan included a measure of
performance and a timeline for implementation of the actions.
Now, is that a plan, or is it a plan to make a plan? Can
you help us with that?
Dr. Runge. Congressman Dicks, the answer is yes. It is a
plan, and it is also a plan to plan further.
I want to point out that even as this interagency planning
document has been produced through a rather exhaustive
interagency process, even of writing it, and assigning
ourselves actions and metrics and timelines, the departments
themselves are busily engaged in doing their own planning for
their areas are of unique responsibility. It is border
management. It is workforce protection. It is quick
consequences. It is a continuation of government, as well as
protection of our critical infrastructures. HHS is busy doing
the things that are unique to HHS. This is a means for us to
coordinate the things which we must do.
Mr. Dicks. Well, how many actions does Homeland Security
have to take?
Dr. Runge. We have 58 that we are responsible for.
Mr. Dicks. How many do you have in place that you would
consider an operational plan for those 58, any of them?
Dr. Runge. We are very close on some, and we are way behind
on others.
Mr. Dicks. Well can you give us a little bit of a more
definitive answer, how many--one, two--what number have you
finished?
Dr. Runge. We have not finished any of them.
Mr. Dicks. There are 58 plans in action.
Dr. Runge. There are 58 actions and another 84 which we are
coordinating--we are coordinating other agencies. We have made
great strides in workforce protection issues, for instance. We
have made great strides in border management issues. We are
still--there are policy issues that have bubbled up as a result
of making these policy plans that actually need resolution
during the policy process. Fortunately, we still have some time
to deal with this.
Mr. Dicks. What about HHS?
Dr. Agwunobi. Sir, we have 199 of the action items dictated
in the plan. We have a Department-wide plan that is already
out, our strategic plan that came out a while ago, late last
year. But in addition to that, we are working on the detailed
implementation steps required to come through on our commitment
to these 199, and that plan will be released shortly.
Mr. Dicks. Are any of them completed now?
Dr. Agwunobi. Any of the individual 199.
Mr. Dicks. Yes.
Dr. Agwunobi. I think a number are actually marked as being
completed.
Mr. Dicks. Could you give us that number for the record?
Dr. Agwunobi. I will be sure to submit to you on the
record, sir, what we have completed. I do want to leave one
point, which is that all of these plans are go to be
iteratively improved over time.
Mr. Dicks. Right. We understand spiral development, maybe
that is for Mr. Verga--we understand you have a plan, and then
you improve on the plan. At least we hope you do.
Dr. Clifford.
Dr. Clifford. With regard to agriculture, I think many of
the action items are enhancements to things that we have
already been doing, so it is a continuation of those things. I
would just like to add--
Mr. Dicks. Are there any brand new ones?
Dr. Clifford. Yes, there are some new ones that we have put
in there as additional enhancements, but it is things
relatively new from a standpoint, just didn't start with this
concept. For example, the National Veterinary Stockpile. We had
already been talking about that and initially were putting
those actions into place.
So it is stockpiling those, it is getting strike packs for
those ready in case of an actual introduction for this National
Veterinary Stockpile. Strike packs are goods that will go to
the location to provide the support needed for the personnel
there.
Mr. Dicks. Now, in order to do a vaccine, you have to have
a strain of the flu; is that correct?
Dr. Agwunobi. That is correct, sir.
Mr. Dicks. You can't really start until you have that
strain, is that correct? I am not a biologist.
Dr. Agwunobi. What we lack today is not only a sample of a
pandemic strain, because there is none yet, there is no
pandemic around the world, but we also lack the capacity to
develop what we plan to do, which is to be able to deliver 300
million doses of pandemic vaccine within 6 months of the
pandemic virus rearing its head. Building that capacity
requires that we begin now to invest not only in science and
development, but also in the industry, trying to get the
industry to be able to have the capacity that it takes to
deliver on that promise.
Mr. Dicks. Those of us who have been through hearings on
bioshield, we haven't seen a great deal of ability for HHS and
DHS and the companies to do very much. Is that going to be a
problem here as well? I mean, are the companies willing to work
on this?
Dr. Agwunobi. We have learned a lot over the years. The
companies are indeed very willing to work with us on this. They
recognize this is a very critically important subject.
Mr. Linder. Thank you. The gentleman from Alabama is
recognized for 5 minutes.
Mr. Rogers. Thank you, Mr. Chairman.
Specifically, Dr. Agwunobi, what are you doing to make sure
that the industrial infrastructure is in place to deal with the
pandemic virus once it is identified?
Dr. Agwunobi. A number of different steps. Specifically,
for example, as recently announced by the Secretary, we have
invested $1 billion in the furthering of our ability to use
cell-based vaccine technology, new ways of producing vaccine.
We are trying to diversify the numbers companies that are in
the business of vaccine manufacturing. We are trying to
diverse--
Mr. Rogers. Are they domestic or foreign or both?
Dr. Agwunobi. They are actually both, but in our approach,
we would have them produce their vaccine right here in the
United States. We believe that is an essential part of the
strategy. So our investment makes that happen.
But we are also diversifying the different ways that you
can make vaccine, egg based, cell based, recombinant. We are
investing in technology to try and get all of those options
under way and to make sure that the first one that gets there
is available to us.
Mr. Rogers. I understand that. There is a company in
Alabama, not in my district, but in Alabama called BioCryst
that has produced permavir. I understand an RFP has recently
gone out from your Department for an award on an antiviral. My
urging to you would be whether it is permavir, or whatever you
discern to be the best vaccine, antiviral vaccine, that you
grant that award in a timely manner and not let that languish
around.
Dr. Agwunobi. I will be sure to take back that message.
Whether it be for antivirals or for vaccines, I concur we need
to move more quickly, and indeed, we are.
Mr. Rogers. One of the things you made reference to in your
earlier comments was stockpiling. What are you stockpiling
since you acknowledge you don't know what the virus would look
like?
Dr. Agwunobi. Well, I think the strategy is to stand ready
with a diverse armamentarium so that regardless of what the
eventual virus might look like, its characteristics to drugs,
that we might have a number of choices on that day.
So we are stockpiling today, H5N1 vaccine, a vaccine
against the virus that we are seeing in birds, the premise
being that if the pandemic virus in the future looks very
similar, that the vaccine that we have on hand today might be
able to offer some abilities to protect.
But we are also stockpiling antivirals, a number of
different antivirals. We are stockpiling ventilators. We are
stockpiling beds. We are stockpiling other medications,
antibiotics others that might be needed, not only in a pandemic
but in other hazards. We are stockpiling masks and gloves and
other resources that might be required to fight a war against a
pandemic. So it is really across the board.
Mr. Rogers. I represent a very rural district in Alabama. I
am curious to know in your action plans how you incorporate
rural hospitals and rural clinics into your ability to
distribute vaccines.
Dr. Agwunobi. Two points. One actually goes to the question
by the Chairman related to surge capacity. That is since 2001,
we have actually, Congress and the Federal Government has
invested $6.7 billion in preparing our Nation for public health
emergencies. We have done so through the CDC. We have done so
through HRSA, Health Resources and Services Administrations in
the Department of Health and Human Services, and that has been
focused on, almost 26 percent of that $6.7 billion has been
focused on making sure that every hospital in our communities
and in our Nation has been better able to take up a public
health emergency. Much of that money has gone to rural
hospitals specifically.
As we move forward, we are investing pandemic influenza
preparedness moneys in preparing states, $350 million, as was
mentioned.
Mr. Rogers. Over what timeline?
Dr. Agwunobi. Our timeline for investing in preparedness is
a 3-year time line. The $7.1 billion that was requested by the
President, $3.8 billion of which has already been delivered, is
really mainly dedicated to this 3-year strategy of building
preparedness, not just in big cities but across every aspect of
our Nation.
Final point, sir, a pandemic is an equal opportunity
threat. It will go to rural hospitals, to cities, to every
corner of our Nation. Therefore, we can't afford to focus on
one area and forget another.
