[Senate Hearing 109-628]
[From the U.S. Government Publishing Office]



                                                        S. Hrg. 109-628
 
                   AVIAN INFLUENZA: ARE WE PREPARED?

=======================================================================

                                HEARING



                               BEFORE THE



                     COMMITTEE ON FOREIGN RELATIONS
                          UNITED STATES SENATE



                       ONE HUNDRED NINTH CONGRESS



                             FIRST SESSION



                               __________

                            NOVEMBER 9, 2005

                               __________



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                     COMMITTEE ON FOREIGN RELATIONS

                  RICHARD G. LUGAR, Indiana, Chairman

CHUCK HAGEL, Nebraska                JOSEPH R. BIDEN, Jr., Delaware
LINCOLN CHAFEE, Rhode Island         PAUL S. SARBANES, Maryland
GEORGE ALLEN, Virginia               CHRISTOPHER J. DODD, Connecticut
NORM COLEMAN, Minnesota              JOHN F. KERRY, Massachusetts
GEORGE V. VOINOVICH, Ohio            RUSSELL D. FEINGOLD, Wisconsin
LAMAR ALEXANDER, Tennessee           BARBARA BOXER, California
JOHN E. SUNUNU, New Hampshire        BILL NELSON, Florida
LISA MURKOWSKI, Alaska               BARACK OBAMA, Illinois
MEL MARTINEZ, Florida
                 Kenneth A. Myers, Jr., Staff Director
              Antony J. Blinken, Democratic Staff Director

                                  (ii)




                            C O N T E N T S

                              ----------                              
                                                                   Page

Biden, Hon. Joseph R., U.S. Senator from Delaware................    39
    Prepared statement...........................................    42
Dobriansky, Hon. Paula J., Under Secretary for Democracy and 
  Global Affairs, Department of State, Washington, DC............    14
    Prepared statement...........................................    16
Fauci, Dr. Anthony S., Director, National Institute of Allergy 
  and Infectious Diseases, National Institutes of Health, 
  Department of Health and Human Services, Bethesda, Md..........    30
    Prepared statement...........................................    32
Frist, Hon. Bill Frist, U.S. Senator from Tennessee..............     3
    Prepared statement...........................................     5
Garrett, Laurie, Senior Fellow for Global Health, Council on 
  Foreign Relations, New York, NY................................    75
    Prepared statement...........................................    78
Gerberding, Dr. Julie, Director, Centers for Disease Control and 
  Prevention, Department of Health and Human Services, Atlanta, 
  GA.............................................................    21
    Prepared statement...........................................    23
Lugar, Hon. Richard G., U.S. Senator from Indiana, opening 
  statement......................................................     1
Natsios, Hon. Andrew S., Administrator, U.S. Agency for 
  International Development, Washington, DC......................     7
    Prepared statement...........................................    10
Newcomb, James, Managing Director of Research, Bio Economic 
  Research Associates, Cambridge, MA.............................    63
    Prepared statement...........................................    66

   Additional Statements and Questions and Answers Submitted for the 
                                 Record

Boxer, Hon. Barbara, U.S. Senator from California, prepared 
  statement......................................................    95
Chan, Dr. Margaret, Assistant Director General, Communicable 
  Diseases, World Health Organization, prepared statement........    87
Feingold, Hon. Russell D., U.S. Senator from Wisconsin, prepared 
  statement......................................................    95
Answers to Questions Submitted for the Record by the following 
  Senators:
    Senator Joseph Biden.........................................    96
    Senator Barbara Boxer........................................   110
    Senator Barack Obama.........................................   116

                                 (iii)

  


                   AVIAN INFLUENZA: ARE WE PREPARED?

                              ----------                              


                      WEDNESDAY, NOVEMBER 9, 2005

                                       U.S. Senate,
                            Committee on Foreign Relations,
                                                    Washington, DC.
    The committee met, pursuant to notice, at 9:35 a.m., in 
room SD-419, Dirksen Senate Office Building, Hon. Richard G. 
Lugar (chairman of the committee) presiding.
    Present: Senators Lugar, Chafee, Murkowski, Biden, 
Sarbanes, Dodd, Feingold, and Obama.

 OPENING STATEMENT OF HON. RICHARD G. LUGAR, U.S. SENATOR FROM 
                            INDIANA

    The Chairman. This meeting of the Senate Foreign Relations 
Committee is called to order.
    The committee meets today to examine the steps being taken 
by the United States Government and the private sector 
healthcare providers and the international community to prevent 
and to prepare for a possible human pandemic of avian 
influenza.
    International health experts believe the stage is set for a 
possible worldwide influenza pandemic originating in Southeast 
Asia. A new strain of bird flu, H5N1, is killing millions of 
birds and Asian poultry flocks. This last Friday, another major 
outbreak was reported in China. The disease has killed about 60 
people, or about half of those known to have been infected. 
Humans have no immunity to this strain. The only obstacle to a 
pandemic is that H5N1 has not yet mutated to a form easily 
transmissible from human to human.
    If that happens, and if the new virus is roughly as 
contagious and lethal as the deadly 1918 Spanish Flu, as many 
experts fear, the disease could quickly sweep the globe. In a 
worst-case scenario, casualties would be in the millions in our 
country, and in the tens of millions worldwide. Hospitals and 
healthcare systems would be overwhelmed. Large numbers of 
workers could lose their jobs as customers stay home and 
economies contract, and governments around the world would be 
destabilized.
    We cannot be certain that such a pandemic will occur, or 
predict its timing or its severity. If we are lucky, the H5N1 
virus will not turn into a human pandemic. But experts say that 
based on historical patterns, we are overdue for a major flu 
pandemic outbreak. If it is not caused by H5N1, then some other 
pathogen may be the source. The human and economic consequences 
of a pandemic could be so severe that we cannot rely on luck. 
Prudence requires we prepare, in the short term, as if an H5N1 
outbreak is probable. Furthermore, we must rebuild our vaccine 
production and infrastructure, strengthen international health 
cooperation, and take other steps for the long term.
    I am pleased the administration, last week, issued its 
long-awaited national pandemic plan. However, I am concerned 
that, up to that point, the administration's response to avian 
influenza had been underfunded and behind schedule. Five years 
have passed since the GAO recommended that the Department of 
Health and Human Services complete the national pandemic plan. 
It's been nearly a year since Tommy Thompson, as departing 
Secretary of HHS, expressed ``grave concern'' about avian 
influenza. Other countries, such as Canada and Japan, seem to 
be much farther along in their preparation and have had 
national plans in place for some time.
    The President must make clear now who is in charge of 
mobilizing government preparedness efforts, and he must give 
that person his vocal and sustained support. The President will 
find many willing partners in Congress for this endeavor.
    With no plan forthcoming, in February Senator Obama and I 
added $25 million to the State Department authorization bill 
for an avian flu initiative. In June, we coauthored an article 
in the New York Times calling for the Government to promptly 
take the leadership role. The Foreign Relations Committee staff 
has met with an array of experts, including Dr. Margaret Chan, 
the World Health Organization's lead pandemic official, and I 
have written to HHS Secretary, Mike Leavitt, asking for 
updates. Along with eight other Senators, I cosponsored Senator 
Obama's pandemic legislation, S. 969, one of several bills 
attempting to strengthen our response to the threat of avian 
influenza.
    In September, still lacking a final plan from the 
administration, the Senate voted to add $3.9 billion for 
civilian pandemic preparedness to the Defense Department 
appropriations bill. Two weeks ago, to ensure that pandemic 
preparedness funds do not get sidetracked by procedural 
disputes, the Senate added $7.9 billion to the Labor-HHS 
appropriations bill--more than the $7.1 billion the 
administration said last week it would request.
    The pandemic threat is a problem of many dimensions that 
will require coordination between many government agencies. Are 
the countries of Southeast Asia sufficiently equipped and 
motivated to stamp out the bird flu among their poultry 
populations, which would reduce the chance that the virus will 
mutate into a human pandemic form? We will need to know, as 
soon as possible, when the virus becomes easily transmissible 
between people. Do countries such as China, Burma, and Laos 
have reliable, countrywide disease reporting systems and 
laboratory facilities to make prompt diagnoses? How can we 
assist in this process?
    If a human outbreak is detected, will it be feasible to 
contain it in a small area for a sufficient period of time to 
allow the rest of the world to take protective measures? What 
arrangements, if any, have been made for the international 
sharing of scarce antiviral drugs and the new, still unproven 
H5N1 vaccine? The administration's proposal does not appear to 
allocate much money for preventing or stopping pandemic 
influenza at its source, which as Dr. Donald Burke of Johns 
Hopkins University noted in an article last week, would be much 
more cost effective than waiting until it gets to our shores.
    If the pandemic does reach the United States, how much 
medicine and vaccine will be available? Who will get priority? 
And how will these vaccines and treatments be physically 
distributed? What steps will the Government take to restrict 
the spread of the disease? Banning international travel, 
closing schools, canceling all public events, or declaring a 
national stay-at-home holiday period are among measures 
suggested by experts. If many thousands of people in a 
metropolitan area become very ill with flu over a short period 
of time, as some fear, how will hospitals and emergency rooms 
handle the overwhelming surge of patients?
    In 2003, a SARS outbreak in Southeast Asia killed 800 
people, a relatively small number compared to the casualties 
expected in a flu pandemic. Nevertheless, SARS caused great 
fear and a sharp economic downturn in several Asian nations. 
Are American businesses prepared if a large number of workers 
and customers don't show up for an extended period? Will 
workers be able to, or willing to, keep transportation, 
electricity, phone, and water systems operating and 
supermarkets stocked? In this era of globalization, how will 
international trade be affected? Have the many businesses that 
rely on regular deliveries of materials from overseas or 
elsewhere made plans for possible supply-chain disruptions?
    We will try to answer some of these questions. We have 
assembled two distinguished panels to help assess the current 
state of preparedness and, more importantly, to discuss the 
next steps that our Government, the international community, 
businesses, and private individuals should take.
    On our first panel, we welcome Dr. Paula Dobriansky, Under 
Secretary of State for Democracy and Global Affairs; Dr. 
Anthony Fauci, Director of the National Institute of Allergy 
and Infectious Diseases at the National Institutes of Health; 
Dr. Julie Gerberding, Director of the Centers for Disease 
Control and Prevention; and Mr. Andrew Natsios, the 
Administrator of the United States Agency for International 
Development.
    On our second panel, we welcome Ms. Laurie Garrett, senior 
fellow for Global Health at the Council on Foreign Relations, 
and Mr. James Newcomb of Bio Economic Research Associates.
    We thank all of our witnesses for coming this morning. We 
look forward to their insights.
    Let me say that, at the time that Senator Biden comes to 
the hearing, he will be recognized for an opening statement, if 
he has one. The majority leader, Dr. Frist, is here.
    Dr. Frist.

   STATEMENT OF HON. BILL FRIST, U.S. SENATOR FROM TENNESSEE

    Senator Frist. Thank you, Mr. Chairman. I'll be very, very 
brief. I did want to really come by to pay my respects for this 
committee, the leadership that you have shown, the leadership 
that both panels have shown, addressing an issue that we can't 
predict with any degree of accuracy. But we know the downside, 
the devastation, the destruction that can occur if we are not 
adequately prepared. And today, in spite of all of the 
intentions and great work that everybody has done, we are not 
adequately prepared.
    Last week, the President unveiled his plan to prepare the 
Nation against a threat of avian flu, and I want to thank the 
President and his Cabinet and the entire administration for 
their leadership in addressing this threat.
    I also want to pay my respects and applaud the work of the 
Department of Health and Human Services, led by Secretary 
Leavitt. I am pleased with these initiatives on behalf of the 
administration.
    During the address that Secretary Leavitt gave at the 
National Press Club, he used the illustration, or the analogy, 
of a spark in a dry forest. And I think that's an accurate 
analogy, a spark which, if you catch it early on, you can crush 
it, you can put it out; but if it's allowed to fester at all, 
it can leave and start lots of little sparks throughout that 
forest and take it down.
    If we can, using that analogy, detect, early on, and 
identify and contain a pathogen, a virus before it spreads, we 
will be able to save millions of lives. And, again, we talk a 
lot about these huge numbers of lives that can potentially be 
lost, and they are real, and we need to address it right up 
front. That's why I thank you for having this hearing today.
    H5N1 shows no signs of fading. We'll hear testimony today, 
the impact here. It's infected or caused the killing or culling 
of over 200 million birds. On Monday, we learned that two new 
human cases--a 19-year-old woman and an 8-year-old brother--
have been infected, bringing the total number of human cases to 
124, 63 of which have been fatal. That is because, in large 
part, it is a virus to which we have no immunity. Nobody in 
this room has immunity to this virus. I just got my flu shot 
earlier this morning, and I'm sure the first question people 
are asking, ``Is that protective?'' And the answer is, ``No.'' 
And, indeed, we have no natural immunity to this H5N1 virus.
    A second component is that infected hosts, we believe, are 
going to be contagious, or infectious, where they can spread 
the disease before they actually have symptoms; something very 
different than SARS or the other more recent viruses that we 
have addressed.
    Today, we lack our best defenses. We lack ample 
surveillance, effective vaccines. We lack a robust antiviral 
stockpile. And until we address the current preparedness gaps 
and challenges, we're going to remain unprepared. And we'll 
hear a little bit today about how we must do that.
    Several observations that I'd like to make is that we do 
have no single authority within the Federal Government 
responsible for advanced research and development of 
countermeasures. There is no clear coordination--or, I would 
say, there is inadequate coordination today among Government 
and industry and academia. Some good things going on, but, I 
think, inadequate to meet the real challenge that is out before 
us. The liability risk we'll be talking about, I'm sure, 
associated with manufacturing and administering the 
countermeasures prevent needed vaccines and drugs from being 
developed or deployed. And that's an immediate concern with 
H5N1 vaccine. If it hit today, how long would it take to 
produce 50 million doses of vaccine? And the answer is: Too 
long. In the Spanish flu, in 1918, more people died in 24 weeks 
than died in HIV/AIDS in its history, in 24 years of HIV/AIDS.
    But I'm confident that, under the President's leadership 
and the bipartisan effort represented by this committee, that 
we can better prepare against these threats that we all know 
are out there, as well as new and emerging threats that we 
cannot yet predict.
    The prices that are paid are more significant than have 
been outlined, I think, which is the importance of hearings 
like this. There's devastating loss of life, but, as the 
chairman mentioned, huge economic impact that we saw just a 
sampling of with SARS, where you have a shutdown both on the 
demand and the supply side of our economy with a fall in GDP, a 
potential donut hole taken out of the most productive people of 
our society.
    The global pandemic, it's a global issue, and that's why 
it's important for it to be before this committee. In fact, in 
all likelihood, H5N1, nobody really knows, is not going to 
start here; it's going to start overseas somewhere, if you 
played the odds. This hearing is particularly timely. Other 
committees are working very hard. The Health, Education, Labor 
and Pension Committee, and, as you mentioned, other areas of 
appropriating appropriate funds, are being addressed.
    So, I'm really here to support the work of this committee. 
I want to congratulate you and Ranking Member Senator Biden in 
putting this hearing together. And I think we all, at the end 
of the day, have to remember that there is no higher duty 
than--for Government--than to protect the health, well-being, 
and security of the American people.
    [The prepared statement of Senator Frist follows:]

   Prepared Statement of Hon. Bill Frist, U.S. Senator From Tennessee

    Mr. Chairman, Senator Biden, let me begin by thanking you for your 
efforts on this important topic.
    Last week, the President unveiled his plan to prepare the Nation 
against the threat of avian flu. I want to thank the President for his 
leadership.
    I also want to acknowledge the work of the Department of Health and 
Human Services led by Secretary Leavitt. I am pleased that both the 
President and Secretary Leavitt recognize the urgency of taking 
aggressive action.
    During an address Secretary Leavitt made at the National Press 
Club, he used the following illustration: A vast dry forest only needs 
one spark to set it on fire. If we're close to where the spark ignites, 
we can stamp it out. But if it's allowed to spread, it will grow beyond 
containment, leaving the forest in smoldering ruins. In other words, if 
we can detect, identify, and contain a viral pathogen before it 
spreads, we'll save millions of lives.
    This is why I have been proud to join you both in cosponsoring the 
Global Pathogen Surveillance bill that will be absolutely critical in 
this capacity.
    H5N1 avian influenza shows no signs of fading. It has infected more 
people and more poultry than any previous strain. It continues to 
extend its geographic reach with outbreaks in 16 countries.
    On Monday, we learned of 2 new human cases--a 19-year-old woman and 
her 8-year-old brother--bringing the total number of human cases to 
124--63 of which have been fatal. And, hundreds of millions of birds 
have died or been culled. This is a virus for which we have no natural 
immunity. Infected hosts are contagious before they are symptomatic. 
And, as the virus mutates, the odds of human-to-human transmission 
multiply.
    Yet, we lack our best defenses: Ample surveillance, effective 
vaccines, and a robust antiviral stockpile. And, until we successfully 
address our current preparedness gaps and challenges, we will remain 
unprepared.

   There is no single authority within the Federal Government 
        responsible for the advanced research and development of 
        countermeasures.
   There is no clear coordination and collaboration among 
        government, industry, and academia.
   The liability risks associated with manufacturing and 
        administering countermeasures prevent needed vaccines and drugs 
        from being developed or deployed--an immediate concern with the 
        H5N1 vaccine.
   And, the United States lacks strong domestic vaccine and 
        antiviral manufacturing capacity. Focusing solely on avian flu, 
        there is only one vaccine manufacturer with production 
        facilities in the United States. And, this same company 
        produces the regular influenza vaccine as well as some 
        childhood vaccines.

    I'm confident that with the President's leadership and a bipartisan 
effort here in Congress we can better prepare America to defend against 
the threats we know of, as well as new and emerging threats.
    Failure carries a price more significant than most have fully 
considered--not only will it bring a devastating loss of life, but it 
will render a powerful blow to our economic and national security. 
Therefore, it is imperative that Congress consider these implications 
of a global pandemic and act boldly and decisively. I am proud to say 
that the Senate is heeding the warnings.
    Today's hearing is particularly timely. And other committees are 
well along in considering policies to improve our preparedness and 
response capabilities.
    For example, last month the Senate HELP Committee--under the steady 
leadership of Senator Burr--reported out comprehensive biodefense 
legislation. And we have passed two appropriations measures to bolster 
our antiviral stockpiles and vaccine development.
    I continue to work with my colleagues on this critical piece of 
legislation and look forward to its swift consideration by the U.S. 
Senate.
    Let us all remember: We have no higher duty than to protect the 
health, well-being, and security of the American people.

    The Chairman. Well, Mr. Leader, we're really pleased and 
honored that you've come. It's a very, very important subject, 
one to which you've devoted, already, a good bit of your 
talents and your time. And we count on your leadership.
    Yes, Senator Dodd.
    Senator Dodd. I had just a question for the Leader, because 
I think--your sense of the importance of the timing of all of 
this--obviously, you're here not only as a witness, but also as 
our leader--is there a sense of emergency about this that we 
ought to be grasping, as an institution?
    Senator Frist. Yes. I do believe that we absolutely must 
address--the difficulty is the lack of predictability----
    Senator Dodd. Right.
    Senator Frist [continuing]. As to when we're going to have 
a pandemic. We're going to have pandemics. But we are 
unprepared. So, whether it's going to happen in the next few 
months--and most people say, ``Well, probably not''--again, 
just statistically. But it could.
    Senator Dodd. Yeah.
    Senator Frist. We're totally unprepared. And, therefore, 
knowing that, and knowing that our obligation, our first and 
foremost thing that we need to do--the security, mortality, 
death, life--when you have a threat this big----
    Senator Dodd. Yeah.
    Senator Frist [continuing]. That the scientific experts 
agree is going to be coming, we need to act. We need to act 
in--before we get out, Thanksgiving.
    Senator Dodd. Thanks.
    The Chairman. Thank you very much, Senator Dodd, for your 
question, and for your response, long before we get to the 
hearing.
    Senator Dodd. I apologize, but----
    The Chairman. No, it was timely, and we have work to do 
here, which I think our witnesses will stimulate this morning.
    I'd like for you to testify in this order. First of all, 
Mr. Natsios, then Secretary Dobriansky and Dr. Gerberding, and 
then Dr. Fauci. And your statements will all be made a part of 
the record completely, so you need not ask for permission that 
occur; it will happen. And please summarize, perhaps within 
about a 10-minute period, but we'll not be restrictive.
    Dr. Natsios, would you proceed, please.

STATEMENT OF HON. ANDREW S. NATSIOS, ADMINISTRATOR, U.S. AGENCY 
         FOR INTERNATIONAL DEVELOPMENT, WASHINGTON, DC

    Mr. Natsios. Thank you, Senator.
    I do have a much longer statement for the record, as you 
just mentioned.
    Senator Lugar, Senator Dodd, Senator Frist, and members of 
the committee, I'd like to thank you for convening this 
important hearing on avian influenza and for inviting me and my 
colleagues to testify.
    I do want to thank you, Senator Lugar and Senator Obama, 
for putting avian influenza into the--I believe it was the 
tsunami supplemental--$25 million to begin the effort. That did 
make a great deal of difference in our ability to begin the 
pilot programming and the program design that we are now going 
to scale up once the larger appropriation goes through.
    H5N1 mainly affects birds. At the present time, the risk to 
human beings is low, because avian influenza viruses do not 
usually infect humans. However, there is growing concern that 
the virus could mutate and spread rapidly from human to human, 
placing millions of lives at risk. There is, as yet, no 
evidence of efficient human-to-human transmissions. 
Nevertheless, mounting an effective response at this stage is 
paramount to halting the spread of this virus in Asia, and, 
thus, preventing what could turn into a pandemic.
    Under the leadership of Secretary Rice, my agency is 
helping countries prepare for a potential pandemic and respond 
to current animal outbreaks. Working in close coordination with 
our other U.S. Government partners, who are at the table, as 
well as the U.S. Department of Agriculture, USAID is supporting 
case detection and tracking animal outbreaks, so that we may 
act as rapidly as possible to put in place aggressive 
containment measures.
    USAID has reached out to all of the countries where we have 
USAID missions, as well as to nonpresence countries. There are 
80 countries where we have a mission, which means that there is 
at least one USAID Foreign Service officer on the ground, and 
another 40 countries--nonpresence countries--where there are 
NGOs or U.N. agencies, or contract agencies that are doing 
work, but there is no Foreign Service officer there. In terms 
of these programs, they're managed regionally.
    To date, we have requested detailed reports from 110 
countries for which USAID could potentially provide assistance. 
Of these, 102 have responded. The reports from our missions 
will serve as a baseline for measuring our programs 
operationally, and will guide our efforts in the coming year in 
mounting effective strategies to meet the threat of avian 
influenza as it evolves.
    Our response strategy is guided by the level of threat in 
each country. For instance, a country with animal infections, 
but no human infections, is at a lower level of threat than one 
with both animal and human infections. Countries with neither 
animal nor human infections are at the lowest level of threat. 
For example, in North and South America, there are no instances 
of any infection at this point; and so, they would be in 
category three, while the Asian countries are in category one, 
because they've had both human and poultry infections. So, they 
would be in the highest category. And then some European and 
Eurasian countries--Romania, Russia, Turkey, and Croatia among 
others--have now had some poultry infections, so they would be 
in category two, but there have been no human infections.
    And the way in which we will allocate the $131 million for 
USAID that is in the President's supplemental budget is based 
on this formula of the degree of risk. Countries will change in 
categories based on circumstances. So, this is not a static 
list.
    In support of the President's national strategy on pandemic 
influenza, the Agency is focusing on four key strategic 
principles. First is preparedness, second is surveillance, 
third is diagnostics and response, and fourth is public 
communication and public education.
    We have moved quickly to operationalize programming in the 
field. We expect that by the end of January 2006, the start of 
the flu season in Southeast Asia, multisector country 
preparedness plans will have been developed with USAID 
assistance, working with international organizations and other 
donors in Vietnam, Cambodia, Indonesia, and Laos. Because of 
endemic animal infections and confirmed human cases, these 
countries represent the greatest risk for human health.
    In addition, national communications campaigns promoting 
safe behavior will be underway in high-risk countries. By the 
end of February, early-warning systems and national response 
teams should be in place in the four countries to report 
outbreaks within 1 week of onset, and to confirm these 
outbreaks no later than 1 additional week. I might add that 
there are practices in some countries that facilitate spread of 
avian influenza--for example, in wedding ceremonies in certain 
Southeast Asian countries, ducks are slaughtered for cooking, 
and then they're given to the guests as just a ritual practice, 
and they drink, as a ritual matter, the duck blood. Well, that 
rapidly spreads the disease if the ducks are infected. And so, 
we need to educate the public that, while this is a traditional 
practice right now, it's very dangerous. And so, there's a 
series of measures, we hope, using the NGO networks we have and 
public communications and the Ministries of Health and U.N. 
agencies to get the message out on what behaviors need to 
change in order to reduce risk. For example, right now in 
Indonesia, USAID is connected into huge NGO networks. These are 
mostly local NGOs. There are 900,000 NGO workers who work for 
these NGO networks, and they are now going door to door in the 
agricultural areas of Indonesia to inform farmers about the 
best practices and safe behavioral patterns with respect to 
this disease.
    We project that a national program to vaccinate chickens 
and ducks will be completed by the end of February in Vietnam. 
Indonesia will benefit from the presence of an emergency team 
of experts, multiagency experts from the U.S. Government, as 
well as international institutions, from the establishment of 
local disease-control centers in hotspot areas. In addition to 
offering update information, these centers will train animal 
health technicians and veterinarians in how to expedite disease 
surveillance and control. With Indonesian authorities, they 
will help decide upon appropriate control measures, such as 
culling, vaccination, and biosecurity. They also provide 
support for animal health teams in their systematic house-to-
house search for diseased birds, which I just mentioned.
    By February, compensation options for farmers should be 
identified for Vietnam, Indonesia, Cambodia, and Laos. These 
options will help national governments, multilateral 
institutions, and others to design and fund programs to help 
farmers reduce the financial burden from losses to their 
flocks. Simply put, they are our first line of defense. Without 
farmers quickly reporting suspected deaths or cases of avian 
influenza, our efforts are handicapped from the outset at one 
of its most critical points. We are attempting to change the 
incentive here. The incentive right now is not to report it, 
because if they report one outbreak, all the animals are going 
to be killed, and the farmers will become impoverished. If we 
do not change that dynamic, people are not going to report 
information quickly. We need to change the incentive structure 
very rapidly.
    Pandemic preparedness training in the affected countries 
will also begin in February. This will give local officials a 
better understanding of the importance of transparency and 
responsiveness in the handling of reports of diseases.
    To date, USAID has obligated $13.7 million in FY 2005 to 
help prevent and contain avian influenza in Southeast Asia, 
where the largest impact of this epidemic has been felt. Ten 
million dollars of these funds were from the 2005 emergency 
supplemental, and I redirected $3.7 million from other USAID 
programs to this.
    On October 1, 2005, the President requested $7.1 billion to 
Congress to fund a comprehensive response. These supplemental 
funds requested in 2006 will build on, and expand, activities 
that were started in 2005. Specifically, USAID will strengthen 
animal and human surveillance, focus on behavior-change 
communications and response capacity in the most affected 
countries: Cambodia, China, Indonesia, Laos, and Vietnam.
    China is a significant poultry producer, which increases 
the risk of human infections, and they are on a major flyway of 
migratory birds. Let me just give you statistics that will show 
why we're at much greater risk than we were in the last 
pandemic.
    In 1968, there were 13 million domesticated poultry in 
China. There are 13 billion today. Thirteen million to thirteen 
billion. That can tell you why the risk of rapid disease spread 
is so much greater. As China has become wealthier, they want 
more protein in their diets, and that has consequences, in 
terms of their agricultural system.
    We'll also create a stockpile to contain outbreaks of H5N1 
among birds and potential outbreaks among people. The stockpile 
will be managed by USAID's Office of Foreign Disaster 
Assistance, which has expertise in warehousing and in logistics 
systems, and will contain personal protective equipment, 
disinfectants, antibiotics, steroids, ventilators with oxygen 
supply, and materials and equipment for communications. The 
stockpile will be sufficient to respond to two simultaneous 
outbreaks of populations of 100,000 people each.
    The first principle of good disaster preparedness and 
management is, that we may be allowed to hope for the best, but 
we must be prepared for the worst. This principle has guided 
our preparedness planning for the challenge of a potential 
outbreak. I would be happy to discuss with you in more detail 
the steps the agency has been taking since then.
    [The prepared statement of Mr. Natsios follows:]

   Prepared Statement of Hon. Andrew S. Natsios, Administrator, U.S. 
          Agency for International Development, Washington, DC

    Chairman Lugar, Senator Biden, members of the committee, I would 
like to thank you for convening this important hearing on avian 
influenza (AI) and for inviting me to testify. As of today, H5N1 
influenza strain mainly affects birds. There is, as yet, no evidence of 
efficient human-to-human transmission. Nevertheless, mounting an 
effective response at this stage is essential to halting the spread of 
this virus in Asia and preventing a pandemic.
    Our technical experts in Washington and the field are working with 
nations, as well as regional and international organizations, to 
prepare for a potential pandemic. USAID has reached out to all of the 
countries where we have missions as well as to nonpresence countries to 
assess the readiness of regional programs to respond to avian 
influenza. To date, detailed reports have been submitted for 98 
countries. These reports will serve as a baseline for measuring our 
programs and will guide our efforts in the coming year in mounting 
effective strategies to meet the threat of AI as it evolves.
    The Agency is working in close coordination with U.S. Government 
partners, in detecting cases and tracking animal outbreaks so that we 
may act as rapidly as possible to put in place aggressive containment 
measures that can prevent the spread of the disease. In this regard, it 
is imperative that we raise the profile of avian influenza to host 
governments so that we can help them undertake efforts to prevent and 
contain the spread of the virus.
    In support of the President's National Strategy on Pandemic 
Influenza, the Agency is focused on the following key principles:

   Preparedness;
   Surveillance;
   Diagnostics and Response; and
   Public Communication and Education.

                         STATUS OF THE DISEASE

    To date, AI has been responsible for 124 confirmed human infections 
with 63 fatalities. More than 200 million domestic poultry in Asia and 
Eastern Europe have died as a result of this avian influenza, or been 
culled or killed. The present threat mainly stems from animal-to-human 
transmission and has been mostly confined to Southeast Asia and 
southern China. But trends are worrisome.
    The recent expansion of AI into Russia and the Eurasia region by 
migratory birds underscores the sobering fact that the whole world is 
potentially at risk. During August 2005, the highly pathogenic H5N1 
strain of avian influenza was confirmed in poultry in parts of Siberia, 
Russia, and in adjacent parts of Kazakhstan. Both countries have 
reported deaths of migratory birds in the vicinity of poultry 
outbreaks. In October 2005 the presence of H5N1 avian influenza was 
confirmed in samples taken from domestic birds in Turkey, Romania, 
Croatia, Kazakhstan, and Russia.
    According to some experts, the migration of infected birds could 
possibly bring the virus to Africa in the coming weeks or months, as it 
follows migratory flight paths southwest from northern Russia to east 
Africa.
    It is important to note that no human cases have been reported in 
any of these newer outbreaks, although it is possible that suspect 
human cases have gone unreported. At the present time, the risk to 
humans is generally low because avian influenza viruses do not usually 
infect humans.
    Despite the limited spread of the virus from animals to humans, 
there is growing concern that this strain of the influenza A virus 
could evolve and spread efficiently from human to human, placing 
millions of lives at risk. If sustained human-to-human transmission 
occurs, our effectiveness in responding and containing the spread of 
the virus will be key to keeping the death toll at the lower end of 
projections.

                          SPECIFIC CHALLENGES

    Success in containing AI requires limiting animal infections. 
However, it is extremely difficult to contain animal infections since 
70 to 80 percent of poultry raised in Southeast Asia live on small, 
``backyard'' farms. We are facing a lack of awareness about the threat 
the virus poses to animals and humans alike in the communities that 
raise these animals. The fact that 50 to 80 percent of poultry deaths 
are from non-AI infections poses a further problem in getting small 
farmers to recognize and report die offs. Farmers who live at 
subsistence levels are also reluctant to report sick birds for fear of 
losing their entire flock to culling.
    The economic consequences of a tardy response could be devastating. 
The Asian Development Bank estimates that the SARS epidemic cost the 
business community some $60 to $80 billion in industries, hitting the 
airlines, manufacturing, and financial sectors particularly hard. The 
United Nation's Food and Agriculture Organization (FAO) estimates that 
AI has already cost private business as much as $10 billion. Should AI 
become easily transmissible between humans, the effects on business 
around the world would be disastrous.
    To effectively meet these threats, USAID, is working in partnership 
with international organizations and governments to bolster disease 
surveillance and testing capacity, draw up preparedness plans, and take 
other preventive actions to contain outbreaks.

                           THE USAID RESPONSE

    On May 11, 2005, President George W. Bush signed an emergency 
appropriations bill, which contained $25 million to prevent and control 
the spread of avian influenza. USAID was allocated a significant 
portion of this funding and is working in conjunction with the 
Department of Health and Human Services (HHS) and the U.S. Department 
of Agriculture (USDA) in developing nations around the globe to address 
the current H5N1 outbreaks within poultry and to prepare for a possible 
pandemic.
    The Agency has moved quickly to operationalize programming in the 
field. We expect that by the end of January, the start of the flu 
season in Southeast Asia, multisector country preparedness plans will 
be developed with USAID assistance in Vietnam, Cambodia, Indonesia, and 
Laos. In addition, national communication campaigns promoting safe 
behavior will be underway in the high-risk countries. By the end of 
February, early warning systems and national response teams should be 
in place in the four countries to report outbreaks within 1 week of 
onset and to confirm these outbreaks no later than 1 additional week.
    We project that a national program to vaccinate chickens and ducks 
will be completed by then in Vietnam. Indonesia will benefit from the 
presence of an emergency team of experts as well as from the 
establishment of local disease control centers in hotspot areas. In 
addition to offering up-to-date information, these centers will train 
animal health technicians and veterinarians in how to expedite disease 
surveillance and control. With Indonesian authorities, they will help 
decide upon appropriate control measures such as culling, vaccination, 
and biosecurity. They also provide support for animal health teams in 
their systematic, house-to-house search for diseased birds.
    By February, compensation options for farmers should be identified 
in Vietnam, Indonesia, Cambodia, and Laos. These options will be for 
national governments, multilateral organizations, and other sources to 
examine as it is critically important to reduce their financial burden 
from losses to their flocks. Simply put, they are our first line of 
defense and without farmers quickly reporting suspected deaths or cases 
of AI, our efforts are handicapped from the outset at one of its most 
critical points.
    Pandemic preparedness training in the affected countries are slated 
to begin in February. This will have local officials gain a better 
understanding of the importance of transparency and responsiveness in 
handling reports of disease.
    Also, by early to mid-2006, the training of active case detection 
teams will have occurred in Vietnam, Cambodia, Indonesia, and Laos. 
They will provide logistical support and ensure quality control for 
sample collections from both animal and human populations. Health 
workers will have completed technical education on identifying cases 
and minimizing their own risks. This will strengthen disease 
surveillance and laboratory diagnosis capacity.
    USAID is working closely with private sector partners as well as 
international organizations, including the World Health Organization 
(WHO) and the FAO. The Agency is also working with the office of the 
new U.N. coordinator for AI who will lead the efforts of the WHO and 
the FAO. We are helping assure that this global threat is met with a 
well coordinated and strategically appropriate global effort.
    As a concrete demonstration of this interagency and collaborative 
approach to our work on this crucial subject, last month USAID Global 
Health Assistant Administrator, Dr. Kent Hill, joined Under Secretary 
of State for International Affairs, Paula Dobriansky, and HHS 
Secretary, Mike Leavitt, on a fact-finding mission to Southeast Asia 
that included stops in Thailand, Cambodia, Laos, Vietnam, and 
Indonesia. The delegation saw firsthand the challenges we face on the 
ground, and urged national government leaders at the highest levels to 
work with us, in a spirit of transparency and open sharing of 
information, to contain the H5N1 virus in animals and prepare for an 
eventual human influenza pandemic. They also saw programs that are 
beginning to be the beneficiaries of our recent investments.
    In total, USAID obligated $13.7 million in FY 2005 to help prevent 
and contain avian influenza in Southeast Asia, where the largest impact 
of this epidemic has been felt. Ten million dollars of these funds were 
from the FY 2005 emergency supplemental and $3.7 million were 
redirected from other programs.
    USAID's Office of Foreign Disaster Assistance (OFDA) has 
prepositioned personal protective gear for local health and 
agricultural staff in Cambodia, Laos, Vietnam, Indonesia, and Thailand 
to be used in the case of an AI emergency. Agency experts are also 
working with FAO and WHO to help strengthen planning for AI control and 
pandemic preparedness, and working with the business community to 
increase the resources, expertise, and financing available for this 
effort.
    In addition, USAID is an active supporter of the International 
Partnership on Avian and Pandemic Influenza, which was announced by 
President Bush at the United Nations in September.
    At USAID's headquarters, I chair the Agency's Avian Influenza 
Preparedness and Response Task Force which meets weekly to consider 
urgent policy and budget issues. It includes representation from all 
Agency bureaus.
    In early October, I personally wrote to all of USAID's missions to 
signal avian influenza as the top agency priority, calling for each 
mission to engage national government and local partners on country-
level preparedness and readiness.
    I also established the Avian and Pandemic Influenza Management and 
Response Unit located in the Bureau for Global Health. This unit is 
responsible for day-to-day management and oversight of the Agency's AI 
activities, including providing direct technical and program support to 
the regional bureaus and field missions, liaising with other U.S. 
Government and international partners on AI, and identifying and 
reporting to the task force on key policy and budget issues that 
require senior level action.
    In the field, USAID missions around the globe are moving ahead 
rapidly with plans to address AI. Many are supporting U.S. Government 
and ministerial task forces, collaborating with international 
organizations, and working with FAO on animal surveillance.
    In addition to the multisector plans for Southeast Asia, USAID is 
also closely working with Ministries of Health and Agriculture and 
international organizations in Africa, Latin America and the Caribbean, 
and Europe and Eurasia to draft preparedness plans to include: 
Establishing sentinel surveillance sites for poultry flocks and wild 
birds; strengthening monitoring and reporting of human respiratory 
illnesses to rapidly identify unusual cases; reinforcing laboratory 
capacity to enable detection of AI, or identify labs, in nearby 
countries that can do testing.
    USAID is working aggressively to address imminent risks in Africa, 
especially the East African countries of Ethiopia, Kenya, and Tanzania 
to increase surveillance especially along trade routes. USAID missions 
are helping host governments to convene donors, establish task forces, 
and develop pandemic preparedness plans. In addition, USAID is 
redirecting its disease surveillance program to include a strong focus 
on detecting and diagnosing AI. And while the threat in West Africa is 
marginal now, it will increase in the spring when wild birds from east 
Africa travel and meet with birds from Europe.
    On October 31, Under Secretary of State for Global Affairs, Paula 
Dobriansky, joined USAID Africa Bureau Assistant Administrator, Lloyd 
Pearson, and Global Health Assistant Administrator, Dr. Kent Hill, and 
Avian and Pandemic Influenza Management and Response Unit Director, Dr. 
Dennis Carroll, at a USAID-sponsored meeting with 12 African 
Ambassadors to provide an update on AI and discuss responses.
    USAID's 16 missions in Latin America and the Caribbean are working 
with host governments and other partners to raise awareness and plan 
for a potential AI outbreak. This involves assessments of the pandemic 
preparedness of host countries, and technical consultations in 
cooperation with other U.S. Government agencies and the Pan American 
Health Organization (PAHO).
    In recent weeks, USAID quickly responded with our other U.S. 
Government counterparts to AI outbreaks in animal populations in 
Eastern European and Eurasian countries. We are providing technical 
assistance to develop and strengthen preparedness plans, conduct 
disease surveillance, and determine immediate needs to head off further 
outbreaks in the region.
    We are also beginning to work with the private sector on possible 
public/private partnerships. USAID's Global Development Alliance (GDA) 
is reaching out to corporations and talking to consumer product 
companies that employ community health advocates to incorporate AI 
information into their curriculum. Businesses can also help bring the 
message beyond the workplace, by educating communities where their 
facilities are located, and promulgating it through their distribution 
channels. USAID is in contact with companies in the poultry and animal 
feed industry to help them improve biosecurity measures and establish 
improved surveillance and control measures within their supply chains.

                               NEXT STEPS

    On November 1, 2005, President George W. Bush requested $7.1 
billion from Congress to fund a comprehensive response to AI. The 
request includes $251 million in support of international efforts to 
detect and contain outbreaks before they spread around the world.
    The budget request reflects a national strategy that is designed to 
meet three critical goals: First, detect and contain outbreaks that 
occur anywhere in the world; second, protect the American people by 
stockpiling vaccines and antiviral drugs, and improve the U.S. ability 
to rapidly produce new vaccines against a pandemic strain; and, third, 
to prepare for an effective response at the Federal, State, and local 
levels in the event that a pandemic reaches our shores.
    The first part of our strategy is to detect outbreaks before they 
spread across the world. In the fight against avian and pandemic flu, 
early detection is our first line of defense. USAID, in partnership 
with HHS, USDA, and the Department of State has been charged to lead 
the international effort. One hundred thirty million dollars of the 
request to Congress is for USAID programs to help our foreign partners 
train local medical personnel, expand their surveillance and testing 
capacity, draw up preparedness plans, and take other critical actions 
to detect and contain outbreaks.
    Specifically, USAID will strengthen animal and human surveillance, 
behavior change communications, and response capacity in the most-
affected countries--Cambodia, China, Indonesia, Laos, and Vietnam. 
Because of endemic animal infections and confirmed human cases, these 
countries represent the greatest risk for human health.
    USAID will also improve pandemic planning and animal surveillance 
in countries where H5N1 has been recently introduced or those at high-
risk of introduction because of bird migration patterns. These 
activities would be focused in Eastern Europe, Eurasia, the Near East, 
and Africa. Activities in Central and South America will focus on 
pandemic planning.
    We will also create a stockpile to contain outbreaks of H5N1 that 
have limited transmission among humans. The stockpile, to be managed by 
OFDA, will contain personal protective equipment, disinfectant, 
antibiotics, and steroids, ventilators with oxygen supply, and 
materials and equipment for communications. The stockpile will be 
sufficient to respond to two simultaneous outbreaks in populations of 
100,000 people.

                               CONCLUSION

    It should be underscored that as of today there is no evidence of 
efficient human-to-human AI transmission. This is not a moment for 
complacency, however, as the distinguished members of this committee 
well know. We may be allowed to hope for the best but we must be 
prepared for the worst. This has been an operating principle at USAID 
when I made the issue of avian influenza the number one priority at the 
Agency in September.

    The Chairman. Thank you very much, sir.
    Secretary Dobriansky.

  STATEMENT OF HON. PAULA J. DOBRIANSKY, UNDER SECRETARY FOR 
DEMOCRACY AND GLOBAL AFFAIRS, DEPARTMENT OF STATE, WASHINGTON, 
                               DC

    Ms. Dobriansky. Thank you, Mr. Chairman, Senator Dodd, 
Senator Frist, and committee members.
    Since diseases do not respect borders, an effective global 
response is critical. No country can fight avian influenza 
alone. Nations must join together to prevent an outbreak while 
preparing to contain and respond if avian flu begins to spread 
among people. Indeed, dealing with avian influenza before it 
reaches our borders is a necessary form of forward defense.
    Avian flu is not just a health matter, but an economic, 
security, and social issue. The social, economic, and political 
impacts of a virulent flu pandemic could be devastating. The 
2003 SARS outbreak cost more than 700 lives and some $80 
billion worldwide. This issue requires the involvement of not 
only Ministries of Health and Agriculture, but also Ministries 
of Foreign Affairs, Trade, executive offices of Presidents and 
Prime Ministers.
    Our framework for action features measures to support 
surveillance, preparedness, and response and containment. 
During the high-level segment of the U.N. General Assembly 
meeting on September 14, President Bush announced the 
establishment of the International Partnership on Avian and 
Pandemic Influenza to combat the threat of avian flu and 
improve global readiness. The partnership is a voluntary 
coalition built on a set of 10 core principles which call for 
enhanced preparedness, surveillance, transparency in the form 
of rapid reporting and the sharing of data and samples, and 
cooperation among partners and with several key international 
organizations, including the World Health Organization, the 
Food and Agriculture Organization, and the World Organization 
for Animal Health.
    The partnership is off to a good start. Senior officials 
from some 88 countries and 9 international organizations 
attended its inaugural meeting in early October and agreed to 
continue to exchange information and monitor progress in 
international efforts to combat avian flu. Three specific areas 
for further work were identified: Building stockpiles of drugs 
and supplies, with Canada in the lead; accelerating vaccine 
development and distribution, spearheaded by the United Kingdom 
with United States support; and implementing rapid response and 
containment measures with Japanese and Australian 
collaboration.
    To build upon the outcome of the partnership's senior 
officials meeting, we have used a number of regional and 
international gatherings to sustain the high-level attention 
devoted to this issue, to monitor developments, and to take 
concrete actions. For example, in October, Canada held a 
meeting of Health Ministers and focused on vaccine development 
and stockpiles. Last week, Australia hosted an APEC meeting on 
containment and response at which delegates agreed to conduct 
an in-region tabletop exercise and to create an inventory of 
experts to be drawn upon for rapid response and containment. 
The WHO organized an experts meeting specifically on vaccine 
development. And presently, in Geneva these last days and 
today, the World Bank, the WHO, and other international 
partners are discussing donor coordination and outreach to help 
Southeast Asian countries, as well as African countries.
    Diplomatic engagement is also important. The President has 
raised this issue, for example, with the Presidents of China, 
Indonesia, Russia, and the Prime Minister of Thailand, as did 
Secretary Rice at the United Nations G-8 ASEAN meeting and in 
her recent visit to Canada. In October, Secretary Leavitt and I 
traveled to Southeast Asia and met with senior government 
officials. And in the next week, APEC leaders will put forth 
several concrete actions.
    The President has charged the State Department with leading 
international activities of the U.S. national strategic for 
pandemic influenza. In doing so, we collaborate closely with 
HHS, CDC, NIH, USAID, and USDA and other technical agencies on 
surveillance, preparedness, and response and containment.
    Using the $37 million that HHS and USAID reprogrammed, we 
are already undertaking a series of activities. Just a few 
examples:
    On surveillance, we're training veterinary experts to 
monitor the virus in domestic and wild birds, and will be 
providing additional monitoring assistance to Southeast Asian 
countries.
    On preparedness, we are supporting the development of 
national pandemic preparedness plans and are helping 
governments conduct pandemic preparedness training and 
simulations.
    And, finally, on response and containment, we are training 
animal and human health professionals on rapid containment and 
prepositioning protective gear.
    These are just a few examples of our activities to date. We 
are planning to use the $250.8 million requested by President 
Bush for international activities to take further steps to 
detect and contain outbreaks before they spread around the 
world. We expect to use our international assistance to 
leverage additional funds from other donors.
    In the 2 months since its creation, the International 
Partnership on Avian Pandemic Influenza has already heightened 
international awareness and made addressing this issue a 
priority for nations. It has fostered closer collaboration 
among Agriculture, Health, Economic and Foreign Ministries. It 
has accelerated the placement of monitors in high-risk 
countries, catalyzed the development and deployment of 
comprehensive surveillance networks, increased donor commitment 
and coordination. We believe that our message of cooperation 
and common cause has resonated with many countries. They 
realize that the cost of taking action now is significantly 
less than the cost of a pandemic.
    At the meeting in Geneva this week, WHO Director General 
Lee estimated that some 120 countries now have, or have begun 
preparing, some form of avian flu preparedness plans. This is 
twice the number estimated just 1 month ago. Those plans will 
serve as the foundation on which national and regional 
surveillance networks will be built and strengthened. We are 
also hearing from the FAO and the OIE that at-risk countries 
are becoming increasingly transparent, sharing information and 
samples more readily than in the past. We will build on this 
solid foundation as the partnership progresses.
    Mr. Chairman, we look forward to working with you, your 
committee, and Congress on avian flu. I thank you for this 
opportunity to testify before the committee, welcome questions, 
and I, too, am submitting a longer version of my testimony for 
the record.
    Thank you.
    [The prepared statement of Ms. Dobriansky follows:]

  Prepared Statement of Hon. Paula J. Dobriansky, Under Secretary for 
   Democracy and Global Affairs, Department of State, Washington, DC

