[House Hearing, 111 Congress]
[From the U.S. Government Printing Office]
GLOBAL HEALTH EMERGENCIES HIT HOME:
THE ``SWINE FLU'' OUTBREAK
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON AFRICA AND GLOBAL HEALTH
OF THE
COMMITTEE ON FOREIGN AFFAIRS
HOUSE OF REPRESENTATIVES
ONE HUNDRED ELEVENTH CONGRESS
FIRST SESSION
__________
MAY 6, 2009
__________
Serial No. 111-56
__________
Printed for the use of the Committee on Foreign Affairs
Available via the World Wide Web: http://www.foreignaffairs.house.gov/
______
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COMMITTEE ON FOREIGN AFFAIRS
HOWARD L. BERMAN, California, Chairman
GARY L. ACKERMAN, New York ILEANA ROS-LEHTINEN, Florida
ENI F.H. FALEOMAVAEGA, American CHRISTOPHER H. SMITH, New Jersey
Samoa DAN BURTON, Indiana
DONALD M. PAYNE, New Jersey ELTON GALLEGLY, California
BRAD SHERMAN, California DANA ROHRABACHER, California
ROBERT WEXLER, Florida DONALD A. MANZULLO, Illinois
ELIOT L. ENGEL, New York EDWARD R. ROYCE, California
BILL DELAHUNT, Massachusetts RON PAUL, Texas
GREGORY W. MEEKS, New York JEFF FLAKE, Arizona
DIANE E. WATSON, California MIKE PENCE, Indiana
RUSS CARNAHAN, Missouri JOE WILSON, South Carolina
ALBIO SIRES, New Jersey JOHN BOOZMAN, Arkansas
GERALD E. CONNOLLY, Virginia J. GRESHAM BARRETT, South Carolina
MICHAEL E. McMAHON, New York CONNIE MACK, Florida
JOHN S. TANNER, Tennessee JEFF FORTENBERRY, Nebraska
GENE GREEN, Texas MICHAEL T. McCAUL, Texas
LYNN WOOLSEY, California TED POE, Texas
SHEILA JACKSON LEE, Texas BOB INGLIS, South Carolina
BARBARA LEE, California GUS BILIRAKIS, Florida
SHELLEY BERKLEY, Nevada
JOSEPH CROWLEY, New York
MIKE ROSS, Arkansas
BRAD MILLER, North Carolina
DAVID SCOTT, Georgia
JIM COSTA, California
KEITH ELLISON, Minnesota
GABRIELLE GIFFORDS, Arizona
RON KLEIN, Florida
Richard J. Kessler, Staff Director
Yleem Poblete, Republican Staff Director
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Subcommittee on Africa and Global Health
DONALD M. PAYNE, New Jersey, Chairman
DIANE E. WATSON, California CHRISTOPHER H. SMITH, New Jersey
BARBARA LEE, California JEFF FLAKE, Arizona
BRAD MILLER, North Carolina JOHN BOOZMAN, Arkansas
GREGORY W. MEEKS, New York JEFF FORTENBERRY, Nebraska
SHEILA JACKSON LEE, Texas
LYNN WOOLSEY, California
Noelle Lusane, Subcommittee Staff Director
Sheri Rickert, Republican Professional Staff Member
Antonina King, Staff Associate
C O N T E N T S
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Page
WITNESSES
Rear Admiral Anne Schuchat, M.D., Interim Deputy Director for
Science and Public Health Program, Center for Disease Control
and Prevention................................................. 9
Anthony Fauci, M.D., Director, National Institute of Allergies
and Infectious Diseases, National Institute of Health.......... 20
Dennis Carroll, M.D., Special Advisor to the Acting
Administrator, on Pandemic Influenza, United States Agency for
International Development...................................... 37
LETTERS, STATEMENTS, ETC., SUBMITTED FOR THE HEARING
The Honorable Donald M. Payne, a Representative in Congress from
the State of New Jersey, and Chairman, Subcommittee on Africa
and Global Health: Prepared statement.......................... 4
Rear Admiral Anne Schuchat, M.D.: Prepared statement............. 13
Anthony Fauci, M.D.: Prepared statement.......................... 22
Dennis Carroll, M.D.: Prepared statement......................... 40
APPENDIX
Hearing notice................................................... 64
Hearing minutes.................................................. 65
GLOBAL HEALTH EMERGENCIES HIT HOME: THE ``SWINE FLU'' OUTBREAK
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WEDNESDAY, MAY 6, 2009
House of Representatives,
Subcommittee on Africa and Global Health,
Committee on Foreign Affairs,
Washington, DC.
The subcommittee met, pursuant to notice, at 9:07 a.m. in
room 2172, Rayburn House Office Building, Hon. Donald Payne
(chairman of the subcommittee) presiding.
Mr. Payne. This hearing will come to order. Let me begin by
saying generally hearings do begin a bit later, but because we
felt the urgency of this matter, we had to take the only time
available so that we can vacate the room for another previously
scheduled hearing; I appreciate all of you coming early this
morning. This meeting, as I mentioned, will officially come to
order, and thank you for joining the Subcommittee on
African deg. and Global Health this morning for this
hearing entitled ``Global Health Emergencies Hit Home: The
`Swine Flu' Outbreak.''
The recent outbreak of a new strain of influenza, a subtype
H1N1 virus commonly referred to as ``Swine Flu,'' sparks
significant global concern and attention and reminds us that
global health challenges are challenges to the health of our
own Nation and the entire international community. We truly
live in a global village and it has been no more apparent than
it is today. Indeed to date, our own hemisphere is most
affected. The first identified cases occurred in Mexico in
March where 590 cases and 25 deaths had been reported, followed
by 286 cases and one death in the United States and 140 cases
and 0 deaths in Canada. On April 29th the World Health
Organization raised its influenza pandemic alert to level five,
a strong signal that a pandemic is eminent. Many questions
remains deg. as to the exact origin of the virus
strain. And while it contains genetic material from flu strains
usually found in swine, pigs have not yet been identified as a
source of human transmission. The association with pigs could
be injurious to the swine industry; and there has been a
request that Members of Congress refer to the strain by one of
its technical terms.
There are many issues associated with this H1N1 virus. The
WHO Phase 5 alert level carries with it a series of public
health measures that countries are expected to adopt to avert a
crisis. Among other issues, this hearing will focus on is how
global health emergencies such as this one challenge the public
health infrastructures of developing nations; and we hope to
learn more about the assistance that the United States is
providing to address these worldwide weaknesses. While no cases
have been confirmed to date in African countries, I am
concerned that the lack of reported cases of H1N1 in Africa may
actually represent the absence of the ability to detect the
virus strain, which could mean that the true impact of this
strain is yet to be seen. Adding to concerns there have been
several recent deaths in Southeast Asia and Africa caused by
the avian flu. These issues underscore the need for greater
investment in health systems in Africa in particular and in
other developing regions.
We will also discuss funding.
As you know, the 2009 Supplemental Appropriations include
$2 billion to fight pandemic flu--$1.5 billion which goes to
Health and Human Services and Centers for Disease Control for
Federal stockpiles, vaccines and detections. Of the remaining
funding, $350 million goes toward State and local response, and
$200 million for global efforts.
President Obama has shown incredible leadership on global
health this week, just yesterday, announcing $63 billion to be
spent over the next 6 years, starting in Fiscal Year 2010
shaped by a new comprehensive global health strategy. Under
President Obama's new plan, $51 billion will go toward fighting
HIV/AIDS, tuberculosis and malaria through the President's
Emergency Plan for AIDS Relief, as we all know as PEPFAR. The
remaining $12 billion will go toward other global health
priorities such as child and parental health, neglected
tropical diseases and an overall investment in building
capacity in health systems. And this is something that African
nations have said this is what we really need. As we get
assistance to deal with the health crisis, we need to be able
to build a health system, and that is what we will concentrate
on. So when the need for overall assistance from the U.S.
dissipates, the health systems will be in place.
I commend the President for this quantum leap in global
health funding. It shows the United States understands global
health challenges and what we must do because these challenges
can hit us here at home as we have seen in the outbreak of H1N1
virus. As we may recall in 2007, the case of the Atlanta
lawyer, Andrew Speaker, who traveled to Europe and back to the
United States all while infected with the deadly extensively
drug resistant tuberculosis strain known as XDR-TB. There is
also a geopolitical dimension to the H1N1 outbreak. The World
Health Organization cautions that those who are ill should
delay international travel; however, warns that ``limiting
travel and imposing travel restrictions would have very little
effect on stopping the virus from spreading, but also would be
highly disruptive to the global community.''
Despite this warning, China has reportedly quarantined a
number of Mexican nationals living in China. Mexico's response
to this was a ban on flights to China. Last week, the European
Union Health Commission urged Europeans to avoid nonessential
travel to the United States and Mexico, following the
confirmation of a case of the H1N1 virus in Spain. U.S.
Homeland Security Secretary Janet Napolitano explained in a
Senate Homeland Security Committee hearing here last Thursday
stated that closing the United States-Mexican border would
incur more costs and benefits to the United States Government's
effort to stop the spread of the virus. I am sure these and
other issues will allow us to have an in-depth discussion on
this important topic.
So we are pleased today to be joined by our distinguished
panel of government witnesses. First, you will hear from Dr.
Anne Schuchat, the interim deputy director for science and
public health program at the Center for Disease Control and
Prevention. Our second witness is a long-time friend, Dr.
Anthony Fauci, director of the National Institute of Allergies
and Infectious Diseases at the National Institute of Health.
And last but not least, a long-time associate also, Dr. Dennis
Carroll, who serves as special advisor to the acting
administrator on influenza pandemic at USAID. And we will go
through the biographies after we hear remarks from the other
members.
And at this time, I will turn to my colleague from New
Jersey, the ranking member, Mr. Smith, for his opening
statement.
[The prepared statement of Mr. Payne
follows:]Payne statement deg.