Mr. Rogers. Which is my point exactly. I want to make sure
that we are just not focused on urban areas, and their
hospitals and their ability to deliver the vaccine once it is
identified--I do want to make sure that your action plans
incorporate rural America, because most of this country is, in
fact, rural and dependent on rural clinics and hospitals for
delivery of this kind of health care.
Mr. Runge, I would ask the same question to you about rural
health care delivery in the area of a pandemic.
Dr. Runge. I think it is important to note, Congressman
Rogers, that we have gone out to, I think, 49 States now. When
we go to these summits, we get representatives from every
corner of every State, the public health community officers, as
well as the State. We met with the hospital associations, the
medical associations, the faith-based groups, the private
sector, all together to talk about their role in a pandemic,
with the major theme that the Federal Government has its
responsibilities, but so do the local communities. In fact,
every family has a responsibility. So this discussion is the
same in virtually every State. I believe that they are
sufficiently involved in the process.
Mr. Rogers. I see my time has expired. I look forward to
the next round of questions.
Mr. Linder. The gentleman from Oregon is recognized for 5
minutes.
Mr. DeFazio. Thank you, Mr. Chairman.
Dr. Agwunobi, gee, I just feel so much better to hear about
the massive stockpiling. Unfortunately, it seems to be defied
by reality.
Let us talk about that a little bit. The Secretary of
Health and Human Services recently came to my State. I will
just give you a few quotes. He urged Oregonians to take
planning seriously. Unlike natural disasters, such as Hurricane
Katrina, there will be no help from the outside.
If Katrina was good, I am really wondering about the
Federal response. People of Oregon will have to take care of
the people of Oregon, Leavitt said. Federal Government can't be
in 5,000 communities.
Surge capacity. Well, he said, elected officials should put
a higher priority on healthcare. Maybe they should build in
surge capacity instead of remodeling the swimming pool.
Now, I am not quite sure what he is talking about here and
what you are talking about. Let us talk about a few issues. You
have a stockpile of 4,000 to 5,000 ventilators. The Center for
Biosecurity says that the--no, excuse me, the shortage is
estimated--that is another shortage--at about 637,000 from that
which we would need.
Have you developed triage guidelines for doctors to tell
them who to disconnect and who to deny service to? Because in a
regular flu year, we use 100,000 of our 105,000 ventilators. We
are talking about a pandemic. You have got a stockpile of 4,000
to 5,000, are you sanguine about that? Do you think that is
enough?
Dr. Agwunobi. Sir, as we work with States and with
providers, hospitals and doctors, we recognize that each State
is going to have to establish a plan.
Mr. DeFazio. So the States are responsible for buying
ventilators?
Dr. Agwunobi. Each State and local community will have to
respond--
Mr. DeFazio. Right. So the States and local communities
should be buying ventilators, not the Federal Government. You
were talking about a stockpile. I am just confused.
When you talk about a stockpile, you think, hey, the
Federal Government has got a big stockpile. They are going to
distribute them. Now you are saying, no, the State is going to
distribute them. The State and the local hospitals, which can't
get reimbursed for things that aren't needed for annual
occurrences or regular Medicare won't factor in their surge
capacity for pandemic or ventilators; will it? They won't allow
that in reimbursement.
Dr. Agwunobi. Some States, sir, require--some communities
won't need to buy ventilators because they need to have plans
for how to manage the resources that they have.
Mr. DeFazio. Right. So you say, then, the article from The
New York Times that says that we are 637,000 ventilators short
is inaccurate.
Let us go to the development and the stockpiling of, you
were very sanguine also you said, about 3 years, we will have
our capacity. The plan says, the primary objective, depending
on availability of future appropriations and responsiveness of
the vaccine industry, is for domestic manufacturers to be able
to produce enough vaccine for the United States population
within 6 months, beginning in 5 years. You said 3 years. I am
confused.
Dr. Agwunobi. Three to five years is the number we--
Mr. DeFazio. Okay, so 3 to 5 years, not 3. It depends on
the response of these manufacturers. Why are we relying on the
private sector here? Is this more privatization? Don't you
think maybe that the government should be mandating that?
Do we have, currently, any modern cell-based manufacturing
capability or any U.S.-owned old-fashioned egg-based capability
in the United States of America for producing vaccines?
Dr. Agwunobi. Sir, we definitely have a need to improve our
capacity.
Mr. DeFazio. Right. So we don't have any U.S. based. The
two we have are foreign-owned, and they are pretty obsolescent,
100-year-old technology, but they sort of work. We haven't been
able to meet the annual flu needs.
Dr. Agwunubi. Sir, our plan fixes all of those--
Mr. DeFazio. It fixes them in 3 to 5 years, not 3 years.
Dr. Agwunubi. In 3 to 5 years--
Mr. DeFazio. Right. Dependent upon appropriations and the
good will of--do you have a commitment from a pharmaceutical
manufacturer to build one of those plants today, in writing?
Dr. Agwunobi. Sir, our contracts with these pharmaceutical
manufacturers contemplates the journey to that point.
Mr. DeFazio. We are going to journey to a point. I mean, so
it just kind of--I don't want to give false assurance to the
American people. I mean, I think Secretary Leavitt, when he
came to Oregon, said you are on your own and was a little more
accurate. You painted a picture we are stockpiling. How about--
let us talk about, okay, antivirals, how big is the stockpile?
Dr. Agwunobi. In terms of an antiviral?
Mr. DeFazio. Yes.
Dr. Agwunobi. We have 5.1 million courses, but we also have
a little less than 5 million courses of ramantidine. We also
have some stockpiles of Tamiflu liquid for infants. We also
have stockpiles--
Mr. DeFazio. Tell us how quickly we will build that up.
Again, we are going to be dependent on the private sector,
foreign manufacturers. As I understand it, we are kind of last
in line, because we didn't order early.
Dr. Agwunobi. Well, sir, our goal is to stockpile 50
million regimens of antivirals.
Mr. DeFazio. In how long?
Dr. Agwunobi. Over the same period of time.
Mr. Dicks. Would the gentleman yield for just one point? I
am having a hard time understanding what happens if the
pandemic is 6 months from now.
Mr. DeFazio. In 5 years, we will build a plant that could
make the vaccine to take care of it.
Mr. Dicks. Thank you.
Mr. DeFazio. My time has expired. I will wait for the next
round.
Mr. Linder. Chairman King is recognized for 5 minutes.
Chairman King. Thank you, Chairman Linder.
First of all, I regret the fact that I was in a prior
meeting and wasn't here to begin.
I want to thank all of you for testimony and all of you for
your efforts and all of you for the contributions you make.
I also want to thank Chairman Linder for the initiative he
has shown on this issue and for the concern he has demonstrated
on this issue. I want to thank him very much.
I am not going to make the mistake too many members make of
coming in after the opening statements have been made and other
questions have been asked and repeat the same questions.
I would like to ask Secretary Verga a few questions though.
Is the Department of Defense monitoring troops overseas,
especially in Asia and Africa, for any signs of avian flu
infection?
Mr. Verga. Yes, sir. We have a very aggressive
biosurveillance program to include some Department of Defense-
operated laboratories overseas to monitor. We have an
aggressive force health protection program designed to be able
to very early detect any possible infection that might come
about.
Chairman King. I don't know if this was covered before I
came here, but in the event we have to use the military for a
pandemic response in this country, do you feel we have
sufficient forces to do that? Are you confident that the
military could make the appropriate response to a pandemic
episode here in this country?
Mr. Verga. Yes, sir, I am very confident. We are in the
final stages of our implementation plan for a pandemic
influenza. It is done, written, staffed and is merely awaiting
signature to cover the 116 of the tasks out of the national
plan that we are required to do. Coincidentally, as we speak,
there is an exercise ongoing that is addressing pandemic
influenza as one of the items that we have to do, and we are
going through the, in DOD speak, the force sourcing of the
forces that might have to be used in that. I am confident that
we will do what we have to be able to do.