                              INTRODUCTION

    Mr. Chairman, thank you for the opportunity to discuss our efforts 
to create a global coalition, which seeks to improve global readiness 
against a possible outbreak of pandemic influenza. Since diseases do 
not respect borders, an effective global response is critical. No 
country can fight avian influenza alone. Nations must join together now 
to prevent an outbreak, while preparing to contain and respond if avian 
flu begins to spread among people. Indeed, dealing with avian influenza 
before it reaches our border is a necessary form of forward defense.
    Avian flu is not just a health matter but an economic, security, 
and social issue. The social, economic, and political impacts of a 
virulent flu pandemic could be devastating. The 2003 SARS outbreak cost 
more than 700 lives and some $80 billion worldwide. The Department of 
State is involved because the only way to avoid the much higher 
potential toll of a flu pandemic is in concert with other nations. This 
issue requires the involvement of not only Ministries of Health and 
Agriculture but also Ministries of Foreign Affairs and executive 
offices of Presidents and Prime Ministers. Our framework for action is 
predicated on measures in support of surveillance, preparedness, and 
response and containment.
The Partnership
    Recognizing this threat can only be averted through coordinated 
international effort, President Bush announced the establishment of the 
International Partnership on Avian and Pandemic Influenza in September 
during the high-level segment of the U.N. General Assembly meeting. The 
President's speech focused the attention of the world community on the 
need for timely and sustained high-level political leadership and 
concrete, cooperative action. Specifically, the Partnership's aim is to 
combat the threat of avian flu and improve global readiness by 
elevating the issue on national agendas; coordinating efforts among 
donor and affected nations; mobilizing and leveraging resources; 
increasing transparency and the quality of surveillance; and building 
local capacity to identify, contain, and respond to a pandemic 
influenza.
    The Partnership is a voluntary coalition built on a set of 10 core 
principles, which call for enhanced preparedness, surveillance, 
transparency in the form of rapid reporting and the sharing of data and 
samples, and cooperation among partners and with several key 
international organizations, including the World Health Organization 
(WHO), Food and Agriculture Organization (FAO), and the World 
Organization for Animal Health (OIE). Through the Partnership, 
countries have agreed to work together to develop the capacity to plan 
for, detect, prevent, and rapidly respond to an incipient epidemic. 
Specifically, these international partners have led global efforts to 
heighten surveillance in poultry and die-offs in migratory birds and 
rapid introduction of containment measures. Members have developed, or 
are in the process of developing, national preparedness plans, setting 
up surveillance networks, and working closely with the WHO, FAO, and 
OIE in the detection of outbreaks.
    I am pleased to report that the Partnership is off to a good start. 
In early October, the State Department hosted a well-attended meeting 
of the Partnership member countries. Senior officials from 88 countries 
and 9 international organizations participated actively in the plenary 
sessions and roundtables, and identified three priority areas for 
collaboration: Building stockpiles of drugs and supplies; speeding 
vaccine development and distribution; and implementing rapid response 
and containment measures. Several conclusions also emerged from these 
productive discussions: Recognizing that many countries lacked the 
capacity to prepare or respond to a pandemic, capacity-building is a 
priority. A number of participants stressed the need for communication 
and education strategies to raise public awareness and change behavior. 
Participants also emphasized the need for prompt reporting of suspected 
cases and for a coordinated international effort. They stated that, in 
addition to the health impacts of the pandemic, we must prepare for the 
economic and social effects, ensuring continuity of business 
operations, for instance.
    The Partnership is truly a cooperative effort. It includes not only 
U.N. agencies and international and regional organizations such as the 
World Health Organization, the Food and Agriculture Organization, the 
World Animal Health Organization, but the World Bank, the Asian Pacific 
Economic Cooperation forum, and the Association of Southeast Asian 
Nations. Significantly, a number of countries have taken leadership 
roles in several key areas. As a result of the Senior Officials 
Meeting, Canada agreed to spearhead follow-on discussions on 
stockpiling of vaccines and antiviral medicines as an important 
component of readiness. We undertook to work with the United Kingdom on 
a comprehensive strategy for vaccine research, development, and 
production. Australia and Japan agreed to collaborate on rapid response 
and containment, including the economic and social impacts of a 
pandemic. Since the October Senior Officials Meeting, all three of 
these working groups have moved forward.
Stockpiles
    In late October, Canada held a meeting of Health Ministers in 
Ottawa and put on the agenda the topic of stockpiles of antiviral 
medicines and vaccines. At the conclusion of the Ottawa meeting, the 
Ministers endorsed a communique stressing the urgent need for 
strengthening surveillance, a global policy on vaccine development, and 
coordinated risk communication. HHS Secretary Leavitt told the assembly 
that the involved countries and relevant international organizations 
would need to agree on a proper doctrine to govern rapid response and 
containment as a prelude to getting national commitments to the 
creation of an international stockpile. In addition, he called for 
holding a tabletop exercise, including simulated drug delivery, to 
enhance international understanding and communication on this important 
topic.
Rapid Response and Containment
    Australia used the Asia Pacific Economic Cooperation (APEC) avian 
influenza preparedness meeting on October 31 through November 1 to make 
progress on response and containment strategies. In addition to the 21 
APEC members, WHO, FAO, ICRC and the World Bank attended the meeting. 
Participants ageed to establish communication and information-sharing 
networks among experts in the region, build an inventory of regional 
resources and capabilities that could be provided to expert 
multilateral organizations for rapid response in the event of an 
outbreak, and conduct a regional desktop simulation in the first half 
of 2006 to test regional communication during a potential pandemic 
outbreak. Given that an influenza pandemic is most likely to emerge 
from Southeast Asia, the work begun at this meeting in Brisbane to 
enhance a regional rapid response capability is essential.
Vaccines
    On November 4-5, the World Health Organization hosted an experts 
meeting on the development of vaccines for pandemic influenza. This 
meeting afforded an opportunity for all countries working on a vaccine 
against avian influenza to share their progress and establish a way to 
share technical information in order to speed the development of a safe 
and effective human vaccine.
Partnership's Next Steps
    This week in Geneva, the WHO, FAO, OIE, and the World Bank are 
hosting a partners meeting on avian influenza and human pandemic 
influenza. Specifically, as an outgrowth of our Partnership's Senior 
Officials Meeting, there were detailed discussions on focusing 
international efforts on short-term animal monitoring, surveillance, 
antiviral stockpiles, expanding vaccine production capacity, 
contingency planning to ensure continuity of operations if an outbreak 
occurs, and communications strategies. In addition there was agreement 
on the importance of working to help African countries--particularly 
those already overwhelmed by HIV/AIDS. One issue to be further 
addressed is donor coordination. In the discussions taking place now in 
Geneva, we are proposing that the WHO, the World Bank and other major 
donors, coordinate with us their assessments of country needs. This 
would allow us to come to a common understanding of what financial and 
technical assistance is necessary. A subsequent conference in January 
will provide an opportunity for donors to outline what they are, and 
will be, doing to help countries affected with avian influenza. And we 
will hold another meeting of the Senior Officials of the International 
Partnership on Avian and Pandemic Influenza in late January or early 
February to take stock of the progress being achieved and to determine 
what additional steps should be taken.
Diplomatic Engagement
    The Bush administration has taken advantage of every possible 
bilateral and multilateral opportunity to stress the seriousness of the 
threat posed by avian influenza and the need for rapid action. The 
President is personally engaged and has raised this issue with the 
Presidents of China, Indonesia, and Russia as well as the Prime 
Minister of Thailand. Secretary Rice reiterated our concerns to ASEAN 
countries, meeting on the margins of the September High-Level Segment 
of the UNGA. She also devoted a significant portion of her recent 
Ottawa trip to a briefing on the progress of the Canadian health 
ministerial discussion on stockpiles of antiviral medicines and 
vaccines.
    We are also advancing this issue at the highest levels in Asia. 
President Bush will attend the APEC Leaders meeting later this month in 
Korea and the topic of avian influenza is a centerpiece of those 
disussions. As the chair of the APEC Health Task Force, we are working 
with our key partners in APEC to strengthen the region's commitment to 
prepare for and prevent an influenza pandemic. In the ASEAN Regional 
Forum (ARF), we are encouraging participants to consider the security 
implications of a pandemic. Deputy Secretary Zoellick raised the threat 
of avian influenza and the need for preparation and planning in the 
ASEAN and ARF meetings in Laos this past July.
    In addition, we are reaching out to the private sector to improve 
their regional capacity to respond and prepare for a pandemic. We will 
urge the APEC Business Advisory Council (ABAC) to look into using 
private sector health facilities to enhance epidemic surveillance and 
detection capabilities. We will also recommend that ABAC consider 
establishing a set of business community ``best practices,'' including 
a checklist for emergency preparedness, paying special attention to 
small- and medium-sized enterprises.
    During mid-October, I traveled to Southeast Asia--Thailand, 
Cambodia, Laos, Vietnam, Indonesia, Singapore, and Malaysia--with 
Secretary of Health and Human Services, Mike Leavitt, and 
representatives from the U.S. Department of Agriculture, USAID, the 
National Institutes of Health, and the Center for Disease Control, as 
well as Dr. Lee, the Director General of the World Health Organization 
(WHO), and representatives of the Food and Agriculture Organization 
(FAO) and the World Organization for Animal Health (OIE). We were very 
pleased that these countries had their Foreign or Prime Ministers meet 
with our delegation--an indication that we were succeeding in our 
efforts to raise the political profile of this issue. Malaysia, for 
instance, named a senior point of contact in its Foreign Ministry to 
enhance bilateral and multilateral communication. Vietnam offered, 
during our visit, to accept international monitors to augment their 
national surveillance efforts.
    As a result of our visit, and additional assessments done by U.S. 
experts, we learned more about the needs of those countries. For 
example, Vietnam, Laos, Cambodia, and Indonesia are particularly in 
need of capacity-building. We stressed our desire to work with them to 
address these shortcomings and the administration has, in fact, already 
begun to fill these critical needs. I'd like to emphasize that this is 
truly an unprecedented interagency effort by the United States. The 
President has charged the State Department with leading the 
international activities of the U.S. National Strategy for Pandemic 
Influenza and, in doing so, we collaborate closely with our dedicated 
colleagues at HHS, CDC, NIH, USAID, USDA, and other technical agencies. 
With that in mind, let me provide some concrete examples of U.S. 
assistance in three key areas of our strategy--surveillance, 
preparedness, and response and containment. Our assistance targets the 
needs of the most affected countries with the least capacity such as 
Laos, Cambodia, Vietnam, and Indonesia. These activities are being 
designed and funded by USAID, HHS, and USDA as part of a coordinated 
interagency process.
    On surveillance, we are providing training, financial, technical, 
and commodity support for national veterinary and other staff to 
monitor the disease in domestic and wild birds. We are increasing the 
capacity of national public health staff to detect new human infections 
and ensure timely and accurate diagnoses. We are working with the FAO 
on strengthening ``early warning systems'' and the ability to 
communicate rapidly about concerning cases. To give a country-specific 
example, we have provided the support of NAMRU2 (a U.S. military 
laboratory) to strengthen surveillance efforts in Indonesia.
    On preparedness, we are supporting Ministries of Health as they 
develop national pandemic preparedness plans. We are helping Ministries 
in Asia to conduct pandemic preparedness training and simulations. We 
are purchasing equipment for experts in the region to test samples. 
With the FAO and WHO, we are engaging Agriculture, Health, and other 
Ministers to increase regional and international coordination. To give 
a country-specific example, the Vietnamese Ministry of Health has 
received support from HHS and CDC for vaccine development and clinical 
trials and has solicited our assistance of monitoring.
    Finally, on response and containment, we are establishing, 
training, and supporting rapid response teams through FAO to conduct 
containment measures in animal populations. We are building local 
capacity to cull and dispose of infected or exposed animals, and 
setting up in-country and regional emergency stockpiles of essential 
commodities. We are, for example, prepositioning protective gear in 
Southeast Asian countries to be used in case of an avian flu emergency.
Funding
    These efforts are already underway because HHS and USAID were able 
to reprogram $37 million in fiscal year 2005 funds for this emerging 
policy priority. This is, of course, only the start. In conjunction 
with his November 1 announcement of the National Strategy, the 
President called for an additional $7.1 billion in emergency funding. 
This request includes $250.8 million to detect and contain outbreaks 
before they spread around the world; as the President rightly noted: 
``early detection is our first line of defense.'' Of the $250.8 
million, the Department of State would receive a total of $38.5 million 
for international response coordination, involving foreign governments 
and nongovernmental organizations, diplomatic outreach, exchanges of 
U.S. and foreign medical personnel, and health support and protection 
of U.S. Goverment employees and families at U.S. missions overseas. Of 
the $38.5 million for the Department of State, $20 million would fund 
the potential evacuation of U.S. Government personnel and dependents 
from overseas missions.
    From the total $250.8 million for international activities, the 
Department of State would receive $8.5 million; USAID would receive 
$131.5 million; HHS, $82.5 million; USDA, $18.3 million; and DOD, $10 
million. The $131.5 million to be programmed by USAID will be used for 
prepositioned supplies and equipment to prevent and control the spread 
of the avian influenza virus; a communication campaign to increase 
awareness of risks and encourage behavior (such as culling bird flocks 
and avoiding crowds) to hinder the spread of the disease; improved 
surveillance and response systems; and accelerated international 
planning and preparedness. Through the Partnership, we expect to 
leverage additional funds from other donors.

                               CONCLUSION

    In the 2 months since its creation, the International Partnership 
on Avian and Pandemic Influenza has already heightened international 
awareness and made addressing this issue a priority for nations; 
fostered closer collaboration among Agriculture, Health, Economic, and 
Foreign Ministries; accelerated the placement of monitors in high-risk 
countries; catalyzed the development and deployment of comprehensive 
surveillance networks; increased donor commitment and coordination. But 
there is still more that needs to be done.
    We believe that our message of cooperation and common cause has 
resonated with many countries, particularly those hardest hit in Asia. 
Countries that lack the capacity to prepare for, and respond to, an 
influenza pandemic are showing growing understanding and increasing 
willingness to confront the problem. They realize that the cost of 
taking action now is significantly less than the cost of a pandemic. At 
the meeting in Geneva this week, WHO Director General Lee estimated 
that 120 countries now have, or have begun preparing, some form of 
avian flu preparedness plans; this is twice the number estimated just 1 
month ago. Those plans will serve as the foundation on which national 
and regional surveillance networks will be built and strengthened. We 
are also hearing from the FAO and OIE that at-risk countries are 
becoming increasingly transparent, sharing information and samples more 
readily than in the past. These international organizations credit 
countries and their leadership for making this issue a priotity and 
laud the United States for helping to make this progress possible 
through the International Partnership on Avian and Pandemic Influenza 
and sustained high-level diplomacy. Even as we work with our partners 
to coordinate assistance, the United States has begun to assist the 
highest risk countries in the key areas of surveillance, preparedness, 
and response and containment. We will build on this solid foundation as 
the Partnership progresses. We look forward to working with you on 
avian flu and I thank you again for this opportunity to testify before 
this committee. I welcome any questions you may have.
                                 ______
                                 

   Avian Influenza--International Partnership To Meet A Global Threat

    ``If left unchallenged, this virus could become the first pandemic 
of the 21st century. We must not allow that to happen. Today I am 
announcing a new international Partnership on Avian and Pandemic 
Influenza . . . It is essential we work together, and as we do so, we 
will fulfill a moral duty to protect our citizens, and heal the sick, 
and comfort the afflicted.''--President George W. Bush

    The U.S. Government is concerned that the ongoing outbreaks of 
avian influenza in birds have the potential to turn into a human 
influenza pandemic that would have significant global health, economic, 
and social consequences. President Bush has requested $7.1 billion in 
emergency funding to immediately begin implementing a national strategy 
for pandemic influenza. This funding includes $251 million to detect 
and contain outbreaks before they spread around the world.

                           WORLDWIDE PROBLEM

    To date, outbreaks of the H5N1 strain of avian influenza have been 
confirmed among birds in Cambodia, China, Croatia, Indonesia, 
Kazakhstan, Laos, Mongolia, Romania, Russia, Thailand, Turkey, and 
Vietnam. Japan, Malaysia, and South Korea have also experienced 
outbreaks in the past. More than 60 deaths out of a total of over 120 
human cases of the disease have been confirmed in Cambodia, Indonesia, 
Thailand, and Vietnam.
    Avian influenza has occasionally spread from bird to human, but is 
not easily spread from human to human. A specific vaccine for humans 
that is effective against avian influenza has not yet been approved. 
Based upon limited data, the Centers for Disease Control have suggested 
that the antiviral medication Oseltamivir (brand name--Tamiflu) may be 
effective in preventing or treating avian influenza.

                       INTERNATIONAL PARTNERSHIP

    President Bush announced the International Partnership on Avian and 
Pandemic Influenza during the U.N. General Assembly in September 2005. 
The first meeting of the Partnership took place October 6-7 in 
Washington, DC, hosted by the U.S. Department of State.
    The meeting involved top foreign affairs, health, and agriculture 
officials from 88 countries, as well as representatives from eight 
international organizations, including the World Health Organization, 
the Food and Agricultural Organization, and the World Organization for 
Animal Health.
    The meeting's main objective was to affirm the commitment of 
participating countries to work together in combating avian and 
pandemic influenza and to identify priority areas for further action. 
Three general topic areas were covered: Surveillance and prevention; 
preparedness, planning and outreach; and response and containment of 
avian influenza.

                   ASSISTANCE FOR AFFECTED COUNTRIES

    The United States is implementing the $25 million that the 
President earlier signed in an emergency supplemental to prevent and 
control the spread of avian influenza in Southeast Asia, in addition to 
providing more than $13 million in technical assistance and grants to 
affected countries in Southeast Asia and to the World Health 
Organization for influenza pandemic preparedness in the past year.

                       U.S. DOMESTIC PREPAREDNESS

    President Bush has released a national strategy that draws on the 
combined efforts of government officials and the public health, 
medical, veterinary, and law enforcement communities, as well as the 
private sector. The strategy is designed to meet three critical goals: 
Detecting human or animal outbreaks that occur anywhere in the world; 
protecting the American people by stockpiling vaccines and antiviral 
drugs while improving the capacity to produce new vaccines; and 
preparing to respond at the Federal, State and local levels in the 
event an avian or pandemic influenza reaches the United States.

                 GOALS OF THE INTERNATIONAL PARTNERSHIP

   Elevate the avian influenza issue on national agendas
   Coordinate efforts among donor and affected nations
   Mobilize and leverage resources
   Increase transparency in disease reporting and the quality 
        of surveillance
   Build local capacity to identify, contain, and respond to an 
        influenza pandemic

    The Chairman. Well, thank you very much, Secretary 
Dobriansky. We appreciate the testimony.
    Dr. Gerberding.

   STATEMENT OF DR. JULIE GERBERDING, DIRECTOR, CENTERS FOR 
DISEASE CONTROL AND PREVENTION, DEPARTMENT OF HEALTH AND HUMAN 
                     SERVICES, ATLANTA, GA

    Dr. Gerberding. Thank you.
    It's really a pleasure to be here to testify in front of 
this committee, Mr. Chairman, Senator Dodd. This is a very 
important, I think, node in our overall preparedness for avian 
pandemic, or any pandemic. And my role here in these opening 
comments is to just give you an update on some of the facts in 
the situation that we see it. My colleague from Health and 
Human Services, Dr. Fauci, will talk a little bit more about 
some of the countermeasures that we're developing.
    Let me just make my first point on the next slide, which is 
basically the point that pandemics happen. We have had three 
important pandemics in the world over the last century. The 
1918 Spanish Flu pandemic, which everyone is aware of, caused 
devastating consequences globally when one new strain, the H1 
strain, of flu emerged. When H2 emerged, we developed the Asian 
pandemic. When H3 emerged, we developed the Hong Kong pandemic. 
Now we're in a situation where we have a smattering of avian 
isolates that have emerged, but it's the H5N1 that, obviously, 
we're so concerned about, because it's--it emerged, it's 
persisted, and it's expanding, and we have no global immunity 
to it. So, basically, everyone in the world is susceptible.
    On the next slide, I have a picture that illustrates, 
today, what the status of the poultry outbreak is in the world. 
And we recognize that today H5N1 is primarily a bird pandemic; 
it is not a people pandemic at this point in time. But there 
are active outbreaks ongoing in many parts of Asia, extending 
now into Western Asia, Eastern Europe, and we still have 
countries like Malaysia, Laos, Burma, where we have no 
information about the overall status.
    As we look at this bird epidemic, I think it's important to 
think, well, what can we do about the problem in birds? On the 
next slide, I've illustrated why it's so difficult to contend 
with the poultry outbreak. These are just some cultural 
practices, where, here, you see duck and geese, which carry the 
virus asymptomatically in the same market basket as the 
chickens, which are vulnerable and usually are the source of 
spread to people. We've got people in these markets working 
with raw materials, living literally in rice patties where the 
migratory birds are swimming or--and children swimming in these 
canals have picked up the virus from the water.
    And the next slide illustrating, again, just the close 
proximity of humans with sick birds. One very poignant story 
that we heard when we were traveling in Asia together was a 
little boy who had a pet chicken who developed the avian virus. 
And, of course, he was comforting his chicken and, sadly, 
picked up the virus and died as a consequence of that exposure. 
So, a tremendously difficult challenge with those 13 billion 
chickens just in one Asian country.
    On the next slide, we've illustrated the flyways, and it is 
really the migratory bird flyways that we feel are what is 
contributing to the spread of this virus throughout Asia and 
into Europe. And we are just one flyway away from having this 
virus enter the flyways into the United States. So, we need to 
be prepared for the expectation that sooner or later a duck or 
a goose or some other migratory bird is going to bring this 
virus into the United States.
    Fortunately, here, our surveillance and our poultry 
containment procedures aren't like they are in Asia, and we 
think our commercial poultry industry is very hardened. Many, 
many steps are in place here, but, nevertheless, it's not going 
to be surprising if we see birds bring this virus into the 
United States.
    The next slide illustrates the status overall, which is to 
say we've checked off widespread prevalence in migratory birds 
and many, many birds are involved. We see continued outbreaks 
ongoing in domestic poultry, despite culling, despite 
vaccination, despite improvements in animal husbandry. We're 
still seeing these outbreaks emerge.
    We know this virus can infect mammals, particularly cats. 
We have evidence from Indonesia that it's affected pigs. This 
is important, because it means the bird virus can efficiently 
move to animals. And we know that the virus is evolving. The 
Vietnam virus, that we have the prototype vaccine to, has 
evolved already over the last year to a new form that is now 
causing infection in Indonesia and elsewhere.
    We've had more than 120--I think, this morning, 125 cases 
of avian spilling over primarily from poultry into people, 
mostly young people, 50 percent mortality rate, a horrible 
clinical disease. This is very much like the flu that we saw in 
1918. It's absolutely a destructive lung infection. It causes 
all kinds of organ complications.
    What we haven't checked yet, on this box, is the sustained 
person-to-person transmission. That's, obviously, what we're 
concerned about. We haven't seen it. Hopefully, we'll never see 
it. But it is the reason why right now we are putting so much 
attention on this particular situation, because we've checked 
the other five boxes.
    On the next slide, I'm just going to summarize for you what 
the Department of Health and Human Services, in conjunction 
with the whole Cabinet of agencies and government and our 
international partners are doing about this. Our doctrine, as 
Secretary Leavitt has very effectively and consistently 
articulated is that if there is a threat of avian flu anywhere, 
we have to assume that there is a threat everywhere, and act 
accordingly. So, our strategy is to, first of all, invest 
heavily in detection and containment, wherever it emerges. And 
that means the kinds of activities that we traditionally do at 
CDC as, sort of, the front line of international health 
protection to support programs in the field, to support disease 
detectives, to support training, and the laboratory support 
necessary to diagnose and isolate the initial patients. The 
international stockpile will help us use antiviral drugs for 
containment. And if that spark that Senator Frist and Senator 
Leavitt talk about, goes off in a place where we have these 
resources in place, we have a very good chance of being able to 
contain this. But in the rest of the region, if that spark goes 
off, we are very concerned that we will be dealing with a much 
more deadly situation.
    Dr. Fauci's going to talk about antivirals and vaccine, but 
I want to emphasize what you've already heard about the 
importance of transparency. We have seen dramatic improvements 
in transparency. But for us at CDC, where we have to be the 
front line of getting the virus, knowing what's going on, 
tracking the progress, we have to get the specimens to our 
agency, and we have to know that the infection is spreading so 
that we have access to those. So, this requires us to work 
collaboratively with a whole range of international and 
domestic organizations, but, in particular, with the World 
Health Organization, the OIE, and the FAO, and, I think, 
importantly, to continue our investment in communication.
    On my last slide, I just wanted to describe for you very 
briefly our vision of a global health protection network. By 
building on the existing investments that CDC has in 43 
countries, the USAID investments for development, the 
Department of Defense laboratories, which, by the way, are 
absolutely critical, the lab in Jakarta, the lab in Cairo are 
the way we get flu specimens for ordinary flu, but also our new 
quarantine stations at our borders here in the United States. 
CDC traditionally had only eight quarantine stations. This 
year, we've added 10, and, by the end of next year, we'll have 
25 fully equipped stations at ports of entry at our airports, 
where we can screen, isolate, and quarantine people, if 
necessary, to prevent introduction of this problem into our 
country.
    And then, last, the hardening of our communication networks 
through broadband, secure communications, as well as IT 
infrastructure development, so that we can rapidly disseminate 
advice and information through our global network.
    So, these, and other, measures, we think, will certainly 
help us be more prepared, but, obviously, we have a long way to 
go. And we appreciate your interest and your help.
    Thank you.
    [The prepared statement of Dr. Gerberding follows:]

 Prepared Statement of Dr. Julie L. Gerberding, Director, Centers for 
    Disease Control and Prevention, Department of Health and Human 
                         Services, Atlanta, GA

                              INTRODUCTION

    Mr. Chairman and members of the committee, I am pleased to be here 
today to describe the current status of avian influenza around the 
world; the consequences of a possible human influenza pandemic; and 
international and domestic efforts to prepare for, and respond to, such 
a pandemic, including the HHS Pandemic Influenza Plan. Thank you for 
the invitation to testify on influenza pandemic planning and 
preparedness which Department of Health and Human Services (HHS) 
Secretary, Mike Leavitt, has made a top priority. The Centers for 
Disease Control and Prevention (CDC) and other agencies within HHS are 
working together formally through the Influenza Preparedness Task Force 
that Secretary Leavitt has chartered to prepare the United States for 
this potential threat to the health of our Nation. We are also working 
with other Federal, State, local, and international organizations to 
ensure close collaboration.
    As you are aware, the potential for a human influenza pandemic is a 
current public health concern with an immense potential impact. 
Interpandemic (seasonal) influenza causes an average of 36,000 deaths 
each year in the United States, mostly among the elderly and nearly 
200,000 hospitalizations. In contrast, scientists cannot predict the 
severity and impact of an influenza pandemic, whether from the H5N1 
virus currently circulating in Asia and Europe, or the emergence of 
another influenza virus of pandemic potential. However, modeling 
studies suggest that, in the absence of any control measures, a 
``medium-level'' pandemic in which 15 percent to 35 percent of the U.S. 
population develops influenza could result in 89,000 to 207,000 deaths, 
between 314,000 and 734,000 hospitalizations, 18 to 42 million 
outpatient visits, and another 20 to 47 million sick people. The 
associated economic impact in our country alone could range between 
$71.3 and $166.5 billion. A more severe pandemic, as happened in 1918, 
could have a much greater impact.
    There are several important points to note about an influenza 
pandemic:

   A pandemic could occur anytime during the year and could 
        last much longer than typical seasonal influenza, with repeated 
        waves of infection that could occur over 1 or 2 years.
   The capacity to intervene and prevent or control 
        transmission of the virus once it gains the ability to be 
        transmitted from person to person will be extremely limited.
   Right now, the H5N1 avian influenza strain that is 
        circulating in Asia among birds is considered the leading 
        candidate to cause the next pandemic. However, it is possible 
        that another influenza virus, which could originate anywhere in 
        the world, could cause the next pandemic. Although researchers 
        believe some viruses are more likely than others to cause a 
        pandemic, they cannot predict with certainty the risks from 
        specific viruses. This uncertainty is one of the reasons why we 
        need to maintain year-round laboratory surveillance of 
        influenza viruses that affect 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 since 
        the last pandemic in 1968, including 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 have made us more vulnerable.
   Because pandemic influenza viruses will emerge in part or 
        wholly from among animal influenza viruses, such as birds, it 
        is critical for human and animal health authorities to closely 
        coordinate activities such as surveillance and to share 
        relevant information as quickly and as transparently as 
        possible.

                THE CURRENT STATUS OF H5N1 VIRUS IN ASIA

    Beginning in late 2003, new outbreaks of lethal avian influenza A 
(H5N1) infection among poultry and waterfowl were reported by several 
countries in Asia. In 2005, outbreaks of H5N1 disease have also been 
reported among poultry in Russia, Kazakhstan, Turkey, and Romania. 
Mongolia has reported outbreaks of the H5N1 virus in wild, migratory 
birds. In October 2005, outbreaks of the H5N1 virus were reported among 
migrating swans in Croatia. In 2004, sporadic human cases of avian 
influenza A (H5N1) were reported in Vietnam and Thailand. In 2005 
additional human cases have been reported in Cambodia, Indonesia, 
Thailand, and Vietnam. Cumulatively, 124 human cases have been reported 
and laboratory confirmed by the World Health Organization (WHO) since 
January 2004. These cases have resulted in 63 deaths, a fatality rate 
of about 51 percent.
    Almost all cases of H5N1 human infection appear to have resulted 
from some form of direct or close contact with infected poultry, 
primarily chickens. In addition, a few persons may have been infected 
through very close contact with another infected person, but this type 
of transmission has not led to sustained transmission.
    For an influenza virus to cause a pandemic, it must: (1) Be a virus 
to which there is little or no preexisting immunity in the human 
population; (2) be able to cause illness in humans; and (3) have the 
ability for sustained transmission from person to person. So far, the 
H5N1 virus circulating in Asia meets the first two criteria but has not 
yet shown the capability for sustained transmission from person to 
person.
    The avian influenza A (H5N1) epizootic (or animal) outbreak in Asia 
that is now beginning to spread into Europe is not expected to diminish 
significantly in the short term. It is likely that H5N1 infection among 
birds has become endemic in Asia and that human infections resulting 
from direct contact with infected poultry will continue to occur. So 
far, scientists have found no evidence for genetic reassortment has 
been found. Reassortment can occur when the genetic code for high 
virulence in an H5N1 strain combines with the genetic code of another 
influenza virus strain which results in easy transmission. However, the 
animal outbreak continues to pose an important public health threat, 
because there is little preexisting natural immunity to H5N1 infection 
in the human population.
    In mid-October 2005, I accompanied Secretary Mike Leavitt when he 
led a delegation of U.S. and international health experts on a 10-day 
trip to five nations in Southeast Asia. The purpose of this trip was: 
(1) To learn from countries that have had firsthand experience with 
avian influenza; (2) to emphasize the importance of timely sharing of 
information in fighting the disease; and (3) to determine the best use 
of our resources abroad to protect people in the United States. We 
learned several important lessons. First, international cooperation is 
absolutely essential; an outbreak anywhere increases risk everywhere. 
Second, surveillance, transparency, and timely sharing of information 
are critical. The ability of the United States and the world to slow or 
stop the spread of an influenza pandemic is highly dependent upon early 
warning of outbreaks. Finally, it is vital to strengthen preparedness 
and response capabilities in Asian countries and other parts of the 
world. The delegation also concluded that pandemic preparedness and 
preparation must be both short and long term in scope. These critical 
elements form the basis of the administration's diplomatic engagement 
strategy through the International Partnership on Avian and Pandemic 
Flu launched by the President in September, and drive our efforts with 
the international health community to effectively prepare for a 
pandemic. As I stated earlier, there is no way to know if the current 
H5N1 virus will evolve into a pandemic. However, we do know that there 
have been three pandemics in the past 100 years, and we can expect more 
in this century.

                 HHS ROLE IN INTERNATIONAL PREPAREDNESS

    The Secretary's and my trip reaffirmed the value of several actions 
undertaken by HHS and its agencies over the last few years. It is vital 
to monitor H5N1 viruses for changes that indicate an elevated threat 
for humans, and we are continuing to strengthen and build effective in-
country surveillance, which includes enhancing the training of 
laboratorians, epidemiologists, veterinarians, and other professionals, 
as well as promoting the comprehensive reporting that is essential for 
monitoring H5N1 and other strains of highly pathogenic avian influenza. 
In collaboration with international partners, HHS is also pursuing a 
strategy of active, aggressive international detection; investigation 
capacity; international containment; and laboratory detection support.
    In the past year, working with the World Health Organization (WHO) 
and other international partners, HHS and its agencies has made 
significant progress toward enhancing surveillance in Southeast Asia. 
However, this initiative needs to continue at both national and 
international levels if we are to sustain our progress, expand 
geographic coverage, and conduct effective surveillance. These efforts 
to build international and domestic surveillance are essential for 
detecting new influenza virus variants earlier and for making informed 
vaccine decisions about interpandemic influenza. With the ever-present 
threat of a newly emerging strain that could spark a human pandemic, we 
need to know what is happening in commercial poultry farms and the 
family backyard flocks found in Southeast Asia, as well as migrating 
birds and animal populations elsewhere throughout the world.
    Earlier this year, Congress passed and the President signed the 
Fiscal Year 2005 Emergency Supplemental Appropriations Act for Defense, 
the Global War on Terror, and Tsunami Relief. This legislation includes 
$25 million in international assistance funds for HHS, the U.S. 
Department of Agriculture, and the United States Agency for 
International Development (USAID) to prevent and control the spread of 
avian influenza in Asia. With these funds, HHS and its agencies are 
working to assist in developing regional capacity in Southeast Asia for 
epidemiology and laboratory management of pandemic influenza. 
Strategies include developing and implementing an avian influenza 
curriculum for epidemiologists and laboratorians, training for public 
health leaders to develop a national network of public health field 
staff, and training for local allied health personnel to detect and 
report human cases of influenza. HHS is assigning staff to Vietnam, 
Cambodia, and Laos to facilitate improvements in the detection of 
influenza cases and to provide technical assistance in investigating 
cases as well as in developing national preparedness plans by the 
Ministries of Health, with the assistance of WHO and other partners.
    We are also working with the U.S. Agency for International 
Development (USAID) WHO Secretariat, its Regional Offices and 
Ministries of Health in these countries to increase public awareness 
about the human health risks associated with pandemic influenza, and to 
advise countries concerning prevention or mitigation measures that can 
be used in the event a pandemic occurs.
    HHS through CDC is vigorously working to increase laboratory 
capacity in the region and to provide laboratory support for outbreak 
investigations, including: (a) Testing clinical samples and influenza 
isolates; (b) diagnosing the presence of avian influenza in humans by 
supplying necessary test reagents to the region and globally; and (c) 
developing vaccine seed stock to produce and test pandemic vaccine 
candidates. The HHS National Institutes of Health (NIH) and Office of 
Public Health Emergency Preparedness are also providing technical 
assistance to the Government of Vietnam as it proceeds with the 
development of a human H5N1 vaccine, including support for clinical 
trials.
    CDC is one of four WHO Global Influenza Collaborating Centers. In 
this capacity, CDC conducts routine worldwide monitoring of influenza 
viruses and provides ongoing support for the global WHO surveillance 
network, laboratory testing, training, and other actions. HHS also 
supports the WHO Headquarters in Geneva and the WHO Regional Offices in 
Manila and New Delhi for pandemic planning, expansion of global 
influenza surveillance, shipment of specimens, training, and enhancing 
communications with agricultural authorities. Several of the top flu 
specialists on the WHO staff are HHS personnel on loan, another 
demonstration of our strong commitment to international collaboration 
in the fight against the threat of a pandemic influenza.
    In addition to our partnership with USAID under the tsunami 
supplemental appropriation, HHS also partners with other U.S. 
Government departments in its international collaboration such as with 
the Department of Defense Naval Medical Research Unit Two (NAMRU2) in 
Indonesia and Naval Medical Research Unit Three in Cairo (NAMRU3). 
These collaborations support training, the expansion of influenza 
surveillance networks to countries where none exists, the enhancement 
of the quality of surveillance in other countries to enhance outbreak 
detection, seroprevalence studies in populations at risk for avian 
influenza such as poultry workers, and enhanced outbreak response.

                          SCIENTIFIC RESEARCH

    Federal agencies have been very active in scientific research on 
avian influenza. Scientists at HHS (CDC and NIH) and the U.S. 
Department of Agriculture (USDA), and the National Institutes of Health 
(NIH) have collaborated to successfully reconstruct the influenza virus 
strain responsible for the 1918 influenza pandemic. The findings from 
this research will greatly advance preparedness efforts for the next 
pandemic. Previously, influenza experts had limited knowledge of 
factors that made the 1918 pandemic so much more deadly than the 1957 
and 1968 pandemics. One of the most striking features of the 1918 
pandemic was its unusually high death rate among otherwise healthy 
people aged 15 to 34. In reconstructing the virus, the researchers are 
learning which genes were responsible for making the virus so harmful. 
This is an important advance to strengthen preparedness efforts, 
because knowing which genes are responsible for causing severe illness 
can help scientists develop new drugs and vaccines that focus on the 
appropriate targets.
    Additionally, researchers at CDC have conducted studies on the 
incidence of adamantane resistance among influenza A viruses isolated 
worldwide from 1994 to 2005. Adamantanes are antiviral drugs that have 
been used to treat influenza A virus infections for many years. 
However, their use is rising worldwide, and viral resistance to the 
drugs has been reported among influenza A viruses (H5N1) strains 
isolated from poultry and humans in Asia. This data raises questions 
about the appropriate use of antiviral drugs, especially adamantines, 
and draws attention to the importance of tracing emergence and spread 
of drug resistant influenza A viruses. It is important to note that, 
although at present the H5N1 viruses isolated from people in Asia 
during the past 2 years appear to be resistant to adamantanes, they 
remain sensitive to neuraminidase inhibitors such as oseltamivir 
(Tamiflu').

                 DEVELOPMENT AND MANUFACTURE OF VACCINE

    Another important research area is vaccines: Seeking improved 
strategies to enhance their development, manufacture, distribution, and 
delivery. The development and role of a pandemic influenza vaccine is a 
principal component of the HHS Pandemic Plan, which I will describe 
later in the testimony. During an influenza pandemic, the existence of 
influenza vaccine manufacturing facilities functioning at full capacity 
in the United States will be critically important. We assume the 
pandemic influenza vaccines produced in other countries are unlikely to 
be available to the U.S. market, because those governments have the 
power to prohibit export of the vaccines produced in their countries 
until their domestic needs are met. The U.S. vaccine supply is 
particularly fragile; only one of four influenza vaccine manufacturers 
that sell in the U.S. market makes its vaccine entirely in the United 
States; one other makes some of its vaccine in the United States.
    Another important factor is that public demand for influenza 
vaccine in the United States varies annually. Having a steadily 
increasing demand would provide companies with a reliable, growing 
market that would be an incentive to increase their vaccine production 
capacity. In FY 2006, CDC will direct $40 million through the Vaccines 
for Children (VFC) program to purchase influenza vaccine for the 
national pediatric stockpile as additional protection against annual 
outbreaks of influenza. These funds to purchase vaccine can be used if 
needed during annual influenza seasons or possibly in a pandemic 
situation. HHS has also signed a $100 million contract with Sanofi 
Pasteur to develop cell culture vaccines. In addition, the President is 
requesting $120 million in FY 2006, an increase of $21 million, to 
encourage greater production capacity that will enhance the U.S.-based 
vaccine manufacturing surge capacity to help prepare for a pandemic and 
further guard against annual shortages.
    Funds from the Strategic National Stockpile (SNS) have purchased 
approximately 2 million bulk doses of unfinished, unfilled H5N1 
vaccine. This vaccine has not yet been formulated into vials, nor is 
the vaccine licensed by the HHS Food and Drug Administration. Clinical 
testing to determine dosage and schedule for this vaccine began in 
April 2005 with funding from NIH. Initial testing shows that, in its 
current form, a much higher volume of vaccine, up to 12 times as much 
as originally predicted, will be needed to produce the desired immune 
response in people. HHS, therefore, is supporting the development and 
testing of potential dose-sparing strategies that could allow a given 
quantity of vaccine stock to be used in more people. These strategies 
include developing adjuvants, substances added to a vaccine to aid its 
action, and the possibility of using intradermal rather than 
intramuscular injections. Such studies are currently underway, funded 
through the NIH. Additionally, HHS recently announced the award of a 
contract to the Chiron Corporation for the development of an H5N1 
vaccine.
    One of the main efforts by HHS in pandemic preparedness is to 
expand the Nation's use of influenza vaccine during interpandemic 
influenza seasons. This increase will help assure that the United 
States is better prepared for a pandemic. Influenza vaccine demand 
drives influenza vaccine supply. As we increase annual production 
efforts, this should strengthen our capacity for vaccine production 
during a pandemic. We are also developing strategies to increase 
influenza vaccine demand and access by persons who are currently 
recommended to receive vaccine each year.

                         DOMESTIC PREPAREDNESS

HHS Pandemic Influenza Plan
    On November 2, 2005, the HHS Pandemic Influenza Plan was released. 
The HHS Plan is a blueprint for pandemic influenza preparedness and 
response and provides guidance to national, State, and local 
policymakers and health departments with the goal of achieving a 
national state of readiness and quick response. The HHS plan also 
includes a description of the relationship of this document to other 
Federal plans and an outline of key roles and responsibilities during a 
pandemic. In the event of a pandemic and the activation of the National 
Response Plan, the CDC has a critical role to support the Department of 
Homeland Security in their role of overall domestic incident management 
and Federal coordination. The President is requesting additional FY 
2006 appropriations for HHS totaling $6.7 billion in support of the HHS 
Pandemic Influenza Plan. In seeking this funding, the goals are: To be 
able to produce a course of pandemic influenza vaccine for every 
American within 6 months of an outbreak; to provide enough antiviral 
drugs and other medical supplies to treat over 25 percent of the U.S. 
population; and to ensure a domestic and international public health 
capacity to respond to a pandemic influenza outbreak.
    In addition to outlining the Federal response in terms of vaccines, 
surveillance, and planning, the HHS Pandemic Influenza Plan makes clear 
the role of individual Americans in the event of an influenza pandemic. 
The importance of such ordinary but simple steps as frequent hand 
washing, containing coughs and sneezes, keeping sick children (and 
adults) home until they are fully recovered are widely seen as 
practical and useful for helping control the spread of infection. The 
plan also describes options for social-distancing actions, such as 
``snow days'' and alterations in school schedules and planned large 
public gatherings. While such measures are, ordinarily, unlikely to 
fully contain an emerging outbreak, they may help slow the spread 
within communities.
State and Local Preparedness and Planning
    All states have submitted interim pandemic influenza plans to CDC 
as part of their 2005 Public Health Emergency Preparedness Cooperative 
Agreements. Key elements of these plans include the use of 
surveillance, infection control, antiviral medications, community 
containment measures, vaccination procedures, and risk communications. 
To support the Federal and State planning efforts, CDC has developed 
detailed guidance and materials for States and localities, which is 
included in the HHS plan. CDC will work with States to build this 
guidance into their plans. CDC has taken a lead role in working with 
the Advisory Committee on Immunization Practices (ACIP) and the 
National Vaccine Advisory Committee (NVAC) to recommend strategic use 
of antiviral medications and vaccines during a pandemic when supplies 
are limited.
    CDC is working to: (1) Ensure that States have sufficient 
epidemiologic and laboratory capacity both to identify novel viruses 
throughout the year and to sustain surveillance during a pandemic; (2) 
improve reporting systems so that information needed to make public 
health decisions is available quickly; (3) enhance systems for 
identifying and reporting severe cases of influenza; (4) develop 
population-based surveillance among adults hospitalized with influenza; 
and (5) enhance monitoring of resistance to current antiviral drugs to 
guide policy for use of scarce antiviral drugs.
    Collaboration with the Council for State and Territorial 
Epidemiologists (CSTE) has considerably improved domestic surveillance 
through making pediatric deaths associated with laboratory-confirmed 
influenza nationally notifiable, and by implementing hospital-based 
surveillance for influenza in children at selected sites. CDC will 
continue to work with CSTE to make all laboratory confirmed influenza 
hospitalizations notifiable. Since 2003, interim guidelines have been 
issued to States and hospitals for enhanced surveillance to identify 
potential H5N1 infections among travelers from affected countries, and 
these enhancements continue. Special laboratory training courses to 
teach State laboratory staff how to use molecular techniques to detect 
avian influenza have been held. In the past year, CDC trained 
professionals from all 48 States that desired training.
Healthcare System
    If an influenza pandemic were to occur in the United States, it 
would place a huge burden on the U.S. healthcare system. Medical surge 
capacity may be limited, and could be vastly outpaced by demand. 
Healthcare facilities need to be prepared for the potential rapid pace 
and dynamic characteristics of a pandemic. All facilities should be 
equipped and ready to care for a limited number of patients infected 
with a pandemic influenza virus as part of normal operations as well as 
a large number of patients in the event of escalating transmission. 
Preparedness activities of healthcare facilities need to be synergistic 
with those of other pandemic influenza planning efforts. Effective 
planning and implementation will depend on close collaboration among 
State and local health departments, community partners, and neighboring 
and regional healthcare facilities. However, despite planning, in a 
severe pandemic it is possible that shortages in staffing, beds, 
equipment (e.g., mechanical ventilators), and supplies will occur and 
medical care standards may need to be adjusted to most effectively 
provide care and save as many lives as possible.
    CDC has developed, with input from State and local health 
departments, and healthcare partners, guidance that provides healthcare 
facilities with recommendations for developing plans to respond to an 
influenza pandemic and guidance on the use of appropriate infection 
control measures to prevent transmission during patient care. 
Development of, and participation in, tabletop exercises over the past 
2 years have identified gaps and provided recommendations for 
healthcare facilities to improve their readiness to respond and their 
integration in the overall planning and response efforts of their local 
and State health departments. The healthcare system has made great 
strides in preparation for a possible pandemic, but additional planning 
still needs to occur.
Antiviral Drugs
    A component of the HHS Pandemic Influenza plan is acquiring, 
distributing, and using antiviral drugs. To date, CDC has been working 
to procure additional influenza countermeasures for the CDC Strategic 
National Stockpile (SNS). Because the H5N1 viruses isolated from people 
in Asia during the past 2 years appear resistant to one class of 
antiviral drugs but sensitive to oseltamivir (Tamiflu'), the 
SNS has purchased enough oseltamivir (Tamiflu') capsules to 
treat approximately 5.5 million adults and has oseltamivir 
(Tamiflu') suspension to treat nearly 110,000 children. The 
SNS also includes 84,000 treatment regimens of zanamivir 
(Relenza'). WHO recently announced that the manufacturer of 
Tamiflu', Roche, has donated 3 million adult courses. These 
will be available to WHO by mid-2006.
Enhancement of Quarantine Stations
    CDC has statutory responsibility to make and enforce regulations 
necessary to prevent the introduction, transmission, or spread of 
communicable diseases from foreign countries into the United States. 
This effort includes maintaining quarantine stations. Quarantine 
stations respond to illness in arriving passengers, assure that the 
appropriate medical and/or procedural action is taken, and train 
immigration, customs, and agriculture inspectors to watch for ill 
persons and imported items having public health significance. 
Currently, CDC's quarantine stations are actively involved in pandemic 
influenza preparedness at their respective ports of entry. CDC's goal 
is to have a quarantine station in any port that admits over 1,000,000 
passengers per year. We are expanding the Nation's quarantine stations; 
staff now have been selected for 18 stations and are on duty at 17 of 
these stations.
    HHS and the Department of Homeland Security (DHS) have recently 
concluded a Memorandum of Understanding setting out the roles and 
responsibilities of the two agencies. DHS will assist in keeping 
communicable diseases from entering the U.S. borders; HHS/CDC will be 
providing training and other necessary support and helping to prevent 
disease from entering the United States.
Informing the Public
    Risk communication planning is critical to pandemic influenza 
preparedness and response. CDC is committed to the scientifically 
validated tenets of outbreak risk communication. It is vital that 
comprehensive information is shared across diverse audiences, 
information is tailored according to need, and information is 
consistent, frank, transparent, and timely. In the event of an 
influenza pandemic, clinicians are likely to detect the first cases; 
therefore messaging in the prepandemic phase must include clinician 
education and discussions of risk factors linked to the likely sources 
of the outbreak. Given the likely surge in demand for health care, 
public communications must include instruction in assessing true 
emergencies, in providing essential home care for routine cases, and 
basic infection control advice. CDC provides the health care and public 
health communities with timely notice of important trends or details 
necessary to support robust domestic surveillance. We also provide 
guidance for public messages through the news media, Internet sites, 
public forums, presentations, and responses to direct inquiries. This 
comprehensive risk-communication strategy can inform the Nation about 
the medical, social, and economic implications of an influenza 
pandemic, including collaborations with the international community. We 
are working through the International Partnership on Avian and Pandemic 
Influenza, established by President Bush in September, and with the WHO 
Secretariat to harmonize our risk-communication messages as much as 
possible with our international partners, so that, in this world of a 
24-hour news cycle, governments are not sending contradictory or 
confusing messages that will reverberate around the global to cause 
confusion.

                               CONCLUSION

    Although much has been accomplished, from a public health 
standpoint more preparation is needed for possible human influenza 
pandemic. As the President mentioned during the announcement of his 
National Strategy last week, our first line of defense is early 
detection. Because early detection means having more time to respond, 
it is critical for the United States to work with domestic and global 
partners to expand and strengthen the scope of early-warning 
surveillance activities used to detect the next pandemic. To monitor 
H5N1 viruses for changes indicating an elevated threat for people, we 
must continue to strengthen and build effective in-country 
surveillance. This must include continued enhancement of training for 
laboratorians, epidemiologists, veterinarians, and other professionals, 
as well as promotion of the comprehensive and transparent reporting 
that is essential to monitor H5N1 and other strains of highly 
pathogenic avian influenza.
    The outbreaks of avian influenza in Asia and Europe have 
highlighted several gaps in global disease surveillance that the United 
States must address in conjunction with partnering nations. These 
limitations include: (1) Insufficient infrastructure in many countries 
for in-country surveillance networks; (2) the need for better training 
of laboratory, epidemiologic, and veterinary staff; and (3) the 
resolution of longstanding obstacles to rapid and open sharing of 
surveillance information, specimens, and viruses among agriculture and 
human health authorities in affected countries and the international 
community. The International Partnership the President established is 
also looking at how best to solve these challenges.
    During an influenza pandemic, the presence of influenza vaccine 
manufacturing facilities in the United States will be critically 
important. The pandemic influenza vaccines produced in other countries 
are unlikely to be available to the U.S. market, because those 
governments have the power to prohibit export of the vaccines until 
their domestic needs are met. The U.S. vaccine supply is particularly 
fragile. Only one of four influenza vaccine manufacturers selling 
vaccine in the U.S. market makes its vaccine entirely in this country. 
It is necessary to ensure an enhanced and stable domestic influenza 
vaccine market to assure both supply and demand.
    Although the present avian influenza H5N1 strain in Southeast Asia 
does not yet have the capability of sustained person-to-person 
transmission, we are concerned that it could develop this capacity. CDC 
is closely monitoring the situation in collaboration with WHO, the 
affected countries, and other partners. We are using its extensive 
network with other Federal agencies, provider groups, nonprofit 
organizations, vaccine and antiviral manufacturers and distributors, 
and State and local health departments to enhance pandemic influenza 
planning. Additionally, the national response to the annual domestic 
influenza seasons provides a core foundation for how the Nation will 
face and address pandemic influenza.
    Thank you for the opportunity to share this information with you. I 
am happy to answer any questions.

    The Chairman. Well, Doctor, we thank you very much for your 
testimony.
    Let me ask my colleague, could we have the testimony of Dr. 
Fauci, and then I then----
    Senator Biden. Oh, please.
    The Chairman [continuing]. I would return to the ranking 
member.
    Senator Biden. I apologize. I'm a daily commuter, and 
sometimes the schedule doesn't agree with me, and I apologize, 
Mr. Chairman, for----
    The Chairman. Thank you.
    We'll proceed, then, with Dr. Fauci.

