[Senate Hearing 113-869]
[From the U.S. Government Publishing Office]
S. Hrg. 113-869
EBOLA IN WEST AFRICA: A GLOBAL CHALLENGE AND PUBLIC HEALTH THREAT
=======================================================================
JOINT HEARING
BEFORE THE
COMMITTEE ON HEALTH, EDUCATION,
LABOR, AND PENSIONS
UNITED STATES SENATE
AND THE
SUBCOMMITTEE ON LABOR,
HEALTH AND HUMAN SERVICES,
EDUCATION AND RELATED AGENCIES
OF THE
COMMITTEE ON APPROPRIATIONS
UNITED STATES SENATE
ONE HUNDRED THIRTEENTH CONGRESS
SECOND SESSION
ON
EXAMINING EBOLA IN WEST AFRICA, FOCUSING ON A GLOBAL CHALLENGE AND
PUBLIC HEALTH THREAT
__________
SEPTEMBER 16, 2014
__________
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COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS
TOM HARKIN, Iowa, Chairman
BARBARA A. MIKULSKI, Maryland LAMAR ALEXANDER, Tennessee
PATTY MURRAY, Washington MICHAEL B. ENZI, Wyoming
BERNARD SANDERS (I), Vermont RICHARD BURR, North Carolina
ROBERT P. CASEY, JR., Pennsylvania JOHNNY ISAKSON, Georgia
KAY R. HAGAN, North Carolina RAND PAUL, Kentucky
AL FRANKEN, Minnesota ORRIN G. HATCH, Utah
MICHAEL F. BENNET, Colorado PAT ROBERTS, Kansas
SHELDON WHITEHOUSE, Rhode Island LISA MURKOWSKI, Alaska
TAMMY BALDWIN, Wisconsin MARK KIRK, Illinois
CHRISTOPHER S. MURPHY, Connecticut TIM SCOTT, South Carolina
ELIZABETH WARREN, Massachusetts
Derek Miller, Staff Director
Lauren McFerran, Deputy Staff Director and Chief Counsel
David P. Cleary, Republican Staff Director
------
(ii)
COMMITTEE ON APPROPRIATIONS
BARBARA A. MIKULSKI, Maryland, Chairman
PATRICK J. LEAHY, Vermont RICHARD C. SHELBY, Alabama
TOM HARKIN, Iowa THAD COCHRAN, Mississippi
PATTY MURRAY, Washington MITCH McCONNELL, Kentucky
DIANE FEINSTEIN, California LAMAR ALEXANDER, Tennessee
RICHARD J. DURBIN, Illinois SUSAN COLLINS, Maine
TIM JOHNSON, South Dakota LISA MURKOWSKI, Alaska
MARY L. LANDRIEU, Louisiana LINDSEY GRAHAM, South Carolina
JACK REED, Rhode Island MARK KIRK, Illinois
MARK L. PRYOR, Arkansas DANIEL COATS, Indiana
JON TESTER, Montana ROY BLUNT, Missouri
TOM UDALL, New Mexico JERRY MORAN, Kansas
JEANNE SHAHEEN, New Hampshire JOHN HOEVEN, North Dakota
JEFF MERKLEY, Oregon MIKE JOHANNS, Nebraska
MARK BEGICH, Alaska JOHN BOOZMAN, Arkansas
CHRISTOPHER A. COONS, Delaware
Charles E. Kieffer, Staff Director
William D. Duhnke III, Minority Staff Director
------
Subcommittee on Labor, Health and Human Services, Education, and
Related Agencies
TOM HARKIN, Iowa, Chairman
PATTY MURRAY, Washington JERRY MORAN, Kansas, Ranking
MARY L. LANDRIEU, Louisiana THAD COCHRAN, Mississippi
RICHARD J. DURBIN, Illinois RICHARD C. SHELBY, Alabama
JACK REED, Rhode Island LAMAR ALEXANDER, Tennessee
MARK L. PRYOR, Arkansas LINDSEY GRAHAM, South Carolina
BARBARA A. MIKULSKI, Maryland MARK KIRK, Illinois
JON TESTER, Montana MIKE JOHANNS, Nebraska
JEANNE SHAHEEN, New Hampshire JOHN BOOZMAN, Arkansas
JEFF MERKLEY, Oregon
Professional Staff
Adrienne Hallett
Mark Laisch
Lisa Bernhardt
Michael Gentile
Robin Juliano
Kelly Brown
Laura A. Friedel (Minority)
Jennifer Castagna (Minority)
Chol Pak (Minority)
M.V. Young (Minority)
Administrative Support
Teri Curtin
C O N T E N T S
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STATEMENTS
TUESDAY, SEPTEMBER 16, 2014
Page
Committee Members
Harkin, Hon. Tom, Chairman, Committee on Health, Education,
Labor, and Pensions, opening statement......................... 1
Alexander, Hon. Lamar, a U.S. Senator from the State of
Tennessee, opening statement................................... 3
Moran, Hon. Jerry, a U.S. Senator from the State of Kansas,
opening statement.............................................. 4
Reed, Hon. Jack, a U.S. Senator from the State of Rhode Island... 32
Burr, Hon. Richard, a U.S. Senator from the State of North
Carolina....................................................... 34
Murray, Hon. Patty, a U.S. Senator from the State of Washington.. 36
Isakson, Hon. Johnny, a U.S. Senator from the State of Georgia... 38
Casey, Hon. Robert P., Jr., a U.S. Senator from the State of
Pennsylvania................................................... 40
Boozman, Hon. John, a U.S. Senator from the State of Arkansas.... 42
Bennet, Hon. Michael F., a U.S. Senator from the State of
Colorado....................................................... 43
Whitehouse, Hon. Sheldon, a U.S. Senator from the State of Rhode
Island......................................................... 46
Durbin, Hon. Richard J., a U.S. Senator from the State of
Illinois....................................................... 47
Mikulski, Hon. Barbara A., a U.S. Senator from the State of
Maryland, opening statement.................................... 49
Witnesses--Panel I
Bell, Beth P., M.D., MPH, Director, National Center for Emerging
and Zoonotic Infectious Diseases, Centers for Disease Control
and Prevention, Atlanta, GA.................................... 5
Prepared statement........................................... 7
Fauci, Anthony S., Director, National Institute of Allergy and
Infectious Diseases, National Institutes of Health, Bethesda,
MD............................................................. 11
Prepared statement........................................... 13
Robinson, Robin A., Ph.D., Director, Biomedical Advanced Research
and Development Authority, Deputy Assistant Secretary for
Preparedness & Response, U.S. Department of Health and Human
Services, Washington, DC....................................... 23
Prepared statement........................................... 25
Witnesses--Panel II
Brantly, Kent, M.D., Former Medical Director, Samaritan's Purse
Ebola Care Center in Monrovia, Liberia, Ebola Survivor, Fort
Worth, TX...................................................... 52
Prepared statement........................................... 55
Charles, Ishmael Alfred, Program Manager, Sierra Leone Healey
International Relief Foundation, Freetown, Sierra Leone........ 59
Prepared statement........................................... 61
(iv)
ADDITIONAL MATERIAL
Statements, articles, publications, letters, etc.:
Response by Beth P. Bell, M.D., MPH to questions of:
Senator Casey............................................ 70
Senator Bennet........................................... 71
Senator Whitehouse....................................... 72
Senator Shaheen.......................................... 74
Senator Baldwin.......................................... 76
Senator Warren........................................... 77
Senator Alexander........................................ 80
Senators Alexander and Burr.............................. 83
Senator Moran............................................ 84
Senator Cochran.......................................... 86
Senator Shelby........................................... 87
Senator Burr............................................. 88
Senator Kirk............................................. 91
Senator Enzi............................................. 92
Response by Anthony S. Fauci, M.D., and Robin A. Robinson,
Ph.D., to questions of:
Senator Casey............................................ 94
Senator Bennet........................................... 95
Senator Whitehouse....................................... 96
Senator Baldwin.......................................... 97
Senator Warren........................................... 98
Senator Alexander........................................ 99
Senator Moran............................................ 101
Senator Shelby........................................... 102
Senator Cochran.......................................... 103
Senator Burr............................................. 104
Senator Kirk............................................. 105
Response by Ishmael Alfred Charles to questions of:
Senator Casey............................................ 107
Senator Warren........................................... 108
EBOLA IN WEST AFRICA: A GLOBAL CHALLENGE AND PUBLIC HEALTH THREAT
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TUESDAY, SEPTEMBER 16, 2014
U.S. Senate Joint Hearing,
Committee on Health, Education, Labor, and Pensions, and
Appropriations Subcommittee on Labor, Health and Human
Services, Education, and Related Agencies,
Washington, DC.
The committees met, pursuant to notice, at 2:52 p.m. in
room SH-216, Hart Senate Office Building, Hon. Tom Harkin,
chairman of the committee and the subcommittee, presiding.
Present: Senators Harkin, Mikulski, Alexander, Moran,
Murray, Casey, Franken, Bennet, Whitehouse, Baldwin, Warren,
Durbin, Reed, Pryor, Burr, Isakson, Cochran, Johanns, and
Boozman.
Opening Statement of Senator Harkin
The Chairman. The Committee on Health, Education, Labor,
and Pensions and the Appropriations Subcommittee on Labor,
Health and Human Services, Education and Related Services will
come to order.
In March of this year, public health officials reported an
outbreak of Ebola virus in the West African country of Guinea.
Unlike past Ebola outbreaks that have been efficiently and
effectively stopped, this outbreak has spread in ways that are
potentially catastrophic for the world. Due to the gravity of
the situation and the danger it poses not only to the affected
region, but also to our country, I have taken the unusual step
of calling together this joint hearing of both the authorizing
committee I chair and the Appropriations subcommittee, which I
also chair. We've come together today to learn all we can so we
can work together effectively over the coming weeks to stop
this deadly plague.
The extent of this epidemic is tragic and it grows more
serious with each passing day. The death toll is already far
greater than all other previous Ebola outbreaks combined. The
World Health Organization estimates that 20,000 people may
become infected by December if current control efforts are not
strengthened, and we know the fatality rate, the mortality
rate, is close to 50 percent, 40 to 50 percent.
We have other estimates that are much higher. And of
course, the constant concern that as this virus spreads it
could also start to mutate and become even more deadly or have
other means of transmission other than through bodily fluids.
Ebola is just one example of a threat from infectious
disease. Others include Avian flu, and the Middle East
Respiratory Syndrome, or MERS. In today's globalized system of
air travel and trade, health threats easily crisscross the
planet. That's why I've worked hard to strengthen, all of us on
both of these committees, to strengthen investments in public
health preparedness and response capabilities at home.
Last year the bipartisan Pandemic and All-Hazards
Preparedness Reauthorization Act was signed into law. That came
through this committee, and of course I see Senator Burr here,
who led a lot of effort on that on his side. Senator Alexander,
Senator Enzi, Senator Casey all worked very hard on this bill.
It advances national health security by strengthening CDC's
public health preparedness response capabilities and ensuring
that the Biomedical Advanced Research and Development
Authority, BARDA, has the authority it needs to support the
development of critical treatments and vaccines.
In the Appropriations Committee, we have worked together
for years to secure additional funding at CDC to set up a
network of disease detection centers across the globe. We now
have 10, including three in Africa. We need one in every
country in Africa. It is these centers that are now deploying
trained epidemiologists and other staff to help in epidemic
areas and those at high risk, and we'll have more discussion on
that when we get to our witnesses with CDC.
I hope and expect that in the next day or two the Senate
will vote in favor of the $88 million that Senator Moran and I
worked to secure in the continuing resolution (CR) to do just
that. This is a crucial investment that will enable 100 CDC
scientists to continue working in West Africa. It will keep the
ZMapp and vaccine candidates moving quickly through clinical
trials.
But, as important as this is, it's just a first step. I
hate to say this, but Ebola will not be conquered in the 10-
weeks of the continuing resolution. When we come back to
negotiate the fiscal year 2015 appropriations bills, the fight
to contain Ebola must continue to be an urgent priority.
The subcommittee passed a Senate Labor-HHS bill that
includes a new $40 million global health security initiative.
We must carefully consider the size and goals of this
initiative in light of the Ebola outbreak, while maintaining
our commitment to CDC staff in the field. As this crisis
illustrates, we must stop chasing diseases after the fact and
start building public health systems around the globe capable
of detecting and stopping diseases before they cross borders.
Last year, with the help of Senator Moran, we were able to
start a new global initiative called the National Public Health
Institute to do just that. This program needs to be expanded in
light of this epidemic.
With these big challenges ahead of us, today's hearing is
absolutely critical. We have a distinguished group here to
educate us and advise us.
I will now turn to Senator Alexander and also to Senator
Moran, but before that I request the record be kept open for 10
days for Senators to submit statements and questions. With
that, I'll recognize Senator Alexander.
Opening Statement of Senator Alexander
Senator Alexander. Thanks, Mr. Chairman, and thanks to the
witnesses for coming here today.
We must take the dangerous, deadly threat of Ebola as
seriously as we take ISIS. Let me say that again, we must take
the dangerous, deadly threat of the Ebola epidemic as seriously
as we take ISIS. I think I have a reputation as a Senator who's
not given to overstatement. I don't believe that's an
overstatement.
The spread of this disease deserves a more urgent response
from our country and other countries around the world than it's
now getting. This is one of the most explosive, deadly
epidemics in modern time if we do not do what we know how to do
to control it. It will require a huge and immediate response.
There is no known cure. There is no vaccine. Half of those who
get sick die. Each sick person, according to the Centers for
Disease Control and Prevention, could infect 20 or more others,
including caregivers, friends, and family.
Samantha Power, the U.N. Ambassador, said to me earlier
this week in a briefing that she's trying to get other
countries to view this with the same urgency that we do. This
is an instance, she said, when we should be running toward the
burning flames with our fireproof suits on. Ebola is killing
people in West Africa at alarming rates and picking up speed.
It's hard to say exactly what the number of cases is. There
is an official number, a little less than 5,000 Ebola cases in
Guinea, Liberia, and Sierra Leone. But the worry is that one-
half of those cases were reported in the last 3 weeks. You
don't have to know very much about mathematics to know that,
whatever the number, if it doubles every 3 weeks, that very
soon we have an out of control epidemic. And we can see easily
what would happen if a single infected traveler reaches another
country and begins to infect others in that country.
We'll learn more today about what we know how to do. We'll
hear from a doctor who has contracted Ebola and who has
recovered from it and who is here to talk about it. It's not
like the flu. It can only be spread by bodily fluids, often
contracted by caring for someone who's sick or through burial
practices.
But with global travel, we're only one airplane ride away
from a person exposed to Ebola getting on a plane to the United
States and then becoming sick once they arrive, and then the
mathematics of that infection could begin to develop in this
country.
There's human tragedy in Africa, but it affects the rest of
the world and it affects the United States. Our State is known
as the Volunteer State and Dr. Brantly, who will testify here,
is an Ebola patient. He was working for Samaritan's Purse. He's
not a Tennessean, but his parents are graduates of Lipscomb
University, which is in Nashville. He, like many Americans, go
on mission trips around the world to help people who need help.
I will support the Administration's request for the $30
million Senator Harkin talked about, for the $58 million for
the Biomedical Advanced Research and Development Authority.
That's for vaccines and cures and treatments. That should pass
this week. There is a request to address $500 million of
reprogramming in the Defense Department. Some have asked, why
should our military be involved? Because they have to be
involved if we want to deal with the problem. There's no way
for the doctors and the nurses and the health care workers to
deal with it.
I'm pleased that on both sides of the aisle we have leaders
who are beginning to recognize the severity of this epidemic.
Dr. Frieden and United Nations Ambassador Power are taking the
lead. We look forward to learning all we can about the severity
of the epidemic and what we must do to control it. But I'll end
where I started, we must take the deadly, dangerous threat of
the Ebola epidemic as seriously as we take ISIS.
The Chairman. Thank you, Senator Alexander.
Senator Moran.
Opening Statement of Senator Moran
Senator Moran. Mr. Chairman, thank you very much. I very
much appreciate you and your leadership, working with the
Senator from Tennessee and me together, to make certain that
this hearing take place.
It's very discouraging to see and know what's taking place
in Africa, but it's very encouraging to know that we have the
ability to make a significant difference in the outcome of
what's occurring. Sometimes we face problems and we don't know
exactly what to do. While I realize we haven't invented and
discovered all the cures and treatments, we know a lot can be
done that will save people's lives and prevent the spread of
Ebola to other places in Africa and around the globe.
The encouraging thing to me is that this is an example of
something where the U.S. Senate or the Congress and the
President can come together and actually make a difference,
something that we ought to take some satisfaction in if we are
able to accomplish that.
I appreciate the leadership here today. We need to declare
a war on Ebola. It's real and yet it's something that, with
that war, with that campaign, we have the ability to change the
people's lives who are affected and to diminish the number of
people whose lives are affected in the future. This requires a
global response and the United States needs to provide the
necessary leadership to make certain that the war is won.
Mr. Chairman, thank you very much.
The Chairman. Thank you, Senator Moran.
We have a distinguished panel, our first panel. I'll
introduce them and then we'll move ahead with the statements.
First is Dr. Beth Bell, Director of the National Center for
Emerging and Zoonotic Infectious Diseases at the Centers for
Disease Control and Prevention. Dr. Bell is responsible for
CDC's efforts in responding to a broad range of emerging and
established threats. Since March, Dr. Bell has helped lead
CDC's response to the Ebola outbreak in West Africa.
Previously, Dr. Bell served in multiple leadership roles at
CDC, including during the agency's response to the 2001 anthrax
attacks and the 2009 H1N1 influenza pandemic.
Dr. Anthony Fauci, Director of the National Institute of
Allergy and Infectious Diseases at the National Institutes of
Health, a position he's held since 1984, for 30 years, and has
provided outstanding leadership there. At NIH Dr. Fauci
oversees a wide portfolio of basic and applied research to
improve our understanding of infectious diseases and applying
this knowledge to develop new detection, prevention, and
treatment strategies.
Dr. Fauci serves as one of the key advisers to the White
House and Department of Health and Human Services on
initiatives to bolster medical and public health preparedness
against emerging infectious disease threats.
Finally, we extend the committee's welcome to Dr. Robin
Robinson, Director of the Biomedical Advanced Research and
Development Authority, BARDA, in the Office of the Assistant
Secretary for Preparedness and Response at the Department of
Health and Human Services. Dr. Robinson is responsible for the
advanced development and acquisition of innovative medical
countermeasures, including vaccines, drugs, and diagnostic
tools, to protect against both man-made and naturally occurring
health threats. BARDA has played a key role in ensuring the
ongoing research and development of experimental Ebola
treatments, and we thank you also for being here today, Dr.
Robinson.
I would just ask consent that all of your statements be
made a part of the record in their entirety.
Dr. Bell, we'll start with you. I know we're going to have
a lot of questions from Senators, so if you sum up in 5 to 7
minutes we'd sure appreciate it.
STATEMENT OF BETH P. BELL, M.D., MPH, DIRECTOR, NATIONAL CENTER
FOR EMERGING AND ZOONOTIC INFECTIOUS DISEASES, CENTERS FOR
DISEASE CONTROL AND PREVENTION, ATLANTA, GA
Dr. Bell. I will. Good afternoon, Chairman Harkin, Ranking
Members Alexander and Moran, and members of the committees. I
am Dr. Beth Bell, Director of the National Center for Emerging
and Zoonotic Infectious Diseases at the CDC. I appreciate the
opportunity to be here today to discuss the current epidemic of
Ebola in West Africa, which illustrates in a tragic way the
need to strengthen global health security.
Dr. Frieden has asked me to extend his sincere regret for
not being here in person and also to express his appreciation
for your continuing support for CDC, enabling us to build and
sustain the capacity to respond to health threats like Ebola.
The Ebola epidemic in Guinea, Liberia, and Sierra Leone is
ferocious and spreading exponentially. The current outbreak is
the first that has been recognized in West Africa and the
biggest and most complex Ebola epidemic ever documented. As of
last week, the epidemic surpassed 4,400 cumulative reported
cases, including nearly 2,300 documented deaths, though we
believe there is considerable underreporting and expect that
the actual numbers would be two to three times higher.
We have now also seen cases imported into Nigeria and
Senegal from the initially affected areas, and other countries
are at risk of similar exportations as the outbreak grows.
There is an urgent need to help bordering countries to better
prepare for cases now and to strengthen detection and response
capabilities throughout Africa.
The secondary effects of this outbreak now include the
collapse of the underlying health care systems, resulting, for
example, in an inability to treat malaria or to safely deliver
an infant, as well as non-health impacts such as economic and
political instability and increased isolation of this area of
Africa. These impacts are intensifying and not only signal a
growing humanitarian crisis, but also have direct impacts on
our ability to respond to the Ebola epidemic itself.
There is a window of opportunity to control the spread of
this disease, but that window is closing. If we do not act now
to stop Ebola, we could be dealing with it for years to come,
affecting larger areas of Africa. Ebola is currently an
epidemic, the worst Ebola outbreak in history, but we have
tools to stop it and an accelerated global response is urgently
needed.
It is important to note that we do not view Ebola as a
significant public health threat to the United States. The best
way to protect the United States is to stop the outbreak in
West Africa. But it is possible that an infected traveler might
arrive in the United States. Should this occur, we are
confident that our public health and health care systems can
prevent an Ebola outbreak here and recognize that the
authorities in investments provided by your committees have put
us in this strong position.
Many challenges remain, particularly since there is
currently no therapy or vaccine shown to be safe and effective
against Ebola. We need to strengthen the global response, which
requires close collaboration with the World Health
Organization, additional assistance from international
partners, and a strong and coordinated U.S. Government
response.
CDC has over 100 staff in West Africa currently and
hundreds of additional staff are supporting this effort from
Atlanta. CDC will continue to work with our partners across the
U.S. Government and elsewhere to focus on five pillars of
response:
establishing effective emergency operations
centers in countries;
rapidly ramping up isolation and treatment
facilities;
helping promote safe burial practices;
strengthening infection control and other elements
of the health care systems; and
improving communication about the disease and how
it can be contained.
Controlling the outbreak will be costly and will require
sustained effort by the United States and the world community.
Within HHS, the administration recently proposed that the
Congress provide $30 million for CDC's response during the
continuing resolution period and for efforts to develop
countermeasures, which my colleagues will describe. And last
week the President indicated that the unique logistics and
material capabilities of the U.S. military would be engaged in
this response, and we are working across the U.S. Government to
assess the full range of resources that can be leveraged to
change the trajectory of this epidemic.
Working with our partners, we have been able to stop every
previous Ebola outbreak and we are determined to stop this one.
It will take meticulous work and we cannot take shortcuts. As
CDC Director Tom Frieden has noted, fighting Ebola is like
fighting a forest fire. Leave behind one burning ember, one
case undetected, and the epidemic could reignite. Ending this
epidemic will take time and continued intensive effort.
This tragedy also highlights the need for stronger public
health systems around the world. There is worldwide agreement
on the importance of global health security, but the Ebola
epidemic demonstrates that there is much more to be done. Any
vulnerability can have widespread impact if not stopped at the
source. As you are aware, the fiscal year 2015 President's
budget includes an increase of $45 million to strengthen
fundamental public health capacities around the globe. If these
people, facilities, and labs had been in place in these
countries currently battling Ebola, the early outbreaks would
not have grown to what we are facing today. Stopping outbreaks
where they occur is the most effective and least expensive way
to protect people's health.
I know that many of you have traveled to Africa to see our
work in global health, as have I, and we all come away with an
appreciation of the enormous challenges many people and
countries face. These may never have been more evident than in
the current Ebola epidemic. Each day of the past several
months, I have been in personal contact with our teams in the
field. Their experiences reinforce the dire need and put real
stories and faces on a tragedy that can't simply be reduced to
numbers and facts. But these stories from the field also
reinforce the unique and indispensable role that CDC and our
partners are playing and the sense that with an intensified
global focus we can make a real difference.
Thank you again for the opportunity to appear before you
today and for making CDC's work on this epidemic and other
health threats possible.
[The prepared statement of Dr. Bell follows:]
Prepared Statement of Beth Bell, M.D., MPH
Good afternoon Chairman Harkin, Ranking Members Alexander and
Moran, and members of the Health, Education, Labor, and Pensions and
Appropriations Committees. Thank you for the opportunity to testify
before you today and for your ongoing support for the Centers for
Disease Control and Prevention's (CDC) work in global health. I am Dr.
Beth Bell, Director of the National Center for Emerging and Zoonotic
Infectious Diseases at the CDC. I appreciate the opportunity to be here
today to discuss the current epidemic of Ebola in West Africa, which
illustrates in a tragic way the need to strengthen global health
security.
We do not view Ebola as a significant public health threat to the
United States. It is not transmitted easily, does not spread from
people who are not ill, and cultural norms that contribute to the
spread of the disease in Africa--such as burial customs--are not a
factor in the United States. We know how to stop Ebola with strict
infection control practices which are already in widespread use in
American hospitals, and by stopping it at the source in Africa. There
is a window of opportunity to tamp down the spread of this disease, but
that window is closing. CDC is committing significant resources both on
the ground in West Africa and through our Emergency Operations Center
here at home. But this is a whole of Government response, with agencies
across the U.S. Government committing human and financial resources.
To date, the U.S. Government has spent more than $100 million to
address the Ebola epidemic, and just last week the U.S. Agency for
International Development (USAID) announced plans to make available up
to $75 million in additional funding. In addition, we have just
proposed that the Congress provide an additional $88 million through
the continuing resolution process. This funding would allow us to
support development and manufacturing of Ebola therapeutic and vaccine
candidates for clinical trials and to send additional response workers
from CDC as well as lab supplies and equipment. If the Congress
includes this additional funding, it would bring our total commitments
to date to over $250 million. Last week, the President indicated the
need to engage the unique logistics and materiel capabilities of the
U.S. military on this response.
We need to, and are, working with our international partners, to
scale up the response to the levels needed to stop this epidemic.
Ebola is a severe, often fatal, viral hemorrhagic fever. The first
Ebola virus was detected in 1976 in what is now the Democratic Republic
of Congo. Since then, outbreaks have appeared sporadically. The current
epidemic in Guinea, Liberia, and Sierra Leone is the first that has
been recognized in West Africa and the biggest and most complex Ebola
epidemic ever documented. We have now also seen cases imported into
Nigeria and Senegal from the initially affected areas, which is of
concern.
Ebola has an abrupt onset of symptoms similar to many other
illnesses, including fever, chills, weakness and body aches.
Gastrointestinal symptoms such as vomiting and diarrhea are common and
severe, and can result in life threatening electrolyte losses. In
approximately half of cases there is hemorrhage--serious internal and
external bleeding. There are two things that are very important to
understand about how Ebola spreads. First, the current evidence
suggests human-to-human transmission of Ebola only happens from people
who are symptomatic--not from people who have been exposed to, but are
not ill with the disease. Second, everything we have seen in our
decades of experience with Ebola indicates that Ebola is not spread by
casual contact; Ebola is spread through direct contact with bodily
fluids of someone who is sick with, or has died from Ebola, or exposure
to objects such as needles that have been contaminated. While the
illness has an average 8-10 day incubation period (though it may be as
short as 2 days and as long as 21 days), we recommend monitoring for
fever and signs of symptoms for the full 21 days. Again, we do not
believe people are contagious during that incubation period, when they
have no symptoms. Evidence does not suggest Ebola is spread through the
air. Catching Ebola is the result of exposure to bodily fluids, which
we are seeing occur in West Africa, for example, in hospitals in weaker
health care systems and in some African burial practices. Getting Ebola
requires exposure to bodily fluids of someone who is ill from--or has
died from--Ebola.
The early recorded cases in the current epidemic were reported in
March of this year. Following an initial response that seemed to slow
the early outbreak for a time, cases flared again due to weak systems
of health care and public health and because of challenges health
workers faced in dealing with communities where critical disease-
control measures were in conflict with cultural norms. As of last week,
the epidemic surpassed 4,400 cumulative reported cases, including
nearly 2,300 documented deaths, though we believe these numbers may be
under-reported, by a factor of at least two- to threefold. The effort
to control the epidemic in some places is complicated by fear of the
disease and distrust of outsiders. Security is tenuous and unstable,
especially in remote isolated rural areas. There have been instances
where public health teams could not do their jobs because of security
concerns.
Many of the health systems in these countries are weak or have
collapsed entirely, and do not reach into rural areas. Health care
workers may be limited (for example, we are aware of one nurse for 90
patients in one hospital in Kenema, Sierra Leone), or may not reliably
be present at facilities, and those facilities may have limited
capacity. Poor infection control in routine health care, along with
local traditions such as public funerals and cultural mourning customs
including preparing bodies of the deceased for burial, make efforts to
contain the illness more difficult. Furthermore, the porous land
borders among countries and remoteness of many villages have greatly
complicated control efforts. The secondary effects now include the
collapse of the underlying health care systems resulting for example,
an inability to treat malaria, diarrheal disease, or to safely deliver
a child, as well as non-health impacts such as economic and political
instability and increased isolation in this area of Africa. These
impacts are intensifying, and not only signal a growing humanitarian
crisis, but also have direct impacts on our ability to respond to the
Ebola epidemic itself.
There are three key things which we need to respond to this
epidemic. The first is resources--this epidemic will take a lot of
resources to confront. That is why the U.S. Government is putting our
resources into this effort and asking the Congress for your assistance.
The United Nations believes the cost of getting supplies needed to West
African countries to get the Ebola crisis under control will be at
least $600 million. I personally believe that to be an underestimate.
The second is technical experts in health care and management to assist
in country. Last, is a coordinated, global unified approach, because
this is not just a problem for Africa. It's a problem for the world,
and the world needs to respond.
Fortunately, we know what we must do. In order to stop an Ebola
outbreak, we must focus on three core activities: find active cases,
respond appropriately, and prevent future cases. The use of real-time
diagnostics is extremely important to identify new cases. We must
support the strengthening of health systems and assist in training
healthcare providers. Once active cases have been identified, we must
support quality patient care in treatment centers, prevent further
transmission through proper infection control practices, and protect
healthcare workers. Epidemiologists must identify contacts of infected
patients and followup with them every day for 21 days, initiating
testing and isolation if symptoms emerge. And, we must intensify our
use of health communication tools to disseminate messages about
effective prevention and risk reduction. These messages include
recommendations to report suspected cases and to avoid close contact
with sick people or the deceased, and to promote safe burial practices.
In Africa, another message is to avoid bush meat and contact with bats,
since ``spillover events,'' or transmission from animals to people, in
Africa has been documented through these sources.
Many challenges remain. While we do know how to stop Ebola through
meticulous case finding, isolation, and contact tracing, there is
currently no cure or vaccine shown to be safe or effective for Ebola.
We need to strengthen the global response, which requires close
collaboration with WHO, additional assistance from our international
partners, as well as a coordinated U.S. Government response. At CDC, we
activated our Emergency Operations Center to respond to the initial
outbreak, and are surging our response. One of the surge objectives was
initial deployment of 50 disease-control experts in 30 days to the
region to support partner governments, WHO, and other partners working
in the region. We surpassed that goal, and as of last week, CDC has
over 100 staff in West Africa, and more than 300 staff in total have
provided logistics, staffing, communication, analytics, management, and
other support functions. CDC will continue to work with our partners
across the U.S. Government and elsewhere to focus on five pillars of
response:
Effective incident management--CDC is supporting countries
to establish national and sub-national Emergency Operations Centers
(EOCs) by providing technical assistance and standard operating
procedures and embedding staff with expertise in emergency operations.
All three West African countries at the center of the epidemic have now
named and empowered an Incident Manager to lead efforts.
Isolation and treatment facilities--It's imperative that
we ramp up our efforts to provide adequate space to treat the number of
people afflicted with this virus.