Chairman King. Thank you, Mr. Chairman. I will yield back
my time to you, Mr. Rogers, Mr. Simmons, if you want to.
Mr. Linder. Dr. Christensen is recognized for 5 minutes.
Mrs. Christensen. Thank you, Mr. Chairman.
At the outset, I want to say that I share the concern of my
colleague, Mr. DeFazio, that even a national strategy says,
tells States that the assistance that they will receive will be
limited, especially in light of the fact that the funding isn't
there to help them prepare.
I want to say at the outset to say to the panelists, what I
say to my fellow committee members, is that in the plan, I am
still not satisfied, and my fellow delegates are not satisfied
the territories are not explicitly listed in the plan.
We are glad, as a State, that we get the same status, but
we do run the risk of being overlooked. For example, when we
said that Dr. Runge had 49 States had summits--
Dr. Runge. That includes territories.
Mrs. Christensen. Exactly. But if I didn't know, it wasn't
my territory, I would have asked you, well, what about the
territories? I think it is important that while we don't want
to lose anything, that some of the unique considerations of
territories are included and are listed separately.
To begin my questions, Assistant Secretary, Admiral, Dr.
Agwunobi, I note, I think his name was Simmons, that was the
Assistant Secretary for Emergency Preparedness and Response.
Dr. Agwunobi. Simonson.
Mrs. Christensen. I think he has left. Is there a new
Assistant Secretary at the Department for Emergency
Preparedness and Response?
Dr. Agwunobi. There is currently an Acting Assistant
Secretary, Gerry Parker. He was the deputy when Stuart Simonson
was in that seat.
Mrs. Christensen. Does he have a public health background?
Dr. Agwunobi. Oh, extensive. He has worked for a number of
years both within the military side and now on the civilian
side on public health emergency preparedness. He is an expert.
Mrs. Christensen. Dr. Runge, in your testimony, you said
that the Secretary has someone in mind to head up the
preparedness and response, to be the PFO in the case of a
pandemic. Is that you?
Dr. Runge. No, it is not.
Mrs. Christensen. Doesn't that create some confusion over
roles here?
Dr. Runge. Not at all. Under the National Response Plan,
the Secretary will appoint a PFO, which truly is not--this
individual needs to have a large operational experience and
capacity. Certainly the public health and medical knowledge
will be at his or her elbow when we need to draw upon it.
Mrs. Christensen. We are not talking about any kind of a
counterterrorism attack. We are not talking about any nuclear
incident or a hurricane. We are talking about a health event.
Dr. Runge. This is much bigger than a health event, ma'am.
We anticipate--by the way, HHS is responsible for that piece of
it. There is the distinct possibility that as we see large
numbers of people ill, demanding health care, demanding
medications that they may not have access to, and all the
things that have been articulated in the room today, we want to
make sure that Americans are safe and secure, that the supply
chain for food and goods and chlorine to the water treatment
plans and so forth, that there are sufficient resources in the
Nation's critical infrastructures to maintain them in the
event--
Mrs. Christensen. What is your role in the case of a
pandemic. Is it clear what the Department's role, the HHS's
role in the medical arena is?
Dr. Runge. Yes, it is very clear to us. I will be the
Secretary's principal advisor on medical issues, which is a
distinct role from the principal Federal official, who will be
guiding the operational command of the incident coordination.
Dr. Agwunobi. I would concur on that. The Department of
Homeland Security and Department of Health and Human Services,
I think we are very clear on what our relative roles would be
in response to a pandemic.
Mrs. Christensen. Dr. Agwunobi, the plan for vaccination
presumes--well, even though it may be a few years hence--that
the virus would be contained and slowed enough, for enough time
that that estimated 6 months time for the development of a
vaccine, in every case of pandemic flu it the local public
health infrastructure, the health system in place, that first
line of defense, which will buy us the time to get us to be
maybe that 6 months while protecting lives.
Do you really think that $644 million or somewhere in that
vicinity can prepare this country with reportedly faulty public
health infrastructure--hospitals have no surge capacity in
general, emergency rooms are over capacity, lab capacities
inadequate, we have a lower number of workers in health and
local health, State and public health than we did in 1979.
So given the fact that it is the local health system, the
public health infrastructure, the private health infrastructure
in communities that is going to be that first line of defense
and maybe now for 3 to 5 years, is that enough money?
Dr. Agwunobi. Since 2001, $6.7 billion has been invested in
public health strengthening, strengthening the infrastructure
of our public health communities across the Nation, designs to
make them better able, better ready to respond to public health
emergencies, and by all definitions a pandemic falls squarely
into that. In addition to that, this $7.1 billion that has been
requested, of which 3.8 has already been appropriated, I think
adds to that investment in our Nation being prepared.
We also have a number of other assets designed at the local
level to help strengthen their ability, like Medical Reserve
Corps and others. Ultimately I do believe that as we continue
this ongoing investment, whether it be for bioterrorism
preparedness, public health emergency preparedness, and these
next few years of investing in pandemic influenza preparedness,
that we will be a Nation ready at the local, State and at the
Federal level.
Mrs. Christensen. I am still concerned that despite that
investment hospitals are still saying they just don't have the
capacity.
Thank you, Mr. Chairman.
Mr. Linder. Does the gentleman from Connecticut wish to
inquire?
Mr. Simmons. I thank you, Mr. Chairman, for holding this
hearing, which I think is tremendously important and timely,
and I appreciate the testimony of the witnesses, even though I
have not heard it but I have read it, and I thank you all for
being here.
I would like to focus--I have two questions; one on the
prepared statement of Dr. John Clifford with regard to
outbreaks of avian influenza in commercial bird flocks. A
couple of years ago in the State of Connecticut a private
company reported the outbreak of avian influenza in a
population of up to 7 million birds and the Department of
Agriculture in the State of Connecticut, working with the
Federal Department of Agriculture, initiated a program not to
depopulate 7 million birds but to vaccinate them, with the idea
that vaccination could work to control the outbreak, which was
very limited but nonetheless it was within this large
commercial flock.
That program was a complete success. The flocks continue in
good health and the outbreak was contained and eventually
eliminated. My understanding is the vaccinations were conducted
through the food that was provided to the birds.
The Federal Government through the Department of
Agriculture does reimburse commercial activities for
depopulated flocks and has the authority to reimburse for
vaccination but never has. I wonder if a practical matter is
that it isn't smart to focus on vaccination rather than
depopulation as a strategy, but current funding does not
support that strategy. Would you comment on that?
Dr. Clifford. Yes, Congressman. I think there is a very
important distinction we need to make here. The particular
situation you were talking about in Connecticut was what we
referred to as low path, low pathogenic avian influenza. That
was one of the first times we used vaccine successfully. It had
been tried in Europe and it was a success. And you can use
those types of strategies dealing with low path avian
influenza, not with high path AI. High path AI is going to kill
80 to 90 percent of the birds and you would need to stop the
virus from circulating, you need to go in and depopulate. The
only time we would use vaccine in that type of situation is to
try to build a firewall around that particular area of
infection to prevent and slow the spread of that virus, so that
is when vaccine would be used.
In addition, we do not want to use wide scale vaccine in
the U.S. poultry industry. Vaccine will not prevent the virus
from circulating. You can still have virus present while it was
successful in eliminating and it would also--it is not an
approach that we think is wise with regards to wide scale use.
Limited use, certain specific circumstances, and very
controlled use.
Mr. Simmons. Does low path lead to high path in some
circumstances?
Dr. Clifford. Low path AI can mutate and become high path
AI, and that is why we actually, beginning in 2005, we have
developed and actually started in 2004 with what we referred to
as our low path AI program to heighten the level of
surveillance activities both in the commercial sector as well
as what we refer to as the live bird marketing system.
We have had an H7N2 into low path AI virus that has been
circulating in the live bird marketing system in the New
England area for years and have been monitoring that actually
since the late 80s. Recently, with the new program we put in
place we have seen great reductions in the circulation of that
virus in those bird markets.