STATEMENT OF DR. ANTHONY S. FAUCI, DIRECTOR, NATIONAL INSTITUTE 
  OF ALLERGY AND INFECTIOUS DISEASES, NATIONAL INSTITUTES OF 
 HEALTH, DEPARTMENT OF HEALTH AND HUMAN SERVICES, BETHESDA, MD

    Dr. Fauci. Thank you very much, Mr. Chairman, Senator 
Biden, Senator Dodd. I appreciate the opportunity to discuss 
pandemic influenza preparedness with you at this hearing this 
morning.
    As you see on this first visual, we have reproductions of 
the President's national strategy for pandemic influenza side 
by side with the pandemic influenza plan that was, as you know, 
released just last week, following the President's announcement 
by Secretary Leavitt. There are six major components of this: 
International surveillance, domestic surveillance, vaccines, 
antivirals, communications, and then State and local 
preparedness. As Dr. Gerberding mentioned, I will focus my 
remarks exclusively on the vaccine and antiviral component of 
this.
    As you may have heard through announcements that occurred 
from the end of August to the present time, about a year and a 
few months ago, we isolated a virus from a Vietnamese patient 
who was infected by a chicken with H5N1, and, from that, 
developed a seed virus for a vaccine for which we contracted 
with two manufacturers, Sanofi Pasteur and Chiron. We had 
results this past summer from the first stage of the Sanofi 
Pasteur trial, which tested the H5N1 vaccine in 450 healthy 
adults. The results had very encouraging news and some sobering 
news. The encouraging news is that it appears to be safe, and 
it was capable of inducing an immune response that you would 
predict would be protective. The sobering news is that the dose 
that was required to get to that level of immunity was 
substantially higher than the dose that we generally use for 
the seasonal flu. This compounds the issue of our global 
deficiencies in production capacity. However, in parallel with 
those studies, they were studies using a compound called an 
adjuvant, which has the capability of expanding the body's 
immune response to whatever you stimulate it with--in this 
case, the vaccine. The Chiron company has some preliminary 
encouraging results with adjuvants used in an H9N2 vaccine, a 
similar bird flu, but not the one that we're concerned with at 
this time. The reason I tell you this is that, in January of 
this year, we will be testing the H5N1 adjuvanted vaccine with 
Sanofi Pasteur and with Chiron. This is going to have 
implications as to the pace with which we can get to where we 
want to go.
    Now, when you talk about vaccines, you talk about 
stockpiles and strategies. First, the stockpile. As I 
mentioned, because of the dose requirement, our stockpile 
currently is relatively small. But, also as you might recall, 
just this past month, a $100 million contract was signed with 
Sanofi, and $62 million with Chiron, to build up the stockpile. 
The ultimate strategy is to manufacture 20 million courses of 
what we call prepandemic vaccine; namely, the H5N1 that we have 
in hand right now, but to simultaneously create the 
manufacturing capacity--and that's one of the major matrices of 
the pandemic flu preparedness plan that's encompassed in the 
$7.1 billion President's request--namely, to get the capacity 
to manufacture 300 million courses of vaccines within 6 months 
of a pandemic outbreak. This gets to Dr. Gerberding's point 
about the need for surveillance and transparency and why it's 
so important to get samples to the CDC in real time as the 
virus evolves, because it will be those samples that will guide 
us to the next generation of the vaccine that would be needed.
    In addition, we are developing adjuvants and cell-culture-
based techniques, which are the technology of the future. We 
currently are confined to egg-based production methods. It is a 
tried-and-true way of making influenza vaccine, but, for scale-
up, we're going to rely on the future, on cell-based.
    Very quickly, moving over to antiviral therapies for 
influenza, there are two major categories. They are aimed 
against two separate components of the virus. The one of great 
interest right now is the class that is directed against the 
neuraminidase component of the virus, and the drug in question 
is Tamiflu, even though Relenza, which is of the same class, is 
likely also a useful drug against the H5N1.
    Again, we talk stockpile and strategy. The stockpile right 
now is relatively small. We had, originally, 2.75 million 
courses, but recently we have brought that up to 4.3 million 
treatment courses of Tamiflu. The strategy is important. We 
have information from Roche, the manufacturer. They will be 
able to get us, by the end of 2006, 20 million treatment 
courses, and, by mid-2007, enough to cover 25 percent of our 
population, which is about 75 million people, plus an 
additional 6 million in order to contain an initial outbreak.
    And then, finally and importantly, at the NIH we are 
accelerating the development of promising new antivirals, 
because we are somewhat concerned that the effectiveness of a 
Tamiflu-type drug may not necessarily be all that people think 
it is, in the sense of being the major way that you can put the 
lid on a pandemic. We do know that Tamiflu is effective in 
seasonal flu in shaving off a day and a half or so of symptoms, 
but we have no concrete evidence that it will have a major 
effect when you have an overwhelming pandemic that brings a lot 
of sick people to emergency rooms and clinics.
    Let me close by this very familiar slide, which tells us of 
the worst-case scenario.
    You hear of the preparedness now and what we talk about, 
the strategies, a robust budget that has been proposed by the 
Senate as well as by the President, and we're often asked, ``Is 
this overkill? Are we really making something out of an issue 
what may not actually be that bad?'' We in the field of public 
health know that it is entirely unpredictable when you come to 
issues like influenza, but history tells us that there has been 
a worst-case scenario, which is exemplified by this slide. And 
we feel, from a public-health standpoint, that we must assume 
in our preparedness the worst-case scenario, because if we do 
not do that, that will be irresponsible.
    Thank you, Mr. Chairman.
    [The prepared statement of Dr. Fauci follows:]

    Prepared Statement of Dr. Anthony S. Fauci, Director, National 
 Institute of Allergy and Infectious Diseases, National Institutes of 
     Health, Department of Health and Human Services, Bethesda, MD

    Mr. Chairman and members of the committee, thank you for the 
opportunity to discuss with you the current global outbreak of avian 
influenza in fowl, the threat of pandemic influenza in humans, and the 
activities of the Federal Government in preparing to meet this threat.
    An influenza virus strain capable of causing the next human 
influenza pandemic could emerge with little or no warning in almost any 
part of the world. Three influenza pandemics occurred in the 20th 
century, in 1918, 1957, and 1968. The pandemics of 1957 and 1968 were 
serious infectious disease events that killed approximately 2 million 
and 700,000 people worldwide, respectively. The 1918-19 pandemic, 
however, was catastrophic: It killed more than 500,000 people in the 
United States and more than 40 million people worldwide. The 
possibility that a new influenza virus could emerge to cause a similar 
pandemic among human beings is a very real threat for which we must be 
prepared.
    Of known influenza viruses, the H5N1 avian influenza strains that 
are spreading in domestic and migratory fowl in Asia and possibly 
Eastern Europe currently are of greatest concern. Although the H5N1 
virus is primarily an animal disease, has not yet demonstrated the 
ability to spread efficiently from animals to humans and is very 
inefficient in spreading person to person, it has infected more than 
120 people in Asia. Approximately half of the people diagnosed with 
H5N1 avian influenza infection have died. Because the virus is now 
endemic in many wild bird species in several countries in Asia, and 
likely elsewhere, eradication is probably not feasible. The feared 
human pandemic could become a reality if the H5N1 virus mutates 
further, remains highly virulent, and acquires the capability to spread 
as efficiently from person to person as do the commonly circulating 
virus strains that produce seasonal influenza epidemics. Even if H5N1 
does not evolve into a pandemic strain, the possibility that a human 
influenza pandemic will occur at some time in the future is real.
    On November 1, 2005, the President announced the National Strategy 
for Pandemic Influenza, and the next day U.S. Department of Health and 
Human Services (HHS) Secretary, Michael O. Leavitt, released an 
integral component of the National Strategy, the HHS Pandemic Influenza 
Preparedness and Response Plan. Together, these two documents provide a 
blueprint for a coordinated national strategy to prepare for and 
respond to a human influenza pandemic. The National Institutes of 
Health within HHS, and the HHS/NIH National Institute of Allergy and 
Infectious Diseases (NIAID), in particular, have the primary 
responsibilities for conducting scientific research and conducting 
clinical trials to foster product development to prepare our Nation for 
a potential human influenza pandemic.
    In my testimony today, I will tell you more about the scientific 
research and development efforts of the Federal Government, the 
academic community, and the private sector to counter the threat of 
pandemic influenza. In particular, I will focus on projects and 
programs that will help ensure that effective influenza vaccines and 
antiviral drugs will be available to counter any human influenza virus 
with pandemic potential that could emerge.

                     BASIC SCIENCE AND SURVEILLANCE

    HHS/NIH/NIAID supports numerous basic research projects intended to 
increase our understanding of how animal and human influenza viruses 
replicate, interact with their hosts, stimulate the immune response, 
and evolve into new strains. These studies lay the foundation for the 
design of new antiviral drugs, diagnostics, and vaccines, and are 
applicable to seasonal epidemic and pandemic strains alike.
    Each year, as influenza viruses circulate through the human 
population, their surface proteins undergo small changes. As these 
small changes accumulate, the influenza virus gains the ability to 
circumvent immunity created by prior exposure to older circulating 
influenza viruses or by vaccination.
    This phenomenon, called ``antigenic drift,'' is the basis for the 
well-recognized patterns of human influenza disease that occur 
predictably every year, and is the reason, with the help of the World 
Health Organization (WHO), we must update influenza vaccines each year. 
Influenza viruses also can change more dramatically. For example, 
viruses can emerge that can jump species from natural reservoirs, such 
as wild ducks, to infect domestic poultry, farm animals, or humans. 
When an influenza virus jumps species from an animal, such as a 
chicken, to infect a human, the result is usually a ``dead-end'' 
infection that cannot readily spread further in the human population. 
However, mutations in the virus could develop that allow human-to-human 
transmission. Furthermore, if an avian influenza virus and another 
human influenza virus were to simultaneously coinfect a person or 
animal, the two viruses might swap genes, which could result in a virus 
that is readily transmissible between humans, and against which the 
population would have no natural immunity. These types of significant 
changes in influenza viruses are referred to as ``antigenic shift.''
    H5N1 and H9N2 are two avian influenza strains that have jumped 
directly from birds to humans, and which have significant pandemic 
potential. In 1998, 1999, and 2003, H9N2 influenza caused illness in 
three people in Hong Kong and in five individuals elsewhere in China, 
but the virus did not spread further among humans, and, reportedly, 
caused no deaths. At this time, H5N1 influenza appears to be a 
significantly greater threat than H9N2. In addition to the high 
fatality rate seen in people with H5N1 influenza, H5N1 viruses are 
evolving in ways that increasingly favor the start of a pandemic, 
including becoming more stable in the environment and expanding their 
host-species range. Moreover, two highly probable cases of human-to-
human transmission of the H5N1 virus have occurred, and it is possible 
that other such transmissions have occurred.
    An understanding of the diversity of influenza viruses--in the 
wild, in domestic animals, and in humans--as well as close surveillance 
for the emergence of new strains are important components of the 
scientific program to prepare for a pandemic. HHS/NIH/NIAID supports 
major research programs that are important in this regard. One is a 
long-standing program based in Hong Kong to detect the emergence of 
influenza viruses with pandemic potential. Dr. Robert Webster and his 
team from St. Jude Children's Research Hospital conduct extensive 
surveillance of influenza viruses in animals in Asia, analyze new 
influenza viruses when they are found, and generate candidate vaccines 
against them. Another effort, the Influenza Genome Sequencing Project 
is a collaborative project of HHS/NIH (NIAID, the Institute for Genomic 
Research and the National Library of Medicine), the Wadsworth Center, 
the U.S. Department of Defense Armed Forces Institute of Pathology, St. 
Jude Children's Research Hospital, and several other organizations. Its 
purpose is to rapidly provide complete genetic sequences of thousands 
of influenza virus isolates to the scientific community. This program 
has enabled scientists to better understand how influenza viruses 
evolve as they spread through the population, and to match viral 
genetic characteristics with virulence, ease of transmissibility, and 
other clinical properties. A high priority of HHS is to further enhance 
international and domestic influenza surveillance systems so they can 
reliably detect an outbreak and to determine accurately the lethality 
and transmissibility of influenza strains.

                                VACCINES

    Vaccines are an essential tool for the control of influenza. 
Unfortunately, current domestic capacity for the manufacturing of 
influenza vaccine can meet only a small fraction of the need projected 
for a pandemic response. For this reason, $4.7 billion of the $6.7 
billion in the President's fiscal year 2006 supplemental appropriations 
request for the implementation of the HHS Pandemic Influenza Plan is 
intended to increase U.S.-based pandemic influenza vaccine-production 
capacity, vaccine stockpiles, and vaccine research. The goal is to have 
the capacity to produce sufficient pandemic influenza vaccine to 
protect every American within 6 months of an outbreak.
    With regard to the development of an H5N1 vaccine, we have made 
rapid progress. HHS/NIH/NIAID-supported researchers at St. Jude 
Children's Research Hospital obtained a clinical isolate of a highly 
virulent H5N1 virus in Vietnam in early 2004, and used a technique 
called reverse genetics to create an H5N1 vaccine reference strain from 
this isolate. HHS/NIH/NIAID then contracted with Sanofi Pasteur and 
Chiron Corporation to manufacture pilot lots of 8,000 and 10,000 
vaccine doses, respectively, of the inactivated virus vaccine, for use 
in clinical trials. The Sanofi Pasteur vaccine is now undergoing 
clinical testing in healthy adults and healthy elderly people, and will 
soon begin evaluation in children.
    Preliminary results from these trials provide both good and 
sobering news. The good news is that the vaccine is safe, and induces a 
vigorous immune response that augurs well for protecting people against 
the H5N1 virus. The sobering news is that two large doses of the Sanofi 
product were needed to elicit an immune response likely to be 
protective. However, preliminary results from a phase I clinical trial 
of an H9N2 influenza vaccine candidate made by Chiron indicate that 
addition of an adjuvant--a vaccine component that increases the immune 
response--can reduce the required dose substantially. Clinical trials 
of H5N1 candidates using adjuvants and other strategies to reduce the 
necessary dose are ongoing or imminent.
    In addition to these inactivated virus vaccines, HHS/NIH/NIAID is 
collaborating with industry to pursue several other vaccine strategies. 
These include recombinant subunit vaccines, in which cultured cells are 
genetically engineered to produce influenza virus proteins that are 
then used in a vaccine, and DNA vaccines, in which scientists inject 
influenza genetic sequences directly into the vaccinee to stimulate an 
immune response. In addition, from the mid-1970s to the early 1990s, 
HHS/NIH/NIAID intramural and extramural researchers developed a cold-
adapted, live attenuated influenza vaccine strain that later became the 
influenza vaccine marketed as FluMist', licensed by the HHS 
Food and Drug Administration (FDA). Today, HHS/NIH/NIAID intramural 
researchers are working with colleagues from Medlmmune, Inc., under a 
Cooperative Research and Development Agreement to produce and test a 
library of similar vaccine candidates against all known influenza 
strains with pandemic potential.
    HHS also has awarded over $162 million in contracts to Sanofi 
Pasteur and Chiron to produce bulk inactivated H5N1 vaccine for the 
Strategic National Stockpile to ensure the manufacturing techniques, 
procedures, and conditions used for large-scale production will yield a 
satisfactory product. Moving to large-scale production of the vaccine 
in parallel with clinical testing of pilot lots is an indication of the 
urgency with which we have determined we must address H5N1 vaccine 
development. We could use the doses of H5N1 vaccine we have ordered, as 
necessary, to vaccinate healthcare workers, researchers, and, if 
indicated, the public in affected areas.
    In addition to creating a safe and effective vaccine candidate, it 
is imperative we have the ability to produce large quantities of 
vaccine quickly, in the United States. To accomplish this, HHS is 
pursuing a multifaceted strategy to create domestic influenza vaccine 
manufacturing capacity capable of producing 300 million vaccine courses 
within 6 months of the onset of a human influenza pandemic.
    The initial component of this strategy is to increase the number of 
domestic manufacturers of traditional egg-based influenza vaccines; 
only one currently exists within the United States. Doing so will allow 
the United States to manufacture a 20-million-course prepandemic 
vaccine stockpile by 2009, without disrupting the production of annual 
seasonal influenza vaccine. In the event a pandemic appears imminent--
or earlier if circumstances warrant--we could use this prepandemic 
vaccine to immunize healthcare workers, frontline responders, vaccine-
manufacturing personnel, and others critical to the pandemic response. 
With the addition of the domestic infrastructure required to produce 
the prepandemic vaccine, egg-based production capacity will be able to 
provide an additional 60 million courses of vaccine within 6 months of 
the emergence of a pandemic.
    Egg-based production alone, however, cannot bring us to our goal of 
having the surge capacity in the United States to produce 300 million 
courses of vaccine in a 6-month timeframe. Instead, the best hope for 
acquiring a vaccine manufacturing capacity in the United States--we 
could ramp up rapidly on short notice--lies in expanding and 
accelerating our investment in non-egg-based technologies, specifically 
cell-based influenza vaccines. Much of the investment in vaccines 
outlined in the HHS plan goes toward this initiative. The proposed 
investments will allow creation of new domestic facilities that would 
provide the surge capacity to manufacture approximately 240 million 
vaccine courses within 6 months of a pandemic outbreak.
    The HHS plan also calls for upgrading existing domestic 
manufacturing facilities to enable the production of pandemic influenza 
vaccine in an emergency. To that end, HHS will work with HHS/FDA to 
establish contingency arrangements with vaccine manufacturers that will 
allow them to quickly adapt their facilities either to produce 
influenza vaccines or to carry out other critical functions, such as 
repackaging bulk vaccine produced by other manufacturers.
    It is important to note, however, that while the technology for 
producing influenza vaccine in cell cultures is promising, successful 
development of the production methods and licensure of the product are 
years in the future, and by no means guaranteed. Moreover, how quickly 
we reach our production goals will depend on the development of 
adjuvants and other dose-sparing techniques that could reduce the 
amount of vaccine needed to protect the U.S. population, and on whether 
required incentives for industry can be successfully implemented.
    Recognizing the urgent need to create and expand vaccine-
manufacturing capacity, we must remove or mitigate deterrents to 
participation in the vaccine enterprise by companies with substantial 
industrial capacity and experience. Accordingly, the administration is 
proposing limited liability protections for vaccine manufacturers and 
providers, except in cases of willful misconduct. We believe this 
proposal will reduce the liability risks that dissuade companies from 
producing pandemic countermeasures, while retaining appropriate access 
by the American public to reasonable and justified court remedies.
    Under the International Partnership on Avian and Pandemic Influenza 
the President launched in September, we are also beginning to 
coordinate our vaccine research with that undertaken by other nations 
and the private sector outside the United States. The World Health 
Organization Secretariat this week sponsored the first of what we hope 
will be a series of meetings to allow us to exchange information with, 
and learn from, our colleagues in other countries who are in various 
stages of research on human vaccines against the H5N1 virus. HHS/NIH/
NIAID and the Office of Public Health Emergency Preparedness are also 
providing technical assistance to the Government of Vietnam as it 
proceeds with the development of a human H5N1 vaccine, including 
support for clinical trials.

                               ANTIVIRALS

    Antiviral medications are an important counterpart to vaccines as a 
means of controlling influenza outbreaks, both to prevent illness after 
exposure and to treat infection after it occurs. Four drugs currently 
are available for the treatment of influenza, three of which HHS/FDA 
has also licensed for influenza prevention for certain populations. 
HHS/NIH/NIAID supports research to identify new anti-influenza drugs 
through the screening of new drug candidates in cell-culture systems 
and in animal models. In the past year, we have identified seven 
promising candidates. Efforts to design drugs that precisely target 
viral proteins and inhibit their functions also are under way. In 
addition, HHS/NIH/NIAID is developing novel, broad-spectrum 
therapeutics that might work against many influenza virus strains. Some 
of these target viral entry into human cells, while others specifically 
attack and degrade the viral genome.
    Efforts also are under way to test and improve the existing anti-
influenza drugs. Researchers have determined that currently circulating 
H5N1 viruses are resistant to two older drugs--rimantadine and 
amantadine--but are sensitive to a newer class of drugs, called 
neuraminidase inhibitors. This class of drugs includes oseltamivir 
(marketed as Tamiflu'), approved by HHS/FDA for treatment of 
individuals older than 1 year. Studies to further characterize the 
safety profile of oseltamivir for very young children are in the 
advanced planning stage. Studies are also in progress to evaluate novel 
drug targets, as well as long-acting next-generation neuraminidase 
inhibitors. In addition, development and testing in animals of a 
combination antiviral regimen against H5N1 and other potential pandemic 
influenza strains are under way.
    If a human influenza pandemic were to occur, a sufficient supply of 
stockpiled antiviral drugs to treat and care for infected individuals 
would be critical. Therefore, the HHS plan requests an investment of 
$1.4 billion to increase the availability of these drugs. These funds 
would help us achieve the President's goal of having available 81 
million courses of antivirals, which would be sufficient to treat 25 
percent of the U.S. population (75 million courses) and also allow for 
a reserve supply (6 million courses) we could use to contain an initial 
U.S. outbreak. Funding would also accelerate the development of 
promising new antiviral drug candidates in collaboration with academia 
and industry, since there is a possibility that none of the antivirals 
available today will be fully effective against whatever strain sparks 
a pandemic influenza among humans.
    The planned acquisition by the U.S. Government of up to 81 million 
courses of antiviral drugs will enable manufacturers to make 
significant expansion in U.S.-based manufacturing capacity, and thereby 
position the United States to meet future demands much more readily 
than is currently possible. HHS also will work with its State partners 
to encourage them to acquire antivirals for rapid use for their 
populations.

                               CONCLUSION

    In closing, Mr. Chairman, I want to reiterate that the threat from 
pandemic influenza, whether from an H5N1 influenza virus or another 
influenza virus still unknown, is real and growing. Along with Under 
Secretary Dobriansky and Dr. Gerberding, I participated in the trip 
that Secretary Leavitt led to Southeast Asia last month, and what I saw 
confirmed this belief. Although we do not know when the next human 
influenza pandemic will occur, or how devastating it will be, we can be 
certain that a new influenza virus ultimately will emerge. And the 
historical precedent of the 1918 pandemic clearly demonstrates that a 
newly emerging influenza virus can wreak catastrophic damage worldwide 
in a matter of months.
    The world is obviously very different today than it was in 1918. In 
some ways we are more vulnerable. Travel that took weeks in 1918 only 
takes hours today. Our globalized economy is exquisitely sensitive to 
the disruptions that would inevitably occur during a pandemic. Many 
parts of the world have weak public health and healthcare delivery 
systems, and poverty and overcrowding are widespread, as we witnessed 
in Southeast Asia. Science and medicine, though, have progressed 
dramatically, and we now have tools such as sophisticated viral 
surveillance techniques, effective vaccines, antibiotics to treat 
secondary bacterial infections, and antiviral drugs against influenza 
that should aid in our response to an emerging influenza pandemic. 
These tools, however, will be of little use if we cannot bring them to 
bear when we need them. For that to occur, we must take all possible 
measures now to ensure that our public health and pharmaceutical 
manufacturing infrastructure is equipped to respond to a pandemic.
    Thank you for this opportunity to testify before you today. I would 
be pleased to answer any questions that you may have.

    The Chairman. Thank you very much, Dr. Fauci.
    We'll have, at this point, a 10-minute round of questions, 
and I'll ask Senator Biden to take more than that, as he 
requires, for his opening statement, as well as questions, as 
his turn comes.
    Let me begin, though, by asking you, Dr. Fauci, as we've 
related already this morning, there are multiple Federal 
departments and agencies involved in planning related to the 
prevention situation. These range from Health and Human 
Services, the Department of Agriculture, the State Department, 
and USAID, among others. In your judgment, who is in charge? If 
you have an idea of how this ought to be run, can you relate 
that to the committee this morning?
    Dr. Fauci. When you talk about the health component of it, 
the things that I spoke of and that Dr. Gerberding spoke of, 
there is no question that that responsibility rests with the 
Department of Health and Human Services, Under Secretary 
Leavitt. But the broad picture that involves multiple 
agencies--as you said, State Department, Transportation, 
Commerce, or what have you--that falls under the auspices of 
the Homeland Security Council and the Department of Homeland 
Security.
    The Chairman. Well, who over there is in charge?
    Dr. Fauci. In the Homeland Security Council, it's Fran 
Townsend who is in charge of that council and is the person 
responsible for coordination. When you involve multiple 
agencies that operate through the Department of Homeland 
Security, obviously it's Secretary Chertoff.
    The Chairman. Now, would Ms. Townsend or Secretary Chertoff 
relate to what we understood, to reach out internationally? 
Homeland defense implies what it means here at home, but how 
about the thought that our best bet might be to go to the 
source and to work with these other countries abroad?
    Dr. Fauci. That is State Department. International clearly 
is under the auspices of the State Department.
    The Chairman. And----
    Dr. Fauci. As you know--as Dr. Gerberding has mentioned, 
many of the on-the-ground activities that we have with the CDC, 
and the point about getting samples, also crosses over with the 
Department of Health and Human Services, because many of the 
CDC's activities, and even the NIH, we have people who are 
doing molecular analysis of the evolution of the viruses, but 
when you're dealing with interactions among countries, that's 
State Department.
    Mr. Natsios. We established, some time ago, at a technical 
level, a coordination council of career officers who meet 
weekly, or biweekly, from HHS, from CDC, NIH, USDA, State 
Department, and AID. We divided the workload up. I'm talking 
about the operational level, exactly what has to get done 
internationally. And it's working very, very well. And I think 
it's organized the way it should be. That doesn't always 
happen, but, in this particular case, it has.
    The Chairman. Secretary.
    Ms. Dobriansky. If I may just add, the White House chairs, 
through the Homeland Security Council and also the Domestic 
Policy Council, they have chaired a series of meetings, right 
from the beginning, coordinating with all agencies. The 
Department of Health and Human Services has been in the lead on 
health-related matters, with the focus on domestic issues and 
health-related matters. The State Department has been charged 
with international activities. We, ourselves, at the State 
Department, have an interagency meeting, which does bring all 
of the players, from the domestic side to the international 
side, together.
    And I'll just add--Andrew had mentioned the operational 
level--when we sent out assessment teams--for example, to 
evaluate the needs on the ground in, for example, Laos, 
Cambodia, Vietnam, and through Thailand, and then, later, to 
China and to Indonesia--it was HHS, State Department, USDA, 
which is also a player in this, the United States Department of 
Agriculture, and then AID. But it is the White House that 
chairs the formal interagency process that brings all of the 
pieces together.
    The Chairman. Well, now, at the White House level, then, 
what comment would you make, Mr. Natsios, about the thought 
that the FAO, which is working to control the influenza, says 
it needs $425 million for the task, but, so far, has received 
pledges of only $30 million? Or, Secretary Dobriansky, some 
critics have said that President Bush's $251 million request 
for all international activities is too small. Now, in this 
White House Council, as you've described, to discuss these 
things, are you--do you take a look at this cosmic picture in 
which somehow the money isn't forthcoming?
    Ms. Dobriansky. Let me take the second half of your 
question. These matters have been discussed, and those moneys 
are derived from--the $251 million, to round it off--are 
derived from not only the assessments that have occurred by the 
interagency process, but also it is derived from the trip which 
I took with Secretary Leavitt, which included CDC, NIH, WHO, 
FAO, OIE, all of the multiple players in this process, 
assessing the needs on the ground.
    But, specifically, I think the answer to the critics is the 
fact--number one, that amount is the largest contribution made 
by any country for international activities, number one, which 
the United States has put forward. Second, we are using these 
moneys, the $251 million, to leverage contributions from other 
countries. I mentioned in my statement that right now the World 
Bank and the WHO are holding, in Geneva, meetings which are 
focused on this. We have spoken about what we see to do. We 
want to encourage other countries to come forward and 
contribute, as well, and to identify, collectively, the needs.
    And, finally, I would say that the $7.1 billion also 
relates to, and includes, vaccine development and production. 
That not only relates to, I think, us, domestically, but we are 
working with many other countries on this very crucial issue, 
and I think the moneys vested there, also, it's an investment, 
more broadly.
    The Chairman. Well--yes, Mr. Natsios, do you have a----
    Mr. Natsios. Yeah, let me deal with the budget issue 
first----
    The Chairman. Yes.
    Mr. Natsios [continuing]. Just from our perspective. As I 
understand it, from the White House and from OMB, the $7.1 
billion, which is principally for domestic purposes, is 
basically what we're going to spend on this. It's frontloaded 
to be able to be spent now. The international section of it, 
which is $250 million of the--$251 million of the $7.1 billion, 
is not the end of what we've--of what we're going to request; 
that is only--we got $25 million, because the Congress was so 
helpful in the tsunami, that amendment that you offered, 
Senator, with Senator Obama; then we have the $131-$251 million 
that's in this proposal. We expect additional money to be in 
the 2007 budget.
    Right now--and so, in terms of--there's a distinction, in 
terms of whether--what's--how comprehensive each of the 
respective proposals are for the domestic versus the 
international. One is frontloaded, the other is being spent, 
but it is not at the end of what we're going to propose.
    In terms of the strategy, operationally, we have two 
strategies. I have worked in this for 16 years now, and the 
United Nations and the World Bank and other international 
institutions do very well at certain things, but all U.N. 
agencies are not the same. Some are very well run, some of them 
are actually not very well run. Some are well run in certain 
regions of the world; in other regions, they are very poorly 
run; there isn't even consistency between--within the same 
institution, sometimes. We are not going to put, in AID, all 
our money into any institution--I'm not going to mention 
specific ones--and then hope that they can spend it properly. 
We are going--we--the first money we gave, before anything 
else, was $2 million to WHO and $2 million to the FAO. And we 
programmed it with them, specifically, exactly what we wanted, 
jointly, to do, in which countries. And they're doing very well 
on that. And we will continue to support the international 
efforts.
    However, international institutions tend to move more 
slowly because of their disbursement mechanisms. It's simply a 
matter of getting consensus among donors. If multiple people 
give money, they all want to participate in it. We can move 
bilaterally much more rapidly. And so, we want to combine our 
strengths to move more rapidly between CDC and AID and USD on 
the operational things, with the very important international 
consenus-building and operational elements of U.N. agencies.
    So, we're going to have a two-pronged institutional 
approach toward implementation. One is multilateral, and one is 
bilateral. And I think what we'll do is complement each other's 
strengths and weaknesses.
    The Chairman. Well, we have to hope that our generosity 
will spur others, that they understand the same problem you're 
discussing today, and that there are urgent hearings going on 
in their Parliaments, because, at this stage, somebody 
indicating we've been the most generous will not cut it. In 
fact, there needs to be something happening out there at the 
source that keeps it from flying in here.
    Senator Biden.

 OPENING STATEMENT OF HON. JOSEPH R. BIDEN, JR., U.S. SENATOR 
                         FROM DELAWARE

    Senator Biden. Thank you, Mr. Chairman.
    I find the answer about leveraging other countries a little 
bit like negotiating the Law of the Seas Treaty or some 
bilateral agreement relating to trade. But we don't have time, 
it seems, based on what we've been told, to let what other 
countries might or might not do dictate what has to be done.
    We begin this effort--as you have said, Doctor, from CDC's 
point of view--with a degree of confidence in our capabilities, 
but also the knowledge that there are a lot of serious 
difficulties ahead here. We have no vaccine with assured 
effectiveness against the H5N1 flu. We--and we won't know what 
strain to combat until it shows up and it's transmitted among 
humans and it begins to spread, if I understand you correctly. 
How quickly we learn of that event is going to depend upon 
disease surveillance and reporting capabilities in less 
developed countries that are hard-put to keep track of 
outbreaks. And it's going to take, at least as I understand it, 
from my meetings prior to this hearing, at least 6 months from 
that point to begin full-scale vaccine production. I realize 
I'm reviewing some of what's been said. All of our major 
vaccine producers are foreign owned. The production process is 
complicated and depends upon eggs, that are also imported. 
Developers of new methods of vaccine production are still years 
away from FDA approval. So, that initial human-to-human 
outbreak will not be treated with vaccines, and the country 
where it occurs will need medicines, instead, if we're going to 
avoid the pandemic outbreak crossing our shores.
    One class of antiviral medicines you've spoken about is 
less than fully effective on H5N1, perhaps because medicines 
were used in livestock in Asia, is what I'm told. The effective 
antiviral medicines--Tamiflu, which you've mentioned, Doctor--
is made only by Roche, a Swiss firm, and the U.S. production 
line for Tamiflu will begin operations shortly, but the United 
States, as I understand it, has yet to put in its order, and it 
could soon lose its place in line, as I understand it. I may be 
mistaken, but I am told that we have to the end of the month, 
or the end of next month, to decide whether or not we are going 
to place our order.
    Roche has contributed 3 million courses of Tamiflu 
treatment to the WHO, but you need to begin taking Tamiflu, as 
I understand it--if it works the way hoped--within 48 hours of 
exhibiting symptoms. So we need an excellent worldwide disease 
surveillance and reporting, and we need a system to get Tamiflu 
immediately to people near the initial outbreak.
    And, as I understand from your testimony, and testimony I 
read of two who couldn't be here, these capabilities are vital 
to buying time for the production of a targeted vaccine to save 
the rest of the world.
    So, you've all spoken to that, to some degree, but I hope 
we'll speak a little bit more about funding and whether we need 
to enact new foreign assistance legislation before we adjourn. 
And I heartily commend to all of you the written statement, 
which I'm sure you're familiar with, of Dr. Margaret Chan, 
Assistant Director of the World Health Organization, who was 
unable to be here because the WHO is hosting, today, a major 
avian flu conference in Geneva. Her statement is forthright 
and, I think, pretty sobering. But let me get to a couple of 
the questions that I have. I was going to start with different 
questions, but, for some continuity, I'd like to follow on what 
the chairman asked about.
    One of the things that has become, I think, more front and 
center even than it was for all the years that I've dealt with 
Federal agencies, which I strongly support, like AID, is, who's 
in charge and who has what capacity and what capabilities? Now, 
Ms. Fran Townsend and Michael Chertoff are really good people, 
but, to the best of my knowledge, they have absolutely no 
background in fighting an epidemic, let alone a pandemic.
    Has there been any thought given to bringing back somebody 
like D.A. Henderson, who was responsible for wiping out 
smallpox--to coordinate the avian flu efforts? Does it make 
sense to have somebody like that, who knows a helluva lot more 
than the two people we're talking about, about these kinds of 
things?
    Anyone.
    Ms. Dobriansky. I'll make a comment. The structure that is 
set up is meant to provide coordination and to reach out to the 
expertise rendered by other institutions. And I think, 
critically, here it has been HHS with the expertise of CDC, 
NIH, there are a number of resident experts working very 
closely with Secretary Leavitt, which I think both of you can 
even address more specifically on that, who have been working 
very closely and, I think, providing that kind of assistance 
from, particularly, the health-related area----
    Senator Biden. No, look--excuse me for interrupting--I got 
it.
    Ms. Dobriansky. OK.
    Senator Biden. I understand that. I've been here 33 years. 
I got it. But, at the end of the day, someone pulls the 
trigger. And I want a person pulling the trigger who 
understands all the information they've got, who is fully 
conversant with it, who knows what in the hell they're talking 
about, who has had some experience. We had the same 
coordination at FEMA. Look, this is not a smack at the 
bureaucracy. I've been defending Federal bureaucracies for all 
my adult life here. We have incredible people. But you will 
forgive us all if we're mildly unimpressed by the coordinating 
capabilities demonstrated by the operations that have been in 
place of late. And so, there is a degree of skepticism about 
having somebody who knows what all of it means, not a very 
bright and talented former judge, not a well-informed U.S. 
Senator, not a--you know, whomever. We need somebody who gets 
it all and says ``Boomp, this is my recommendation, Mr. 
President. Bang.'' That's why I'm asking the question.
    Yeah, anybody.
    Dr. Fauci. Senator, I appreciate your concern on that, but 
when you talk about pulling the trigger, you're talking about a 
health event. When do you decide that you are going to do 
something like switch the production of the seasonal flu to the 
production, all out, of a vaccine that would approach the----
    Senator Biden. Right.
    Dr. Fauci [continuing]. The potentially pandemic flu. I 
would, submit to you that that--the expertise for those 
decisions are very well ensconced in the Department of Health 
and Human Services under the leadership of Secretary Leavitt. 
So, although Secretary Leavitt is not a physician or a public-
health person, he understands very well the situation and 
literally, on a daily basis, consults with the health people, 
myself, and Dr. Gerberding and others, including the 
consultation that we get not infrequently from D.A. Henderson. 
So, I think the leadership----
    Senator Biden. Let me get to a specific. Am I right about 
the option relating to Tamiflu and us being able to purchase 
the first major batch? Am I right about that? Is that 
technically correct? I'm not sure I'm right about it.
    Yes, Doctor.
    Dr. Gerberding. Sir, right now, in the strategic national 
stockpile, we have 4.3 million treatment courses of Tamiflu. 
That's up by 2 million from a month ago.
    Senator Biden. Right.
    Dr. Gerberding. We cannot order additional Tamiflu for the 
stockpile until we have an appropriation. So, the appropriation 
that's been proposed to augment the stockpile to get to the 81 
million treatment courses is the step that needs to be taken.
    Senator Biden. We can do that in a heartbeat. You tell us. 
Who says, ``Do it. Pull the trigger. Congress, we need the 
money now''? I promise you, if someone we trust says, ``We need 
it now,'' this will happen in a heartbeat.
    Dr. Gerberding. Well, we're here to tell you that we need 
it now. That's what the President's----
    Senator Biden. So, you----
    Dr. Gerberding [continuing]. Proposal does. [Laughter.]
    Senator Biden. All right. So, you're saying that's what we 
should do? We should ramp up to $80 million now. Is that--now 
are you speaking for the administration?
    Dr. Gerberding. That was what the President's budget 
proposal contained.
    Dr. Fauci. The President's budget has $4.7 billion for 
vaccine, $1.4 billion for antiviral, and a----
    Senator Biden. And that will take care of what we're 
talking about. That's encompassed. So, you need that now.
    Dr. Fauci. Yes.
    Dr. Gerberding. We need that now.
    Senator Biden. Good. That's all I have.
    The Chairman. Very well.
    [The prepared statement of Senator Biden follows:]

  Prepared Statement of Hon. Joseph R. Biden, Jr., U.S. Senator From 
                                Delaware

    Mr. Chairman, today's hearing deals with a terrible threat that is, 
to a degree, inevitable. And you are to be praised, Mr. Chairman, for 
holding this hearing and forcing all of us to focus on the very real 
and large challenges that we face.
    Someday, Mr. Chairman, a pandemic will wreak worldwide havoc. It 
may well be an outgrowth of the avian influenza that is currently 
moving into Europe from Asia; or it may be something else. But, 
clearly--

   It will come;
   We may not be prepared for it;
   Many other countries will be desperately unprepared or 
        unable to respond to such terrible events; and
   Their lack of preparedness will harm us, as well the rest of 
        the world.

    We are talking about a risk of social and economic disruption on a 
scale that our country has not endured since the Spanish flu epidemic 
of 1918-19, or perhaps since the Civil War.
    Last week, the administration and the Department of Health and 
Human Services issued a Pandemic Influenza Strategy and Plan. I am 
pleased that they did so, and the plan is very sensible, as far as it 
goes.
    I am also pleased that four high-ranking officials, who will 
implement the administration's plan, will present the plan and answer 
our questions. This is not a time for sitting quietly.

   It is a time to probe;
   It is a time to gain understanding, and
   It is a time to take action, before it's too late.

    We do not know when avian flu will become readily transmitted 
between humans, or how deadly it will be when that occurs. But we know 
that we must prepare for the worst.
    We begin this effort with confidence in our capabilities, but also 
with knowledge of the serious difficulties we face:

   We have no vaccine with assured effectiveness against avian 
        flu, and we won't know what strain to combat until it shows up 
        and is transmitted among humans.
   How quickly we learn of that event will depend upon disease 
        surveillance and reporting capabilities of less developed 
        countries that are hard put to keep track of outbreaks.
   It will take at least 6 months from that point to begin 
        full-scale vaccine production.
   All our major vaccine producers are foreign owned.
   The production process is very complicated and it depends 
        upon eggs that are also imported.
   The developers of new methods of vaccine production are 
        still years away from gaining FDA approval.
   So that initial human-to-human outbreak will not be treated 
        with vaccines. The country where it occurs will need medicines, 
        instead, if we are to avoid the outbreak becoming a pandemic.
   One class of antiviral medicines is less than fully 
        effective on H5N1, perhaps because the medicines were used on 
        livestock in Asia.
   The effective antiviral medicine Tamiflu is made only by 
        Roche, a Swiss firm.
   A U.S. production line for Tamiflu will begin operation 
        shortly, but the United States has yet to put in its order and 
        could soon lose its place in line.
   Roche has contributed 3 million courses of Tamiflu treatment 
        to the WHO.
   But you need to begin taking Tamiflu within 48 hours of 
        exhibiting symptoms.
   So we need excellent worldwide disease surveillance and 
        reporting and we need a system to get the Tamiflu immediately 
        to people near the initial outbreak.
   Those capabilities are vital to buying time for the 
        production of a targeted vaccine to save the rest of the world.

    I hope our witnesses will speak in some detail to what we are doing 
to create those capabilities.
    I hope they will also address the question of funding, and whether 
we need to enact new foreign assistance legislation before we adjourn.
    And I heartily commend to them the written statement submitted by 
Dr. Margaret Chan, Assistant Director General of the World Health 
Organization, who was unable to be here because the WHO is hosting 
today a major avian flu conference in Geneva. Her statement is 
forthright and sobering.
    I also have two questions of particular, personal interest.
    The first relates to disease surveillance. I have urged, for over 3 
years, that the United States help train and equip foreign countries to 
recognize disease outbreaks that might be the result of bioterrorism. 
If we are going to help countries detect avian flu--and we absolutely 
must do that--then why not also train those people to recognize other 
new or emerging diseases, including those that might be the result of 
bioterrorism?
    My second concern relates to avian flu as a threat to commercial 
poultry production in the United States. That's a big thing in 
Delaware, as well as elsewhere.
    I want to make sure that we defend the United States against the 
economic impact of avian flu. It's reaching Europe now and someday it 
will get here, even if that first wave affects only birds, and not 
people.

   What are we doing to monitor its spread among birds?
   What should American producers do to limit the risk to their 
        flocks?
   Should live markets be shut down or more tightly controlled 
        in the United States?
   Should U.S. birds be vaccinated? If so, when?
   What will all this cost?
   And how will we ensure that everybody is included--not just 
        the big companies, but also the mom-and-pop operations?

    That's a lot to ask, and I will ask more during the question 
period. But if ever there was an issue on which we needed to be 
educated, this is it. Many lives hang in the balance.
    Thank you, Mr. Chairman.