Safe burial practices--Effectively shifting local cultural
norms on burial practices is one of the keys to stopping this epidemic.
CDC is providing technical assistance for safe burials.
Health care system strengthening--Good infection control
will greatly reduce the spread of Ebola and help control future
outbreaks. CDC has a lead role in infection control training for health
care workers and safe patient triage throughout the health care system,
communities, and households.
Communications--CDC will continue to work on building the
public's trust in health and government institutions by effectively
communicating facts about the disease and how to contain it,
particularly targeting communities that have presented challenges to
date.
The public health response to Ebola rests on the same proven public
health approaches that we employ for other outbreaks, and many of our
experts are working in the affected countries to rapidly apply these
approaches and build local capacity. These include strong surveillance
and epidemiology, using real-time data to improve rapid response; case-
finding and tracing of the contacts of Ebola patients to identify those
with symptoms and monitor their status; and strong laboratory networks
that allow rapid diagnosis.
CDC's request for an additional $30 million for the period of the
continuing resolution will support our response and to allow us to ramp
up efforts to contain the spread of this virus. More than half of the
funds are expected to directly support staff, travel, security and
related expenses. A portion of the funds will be provided to the
affected area to assist with basic public health infrastructure, such
as laboratory and surveillance capacity, and improvements in outbreak
management and infection control. Should outbreaks recur in this
region, they will have the experience and capacity to respond without
massive external influx of aid, due to this investment. The remaining
funds will be used for other aspects of strengthening the public health
response such as laboratory supplies/equipment, and other urgent needs
to enable a rapid and flexible response to an unprecedented global
epidemic. CDC will continue to coordinate activities directly with
critical Federal partners, including USAID and non-governmental
organizations.
Though the most effective step we can take to protect the United
States is to stop the epidemic where it is occurring, we are also
taking strong steps to protect Americans here at home. For example, it
is possible that infected travelers may arrive in the United States,
despite all efforts to prevent this; therefore we need to ensure the
United States' public health and health care systems are prepared to
rapidly manage cases to avoid further transmission. We are confident
that our public health and health care systems can prevent an Ebola
outbreak here, and that the authorities and investments provided by
your committees have put us in a strong position to protect Americans.
To make sure the United States is prepared, as the epidemic in West
Africa has intensified, CDC has:
Assisted with extensive screening and education efforts on
the ground in West Africa to prevent ill travelers from getting on
planes.
Developed guidance for monitoring and movement of people
with possible exposures, and guidance and training for partners
(including airlines, Customs and Border Protection officers, and
Emergency Medical Systems personnel).
Provided guidance for travelers, humanitarian
organizations, and students/universities.
Advised United States' health care providers to consider
Ebola if symptoms present within 3 weeks of a traveler returning from
an affected area.
Provided guidance for infection control practices in
hospitals to prevent further spread to United States health care
workers and communities.
Developed response protocols for the evaluation, isolation
and investigation of any incoming individuals with relevant symptoms.
Expanded the capacity of our Laboratory Response Network
to rapidly test suspected cases so that appropriate measures can be
taken.
Working with our partners, we have been able to stop every prior
Ebola outbreak, and we will stop this one. It will take meticulous work
and we cannot take short cuts. It's like fighting a forest fire: leave
behind one burning ember, one case undetected, and the epidemic could
re-ignite. For example, in response to the case in Nigeria, 10 CDC
staff and 40 top Nigerian epidemiologists rapidly deployed, identified,
and followed 1,000 contacts for 21 days. Even with these resources, one
case was missed, which resulted in a new cluster of cases in Port
Harcourt.
Ending this epidemic will take time and continued, intensive
effort. The fiscal year 2015 President's Budget includes an increase of
$45 million to strengthen lab networks that can rapidly diagnose Ebola
and other threats, emergency operations centers that can swing into
action at a moment's notice, and trained disease detectives who can
find an emerging threat and stop it quickly. Building these
capabilities around the globe is key to preventing this type of event
elsewhere and ensuring countries are prepared to deal with the
consequences of outbreaks in other countries. We must do more, and do
it quickly, to strengthen global health security around the world,
because we are all connected. Diseases can be unpredictable--such as
H1N1 coming from Mexico, MERS emerging from the Middle East, or Ebola
in West Africa, where it had never been recognized before--which is why
we have to be prepared globally for anything nature can create that
could threaten our global health security.
There is worldwide agreement on the importance of global health
security, but as the Ebola epidemic demonstrates, there is much more to
be done. All 194 World Health Organization Member States have adopted
the International Health Regulations (IHR). Progress has occurred over
the past years, but 80 percent of countries did not claim to meet the
IHR capacity required to prevent, detect, and rapidly respond to
infectious disease threats by the June 2012 deadline set by WHO. No
globally linked, inter-operable system exists to prevent epidemic
threats, detect disease outbreaks in real-time, and respond
effectively. Despite improved technologies and knowledge, concerning
gaps remain in many countries in the workforce, tools, training,
surveillance capabilities, and coordination that are crucial to protect
against the spread of infectious disease, whether naturally occurring,
deliberate, or accidental. The technology, capacity, and resources
exist to make measurable progress across member countries, but focused
leadership is required to make it happen. If even modest investments
had been made to build a public health infrastructure in West Africa
previously, the current Ebola epidemic could have been detected
earlier, and it could have been identified and contained. This Ebola
epidemic shows that any vulnerability could have widespread impact if
not stopped at the source.
Earlier this year, the U.S. Government joined with partner
governments, WHO and other multilateral organizations, and non-
governmental actors to launch the Global Health Security Agenda. Over
the next 5 years, the United States has committed to working with at
least 30 partner countries (with a combined population of at least four
billion people) to improve their ability to prevent, detect, and
effectively respond to infectious disease threats--whether naturally
occurring or caused by accidental or intentional release of pathogens.
As part of this Agenda, the President's fiscal year 2015 Budget
includes $45 million for CDC to accelerate progress in detection,
prevention, and response, and we appreciate your support for this
investment. The economic cost of large public health emergencies can be
tremendous--the 2003 Severe Acute Respiratory Syndrome epidemic, known
as SARS, disrupted travel, trade, and the workplace and cost to the
Asia-Pacific region alone $40 billion. Resources provided for the
Global Health Security Agenda can improve detection, prevention, and
response and potentially reduce some of the direct and indirect costs
of infectious diseases.
Improving these capabilities for each nation improves health
security for all nations. Stopping outbreaks where they occur is the
most effective and least expensive way to protect people's health.
While this tragic epidemic reminds us that there is still much to be
done, we know that sustained commitment and the application of the best
evidence and practices will lead us to a safer, healthier world. With a
focused effort and resources proposed in the fiscal year 2015
President's Budget, we can stop this epidemic, and leave behind strong
systems in West Africa and elsewhere to prevent Ebola and other health
threats in the future.
Thank you again for the opportunity to appear before you today. I
appreciate your attention to this terrible outbreak and I look forward
to answering your questions.
The Chairman. Thank you very much, Dr. Bell.
Dr. Fauci, welcome. Please proceed.
STATEMENT OF ANTHONY S. FAUCI, M.D., DIRECTOR, NATIONAL
INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES, NATIONAL
INSTITUTES OF HEALTH, BETHESDA, MD
Dr. Fauci. Thank you very much, Mr. Chairman, Ranking
Member, members of the committee. I appreciate the opportunity
to be able to speak to you today about the role of the National
Institute of Allergy and Infectious Diseases in research
addressing the Ebola virus disease. I have some handouts that
your staff has put in front of you and it's on the visuals
there.
The involvement of the NIH and NIAID in Ebola really dates
back to the tragic events of 9-11-2001, which was followed
closely by the anthrax attacks through the mail in letters to
United States Senators as well as to members of the press,
because this led to a broad, multi-agency endeavor to develop
what we call biodefense against threats, not only of deliberate
threats, but of unexpected naturally emerging and reemerging
threats.
As you see on the right-hand side of this, there was an
agenda, a research agenda involving what we called category A
agents. They're listed there and they're familiar to you.
They're anthrax, botulism, plague, smallpox, tularemia, and on
the bottom bullet you see a category called the viral
hemorrhagic fever viruses, which are Ebola, as well as Marburg,
Lassa, and others.
The reason why these viral hemorrhagic fever viruses were
so important and so deadly and so in need of countermeasures is
that, as you mentioned in your introductory remarks, as have
the other Senators, they have a high degree of lethality and
infectivity. Unfortunately, the therapy is essentially mostly
supportive, without specific antiviral drugs directed against
the microbes in question. As we know, a vaccine for any of
these is not available at present.
This is an electron micrograph of the Ebola virus, which is
a filovirus, given the name because of the filamentous
appearance that it has when one looks at it.
The NIH's Countermeasure Research and Development Program
is ongoing and has been for several years. But before I even
mention that, I wanted to underscore something that Dr. Bell
said, is that right now today the best way to contain this
epidemic, this outbreak, is by intensifying infection control
capabilities, what we're seeing now evolve and what we've seen
for some time, the ability to isolate, identify, contact trace,
and protect our health care workers with personal protective
equipment.
But if we want to be prepared in a durable way, we need
countermeasures, and that's what I'm going to spend the next
couple of minutes telling you about. What we do is basic and
clinical research, but we also supply the resources for
researchers in industry and in academia to get to our end game,
which is better diagnostics and, of course, therapeutics and
vaccines.
The product development pipeline is not unidimensional. The
NIH is fundamentally responsible for developing the early
concepts, doing what we call preclinical studies and early
clinical studies, which I'll mention in a moment. We partner
with our colleagues from BARDA, which you mentioned, who are
involved in the advanced development to hand the baton over to
industry for commercial manufacturing, with ultimate regulation
and approval by the U.S. FDA, among other regulatory agencies,
and you'll hear from Dr. Robinson shortly.
Let me spend a moment outlining some of the promising
therapeutics. You mentioned and you've heard of ZMapp from Mapp
Biopharmaceuticals. This is a combination of three artificially
produced antibodies directed against the Ebola virus. It has
been shown to be very promising in an animal model and, as you
will hear from the next witnesses when Dr. Brantly speaks, that
this was given for the first time in humans.
It is very, very important that we understand whether it
truly works, how well it works, what's the proper dose, and is
it safe. Anecdotal, we have determined that it looks like under
circumstances it could be beneficial, but we don't know that,
and it's our job to prove it so that we can have it readily
available for larger numbers of people.
On this slide there's another couple among several
interventions, one by the company BioCryst, which we're
collaborating with, which is one of several novel drugs that
interfere with the reproductive process of the virus. Then our
Department of Defense is in collaboration with a company called
Tekmira to get a drug which is actually a small inhibitory
molecule, again interfering with the replication of the virus.
As I mentioned, ZMapp has been administered to seven
individuals. This is probably, when you look at the animal
model, a very encouraging result that we've seen in the
animals. As we know, this has the potential, because it can
block the virus, to do something that we hope we will be able
to capitalize on, again with research ahead.
Then finally, there's the issue of vaccines. This is
something that traditionally in infectious diseases has been
the stalwart of preventing and protecting people. We have been
working on an Ebola vaccine for several years in an iterative
process that we've improved upon. We have favorable results in
an animal model using one of a few candidates, and the one I
will mention in closing is the NIAID GlaxoSmithKlein candidate,
which was developed at the NIH in collaboration with
GlaxoSmithKlein and looked very good in an animal study. But as
I have told you, Mr. Chairman and others on the committee, many
times, the proof is in the pudding to show scientifically that
it works.
We have actually started that process. On September 2d at
the NIH Clinical Center in Bethesda, we started the first phase
I study of this vaccine, aimed at vaccinating 20 normal
volunteers. So far 10 of the 20 volunteers have been vaccinated
and thus far there have been no red flags. Following this,
which will likely end at the end of November, the beginning of
December, we will expand these studies to try and prove in fact
that we have a safe and effective vaccine.
In closing I'd like to reiterate what I refer to as the
dual mandate of NIH and NIAID research when it comes to
infectious diseases. It's our responsibility to maintain a
robust basic and applied research portfolio in microbiology and
infectious diseases. But also we have the other mandate, to
have to respond rapidly and efficiently to emerging and
reemerging infectious diseases with the kinds of
countermeasures that would prevent morbidity and mortality and
would have our citizens feel safe both home and abroad, and
clearly Ebola is one of the most daunting of those reemerging
infectious diseases. It's our aim over the next months to years
to make sure that we do have the countermeasures to prepare us
to address this problem.
Thank you very much, Mr. Chairman.
[The prepared statement of Dr. Fauci follows:]
Prepared Statement of Anthony S. Fauci, M.D.
Mr. Chairman and members of the committees, thank you for the
opportunity to discuss the National Institutes of Health (NIH) response
to the global health emergency of Ebola virus disease. I direct the
National Institute of Allergy and Infectious Diseases (NIAID), the lead
institute of the NIH for conducting and supporting research on
infectious diseases, including viral hemorrhagic fevers such as those
caused by Ebola virus infection.
For over six decades, NIAID has made important contributions to
advancing the understanding of infectious, immunologic, and allergic
diseases, from basic research on mechanisms of disease to applied
research to develop diagnostics, therapeutics, and vaccines. NIAID has
a dual mandate that balances research addressing current biomedical
challenges with the capacity to respond quickly to newly emerging and
re-emerging infectious diseases, including bioterror threats. Critical
to these efforts are NIAID's partnerships with academia, pharmaceutical
companies, international organizations such as the World Health
Organization, and collaborations with other Federal entities,
particularly the Centers for Disease Control and Prevention, the Food
and Drug Administration (FDA), the Biomedical Advanced Research and
Development Authority (BARDA), and the Department of Defense (DoD).
overview of ebola virus disease
Viral hemorrhagic fevers are severe illnesses that can be fatal and
are caused by a diverse group of viruses including Marburg virus, Lassa
virus, and Ebola virus. Infection with Ebola virus typically causes
fever, severe vomiting, diarrhea, rash, profound weakness, electrolyte
loss, impaired kidney and liver function, and in some cases internal
and external bleeding. Since the discovery of Ebola virus in 1976,
outbreaks of hemorrhagic fever caused by Ebola virus have had fatality
rates ranging from 25 percent to 90 percent, depending on the species
of virus and the availability of medical facilities to care for
infected patients. West Africa is currently experiencing the most
severe Ebola epidemic ever recorded. As of last week, the epidemic
surpassed 4,400 cumulative reported cases, including nearly 2,300
documented deaths according to CDC. The ongoing Ebola epidemic in
Guinea, Liberia, Sierra Leone, Nigeria, and Senegal has generated more
cases and deaths than the 24 previous Ebola outbreaks combined.
The ongoing public health crisis in West Africa demands a major
amplification of efforts to identify and isolate infected individuals,
perform contact tracing, and provide personal protective equipment for
healthcare workers involved in the treatment of infected individuals.
This still remains the time-proven approach to controlling and
ultimately ending the epidemic. However, there is also a critical need
to develop improved diagnostics, as well as safe and effective
therapeutics and vaccines for Ebola since there are no such FDA-
approved interventions available at this time. In this regard, NIAID
has a longstanding commitment to advancing research to combat Ebola
while ensuring the safety and efficacy of potential medical
countermeasures such as treatments and vaccines.
history of niaid ebola virus research: relationship to biodefense
research
The ability to safely and effectively prevent and treat Ebola virus
infection is a longstanding NIAID priority. Since the 2001 anthrax
attacks, NIAID has vastly expanded its research portfolio in biodefense
and naturally emerging and re-emerging infectious diseases. This
research targets pathogens that pose high risks to public health and
national security. NIAID has designated pathogens with high mortality
such as anthrax, plague, smallpox, and Ebola virus as NIAID Category A
Priority Pathogens to highlight the need for medical countermeasures
against these dangerous microbes.
NIAID's expanded efforts in biodefense and emerging and re-emerging
infectious diseases were undertaken with specific objectives. The first
is to advance basic and translational research and facilitate
development of effective products to combat deadly diseases such as
Ebola. The second is to employ innovative strategies, such as broad
spectrum vaccines and therapeutics, to prevent and treat a variety of
related infectious diseases. The third is to strengthen our
partnerships with biotechnology and pharmaceutical companies to help
accelerate the availability of needed products for affected and at risk
individuals.
Since 2001, NIAID's biodefense research has supported the
development and testing of numerous candidate products to prevent or
treat viral hemorrhagic fevers, including those caused by Ebola and
other related viruses. The progress we have made with candidate
vaccines, therapeutics, and diagnostics for Ebola virus would not be
possible had we not made this important investment.
development and testing of ebola medical countermeasures
In response to the Ebola public health emergency in West Africa,
NIAID is accelerating ongoing research efforts and partnering with
governments and private companies throughout the world to speed the
development of medical countermeasures that could help control the
current epidemic and future outbreaks. NIAID research on Ebola virus
focuses on basic research to understand how Ebola virus causes illness
in animals and in people as well as applied research to develop
diagnostics, vaccines, and therapeutics.
diagnostics
Accurate and accessible diagnostics for Ebola virus infection are
needed for the rapid identification and treatment of patients in an
outbreak because the symptoms of Ebola can be easily mistaken for other
common causes of fever in affected areas, such as malaria. NIAID
continues to provide resources to investigators attempting to develop
Ebola diagnostics. With NIAID support, Corgenix Medical Corporation is
developing diagnostics for Ebola virus using recombinant DNA
technology. NIAID also is advancing development of diagnostics,
including those using novel technologies, which are capable of
detecting multiple viruses including Ebola. Such innovative approaches
can provide information critical to the creation of point-of-care
diagnostics that could be distributed and used in areas where Ebola
virus outbreaks occur. Intramural scientists from NIAID's Rocky
Mountain Laboratories (RML) in Hamilton, MT, and Integrated Research
Facility in Frederick, MD, have responded to the epidemic by providing
technical diagnostic support in Liberia.
therapeutics
Currently, supportive care, including careful attention to fluid
and electrolyte replacement, is the only effective medical intervention
for patients with Ebola virus disease; no drugs are available
specifically to treat Ebola virus infection. Experts are now evaluating
whether drugs licensed or approved for the treatment of other diseases
should be reevaluated for potential treatment of patients with Ebola in
the current epidemic on an emergency basis. In parallel, NIAID is
supporting the development of novel therapeutics targeting Ebola virus.
These investigational candidate therapeutics could possibly be used in
clinical trials in the current epidemic and hopefully will prove to be
safe and effective; if so, such treatments could be more widely
available for future outbreaks. It is important to note that NIAID-
supported candidate therapeutics are in early development and are
currently available only in limited quantities.
NIAID has provided support to and collaborated with Mapp
Biopharmaceutical, Inc., to develop MB-003, a combination of three
antibodies that prevents Ebola virus disease in monkeys when
administered as late as 48 hours after exposure. An optimized product
derived from MB-003, known as ZMapp, has shown to be substantially more
effective in animal models than earlier combinations and protected
monkeys from death due to Ebola virus up to 5 days after infection,
according to Mapp Biopharmaceutical, Inc. NIAID's preclinical services
are now being used to provide pivotal safety data to support the use of
ZMapp for clinical trials in humans. Mapp Biopharmaceutical, Inc., has
announced that ZMapp was recently administered to humans for the first
time as an experimental treatment to several Ebola-infected patients,
including two Americans. It is not possible at this time to determine
whether ZMapp benefited these patients. NIAID is working closely with
partners at DoD, BARDA, and FDA to advance development and testing of
ZMapp to determine whether it is safe and effective. BARDA has recently
announced plans to optimize and accelerate the manufacturing of ZMapp
so that clinical safety testing can proceed as soon as possible.
NIAID also has funded BioCryst Pharmaceuticals to develop and test
BCX4430, a novel drug that interferes with the reproductive process of
the virus and has activity against a broad spectrum of viruses.
According to BioCryst, BCX4430 has protected animals against infection
by Ebola virus and the related Marburg virus. BioCryst has announced
that a Phase 1 clinical trial of this drug is expected to begin in late
2014 or early 2015.
In related work, NIAID intramural scientists at RML are working on
therapeutics that might be effective against all hemorrhagic fever
viruses including the filoviruses Ebola and Marburg and the arenavirus
Lassa. Ribavirin, a drug currently used to treat hemorrhagic fever
viruses such as Lassa virus, is being examined for its potential use in
combination therapy to treat Ebola virus infection. NIAID scientists
also are studying human interferons as Ebola therapies. Other
therapeutics being examined by scientists at RML are in early stages of
study and if successful, will advance to animal model testing.
vaccines
A safe and effective Ebola vaccine could be a critically important
tool to help prevent Ebola virus disease and help contain future
outbreaks. The hope is that such a vaccine could be licensed and used
in the field to protect frontline healthcare workers and individuals
living in areas where Ebola virus exists. Two Ebola vaccine candidates
are entering Phase 1 clinical testing this fall. NIAID will play a
critical role in advancing these Ebola vaccine candidates. The results
of these Phase 1 studies will inform essential discussions about
whether and how such vaccines could be of use in the current epidemic
or future Ebola outbreaks.
The NIAID Vaccine Research Center (VRC) has a robust viral
hemorrhagic fever vaccine development program. Since 2003, the VRC has
evaluated three early generation Ebola vaccine candidates and one
Marburg vaccine candidate in Phase 1 clinical trials at the NIH campus.
An additional Phase 1 clinical trial was conducted in Kampala, Uganda,
in collaboration with DoD. None of the early generation candidates
raised safety concerns in these small trials; however, they did not
elicit the level of immune response thought to be needed to provide
protection against exposure to the virus. The data from those trials
have contributed directly to the VRC's current Ebola vaccine
collaboration with the pharmaceutical company GlaxoSmithKline (GSK).
VRC and GSK have developed an experimental vaccine that uses a
chimpanzee virus (similar to the common cold virus), Chimp Adenovirus 3
(CAd3), as a carrier, or vector, to introduce Ebola virus genes into
the body; these genes code for Ebola proteins that stimulate an immune
response. The vaccine candidate has shown promising results in animal
models against two Ebola virus species, including the Zaire Ebola
species responsible for the current epidemic in West Africa. A small
Phase 1 study to examine the safety and ability of this candidate to
induce an immune response in humans began on September 2, 2014, at the
NIH Clinical Center in Bethesda, MD. Results from the study are
anticipated by the end of this calendar year, and will help inform
future development of the vaccine.
Additional Phase 1 clinical trials of Ebola vaccine candidates are
expected to launch before the end of 2014. In October, testing will
begin in the United States on a vaccine candidate derived from the
CAd3-vector designed to protect against a single Ebola virus species,
the Zaire Ebola virus. NIAID and GSK also will donate doses of this
vaccine candidate to enable testing by NIAID partners in the United
Kingdom and the West African country of Mali, where existing NIAID
research infrastructure will support the vaccine trial. Also this fall,
NIH is collaborating with DoD and NewLink Genetics Corporation on Phase
1 safety studies of an investigational Ebola vaccine based on vesicular
stomatitis virus (VSV). The VSV vaccine will serve as a vector or
carrier for an Ebola gene similar to how the Chimp adenovirus served as
a vector or carrier as described above for the NIAID/GSK vaccine. This
vaccine candidate was developed by and licensed from the Public Health
Agency of Canada.
In addition to these Ebola candidates entering Phase 1 trials in
2014, NIAID supports a broad portfolio of Ebola vaccine research,
including partnering with biopharmaceutical companies. NIAID also makes
preclinical services such as animal testing to advance product
development available to researchers in academia and industry. More
than 30 different filovirus vaccine formulations have been evaluated
through NIAID's preclinical services since 2011 using animal models and
assays that NIAID has developed over many years.
NIAID has supported the biopharmaceutical company Crucell to
develop a recombinant adenovirus-vectored Ebola vaccine. In animal
studies, this vaccine candidate protected against filovirus infection,
including Ebola virus. NIAID has played an instrumental role in the
recent announcements by Johnson & Johnson (parent company of Crucell)
and Bavarian Nordic that they will collaborate on a two dose (prime-
boost) vaccination regimen that will begin Phase 1 testing in 2015.
NIAID intramural scientists are collaborating with Thomas Jefferson
University investigators to produce a vaccine candidate based on an
existing rabies vaccine. The researchers aim to generate immunity to
Ebola, Marburg, and rabies viruses, important diseases in certain
regions in Africa. The investigators plan to pursue a version of the
vaccine for human and veterinary use as well as a version for use in
African wildlife. The wildlife vaccine could help prevent transmission
of Ebola virus from animals to humans. The vaccine candidate for use in
humans is undergoing preclinical testing and has demonstrated
protection against infection by rabies and Ebola viruses in animal
models. NIAID is currently partnering with DoD to produce sufficient
quantities of the vaccine candidate to begin clinical testing in early
2015.
NIAID also is supporting the biotechnology company Profectus
BioSciences, Inc., to investigate a second recombinant VSV-vectored
vaccine candidate against Ebola and Marburg viruses. Profectus is
pursing preclinical testing of the vaccine in preparation for a future
Phase 1 clinical trial. Additionally, NIAID is collaborating with the
Galveston National Laboratory & Institute for Human Infections and
Immunity at the University of Texas Medical Branch at Galveston to
further progress made by NIAID intramural scientists on a
paramyxovirus-based vaccine against Ebola and Marburg viruses.
Other NIAID-supported efforts include Ebola virus vaccine
candidates in early development, such as a DNA vaccine targeting Ebola
and Marburg viruses, an adenovirus-5-based intranasal Ebola vaccine,
and a combination virus-like particle/DNA vaccine targeting Ebola and
Marburg viruses to be delivered by microneedle patch. Knowledge gained
through these studies will further the goal of the ultimate deployment
of a safe and effective vaccine that will prevent this deadly disease.
clinical trials
It is important to balance the urgency to deploy investigational
medical countermeasures in an emergency such as the current Ebola
outbreak with the need to ensure the maximal safety and to determine
the efficacy of candidate drugs and vaccines for Ebola. We will do this
with the strictest attention to safety considerations, established
scientific principles, and ethical considerations and compassion for
and realization of the immediate needs of the affected populations. The
U.S. Government, working in partnership with industry, has an
established mechanism for testing and reviewing the safety and efficacy
of potential medical interventions. We also have an emergent crisis in
West Africa that demands a quick and compassionate response.
NIAID is committed to working with our partners to evaluate
candidate drugs and vaccines for safety and efficacy. We are working to
generate the evidence to show whether potential interventions are safe
and effective to reassure affected communities that we are pursuing the
tools needed to prevent and treat this deadly disease. Our partnerships
with industry will be critical to move these products expeditiously
along the development pipeline into clinical trials. NIAID is currently
working to accelerate the vaccines discussed above into Phase 1
clinical trials in healthy volunteers. The data from these trials will
help demonstrate whether candidate Ebola vaccines are safe in humans
and are capable of generating the desired immune response. Candidate
Ebola treatments will be similarly evaluated for safety and markers of
potential efficacy. If successful, these candidates will be advanced to
further testing in larger numbers of people. As we proceed through
clinical testing, we will continue to work with our partners in the FDA
to accelerate development of and speed access to the products, while
also protecting the safety and rights of study volunteers.
conclusion
While NIAID is an active participant in the global effort to
address the public health emergency occurring in West Africa, it is
important to recognize that we are still in the early stages of
understanding how infection with the Ebola virus can be treated and
prevented. As we continue to expedite research while enforcing high
safety and efficacy standards, the implementation of the public health
measures already known to contain prior Ebola virus outbreaks and the
implementation of treatment strategies such as fluid and electrolyte
replacement are essential to preventing additional infections, treating
those already infected, protecting health care providers, and
ultimately bringing this epidemic to an end. We will continue to work
with biopharmaceutical companies and public health agencies throughout
the world to develop and distribute medical countermeasures for Ebola
virus disease as quickly as possible. NIAID remains committed to
fulfilling its dual mandate to balance research on current biomedical
challenges with the capability to mobilize a rapid response to newly
emerging and re-emerging infectious diseases.
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The Chairman. Thank you, Dr. Fauci.
Dr. Robinson, please proceed.
STATEMENT OF ROBIN A. ROBINSON, PH.D., DIRECTOR, BIOMEDICAL
ADVANCED RESEARCH AND DEVELOPMENT AUTHORITY, DEPUTY ASSISTANT
SECRETARY FOR PREPAREDNESS AND RESPONSE, UNITED STATES
DEPARTMENT OF HEALTH AND HUMAN SERVICES, WASHINGTON, DC
Mr. Robinson. Good afternoon. Thank you, Chairman Harkin,
Ranking Members Alexander and Moran, and other distinguished
members of the committee. We thank you for your generous
appropriations over the years and the opportunity to speak with
you today about our government's Ebola response efforts. I'm
Dr. Robin Robinson, BARDA Director and ASPR Deputy Assistant
Secretary in HHS.
BARDA, which was created by the Pandemic and All-Hazards
Preparedness Act in 2006, is the government agency responsible
for supporting advanced development and procurement of novel
and innovative medical countermeasures, such as vaccines,
therapeutic drugs, diagnostics, and medical devices for the
entire Nation. BARDA exists to address the medical consequences
of biothreats and emerging infectious diseases. BARDA has
supported medical countermeasure development for manmade
threats on a routine basis under Project Bioshield and
responded to emerging threats like the HIN1 pandemic in 2009
and the Avian H7N9 outbreak last year with CDC, FDA, and NIH.
Today we face Ebola, which is simultaneously a biothreat
and a material threat determination by the Department of
Homeland Security in 2006 and an emerging infectious disease.
As Dr. Fauci and Dr. Bell have said, when it comes to Ebola as
a biothreat the best way to protect our country is to address
the current epidemic in Africa, the worst in history.
BARDA works with its Federal partners to transition medical
countermeasures from early development at NIH and Department of
Defense and to advance development toward ultimate FDA
approval. Since 2006 we have built an advanced development
pipeline of more than 150 medical countermeasures for chemical,
biological, radiological, and nuclear threats, and pandemic
influenza. Seven of these products have received FDA approval
in just the last 2 years. Today we are transitioning several
promising Ebola vaccine and therapeutic candidates from early
development under NIH and DoD support to advanced development.
BARDA, in concert with our Federal partners, utilizes
public-private partnerships with industry to ensure that we
have countermeasures to protect our citizens. Over the past 5
years, BARDA, with NIH, CDC, and FDA and industry partners, we
have built a flexible and rapid response infrastructure to
develop and manufacture medical countermeasures.
As a result of the Pandemic and All-Hazards Preparedness
Reauthorization Act, an improved framework of medical
countermeasures development has been afforded to Federal and
industry partners. Indeed, last year we utilized these
partnerships to design, develop, manufacture, test, and
stockpile five vaccine candidates in record time for the H7N9
outbreaks in China.
In the current Ebola response, we are working with a wider
array of partners, including Canada, the U.K., West African
countries, the World Health Organization, the Gates Foundation,
and many others to make and test these Ebola product
candidates.
BARDA has established a medical countermeasures
infrastructure to assist product developers on a daily basis
and to respond immediately in a public health emergency. Today
we're using our Animal Studies Network to conduct critical
animal challenge studies, our Centers for Innovation in
Advanced Development and Manufacturing to expand production of
Ebola monoclonal antibodies, and our Fill-Finish Manufacturing
Network to fill Ebola antibody and vaccine products into vials.
Additionally, our Modeling Division, which develops
computer models of the medical consequences of manmade threats
on a routine basis, is coordinating international and Federal
modeling efforts on the current Ebola epidemic and possible
impacts of non-medical and medical interventions. Last, BARDA
supports a large-scale production of medical countermeasures as
a response measure for public health emergencies.
BARDA led the vaccine manufacturing responses in the H1N1
pandemic in 2009 and the H7N9 outbreak in 2013. Today we are
assisting the Ebola vaccine and therapeutic manufacturers with
scaled-up manufacturing. Specifically, we are supporting the
development and manufacture of the ZMapp monoclonal antibody
therapy for clinical studies at one manufacturer; additionally,
expanding overall manufacturing capacity of ZMapp by enlisting
the help of other tobacco plant-based manufacturers; and third,
seeking alternative Ebola monoclonal candidates to expand the
production capacity.