Mr. Simmons. Thank you for that response. I guess, again, I
felt that the Department of Agriculture did a great job of
monitoring the situation and saving the industry whereas
depopulation essentially is very, very expensive and destroys
the industry. And for those human-cost infections, depopulation
accomplishes the task. People want to disrupt the economy, they
want to disrupt the food supply, and depopulation certainly
does that.
My second question--I am out of time. I will wait for the
next round.
Thank you, Mr. Chairman.
Mr. Linder. Does the gentleman from North Carolina wish to
inquire?
Mr. Etheridge. Thank you, Mr. Chairman.
Let me follow that up, Mr. Clifford. When you talk about
depopulation, especially with flocks, the person who really
gets burned is the grower. All he has is his time and effort.
If you depopulate the whole thing, and they have a contract,
they are still paying their revenues.
Does the Department have funds to reimburse for the
depopulation for the farmers or is that a direct appropriation
from Congress?
Dr. Clifford. No, sir. We have the authority for use for
depopulation.
Mr. Etheridge. I understand you have the authority for
depopulation; my question was for reimbursement.
Dr. Clifford. Yes, sir.
Mr. Etheridge. At what rate?
Dr. Clifford. For highly pathogenic avian influenza, it is
at 100 percent rate.
Mr. Etheridge. For the birds. That would go directly to the
grower as well?
Dr. Clifford. The split on that, we are trying to address
that in some rulemaking, but obviously if you go back to the
situation where we dealt with the low path AI in Virginia a few
years ago, we did split that out with the growers as well. So
we will need to work that with the poultry companies.
Mr. Etheridge. I would encourage you to look at it because
the company is in a far better position to absorb loss than the
individual at the end of the line. They are the ones that are
going to go broke. So I would hope you would follow up, and I
look forward to hearing from you personally on that one.
Mr. Simmons. Would the gentleman yield for 15 seconds?
Mr. Etheridge. I will be happy to.
Mr. Simmons. The depopulation is getting reimbursed. In our
case the vaccination did not. So the company accrued about a
$20 million bill to preserve and protect the flock.
Mr. Etheridge. I recognize the company, but the grower is
the one who stands to have the great loss. The companies will
lose, but they have more to absorb.
Let me go to Dr. Runge, and, Dr. Agwunobi, if would please
answer this one because you have been talking about a number of
the issues. Recently Secretary Leavitt has stressed that State
and local government, schools and private businesses will bear
much of the preparation and response burdens during the
pandemic.
My question is what role will the Federal Government expect
schools to play in this crisis. Secondly, have any of you given
any thought to what the trigger point will be for closing
schools if you are going to play a role?
While I am at it let me get the third one in so we can get
it quickly. What kind of support would the Federal Government
give to school districts to prepare for these roles? You are
only talking about 50 some million students and a lot of
personnel in a place where if you have an outbreak it is going
to spread like that.
Dr. Agwunobi. There are some obvious situations in which
schools are going to have to close, and that would be those
circumstances where--
Mr. Etheridge. I understand that. My question is: Is there
a plan in place, has it been distributed to the local schools
and to the States?
Dr. Agwunobi. Sir, we recognize that no two school
districts are the same and we are working very closely with
them.
Mr. Etheridge. I don't want to keep butting in. I was a
State superintendent of schools. Have you corresponded with the
State superintendents and with the local independent school
districts across America?
Dr. Agwunobi. We have actively reached out to the State
governments in each State urging them to pass on, and we are
reaching out to schools in those State pandemic summits, they
are all invited, school districts are invited to send their
leadership to those pandemic summits in which the Secretary and
experts from CDC and others sit and have usually an all day
long event in which we dialogue with those very leaders that
you described.
Mr. Etheridge. So the superintendents are involved in every
State?
Dr. Agwunobi. In every State they are invited to these
pandemic summits, and we have made available written guidance
that schools can use, they can draw down from the website,
www.pandemic.gov, that offer not just guidance in terms of
universities and day cares but also specific guidance for K
through 12 that school superintendents can use to build their
plans. So the answer would be yes, sir.
Mr. Etheridge. How about Homeland Security?
Dr. Runge. We have been attending these State summits with
HHS, and the ones I have been to, 8 of the 49 myself, the
schools are very well represented, not only the public school
systems but also colleges and universities.
Dr. Agwunobi. I find teachers and PTA are also showing up.
Mr. Etheridge. Let me--I am about out of time but let me
come back to the amount of money appropriated. I think it is
woefully inadequate for what we are talking about when we could
be facing this within 6 months, a year. We have no idea what it
is and yet we have put so little funds out there to prepare the
public. Would you not agree with that?
Dr. Agwunobi. Sir, we invested, as I said, $6.7 billion
since 2001. I would like to make the point that States haven't
drawn down all that money. There is still about a billion
dollars sitting, waiting on States to draw that money down so
that they can prepare their public health infrastructure for a
public health emergency. And that is before we began--
Mr. Dicks. Would the gentlemen yield? Bob, would you just
ask him are you talking about the problems with DHS grants, are
you talking about some HHS grants for public health?
Dr. Agwunobi. I am talking about public health dollars that
went out to States through the CDC and HRSA, both agencies
within the Department of Health and Human Services, a total of
about $6.7 billion invested since 2001, of which $1 billion has
yet to be drawn down.
Mr. Etheridge. Mr. Chairman, would it be possible for us to
get that--the States that haven't drawn theirs down? I think
that would be helpful for this committee to know that.
Mr. Linder. The Department will respond in writing. Thank
you.
Dr. Runge, how much time did you engage the private sector
in the planning process? We have got major corporations with
plants all over Asia. An event is going to be a serious problem
for them to keep their plants open. How much are they engaged?
Dr. Runge. Mr. Chairman, that is exceedingly important.
Even as the President was unveiling the national strategy in
November, our Critical Infrastructure Partnership Office was
reaching out to the private sector. As you know, Mr. Chairman,
80 percent or so of our critical infrastructures are owned by
the private sector. Our office was going and actually having
tabletops just to begin to acquaint them with the issue.
I believe we have had 4 or 5 of those now among the
critical infrastructures together and as recently as 2 weeks
ago I was in Boston speaking with leaders of major health care
companies who were very, very engaged in this topic, not only
as to what they can do but also how they need to protect their
employees and keep the country moving in the event of a
pandemic. This is exceedingly important and we have been doing
that outreach.
Mr. Linder. Dr. Clifford, would you like to comment on
that?
Dr. Clifford. I am sorry, can you repeat that question?
Mr. Linder. How much are you and the Department of
Agriculture reaching out to the private sector for not only
surveillance, because they have workforces that are affected,
but responses?
Dr. Clifford. We have actually been outreaching a lot with
the industry side of the sector. Actually, just last month or
at the beginning of this month we just held a meeting in
Atlanta with the industry and the States as well as the Federal
with regards to our response plan and preparedness.
Mr. Linder. Dr. Agwunobi, how much are you including the
CDC's BioSense program, which is in development? How much of
that is being included in planning?
Dr. Agwunobi. All of the assets of the Department of Health
and Human Services, as you can well imagine, are an integral
part of any response to a public health emergency, especially
one of the size and scope of a pandemic.
BioSense offers us a great opportunity in the future as it
develops out and strengthens the ability to not only identify
perhaps the onset of a public health event of major
significance but also, for example, it offers a great
opportunity to manage resources because it gives us a sense of
how the pandemic is affecting a community and how that
community is responding to the pandemic. So it is a part of our
plan, an integral part of our plan.
Mr. Linder. Does the gentleman from Washington wish to
inquire again?
Mr. Dicks. Yes, I would like to.
Who is in charge of assuring that States and localities
create the surge capacity for treating people who become ill
during a pandemic?
Dr. Agwunobi. That would be the Department of Health and
Human Services working in concert with State governments.
Mr. Dicks. We have been informed that emergency rooms and
trauma centers are closing all across the country because they
are considered a money loser by many hospital administrators.