    The Chairman. Senator Chafee.
    Senator Chafee. Thank you, Mr. Chairman. Welcome, 
distinguished panel.
    The World Health Organization, is that the lead 
international body that's going to be overseeing all these 
efforts? And I guess I'll ask Secretary Dobriansky, How's our 
relationship with the Health--WHO? And are there still issues 
of--I remember back in SARS outbreak, the PRC did not want 
Taiwan even to have observer status. Are these some of the 
complications, as we look ahead, to the WHO being the lead 
international organization at this--on this challenge?
    Ms. Dobriansky. We are all working very closely with the 
WHO. The WHO is part of the international partnership on avian 
and pandemic influenza, as is the FAO and the OIE and other 
international organizations. They are not only working closely 
with us, meaning the State Department and USAID, but also with 
the Department of Health and Human Services, CDC, NIH, in 
addition to the FAO and the OIE, on animal health, working with 
USDA. We have a close relationship. They're part of the 
partnership.
    Dr. Lee, in fact, has not only traveled with us. We all 
went to Southeast Asia together, along with Dr. Margaret Chan, 
to evaluate the needs on the ground, to take stock of what are 
the most pressing needs and priorities and how we, in turn, can 
fund it. As I also mentioned before, we're working very closely 
with the WHO and the World Bank on funding, and not only just 
on, you know, the issue of what we're putting in, but what 
others are putting in. So, I will say to you that, yes, we have 
a very close relationship. They're the ones who also have been 
looking at national preparedness plans. There's a lot of 
exchange and give and take on these issues technically, from a 
donor standpoint, and also one of the crucial needs, as 
mentioned in our partnership, is providing them with access, to 
be able to get epidemiological samples, to be able to also, you 
know, be provided for support in the conduct of their 
activities abroad. And, toward that end, we have worked 
closely.
    Last comment I'll make. You raised the issue of Taiwan and 
China. We have the APEC meeting, which is coming up next week, 
of which Taiwan, Hong Kong, China, other countries, APEC 
members, are present. We expect a number of concrete 
initiatives to come forth very relevant to surveillance needs, 
especially in preparedness needs.
    Senator Chafee. In this----
    Mr. Natsios. If I could just add one----
    Senator Chafee. Yeah, if you could just answer the old 
issue of Taiwan. And I remember, during the SARS outbreak, as I 
said, the PRC was adamant about not even granting Taiwan 
observer--not even observe status at WHO, if my memory serves 
me right. Is that still going to be an issue?
    Mr. Natsios. Well, there are going to be issues like that 
with any international organization. And that is why we need a 
bilateral approach and a multilateral approach. Because there 
are things the United Nations cannot do quickly and easily 
because of these kinds of complications, but we can do 
bilaterally. So, we need to do both.
    I've been talking to my developed Minister colleagues and 
other Western donor governments about coordinating the things 
that we can do the best, and then supporting the United Nations 
to do things that they do best.
    I might add that it can't just be a human health response. 
WHO has the lead on the human health part of it. But right now 
the biggest risk is actually in the animal population--is the 
poultry population. That's a responsibility of two other U.N. 
agencies. So, Secretary Annan has set up a task force in his 
Secretariat in New York and taken Dr. David Nabarro, seconded 
him from WHO, to head that task force. I've met with him. I 
told him if he needed more staff, more money, more technical 
assistance, he needed fast disbursement mechanisms, USAID has 
them, we will do whatever he needs. And he said he will be 
calling on us as he needs things. We will provide that kind of 
support.
    So, it has to be multiagency, it can't be just one agency--
not just in the U.S. Government, but internationally, as well--
because the disease does not manifest itself simply as a human 
disease, as you know.
    Senator Chafee. And back to the original question. If the 
WHO is this lead international organization, they're the top of 
the pyramid. There seems to be this critical gap in--between 
Taiwan, as I said, and the Secretary saying, at the APEC 
meetings, this will be discussed. How will it be resolved? If 
there's an outbreak in Taiwan and they're not even part of this 
lead organization, it----
    Mr. Natsios. They've had----
    Senator Chafee [continuing]. Seems like a critical gap----
    Mr. Natsios [continuing]. An outbreak already a couple of 
years ago of something related to this, and they eradicated it 
very rapidly. Their Ministry of Health doesn't actually need 
much outside help. It's very competently run, very well 
staffed, and very well funded. It's a developed country, 
Taiwan; and so, it's good to have coordination with them, and 
we need to do that, and get samples transferred and tested. But 
they don't need a lot of technical help from the outside.
    Senator Chafee. It's always good to have the coordination 
through the lead organization, I would think, though.
    Mr. Natsios. Yes.
    Senator Chafee. Is it just done as a de facto member, 
everybody just recognizes the political issue and works around 
it?
    Ms. Dobriansky. You asked the question if their membership 
is still being blocked. Yes, that is the case. And that's why I 
think, as my colleague indicated, there are different ways of 
dealing with these challenges internationally. There are also a 
number of closed societies which are difficult in getting 
information about, and how we have to work through a variety of 
means, it might not be just one single means, through an 
international organization. That's why there is a partnership. 
We felt it was crucial to have a partnership, to bring not only 
countries together, but international organizations, and to try 
to work as effectively as we can when we know of cases.
    Senator Chafee. Thank you very much.
    Senator Biden was asking about the funding and the amount 
needed. We had an outbreak of bird flu in Rhode Island, believe 
it or not, and the farmer was asked to euthanize his chickens. 
And I was involved in trying to get him some reimbursement 
through the Animal and Plant Health Inspection Service from the 
Department of Agriculture, and it took the longest time to get 
the $80,000 he wanted to compensate him for his losses. And if 
we're having that problem in an economically robust and 
advanced country like the United States--and that's the key; if 
a farmer is going to know that he's going to get some 
compensation before he reports any kind of sickness in his 
flock; swiftness of the reporting, I think, is key here--if 
there's not that incentive they're going to know they're going 
to get some compensation, I think we're going to be in trouble. 
Does this money include compensation for farmers?
    Mr. Natsios. There's no funding in this $250 million for 
that. That is something that countries themselves are going to 
do. But what we're doing, working with the Food and Agriculture 
Organization of the United Nations, in the four most at-risk 
countries, is testing some new incentive systems for the 
farmers to see which ones work, to make sure that they are 
transparent and rapid in their response.
    I think there is a psychological element to this. The flu 
that you saw in Rhode Island was not H5N1.
    Senator Chafee. Right.
    Mr. Natsios. It did not have the kind of frightening 
prospect that this virus, has. And if you read the newspapers, 
which we do every day in Southeast Asia, this is on the front 
page of every newspaper in that region. It is frightening 
people. And people are paying attention to it now, not just in 
the Ministries, but at the grassroots level. People are very, 
very nervous about this. Every one of these human infections is 
on the front page of the newspapers. I think that will help us 
to convince farmers and people that they need to cooperate on 
this, or this could get out of control. And that is going to 
facilitate--without creating panic--facilitate the whole effort 
to move this incentive system along. We're testing it, and I 
think by February we should have a system in place that 
actually does work from field tests in those four countries 
that are most at risk.
    Senator Chafee. And is it in our personal interest here to 
have a fund that might help if some of these developing 
countries cannot afford to have compensation programs? Isn't it 
in our interest to have a fund that can address some of the----
    Ms. Dobriansky. If I may address that, at this----
    Senator Chafee [continuing]. Funding shortfalls?
    Ms. Dobriansky [continuing]. At this meeting in Geneva, 
this has been the very topic of discussion with the World Bank, 
with developed countries. Countries--the developing countries 
have, in fact, literally made statements about how they see 
their particular needs. And they even have given rough figures 
as to what they see as what they are in need of, moneywise. 
That particular meeting has discussed this quite tangibly, that 
there is a need. There may very well be, in about, I'd say, 
approximately about a month time, a month and a half time, 
where there will be a meeting that will be held to actually 
bring countries together to make pledges. We are hoping to get 
these pledges beforehand.
    When Senator Biden mentioned the issue of leveraging, the 
only reason I raise it is because we do want others to come 
forward and to contribute. There is an urgency, and there's a 
need to do this. And this has been the topic of the day at this 
meeting.
    Senator Chafee. Thank you, Mr. Chairman.
    The Chairman. Thank you very much, Senator Chafee.
    Senator Sarbanes.
    Senator Sarbanes. Thank you very much, Mr. Chairman. I want 
to join my colleagues in welcoming this distinguished panel.
    I've been listening carefully to the questions and answers, 
and it's still not clear to me who the coordinator is in the 
executive branch of the U.S. Government on this issue. Now, I'm 
told, it's the White House. At least at one point, the response 
was the White House. I have difficulty getting my mind around 
the concept of ``the White House,'' as an entity, coordinating. 
I want to know who the person is that is coordinating. Is there 
such a person.
    Dr. Gerberding. Yes, there is.
    Senator Sarbanes. Who is it?
    Dr. Gerberding. We have all, at this table, been at the 
White House with the President and the Vice President, 
Secretary Leavitt and the Cabinet Secretaries, time and time 
again, where the issue of pandemic preparedness and the 
national strategy for that preparedness has been discussed. The 
President, himself, is very much engaged in setting the 
national strategy here, and I believe he would probably own the 
strategy, but he was also very clear that Secretary Mike 
Leavitt had the accountability for developing the plan for the 
health components of it, and, should we have a pandemic where 
we needed to mobilize all of our national resources, from 
transportation, commerce, et cetera----
    Senator Sarbanes. You mean a pandemic in the United States.
    Dr. Gerberding. If a pandemic occurs anywhere, it's an 
issue of national health and security and economic concern 
domestically. So, if there is a global emergence of a pandemic 
strain, we, in the United States, will be responding as if 
there was a health emergency on our shores, even if it hasn't 
arrived. And Homeland Security, in that context, will have the 
accountability for mobilizing all the other support resources 
necessary for the Secretary to execute the health plan.
    Senator Sarbanes. So, who's the person? The Secretary of 
Health and Human Services?
    Dr. Gerberding. Secretary Mike Leavitt, under the National 
Response Plan, is accountable for managing the health 
consequences----
    Senator Sarbanes. Now, is he accountable for dealing with 
this problem of compensation for the farmers in these four 
affected countries, where I understand there is no plan, at the 
moment, for compensation? And who's responsible for that----
    Ms. Dobriansky. It also----
    Senator Sarbanes [continuing]. In our structure?
    Ms. Dobriansky [continuing]. It also indicates that the 
Department of State--and USAID is part of the Department of 
State--is discharged with--or charged with international 
activities, so the specific matter that you just raised falls 
to the Department of State, USAID. We work----
    Senator Sarbanes. Are you----
    Ms. Dobriansky [continuing]. With the others.
    Senator Sarbanes [continuing]. Are you the responsible 
person in the Department of State on this issue?
    Ms. Dobriansky. I am the point person at the Secretary--
Under Secretary level, and I work very closely with the 
Secretary of State and the Deputy Secretary of State. That is 
correct.
    Senator Sarbanes. But is it your charge, on a daily basis, 
to----
    Ms. Dobriansky. It is my charge----
    Senator Sarbanes [continuing]. Follow this issue.
    Ms. Dobriansky. It is my charge, on a daily basis, 
internationally, to work this issue in the Department of State.
    Senator Sarbanes. OK.
    Ms. Dobriansky. And I work----
    Senator Sarbanes. Now, Andrew is it----
    Ms. Dobriansky [continuing]. Very closely with Andrew.
    Senator Sarbanes. Is it held at your level at AID, or is it 
somebody at a lesser rank?
    Mr. Natsios. I have appointed one of our senior 
epidemiologists, Dr. Dennis Carroll, to head the USAID Task 
Force on this, and I had in my testimony exactly what our plan 
is for the next 5 months, how we're going to program the $131 
million we expect to get, what measures we're taking now, what 
we've already done, what we're planning to do, and what's going 
on right now.
    I meet with them once a week, and I bring everybody from 
all over the agency in on the task force with Dr. Carroll, and 
we sit down and go over what's been accomplished in the 
preceding
week. Dr. Kent Hill would be here himself, but he's in Geneva
at the WHO meeting on this issue. He's the Assistant 
Administrator of the Global Health Bureau, equivalent to an 
Assistant Secretary. So, within USAID, it's very clear what 
we're doing. We have weekly meetings at the technical level, at 
Dr. Carroll's level, with Paula's staff and with CDC and HHS.
    Senator Sarbanes. Well, now, who in CDC is responsible?
    Dr. Gerberding. I am accountable.
    Senator Sarbanes. You're directly responsible?
    Dr. Gerberding. Yes, I am.
    Senator Sarbanes. Now, when these groups all meet, who 
coordinates that meeting? Who calls that meeting?
    Dr. Fauci. That's the Homeland Security Council at the 
White House, together with the National Security Council, 
Domestic Policy Council. But the Homeland Security Council is 
the lead coordinator at the level of the White House. So, as 
we've said, when you're talking about health issues, the issues 
that we're talking about--vaccines, therapies, et cetera--
there's no question, Secretary Leavitt is in charge of that. 
When the situation involves multiple agencies that are 
coordinated under the White House, the Homeland Security 
Council, under Fran Townsend, is the person and organization 
that coordinates that.
    Dr. Gerberding. You know, if I could just add to this, 
because in the time that I've been the CDC Director, I've 
personally been involved in 25 public-health emergencies, and 
all of them have involved complicated coordination with a lot 
of other agencies, ranging from the DOD to the Department of 
State and everyone in between. And I think one of the lessons 
that we've learned is that there are two really critical 
components of this. One is strategy, and if you can get the 
agencies to have a clear understanding of what is the 
strategy--in this case, the strategy--if there's a threat 
anywhere, it's everywhere; we will contain, if possible; we 
will slow; if we can't, we'll get countermeasures developed--
that's the national strategy. Executing that strategy has to be 
a distributed function to the agencies with the technical 
expertise and the capacity to do that. CDC has specific 
responsibilities. NIH has specific responsibilities. USAID has 
specific responsibilities. I think when you learn how to work 
in this complicated----
    Senator Sarbanes. Who is overseeing or riding herd on those 
specific responsibilities amongst the agencies?
    Dr. Gerberding. It depends on what level you're talking 
about. Operationally at CDC, I am. If you're talking about 
the----
    Senator Sarbanes. No, above you.
    Dr. Gerberding [continuing]. Overall health plan, Secretary 
Leavitt.
    Senator Sarbanes. I mean, I asked you who at the White 
House, and I'm told you met with the President and the Vice 
President.
    Dr. Gerberding. It's the President.
    Senator Sarbanes. But presumably they don't do it day to 
day, do they?
    Dr. Gerberding. The President has had multiple meetings 
with the high Cabinet officials, and he has specifically tasked 
Secretary Leavitt to specifically brief----
    Senator Sarbanes. So, you're telling me the President is 
the coordinator on this issue?
    Dr. Gerberding. I am telling you that the President is 
accountable for the strategy, and he has delegated the 
authority to brief Cabinet Secretaries one by one to charge 
them to prepare their cabinets. Dr. Fauci and I have both gone 
with Secretary Leavitt to every single Cabinet Secretary and 
sat down and walked through the national strategy so that 
everyone understands what their contribution needs to be.
    Ms. Dobriansky. Senator, if I may just add something. 
Because I mentioned, earlier, the White House. There is a 
formal structure of the Homeland Security Council in 
conjunction with the--what's known as the Domestic Policy 
Council.
    Senator Sarbanes. And the National Security Council.
    Ms. Dobriansky. And the NSC, correct--which has brought 
together, in a coordinative way, all of the agencies. There is 
high-level engagement on this at each of the agencies. You 
asked at the State Department--I work very closely with both 
the Secretary of State on this issue and the Deputy Secretary 
of State on the--on this issue, as well as those that have 
technical expertise below.
    Senator Sarbanes. The four of you are here today. Senator 
Lugar, in his wisdom, has brought you together. When was the 
last time the four of you were together to meet on this issue?
    Ms. Dobriansky. Just last week. We've traveled to Southeast 
Asia together, we have sent missions to conduct assessments----
    Senator Sarbanes. And who convened the meeting at which the 
four of you were together? I'm just trying very hard to find 
out where the point person is here----
    Ms. Dobriansky. We have had----
    Senator Sarbanes [continuing]. And I'm still struggling and 
trying to do the----
    Ms. Dobriansky [continuing]. Meetings with the President--
in fact, directly--in which we have discussed what each of us 
are doing and our accountability in different areas. The last 
meeting----
    Senator Sarbanes. The President's not going to ride herd on 
this day to day. The President's out traveling across the 
country most days, as best I can tell. He's not going to ride 
herd on this. Who rides herd on this, day to day?
    Ms. Dobriansky. It is the Domestic Policy Council and the 
Homeland Security Council--Fran Townsend----
    Senator Sarbanes. Well, who is that?
    Ms. Dobriansky [continuing]. And Claude Allen, who was the 
former Deputy Secretary of HHS, and the National Security 
Council, in Steve Hadley.
    Senator Sarbanes. Well, they need a council to coordinate 
the councils, from the sound of it. Let me ask you a strategy 
question.
    This proposal of the President's for $7.1 billion for 
preparedness surveillance and containment programs, of which 
$250 million is for international spending--although 
Administrator Natsios pointed out that that's not the end of 
it, that's just the beginning--but, still, less than 4 percent 
of the money is going to international spending. The Washington 
Post had an editorial recently saying, ``Both the plan and the 
funding proposal ignore the benefits to Americans of working 
with countries in Asia and possibly Africa, where the virus 
could break out first and be halted or slowed before it gets 
here.''
    What about that observation, in terms of how we address our 
resources in order to try to stop this virus at the earliest 
possible time?
    Mr. Natsios. Senator, let me just answer that, because 
we're exclusively focused internationally, we have no domestic 
responsibilities, as you know. I have written, which I have not 
done on any other issue, to all of our mission directors all 
over the world and said, ``This is now the number one priority 
for the agency, above all other issues.'' I read John Barry's 
book, ``The Great Influenza,'' and I had our senior staff read 
it, and other books, and it was so frightening to me, the 
potential for this, that I said, ``We must take the steps 
now.''
    We have done--we've just got in, now, reports from 102 of 
110 countries that we've asked for comprehensive reviews of 
what status they have, in terms of knowing what they need to 
do, what plans are in place, whether they have stockpiles. We 
can show that to your staff, if you'd like to see it. So, 102 
of the 110 countries we've surveyed. Who are the countries that 
are most at risk or that are the poorest countries that don't 
have the infrastructure to deal with this. In the field, in the 
developing world, USAID is the predominant by far, bilateral 
aid institution. We work with our other colleagues--I meet with 
them, I talk to them every day--all over the world, from other 
donor governments. And so, we have an operational plan in 
place. We're working with the Ministries of Health, the 
Ministries of Agriculture, the Ministries of Finance in these 
countries. Bob Zoellick has--and under the orders of the 
Secretary--informed the American Ambassadors abroad they are 
responsible--our mission directors report to the Ambassadors--
and to take this as their priority, as well.
    And so, in the field, the best defense we have--which is 
the best defense for the country--is in the developing world. 
It's not on our borders. I mean, that's the next line of 
defense. And the best line of defense that we have are USAID 
missions. Three-quarters of our staff are not in Washington, 
they're in the field. We have 5,200 Foreign Service nationals 
that work for us, we have 1,100 Foreign Service officers 
arrayed in these missions, who have now realized how dangerous 
this is to the countries they work in and to the United States 
and to the whole global economy. So, I've told them they are 
responsible for this. The Ambassadors have been told the same 
thing by Secretary Zoellick, on orders from Dr. Rice.
    So, that is our best line of defense. Now, we're working 
bilaterally, but we're also working multilaterally, through the 
international institutions. As I said, I think before you came 
in, our first contributions were to the World Health 
Organization and to the Food and Agriculture Organization. 
They're the two first obligations we made from the money you 
generously gave us in the supplemental budget. Because we 
regard that as a critical element of this. And we will continue 
to support them in every way we can, work with them on a daily 
basis, second staff, use our contracting mechanisms, if that's 
useful to them. Because this has to be a world international 
effort. It can't be just one country doing it.
    The Chairman. Thank you very much, Senator Sarbanes.
    Senator Dodd.
    Senator Dodd. Thank you very much, Mr. Chairman. Mr. 
Chairman, thank you for holding this hearing today. I want to 
thank all of you for being here.
    We've had the opportunity to have all of you here at one 
time or another over the years on various subject matters, and 
I watched the other day, I think, all of you, or maybe with the 
exception of Mr. Natsios, in front of the House committees 
dealing with these issues, along with Mike Leavitt, who was 
there. I found it an interesting hearing. It was very, very 
worthwhile.
    I raise the first question for you as a sense of emergency. 
I raised the issue when Majority Leader Frist was here, at the 
outset of the hearing, about the sense of crisis--maybe that's 
not the right word, but there is a--there's a sense of 
emergency about this, I gather. Senator Frist certainly made 
that point. His intention is to have legislation before us 
before our departure here for Thanksgiving. And I gather, 
reading the testimony of all of you here, that there's a real 
sense that we're in a major issue. In fact, you, Mr. Natsios, 
have written to all of your offices globally that this is the 
number one issue. Dr. Fauci, your testimony, and, Dr. 
Gerberding, your testimony, as well, give us some sense of 
this. I'd like to get some sense of proportionality here about 
the sense of emergency here. I know you've talked about the 
epidemics of 1917-18, 1957, so forth. Tell us what we're 
looking at here, potentially. And to what extent is there a 
likelihood that, in fact, we're going to face a pandemic at one 
point or another in the relatively near future?
    Dr. Gerberding. No, we've worked really hard to get a 
precise answer to that question, and there just isn't one. We 
know pandemics happen. We know we're due for one. We look at 
this situation, and we see very worrisome components of the 
overall global status of this H5N1 virus. We know the fragility 
of our vaccine and our antiviral production system right now. 
So, we're vulnerable if one happens.
    I would characterize it as probably low statistical 
probability but enormously high consequences, and that's really 
why we're in a situation right now where we feel compelled to 
take these large-scale urgent actions, because we've got only 
one more box to check on the list before we truly do have a 
pandemic.
    We've looked at models. We've looked at the virus itself. 
We can say that this H5N1 virus has the characteristics of the 
1918 virus. That was another worrisome observation in the last 
couple of weeks. All the signs are worrisome. And yet, you 
know, it hasn't happened yet, and it might not ever happen. I 
think one point that I would like to make in that context is 
that while there will be some who will say exaggerating a 
concern, crying wolf, overemphasizing this for the sake of a 
budget proposal, whatever, I don't think that's all an 
appropriate assessment. And, in fact, whatever we do with these 
investments, we're going to end up with fixing the vaccine 
supply problem. We will fix the antiviral supply problem. We 
will have international surveillance, and we'll have some peace 
of mind.
    Senator Dodd. Dr. Fauci, put some mean on this for me, will 
you?
    Dr. Fauci. If you look, just historically--and that's what 
we can go by--and look at the 20th century, there were three 
pandemics. That means that it's a virus to which we've never 
had any exposure to, and, therefore, we were quite vulnerable.
    The spectrum of severity of that was enormous. The mother 
of all pandemics was 1918. Probably the worst public health 
catastrophe that our civilization has ever experienced. In 24 
weeks or a few months, there were 40 to 50 million deaths 
worldwide. In the same century, in 1968, we had another 
pandemic, which, by pandemic standards, really wasn't 
particularly severe, although the potential was there that it 
could have been.
    So, when you're talking about preparedness, and you're 
looking at the fact that, from a pure temporal standpoint, if 
you average about three per century, then we're temporally 
overdue. But that's sort of like saying you're going to have an 
earthquake. What does that mean? Put it into the context of 
what's going on in Southeast Asia now where there are very 
troublesome signs because you're having a virus that's actually 
jumping species from chicken to human in a very inefficient 
way. In the big picture of life, 125 cases and 64 deaths is not 
a lot, but it tells us that the potential exists for that to 
change a lot.
    And, as I said in the last comment in my opening statement, 
which you didn't hear, but I'll repeat it for you, because I 
think it answers, directly, your question. You must assume the 
worst-case scenario, even though in pure statistical analysis, 
the way Dr. Gerberding said, it's unlikely that that would 
happen. If you don't assume that, then I think it borders on 
irresponsibility.
    So, the way the plan has been fashioned is that even if 
nothing happens, we will have built up the vaccine production 
capacity, we will have had a greater number of drugs to use 
against this----
    Senator Dodd. Yeah.
    Dr. Fauci [continuing]. So that when we do face, in the 
future with these threats, we don't want to start from such a 
low baseline. We're at a very low baseline right now, because 
the influenza vaccine production capacity has been fragile for 
years and years and years. And only when you're now faced with 
a potential global catastrophe do you realize you have to fix 
it. So, if nothing else comes of all of this, and we just fix 
that capacity that we have, I think we will have done a very 
good thing for the public health.
    Senator Dodd. Well, let me just--because I notice that in 
today's CQ, quoting some of the House leadership, Republican 
leadership, one Member there compared this situation, I'm 
quoting, ``There is a preparedness gap for the Martians 
attacking us,'' the suggestion being that we ought to have 
offsets here and take our time on this. Without getting into 
the details, that's the comment on specific Members. That 
attitude of comparing what we're talking about here to the 
Martians landing, what's your reaction to that?
    Dr. Fauci. Well, I was at that hearing. I was testifying at 
that hearing. With all due respect, I think that that--yeah, it 
was a great hearing, Senator----
    [Laughter.]
    Dr. Fauci. I don't think that appropriately describes the 
situation right now.
    Senator Dodd. Would it be irresponsible for us to be 
dragging our feet here, in terms of the resources necessary, to 
respond to the very facts, situation, you've just described?
    Dr. Fauci. I believe so, Senator Dodd. I believe that we 
must treat this as an imminent worst-case scenario, even 
though, statistically, it's unlikely that it would happen next 
month or a few months from now. We have to treat it like the 
worst-case scenario.
    Senator Dodd. But is there a likelihood, looking back over 
the charts and the graphs you put here, where you have 1917-
1918 period, and then, of course, late 1950s and 1960s, and 
then you point out, in this period here, there have been 
smaller incidences of these H1 variations that haven't 
developed, at least into the pandemic situation. I presume that 
if one went back and looked at those periods between 1917-1918 
and 1950s, there were also smaller incidences that did not 
develop into pandemics if we had the ability to detect them in 
those days. Is that true?
    Dr. Fauci. Yes, but we didn't have the situation we're in 
now--what's so different about now, November 2005, is that we 
have, going on in Southeast Asia, an extraordinarily pervasive 
virulent bird flu that is involving migratory birds, that is 
now continuing to infect----
    Senator Dodd. Yeah.
    Dr. Fauci [continuing]. Flocks in a highly virulent way. 
This is unprecedented, to have so much of that going on the 
same time. So, when you get back to what we were alluding to 
before----
    Senator Dodd. Yeah.
    Dr. Fauci [continuing]. About what the probability is, as 
you get more chickens infected and----
    Senator Dodd. Yeah.
    Dr. Fauci [continuing]. More people exposed to chickens, 
you have more of a chance of people getting infected. The more 
people that get infected, the greater chance the virus has to 
evolve into something much more formidable than it is.
    Senator Dodd. What I'm getting at here, in a sense, or 
driving--I'm going to get to it quickly--is, looking ahead into 
the 21st century at all, what we're seeing here, what's 
happened here, given globalization, given the expansion of 
markets and so forth--the comment someone made of 13, was it, 
million to 13 billion poultry in this relatively short period 
of time, for instance, are we looking at more of this kind of a 
problem emerging, in your view, in the 21st century than we've 
seen, because of all of these other factors?
    Dr. Fauci. Well, I think emerging and reemerging infectious 
diseases is something that we've been speaking about to this 
committee--I see Senator Biden shaking his head, because I've 
testified before you, Senator, several times about emerging and 
reemerging infections--they'll always be a threat. And the fact 
that we live in a global community----
    Senator Dodd. Right.
    Dr. Fauci [continuing]. Makes it even more problematic. And 
when you have something that could have the public health 
impact of an influenza which is very unique--one, in its 
ability to spread, and, two, in the fact that it makes people 
very sick; it's not a trivial disease--living in a global 
economy, you could have economic disruptions that you would 
never have imagined----
    Senator Dodd. Yeah.
    Dr. Fauci [continuing]. Because we live in a just-in-time 
society. I mean, you----
    Senator Dodd. I'd like you to comment----
    Dr. Fauci [continuing]. Cut off imports, we're in real 
trouble.
    Senator Dodd [continuing]. I'd like you to comment, then, 
on the capacity. I was--looked down the number of the--the 
companies here. You're talking about Roche, you're talking 
about--I may be mispronouncing these names--Sanofi or Chiron--
--
    Dr. Fauci. Sanofi Pasteur, right.
    Senator Dodd. Yeah. At least two of those companies are 
international companies, not----
    Dr. Fauci. Right.
    Senator Dodd [continuing]. Not located in the United 
States. What's the argument for talking about some sort of 
governmental capacity here? I mean, we're relying here--which 
does a very good job, by the way, generally speaking, on the 
private sector, the drug industry producing vaccines and 
antivirals--but what you've just described here is something 
far more sinister in many ways. And if we're going to be 
dependent upon a private sector industry here to produce the 
vaccines and the antivirals, that seems to me to sort of be 
dragging our feet a bit. Is there an argument here that you 
think is worthy of exploring to talk about a governmental 
capacity, where we could develop these vaccines far more 
rapidly than depending upon the vagaries of a private sector 
that may want to respond?
    Dr. Fauci. Yeah. With all due respect, Senator, I don't 
agree with that. I think we need to continue to rely on the 
extraordinary expertise and capabilities of industry. And 
that's one of the reasons why, in this plan, we talk about 
building the capacity and sharing some of those risks so that 
we can get companies to build their plants here in the United 
States and to have a stable market for influenza vaccines so 
that you link it to what we do on a seasonal basis so----
    Senator Dodd. Let me just ask one more question of all of 
you. Well, I want to know whether or not, first of all, just 
quickly on this, we're talking about companies overseas--
compensation. As we know, over the years, we've talked about 
compensation programs, where we encourage people to take 
vaccines. We saw it with smallpox and first-responders, where 
there was a feeling that compensation wouldn't be there, and, 
therefore, there was a difficult problem we had, at least 
initially, in getting first-responders to take the vaccines. In 
any program we develop here in the coming days, should there be 
a comprehensive compensation program for people who will have 
adverse reactions to any vaccines we may develop, in your view?
    Dr. Fauci. I think that's something that certainly needs to 
be discussed.
    Senator Dodd. Well, are you in favor of it or----
    Dr. Fauci. Yeah, you know, I can't say that, because that's 
not my area of expertise----
    Senator Dodd. Well, Dr.----
    Dr. Fauci [continuing]. To look at compensation----
    Senator Dodd [continuing]. Gerberding, is----
    Dr. Fauci [continuing]. But I would----
    Senator Dodd [continuing]. That your expertise----
    Dr. Fauci [continuing]. Think it certainly needs to be 
discussed.
    Senator Dodd [continuing]. What is your view on that?
    Dr. Gerberding. I certainly feel that, from the standpoint 
of the smallpox vaccination program, that the absence of a 
compensation program that was acceptable to the people we were 
hoping to vaccinate was the major barrier. And I think we've 
learned some lessons from that. I'm not sure what the best 
solution is, as we look forward to the kind of circumstances 
we'd be operating in a pandemic, but I know Secretary Leavitt 
is committed to having those discussions and figuring out a 
solution.
    Senator Dodd. Yeah. And are we prepared to share, by the 
way, any of these vaccines that we develop for antivirals--if 
you have an pandemic explode in some Asian country, are we 
prepared, then, to share these products with these other people 
around the world?
    Dr. Gerberding. In fact, the plan includes a budget 
proposal to do a vaccine trial in Vietnam to make sure that the 
products we're developing here could be used in other 
populations, as well.
    Senator Dodd. Thank you.
    Thank you, Mr. Chairman. I apologize.
    Senator Sarbanes. Can I just ask a clarifying question?
    The Chairman. Senator Sarbanes.
    Senator Sarbanes. Secretary Dobriansky, am I to understand 
that the Secretary of State has sent out instructions or an 
alert to all Ambassadors comparable to what Administrator 
Natsios sent out to all AID mission directors? Is that correct?
    Ms. Dobriansky. What we have done is, we have sent out an 
ALDAC cable, which goes to all of our posts worldwide. And, in 
this case, not only addressing the broader issue, the policy 
ramifications, but alerting all of our posts through the Med 
Units and also Consular Affairs, as well as all of the 
Ambassadors. So, to answer your question, yes, we have.
    The Chairman. Thank you.
    Senator Obama.
    Senator Obama. Thank you, Mr. Chairman.
    Thanks to all of you for taking the time to be here. You 
know, I have heard many of you in previous settings, panels, 
and am struck by your seriousness and knowledgability about 
these issues.
    I want to follow up on, I guess, a point that's already 
been made by Senator Biden and Senator Sarbanes. And let me 
just not beat around the bush. Why don't we just have one 
person in charge of these efforts? All of you are busy. All of 
you have other responsibilities. All of you are managing large 
operations. It's not as if USAID has nothing to do, other than 
prepare for avian flu. It's not as if the CDC is without any 
other responsibilities. As capable as you all are, it seems to 
me that identifying an individual to be responsible would make 
sense. And I have to tell you, you know, Dr. Gerberding, I am 
always impressed with your testimony, but the notion that the 
President of the United States is, on a day-to-day basis, 
carefully scrutinizing these issues, monitoring them, and is in 
the position to operationalize them and be the key 
decisionmaker on these issues just defies credulity. He's got a 
lot of things to do, too.
    Dr. Gerberding. But let me clarify, because I don't think 
that's what I said, or what I meant to imply.
    Senator Obama. Well, but it was, sort of--the response that 
you gave to Senator Sarbanes was--I mean, he kept on pressing, 
``Who's in charge?'' And your----
    Dr. Gerberding. Let me----
    Senator Obama [continuing]. You kept on repeating, ``The 
President's in charge.''
    Dr. Gerberding. Let me reply to that. What I said was that 
there is strategy and there's operations. And, in terms of 
defining the Nation's strategy, which are the five or six 
bullets that I mentioned, that decision was reached with a 
great deal of input from experts across the U.S. Government and 
outside of the Government, and the President made a policy 
decision that this is the U.S. strategy. And he has met with us 
periodically, as that strategy was developed and----
    Senator Obama. I----
    Dr. Gerberding [continuing]. Then to discharge the 
responsibility for executing it primarily to Secretary Mike 
Leavitt, and the coordination functions at the strategic level, 
as we've already discussed, with the--Homeland Security having 
the lead, Domestic Policy----
    Senator Obama. But I----
    Dr. Gerberding [continuing]. And Security Council----
    Senator Obama [continuing]. I'm sorry, that doesn't make 
sense to me. Now, I understand the President's the ultimate 
decisionmaker, the same way that he makes the decision to go to 
war in Iraq. But then, you know, he's not looking over the maps 
on a daily basis, trying to make determinations, in terms of 
how to prosecute that war.
    Dr. Gerberding. The person----
    Senator Obama. Now, Secretary--let me just finish, because 
I want to respond to what you said--I understand what you said 
with respect to Secretary Leavitt being responsible for the 
health issues involved. But the point I think that this panel 
is making is that there are multiple functions that have been 
described by this panel. There are functions related to health. 
Who's going to be responsible for deciding that a quarantine, 
in some circumstances, is warranted? OK, that's you. Who's in 
charge of calling for, and implementing, border closings or 
restricting flights? Is that you?
    Dr. Gerberding. Secretary Leavitt would make that----
    Senator Obama. OK.
    Dr. Gerberding [continuing]. Recommendation.
    Senator Obama. Who's in charge of managing, you know, 
economic shocks, such as supply-chain disruptions? Is that 
Secretary Leavitt, as well?
    Dr. Gerberding. If we are in a situation where those 
operational decisions need to be executed, we will be 
functioning under the National Response Plan, in which case 
Secretary Leavitt would have the responsibility for health, and 
the other people defined under that plan for those border 
decisions or the logistic decisions would have their respective 
Cabinet responsibilities.
    Senator Obama. OK. So, you don't think that it makes any 
sense to have somebody whose full-time job is to think about 
how all these multiple functions are being carried out. You 
don't think that that is a sound management approach, but it 
makes more sense to have everybody responsible for these 
various functions, with the President sorting through----
    Dr. Gerberding. I really----
    Senator Obama [continuing]. These various issues.
    Dr. Gerberding. I have to object to that characterization, 
because that's really not what I said. I do think the 
President--and, to my amazed relief, as a person in public 
health who, for decades, has been trying to get people to pay 
attention to this--that our leaders are concerned and are 
engaged in and----
    Senator Obama. I am not----
    Dr. Gerberding [continuing]. Are participating----
    Senator Obama [continuing]. I'm not challenging----
    Dr. Gerberding [continuing]. In the policies----
    Senator Obama [continuing]. Whether they are concerned or 
engaged. What I'm asking is that--you know, if we have some 
sense of who--what I'm asking is, Do you think that this 
structure that you described that, frankly, many of us on this 
panel still don't understand, after, what five sets of 
questions from Senators--do you think that that is the optimal 
approach? Or do you think it would make sense to have yourself 
or Dr. Fauci or others, somebody, who was saying, ``You know 
what? I am keeping track of all this stuff. I'm calling these 
various council meetings together. I'm making sure that each 
agency is working in a clear sense. If the President has a 
question, he knows the person to call,'' that----
    Dr. Gerberding. I----
    Senator Obama [continuing]. You don't think that would be--
--
    Dr. Gerberding [continuing]. I think what----
    Senator Obama [continuing]. Preferable approach?
    Dr. Gerberding [continuing]. You're hearing from us is that 
we think we have that. We think that Fran Townsend is the point 
person who's coordinating for the----
    Senator Obama. Fran Townsend is----
    Dr. Gerberding [continuing]. White House----
    Senator Obama [continuing]. The person.
    Dr. Gerberding [continuing]. As the head of the Homeland 
Security Council. And so, the coordination and the strategic 
collaboration necessary to bring all these Cabinets together, 
that's the logical place for that----
    Senator Obama. So, is----
    Dr. Gerberding [continuing]. To occur.
    Senator Obama [continuing]. Is Fran Townsend reporting to 
Michael Leavitt?
    Dr. Gerberding. Fran Townsend reports to the President.
    Senator Obama. OK. So, Fran Townsend is the person in 
charge?
    Dr. Gerberding. Fran Townsend is the person in charge of 
the coordination at the White House level for the 
administration in assuring that the Cabinets have clearly 
defined execution strategies so that we're all able to execute 
the administration's policy around pandemic preparedness.
    When it comes to the technical content of that policy as it 
pertains to health, Mike Leavitt is accountable. And he's also 
accountable for assuring that the technical execution 
operational plans from the other Cabinets make sense and are 
integrated with the overall health policy.
    Now, it is a very complicated situation. I don't think 
we've ever faced a health challenge as complicated as this one. 
The balance between getting the people who have the technical 
and operational capability to be coordinated across such a 
broad range of functions is a very difficult challenge.
    We went to the Department of Defense, myself, from a CDC 
perspective, to understand how could this be done, what is the 
best way. And what we are learning from those who have far more 
operational execution capability than we do is that when you've 
got to manage a network as broad and as complicated as this 
one, coordination at the top is very, very important. These are 
coordinating mechanisms to try to bring the top leaders 
together to understand, ``What is it that we need to do? Who's 
doing what? Now go out and get it done.'' And, in our case, 
Mike Leavitt has the accountability for going out and getting 
the vast majority of this done, which is the health piece. But 
if we had a pandemic, just as if we had any other national 
disaster, other people from other agencies would have to know 
and understand their specific contributions. Our Government has 
made the decision that the coordination of that should lie with 
the Department of Homeland Security, so that is the plan that 
we are operating under.
    Senator Obama. OK. I have to say I'm now confused again. 
I'm--but I don't want to--I don't want another explanation of 
it. I thought Michael Leavitt was in charge. Now you're telling 
me the Department of Homeland Security is in charge.
    Dr. Gerberding. I think we would be happy to----
    Senator Obama. And then there's this person, Fran----
    Dr. Fauci. Senator, can I just make----
    Senator Obama. Please.
    Dr. Fauci. I hope I can help. I know this has been a--
obviously, a back and forth, confusing issue. In reality, we're 
talking about something that's overwhelmingly a health issue.
    Senator Obama. Right.
    Dr. Fauci. There are other things that will come in, like 
border closings and things like that, that will involve other 
agencies.
    Senator Obama. OK.
    Dr. Fauci. But this is overwhelmingly a health issue.
    Senator Obama. Understood.
    Dr. Fauci. In this regard, the President has delegated 
Secretary Leavitt to be in charge of the health issues. When 
there are other issues that might involve other agencies of the 
Federal Government, that is coordinated. A policy has been 
made, if this happens, this agency does that, and that agency 
does that. That coordination is under the Homeland Security 
Council in the White House under Fran Townsend. But the health 
issues about vaccines and isolating isolates from Vietnam and 
getting it to be a vaccine has little to do with Fran Townsend, 
it has everything to do with Secretary Leavitt.
    Senator Obama. OK. I guess I would just say this, that if 
it takes this much time to describe what the structure is--I 
mean, you're a scientist, and, generally, you know, the--
simplicity is not always the best solution, but it strikes me, 
just organizationally, my experience has been that a 
streamlined process in which somebody is in charge is 
particularly important precisely when you have major 
complicated decisions with a lot of aspects to it that may be--
where decisions may have to be made in the situation in which 
there is a breakdown and there's a significant crisis. And so, 
I am deeply concerned about this. I think this is a--this is 
not the optimal structure.
    Mr. Chairman, I know that my time is up, but, since I'm the 
last guy, could I maybe ask one more question, just real 
quickly, please?
    The Chairman. Yes.
    Senator Obama. You know, Senator Lugar and myself, you 
know, appropriated $25 million in the emergency supplemental 
several months ago, and I'm glad to see that we're making some 
progress. I think the majority of that money is going to AID 
for some of the work that you've just discussed. Can you talk a 
little bit--and this is--you know, this may be a question 
that's more geared toward the scientists, although I'll be 
interested in figuring out how it's being coordinated 
internationally--can you describe to me, sort of, some of the 
concerns that may arise as a consequence of vaccination of 
poultry, as opposed to vaccination--developing, you know, 
individual vaccinations for humans? You know, there--I was 
getting reports that, for example, China was engaging in large-
scale vaccinations, and those may end up eroding how effective 
they are. Whether antiviral distribution in the four countries 
that have been targeted as most significant concerns are part 
of the package and how helpful that is in stopping the spread, 
if there was human-to-human transmission. And then, I guess 
the--this was sort of a tricky--there were actually three 
questions here, but I snuck 'em into one--and then, finally, 
how are we dealing with countries that are far more secretive? 
I guess China would be included in this, but I'd also--you 
know, I think about a country like Myanmar, where we generally 
don't have good government-to-government relations--how 
responsive have they been, and how much concern have they shown 
toward this issue? So----
    Dr. Gerberding. I could take the vaccine question and defer 
to my colleagues for the other answers.
    We actually have conflicting information about the 
vaccination programs in some of these countries and the 
efficacy of the vaccine. And when we were in Vietnam together, 
there was a vaccine clinic in progress, and what happened at 
the vaccine clinic was some--lots of chickens and some ducks 
were brought up in, and, while they were vaccinating them, a 
few of the ducks got out and ran away. There was no method to 
really identify which birds had been vaccinated and which 
hadn't. The sense was that this would be a very incomplete and 
ineffective method for truly protecting the poultry population. 
If it was done compulsively and compliantly with an effective 
vaccine, it might be a helpful solution, but the practical 
application of it has raised some questions about its utility. 
And the worrisome aspect about it is that if it actually 
disguises the illness in the chicken, but allows the virus to 
be present and grow and evolve, might actually be covering up 
the ongoing spread and evolution of the H5N1. So, we aren't in 
a position right now to make any recommendations about its use 
or nonuse, but it's something that we need more science and 
more research to evaluate. So, I think it's one of the big 
question marks that we still have on our plate.
    Dr. Fauci. The use of antivirals in chickens is quite 
dangerous, and that's what we're really concerned about. And 
that has been done in China, years ago, of using Rimantadine 
and Amantadine, which, unfortunately, then led to the emergence 
of resistance of the virus to that. So, it's pretty clear cut 
when it comes to antivirals that that's something you've got to 
be very careful about.
    Senator Obama. And this is something that the countries are 
aware of, that----
    Dr. Fauci. They are certainly aware of that now.
    Ms. Dobriansky. On the question about secrecy and how one 
deals with situations like Burma, North Korea. In the case of 
Burma, we have worked very closely with ASEAN countries. Burma 
is part of ASEAN. And it has been through many of the 
neighboring ASEAN partners that have engaged Burma. Also, our 
own mission on the ground is present there, working with as 
many as one can to get rapid information, and render 
information.
    I want to mention, in the case of North Korea--I don't 
think you mentioned it, but looking at that case, there was 
actually a report this last April, an indication that they 
thought it--there was a report of H5N1. We worked with the FAO 
and the OIE. They have representatives in-country to try to 
discern that immediately. And it was working through them, in 
that particular case. So, there are various means in such 
situations where we try to get as rapid information and 
cooperate.
    Senator Obama. Thank you.
    Senator Chafee [presiding]: Senator Murkowski.
    Senator Murkowski. Thank you, Mr. Chairman.
    And I apologize to the members of the panel that I was not 
here to hear your testimony earlier. There's many conflicting 
hearings going on this morning.
    I had a very interesting briefing yesterday by a doctor 
that is affiliated with the Alaska Native Tribal Health 
Consortium, Dr. Kim Berner, who has been working on an 
initiative amongst the Alaska natives in conjunction with the 
University of Alaska in doing what we can do to help identify 
and track the flus, the influenzas, that are associated with 
the migratory waterfowl that come through Alaska. And I had--I 
turned this into an educational opportunity last night for my 
teenage sons, as we talked about the migratory patterns of the 
birds coming out of Asia and coming out of the European 
Continent and coming to gather in Alaska. A wonderful story, 
except if there is the possibility to transmit this very lethal 
strain of avian influenza.
    It raised the question, in terms of what it is that we can 
do to track and monitor and to surveil what is going through 
the State of Alaska in some very, very remote areas. We don't 
have the population. We don't have the ability to really put 
the scientists out there that we need. But we have a lot of 
local people with a great deal of local knowledge that are 
ready and willing to help us in this effort.
    But I raised the question to Dr. Berner about, How are we 
educating the Alaska natives about the dangers and the threats? 
Because they go out, and they hunt, and then they eat the duck 
and the geese and everything else that they have hunted. What 
are we doing with the education effort? How can we use the 
educational effort that we're utilizing up in Alaska to--and 
spread this same effort into regions of Southeast Asia? And 
what more can we do from the perspective of using Alaska as the 
laboratory here to understand more about how the influenza will 
travel and how we can deal with it.
    So, I throw that out to you. Doctor, it looks like you're 
poised to take it.
    Dr. Gerberding. Thank you.
    We're actually very grateful to the University of Alaska 
for the work that they are doing in the bird surveillance and 
their outreach, because it's really part of the front line 
around detection. And I am a little bit nervous about bringing 
up integration with other agencies, but we do work with the 
Department of Agriculture and the Department of the Interior, 
because all of us have a different frame on issues related to 
human/animal health interface. The--I was pleased, because I've 
been concerned about this issue in Alaska, but also the issue 
with just hunters more generically in the United States, that 
when we begin to see new viruses emerge in avian species, those 
people who are having close contact with blood and with 
secretions, potentially, from these birds would be at the 
highest risk, just as they are in Asia. There is a great deal 
of useful practical information that's been created about the 
safe handling of birds. What do you do if you find a dead bird? 
What
do you do if you're a hunter? All of these information 
resources are actually available on the Web site that you can 
get to from pandemicflu.gov.
    But what I can't answer for you today is, What is the 
communications strategy for moving that nice Web-based 
information out to the remote areas of the people who need it 
the most? I can find out. CDC has a field station in Anchorage 
with the Arctic Investigations Program, and we've done a lot of 
this with other emerging infectious diseases, including 
hepatitis and so forth. So, I will specifically get back to you 
with what we are doing, or what else we could do, to be sure 
that that information is being moved forward. I'm sure the 
Health Department in Alaska is engaged, but this is a real 
important potential gap.
    Senator Murkowski. Well, it's something that, if we can do 
it effectively in remote areas of Alaska, like we're talking 
about, we ought to be able to translate that to other 
countries. You know, look at a country like Mongolia. I want to 
be able to know that we can share this information, and share 
this educational effort.
    A second question, on a different note, in terms of the 
dollars that will be required, where do we put the priority? Is 
it on stockpiling a vaccine here in the United States that may 
or may not be effective against a mutated strain? Or do we put 
it in containment activities--for instance, over in Southeast 
Asia--to slow down the potential outbreak? If you have to 
prioritize one over the other, where do you go?
    Dr. Fauci. Yeah. Well, first of all, we have to say, 
Senator, that we do have a balanced program that includes 
public health, antivirals, and vaccine, but very, very clearly 
the bedrock and the foundation of the preparedness strategy is 
to develop the vaccine production capacity to be able to scale 
up and have doses of the relevant vaccine available were we to 
have a pandemic, and to have it within a reasonable period of 
time.
    So, everything you see in the plan hits one or the other of 
the components of preparedness. But, fundamentally--and the 
dollars speak to it--of the $6.7 billion that's in the 
Department of Health and Human Services, $4.7 billion of it is 
in the vaccine area, much of that to build up the vaccine 
capacity so that we can scale up when we need to. Getting an 
isolate, getting it to the point where you could put it in a 
vaccine is not terribly difficult. The big stumbling block what 
we're facing is our vaccine manufacturing capacity.
    Senator Murkowski. Let me ask one more question, if I may, 
Mr. Chairman. This was a question that I had asked yesterday, 
and wasn't able to get an answer to. But, as I understand, one 
of the ways that the avia flu is transmitted is through pigs. 
The ducks or the domestic--the domestic ducks, the chickens are 
in contact with the pigs, the pigs have an immune system 
similar to the humans, and then it can migrate or mutate, 
whatever, in a form that is deadly to humans. The question that 
I had asked was whether or not we're doing any testing on pigs 
to determine if they have been infected, and what the risk of 
spreading the influenza through the pigs is.
    Dr. Gerberding. We are very interested in pigs. There are 
two ways that flu typically evolves. One is through incremental 
changes in the virus, which we are seeing right now with the 
H5N1. The other way it emerges, typically, is that a bird virus 
infects a pig, a human virus infects a pig, they mix their 
genes up, and the new virus that emerges has got a new set of 
genes that makes it very transmissible in people. That hasn't 
happened yet, but that's another concern we have in Asia right 
now. So, the pigs are being checked.
    In the Mekong Delta, we have not found evidence of pig 
infection, but in Indonesia, there has been very well-defined 
evidence of at least one barnyard full of pigs that had the 
virus in their tissues. Which could just mean they were in 
areas where the infected chickens were and they picked up 
transiently, but their bodies also had an immune response to 
the virus, which indicates true infection. So, in a reliable 
laboratory in Hong Kong, it was documented that, at least some 
pigs in Indonesia have been infected with the H5N1 strain. 
That's worrisome because, again, you can get that virus into 
the pigs, get the human seasonal viruses into the pig, it just 
creates another whole set of incubators for change and 
evolution and potentially in an ominous direction.
    Senator Murkowski. And then back to the educational effort 
here in this country, Are our farmers being advised that it's 
not wise to have your pigs and chickens in close proximity?
    Dr. Gerberding. Yeah, in the United States the animal 
husbandry practices are, as you know, light years away from 
what they are in Asia. And I--we visited a commercial chicken 
production facility in Thailand that was using Western standard 
of biocontainment. But here in the United States, not only do 
we use those biocontainment, but animals are actually screened 
periodically and checked for the presence of a number of 
viruses. So, our food production is much safer here because of 
our animal husbandry practices, like you've said, but also 
because of the additional requirements that USDA has worked 
through State veterinary associations and so forth.
    So, I would never say there's no threat. We've seen, as one 
of the Senators pointed out, that occasionally we do have small 
outbreaks of avian flu. Not this highly pathogenic form. But by 
going in--these are typically recognized very early, and, very 
early on, the appropriate biocontainment steps are taken and, 
effectively, simply quenched the problem. So, our opportunities 
here are obviously drastically different than they are in these 
other areas in the world.
    Senator Murkowski. We need to get out to the 4-H Clubs, 
too.
    Thank you, Mr. Chairman.
    Senator Chafee. Thank you, Senator Murkowski.
    And I'd like to thank the first panel for their expert 
testimony and generous contribution of their time and 
information. Have a good day.
    Welcome, the second panel.
    [Pause.]
    Senator Chafee. I'd like to welcome James Newcomb, who is 
the managing director of research for the Bio-Economic Research 
Associates, in Cambridge, MA. And I think we can get started. 
And we also welcome Laurie Garrett, who's a senior fellow for 
global health for the Council on Foreign Relations in New York 
City.
    So, we'll start with Mr. Newcomb. Welcome.

STATEMENT OF JAMES NEWCOMB, MANAGING DIRECTOR OF RESEARCH, BIO 
          ECONOMIC RESEARCH ASSOCIATES, CAMBRIDGE, MA

    Mr. Newcomb. Thank you, Senator Chafee, members of the 
committee.
    I'm pleased to have the opportunity--is that better?
    Senator Chafee. And, if I could, I might also suggest that 
we have our comments limited to 5 to 7 minutes.
    Mr. Newcomb. All right, thank you.
    Senator Chafee. Thank you.
    Mr. Newcomb. I'm pleased to have the opportunity to address 
the committee this morning regarding the potential economic 
implications of an influenza pandemic. I'm especially grateful 
to the committee for calling attention to global economic and 
trade-related issues that are closely conjoined with questions 
of how governments and other public and private institutions 
can better prepare for, and respond to, the risk of pandemic. 
Economic, social, and environmental problems are part of the 
issues we face, and they must be a part of the solution.
    At bio-era, my colleagues and I have been studying the 
economic implications of H5N1 for more than 2 years. We agree 
with most other economic analysts that the economic 
implications of an influenza pandemic would entail significant 
shocks to the global economy, with costs ranging upward of 
$500-$800 billion worldwide, depending on the severity of the 
disease. Perhaps more importantly, cascading disruptions of 
economic systems triggered by fear-based reactions of 
consumers, investors, and governments could impair our ability 
to combat the disease itself to the extent that these 
disruptions affect our ability to deliver essential goods and 
services during a pandemic. Coordination preparation by 
governments, multilateral institutions, and private companies 
can significantly reduce the risk that such a pandemic of fear 
might spiral out of control.
    Numerous efforts have been made to estimate the potential 
costs of a pandemic. For example, the World Bank has estimated 
that the costs of--to the global economy of a relatively mild 
pandemic could exceed $800 billion. The Department of Health 
and Human Services has estimated that direct and indirect 
health costs alone of a pandemic similar to the relatively mild 
1968 pandemic could cost the United States $181 billion. Their 
analysis of a worst-case scenario reported costs of more than 
$450 billion in the United States. The Asian Development Bank 
has estimated costs in Asia, excluding Japan, could range to--
from $100-$300 billion, assuming relatively mild pandemic 
circumstances.
    All of these estimates must be considered, at best, to be 
scenarios based on critically sensitive assumptions. None are 
able to accurately predict the implications of unprecedented 
disruptions to trade that could ensue. SARS cost the global 
economy $30-$50 billion, even though it caused only around 
8,000 infections worldwide. A pandemic could infect billions.
    While estimates that the costs of a pandemic are highly 
speculative, measuring the cost of H5N1 in the affected 
economies in Asia and parts of Europe today are much more 
concrete. These costs have struck a heavy blow to poor rural 
farmers least able to respond in a growing number of countries. 
H5N1, in the months ahead, is likely to expand its range 
geographically, potentially affecting some of the world's 
poorest countries.
    It is worth noting that our attention to H5N1 falls in the 
context of a broader trend toward rising economic costs of 
emerging infections in livestock worldwide. The emergency of 
foot-and-mouth disease among cattle in Brazil in recent months 
has the potential to further compound the challenges already 
facing the global meat industry and the developing world. Other 
costly disease events are likely to emerge at the intersection 
of human, livestock, and wildlife health.
    So, how can we respond to the threat posed by H5N1 in ways 
that reduce the risk of disease emergence and improve the 
resilience of our economies? In terms of the economic 
implications, we learned several important lessons from the 
SARS experience.
    First, the wave of economic reactions moves much faster 
than the disease itself. Even if we have a crash program that 
promises to reliably produce a vaccine within months, the 
economic consequences of emerging disease will be felt 
immediately around the world.
    Second, public fears from SARS were amplified by concerns 
that governments were withholding information about the spread 
of the disease.
    Third, the most open economies were the hardest hit.
    Fourth, the secondary effects of the disease caused 
surprisingly significant and unanticipated disruptions to 
global supply chains.
    Fifth, control measures asserted at national borders had 
little measurable impact on the spread of the disease, but they 
had significant economic consequences.
    And, sixth, once SARS was contained, the economic rebound 
was swift.
    In the face of the risk of H5N1 influenza pandemic, the 
SARS experience underscores the fact that the economic 
implications of emergence are extremely sensitive to the 
behaviors of governments, companies, and key actors well in 
advance of the spread of the disease itself. Should it occur, 
the emergence of H5N1 as a pandemic can be expected to trigger 
swift reactions in financial markets around the world, to 
heighten public fears, and to provoke immediate calls for 
government actions. How governments respond in this initial 
period of just days or weeks could have far-reaching 
implications economically.
    What we can now do is to prepare at several levels.
    First, public and private institutions should continue to 
work to reduce the risk of pandemic emergence at its source by 
lowering the incidence of H5N1 in birds and improving 
capabilities for responding quickly to disease outbreaks where 
they occur. This means, for example, better biosecurity in 
poultry operations worldwide. Some United States companies 
operate best-of-class livestock operations in a variety of 
countries, including Asia and other developing parts of the 
world. These practices significantly reduce the risks to 
humans, to wild birds, and to poultry from these diseases. 
Moreover, better disease surveillance and monitoring for 
humans, livestock, and wildlife, will entail better integration 
of human and animal disease activities, as is already beginning 
to occur. Efforts by the Wildlife Conservation Society to 
collect samples from wild birds in Mongolia earlier this year 
yielded H5N1 sequences that are now being used to develop human 
vaccines. Additional funding through both multilateral and 
bilateral channels is essential to support these types of 
efforts.
    Second, private companies can strengthen supply-chain 
planning and operational capabilities to respond to alternative 
disease scenarios. A group of leading companies in food and 
agriculture, for example, has recently launched a collaborative 
initiative to coordinate and strengthen response capabilities 
for these risks. These types of efforts in the private sector 
can be further enhanced by greater clarity about potential 
Government policies, in particular with respect to border 
control and restrictive measures that would affect trade and 
transportation under various contingencies. The private sector 
can better prepare if it knows what it's preparing for with 
respect to government policies in this area.
    Third, Government plans should anticipate and respond to 
fear-driven consumer behaviors such as hoarding. Ensuring 
adequate supplies of basic medical and hygienic products, and 
strengthening public-health capabilities would be important 
complements to stockpiling vaccines and antiviral drugs.
    Finally, international coordination of border-control 
policies to avoid misunderstandings and to promote coordination 
would be essential to managing the economic disruption caused 
by the disease in its earliest stages.
    To the extent that these policies are transparently based 
on expert scientific and medical advice from institutions such 
as the World Health Organization and the CDC, and that these 
policies are widely and jointly communicated to the public in 
advance, the foundation of public reassurance and international 
cooperation will be solidly established.
    Thank you, Mr. Chairman. I look forward to your comments.
    [The prepared statement of Mr. Newcomb follows:]

 Prepared Statement of James Newcomb, Managing Director for Research, 
            Bio Economic Research Associates, Cambridge, MA

    Good morning, Mr. Chairman, distinguished members of the committee, 
invited guests. I am pleased to have the opportunity to address you 
today regarding the potential economic implications of an influenza 
pandemic. I am especially grateful to the committee for calling 
attention to the global economic and trade-related issues that are 
closely conjoined with questions of how governments and other public 
and private institutions can better prepare for and respond to the risk 
of pandemic.
    At bio-era, my colleagues and I have been studying the economic 
impacts of H5N1 avian influenza for more than 2 years. We agree with 
most other economic analysts that the emergence of highly virulent, 
pandemic influenza would be accompanied by significant shocks to the 
global economy, with costs ranging upward of $500-$800 billion 
worldwide, depending on the severity of the disease. Table 1 provides a 
comparison of various institutions' estimates of the economic costs of 
a pandemic. The bottom line is that a pandemic could affect our highly 
integrated global economy in a way that has no real precedent in recent 
decades. While we know that human societies and economies are highly 
resilient in the long run, the economic disruption caused by a pandemic 
in the short run could exacerbate the problem of responding to the 
disease.

