[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
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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?
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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.