What is the current state of readiness of our emergency
departments?
Dr. Agwunobi. Sir, I read the same reports you do and we
recognize that our emergency departments across the Nation
continue to face significant challenges, in some communities
more than others. We continue to work with them across the
Nation to try and help them as they go through these
transitions.
Mr. Dicks. But in light of the fact we could be facing a
pandemic flu outbreak, don't you think people would--I mean
they would turn to emergency rooms, so if they are being closed
down, this is not good? And should we be doing more to help
them financially as part of our preparation for this--to be
prepared for this possible outbreak?
Dr. Agwunobi. As we work with State and local leadership we
are urging them to do an inventory of their current capacity to
meet the needs that might appear in a pandemic, not just the
emergency room care but potentially inpatient care and
outpatient care, and we are providing them with guidance on
what they might expect in a pandemic and offering them, as I
said, this significant investment in their infrastructure.
Mr. Dicks. Let me talk about one thing. Time is quite
limited here. Congress has appropriated 350 million for
assistance to the States and localities for pandemic
preparedness. The goal of this program is to assure that all
localities meet a minimum level of preparedness.
Are you going to create a single course set of performance
standards that all jurisdictions must achieve with these funds?
Dr. Agwunobi. Yes. The guidance that is attached to these
funds has very specific expectations of what a State will
commit to achieving in its plan and across its community, not
just a written plan but an exercise plan that proves those
achievements have occurred.
Mr. Dicks. Given that one of the most critical aspects of
preparedness will be the ability of local jurisdictions to
rapidly distribute a pandemic vaccine, will the Department
encourage States to organize mass vaccination exercises during
the next flu season to test their distribution plans?
Dr. Agwunobi. I won't tie the timeline to the flu season. I
will tie it to the guidance issued associated with the 350 you
mentioned. It has specific timelines around which we expect
States will have developed distribution plans not just for
vaccines but anti-virals and other countermeasures. It has very
specific timelines on when we expect those achievements to have
occurred, including, as you state, exercises.
Mr. Dicks. While significant funds are being invested in
preparedness, when a pandemic hits, the cost for Federal, State
and local governments will be significantly higher. Has anyone
estimated what the cost would be to implement its pandemic
preparedness plans?
Dr. Agwunobi. When you say its, you mean--
Mr. Dicks. For example, is there an estimate for what the
actually pandemic flu vaccine will cost once it is available?
Has the Department asked States and localities to estimate the
cost of responding to the pandemic as opposed to planning for
one? In other words, it is one thing to plan, it is another
thing to then have to respond, and who is going to pay that
bill?
Dr. Agwunobi. As we work with States we recognize each of
them makes decisions in their plan. They have a number of
options on how they might, for example, care for overflow
patients. Each State, each community makes a decision based on
what its specific plan says.
We haven't rolled up the costs of the hundreds or thousands
of plans that might developed at the local, State and Federal
level into one bottom line, but I would imagine that each State
and each community as they develop their plans, that they
contemplate where they might need increased costs or where they
might use existing funds to develop our capacity use within
those plans.
Mr. Dicks. Thank you, Mr. Chairman.
Mr. Linder. Does the gentleman from Alabama wish to
question further?
Mr. Rogers. Thank you, Mr. Chairman. Before I go to my
questions, I want to follow up on Mr. Etheridge's request. I
would like to be included in being given a list of the State
boards of education that have not drawn down their funds.
Dr. Agwunobi. Not boards of education, the State
government; actually, the public health.
Mr. Rogers. I would like to know if Alabama is on that
list.
Mr. Clifford, also the point about the poultry growers, I
would look to be given the same information that you are going
to provide him about grower reimbursement, because he is
absolutely right, the growers are the least able to absorb that
loss.
Dr. Runge, where I left off before, talking about rural
hospitals in particular, I have in my district a couple of
large hospitals that have an average day census of 3 to 500 and
I would expect them to be sophisticated enough to be included
in any information systems. But I have about a half a dozen who
keep an average day census of 10 to 15 and one that keeps 3.
These folks are going to need their hands held in making sure
they are prepared and I am interested in knowing along what
timeline you think you will be able to reach down to these
smaller rural hospitals to make sure they are as prepared as
they can be in the event you are dealing with a pandemic.
Dr. Runge. Is that question to me?
Mr. Rogers. Yes.
Dr. Runge. I will go back to this issue, and quite frankly
I don't want you to get the mistaken impression we think
everything is going to be just fine out there if they have a
plan. We expect if the pandemic hits us and if it maintains a
virulence to anything like we are seeing in the current virus
or what occurred during 1918, there will be unmet needs in
every size hospital, whether it is an emergency department with
60 beds or whether it is one with 2 beds as the ones you are
describing.
We have encouraged the Hospital Association, the American
Hospital Association, as well as State entities to make sure
that all of their members have a contingency plan on what
happens if you have eight ventilators in a hospital and the
ninth patient arrives who needs artificial ventilation.
Mr. Rogers. So you are waiting for them to reach out to
you?
Dr. Runge. No. Basically, this is an educational process we
have entered into with States, with the private sector. Much of
this health care is provided not by public health but also the
private medical sector.
This is not something where we are coming in with a magic
pill that can cure this. We want to make sure that every
hospital, every ambulance service, every clinic has taken into
account what could happen if it loses 40 percent of its
workforce.
Mr. Rogers. What I am interested in is if you develop a
vaccine, if we see a pandemic coming and you are able to draw
on the infrastructure to develop a vaccine, I want to know that
there is a way that--because that is where people are going to
go, to their local hospital to try to get a shot. I want to
know that every hospital knows how they are supposed to draw
down their proportioned amount of the vaccine.
Before my time runs out, I want to turn to Mr. Clifford for
a minute. Poultry is the number one industry in my State, and
obviously in my district it is the largest. You talked a little
while ago about your action plans and vaccines but also I heard
you make reference to Mr. Simmons' question about vaccines,
certain vaccines not being useful. I know that Auburn
University has developed a vaccine that you can put in the egg
and it prevents the chicken that is producing that egg from
being susceptible to vaccines that are known at present.
My question is: Are you all spending significant amounts of
money or any money for continued R&D to make sure that when a
bird flu arrives here that we are able to provide those kind of
vaccines to prevent its spread, because we are going to be
killing flocks?
Dr. Clifford. Yes, sir. We already have on hand 40 million
doses of avian influenza vaccine as well as purchasing an
additional 70 million doses for our vaccine bank. Those are
made up of four different subtypes of vaccine and we know that
two of those subtypes are effective in assisting and helping
protect the birds and spread of the virus for the highly
contagious H5N1 that we are seeing.
Mr. Rogers. Do you have additional R&D funds to continue to
make sure we are on the cutting edge of being able to fight
this?
Dr. Clifford. Yes, sir. There are research dollars there
for ARS, part of USDA, to continue research and development as
well.
Mr. Rogers. You talked about firewalls in the poultry
industry a little while ago. I have been through the processing
plants and I agree there are incredible firewalls, but when it
comes to growers what kind of firewalls do you see there and in
the feed lots?
Dr. Clifford. Actually, good biosecurity is the key to the
prevention of spread of this disease. So if you have the
disease introduced in an area you have got to quickly contain
it and have good biosecurity, and that means in these grower
facilities, or no matter what type of facility, people cannot
have free access. They have got to clean and disinfect their
footwear and outerwear. They should not have ongoing contact
with birds outside of that. So there are a lot of things that
the poultry industry is doing as well to beef up, as well as
have very good sound biosecurity to protect that investment out
there.
Mr. Rogers. Thank you. I see my time is up.
Mr. Linder. Does the gentleman from Oregon wish to inquire
further?
Mr. DeFazio. On the issue of Tamiflu, Dr. Agwunobi, it adds
apparently some potential utility as a prophylactic, is that
correct?
Dr. Agwunobi. Yes, sir.