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Mr. Smith. Thank you very much, Mr. Chairman, for calling
this very important hearing on the issue of the recent outbreak
of the H1N1 influenza. I am particularly appreciative that our
witnesses have taken the time to be with us this morning, as
they are extremely busy addressing the current situation in
their representative agencies. Thank you for your tremendous
service on behalf of all those who potentially could become
sick, as well as those who are. In its latest update, the World
Health Organization has officially reported 1,516 cases of the
influenza, including 30 deaths, 29 in Mexico. This count does
not include the death of the first United States resident that
is being reported this morning.
Despite that tragic news, it seems that in general, the
virus within the United States is no more infectious or deadly
than the seasonal flu. It is still uncertain as to why Mexico
experienced so many deaths from the Swine Flu and cases in the
United States have been relatively mild. In any event, experts
are warning that we must remain vigilant and take prudent
precautions until more is known about the virus, and there is
concern that a more dangerous reemergence of it could occur in
the fall.
Our country has benefited from procedures set in place
during the Bush administration to respond to such a potential
crisis. President Bush implemented the national pandemic
strategy in 2005 and the domestic readiness group, a broad
interagency panel, which he established to respond to national
emergencies and has been active from the beginning of the
outbreak. We have been fortunate to have a well-developed
system in place for the new administration to utilize, and they
have done so well.
However, despite these efforts that have apparently served
us well, so far some experts are asserting that we need to be
doing even more to prepare for likely pandemics. The National
Biosurveillance Subcommittee that was created by a presidential
directive in 2008 is expected to release its first report soon.
Dr. Larry Brilliant, chairman of that subcommittee, stated in
an article published in last weekend's Wall Street Journal that
the report concludes that our country and the world do not have
adequately early warning biosurveillance capabilities. The NBA
subcommittee will be recommending that ``governments need far
better early warning systems for potential pandemics and other
epidemic threats.''
Dr. Brilliant added that the subcommittee is also
emphasizing that public health be restored to a position of
respect and be given resources commensurate with its duty to
protect us from these and other threats to our health. I look
forward to hearing from our witnesses whether they agree with
this recommendation, and if so whether they have concrete ideas
as to what actions our Government should undertake to address
it. Mr. Chairman, the Global Health Initiative announced
yesterday by President Barack Obama could be an early and
timely response to this recommendation by the National
Biosurveillance Advisory Subcommittee.
In his announcement, President Obama referred to the
outbreak of the H1N1 virus and the need to address public
health challenges beyond our borders. The additional resources
he is proposing could prove extremely useful to help save lives
as we all become more aware of the importance of addressing
health threats, not only within our own borders, but around the
world.
However, the President emphasized that his initiative will
be pursuing a ``integrated approach to global health,'' and the
administration has indicated that reproductive health is high
on its list of priorities. Therefore this new initiative must
be assessed in the context of the statements made by Secretary
of State Hillary Clinton during a Foreign Affairs Committee 2
weeks ago that this administration's definition of reproductive
health also includes access to abortion.
I would note with extreme concern that this announcement
follows the President's rescission of the Mexico City policy
that prevented taxpayer monies from going to foreign
nongovernment organizations that perform and promote abortion
as a method of family planning. As you know, Mr. Chairman, the
bipartisan support that resulted in the passage of the Tom
Lantos and Henry J. Hyde U.S. Global Leadership Act against
HIV/AIDS, tuberculosis and malaria last year was the result of
a consensus that rejected references to the integration and
other linkages of reproductive health services with HIV/AIDS
and malaria programs.
Any attempt by this Congress or the new administration to
break that consensus and to direct billions of dollars to
organizations that kill unborn babies by way of chemical
poisoning or dismemberment, and wounding their mothers instead
of to organizations and programs that will save lives and
improve the health of all children, born or unborn, women and
men, will destroy that consensus.
President Obama and his administration should be working to
galvanize bipartisan political support to address the major
global health challenges of our time, not to channel money to
groups that seek to destroy the most vulnerable, the unborn
child. I look forward to learning more from the administration
as to how they will address this sensitive and extremely
important human rights issue. The human rights of the unborn is
the human rights issue of our day, and I believe, passionately,
that the most persecuted minority in our world today are unborn
children.
In his brilliant article, Dr. Brilliant also describes his
participation in eradication of smallpox and the importance of
pursuing public health initiatives to prevent or end other
health threats.
Early in my tenure in Congress, I had personal experience
of both the importance and the possibility of making public
health a priority even in most difficult circumstances. During
the FML conflict in El Salvador in the early 1980s, I visited
on several occasions vaccination sites sponsored by UNICEF and
the United States during which days of
tranquil deg.lity were agreed to by both fighting
factions. For 3 days the fighting stopped on one of those
occasions so that upwards of 250,000 children could be
vaccinated against polio, measles, diphtheria, tetanus and
whooping cough.
Since then, days of tranquility have been implemented in
other countries including and Lebanon, Sudan, Iraq and Sierra
Leone. This experience impressed upon me the public can be
galvanized when people realize that the goal is to save the
health and life of children. I am sure the same public will
exist to address major health hazards that threaten our global
community as a whole. It is extremely important for those of us
in Congress to understand the health threats that face our
world, including this new virus and the possible means of
preventing or eradicating them. And again, I thank you, Mr.
Chairman, and again, I welcome our distinguished witnesses.
Mr. Payne. Thank you very much. At this time we will hear
from our other subcommittee members. Ms. Woolsey, an opening
statement?
Ms. Woolsey. Thank you, Mr. Chairman. If everybody else
would waive their opening statements, I will because we have a
10 o'clock markup and these nice people have been sitting here.
Mr. Payne. Thank you. Dr. Boozman.
Mr. Boozman. I agree.
Mr. Payne. Thank you. Ms. Lee. Thank you. Ms. Jackson Lee,
do you waive your opening statement?
Ms. Jackson Lee. Mr. Chairman, I will have to leave for a
markup as well, so I will just simply say that because of the
two deaths in the United States were in Texas, let me thank the
witnesses for the faith they put on this cause. I do think we
have a pending pandemic. And I want to thank the chairman for
holding this hearing, and I hope to be able to engage with all
of you as witnesses. Thank you very much. I yield back.
Mr. Payne. Thank you very much. We have a very
distinguished panel today. And we will hear from them. Dr.
Schuchat, Dr. Fauci and Dr. Carroll. First, Dr. Anne Schuchat,
the interim deputy director for science and public health
program, has been at CDC since 1988 when she entered the U.S.
Public Health Service as an epidemic intelligence service
officer. She has made significant contributions to prevent
infectious diseases in children through her work, informing
vaccine and prevention policies, developing guidelines and
disease monitoring systems, conducting pre- and post-licensure
vaccine evaluations and collaborating with international,
national and state partners to accelerate the availability of
vaccine and prevention programs. Internationally she has worked
in West Africa on meningitis and pneumonia vaccine studies, in
South Africa on surveillance and prevention projects, and in
China on SARS emergency.
Dr. Schuchat graduated with highest honors from Swarthmore
College and with honors from Dartmouth Medical School. She
completed residency training in internal medicine at New York
University's Manhattan VA Hospital. She has co-authored more
than 180 scientific articles and received numerous awards,
including the Public Health Services Meritorious Service Medal,
and the Physicians Research Officer of the Year for her
contributions to preventing group B streptococcal infections in
newborns.
Dr. Schuchat assumed leadership of CDC's National Center
for Immunization and Respiratory Diseases in December 2005. In
2006, she was promoted to the rank of assistant surgeon general
within the U.S. Public Health Service; and in 2008, she was
elected to the Institute of Medicine. In February 2009, she
began a detail serving as CDC's deputy director for science and
public health program.
Next we have Dr. Anthony Fauci, who has been the director
of the National Institute of Allergy and Infectious Diseases
(NIAID) since 1984 and came to the National Institutes of
Health in 1968. In his position, he oversees an extensive
research portfolio on basic and applied research to prevent,
diagnose and treat infectious diseases, such as, HIV/AIDS and
other sexually transmitted infections, influenza, tuberculosis,
malaria and illnesses from potential agents of bioterrorism.
NIAID also supports research on transplantation in immune
related illnesses, including audio-immune disorders, asthma and
allergies.
Dr. Fauci serves as one of the key advisors to the White
House and the Department of Health and Human Services on global
AIDS issues and on initiatives to bolster medical and public
health preparedness against emerging infectious diseases such
as pandemic influenza.
Dr. Fauci received his M.D. degree from Cornell University
Medical College in 1966 and completed his residency at the New
York Hospital Cornell Medical Center. Dr. Fauci has made many
contributions to basic and clinical research on pathogenic and
treatment immunizing mediated and infectious diseases.
He has pioneered the field of human immunoregulation by
making a number of scientific observations that served as the
basis for a current understanding of the regulations of the
human immune response. In addition, Dr. Fauci is widely
recognized for delineating the precise mechanism whereby
immunosuppressive agents modulate the human immune response--I
am going to end up being a doctor--Dr. Fauci is a recipient of
many awards, including the Presidential Medal of Freedom, which
is very prestigious, and 34 honorary doctorate degrees from
universities.
Finally, testifying on behalf of USAID is Dr. Dennis
Carroll, who is the special advisor for the United States
Agency for International Development's, acting administrator on
pandemic influenza. He also serves as director of the USAID's
Avian and Pandemic Influenza Preparedness and Response Unit,
which oversees the agency's response to avian and pandemic
influenza. From 1991 to 2005, Dr. Carroll served as the senior
infectious disease advisor for USAID and was responsible for
providing strategic and operational leadership for USAID's
infectious disease program. Dr. Carroll has a Ph.D. in
molecular biochemistry from the University of Massachusetts at
Amherst with a specialized focus on tropical infectious
diseases. He was a research scientist at Cold Spring Harbor
Laboratory where he studied the molecular mechanisms of viral
infections.
At this time now, I will turn to our first witness, Dr.
Schuchat.