  TABLE 1.--ESTIMATES OF HUMAN LOSS AND ECONOMIC DAMAGE FROM A PANDEMIC
------------------------------------------------------------------------
                              Estimated economic
           Source                damage from a            Comments
                                   pandemic
------------------------------------------------------------------------
U.S. Centers for Disease      Cost to      Widely cited in the
 Control (Meltzer, Cox,       U.S. economy $71-     press and by other
 Fukuda; 1999).               $167 billion (1995    analysts; based on
                              dollars); $88-$206    estimates of primary
                              billion in current    costs derived from
                              dollars.              case numbers,
                                                    hospitalizations,
                                                    and deaths, and the
                                                    associated costs for
                                                    each of these
                                                    events. Assumes
                                                    89,000-207,000
                                                    deaths and 314,000-
                                                    734,000
                                                    hospitalizations in
                                                    the U.S.
------------------------------------------------------------------------
U.S. Health and Human         $181         Earlier press reports
 Services (Pandemic           billion in direct     indicated that HHS
 Influenza Strategic Plan;    and indirect health   estimated costs of a
 November 2005).              costs alone (not      ``worst case
                              including             scenario'' (1.9
                              disruptions in        million deaths and
                              trade and other       8.5 million
                              costs to business     hospitalizations) to
                              and industry) for a   be $450 billion for
                              moderate pandemic     the U.S. economy.
                              with no
                              interventions.
------------------------------------------------------------------------
Asian Development Bank       Asian Implications:   Both cases assume a
 (November 2005).             Mild shock:   relatively mild
                              $99 billion in lost   pandemic, with an
                              consumption, $14      infection rate of
                              billion in death      20% and a case
                              and incapacity;       fatality of 0.5%. In
                              losses equal 2.6%     the more severe
                              of GDP.               scenario, the
                              Severe        psychological impact
                              shock: $297 billion   on demand and
                              in short-term         consumption is
                              losses or 6.8% of     greater.
                              GDP.
------------------------------------------------------------------------
World Bank (Brahmbhatt;       Total costs  Assumes a case
 November 2005).              to the world          fatality rate of
                              economy could reach   less than 0.1% in
                              $800 billion.         the U.S.
------------------------------------------------------------------------
ING Bank (October 2005)....   ``Large      Assessment by a
                              swathes of economic   leading European
                              activity could        bank.
                              simply cease.''
                              ``A
                              realistic scenario
                              might involve GDP
                              declines of tens of
                              percent.''
                              ``. . .
                              fear of infection
                              leading to
                              drastically altered
                              behavior would
                              result in the
                              greatest economic
                              damage.''
------------------------------------------------------------------------
Conference Board of Canada    ``A flu      No quantitative
 (October 2005).              pandemic on a large   estimates.
                              scale would throw
                              the world into a
                              sudden and possibly
                              dramatic global
                              recession.''
------------------------------------------------------------------------
BMO Nesbitt Burns (August,    Cites CDC    A report produced by
 October 2005).               estimates in 1995     BMO Nesbitt Burns;
                              dollars.              widely cited by the
                              ``Depending   media.
                              on [a pandemic's]
                              length and
                              severity, its
                              economic impact
                              could be
                              comparable, at
                              least for a short
                              time, to the Great
                              Depression of the
                              1930s.''
------------------------------------------------------------------------

    This risk falls in the context of a broader trend toward rising 
economic costs of emerging infectious diseases in animals and humans in 
recent years (see Figure 1). The ongoing spread of highly pathogenic 
avian influenza is exacting a significant economic toll on poultry 
producers in the countries already affected by the disease, often 
striking a heavy blow to poor rural farmers who are the least able to 
respond. But it is hardly the only disease to pose a significant threat 
to human health and economic prosperity.


    From a policy perspective, our analysis of these risks underscores 
the message that ``an ounce of prevention is worth a pound of cure.'' 
By investing in efforts to control the spread of highly pathogenic 
avian flu in wild birds and poultry, we may reduce the risk that a 
human pandemic will emerge in the first place. Moreover, the 
investments we make in disease surveillance, monitoring, and prevention 
at the intersection of animal and human health are multipurpose 
investments that may help to reduce the risks of emerging infectious 
diseases in general. Attacking the root causes from a long-term 
perspective will require an integrated cross-sectoral approach to human 
and animal health. It will take time to build the scientific, 
institutional, and regulatory systems to support this effort. But the 
potential returns from doing so are large.
    In the event that a human pandemic does emerge, despite our efforts 
to prevent it, the economic impacts would likely spread around the 
world in two waves. The first wave of economic impacts would result 
from fearful anticipatory reactions to the spread of the disease; these 
effects include shocks to financial markets, reductions in consumption 
and investment, and disruptions of trade and travel. As in the case of 
the SARS outbreak, these reactions could ripple through the economy 
very rapidly.
    Reactive and uncoordinated national actions to close borders or 
embargo trade could be exactly the wrong prescription in the early days 
of pandemic emergence, These could inadvertently fuel fears at the 
point of emergence and compound the challenges of disease management on 
the ground. Shutting down transportation hubs, such as airports and 
ports, would disrupt key supply chains and create unpredictable 
secondary effects that would compound the effects of the initial 
outbreak. These feedbacks, coupled with growing fears about the disease 
itself, would be increasingly difficult to manage as the pandemic 
spreads globally.
    The second wave of economic impacts would be experienced as a 
result of the spread of the disease itself, with potentially large 
impacts on the workforce and the flow of goods and services as well as 
the overburdened medical system. While these direct economic impacts of 
the disease could be quite significant, these costs are almost 
certainly manageable from a macroeconomic perspective, even in the case 
of a moderate pandemic, provided they are not overly compounded by 
fear-driven reactions.
    The SARS outbreak illustrated the sensitivity of the global economy 
to such threats and, in particular, to the fear of disease. Although 
the number of people infected with the SARS virus was relatively 
small--with only about 8,000 infections globally and 774 deaths--we 
estimate that the cost to the global economy was $30-$50 billion 
dollars.
    But SARS also marked a turning point for public and private 
institutions that must respond to human and animal diseases. SARS 
stimulated the response capability of political, social, and economic 
institutions globally by raising awareness of the economic potency of 
disease events. It is one reason for the high level of media attention 
and public policy discussion today about the pandemic risk posed by the 
H5N1 avian influenza virus. The subtle shift that began in 2003 is 
still incomplete, but governments and private companies have begun to 
take steps that could make it less likely that a worst-case scenario 
will actually come to pass.
    In my testimony this morning, I will focus on three topics:

   Lessons learned from the SARS outbreak;
   Possible economic implications of a pandemic; and
   Actions that the government and private companies can take 
        to prepare for the economic consequences of a pandemic.

                       LESSONS LEARNED FROM SARS

    It is worth taking a close look at the events that took place 
during the SARS outbreak, since they offer us valuable insights that 
could reduce the unintended economic consequences of government 
policies in the future. While the SARS outbreak was quickly contained, 
the economic events that it triggered illustrate several key points:
    The economic contagion of fear and uncertainty moved even faster 
than the disease itself. Between March and May of 2003, when 
international media attention was intensely focused on the disease, 
tourist arrivals in Asia dropped 30-80 percent for various countries in 
the region, compared with previous growth rates of 10-15 percent (see 
Figure 2). After travel bans were put in place in some affected areas 
on the heels of World Health Organization (WHO) warnings, almost half 
the planned international flights to Southeast Asia were cancelled. 
Even Australia, which was largely unaffected by the disease, saw a 20-
percent decline in international arrivals between January and May. The 
downturn in travel and trade quickly rippled through economies in the 
region, with the most pronounced effects on those economies that are 
highly dependent on these sectors. According to the World Bank, SARS 
caused an immediate economic loss of approximately 2 percent of East 
Asian regional GDP in the second quarter of 2003. Foreign direct 
investment in the Asian region slowed sharply and almost 
instantaneously in response to news of the disease's emergence, while 
retail sales in Hong Kong fell by 8.5 percent. Canada suffered economic 
losses of more than $1 billion, although the disease directly affected 
less than 500 people there (see Figure 3).



    The direct economic costs of the SARS--that is, the medical 
treatment costs and lost productivity associated with SARS cases--
probably accounted for only about 1-2 percent of the $30-$50 billion of 
economic damage caused by the disease. The costs of the SARS epidemic 
were caused largely by the indirect economic impacts: Disruptions of 
trade, travel and investment, interruption of product supply chains, 
and fear-based changes in behavior on the part of consumers, travelers, 
and businesses.
    Public fears in the early stages of the SARS epidemic were 
amplified by concerns that some governments were withholding 
information about the disease. The SARS scare was made worse, and the 
economic reactions more severe, by the perception that some governments 
were less than completely forthcoming with news about disease 
outbreaks. We can say in retrospect that the public overreacted to the 
news of SARS in terms of assessing the risk of infection and death, but 
it was difficult for either the public or the scientific community to 
assess these risks in the early stages of the disease. Nonetheless, 
dissemination of credible scientific information as early as possible 
can significantly affect public responses.
    The most ``open'' economies were the hardest hit. Hong Kong and 
Singapore were the worst affected Asian economies, largely because of 
their heavy dependence on international trade and travel. The number of 
tourist arrivals annually in these two economies is approximately twice 
the resident population. Overall, tourism accounts for a surprisingly 
high 11 percent of GDP in Southeast Asia. A 10-percent reduction in 
tourism in Vietnam would have an economic impact eight times greater 
than that caused by the recent 15 percent contraction in the poultry 
industry there. Based on a composite index of economic factors, taking 
into consideration the openness of the economy and healthcare 
expenditures, Hong Kong, Singapore, and China are the economies in Asia 
most exposed to the risk of a pandemic (see Figure 4).



    The secondary effects of the disease caused significant and 
unanticipated disruptions to global supply chains. While the direct 
impact of SARS was miniscule in terms of worker absenteeism 
attributable to illness, the epidemic nonetheless caused significant 
disruptions to global supply chains in some key areas. In the high-tech 
sector, for example, the cancellation of commercial airline flights 
disrupted just-in-time delivery of some goods and components. In some 
key countries, approximately 50 percent of freight shipments by the 
semiconductor industry are carried on passenger flights. Trade and 
travel problems in some areas interrupted the flow of goods and 
services, with cascading effects in industries with tightly linked 
supply chains that depended heavily on suppliers in the affected areas.
    There is little evidence that control measures asserted at national 
borders had a significant impact on the spread of SARS. Entry screening 
of travelers through health declarations or thermal scanning at 
international borders had little measurable effect on the detection of 
SARS, and exit screening appeared to be only marginally more 
effective.\1\ On the other hand, basic measures taken in Hong Kong to 
increase ``social distance'' and improve community hygiene, including 
hand washing and wearing masks, during the SARS outbreak significantly 
reduced the incidence of respiratory viral infections.\2\ From an 
economic perspective, control measures at borders, especially trade 
embargoes and travel restrictions that effectively close borders, are 
blunt instruments that come at high cost and can compound supply chain 
problems that reduce a nation's ability to corn-bat disease.
---------------------------------------------------------------------------
    \1\ David M. Bell, ``Public Health Interventions and SARS Spread, 
2003,'' Emerging Infectious Diseases, vol. 11, No. 10, November 2004.
    \2\ Janice Y. C. Lo, et al., ``Respiratory Infections During SARS 
Outbreak, Hong Kong, 2003,'' Emerging Infectious Diseases, vol. 11, No. 
11, November 2005.
---------------------------------------------------------------------------
    Once SARS was contained, the economic rebound was swift. The 
economic rebound in the aftermath of SARS was speedy and vigorous, 
partly because little lasting damage had been done to the affected 
economies. In this instance, the short duration of the crisis meant 
that most companies could withstand the financial impacts without 
facing insolvency or restructuring. While some service sector goods, 
such as those delivered by airlines, hotels, and restaurants are not 
recoverable, at least part of the losses incurred in other sectors, 
such as manufacturing, could be recovered.
    Overall, SARS illustrates the tremendous economic damage that can 
be incurred as a result of the secondary effects of disease emergence 
in the context of the highly interconnected global economy.

                  ECONOMIC IMPLICATIONS OF A PANDEMIC

    The economic implications of an influenza pandemic are nearly 
impossible to predict, given the wide range of possible outcomes with 
respect to the evolution and spread of the disease, its virulence, and 
the availability of effective countermeasures such as antiviral drugs 
or vaccines. The often-cited estimate of the economic cost to the U.S. 
economy of a pandemic provided by the Centers for Disease Control and 
Prevention places these costs at $71-$166 billion in 1995 dollars, or 
approximately $88-$206 billion in current dollars. The estimate is 
based on estimates of the direct costs of illness and does not take 
into consideration the possible effects of global economic disruption, 
supply chain problems, and other secondary effects. More recent 
estimates of the possible costs of pandemic to the U.S. economy span a 
wide range, reaching as high as $450 billion in a worst case outcome in 
which more than 1.9 million people in the country would die and 8.5 
million would be hospitalized.
    We can better understand the potential economic consequences of a 
pandemic and the related uncertainties and vulnerabilities, by 
addressing them in relation to the possible stages of the disease's 
emergence and progression (see Table 2).

                 TABLE 2.--ECONOMIC STAGES OF A PANDEMIC
------------------------------------------------------------------------
           Stage                   Features           Economic shocks
------------------------------------------------------------------------
Pandemic Alert............  Increasing global      Mild and largely
                             demand for and         localized. As the
                             investment in          virus spreads, fear-
                             countermeasures;       based reactions
                             countermeasure         cause mostly local
                             production capacity    disruptions.
                             operating at near
                             100% utilization
                             rates; declines in
                             poultry demand in
                             areas of active H5N1
                             infection.
------------------------------------------------------------------------
Emergence.................  Global media           The first serious
                             amplification of       shocks are likely to
                             pandemic spread.       fall most heavily on
                             Trade and travel       the national and
                             likely to be           regional economies
                             seriously disrupted    nearest the
                             locally, with          emergence event. Key
                             unpredictable          determinants are:
                             secondary effects on   How deadly is the
                             global supply          disease? How easily
                             chains.                does it transmit?
                             International          How rapid and
                             cooperation and        resolute is the
                             coordination is        response? How
                             critical for           responsibly does the
                             minimizing economic    media behave? some
                             disruptions.           fear-driven
                                                    spillover into
                                                    global financial
                                                    markets should be
                                                    expected.
------------------------------------------------------------------------
Containment Efforts.......  Countermeasures to     If containment
                             prevent spread         efforts fail, the
                             rushed into outbreak   inadvertent
                             area; political        compounding of fear
                             finger-pointing in     becomes a major
                             the event that         threat. Will there
                             stockpiles are not     be widespread,
                             accessible to          immediate, and
                             outbreak areas could   uncoordinated
                             threaten               national bans on
                             coordinated,           travel and trade?
                             cooperative response.  Or, will there be a
                                                    highly coordinated
                                                    and measured
                                                    response from
                                                    national
                                                    governments?
------------------------------------------------------------------------
Global Spread.............  Despite containment    The depth of the
                             efforts, disease       shock to the global
                             enters the general     economy will depend
                             population and         on the severity
                             begins global          (measured in terms
                             spread. The timing     of morbidity and
                             of spread to major     mortality) and
                             urban centers is       duration of the
                             unpredictable, but     pandemic and the
                             for each wave of the   extent to which fear
                             disease, local         effects are
                             epidemics mostly run   minimized, effective
                             their course in        countermeasures are
                             about 4-6 weeks.       available, and risk-
                             Supply strains on      reducing behavioral
                             hospital beds and      changes are widely
                             other                  supported and
                             countermeasures.       adopted.
------------------------------------------------------------------------
Abatement & Recovery......  Normal economic        Indications of a
                             activity begins to     second wave of
                             resume as fear and     disease spreading,
                             disease incidences     or fear of such a
                             abate. Timing will     recurrence, could
                             depend on the damage   interrupt the
                             done to economies      recovery unless
                             and businesses, and    effective
                             whether concerns       countermeasures are
                             over a second wave     widely available.
                             of disease can be
                             addressed.
------------------------------------------------------------------------

Stage 1: Pandemic Alert
    The world is now on high alert for the further spread of avian 
influenza among wild birds and poultry, especially in parts of Asia, 
Europe, and Africa. Additional human cases of the disease raise the 
possibility that efficient human-to-human transmission will emerge and, 
at the same time, the news of these cases heightens public fears about 
the disease.
    The economic costs of H5N1 outbreaks in poultry, and the related 
damage to economies in Asia alone already totals $10-$15 billion. 
Significant costs are now being incurred in parts of Russia and Europe, 
where outbreaks have required the destruction of birds in some areas, 
intensified monitoring and testing, and have led to the imposition of 
new biosecurity regulations for poultry producers. Consumer fears about 
bird flu have led to declines of 20-40 percent in poultry sales in 
France and Italy.
    The H5N1 virus could continue to spread to new regions around the 
world for years to come, with no evidence of efficient human-to-human 
transmission. The economic consequences of this situation could be 
further compounded by the simultaneous emergence of other diseases with 
significant effects on global livestock production and trade. Notably, 
Brazil's recent confirmation that foot-and-mouth disease has been 
detected among cattle in Matto Grosso do Sul has led nearly 50 nations 
to impose total or partial bans on imports of Brazilian beef, and could 
result in losses of more than $1 billion. Such events could lead to a 
repeat of the situation in early 2003, when the U.N. Food and 
Agriculture Organization (FAO) reported that fully one-third of global 
meat trade was subject to embargoes due to disease outbreaks.
    Media coverage and government communications at this stage have the 
potential to significantly influence reactions to a future announcement 
that a pandemic has begun, either by preparing the public for possible 
events or by heightening fear. The investment in medical 
countermeasures to combat a pandemic is rising rapidly, and probably 
exceeds by an order of magnitude spending on trying to prevent the 
further spread of the disease in birds and humans in the countries 
already affected. Likely commitments by governments around the world to 
stockpile antiviral drugs and vaccines to combat a pandemic already 
exceed $6 billion (see Table 3).

   TABLE 3.--EXISTING AND PLANNED STOCKPILES OF VACCINES AND ANTIVIRAL
                                  DRUGS
------------------------------------------------------------------------
          Country                     Product               Comments
------------------------------------------------------------------------
Australia.................  Tamiflu...................  3.5 million 5-
                                                         day treatment
                                                         courses.
                            Relenza...................  3.95 million 5-
                                                         day treatment
                                                         courses.
Canada....................  Tamiflu...................  35 million
                                                         doses.
                            H5N1 vaccine..............  ``Several
                                                         thousand''
                                                         doses ordered
                                                         for clinical
                                                         testing.
China.....................  H5N1 vaccine..............  Developing and
                                                         testing H5N1
                                                         vaccine;
                                                         planned
                                                         stockpile
                                                         levels unknown.
France....................  Tamiflu...................  13 million 5-day
                                                         treatment
                                                         courses.
                            H5N1 vaccine..............  2 million doses.
Hong Kong.................  Tamiflu...................  2.7 million
                                                         doses
                                                         stockpiled;
                                                         additional
                                                         purchases
                                                         planned to
                                                         reach 18
                                                         million doses
                                                         in 2007.
                            Relenza...................  300,000 doses
                                                         stockpiled;
                                                         additional
                                                         purchases
                                                         planned to
                                                         reach 2 million
                                                         doses in 2007.
Italy.....................  H5N1 vaccine..............  2 million doses
                                                         ordered.
Japan.....................  Tamiflu...................  Plans to
                                                         stockpile 20
                                                         million doses.
Netherlands...............  Tamiflu...................  220,000 doses
                                                         stockpiled; 5
                                                         million doses
                                                         ordered.
New Zealand...............  Tamiflu...................  835,000 doses
                                                         ordered; to be
                                                         delivered by
                                                         year-end.
Singapore.................  Tamiflu...................  350,000 courses
                                                         planned.
South Korea...............  Tamiflu...................  700,000 doses;
                                                         900,000 by
                                                         January 2006.
Taiwan....................  Tamiflu...................  230,000 doses;
                                                         700,000
                                                         additional
                                                         planned.
Thailand..................  Tamiflu...................  700,000 courses;
                                                         3 million
                                                         planned by
                                                         2007.
United States.............  Tamiflu...................  Up to $3.1
                                                         billion
                                                         proposed for
                                                         additional
                                                         supplies.
                            H5N1 vaccine..............  Up to $3.3
                                                         billion
                                                         proposed for
                                                         additional
                                                         supplies.
United Kingdom............  Tamiflu...................  14.6 million
                                                         courses; to be
                                                         delivered over
                                                         the next 2
                                                         years.
------------------------------------------------------------------------
* Tamiflu stockpiles have been variously reported by governments and in
  the press in terms of numbers of ``doses'' (individual pills or the
  equivalent) and/or ``courses'' (a standard treatment course is two
  doses a day for five days--10 pills; taking the drug preventively
  might require two doses a day for several months). The data reported
  here reflect the best available public information based on press
  accounts and, in some cases, interviews with government officials.
  Substantial uncertainty remains about the timetable for delivery of
  the large amounts of Tamiflu ordered by many governments, as the
  amounts described here exceed Roche's annual production capacity for
  Tamiflu.

Stage 2: Emergence
    An official announcement that H5N1 has acquired the capacity for 
efficient human-to-human transmission can be expected to trigger 
immediate reactions in financial markets around the world, stimulate 
intense media coverage, and provoke strong public interest accompanied 
by strident calls for immediate government actions. The initial market 
reactions might include downward shocks in financial markets in the 
parts of the world nearest to the initial outbreak of the disease, 
severe contractions in the most vulnerable industries, such as travel 
and tourism, and a weakening of consumer and investor confidence 
worldwide. As one of the largest sectors of the global economy, the 
impact on international tourism alone, which accounted for $622 billion 
in revenues in 2004 and involved more than 763 million tourists 
worldwide, would have serious economic consequences, especially in 
Southeast Asia and other parts of the world that are heavily dependent 
on tourism.
    There is a danger that fear of a rapidly spreading pandemic might 
trigger panic in the country or countries initially affected, as 
officials trying to impose quarantines confront citizens hoping to flee 
the affected areas. Some of the countries at greatest risk for 
emergence of an H5N1 pandemic have extremely limited resources to 
educate the public or to manage emergency responses in the event of a 
crisis. According to WHO, the total annual per capita healthcare 
expenditure in Vietnam is less than $25. Media coverage of an emerging 
crisis could heighten fears globally about the spread of the disease, 
spurring citizens in other areas to begin hoarding food and emergency 
supplies. The extent of economic disruption at this stage will be 
highly sensitive to the effectiveness of prepandemic planning and 
preparedness, especially the degree to which the public has come to 
trust government communications, leadership, and responsiveness at all 
levels.
Stage 3: Containment Efforts
    Governments around the world would quickly begin to take measures 
in an effort to slow the spread of the disease. Emergency plans 
including, under certain circumstances, restrictions on trade and 
travel that entail the complete closure of all international airports 
and ports have been announced by some governments. Such severe control 
measures at national borders would have profound economic consequences. 
Ideally, decisions regarding the implementation of various control 
measures, including travel and trade restrictions imposed at national 
borders, should be based on the best available information about the 
epidemiological features of the disease. Asian nations gathering at the 
recent APEC conference in Brisbane discussed containment policies in an 
effort to strengthen and coordinate these policies on a regional basis. 
Regional and global coordination of such policies could significantly 
reduce the economic disruption caused by a pandemic.
    Nonetheless, the serious economic effects of a pandemic in the 
countries initially affected by the disease could disrupt global supply 
chains. Pandemic emergence in Asia could have serious consequences for 
China and India, which together account for more than one-third of the 
world's population and represent the fastest growing economies in the 
world. Moreover, lean inventories and just-in-time delivery in the 
high-tech sector make this industry potentially vulnerable to 
disruption, especially in view of the high proportion of manufacturing 
that takes place in Asia.
Stage 4: Global Spread
    As the disease spreads globally, economies in areas of the world 
not initially affected would begin to feel the direct economic impacts 
of the disease. These impacts would arrive through illness and 
absenteeism of workers, declines in consumption and spending, increased 
medical costs and hospitalizations, and pressures on the insurance 
industry.
    In addition to the direct effects of worker illnesses, some workers 
would stay home to care for children during school closures, care for 
the sick, or to avoid the risk of infection. Analysis of scenarios 
assuming an infection rate of 40 percent suggest that only about 50-60 
percent of workers would be able to come to work during the 3 or 4 
weeks at the peak of the pandemic in a given area. But fear of 
infection could cause even greater absenteeism.
    Fear of contracting influenza in the workplace and other 
constraints on workers' ability to come to work could contribute to 
absenteeism among healthcare workers at the same time that the 
healthcare system is under the greatest pressure. A survey of over 
6,000 healthcare workers in the New York metropolitan area conducted by 
the Mailman School of Public Health at Columbia University indicated 
that only 48 percent of healthcare workers would be willing to come to 
work during a SARS outbreak. The combined effects of high worker 
absenteeism, curtailment of supplies and raw materials from other 
suppliers, and sharp changes in demand caused by the pandemic could hit 
many metropolitan areas simultaneously. The financial strain on 
companies whose cash flows are most severely affected by the pandemic 
will be greatest during this stage.
Stage 5: Abatement and Recovery
    As the disease begins to abate, economic activity could rebound 
quickly, as was the case for SARS, or quite slowly, depending on the 
severity of the pandemic and the post-pandemic condition of major 
companies, the government, and the economy as a whole. The condition of 
financial markets, currencies, and interest rates will affect the speed 
of the recovery, but the underlying, real economy--the demand for goods 
and services--will be the fundamental driver of the recovery.

                         WATCHING FOR SIGNPOSTS

    The many unknowns inherent in the current situation make it 
difficult to reduce the level of uncertainty surrounding the pandemic 
risk posed by H5N1. There is little that can be done about this, and no 
fixed timetable by which the current questions about H5N1 pandemic risk 
will be answered. Still, governments and companies can prepare 
contingency plans based on scenario outcomes and, at the same time, 
make operational plans that take into consideration the broader range 
of possible emerging disease events.
    Experience with the SARS outbreak indicates that the initial fears 
triggered by announcements of disease emergence can have sudden 
economic consequences. So far, events have paralleled those bio-era 
outlined in April 2005 under a scenario we named ``Big Noise on Stairs 
. . . Nobody Coming Down.'' The noise has certainly increased, but 
there is still no clear evidence that a human pandemic will ensue. 
Indeed, although most attention by policymakers is justifiably focused 
on pandemic risks, a scenario that entails the global spread of H5N1 
among birds over the next 2-3 years--without efficient human-to-human 
transmission--remains plausible.
    Rather than claiming that the possibility of a deadly global 
pandemic hangs over the world by a single thread--like a Sword of 
Damocles--we find a complex situation in which many different outcomes 
are possible. The course of the disease and the economic reactions to 
its emergence are, in fact, being significantly shaped by the actions 
and reactions of governments, corporations, and other stakeholders. In 
light of this, it is only prudent to prepare now by thinking through 
possible scenarios, and considering their implications.

                          HOW CAN WE PREPARE?

    Based on what we know about the potential economic dimensions of a 
pandemic, what steps can the government and other public and private 
institutions take in advance to reduce the potential economic damage?
    First, these institutions should continue to work to reduce the 
risk of pandemic emergence at its source, by lowering the incidence of 
highly pathogenic avian influenza in birds and improving capabilities 
for responding rapidly to disease outbreaks where they occur. These are 
the most cost-effective investments that can be made in advance of 
pandemic. Specific things that should be done include:

   Strengthening disease monitoring and surveillance for 
        humans, livestock, and wildlife, and enhancing and integrating 
        national, regional, and international reporting systems and 
        networks.
   Improving biosecurity standards and practices for the 
        poultry industry globally and incease access to low-cost rapid 
        diagnostic tests.
   Enhancing early rapid response, including culling 
        capabilities, deployable stockpiling of countermeasures, and 
        targeted vaccination in countries facing the greatest risks.

    Second, our analysis indicates that events and decisions at the 
interface between government and the private sector have the potential 
to significantly encourage private companies to review supply chain 
vulnerabilities and other economic and business risks that might be 
incurred under various pandemic emergence scenarios. Some leading 
corporations have already developed plans and strategies addressing 
business operations and continuity management, supply chain management, 
employee health and safety, and community involvement. But, many 
companies have not. In encouraging the development of these plans, the 
government should support public-private dialogue at the interface 
between the nation's pandemic preparedness plans and the role companies 
will play in the private sector.
    Third, U.S. government response plans should anticipate and respond 
to the challenges of fear-driven herd behaviors, as has already been 
foreshadowed by the sudden surge in demand for antiviral drugs and 
other countermeasures. Efforts should be made to limit potentially 
damaging and unnecessary hoarding behavior, and the possibility of the 
sudden mass movement of populations. To date, government efforts to 
build strategic stockpiles have largely focused on antiviral drugs and 
vaccines of uncertain effectiveness against a pandemic virus. But 
medical and hygienic supplies, such as masks, gloves, sanitary wipes, 
hand-cleaning supplies, syringes and hypodermic needles will certainly 
be in very high demand in the event of a pandemic, and governments 
might be wise to secure ample supplies of these materials in advance as 
well.
    Finally, given the sensitivity of economic consequences to 
disruptions of trade and travel in the earliest stages of a pandemic, 
international coordination of border control policies to avoid 
misunderstanding and promote cooperation will be essential. To the 
extent that these policies are transparently based on expert scientific 
advice from WHO and CDC authorities, and widely and jointly 
communicated to the public beforehand, the foundation for public 
reassurance and international cooperation will be solidly established--
along with our best chance to minimize the severity of global economic 
disruption.

    Senator Chafee. Thank you, Mr. Newcomb.
    Welcome, Ms. Garrett.

 STATEMENT OF LAURIE GARRETT, SENIOR FELLOW FOR GLOBAL HEALTH, 
           COUNCIL ON FOREIGN RELATIONS, NEW YORK, NY

    Ms. Garrett. Thank you, Senators and staff.
    I have submitted prepared remarks. I am not going to read 
remarks. But what I would think would be more useful is to 
react a little bit to some of what you've already heard this 
morning. So, I will jump around very quickly over a number of 
different issues. I hope that will be useful.
    First of all, many people have bandied the figure from the 
World Bank of $800 billion as the projected cost of a pandemic. 
That is not actually what the World Bank said in the report 
released yesterday. What they said was, it would be $800 
billion for Asia, another $550 billion for the OECD nations, 
and an untold amount for all of Latin America, all of Africa 
and Eastern Europe, so that it would top a $1.35 trillion 
impact. That's rather considerable.
    We also, yesterday, got from ASEAN, their estimate--or the 
Asia Development Bank--of something in the neighborhood, much 
lower, of $400 billion as the likely impact for Asia.
    We've seen estimates from our own Institute of Medicine 
putting impact in the range, just for direct medical costs in 
the United States alone, at something like $166 billion.
    Look, I think the bottom line here is that you should 
ignore all these numbers. You should ignore all numbers about 
how many people are likely to get sick, how many are likely to 
die. It's all garbage in, garbage out. They all depend on what 
the assumed attack rate is of the virus, its assumed virulence, 
a number of factors that we can't possibly know at this time.
    So that I would say, to be honest, I believe the only 
empirically valid statement that can be made, and that should 
be used in your policy assumptions, is that a highly virulent, 
highly transmissible pandemic influenza that circulates the 
world repeatedly for more than a year will kill more people 
than all the weapons of mass destruction that have been of 
concern to this committee, save perhaps a thermonuclear 
exchange. And such a catastrophe will be astoundingly expensive 
to the global economy, not only in immediate GDP losses, but 
quite possibly in the form of a long-term shock to the entire 
globalized trade environment.
    This morning, I felt that much of the discussion centered 
on two key concepts. One, containment and the possibility that 
containing a small-scale outbreak in a remote region is 
possible; and, second, the assumption that with such 
containment we would have a short-lived phenomenon. In fact, I 
kept feeling that I was hearing a discussion that was about 
something that would be like a hurricane. It would hit, you 
know, we have this chain of command, the Department of Homeland 
Security would jump to the fore, and, boom, we'd take care of 
it. That is absolutely contrary to all known biology of this 
virus and its likely behavior.
    In fact, the best way to think about the containment 
question, first of all, is that the Achilles heel of all 
containment strategies are recognition and notification. Local 
health providers must recognize that an unusually virulent form 
of flu is in circulation. Then they must notify higher 
authorities, and have means to do so. Do they have a telephone? 
Do they have any communications devices? Then they must send 
samples to a laboratory. How far away is said laboratory, and 
what is its level of competence? That laboratory must, over a 
period of time--often, a lengthy period of time--conduct 
necessary experiments to do confirmation that, indeed, a 
dreaded flu has emerged. Then they must gain the clearance of 
their government authorities--or, in some of the countries 
we're worried about, the political party--in order to 
officially notify the World Health Organization or neighbor 
states. By that time, well over 30 days has transpired. Indeed, 
here in the United States, we have communities that would be 
hard-pressed to go through that chain of events in public 
health, recognition, and notification in 30 days. And to 
imagine that poor countries, where per capita spending on 
health is less than $50 a year could do it any more rapidly and 
with any greater efficiency is very difficult to understand.
    Also, it seemed as if all the discussion was predicated on 
the assumption that the initial emergence event, should it 
occur--this dreaded mutational event in which a human-to-human 
highly transmissible form of the H5N1--would occur in a rural 
area such as some part of the Mekong Delta or some remote part 
of Laos. Why? It could very well be Jakarta, tomorrow, with an 
international airport and a population of 9 million people. Or, 
for that matter, the flyway piece that is about to connect, and 
will connect, with contamination, I would be willing to wager, 
within the next 60 days, is sub-Saharan Africa. And we may very 
well begin to have reports of dead and dying birds carrying 
H5N1 in the Serengeti--in Ngorongoro Crater, all the way down 
to South Africa. What imaginary infrastructure do we have in 
place that would give anyone confidence that there would be 
recognition, analysis, and transmission of the alert within 30 
days from such a region?
    There are some things that we could be doing that I did not 
hear highlighted this morning, and I hoped would be. One of the 
big lessons of SARS is that it was a nosocomial disease, which 
means it was spread and acquired within hospital facilities. In 
fact, if you look around at the recent surge of emerging 
diseases in epidemics--I've been in nearly every one of them. 
And in these epidemics, whether it's been SARS or the Ebola 
epidemic I was in in 1995, or the pneumonic plague epidemic I 
was in in 1994, or--we could go down the list--repeatedly, the 
major magnifier of the epidemic is the hospital facilities 
themselves. And that is something that, if we could expand our 
$250 million thinking about foreign assistance to something 
realistic, we would be immediately asking, How do you improve 
infection control in these hospital facilities? Where do we get 
sufficient supplies of latex gloves, of masks, of sterile 
syringes, of autoclaves, of generators to power the autoclaves, 
so that hospitals do not become foci of extraordinary 
infection?
    I think Tamiflu is a rotten drug. I think there are plenty 
of reasons why Roche only built one factory. I don't think 
Roche was particularly excited about the drug, or thought they 
had a huge market for it, until relatively recently.
    I've submitted a good deal of written information about the 
limitations of Tamiflu. But any public-health policy that is 
predicated on the assumption that either in the Third World 
emergent situation with a hope for localized containment, or 
here in the United States, Tamiflu will play a pivotal role in 
being the decisive factor that turns the tide of a pandemic, is 
a public-health policy that will fail.
    I heard a great deal this morning about chain-of-command 
questions. And I wholeheartedly support the skepticism and 
concern that was expressed by many Members of the Senate. And I 
am also looking to know who is in charge.
    And, perhaps the big problem is understanding the 
difference between a pandemic and a hurricane. It is totally 
appropriate that Secretary Leavitt would play the lead role if 
we were talking about an outbreak that would come and go in a 
matter of a week or two. But looking out over a year, or two 
years, with consistent waves, and these waves are mutated 
forms, different from the prior wave of flu--indeed, I would 
remind this group that in 1918, the first wave was not a 
particularly dangerous flu wave; it was the second wave that 
was the great killer--waves of mutating viruses coming through, 
surging over the continent, over the planet, one after another. 
And, in each case, there will be another impact on the economy, 
another impact on trade, another impact on the flow of 
essential goods and services, another impact on the United 
States military and its ability to conduct war on two fronts 
and protect national security. And these are issues that go far 
beyond the authority of Secretary Leavitt, or, indeed, any one 
Cabinet leader. And I would hope that, at the very least, the 
Senate would urgently request greater clarification on this 
chain-of-command issue, in light of a very long-term, 
protracted, and constantly changing event, and that part of 
that would recognize the tremendous value in coordinating with 
nongovernmental agencies, not just the corporate sector, as my 
colleague here quite well covered, but also the humanitarian 
sector. Many emerging diseases have first been spotted by MSF, 
Medecins Sans Frontieres, or other on-the-ground organizations 
that are not associated with any government. We need to 
coordinate with them.
    None of the Federal plans released to date mention the Red 
Cross, tell us what CARE will do, United Way will do. When we 
have every single hospital bed in America full, and now we're 
warehousing patients in school auditoriums and in gymnasiums, 
who is it that's giving food, water, and sustenance, and tender 
loving care to those people? It won't be the healthcare 
workers: It's some volunteer force that is not named in any of 
the Federal documents.
    Let us just remind ourselves that we have many 
unprecedented events associated with H5N1. Dr. Fauci listed 
some of them. We could go into a long list of reasons why this 
is a virus like no other, this is not a normal event, and that 
it is truly aberrant. But the one that concerns me the most is, 
we did not, in 1918, have 42 million people living in the world 
with an immunosuppressive virus in their body called HIV. We do 
not know what will happen when H5N1 gets in the body of an HIV-
positive person. There are two theories about what could 
happen. In one theoretical frame, biologically, all those HIV-
positive people would have weakened immune systems and would be 
like--to use Secretary Leavitt's analogy of a forest fire, 
kindling, horribly stoking a mass conflagration that would 
devour the world.
    In another scenario, it would be quite the opposite. Then 
it might be like SARS. Most people don't know that all the 
original SARS patients in Guangzhou were placed on the AIDS 
ward by the Chinese authorities. Most of their healthcare 
workers contracted SARS. But not a single HIV-positive person 
ever developed SARS. Why? Well, it appears that SARS was so 
foreign to the human body that what really killed individuals 
was their immune systems going crazy, saying, ``Oh, my God, I 
don't know what this is. Bring out the thermonuclear-weapons 
equivalent of an immune response.'' And it was the collateral 
damage of that great battle between their immune systems and 
the virus that proved so deadly to so many people.
    Well, we now know that was also true in 1918, with flu. And 
the few deeply analyzed clinical cases that have been looked at 
so far with H5N1 look the same way. So, another possibility is 
that HIV-positive people actually wouldn't mount a serious, 
obvious symptomatic response to pandemic flu, might actually be 
able to harbor the virus, in which case, they could be walking 
ambulatory petri dishes for mutating strains of H5N1 that would 
find a way to adapt to our species.
    With that in mind, I would hope that, as we consider 
whether or not the $250 million figure is an adequate number to 
put on the foreign assistance budget for pandemic flu 
preparedness, we would be very seriously considering that, at 
this time, almost all energies are focused on Asia. If we want 
to look at a region of the world with a desperate public-health 
infrastructure, desperate medical infrastructure, by one key 
estimate put forward by Lincoln Chen and Associates, a dearth 
of missing 1 million healthcare workers, the eyes should look 
to Africa.
    [The prepared statement of Ms. Garrett follows:]

Prepared Statement of Laurie Garrett, Senior Fellow for Global Health, 
               Council on Foreign Relations, New York, NY

    Chairman Lugar, Senator Biden, and distinguished members of the 
U.S. Senate Committee on Foreign Relations. I am honored to appear 
before you this morning to discuss our Nation's response to the threat 
of pandemic influenza, with special attention to implications for 
foreign policy and national security.
    Since late May of this year, when the Council on Foreign Relations 
publication Foreign Affairs published a special issue on the threat 
entitled ``The Next Pandemic?'' we have been pleased to see a marked 
increase in the level of concern and action regarding the flu threat, 
both within our government as well as at the highest levels of other 
governments, international agencies, the United Nations system, trade 
organizations, and multinational corporations. As we meet here today a 
major 3-day flu summit is winding up in Geneva, involving more than 600 
representatives of 100 nations. Grim news has poured from that summit, 
including a World Bank estimate that a pandemic would cost the global 
economy some $1.35 trillion. The good news is that such a meeting, 
bringing together rich and poor nations and U.N. agencies to plan a 
pandemic response, has happened. The bad news: It was the first such 
gathering, coming only after the H5N1 virulent avian influenza virus 
has been in circulation for at least 9 years in Asia, has now spread to 
Europe, and threatens to surface in the next 30-60 days in sub-Saharan 
Africa.
    In recent days we have seen pandemic plans released by the 
governments of the United Kingdom, Canada, Hong Kong--according to the 
World Health Organization some 60 percent of the world's nations have 
created some type of pandemic plan in recent weeks. Our own government 
has in the last 2 months: Issued the ``Ten Core Principles'' of global 
pandemic response, hammered out in September negotiations between 
Presidents George W. Bush and Hu Jintao and now signed onto by 88 
nations and agencies; released the President's $7.1 billion pandemic 
budget request; the Department of Homeland Security released its 12-
page plan; and the Department of Health and Human Services released a 
300-plus-page influenza pandemic plan. We are told that a detailed, 
all-agencies Federal plan will soon be released, offering details that 
are sorely lacking in those schemes that have, to date, been published.
    This is a very good start. But let's be clear--that is all we are 
seeing, even with pandemic flu threats making the covers of every major 
news weekly and newspaper in the Nation--a start.
    From the foreign relations perspective of this committee I would 
like to offer a few key concerns, drawn from the scientific and public 
health communities.

   If prognostic forecasts of human death tolls or economic 
        costs are going to be released by ``official voices,'' let's be 
        clear about the motivations behind those numbers, and the data 
        assumptions used in their derivations.

    Fear can motivate policy, and conversely low-ball estimates may 
prompt sighs of relief and eventual complacency. Some global and 
national agencies, concerned that high numbers might lead to public 
panic or to fret that response agencies are inadequate to the task, 
have chosen to derive all their numbers from comparatively mild flu 
data. For example, WHO and CDC have extrapolated their estimates that, 
at most, the world might experience 7.5 million deaths from virulent 
flu from the 1968 flu database. That influenza, however, killed roughly 
0.6 percent of those humans it infected. That's a far cry from the 55 
percent who have succumbed following infection with the H5N1 strain. On 
the other hand, extrapolating from that 55 percent mortality rate to a 
global scale would lead to a staggering, terrifying number that cannot 
possible motivate a reasonable policy response. Reckonings based on a 
somewhat dampened mortality rate have put the projected death toll as 
high as 360 million deaths globally, with 1.7 million of them being 
Americans. It is imperative, when looking either at global mortality 
data or economic costs, that policymakers demand to know the 
assumptions used to derive reckonings.
    The two most important assumptions are (1) the virulence, or 
mortality rate, of the virus--How many infected people will die? And 
(2) the attack rate, or transmissibility of the virus--What percentage 
of an exposed human population will actually become infected with the 
given flu strain? There is no way to know the answers to those two 
points until a virulent, human-to-human transmissible flu emerges. 
Therefore, ladies and gentlemen, it is all guesswork. You should be 
skeptical of claims, scrutinize the assumptions made to derive any 
numbers, and avoid basing your policies on them. A quick example: 
Earlier this year the Institute of Medicine estimated that a pandemic 
flu would cost the United States somewhere between $151-$166 billion, 
just for medical care and direct costs to the health system. The larger 
costs to the U.S. economy due to lost productivity, sustained market 
failures, projected stock losses and international trade disruptions 
are considered virtually unknowable. Yet the World Bank this week 
released its estimates, based on a pandemic that lasts for a full year: 
$800 billion lost to the Asian economies, plus $550 billion for the 
United States and OECD nations, with no estimates for Africa or most of 
Latin America, for a ball park total of $1.35 trillion.
    To be honest, I believe the only empirically valid statement that 
can be made--and that should be used in your policy assumptions--is 
that a highly virulent, highly transmissible pandemic influenza that 
circulates the world repeatedly for more than a year will kill more 
people than all the weapons of mass destruction that have been of 
concern to this committee save, perhaps, a thermonuclear exchange. And 
such a catastrophe will be astoundingly expensive to the global 
economy, not only in immediate GDP losses, but quite possibly in the 
form of a long-term shock to the entire globalized trade environment.

   Containment is not possible with currently available health 
        infrastructures and technology, and funding priorities stated 
        to date do not reflect the needs levels.

    Two major computer modeling studies published this summer in 
Science and Nature demonstrate that only the most Pollyanna of 
assumptions can possibly result in containment of an initial outbreak 
of human-to-human transmissible influenza. WHO's flu leadership has 
concluded that the agency and its global partners--such as the CDC--
would have only 30 days to throw a Tamiflu and quarantine ring around 
an outbreak site before the virus would manage to get into regional, 
and probably global, circulation. But it's not really even 30 days, as 
the Achilles heel of all containment strategies are recognition and 
notification. Local health providers must recognize that an unusually 
virulent form of flu is in circulation, notify high authorities, send 
samples to laboratories for confirmation, gain their government's 
clearance and then officially inform WHO. Let's be clear about this: 
There are places inside the United States of America that would be 
hard-pressed to accomplish all of these steps in 30 days; expecting 
such performance from countries with per capita health spending below 
$50/year is naive in the extreme.
    What, after all, is the incentive to report? If you were a poor 
farmer in southern Indonesia and suddenly half your chicken flock was 
sick, why is it in your interests to let anybody know about it? Even a 
wealthy livestock company in a G-8 nation might consider it ``wise'' to 
try limiting damage on its own, never reporting an outbreak. Unless 
governments have the clout to force notification, and can offer 
compensation to farmers that lack flock/herd insurance, this will 
always be the Achilles heel of animal surveillance.
    Human disease surveillance systems are only as good as the public 
health infrastructure. SARS started in November 2002. The world 
officially learned of it 5\1/2\ months later. Ebola broke out in 
Kikwit, Zaire, in January 1995. WHO was notified that samples of 
suspected Ebola-contaminated blood had been shipped to Belgium 3 months 
later. Even now human cases of H5N1 infection in Asia are being 
reported more than 80 days after they occur. Some of these lag-time 
issues are political (government coverup; appointment of incompetent 
officials to crucial health positions; corruption), and it is difficult 
for representatives of an outside government or agency to confront 
them. But the real problem in most cases is capacity.
    Last May, at the annual World Health Assembly, the 192-member 
nations debated pandemic flu policies and changes in the International 
Health Regulations (IHR) for many days, with official arguments raging 
as late as 5 a.m. Happily, the IHR were changed to a form that offers 
greater national transparency about disease and collective response to 
emerging threats. And the flu policy that was ultimately hammered out 
forms a good international legal framework of response. But throughout 
the long hours of debate the vast majority of nations repeated the same 
mantra, over and over: We need resources. That same mantra was heard 
this week in Geneva at the flu summit.
    Wealthy country governments, the G-8, and the World Bank have long 
neglected the public health infrastructure problem. The HIV/AIDS 
pandemic has sapped systems that in many cases were barely functional 
to begin with. If the Africa flyway becomes contaminated with H5N1 (and 
it will, soon) we will see what happens when nonexistent public health 
infrastructures, enormous HIV+ populations, and a vast range of bird 
species meet H5N1.
    In the long run we should view H5N1 as yet another warning shot 
across the bow for the wealthy world, signaling the need to invest 
heavily in development of public health infrastructures in poor 
countries. But H5N1 may not give us time to create such 
infrastructures.
    Short-term ``solutions'' are obvious: Bolster laboratory 
capacities, create standardized reporting mechanisms that are 
accessible to poor country residents, improve satellite and cell phone 
connections to allow rapid reporting of observations from all over the 
world. Syndromic surveillance is unlikely to be useful with flu, as the 
essential symptoms overlap with hundreds of other diseases, and the 
course of the illness in individuals is very rapid. Against a 
background of, for example, meningitis, malaria, HIV and TB, spotting 
high fevers due to flu could be impossible.
    One immediate technological breakthrough that could make an 
enormous difference would be a rapid saliva-based dip stick assay 
specific for H5N1. It would look like litmus paper--lick it, it changes 
color, and we know you have H5N1. I am aware of several labs that are 
working on such a technology. The key will be finding manufacturers 
that are willing and able to manufacture hundreds of millions of these 
diagnostics at a price affordable to countries like Cambodia, Laos, 
Malawi, and Ecuador.
    The President's proposal and the HHS plan released this week offer 
no specific allocations for development, manufacture, and global 
distribution of specific rapid diagnostics. That is a tragic oversight. 
The plans also spend only 4 percent of the President's $7.1 billion 
request on improving the surveillance and response infrastructures in 
poor countries; that, too, is an oversight.
    Last week the World Bank indicated it will put $500 million into 
the public health infrastructure effort, and the European Union this 
week promised to pony up $35 million. Combined, however, the $786 
million promised by various wealthy-nation sources will not come close 
to meeting needs, especially if human-to-human transmissible H5N1 
emerges in HIV-ravaged Africa.

   Stop spread of influenza inside hospitals and medical 
        facilities worldwide.

     SARS is an order of magnitude less contagious than influenza, 
ultimately proving to be primarily a nosocomial disease. Such measures 
as quarantine, travel advisories, and restrictions could succeed with 
SARS, but would have little, if any, efficacy in controlling spread of 
influenza. The most crucial lesson of SARS that would be applicable 
widely is that of hospital infection control. SARS spread primarily 
inside medical facilities, and comparisons of hospitals with very low 
levels of transmission (e.g., Queen Mary, Hong Kong or Bach Mai, Hanoi) 
to those with horribly high rates of in-hospital spread and death 
(e.g., Prince of Wales, HK) offers elegant and empirical proof of the 
efficacy of solid programs of infection control and patient isolation. 
Whether pandemic flu would prove open to mitigation through such means 
is doubtful, on a large scale, but individual lives and healthcare 
workers could well be saved by careful advance study and implementation 
of infection control measures. Further, epidemics have always spawned 
mass population migrations toward hospitals, particularly in poor 
areas, as desperate people search for solace, even if they are not 
themselves ill. The global paucity of such basics as soap, latex 
gloves, surgical masks, protective medical gowns, sterile syringes, 
autoclaves, and portable generators to power sterilizers guarantees 
that hospitals the world over will be cauldrons of infection.