Mr. DeFazio. It is also used, as I understand, in
treatment, it has been in the bird flu cases, massive doses
have been given and it is not quite clear what role it played
there. Is that correct?
Dr. Agwunobi. That is correct, sir.
Mr. DeFazio. Seems like it would be prudent to have on hand
a significant amount, is that correct?
Dr. Agwunobi. And a diversity of anti-virals, number of
different anti-virals.
Mr. DeFazio. At the moment we have only 4 or 5 million
courses, which if you were treating people, would maybe treat a
couple million. I guess you give a double dose.
Dr. Agwunobi. Our goal is to maintain a stockpile of 25
percent of the population. 26 million doses by the end of this
year, sir.
Mr. DeFazio. 25 percent would be--
Mr. Linder. Would the gentleman yield on that point? What
is the shelf life of those vaccines?
Mr. DeFazio. This is the anti-viral.
Mr. Linder. Could you tell us about the shelf life?
Dr. Agwunobi. Different anti-virals have different shelf
lives. I believe Tamiflu is 5 years, but there are a number of
others and they may have different shelf lives. If I might get
back to you on the record on each of the different anti-virals.
Mr. DeFazio. Thank you, Mr. Chairman.
So what is the major constraint; is it production
capability?
Dr. Agwunobi. Constraints in regards to? One is
appropriations, obviously.
Mr. DeFazio. So there isn't money; we don't have enough
money, right?
Dr. Agwunobi. Our plan is to purchase it over the course of
the 3 years, and by the end of this year--
Mr. DeFazio. If we had more money could we purchase it more
quickly? Is the capability there to produce it more quickly?
Dr. Agwunobi. I am not sure about the companies in terms of
whether they can deliver it all today or tomorrow.
Mr. DeFazio. I am thinking back to Cipro. Worldwide panic,
anthrax, a few countries said hey, we don't care about the WTO
and the patent rights, we are just going to produce it. After a
while the company said okay, all right, we will license the
production. I am wondering if we are looking at a similar thing
here.
Dr. Agwunobi. I think appropriations is the key limitation
at the moment. We are getting everything we can buy. 26 million
courses by the end of this year, our goal being to provide for
25 percent of the population; 81 million courses.
Mr. DeFazio. That is good. How about something very simple
like surgical masks? My understanding is that the French have
200 million on order, we have 100 million on order and they
have one-fifth our population and we recently saw guidelines
you shouldn't reuse them. A hundred million isn't going to go
too far. I assume that has a prophylactic effect, both putting
it on the affected person or healthy wearing it to avoid the
infection.
Dr. Agwunobi. I am not sure what the French are
stockpiling.
Mr. DeFazio. Let's go to are surgical masks useful?
Dr. Agwunobi. Some are.
Mr. DeFazio. M-95s.
Dr. Agwunobi. As opposed to surgical masks. Surgical masks
can be useful in certain circumstances. There isn't an awful
lot of science on whether or not what their use--how you might
optimally use them in a pandemic because we don't have that
science available.
Mr. DeFazio. Would it be prudent to have perhaps a few for
every American? Looking toward a million as opposed to hundred
million.
Dr. Agwunobi. A pandemic lasts anywhere from 12 to 16
months with waves that might be 6 weeks long sweeping through
communities. I think it would be impractical to have every
citizen maintain a stack of 5 M-95 mask. These require
specialized fitting techniques.
Mr. DeFazio. You can buy them on line for less than a buck
each or buy the ones that you can breathe more easily through
for a little bit more, over $2.30 each. I realize you may be
concerned about how I fit myself or other people but I think
the American people might want--if they have to go to work, if
they are running a nuclear plant and make sure they are there,
they would want some protection in addition to the hand washing
and the other things. Don't you think it would be prudent to
have masks?
Dr. Agwunobi. We are not sure that science supports
surgical mask use by the general population.
Mr. DeFazio. We should forget about them. Tell people to go
out and breathe, right? Don't put them on.
Dr. Agwunobi. We have the tried and true public health
interventions.
Mr. DeFazio. I sit next to people on airplanes. My doctor
wears a mask on the airplane. He is recommending I should too
because he is tired of people getting sick on the plane, people
snorting on you. It would be kind of good to have some
protection at that point, wouldn't it?
Dr. Agwunobi. The question is does the mask protect them at
all.
Mr. DeFazio. My doctor thinks it does. I guess you don't.
Just back to the--this is a pretty basic thing. I hear over
here HHS is in charge, it is an incidence of national
significance--I mean DHS. Over here, HHS is in charge, it is a
health emergency. I am just concerned that we saw this kind of
interplay and problem with Katrina and FEMA within DHS and the
gentleman wanting to call the White House. I am concerned here.
Have you guys really worked this all out?
Dr. Agwunobi. Yes, sir.
Mr. DeFazio. How is it going to work? Who are you in charge
of and what are you in charge of?
Dr. Agwunobi. In a pandemic I think it is critical that we
restate the fact it is not just about health and medical. They
are clear, we all know what they are, the need for surge
capacity and the numbers of individuals who might be ill. But
in a pandemic there is so much more; it is about maintaining
our society, our businesses, it is about educating our
children, conducting our lives through the course of 18 months.
The Department of Health and Human Services is very clearly
responsible for the public health, the health and the medical
aspects of the response to a pandemic, while our colleagues Dr.
Runge and others in the Department of Homeland Security will
handle the maintaining of society.
Mr. DeFazio. Civil order, logistics, National Guard.
Dr. Agwunobi. I will let my colleague go into those
details.
Mr. DeFazio. Is that correct?
Dr. Runge. Particularly the maintenance of critical
infrastructures of maintaining of civil order, of coordinating
the various Federal responses to this that are needed by many,
many departments, not just the two of ours.
Mr. DeFazio. Thank you. Thank you, Mr. Chairman. My time
has expired.
Mr. Linder. The gentleman from Connecticut is recognized.
Mr. Simmons. Thank you, Mr. Chairman.
For any members of the panels, we have talked a lot about
vaccines and vaccinations, and the testimony shows that there
are plans to stockpile vaccines. Vaccines are usually
administered with needles, I believe. How is our stockpile of
needles?
Dr. Agwunobi. We are stockpiling, in addition to
countermeasures, anti-virals and vaccines, the resources needed
to administer them, including gloves, swabs, syringes and
needles. Clearly that is an important part. We recognize that
is important.
Mr. Simmons. The reason I ask is because a needle
manufacturer in my State, not my district but in my State, has
manufactured needles for vaccinations for the civilian
population of France, but the orders from the United States
Government have been a fraction of that amount, and so that is
why I raise the issue.
Dr. Agwunobi. We currently are stockpiling vaccine, H5N1,
for example, in bulk. It needs to go through certain final
tests before we package it into smaller vials and therefore
acquire the syringes and the needles necessary to administer
it.
Our stockpile, however, today, where it does contain
countermeasures that require needles and syringes, those
needles and syringes alongside these push packs that are in the
strategic national stockpile contain all that is necessary to
get the countermeasure into the arm of the citizen.
Mr. Simmons. Thank you very much. My second question is to
Secretary Verga. Thank you for your service to your country.
Welcome home. And thank you for your continued service in this
capacity.
You mention in your testimony on page 6 that one of the
critical tasks identified by the Department of Defense is to
provide surge medical capability to assist civilian
authorities. I assume that would be through military hospitals,
military personnel. In identifying those surge capabilities do
you reach out to and include the facilities of the Veterans
Administration?
Mr. Verga. We in DOD don't but the Veterans Administration
is part of what is called the National Disaster Medical System,
of which DOD is a participant along with the Public Health
Service, and that is also included. So the Veterans
Administration is included.
Mr. Simmons. How would you evaluate the cooperation of the
Veterans Administration with you as you engage in this reaching
out?
Mr. Verga. Very good. My experience in working with the
Veterans Administration on all sorts of emergency planning
aspects, not just pandemic influenza but the medical aspects of
any emergency has been very good.