STATEMENT OF REAR ADMIRAL ANNE SCHUCHAT, M.D., INTERIM DEPUTY
DIRECTOR FOR SCIENCE AND PUBLIC HEALTH PROGRAM, CENTER FOR
DISEASE CONTROL AND PREVENTION
Dr. Schuchat. Good morning, Chairman Payne, Ranking Member
Smith, and other distinguished members of the subcommittee. I
am Dr. Anne Schuchat, the acting deputy director for science
and program at the Centers for Disease Control and Prevention,
and I appreciate the opportunity to speak with you this morning
about the current outbreak of a novel H1N1 influenza virus and
to focus on the global implications of the outbreak and the
steps being taken by CDC and our global partners to mitigate
this problem. We share the concern of people around the U.S.
and the globe, and particularly those in Texas, who have been
impacted by this outbreak, and are responding aggressively at
the international, Federal, State and local level, to
understand the complexities of this situation and to implement
control measures. Our aggressive actions are possible in many
respects because of investments and support of the Congress in
U.S. pandemic preparedness, which has provided us with many of
the tools we are using today to detect, track and control the
outbreak and its impact. This support has also enabled the
critical work of State and local public health officials across
the country.
In a global context the work of the committee in promoting
global health through programs such as PEPFAR and the
President's Malaria Initiative have been critical in improving
the capacity of health systems that will be relied upon with
this outbreak. Once again, we are reminded that global public
health is inextricably linked with the health of the American
people and that investments in global health have a direct
benefit to our own health. I have noted in the written
statement some of the important investments we have made in
global pandemic preparedness, in global disease detection and
the remarkable international collaborations taking place to
address the threat from this new virus. In summary, without
these global mechanisms to detect disease, share information
across the globe and cooperate on response we would not be able
to mount the effective response we have carried out to date.
Influenza viruses are extremely unpredictable, making it
hard to anticipate the course of this outbreak with any
certainty. We have seen an increase in the number of cases and
the number of States and the countries affected and we expect
more. We are carefully monitoring the severity of illness
caused by this virus. While the primary evidence as of today is
encouraging we understand that this too could change. Amid this
uncertainty, we hope to be clear in communicating what we do
know, acknowledge the uncertainties, clearly communicate what
we are doing to protect the health of Americans and people
around the world and help people understand the steps that they
can take to protect their own health and that of their families
and their communities.
As we look to the future, we will be looking carefully and
are already providing assistance to countries in the southern
hemisphere where influenza season is now beginning, both to
help them respond and to examine clues about the direction that
this epidemic will take. Unfortunately, as with many public
health problems, lack of infrastructure and resources mean
developing countries in particular can expect to bear a
significant burden in this epidemic, and we hope to provide
assistance to mitigate the impact that the epidemic may have.
Influenza arises from a variety of sources. And in this
case, we have determined that we have a novel 2001--2009 H1N1
virus circulating around the globe that contains genetic pieces
from four different virus sources. We have been able to move
within 2 short weeks to identify this novel virus, understand
the complete genetic characteristics and compare the genetic
composition of specimens from U.S. patients to others around
the globe to watch for mutations.
We have also with unprecedented speed developed and
deployed test kits for use in a widening network of
laboratories, both here in the United States and around the
world. These steps, along with capacity in place as a result of
effective planning, have allowed for the rapid diagnostics in
epidemiology that have contributed to a clearer understanding
of the transmission and the current severity of illness caused
by the virus. These scientific accomplishments have provided
the basis for an evolving set of responses that greatly enhance
our Nation's ability to address this threat. CDC has determined
that this virus is contagious. It is spreading from human to
human, similarly to the way that seasonal influenza spreads
through causing or sneezing.
Sometimes people may become infected by touching something
with a flu virus on it and then touching their mouth or nose.
There is no evidence to suggest that this virus has been found
in swine in the U.S. and there have been no illnesses
attributed to eating pork or pork products, so there is no
evidence you can get this influenza from eating pork or pork
products. As of this morning, according to the World Health
Organization, a total of 1,516 cases have been confirmed in 22
countries, including Guatemala, which was added to the list
today. Here in the U.S., we have 403 confirmed cases and 702
probable cases for a total of 1,105. Aggressive actions are
being taken here as well as abroad.
We are working very closely with state and local health
officials around the U.S. to investigate and implement control
measures. We are providing both technical support on the
epidemiology, as well as laboratory support for confirming
cases. We are working with our international partners on this
outbreak, including a collaborative effort in Mexico to better
understand the outbreak to enhance surveillance and strengthen
laboratory capacity, and we are working closely with multiple
Federal partners to ensure that our efforts are coordinated and
effective.
Yesterday we updated our guidance on school closings based
on a more clear understanding of the severity of illness. A key
message we have from CDC is that there is a role for everyone
to play during an outbreak, at the individual level for people
to understand how they can prevent respiratory infections, with
frequent hand washing, staying home if you are sick, keeping
your children home if they are sick and if you are ill not
getting on an airplane or taking public transport where you may
spread the infection. We think that personal responsibility for
these things will help reduce the spread of this new virus as
well as other respiratory illnesses. The path this outbreak may
take may change and we need to be prepared for a return of this
virus here in the U.S. in the fall.
It is important that public officials continue to think
about what might be needed if this outbreak deepens in
communities here in the U.S. We have encouraged communities,
businesses, schools and local governments to make specific
plans for how to manage this outbreak if cases appear in their
communities and advise parents to prepare for what they would
do in terms of their own children's illness. We continually
monitor the path and severity of the outbreak and have adapted
our guidance accordingly, as we did yesterday with the change
in our school guidance. We are mindful that science is a
critical component in decision making about how communities
respond and that there are many other considerations that
communities must evaluate in making appropriate decisions.
Whenever we see a novel strain of influenza, we begin to work
toward the development of a vaccine in case one will need to be
produced.
CDC is working to develop a vaccine seed strain specific to
this novel virus, the first step in manufacturing. We have
initiated steps so that should we need to manufacture a vaccine
in terms of the U.S. Government's role we can work toward that
goal very quickly. And rapid progress will be possible through
the combined efforts of CDC, NIH, FDA, BARDA and the
manufacturers. Another critical component of our response has
been our deployment of the strategic national stockpile of
medications and personal protective equipment.
Finally, it is important to recognize that with the strong
support of the Congress, there have been enormous efforts in
the U.S. to prepare for this kind of an outbreak and a
pandemic. Our detection of this strain in the U.S. came as a
result of that investment and our enhanced surveillance and
laboratory capacity are critical to understanding and
mitigating the threat. The investments made in global health
and development will prove crucial pieces of the global health
system that will be needed to respond.
While we must remain vigilant throughout this and
subsequent outbreaks, it is important to note that at no time
in our history have we been more prepared to face this kind of
challenge. And as we face the challenge in the weeks ahead we
look forward to working closely with you in the committee and
Congress in general to best address this evolving situation.
Thank you.
Mr. Payne. Thank you very much.
[The prepared statement of Dr. Schuchat
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Mr. Payne. Dr. Fauci.
STATEMENT OF ANTHONY FAUCI, M.D., DIRECTOR, NATIONAL INSTITUTE
OF ALLERGIES AND INFECTIOUS DISEASES, NATIONAL INSTITUTE OF
HEALTH
Dr. Fauci. Thank you very much, Mr. Chairman, Ranking
Member Smith, members of the committee, thank you for calling
this hearing and thank you for giving me the opportunity to
briefly describe for you today the role of the NIH's research
efforts in addressing the problem that we are facing now with
the H1N1 new novel influenza A. On this first visual I would
like to first take a brief moment to describe the difference
between what we call seasonal flu and pandemic flu. As you see
on this visual, the influenza virus is made up of a number of
components. We identify influenza by two proteins on its
surface called hemagglutinin and neuraminidase, and hence, the
terminology H and N and the designation here of H1N1; and
seasonal flus also have H3N2.
Each year, we have a relatively predictable annual
occurrence of seasonal flu that from one year to another may
modify slightly in what we call a drift, a little bit different
from one year to another, which necessitates sometimes a
modification of our seasonal influenza program for vaccination.
However it doesn't change enough to leave the population
vulnerable with no background immunity. Rarely in the last
century--three times--we have a major change which we refer to
as a shift. This situation is unpredictable. And the population
is naive to this particular virus because they have never had
any personal experience with it. That is the case that we are
facing now with the novel H1N1.
But before we go on, it is important to put into context
seasonal influenza which is underappreciated as a serious issue
with 36,000 deaths each year in the United States and about
200,000 excess hospitalization and significant economic impact.
The concern we all have is that will this turn into a pandemic.
So if you look on this slide here, there were three historic
pandemics in the 21st century. One which was catastrophic, the
1918, what we call Spanish flu, in which about 50 million
people died worldwide. In 1957 was another new virus that was
moderately severe. And in 1968 was the first time we saw the
H3N2, which, in fact, was relatively mild in the sense that it
wasn't significantly different than what we see in a regular
seasonal flu.
So the point to be made is that pandemics occur for sure,
but they vary widely in their degree of severity. So now
quickly moving on what about the NIH and what we are doing in
partnership with our sister agencies, the CDC and the FDA, our
responsibility is the basic and clinical research. As shown on
this slide, what we do is founded in a basic research study and
research resources which we make available to the academic
research community and the pharmaceutical companies. We also
have clinical research networks that allow for clinical trials.
All of this is directed to the ultimate goal of developing
countermeasures in the form of therapeutics, diagnostics and
vaccines. So, quickly, we will start with basic research.
The CDC, as you have heard from Dr. Schuchat, has already
isolated and characterized the virus and made it available to
the NIH as well as to giving us the opportunity to make it
available to our grantees and contractors to study intensively.
And when we say study intensively, we do sophisticated work on
delineating the molecular analysis or the molecular
fingerprints that might predict which way this virus may go,
because as you have heard, it is quite unpredictable; studies
on transmissibility in animal models such as the mouse, the
ferret and the nonhuman primate; how the virus might
molecularly evolve; and importantly its pathogenesis and
virulence, what are the molecular correlates for it being a
very virulent virus or not; and finally, relevant to vaccine
development, what kind of immune response does it elicit and
what kind of immune response is protective.