   Managing to think, in a time of great uncertainty, on three 
        planes at a time.

    It is difficult for any leaders, whether in politics, industry, or 
nonprofit sectors, to create policies that address a given problem from 
three different event horizons all at the same time. But we have no 
choice with pandemic flu: It may emerge in a human-to-human 
transmissible form within 24 months, within 3-5 years, not for a full 
decade's time, or, if we are lucky, not at all. Investments and 
preparedness plans must consider the alarmingly slim list of options we 
have for action should H5N1 take on a rapid transmission form in the 
near future, but simultaneously we must invest in research and planning 
that may provide us with a far longer list of options for action in 
2010, or 2015.
    In the past, Federal plans (and local, State, and international 
ones) tended to rest on overly optimistic assumptions about vaccine 
production and rather blithely ignored the vast chasms that exist in 
emergency response coordination and communications. Since the state of 
urgency over H5N1 escalated radically this summer, the weaknesses in 
past plans have become obvious to all.
    In the short term, then, planning must emphasize organizational 
issues, chains of command, international cooperation, melding of human 
health and veterinary efforts, supply problems for both antiflu drugs 
(e.g., Tamiflu and Relenza) and a long list of general medications, 
hospital equipment, and even food.
    For a middle-term event horizon it is reasonable to expect that 
investments made today may result in vast improvements in diagnostics, 
vaccines, and perhaps even antivirals. Further, tabletop exercises, 
computer modeling, and a host of international efforts should provide 
planners with far more sophisticated understandings of the gaps and 
weaknesses in current systems of coordination and communication at all 
tiers, from the United Nations to city halls.
    And looking forward a decade it is reasonable to assume that a 
sound investment today in R&D will result in development and commercial 
production of a safe, effective, universal flu vaccine that, with a 
single round of immunization, will protect individuals against all 
forms of influenza viruses to which they may be exposed in their 
lifetimes. Further, investments made today in ecological improvements 
in Asia--particularly China--could reasonably be expected to vastly 
decrease the probability of any given wild bird virus crossing to 
domestic animals and humans.
    The trick is to comprehend how budgets, at all levels from the 
United Nations on down, can appropriately reflect all three planes, all 
three event horizons.

   Appreciate the limitations of current technologies, and 
        understand that Tamiflu is not a terrific drug.

    Several of the pandemic plans released by governments around the 
world, as well as the U.S. plans released to date, rested heavily on 
the use of the antiflu drug, Tamiflu. Made by Roche Pharmaceuticals in 
Switzerland, Tamiflu is not curative, but does slow down influenza 
viruses and offer patients some opportunity for a swifter recovery. In 
addition, some studies indicate prophylactic use of Tamiflu reduces the 
chances that any given individual will become infected with circulating 
viruses. The later finding has prompted many governments to build 
pandemic control plans around various schemes of widespread Tamiflu 
use. In some iterations, the U.S. plan posited widespread prophylactic 
use of Tamiflu by first responders: Physicians, nurses, EMT personnel. 
It will be important to see which groups are targeted for Tamiflu use, 
and over what period of time.
    While it is true that Tamiflu is the only drug we have, I hope that 
budgets will reflect recognition of the limitations of this drug and 
push for R&D aimed at replacing Tamiflu with far superior medications. 
Even in the short term I am anxious about Tamiflu.
    The FDA has approved use in kids over 1 year of age for treatment, 
but there is no approved pediatric use for prophylaxis. (Yes, 
physicians can prescribe any drug for off-label purposes, but a 
national public health policy ought not rest on such flip use.) The 
public health model requires using Tamiflu on all humans in an exposed 
area to control spread. Worse, H5N1 seems to have been especially 
likely to target children so far, which means that any effective public 
health strategy for use of the compound would have to posit widespread 
distribution for prophylactic purposes to children of all ages. But 
there are no approved uses and no studies to guide decisions on the 
safety of giving Tamiflu (or Relenza) to kids who aren't already 
suffering flu.
    Further, a manufacturer's warning was issued by Roche in 2003, 
based on rat studies: The extrapolation was that the babies and 
toddlers could have lethal effects from Tamiflu when taken correctly as 
treatment for flu. The manufacturer suggested (but offered no evidence) 
that the drug was crossing the blood/brain barrier in babies, and would 
cause lethal central nervous system effects. Roche, therefore, warned 
that no children under 1 year of age should ever take the drug.
    Even in adults there are problems. Roche's own studies show that 
people who take Tamiflu suffer more nausea, vomiting, stomach pains, 
and headaches than people given placebos and it is statistically 
significant. For example, twice as many Tamiflu users vs. placebo users 
suffered nausea; twice as many had vomiting; 1.5 times as many had 
diarrhea. (This may be a universal problem with neuraminidase 
inhibitors, as Relenza also produces nausea, vomiting, diarrhea, and 
stomach pains in a sizeable subset of users.) Because of the way the 
data was presented it is not possible to discern whether these side 
effects are experienced in a small subset of users who have multiple 
problems with the drugs, or in a sizeable percentage of the drugs' 
users, each of whom experience one or two of the side effects. One 
prominent scientist who sat on the FDA's Tamiflu review panel recently 
told me, ``You want to take Tamiflu? Prepare to be nauseated.''
    The side effects may not matter when an individual already has the 
flu, but in a prophylaxis context it may prove impossible to get mass 
compliance with these drugs over a sustained period. It is important to 
understand the compliance issue before making plans for large-scale, 
sustained-use of the drug(s).
    All prophylaxis studies have been done in adults--none are 
pediatric, though some involve teenagers. They do show efficacy, with 
3- to 12-fold reductions in flu cases compared to placebo recipients 
(the variation in efficacy covers a wide range, depending on the study, 
however). That's good news. But given the drug appears to produce some 
``flu-like symptoms,'' such as nausea, vomiting, and diarrhea, 
compliance with long-term self-medication could be a problem. And, 
again, we have no pediatric data.
    For Relenza we have data that shows it may reduce the length of flu 
illness by a mean of 1 day in infected kids. But the efficacy in kids 
under 6 years of age was so low that the manufacturer recommends it 
only for kids over 6. Here, too, there is no long-term-use data, though 
the inhalant drug is not really under consideration for prophylactic 
use.
    Large pooled studies (metaanalyses contrasting the results of many 
separate studies) conclude that Tamiflu cuts the length of a flu 
episode by about 1 day in adults, and 0.9 days in children. Relenza's 
efficacy appears to be about the same. As prophylaxis, Tamiflu and 
Relenza appear to reduce the odds of coming down with flu by about 70-
90 percent in adults.
    But, the best such study (Cooper, NJ, et al., BMJ 326:June 7 2003; 
obtained on line) has this crucial statement: ``Lack of evidence exists 
for the use of neuraminidase inhibitors for preventing flu in children 
and in frail elderly people in residential care.''
    A final consideration regarding pediatric use: Metabolism. All 
studies indicate kids metabolize the drugs faster than adults, and this 
means direct mg/kg dosing comparatives are unwise. Though the drugs 
were eventually licensed for treatment of flu in kids, the scientific 
review panels argued about proper dosing, and were troubled by the 
direct mg/kg choice. The kids simply clear the drugs from their systems 
faster, meaning there is less available drug over time. In the end, the 
panel compromised and decided that the drugs were safe enough to 
warrant a blunt instrument approach to pediatric dosing.
    Data submitted to the FDA by Roche shows a few other 
considerations:

--There was no statistically significant difference between placebo and 
    Tamiflu in terms of delaying otitis media (ear infections) in kids, 
    the most common outcome of bad bouts of flu. Since OM was the FDA-
    agreed measure of the efficacy of the drug for preventing serious 
    forms of influenza illness, this has got to raise concerns about 
    whether the drug worked. (In contrast, adult studies show marked 
    reductions in bacterial pneumonia among older Tamiflu users.)
--Pediatric use of Tamiflu was eight times more likely to result in 
    emergence of drug resistant forms of the virus, compared to adult 
    use. (This could be related to the rapid metabolism issue in kids.) 
    Kids who developed resistant viruses stayed sicker longer on 
    Tamiflu, thereby erasing the drug's benefit of, statistically, 
    reducing the length of a bout of flu in kids by 0.9 days.
--This emergence of drug resistant mutants was quite troubling to the 
    FDA panel. Keep in mind that a baseline survey of flu strains 
    circulating worldwide in 2002-3 season found no examples of 
    resistance in nature to these drugs. So the possibility that 
    pediatric use of the drugs promotes emergence of drug resistant 
    strains clearly worried the FDA panel. A crucial FDA review of the 
    Roche data states:

          It also appeared that the mutant virus may be shed at high 
        titers in some subjects before being cleared. Therefore, this 
        reviewer has not been reassured that these viruses are harmless 
        to the general population. The pediatric studies were not 
        designed to determine if there was secondary spread of the 
        mutant viruses to household or other contacts so there is no 
        data regarding transmission of these viruses in vivo. Since 
        these mutations involve the neuraminidase enzyme and to a 
        lesser (but undefined) extent the hemagglutinin, there are also 
        theoretical concerns that they could be antigenically distinct 
        from wild type influenza. The review team believes that it will 
        be of critical importance for the sponsor to further 
        characterize these mutant viruses, the course of clinical 
        disease associated with them, their potential for transmission 
        in households and the nature of the antibody response to them 
        compared to wild type influenza. (NDA 21-087, NDA 21-246, June 
        2000.)

    In reviewing all data on Tamiflu provided by the manufacturer as of 
March 2001, the FDA's Dr. Heidi Jolson, Director of Antiviral Drug 
Products, concluded:

          . . . once an individual contracts infection and develops 
        influenza symptoms, the role of an antiviral appears to be 
        limited. As demonstrated in the studies submitted in support of 
        the applications for oseltamivir and zanamivir, early antiviral 
        treatment results in only a modest attenuation of the course of 
        clinical illness (approximately 1-day shortening in the median 
        duration of major symptoms with both products). Therefore, if 
        promoted to the consumer, balanced promotion should contain 
        information regarding the importance of vaccination, the 
        reminder that not all viral illness is caused by influenza 
        virus, and the likely modest treatment benefit a patient and 
        healthcare provider elect to treat influenza with an antiviral 
        medication.
          The clinical relevance of the modest treatment benefit is a 
        highly subjective question.
          More definitive demonstration of clinical or public health 
        relevance with the neuraminidase inhibitors will require 
        additional data, such as studies to demonstrate prevention of 
        influenza transmission or prophylaxis, reduction in influenza-
        associated complications or mortality, or the pharmacoeconomic 
        gain due to illness shortening.

    In FDA hearings on February 24, 1999, regarding the licensing of 
the first of the neuraminidase inhibitors to reach the agency, Relenza, 
independent scientists were convinced that Relenza's efficacy was 
barely discernible in patients who simultaneously took over-the-counter 
drugs, such as aspirin and ``flu medicines.'' Much of the debate among 
the review panel concerned how, exactly, the ``efficacy'' of the drug 
could be measured. Panel members were clearly skeptical that Relenza 
had much benefit, at all, and some argued that the FDA and Glaxo had 
agreed on a set of clinical trial endpoints that ended up providing no 
real clarity. I have spoken to some members of that panel and they 
describe a great reluctance in the room to accept that the drug offered 
much, if any, benefit beyond what patients could obtain from the 
shelves of their local drug stores.
    In the above metaanalyses that I referred to, this question of how 
many patients simultaneously took other flu medicines that they 
purchased at their neighborhood drug stores was not addressed. So we 
have no idea how profound a confounder over-the-counter drug-use may 
be. It's possible Tamiflu and Relenza still have powerful impacts, 
beyond the OTC drug impacts. (Certainly, the adult prophylactic use 
benefit can be considered a genuine one, to be credited to Tamiflu, 
based on the studies' designs.) It is also possible that factoring for 
OTC drug use in the test subjects (both placebo groups and Tamiflu/
Relenza recipients) would have revealed more problematic benefits from 
these pharmaceuticals, particularly in treatment for flu infections.

   The Number One priority in the short term: Chain of command.

    In any complex crisis the greatest failure is command, and its 
corollary, communication. In recent history only one American disaster 
witnessed a clear chain of command understanding, namely Rudolph 
Giuliani's clear leadership of 9/11/2001 responses. Conversely, lack of 
clear chain of command and communication was key to failures in New 
Orleans.
    Influenza pandemics are not singular events, such as the strike of 
a hurricane, the slip of an earthquake fault, or the suicidal attack by 
a terrorist. Rather, pandemics unfold over time, recirculate in waves, 
continually mutate and persist for months, perhaps years. Planning must 
appreciate the difference between emergency response and long-term 
disastrous outcomes, including shortages of food, medical supplies, 
essential products, and business equipment. Chain of command for 
singular emergency events may differ from that which will be key to 
keeping societies functioning throughout a prolonged, horrible event.
    Few cities, states, provinces, agencies, or nations have thought 
this through and developed clear understandings of which individuals 
and agencies are in charge of the various facets of a pandemic 
response. We look forward to seeing clear delineation of these issues 
in the forthcoming multiagency Federal response plan for the United 
States.

   Global and domestic responses must coordinate with 
        nongovernmental and humanitarian organizations.

    None of the plans presented to date at the international or 
national levels delineate roles for volunteers and nongovernmental 
groups, such as the Red Cross, Medecins Sans Frontiers (MSF), CARE, 
Oxfam, the Red Crescent, or WorldVision. No matter what assumptions are 
made about the expected numbers of infected and dying people in a flu 
pandemic the world lacks sufficient nurses, physicians, government 
first responders, and employed officials to adequately respond. In some 
parts of the world the first warnings about new epidemics and disease 
emergences have come from humanitarian groups, particularly MSF. It is 
imperative that governments work closely, at all tiers, with private 
volunteer organizations to coordinate recognition, surveillance, and 
response efforts. Such groups must be considered partners, not mere 
adjuncts, in a global effort.

   The role of the military and national security response is 
        complex and requires considerable forethought.

    In the United States we face a unique problem, born from our 
engagement in Iraq. In order to avoid a divisive military draft, the 
Bush administration ordered the Army Reserves and National Guard into 
foreign combat. Among other things, this has blurred the lines between 
the various Armed Forces in America and left us bereft of National 
Guard under individual States control for response to domestic crises. 
The weakening of the National Guard was an apparent problem following 
Hurricane Katrina and will continue to be a special issue for the 
United States.
    Historically, the lines between the National Guard and U.S. Army, 
Air Force, Navy, and Marines were far clearer, and it was entirely 
appropriate to posit a role for the National Guard in a pandemic 
response. That is no longer the case.
    Internationally, the nature of State response to this issue will 
vary dramatically. Some countries routinely use their armed forces for 
police actions and probably will not hesitate to do the same in a 
pandemic. The opposite may also be true: When I was in the Ebola 
epidemic in Zaire in 1995 the army fled the region, leaving the people 
to fend for themselves for several weeks.
    You might well ask this question: If a nation has an adult HIV 
prevalence of 35 percent, and the effect of HIV on H5N1 infection is to 
double the flu mortality rate, what will happen to the forces of State 
security? If a nation is fighting wars on two fronts involving more 
than 200,000 troops, and H5N1 turns out to mirror the 1918 flu in that 
it takes its highest toll among young adults, how can the armies 
continue to carry out their operations? If, in addition, their enemy 
practices suicide bombings, and, therefore, cares not whether it is 
infected with a deadly virus, how might the pandemic affect the course 
of the wars?
    The Armed Forces of the United States, Canada, France, and dozens 
of other nations are among the best organized forces for rapid 
deployment, transport, and infrastructural support. There is more to 
modern militaries than shooting guns and dropping bombs. Just ask the 
people of Aceh: Who got there first, after the tsunami? I'll give you a 
hint--it was a navy with red, white, and blue flags flying. Why? 
Because making one's way thru newly reshaped reefs and shoals, with 
entire coastlines utterly remapped, to deliver supplies for hundreds of 
thousands of people required a modern satellite-guided naval armada.
    While I strongly support the use of U.S. military personnel for 
logistics, supply and support activities, both domestically and 
overseas, in response to a flu pandemic, I do not believe the Army, 
Navy, Air Force, or Marines ought to be considered primary enforcers of 
domestic quarantines or public health actions.

   A final note . . .

    There are at this moment unconfirmed reports of H5N1 die-offs among 
bird populations in Iran and Iraq. If true, these could foretell spread 
of the virus to the African flyway, which would include a spectacular 
range of species migrating from Ethiopia to South Africa. We do not 
know how H5N1 will behave in the body of an HIV+ human being. There are 
two theories, scientific rationales for which are a bit too complicated 
to detail here. Nevertheless, in one scenario the HIV-weakened immune 
systems of infected individuals create permissive environments for 
H5N1, allowing the flu virus to thrive, mutate, and adapt to human 
beings. In such a scenario, the HIV+ person is, in a sense, an 
ambulatory Petri dish, incubating, and possibly spreading, new forms of 
the virus.
    In a second scenario, however, the HIV+ individual, unable to mount 
a protective immune response against H5N1 is easily infected and 
swiftly devastated. In that situation vast populations of HIV+ people 
could be obliterated by the pandemic flu. This is a horrible notion, 
and ominous given the extraordinary HIV infection rates in many African 
countries.
    Regardless of which HIV/H5N1 scenario is correct, spotting any 
movement of the flu virus from African birds to the continent's peoples 
will be exceedingly difficult. As weak as the public health 
infrastructures and surveillance systems are in much of Asia, such 
capacities are far worse in sub-Saharan Africa. Further, spotting 
symptoms such as the emergence of clusters of people with high fevers 
and nausea might be impossible against a background of malaria, 
tuberculosis, and HIV.
    It is imperative that the international cooperation components of 
the forthcoming multiagency U.S. pandemic plan will give close 
attention not only to improving surveillance and response capacities in 
Asia, but also in Africa.

    Senator Chafee. Thank you very much for your expert 
testimony.
    And since this is the Senate Foreign Relations Committee, I 
thought I might just stress our international effort here. And 
the Under Secretary testified earlier that the President has 
established the International Partnership on Avian and Pandemic 
Influenza as an umbrella organization to bring everybody 
together. Do you think that this initiative is the right 
direction to go as we look at this as an international issue 
and--Mr. Newcomb, particularly on economic issues that--to have 
this one international partnership on avian and pandemic 
influenza as the lead agency here?
    Mr. Newcomb. I think it's certainly an important and 
valuable centerpiece for that strategy, although I'd underscore 
that there are really many different channels by which public 
and private efforts need to be coordinated.
    I'd mention, in particular, concerns about--questions about 
potential border-control policies that might be put in place by 
governments around the world. It's an especially important area 
for companies that are trying to develop contingency plans 
today. So, the greater clarity that can be brought forward, 
whether that is in the Asian context, as has recently been 
discovered, explored through APEC, or through other 
collaborative international discussions, any of those will be 
effective, to the extent that they bring forward greater 
coordination and greater communication or clarity in advance of 
what those policies might look like. Because I think those are 
the--a building block for the kinds of supply-chain planning 
and preparation measures that the private sector has to 
undertake.
    I'm only underscoring that point from the perspective that 
a healthy economy is an important component of our ability to 
respond to the disease. We know from our own work that many 
companies are moving very quickly to develop, in some cases, 
quite sophisticated plans for response. And it's difficult 
planning work to do, because of the nature of uncertainty of 
the situation. But there's certainly a tremendous amount of 
work being undertaken in the private sector, and the private 
sector, I would only--I would only underscore looks to 
government policies in this area as a guidepost or a starting 
point for its own planning efforts.
    Senator Chafee. Thank you.
    Ms. Garrett, you mentioned wave after wave of mutating 
viruses sweeping across the globe. Are we ready?
    Ms. Garrett. No, we are not. Not--we aren't remotely ready. 
And I don't even think that in most of the planning the word 
``ready'' is associated with an appropriate level of 
imagination of the complexity of what we're up against. It's 
very exciting for me to see the increase in concern and 
attention that this issue has gotten in the last 3-4 months. 
Would that it had been building over the last several years. 
Perhaps the best way to put this in perspective is, in May 
every year, the World Health Assembly convenes. That is the 
legislative body, if you will, or governing body, of the World 
Health Organization. This year, there were two key issues on 
that agenda, one of which touched on one of your earlier 
questions related to Taiwan and China. The two key issues that 
gathering faced, were, one, Could we all agree to change the 
international health regulations that guide WHO so that they'd 
actually have the capacity to respond to a pandemic, to be in 
the middle of an epidemic, and to put pressure on countries to 
be transparent? And the second was, specifically, Could the 
global community agree on the sort of baseline set of 
principles for a flu pandemic? In both cases, the negotiations 
were heated, lengthy, and broke down many times over the 
Taiwan/China question, with Taiwan lobbying very hard for other 
countries that were allowed to be speaking in the room to say, 
``Yes, but what about countries not officially part of WHO's 
system or the U.N. system? What about regions not officially 
recognized?''
    The other was the question, just generally, about pandemic 
flu, that, once the actual voting took place every country 
said, ``Of course we support, in principle, having a pandemic 
flu plan, but the world should know we have not one penny that 
we can direct to it, and that unless the wealthy world is 
willing to redirect funds toward our efforts, this is just so 
much paper. It's paper we sign, but it's not paper we can 
implement.''
    Senator Chafee. How much do you know about the 1918 
outbreak and--you said it was the second wave that was the most 
lethal--what caused it to subside, these waves of mutating 
viruses, back, you know----
    Ms. Garrett. Very interesting question. And, of course----
    Senator Chafee [continuing]. A hundred years ago?
    Ms. Garrett [continuing]. There are a number of things, in 
hindsight, we can only speculate about, so, forgive me if 
that's probably what I'm doing.
    We're not exactly sure where the first wave came from. 
Various places have been named, but probably it was from Asia. 
That's where flu comes from. It circulated the world and in its 
original form, was mild enough that, actually, in the heat of 
World War I, the British High Command officially set down that 
this was nothing to worry about, and it would not affect our 
war effort.
    There are some strong indications that the pivotal event 
may have taken place in Kansas, where the U.S. Cavalry was 
bivouacked at Fort Riley. There, in Kansas, the virus would 
have had opportunity--and there's some evidence that it did--to 
pass both through horses and pigs. And it underwent a critical 
mutational event and became a far more lethal virus than the 
wave that had preceded it. There was a third wave that was 
considerably milder, and then it was over.
    Why was it over? Well, probably two reasons. One, the virus 
itself attenuated, it dampened down, it became a less virulent 
virus. And, two, the surviving populations had a pretty high 
level of herd immunity so that it was as if there had been a 
mass immunization campaign, only it was carried out through 
contagion, not through syringes.
    Senator Chafee. Well, very good.
    I don't have any further questions. I'd like to thank you 
for your time and patience for sitting through the morning's 
testimony, the first panel's testimony.
    And we wish you well, and, once again, thank you.
    [Whereupon, at 12:20 p.m., the hearing was adjourned.]
                              ----------                              


   Additional Statements and Questions and Answers Submitted for the 
                                 Record


 Prepared Statement of Dr. Margaret Chan, Assistant Director General, 
            Communicable Diseases, World Health Organization

                              INTRODUCTION

    The World Health Organization would like to thank Chairman Lugar 
and the committee for the invitation to provide a statement in the 
context of its timely hearing on ``The Current Status of Avian 
Influenza and the Consequences of an Influenza Pandemic.'' Today, in 
Geneva, WHO is cohosting, with FAO, OIE, and the World Bank, a meeting 
of the cosponsoring organizations, country representatives, donor 
partners, and regional organizations involved in the influenza issue. 
This international meeting will enable an examination of integrated 
national plans to deal with the issue, focusing on affected countries 
and countries at risk. One expected outcome of this meeting is to 
identify key next steps based on an agreed strategy with political 
support and backing from the international community. I look forward to 
being in further contact with the committee about the outcomes of the 
meeting.
    As requested, this statement will address reasons for the concern 
about the current H5N1 virus in Asia and elsewhere, WHO's work in 
assisting countries to prepare for a human influenza pandemic including 
the status of stockpiling of antiviral drugs and vaccines, WHO's key 
recommendations for the international community on human pandemic 
preparedness, and lessons learned from the SARS epidemic.
           reasons for concern about the h5n1 influenza virus
--The virus causes extremely severe disease in humans.
--It has considerable pandemic potential.
--The source of human exposure is not easily removed.
--The virus is evolving in ominous ways.
--The world may be on the brink of another pandemic.
Severe human disease
    Of all influenza viruses that circulate in birds, the highly 
pathogenic H5N1 virus currently becoming widespread in animals is of 
greatest present concern for human health for several reasons. First, 
though avian influenza viruses rarely cross the species barrier to 
infect humans, H5N1 has done so on three occasions since 1997. This 
virus has also caused, by far, the greatest number of human cases of 
very severe disease and the greatest number of deaths. Unlike normal 
seasonal influenza, where infection causes only mild respiratory 
symptoms in most people, the disease caused by H5N1 follows an 
unusually aggressive clinical course, with rapid deterioration and high 
fatality. Primary viral pneumonia (which does not respond to 
antibiotics) and multiorgan failure are common. For unknown reasons, 
most cases have occurred in previously healthy children and young 
adults.
Pandemic potential
    The H5N1 virus has considerable potential to spark another 
influenza pandemic. At present, all conditions for the start of a 
pandemic have been met save one: The establishment of efficient and 
sustained human-to-human transmission. Each additional human case gives 
the virus an opportunity to combine with other viruses or adapt in ways 
that allow it to spread easily among humans. The risk of human cases 
persists as long as the virus continues to circulate in birds; the 
virus will not be eliminated from birds for some years to come.
A tenacious virus in poultry
    The current outbreaks in poultry are historically unprecedented in 
their scale and geographical scope. Never before have so many birds 
been affected in such a large number of countries. Despite intense 
control efforts, the virus has become firmly entrenched in large parts 
of Asia. On numerous occasions, countries thought close to control have 
experienced setbacks as outbreaks recurred and then spread rapidly. 
Timeframes for controlling the disease are now being measured in years. 
Recent evidence that wild waterfowl are now carrying the virus in its 
highly pathogenic form is particularly worrisome, as all experts agree 
that elimination of the virus from wild birds is impossible.
An ominous evolution
    Like all influenza viruses, H5N1 is notoriously unstable and 
unpredictable. In an historically unprecedented situation involving a 
constantly changing virus, unusual developments can be expected, and 
these have occurred. During the past 18 months, the virus has evolved 
in ways that increase the complexity of control and heighten concern 
about the pandemic threat.
    Domestic ducks can now excrete lethal virus without showing signs 
of illness, thus acting as a ``silent'' reservoir of the virus, 
perpetuating transmission to other birds. This adds yet another layer 
of complexity to control efforts and removes the warning signal for 
humans to avoid risky contact with sick or affected animals. Second, 
the relationship between the virus and its natural animal reservoir, 
wild waterfowl, appears to have changed, possibly for the first time in 
centuries. The spring 2005 die-off of more than 6,000 migratory birds 
at a nature reserve in central China, caused by highly pathogenic H5N1 
virus, was highly unusual and probably unprecedented. Scientists are 
increasingly certain that at least some wild waterfowl are now 
harbouring and excreting highly pathogenic H5N1 virus and carrying this 
virus with them along their migratory flyways. The recent spread of the 
virus to Russia and parts of Europe is thought to have occurred via 
this wild-bird vector; spread to additional areas is considered 
inevitable.
    When compared with H5N1 viruses from 1997 and early 2004, viruses 
now circulating are more lethal to experimentally infected mammals and 
survive longer in the environment. Mammalian species previously 
considered resistant to infection have developed disease and can spread 
it to others within their species. Expansion of the mammalian host 
range of the virus is of concern as it gives this purely avian virus 
more opportunities to adapt to a form that spreads more easily among 
mammals, including humans.
    Perhaps most significantly, recent research on both human and 
animal viruses circulating in Asia in 2005 has detected several 
mutations, some of which may affect transmissibility in humans. 
Research following recent reconstruction of the highly lethal 1918 
pandemic virus determined that this virus was entirely avian and may 
have evolved along an evolutionary pathway similar to that being seen 
with the H5N1 virus.
On the brink of a pandemic
    For all these reasons, WHO and international experts believe that 
the world is now closer to another influenza pandemic than at any time 
since 1968, when the last of the previous century's three pandemics 
began.
    A pandemic is caused by a new influenza virus that has either never 
circulated in humans or has not done so for a number of years. Because 
humans will have little, if any, immunity to this ``foreign'' virus, 
susceptibility is virtually universal. This lack of immunity also 
results in more severe disease than seen during seasonal epidemics of 
normal influenza. The result is a worldwide epidemic (pandemic) that 
sweeps through susceptible populations, rapidly encircles the globe, 
and causes excess morbidity and mortality, usually far above that seen 
during seasonal epidemics. Whereas, seasonal influenza usually has its 
most severe effects on a limited number of risk groups (the very young 
and the elderly, persons with underlying chronic disease or compromised 
immune systems), pandemics can cause severe illness and deaths in all 
age groups, including the young and healthy. The newness of the virus 
also means that existing vaccines will not confer protection.
    With the H5N1 virus now considered endemic in large areas, and 
spreading to new ones, the probability that a human pandemic will occur 
has increased. As no virus of the H5 subtype has ever circulated widely 
in human populations, human vulnerability to infection with this virus 
will be universal. On the positive side, experts anticipate that the 
virus will lose some of its virulence (the present case fatality rate 
is higher than 50 percent) when it improves its transmissibility; this 
is not, however, known with certainty. Historically, pandemics have 
encircled the globe in 6 to 9 months, even at times when international 
travel was mainly by ship. Today, experts believe that the first 
pandemic of the 21st century will reach all parts of the world within 3 
months.

               STATUS OF H5N1 OUTBREAKS IN SOUTHEAST ASIA

    The recent history of avian influenza in Asia begins in 1996, when 
a highly pathogenic H5N1 virus was isolated from a farmed goose in 
Guangdong Province, China. The following year, Hong Kong experienced 
poultry outbreaks, caused by this virus, on farms and in wet markets. 
Coincident with these outbreaks, the first instances of human 
infections with the H5N1 virus were recorded in Hong Kong. Altogether, 
18 cases, of which 6 were fatal, were identified in that outbreak. This 
event changed scientific thinking about how pandemic viruses might 
emerge, raising--for the first time--the possibility that an entirely 
avian virus, capable of causing severe human disease, could be the 
origin of the next pandemic if given enough opportunities to infect 
humans and adapt to them. The destruction of Hong Kong's entire poultry 
population of around 1.5 million birds within 3 days is thought by some 
experts to have averted an influenza pandemic at that time. Human cases 
were again detected in Hong Kong in February 2003 in members of a 
family with a recent travel history to Fujian Province, China.
    After a period of quiescence, the virus resurfaced at some time 
during mid-2003, and quickly erupted into the largest outbreaks of this 
disease seen in history. Beginning in late December 2003, outbreaks of 
highly pathogenic H5N1 avian influenza in poultry were reported in nine 
Southeast Asian nations (listed in order of reporting): Republic of 
Korea, Vietnam, Japan, Thailand, Cambodia, Lao People's Democratic 
Republic, Indonesia, China, and Malaysia. Of these countries, three 
have controlled their outbreaks and are now considered disease-free: 
Japan, Republic of Korea, and Malaysia. Elsewhere, experience shows how 
firmly entrenched this virus has become and how difficult its complete 
elimination will be. Despite the death or destruction of around 150 
million birds, at a cost to agriculture of an estimated US$10 billion, 
the virus is now considered endemic in Indonesia and Vietnam and in 
some parts of Cambodia, China, Thailand, and possibly also Lao PDR.
    In late December 2003, human infections were identified in people 
exposed to infected poultry in Vietnam. Since then, at least 120 human 
cases have been laboratory confirmed in four Asian countries (Cambodia, 
Indonesia, Thailand, and Vietnam), and more than half of these people 
have died. At present, however, the species barrier is significant. The 
number of human cases is small in comparison with the huge number of 
birds affected, over large geographical areas, for 2 years, and under 
circumstances offering abundant opportunities for human exposure to 
occur.
    Control of the disease in animals faces several serious challenges, 
and opportunities for further human infections to occur will persist. 
In some affected countries, up to 80 percent of poultry production 
takes place in small backyard flocks, where surveillance is weak, 
reporting is poor, and control measures are difficult to implement. 
These are the areas of greatest concern for human health. To date, the 
majority of human cases have been linked to exposure to infected 
poultry in rural and periurban areas. In these areas, poultry usually 
roam freely, scavenging for food, often entering homes or sharing 
outdoor areas where children play. Populations traditionally sell or 
consume birds when signs of illness appear in a flock, and this 
practice has proved hard to change, especially when poultry are a 
principal source of income and food. Behaviours thought to carry a high 
risk of infection include the home slaughtering, butchering, 
defeathering, and preparation for consumption of diseased birds.
    Most affected countries cannot adequately compensate farmers for 
culled poultry, thus discouraging the reporting of outbreaks in the 
rural areas where the vast majority of human cases have occurred. 
Veterinary services frequently fail to reach these areas. Detection of 
human cases is impeded by patchy surveillance. Diagnosis of human cases 
is impeded by weak laboratory support and the complexity and high costs 
of testing. Few affected countries have the staff and resources needed 
to thoroughly investigate human cases and, most importantly, to detect 
and investigate clusters of cases--an essential warning signal that the 
virus may be improving its transmissibility among humans.
    Not all countries have undertaken control measures to reduce the 
presence of the virus in poultry. As a result, the virus is now 
pervasive in Indonesia and Vietnam and perhaps elsewhere. In Vietnam, 
detection of human cases has often been the first signal that outbreaks 
in poultry were occurring in a given area. In Cambodia, all human cases 
were detected only after patients crossed the border for medical care 
in Vietnam, and were managed by doctors well-acquainted with the 
clinical features of this disease. Because of this inadequacy of the 
surveillance system, the possibility that poultry outbreaks and 
sporadic human cases are occurring--undetected and unreported--
elsewhere cannot be ruled out. Such lapses are of critical importance 
to the international community, as timely case reporting constitutes 
the backbone of the early warning system for detecting the emergence of 
a pandemic virus.

                   THE ROLE OF WHO IN SOUTHEAST ASIA

    WHO staff at country offices work closely with Ministries of 
Health, assist in the diagnostic confirmation and field investigation 
of cases, and provide the interface between these Ministries and the 
international community. Diagnostic confirmation of human cases is 
technically challenging; work with the virus can be safely performed 
only in laboratories with a high level of biosecurity, and such 
laboratories are rarely available in affected countries. For these 
reasons, WHO provides diagnostic support through its coordination of 
the global network of influenza laboratories specialized in work on H5 
virus subtypes. In the United States, this network includes the U.S. 
Centers for Disease Control and Prevention (CDC) and a second 
laboratory, for animal influenza viruses, at St Jude Children's 
Research Hospital in Memphis. The U.S. Naval Medical Research Unit 2 
(NAMRU2), located in Jakarta, Indonesia, has been another source of 
rapid diagnostic support, particularly for cases in Indonesia that have 
been occurring since mid-September 2005. All of these laboratories are 
equipped to handle H5N1 viruses at the highest level of biosecurity. 
WHO country staff arrange for patient samples to be shipped safely to 
these laboratories for diagnostic confirmation. These laboratories also 
conduct molecular studies of viruses to look for evolutionary changes 
that might signal improved transmissibility and to ensure that work on 
a pandemic vaccine remains on track.
    While molecular studies of the virus are one important part of the 
early warning system, rapid detection and investigation of human cases 
are even more important, as the occurrence of clusters of cases, 
closely related in time and place, will probably be the first signal 
that the virus is spreading more easily among humans. At the request of 
governments, WHO regularly sends international teams of experts, drawn 
from institutions in its Global Outbreak Alert and Response Network 
(GOARN), to conduct on-site investigations when unusual disease events 
of potential international public health importance--such as H5N1 cases 
in humans--occur. Such teams also assist in the development of national 
surveillance and diagnostic capacity. Experts from the CDC are usually 
part of these teams. WHO also procures essential supplies to support 
laboratory work and the clinical management of cases. Video conferences 
and teleconferences are regularly held with international experts to 
gather consensus on the evolution of the threat and to assist WHO in 
its overall assessments of the situation.

                   THE OUTBREAKS IN RUSSIA AND EUROPE

    Beginning in late July 2005, highly pathogenic H5N1 was detected in 
wild and domestic birds in Siberia (Russia) and in adjacent parts of 
Kazakhstan. Almost simultaneously, Mongolia reported H5N1 in a large 
number of dead migratory birds. In Russia, poultry outbreaks have since 
spread westward toward Europe. In October 2005, Turkey and Romania 
confirmed H5N1 outbreaks in poultry, and Croatia detected the virus in 
dead migratory birds. Deaths of wild and domestic birds in several 
other areas are under investigation. All newly affected areas are 
located along the flight paths of migratory birds.
    Throughout Europe, vigilance for the appearance of outbreaks in 
wild and domestic birds and for the occurrence of associated human 
cases is high. Outbreaks in animals have been detected and reported 
quickly, and extensive control measures have followed immediately. WHO 
epidemiologists and virologists have assisted in investigations, when 
requested. Diagnostic reagents have been sent to national laboratories, 
and WHO has provided training in H5N1 diagnostic techniques. Viruses 
have been shared internationally and are undergoing analysis at WHO 
reference laboratories. These laboratories have also helped to rule 
out, authoritatively, the many false rumours of cases. To date, no 
human cases have been associated with any of these newer animal 
outbreaks outside Asia.
    Several high-level meetings of European Ministries of Health and 
Agriculture have been held to discuss the avian influenza threat and 
consider the best preventive and control measures. These meetings have 
led to the development or refinement, with WHO assistance, of pandemic 
response plans in the vast majority of European countries.
    Europe has areas with dense poultry populations and has experienced 
outbreaks of highly pathogenic avian influenza in recent years, though 
caused by influenza viruses other than H5N1. While the further 
evolution of poultry outbreaks caused by H5N1 in Europe cannot be 
predicted, prompt detection of outbreaks and the rapid introduction of 
control measures will hopefully prevent the virus from establishing 
endemicity outside its present epicentre in Southeast Asia. Differences 
in farming systems between Western Europe and Asia, and the greater 
availability of resources in Europe, should give established control 
measures a greater chance of success. Many European countries do, 
however, have rural areas where poultry flocks are kept in close 
contact with households, and these areas could pose a heightened risk 
of human cases should outbreaks in poultry become established.

                      VACCINES AND ANTIVIRAL DRUGS

    Vaccines and antiviral drugs are the most important medical 
interventions for reducing morbidity and mortality during a pandemic. 
Vaccines are the most important intervention for conferring 
populationwide protection, but vaccine effectiveness requires a close 
match with the actual pandemic strain of the virus. Because a pandemic 
strain, capable of efficient and sustained human-to-human transmission, 
does not yet exist, the specific pandemic vaccine does not yet exist 
either. As no country will have adequate vaccines at the start of a 
pandemic, antiviral drugs assume particular importance as the only 
possible medical intervention for protecting priority groups pending 
the arrival of vaccines. Antiviral drugs might also be used to contain 
or delay the spread of a pandemic at its source. For both vaccines and 
antiviral drugs, present constraints--which are considerable--mean that 
most developing countries will have no, or very limited, access to 
either throughout the course of a pandemic.
Vaccines
    Vaccines are considered the first line of defence during a 
pandemic. For several reasons, no country will have adequate supplies 
of vaccine at the start of a pandemic and for many months thereafter. 
Large-scale commercial vaccine production of a pandemic vaccine is not 
expected to commence until about 3 to 6 months following the emergence 
and characterization of a pandemic virus.
    Manufacturing capacity for influenza vaccines is overwhelmingly 
concentrated in Europe and North America. Current production capacity--
estimated at around 300 million doses of trivalent seasonal vaccine per 
year--falls far below the demand that will arise during a pandemic.
    WHO, through its network of specialized influenza laboratories, has 
constantly monitored the evolution of seasonal viruses and also of the 
H5N1 virus since its initial infection of humans in 1997. These 
laboratories prepare the prototype virus strain that is being provided 
to industry as the ``seed'' for vaccine development. Constant molecular 
analyses of viruses, conducted by these laboratories, help ensure that 
this ``seed'' strain continues to closely match the genetic 
characteristics of currently circulating viruses. This activity is 
particularly important in view of mutations in the H5N1 virus detected 
during 2005.
    At present, around 80 percent of vaccine manufacturing capacity is 
concentrated in Europe and North America. Just under 20 countries have 
domestic manufacturers producing influenza vaccines for the seasonal 
influenza viruses; several of the largest of these companies are 
presently working on the development of a pandemic vaccine. Some of 
these development projects have reached the stage of clinical trials; 
clinical trials of other candidate vaccines are expected to begin 
shortly. In early November 2005, WHO convened a meeting of influenza 
vaccine manufacturers to assess progress in the development of a 
pandemic vaccine and to conduct an inventory of global manufacturing 
capacity, particularly in developing countries. While overall capacity 
looks somewhat more encouraging than 1 year ago, if a pandemic were to 
begin within the next few months, no company would be ready to move 
immediately into commercial production of a pandemic vaccine. Several 
companies have plans to expand production capacity, but these plans 
will not be realized for at least another 2 to 3 years.
    At present, little knowledge exists to guide formulation of an 
influenza vaccine that is both effective and economizes on the use of 
antigen--the component of the vaccine that elicits the immune response. 
Clinical trials are under way to test different formulations, and these 
trials will provide some answers. WHO has encouraged companies to test 
vaccine formulations that include an adjuvant. This substance boosts 
the immune response, and theoretically could allow adequate protection 
at lower quantities of antigen. Work on this approach is also under 
way.
    As a pandemic vaccine needs to be a close match to the actual 
pandemic virus, commercial production cannot begin prior to emergence 
and characterization of the pandemic virus. WHO has, however, 
encouraged industry and regulatory authorities to develop fast-track 
procedures for licensing and marketing authorization of a pandemic 
vaccine, and this has been done.
    WHO is using international meetings to urge the international 
community to find ways to increase manufacturing capacity and ensure 
that developing countries have access to an effective vaccine at an 
affordable price. As another strategy, WHO has provided direct 
assistance to some developing countries engaged in work on a pandemic 
vaccine. On current trends, however, most developing countries will 
have no access to a vaccine during the first wave of a pandemic and 
perhaps throughout its duration.
Antiviral drugs
    Pending the availability of vaccines, several antiviral drugs are 
expected to be useful for prophylaxis (prevention of illness) or 
treatment purposes. Two drugs (in the neuraminidase inhibitors class), 
oseltamivir (commercially known as Tamiflu) and zanamivir (commercially 
known as Relenza), have been shown, in laboratory studies, to reduce 
the severity and duration of illness caused by seasonal influenza. The 
efficacy of the neuraminidase inhibitors depends on their 
administration within 48 hours after symptom onset. For cases of human 
infection with H5N1, the drugs may reduce the severity of disease and 
improve prospects of survival, if administered early, but clinical data 
are limited. The H5N1 virus is expected to be susceptible to the 
neuraminidase inhibitors.
    Another class of antiviral drugs, the M2 inhibitors amantadine and 
rimantadine, could potentially be used against pandemic influenza, but 
resistance to these drugs may develop rapidly and this could 
significantly limit their effectiveness. Some currently circulating 
avian H5N1 strains are fully resistant to the M2 inhibitors, while 
others remain fully susceptible.
    For the neuraminidase inhibitors, the main constraints--which are 
substantial--involve limited production capacity and a price that is 
prohibitively high for many countries. Because of the complex and time-
consuming manufacturing process, the sole manufacturer of oseltamivir 
is unable, fully, to meet demand and faces a backlog of orders. At 
present manufacturing capacity, which has recently quadrupled, it will 
take a decade to produce enough oseltamivir to treat 20 percent of the 
world's population.
    The complex manufacturing process also makes it difficult to 
transfer production technology to other facilities. Nonetheless, 
strategies for doing so are being explored as a matter of urgency, and 
particular attention is being given to the option of manufacturing 
oseltamivir in developing countries.
    Since supplies are severely constrained, countries now stockpiling 
antiviral drugs need to decide in advance, on priority groups for 
administration, particularly for prophylactic purposes. Frontline 
health care workers would be an obvious first choice, but such 
decisions are the responsibility of governments. While antiviral drugs 
can confer some measure of protection pending the availability of 
vaccines, these drugs should not be used to perform the same public 
health function as vaccines--even if supplies would permit. The mass 
administration, for prophylactic purposes, of antiviral drugs to large 
numbers of healthy people for extended periods is not recommended, as 
this could accelerate the development of drug resistance.
    Following a donation by industry, WHO will have a dedicated 
stockpile of antiviral drugs (oseltamivir), sufficient for 3 million 
treatment courses, by early 2006. These drugs are strictly reserved for 
use in the first areas affected by an emerging pandemic virus. Recent 
studies, based on mathematical modeling, suggest that these drugs could 
be used prophylactically near the start of sustained human-to-human 
transmission to reduce the risk that a fully transmissible pandemic 
virus will emerge or at least to delay its international spread, thus 
gaining time to augment vaccine supplies. The drugs will be stored 
centrally; WHO has considerable experience in the rapid dispatch of 
medical supplies during emergencies.
    The success of this strategy, which has never been tested, depends 
on several assumptions about the early behaviour of a pandemic virus, 
which cannot be known in advance. Success also depends on excellent 
surveillance and logistics capacity in the initially affected areas, 
combined with an ability to enforce movement restrictions in and out of 
the affected area. To increase the likelihood that early intervention 
using the WHO rapid-intervention stockpile of antiviral drugs will be 
successful, surveillance in affected countries needs to improve, 
particularly concerning the capacity to detect clusters of cases 
closely related in time and place.
    Should the virus behave in ways that preclude rapid intervention to 
contain a pandemic or delay its spread, drugs in the stockpile will be 
used to provide treatment in the initially affected countries.

              URGENT ACTIVITIES IN AN EMERGENCY SITUATION

    The seriousness of the present threat to international public 
health calls for emergency actions calculated to provide the greatest 
level of protection as quickly as possible. The most reliable and 
predictable way immediately to improve the world's defences is to build 
on existing structures and mechanisms that have worked well in similar 
emergencies.
    No health emergency on the scale of a severe influenza pandemic has 
confronted the international community for several decades. At the same 
time, however, WHO and its international partners have acquired 
considerable experience in responding to outbreaks of new and epidemic-
prone diseases that have occurred, in unprecedented numbers, in recent 
years. Each outbreak presents a unique set of problems that have to be 
solved, innovatively and quickly, under emergency conditions. Each 
outbreak response has left WHO and its partners with more experience 
and more technical innovations to draw on when crafting a response plan 
for the next unique event. These experiences, and the existing 
mechanisms that sustain them, can be immediately adapted to provide a 
strengthened response near the start of a pandemic. WHO now has a 
flexible fund of operational options to draw on, and these are backed 
by standardized protocols for outbreak investigation and standard 
operating procedures as well as by considerable experience under a 
variety of country settings.
    The type of support that can be provided by WHO and its 
institutional partners in the Global Outbreak Alert and Response 
Network (GOARN) will probably be most decisive in the first countries 
experiencing evidence of efficient human-to-human transmission.
    For almost 2 years, several Asian nations have undertaken resource-
intensive activities in the interest of protecting the international 
community from an unpredictable, yet potentially catastrophic event. 
These activities have been undertaken despite low national budgets for 
health care and the presence of many other high-priority diseases. Many 
of these activities, specific to the control of avian influenza and 
prevention of another pandemic, must now be given full international 
support. Only through such support will the international community 
receive the data needed for a reliable risk assessment which, in turn, 
guides many interventions in line with the WHO phases of pandemic 
alert. If this support is not provided, triggers for scaling up 
activities will be missed and the world may, once again, be taken by 
surprise when a pandemic virus emerges.

           WHO RECOMMENDATIONS FOR INTERNATIONAL PREPAREDNESS

    WHO has issued a number of documents to assist countries, at 
various levels of development, in preparing their strategies and 
detailed responses to pandemic influenza. These technical and strategic 
documents are available on the WHO Web site (www.who.int). Last week, 
WHO launched a new Web site devoted to assessment of the influenza 
pandemic threat. (http://www.who.int/csr/disease/avian_influenza/
pandemic/en/index.html)
    For the international community, WHO stresses four main priority 
actions for the prepandemic and early pandemic phases:

--Accelerate vaccine development and vastly expand capacity. Improving 
    the ability of the world to vaccinate large numbers of people in a 
    timely manner is the single greatest challenge facing the 
    international community as it considers how to respond to an 
    influenza pandemic.
--Strengthen the early warning system. The capacity of the 
    international community to move forward decisively, and to invest 
    its resources wisely, depends on understanding what is happening 
    with the H5N1 virus in both animals and humans in all affected 
    countries. Surveillance in affected and high-risk countries needs 
    to improve. Each human case needs to be investigated, and viruses 
    must be shared internationally with WHO network laboratories.
--Intensify containment operations. A rapid response to each human 
    case, involving contact tracing and monitoring and prophylactic 
    administration of antiviral drugs, can minimize the risk of onward 
    transmission and thus reduce opportunities for the virus to improve 
    its transmissibility. Proper infection control in hospitals 
    treating patients is equally important. WHO will use its 
    international stockpile to intervene rapidly following the first 
    signs that the virus is improving its transmissibility. If 
    quantities suffice, drugs from this stockpile will also be used to 
    provide treatment in the initially affected areas and to protect 
    frontline workers.
--Build capacity to cope with a pandemic. Once a pandemic virus has 
    begun to spread internationally, the focus must shift to reducing 
    morbidity and mortality. All countries must have preparedness 
    plans, and WHO must be fully equipped to perform its 
    constitutionally mandated leadership role during a public health 
    emergency.