Mr. Simmons. Over the last year and a half or 2 years the
VA has implemented the CARES program, which is a program to
realign VA facilities. There has been a focus on community-
based outpatient clinics and less focus on beds in traditional
hospital environments.
Has any effort been made to identify those beds for
purposes of surge capability?
Mr. Verga. Sir, I am just not familiar with that. I would
be happy to go back and try to get you an answer. I just don't
know.
Mr. Simmons. Over the last year and a half or 2 years, the VA has
implemented the CARES program, which is a program to realign VA
facilities. There has been a focus on community-based outpatient
clinics and less focus on beds in traditional hospital environments.
Has any effort been made to identify those beds for purposes of surge
capability?
Mr. Vega. CARES (Capital Asset Realignment for Enhanced Services)
plans are developed by individual Veterans Affairs Medical Centers and
Veteran's Integrated Service Networks (VISNs) and use of surge capacity
is one of the factors considered as part of the overall process for
developing the CARES plan.
For example, during the response to Hurricane Katrina, the Veterans
Administration established and staffed 2 Federal Medical Shelters
provided by the Department of Health and Human Services for housing
evacuees from both Hurricanes Rita and Katrina at the Waco and Marlin
VA Medical Centers. These vacant buildings were mothballed under CARES
and were able to be reactivated.
Also during the response to Hurricane Katrina, the Veterans
Administration developed an inventory of vacant spaces created as a
result of CARES or other reasons that could be activated with some work
to be used for surge capacity for shelters as well as beds.
Mr. Simmons. Thank you, Mr. Chairman. I yield back.
Mr. Linder. Dr. Christensen, do you wish to inquire
further?
Mrs. Christensen. Thank you, Mr. Chairman. I would like to
ask Dr. Agwunobi and perhaps Dr. Runge also to respond. We
spent a lot of time in the committee on BioShield and
authorized a great deal of funds to spur the development of
countermeasures, and I am not really seeing this project being
utilized to its fullest extent. But I have also introduced in
this Congress and the one before the Rapid Cures Act. This bill
would fund basic research on shortening the time, as we call
it, from bug to drug, including vaccines.
Are we focusing enough on that particular area, shortening
that time, since we can't predict even how this particular
virus will look like if and when it begins to be transmitted
from human to human, and do you think the Department has enough
authority to do what is needed or does it require more like our
legislation would provide?
Dr. Agwunobi. The $1 billion that was recently announced as
being invested in five companies to develop and further their
ability to produce cell-based vaccine technology, one of its
ultimate goals is to try and shorten that process. We have five
companies from around the world. The commitment is to build the
technology, develop plans--
Mrs. Christensen. Just focusing on one cell right now.
Dr. Agwunobi. Our strategy also involves investing in other
technologies, not just about diversifying the number of ways we
can get to a vaccine, it is about trying to find and improve
the speed it will take for us to get there.
Mrs. Christensen. You agree that it is really--that is
where we need to be focusing. BioShield will take us from--if
you have a countermeasure to manufacturing in large amounts,
but we can't even get to shortening the time to get there. We
don't have time. Six months is not a time that is available to
us right now.
So you agree that we really need to put a lot more focus on
shortening that.
Dr. Agwunobi. The process isn't just about industry though.
If you think about it, it is about identifying the virus,
getting a sample, bringing it into the system, studying that
sample, developing a pilot vaccine, getting that into the
industry, getting it approved and tested so we know it is safe
for human beings.
So there is some process that has to go into this, but we
have to get that as short as we can. We are trying to advance
late stage R&D, and I think in this current budget request
there is a request for an additional 160 million to find ways
to shorten the process.
Mrs. Christensen. I would ask this of all of the panelists.
In studying the economic impacts of SARS and other past
pandemics, economists have said that the most important factor
attributing to the losses suffered were, quote, the behavior of
consumers and investors. We will also depend on the citizenry
to follow instructions now and should we have a pandemic.
The IOM did a survey of regular citizens and whether they
would be likely to follow instructions; in this case it was a
terrorist attack. I think it was up to two-thirds said no.
Another IOM report on what we have learned from SARS says that
research designed to identify why societies respond
dramatically and irrationally to certain types of public health
threats might help communicators develop messages and
positively influence the public's behavior. This is really
important. How much research is being done on that?
Dr. Agwunobi. I can't give you a measure of how much
research is being done on this subject because I don't see into
every university, but I do know social scientists and risk
communicators recognize this is an important part of the
challenge.
In the Department of Health we are investing heavily into
trying to not only prepare ourselves and to work with our
Federal agencies but urging State and local entities as well,
the people who will be first on the scene, first on the stage,
so to speak, to take the time to learn about what it takes to
accurately and efficiently develop risk communication
strategies and to develop--deliver those messages.
I think when all is said and done it is going to be about
educating, sharing with the public the challenge, and making
sure that on that day the leaders that do represent what we are
doing and why we are doing it and what we need the public to
do, making sure those leaders are the most trusted leaders for
that particular community, meaning local leadership, will be
key.
Mrs. Christensen. Dr. Runge, did you want to answer either
one of those questions?
Dr. Runge. I would add to what Dr. Agwunobi just said. Dr.
Christensen, I am sure you are aware more than most people in
this room how difficult it is to communicate a public health
message and have it internalized. HHS, we are working on
messages, message mapping, actually, since last August or
September on this subject and they clearly have a way forward
with doing this. Much of this information is on
pandemicflu.gov.
There is no question we need to do more in communicating
with our citizens as to what the real threats are. There is no
prevention for irrational behavior better than good education.
Mrs. Christensen. Thank you, Mr. Chairman.
Mr. Linder. The gentleman from North Carolina, do you wish
to inquire further?
Mr. Etheridge. I do. Thank you, Mr. Chairman.
Dr. Agwunobi, a few minutes ago you said there was over a
billion dollars that had not been drawn down.
Dr. Agwunobi. Approximately, sir.
Mr. Etheridge. Approximately. But here you are talking
about HRSA and CDC grants because only 350 million has been
appropriated for pandemic flu. Can you be more specific about
what funding stream you are talking about?
Dr. Agwunobi. If I may, let me clarify. Since 2001 the
Federal Government has been investing in State and local public
health preparedness, getting the public health infrastructure
to the point that it can respond to public health emergencies,
all hazard-type emergencies. That funding has been about $6.7
billion since 2001, of which approximately a billion dollars
has yet to be drawn down by the States.
In actual fact, in this latest budget request that the
administration has brought forward, we have an additional $1.3
billion that we propose to invest in public health
preparedness, including surge capacity in hospitals, public
health response to emergencies. This is before the investment
in pandemic influenza preparedness, the $7.1 billion, of which
350 is focused on exercising and the development of plans such
as distribution plans, the spreading of plans down into
communities.
Mr. Etheridge. Part of the recognition was that the public
health infrastructure across this country was in horrible shape
was a reason a lot of this money was put in place; I think that
is correct, is it not?
Dr. Agwunobi. I recognize that that was probably one of the
reasons Congress decided to invest in the public health
infrastructure of our Nation.
Mr. Etheridge. Yes. Can you also tell us how much of the
350 million allocated to the States has been drawn down thus
far?
Dr. Agwunobi. We have actually distributed a hundred
million already. I am not sure it has been actually spent. They
are working on it. The remaining 250 million will come out
later, I think within the next few months, with detailed
guidance on what we are expecting the plans and the exercises
to do for each State, what we are expecting them to be left
with when they are done.
Mr. Etheridge. Any one of you or all can respond to this
because this is a challenge we face when we talk about getting
information to the public and them believing it. Two years ago
when we had a shortage in the regular flu vaccine and the
President had to go on TV and say well, we don't have enough so
those of you who are healthy just don't take the flu shot, and
here we are talking about a pandemic that is very serious, can
have catastrophic affects if it happens.
The point is how do we make the public believe us when we
can't be prepared for the regular flu and we say to folks well,
just don't take a shot, those of you that are healthy, do the
best you can.