On the next visual, you see the map of the United States
showing the network of a Vaccine and Treatment Evaluation Units
which will be used in clinical trials of pilot lots that will
be made from the seed viruses that the CDC is now growing in
preparation for the multi-step process of developing a vaccine,
which is shown on this next slide. It is a very well-delineated
process that we go through when we develop a vaccine for any
microbe, in this case, influenza. First you get the virus. The
CDC has done that. You start to grow it up as a reference
strain or aseed virus. This allows the further growth. And in
this case we get that seed virus which is currently now being
grown by the CDC and will be made available to the
pharmaceutical companies to grow up for what we call pilot
lots.
A pilot lot is tested in humans for three things: Is it
safe, does it induce an immune response that you would predict
would be protective, and thirdly what is the right dose and
dose regimen, how many doses would you need? The decision to
scale up and manufacture tens of millions of doses has not been
made at this point, nor has any decision been made regarding
the administration. We are just in the early part of the step-
wise process of developing a vaccine. And on this final slide I
just want to reiterate what we said in the very beginning. The
relationship between the preparedness of seasonal influenza
versus pandemic influenza. What we learn from one we apply to
the other and vice versa. We had a pandemic plan from 2005
which we have implemented. And the resources that have been put
in thanks to the Congress and your support for us have allowed
us to be at the level of preparedness where we are right now.
Thank you very much. I would be happy to answer questions
after. Thank you.
[The prepared statement of Dr. Fauci
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Mr. Payne. Thank you very much.
STATEMENT OF DENNIS CARROLL, M.D., SPECIAL ADVISOR TO THE
ACTING ADMINISTRATOR, ON PANDEMIC INFLUENZA, UNITED STATES
AGENCY FOR INTERNATIONAL DEVELOPMENT
Dr. Carroll. Chairman Payne, Representative Smith and other
distinguished members of the subcommittee. First off, I would
like to thank you for convening this committee. I think we all
appreciate its significance and certainly the topic which
brings us here today. But I would also like to extend the
thanks of USAID to this committee for the strong support you
have provided over the years to our global health program. In
my written comments, I discuss at some length USAID's response
to the recent events in Mexico as part of the larger effort by
the United States Government.
In these remarks today I would like to focus more
specifically on two aspects of USAID's overall effort to
address the threats posed by a pandemic with a particular focus
on USAIDS deg.'s primary responsibility as the
international response and humanitarian assistance role that we
have. USAID has been helping to prepare for just such an event,
as we have seen rollout over the last several weeks, over the
past 3 years. And as a previous talker have referred to the
efforts underway having to do with H5N1 avian influenza, work
that we have been doing since 2005 specifically supported by
this Congress, have really established a platform which has
allowed significant capabilities that otherwise had not
previously been available.
What I would like to do is to just talk about some of those
capabilities today and how they may play themselves out in the
coming months. First off, in terms of a pandemic preparedness
program focusing on global response capabilities: USAID has
partnered through a U.N. family of agencies, the International
Federation of Red Cross and Red Crescent Societies and a
coalition of humanitarian response nongovernmental
organizations to work with WHO, our colleagues at Centers for
Disease Control and other international partners to focus on 30
countries in Asia, Africa and Latin America that have been
specifically identified as countries of high risk consequences
in terms of a potential pandemic. And with these countries we
have been working to mobilize pandemic preparedness planning.
Whereas coordinated efforts to respond to disaster such as
pandemics usually begin only after the disaster has occurred,
the concerns of a global pandemic caused by avian influenza
created an unprecedented opportunity to develop planning and
coordination for a pandemic in advance of the event.
Because of this work, a developing country's ability to
respond to a pandemic today while still far from perfect will
be both better and faster than it otherwise would have been
possible in years past. While the world remains at Phase 5
USAID is engaged in several critical activities to help monitor
the progress of the H1N1 novel virus and assist countries in
preparing for a possible Phase 6 pandemic. These activities
include testing--first off, testing the appropriate of national
pandemic plans. Just last week, USAID supported a regional
pandemic readiness exercise as part of our avian and pandemic
preparedness program in Addis Ababa, Ethiopia. Country
representatives from seven east African countries were able to
draw from their experiences developing national pandemic plans
to test them in real-time context of a possible H1N1 pandemic.
We have similar exercises already planned for South African
countries in June and Asian countries in August. In addition,
USAID is working closely with the Department of Defense and its
specific and African combatant commands PACOM and AFRICOM to
provide direct military-to-military assistance in these 30
countries across Africa and Asia to strengthen their own
readiness, the readiness of the military to work in concert
with civilian authorities to ensure the military is fully
prepared and capable of executing their responsibilities during
a pandemic.
And in just 2 weeks as part of USAIDS deg.'s
pandemic preparedness program USAID will co-host with AFRICOM
and PACOM and the U.N.'s world food program a joint pandemic
preparedness exercise in Rome involving 27 countries and their
military representatives from Africa and Asia. USAID will also
continue to support activities that directly contribute to
tracking the circulation of the novel H1N1 virus in both human
and swine populations worldwide.
As noted by President Obama, even if it turns out that the
H1N1 virus is relatively mild in the front end, it could come
back in a more virulent form during the actual flu season. It
is important to note that in the 1918-1919 influenza pandemic,
which also began the virus emerged first in the spring
relatively mild for 6 months until the second pandemic wave
revised in a much more lethal version that October. With the
advent of influenza season in the Southern Hemisphere now it
will be critical that we are able to monitor changes in the
virus' virulence and transmissibility and mobilize effective
response should it occur.
USAID has also as part of its avian and pandemic influenza
program, which we have now adapted to our H1N1 novel virus
response, established an emergency stockpile of more than
800,000 personal protective equipment kits, PPEs that include
protective gowns, gloves, goggles and masks, 100,000 of which
just this past Saturday arrived in Mexico City, the remaining
being equivalently ready for rapid deployment as needed. These
kits protect health care providers as well as case
investigators.
To date USAID has also prepositioned an additional 400,000
kits in 82 countries for use in the event of a pandemic. But
even as we mobilize to respond to the threat of H1N1 or the
earlier emergence of the H5N1 avian influenza virus, it is
important that we appreciate that their emergence is indicative
of a broader dynamic that over the past half century has given
rise to a steady stream of new and increasingly deadly diseases
that originate in animals. In fact, 75 percent of all new
emergent diseases that have emerged in the past 50 years their
origin are animal.
Having already identified this rising threat as a major new
area of focus USAID coincidentally announced last Wednesday at
a conference we had organized a new emerging pandemic threats
program using Fiscal Year 2009 monies which we plan to have
fully launched by October of this year, this program which we
will initiate in strong collaboration with our colleagues from
the Centers for Disease Control and prevention, as well as our
colleagues from the U.S. Department of Agriculture, is intended
to support the development of a global early warning system for
the threat posed by diseases of animal origin that infect
humans.
The objective of this new program is, in fact, a preempt
for combat at their source the emergence of new diseases of
animals such as H5N1, H1N1 or even the earlier SARS or HIV that
pose significant threats to public health. I need to be very
clear that this effort builds on the agency's ongoing work for
H5N1. Clearly the platforms which have been supported by this
Congress to respond to H5N1 has given us new capabilities and
understandings to address these threats and mobilize a global
response that should allow us to better predict and respond and
in effect put the canary back in the mine shaft.
In closing, let me say that even as we do not yet know how
severe the novel H1N1 pandemic will be or how long it will
last, as the lead U.S. agency for foreign disaster assistance
we will continue to provide emergency support to countries in
response to this threat. However, even in the face of the
immediate threat posed by H1N1 recent history has been very
clear on a core lesson, we must remain vigilant in our response
to the larger threat posed by emerging pandemic diseases if we
are to be able to ensure a secure future for the world's
population. Thank you very much.
[The prepared statement of Dr. Carroll
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Mr. Payne. Let me thank all of the panelists for your very
insightful testimony. I will yield to the gentlelady from Texas
who says she has to leave to conduct a hearing herself. And
because of the death of a Texan, I will yield to let her ask a
question before she leaves.
Ms. Jackson Lee. Thank you, Mr. Chairman. I will, in
essence, put these two questions on the record and probably
will not be able to be here for the response, but I would
greatly appreciate the response because I believe Texas has
been the epicenter, particularly for its proximity to Mexico in
the increasing number of cases that we seem to be determining.
One, what will be the reimbursement procedures for health
facilities, the clinics and city and county health entities
that have been in the midst of this? And I convened a meeting
of these individuals last Friday and they do have a long
litany. Two, will you continue to provide the, I believe it is
the laboratory resource network 1-day testing confirmation
which is urgent?
And three, will you as we move into the graduation season
our school districts in Texas, universities, are in a flux
about whether or not these large venues will be allowed to
continue? And I would very much thank you for the answers to
those questions. Mr. Chairman, thank you very much and I yield
back.
Mr. Payne. Thank you. We will now hear from the ranking
member, Mr. Smith, and then we will hear from Representative
Woolsey who also indicated she has to leave. If you want to go
first Mr. Smith said that he would yield to you.
Ms. Woolsey. I don't have to go right yet. I have about 5
minutes.
Mr. Payne. All right. Then I will yield to the ranking
member.
Mr. Smith. Thank you. Again, I want to thank our very
distinguished witnesses for the great work you are doing, but
also the insights you are providing to the committee today.
First, Dr. Carroll. The USAID reported that the humanitarian
pandemic preparedness initiative convened a 3-day conference or
exercise to improve the capacity to avert and respond to the
pandemic in east Africa. You indicated that some other similar
types of exercises are likely to occur. What kind of
deficiencies are we gleaning from that exercise as they exist
among some of these countries? You talked about some 800,000
personal protective equipment kits being deployed. And I would
suspect that is for the health care workers especially so that
they can go out and do their work without contracting the
disease. But what was learned in terms of any gaps that need to
be fixed from those exercises.
Dr. Carroll. Congressman Smith, thank you very much for
this question. And in fact, it is an important one because from
a humanitarian response perspective, having the opportunity to
prepare for a disaster in advance is a rare opportunity. For
tsunamis or earthquakes, we are usually in a reactive mode. And
one of the critical challenges and frequently one of the
critical failures of an emergency disaster response is poor
coordination. One of my colleagues who specializes in emergency
response has frequently commented that when they write on the
death certificate, the cause of death, more often than not, it
should not be malaria or diarrhea, it should be poor
coordination.