                           LESSONS FROM SARS

    The international outbreak of severe acute respiratory syndrome 
(SARS) was a watershed event. It revealed how much the world has 
changed in terms of the impact that outbreaks of a severe new disease 
can have in a highly mobile and closely interconnected world. During a 
fortunately brief stay in its new human host, the SARS virus traveled 
rapidly along the routes of international air travel to infect more 
than 8,000 people in about 30 countries. Of these people, SARS killed 
just under 800.
    The SARS experience was remarkable in several ways. It caused 
enormous economic damage and social disruption in areas far beyond the 
outbreak sites. The previous estimates of the economic costs of that 
outbreak, US$30 billion, are now considered conservative. The SARS 
experience showed that decisive national and international action, 
taking full advantage of modern communication tools, could prevent a 
new disease from establishing endemicity. It raised the profile of 
public health and appreciation of the importance of international 
cooperation in health to new heights.
    SARS primed politicians to understand both the far-reaching 
consequences of outbreaks and the need to make rapid containment a high 
priority. SARS also stimulated efforts to find ways to make the impact 
of the next international outbreak less dramatic.
    Many--but not all--of these lessons are useful as the world braces 
itself against the prospect of another human influenza pandemic. The 
unprecedented scientific and medical collaboration that characterized 
the SARS outbreak, with leading experts openly sharing their latest 
findings, can also be expected to help the world understand a new 
pandemic virus quickly and translate this new knowledge rapidly into 
practical advice for control. The threat posed by the H5N1 virus has 
already attracted political attention at the highest levels, including 
the launch of the U.S.-initiated International Partnership for Avian 
and Pandemic Influenza. This is valuable to advance necessary 
prevention and preparedness activities worldwide at national, regional, 
and global levels.
    Unlike SARS, however, pandemic influenza is considered unstoppable 
once international spread is fully under way. The classic public health 
interventions--screening, early detection of cases, and tracing and 
followup of contacts--that proved decisive in containing SARS will not 
be sufficient to interrupt the transmission of a pandemic influenza 
virus. Because influenza virus can be transmitted prior to the onset of 
symptoms, programmes to screen for symptoms will not detect all 
carriers. The very short incubation period leaves too little time to 
conduct contact tracing. Each influenza patient can be expected to 
transmit the virus to another person within 2 days; the number of cases 
will grow exponentially. Moreover, influenza spreads easily through the 
air via coughing or sneezing; SARS transmission required close face-to-
face contact with a patient.
    One important lesson from SARS is paramount: The importance of 
real-time monitoring of the evolving situation, supported by advice 
from the world's best experts, and immediate communication of 
information. The effectiveness of nonpharmaceutical measures for 
control will depend on the characteristics of the pandemic virus 
(attack rate, virulence, principal age groups affected, patterns of 
spread within and between countries), and these cannot be known in 
advance. After a pandemic is declared, WHO will monitor its evolution 
in real time and issue updated advice accordingly. Recommendations 
about the most effective control measures will therefore become more 
precise as the epidemiological potential of the virus unfolds. Virtual 
networks of experts will advise WHO on such issues as projected 
patterns of spread, modes of transmission, laboratory diagnosis, and 
clinical management of patients, and this information will be 
communicated immediately. All experts hope that use of good risk 
communications practices at every level and an informed public will 
facilitate the smooth implementation of control measures, while also 
reducing some of the social and economic disruption that make pandemics 
such dreaded events.
    WHO will continue to work with its 192 Member States and other 
international organizations on an ongoing basis to assess the threat of 
pandemic influenza and to help improve preparedness and response to 
mitigate the consequences of a pandemic.
                                 ______
                                 

   Prepared Statement of Hon. Russell D. Feingold, U.S. Senator From 
                               Wisconsin

    I thank the chairman for holding this hearing today. I am concerned 
about America's preparedness for a global pandemic, and I am even more 
concerned about the global response to an influenza pandemic.
    As we all well know, migratory birds are steadily carrying the 
avian flu virus from throughout Southeast Asia and Siberia, to Romania, 
Turkey, and now Greece. International health officials predicted that 
this spread could happen, and it no surprise that this disease is 
taking this course. In the 20th century alone, three influenza 
pandemics swept throughout the world, most notably the 1918 flu 
pandemic, which took 500,000 American lives, and an estimated 20 to 50 
million people worldwide. Our knowledge of disease and hygiene has 
improved dramatically since then, and our ability to ready ourselves 
has subsequently advanced, but our risk for a pandemic remains a 
danger.
    Scientists and public health officials throughout the world have 
warned that a flu pandemic will take place, have alerted governments to 
the possibility of pandemic through the avian flu, and have watched as 
little has been done to prepare for the occurrence. Despite the 
warnings of the inevitability of pandemic, research into influenza 
vaccine and therapy has been continually underfunded, as have our 
programs that would provide emergency health care relief in a time of 
crisis, Hurricane Katrina illustrated our lack of preparedness for a 
true disaster, and the government's failure to quickly bring relief to 
our friends along the gulf coast should send a resounding message that 
we must better prepare for an emergency in the future. That emergency 
may very well be the avian flu pandemic. Let us not be caught unaware. 
While there is no guarantee that this will occur this winter, next 
winter, or even the year after that, we know that it is only a matter 
of time, and we should use that time to build our stockpiles of 
vaccines and medicines, and to support global initiatives to help 
prevent the spread of the disease through containment strategies and 
alerts.
    I am pleased that I was able to join many of my colleagues in 
sending a letter to President Bush on October 4, 2005, that urged the 
administration to release a finalized Pandemic Influenza Response and 
Preparedness Plan, which the World Health Organization has deemed 
essential to planning a strategy in the case of a global pandemic. I am 
glad the President released this plan, but I also have many questions 
regarding the strategies and responses.
    I look forward to hearing from our witnesses about the President's 
plan, about the next steps that the administration will be taking to 
help develop and stockpile vaccines, and what is being done to protect 
our country and the rest of the world through surveillance and 
containment.
                                 ______
                                 

 Prepared Statement of Hon. Barbara Boxer, U.S. Senator From California

    Mr. Chairman, thank you for holding this hearing today. This is an 
extremely important issue because if we do not focus on the avian flu, 
the results could be devastating. The avian flu is the most lethal flu 
the world has encountered--killing 55 percent of the people who are 
infected.
    In the last 4 years, this Nation has been unprepared for terrorist 
attacks and natural disasters. And, now, we are unprepared for an 
epidemic.
    Health and Human Services Secretary, Michael Leavitt, has said, 
``The world is woefully unprepared.''
    I agree. We should have been developing a vaccine. We should have a 
plan in place to contain the disease before it spreads around the 
world. We should have enough of the antiviral treatment stockpiled to 
save millions from the avian flu. But, we don't.
    Since this is the Foreign Relations Committee, today's hearing will 
focus on the international aspect of this issue. We will hear what the 
international community needs in order to stop the avian flu. We will 
hear about what we should be doing in the United States to help other 
countries.
    If it is not stopped abroad, the avian flu will make it to the 
United States. And, we must have a plan. That is why I was pleased the 
Senate passed my amendment requiring the administration to implement 
procedures for U.S. airports and air carriers to deal with suspected 
cases of the virus.
    Specifically, the Transportation Secretary, in consultation with 
the Secretary of Health and Human Services (HSS) and the Administrator 
of the Federal Aviation Administration, would be required to develop a 
plan for airports and air carriers in case a passenger on a flight from 
a country that has cases of avian flu shows symptoms of the disease. 
These standard operating procedures would help ensure that airports and 
air carriers know how to respond appropriately to minimize the spread 
of the virus.
    We know that avian flu poses a huge public health threat to our 
country. By establishing clear guidelines for airports and airlines, my 
amendment will help ensure that our country responds quickly and 
appropriately to prevent the spread of the deadly avian flu virus.
    I hope, Mr. Chairman, it doesn't come to that. And, I hope we will 
get some insights today about what we can do to stop it now.
                                 ______
                                 

 Responses of Panel I Witnesses from the State Department to Questions 
               Submitted by Senator Joseph R. Biden, Jr.

    Question. Recent statistical modeling studies hold out the hope 
that an initial outbreak of human-transmissible H5N1 could be stemmed. 
The assumptions underlying that conclusion are daunting, however. Aside 
from assumptions regarding characteristics of the virus itself, they 
include: Location of the outbreak in a rural area or small town, so 
that it does not immediately spread great distances; identification of 
the outbreak within a few weeks, before more than some tens of people 
have become infected; immediate medical intervention with Tamiflu or a 
similar medication, both to treat victims and as a prophylactic for 
tens of thousands of people; and restriction of population movements so 
as to limit the spread of the disease. Will the President's funding 
request for fiscal year 2006 provide other countries and international 
organizations the ability to meet those modeling assumptions regarding 
both the speed of identification and the speed and extent of social and 
medical intervention? If not, how short of that objective will it leave 
us and how many years (and/or how much other outside assistance) will 
be needed to achieve that objective?

    Answer. As was noted in the statement prefacing your question, the 
assumptions are daunting. There is no doubt that the President's 
funding request for fiscal year 2006 will greatly enhance the speed of 
identification efforts and the speed and extent of social and medical 
intervention. However, it must be noted that the administration's 2006 
funding request is the U.S. Government's initial effort to jumpstart 
and support an ongoing preparedness process in coordination with the 
activities of other multilateral, bilateral, and private sector donors. 
The reality of the threat of pandemic influenza is that it is too large 
for any one country to address, and requires a comprehensive and 
coordinated response from the international community. In addition to 
supporting the World Health Organization and the Food and Agriculture 
Organization as key international authorities in human and animal 
health respectively, USAID and HHS are working closely with the 
Department of State to support the International Partnership for Avian 
and Pandemic Influenza. CDC experts have been seconded to WHO to assist 
in developing a containment strategy. WHO has consulted with Asian 
experts and will hold a meeting in March to finalize its plan for 
adoption by the World Health Assembly in May. Experts will then work 
with nations to adapt their national plans and develop their capacities 
to implement the strategy. U.S. assistance funds will support this 
effort.
    Increasing human population numbers and emerging and re-emerging 
diseases will continue to create conditions ripe for new pandemics, and 
U.S. support for enhancing the capacity of countries to respond to 
emerging infectious disease threats such as the one posed by avian 
influenza will require time, effort, dedicated work, funding, and close 
collaboration with the international community.

    Question. Dr. Margaret Chan of the World Health Organization (WHO) 
warns that disease surveillance in Southeast Asia ``is impeded by weak 
laboratory support and the complexity and high costs of testing.'' She 
adds: ``In Vietnam, detection of human cases has often been the first 
signal that outbreaks in poultry were occurring in a given area. In 
Cambodia, all human cases were detected only after patients crossed the 
border for medical care in Vietnam.'' What can be done, and what will 
be done, to improve dramatically and quickly the animal and human 
disease surveillance capabilities in Vietnam, Cambodia, and Laos?

    Answer. International sharing of disease surveillance information 
and laboratory resources or support is specifically called for in the 
International Coordination Support Annex of the Homeland Security 
Department's December 2004 National Response Plan. It is a part of the 
draft National Implementation Plan.
    The Department of Health and Human Services (HHS) has been pursuing 
a policy of developing and supporting active and aggressive 
international detection and investigation capability. Activities are 
supported with ongoing funds and have been greatly enhanced with the 
addition of $15 million in emergency supplemental funding in FY 2005. 
HHS is providing bilateral support to the Ministries of Health in 12 
countries for the development of influenza surveillance networks. These 
networks will enhance the capacity to detect influenza in people, 
including avian influenza.
    One focus for HHS is to assist the development of regional capacity 
in Southeast Asia in epidemiology and laboratory surveillance of 
influenza. This includes developing and teaching an avian influenza 
curriculum to epidemiologists and laboratorians. Through its Center for 
Disease Control and Prevention (CDC), HHS also conducts training for 
public health leaders to develop a national network of public health 
field staff, and allied health personnel for detecting and reporting 
human cases of influenza.
    HHS is also working with the World Health Organization (WHO) and 
countries' Ministries of Health to increase population awareness about 
the human health risks associated with pandemic influenza, and to 
advise affected countries concerning prevention or mitigation measures 
that can be used in the event a pandemic occurs. Methods to increase 
public awareness include broadcasting radio messages and training local 
physicians, healthcare workers, and community public health leaders.
    To assist in international containment activities, HHS is working 
to develop, train, and equip rapid field response teams to be deployed 
in the event of a pandemic influenza outbreak. These teams will be 
trained to undertake emergency field epidemiology studies, collect 
samples for shipment to laboratories, and institute emergency control 
measures, such as quarantine and isolation, in a standardized manner.
    In support of these activities, HHS staff have been assigned to 
Vietnam, Cambodia, and Laos to facilitate improvements in the detection 
of influenza cases. These senior-level staff will be providing 
technical assistance on how to investigate cases as well as assisting 
in the development of a national preparedness plan by the Ministry of 
Health, with the support of WHO and other partners.
    HHS's FY 2005 emergency supplemental funding also provides 
laboratory support for outbreak investigations. Activities include 
testing clinical samples and influenza isolates shipped to HHS by 
affected countries, diagnosing the presence of avian influenza viruses 
in humans by supplying necessary test reagents to the affected region 
and globally, and developing vaccine seed stock to produce and test 
pandemic vaccine candidates. Additional laboratory work will be 
conducted at HHS on samples and isolates sent from Southeast Asia. HHS 
is also a WHO Influenza Collaborating Center and conducts routine 
worldwide monitoring of influenza viruses.
    Of the $10 million allocated to USAID for avian influenza in the 
Tsunami Relief Act supplemental, over 39 percent is supporting 
activities to increase both human and animal disease surveillance 
primarily in Cambodia, Laos, and Vietnam. This assistance supports a 
variety of activities to enhance timely detection and confirmation of 
outbreaks.
    USAID has provided funding to the Food and Agriculture Organization 
(FAO) and has funded technical assistance from USDA to strengthen 
active surveillance of avian influenza infections in animals by 
training national veterinary staff and providing financial, technical, 
and commodity support to monitor disease in domestic and wild birds. To 
further increase the timely reporting of new outbreaks, funds are 
supporting the creation of a grassroots early-warning system comprised 
of local and international NGOs with established in-country presence. 
Support also is being provided to enhance national and regional 
capacities to collect, ship, and analyze animal samples for rapid and 
accurate laboratory confirmation. In some regions USAID is programming 
funds for upgrading veterinary laboratories with the latest diagnostic 
equipment and training to enable them to better diagnose the specific 
type of virus in a timely manner.
    To enhance surveillance for AI infection in humans, USAID is 
working with HHS/CDC to mobilize staff and technical support resources 
in the region to work closely with Ministries of Health to strengthen 
national surveillance systems. USAID assistance will provide for 
deployment of specialized technical assistance, training, and equipment 
to increase the capacity of national public health staff to detect new 
infections and ensure timely and accurate laboratory diagnosis and 
confirmation. USAID has provided support to the WHO to further enhance 
human surveillance and diagnostic capacity in the region. Finally, 
USAID and HHS have long supported the development of CDC's Field 
Epidemiology Training Programs (FETPs) which build the epidemiological 
capacity needed to conduct field investigations and establish the 
surveillance systems needed to detect and track new viruses such as 
avian influenza. This investment is paying off by supplying the human 
capacity needed for improved national surveillance systems in the 
affected areas.

    Question. Ms. Garrett cited in her written statement the need for 
``a rapid saliva-based dipstick assay specific for H5N1'' that would be 
affordable in developing countries. How feasible is this, how long 
would it take to develop it, what would be the cost, and what U.S. 
agency could best oversee the effort?

    Answer. According to CDC, currently, H5N1 virus infection is best 
detected by testing respiratory specimens by reverse transcriptase 
polymerise chain reaction which takes 4 hours, or by isolation of H5N1 
viruses in appropriate laboratory settings. Rapid diagnostic tests are 
available to test respiratory specimens, but have poor accuracy and are 
not specific for H5N1 viruses. A rapid test that is accurate and 
specific for H5N1 and inexpensive would be very useful for use in 
developing countries. Based on the current state of scientific 
knowledge, it is not likely that an acceptably rapid, accurate, 
specific, and inexpensive saliva-based test for detection of H5N1 
viruses or H5N1 antibodies can be developed.
    According to USAID, other types of rapid screening tests for 
detection of influenza viruses in animals are available and can be used 
under field conditions in developing countries, but the validity and 
sensitivity of these tests has not been determined. In addition, such 
tests only indicate whether the influenza virus is present and are not 
sensitive enough to provide conclusive evidence of the H5N1 subtype, 
which currently requires testing in an advanced laboratory with access 
to sophisticated equipment and supplies not available in many areas 
likely to be affected by avian influenza outbreaks.
    A number of private companies are developing other types of rapid 
avian influenza diagnostic tests. Rockeby Biomed, a Singapore-based 
biotechnology company, developed an avian virus antigen detection test 
for diagnosing avian influenza in birds and humans. Results are 
obtained in 10 minutes, and the test has been approved for use in 
Thailand, Malaysia, and Brunei even though field validation tests have 
not been conducted. The cost for this test ranges from $6 for birds up 
to $12 for human diagnostics. Penn State has developed a prototype and 
applied for a patent on a rapid diagnostic called the ``dot-ELISA.'' 
This test is being promoted as a rapid diagnostic test that can 
inexpensively detect all subtypes of avian influenza virus--one test 
costs approximately 50 cents. However, because the test is based on 
detecting a specific monoclonal antibody, the test won't work if the 
current H5N1 virus mutates or reassorts, as we believe it will.
    It will only be a matter of time before a reliable rapid-test 
technology is developed by the private sector, but ensuring that such a 
technology is affordable and can be produced for use in developing 
countries without public sector involvement is a key concern.
    With adequate support, a simple rapid test could be developed for 
epidemiological applications to detect H5N1 antibodies post-infection 
in humans or animals in a year or less. In order to detect H5N1 in 
birds or humans while they are still sick, however, a test would need 
to detect the virus directly. A relatively rapid field test for the 
virus is feasible with known core technologies, but some additional 
advanced techniques such as Polymerase Chain Reaction-on-a-strip may be 
needed. Such antigen tests would require some hand-held 
instrumentation. Several tests under development for other diseases 
probably could be adapted for this purpose. An accelerated development 
program, conducted synergistically with these other development 
projects and with facilitated access to screening panels, might 
reasonably achieve a functional test in 18 months.

    Question. Dr. Chan states that avian flu ``is now considered 
endemic in Indonesia,'' in parts of Cambodia, China, and Thailand, and 
possibly in Laos. Assuming the level of effort reflected by the 
President's request for FY 2006, how long will it take before H5N1 is 
no longer endemic in those areas? Or is achieving that objective simply 
not feasible?

    Answer. According to HHS and USAID, the current poultry outbreaks 
of highly pathogenic avian influenza A (H5N1), which began in Southeast 
Asia in mid-2003, are the largest and most severe on record. Many 
countries have been affected simultaneously, and the loss of millions 
of birds has resulted in serious economic disruptions. The causative 
agent, the H5N1 virus, has proved to be especially tenacious. Despite 
the death or destruction of an estimated 150 million birds, the virus 
is now considered endemic in many parts of Southeast Asia, and control 
of the disease in poultry is expected to take years. It is probably not 
possible to eradicate H5N1 viruses from poultry and wild birds in Asia. 
The goal should be toward control and reduction of H5N1 viruses among 
birds and poultry populations, but not eradication.
    Our approach is to quickly detect the virus in birds and contain it 
by quickly culling infected animals and vaccinating exposed animals. 
Some countries such as Indonesia and Vietnam use a combined approach of 
both culling and vaccination to reduce the chance of the virus passing 
to humans. We also support surveillance systems that monitor ducks, 
pigs, and other animals sold in live-animal markets in Southeast Asia.
    In addition, improving animal handling practices is essential to 
address the root causes of disease transmission between animals and 
from animals to humans. USAID will work at the community level by 
educating commercial and backyard farmers and work to create 
incentives--such as replacements for culled animals--to identify and 
report cases quickly. A comprehensive approach also includes conducting 
communications campaigns and training to ensure use of best practices 
for poultry producers, transporters, processors, and retailers; and 
building national and local capacity to provide animal health services 
that support effective detection, diagnostics, and containment.
    This is important to address the current outbreak and to develop 
long-term animal health and management capacities in these countries to 
better prepare them against future threats. USAID has proposed the 
development of a National Poultry Sector Action Plan bringing together 
key players in each national government to identify clear 
organizational responsibilities and a chain of command for 
implementation of the above activities. In addition, USAID, in concert 
with other U.S. Government agencies, is coordinating its activities 
closely with a wide variety of players in the international community, 
including other donors, multilaterals, environmental and veterinary 
organizations, and private sector organizations to ensure a 
comprehensive response that will stem the spread of H5N1.

    Question. Dr. Chan states that ``most developing countries will 
have no access to a vaccine during the first wave of a pandemic and 
perhaps throughout its duration.'' That leaves the world dependent upon 
antiviral medicines that have to be given within 48 hours of a person 
becoming symptomatic. Is the WHO capable of providing that instant 
response, or will it be dependent upon U.S. logistics and/or medical 
personnel?

    Answer. According to USAID, given the limited availability of 
antivirals, it is unlikely that during a pandemic most developing 
countries will have large quantities of antiviral medications. 
Widespread use of these medicines using internal stockpiles will not be 
possible. Countries will need to determine which key people (e.g., 
health staff, first responders) will receive the limited quantities. So 
far, all discussions of international stockpiles of antiviral 
medications have focused on containing an outbreak of AI that is 
spreading from human to human before it becomes a pandemic.
    CDC notes that it is important to distinguish the difference 
between the use of antiviral medications for treatment of influenza and 
their use for the control of an epidemic. The 48-hour timeframe is 
relevant in terms of the effectiveness of treatment for individuals who 
have contracted influenza. This type of clinical treatment with 
antivirals would be undertaken within the context of national 
healthcare systems. However, there is also an important use for 
antivirals in the control of an epidemic. WHO along with CDC and all of 
our international partners, are working together to establish systems 
that would enable us to detect the earliest possible signal of person-
to-person spread of H5N1 and other strains of influenza. At the point 
that such person-to-person transmission is identified, a rapid public 
health response would be initiated. Such a response would require 
deployment of personnel, appropriate protective equipment, an effective 
communications plan, and a stockpile of antiviral medications. The goal 
of the response would be to undertake ring containment of the emerging 
epidemic through isolation and treatment of affected individuals, and 
prophylactic treatment of contacts and others within a defined radius. 
This type of ring containment, if implemented within 2 to 3 weeks after 
person-to-person spread has begun, may slow an epidemic in the early 
stages. To achieve success in this type of unique endeavor, WHO, CDC, 
other international organizations and Health Ministries across the 
world are working closely together as was the case with smallpox 
eradication and SARS, and is the case in the ongoing efforts to 
eradicate polio. The critical factor in determining our success is open 
and transparent processes for identifying and reporting human-to-human 
transmission of these diseases, and rapid deployment of the appropriate 
response tools.
    The U.S. Government is now considering how to participate in 
international efforts to stockpile antiviral medications, and has 
already allocated funding to support the stockpiling of associated 
medical supplies and personal protective equipment under international 
auspices.

    Question. What is being done to prepare for the spread of H5N1 to 
sub-Saharan Africa, which has even fewer public health resources than 
Southeast Asia and larger HIV-positive populations?

    Answer. According to CDC, while the current focus of the H5N1 
outbreak is in Asia, it is agreed that avian influenza is a global 
problem. CDC has developed an extensive network with Ministries of 
Health and other partners in Southeast Asia for H5N1 activities. We 
recognize that other areas are also particularly vulnerable. According 
to UNAIDS, Sub-Saharan Africa (SSA), for instance, is home to nearly 26 
million people living with HIV--this represents nearly 60 percent of 
the global epidemic. In many SSA countries, prevalence of HIV is very 
high. The prevalence among pregnant women in South Africa was nearly 30 
percent in 2004, and an estimated 1.5 million people were living with 
HIV in Ethiopia. Persons with immunocompromised states like late-stage 
HIV infection may not only suffer magnified effects from influenza 
infection negatively impacting their HIV infection, but also 
potentially shed influenza virus longer, theoretically increasing the 
risk of transmission. Thus, effective immunization practices for the 
HIV seropositive persons would need to be considered.
    In terms of expanding into other areas, CDC has a close working 
relationship with portions of the Department of Defense, in particular 
with the Naval Medical Research Unit (NAMRU). CDC provides funding for, 
and collaborates with, NAMRU3 in Cairo, Egypt, to support training and 
the expansion of influenza surveillance networks to countries where 
none exist. CDC's work with NAMRU3 includes the enhancement of the 
quality of surveillance in other countries to enhance outbreak 
detection, seroprevalence studies in populations at risk for avian 
influenza such as poultry workers, and enhanced outbreak response in 
the region.
    Furthermore, CDC has full-time staff in 43 countries, including 
countries in Africa. CDC is already working closely with our staff in 
all 43 countries to provide them with the latest information about the 
current situation, assess country preparedness, assist in the 
development of pandemic influenza plans, and provide policy and 
technical guidance as requested. In addition, previous investments, 
such as the establishment of International Emerging Infections Programs 
(IEIP) in Thailand and Kenya, provide the foundation for rapid response 
to an emerging pandemic. The IEIP program in Kenya is undertaking 
similar activities, and recently convened representatives from eight 
African countries to coordinate CDC efforts across Africa to detect the 
introduction of H5N1 into the continent. Finally, CDC has longstanding 
collaborative relationships with others working in the global arena, 
such as USAID, the DOD, WHO, and the World Bank, which can facilitate a 
coordinated and effective response to international needs. The staff, 
programs, and capabilities developed by CDC over several decades to 
address a broad range of global health challenges are well-positioned 
to play a critical role in responding to an influenza pandemic.
    In Africa where outbreaks in animal populations due to bird 
migration from affected countries in Europe and Asia are possible, 
USAID missions are providing assistance to host governments to assemble 
donors, establish task forces, and develop pandemic preparedness plans 
in cooperation with other U.S. Government agencies, FAO, and WHO. In 
addition, countries with USAID support are strengthening disease 
surveillance programs to include a strong focus on detecting, 
diagnosing, and responding to avian influenza.
    USAID has designated a person as point of contact for avian 
influenza in every mission and regional office and, through their 
efforts, has received assessments from 40 African countries detailing 
country activities, preparedness level, and potential roles of USAID. 
These assessments are being used in the planning and resource 
distribution process. In addition, some African countries, including 
Ethiopia, Uganda, Senegal, Tanzania, and Nigeria have provided detailed 
plans for avian influenza preparedness activities. Many countries are 
building upon existing SARS and influenza preparedness plans and task 
forces and focusing on strengthening existing surveillance and 
laboratory capacity.
    Tanzania and Ethiopia, for example, have moved ahead quickly to 
address the potential threat of avian influenza. USAID/Ethiopia has 
reallocated $600,000 to support surveillance and diagnostics for H5N1 
outbreaks in animal populations and to begin communications campaigns. 
The USAID mission in Tanzania has reallocated $75,000 of existing 
surveillance funds to focus on wild bird surveillance and has been 
asked to write the wild bird risk assessment section of the health 
sector National Preparedness Plan. The mission has also supported 
multisectoral work on avian influenza, including the convening of a 
multisector task force with participation of the Ministries of Health, 
Water and Livestock Development, and Natural Resources and Tourism.
    At USAID headquarters, the Bureau for Africa (AFR) has been engaged 
in activities to support and guide the work of missions and harmonize 
plans and activities with other USG agencies and partners. In October, 
AFR convened a conference call with the head of FAO and USAID missions 
and held a briefing for African Ambassadors to provide general 
technical information on avian influenza and discuss steps countries 
can take to prepare for the disease AFR has met with officials from the 
Africa Regional Office at the Department of State and technical experts 
from the U.S. Department of Agriculture to ensure collaboration and 
appropriate next steps for AFR missions in avian flu preparedness and 
surveillance.

    Question. If U.S. assistance is required, who will have the 
authority to order the immediate diversion of sufficient resources to 
meet this need? In light of our sluggish response to Hurricane Katrina 
and to the earthquake in Pakistan, what steps have been taken to assure 
that the United States will be there to help the WHO immediately when 
an avian flu crisis emerges?

    Answer. If there is a sustained outbreak of H5N1 in large 
population clusters overseas, the Department of State, as set forth in 
the International Coordination Support Annex of the National Response 
Plan, will coordinate the efforts of all USG departments and agencies 
and work with other international organizations and affected countries 
to address the outbreak.
    The FY06 budget for avian influenza includes $56 million for USAID 
to preposition, in close coordination with HHS, USDA, and the World 
Health Organization, supplies that can be mobilized at a short notice 
to contain outbreaks of H5N1. This stockpile, to be managed by USAID's 
Office of Foreign Disaster Assistance (OFDA), will contain key medical 
commodities that may include personal protective equipment, 
disinfectant, medicines (excluding Tamiflu), and materials and 
equipment for communications. This strategy is for a rapid response 
capacity that will enable the international community to control the 
disease as it develops into a more transmissible form.
    Additionally, the United States mobilized interagency teams to 
assess the avian flu situation. In mid-January a team of experts in 
animal and human health surveillance, laboratory capacity, and public 
health communication from DOS, USDA, USAID, and HHS went to Turkey, 
Azerbaijan, Georgia, Armenia, and Ukraine to meet with government 
officials and representatives of international organizations working 
locally on avian influenza. The Navy Medical Research Unit (NAMRU) and 
WHO teams are in Iraq meeting with government officials, investigating 
the outbreak and providing support.

    Question. In some past medical emergencies, multiple agencies and 
entities provided confusing and conflicting messages to the public. 
This happened in the anthrax attacks, which we in the Senate remember 
very well. How will you ensure that information provided to the public, 
next time, is clear and accurate? Who will be in charge of 
communicating with the American public?

    Answer. In the case of Incidents of National Significance, the 
Department of Homeland Security has the primary responsibility for 
coordinating communications to the public, as set forth in the Public 
Affairs Support Annex of the National Response Plan.
    In the current situation, HHS is fully engaged in pandemic flu 
planning, including aspects of communications. For communications 
during a potential pandemic influenza emergency, a formal plan has been 
developed and is in place. This plan commits HHS and its agencies to 
consistency and accuracy with messaging based on science and cleared 
through subject matter experts.
    Risk communication planning is critical to pandemic influenza 
preparedness and response. CDC is committed to the scientifically 
validated tenets of outbreak risk communication. It is vital that 
comprehensive information is shared across diverse audiences, tailored 
according to need, and is consistent, frank, transparent, and timely. 
In the event of an influenza pandemic, clinicians are likely to detect 
the first cases; therefore messaging in the prepandemic phase must 
include clinician education and discussions of risk factors linked to 
the likely sources of the outbreak. Given the likely surge in demand 
for health care, public communications must include instruction in 
assessing true emergencies, in providing essential home care for 
routine cases, and in basic infection control.
    CDC provides the healthcare and public health communities with 
timely notice of important trends and details necessary to support 
robust domestic surveillance. CDC also provides guidance for public 
messages through the news media, Internet sites, public forums, 
presentations, and responses to direct inquiries. This comprehensive 
risk-communication strategy can inform the nation about the medical, 
social, and economic implications of an influenza pandemic, including 
collaborations with the international community. USG agencies are 
working through the International Partnership on Avian and Pandemic 
Influenza, established by President Bush in September 2005, and with 
the WHO Secretariat to harmonize their risk-communication messages as 
much as possible with all international partners.

    Question. What is the administration's policy on the stockpiling 
and provision of Tamiflu for use by U.S. personnel or other American 
citizens overseas?

    Answer. U.S. embassies and consulates are actively engaged in 
outreach to all Americans abroad, to ensure they have accurate and 
timely information in order to make appropriate plans in light of their 
personal needs. This includes the holding of townhall meetings and use 
of the warden system to disseminate information quickly to all American 
citizens, as would be done in the event of an emergency.
    State Department physicians and medical staff have an obligation to 
treat only those official employees and their families, who are under 
Chief of Mission authority, and are participants in the International 
Cooperative Administrative Support Services (ICASS) system. The 
Department of State lacks the legal authority to provide any type of 
medication, including Tamiflu, to private American citizens. MED has 
already stockpiled Tamiflu for the USG Missions in Southeast Asia. 
Funding is available in the FY 2006 Department of Defense, Emergency 
Supplemental Appropriations to Address Hurricanes in the Gulf of 
Mexico, and Pandemic Influenza Act, 2006, for additional Tamiflu 
sufficient to provide global coverage for this population of USG 
employees and family members.
    Because of restrictions against the Department's ability to 
administer Tamiflu or any medication to private American citizens, and 
because Tamiflu may not be readily available overseas, the State 
Department has conducted an active outreach program to encourage 
American citizens traveling or living abroad to consult with private 
physicians about obtaining Tamiflu prior to travel, or to determine if 
Tamiflu is readily available in the country where they reside. In 
addition, the Department of State has asked its embassies and 
consulates to develop plans that take into consideration the 
possibility that travel into or out of a country may not be possible, 
safe or medically advisable.
    We have taken steps to inform American citizens traveling to, or 
living in, countries where avian influenza is prevalent to consider the 
potential risks and keep informed of the latest medical guidance and 
information in order to make appropriate plans. Specific CDC travel 
information relating to avian influenza, including preventive measures, 
is available at http://www.cdc.gov/flu/avian/index.htm. WHO guidance 
related to avian influenza is available at http://www.who.int/csr/
disease/avian_influenza/en/. Guidance on how private citizens can 
prepare for a ``stay in place'' response, including stockpiling food, 
water, and medical supplies, is available on the CDC and 
pandemicflu.gov Web sites.
    It is also likely that governments will respond to a pandemic by 
imposing public health measures that restrict domestic and 
international movement, further limiting the U.S. Government's ability 
to assist Americans in these countries. The vast majority of the known 
human cases have resulted from direct contact with poultry, and there 
is only limited evidence to suggest possible human-to-human 
transmission. However, the Centers for Disease Control and Prevention 
(CDC), the WHO, and the Department of State are nonetheless concerned 
about the potential for human-to-human transmission of this highly 
dangerous flu strain, and are working closely with other partners in an 
effort to monitor any potential outbreak.
    DOD is maintaining a stockpile for its Service members overseas for 
the purpose of force protection, as well as DOD dependents and other 
beneficiaries. However, medication from this stockpile will not be 
available for general use by private American citizens traveling 
abroad.

    Question. Who will be the senior public health official handling 
pandemic response? What powers will that official be given, and how 
will he or she rank by comparison with Cabinet officers and the 
relevant military commanders?

    Answer. The Secretary of HHS is the senior public health official 
responsible for the overall response to pandemic influenza and other 
public health and medical emergencies. The Secretary is a Cabinet 
officer and reports directly to the President. The Secretary determines 
the nature and scope of the HHS response, and may delegate to the 
Assistant Secretary for Public Health Emergency Preparedness (ASPHEP) 
the authority to coordinate and direct HHS-wide efforts with respect to 
preparedness for, and response to, public health and medical 
emergencies, including pandemic influenza preparedness and response 
activities. Under the Public Health Service Act, the ASPHEP is 
authorized to coordinate these activities on behalf of the Secretary 
and in conjunction with other Federal agencies and State and local 
entities.
    Under the National Response Plan the Department of State has 
overall responsibility for international coordination in support of the 
USG's response to pandemic influenza. HHS, domestically, under the 
National Response Plan is the primary Federal Agency responsible for 
public health and medical emergency planning, preparations, response, 
and recovery when one or more of the following apply:

   State, local, or tribal resources are insufficient to 
        address all of the public health needs.
   The resources of State, local, or tribal public health and/
        or medical authorities are overwhelmed and HHS assistance has 
        been requested by the appropriate authorities.
   The Federal Government has the lead responsibility under 
        public health authorities.
   A Federal department or agency acting under its own 
        authority has requested the assistance of HHS.

    In order to carry out its responsibilities for public health and 
medical emergencies, HHS relies primarily on authorities contained in 
the Public Health Service Act, the Federal Food, Drug and Cosmetic Act, 
the Stafford Act and the Social Security Act. For example, the Public 
Health Service Act authorizes the Secretary of HHS to:

   Declare a public health emergency and take such action as 
        may be appropriate to respond to the emergency.
   Make and enforce regulations to prevent the introduction, 
        transmission, or spread of communicable diseases into the 
        United States or from one State or possession into another, 
        including isolation and quarantine.
   Conduct and support research and investigations into the 
        cause, treatment, or prevention of a disease or disorder.
   Direct the deployment of officers of the Public Health 
        Service in support of public health and medical operations.
   Assist States and localities to provide public health and 
        medical services.
   Provide for the licensure of biological products.

    Additionally, HHS can issue an Emergency Use Authorization under 
section 564 of the FFDCA. It also has authority under that act to 
permit emergency use of investigational products and to expedite 
approval of drugs and devices. The Stafford Act authorizes agencies of 
the Federal Government, including HHS to use their authorities and 
resources for emergency preparedness and response, as directed by the 
President. Under section 1135 of the SSA, HHS can waive certain 
requirements of the Medicare, Medicaid, and State Children's Health 
Insurance Programs, such as preapproval requirements, sanctions for 
violating self-referral prohibitions, and sanctions for impermissible 
redirection of patients under the Emergency Medical Treatment and 
Active Labor Act.

    Question. By definition, pandemics cross national boundaries. Their 
control may require highly coordinated actions by many nations. But WHO 
has only advisory and supportive powers. Does the world need a new 
international structure to deal with this type of international 
emergency? Or will the U.N. Security Council issue binding resolutions 
on pandemic response? What is being done to plan for and exercise the 
international coordination and decisionmaking that will be required?

    Answer. The world needs neither a new international structure to 
deal with avian and pandemic influenza nor Security Council resolutions 
on a pandemic response. The World Health Organization (WHO), is one of 
a number of intergovernmental organizations, including the United 
Nations Food and Agriculture Organization (FAO) and the World 
Organization for Animal Health (OIE), that is urgently addressing 
concerns related to an avian flu outbreak. Acting in accordance with 
its mandate WHO is engaged in a concerted effort to coordinate actions 
involving its Member States, including the United States, as well as 
its other partners to urgently address issues of international 
preparedness, rapid containment, and response. WHO Member States, in 
May 2005, adopted the International Health Regulations (2005) which 
will enter into force in June 2007, and in so doing, replace the 
current regulations that are narrower in scope. The WHO International 
Health Regulation (2005) (IHRs) will place new requirements on WHO 
Member States which will facilitate effective responses to public 
health emergencies of international concern such as avian flu through 
improved disease surveillance, reporting, response, and containment 
actions. The United States, along with many other nations, has strongly 
supported voluntary early implementation of relevant provisions of the 
IHRs.
    The International Partnership on Avian and Pandemic Influenza 
(IPAPI) announced by President Bush at the United Nations on September 
14, 2005, helps to facilitate high-level political attention. The 
objective of the Partnership is to bring together countries that share 
a set of core principles to generate and coordinate political momentum 
and action for addressing the threats of avian and pandemic influenza. 
The Partnership's work will supplement ongoing and planned 
international and regional efforts and support the work of the relevant 
international organizations, including the WHO, the World Organization 
for Animal Health (OIE), and the United Nations Food and Agriculture 
Organization (FAO). The new Office of the United Nations Coordinator 
for Avian Influenza, responsible for coordinating the efforts of WHO, 
FAO, and other U.N. agencies involved in the international response, 
will further strengthen the capacity of the U.N. system to provide a 
coordinated international response. USAID provided over $7.6 million in 
FY05 for avian influenza activities in partnership with WHO and FAO, 
including $879,000 to support the new U.N. Coordinator. Within the 
President's FY06 request for avian flu containment USAID estimates that 
approximately $26 million will go to support the WHO and FAO.
    The U.S. Government is providing regional and bilateral support to 
help our IPAPI partners train personnel, expand surveillance and 
testing, draw up and enhance preparedness plans, and take action to 
detect and contain outbreaks. The U.S. Government is working with our 
IPAPI partners and the WHO to support the development of integrated 
national plans for avian influenza control and human pandemic influenza 
preparedness and response. Integrated country plans will build on and 
strengthen existing systems and mechanisms. Response mechanisms should 
be rehearsed through simulation exercises.
    On November 1, 2005, the White House issued the U.S. National 
Strategy for Pandemic Influenza. Department-specific implementation 
plans are being developed and simulations and tabletop exercises are 
being conducted by relevant U.S. Government agencies and similar 
efforts are underway in many other countries. The U.S. Government is 
working to develop an integrated response plan that will be consistent 
with the WHO response plan for avian and pandemic influenza. The WHO 
plan will reflect a coordination framework building on existing 
mechanisms at the country level, and at the global level, building on 
international best practices.
    Furthermore, WHO, as a key actor in directing and coordinating 
international health work, has demonstrated its ability to 
significantly influence the public health actions of its 192 Member 
States. For instance, WHO played an effective role during the 2002-2003 
SARS epidemic and was instrumental in urging better cooperation and 
transparency from Chinese health authorities.
    While the transmission rate of SARS may have been lower than that 
of influenza, the public health response to the SARS epidemic is 
illustrative. During the SARS outbreak, WHO initiated and coordinated 
much of its response through its Global Outbreak Alert and Response 
Network (GOARN). GOARN provides technical and operational resources 
from scientific institutions in WHO Member States, medical and 
surveillance initiatives, regional technical networks, networks of 
laboratories, United Nations organizations, the Red Cross, and other 
international humanitarian nongovernmental organizations. WHO issued 
recommendations to airlines for screening of passengers and advisories 
to avoid nonessential travel to high-risk areas. While these 
recommendations are advisory, the travel advisories may have helped to 
control SARS, as travel volume decreased and countries experiencing 
outbreaks responded with effective infection control, isolation, and 
quarantine strategies.

    Question. Ms. Garrett's testimony notes the need to prepare for 
giving nongovernmental organizations a major role, both at home and 
abroad. NGOs have approached me with the same concern. What plans are 
there for enlisting their support for using their scientific and 
logistical expertise, and how are they reflected in the President's 
budget request for fiscal year 2006?

    Answer. Responding to AI and a pandemic will require the expertise 
of a broad coalition of partners including governments, international 
organizations, businesses, and NGOs. The Department of State is working 
with other Federal agencies on its international outreach strategy, 
which covers a number of issues involving work with the private sector 
writ large including the NGO community vis-a-vis their capabilities and 
needs in prevention of, and response to, a flu pandemic. DOS has 
engaged the private sector--businesses, the scientific community, as 
well as NGOs to urge pandemic preparedness, and additional meetings are 
being planned. We are working with USAID and HHS to address the 
particular needs of NGOs and businesses for protecting the health of 
their workers, both U.S. and host country nationals. We are also 
providing guidance on their need to address a range of contingency 
planning concerns, including security-related issues.
    The NGO community is especially critical to mobilize local action 
against the threat of avian influenza, and USAID and CDC have already 
taken steps to engage the NGO community under the $25 million 
supplemental appropriations provided in FY05. USAID is partnering with 
a number of private sector organizations, such as Veterinarians without 
Borders (VSF) in Vietnam, to train 5,000 private and public 
veterinarians and ``paravets''--serving over 1 million people in 10 
high-risk provinces in the Mekong and Red River Deltas--to use and 
disseminate national and international guidelines for avian flu 
prevention and control in backyard poultry farms. An increasing number 
of NGOs are becoming involved in the effort to control bird flu in 
Vietnam, and they have expressed the need to share information, and 
ensure consistency in messages and coordination in programming. USAID 
is partnering with WHO and Plan International to support a Web site in 
conjunction with the NGO Resource Center in Hanoi that will facilitate 
information-sharing and coordination between NGOs, donors, and the 
Vietnamese Government.
    USAID's newly established Avian and Pandemic Influenza Response 
Unit already is working to engage NGO networks through NGO umbrella 
organizations such as the Core Group for Child Survival and InterAction 
on their possible role in bringing together a broad coalition of NGOs 
representing all relevant sectors to support effective containment.
    USAID plans to use $7 million of the Emergency Supplemental 
Appropriations to Address Hurricanes in the Gulf of Mexico, and 
Pandemic Influenza Act, 2006, to develop ``early warning'' surveillance 
networks that will include the on-the-ground capacity of NGOs in 
affected countries as part of an alert network for suspicious poultry 
die-offs or illness among people. In addition, NGOs will be critical 
partners for increasing public awareness of avian flu and promoting 
safe practices to prevent infection. When outbreaks are confirmed among 
either poultry or humans, NGOs will frequently be the first line of 
action to ensure timely and effective response in coordination with 
local, national, and international health authorities.

    Question. What should American poultry producers do to limit the 
risk to their flocks from H5N1? Should live markets be shut down or 
more tightly controlled in the United States? If so, are the necessary 
authorities in place and have those with the authority prepared to 
exercise it? Should U.S. poultry be vaccinated? If so, when and by 
whom? What will all this cost? And how will we ensure that everybody is 
included--not just the big companies, but also the mom-and-pop 
operations?

    Answer. USDA is committed to preventing the introduction of any 
avian influenza viruses, especially highly pathogenic H5N1 into the 
United States. Moreover, the Department works closely with State and 
local authorities and with individual producers to limit the risk of 
H5N1 and other animal diseases. USDA has engaged in extensive education 
and outreach to inform American poultry producers how to safeguard 
against AI. Our ``Biosecurity for the Birds'' outreach initiative has 
been widely successful. That initiative describes biosecurity as the 
first line of defense against all AI viruses. Reducing the likelihood 
of the introduction of AI by minimizing contact among commercial 
poultry and wild birds, swine farms, and live bird markets is a common 
and successful practice. However, occasionally when AI is introduced 
into the U.S. poultry population, USDA along with State governments and 
industry act to eliminate the virus.
    A successful strategy requires multiple controls. The components of 
a control strategy can vary but generally include five categories: (1) 
Biosecurity (including quarantine); (2) diagnostics and surveillance; 
(3) elimination of infected poultry; (4) decreasing host susceptibility 
to the pathogen (for example, through vaccination when appropriate); 
and (5) education of personnel in the animal production chain and 
allied industries to better understand how diseases are transmitted so 
personnel with responsibility to prevent transmission or spread can be 
incorporated into action plans.
    Live bird markets in the United States should not be shut down. 
Closing these markets would not eliminate the demand for purchasing 
live/fresh slaughtered birds in these communities throughout the United 
States. Consequently, closing the markets would only drive this 
marketing system underground. Since we have identified an H7N2 low 
pathogenicity avian influenza (LPAI) virus in the live bird marketing 
system in the Northeast in recent years, APHIS has partnered with the 
States in the region to assist these markets in controlling this virus. 
These efforts have resulted in significant reduction of the prevalence 
of LPAI in these markets. With full implementation of this program, we 
expect to keep introductions of LPAI into these markets to a negligible 
level.
    APHIS is developing a federally coordinated and state-assisted 
domestic LPAI program that will enhance surveillance for H5 and H7 
avian influenza for the U.S. commercial broiler, layers, and turkey 
industries and the live bird marketing system. The national program is 
designed to: (1) Diagnose, control, and prevent the H5 and H7 LPAI 
subtypes; (2) improve biosecurity, sanitation, and disease control at 
participating operations; and (3) minimize the effects of LPAI on the 
U.S. commercial poultry industry. The National Poultry Improvement Plan 
(NPIP) is developing the commercial poultry segment of this program. 
NPIP participants have adopted a new LPAI program that is currently 
proceeding through the regulatory process that will fully establish 
this voluntary program as part of the NPIP.
    Vaccination alone is not an effective strategy to combat avian 
influenza. Vaccine alone would never fully eradicate the AI virus and 
would be unlikely to even slow down an outbreak; however, the use of 
highly efficacious vaccines may be an essential component of any AI 
countermeasure program to reduce disease transmission (including 
zoonotic spread) and economic impact. Furthermore, vaccinating poultry 
can have deleterious trade implications. However, vaccination can be a 
very useful component of an overarching AI control strategy. The 
current APHIS policy, as described in VS Memorandum No. 565.12, allows 
``H5 and H7 vaccines to be used as a tool for combating any potential 
outbreak of HPAI in the United States.'' AI vaccines may be prepared 
from any serotype, including H5 and H7, and may be recommended for use 
in chickens or turkeys subject to the requirements and restrictions 
specified in VS Memorandum No. 800.85. This memorandum allows H5 and H7 
vaccines to only be used under the supervision or control of USDA, 
APHIS, VS, as part of an official USDA animal disease control program. 
The USDA, APHIS, VS, Center for Veterinary Biologics, implements the 
provisions of the Virus-Serum-Toxin Act to ensure that veterinary 
biologics available for the diagnosis, prevention, and treatment of 
animal disease are pure, safe, potent, and effective.
    Cost is determined by a number of variables. How and when AI 
vaccine from the H5/H7 vaccine stockpile is used is dependent upon the 
type of birds (broilers, layers, parent flocks, etc.), the level of 
biosecurity, and how geographically spread out the disease situation 
may be. Vaccine use needs to be tailored to the specific set of disease 
circumstances. It is a component of a disease control strategy, not the 
whole program.
    APHIS supports the general concept of vaccination as a tool in the 
eradication of notifiable AI. However, vaccination should be available 
as part of a science-based influenza control strategy that includes: 
(1) Enhanced biosecurity; (2) an eradication plan; (3) controlled 
vaccination for flocks deemed to be at risk; (4) suitable monitoring of 
all flocks at risk and of all vaccinated flocks; and (5) a repopulation 
plan. Thus, who would be included in a vaccination program would be the 
result of a science-based strategy, not the size of the producers.

    Question. We must do all that we can to change livestock production 
and marketing practices in developing countries, so as to reduce 
contact between animals and humans. This applies not just to poultry, 
but also especially to pigs. How does the President's new pandemic 
influenza strategy address this concern? Are American poultry and 
livestock producers being mobilized to help other countries bring their 
animal husbandry and marketing practices into the 21st century?

    Answer. U.S. Government officials understand the importance of the 
long-term investment aimed at changing livestock production and 
marketing practices in other countries and strengthening the systems to 
reduce contact between animals and between humans and animals. In the 
new pandemic strategy, USAID plans to make significant investments in 
countries to mitigate the risk of transmission. Activities which 
contribute to this goal include: Profiling the livestock and poultry 
sector, identifying, organizing, and mobilizing local stakeholders, 
identifying areas of greatest risk for transmission such as farm 
practices and live (wet) markets, implementing risk management 
practices such as application of appropriate biosecurity measures at 
both backyard farm and commercial poultry/livestock operations, 
building on existing awareness raising and education campaigns aimed at 
improving farming practices and response measures to reduce risk of 
transmission. USAID understands the importance of engaging the American 
poultry and livestock sector in these efforts and is in close contact 
with USDA, which has met with U.S. industry groups seeking partnerships 
to mitigate the economic, social, and security impact of highly 
pathogenic avian influenza.
    USDA has gathered information about private sector efforts on 
emergency preparedness in this area to identify and create 
opportunities for partnering with industry and to identify technical 
resource experts to apply best practices for technical assistance 
activities. The goal of these efforts is to encourage farmers in other 
countries to participate in surveillance and adopt desirable farm-level 
biosecurity measures and influence changes throughout the poultry 
supply and marketing chain. To date, the industry groups that have 
participated include: The U.S. American Poultry Egg and Export Council, 
American Egg Board, United Egg Producers, National Turkey Federation, 
National Chicken Council, and the American Soybean Association. Under 
the President's pandemic influenza strategy, USAID and USDA will 
continue to engage with American producers to strengthen the animal 
husbandry and marketing practices in developing countries.
    The President's FY06 Emergency Supplemental Appropriations to 
Address Hurricanes in the Gulf of Mexico, and Pandemic Influenza 
includes support for USAID to take immediate action to improve animal 
handling practices by training veterinary workers, conducting targeted 
communications campaigns, and working directly with Ministries of 
Agricultures to improve practices for handling diseased animals. USAID 
will also continue its work with private companies and other donors and 
organizations--including in the livestock industry--to increase the 
availability of incentives, technical support, and financing to 
increase biosecurity in livestock production and marketing.
    Engaging the American poultry and livestock sector--a global leader 
in promoting biosecurity practices--will be essential in promoting safe 
practices abroad. USAID is working closely with USDA and provided $1.5 
million in FY05 in partnership with USDA to increase U.S. technical 
assistance for avian influenza control efforts, including activities to 
improve biosecurity and engage and leverage private companies. USDA has 
met with U.S. industry groups seeking partnerships to mitigate the 
economic, social, and security impact of highly pathogenic avian 
influenza and has gathered information about private sector efforts in 
order to identify opportunities for public/private partnerships that 
will increase the use of best practices abroad.