Additionally, BARDA is working with the NIH and DoD and
industry partners to scale up the manufacturing of two
promising Ebola candidates, one of which Dr. Fauci talked
about, for clinical studies in Africa next year.
The fiscal year 2015 continuing resolution and
appropriations are needed now to fund investments in these
medical countermeasures candidates. BARDA faces challenges in
the coming weeks and months with the manufacturing of these
medical countermeasures, but the bottom line is that BARDA,
with our Federal and industry partners, will use our collective
capabilities to address today's Ebola epidemic and to be better
prepared for future Ebola outbreaks or bioterrorism events
going forward.
We thank the committee and subcommittee for your generous
and continued support and the opportunity to testify, and I
look forward to your questions. Thank you.
[The prepared statement of Mr. Robinson follows:]
Prepared Statement of Robin A. Robinson, Ph.D.
Good afternoon. Chairman Harkin, Ranking Members Alexander and
Moran, and other distinguished members of the committees, thank you for
the opportunity to speak with you today about our Government's Ebola
epidemic response efforts. I am Dr. Robin Robinson, Director of the
Biomedical Advanced Research and Development Authority (BARDA) and
Deputy Assistant Secretary to the Assistant Secretary for Preparedness
and Response (ASPR) of the Department of Health and Human Services
(HHS).
In 2006, the Pandemic and All-Hazards Preparedness Act (PAHPA)
created BARDA and its parent organization, ASPR. Two years ago, the
Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA)
established the Public Health Emergency Medical Countermeasures
Enterprise (PHEMCE). BARDA is the Government agency mandated to support
advanced research and development and procurement of novel and
innovative medical countermeasures such as vaccines, antimicrobial
drugs, diagnostics, and medical devices for the entire Nation to
address the medical consequences of chemical, biological, radiological,
and nuclear agents of terrorism (``biothreats'') and naturally
occurring and emerging threats like the H1N1 pandemic, the H7N9
influenza outbreak last year, and the current Ebola epidemic.
BARDA exists to address the medical consequences of these threats
and to bridge the gap between early development and procurement of
medical countermeasures for novel threats. Ebola is simultaneously a
biothreat (with a Material Threat Determination issued in 2006 by the
Department of Homeland Security) and an emerging infectious disease.
The current Ebola epidemic is the worst on record. As CDC has said, we
do not view Ebola as a significant public health threat to the United
States. The best way to continue to protect our country from any
domestic threat posed by Ebola is to take action to address the
epidemic in Africa.
BARDA works with our PHEMCE partners in HHS and other Federal
agencies to transition medical countermeasures from early development
into advanced development and ultimately to Food and Drug
Administration (FDA) regulatory review and approval. Advanced
development includes critical steps needed for a product to be ready to
use, such as optimizing manufacturing processes so products can be made
in quantity to scale, creating and optimizing assays to assure product
integrity, conducting late-stage clinical safety and efficacy studies,
and carrying out pivotal animal efficacy studies that are often
required for approval. Since 2006, BARDA has managed the advanced
development of more than 150 medical countermeasures for chemical,
biological, radiological, and nuclear threats and pandemic influenza.
Seven of these products have received FDA approval in the last 2 years
alone.
Over the last decade, the PHEMCE has supported basic research and
early stage development of numerous Ebola and Marburg virus medical
countermeasure candidates. Now, as a result of this work, several
promising Ebola vaccine and therapeutic candidates have matured enough
for BARDA to transition them rapidly from early development to advanced
development. Our aim is to have products we can use in time to make a
difference in the current Ebola epidemic. We seek to have FDA-approved
medical countermeasures as soon as it is feasible. Specifically, BARDA
is now providing assistance for the development and scaled-up
manufacturing of the ZMapp monoclonal antibody therapeutic and two
Ebola vaccine candidates, early development of which has been supported
by the National Institutes of Health's (NIH) National Institute of
Allergy and Infectious Diseases (NIAID) and the Department of Defense's
(DoD) Defense Threat Reduction Agency (DTRA).
Working in conjunction with PHEMCE partners, BARDA uses public-
private partnerships with industry to ensure that we have the medical
countermeasures to protect the emergency health security of the United
States. Over the past 5 years, BARDA--with NIH, CDC, FDA, and industry
partners--has built a flexible and rapidly responsive infrastructure to
develop and manufacture medical countermeasures. Last year, for
example, in response to the H7N9 influenza outbreaks in China, the
PHEMCE mobilized these partnerships to design, develop, manufacture,
clinically evaluate, and stockpile several vaccine candidates in record
time. In the current Ebola response, the PHEMCE is working with a wider
array of partners in addition to our Federal partners. They include
other countries, specifically the affected and at-risk African
countries; the World Health Organization (WHO); the Bill and Melinda
Gates Foundation; and others. These expanded partnerships are critical
to our efforts to address the current Ebola epidemic.
BARDA has established a medical countermeasure infrastructure to
assist product developers on a daily basis. The medical countermeasure
infrastructure also allows for BARDA to respond immediately in a public
health emergency. Today, BARDA is using this infrastructure to respond
to the current Ebola epidemic by helping to develop and manufacture
several investigational Ebola therapeutics and vaccines. BARDA's Animal
Studies Network is conducting critical animal challenge studies for
promising investigational Ebola therapeutic candidates. BARDA's Centers
for Innovation in Advanced Development and Manufacturing, established
in 2012, are positioned to accelerate production of Ebola monoclonal
antibodies, like those in ZMapp, in tobacco plants and mammalian cells
if clinical trials demonstrate that ZMapp is safe and effective. BARDA
will monitor ZMapp throughout the development cycle, and, if necessary,
can shift funds to test other candidate therapeutics. Our Fill-Finish
Manufacturing Network, established last year for pandemic preparedness,
stands ready to formulate and fill Ebola antibody and vaccine products
into vials for studies and other uses. The investments we have made to
create this infrastructure over the past 4 years are helping us respond
to the current epidemic.
BARDA also supports large-scale production of medical
countermeasures as a response measure for public health emergencies.
BARDA led the manufacturing of vaccine and antiviral drugs in response
to the H1N1 pandemic in 2009 and of vaccines as a preparedness measure
for H7N9 in 2013. In the current Ebola epidemic, BARDA is providing
assistance to vaccine and therapeutic manufacturers to scale up
production from pilot scale, in which a handful of doses can be made,
to commercial scale. For ZMapp, we are currently supporting the
manufacture of enough doses for clinical safety studies, but we need to
start now to expand the number of domestic manufacturers who can
produce Ebola monoclonal antibodies using tobacco plants. Therefore,
the Administration is requesting funding for this purpose through an
anomaly to the fiscal year 2015 continuing resolution. Additionally, we
are looking at alternative Ebola monoclonal antibody production
systems, including those used for similar families of products in the
commercial market, as a means of further expanding production capacity
for this product. With respect to vaccines,
BARDA is working with NIH/NIAID, DoD/DTRA, and industry partners to
scale up the manufacturing of the two promising investigational Ebola
vaccine candidates. To enable the conduct of clinical efficacy studies
for investigational Ebola therapeutics and vaccines in Africa
throughout the next year, we need appropriations to fund investments in
these medical countermeasure candidates now as proposed through the
continuing resolution anomaly.
BARDA faces significant challenges in the coming weeks and months
with the manufacturing of these medical countermeasures. The major
challenge is being able to provide sufficient quantities soon enough to
support clinical studies. BARDA is prepared to meet those challenges
and provide resources, expertise, and technical assistance for other
promising investigational Ebola vaccine and therapeutic candidates. We
are working with our U.S. Government partners, new and existing
industry partners, the WHO, non-governmental organizations, African
countries, and others to meet these challenges.
In conclusion, BARDA has established a solid track record in
developing medical countermeasures. With the rest of the PHEMCE, we are
using all of our capabilities to address the Ebola epidemic in Africa,
and have identified crucial additional steps that can be supported
through the fiscal year 2015 continuing resolution. BARDA's investments
today into Ebola medical countermeasures will address not only the
current epidemic and any future Ebola outbreaks, but they will also
help the United States to become better prepared for bioterrorism.
Again, I would like to thank the committee and subcommittee for your
generous and continued support, and for the opportunity to testify. I
look forward to your questions.
The Chairman. Thank you very much, Dr. Robinson. Thank you
all for your very succinct summations of your statements. We'll
start a round of 5-minute questions. I'm going to ask people to
try to adhere to that. We have another panel that's going to be
very interesting also, Dr. Brantly, who is a survivor, and
Ishmael Charles, who is a worker on the ground in western
Africa. We would like to get to that panel this afternoon.
I'll start a 5-minute round. Dr. Bell, these disease
outbreaks seem to be becoming more common because of the close
proximity of humans and animals, because of the close proximity
of humans. Travel is common, and what's happened in West Africa
I believe is due to a failure of the public health system or
the nonexistence of a public health system in those countries.
A couple of years ago, in traveling through Africa with Dr.
Frieden it occurred to me that in some of these countries they
need a CDC. They need an entity that is culturally sensitive,
that involves people of that country, that can detect these
early, do the epidemiological work, isolate and control at the
beginning. And they need to be connected with our CDC so that
we can work together. Last year, Senator Moran and I put money
in the appropriations bill--I forget how much it was, $10
million or something like that--to start expanding this.
Would you speak to this, and how important is it for these
other countries to create their own version of the CDC so that
these outbreaks can be controlled right from the beginning? In
other words, every country having their own CDC.
Dr. Bell. Yes, thank you, Senator. You make some very
important points. There are some fundamental capabilities that
we at the CDC almost take for granted because they're so
fundamental, that are really absent in many of these countries:
basic laboratory capacity, rapid response teams, some
understanding of what it takes to investigate an outbreak,
emergency operations centers where we understand the structure
that one needs in order to control, to identify and control an
outbreak, telecommunications systems, some very basic
capabilities.
These are capabilities that we agree with you really need--
they're fundamental and really every country needs these
capabilities. In many ways, that's what the Global Health
Security Agenda is about.
I might give you an example from another country in Africa
by way of contrast. We're in the midst now of the largest and
extremely challenging Ebola outbreak, but we at the CDC have
actually been investigating and stopping Ebola outbreaks in
East Africa for actually quite a long time. One of the
countries in which we've been working is Uganda. If you look at
the list of Ebola outbreaks of the past, you'll see that many
of them were in Uganda, some of the largest ones involving
hundreds of people, which of course at that time we thought was
a lot.
Over the last decade or so, we've been working with Uganda,
with the Ministry of Health and with the Uganda Virus Research
Institute to build capacity there. They now have a laboratory,
which allows them to do their own testing and detect Ebola and
other viral hemorrhagic fevers. They have a transportation
network, which allows them to move specimens around the country
and get them to the laboratory. They have rapid response teams
that know how to find Ebola outbreaks and stop them.
Consequently, what we've seen in Uganda over the last few
years is more outbreaks being detected, which is good because
we know that they're going on, and then they're much smaller,
to the point where a year or two ago there was an outbreak of
Ebola which involved one person. They were able to stop it
after one person. Most of these are small clusters which are
stopped quickly.
This is an example of building the kind of capacity that
you're talking about, which is of benefit to the country. It
helps the country solve some very fundamental health problems
that they have. This is an example of the kind of thing that we
think, we agree with you, really needs to be built in every
country.
The Chairman. I hope this Congress and the one to follow--I
won't be here, but the one that follows--will really take this
up. We have spent lots of taxpayers' dollars in shoring up
military operations around the globe so people could defend
themselves against insurgencies, could defend themselves. Yet
on this one aspect we have been woefully inadequate. It's like
we expect our CDC to do everything. It can do a lot, as we've
shown, but we need those other CDC's in those countries out
there. Think about those as forward outposts where people can
defend themselves and in turn defend us from the rapid
transmission of these viruses.
I thank you very much. I thank Dr. Frieden and all of you
down there for your great leadership. I hope that in the next
few years we can see CDC replicated in countries around the
globe.
Thank you, Dr. Bell.
Senator Alexander.
Senator Alexander. Dr. Bell, you and the other witnesses
have carefully explained that we know what to do about Ebola
and we've demonstrated that it can be controlled. However, in
talking with you and Dr. Frieden, without putting words in your
mouth, I can tell you feel like this epidemic, this outbreak,
is a very, very serious problem that we ought to jump all over.
Let me try to put that into some perspective. You said a
moment ago that a few hundred cases would have been a big
outbreak. Today the official report says you have identified a
little less than 5,000 cases, correct? But it might be higher
than that. Is that right? What are the chances that that's
underreporting the number of cases in West Africa?
Dr. Bell. Quite likely, Senator.
Senator Alexander. Quite likely higher. It's also true
that, of those cases that you reported, half of them were
reported in the last 3 weeks, is that correct?
Dr. Bell. More or less, yes, sir.
Senator Alexander. So if the number were 10,000 or 15,000
instead of 5,000, perhaps half those cases would have been
reported in the last 3 weeks.
Dr. Bell. Quite possibly.
Senator Alexander. The danger is the rapid infection. Why
such a worry? Is it that the infection spreads more rapidly? Is
that the concern? We've had many kinds of epidemics, but why
such a grim outlook about this epidemic? Why does CDC say it
may be the most dangerous epidemic of modern times if it's not
controlled?
Dr. Bell. Yes, sir. Thank you, Senator. As you've heard,
Ebola actually is not easily transmitted. It isn't transmitted
through the air and it requires direct contact with bodily
fluids, with dead bodies. But what we're seeing in this
outbreak is, because of right now insufficient capacity to
isolate patients with Ebola, we are seeing these chains of
transmission. You can imagine, as the number of cases grows,
the number of contacts for each case, that these chains of
transmission continue to propagate. That's how the number of
cases grows and continues to grow faster as the number of cases
increase.
It's really a matter of arithmetic, and it brings me to the
point of what is the critical issue right now, especially in
Liberia, but really in all of these countries. That is that we
must come up with some ways to effectively isolate and treat
Ebola patients. Right now our capacity----
Senator Alexander. But first you have to find them, right?
You have to chase down every infected person or person who
might be infected, right?
Dr. Bell. Right now, Senator, certainly in Liberia there
are patients that we know about and there are no Ebola
treatment units in which to house them. So yes, we must do
meticulous contact tracing. We must identify all the potential
cases, isolate them, check their temperatures for 21 days to
make sure that they're not infected. But right now, especially
in Liberia, the problem that we have is that we don't have
measures to effectively isolate cases that we do identify.
That's right now the limiting factor, I would say, in Liberia.
Senator Alexander. So the new cases seem to appear to
double in 3 weeks, and half those infected die?
Dr. Bell. Right now it appears that's the mortality rate,
that's right, sir.
Senator Alexander. Dr. Fauci, I have one question for you.
Dr. Bell pointed out that you don't catch Ebola by breathing on
someone. It's bodily fluids, usually when someone is infected
and has symptoms.
Dr. Fauci. Right.
Senator Alexander. Or someone is dead. And those two
instances are most of the infections. You were quoted recently
as saying it's not likely that Ebola will change how it's
transmitted, which produces an even more serious set of
possibilities. Are you tracking the virus in this outbreak as
it affects more and more people to see if in fact it's mutating
and changing in the way it's transmitted, so that we're not
deceived by that?
Dr. Fauci. Very important question, Senator. So let me just
first answer the question and then I'll tell you what we're
doing to make sure we're on top of this. Right now the Ebola
virus is not transmitted by the respiratory route. There has
been some discussion that since the virus replicates a lot--
whenever you have an RNA virus, the more it replicates the
greater the possibility of it mutating is. And most mutations
are irrelevant mutations. They're not associated with a
biological change or a biological function. So even though you
see a lot of mutations, it is unlikely that there will be a
change, but there's a possibility that there will be a change.
Usually when you have a change in function it could get a
little bit more virulent, a little bit less virulent, be
efficiently spread in the way it usually is spread or less
efficient. It is an unusual situation where a mutation would
completely change the way a virus is transmitted. It's not
impossible, but it would be unlikely.
We never take anything like that lightly, we follow it
very, very carefully. In fact, in direct answer to your first
question, we have an arrangement with one of the best microbial
sequencing groups in the world at the Broad Institute in Boston
that is getting samples and looking at the evolution of the
mutations to try and make sure that mutations are not occurring
that would have an important impact on what we call a
biological function, like transmissibility.
The reason I made that comment is that I wanted to make
sure that people understand that changing transmissibility so
that it could be transmitted by the respiratory route is
obviously something that could be a frightening thing. I want
to make sure that people understand that we're watching that
carefully, but that's an unlikely event, not an impossible
event, unlikely.
What is likely is that if we don't do what we're doing now
in the sense of a major ramping up of infection control
capabilities, including what we're hearing about getting the
military heavily involved with all of the things they bring to
the table, it is very likely if we don't stop this epidemic
it's just going to get worse and worse, the way Dr. Bell said.
That's the more likely phenomenon, so that's the reason why we
concentrate on getting it under control so you don't give it
the opportunity to mutate any more.
A virus that doesn't replicate can't mutate. So if we just
put the lid on this, that'll be it.
Senator Alexander. Thank you, Mr. Chairman.
The Chairman. Thank you.
I will recognize Ranking Member Moran next, and in order of
appearance I have here, I have then Senator Warren, Senator
Burr, Senator Reed, Senator Isakson, Senator Murray, Senator
Cochran, Senator Casey, Senator Johanns, Senator Bennet,
Senator Boozman, and then Senator Whitehouse, Senator Pryor,
and Senator Durbin.
Senator Moran.
Senator Moran. Chairman Harkin, thank you.
Dr. Bell, thank you to you and Dr. Frieden for the visit we
had in Atlanta a few days back and for the visit I had with Dr.
Frieden in my office this week. At that point in time, I
expressed to Dr. Frieden my request that he express gratitude
on behalf of me and all of us in this country for the efforts
by the people who work at CDC, who are working now globally,
trying to contain and change lives. We're very grateful for
what you have undertaken.
Let me ask first a question. Dr. Fauci just indicated about
the potential response of use of the military. Is there
something that you can say to the American people that assures
them that our military men and women will be safe and secure
from Ebola in the new tasks that they're now being asked to
undertake?
Dr. Bell. Thank you, Senator, and thank you for the kind
words about the CDC.
The CDC already has more than 100 people in the field, and
this question of safety and security of our own staff or any
staff or any members of the U.S. Government or many of our
colleagues here, their safety and security is really our No. 1
priority. We've been actually paying a lot of attention to this
issue, certainly, as I say, starting with our own staff, with
making sure that the staff understands what the situation is
like on the ground before they go, having them understand very
clearly what are the interventions that they need to take,
making sure they have the right kind of personal protective
equipment, that they understand some basic strategies in terms
of distancing, and that they know what to look for should they
start to feel ill.
I think that the bottom line here is that it is a very dire
situation. We are concerned about safety and security. We are
taking that very seriously and have taken a lot of steps to do
everything that we can to minimize the risk. But it is a very
difficult situation and this is something that I worry about
certainly every day with my own staff that are out there on the
front lines.
Senator Moran. Let me expand my expression of gratitude to
the private religious charitable organizations and health care
organizations that are working globally, at significant risk to
themselves.
What kind of coordination, education, training, do you
understand either has taken place in regard to our military and
their preparation for this assignment?
Dr. Bell. Senator, I don't have any specific information
about the preparation of the Department of Defense, but I will
say that this is one of the areas that we at CDC have actually
been working quite closely on, that being in training. Next
week we'll be hosting a course in Aniston, AL, at the FEMA
facility there, which is a 3-day safety training for health
care workers who are planning to deploy to work for
nongovernmental organizations in Liberia, Sierra Leone, or
Guinea.
This is a course that our colleagues at Medecins Sans
Frontieres, Doctors Without Borders, helped us develop, and the
precise purpose is to explicitly teach--these are health care
workers; they already know, supposedly, about infection
control--but explicitly teach them about the important
principles that they need to know in order to safely care for
Ebola patients. There's a mock facility there and, as I say,
we're hoping to actually have this course weekly over the next
period of months. Our first course is actually completely full.
There's a lot of interest. And we think that this kind of
training is really pivotal before Americans deploy to work in
treatment facilities in the region in order, to your point, to
make sure that they can care for patients safely.
Senator Moran. Dr. Bell, let me ask a broader question. How
would you describe the best case scenario in regard to Ebola
and its spread and consequences and the worst case scenario,
and what is the difference--what is the item that makes the
worst case scenario not happen, and the best case scenario to
occur?
Dr. Bell. The best case scenario is that over the coming
months we're able to effectively isolate and treat Ebola
patients, we're able to effectively trace all of the contacts,
make sure they're all followed for 21 days, and we're able to
do something about safe burial practices so that we don't have
bodies in the street and people are able to respectfully bury
their dead and not put themselves at risk, so that over a
period of the coming months we're able to interrupt chains of
transmission and start to see this increase in cases that
Senator Alexander was talking about, bend that curve in the
other direction.
The worst case scenario is that we continue to see the
exponential rise in cases that we're currently seeing. An
important corollary of that is exportation to other countries.
As I mentioned, we've already had exportation to Nigeria and
Senegal. I will say that the situation in Nigeria was one that
we were extremely concerned about. You could imagine, in a
country like Nigeria, should we have Ebola get out of control
how incredibly dangerous this would be. It was an enormous
effort in order to get the situation in Nigeria to the point
that it is today, which is that, while we're not completely out
of the woods, we do not think that there's uncontrolled
transmission happening in Nigeria.
But just for an example, this involved following up on
thousands of contacts, hundreds of people working in the
emergency operations center in Lagos and then in Port Harcourt.
So one exportation like that, it requires an enormous amount of
work.
If this outbreak spirals out of control, we can expect many
more of these exportations to other countries. Each one of
those, as I say, requires a huge amount of work, and we have no
guarantee that we'll be successful. You could imagine the
outbreak spreading outside of the borders of the countries that
are currently affected as certainly part of a worst case
scenario.
Senator Moran. Thank you, Dr. Bell.
The Chairman. I'm going to recognize Senator Reed. Before I
do it, I just have one clarification. Dr. Fauci, you said this
was non-respiratory communicable. But what if someone sneezes
on somebody?
Dr. Fauci. Mr. Chairman, there is no evidence, with a lot
of experience over multiple outbreaks, including the current
outbreak, that respiratory spread occurs, or if it does it's
extraordinarily rare. You never say never in biology, but
people who have been in situations in which that particular
phenomenon would have been noticed clearly indicate that that's
not the case.
The Chairman. Got it. Thank you.
Senator Reed.
Statement of Senator Reed
Senator Reed. Thank you very much, Mr. Chairman.
Let me first thank you and your colleagues for your
extraordinary service to the Nation and to the world. One of
the reasons that this issue is so important in Rhode Island is
that we have a large Liberian community, probably the largest
Liberian community per capita in the United States, and they
are hardworking and they are terribly concerned about their
families in Liberia.
I want to thank, Dr. Bell, you and Dr. Moro, because Dr.
Moro actually participated in a conference call with our
Liberian leaders. Senator Whitehouse and I were both involved
in setting it up. Thank you very, very much.
I also want to join Senator Moran in saluting those
volunteers. We have two doctors on the Brown University
faculty, Dr. Tim Flanagan and Adam Levine, who are in the
country giving their skills and courageously working on behalf
of the people of Liberia. Thank you for that.
One other point I'll make, and this is something of an
aside. A number of the Liberians in Rhode Island and across the
country are here legally on a status of deferred enforced
departure, but let me make the point: That status expires
September 30th unless the President extends it. I would hope
that he would do so because to send people back to this,
literally, danger would be I think inappropriate.
But let me ask Dr. Fauci and Dr. Robinson, you talked about
a vaccine. Do you have sort of a sense of how fast this could
be deployed in West Africa? And second, would you reach the
point where you basically said, it's a huge risk, but it has to
be done, even if you don't have all of the usual protocols
completed?
Dr. Fauci. Excellent question, Senator Reed. The standard
way of implementing a vaccine in the field and deploying it is
to go through a series of steps of what I just described--phase
I, show is it safe and does it or does it not induce unexpected
reaction, a hypersensitivity reaction or whatever; then find
out what the right dose is and does it induce the right immune
response. Then you go to larger numbers of people, because now
you're pretty sure it's safe, you can do larger numbers of
people in what's called a phase IIA or IIB.
Then, depending on the disease, you can go out in the field
and test if it works, because the worst thing that you'd want
is have a vaccine that you're deploying that you think works,
but it doesn't work, or even one that would be even more
terrible is a vaccine that actually makes things worse.
So we have to consider all of that. But when you have an
emergent situation like this, where you have the desire to get
people protected if in fact the vaccine is protective, there
are ways to get the answers, not as definitively as if you did
a pristine type of a trial, but if you would then employ the
people who are needing the vaccine as part of the clinical
trial, where you either compare one vaccine against another or
one dose against another, so that you accomplish two things.
You try and determine if it's safe and effective, even though
it isn't as definitive as the pristine trial, but at the same
time by getting people into these expanded trials you actually
make it available.
Right now the thought is once we get this situation where
we can say we know what the dose is and we know it's safe, to
have an expanded trial and within the context of that trial
more people would get the opportunity to be vaccinated.
I might say that the target of the vaccinations is clearly
directed, among others, to the health care workers, the people
on the front line, the emergency responders, because those are
the ones that put themselves at risk, as did Dr. Brantly, in
taking care of individuals.
Senator Reed. So if you can prove, which is what you're
trying to do right now, that it's safe, but I don't know if
it's effective, you can try to prove its effectiveness by
inoculating the health care workers and others.
Dr. Fauci. Right.
Senator Reed. It's better than nothing, but it's not quite
definitive.
Dr. Fauci. Right. Fully knowing that you're not going to
get a definitive answer. But still, when you're in an emergent
situation you've got to do the best with what you have.
Senator Reed. Briefly, any further comments, Dr. Robinson?
Mr. Robinson. Commensurate with those clinical trials that
Dr. Fauci is talking about is that we have to have the product
there, the vaccines, to be made available. Part of that is
taking these products that are very early in development, that
are pilot scale, and making sure we can go to commercial scale
and produce those in large quantities, so that these studies
can be done and after that, if they are shown to be well
tolerated and immunogenic and protective, that there's more
vaccine available.
Senator Reed. Thank you all for your extraordinary work,
and please thank your colleagues, particularly those who are in
the field at risk.
Thank you.
The Chairman. Thank you very much.
Senator Burr.
Statement of Senator Burr
Senator Burr. Mr. Chairman, thank you.
Thank you to this panel, the next panel, and thousands who
will be called into action over the next weeks and months,
hopefully not years.
Dr. Bell, you said if we don't act now. Can you define
``now'' for me from the standpoint of a time line? At what
point will we have reached where we said we've missed our
opportunity? How long is that?
Dr. Bell. Senator, I wish I had a crystal ball and could
tell you precisely the answer to that. But the situation is
quite fluid and I think it's quite hard to predict with any
kind of precision. I certainly can say that speed and scale is
of the essence.
Senator Burr. You used the term several times ``controlling
the outbreak.'' Is controlling the outbreak the same or do you
use that the same way you do ``containment''?
Dr. Bell. Yes, sir, more or less, yes.
Senator Burr. How do you achieve containment on a disease
that's already broken the containment?
Dr. Bell. You can think of this as bending a curve. A curve
is going in one direction. We want to make it go in the other
direction. In order to do that, what we have to do is break
these chains of transmission. The way we break the chains of
transmission is by having effective ways, to isolate patients
so that they can't transmit and to make sure that there isn't
ongoing transmission happening, for example in health care
facilities or from unsafe burial practices.
Senator Burr. Let's just take Liberia as an example, 1,383
cases in the last 21 days, and we're surging through DoD the
capacity for 1,700 beds in a country where they have zero now.
My math is not great, but my math says we're going to be behind
the eightball on day one because we won't have enough beds.
Dr. Fauci, I'm told the most infectious tool or method in
these countries today is the back of a cab, where individuals
ride with their family to find that there are no beds in the
clinic and they ride home. Let me ask you, how long can the
virus survive, whether it's on a cab seat or whether it's on a
sheet or whether it's on a table? How long can it infect
somebody?
Dr. Fauci. There have not been definitive studies giving a
timeframe. It is not very durable, it's somewhat of a fragile
virus. But we do know that people get infected from touching
the dead bodies of people who have the virus--probably
contaminated with blood or bodily fluids. It certainly is
within the timeframe of when someone dies to a funeral, because
that's when people have been documented to get infected.
I don't think we could go, Senator Burr, beyond, giving you
days, weeks, or whatever. But it clearly is not instantaneous,
where once the virus gets out of the body it's gone, because we
know people have been infected at funerals by touching the
body.
Senator Burr. I understand on previous Ebola outbreaks
we've seen five generations of transmission. How many
generations of transmission have we seen so far with this
epidemic and how many mutations are we seeing as the virus
continues to spread with each chain of transmission?
Dr. Fauci. I can't give you a number on that, but when you
have an RNA virus it notoriously is a bad reproducer. It makes
mistakes, and when it makes mistakes it mutates. Most of the
mutations don't mean anything. They're just irrelevant. They're
called synonymous mutations. They don't mean anything.
Some of them, rarely, do mean something. Sometimes it means
that it kills the virus. Other times it maybe modifies some of
its biological function.
I can't tell you how many generations, but that could
mathematically likely be figured out on the basis of a paper
that just came out about a couple of weeks ago from Boston,
where they looked at 78 people and the virus taken from them,
and if you did a mathematical computerized informatics you'd be
able to say how many replications. I don't have that number for
you now, but you can determine that.
Senator Burr. If you'd get that to us, I'd appreciate it.
Dr. Fauci. I will.
Senator Burr. Dr. Bell, in recent days there have been
reports of modeling that suggest we could see 20,000 cases a
month and that the outbreak may last 12 to 18 months, which
would calculate to roughly 360,000 cases. Again, I think we
continue to be a step behind up until this point, this response
point. On what projected number of cases and period of outbreak
did the administration base its response strategy to date and
the latest actions announced today?
Dr. Bell. As you say, Senator, there have been a number of
models out there and we ourselves have been working on a model,
and I think it is certainly true that a number of these models
predict without additional effective interventions that we
could see hundreds of thousands of cases. So all of those
modeling exercises I think have certainly been taken into
account as we've been calling for additional interventions in
these countries.
I think the critical point here is that those models for
the most part, as I say, are based on not scaling up and what
we're doing right now is scaling up. In addition to all the
things that the U.S. Government is doing to scale up, including
the announcements from the Department of Defense, there are
also many other international partners who are also scaling
up--the World Health Organization, other countries, many
nongovernmental organizations, some of our colleagues here that
will be testifying in the next panel. There's also more
financing that's become available, for example from the World
Bank. The United Nations is becoming involved.
I think that it's fair to say that there is a general
mobilization of forces here and what we're looking for is, with
that mobilization of forces, these models, what they're
predicting is not in fact what we're going to see happen.
Senator Burr. Dr. Bell, I appreciate that and follow it
very closely, and I know the mobilization of most other
countries and the United Nations is not near the timeframe that
ours is, and that's why it scares me to death.
Mr. Chairman, thank you for your generosity, but let me ask
Dr. Robinson, does BARDA have the resources it needs?
Mr. Robinson. To begin the medical countermeasure
development or advanced development, yes, for this fall. We
don't have going forward for Ebola next year to produce more
vaccines and more therapeutics if we actually want to do more
than just Zmapp for therapeutics. There are others that we have
under consideration that Dr. Fauci has talked about. So we and
others will need more funding, there's no doubt about that.
Senator Burr. Thank you.
Thank you, Mr. Chairman.
The Chairman. Thank you.
Senator Murray.
Statement of Senator Murray
Senator Murray. Thank you very much to the panel and Mr.