I say that point because the exercises in Addis Ababa and
shortly in Johannesburg, and then in Ho Chi Minh City are
intended to bring national authorities together across civilian
nongovernmental and military representatives to arc out and
clearly identify roles and responsibilities, to establish in
advance coordination principles, and to ensure that the lines
of authority and the lines of appropriate action are there,
understood and that they have an opportunity in these meetings,
such as we just hosted in Addis Ababa, to go through a
simulation exercise that allows them to test their plans,
identify their weaknesses and then to be able to further
improve and refine.
The other advantage of these meetings, these regional
gatherings is that there also is significant issues having to
do with cross-border movement of populations. And these fora
also offer that opportunity for national authorities to
interact with each other and to identify what might be some of
the critical issues which certainly have arisen in our own
situation between the United States and Mexico.
So those are the key issues. I can say Addis Ababa
certainly benefited by the timing from H1N1. And we look
forward to certainly the activities rolling out in Johannesburg
and Ho Chi Minh City, and as I mentioned, we have a similar
exercise in Rome with respect to the mill-to-mill activities as
well.
Mr. Smith. Just one quick follow-up. I have some more for
the second round. Is any special attention being paid to those
countries where the system really is broken, particularly in a
dictatorship, particularly in a place like Sudan which could
quickly find all of its current problems exacerbated and
exponentially confounded by--or compounded, I should say, by a
pandemic breaking out.
It seems to me that the vulnerable become even more
vulnerable. And what provision--we are talking about
stockpiling Tamiflu and other kinds of interventions to help
alleviate those who contract it. The developing world and the
poor, will they have access to those as well.
Dr. Carroll. Well, let me say two things: Part of the issue
that you talked about was the ability to deliver, delivery
services. That is one of the reasons we have gone into a
partnership for instance with the International Federation of
Red Cross and Red Crescents. They frequently act as a
parastatal responsible for humanitarian response. And clearly,
when you think about Sudan, they have a critical role to play
in countries where governance is clearly an issue. In terms of
the services that are looking to be provided, we are right now
going through our Fiscal Year 2009 budget, and in particular,
looking at our avian and pandemic influenza resources, to see
to what extent we might be able to free up resources with an
eye toward being able to make immediate contributions to the
kind of expanded commodity support beyond that related to the
protective equipment that we already have.
And so we are working closely with our colleagues at
Centers for Disease Control to identify what those resource
needs might be and then look at how we might best be able to
address both pharmaceutical and nonpharmaceutical as well as
delivery competencies.
Mr. Payne. Thank you very much. Representative Woolsey.
Ms. Woolsey. Thank you, Mr. Chairman. Somebody has to help
me with this, and I think you can, because I don't think I am
the only one that is looking for the big picture in questioning
how when we have for the seasonal flu 3 million to 5 million
people getting the flu every year and internationally 250,000
to 5,000 people dying.
In the United States, the average is 36,000 deaths from
seasonal flu. And so far this year, 13,000 deaths. Okay, where
along this H1N1 line, where do we get to the point, and what
are you looking for until this becomes ho-hum seasonal flu. I
mean, because it just seems out of context. Go ahead, Dr.
Schuchat.
Dr. Schuchat. Seasonal influenza does have a large toll on
health in the United States, despite the fact that we vaccinate
many people for it, and that many people are immune already
because of exposure to similar viruses. The difference with a
new influenza virus like what we see right now is that we don't
expect very many people in the general population to already be
protected.
So it means everybody is vulnerable. Your question of
whether this particular new virus is going to look like
seasonal influenza in terms of that 36,000 deaths in the U.S.
will it look worse than that, substantially worse than that or
not that bad, we unfortunately don't know.
We know that this influenza virus can cause severe disease
just like the seasonal strains can, and we know that it is
easily transmissible, as we have seen in the New York City
school outbreak, and so forth. But we don't know whether over
the weeks ahead it will just fizzle out or not come back in the
fall season or whether it will mutate and become a bit more
severe or whether it will have a similar amount of severity as
it has right now. If it keeps this similar severity, we are
concerned that among the people who are sick and who are
becoming hospitalized are younger persons who don't usually get
hospitalized with flu, seasonal flu.
So unfortunately, we don't have that crystal ball and with
influenza, a new strain in particular, our predictions really
need to be cautious.
Dr. Fauci. Just to add to that, Congresswoman Woolsey, as
we have said all along, influenza viruses are inherently
unpredictable anyway. When you have a virus that you have never
had experience with before, that compounds the
unpredictability. So I don't think any of us are going to feel
this will become ho-hum, as you said. We have to continue to
watch what it is doing and what happens in the fall and winter.
So there are a lot of things that we are still uncertain about,
as Dr. Schuchat said. So I don't think this will become a ho-
hum thing. Even if it remains relatively mild and acts like a
seasonal flu, we are going to be watching this very carefully.
Ms. Woolsey. Mr. Chairman, just a remark because I do have
to leave. I was in Tanzania over the Easter break. The women
giving birth have to bring their own gloves to the clinics and
their own supplies. How are you going to distribute these kits?
I just can't see how that can happen.
Dr. Carroll. Thank you. Congresswoman, obviously it is a
challenge. There is no question about that. Africa has been a
remarkable challenge in terms of meeting the infrastructure
needs, and the human resource issues plaguing the health
systems there are enormous. Quality control issues are a major
challenge. Let me say we have drafted an initial plan about
service delivery, part of it having to do with infection
control within health facilities, within the various settings
that you are talking about. So part of this review we are going
through right now is to really focus in on those countries
where we feel the vulnerabilities are greatest and what lines
of action questions take. Infection control, as you were
describing, right now is clearly a major issue. So we will be
working with our international and U.S. colleagues to assess
how we can most effectively do this in an environment, as you
know, that is very, very challenging.
Ms. Woolsey. Thank you, Mr. Chairman.
Mr. Payne. Thank you. Congresswoman Lee.
Ms. Lee. Thank you very much, Mr. Chairman, and good
morning. I want to thank all of our witnesses for being here
and presenting your very clear and succinct testimony. Let me
ask you, going back to the continent of Africa, noting that
there have been no reported H1N1 diagnoses, surveillance we
know is an issue on the continent. What health care systems in
terms of labs, in terms of health care workers is an issue?
Infrastructure. What do you think is going on on the continent?
Can we anticipate cases or do we believe that for whatever
reason there just are no cases on the continent of Africa, and
also what should we be doing?
And I was just reading the President's statement, which I
think is a great statement, and I am going to also commend him
for his leadership because we all recognize that not only is
this a public health emergency and a humanitarian crisis, but
also a national security issue that we have to recognize as
such. And this is the way to address it within a comprehensive
fashion. So in terms of the continent of Africa, what do you
think are some of the key investments that we need to make to
really begin to address this in a big way in terms of the
spread of this disease and other diseases, and also what do you
think the real reason is that we don't see any signs yet on the
continent? And none of the countries, as I look at this chart,
have any cases at all.
Dr. Schuchat. I can start with the issue of what is going
on in Africa. One of the values of the investments that have
been made in global health is the international network that we
have on--the CDC has people in over 45 countries working on a
variety of issues, things like PEPFAR, polio eradication,
measles, and our Global Disease Detection Program, and we have
been holding very frequent phone calls with all of our
international staff to both share information of what is going
on here and learn from them situational awareness of what is
happening. Also they have facilitated our providing these
diagnostic kits for the new virus so laboratories in some of
these countries will be able to test right there without
shipping to one of the WHO labs or here to the U.S. at the CDC.
We don't yet have confirmed cases from Africa, but I share your
suspicion that that doesn't mean they haven't happened yet.
There are lots of variables in terms of temperature and
populations and travel.
So where the disease has been confirmed so far, it has been
related initially to travel exposure to Mexico. At this point,
with disease in the United States and Europe and New Zealand
and many other places, the risk for Africa continues. So one of
the issues is how do we find out what is going on, and I think
that is through our investments in laboratory capacity,
epidemiologic capacity, training, so that the next generation
in these countries will be able to detect and respond,
communication and information technology, so that we can know
what is going on and share that information, and really the
governance that allows the different networks to interact. We
are working not just with the CDC network, with the WHO
network, with Pasteur Institute, of course with the USAID
missions.
So I think that--and then the other comment is that some of
Africa is in the Southern Hemisphere, where we would expect a
reverse season from what we are seeing. In particular, we have
a strong collaboration with South Africa, which does have very
good laboratory capacities, and that is a place we are going to
be looking intensively to understand whether this virus emerges
in the summer.
Mr. Carroll. And if I might add to the answer, I think it
is reasonable to assume that this virus will show up in the
subcontinent of Africa. The problem of detecting it will be
significant. There are steps--your question really had a two-
part component, temporal component. What can we do now to make
sure we can pick up this virus at the earliest possible moment
for the purposes of being able to track it, monitor it, and
deliver life saving interventions as needed? But the second
part of your question had to do with seeing this as symptomatic
of a broader array of challenges within Africa in terms of
picking up new diseases and being able to respond.
Specifically, I can tell you two things about that from
USAID's side and again with our partnership with Centers for
Disease Control. We are looking to have a consultation with CDC
next week that will hopefully include WHO and FAO. That will
identify immediate actions that we can take and part of this
reprogramming of some of our resources will be specifically
asking: How can we make investments immediately with resources
on hand to increase the likelihood of picking up this virus? So
create a better, more focused and coordinated effort toward
that end.
The second part of the question has to do with the broader
issue of being able to pick up diseases before they become
large public health threats within the region. I mentioned to
you that we have launched an Emerging Pandemic Threats Program.
This is a 5-year down payment program that has as a central
part of it investing in a network of laboratories within
Africa, specifically intended to increase our ability to
diagnose both within animal and human populations new emergent
pathogens that we will be in a better position to signal when
something novel is occurring and help us to more effectively
respond. So that is part of a systems approach toward
responding to the larger, more long-term challenges.