    Question. One indicator of how effective our country will be in 
implementing a response to pandemic flu might be how well we handle the 
existing seasonal flu. In Delaware and elsewhere, we have seen 
widespread and growing unavailability of this year's flu vaccine. These 
shortages appear to affect all providers (doctor's offices, companies, 
public health agencies) and involve the Sanofi as well as Chiron 
vaccines. Yet the CDC has routinely said that there is no shortage of 
vaccine. How do you reconcile the contradiction between what is 
happening on the ground with what public health officials in Washington 
and Atlanta are saying?

    Answer. CDC planned for multiple scenarios of influenza vaccine 
shortages and even for a greater supply than usual. We are in what we 
thought would be the best case scenario in that there are four 
manufacturers providing influenza vaccine in the United States this 
season: Chiron, GSK, Medlmmune, and Sanofi Pasteur. To date, more than 
80 million doses of influenza vaccine have been distributed and 
approximately 86 million doses have been produced. There is vaccine 
still available for purchase from at least one manufacturer and one 
distributor. Influenza vaccine is also available for children who are 
eligible for the Vaccines for Children (VFC) program as part of the VFC 
influenza vaccine stockpile. The very last doses of influenza vaccine 
are currently being produced (3.5 million doses from Sanofi Pasteur and 
680,000 doses from Chiron) and were available late in December or 
January as part of the CDC influenza vaccine stockpile.
    Despite the total number of doses available this season, however, 
the delay and decreased production of vaccines by one of the 
manufacturers has resulted in a mismatch between supply and demand for 
influenza vaccine that has left a number of providers, facilities such 
as hospitals and long-term care facilities, and vaccine distributors 
without sufficient vaccine.
    To assess the extent of this mismatch, CDC has begun systematic 
assessments of vaccine supply problems experienced by various key 
stakeholders, including State and local public health officials; 
private providers; other providers and facilities who administer 
influenza vaccine; the public; and vaccine distributors to understand 
the extent and duration of problems associated with vaccine supply and 
access to influenza vaccine this season. The information collected will 
help CDC evaluate and respond to challenges in the current influenza 
season and to plan for next year's influenza season.
    We recognize that it is necessary to ensure an enhanced and stable 
domestic influenza vaccine market to improve the response to both 
annual and pandemic influenza. CDC continually works to improve our 
response to vaccine shortages and to unusual situations, such as the 
one occurring this year when the timing of demand and supply is not 
synchronized. We will continue to work with private industry 
manufacturers and our international partners to find solutions to the 
challenges we face related to influenza vaccine supplies.

    Question. As you know, I have long advocated greater U.S. support 
for disease surveillance capabilities overseas, with a special emphasis 
on those diseases that might be the result of some bioterrorist 
activity. As the United States helps to improve disease surveillance 
efforts in the context of avian influenza, will it also train personnel 
to identify other diseases? Could it readily include training to spot 
the diseases that have been associated with past bioweapons programs? 
What would it cost to include a module of that sort for a significant 
proportion of those persons who receive U.S. training?

    Answer. All CDC bioterrorism training is maintained online as long 
as the content remains up-to-date (http://www.bt.cdc.gov/training/). 
The training sessions have been viewed and adapted by several countries 
to train their public health staff.
    CDC has developed other types of training currently in use by other 
countries. One of CDC's earliest international collaborations for 
training was with WHO to develop the course ``Smallpox: Disease, 
Prevention and Intervention'' (http://www.bt.cdc.gov/agent/smallpox/
training/overview/). The course provides a set of teaching slides that 
can be easily customized for a country's specific plan.
    In addition, CDC's Bioterrorism Preparedness and Response Program 
(BPRP) has assisted other countries in preparation for the Olympic 
Games. During the Athens games, BPRP staff worked over a 9-month period 
to conduct trainings of clinical staff in Greece to recognize possible 
bioterrorism. They also helped establish a syndromic surveillance 
system to detect patterns in illness syndromes that might detect 
events. Most recently, BPRP staff worked with the Italian Government to 
develop a training plan and Web site for its clinicians in preparation 
for the upcoming Olympics, as well as for general preparedness. Italy 
will be adapting CDC courses and information from the Emergency 
Preparedness and Response Web site (www.bt.cdc.gov) for this purpose.
    HHS, through its Office of Global Health Affairs and its CDC, is 
currently participating in the DOD project concerning ``Threat Agent 
Detection and Response'' (TADR) in countries of the former Soviet 
Union. This is a multiyear collaborative project with the Ministries of 
Health of Uzbekistan, Kazakhstan, Georgia, Azerbaijan, and Ukraine, to 
rapidly design and implement biothreat surveillance and response plans, 
build laboratory capacity, and promote biosafety and biosecurity for 
biothreat agents and other highly pathogenic diseases, including human 
and veterinary surveillance for avian influenza. The objectives of this 
collaboration are to enhance local surveillance to protect U.S. forces 
and local populations in the region, to detect highly pathogenic 
diseases early in their transmission cycle, and also to develop a 
sustainable surveillance system that will improve the public health 
infrastructure in participating countries. CDC has developed 
laboratory, surveillance, and epidemiology training modules, which have 
been used in Uzbekistan and will be used in Kazakhstan. Furthermore, 
these modules are being used by colleagues at the Walter Reed Army 
Institute of Research for training in Georgia and Azerbaijan. Similar 
or identical modules will be used in Ukraine and other countries in the 
future. Training is centered on a list of TADR diseases including 
anthrax, plague, tularemia, brucellosis, Crimean Congo Hemorrhagic 
Fever, and avian influenza. CDC is also involved with the information 
technology component of this project, which is designed to support 
rapid reporting of these diseases to the United States.
    Funding for all projects is contingent upon the bioterrorism budget 
and the other priorities for that budget in any given year. 
Bioterrorism training is coordinated through CDC's Terrorism Training 
and Education Working Group. This group of representatives from all CDC 
response centers prioritizes training projects and funding for the 
year. All projects are developed with the view of their applicability 
to a wide group of people. The costs to ensure that all trainings are 
available to as many other countries as possible are principally the 
costs of hiring translators for the materials. The total cost would 
depend upon the languages requested and the number of items translated.
    The capacity USAID is building in surveillance and response to 
infectious disease outbreaks will help countries to better respond to 
new threats from natural disease or bioterrorism. The ability to detect 
unusual events quickly is vital to responding to avian influenza as 
well as bioterrorism. Better national surveillance and laboratories 
will allow countries to be better partners in detecting and tracking 
acts of bioterrorism. Investment is building capacity in surveillance, 
laboratories, epidemiology and disease control measures that are needed 
to control other diseases such as SARS, measles, cholera, etc. The 
extensive surveillance network developed by the Polio Eradication 
Program already is being employed to act as an early warning system for 
avian influenza. Investments are being made in the CDC's Field 
Epidemiology Training Program (FETP) in Thailand to train more local 
field epidemiologists. These individuals receive extensive training in 
how to detect and respond to outbreaks from a variety of disease, 
including those that could possibly be used by bioterrorists. This 
investment will enhance the capacity of the pharmaceutical industry to 
respond to infectious diseases by developing new technologies for more 
effective vaccines and drugs.
    Additional training can always be provided, but it must be matched 
with the absorptive capacity of the country. Right now, USAID is 
working to raise that capacity so that more sophisticated skills can be 
developed and countries can become more self-reliant in their ability 
to detect and respond to new biothreats. USAID, in cooperation with 
HHS, is supporting new CDC FETP programs in Pakistan and Africa in 
order to better equip countries with the technical skills needed for 
rapid detection of disease threats, both natural and intentional. The 
Threat Agent Detection and Response (TADR) project in the DOD has just 
recently added on avian influenza as a biothreat subject to 
surveillance.
                                 ______
                                 

Responses of Panel II to Questions Submitted for the Record by Senator 
                          Joseph R. Biden, Jr.

    Question. Mr. Newcomb advocates ``improving biosecurity standards 
and practices for the poultry industry globally.'' What improvements do 
you recommend? What changes are needed in poultry biosecurity standards 
here at home? Should U.S. manufacturers be sent overseas to help other 
countries improve the safety and efficiency of their poultry 
production?

    Answer. At a minimum, Asian countries must move away from live 
animal sales and home-slaughter of poultry, creating centralized 
slaughter and meat packaging facilities. To avoid salmonella and other 
bacterial diseases, the wealthy world should assist in creating 
hygienic, refrigerated facilities for these endeavors.

    Question. Do you expect quarantines to be useful in the United 
States? Or do you agree with Dr. Chan of the WHO, who says, ``pandemic 
influenza is considered unstoppable once international spread is fully 
under way?''

    Answer. Though virtually all political leaders will feel compelled 
to order quarantines of one kid or another, or shut down borders and 
human movement, these efforts will have little or no positive impact on 
the pandemic. Worse, they could hamper the flow of vital goods, such as 
medical supplies and food.

    Question. Some people suggest that more limited restrictions on 
personal movements might be more useful. This might include closing 
schools, canceling public events, changing work venues, and the like. 
What do you think?

    Answer. Parents will withdraw their children from schools, whether 
or not the facilities are officially closed. Similarly, as occurred in 
Asia with SARS, employees will stay home, restaurants and movie 
theaters will close, and most large-scale group activities will halt. 
These steps will occur whether or not they are ordered by government, 
as people will take their own actions. Airports and airlines, passenger 
buses and trains, and other forms of mass transit will empty of 
passengers because people will be afraid to use them. Again, this will 
occur whether or not government mandates it. Employers and schools are 
wise to consider now how they could continue their business and 
scholastic activities via telecommuting.

    Question. Do you anticipate a need to use the U.S. Armed Forces in 
controlling the domestic travel of U.S. citizens during an emergency, 
controlling access to medicines, or preventing riots over such access?

    Answer. I do not share the grim views expressed by some regarding 
riots and irrational human behavior. Having been at Ground Zero on 9/
11, I know that most people respond to massive crisis with humanity and 
decency. If government does its job properly, providing equitable 
access to information, medicine, and services to all Americans, there 
will be no cause for rioting. In 1918 civil unrest generally occurred 
where poor and immigrant populations felt they were either singled out 
for punitive health action (e.g. quarantine), or were denied services 
that were accessible to richer, or native populations of their 
communities. As New Orleans showed us, government has a special duty to 
demonstrate that it cares about all its citizens and residents. The 
only reasons to draw on U.S. military personnel, assuming equity and 
clear communication are provided by government, are logistic. The 
military is uniquely capable of mobilizing large movements of 
personnel, supplies, food and medicine--both domestically and overseas.

    Question. Ms. Garrett noted the need to prepare for giving 
nongovernmental organizations a major role, both at home and abroad. 
NGOs have approached me with the same concern. What roles ought they to 
fill, and how should their activities be coordinated, both here and 
overseas?

    Answer. I was surprised to learn this summer that the American Red 
Cross did not envision a role for itself in a pandemic beyond, perhaps, 
lining Americans up for vaccination. Americans will expect the Red 
Cross and other volunteer organizations to provide tender loving care 
to ailing patients who are warehoused outside of hospital facilities. 
Certainly, there will be inadequate numbers of trained health 
professionals to meet the patient care demands of a pandemic.
    In addition, because millions of people will be home-bound, afraid 
to venture into perceived contagion, there will be a strong need for 
coordinated volunteers to ensure deliveries of food, water, basic 
nonflu medicines (e.g. insulin for diabetics), and other essential 
supplies on a door-to-door basis. If well coordinated by government, 
such volunteer energy could be drawn from forces ranging from Boy and 
Girl Scouts to United Way and CARE.
    Overseas, history has repeatedly shown that NGOs and humanitarian 
relief organizations are among the first to spot outbreaks. Groups like 
MSF and WorldVision, with vast networks of volunteers and paid staff 
deployed in remote and troubled parts of the world, are uniquely 
positioned to spot an outbreak. They must be coordinated, and know to 
whom they ought to direct their alerts, how samples should (and should 
not) be collected and shipped, and what sorts of logistic and care 
support they can best provide internationally.
    Finally, government must consider how it can creatively marshal 
private sector skills and energy in a prolonged pandemic. Companies 
like DHL, FedEX, General Motors, Microsoft, and hundreds more may well 
have skilled labor forces capable of augmenting government activities 
in dramatic ways. These must be considered now, at local, federal, and 
international levels, as their utility can only be felt if bridges and 
planning between government and the private sector commence well in 
advance of a crisis.
                                 ______
                                 

  Responses of the State Department to Questions Submitted by Senator 
                             Barbara Boxer

    Question. The recently published Pandemic Influenza Plan states 
that the Department of Health and Human Services has greatly 
intensified its global surveillance activities. Can you describe those 
global surveillance activities?

    Answer. The Centers for Disease Control and Prevention has been 
pursuing a policy of developing and supporting active and aggressive 
international detection and investigation capability. This is supported 
with ongoing funds and has been greatly enhanced with the addition of 
$15 million in emergency supplemental funding in FY 2005. CDC is 
providing bilateral support to 12 Foreign Ministries of Health for the 
development of influenza surveillance networks. These networks will 
enhance the capacity to detect influenza, including avian influenza.
    One area of particular focus is developing regional capacity in 
Southeast Asia in epidemiology and laboratory management in pandemic 
influenza. This includes developing and teaching an avian influenza 
curriculum to epidemiologists and laboratorians. Training also involves 
public health leaders to develop a national network of public health 
field staff, and allied health personnel for detecting and reporting 
human cases of influenza.
    CDC is also working with the World Health Organization (WHO) and 
Ministries of Health to increase population awareness about the human 
health risks associated with pandemic influenza, and to advise affected 
countries concerning prevention or mitigation measures that can be used 
in the event a pandemic occurs. Methods to increase public awareness 
include: Broadcast radio messages, training local physicians, 
healthcare workers and community public health leaders.
    In order to assist in international containment activities, CDC is 
working to develop, train, and equip rapid field response teams to be 
deployed in the event of a pandemic influenza outbreak. These teams 
will be trained to undertake emergency field epidemiology studies, 
collect samples for shipment to laboratories, and institute emergency 
control measures such as quarantine and isolation in a standardized 
manner.
    In support of these activities, CDC staff will be assigned to 
Vietnam, Cambodia, and Laos to facilitate improvements in the detection 
of influenza cases. These senior-level staff will be providing 
technical assistance on how to investigate cases as well as assisting 
in the development of a national preparedness plan by the Ministry of 
Health, with the support of WHO and partners.
    CDC's FY 2005 emergency supplemental funding also provides 
laboratory support for outbreak investigations. Activities include 
testing clinical samples and influenza isolates shipped to CDC by 
affected countries, diagnosing the presence of avian influenza in 
humans by supplying necessary test reagents to the affected region and 
globally, and developing vaccine seed stock to produce and test 
pandemic vaccine candidates. Additional laboratory work will be 
conducted at CDC/Atlanta on samples and isolates sent from Southeast 
Asia. CDC is also a WHO Influenza Collaborating Center and conducts 
routine worldwide monitoring of influenza viruses.
    CDC is also working with the Department of Homeland Security in the 
National Biosurveillance Integration System (NBIS) program to conduct 
near-real-time monitoring of avian flu progression. NBIS will have the 
capability to detect indicators suggesting the development of a 
potential biorisk amidst the daily background noise of activity, 
processes, and routine anomalies within our health communities. NBIS 
will facilitate collaborative interagency analysis to ensure fully 
integrated biosurveillance situational awareness is developed and 
maintained.

    Question. Can you also describe the comprehensive infection control 
strategies that you are developing to be used on an international 
basis? And when will these strategies be in place?

    Answer. Developing infection control strategies are an ongoing USG-
wide responsibility drawing on many authorities encompassing many 
activities. CDC is preparing Web-based training programs for infection 
control that will be applicable to national and international settings. 
CDC is in the process of using this training to increase the agency's 
capacity for providing expert infection control consultation for 
infectious disease emergencies, both abroad and in the United States. 
Laboratory detection support for outbreak investigations is also an 
important part of infection control. CDC is also working to develop 
laboratory capacity in Southeast Asia. As a World Health Organization 
Collaborating Center on Influenza, we expect these capacity-building 
efforts to extend within the next 9 to 18 months. CDC tests clinical 
samples and influenza isolates shipped to CDC by affected countries; 
diagnoses the presence of avian influenza in humans by supplying 
necessary test reagents to the region and globally; and develops 
vaccine seed stock to produce and test pandemic vaccine candidates.
    CDC has taken steps to strengthen infection control through the 
development of rapid field response teams that would be deployed under 
WHO auspices in the event of a pandemic. These teams, comprised of 
local and international staff at individual field sites, are trained to 
undertake emergency field epidemiology studies, collect samples for 
shipment to laboratories, and institute emergency control measures such 
as quarantine and isolation in a standardized manner. Over the next 12 
months, the teams will develop a regional stockpile of essential 
materials, including Personal Protective Equipment (PPE). CDC staff 
have been assigned to Vietnam, Cambodia, and Laos to facilitate 
improvements in the detection of influenza cases and to provide 
technical assistance on how to investigate cases. CDC is working with 
Ministries of Health in these countries to develop national 
preparedness plans, with assistance from WHO and other partners, within 
12 months.

    Question. I understand there is a concern that certain nations in 
Asia have not been aggressively dealing with outbreaks of avian flu in 
birds. What is the United States doing in conjunction with its 
international partners to ensure that birds infected with the flu are 
destroyed?

    Answer. USDA believes it is critical that the H5N1 strain of avian 
influenza circulating in Southeast Asia be effectively addressed in the 
region's poultry populations. USDA strongly believes that 
implementation of effective biosecurity measures and control and 
eradication programs will go a long way toward reducing the amount of 
virus in these H5N1-affected countries and minimize the potential for 
the virus to spread to poultry in other areas of the world. These 
actions, if effectively implemented, would diminish the potential for a 
human influenza pandemic.
    Dr. Ron DeHaven, Administrator of USDA's Animal and Plant Health 
Inspection Service (APHIS), traveled extensively in Southeast Asia in 
early December 2005 in an effort to evaluate the animal health 
infrastructure in Southeast Asia and determine what steps can be taken 
to improve disease safeguarding and surveillance programs in the 
region. During his trip, Dr. Ron DeHaven assessed the animal disease 
situation in several countries and the steps being taken in response. 
The information and observations he collected are helping USDA develop 
its plan to work with international organizations, primarily the United 
Nations Food and Agriculture Organization, to deliver the best possible 
technical assistance to these countries. In this regard, APHIS is 
opening a new office in Bangkok, Thailand, that will be responsible, 
among other things, for working with nongovernmental organizations and 
coordinating efforts in the region to assess countries' veterinary 
infrastructures and steps that need to be taken to address the Asian 
H5N1 virus in poultry populations. To further assist with these 
important efforts in the coming months, APHIS will also be placing 
contractors with animal health expertise in U.S. Embassies in Laos, 
Cambodia, Vietnam, and Indonesia. A foreign service national will also 
be placed in the U.S. Embassy in Burma.
    The National Strategy for Pandemic Influenza, announced by 
President Bush on November 1, reflects the importance of these 
proactive measures on the animal health front. The Congress provided 
$91 million in emergency funding for USDA to further intensify its 
surveillance here at home and to deliver increased assistance to 
countries impacted by the disease, in hopes of preventing further 
spread of avian influenza. On the international front, $18 million of 
the emergency funding for USDA will be used for additional 
bisosecurity, surveillance, and diagnostic measures. This funding will 
significantly advance USDA's efforts that build on the Food and 
Agriculture Organization's work to prevent, control, and eradicate 
avian influenza where it currently exists in Asia. USDA believes it is 
most appropriate to continue working through international 
organizations like the FAO to address the disease situation in 
Southeast Asia.
    Having said that, the Food and Agriculture Organization, as well as 
other international animal health standard-setting organizations, 
recommend that high pathogenicity avian influenza be dealt with by 
stamping out (bird depopulation) when active infection is detected; and 
by implementing movement controls; cleaning and disinfection protocols; 
and other related steps. Animal vaccination is another tool that can be 
used as part of a multifaceted approach to managing the disease, given 
that conditions in each country in the region can vary widely.
    Former USAID Administrator, Andrew S. Natsios, declared avian 
influenza a top priority for the Agency and stressed the importance of 
an early and effective response. USAID is fully engaged in the U.S. 
Government's response to this threat by supporting prevention and 
containment efforts in affected countries and working with developing 
nations around the globe to prepare for a possible pandemic. These 
efforts are being closely collaborated with those of the Departments of 
State, Agriculture, Defense, and Health and Human Services. USAID is 
also working closely with international and private sector partners, 
including WHO, the U.N. Food and Agriculture Organization (FAO), and 
NGOs to ensure a well-coordinated and strategically sound response to 
this global threat.
    A key part of limiting the spread of H5N1 among birds and from 
birds to humans is identifying and culling poultry that are sick or 
have been exposed to the virus. In order to improve identification of 
sick birds, USAID is taking several approaches, including: Working with 
affected countries to promote active surveillance of AI infection in 
animals; strengthening diagnostic capacities; and facilitating the 
availability of incentives to farmers to minimize underreporting of 
bird deaths. The incentives may include: Compensation in the form of 
cash, replacement chicks, or technical assistance. On the response 
side, USAID is supporting public awareness and education activities for 
farmers on appropriate behaviors and training and supporting rapid 
response teams to conduct appropriate control measures, including 
culling and disposal.

    Question. Also, what actions is it taking to make sure that all 
cases of avian flu in humans are reported?

    Answer. For AI cases to be reported, two criteria are necessary--
the affected country must have the capacity to detect cases, and it 
must be willing to share that information and patient samples with the 
WHO. The United States is working with several affected countries and 
with the WHO to establish the public health infrastructure necessary 
for effective surveillance for avian influenza cases. In addition, we 
are working to build relationships with countries and to address all of 
the various disincentives which impair transparency and reporting. 
These include studies of effective means for compensation for farmers' 
losses due to culling, as well as diplomatic initiatives through the 
President's International Partnership of Avian and Pandemic Influenza 
to encourage countries to rapidly and transparently share information 
and samples. Recognizing this threat can only be averted through 
coordinated international effort, President Bush announced the 
establishment of the Partnership in September 2005 during the high-
level segment of the U.N. General Assembly meeting. The Partnership is 
built on a set of 10 core principles which call for enhanced 
preparedness, surveillance, and transparency.
    Actions the U.S. Government has taken include mobilizing 
interagency teams to assess the avian flu situation. In particular, in 
mid-January, a team of experts in animal and human health surveillance, 
laboratory capacity, and public health communication from the State 
Department, USDA, USAID, and HHS went to Turkey, Azerbaijan, Georgia, 
Armenia, and Ukraine to meet with government officials and 
representatives of international organizations working locally on avian 
influenza. The purpose of the visit was to assess the avian flu 
situation there and to make recommendations on what the United States 
could to support efforts in Turkey to deal with and prepare for avian 
flu. The team experts met with Turkish Government officials and with 
representatives of international organizations, such as the World 
Health Organization, the U.N. Food and Agriculture Organization (FAO) 
and the European Centre for Disease Prevention and Control, which are 
working locally on avian influenza. Teams have also been sent to Iraq 
to support WHO and the Navy Medical Research Unit (NAMRU) and to meet 
with government officials to investigate the outbreak and provide 
support.

    Question. The United States is stockpiling Tamiflu and other 
antivirals for the U.S. population. Have there been any discussions or 
agreements between the United States and any other country or 
organization like the World Health Organization to provide antivirals 
to other countries that are most vulnerable to the avian flu?

    Answer. Although no final decisions have been made, discussions are 
currently underway regarding possible U.S. support for an international 
stockpile and the parameters of such support.
    No one knows with any certainty, if a pandemic can be prevented. 
The best way to prevent a pandemic would be to eliminate the virus from 
birds, but it has become increasingly doubtful if this can be achieved 
within the near future. One of several important steps to enhance a 
rapid response anywhere in the world is to develop an international 
stockpile which can be deployed quickly by health authorities. The 
United States is working closely with the WHO to develop a doctrine for 
deploying this stockpile, and we are assessing how we and other 
countries could best contribute to this stockpile and to facilitate its 
rapid distribution to an affected country.

    Question. Do you have any plans to assist in surveillance 
activities for Africa or in other potentially vulnerable regions?

    Answer. Avian influenza is a global problem. CDC has developed an 
extensive network with Ministries of Health and other partners in 
Southeast Asia for H5N1 activities. In terms of expanding into other 
areas including Africa, the Centers for Disease Control and Prevention 
has a close working relationship with portions of the Department of 
Defense, in particular with the Naval Medical Research Unit (NAMRU). 
CDC provides funding for and collaborates with NAMRU3 in Cairo, Egypt, 
to support training and the expansion of influenza surveillance 
networks to countries where none exist. CDC's work with NAMRU3 includes 
the enhancement of the quality of surveillance in other countries to 
enhance outbreak detection, seroprevalence studies in populations at 
risk for avian influenza such as poultry workers, and enhanced outbreak 
response in the region.
    Furthermore, CDC has full-time staff in 43 countries, including 
many countries in Africa. CDC is already working closely with our staff 
in all 43 countries to provide them with the latest information about 
the current situation, assess country preparedness, assist in the 
development of pandemic influenza plans, and provide policy and 
technical guidance as requested. In addition, previous investments, 
such as the establishment of International Emerging Infections Programs 
(IEIP) in Thailand and Kenya, provide the foundation for rapid response 
to an emerging pandemic. For example, the IEIP program in Thailand is 
working to enhance laboratory diagnostic capacity, and establishing an 
acute respiratory disease surveillance system. The IEIP program in 
Kenya is undertaking similar activities, and recently convened 
representatives from 8 African countries to coordinate CDC efforts 
across Africa to detect the introduction of H5N1 into the continent. 
Finally, CDC has longstanding collaborative relationships with others 
working in the global arena, such as USAID, the Department of Defense, 
WHO, and the World Bank, which can facilitate a coordinated and 
effective response to international needs. The staff, programs, and 
capabilities developed by CDC over several decades to address a broad 
range of global health challenges are well-positioned to play a 
critical role in responding to an influenza pandemic.
    In addition, USAID is actively tracking migratory birds that carry 
the virus around the world. For example, USAID is supporting work in 
Tanzania to monitor migratory birds arriving from Eastern Europe that 
may carry the virus. This work will soon be expanded to other target 
countries in East Africa. Further, 107 rapid assessments on the state 
of preparedness have been completed in countries where USAID could 
potentially provide assistance. These reports will serve as a baseline 
for measuring the success of our programs and will guide our efforts in 
the coming year to mount effective strategies to meet the evolving 
threat of AI.
    USAID has also been supporting the development of infectious 
disease surveillance activities in Africa, the former Soviet Union, and 
Eastern Europe for a number of years. In Africa USAID further has 
supported the development of CDC's Field Epidemiology Training Programs 
(FETP) in Uganda, Zimbabwe, Ghana, and Kenya. These programs train the 
epidemiologists that form the core of the national surveillance 
programs. In Tanzania, USAID worked with the government to redesign the 
national disease surveillance system and retrain over 250 national 
surveillance officers.
    In Ethiopia, USAID is planning to commit $600,000 to support 
surveillance activities and purchase equipment for enhancing laboratory 
diagnosis of animal H5N1 infections. In addition, USAID/Tanzania 
provided $75,000--and leveraged an additional $70,000 from the German 
Government--to strengthen surveillance and laboratory diagnosis of wild 
birds. The administration's request for supplemental FY06 funding for 
avian influenza activities included $1 million to strengthen animal 
surveillance in Africa and another $3.25 million to bolster planning 
and preparedness for avian flu control in the event of an H5N1 
outbreak. The request also included $1 million to conduct public 
communications campaigns to educate at-risk populations on how to 
recognize outbreaks and limit human exposure.
    In the former Soviet Republics, USAID has worked with CDC to 
strengthen the Central Asian regional FETP and has supported the reform 
of antiquated Soviet surveillance systems into more efficient and 
effective programs. This work has taken place in Kyrgyzstan, Ukraine, 
Belarus, Georgia, and Moldova. In Eastern Europe, USAID is supporting 
improved avian influenza surveillance in Turkey and Romania and has 
been working with the WHO regional office to reform the overall disease 
surveillance program in Bulgaria and Albania. These development efforts 
will reap true benefits with respect to the ability of these countries 
to adequately respond to the threat of avian influenza.

    Question. What are your concerns about the response so far of the 
individual countries where avian flu has occurred in both birds and 
humans?

    Answer. Seven countries (Thailand, Cambodia, Indonesia, Vietnam, 
China, Turkey, and Iraq) so far, according to the WHO, have reported AI 
cases in both animals and humans. In general, there are three major 
concerns concerning their responses to date. Some of the countries at 
greatest risk to experience the first ``spark'' of a pandemic have the 
fewest resources and capabilities to detect a problem early and 
respond. First, the detection systems in place are passive and not 
sensitive enough to pick up all animal and human cases which limits 
ability to respond. This is in part due to the varying public health 
capacities in different countries, and in part due to differences in 
countries' political situations and their willingness to be 
transparent. Active surveillance does take place once cases are 
reported, but underreporting for a variety of reasons limits where 
active surveillance is conducted.
    Second, the existing systems have limited capacity and can be 
easily overwhelmed if there are simultaneous outbreaks or if 
investigations are generating large numbers of suspected cases and 
clinical samples for testing. Last, the response systems are not fast 
enough and/or comprehensive enough to limit the spread of the virus 
when there are outbreaks in animal populations and potentially human 
populations. For the moment, the response systems appear to be able to 
handle instances of limited human-to-human transmission. However, 
countries are likely to be unable to contain larger clusters of human-
to-human transmission that would likely precede a pandemic.
    The issue you have raised was among the topics USDA Administrator 
DeHaven assessed during his travel to southeast Asia in early December. 
Greater transparency regarding the timely reporting of suspect H5N1 
cases in poultry in the region is vital to ensuring that timely, 
effective measures are taken to control the spread of the disease in 
the animal population.
    HHS is working with the countries at greatest risk to ensure they 
have the core capacities in place to detect an outbreak as early as 
possible, report the findings, and validate the report with laboratory 
diagnostic confirmation and specific virus characterization. In the 
same vein, these countries at greatest risk lack pandemic influenza 
preparedness plans. In recognition of this need, we are using our own 
National Strategy and our Department of Health and Human Services Plan 
as an example others can use, as well as encouraging that countries use 
WHO's plan as guidance for development of their own regional and 
national plans. To address the concern of lack of coordination among 
different sectors, through our own efforts toward an integrated cross-
sectoral approach to addressing this zoonotic disease threat, we are 
demonstrating to other countries the importance of strengthening 
partnerships between agricultural/animal health and human health 
sectors, as well as including technical experts and policy officials 
from transportation, commerce, environmental health, wildlife, law 
enforcement, and the private sector. Cross-sectoral activities include 
developing and exercising preparedness and response plans, training, 
sharing information and diagnostic samples, and working together on 
risk assessment and communication strategies.

    Question. What can the international community do to improve these 
responses?

    Answer. Support from the international community is vital to 
continue building the infrastructure for an international response. One 
of the most important steps is to ensure that efforts to support 
activities for technical assistance for avian influenza are well 
coordinated with global partners. We are working through the 
International Partnership for Avian and Pandemic Influenza to develop 
public health capacity to enhance surveillance and to present a broad 
array of diplomatic initiatives to promote transparency in reporting 
and rapid sharing of samples.
    The Partnership is truly a cooperative effort. It includes not only 
key U.N. agencies and international organizations such as the World 
Health Organization, the Food and Agriculture Organization, the World 
Organization for Animal Health, and the World Bank, but also regional 
organizations such as the Asia Pacific Economic Cooperation (APEC) 
forum, the Association of Southeast Asian Nations (ASEAN), the African 
Union, the European Union, and the Summit of the Americas. 
Significantly, a number of countries have supported the Partnership by 
taking leadership roles in several key areas. As a result of the Senior 
Officials Meeting, Canada agreed for example, to spearhead follow-on 
discussions on international stockpiling of vaccines and antiviral 
medicines as an important component of readiness. We held discussions 
with representatives of the European Union on a comprehensive strategy 
for vaccine research, development, and production. Australia and Japan 
agreed to collaborate on rapid response and containment, including the 
economic and social impacts of a pandemic.
    Since the October Senior Officials Meeting, work is progressing on 
the issues of stockpiles, rapid response and containment, and vaccines. 
Much of this work was carried forward at a meeting cohosted by the WHO, 
FAO, OIE, and the World Bank in Geneva on November 7-9, 2005, and at 
the annual Ministerial meeting of the Global Health Security Action 
Initiative (GHSI), in Rome on November 17-18, 2005, which brought 
together the Health Ministers of Canada, France, Germany, Italy, Japan, 
Mexico, the United Kingdom, and the United States, along with the 
Commissioner of Health and Consumer Protection of the European 
Commission and the Director General of the WHO. The next meeting of 
IPAPI is planned for June.
    The three areas of concern mentioned in the response to the 
previous question--passivity of the detection systems; limited capacity 
of existing systems; and lag time of response systems--are areas where 
the USG and international community are providing support. Surveillance 
and laboratory capacity, for example, are being strengthened to improve 
detection so that response can be targeted where needed. Sample 
processing capabilities are being expanded to deal with increasing 
needs. Existing and additional rapid response teams are being trained 
for outbreak investigation/containment, and additional containment 
measures (e.g., vaccination) are being added to contain the virus. In 
addition, the U.S. Government is discussing with international partners 
how to participate in the international stockpiling of antiviral 
medicines to help developing countries deal with clusters of human-to-
human transmission.
    On October 10, 2005, Cabinet-level officials conducted an extremely 
important exercise related to the Federal Government's preparedness to 
deal with an influenza pandemic. The Department of State has encouraged 
foreign government officials to engage in similar exercises to test 
their degree of preparedness. Japan and WHO hosted a meeting January 
12-13 in Tokyo to address early detection and reporting; issues and 
challenges to implement rapid response measures at the country level; 
and regional and international coordinated mechanisms. A donors meeting 
cosponsored by the EC and China was held January 17-18 in Beijing to 
address international funding for pandemic influenza. Among major 
contributions, in addition to the U.S. pledge of $334 million, the 
European Union pledged $150 million euros; Japan pledged $125 million; 
and Australia pledged $100 million AUD. The Asian Development Bank also 
plans to contribute $430 million to avian influenza efforts.

    Question. WHO is developing a stockpile of antiviral drugs. How 
many doses does it have to date and how many will be acquired?

    Answer. Roche, the manufacturer of Tamiflu, is stockpiling the 
antiviral drug in concert with WHO and expects to have 3 million doses 
ready by the second quarter of 2006 between the Roche factories in 
Connecticut and Switzerland. Roche has pledged another 2 million 
courses which will be available in September 2006 to help poor 
developing countries, which have reported H5N1 outbreaks, to prevent 
human transmission. The WHO hosted a meeting in Geneva on December 12, 
2005, to put together an international strategy for stockpiling and 
containment of avian influenza. U.S Government officials were actively 
involved in these discussions.
                                 ______
                                 

  Responses of the State Department to Questions Submitted by Senator 
                              Barack Obama

                      STOCKPILES FOR POOR NATIONS

    Question. Some experts believe that the impact of an avian flu 
pandemic can be mitigated if it is identified and isolated early 
enough. A key part of this would include administering antiviral drugs 
quickly enough to people--presumably in Southeast Asia--who have been 
exposed to the virus. However, most developing countries do not have 
sufficient antiviral drugs stockpiled to treat an outbreak.
    What should we be doing to address this shortcoming? Should we 
allocate a portion of our future stockpile toward the prevention of 
early outbreaks in developing countries? Should we establish some sort 
of international fund to help address this issue?

    Answer. No one knows with any certainty, if a pandemic can be 
prevented. The best way to prevent a pandemic would be to eliminate the 
virus from birds, but it has become increasingly doubtful if this can 
be achieved within the near future. One of several important steps to 
enhance a rapid response anywhere in the world is to develop an 
international stockpile of antiviral drugs, which can be deployed 
quickly by health authorities. The United States is working closely 
with the WHO to develop a doctrine for deploying this stockpile, and we 
are assessing how we and other countries could best contribute to this 
stockpile and to facilitate its rapid distribution to an affected 
country.
    Roche, the manufacturer of Tamiflu, is stockpiling the antiviral 
drug in concert with WHO and expects to have 3 million doses ready by 
the second quarter of 2006 between the Roche factories in Connecticut 
and Switzerland. Roche has pledged another 2 million courses which will 
be available in September 2006 to help poor developing countries which 
have reported H5N1 outbreaks to prevent human transmission. Recent 
studies, based on mathematical modeling, suggest that these drugs could 
be used prophylactically near the start of a pandemic to reduce the 
risk that a fully transmissible virus will emerge, or at least to delay 
its international spread, thus gaining time to augment vaccine 
supplies.
    However, stockpiling antivirals alone is not sufficient nor 
synonymous with being prepared to respond to pandemic influenza. The 
success of this strategy, which has never been tested, depends on 
several assumptions about the early behavior of a pandemic virus, which 
cannot be known in advance. Success also depends on excellent 
surveillance and logistics capacity in the initially affected areas, 
combined with an ability to enforce movement restrictions in and out of 
the affected area. To increase the likelihood that early intervention 
using the WHO rapid-intervention stockpile of antiviral drugs will be 
successful, surveillance in affected countries needs to improve, 
particularly concerning the capacity to detect clusters of cases 
closely related in time and place.
    U.S. Government support for the creation of early-warning 
surveillance networks and for national surveillance systems can also 
help limit the number of infections by reducing response time and 
improving the information that reaches authorities. U.S. Government 
support for training and equipping rapid responders to treat infection 
and prevent further spread can reduce the impact and spread of an 
outbreak. Supporting risk-communications campaigns in local languages 
to raise public awareness of high-risk behaviors can help people 
recognize infections early and take appropriate measures to prevent 
infection. We are working toward this end.
    While no final decision has been made, we anticipate that we are 
prepared to contribute a portion of our stockpile toward attempts to 
contain the disease abroad. This is only a rational decision so long as 
there is a possibility of containing the outbreak and preventing its 
introduction into the United States.
    The U.S. Government is in a strong position to support the ability 
of developing nations to effectively respond to H5N1 infections in 
humans through assistance in a number of areas.
    An international fund has been considered, but the consensus of USG 
agencies is that an actual stockpile, prepositioned in one or more 
locations in Asia, would avoid delays in making decisions and procuring 
commodities. The FY 2006 Department of Defense, Emergency Supplemental 
Appropriations to Address Hurricanes in the Gulf of Mexico, and 
Pandemic Influenza, 2006, contains $56 million to stockpile and 
preposition, in close coordination with HHS, USDA, and the World Health 
Organization, key ``non antiviral'' commodities that can be quickly 
mobilized to support outbreak containment.
    This stockpile, to be managed under the auspices of an 
international organization, will contain key ``non antiviral'' 
commodities that may include personal protective equipment, 
disinfectants, soap, and poultry vaccines. This strategy is for a rapid 
response capacity that will enable the international community to 
control the disease as it develops into a more transmissible form. 
USAID and HHS will work closely with the WHO to identify stockpile 
locations and specific contents, and to develop guidelines and trip 
wires for deployment.

                 ENHANCING INCENTIVES FOR SURVEILLANCE

    Question. Despite human deaths from the H5N1 strain, avian 
influenza remains overwhelmingly an animal pathogen. In countries like 
Vietnam and Cambodia--where farmers rely heavily on poultry for income 
and food--farmers have little incentive to report possible outbreaks 
when they know that they and their neighbors will be losing what may be 
one of their only sources of nutrition and income.
    Governments lack the means to compensate farmers who lose their 
poultry to culling. This is a significant impediment to surveillance 
and control of avian flu and could result in widespread economic damage 
to countries in the region. As a point of comparison--in 2003, a short-
lived and well-controlled outbreak of SARS caused a 2-percent drop in 
Southeast Asia's GDP in a single quarter.
    What efforts are underway to either support the compensation 
programs of those countries most affected or make alternative sources 
of income available, such as microfinance programs?
    Where is this incorporated into the administration's plans?
    Are we putting enough resources into these programs?

    Answer. In many of the countries in Southeast Asia that have been 
affected by H5N1, efforts to detect outbreaks in animals have been 
hampered by the failure of governments to provide fair compensation to 
small farmers and households. Recognizing this limitation, USAID began 
working on issues related to compensation in Vietnam, Indonesia, 
Cambodia, and Laos, using FY05 supplemental funds. Since the amount of 
money needed for compensation is very large, USAID's efforts have 
focused on: (1) Decreasing the need for compensation by minimizing 
disease risk in the poultry sector through the use of industry best-
practices (e.g., farm biosecurity, practices at animal markets), and 
(2) engaging the local, regional, and international business community 
to leverage financial, commodity, technical, and in-kind contributions 
for avian influenza response and containment. Businesses, for example, 
could provide cash or replacement chicks to farmers who have lost their 
flocks to disease or culling. This work will be expanded with the 
funding requested for FY06.
    The FY06 supplemental budget contains $7 million for USAID to take 
steps to increase the availability of key commodities, incentives, 
technical support, and financing for avian influenza control. USAID has 
had discussions about the compensation issue with the World Bank and 
will coordinate with their proposed $500 million effort for AI control.
    Compensation will be very expensive and probably beyond the 
capacity of any single country to manage. Currently, USAID is working 
with the World Bank to identify resources for compensation. The World 
Bank is planning a trial compensation program in Turkey. Current 
funding for international control of avian influenza by the USG, 
however, does not include contributions to a compensation program, 
which would require a significant increase in the level of funding.

             ENHANCING INFRASTRUCTURE IN DEVELOPING NATIONS

    Question. In order to fight avian flu in developing countries--and 
similar viruses that will undoubtedly follow--it is important to have 
strong public health and veterinary health systems and services to 
prevent, detect, and contain possible outbreaks.
    However, this infrastructure and capacity is lacking throughout 
Southeast Asia. Due to conflict, poverty, and neglect, the systems and 
services in Asia are weak and do not have the capacity to respond to an 
outbreak.
    How much funding is included in the administration's request to 
strengthen these essential services and systems in developing 
countries? Are we doing enough in this area? Is this something that 
should be addressed by Congress when trying to reach agreement during 
the conference committee on the $8 billion appropriated for the avian 
flu?

    Answer. The $280 million included in the enacted FY 2006 Department 
of Defense, Emergency Supplemental Appropriations to Address Hurricanes 
in the Gulf of Mexico, and Pandemic Influenza, 2006, will help 
strengthen the abilities of national animal and human health systems in 
affected countries to more efficiently detect, and more effectively 
respond to, emerging infectious diseases such as H5N1 avian influenza. 
Assistance to WHO and FAO will help establish structures that function 
at the regional and international level to support a robust response to 
the H5N1 threat. Support for physical infrastructure is not part of the 
request as it would be costly and divert funds away from emergency 
containment activities needed right now. Other organizations (e.g., 
World Bank, Asian Development Bank) and donors traditionally address 
infrastructure issues.
    Since the President's request was developed, a number of new 
countries have reported outbreaks. As a result, the needs in developing 
countries for assistance related to AI surveillance and response are 
greater.
    With the spread of AI to previously unaffected countries in Eastern 
Europe and the Middle East, AI is moving closer to Western Europe and 
Africa. The continual presence of AI in Southeast Asia is providing 
more opportunities for the virus to mutate into a form that can be 
transmitted easily from human to human. Both trends have significant 
economic and social consequences. Increasing the U.S. investment in 
international containment efforts could help limit the damage in 
affected countries and help keep unaffected countries free of the virus 
for as long as possible.
    The Centers for Disease Control and Prevention has been pursuing a 
policy of developing and supporting active and aggressive international 
detection and investigation capability. This is supported with ongoing 
funds and has been greatly enhanced with the addition of $15 million in 
emergency supplemental funding in FY 2005. CDC is providing bilateral 
support to the Ministries of Health in 12 countries for the development 
of influenza surveillance networks. These networks will enhance the 
capacity to detect influenza, including avian influenza.
    One area of particular focus is developing the regional capacity in 
Southeast Asia in epidemiology and laboratory management for pandemic 
influenza. This includes developing and teaching an avian influenza 
curriculum to epidemiologists and laboratorians. Training also involves 
public health leaders to develop a national network of public health 
field staff, and allied health personnel for detecting and reporting 
human cases of influenza.
    CDC is also working with the World Health Organization (WHO) and 
Ministries of Health to increase public awareness about the human 
health risks associated with pandemic influenza, and to advise affected 
countries concerning prevention or mitigation measures that can be used 
in the event a pandemic occurs. Methods to increase public awareness 
include: Broadcast radio messages, training local physicians, 
healthcare workers and community public health leaders.
    In order to assist in international containment activities, CDC is 
working to develop, train, and equip rapid field response teams to be 
deployed in the event of a pandemic influenza outbreak. These teams 
will be trained to undertake emergency field epidemiology studies, 
collect samples for shipment to laboratories, and institute emergency 
control measures such as quarantine and isolation in a standardized 
manner.
    In support of these activities, CDC staff have been assigned to 
Vietnam, Cambodia, and Laos to facilitate improvements in the detection 
of influenza cases. These senior-level staff will be providing 
technical assistance on how to investigate cases as well as assisting 
in the development of a national preparedness plan by the Ministry of 
Health, with the support of WHO and partners.
    CDC's FY 2005 emergency supplemental funding also provides 
laboratory support for outbreak investigations. Activities include 
testing clinical samples and influenza isolates shipped to CDC by 
affected countries, diagnosing the presence of avian influenza in 
humans by supplying necessary test reagents to the affected region and 
globally, and developing vaccine seed stock to produce and test 
pandemic vaccine candidates. Additional laboratory work will be 
conducted at CDC/Atlanta on samples and isolates sent from Southeast 
Asia. CDC is also a WHO Influenza Collaborating Center and conducts 
routine worldwide monitoring of influenza viruses.
    The Department of Defense is participating with CDC and the World 
Health Organization in the development of surveillance networks in 
Southeast Asia. DOD currently has three regional laboratories in Asia 
that are involved in testing for avian influenza, with the specimens 
taken from the local civilian population as well as military. For 
example, in Jakarta, NAMRU2 was performing much of the preliminary 
testing on specimens from the Indonesian outbreaks, and NAMRU3 in Cairo 
is now involved in testing specimens from civilians in Iraq. CDC, WHO, 
and DOD have made a cooperative effort to extend their resources as 
much as possible while avoiding duplications of capabilities.

                  DEPARTMENT OF DEFENSE ROLE--USAMRIID

    Question. One important resource that the United States has in 
dealing with international health problems is the U.S. Army Medical 
Research Institute of Infectious Diseases (USAMRIID).
    My understanding is that USAMRIID (pronounced US-AM-I-RID) has 
achieved positive results, collaborating with the private sector, to 
develop vaccines and antivirals against some of the most deadly single-
strand RNA viruses in the world, including Ebola and Marburg.
    I also understand that H5N1 is a single-strand RNA virus, so 
USAMRIID could be a resource here as well. To what extent are the 
civilian agencies tapping into the research and expertise provided by 
the U.S. military--and vice versa--to deal with the avian flu?
    Please describe in detail this cooperation. Should we be doing more 
to facilitate joint research between the civilian and military sides?

    Answer. In addition, the Centers for Disease Control and 
Prevention, has a close working relationship with portions of the 
Department of Defense, including AMRIID and the DIA's Armed Forces 
Medical Intelligence Center (AFMIC) as well as the Naval Medical 
Research Units (NAMRU).
     NAMRU has been instrumental in providing assessments and briefings 
on outbreaks. CDC provides funding and technical assistance for NAMRU2, 
which is located in Jakarta, Indonesia, for activities in Indonesia to 
expand avian influenza surveillance network. CDC also provides funding 
for, and collaborates with, NAMRU3 in Cairo, Egypt, to support 
training, and the expansion of influenza surveillance networks to 
countries where none exist. CDC's work with NAMRU3 includes an 
enhancement of the quality of surveillance in other countries to 
improve outbreak detection, seroprevalence studies in populations at 
risk for avian influenza such as poultry workers, and enhanced outbreak 
response in the region.
    AFMIC has been very helpful, providing policymakers with extensive 
research and analyses on AI developments. AFMIC has provided us with 
assessments on where AI is occurring and updates on the status of 
vaccine production efforts worldwide. CDC and USAMRIID both participate 
in the National Interagency Biodefense Campus (NIBC). The NIBC will 
leverage and expand key competencies to achieve productive and 
efficient interagency cooperation in support of homeland security 
biodefense. At the NIBC, located at Fort Detrick, Federal agencies will 
colocate laboratories that support our country's biodefense research 
program. The NIBC will include laboratory, administrative, utility, and 
support facilities. The colocation and collaboration of partners from 
DOD, HHS, DHS, and USDA provides a unique opportunity for coordinating 
and synchronizing areas of common interest among the Federal agencies 
involved in medical research and/or biotechnology related to 
biodefense.
    The National Institutes of Allergy and Infectious Diseases (NIAID), 
a component of the National Institutes of Health (NIH) at the 
Department of Health and Human Services (HHS), maintains a very dynamic 
biomedical research collaboration with the Department of Defense (DOD). 
The NIAID collaborates with the U.S. Army Medical Research Institute of 
Infectious Diseases (USAMRIID) on research related to the development 
of safe and effective medical countermeasures against potential agents 
of bioterrorism.
    One important DOD and NIH collaboration on influenza is the 
Influenza Genome Sequencing Project. This project is a partnership 
between the NIH (the NIAID and the National Library of Medicine), the 
Armed Forces Institute of Pathology, and several other organizations 
including the Institute for Genomic Research. The purpose of the 
Influenza Genome Sequencing Project is to complete genetic sequences of 
new virus isolates and rapidly make this sequence information publicly 
available through GenBank'. This program has enabled 
scientists to better understand how influenza viruses evolve as they 
spread through populations, and to match viral genetic characteristics 
with virulence, easy of transmissibility, and other clinical 
properties. An important goal of this project is to provide scientists 
with the knowledge they need to uncover potential targets for new 
vaccines, therapies, and diagnostics against influenza.
    Another research collaboration with the DOD on influenza is 
accomplished through an interagency Agreement (IAA) between NIAID and 
the Uniformed Services University of the Health Sciences. This IAA, 
which was signed in August 2005, established the NIAID/DOD Emerging 
Infectious Diseases Clinical Research Program. Shortly after being 
established, this Research Program created an Influenza Working Group 
to develop clinical research projects for avian influenza that leverage 
existing NIH and DOD domestic and international scientific capacity to 
advance the understanding, diagnosis, prevention, and control of avian 
influenza. The Working Group is comprised of representatives from NIAID 
and all branches of the DOD.

                                  
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