Chairman for having this hearing.
I'm very proud to represent a State that is producing some
truly incredible research in the biomedical field, including
several ongoing studies and efforts that are aimed at curing
Ebola. We've got World Vision, which is supporting the
Ministries of Health, the Geneva Foundation, which is working
on a treatment drug. Washington State University's Paul G.
Allen School for Global Animal Health, they're looking at some
culturally appropriate ways to prevent further transmissions;
and of course the University of Washington Katz Lab which is
looking at some vaccines and drug development. We're doing a
lot out there.
But the reality is that we all have to do more. I think
it's important to mention that one of the reasons I fought so
hard to roll back sequestration in the Bipartisan Budget Act
was to provide certainty for organizations like NIH and CDC,
which have had to deal with, as we all know, some very steep
and harmful budget cuts. I believe it's going to be very
critical that we continue to focus on rolling back this trend
of disinvestment in research and development so we can ensure
that our country continues to produce the kind of live-saving,
world-changing research that we know we're capable of. But I am
very concerned--I just need to say this--that fiscal austerity
and the return of sequestration is going to continue to weaken
our ability to respond to needs like this.
Dr. Fauci, while you're here, I wanted to ask you, can you
talk a little bit about how the lack of budget certainty and
sequestration and the budget fights of the last 2 years have
really impacted the U.S.'s ability to respond to the Ebola
situation?
Dr. Fauci. Thank you for the question, Senator Murray. I'd
have to tell you, honestly, it's been a significant impact on
us, as you well know, and I know you've been fighting for us
for quite a long period of time. Our budget has been flat since
the end of the doubling in 2003, with the 2-plus percent
inflationary index, that over a 10-year period we've lost about
22 percent in our purchasing power.
That was the left hook. The right cross was the
sequestration that came in and pulled out a significant amount
of money, $1.5 billion, of which we got reconstituted not all
of it. We try to preserve the fundamental basic research of the
investigators, the bright ideas that people have. If you want
to preserve that, the money that you have for initiatives such
as the development of vaccines and the development of drugs
suffers, because it's a balance. There's programmatic
initiatives and there's investigator-initiated awards, and when
you shrink the budget or don't give even an inflationary
increase all of that starts to whittle away and you get even
secondary effects, like disincentives of getting bright people
involved from your State or any State, who feel that there's a
disincentive to get involved.
It has both in an acute and in a chronic insidious way
eroded our ability to respond in the way that I and my
colleagues would like to see us be able to respond to these
emerging threats. In my Institute particularly, that's
responsible for responding on the dime to an emerging
infectious disease threat, this is particularly damaging.
Senator Murray. I hope that all of us keep that in mind
moving forward.
Again, I'm proud of the folks in my State. The Bill and
Melinda Gates Foundation gave $50 million to scale up emergency
operations. Paul G. Allen Foundation has contributed $9 million
to open emergency operations sites in three of the most
affected countries.
Dr. Robinson, Director Bell, knowing that the Gates and
Allen Foundations have stepped up that way and the money that
is going to be included in this CR--thank you to our
Appropriations chair who's sitting next to me--is that enough
money and global support to stop this outbreak?
Dr. Bell. I'll answer, Senator, for the CDC. We do
appreciate the $30 million that's in the CR. That amount of
money is enough to keep us operating through the end of the
continuing resolution on December 11th. It will allow us to
keep our people in the field, to pay for our staff, and to
begin to scale up in a way that we think is necessary.
We will be kind of considering over the time period of the
CR what additional resources we will need for the rest of the
fiscal year in order to fulfil our responsibilities and
response to the Ebola outbreak in the way that we need to.
Senator Murray. Dr. Robinson.
Mr. Robinson. The $50 million that we requested will get us
through this fall. If we want more vaccines and more
therapeutics, there will have to be more funding for us to go
forward.
Senator Murray. Thank you, Mr. Chairman.
The Chairman. Thank you, Senator Murray.
Senator Isakson.
Statement of Senator Isakson
Senator Isakson. Thank you, Mr. Chairman.
Dr. Bell, I want to echo what Senator Moran, Senator
Harkin, Senator Alexander, and Senator Reed said about how
proud we are of CDC. As one of Georgia's two Senators, however,
I want to add how proud we are of Emory University and Dr. Jim
Wagner and the staff there--I know Dr. Brantly would probably
feel the same way--as well as Phoenix Air, which I believe was
the contractor from Bartow County, Georgia, that brought the
patients back from Liberia to the United States. That was a
tremendous effort.
For the committee's benefit, Saxby was gone when this
happened, so I was the only Senator reachable by the press the
day it was announced they were coming to Emory University. The
press immediately looked for the wisdom in bringing an Ebola
patient back to the United States, whether or not we had the
capability of preventing the disease from spreading while we
were treating Ebola patients. Emory University and the CDC did
a marvelous job of making those transfers seamless and complete
and proving to the media, that was trying their best to start a
riot, I think, that the Ebola virus was going to be safely
contained, that they were in the best place in the world. So
you deserve a tremendous amount of credit. I just wanted to say
that. I just wanted to say that publicly to you.
Dr. Bell. Thank you, Senator.
Senator Isakson. Tell me. You said this is by far the worst
outbreak you've ever seen. What was the next worst before it in
terms of numbers?
Dr. Bell. Let's see.
Dr. Fauci. Uganda in 2000.
Dr. Bell. Yes. That was about 400 and some cases.
Senator Isakson. Here's my question, what makes this one so
different?
Dr. Bell. There are a number of factors, Senator, that has
made this one quite a bit different. No. 1, this is the first
time we've seen Ebola in a large urban setting. Our previous
experience with Ebola outbreaks has been primarily in rural
areas, and there are many, many different factors that come
into play when you have Ebola in a situation with people packed
very closely together in a large city. That's one thing.
Another issue that has been challenging is that the area,
the sort of three-country area where the outbreak sort of began
and has been propagating from, is an area with communities that
are sometimes not very receptive to interventions by either
government or by public health officials.
A third point is that these are countries with very, very
weak infrastructure to start with. They've just been emerging
from decades of war. They have very weak health systems and
very little capabilities, to Senator Harkin's point about
public health capabilities, but even health care capabilities,
so very little with which to battle this outbreak from the
beginning.
Senator Isakson. I've traveled extensively in West Africa
and I've seen firsthand exactly--they're almost bereft of
health care facilities, of anything close to what we would
consider to be reasonable.
Which brings me to this question. When you described
containment, you described a very labor-intensive process. You
talked about people taking temperatures for 21 days to see if
somebody who's been exposed had been infected. You talked about
monitoring. You talked about isolating. We're sending 3,000
American troops to West Africa as I understand it. We've got
100 CDC personnel. We have NGO's and other volunteers. But it
seems like to me it's going to take a lot bigger labor force
just to contain the disease at its current level; am I correct?
Dr. Bell. Yes, sir. There's lots of different settings that
we can talk about, but for example in the Ebola treatment units
90 percent of the staff are local. I think it is important to
remember that the governments, the people in the countries and
the governments themselves, are stepping up and, with
assistance from those of us that have the technical
capabilities, are really able to fill many of these roles and
responsibilities. As I say, some of the work in the treatment
units, much of this going out into communities every day and
checking in with contacts to see how they're doing, these are
roles that the people themselves, the local people themselves
in these countries, can undertake, as I say, with some
technical guidance from some of us that have this experience.
This is not to minimize the scale of the human resources
that will be needed to contain this. But as I say, I think that
there are many of these sorts of functions that we're already
seeing the local people help with. There's also other groups
around Africa, the African Union, many of our field training
programs from around Africa, that are also stepping up.
It is an enormous job, but it's a job where I think there
are lots of different sectors and parts of the local community
in addition to the international community that can work
together to address this.
Senator Isakson. I know my time's up, but I wanted to make
a comment. At the Africa Summit, which was here just about a
month ago, I had the privilege of participating in a lot of
that with some of the West Africa leaders. I noted how they
were begging--not begging, but they were wanting so much
American knowledge, CDC, NIH, all the technology, but they
seemed very--even the bordering countries seemed like they were
very willing to provide manpower, but they badly needed
leadership in terms of health care. Is that correct?
Dr. Bell. Yes, sir. We've actually made quite a bit of
progress in that regard over the last month or so and are
working very closely with the African Union to have them deploy
staff to the area.
Senator Isakson. Thank you very much.
Thank you, Mr. Chairman.
The Chairman. Thank you.
Before I recognize Senator Casey, you mentioned all these
different entities. Addressing this we have CDC, USAID, State
Department, World Health Organization, and Doctors Without
Borders. Can you tell us who's in charge of coordinating our
government's response effort in Africa?
Dr. Bell. Yes, sir. In terms of the U.S. Government, in
each of the countries there is the Disaster Assistance Response
Teams, the DART. This is a USAID umbrella under which all of
the U.S. Government efforts are coordinated. We are quite well
coordinated with the USG organizations.
In the larger sort of undertaking, in each of these
countries people are getting organized, generally speaking with
the government.
The Chairman. The USAID is in charge intra-country, in a
country. But overall who is in charge of coordinating?
Dr. Bell. The three countries together are all under the
umbrella of the USAID DART.
Senator Mikulski. Of USAID?
Dr. Bell. Yes.
The Chairman. I'm startled to find that out, that USAID
would be in charge of coordinating.
Dr. Bell. Well, it's a disaster. When a disaster is
declared--I don't know; as we scale up, I'm sure that there'll
be other mechanisms for the various parts of the government to
collaborate and coordinate with each other. But there is this
kind of structure on the ground which is meant to----
The Chairman. I think this requires further looking into by
this committee, by both these committees.
Senator Casey.
Senator Mikulski. I would concur, Mr. Chairman.
The Chairman. Thank you.
Statement of Senator Casey
Senator Casey. Mr. Chairman, thank you very much.
I want to thank the members of the panel, Dr. Bell, Dr.
Fauci, and Dr. Robinson, for being here. I also want to note
the good work that's been done by this committee and members of
this committee for a lot of years, the chairman, Chairman
Harkin, Senator Mikulski as well with her experience; grateful
to work with them; Senator Burr, who has spent a lot of time on
this and a lot of time on these issues and has become such a
leading voice on this.
I don't want to plow ground that's already been plowed
through. I apologize for having to juggle two hearings. But I
wanted to ask Dr. Bell. I know that one of the fundamental
questions you're asked is what's the threat to the United
States, if any, and how you articulate that. Let's just say--
for purposes of process and the mechanics of confronting this
kind of a threat were it to arise here--pick a town in
Pennsylvania. I won't pinpoint one, but if there was a patient
at a hospital in that town and they tested positive for Ebola,
what would be the steps that would be undertaken at that point?
Dr. Bell. Yes, thank you, Senator. We have been working
quite closely here in the United States to prepare for this
sort of eventuality that you describe. As we've mentioned,
Ebola really is not easily transmitted.
I think in terms of helping to understand the context to
answering this question, I just want to say a word or two about
what a hospital in these countries in Africa looks like, as a
way of contrasting. When we think of a hospital, we think of a
shiny, clean building with lots of equipment. Most of the
hospitals in this region, as many of you that have traveled to
this area are aware, oftentimes there's no running water, there
is no soap, there may not even be beds. There may be mattresses
on the floor. Every health care worker is caring for a large
number of patients. There'll be beds around them. They may not
have the appropriate personal protective equipment, like gloves
and gowns and masks.
That's the environment in Africa where Ebola is currently
raging. In the United States, by contrast, we have many, many
protocols in place, and with these protocols most hospitals
that can isolate a patient in a private room with their own
bathroom and can follow very strict and meticulous infection
control practices which have been well outlined and which
health care workers are quite aware of, can safely take care of
Ebola patients.
I'll mention that, while we haven't taken care of any Ebola
patients prior to this outbreak here in the United States, we
have safely cared for at least five patients in recent years
who have had other viral hemorrhagic fever, what we call
Marburg virus and Lassa fever. In each of these circumstances,
these patients were cared for quite safely in our hospitals
around the country and we didn't see any ongoing transmission.
While this is certainly something to be taken quite
seriously and we're doing a lot to educate health care workers,
to educate laboratory workers, and to answer people's
questions, to sensitize them to these issues, really most
hospitals in the United States with these sort of basic
capabilities should be able to safely care for Ebola patients.
Senator Casey. Thank you, doctor.
I have limited time, but I wanted to ask Dr. Fauci one
question. You noted in your testimony there are a number of
Ebola therapeutics and vaccines in development. Recognizing
that all these products are still rather early in their
development, do any of them have clear advantages or
disadvantages over the others? Can you make that assessment
yet?
Dr. Fauci. No, I don't think, honestly, Senator Casey, we
can say that, because apart from ZMapp and one other perhaps,
they have not really been in humans. We have in the past had
experience where things look really good in an animal and then
when they get into the human for one reason or other it doesn't
work or it's too toxic.
It would be premature--I can say that there are a number of
candidates that look favorable enough in an animal model that
we're enthusiastic about moving them into a phase I and then
beyond that. So there are a number of candidates that have a
favorable profile in an animal model. But I think it would be
unwise to say this one looks a little better than this one,
because it just is too premature to do that.
Senator Casey. I know I'm out of time, but I hope there's
nothing that the Congress has not done, not been able to
achieve, that would be an impediment for you to be able to
answer that question down the road and to be able to make the
progress you want to make on these developments, because we
have an obligation, I believe, to fund NIH and to fund this
research in a manner that leads to the result that we hope. I
think that's a bipartisan obligation and I say it for the
record.
Thanks, doctor.
Dr. Fauci. Thank you. We appreciate it very much, sir.
Senator Casey. Thank you.
The Chairman. Thank you, Senator.
Senator Boozman.
Statement of Senator Boozman
Senator Boozman. Thank you, Mr. Chairman, and thank you
very much for having this hearing, you and the rest of the
leadership on both sides. This is so important.
To you all, we appreciate you being here. All of you have
just sterling, excellent reputations and we appreciate the fact
that you're working very, very hard to keep us safe.
From what I've read and from the testimony, it seems like
speed is important, education is important, coordination is
important. We have the CDC involved. We have the NIH. We have
the DoD. We have the Department of State. Samantha Power is
calling the Security Council for the first time ever in an
event like this.
I would like to get into this a little deeper--we heard
that USAID was distributing stuff over there. Who's in charge
of all of that at the Washington level? Who's taking this on so
that we can get coordination, so we can get speed and get the
education component done? Is that CDC? Are you doing that, Ms.
Bell? Dr. Bell, I'm sorry.
Dr. Bell. That's OK. We at CDC have the lead on the public
health aspects of the response. The DoD and USAID have the lead
on logistics and material. The National Security Council is
coordinating, certainly from Washington, and it's really
important that we draw on all of our assets from all of the
different agencies working in our particular lanes and
coordinating all together.
There is very strong inter-agency coordination. The NSC is
deeply involved in bringing all the agencies together, and we
at CDC take the lead in the public health aspect.
Senator Boozman. Good. I hope we get this worked out where
we actually have somebody that we can point to, an individual
that's kind of in charge of coordinating, because the same
thing that's going on on the ground, that needs to be going on
over there, is simply not going to happen without that
happening here.
One thing that's happened, Dr. Bell, Dr. Fauci, there's an
Ebola outbreak going on in the Democratic Republic of the
Congo. Is that related to this or is this a whole separate
thing that we've seen in the past?
Dr. Bell. I'll say something. I'm sure Dr. Fauci can add.
This outbreak is not related to what we're seeing in West
Africa. As you say, Senator, this area of DRC is an area in
which we've seen many Ebola outbreaks in the past, and this
outbreak is of a strain that's quite similar to those
outbreaks. So while we are taking it very seriously, and
actually CDC have sent a team into that area, we don't think
that that outbreak is at all connected. We're actually aware of
the individual case that began that outbreak and it had no
relationship to what's been going on in West Africa.
Dr. Fauci. I agree with Dr. Bell that that will be
determined. It does not look like it's the same. The
extraordinary ability to do rapid deep sequencing of the genome
of these viruses can actually pinpoint whether or not they're
related. It's very interesting that the study that was done and
published very recently showed the exact point introduction of
what we're seeing in West Africa and how it went from Guinea to
Sierra Leone to Liberia, and it doesn't look like the strain
that is in the Democratic Republic of the Congo is in that
lineage, even though it's the same general strain.
Senator Boozman. Dr. Bell, can you reassure the--I know the
public is concerned about bringing it into the country. Can you
talk to us a little bit about the steps with helping those that
are at the airports and identifying people that possibly have
the virus?
Dr. Bell. Yes, Senator. It's certainly quite understandable
why people would be concerned. The images that we're seeing are
quite alarming. As you know, we have been working in the
countries to improve their abilities to do exit screening. We
have teams in each of the countries and we've really been able
to help them improve their capability to do exit screening
considerably over the last month or so and are quite pleased
with the progress in these countries.
They have equipment. They understand what they're supposed
to do. They have the protocols in place and they are really
moving forward.
In addition, I'll mention that we also have been doing a
lot of work with our own border agencies, so with the TSA and
with the CBP, to train them so that they understand what to
look for and they understand when they need to call on us--as
you know, CDC has quarantine stations in the major airports
around the country--so that they also are sensitized to what
needs to be done.
Then the final point I guess I would make on this topic to
Senator Casey's point is that we've done a lot of work here in
the United States with health care providers, even with just
citizens, so that they know what to look for, to remember to
ask for a travel history. There are a number of our Laboratory
Response Network laboratories around the country who now have
the capacity to test for Ebola, and then the health care
facilities themselves are very tuned into the appropriate
isolation methods that would be needed should they have a
suspected Ebola patient.
Senator Boozman. Thank you, Mr. Chairman.
Thank you.
The Chairman. Thank you, Senator Boozman.
Senator Bennet.
Statement of Senator Bennet
Senator Bennet. Thank you, Mr. Chairman. Thank you very
much for holding this hearing.
Dr. Bell, you mentioned in your opening comments a
particular problem in Liberia of there being a lack of
isolation capacity. I wonder if you could describe for us--if
everything actually worked the way it's supposed to work to
make the decision, to make these fundings, first of all, what
the experience of somebody today who's infected with Ebola is
in Liberia if they don't have access to an isolation chamber;
and then second, what you would expect to be the progress
points we need to see in order to know that we're actually
creating an infrastructure that really can change the outcomes,
the course of the disease?
Dr. Bell. Yes, thank you, Senator. As you mentioned, there
are not enough treatment facilities, isolation facilities, in
Liberia right now to take care of all of the cases. Because of
that, there is ongoing transmission that's occurring because we
can't isolate them. So we're working on this in a number of
fronts.
First, as many of the Senators have mentioned, we will be
building more Ebola treatment units, and in addition a number
of other entities, including the government of Liberia, are
also building Ebola treatment units. So there will be a scale-
up of Ebola treatment units. Medecins Sans Frontieres is
building another. There's a number of groups that are actually
working to scale it up.
In the mean time, there are a number of interim measures
that we're also going to be taking so that people can be
isolated safely not in a treatment unit. So there's a number of
ways to approach that. There are community sort of holding
centers, for lack of a better term, where people can be
isolated safely with one caregiver and that caregiver can be
provided with the appropriate personal protective equipment
that they need to prevent transmission to themselves.
There are also some efforts afoot to do that in households,
where a caregiver in a household would be given a kit which
provided all the equipment that the person would need to
protect themselves and also some of the medications, such as
oral rehydration for example, Tylenol to help with fever, that
the patient themselves could use during their illness.
There's a number of different kinds of interim measures
that we're working to scale up now at the same time as we're
working on building additional isolation facilities in Liberia.
Senator Bennet. How are you or with whom are you working to
make sure that that work is actually happening, rather than
just being thought about?
Dr. Bell. There is actually quite a bit going on right now.
Actually, USAID has been working with a number of
nongovernmental organizations, including MSF. They've actually
produced tens of thousands of these kits and have a plan in
place to scale them up to hundreds of thousands in the near
future.
Senator Bennet. Thank you. In his first question or one of
his first questions the chairman talked about the need to have
a CDC or something like it in every country, and that is
something I think we ought to aspire to. We have a long way to
go to get there. I just wondered if you could talk a little bit
about the efforts that you're making to create a more global,
interoperable network of real-time detection of diseases and
collaboration among these various countries in our response?
Dr. Bell. Yes. Part of our response here is to buildup
these basic capacities in these countries. In addition, right
now as an urgent matter we're working to buildup these
capacities in the bordering countries--laboratory capacity,
emergency operations centers, rapid response teams, beginning
planning on what they would need to do in terms of isolation
should they need to do that, working on culturally appropriate
burial practices.
In those bordering countries that's an urgent priority for
us. Then across the rest of Africa we're also working to harden
the countries' ability to be able to recognize imported cases,
to know who is the incident manager, how is their emergency
operations center going to work, and what are the steps that
they would take in order to respond to an additional case. Do
they know how to do contact tracing? Who would be responsible
for the contact tracing? Where would they isolate the patients?
These are all things that we're working on now in the context
of this outbreak.
In the bigger picture, these are basic capabilities that
the Global Health Security Agenda, for example, has been
calling for. As you probably know, we at CDC have been working
with a number of countries in a pilot kind of way over the last
couple of fiscal years to show the proof of principle of what
global health security can mean, to detect, to respond, and to
prevent these outbreaks with basic capabilities around
laboratory capacity, around communications strategies, around
emergency operation centers, basic epidemiology.
These are all fundamental capabilities that country by
country we really need to build if we want to prevent this kind
of thing from happening again in the future.
Senator Bennet. Thank you. I appreciate that testimony.
Thank you for your testimony.
Thank you, Mr. Chairman.
The Chairman. I would say to my colleague from Colorado
that last year the Appropriations Committee put in $6 million
to start this process of establishing CDC's in key countries
designated by CDC. I understand that some time this fall, the
CDC will announce those initial grants.
We put $10 million in the appropriations bill this year to
continue that effort. In light of the Ebola outbreak and
others, I am hopeful that maybe we can take a second look at
this if in fact we do have an omnibus appropriations bill that
we can do, that we might want to put some more in there,
understanding of course you can't do it all at once, but still
so that the pipeline is there, that we can start bringing
people to train them, train them in laboratory procedures,
start buying the equipment they need, to kind of get a jump
start on even more countries next year.
Senator Bennet. I appreciate that. I think there are a
number of us that would love to work with you and the chair of
the Appropriations Committee on this.
The Chairman. We need the money, that's right. Thank you
very much.
Senator Whitehouse.
Statement of Senator Whitehouse
Senator Whitehouse. Two questions. I'm not expert in
epidemics and I don't know if there are accepted stages in the
acceleration of an epidemic, when it goes from just an outbreak
to a full epidemic to a raging out of control forest fire. If
there are, what are the red flags that we should be looking for
that this epidemic has gone to the next stage in terms of the
threat that it presents?
Dr. Bell. There are some key indicators that we use. It
sort of depends on the situation what the indicators are. In
this situation, certainly there are some basic indicators, like
the number of cases and the number of cases per week, as
Senator Alexander has discussed. There are other indicators,
for example the number of cases in health care workers. We
should not be seeing cases in health care workers if our
infection control interventions are working.
After that, I think that we are working to track things
like whether patients that need to be isolated have a way to be
appropriately isolated, whether or not we stop seeing bodies
that can't be picked up in a timely fashion, and a number of
different sort of indicators like that that we use to help us
understand if in fact we're bending the curve and whether it's
going in the right direction.
Senator Whitehouse. When you consider the existing effort,
which has been heroic, but measured against the threat has
obviously not kept it from accelerating, how many multiples of
the existing level of effort do you think are required to be
able to get ahead of this and bring it back under control? Ten
times the effort, a hundred times the effort?
Dr. Bell. I would say a very large increase in the effort,
and also a very large increase in the effort with a sense of
urgency, so that the increase happens very quickly. It's hard
to say how many multiples, but there needs to be--and I think
we can safely say that there is----
Senator Whitehouse. We're not even close to meeting the
threat right now?
Dr. Bell. I would say that the sorts of interventions and
scale-up that we've been hearing about in recent days is the
sort of scale that we need in order to address this outbreak,
this epidemic.
Senator Whitehouse. Dr. Fauci I guess might be the best
person to answer this question. Is this a virus that is capable
of being manipulated by humans? Could one go into it if one had
a sample of the Ebola virus and meddle with a portion of the
DNA strain that relates to how it's transmitted? Could somebody
up to mischief try to make something that was more
transmittable out of this existing virus?
Dr. Fauci. Theoretically, you can manipulate almost any
virus to change it any way you want. That's a question that
always raises red flags about it, but the fact is yes. The only
trouble is it wouldn't be easy for somebody to do that in their
laboratory backyard. They would probably kill themselves doing
that.
Senator Whitehouse. It would take a nation State to do
that?
Dr. Fauci. Yes, it would take a state-type thing. I don't
know whether you were here when I made my opening presentation,
Senator Whitehouse, but I mentioned that our getting involved
in the hemorrhagic fever viruses was part of a biodefense
agenda because way back during the cold war it was clear from
intelligence and proven that the Soviets were stockpiling
hemorrhagic fever viruses and things like that for just the
purpose that you make.
So it would have to be a State thing. I don't think you're
going to get some rogue person being able to do that.
Senator Whitehouse. Senator Burr and Senator Casey and
others and I, would love to work with you on trying to explore
that further. Thank you very much.
The Chairman. Thank you, Senator.
Senator Durbin.
Statement of Senator Durbin
Senator Durbin. Dr. Bell, is CDC working with the World
Health Organization?
Dr. Bell. Yes, we are, Senator, very, very closely.
Senator Durbin. It is my understanding that the President
submitted the name of Dr. Frieden from the CDC to be our
representative to the World Health Organization in July of this
year and it is still lost somewhere in the U.S. Senate. I would
hope before this week ends and we return home that we might
consider bringing this to the floor on a bipartisan basis and
expedite the appointment of Dr. Frieden, whom we know well and
we have studied, we know his background, so that he can be with
the WHO and not wait for 2 months or more for us to return and
consider that nomination. I'd like to suggest that to the
chairman and see if we can get that done.
I'd like to ask a second question of Dr. Fauci, following
up on what Senator Casey said, which was:
``I hope that there's nothing that's been done on a
budgetary basis that has slowed down the development of
an Ebola vaccine or a response that might be helpful.''
You've talked about a 22 percent decline in the funding in NIH
research over the last 10 years and the impact of
sequestration. Has there been to your knowledge any shortage of
funds which has led to a delay in testing or development of an
Ebola vaccine?
Dr. Fauci. I think one could say honestly, Senator, that
everything really over the last several years, with few
exceptions, has been at a level less productive than we would
been, purely on the basis of significant constraints. I don't
think we can say that there's been a serious delay in this
particular vaccine. I think that would be an overexaggeration.
I would have to put it under the umbrella of the entire effort
that we've been putting forth over the last several years have
had to be muted somewhat by a budget that in real dollars is
shrinking.
Senator Durbin. It's my understanding, based on WHO
statistics that I've read, about the physicians per capita that
in my home town of Springfield, IL, with about a population of
100,000, there would be expected to be 240 physicians, in
Sierra Leone two physicians for 100,000 people, and in Liberia
one physician for 100,000 people.
That I think is an indication, at least a few years ago, a
snapshot of the scarcity of medical professionals at the
highest level, doctors and such. I have been working and we
included in the immigration bill which passed the U.S. Senate a
provision which provided in one respect if you are medically
trained in Africa and have promised to serve in Africa for a
certain period of time before going anywhere else that we would
honor that, respect that, and not allow people to be recruited
into the United States when they still had an obligation to
their country; and second, that doctors in the United States
would be able to serve in these crisis situations overseas
without jeopardizing their immigration status. That passed the
Senate. That was in the immigration bill. It was never called
for consideration in the House of Representatives.
Speak to, not just the terrible infrastructure when it
comes to hospitals, but the medical professionals and the
health workers available in these countries that are facing
this.
Dr. Bell. Yes, Senator, you're right that the number of
doctors in Liberia and in Sierra Leone is extremely small. In
Liberia I think the number of doctors before the outbreak
numbered in the hundreds, as you say. Tragically, because of
sort of the lack of infection control and the very, very poor
conditions in the health care facilities and the inability of
the health care workers to recognize Ebola patients when they
came with a fever, and you think it's malaria, it turns out
it's Ebola, and the fact that the health care workers were not
able to protect themselves, tragically, a lot of these sort of
scarce health care workers have died in the context of the
Ebola outbreak.
Many of these facilities now, that already were very
rudimentary, are closed. This is one of the things that we need
to do, is to train in infection control, provide appropriate
personal protective equipment, and get the facilities back up
and running safely, so that we don't continue this spiral of
not only the Ebola outbreak, but also many other conditions
that are actually not getting treated right now in these
countries.
Senator Durbin. We've learned the hard way that these
countries with very few medical resources, when they face this
kind of epidemic challenge, are only a 10-hour plane ride away
from the United States.
Thank you.
The Chairman. Senator Durbin, I must say that when you
talked about Dr. Frieden's nomination I thought that we'd
dropped the ball on this. How could we have dropped the ball on
something like this? I just found out that it does not come to
this committee, but to the Foreign Relations Committee. So
hopefully, hopefully----
Senator Alexander. Mr. Chairman, the information we have is
the President didn't nominate him until the end of July. We
were gone in August. The Foreign Relations Committee staff is
meeting with him tomorrow. They're doing that in a bipartisan
way. They could move him. I heard Senator McConnell say on the
floor this morning that he supported President Obama's
proposals to deal with Ebola. I know of no reason why the
Majority Leader and the Whip couldn't work with Senator
McConnell and bring it up before we leave.
I would hope so, and I would be glad to support that, as I
imagine the chairman would.
The Chairman. I would support him. I'm not on the
committee, but you know, one of those little meetings in back
of the Senate floor, like we do all the time; get that job done
in a hurry.
Our wonderful chairman of the full Appropriations
Committee, Senator Mikulski.
Opening Statement of Senator Mikulski
Senator Mikulski. Thank you very much, Mr. Chairman. First
of all, thank you for organizing this hearing of both the
authorizing and the appropriations committee, and to my
colleagues for such strong bipartisan participation in this.
I want to thank the people at the head table and all who
work behind them for the outstanding job they're doing to
organize the American government's response to this, and also
to Dr. Brantly and Mr. Charles, representatives of the people
who are really in Africa trying to help people in this most
horrific of challenges facing not only the countries, but the
people, and particularly the workers who are there that must be
facing just incredible stress.
This is such a grim, horrific proportion, and they're
working 36-hour days, just as you are. We want to acknowledge
that and thank them.
Mr. Charles, it's wonderful to have you here. Dr. Brantly
and Mrs. Brantly, good to see you. What's so great about seeing
you, Dr. Brantly, is, one, that you're well enough to be here,
you were well enough to travel here, and you're well enough
that we're not afraid to have you here. We can smile, but this
is a stunning, stunning, stunning accomplishment. But again,
we're glad to see you.
Mrs. Brantly, you look so much like Samantha Power, I said,
what is Samantha Power doing sitting next to Dr. Brantly? We
could send you to the U.N. and I bet you'd have a lot to say
that would shake them up in helping them respond. We're glad
that you're here.
I want to make a couple of comments and then a few
questions if I could. First of all on this issue of who's in
charge that was raised by both Senator Harkin and Senator
Boozman, I think USAID is in charge of responding in a
disaster--an earthquake, in Haiti, the many disasters--and
they're to be acknowledged for their ability to do that. But
the size and scope and multiple government agencies involved in
this I think needs a higher authority that actually can command
personnel and organize, working with us on, again, a bipartisan
basis, for the kind of resources to do this, because just
listening to what we're doing today, we need the HELP
Committee, we need Labor. Now go to the Appropriations
Committee. We're going to need Foreign Ops and we're going to
need DoD. Within the Labor-HHS subcommittee, it's CDC, it's
NIH, it's FDA.