So two-part, immediate consultations, reprogramming funds,
and creating an opportunity to diagnose now and take
simultaneous steps for the longer term.
Mr. Payne. Thank you very much. At this time, we will hear
from Congresswoman Watson.
Ms. Watson. Thank you, Mr. Chairman. And one thing I would
ask of the witnesses, can you get to the media and ask them to
stop identifying this as Swine Flu? I think that educating the
general public about this new strain is very, very important.
And as I monitor the media, both written, television, and
radio, they are referring to it--that gets people in an uproar,
and it is not Swine Flu. So if you could help us with that, I
would appreciate it.
Let me direct this to Dr. Fauci. I understand there are two
vaccines already, Tamiflu and Relenza, that are on the market
that are sensitive to H1N1. But how close are we--and all of
you can jump in--to finding a particular vaccine that would be
specific to H1N1?
Dr. Fauci. Thank you for the question, Congresswoman
Watson. Tamiflu and Relenza are treatments that are used to
treat people who get infected to mitigate the severity of
disease, and sometimes used as prophylaxis to prevent. Your
question about vaccines is one that we have already started the
process on, the multi-step process toward developing a vaccine.
And as this--I don't think you heard it in my opening
statement, but very briefly what happens when you get into a
situation like this is you isolate and characterize the virus.
The CDC has already done that. They are currently in the
process of developing what we call reference strains or seed
viruses. Seed viruses are grown up for the purpose of
collaborating with our pharmaceutical company partners, to give
it to them so that they can start growing it up in large
amounts for two reasons, sometimes in parallel. It is to
develop what we call pilot lots of a vaccine. We are not there
yet because we are still at the process of the seed virus
growing up to be able to give to them. Pilot lots are then put
into what we call clinical trials by the company themselves or
more often than not by the NIH's clinical trial network to
determine three things. Is it safe, does it induce the kind of
immune response that would be predictive of being protective,
and what is the right dosage and number of doses? At that point
then you have the option, a decision that has not yet been
made, of scaling up a manufacturing, what we call manufacturing
scale-up of tens of millions of doses. You then make a decision
at an another critical point in that process--what you are
going to do with it. Are you going to administer it, what are
you going to do? So right now the very earliest of the stages
of that step-wide process has already begun.
Ms. Watson. Thank you for the information. I am a bit
confused as to who is most susceptible. Is this H1N1 a flu or
strain of flu running across age levels or young people, middle
age, older people? I have heard several different things over
the media.
Dr. Schuchat.
Dr. Schuchat. Sure. Of the cases that we have confirmed
here in the United States, they are primarily in the age groups
of 5 to 50. This is different from the usual influenza season
where we see a lot of disease in seniors as well. We don't know
yet whether this disease will become quite common among older
persons or whether people over 50 may have some protection
against this virus, perhaps because of viruses they saw when
they were young or perhaps because of other factors. But it is
also possible that in the U.S. the virus first emerged in
teenagers and young adults and their social networks are such
that they are spreading to each other before we eventually see
disease in older age groups.
So right now we don't see the pattern of lots of
hospitalizations in very older people and very young people.
Even the hospitalizations that we have primarily are in that
group of 5 to 50.
So it is confusing because the seasonal flu doesn't look
that way in terms of the risk groups we talk about. I would
say, though, that we do have some information already that
people with underlying medical problems might be at higher risk
in terms of our hospitalization data. It is very preliminary,
but as we review those data we do note that some of the people
who are requiring hospitalization have underlying medical
problems that would be classical risk factors for influenza.
So unfortunately, I gave a really long answer,
unfortunately it is early and things may change. But right now
we have a little bit of difference with the seasonal flu and a
little bit of similarity with the underlying diseases.
Ms. Watson. And finally, some of the schools--I am out in
Virginia--are opening back up. Parents are very confused and
they want to be able to plan their lives, and I know that is
kind of improbable at this particular time. But some of the
smaller schools, the private schools are staying closed.
What does that indicate?
Dr. Schuchat. This is a challenging time for families and
communities because information is changing quickly and of
course when our children are involved that hits right to the
heart. The CDC has been working with the State and local public
health officials on the response. We issue guidance to--always
saying that local and State decisions really are important
because of the circumstances in the community, the locals have
so much more information than we do. Yesterday we announced
updated guidance that the schools that were closed could reopen
and that people could really focus on making sure sick children
stay home and that the teachers and parents are attuned to
whether their children are ill and we try to keep the ill
children out and let the other children benefit from school and
school lunches, and so forth.
So I think it is a challenging time and each of those
school authorities are making decisions hopefully in
conjunction with the local public health officials. There are
other circumstances, like whether the teacher has left town and
is able to be back and reopen. So I do think in the next
several days there will be variability. And we want to make
sure that as we find information we get it out and people can
react appropriately.
Ms. Watson. Thank you. Thank you, Mr. Chairman.
Mr. Payne. Thank you. Dr. Schuchat, you mentioned in your
testimony that CDC funds over 30 countries in pandemic
preparedness to improve their ability to detect and respond to
pandemic flu. Would you be able to tell us generally what
countries these are that you are funding?
Dr. Schuchat. Yes. We actually--I believe for influenza we
either directly or indirectly support more than 50 countries.
Some of that is through a person assigned to work in the
country, either with the World Health Organization or the
Ministry of Health. Some of that is through cooperative
agreements where we provide funding for the countries and some
of it is through networks that we are part of. We can provide
the committee a list of the countries. Originally we had some
priority countries related to where the H5N1 virus, the avian
flu virus, was emerging, primarily in Asia and some in Africa.
We have actually expanded to make sure that we have support
really to all of the developing country regions, often through
the World Health Organization regional offices, sometimes
through PAHO.
So even though our eyes were really keenly pointed toward
Asia, we have been working with Latin America on the pandemic
preparedness. But we will be able to offer you a list of the
individual countries. We do have a number of countries in
Africa, and we have 11 countries in the Southern Hemisphere
that have gotten support from us.
Mr. Payne. In Europe, what organization do you work with?
Is it through the EU or individual countries? What is their
CDC/NIH component? Is it the European Parliament?
Dr. Schuchat. There are a number of organizations, and of
course that is one of the important aspects of this, is
coordinating across the governments. We work with the World
Health Organization working in all regions. We also work with
the European CDC. Our CDC in Atlanta has secunded an influenza
expert to the European CDC in Stockholm, and we have been
working very closely with our colleague there over the
situation in Europe. We also have liaisons assigned to the FAO
and the OIE related to all of this human-animal interface work
and understanding what is going on in the animal populations
around the world as well as in the wildlife.
So I think that we are trying to stay connected. A lot of
the leadership globally comes from the World Health
Organization in Geneva with the Director General Margaret Chan.
Mr. Payne. I think I heard you mention some of the
military-to-military, AFRICOM, and so forth. Is there any
component in NATO since that tends to be a quasi-political
although military organization? Have you worked with them in
this area?
Mr. Carroll. Thank you, Chairman. We have not worked with
NATO. The reason we are working with AFRICOM and PACOM is that
we did essentially a risk analysis. Were there a pandemic virus
similar to the one that emerged in 1918, and I can say we did
this with the Central Intelligence Agency, we basically
identified how that might play itself out around the world in
terms of mortality and morbidity using a variety of modeling
factors. Those countries largely fall within the Africa and the
Asia region. Our focus is clearly going after where the risk is
greatest, the burden is maximum.
So where we entered into the agreements with PACOM and
AFRICOM is with a focus toward those countries in that region
where the vulnerability is greatest. With respect to NATO, that
is not something we have direct engagement with.
Thank you.
Mr. Payne. Now, with H5N1, everyone was expecting it to
come back. And in Egypt, where I think there was a real problem
with that, it seems that they went and killed 350,000 pigs. Do
you think it is an overreaction or is it tied into their fear
of the H5N1 and whether there could be a connection between
H1N1 and H5N1?
Mr. Carroll. Again, thank you, Mr. Chairman. Let me first
off say in terms of the Government of Egypt, we have a very
strong and very good program with them, specifically with
respect to H5N1, and they have shown extraordinary leadership
and effectiveness in their program over the last couple of
years. The events over the last week where swine throughout
Egypt have been targeted quite frankly is an unfortunate one.
There has been no documentation of H1N1. It clearly is an
overreaction at this point. And there is no apparent public
health value.
We have been in direct consultation with the Government of
Egypt with respect to this issue, and we will continue to do
so. But our focus remains strengthening their H5N1. And even as
we talk about H1N1, this is an issue of H5N1 that we need not
lose focus on. It remains a very dangerous virus, mortality
rates continue to be in excess of 60 percent. And if I may just
add, H5N1 has been one of those success stories over the last
couple of years. Were we sitting here 3 years ago in 2006, we
would be talking about 53 countries with reported, confirmed
outbreaks of H5N1. We have just finished what is in effect the
H5N1 transmission influenza season end of April. This past
2008-2009 influenza season, that number has gone from 53 down
to 9 countries, and of those 9 countries, 4 countries account
for 95 percent of all outbreaks involving animals or humans. So
there has been a tremendous progress in terms of moving this
virus back, and the platforms that have been invested in for
surveillance, for coordinated response, for communications, for
laboratory strengthening, those are the very platforms we are
looking now to adapt in other parts of the world where the H5N1
is less of a risk now to this broader agenda of dealing with
other emergent disease threats.
So the support you have provided quite frankly has been
hugely successful, led to huge success with this respect and
the U.S. Government across the board has played a
disproportionate leadership role in delivering support for this
global effort. Egypt continues to be a point of concern.
Mr. Payne. Thank you. My last question, and I will yield
back to the ranking member. Dr. Fauci, I am just curious. The
1918 flu had just come out and, you know, 50 million deaths
resulted. There was nothing like it before and nothing like it
after. Is there the potential for another Spanish flu type? Or
what was so peculiar about 1918? Do you know--I mean, it was
just unbelievable that it caused more deaths than the war going
on.