Dr. Agwunobi. This conversation and the many others like it
that are happening around the Nation, both at the State and
locals level, are an essential part of that dialogue. We are
one of the first generations this planet has ever seen that has
the ability to stand before a pandemic occurs in preparation
for it, and it allows us the opportunity to have these
discussions and to better educate the public as to the
realities of pandemic preparedness and what it takes to be
prepared.
And so I think, as my colleague Dr. Runge just stated, a
better educated public is a public far more likely to respond
appropriately to the threat when it occurs.
Dr. Runge. If I could also add to that, Congressman
Etheridge. I have been talking a lot when we talk about flu
preparation about collateral benefits, and I think that bolting
together the public health community and the homeland security
community in every State really puts us in a much better
position to handle any sort of biological threat.
In this case this vaccine technology is as much about
seasonal flu as anything else. If we do this right, if we gear
up our vaccine manufacturers, if we invest in industry, if we
get cell-based or DNA-based vaccines into industrial production
and have universal vaccine every year for seasonal flu, we will
save 30,000 lives a year.
To me, this is Y2K, that is fine; I had a brand new
computer on my desk January 1st of 2000. What we are interested
in here is the collateral benefits that this brings with us.
Mr. Etheridge. Do I take that to be an indication there
will be an adequate amount of flu vaccine this winter?
Dr. Agwunobi. Sir, this notion of the ability to deliver
300 million vaccines within 6 months is a strategy that
inherently provides us with the guarantee down the road--
perhaps guarantee is a little strong given in--
Mr. Etheridge. How far down the road? When people talk
about the flu--
Dr. Agwunobi. Our 3 to 5-year strategy is that we would
have the capacity to not only address a pandemic but therefore
to address the seasonal flu needs of our States.
One last point on that. The issue is not just vaccine
manufacturing and stockpiling, whether it be for seasonal or
pandemic, it is also about distribution. Ours is a plan today,
this work we are doing with States, that would improve that
aspect of the seasonal flu dilemma as well.
Mr. Etheridge. Thank you, Mr. Chairman. I want to say for
the last couple of years it hasn't been distribution, it has
been supply.
Dr. Agwunobi. A little of both, perhaps.
Mr. Linder. Thank you.
Ms. Norton.
Ms. Norton. Thank you, Mr. Chairman. I regret I couldn't be
here for all the testimony. I have a very special interest
here. My district, your Nation's Capitol, suffered the worst of
the anthrax biological attack and frankly I have in mind what
could happen; that Members could be here, the entire Federal
presence, certainly the Cabinet agencies are here, and somehow
the word could come that something had been spotted and
everybody should stay where they are and I could understand
that.
I for one don't expect the government to have an instant
answer here and indeed some people have speculated that this
isn't going to happen at all and this is all much ado about
nothing. They have gotten us all excited. I think you certainly
have got to respond as if this were going to happen tomorrow.
This is my concern, and perhaps I have not gotten the
information, but as I understand it, particularly with the
minimal number of doses of anti-viral and of vaccine, of
Tamiflu and the like, some kind of decision is going to have to
be made about who gets what, particularly in a district like
this.
Now I have always thought you always give it to the people
who are the first responders, but that apparently is not
necessarily the case here. I have been very confused by
reports. One report said the notion that the old and the infirm
and the disabled should get medicine first perhaps should not
apply here, maybe that the young should get them.
But my understanding is that there has been no
recommendation from the government concerning that matter. Is
that true? Have you nothing to advise us about who should get
what in case the word comes that we do have the virus in some
form in this country?
Dr. Agwunobi. A prominent advisory panel, ACIP, has issued
guidelines. They issued them last year, and they are actually
written in the HHS plan that was originally--
Ms. Norton. That is an advisory panel of who?
Dr. Agwunobi. Advises the Centers for Disease Control, the
Immunization Practice Advisory Council, and they provided
guidance that was placed in the HHS plan back in October.
One of the importance things that I think we need to talk
about as we talk about this is the fact that seasonal flu, the
seasonal flu virus, as you know, goes after the elderly and the
frail, the infirm and the very young. They are its primary
target in terms of its ability to hurt our citizens.
The 1918 pandemic, on the other hand, that virus went after
the young, strong, healthy individuals in our community.
The point that I am trying to make is that until we see the
pandemic virus itself, we won't know specifically which groups
are most at risk. Now on top of that there is a growing body
of--I don't know if it has a body of science, but there is
recent modeling that seems to indicate that there might be a
number of different strategies for addressing a pandemic.
Ms. Norton. If I could just pause, the 1918--the notion
that it went after the young and the healthy and the strong at
a time when there were 12-hour working days and the people were
out there associating with one another is one thing. People
died earlier. I am not sure I would be instructed by that to in
fact conclude that it did not go after the elderly.
Dr. Agwunobi. We really don't have a lot of evidence as to
where this is going to go. We know H5N1 today in the human
beings it has affected seems to have a predilection for the
young and for younger members of a family. The question is, is
that inherent with the virus or something to do with the way
they interact with lifestyle?
The bottom line is there is a debate right now that we are
encouraging around the Nation both in scientific circles and
the community as we try to get a sense of what are the
priorities that this community values, our Nation values, what
is science really telling us about this.
I will end by saying that the scientific bottom line on
this isn't in yet.
Ms. Norton. Understanding that, does the government, given
the state of knowledge, have any advice for the States and
localities who certainly don't have as much as you do about who
should get the anti-viral first, who should get the vaccine
first, even understanding you don't have anything like perfect
knowledge? Are really people supposed to guess at the local
level on their own? What is your advice to local jurisdictions?
Dr. Agwunobi. Our health and human services plan contains
guidance. We are urging each local jurisdiction as they develop
their plan to start with that guidance but to have a
conversation in their community.
Ms. Norton. I am trying to find out what that guidance is
in general terms.
Dr. Agwunobi. I will be sure to on the record submit it to
you. It is fairly detailed and it lays out a number of
different categories, including first responders and the
elderly and the like, and I will be sure to submit to you a
copy.
Ms. Norton. I wish you would because the press says you all
have no recommendations of the kind you ordinarily give
concerning who should get it. So everybody thinks that the
people who have to administer to the sick should always get it.
Dr. Agwunobi. That guidance is available on
www.pandemicflu.gov. It is readily available. We are urging
people not to stop there. We are urging people to have a
conversation both at the science level and in the communities
at what the priority should be.
Ms. Norton. I take that to mean that you don't--if people
are having a conversation, it is one thing to have a
conversation and to say you may change these priorities,
because they really may differ. It is another thing not to have
any recommendations at all from the Federal Government.
Mr. Linder. Will the gentlelady yield?
Ms. Norton. Yes, sir.
Mr. Linder. This week's Science Magazine on page 855:
Priorities for distribution of influenza vaccine.
We will get you a copy of that.
Ms. Norton. Okay. All right. Well, I would think that one
of the things we ought to do since some of the press is running
that you don't have any recommendations, and I think you are
doing the right thing to say to local jurisdictions make sure
you have your own plan. Really, given the limited amount of
anti-viral vaccine that is there, we really do need to tell
people in advance that while your local jurisdiction may
differ, and here my colleague is just giving me something here
that says health care workers with direct patient contact and
so forth, so we don't have people calling our offices to say
how come I am not getting it, I am pregnant. If they know the
Federal Government has advised this or it can be change in your
local jurisdiction, then at least people understand because
they trust the Federal Government to somehow have looked at all
the possibilities, all of the options to come to this
conclusion.
Mr. Dicks. They will call our offices, no matter what.
Ms. Norton. I would like to minimize those in the District
of Columbia at the very least. Thank you very much, Mr.
Chairman.
Mr. Linder. Thank you. I want to thank the witnesses for
their testimony today and the members for their questions.
Members may have additional questions, and we would ask you to
respond to these in writing. The hearing record will be held
open for 10 days.
Without objection, the committee stands adjourned.
[Whereupon, at 3:55 p.m., the committee was adjourned.]