Mr. Chairman, working across the aisle, we should ask the
President, through whatever mechanism they're going to say, we
need a point person in addition to OMB, which will be here, to
do this.
Dr. Bell, do you want to comment?
Dr. Bell. I thank you, Senator. I just wanted to make sure
that I didn't create a misconception in what I said about the
DART. What I meant was on-the-ground coordination in the middle
of that area USAID is coordinating. But I take your point and I
think----
Senator Mikulski. Well, here is my point.
Dr. Bell. Yes, ma'am.
Senator Mikulski. That presuming that there is a bipartisan
group and there is the will here--we have one of the leading
Senators within the Republican Party. Senator Burr has been one
of the leading experts on biohazards. We worked together to
create BARDA. If we wanted to meet with the person in charge,
who would be the person in charge? AID? Frieden? Dempsey?
Kerry?
Dr. Bell. I take your point, Senator.
Senator Mikulski. Dr. Rice? We want to maximize and
leverage everything we have and also create that sense of
urgency.
Let's talk about resources. I'll be leaving shortly, so,
Dr. Brantly, if you see me go before you give your testimony
it's because I'm going to work on the continuing resolution so
we can, on a bipartisan basis, bicameral basis, pass that.
But I'm looking ahead to December 11th and also the 2016
fiscal year. So the CR is really a down payment to keep your
current response functioning, but it is not of the size and
scope that you need to respond in Africa and prevent it from
spreading globally. Am I correct in that?
Dr. Bell. From the CDC perspective, yes. The CR will allow
us to continue our field operations through the end of the CR,
but the situation is very fluid and we're assessing what we
would need for the rest of the year.
Senator Mikulski. Dr. Bell, when did you have to submit to
OMB your fiscal 2016 request?
Dr. Bell. I'm sorry, Senator. I don't know the answer to
that question.
Senator Mikulski. Well, let me tell you.
Dr. Bell. I thought you might be able to.
[Laughter.]
Senator Mikulski. It was a few months ago. So whatever Dr.
Frieden told OMB and the White House that he needed for CDC, it
is really 3 to 5 months behind. As we get ready to work, we're
encouraging OMB--this is our administration here--to go back
and say, what is it that you need for the CR and omnibus, which
I hope we can achieve, but also a look ahead at fiscal 2016,
presuming we can find a way to cancel sequester.
I would say to all of the agencies involved, look at that
and revisit that. And it's our job to get OMB to give you the
latitude to come back because of this new need.
Dr. Fauci, wherever there's been an infectious disease
crisis you've been in the forefront of trying to find solutions
for 30 years, since AID to now. We're so lucky to have you in
all of these. But you spoke to us eloquently a few years ago
about a pandemic, that when you have a global infectious
disease crisis you need to have an infrastructure to be able to
respond. Am I correct?
Dr. Fauci. Correct.
Senator Mikulski. This is contained to one continent and
one part of a continent. Do you think we're heading to a
pandemic with this?
Dr. Fauci. No, I don't, Senator Mikulski, because, as we
have mentioned, the spread of this in the West African
countries is really a reflection of the extraordinary disparity
of lack of health care infrastructure--to be able to handle an
outbreak, to get the people isolated, taken care of, contact
traced, so that you don't have essentially unfettered spread.
In a country like the United States and other developed
countries, we may, and it's entirely conceivable, have someone
get on a plane infected in a West African country, be
asymptomatic and land in Washington or New York or Paris or
London, get out of the plane, get sick, and perhaps go to an
emergency room, and even infect a person or two because someone
didn't take a travel history. But at that point, once it's
recognized, the kinds of capabilities we have would make it
almost impossible to have the kind of outbreak that you're
seeing in a country in which the outbreak is driven by a lack
of ability to handle infection control, and we have that.
Senator Mikulski. Well then, let's go to the disease. If
this disease mutates, would mutation be of concern to you? And
if it would mutate, do the current suggested treatments,
possible treatments, become ineffective because it's a new
disease, and then could it even become airborne?
Dr. Fauci. Any hypothetical you say, we'd have to say it's
not impossible, though I think as a person who's been dealing
with viruses for so long, do I think that this is likely that
this is going to happen? No. You never rule anything out,
Senator. You always keep an eye out on it, and we are following
the genetic moveability or mutation of this very, very
carefully.
When people ask me this question, I say what I know will
happen, not hypothetical, is that unless we get control of this
it will continue to not only devastate, but it will be much
more difficult to ultimately get in control. So although we
always in the back of our mind are concerned about mutations,
right now today, in September 2014, mutation is not the
problem. The problem is the full court press we need to put on
getting this under control by standard classical infection
control methods.
Senator Mikulski. Which is a public health infrastructure--
--
Dr. Fauci. Exactly.
Senator Mikulski [continuing]. In this country and helping
other countries?
Dr. Fauci. Quite correct.
Senator Mikulski. Thank you very much, Mr. Chairman.
The Chairman. Thank you very much, Senator Mikulski.
I want to thank this panel. We're running very late, but
it's been very informative. We thank you all very, very much
for your great leadership, and the record will remain open, as
I said, for 10 days, and I hope that we can continue to call
upon you for advice and consultation as we move ahead on this.
Dr. Fauci. Thank you.
The Chairman. Thank you, Dr. Fauci.
Dr. Bell. Thank you very much.
The Chairman. Thank you, Dr. Bell.
Mr. Robinson. Thank you, chairman.
The Chairman. Now we'll call our second panel, Dr. Kent
Brantly and Ishmael Charles. Dr. Brantly served as the Medical
Director for the Samaritan's Purse Ebola Care Center in the
Liberian capital of Monrovia. In July, Dr. Brantly's life
changed abruptly when he contracted the Ebola virus while
treating patients in Liberia. We're thankful that he's
recovered and is feeling well enough to offer his unique
insight as both a provider and a patient. Dr. Brantly, as
Senator Mikulski pointed out, is joined today by his wife Amber
and we welcome you here also. Dr. Brantly, thank you for being
here.
Ishmael Charles is a survivor of Sierra Leone's 11-year
brutal civil war. He is a Program Manager for Healey
International Relief Foundation in Sierra Leone. In that
capacity he manages and monitors all Healey International
Relief Foundation projects in Sierra Leone, including an Ebola
awareness and prevention project in 11 communities in the rural
western district of Sierra Leone. Thank you, Mr. Charles, also
for being here today.
We'll start again with Dr. Brantly. Dr. Brantly, your
statement will be made a part of the record in its entirety, as
will yours, Mr. Charles. Again, I apologize for the long
period, but, as you can tell, people here are very interested
in what's happening with Ebola, and you do bring a very unique
perspective. You had, you've contracted Ebola. You're alive and
well today. You are a provider. Dr. Brantly, welcome. Please
proceed as you so desire.
STATEMENT OF KENT BRANTLY, M.D., FORMER MEDICAL DIRECTOR,
SAMARITAN'S PURSE EBOLA CARE CENTER IN MONROVIA, LIBERIA, AND
EBOLA SURVIVOR
Dr. Brantly. Chairman Harkin, esteemed Senators, guests of
this committee, I'm grateful for the opportunity to testify
before you today about the unprecedented Ebola virus outbreak
that's occurring in West Africa, that has already claimed
thousands of lives and threatens to kill tens of thousands
more.
Let me also take this opportunity to thank each and every
one of you. I know there were many people, maybe some of you on
this committee, who helped play a role in bringing me home when
I was so sick, and I just want to say thank you.
On October 16, 2013, I moved to Liberia with my family to
serve as a medical missionary at ELWA Hospital in the capital
city of Monrovia. I worked as a physician to support the
woefully inadequate health care system in a country that is
still struggling to recover from a brutal civil war. In late
March of this year, we learned that there were cases of Ebola
in our region and we began preparing our staff as well as our
facility to be ready to care for patients in the safest way
possible should that need arise.
Three months later in June, our hospital had the only
available Ebola treatment unit in southern Liberia and I was
one of only two physicians to treat the first infected
individuals in that area. From June 11th when we received our
first patient until July 20th, the number of cases continued to
grow at an incredible rate. The disease was spiraling out of
control and it was clear that we were not equipped to fight it
effectively on our own. We began to call for more international
assistance, but our pleas appeared to fall on deaf ears.
As the Ebola virus continued to consume my patients, I
witnessed the horror that this disease visits upon its victims,
the intense pain and humiliation of those who suffer with it,
the irrational fear and superstition that pervades communities,
and the violence and unrest that now threatens entire nations.
Then, on July 23d I fell ill. Three days later, I learned
that I had tested positive for Ebola virus disease and I came
to understand firsthand what my patients had suffered. I was
isolated and unsure if I would ever see my family again. Even
though I knew most of my caregivers, I could see nothing but
their eyes through their protective goggles when they came to
treat me. I experienced the humiliation of losing control of my
bodily functions and I faced the horror of vomiting blood, a
sign of the internal bleeding that could have led to my death.
I'm grateful to the team that worked tirelessly to keep me
alive in Liberia, despite a severe lack of medical resources.
They were courageous.
I was then evacuated to Emory University Hospital, where I
eventually became one of the few to recover from Ebola. As a
survivor, it is not only my privilege, but it is my duty, to
speak out on behalf of the people of West Africa who continue
to face unspeakable devastation because of this horrific
disease.
This unprecedented outbreak received very little notice
from the international community until those events of mid-July
when Nancy Writebol and I became infected. Since that time,
there has been intense media attention and increased awareness
of the situation on the ground in West Africa. The response to
date, however, has remained sluggish and unacceptably out of
step with the scope and the size of the problem that is now
before us. The U.S. Government has been closely following these
events in West Africa since that time, if not before, and only
now are we seeing a significant commitment to a solution.
I had the privilege and honor of meeting with President
Obama this morning and we discussed his commitment of more
military and medical resources to fight this epidemic. He has
also requested increased funding for the CDC. I thanked him for
entering into this battle with us in a larger way. Now it is
imperative that these words are backed up by immediate action.
To control this outbreak and save the lives of thousands of
West Africans and possibly many Americans, we need the promised
Ebola treatment units, the surge in health care workers, the
U.S. military regional command and control center, and we need
it immediately. We also need the 400,000 home treatment kits
that have been committed to be sent without delay.
There is no time to waste if we are to contain Ebola and
adequately care for the thousands of people that
epidemiologists are now predicting will fall victim in just the
next few weeks. The U.S. military must establish and maintain
an air bridge to deliver critically needed personnel and
medical supplies and to continue bringing in more resources in
the future. We cannot turn the tide of this disease without
regular flights of personnel and large cargo loads of equipment
and supplies.
I am grateful to the President for his decision to send
tens of thousands of Ebola test kits to the region, but these
will only be helpful if we also deploy all available mobile
laboratories and increase funding for more to be built as
quickly as possible. During my time in Liberia, the laboratory
we used to confirm Ebola virus infection in patients was 45
minutes away from our hospital and it was inadequately staffed.
The turnaround time to positively identify an Ebola case was
anywhere from 12 to 36 hours after the blood was drawn. If a
patient is not infected with the virus, that can be a life-
threatening delay. More kits are not effective unless we have
the facilities and the staffing to use them.
As the first human being to ever receive the experimental
drug ZMapp, I am a strong advocate for the CDC and the NIH as
they research vaccines and drugs, as we've just heard about,
and these drugs can give patients hope for recovery. I'm deeply
grateful to the personnel at Mapp Biopharmaceuticals who, even
before this outbreak, dedicated their lives to combating Ebola.
We cannot wait, however, for a magic bullet to halt the
spread of this virus in West Africa. The current epidemic is
beyond anything we have seen before and it's time to think
outside the box. I realize that home health care interventions
can be controversial. However, we know that many Ebola-positive
people are staying at home and even hiding after they become
infected. Because of fear and superstition, their families
either abandon them or they lovingly care for them in ways that
almost always result in infection of the caregivers. This is a
major contributor to the spread of Ebola and we cannot contain
the disease without addressing this problem head on.
Caregivers must be trained in safety measures and supplied
with basic protective equipment so they can care for their
loved ones while protecting themselves. As the number of
survivors increases, these individuals should be mobilized to
help educate and support their own communities. They would be a
powerful witness that the disease is not 100 percent fatal and
they could provide much-needed support to those who are trying
to do what is best for their family members.
Admittedly, home care is less ideal than treatment in an
isolation unit. In the home it's impossible to administer IV
fluids and other supportive medical interventions. However,
there are not enough beds in the Ebola treatment units right
now and many infected people are choosing to suffer and die at
home. The least we can do is try to give their caregivers the
information and resources they need to protect themselves from
this deadly virus.
All of these interventions that are needed to stop this
horrendous transnational outbreak require significant funding
and budgets must be adjusted appropriately. This is not simply
a matter of providing humanitarian aid. It is very much a
national security concern.
One of my patients in Liberia was a man named Francis. Like
most patients, at first he was fearful. But eventually he
shared the story of how he contracted the disease. He said to
me:
``Doc, I remember who the man was that I got this
infection from. He was sick at home and his condition
worsened, and when he began vomiting blood everyone
around him fled.''
But his wife was determined to get him to the hospital. Since
no one else was around to help, Francis went to this man's
house and helped carry him out of the house and put him in a
taxi. On the way to the hospital, that man died.
If someone had come alongside Francis and given him a
little bit of education and provided him with the personal
protective equipment he needed, his family would still have
their father and their son and their brother, and the world
might still have this good samaritan. But unfortunately,
Francis fell victim to Ebola and died.
Many, including one of the Senators today, used the analogy
of a fire burning out of control to describe this unprecedented
Ebola outbreak. Indeed, it is a fire. It is a fire straight
from the pit of hell. We cannot fool ourselves into thinking
that the vast moat of the Atlantic Ocean will protect us from
the flames of this fire. Instead, we must move quickly and
immediately to deliver the promises that have been made and to
be open to practical, innovative interventions. This is the
only way to keep entire nations from being reduced to ashes.
Thank you very much, Mr. Chairman.
[The prepared statement of Dr. Brantly follows:]
Prepared Statement of Kent Brantly, M.D.
summary
Background
In July of this year, my organization, Samaritan's Purse, took over
responsibility for all direct clinical care of those infected with
Ebola in the Nation of Liberia. I was appointed Medical Director of
what would become the only isolation unit in the Monrovia area.
On July 26, I learned that I had tested positive for Ebola Virus
Disease. Eventually, I was evacuated to Emory University Hospital where
I was given world-class medical treatment and beat the odds to become
one of the few who recover from Ebola.
As a survivor of this horrific disease, I feel it is my duty to
speak out on behalf of the people of West Africa. The response of the
international community is still unacceptably out-of-step with the size
and scope of the problem now before us. The only way to combat this
unprecedented outbreak is for the U.S. Government to take the lead.
Key Points
The United States must begin providing large treatment
facilities, skilled personnel, medical supplies, logistical support,
mobile laboratories, and security. This will require the deployment of
military personnel and other assets. Congress must also increase
funding for the Centers for Disease Control and other agencies.
We have to consider the role of home-based care and other
outside-of-the-box methods as critical community interventions. Those
caring for family members at home must be trained and given basic
equipment--gloves and masks at a minimum--to protect themselves. The
United States should provide advisors and experts and support the
delivery of supplies to affected areas.
The U.S. military is the only global force with the
capacity to immediately mobilize the kind of support needed to defeat
the scourge of Ebola. If we do not deploy military assets now, the
situation could quickly become a matter of U.S. national security--
whether that means a regional war in West Africa or the spread of Ebola
into America.
Closing
Many have used the analogy of a fire burning out of control to
describe this unprecedented Ebola outbreak. Indeed it is a fire--a fire
straight from the pit of hell. We cannot fool ourselves into thinking
that the vast moat of the Atlantic Ocean will keep the flames away from
our shores. Instead, we must take the lead and mobilize the resources
needed to keep entire nations from being reduced to ashes.
______
Chairman Harkin, esteemed Senators, and fellow guests of this
committee, I am grateful for the opportunity to testify in front of you
today about the unprecedented Ebola virus outbreak that has already
claimed thousands of lives in West Africa and threatens to kill tens of
thousands more.
On October 16, 2013, I moved to Liberia with my family to serve as
a medical missionary at ELWA Hospital in the capital city, Monrovia. I
worked as a physician to support the woefully inadequate healthcare
system of a country still struggling to recover from a brutal civil
war. Resources were limited, and we often saw patients die of diseases
that would be easily treatable in the United States. It was a
challenging job to provide quality care even before the Ebola virus
tore through the country.
In late March, we learned that there were cases of Ebola in our
region, and we began preparing our staff and the ELWA facility so that
we would be ready to care for patients in the safest way possible
should the need arise. Three months later, our hospital had the only
available Ebola Treatment Unit, also known as an isolation center, and
I was one of two physicians to treat the first Ebola-infected
individuals in southern Liberia.
From June 11 to July 20, the number of Ebola patients we saw
increased exponentially. During that time, my organization, Samaritan's
Purse, took over responsibility for all direct clinical care of those
infected with the disease. I was appointed Medical Director of what
would become the only isolation unit in the Monrovia area.
We opened a new, larger Ebola Treatment Unit and brought in
patients from the government hospital. During that time, the number of
cases continued to grow at an incredible rate. Within days, our 20-bed
facility was housing 30 patients, and there was no end in sight. The
disease was spiraling out of control, and it was clear that we were not
equipped to fight it effectively on our own. We began to call for more
international assistance, but our pleas seemed to fall on deaf ears.
As the Ebola virus continued to consume my patients, I witnessed
the horror that this disease visits upon its victims--the intense pain
and humiliation of those who suffer with it, the irrational fear and
superstition that pervades communities, and the violence and unrest
that now threatens entire nations.
Then on July 23, I started to feel ill. Three days later, I learned
that I had tested positive for Ebola Virus Disease. I became a patient,
and I came to understand firsthand what my own patients had suffered. I
was isolated from my family, and I was unsure if I would ever see them
again. Even though I knew most of my caretakers, I could see nothing
but their eyes through their protective goggles when they came to treat
me. I experienced the humiliation of losing control of my bodily
functions and faced the horror of vomiting blood--a sign of the
internal bleeding that could have eventually led to my death.
I received the best care possible in Liberia, and I am grateful for
the team that worked tirelessly to keep me alive despite a severe lack
of medical resources and other limitations. I was then evacuated to
Emory University Hospital where I was given world-class medical
treatment and eventually beat the odds to become one of the few who
recover from Ebola. As a survivor, it is not only my privilege but also
my duty to speak out on behalf of the people of West Africa who
continue to face unspeakable devastation because of this horrific
disease.
This unprecedented outbreak began 9 months ago but received very
little attention from the international community until the events of
mid-July when my friend and colleague, Nancy Writebol, and I became
infected. Since that time, there has been intense media attention and
therefore increased awareness of the situation on the ground in
Liberia, Guinea, Sierra Leone and neighboring countries. The response,
however, is still unacceptably out-of-step with the size and scope of
the problem now before us.
On September 7, President Obama committed U.S. military support in
the fight against Ebola in West Africa. He also is requesting an
additional $88 million for the Centers for Disease Control to send in
more personnel, equipment, and laboratory supplies. This is great news,
and I applaud his willingness to enter into this battle with us. Now it
is imperative that these words are backed up by immediate, decisive
action. We need more than just a 25-bed Ebola Treatment Unit and
training for local security forces. To control this outbreak and save
the lives of thousands of West Africans--and possibly even more
Americans--we need the United States to take the lead in providing
large treatment facilities, skilled personnel, medical supplies,
logistical support, mobile laboratories, and security. We also need to
implement innovative community programs to stop the spread of the
virus.
In a recent Washington Post op-ed, the International President of
Doctors Without Borders, Joanne Liu, called for a ``large-scale
deployment of highly trained personnel who know the protocols for
protecting themselves against highly contagious diseases and who have
the necessary logistical support to be immediately operational.'' She
went on to say, ``Private aid groups simply cannot confront this
alone.'' I agree with her assessment of the desperate need for medical
boots on the ground.
Treating Ebola patients is not like caring for other patients. It
is grueling work. The personal protective equipment (PPE) we wore in
the Ebola Treatment Unit becomes excruciatingly hot, with temperatures
inside the suit reaching up to 115 degrees. It cannot be worn for more
than an hour and a half. Because of the elaborate safety protocols
involved in treating an Ebola patient, each one takes an average of 30
minutes of time from a team of three to five people. It is easy to see
that a significant influx of medical personnel will be needed to
adequately care for the thousands of people that epidemiologists now
are predicting will fall victim to the disease in the coming weeks.
The U.S. military also must establish an ``air bridge'' for the
delivery of critically needed personnel and supplies. Right now, those
who are fighting this disease are forced to rely on commercial airlines
even as flights into and out of the affected countries are scarce and
unreliable. Our military is the only global force with the capacity to
immediately and effectively mobilize this kind of logistical support.
We cannot turn the tide of this disease without regular flights of
personnel and large cargo loads of equipment and supplies.
The use of our military is a legitimate and defensible request
because if we do not do something to stop this outbreak now, it quickly
could become a matter of U.S. national security--whether that means a
regional war that gives terrorist groups like Boko Haram a foothold in
West Africa or the spread of the disease into America. Fighting those
kinds of threats would require more from the Department of Defense than
what I am asking for today.
A surge in medical treatment capacity also must include the
deployment of all available mobile laboratories and increased funding
for more to be built as quickly as possible. During my time in Liberia,
ELWA Hospital was the only Ebola Treatment Unit for all of Monrovia and
the surrounding area--serving a population of more than 1 million. The
laboratory we used to confirm Ebola Virus Disease in patients was 45
minutes away and inadequately staffed. A patient would arrive at our
center in the afternoon, and their blood specimen would not be
collected until the following morning. We would receive results later
that night at the earliest. This means that the turn-around time to
positively identify Ebola cases was anywhere from 12 to 36 hours after
the blood was drawn. If a patient is not infected with the virus, that
can be a life-threatening delay.
I remember one patient who presented with symptoms of Ebola--fever,
diarrhea, and vomiting. She was in our unit 36 hours before we received
confirmation that she was not infected with the virus. We were then
able to determine that she was actually suffering from diabetic
ketoacidosis. Her treatment had been delayed for a day and a half
because of inadequate laboratory support. Amazingly, she survived, but
she was in a coma for 3 weeks. That didn't have to happen.
These laboratory delays can have an even greater--and deadlier
consequence. The longer it takes to confirm a positive result, the
longer an Ebola-infected patient is left in the ``suspected'' side of
the isolation unit. Every precaution is taken to protect people in that
part of the facility from cross-contamination, but there is always the
potential that those without the disease can become infected if they
are in close proximity to an Ebola-positive person.
As you have heard today, I am a strong advocate for sending large
numbers of medical personnel and supplies to increase capacity for
Ebola treatment. I also believe we must do more to support the Centers
for Disease Control and the National Institutes of Health as they
research vaccines and drugs that can give patients hope for recovery. I
am deeply grateful to the personnel at Mapp Biopharmaceuticals who even
before this outbreak had devoted their lives to combating Ebola. I hope
that the devastating impact of the current epidemic will result in new
discoveries for treatments and vaccines in the future, but we cannot
wait for a magic bullet to halt the spread of Ebola in West Africa. The
current epidemic is beyond anything we have ever seen, and it is time
to think outside of the box.
Historically, Ebola outbreaks have been contained through the
identification and isolation of suspected cases, and this has worked
extremely well to stop the disease. Today, however, the number of cases
and rate of transmission are surpassing the ability of these
traditional interventions to bring the situation under control.
Intensive medical care is important, but it is given only to patients
in isolation units. We know that the virus is being spread primarily by
those who are unwilling or unable to go to an Ebola Treatment Unit.
Many Ebola-positive people are staying at home and even hiding when
they become ill. Because of fear and superstition, their family members
either abandon them or lovingly tend to them in ways that almost always
result in the infection of the caregivers. We have to consider the role
of home care as we seek to stop the transmission of Ebola.
Caregivers must be trained in safety measures and supplied with
basic protective equipment--gloves and masks at a minimum--so that they
can care for their loved ones while protecting themselves. As the
number of survivors increases, these individuals should be mobilized to
help educate and support their own communities. They would be a
powerful witness that this disease is not 100 percent fatal and provide
much-needed support to those who are trying to do what is best for
their loved ones.
Survivors are sometimes unable to return home because of stigma in
their communities, but the great majority of them are looking for ways
to be useful to society again. They can be given important roles in
educating home caregivers and disseminate the facts about Ebola with
their communities.
These are just normal people. Yes, sometimes they are doctors and
nurses, but they are also uneducated day laborers and children. Mothers
and other respected members of society can play an especially critical
role. They have to be trained and given resources.
To effectively execute this strategy, a technical and logistical
infrastructure would have to be put in place. The United States should
provide advisors and experts to train survivors and others and support
the delivery of supplies to affected areas. We must also ensure the
personal safety of these outreach workers so that they can do this
potentially life-saving job confidently. That may require security
forces to protect them. I am not suggesting that we have troops staring
people down with guns. They have seen too much of that in their recent
history. We just need to make sure that these community workers are
safe.
Admittedly, homecare is less ideal than the treatment provided in
an isolation unit. It would be impossible to administer I.V. fluids and
provide other supportive medical interventions. However, there are not
enough beds in the Ebola Treatment Units, and many infected people are
choosing to suffer and die at home anyway. The least we can do is to
try to give their caregivers the information and resources to protect
themselves from this deadly virus.
The World Health Organization has laid out a roadmap similar to
what I have just described, but they are so bound up by bureaucracy
that they have been painfully slow and ineffective in this response.
Their recommendations for home care were made August 28, and I am not
aware of any significant progress in the implementation of their plan
to date. It is imperative that the United States take the lead instead
of relying on other agencies.
The U.S. military is highly trained with a clear chain of command.
They are experienced in responding to complex international crises such
as what we are facing now. I believe they are the only force capable of
mounting an immediate, large-scale offensive to defeat this virus
before it lays waste to all of West Africa.
All of the interventions needed to stop this horrendous
transnational outbreak also require significant funding, and budgets
must be adjusted appropriately. This is not simply a matter of
providing humanitarian aid, it is very much a national security
concern.
One of my patients in Liberia was a man named Francis. Initially,
the lab told us that he was positive for Ebola, but the written report
we received said ``Negative.'' Everything about his clinical case said
that he was infected, so we made plans to retest him. We then received
word that there was a typo on the first report and that his test was
indeed positive.
Like most patients at first, he was fearful, but he eventually
shared the story of how he contracted the disease. ``Doc, I remember
who the man was,'' he said. ``His condition worsened in his home, and
his wife made the decision to take him to the hospital. Everyone around
them fled, so I helped his wife carry him to the taxi.'' On his way to
the hospital that man died. Had someone come alongside Francis with
training and some basic personal protective equipment, his family might
still have their husband, father, and son, and the world might still
have this Good Samaritan.
Many have used the analogy of a fire burning out of control to
describe this unprecedented Ebola outbreak. Indeed it is a fire--a fire
straight from the pit of hell. We cannot fool ourselves into thinking
that the vast moat of the Atlantic Ocean will keep the flames away from
our shores. Instead, we must mobilize the resources needed to keep
entire nations from being reduced to ashes.
The Chairman. Thank you, Dr. Brantly. Thank you for your
courage and for being here, being an example. Thank you.
We'll get on to questions, but, Mr. Charles, welcome and
please proceed.
STATEMENT OF ISHMAEL ALFRED CHARLES, PROGRAM MANAGER, SIERRA
LEONE, HEALEY INTERNATIONAL RELIEF FOUNDATION, FREETOWN, SIERRA
LEONE
Mr. Charles. Thank you very much. Chairman Harkin,
honorable Senators, Dr. Kent Brantly, and fellow guests of this
committee, thank you for the opportunity to allow me to come
all the way from West Africa and testify in front of you today.
My name is Ishmael Alfred Charles, a resident of Freetown,
Sierra Leone. I'm married and a father of two children, two
girls, 9 months and 10 years. I arrived yesterday morning
around 2 a.m. to share with you what my country is currently
dealing with on a daily basis with the current Ebola outbreak,
while still trying to rebuild from the brutal civil war. Unlike
the civil war, in Sierra Leone the outbreak creates more fear
to the entire population at one go. In the civil war it was at
a time a certain population would be afraid of the attack.
Today the general atmosphere in my country and among all
Africans within the West African region, they are afraid of
fear--the biggest crisis that we have ever faced, bigger than
even the civil war.
As a former child soldier, I was able to survive the war.
But I fear that this is going to be worse than the war.
The Healey International Relief Foundation, based in
Lumberton, NJ, supports the rebuilding of health care services
in Sierra Leone and provided relief and other supports to war-
torn countries like Sierra Leone, and they have been working in
Sierra Leone for more than 12 years. The foundation's mission
is to invest and support families and individuals affected by
disaster, war, and adverse socioeconomic conditions, through
the delivery of health care, food, and training and other kinds
of programs. Hence, the mandate is to empower communities and
build the capacity to become self-sustaining.
The foundation partners with Caritas Freetown, which I am
placed with, and Caritas Freetown runs all the foundation's
projects in Sierra Leone. Caritas Freetown, whose mission is to
eradicate poverty, corruption, injustice, improve equality,
advance good governance, and achieve peace and human rights,
empower women and the disabled.
As the spokesperson for the Healey International Relief
Foundation in Sierra Leone, I feel privileged to share with you
our experience on the ground in the war front. As it is today,
Sierra Leone is considered to be a war front, and so is
Liberia, Guinea, and the other West African countries that are
threatened. Since the outbreak, we have been implementing the
Ebola Outbreak Response Project in the western area rural and
urban districts. We work closely with the Ministry of Health
and Sanitation, Ministry of Social Welfare, and the Emergency
Operations Centers.
What this essentially shows is that small organizations
with lower human capacity and budgets are able to make impacts
at the lowest community level because they live within the
community and they understand the reality on the ground.
As part of this project, we have been working with a number
of communities in the western area rural districts with a
catchment of about 219,000 people, raising awareness, providing
chlorine, which serves as a detergent to kill the virus, soap
and buckets to police stations and police posts. In addition,
we have a strong national media campaign in collaboration with
our counterpart Caritas organizations in the other regions of
the country.
The growing number of cases recorded on a daily basis has
made the situation in Sierra Leone very scary. Each day the
situation becomes worse and the effect of Ebola cannot be
overemphasized, as Dr. Brantly has painted a picture very
clearly for you to see.
When I was about to leave, my 10-year-old daughter asked
me, she said:
``Dad, are you going to leave us in this country and
go to America, where they say there is no Ebola?'' I
stared at her for a minute and said, ``Maa''--as I call
her--``my trip is for the general good of the family
and for your future. I will be back in 2 weeks.'' And
she said again, ``Are you sure, because every day
flights are being canceled?''
As I speak, there are only two flights going to Sierra Leone or
Liberia.
Similarly, my wife said:
``Dear, the money you used to leave normally when you
travel is not going to be enough this time around,
because the price of commodities has tripled.''
What I'm trying to say in essence, the situation in Sierra
Leone is getting very difficult every day, and so it is in the
other countries that have been faced with the current outbreak
challenge. And the economic burden is getting very heavy on a
number of people.
As I was about to leave, my biggest stress was in the
situation if anyone gets sick behind me, the health system is
not functional. When you go to a hospital, the doctors are not
there any more. And even when they are there, they deny that
they are doctors, because they are afraid that they might be
infected and they're not sure what sort of sickness a patient
might have come in with.
The Ebola phobia is increasing. Even people who do not have
Ebola are being stigmatized. We have suffered equally, not to
talk about those who have tested positive.
The State is overwhelmed and unable to coordinate
effectively the Ebola response. People are losing their
confidence every day. The Ebola crisis has escalated into
widening economic situations and has damaged further the health
care systems, which are not prepared to manage such a difficult
situation.