Dr. Fauci. Well, the answer to that is it gets back to what
we had been saying just a little bit ago about the
unpredictability of pandemics, the unpredictability of
influenza, particularly when you have a brand new virus to
which the community has never been exposed. That was the
scenario in 1918 when you had the first H1N1. And as you know,
historically it came in the spring and was acting in a way that
was not substantially different than what you would expect from
a flu. But then it came around in the following fall and
winter, came back with--as we say, with a vengeance and was
very devastating. We don't know the reason for that. We have
studied from a molecular biological standpoint how some of the
signatures that might be related to virulence or not are
spread. But it still remains a mystery how and why that
happened, which is always the case with potential pandemics,
which is one of the reasons why we are so vigilant now and we
take this seriously and continue to take this seriously. We
don't want to get anyone alarmed that it is a 1918 type at all,
and I don't think we should even be talking about that. But the
fact is when you are dealing with brand new viruses, influenza
viruses, to which the population does not have any experience
with, no background immunity, you have to have an overabundance
of diligence and caution, which is what you are seeing right
now in how we are responding right here.
Mr. Payne. And just the last point, how was the breakdown
of the 50 million here in the United States and Europe?
Dr. Fauci. There were 500,000 people in the United States
who died. The 50 million, 40-50 million were distributed
throughout the rest of the world. But in the United States,
there were at least 500,000 people who died in the 1918
pandemic.
Mr. Payne. Thank you. And we won't talk about it anymore,
like you said. We will try to go forward. Thank you.
Mr. Smith.
Mr. Smith. Mr. Chairman, thank you very much. Dr. Schuchat,
if you could with regards to the Global Disease Detection
Program, the GDD centers in Kenya, Guatemala, Thailand,
Kazakhstan, Egypt and China, do they operate in a regional
mode? And are there any countries that are outside of their
reign of influence?
Dr. Schuchat. Yes, the intent of the Global Disease
Detection Centers is to both work with a country through the
Ministry of Health and also to provide regional leadership for
training, for laboratory and epidemiologic capacity
development. At this point, there are six full GDD centers.
There are a few other sites that are carrying out some of the
components, but we don't really have the entire globe covered.
We are making sure that where we do have these integrated
centers, they are able to provide services way beyond the
national borders. But there are some gaps probably around the
world.
Mr. Smith. For the record could you provide what countries
to date have not been included in that regional coverage? It
seems to me an opportunistic infection if all a sudden
something breaks out and it goes less than it could have been
detected had we had that kind of surveillance. If you could
provide that for the record, I would appreciate that.
With regards to our operations in China, what protections--
and this would be for all of the countries of course. But I
spend an enormous amount of time working on human rights
issues, vis-a-vis China, and have grown increasingly alarmed
about their--I even had a hearing in this room on the
transplantation of organs, which is done routinely in China
through the death of the prison or the inmate population. And
there is great concern that Falun Gong, political prisoners,
other political prisoners become fodder for experimentation.
And I am wondering with regards to China in our interface with
them, what protection, what kind of best practices, ethical and
otherwise, do we insist upon--and this would go for any of our
distinguished witnesses--so that human subjects are protected
and the most vulnerable, someone who is a prisoner, is not
compelled into signing a disclosure or an informed consent when
he or she had no ability to resist and then they become the
subject of an experimentation? How do we protect human
subjects?
Dr. Schuchat. The CDC has quite a number of collaborations
in China, including our Global Disease Detection and Response
Program there. And when we are involved in activities, the
international standards for human subjects research are always
followed. The NIH also probably wants to comment on this, but
this is a U.S. Government-wide requirement. We are not allowed
to provide funding to entities that don't follow the
appropriate institutional review board.
Mr. Smith. But are we able to exercise a kind of oversight?
We know that when it came to drugs, there were some serious
problems with drugs that were manufactured in China, even baby
toys and children's toys were laden with lead, which raised
serious problems about quality control. But the record on human
rights in China is an abysmal record. It is beyond poor. It is
among the worst in the world. And it would seem to me if we are
not checking that ethical standards are being consistently and
aggressively applied, human subjects, especially if we get to
the point of another Spanish flu-like situation where panic
sets in and we have got to find an answer to this becomes the
modus operandi, human subjects could very quickly become
utilized in experimentation.
Dr. Schuchat. Yeah. The ethics of what we do is vital, and
I would say that the exchange in collaborations that we have
with China are a very positive step in terms of ability to
influence each other and work in a transparent way. We have
probably advanced this quite a bit in the past several years.
Mr. Smith. Could you as a result of this question maybe
look into it even further? And I raise that again. Again, we
had a guard testify here who Harry Wu smuggled out of the
country, who told how they would not kill the prisoner, but
then they would kill them, he or she, through a capital
punishment regimen, only after they took the desired body
parts, mostly internal organs, and we had an enormous amount of
collaboration for that. And I would hate for us to be less than
vigilant in ensuring that no human subjects are abused,
particularly the prison population, political prisoners
especially.
Dr. Fauci, did you want to--okay.
With regards to Russia, are they involved with the GDD
center? How do we interface with Russia, which could be
experiencing----
Dr. Schuchat. One of our centers is in Kazakhstan, so that
is the regional place. So some of the places we have
established centers are ones where enhancing capacity would be
very valuable and other times it has been a place of strategic
importance. So our work in Russia is not necessarily through
our Kazakhstan center but more bilaterally at this point.
Mr. Smith. Just briefly because we are running out of time.
Dr. Fauci, you mentioned that the H1N1 virus is sensitive to
Tamiflu and Relenza. But experience tells us that resistance to
influenza and to viral medications frequently emerges. What
other potential treatments are in development?
And finally, Dr. Carroll, refugee populations, the 25-plus
million who are of interest to the UNHCR High Representative,
any special concerns being expressed by the UNHCR working with
WHO, with us, to ensure that we don't get a massive outbreak in
the close confines of a refugee camp or something like it?
Dr. Fauci. Let me answer the first question about
resistance. That is one of the reasons we have a very active
and aggressive program of drug screening and drug development.
There are already a number of compounds that are in the
pipeline, some of which are being tested, some of which are in
preclinical development to try and, as we say, keep a pipeline
of drugs available in the eventuality that we might see
resistance. And we have seen resistance, on and off, to various
anti-influenza drugs through the regular pandemic flu season.
Fortunately, we have not been in a situation where there has
been resistance to all of them. There has been resistance to
one or the other. But the precise answers deg. to your
question is that is the precise reason why we have a very
active drug development and screening program.
Mr. Carroll. Congressman Smith. Thank you very much for the
question about the vulnerability of refugee and migratory
populations. It is clearly a major one. And I mentioned in my
comments that part of our strategy for pandemic preparedness
was to enter into an alliance with the family of the United
Nations that includes, in fact, UNHCR and IOM. In addition to
the 30 countries that we are working with to develop pandemic
preparedness plans and test those out, we have been working
explicitly with UNHCR and IOM to make sure that the large
populations of refugees that fall within the world have
adequate planning capability and identification of needs. So we
have been working very aggressively with them, and it is a
major part of our effort and they are a major recipient of
support from us.
And I might just add that today in Paris, yesterday and
today in Paris, all of our U.N. and international partners are
in fact, including UNHCR and IOM, are explicitly addressing the
issues of refugee populations and migratory populations.
Mr. Payne. Thank you very much.
Representative Lee.
Ms. Lee. Thank you, Mr. Chairman.
Dr. Schuchat, at the end of your testimony--let me just
read you one paragraph. You said the government cannot solve
this alone and, as I have noted, all of us must take
constructive steps. If you are sick, stay home. If your
children are sick, keep them home from school, wash your hands,
take all of those reasonable measures that will help us
mitigate how many people actually get sick in our country.
I read this and I said, okay. Is this a teaching moment?
And I say that because these are standards that we should
follow each and every day in terms of public health, in terms
of prevention, in terms of making sure that transmission of
infections and diseases are reduced.
And so one is, is this a teaching moment? Can we mount a
public information campaign so that people understand how to
prevent the transmission of other types of infections and
diseases? And also, secondly, is there anything else we need to
do as it relates to H1N1?
Dr. Schuchat. Thank you for that comment. The advice about
hand washing and these sort of basic guidances are prudent for
this particular virus, but as you say, they are also helpful
for other respiratory infectious diseases, and we are very
pleased that the Harvard poll results came out a few days ago
and said that 59 percent of Americans say that they are washing
their hands more than they ever did in the past. I think it is
going to be important to sustain that type of behavior, not
just when you are fearful because you are bombarded on TV, but
over the long haul because it can really help a lot of
infectious disease transmission.
I think there is another thing we can do long term. It is
really important for people to know that seasonal influenza is
an important public health problem. We hope this new H1N1
strain will not become more severe and cause lots of problems,
and, of course, we are working aggressively to attend to what
needs to be done in the short term. But year in and year out,
36,000 people die from seasonal influenza in the U.S., and we
do have a better vaccine manufacturing capacity than ever and
we really want people to know they can protect themselves from
that infectious disease year in and year out. A lot of steps in
play for vaccine development work against this new strain. But
that is the kind of long-term guidance that we think is
important.
Ms. Lee. But with this new strain, are there any additional
precautionary measures that people should take?
Dr. Schuchat. The other thing that is important is to plan
ahead. The behavioral advice we have made about washing hands
and stuff will help with reducing respiratory infections, but
if we do see a substantial increase in illness,
hospitalizations and social disruption, we think people need to
be prepared for how they are going to manage that kind of
disruption in the family or the workplace. We are also reminded
we are coming into hurricane season, tornado season, these
types of things and knowing how to handle the types of
disruptions with your family, the family communication plan,
the provisions that you have, the way you are going to stay in
touch with people, those are important steps, whatever the
disaster or emergency is.
Ms. Lee. Thank you very much. Could I ask one more question
of Dr. Fauci? Dr. Fauci, good to see you again.