Harvests have been canceled because too many farmers are
dying. In the capital, Freetown, hotels have very few number of
guests. A very big hotel that might have the capacity to house
300 guests will only have 4 guests or even less. And these
hotels keep dropping their staff every day because they don't
have the money, the resources, to take care of the staff. And
this staff that they're dropping are parents who have families
they need to take care of.
In a country with 70 percent illiteracy, schools have been
closed indefinitely because of Ebola. We have no idea when
we're going to reopen schools. Our country has a high orphan
population and Ebola is increasing that on a daily basis.
Through the foundation, we are able to make donations to the
Ministry of Social Welfare and support the Ministry of Social
Welfare, who are currently taking care of the Ebola orphans,
while we are also very careful that these orphans will be
stigmatized and at the same time could be positive. It's a very
delicate situation.
People do not have the free will to bury their loved ones
any more and show the compassion and care and emotional love to
those who are sick which normally help people to recover very
fast when you know that you have a social support around you.
Flights have been canceled. The economic situation is
getting worse every day. As a result, households are
struggling. Not just the Ebola is killing people in Sierra
Leone. Poverty, hunger, lack of medical facilities. Families go
hungry when the breadwinner dies or gets sick or loses their
job, which is happening on a daily basis.
With the support of the United States, the international
community, and the spirit of Sierra Leoneans, we believe we
will put Ebola at our back. However, a decade's progress will
have been lost, especially so when already the health
facilities were in bad shape before the outbreak.
I plead to this house and to the United States and the
international community not to leave Sierra Leone when the
outbreak may subside. We will need help investing in Sierra
Leone so that we can be able to be self-reliant again because
we will not need to continue to rely on international support.
But if we are self-sustainable, we will be able.
I've heard about the CDC report that Dr. Bell spoke about.
She gave a number of incidents or instances specifically
talking about Liberia. Every picture that she painted is
equally as devastating in Sierra Leone and probably even worse.
The numbers that the government gives on a daily basis of
infected people, is definitely much less than what is really
happening on the ground, for various reasons, and the health
facilities or the support that we have currently does not
really match with the number of infections that we have.
Last, I want to thank this house for listening to me, and
please, we will look forward to the continued support of the
United States in Sierra Leone. I thank you very much for your
attention and for the privilege you give me in listening to me.
Thank you.
[The prepared statement of Mr. Charles follows:]
Prepared Statement of Ishmael Alfred Charles
Good afternoon, my name is Ishmael Alfred Charles, a resident of
Freetown, Sierra Leone, married and a father of two children, 9 months
and 10 years. I arrived yesterday morning to share with you what my
country is dealing with on a daily basis with the current Ebola
outbreak, while still rebuilding after a brutal civil war; unlike the
civil war, the outbreak creates more fear to the entire population.
Today there is a general atmosphere of fear. This is the biggest
crisis we have faced since the end of our civil war.
As a former Child soldier, I was able to survive the war, and now I
fear, ``This is going to be worse than the war.''
The Healey International Relief Foundation, based in Lumberton, NJ,
supports the rebuilding of Sierra Leone's healthcare system and has
provided relief services to our country since the end of our civil war,
over 12 years ago.
The Foundation Mission is to invest and support families and
individuals affected by war, disaster and adverse socio-economic
conditions through the delivery of healthcare, clean water, food,
training and other programs, hence it's mandate is to empower
communities and build their capacity to become self-sustaining.
The foundation partners with Caritas Freetown on all its projects
in Sierra Leone.
Caritas Freetown whose mission is to eradicate poverty, corruption,
and injustice; to improve equality, advance good governance, achieve
peace and human rights, empower women, youth and the disabled.
As the spokesperson for the Healey International Relief Foundation
in Sierra Leone, I feel privileged to share with you our experience.
Since the outbreak, we have implemented the ``Ebola Outbreak Response
Project'' in the rural and urban districts of Sierra Leone. We work
closely with the Ministry of Health and Sanitation, Ministry of Social
Welfare and the Emergency Operation Center.
As part of this project, we have been working in a number of
communities within the Western Area Districts with a catchment area of
about 219,000 people, raising awareness and providing chlorine, soaps
and tap buckets to all police stations and posts. In addition we have a
strong national media campaign in collaboration with our counterpart
Caritas organizations in the other regions.
The growing number of cases recorded on a daily basis has made the
situation in Sierra Leone very scary. Each day the situation becomes
worse and the effects of the Ebola cannot be over emphasized. When I
was about to leave, my 10-year-old daughter asked ``Dad are you leaving
us here in this difficult situation with this Ebola, they said there is
no Ebola in America, why can't you take us along?'' I starred at her
for a minute and said ``Maa,'' as I call her, ``my trip is for the
general good of all our family and your future. I will be back in 2
weeks.'' She asked again, ``Are you sure when flights are being cutoff
daily?''
Similarly, my wife said, ``Dear the money you normally leave when
traveling will not be enough as the cost of commodities has tripled.''
This was another difficult situation.
As I leave, my biggest stress is if anyone gets sick while I am
away, the health system is not functional.
The Ebola phobia is increasing. Even people who do not have Ebola
are being stigmatized, not to talk about those who are tested positive.
The state is overwhelmed and unable to effectively coordinate the
Ebola response and people are losing their confidence. The Ebola crisis
has escalated quickly and has led to the widespread fallout of the
healthcare system:
Harvests are being canceled because so many farmers had
died;
In the capital, Freetown, patrons are sparse at hotels and
restaurants especially those catering to the expatriates. Hotel
occupancy rates have dropped and large hotels have only 4 guests and
these hotels are laying off staff daily;
In a country with 70 percent illiteracy, schools are
closed indefinitely;
Our country's high orphan population, is increasing every
day;
People do not have the free will to bury their loved ones,
and even the sick ones are deprived of the emotional care from their
family needed to recover;
Many companies are laying off staff amidst the slowdown in
commerce, restrictions on travel and decrease in other economic
activity.
As a result, households are struggling with food shortages and
increase costs due to panic buying.
Families go hungry when the bread winner dies, gets sick or loses
his or her jobs.
With the support of the United States, the International Community
and the survival spirit of the people of Sierra Leone, I am confident
we will defeat this deadly virus. However, a decade of progress will be
lost, especially so when the health care was already in bad shape
before the outbreak.
I plead not to leave once the crisis is over and help us rebuild
our country physically and economically by investing in Sierra Leone to
empower our people to become self-reliant.
I thank you for your attention.
The Chairman. Thank you, Mr. Charles. It's always important
to put a human face on matters like this. I think people read
about it, you get the numbers, you say it's horrible. But one
has to understand the human impact and what this is doing to
families in your country, in Liberia, and other countries, and
the nature that I am now beginning to understand is, if we
don't get it controlled soon, it will spiral out of control and
it will have the devastating effects that Mr. Charles is
talking about. No more people will go there. Business will end.
The whole economy will start grinding to a halt.
Dr. Brantly, I'm sure I can speak for many in America and
around the world when I say thank you. Thank you for being such
an example for all of us on how to serve others. We regularly
thank our soldiers for marching into harm's way, rightfully so.
Let me say this is no different. You and others like you run
toward the risk to help those standing in the path of this
terrible disease. So I want to include you and others like you
in that pantheon of American heroes. You do us proud, real
proud.
I have so many questions, but I know we're running out of
time. Dr. Brantly, what I would ask you first is, with all that
you know, and you've been there with your family, you know what
the situation is like, give me one, two, three, what's the most
important thing we could do now? What's the most important
response that we could do now?
Dr. Brantly. Thank you, Mr. Chairman.
The Chairman. If you were in charge and you had a magic
wand, what would you do with it?
Dr. Brantly. I think one of the most important points is in
your very question. We have to do it now. This has been in the
eye of the government for months. We can't afford to wait
months or even weeks to take action, to put people on the
ground, to begin opening those logistical bridges and pathways,
to begin going out into the communities and educating
caregivers.
It's not that we're trying to keep people at home, but we
need to increase the capacity to care for them in facilities.
And that means not only creating more beds, but having the
staff to care for them in those beds. Putting them in a bed may
keep them from giving the disease to someone else, but it does
nothing to improve their chances of survival unless they're
receiving good quality supportive care.
So we need more capacity in Ebola treatment units, but we
must have the staff for those units as well. And we need to
start educating people right now in their communities about how
to safely care for their family members who are hiding at home
and dying from Ebola and ashamed or scared of their own
situation.
The Chairman. You must have a valuable perspective on
Liberian culture and society, having been there. We send in a
lot of people. Maybe they're not culturally sensitive. I don't
know exactly what I mean by that, but they don't understand the
situation; and could people actually become more afraid of the
workers that we send in if they're not adequately trained and
equipped?
Dr. Brantly. I think that's a very real possibility, Mr.
Chairman. I think that, yes, Liberia's civil war ended 10 years
ago, but think about the situation in the United States 10
years after our own Civil War. There was still a lot of
tension, and in Liberia there is still a lot of tension between
people, groups, and society in general, and there's a sense of
distrust, distrust of government, distrust of authority,
distrust of foreigners.
So yes, people will be resistant to help. But I think
because of the devastation of this outbreak even those people
who have been resistant to help are starting to see the need
for some assistance. I think that's why it's important that we
don't just march in there with our military and take over, but
we partner with the NGO's, like Doctors Without Borders and
Samaritan's Purse, and the Ministry of Health of Liberia, so
that it's a partnership and we're using people like the
survivors from Ebola.
There are more and more survivors every day in places where
they can get good, supportive care, and those survivors are the
ones who can go out and, in what you refer to as a culturally
appropriate way, educate and support the communities and
distribute the needed personal protective equipment to protect
those home care providers. I think that is very much an
important part of the strategy.
But again, it has to start now. It has to start in a matter
of days. From the time I fell sick just less than 2 months ago,
the death toll has tripled. If we take 2 months to get our
response up and going, even if we only maintain that rate of
growth, we're looking at thousands and tens of thousands. And 9
months down the road, we're looking at hundreds of thousands of
not only cases of Ebola, but deaths. And we can't afford that.
The Chairman. That's where I hope our military airlift
capability will come in and start moving material and personnel
over there.
Senator Alexander.
Senator Alexander. Dr. Brantly, Mr. Charles, let me thank
you both. Mr. Charles, thank you for your work in prevention
and bringing awareness here. Dr. Brantly, thanks for your being
a good samaritan. We greatly admire what you've done.
You're a survivor of Ebola. Is that like cancer? Is that in
remission, or are you cured, or do you know?
Dr. Brantly. Thank you, Senator. I'm cured from Ebola.
Senator Alexander. So you don't have it--it's gone from
you?
Dr. Brantly. Yes. When a person survives Ebola, when they
recover they're not a carrier of the virus. Dr. Ribner at Emory
University was very clear to say that Nancy Writebol and I
posed no public health risk. So there's no risk to the public
from a survivor. There's a lot of stigma attached to being a
survivor of Ebola, but we----
Senator Alexander. Can an Ebola survivor become infected
once again, or are you immune then from Ebola?
Dr. Brantly. In theory and I think in practice, I am immune
to the strain of Ebola that I was infected with. But there are
five different strains of Ebola, so if I went to the Democratic
Republic of the Congo I may not be immune to the strain that's
causing the outbreak there.
Senator Alexander. You talk about how you treated a lot of
patients. Would you say it's accurate that about half the
patients who are infected died, or is it higher or lower than
that?
Dr. Brantly. Unfortunately, Senator, in my experience we
did not have a 50 percent mortality rate of 50 percent survival
rate in our facility. As we saw patients early on in the
outbreak, they were usually showing up very late in their
course, and in the month and a half that I was treating Ebola
patients we had one survivor.
Senator Alexander. From the time you discover an infection
until death, how long is that typically?
Dr. Brantly. That varies greatly depending on how early the
person seeks care. We had some people who came and died in a
matter of hours from the time they presented, and we had others
who were under our care for a matter of days, 4 or 5 or 6 days,
before they passed away.
Senator Alexander. But it's not months?
Dr. Brantly. No. The illness generally is a 2-week course,
and by the end of 2 weeks the person has either died or they're
on the road to recovery.
Senator Alexander. Which is one reason there's such
concern, because it's so explosive, it moves so rapidly. Is
that right? As I listen to you, I hear you talking about lots
of people at home sick for a variety of reasons. We've heard
the official statistics say there are less than 5,000
infections. It sounds to me like there might be many more.
Dr. Brantly. I think that's very accurate, sir. As many of
the witnesses today have said, those numbers are based on the
cases we have tested and identified or are housing in isolation
units. But there are many, many more at home.
Senator Alexander. So there are many more, and what you're
saying is the course of the disease might run a couple of weeks
and you're either dead or a survivor after that period of time.
In your experience, all but one died. Others, they say half.
The official statistics say the cases have doubled over the
last 3 weeks. So you don't have to do much math to see that the
numbers, as you say, can quickly go to tens of thousands,
hundreds of thousands, if we don't get control.
Am I correct that the home health kits are primarily for
the benefit of the caregivers, that it's to keep the infection
from spreading? Does it make the home sort of a hospice for the
infected person with Ebola?
Dr. Brantly. I think that's a fair way to look at it. As I
said, you can't carry out complicated medical interventions in
a home, but you can give people oral rehydration solution. You
can give them Tylenol to help with their fever and pain. But
the most important part of that kit is the part that offers
protection to the caregiver, because without that we're not
stopping transmission, and that's what has to happen to control
this epidemic, is to stop the transmission of this disease.
Senator Alexander. You took a great risk in going there and
it's obvious from the testimony of you and Mr. Charles and
others that we'll need hundreds, thousands of people, in
addition to the soldiers who are going. What would you say to
others, people like yourself? We have a tradition in this
country of Doctors Without Borders, Samaritan's Purse, of which
you were a part. What would you say to Americans who are seeing
this and trying to decide whether to go to West Africa to help
control this disease?
Dr. Brantly. Thank you, Senator. This is a topic very dear
to my heart. I think the International President of Doctors
Without Borders said it very well in a recent article. She
said,
``Comparing Ebola to a fire, this is not the time to
run away; this is the time to put on our protective
gear and run into the burning building.''
Physicians and health care professionals, even if it's just
symbolic, have taken an oath. In many institutions they still
take the Hippocratic Oath, and that oath is to the service of
mankind. I think if we can help people overcome the fear of
facing a deadly disease and remember that this is not just a
disease, these are people who need help, societies that are
collapsing because of the weight of this burden, we just need
people to go help.
The Chairman. Senator Burr.
Senator Burr. Thank you, Mr. Chairman.
Dr. Brantly, Mr. Charles, thank you for being here. Mr.
Charles, when you go back and see your daughters, I hope you'll
share with them that the purpose of this committee is to try to
make sure we can process enough fact to make sure that we can
provide what's needed from a standpoint of the resources. There
are other parts of government that has the responsibility to
get them there, to train, to equip. But we have to make sure
that we have the resources. And what you've shared with us,
both of you, is invaluable from a standpoint of how we look at
it. As I think both Senators said, to see the human face behind
the issue is absolutely crucial to those of us who sit on this
committee and in this institution and ask taxpayers to in turn
fund things for people that they'll never meet.
But I do have a couple of questions. Dr. Brantly, are you
convinced that ZMapp played a role in your cure?
Dr. Brantly. Thank you, Senator Burr. My opinion----
Senator Burr. I take for granted that from a standpoint of
good supportive care, since you knew them, you were getting it.
Dr. Brantly. I was receiving the best care that they could
afford to give me in Liberia.
My own opinion is that ZMapp, I believe, had a beneficial
effect in my treatment. But, as Dr. Fauci very clearly said,
this is an experimental drug, that my story is an anecdote and,
while a very convincing one, it's just one. And it really
requires more extensive testing of an experimental drug to
prove whether or not it is beneficial on a large scale. I'm
very thankful for Mr. Zetland and all the people at Mapp
Biopharmaceuticals because I think it was helpful to me, and I
think it will be helpful in future Ebola outbreaks, because
there will be more Ebola outbreaks.
Senator Burr. Let me say, Dr. Brantly, when the chairman
said he was concerned this might spiral out of control, I think
we've already spiraled. I think we're in that spiral now. I
think had we had more time with Robin Robinson we would
understand that we're probably January at the earliest for
therapy, and that's without extensive clinical trials, as you
can imagine. We're January, first quarter, with potentially
some vaccine product, and that's with--doctor, you know, if
we're talking about a 5-month clinical trial process, we have
accelerated it greatly.
We're going to break every fail-safe that exists at the
FDA, just like they did in the decision to administer ZMapp to
you. And because that's jurisdictionally under this committee,
it's important that we all understand. We're going to sort of
recreate the wheel, because this is an extraordinary
circumstance.
I guess I'm asking for your medical opinion and your
opinion as somebody that knows the folks that are being
affected. If we choose to go before we know everything with
some type of therapeutic response, is that the best course for
us to follow, or should we be prudent and take longer, knowing
that we know a little more about the therapy or the vaccine?
Dr. Brantly. I think WHO came out with a statement several
weeks ago saying they believe it's ethical to use experimental
drugs in circumstances such as this. I would agree with them
that if we know--in my case, we didn't even know if it would be
harmful or not. I think if you're going to start giving it to
people who don't have the background to be able to give really
understood informed consent, it's important that we know that
what we're giving them is safe and potentially beneficial.
But I think those types of drugs, especially vaccines--I
think the other panelists spoke to that better than I can, but
I think they would have a role, especially if we don't have
this thing under control by January.
Senator Burr. The numbers that we look at suggest for every
infected individual that they will infect somewhere between 5
and 20 additional individuals. The multiples are huge. I think
I heard both of you say that when we look at Sierra Leone,
1,620 cases, 653 in the last 21 days, Liberia 2,407, 1,383, you
think those are woefully understating the size of the problem.
Did I hear both of you correctly?
Mr. Charles. Yes, Senator.
Senator Burr. OK.
Dr. Brantly. Senator, may I speak just a moment on that?
Senator Burr. Sure.
Dr. Brantly. I think those numbers may be underestimated
for sure, but I think what you're seeing is a representation of
how quickly this thing is growing when you compare what the
numbers were to how fast they're growing now. And those
experimental drugs don't have anything to do with the
transmission. That's why we need to intervene in the
communities to disrupt the transmission of this disease.
Senator Burr. When CDC said act now, I sort of agree with
your definition of ``now.'' ``Now'' is like tomorrow. I'm not
sure that we've ever had that type of turnaround out of
government. So facing the reality of what's in front of us is
also important.
Last question, and you've been very patient to stick with
us as long as you have. What are the possibilities of using
social media as our communication tool in West Africa, and can
that be effective?
Mr. Charles. Yes, the use of social media has a lot of
effects in Sierra Leone specifically, especially among young
people who are literate, maybe the school-going population and
those who also have access to mobile phones. But the cost of
communication is tremendously expensive compared to what I can
access in America on my cellphone at the cost and what I can
access in Sierra Leone on a monthly basis for the same
cellphone. It's very expensive. But it definitely has a very
big impact because a lot of information is being--it's
sometimes misleading also. That's another negative aspect. But
the fact is a lot of this information, good information, is
also being transmitted and communicated through WhatsApp and
Facebook especially.
Senator Burr. Dr. Brantly, you agree?
Dr. Brantly. I agree. I think even up until this point
Liberia has been using social media and radio and print media
to reach the population. There's even a really catchy tune that
they play on the radio about Ebola, reminding people that Ebola
is real and they need to protect themselves and protect their
families, and that talks about how the disease is spread. I
think it's a very important means of reaching people.
Senator Burr. I want to thank both of you. I especially
want to thank Samaritan's Purse. Whenever you have a tragedy
somewhere in the world, they are certainly there. They're part
of the story. I think a lot of the presence in North Carolina
and I think a lot of Franklin and the vision and the
commitment. Not to say that we don't have a lot of good NGO's
around the world that respond, but they're certainly
consistently there, and for that we're grateful.
I thank you both.
Dr. Brantly. Thank you.
Senator Alexander. Thanks to both of you for coming. We're
at the end and Senator Harkin will end this in a minute. But I
want to make sure I understood something you said. You said you
began to treat patients on June 11 and became ill on July 20,
is that right?
Dr. Brantly. July 23d, yes.
Senator Alexander. You became ill on July 23d. About how
many patients did you treat?
Dr. Brantly. I believe during that time we had about 45 or
50 patients come through our unit. Not every one of those was
positive for Ebola, but even many of them who were negative for
Ebola died because of the severe illness they came to our
hospital with.
Senator Alexander. So of the 45 or 50, all but one died?
Dr. Brantly. No, sir. There were some who tested negative
and we discharged them from the unit.
Senator Alexander. Of those 45 or 50, some had Ebola?
Dr. Brantly. I can't remember the numbers exactly, but I
would say of those 45 probably 20 of them had Ebola and
probably 10 or 12 of them were tested negative and discharged.
So that would leave another five or so who came to us with
something other than Ebola, but unfortunately died because of
the severity of their illness.
Senator Alexander. Now, you became ill on July 23d. You
were tested on July 26th. You said something about a 2-week
course. Does that mean that within 2 weeks you know whether
you're going to recover or die if you have Ebola? Is that
right?
Dr. Brantly. In general. Most people with Ebola, they
usually, if they die from it, they die between days four and
ten. But it can be a 14 or 16-day illness. So you can't just
say, oh, you're on day ten, you're out of the woods. That's not
the case. It was day nine when I was the sickest and almost
died.
Senator Alexander. So you become infected, you don't infect
others until you have symptoms, correct?
Dr. Brantly. Correct.
Senator Alexander. So there's a period of time of about
maybe 2 weeks, a week or two, when you can infect other people,
plus the time after--if you die, there's that period of time.
Dr. Brantly. Correct. You contract the virus and you have a
2 to 21-day window before you become symptomatic. Once you
become symptomatic, your illness may run from 3 days, where you
die after 3 days, or you may be sick for 2 weeks. In my case, I
was sick for almost 4 weeks before the CDC decided that my test
was negative enough consecutive times that they could discharge
me from the hospital.
So you're correct, people are infectious during their
illness and usually that is less than a 2- or 3-week period.
Senator Alexander. So what's really different about this
epidemic is how fast it moves, is that right?
Dr. Brantly. The virus moves--it kills quickly. Like Dr.
Fauci and Dr. Bell said, it's not so contagious like the flu
virus that someone will get it by sitting near you. But it
kills its victims quickly.
Senator Alexander. So within that 2-week period or so of
infection, to use Senator Burr's figures, one might infect 5 to
20 other people. They have an incubation period of 2 to 21 days
and then they may have a 2-week period of infection during
which they might infect 5 to 20 more people. So that all
happens very, very rapidly if it happens.
Dr. Brantly. Yes, sir.
Senator Alexander. Thank you, Mr. Chairman.
The Chairman. Thank you, Senator Alexander. Senator Burr,
thank you.
Again, both of you, thank you very much for being here, for
your patience, and for sharing with us your personal stories.
The Obama administration is moving rapidly on this. Today
President Obama went to the CDC. We are ourselves working here
to do everything we can to rapidly respond and to support the
President in this effort. I think you're right, time is of the
essence, but it has to be done correctly rather than rushing in
and doing things that may even make it worse. Certainly we need
to get the equipment there, the personal protection gear for
home health and health care workers in these countries. We need
to do a rapid series of educational programs so that the local
populace begins to know what to do and how to respond and not
to be afraid. That needs to be done rapidly.
I trust that there are NGO's like the one you are with, Mr.
Charles, there are NGO's there that could be very helpful on
this, I believe, and who have been there for some time and who
have good relations with people in these countries. I'm hopeful
that as we do this rapidly, we will learn from, lean on, ask
the help of the NGO's that are in these countries. They can be
extremely helpful. Do you concur with that? We need to really
ask them for their help.
Thank you very much, and I hope and trust, Mr. Charles,
that your wife and your daughters are safe, and if they hear
any of this at all I want to assure them that you're going to
be back home and you'll be safe.
Mr. Charles. Thank you very much.
The Chairman. Thank you. And thank you, Dr. Brantly, again
for your great example.
The record will remain open for 10 days. Thank you very
much. We'll stand adjourned.
[Additional material follows.]
ADDITIONAL MATERIAL
Response by Beth P. Bell, M.D., MPH to Questions of Senator Casey,
Senator Bennet, Senator Whitehouse, Senator Shaheen, Senator Baldwin,
Senator Warren, Senator Alexander, Senators Alexander and Burr, Senator
Moran, Senator Cochran, Senator Shelby, Senator Burr, Senator Kirk, and
Senator Enzi \1\
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\1\ Note: Content accurate as of October 15, 2014. Responses do not
reflect enactment of the $1.777 billion for CDC in emergency funding to
prevent, detect, and respond to the Ebola Epidemic.
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senator casey
Question 1. What is the CDC's plan to communicate with the public
regarding the current threat posed by Ebola, and how will these
communications change should Ebola reach the United States?
Answer 1. CDC educates Americans on ways to protect themselves when
traveling in numerous ways, such as:
Issuing travel health notices advising U.S. citizens to
avoid nonessential travel and to take enhanced precautions if they are
visiting the affected West African nations.\2\ The recommendation to
avoid nonessential travel is intended to help control the outbreak and
prevent continued spread by:
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\2\ For more information about travel notices to the West Africa
region and other countries, please visit CDC's Travelers' Health
website.
1. Protecting U.S. residents who may be planning travel to the
affected areas, and
2. Enabling the government of the affected countries to respond
most effectively to contain this outbreak.
Working closely with Customs and Border Protection (CBP)
in the Department of Homeland Security (DHS) and other partners to
enhance practices at U.S. ports of entry to use routine procedures to
identify travelers who show signs of infectious disease. In response to
the outbreak, these procedures have been enhanced through guidance and
training. CDC's quarantine station staff respond as needed, for example
by evaluating ill travelers identified by CBP officers.
Providing comprehensive information to travelers at U.S.
ports of entry through airport messaging to outbound and inbound
travelers, CDC website, and social media. Ebola-specific travel
messages have been developed for electronic monitors and posted to
reach travelers from West Africa, and posters have been displayed in
Transportation Security Administration (TSA) screening areas of
airports to reach outbound travelers. Furthermore, CDC maintains
detailed and updated actions for travelers to take before international
travel on the CDC website, including Ebola-related recommendations.
Developing interim guidance to provide public health
authorities and other partners with a framework for evaluating people's
level of exposure to Ebola and initiating appropriate public health
actions on the basis of exposure level and clinical assessment.
Specifically, CDC developed ``Interim Guidance about Ebola Virus
Infection for Airline Flight Crews, Cleaning Personnel, and Cargo
Personnel,'' As well as ``Interim U.S. Guidance for Monitoring and
Movement of Persons with Potential Ebola Virus Exposure.''
Issuing advice for colleges, universities, and students
about study abroad, foreign exchange, and other education-related
travel, as well as advice for students who have recently traveled from
a country in which an Ebola outbreak is occurring.
Developing guidance for humanitarian aid organizations
whose employees or volunteers are working in countries where an Ebola
outbreak is occurring. Humanitarian aid workers play a vital role in
the Ebola outbreak response, and CDC encourages them to continue the
important work being done to stop the disease's spread at its source.
CDC will continue to update its communication products and webpages
with new information on the Ebola outbreak for the general public and
specific audiences to share credible, factual information and to dispel
misconceptions about Ebola.
Question 2. You noted in your testimony that there are three key
things that we need to respond to this epidemic: resources, technical
experts, and a coordinated, global unified approach. Which of these
things do you feel we are currently doing well? Which of them do you
feel we are currently doing poorly, and how do you suggest we improve
our efforts?
Answer 2. We are continuously evaluating all three of these areas.
On resources, we continue to work across the U.S. Government to
determine the resource needs to ramp up the response and stop this
epidemic globally while protecting the United States. The U.S.
Government also is actively coordinating with other donors to support
these efforts. For technical expertise, CDC has been fighting this
disease for decades, and along with our partners, we have the technical
expertise to stop this. We need to transfer some of that expertise to
countries experiencing the epidemic and those at risk, so that our pool
of experts is larger and is on the ground when outbreaks occur. Global
coordination continues to improve. We are doing our best to respond to
the current epidemic both by working intensively in the countries
currently experiencing the epidemic as well as by preparing nearby
countries to be ready to respond to imported cases. CDC has identified
11 countries at high risk for importation and potential outbreaks and
is working intensively with these countries to improve their
surveillance, laboratory, and other pivotal capabilities.
Question 3. Is there a sufficient supply of personal protective
equipment (PPE) available (or capable of being procured) to supply the
affected West African nations? Do we also have a sufficient supply of
PPE available should Ebola reach the United States?
Answer 3. CDC is aware that challenges remain with the supply of
PPE in West Africa. The United Nations Logistics Cluster has been
activated to assist with PPE needs and supplies. WHO and MSF also
communicate directly with the largest PPE manufacturers to ensure that
they can produce the necessary PPE for the response. Thus far, the
manufacturers have not had problems producing PPE supplies in
sufficient quantities; however, procurement and distribution remain
challenging.
In the United States, as of October 15, 2014, there have been no
reported shortages of PPE. Hospitals have reported sufficient
quantities for health care workers who might treat suspect or confirmed
patients with Ebola virus disease (EVD). Moreover, as we understand it,
manufacturers are aware that there may be increased demand, and they
are preparing for that demand.
senator bennet
Question 1. Dr. Bell, in your testimony you say that ``the
technology, capacity, and resources exist to make measurable progress
across member countries, but focused leadership is required to make it
happen.'' Can you expand upon what kind of focused leadership you think
is needed here?
Answer 1. The importance of having a well-functioning incident
management system in an Emergency Operations Center (EOC) in each
affected country cannot be overemphasized. It is critical that there be
strong coordination and communication among countries, with clear
delineation of responsibilities. For its part, CDC has activated its
EOC to help coordinate technical assistance and control activities with
partners. On August 6, 2014, CDC elevated the EOC to a Level 1
activation, its highest level, because of the significance of the
outbreak. CDC supports countries in establishing their own national and
sub-national EOCs. Each of the three West African countries at the
center of the epidemic now have an Incident Manager, reporting to the
President of the country, to lead response efforts.
Question 2. There are many charities and volunteers here that want
to help end this outbreak and care deeply about the outcome. For
example, in my home State, the Centennial-based Project CURE has been
working with local volunteers and high schools, like Valor Christian
High School in Highlands Ranch, to send medical supplies to West
Africa. They have already sent four large containers of supplies for
medical workers there. They want to know that their government is
showing a coordinated response to this effort, and that their work will
not be in vain. Can you give them and other volunteers across the
country some peace of mind that their work is helping and you all are
doing everything you can to coordinate an effective response to this
outbreak?
Answer 2. The U.S. Government's goal is to enable the most
effective and coordinated international response possible, using our
governmentwide capabilities to fight the Ebola epidemic on a regional
basis. In September 2014, President Obama announced a scaled-up U.S.
response to the crisis, building on a whole-of-government response
across the U.S. Agency for International Development (USAID), the
Department of Defense (DoD), Department of State, CDC, and other
Federal Departments and Agencies. The United States also is working
intensively on this effort with the United Nations, the governments of
the affected countries, and other donor partners.
We continue to appreciate the efforts of the Congress and concerned
American citizens to raise awareness and get involved in the response
to this crisis. USAID is coordinating all kinds of donations and
volunteers, and suggests a list of charities for the public at http://
www.usaid.gov/ebola. These efforts make a tremendous difference.\3\
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\3\ For further information on the organizations working to combat
the crisis, additional ways to volunteer or contribute, or more
information on the response, please visit USAID's Center for
International Disaster Information website.