Of course concerns many of us have regarding the impact of
H1N1 now and in the future on underserved communities,
particularly communities of color, the uninsured here in our
own country, and of course outside of the country. So what
steps are we taking to ensure that individuals who are not
insured are educated properly with regard to prevention but
also have access to the preventive types of measures and the
type of treatments, if, in fact, they are uninsured, no
insurance and end up in the emergency rooms. You know what I am
talking about. So, you know, we have an additional problem here
in our own country with 47 million uninsured.
Dr. Fauci. Well, I am always happy to answer your
questions. That is not an area at the NIH that we are involved
in. One of the things that has been done, and I think very
well, by the CDC is to get the message out broadly to everyone
that you possibly can get to. We always are faced with a system
of health care issues in this country and people who are
underserved and any disease generally, particularly people in
poverty tend to do more poorly than others, and we have seen
that with virtually every disease that I have ever testified
before this committee for and other committees, and that is
just something that hopefully that will improve as we get the
health care delivery system better.
Ms. Lee. Thank you very much, Mr. Chairman. Because I think
as we look at H1N1 and all these other diseases, within the
context of developing a universal health care system, we have
to look at how we rev up in communities that are left behind.
Thank you.
Mr. Payne. Representative Watson.
Ms. Watson. Yes. At the end of this month a codel is going
down to South Africa to take a project to our library in
Soweto, an information center. Possibly if we have a CDC
location down in that area, we might take some time. We are
going to fly into Johannesburg, and we are going to look at a
PEPFAR program relative to USAIDS deg.'s. Since there
seems to be no reported cases on the continent, we might want
to go to a CDC center and get an update. Do we have a CDC
center in that area?
Mr. Schuchat. The CDC has a large program in South Africa
based in Pretoria and----
Ms. Watson. We are going to Pretoria.
Dr. Schuchat. Most of the activities are PEPFAR, TB
related. But there is actually influenza work going on as part
of the CDC cooperation with South Africa. And if you are in
Johannesburg, you would be able to see it right there.
Ms. Watson. Very good. Thank you.
Mr. Payne. Thank you. Overall would you say the CDC's work
focuses on building capacity of health systems, particularly in
Africa and Latin America? Is that one of your goals?
Dr. Schuchat. We certainly think that improving capacity is
vital to the long-term protection of populations in Africa as
well as in the United States. So the strategies that we have
for our investments and collaborations in Africa are not just
one-time interventions but really with a mind toward
sustainability. Part of our PEPFAR strategy is to work directly
with the ministries of health and really improve their ability
to long-term strengthen the health services, the evaluations,
the ability to improve policies and such.
So I think that it is a huge mission, but we do try to do
our technical support in a way that will be capacity building.
Mr. Payne. Thank you very much. How about USAID's work in
this area also focusing on capacity building in particular but
not just to combat pandemic influenza but overall to combat
HIV/AIDS, tuberculosis, malaria, neglected tropical diseases
and things of that nature? How does USAID work in this area?
Mr. Carroll. Thank you, Chairman. First off, I think it is
worth noting that the efforts in these countries are all part
of a very well-coordinated U.S. Government response. So as we
speak about what USAID is doing, I think we also are reflecting
what CDC and other colleagues are doing as well. PEPFAR, the
President's Malaria Initiative, the TB programs that we are all
supporting clearly have at their center the investments in
local capacities. These are insidious diseases. They are only
going to be solved if--solved for the long term if there are
the local capacities at national, provincial, district, local
levels to be able to carry out these activities.
So there is a major investment, and I think it was
reflected yesterday in President Obama's announcement. The
whole issue of health systems that has been a major area of
challenge over the last decade as we have rolled out other
programs and understanding and investing in the system
capacities to deal with HIV/AIDS, to deal with malaria, that is
a centerpiece for our work, for Centers for Disease Control's
work as part of these larger programs.
So I think the answer to your question is, yes, capacity
building and indigenous strengthening is a part of our program,
but I think it is the U.S. Government's program at large.
Mr. Payne. Dr. Schuchat, in your testimony you mentioned
the CDC's Global Disease Detection Program, the GDD centers in
Kenya, Thailand, Kazakhstan, Egypt and China. And Mr. Smith
mentioned it also. Do each of these centers have the capacity
to detect this H1N1 strain and what other diseases, if they do,
can they detect at the center, such as MDR and XDR-TB? And what
are we doing to build lab capacity in general as we dealt with
MDR and XDR-TB. Once again as you mentioned earlier in your
testimony, South Africa had the capacity to have labs. We found
out that there are 20 labs in all of sub-Saharan Africa that
could detect MDR and XDR-TB and 19 of the 20 were in South
Africa and one in the rest of the other 52 sub-Saharan African
countries. So there is definitely a disparity and a very lack
of ability to really detect. And so when we were trying to
determine the severity, we knew the damage that MDR and XDR-TB
were doing in South Africa. Archbishop Desmond Tutu sent a
letter to me about 2 years ago where he mentioned that at a
hospital in Cape Town there were 53 patients that were HIV
positive and the MDR strain of tuberculosis was detected in
that particular ward. Out of the 53 patients, 52 died within 2
weeks from either MDR or XDR-TB. We got a $50-million
additional appropriation--overnight really and then a large
amount I think, 400 million or 500 million, to deal with MDR
and XDR. But how do we stand in that area?
Dr. Schuchat. One of the strategies for the Global Disease
Detection and Response Centers is to strengthen laboratory
capacity for the known, but it is also to strengthen the
ability to detect the new or unknown. So, yes, we have had
respiratory infectious syndromes as a priority for the GDD
centers and they have been trained to recognize the typical and
then the unusual respiratory infections, including unusual
influenza strains, and of course we have recently shipped out
these new kits for the novel H1N1 strain. But the centers also
work in an integrated way, the laboratory strengthening with
epidemiologic and rapid response teams, to really respond when
there is an unusual cluster and we don't actually know what it
is, so that their investigation will permit us to find the new.
One of these sites in Thailand was very helpful in the SARS
epidemic in assisting in other countries in that region and
understanding what that new particular virus was.
So with infectious diseases, certainly something like MDR-
TB is a major concern and a priority. But we also need to be
ready for the new and unpredictable and have high quality,
trained laboratory staff who can adapt some of the molecular
techniques for one infection and look at others and really know
how to work in partnership with reference support.
So I would say that there is lots more readiness that we
could have for a long list of important infectious diseases,
but it also a strategy of ability to respond to something new
and potentially concerning.
Mr. Payne. Thank you very much. Mr. Smith.
Mr. Smith. Thank you, Mr. Chairman. Just one final
question. It was reported that the woman who died this morning
apparently attributed it to H1N1 influenza. She was pregnant.
She had a cesarean section and her baby was born apparently
healthy. Every year, about 4 million babies are born in the
United States. If this comes back especially more virulent and
our worst nightmare, what thoughts are being given and what
precautions are being taken? What special protocols perhaps are
being devised to ensure that pregnant women who may need a
different kind of case management, if they get sick, are
protected as well as their unborn child? We are talking about
two patient, mother and baby. I am not sure you could tell us,
our committee, is this like HIV/AIDS where HIV contagion can be
transferred during the birthing process, and we know that
certain drugs can mitigate that which are now mother-to-child
transmission has been cutting significantly. So I don't know
that answer and I really would like to know. Again this baby
was born via C-section. But 4 million kids and their mothers
could be at risk if this comes back and depending on how long
it does last.
Dr. Schuchat. We know from seasonal influenza and studies
in the past that pregnant women are at higher risk for
complications of regular influenza, and they are one of the
groups that we have always recommended get influenza vaccines
each year to help protect them and their babies. The
preliminary information that we have right now on the cases in
the United States doesn't as of today suggest that pregnant
women are at greater risk than the general population. But it
is an important issue that we are monitoring. We have also
issued interim guidance for care of pregnant women, the ways to
diagnose and treat pregnant women, because as you know many
medicines are not necessarily tested as fully in that
population and yet physicians and their patients need guidance.
The third comment is that the anti-viral drug, Oseltamivir,
had not been licensed for use in young children under 1. And
one of the things that happened in the past 10 days was an
emergency use authorization was approved through the FDA and
CDC and HHS so that use of that drug for younger age, not for
newborns, but for older babies would be available under certain
circumstances.
So I think, though, the vulnerable infants, newborns, the
pregnant women are always a concern and influenza is a
particular challenge in those populations, but we are trying to
stay focused on it.
Mr. Smith. Does the virus go through the umbilical cord or
is it stopped? If the mother has it, does the baby get it?
Dr. Schuchat. Yeah. I am not familiar with that as a route
of infection. But with a new virus we always are mindful that
there are lots of things to learn. So this particular H1N1
influenza virus I am not aware of that we have any mother-to-
baby transmission. But with viruses, that can happen for many
of them.
Mr. Smith. But we are looking for that to see if that is a
possibility?
Dr. Schuchat. We are looking actively at all routes of
transmission right now.
Mr. Smith. Thank you, Mr. Chairman.
Mr. Payne. Let me certainly thank each of you for your very
important testimony. It is something that we are proud that we
are able to be prepared. As you have indicated there, years ago
we would not have all of these various procedures in place. And
so I really commend the work that CDC, NIH, USAID and all of
you that work in government agencies are doing. Also once
again, I commend President Obama for the $63 billion over the
next 6 years that will really continue our vigilance in working
to try to eliminate HIV and AIDS and tuberculosis. Malaria is
really getting a tremendous amount of attention; we are seeing
very good results in other tropical diseases that have not
gotten the attention, river blindness and other kinds of
tropical diseases. So we are very, very pleased.
Congresswoman Jackson Lee has additional questions, which
we will forward to our witnesses and we will ask that you
respond to these in a timely manner so that we can get the
answers back to her, and we certainly greatly appreciate your
participation.
Before closing I want to ask for unanimous consent for
members that have 5 days to revise and extend their remarks and
submit questions for the record. Without objection, so ordered.
Once again, thank you. We had such a distinguished panel
here testifying this morning and with kind of short notice.
Thank you again, and the meeting stands adjourned.
[Whereupon, at 11 o'clock a.m., the subcommittee was
adjourned.]
A P P E N D I X
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