Question 3. Given the emergence of Ebola as a significant public
health threat--and the level of funds understandably being allocated in
response--I am concerned about our ability to respond to other
emergencies, such as pandemic influenza, which are far more common
threats. In particular, I'm concerned that we are jumping from crisis
to crisis and failing to adequately budget for rapid response
capabilities to public health pandemics, like Ebola, pandemic
influenza, and MERS. Just earlier this month, for instance, a DHS OIG
report highlighted that our pandemic influenza stockpiles have not been
effectively managed, and I'm concerned that we may be falling behind on
these other types of preparedness issues. How are you assuring that we
are adequately prepared and not compromising our ability to rapidly
respond to address other public health crises, like pandemic influenza,
in addition to emerging threats like Ebola?
Answer 3. The emergence of a novel, pandemic strain of influenza
represents a continued threat to global health. To address this threat,
CDC has developed plans and capabilities to respond to pandemic
influenza at any time, regardless of other ongoing response activities.
Since the 2009 H1N1 pandemic, we have enhanced our capabilities with
more robust domestic and international surveillance systems, improved
communication with partners, and increased public health laboratory
capacity at the State, local and international levels. CDC is prepared
to address public health crises, but the agency would be concerned
about the ability to respond effectively to multiple, large-scale,
concurrent events.
With respect to the referenced report by the DHS Office of the
Inspector General, CDC cannot speak to the work product of another
department. However, it is important to note that this report
encompasses a review of DHS preparedness to continue critical
operations of DHS activities during an influenza pandemic. This report
does not evaluate the nationwide preparedness to respond to such a
pandemic.
senator whitehouse
Question 1. Several commentators have cited distrust of health care
officials by people in affected regions as one of the barriers to
receiving care. What steps has CDC taken to overcome this mistrust? How
are CDC and the World Health Organization partnering with trusted local
leaders and communications outlets to disseminate information?
Answer 1. CDC has deployed several teams of public health experts
to the West Africa region to work directly with local leaders and
stakeholders who can inform on the best ways to foster trust and reach
communities. CDC's health promotion teams, consisting of health
communicators and public health advisors deployed to Guinea, Liberia,
and Sierra Leone, are working closely with country embassies, UNICEF,
WHO, ministries of health, and nongovernment organizations to develop
public health messages and implement social mobilization activities. In
all three countries, CDC health communicators are meeting with local
community leaders beyond capital cities.
Question 2. In Rhode Island, public health officials at the
Department of Health and elsewhere are working with local residents
from West Africa to help them communicate to their family and friends
on ways to stay safe. Do you recommend outreach and education efforts
of this kind? Will you be supporting and spreading this approach to
other States that are part of the Liberian diaspora in the United
States like Minnesota, Pennsylvania, Maryland, Georgia, and Washington,
DC?
Answer 2. CDC has engaged and continues to engage in outreach
directly to West African communities and organizations serving the West
African diaspora across the country, including groups in Dallas/Dallas
County, Rhode Island, California, Minnesota, and the Bronx. CDC's
specific activities include:
CDC is helping counter stigma during the Ebola response
and encourages our public health partners to do so as well. CDC has
developed messaging on avoiding stigma in West African populations in
the United States and shared it with all State health departments and
others. CDC has also created guidance for social service and community-
based organizations in the United States serving immigrant communities,
including additional guidance on preventing stigma for sharing with the
population they serve.
CDC has hosted several calls for West African community
groups to provide the most up to date information on Ebola and
opportunities for these groups to support Ebola response efforts,
delivery of key health messages and CDC resources, and securing CDC
speakers for special events. Participants have included faith-based
groups and national organizations serving Liberians, Sierra Leoneans,
and Guineans in the United States. For example, two calls were held on
September 30, 2014 with groups representing the West African diaspora
population. One call was organized by Congressman David Cicilline's
office for the diaspora in Rhode Island, and the other call was open to
diaspora groups and individuals across the country. CDC is planning to
continue this type of outreach on an ongoing basis.
CDC is collaborating with a private partner, AudioNow, to
deliver PSAs on their call-to-listen platform popular with West African
communities in the United States. Several PSAs have been developed
targeting this group, with a focus on how to inform relatives in the
West African region about Ebola, and travel related issues (e.g.,
visitors coming from and traveling to the region). These are in
production now in four languages for 72 radio stations that are
identified as reaching large groups of West Africans in the United
States. CDC has also worked with President Jimmy Carter and the Carter
Center to develop some specific messages, building on their existing
relationships and portfolio of work in Liberia.
CDC will continue to take measures to ensure that geographic areas
with large West African populations receive timely information and make
available resources as needed. CDC has a cadre of experts who have
experience reaching immigrant populations, including individuals that
speak Hausa and Fulani, two of the major non-English and non-French
languages in the region, to provide consultation on linguistic and
cultural issues.
Question 3. What do you advise State and local health officials to
do to protect their populations? What additional resources are needed
at the State and local level to insure that Ebola from any imported
case is not spread?
Answer 3. CDC has created plans outlining its course of action for
when a laboratory-confirmed Ebola diagnosis occurs in the United States
and continues to work with other Federal, State, and local health
governments and private organizations to strengthen U.S. readiness for
detecting and preventing Ebola cases.
Recognizing that even a single case of Ebola diagnosed in the
United States is a concern, CDC is working with medical and public
health professionals and health care facilities across the country to
prepare and respond and to safely manage a patient with suspected Ebola
Virus Disease. This includes engagement in the following activities:
Enhancing surveillance and laboratory testing capacity to
detect cases domestically;
Developing guidance and tools, such as checklists for
health departments, hospitals, emergency medical services, and health
care coalitions to conduct public health investigations;
Providing recommendations for health care infection
control and other measures to prevent disease spread;
Providing guidance for flight crews, emergency medical
units at airports, and U.S. CBP officers about reporting ill travelers
to CDC;
Coordinating with maritime authorities to assess the
potential risk to the United States from cargo vessels from the four
affected West African countries; and
Disseminating up-to-date information about the epidemic to
the general public, international travelers, and public health
partners.
Since July, CDC's Health Alert Network has issued seven notices on
Ebola, reaching hundreds of thousands of clinicians and others.
CDC also is working to prepare U.S. healthcare facilities for safe
management of patients with suspected Ebola virus and to educate health
care professionals across the country about important precautionary
measures related to Ebola. CDC communicates with health care workers on
an ongoing basis through the HAN, Clinician Outreach and Communication
Activities, and a variety of other existing tools and mechanisms.
In regards to what private health organizations can do to prepare
for such a public health emergency, CDC recommends the following steps
to assist in any potential response:
Health care organizations can encourage U.S. hospitals to
be prepared to identify and initially manage patients with Ebola;
Health care providers can increase their understanding of
Ebola, using the latest healthcare guidance; and
Health care organizations can support health care provider
requests to work in West Africa assisting those affected by the Ebola
epidemic. USAID provides information on volunteer needs on its website.
Finally, CDC has issued advice for colleges, universities, and
students about study abroad, foreign exchange, and other education-
related travel, as well as advice for students who have recently
traveled from a country in which an Ebola outbreak is occurring. CDC
advises that all non-essential travel, including education-related
travel, to Guinea, Liberia, and Sierra Leone be postponed until further
notice. Students, faculty, and staff who have recently traveled to
countries where the Ebola outbreaks are occurring should consult with
school authorities on what instructions to follow, and monitor their
health for 21 days after returning. CDC advises colleges and
universities to identify students, faculty, and staff who, within the
past 21 days, have been in countries where Ebola outbreaks are
occurring and conduct a risk assessment for each person to determine
his or her level of risk exposure, as well as the appropriate public
health response and medical care based on CDC's Interim Guidance for
Monitoring and Movement of Persons with Ebola Virus Disease Exposure.
senator shaheen
Question 1. How can we apply the lessons we are learning in the
current global emergency response to better leverage our resources to
support a long-term local epidemiologic infrastructure operated and
staffed by local scientists and public health officials?
Answer 1. The global response to Ebola underscores the need for
well-functioning and effective health and public health systems across
the world. The current response shows that capacities outlined in the
Global Health Security (GHS) Agenda to prevent, detect, and respond to
public health emergencies are critical in a country's ability to lessen
the impact of infectious disease outbreaks. Several components of the
immediate response to Ebola are key areas for GHS implementation--an
EOC, laboratory capacity, surveillance, and workforce development.
In this epidemic, we have seen that some countries, even with
nascent detection and response capacities, were able to successfully
contain and eradicate the outbreak after experiencing cases in their
countries. An example is Nigeria, which used its existing EOC developed
for the polio response and Field Epidemiology Training Program to
monitor operations, conduct surveillance and contact tracing, showing
that improvements to core public health systems are critical to
responding to emerging threats.
Some of the work we are currently doing for the response, including
surveillance, information systems, workforce strengthening, EOC
development, and laboratory services, will serve as the foundation for
longer term GHS strengthening.
Question 2. Among the various challenges that we face with this
ongoing epidemic is collecting real time data in a rapidly changing
situation. Further, sharing this information between corroborating
agencies in an international context is challenging. How is CDC keeping
pace with the data and making sure that decisionmakers have the best up
to date information available to inform their planning?
Answer 2. CDC has activated its EOC to help coordinate technical
assistance and control activities with partners. On August 6, 2014, CDC
elevated the EOC to a Level 1 activation, its highest level, because of
the significance of the outbreak. CDC supports countries in
establishing their own national and sub-national EOCs. Each of the
three West African countries at the center of the epidemic now has an
Incident Manager, reporting to the President of the country, to lead
response efforts.
Hundreds of CDC staff members have provided logistics, staffing,
communication, analytics, management, and other support functions for
the response. CDC has deployed several teams of public health experts
to the West Africa region. CDC staff are deployed to Guinea, Liberia,
Nigeria, Senegal, and Sierra Leone to assist with response efforts,
including surveillance, contact tracing, data management, laboratory
testing, and health education. CDC continues to send additional public
health experts to the affected and neighboring countries. CDC experts
have been deployed to non-affected border countries, including Cote
d'Ivoire, to conduct assessments of Ebola preparedness in those
countries.
Through the Disaster Assistance Response Team (DART), led by USAID
with CDC staff embedded, and regular communication with on-the-ground
staff, the CDC EOC maintains daily interaction to obtain the most up-
to-date data from the field. This data feeds directly to each Ebola
response team to shape plans and allow for nimble changes in tactics to
address evolving situations in each affected country.
In the United States, CDC has data collection and tracking
mechanisms in place to monitor any potential case of the disease. CDC,
along with other Federal agencies, has created and implemented a
response plan to manage a laboratory-confirmed case of EVD in the
United States, and is providing guidance to health care facilities
about how to safely manage a patient with suspected EVD. This includes
engagement in the following activities:
Enhancing surveillance and laboratory testing capacity to
detect cases domestically.
Developing guidance and tools for health departments to
conduct public health investigations.
Providing recommendations for healthcare infection control
and other measures to prevent disease spread.
Providing guidance for flight crews, emergency medical
units at airports, and U.S. CBP officers about reporting ill travelers
to CDC.
Coordinating with maritime authorities to assess the
potential risk to the United States from cargo vessels from the four
affected West African countries.
Disseminating up-to-date information about the outbreak to
the general public, international travelers, and public health
partners.
Question 3. Is CDC employing the latest mobile technologies and
software to record and disseminate information?
Answer 3. CDC employs extensive surveillance and sophisticated
modeling techniques to gather, analyze and act on data and information,
in cooperation with global partners.
The Department of Health and Human Services (HHS), and in
particular CDC, is working closely with the World Health Organization
(WHO), the United Nations, the Ministries of Health in affected
countries, and other international partners to respond to the current
Ebola outbreak in West Africa. CDC receives regular updates of
morbidity and mortality to evaluate the spread of the disease and
combines this information with reports from CDC's staff deployed to the
area. Hundreds of CDC staff members have provided logistics, staffing,
communication, analytics, management, and other support functions for
the response. CDC continues to commit significant staffing and
financial resources to the international Ebola response both on the
ground in West Africa and through its domestic EOC. CDC's health
promotion teams, consisting of health communicators and public health
advisors deployed to Guinea, Liberia, and Sierra Leone, are working
closely with country embassies, UNICEF, WHO, ministries of health, and
nongovernment organizations to develop public health messages and
implement social mobilization activities. CDC is partnering with major
telecommunications companies in the affected countries to disseminate
messages across the countries (ORANGE and Cellcom in Guinea; Africell
in Sierra Leone; and Cellcom and Lonestar in Liberia). CDC engaged with
UNICEF and Focus 1000 in the development of a Knowledge, Attitudes, and
Practices study and preliminary report in Sierra Leone and is using
this report to inform future message strategies.
CDC continues to update its communication products and webpages
with new information on the Ebola outbreak for the general public and
specific audiences. CDC is using social media as a way to share
credible, factual information and to dispel misconceptions about Ebola.
Question 4. Our Nation's intensive care units are at the forefront
of caring for the most critically ill patients including during times
of widespread medical emergencies such as pandemics. While we know that
Ebola is not affecting a large number of Americans today, we do know
that the next pandemic could be just around the corner and we need to
ensure that our critical care system is equipped to respond. Dr. Bell
and Dr. Robinson, does our hospital system currently have the necessary
critical care infrastructure in place for this type of virus, such as
appropriate critical care containment rooms?
Answer 4. Any U.S. hospital should be prepared to identify, assess
and isolate a patient with Ebola. CDC developed guidance documents and
checklists to help U.S. hospitals prepare for, test, and treat patients
with Ebola, and works to keep the health care system informed of new
developments. CDC uses its HAN to provide information and guidance to
U.S. healthcare workers and hospitals regarding EVD. CDC distributed a
HAN notice August 1, 2014, and five updates have followed. The most
recent HAN notice about Ebola was distributed on October 2, 2014.
CDC created and implemented an operational plan outlining the
course of action for the first 72 hours to manage a laboratory-
confirmed Ebola diagnosis in a patient. Plan activities include rapid
dissemination of news regarding the Ebola case(s) to key public health,
healthcare system, and emergency management partner organizations;
providing current and timely information to State, local, and
territorial public health departments; and coordinating critical issues
management regarding State and local needs for the CDC EOC incident
manager and other response task force teams.
CDC has redoubled its efforts to educate American health care
workers about how to isolate patients and how to protect themselves
from infection, including developing and disseminating resources,
hosting informational calls, and creating trainings. CDC has:
Hosted Clinician Outreach and Community Activity calls for
clinical professionals to provide information about what U.S. hospitals
need to know to prepare for EVD.
Created guidance about EVD for clinicians in U.S. health
care settings.
Posted a Medscape Expert Commentary for healthcare
providers whose patients are travelers with concerns about Ebola. The
commentary includes information about the Ebola outbreak in West
Africa, the transmission Ebola virus, and how to talk to travelers
about their risk.
Created guidance for U.S. healthcare workers on
``Infection Prevention and Control Recommendations for Hospitalized
Patients with Known or Suspected Ebola Hemorrhagic Fever in U.S.
Hospitals.''
Developed a checklist for hospitals to aid in Ebola
preparedness that can be found on the CDC website.
Built a Safety Training Course for Healthcare Workers
Going to West Africa in Response to the 2014 Ebola Outbreak. The
primary purpose of the course is to ensure that clinicians intending to
provide medical care to patients with Ebola have sufficient knowledge
of the disease and its transmission routes to work safely and
efficiently in a well-designed Ebola Treatment Unit (ETU).
Collated the Top 10 Ebola Response Planning Tips: Ebola
Readiness Self-Assessment for State and Local Public Health Officials
to help guide planning and readiness for Ebola response at State and
local levels and assist health officials in assessing their
jurisdictions' level of readiness for a potential Ebola response.
senator baldwin
Question. The President recently outlined a comprehensive response
to combat this epidemic that includes the efforts of an estimated 3,000
U.S. forces and a strong partnership with the United Nations and our
other international partners. The first cases of Ebola were reported in
March; it is now October and the Ebola crisis is only worsening. Why
did we not initiate this response in March? In hindsight, what should
have been the United States' first action item when cases were first
reported, and what can we learn from this to prevent the world from
seeing such tragedy again?
Answer. CDC is incorporating lessons learned as the response
evolves, and, as is done after all large-scale responses, the agency
will conduct a comprehensive ``after-action'' review to learn
additional lessons that will prepare the agency to better respond to
future events.
CDC initiated the first stages of response in March 2014 when it
activated its EOC to help coordinate technical assistance and control
activities with partners. On August 6, 2014, CDC elevated the EOC to a
Level 1 activation, its highest level, because of the significance of
the outbreak. CDC supports countries in establishing their own national
and sub-national EOCs. Each of the three West African countries at the
center of the epidemic now has an Incident Manager, reporting to the
President of the country, to lead response efforts.
Hundreds of CDC staff members have provided logistics, staffing,
communication, analytics, management, and other support functions for
the response. CDC has deployed several teams of public health experts
to the West Africa region. CDC staff are deployed to Guinea, Liberia,
Nigeria, Senegal, and Sierra Leone to assist with response efforts,
including surveillance, contact tracing, data management, laboratory
testing, and health education. CDC continues to send additional public
health experts to the affected and neighboring countries. CDC experts
have been deployed to non-affected border countries, including Cote
d'Ivoire, to conduct assessments of Ebola preparedness in those
countries.
Through the Global Disease Detection (GDD) program, CDC develops
and strengthens global capacity to rapidly detect, accurately identify,
and promptly contain emerging infectious disease and bioterrorist
threats that occur internationally. The GDD Operations Center,
implemented in 2007, is a surveillance system that enables the ongoing,
systematic collection, management, analysis, interpretation, and
dissemination of health-related data.
senator warren
Question 1. If the Global Security Agenda had been launched 5 years
ago, and we already had these pieces in place, would this epidemic have
been better contained?
Answer 1. The global response to Ebola underscores the need for
well-functioning and effective health and public health systems across
the world. The current response shows that capacities outlined in the
Global Health Security Agenda (GHSA) to prevent, detect, and respond to
public health emergencies are critical in a country's ability to lessen
the impact of infectious disease outbreaks. Had these capacities been
developed, the course of this outbreak would likely have resulted in
earlier containment, fewer deaths and decreased economic ramifications.
Several components of the immediate response to Ebola are key areas
for GHSA implementation--EOC, laboratory capacity, surveillance, and
workforce development. In this epidemic, we have seen that some
countries, even with nascent detection and response capacities, were
able to successfully contain the outbreak after experiencing cases in
their countries. An example is Nigeria, which used its existing EOC and
Field Epidemiology Training Program to monitor operations, conduct
surveillance, and conduct contact tracing, proving that even basic
improvements to public health systems can be effective in responding to
emerging threats.
Some of CDC's work in this response, including surveillance,
information systems, workforce strengthening, EOC development, and
laboratory services will serve as the foundation for longer-term,
broad, global health security strengthening.
Question 2. How will the Agenda help to address the challenges of
political instability, the lack of infrastructure, and the lack of
basic health care resources that have all played a huge role in the
continued spread of this epidemic?
Answer 2. The vision of the Global Health Security Agenda is a
world safe and secure from global health threats posed by infectious
diseases--where we can prevent or mitigate the impact of naturally
occurring outbreaks and intentional or accidental releases of dangerous
pathogens, rapidly detect and transparently report outbreaks when they
occur, and employ an interconnected global network that can respond
effectively to limit the spread of infectious disease outbreaks in
humans and animals, mitigate human suffering and the loss of human
life, and reduce economic impact.
Ebola is the most tangible--and tragic--example so far for why the
global community must work together to make the world safer from
infectious disease outbreaks. The Ebola crisis in West Africa is
precisely the kind of complicated disease eruption the Global Health
Security Agenda is designed to address. The GHSA will help prevent,
detect and respond to infectious disease outbreaks in the following
ways:
Coordination and communication among nations will be
strengthened and streamlined, allowing disease outbreaks to be
discovered and characterized at the earliest possible moment.
Laboratory capacity will be increased and operating
standards strengthened so that potential diseases can be accurately and
precisely identified. Then treatment protocols can be established more
quickly to effectively treat patients and protect health care workers.
New disease detectives will be trained around the world
and deployed to close gaps in surveillance and provide early detection.
More countries will be equipped with networked EOCs
governed by a universal set of standards and rules that will allow a
unified and effective response.
The availability of more detailed information sooner will
allow a more unified response and, if needed, the ability of partner
countries to surge experts to affected areas so disease outbreaks are
contained at the earliest possible moment and while they are still
small in scope.
Ultimately, having better information around disease detection and
response enables more timely and accurate communication with the
public. This can help limit unease and panic that affects commerce,
travel, political stability and public health.
Question 3. How would the effectiveness of the Agenda be maximized
by investments to improve the basic healthcare infrastructure of
developing nations?
Answer 3. The GHSA outlines nine objectives to accelerate progress
toward a world safe and secure from infectious disease threats in
partnership with other nations, international organizations and public
and private stakeholders. Several of these address the investments
related to improve health care systems:
Reduce the number and magnitude of infectious disease
outbreaks. Establish effective programs for vaccination against
epidemic-prone diseases and for nosocomial infection control.
Train and deploy an effective disease surveillance
workforce. Build capacity for trained and functioning biosurveillance
workforce, with trained disease detectives and laboratory scientists.
Improve global access to medical and non-medical
countermeasures during health emergencies. Strengthen capacity to
produce or procure personal protective equipment, medications,
vaccines, and technical expertise, as well as the capacity to plan for
and deploy non-medical countermeasures. Strengthen policies and
operational frameworks to share public and animal health and medical
personnel and countermeasures with partners.
Question 4. Who do you think should be ultimately responsible for
the international coordination and financing of outbreak responses when
local governments are unable to do so?
Answer 4. To respond adequately to a major crisis such as the Ebola
Outbreak in West Africa, multiple actors are needed and, in fact, are
now responding. They include U.N. agencies (such as WHO, UNICEF, World
Bank), the U.S. Government, other countries, NGO's (such as MSF and the
International Red Cross), as well as other entities within the private
sector. Within the West Africa region affected by the Ebola outbreak,
USAID continues to lead the United States' overseas response, while the
Department of Defense, CDC, Department of State, and other departments
and agencies are supporting the whole-of-government approach to this
national security priority. USAID has deployed a DART to coordinate
planning, operations, logistics and other components of the interagency
effort. CDC staff is working with Ministries of Health to improve
surveillance, contact tracing, laboratory capacity, emergency
operations planning and other critical capabilities.
HHS, and in particular CDC, is working closely with the World
Health Organization (WHO), the United Nations, the Ministries of Health
in affected countries, and other international partners to respond to
the current Ebola outbreak in West Africa. The Ebola epidemic reminds
us that our global efforts to build the capacity to prevent, detect,
and rapidly respond to infectious disease threats like EVD have never
been more vital.
In February 2014, the United States came together with nations
around the world to launch the Global Health Security Agenda (GHSA) as
a 5-year effort to accelerate action. On September 26, 2014, President
Obama met with leaders of 40 nations as well as top Administration
officials to advance progress in the GHSA.
CDC receives regular updates of morbidity and mortality to evaluate
the spread of the disease and combines this information with reports
from CDC's staff deployed to the area. Hundreds of CDC staff members
have provided logistics, staffing, communication, analytics,
management, and other support functions for the response. CDC continues
to commit significant staffing and financial resources to the
international Ebola response both on the ground in West Africa and
through its domestic EOC.
CDC has activated its EOC to help coordinate technical assistance
and control activities with partners. CDC supports countries in
establishing their own national and sub-national EOCs. Each of the
three West African countries at the center of the epidemic now has an
Incident Manager, reporting to the President of the country, to lead
efforts.
CDC continues to send additional public health experts to the
affected countries. CDC staff are assisting with setting up an
emergency response structure, contact tracing, providing advice on exit
screening and infection control at major airports, and providing
training and education in the affected countries.
The below mechanisms for coordination have been developed to direct
their support to the target population in West Africa. At the
international level, the United Nations has established its Mission for
Ebola Emergency Response (UNMEER) in Ghana, and is serving as a
regional hub for logistics and coordination of the U.N. Bodies
(including WHO, UNICEF, and others), while working closely with the
Governments of Guinea, Liberia and Sierra Leone.
WHO-AFRO has established a Regional Outbreak Coordination Center in
Conakry, Guinea.
Within countries, through their country offices, WHO is
coordinating support to the national operational plans. The United
States has established DARTs in each of the affected countries for
coordination of U.S. Government planning, operations, logistics,
administrative issues and other critical areas related to the U.S.
Government interagency response. These efforts are all done in direct
coordination with national governments, given that they have
responsibility for coordinating their respective national response
efforts.
Private sector resources also may be called upon to support lead
agencies and directly impacted areas. For the private sector, this
includes companies lending their core competencies and assets on the
ground as well as providing financial resources to support other
priorities. The private sector also can contribute by maintaining
operations in impacted countries/regions as they are an important part
of local economies.
Question 5. What is the ideal design for an international response
system for future outbreaks?
Answer 5. The International Health Regulations (IHR, 2005) provide
the legally binding framework for the coordination of the management of
events that may constitute a public health emergency of international
concern. IHR aims to improve the capacity of all countries to detect,
assess, notify, and respond to public health threats. While IHR was
signed by the 194 member states of the World Health Organization, fewer
than 20 percent of those countries reported in 2012 that they have
fully achieved compliance with IHR and are fully prepared to detect and
respond to disease threats. The aim of the Global Health Security
Agenda is to close this gap.
The Global Health Security Agenda (GHSA) is an effort by nations,
international organizations, and civil society to accelerate progress
toward a world safe and secure from infectious disease threats; to
promote global health security as an international priority; and to
spur progress toward full implementation IHR and other relevant global
health security frameworks.
Question 6. What is the ideal design for our national response
system for future international outbreaks?
Answer 6. CDC is fully supportive of the National Response
Framework (updated in 2013) and the National Incident Management System
(NIMS) outlined within it. The guiding principles of NIMS are: engaged
partnership; tiered response; scalable, flexible, and adaptable
operational capabilities; unity of effort through unified command; and
readiness to act.
The National Response Framework works best when State and local
health departments are fully staffed and well trained and have robust
surveillance and laboratory capacity. Strong clinical networks that
local health departments can link into for novel or unfamiliar global
infectious disease outbreaks and a stockpile of medical countermeasures
are also important as scalable resources. Another scalable resource
that is needed for international and domestic outbreaks is a cadre of
highly trained public health workers, including disease detectives,
capable and ready to respond. CDC supports these goals domestically
through the Public Health Emergency Response (PHEP) and Epidemiology
and Laboratory Capacity (ELC) cooperative agreements, the Strategic
National Stockpile (SNS), and support for the Laboratory Response
Network (LRN) as well as internationally through programs such as the
Field Epidemiology Training Program (FETP), Global Disease Detection
Centers, and the Global Health Security Agenda.
Question 7. How would long term investments to improve the basic
healthcare infrastructure of developing nations help to improve our
ability to respond to new outbreaks and epidemics?
Answer 7. Health care services are a part of every nation's public
health system, and they play a crucial role. There are linkages between
Global Health Security and health care services. The Global Health
Security Agenda takes a public health, or systems-level approach.
Through the Agenda, the United States commits to working with at least
30 partner countries (containing at least 4 billion people) to prevent,
detect and effectively respond to infectious disease threats, whether
naturally occurring or caused by accidental or intentional releases of
dangerous pathogens. The objectives of the agenda emphasize systems-
level interventions in the three areas: Prevent, Detect, and Respond.
Select activities include:
Prevent: Countries will have systems, policies and
procedures in place to prevent or mitigate avoidable outbreaks.
Detect: Countries will have real-time biosurveillance and
effective modern diagnostics in place that are able to reliably conduct
at least five of the 10 core tests.
Respond: Countries will have a public health EOC
functioning according to minimum common standards.
Investing in global health security means investing in public
health systems, and systems such as these provide critical information
needed to inform health care practice. For instance, reliable nation-
wide laboratory networks are needed for the detection of priority
pathogens. These same networks also are needed for the accurate
diagnosis of priority pathogens in individuals. In addition,
information gathered through public health surveillance can help inform
decisions about how limited healthcare resources could be targeted to
be most impactful.
Question 8. How are the United States and international aid
organizations helping to take care of health care needs besides Ebola
in the epidemic regions?
Answer 8. The U.S. Government is making investments in the region
to address multiple health issues such as HIV and AIDS, maternal and
child health, nutrition, malaria, and vaccine preventable diseases,
including polio. Relationships on the ground, nurtured in part by CDC's
work in the region have proven to be important assets in addressing the
current Ebola outbreak. CDC also continues to support priority
activities in the region as well.
The United States and international organization partners continue
to support the President's Malaria Initiative in the epidemic regions
ensuring that planned malaria prevention activities, such as long-
lasting insecticide treated bed net distributions, health indicator
surveys, and healthcare working trainings are minimally disrupted. CDC
is sending staff to support in-country national malaria control
programs while the Resident Advisors are engaged in the Ebola response.
Recently, CDC/WHO revised guidance for the diagnosis of malaria in
Ebola countries to respond to the needs of the healthcare workers and
partner organizations by recommending treatment options for specific
populations in the Ebola affected areas to reduce the incidence of
febrile illnesses.
CDC plays a critical role in helping Ministries of Health in
partner countries build strong, sustainable programs that respond
effectively to the HIV/AIDS epidemic. CDC provides support to more than
60 countries as a key partner in the U.S. President's Emergency Plan
for AIDS Relief (PEPFAR). CDC through PEPFAR, is working to achieve
that inspiring goal through proven science, smart investments, and
shared responsibility with partner countries.
CDC also is continuing immunization activities in the region. CDC
is working with partners at WHO and UNICEF to maintain high levels of
polio immunity there as part of the global effort to eradicate polio.
CDC also supports measles vaccination and related immunization
activities there. The worsening epidemic has slowed immunization
activities in Ebola affected areas; however, the networks established
by immunization activities are being used to provide education and
information about stopping the spread of Ebola.
In addition, CDC's expertise in responding to the polio epidemic in
Nigeria was leveraged to assist in establishing emergency response
operations in that country to stop the spread of Ebola. The threat to
Nigeria posed by the arrival in Lagos of a patient acutely ill with
Ebola was potentially enormous, but the virus does not appear to have
been widely spread there. The limited spread against the backdrop of
the large, dense, urban environment suggests early response efforts
were successful. CDC provided key guidance, and leadership, in a
variety of areas, including incident management, contact tracing,
public messaging and information, and port security to encourage a
quick and effective response.
senator alexander
Question 1. The United States has pledged support to help fight
Ebola, and there are other countries stepping up to the plate as well.
How are these efforts being coordinated and is it effective? Who is on
the flagpole?
Answer 1. Within the West Africa region affected by the Ebola
outbreak, USAID continues to lead the United States' overseas response,
while CDC, the Department of Defense, Department of State, and other
Federal Departments and Agencies are supporting the whole-of-government
approach to this national security priority. USAID has deployed a DART
to coordinate planning, operations, logistics and other components of
the interagency effort. CDC staff is working with Ministries of Health
to improve surveillance, contact tracing, laboratory capacity,
emergency operations planning and other critical capabilities.
HHS, and in particular CDC, is working closely with the World
Health Organization (WHO), the United Nations, the Ministries of Health
in affected countries, and other international partners to respond to
the current Ebola outbreak in West Africa. The Ebola epidemic reminds
us that our global efforts to build the capacity to prevent, detect,
and rapidly respond to infectious disease threats like EVD have never
been more vital. In February 2014, CDC came together with nations
around the world to launch the GHSA as a 5-year effort to accelerate
action. On September 26, 2014, President Obama met with leaders of 40
nations as well as top Administration officials to advance progress in
the GHSA.
CDC receives regular updates of morbidity and mortality to evaluate
the spread of the disease and combines this information with reports
from CDC's staff deployed to the area. Hundreds of CDC staff members
have provided logistics, staffing, communication, analytics,
management, and other support functions for the response. CDC continues
to commit significant staffing and financial resources to the
international Ebola response both on the ground in West Africa and
through its domestic EOC.
CDC has activated its EOC to help coordinate technical assistance
and control activities with partners. CDC supports countries in
establishing their own national and sub-national EOCs. Each of the
three West African countries at the center of the epidemic now has an
Incident Manager, reporting to the President of the country, to lead
efforts.
CDC continues to send additional public health experts to the
affected countries. CDC staff are assisting with setting up an
emergency response structure, contact tracing, providing advice on exit
screening and infection control at major airports, and providing
training and education in the affected countries.
Question 2. Dr. Frieden cautioned that, ``The window of opportunity
to stop Ebola from spreading widely through Africa and becoming a
global threat for years to come is closing, but it is not yet
closed.''Is that window still open? What do we need to be doing to keep
that window open?
Answer 2. CDC continues to increase our efforts, and strongly
encourage global partners, to ``keep the window open.'' The global
community still has an opportunity to reverse the course of the
epidemic in the three affected countries and prevent the spread of
Ebola to other countries in Africa and throughout the world, but
coordinated leadership and unwavering support must be brought to bear.
HHS, and in particular CDC, is working closely with the World Health
Organization (WHO), the United Nations, the Ministries of Health in
affected countries, and other international partners to respond to the
current Ebola outbreak in West Africa.
CDC continues to commit resources at never-before seen levels to
support the U.S. Government response to the Ebola outbreak. CDC has
activated its EOC to help coordinate technical assistance and control
activities with partners. CDC supports countries in establishing their
own national and sub-national EOCs. Each of the three West African
countries at the center of the epidemic now has an Incident Manager,
reporting to the President of the country, to lead response efforts.
CDC is also:
Providing hundreds of CDC staff members for logistics,
staffing, communication, analytics, management, and other support
functions for the response. CDC has deployed several teams of public
health experts to the West Africa region. CDC staff are deployed to
Guinea, Liberia, Nigeria, Senegal, and Sierra Leone to assist with
response efforts, including surveillance, contact tracing, data
management, laboratory testing, and health education. CDC staff are
assisting with setting up an emergency response structure, contact
tracing, providing advice on exit screening and infection control at
major airports, and providing training and education in the affected
countries. CDC experts have also been deployed to non-affected border
countries, including Cote d'Ivoire, to conduct assessments of Ebola
preparedness in those countries.
Working with airlines, airports, and ministries of health
in West Africa to provide technical assistance for developing exit
screening and travel restrictions in the countries where Ebola
outbreaks are occurring.
With CBP, conducting enhanced entry screening to detect
possible cases of Ebola in travelers who have traveled to the United
States from or through Guinea, Liberia, and Sierra Leone. Enhanced
entry screening at five U.S. airports (New York-JFK, Washington-Dulles,
Newark, Chicago-O'Hare, and Atlanta) will evaluate travelers from the
affected countries in West Africa.
Redoubling its efforts to educate U.S. healthcare workers
on how to isolate patients and how to protect themselves from
infection. Resources for U.S. healthcare workers are available on the
CDC website. Over the coming days and weeks, CDC will be working with
other Federal, State, and local governments and private organizations
to strengthen U.S. readiness for the detecting and preventing
additional cases of Ebola in this country. These efforts include the
aforementioned enhanced entry screening at five U.S. ports of entry and
enhanced outreach to healthcare workers and hospitals to improve their
infection control practices and policies.
Question 3. How is this outbreak testing the boundaries of what we
know? In what manner will we need to alter the response given the
different characteristics of this epidemic?
Answer 3. The epidemic is unprecedented in size, scope, and
complexity, but the fundamental risk factors and primary modes of
transmission are the same as in previous Ebola outbreaks. The core
public health interventions that have worked to stop previous Ebola
outbreaks--surveillance, case identification and contact tracing,
isolation and treatment, safe burials--will work to stop this epidemic.
CDC along with other parts of the U.S. Government and global partners
are working on multiple fronts to expand capacity to meet this
challenge.
Question 4. We know that there is desperate need for doctors and
nurses to care for people sick with Ebola. Estimates suggest a facility
treating 70 Ebola patients' needs a minimum of 250 health care staff,
but Liberia didn't even have that many doctors in its country even
before the outbreak. The United States Agency for International
Development has created a website where health professionals can sign
up to help with the Ebola response.
How are you coordinating with USAID? What are you doing to prepare
these volunteers? Please describe any training provided to these
volunteers.
Answer 4. Within the West Africa region affected by the Ebola
outbreak, USAID continues to lead the United States' overseas response,
while CDC, the Department of Defense, Department of State, and other
Federal Departments and Agencies are supporting the whole-of-government
approach to this national security priority. USAID deployed a DART to
coordinate planning, operations, logistics and other components of the
interagency effort. USAID is the lead Agency for recruiting and
coordinating volunteers for the response.
Humanitarian aid workers play a vital role in the Ebola outbreak
response, and CDC encourages them to continue the important work being
done to stop the disease's spread at its source. CDC developed guidance
for humanitarian aid organizations whose employees or volunteers are
working in countries where an Ebola outbreak is occurring to help them
plan for safe deployment. The recommendations include steps to take
before departure, during travel, and upon return to the United States.
CDC also created a Safety Training Course for healthcare workers
going to West Africa in response to the 2014 Ebola outbreak. The
primary purpose of the course is to ensure that clinicians intending to
provide medical care to patients with EVD have sufficient knowledge of
the disease and its transmission routes to work safely and efficiently
in a well-designed Ebola Treatment Unit (ETU). In addition, CDC
developed an introductory training course for licensed clinicians
(e.g., nurses, physicians, and other healthcare providers) intending to
work in an ETU in Africa to ensure that these clinicians have
sufficient knowledge of the disease and its transmission routes to work
safely and efficiently. The 3-day course is being given weekly and is
already full for the next few months.
Question 5. Since the hearing, we have had a patient land in the
United States one airplane ride away from a person who was exposed to
Ebola landing in the United States and becoming ill. What is the
Department of Health and Human Services doing to prepare?
There are four specialized medical isolation units in the United
States that have been reported to be available to treat Ebola patients.
Three of these have been used to treat the patients or exposed
individuals brought back to the United States. If these fill to
capacity and other individuals sick with Ebola are in need of care, how
prepared are our hospitals to take care of Ebola patients?
Answer 5. CDC has created plans outlining its course of action for
when a laboratory-confirmed Ebola diagnosis occurs in the United
States. The operational plans include assistance to State, tribal,
territorial and local officials and the domestic health care community,
and leverage CDC's expertise and resources in epidemiology,
surveillance, coordination of laboratory testing, health promotion and
communication, healthcare and infection control, traveler health and
screening.
CDC's response to a diagnosed case follows three key public health
tenets: prevention, detection and response. The concept of prevention
focuses on actions which can affect the spread of the disease.
Detection centers on activities to find the disease through
surveillance and contact tracing. CDC's response efforts include its
agency-wide incident management and response capabilities in support of
domestic requirements. CDC, along with other Federal agencies, has
created and implemented a response plan to manage a laboratory-
confirmed case of EVD in the United States and is providing guidance to
health care facilities about how to safely manage a patient with
suspected EVD. This includes engagement in the following activities:
Enhancing surveillance and laboratory testing capacity to
detect cases domestically.
Developing guidance and tools for health departments to
conduct public health investigations.
Providing recommendations for healthcare infection control
and other measures to prevent disease spread.
Providing guidance for flight crews, emergency medical
units at airports, and CBP officers about reporting ill travelers to
CDC.
Coordinating with maritime authorities to assess the
potential risk to the United States from cargo vessels from the four
affected West African countries.
Disseminating up-to-date information about the outbreak to
the general public, international travelers, and public health
partners.
CDC has developed guidance documents and checklists to help U.S.
hospitals prepare for, test, and treat patients with Ebola, and works
to keep the health care system informed of new developments. CDC uses
its Health Alert Network (HAN) to provide information and guidance to
U.S. healthcare workers and hospitals regarding EVD. A HAN notice was
distributed by CDC on August 1, 2014, and five updates have followed.
The most recent HAN notice about Ebola was distributed on October 2,
2014.
CDC has redoubled its efforts to educate American health care
workers about how to isolate patients and how to protect themselves
from infection, including developing and disseminating resources,
hosting informational calls, and creating trainings. CDC has:
Hosted Clinician Outreach and Community Activity calls for
clinical professionals to provide information about what U.S. hospitals
need to know to prepare for EVD.
Created guidance about EVD for clinicians in U.S. health
care settings.
Posted a Medscape Expert Commentary for healthcare
providers whose patients are travelers with concerns about Ebola. The
commentary includes information about the Ebola outbreak in West
Africa, the transmission of the Ebola virus, and how to talk to
travelers about their risk.
Created guidance for U.S. healthcare workers on
``Infection Prevention and Control Recommendations for Hospitalized
Patients with Known or Suspected Ebola Hemorrhagic Fever in U.S.
Hospitals.''
Developed a checklist for hospitals to aid in Ebola
preparedness, which can also be found on the CDC website.
Built a Safety Training Course for Healthcare Workers
Going to West Africa in Response to the 2014 Ebola Outbreak. The
primary purpose of the course is to ensure that clinicians intending to
provide medical care to patients with Ebola have sufficient knowledge
of the disease and its transmission routes to work safely and
efficiently in a well-designed ETU.
Collated the Top 10 Ebola Response Planning Tips: Ebola
Readiness Self-Assessment for State and Local Public Health Officials
to help guide planning and readiness for Ebola response at State and
local levels and assist health officials in assessing their
jurisdictions' level of readiness for a potential Ebola response.
CDC also is working with additional hospitals to ready their
facilities for additional patients with Ebola. Any U.S. hospital should
be prepared to identify, assess and isolate a patient with Ebola. CDC
developed guidance documents and checklists to help U.S. hospitals
prepare for, test, and treat patients with Ebola, and works to keep the
health care system informed of new developments. CDC uses its HAN to
provide information and guidance to U.S. healthcare workers and
hospitals regarding Ebola. CDC distributed a HAN notice August 1, 2014,
and five updates have followed. The most recent HAN notice about Ebola
was distributed on October 2, 2014.
CDC created plans outlining its course of action for when a
laboratory-confirmed Ebola diagnosis occurs in the United States. The
operational plans include assistance to State, tribal, territorial and
local officials and the domestic health care community, and leverage
CDC's expertise and resources in epidemiology, surveillance,
coordination of laboratory testing, health promotion and communication,
healthcare and infection control, traveler health and screening.
CDC's response to a diagnosed case follows three key public health
tenets: prevention, detection and response. The concept of prevention
focuses on actions which can affect the spread of the disease.
Detection centers on activities to find the disease through
surveillance and contact tracing. CDC's response efforts include its
agency-wide incident management and response capabilities in support of
domestic requirements.
senator alexander and senator burr
Question. You State in your testimony, ``We do not view Ebola as a
significant public health threat to the United States.'' Could you
please reconcile this statement with the fact that in 2006 then
Secretary of Homeland Security Michael Chertoff determined, pursuant to
Section 319F-2 of the Public Health Service Act that the Ebola virus
presents a material threat against the United States population
sufficient to affect national security, and that in August of this year
the Secretary used this determination to authorize emergency use of a
diagnostic for identification of Ebola virus.
Answer. The difference between the two statements is that the
former deals with the natural transmission of Ebola as a public health
concern, whereas the latter primarily has to do with Ebola's potential
for harm if artificially disseminated in a bioterrorist attack. In the
United States, while there may be secondary cases among contacts of an
imported Ebola case, the public health system will stop Ebola before an
outbreak occurs. From a public health perspective, we know how to
contain Ebola and we have the systems to do so. A DHS Material Threat
Determination is made based on the risk of a terrorist using Ebola as a
bio-weapon. DHS has determined that in certain scenarios the
intentional use of the Ebola virus as a weapon could affect national
security, even recognizing the public health system's ability to
control outbreaks. CDC is working closely with the Food and Drug
Administration (FDA) to approve Emergency Use Authorizations (EUAs)
that make available diagnostic and therapeutic medical devices to
diagnose and respond to public health emergencies, whether of natural
or deliberate origin. As a result, FDA has enacted several EUAs for
laboratory tests to aid in detecting the Ebola virus.
senator moran
Global Health Security
Question 1. Dr. Bell, the Administration requested a new Global
Health Security Initiative in fiscal year 2015. This Initiative would
strengthen the capacity to prevent the introduction and spread of
global health threats in 12 countries: Uganda, Vietnam, India, Kenya,
South Africa, Kazakhstan, Georgia, Thailand, Tanzania, Jordan,
Philippines, and Ethiopia. Given the need for this kind of program in
West Africa, would the list of 12 countries change given the Ebola
outbreak?
Answer 1. As part of the Ebola response, CDC is working to build
key components of the Global Health Security Agenda (GHSA), but the
scope and impact is much greater than just stopping the Ebola outbreak.
The vision of the Global Health Security Agenda is to create a world
safe and secure from global health threats posed by infectious
diseases--where we can prevent or mitigate the impact of naturally
occurring outbreaks and intentional or accidental releases of dangerous
pathogens, rapidly detect and transparently report outbreaks when they
occur, and employ an interconnected global network that can respond
effectively to limit the spread of infectious disease outbreaks in
humans and animals, mitigate human suffering and the loss of human
life, and reduce economic impact.
We want to be sure to increase country capacity throughout the
world so that another Ebola-like crisis can be averted. We don't know
where the next public health emergency will occur, so it is imperative
to assist as many countries as possible to be able to prevent, detect
and respond to emerging threats.
We are expanding our efforts in West Africa and exploring
opportunities to engage with Ministries of Health on GHSA once the
acute needs of the Ebola response are met.
Question 2. If so, which countries will receive funding in fiscal
year 2015 if the Global Health Security Initiative is funded?
Answer 2. The requested funding will reduce risks to Americans by
enhancing capacity for vulnerable countries to prevent disease
outbreaks, detect them early, and swiftly respond before they become
epidemics that threaten our national security. We will prioritize
urgently needed investments in vulnerable nations, transport hubs, and
States without the capacity to prevent global spread of Ebola or stem
the tide of future threats. It is important to maintain the flexibility
to make adjustments given the dynamic national and global health
security environment in these countries. We also expect that other key
donor partners will leverage this effort under the Global Health
Security Agenda to complement our funding.
Ebola Response Plan
Question 3. Dr. Bell, what is the plan for a U.S. Government
response? How do we help get the Ebola outbreak under control? Which
agency is in charge of the response efforts?
Answer 3. Public health knows how to stop the spread of
communicable diseases. To halt the spread of Ebola, the links of
transmission between people must be interrupted. Public health does
that by making sure that every person with Ebola is promptly diagnosed
and promptly isolated and that their contacts are identified and
actively monitored every day for 21 days. If any of the contacts
develop symptoms or fever, we follow the same process again. That is
how public health authorities have stopped every Ebola outbreak in
history except the one currently in West Africa.
HHS, and in particular CDC, is working closely with the World
Health Organization (WHO), the United Nations, the Ministries of Health
in affected countries, and other international partners to respond to
the current Ebola outbreak in West Africa. CDC receives regular updates
of morbidity and mortality to evaluate the spread of the disease and
combines this information with reports from CDC's staff deployed to the
area. Hundreds of CDC staff members have provided logistics, staffing,
communication, analytics, management, and other support functions for
the response. CDC continues to commit significant staffing and
financial resources to the international Ebola response both on the
ground in West Africa and through its domestic EOC.
CDC is working closely with U.S. Agency for International
Development (USAID) and its Office of Foreign Disaster Assistance
(OFDA) to support the deployment to Liberia of a DART, which is
overseeing the U.S. Government's Ebola response in West Africa.
CDC, in partnership with WHO's Global Outbreak Alert and Response
Network and the U.S. National Institutes of Health (NIH), provided a
field laboratory to Liberia to increase the number of specimens being
tested for Ebola. The lab is currently operating at full capacity and
is only the second site in Liberia capable of testing specimens from
patients with suspected Ebola. CDC has also deployed a second
laboratory in Sierra Leone.
CDC has activated its EOC to help coordinate technical assistance
and control activities with partners. On August 6, 14, CDC elevated the
EOC to a Level 1 activation, its highest level, because of the
significance of the outbreak. CDC supports countries in establishing
their own national and sub-national EOCs. Each of the three West
African countries at the center of the epidemic now has an Incident
Manager, reporting to the President of the country, to lead response
efforts.
Hundreds of CDC staff members have provided logistics, staffing,
communication, analytics, management, and other support functions for
the response. CDC has deployed several teams of public health experts
to the West Africa region. CDC staff are deployed to Guinea, Liberia,
Nigeria, Senegal, and Sierra Leone to assist with response efforts,
including surveillance, contact tracing, data management, laboratory
testing, and health education. CDC continues to send additional public
health experts to the affected and neighboring countries. CDC experts
have been deployed to non-affected border countries, including Cote
d'Ivoire, to conduct assessments of Ebola preparedness in those
countries.
Risk to Americans
Question 4. Dr. Bell, what is the risk of Ebola spreading from West
Africa to the United States?
Answer 4. In response to the case of Ebola in the United States,
teams from CDC are deployed to Dallas to assist with the investigation.
They are supported 24/7 by CDC's EOC and Ebola experts at CDC's Atlanta
headquarters. Teams work closely with State and local health
departments in finding, assessing, and assisting everyone who came into
contact with the Ebola patient. Although the risk spread of Ebola in
the United States is very low, CDC and partners are taking precautions
to isolate any cases of Ebola and prevent the spread of the disease.
CDC recognizes that even a single case of Ebola diagnosed in the United
States raises concerns and that when a case is imported into the United
States, secondary cases resulting from transmission from that case may
occur. CDC and partners are taking precautions to contain any cases of
Ebola and prevent the spread of the disease.
Every day, CDC works closely with partners at U.S. international
airports and other ports of entry to look for sick travelers with
possible contagious diseases. CDC has enhanced its outreach with DHS
and other partners at ports of entry (primarily international airports)
to use routine procedures for identifying and reporting travelers who
show signs of infectious disease. CDC and DHS are conducting enhanced
entry screening at five U.S. airports (New York's JFK International,
Washington-Dulles, Newark, Chicago-O'Hare, and Atlanta) for all U.S.-
bound air travelers who have been in Guinea, Liberia, or Sierra Leone.
CDC provides interim guidance for monitoring people potentially exposed
to Ebola and for evaluating their intended travel, including the
application of movement restrictions when indicated.
The virus is not transmitted easily, does not spread from people
who are asymptomatic, and the United States has effective infection
control measures in place to prevent the spread of the disease in the
United States. Medical and public health professionals across the
country have been preparing to respond, and any U.S. hospital should be
prepared to identify, assess and isolate a patient with Ebola.
senator cochran
Border Security and Ebola
Question 1. Dr. Bell, it is my understanding that the Centers for
Disease Control and Prevention is working closely with U.S. Customs and
Border Protection and other partners at our ports of entry,
particularly international airports, to identify travelers who show
signs of infectious disease. While this is an important step, I am
hopeful that we are also paying close attention to our land border as a
potential entry location. Can you specifically speak to the
contingencies that are being deployed in the event Ebola arrives from
our Nation's Southwest border?
Answer 1. We defer to the DHS with regard to contingencies at U.S.
borders. We do note that CDC and partners are taking precautions to
prevent the spread of Ebola to other countries. The U.S. Southwest
border is not a major route of entry for people coming from the
affected countries in West Africa. CDC has issued a Warning Level 3
(the highest level) travel notice for the three countries where the
Ebola outbreak is severe. U.S. citizens should avoid all nonessential
travel to Guinea, Liberia, and Sierra Leone. CDC is assisting with exit
screening and communication efforts in West Africa to prevent sick
travelers from boarding commercial planes, buses, trains, or ships. CDC
also has issued interim guidance about Ebola virus infection for
airline flight crews, cleaning personnel, and cargo personnel. This is
part of a layered approach that includes exit screening and standard
public health practices such as patient isolation and contact tracing
in countries with Ebola outbreaks. Successful containment of the recent
Ebola outbreaks in Nigeria and the Democratic Republic of Congo
demonstrate the effectiveness of this approach. Increasing awareness
and preparedness here in the United States to rapidly identify and
isolate potential Ebola patients and ensuring ready access to
diagnostic testing through the Laboratory Response Network are
additional components of this approach. Ultimately, the best way to
protect Americans from Ebola is to stop the outbreak in West Africa.
Response from International Community
Question 2. Thank you for coming in today to describe efforts by
the U.S. Government to respond to the Ebola outbreak in West Africa. I
am hopeful that the United States can play a leadership role in
addressing this humanitarian crisis, but I am also curious about the
contributions of international organizations and our partner nations.
Will you please describe efforts by the international community to stop
the Ebola epidemic?
Answer 2. Generating increased international support for the
response is a top priority for the U.S. Government. As the United
States expanded our response (scaling from 20 to over 100 personnel
from CDC, deploying the largest DART in USAID's history and then
establishing the Joint Force Command), agencies and departments have
been engaged in a steady campaign to mobilize contributions of
resources and personnel from other countries, including direct outreach
to international counterparts by principals.
Pressing other countries to increase their responses to the Ebola
epidemic has been a feature of nearly all bilateral engagements, and we
have also used the announcement of the Joint Task Force deployment on
September 16, 2014, the U.N. Security Council session hosted by the
United States on September 18, 2014, and the U.N. Secretary General's
High-Level Meeting on September 25, 2014, to mobilize increased
engagement and investment from other governments. The U.N. Secretary
General initiated the United Nations Mission for Ebola Emergency
Response (UNMEER), and the Mission was approved unanimously by the U.N.
General Assembly on September 18, 2014.
The Mission's overall aim is to reinforce government leadership and
for a rapid and coherent response focused on five strategic
priorities--stop the spread of the disease; treat the infected; ensure
essential services; preserve stability in affected communities; and
prevent the spread to neighboring countries and beyond. The immediate
focus is on getting treatment units built, staffing them, and tracing
contacts of those infected with Ebola to isolate and treat them if they
come down with the disease.
To date, more than 35 donor countries have contributed and pledged
upwards of $690 million to the response. Highlights include:
Following the announcement of the Joint Force Command, the
United Kingdom, which had previously committed to establish a hospital
in Sierra Leone to care for infected health workers, announced that it
will stand up 700 Ebola treatment beds in Sierra Leone and establish a
military command center there.
France has announced additional resources, and that it
will provide a hospital facility in Guinea.
Germany has pledged to build additional Ebola treatment
units, will provide C-160 transport aircraft to support the air bridge
in West Africa, and is mobilizing volunteers to support the response.
The World Bank has committed $400 million, and the African
Development Bank has committed $150 million.
The European Union has committed to providing $180 million
and to expanding its response effort.
The IMF Executive Board approved $130 million expansion of
zero-interest loans for the three affected West African nations.
South Africa has committed to build and staff an Ebola
treatment unit as well.
Others, including China, Cuba, India, Japan, Canada,
Sweden, Australia, Norway, Switzerland, South Korea, Thailand, Ghana,
Malaysia, Denmark, Spain, Ireland and the African Union, are providing
significant financial and in-kind support.
Ebola Protection and Control
Question 3. Do you believe the additional $88 million that has been
requested by the President to respond to this Ebola crisis will provide
you with the resources required to protect against the potential spread
of Ebola in the United States and to address needs abroad?
Answer 3. The Congress appropriated $30 million for CDC through the
continuing resolution. These resources will support CDC for period of
the continuing resolution, allowing us to ramp up efforts to contain
the spread of this virus. More than half of the funds are expected to
directly support staff, travel, security and related expenses. A
portion of the funds will be provided to the affected area to assist
with basic public health infrastructure, such as laboratory and
surveillance capacity, and improvements in outbreak management and
infection control. Should outbreaks recur in this region, they will
have the experience and capacity to respond without massive external
influx of aid, due to this investment.
The remaining funds will be used for other aspects of strengthening
the public health response such as laboratory supplies/equipment, and
other urgent needs to enable a rapid and flexible response to an
unprecedented global epidemic. CDC is working to identify our potential
resource needs for the rest of the fiscal year, and possibly further,
as we deal with this evolving public health emergency.
Capacity for Drugs or Vaccines
Question 4. Do you believe the capacity we have to approve,
produce, and distribute drugs and vaccines here in the United States is
sufficient to contain an infectious disease such as Ebola should it
make its way here to the United States?
Answer 4. The United States has the capacity to approve, produce,
and distribute drugs and vaccines in the United States for many
infectious diseases for which there are commercial products (e.g.,
pandemic influenza) to prevent or treat these diseases or there are
late-stage product candidates in the pipeline (e.g., H7N9 avian
influenza). However, we, like other industrialized countries, must
depend initially on a high quality healthcare system to provide
supportive care for infectious diseases where the drug and vaccine
development pipeline is comprised of very early stage product
candidates like Ebola or there are no candidates at all in the pipeline
like MERS-CoV; the domestic development and manufacturing
infrastructure established over the past 5 years (e.g., CIADMs) is
engaged and rapidly responding with the advanced development and
manufacturing of new experimental drugs and vaccines. This
infrastructure is being utilized today in the Ebola response by
transitioning early stage drug and vaccine candidates into advanced
development by conducting clinical trials and scaling up manufacturing
to commercial scale, leading to an accelerated availability of these
product candidates from several years to less than 1 year.
senator shelby
Auburn Canine Program
Question 1. Dr. Bell, today, canines are trained to detect
explosives, drugs, chemical changes in people with diabetes and
epilepsy, and even certain cancers quicker and more effectively than
any mechanism available to us. Researchers at Auburn University are
currently using decades of research and development in canine detection
to train dogs to instantly detect viruses like Ebola in the field.
While this research area is new, its foundation is based on decades of
research that has proven the canine nose to be one of the greatest
detection devices in the world. This would provide first responders and
medical professionals in the field a much more effective method to
detect a virus in a person or on materials and surfaces that could
spread the deadly virus. The possibilities are limitless in diagnoses,
triage, and containment. It would also establish a baseline capability
that would have applications across the spectrum of disease prevention.
Are you familiar with this concept and would this type of effort fit
within your purview and capability to support and fund?
Answer 1. Efforts of this kind are outside of CDC's scope of
responsibility and expertise; however, CDC is open to exploring
rigorously evaluated and proven innovations as they emerge from private
or public partners.
Components to a Response
Question 2. Dr. Bell, you have stated that there are 4 necessary
components to the Ebola response:
Case identification and prompt isolation and treatment of
patients;
Identify contacts, monitor them for 21 days, isolate if
they become sick, and identify and monitor their contacts;
Infection control in health care facilities; and
Safe burial practices.
How much of this has been occurring in the affected countries?
Answer 2. CDC is employing a variety of strategies in the affected
countries. The success of multiple approaches to halting an outbreak
has been borne out by Nigeria. Multiple partners are working in each of
the three affected countries to implement each component of the
response. Progress is being made, but significant challenges remain on
all fronts.
Question 3. In particular, how important and difficult is it to
perform adequate contact tracing in this region when many of the
citizens do not have regular access to phone and Internet?
Answer 3. Contact tracing is a challenge in the affected countries.
In some settings where the number of cases is very large or there are
security concerns, contact tracing is incomplete, but CDC teams and
partners continue to support contact tracing in most settings. CDC
teams in the affected countries report that cell phones are generally
not being used to reach people. Home visits are the most common method
of contact tracing.
Training American Health Workers for Ebola Care in West Africa
Question 4. Dr. Bell, the U.S. Government does not provide direct
care to Ebola patients in West Africa. With a significant deficit of
trained health workers to provide care in these countries, how is the
United States contributing to help address this issue?
Answer 4. CDC has taken several steps to provide training and
guidance to health care workers to respond to cases of Ebola. CDC has a
lead role in infection control training for health care workers and
safe patient triage throughout the health care system, communities, and
households in Liberia, Sierra Leone and Guinea. In addition, CDC
created a Safety Training Course for Healthcare Workers Going to West
Africa in Response to the 2014 Ebola Outbreak. The primary purpose of
the course is to ensure that clinicians intending to provide medical
care to patients with Ebola have sufficient knowledge of the disease
and its transmission routes to work safely and efficiently in a well-
designed Ebola Treatment Unit.
The U.S. Agency for International Development (USAID) is managing
the recruitment of health care workers interested in volunteering in
West Africa. More information about their efforts can be found on the
USAID website.
senator burr
Question 1. What are the current mortality rates associated with
the Ebola outbreak for each country in Africa with an Ebola outbreak?
How have these mortality rates changed since the outset of the outbreak
in each country? Have these countries experienced a change in the
mortality rates since additional support has been provided by the
international community? If so, how have these mortality rates changed
over the course of the outbreak?
Answer 1. CDC's ability to calculate case fatality rates is limited
by the available data. While CDC can calculate crude case fatality
rates from the data provided in the situation reports shared by Guinea,
Liberia, and Sierra Leone, these likely do not reflect the true case
fatality rates in each country because of limitations in reported data.
These limitations include unknown clinical outcomes as well as under-
reporting of both cases and deaths. Reporting differs across country,
resulting in differences in crude case fatality rates that are unlikely
to reflect true differences.
In Guinea, as of October_ 14, there are a reported 1,243 cases and
748 deaths, corresponding to a crude case fatality rate of 60.2
percent. In Liberia, as of October 4, 2014, there are a reported 3,929
cases and 2,210 deaths, corresponding to a crude case fatality rate of
56.2 percent. In Sierra Leone, as of October 6, 2014, there are a
reported 2,823 cases and 880 deaths, corresponding to a crude case
fatality rate of 31.1 percent.
In a report in the New England Journal of Medicine, the World
Health Organization authors reported a case fatality rate based on only
a subset of cases with a known clinical outcome. They report, ``This
analysis shows that by September 14, 2014, a total of 70.8 percent (95
percent confidence interval [CI], 68.6 to 72.8) of case patients with
definitive outcomes have died, and this rate was consistent among
Guinea, Liberia, and Sierra Leone.'' \4\ Because of the limitations of
the data, we are unable to report on the change in case fatality rates
over time. Observed changes over time in the crude case fatality
rates--like the reported differences between countries--are likely
artifacts of reporting.
---------------------------------------------------------------------------
\4\ WHO Ebola Response Team. Ebola Virus Disease in West Africa--
The First 9 Months of the Epidemic and Forward Projections. N Engl J
Med. 2014 Sep 22. [Epub ahead of print] PubMed PMID: 25244186.
Question 2. Will the United States' response to the current
outbreak, including the CDC, change if Ebola becomes endemic to West
Africa? If so, how will the current strategies to reduce the rate of
transmission, and ultimately break the chains of Ebola transmission,
change in the event the Ebola virus becomes endemic to West Africa?
Answer 2. Strategies to control Ebola and break transmission chains
will not change if Ebola transmission becomes more widespread in
Africa. However, the magnitude and complexity of the effort to reverse
the trend will be much greater, further stretching the limited
capacities of countries and the international community and making
success that much harder to achieve. Further, the risk of multiple
exportations of cases from affected countries will increase. It is for
these reasons that it is so critical to stop the outbreak in the three
currently affected countries.
Question 3. How would point of care rapid diagnostics change the
current trajectory of the Ebola outbreak? How would identifying an
infected individual before the onset of symptoms change the current
response strategy being deployed overseas in Africa? How quickly could
CDC deploy point of care rapid diagnostics in the field clinics in West
Africa should such diagnostic tools become available? Could this length
of time be further reduced, and if so, what steps need to be taken to
ensure that the time it would take to deploy and utilize such
diagnostics is as short as possible, including as part of either a
domestic or international response?
Answer 3. There is not currently an approved test that can
determine if a person is ill with Ebola before symptoms appear although
there are products under investigation. CDC is not aware of any that
have been approved by recognized governmental bodies comparable to FDA.
Rapid diagnostics allow for testing for Ebola in a non-laboratory
environment, such as in a health care facility. In health care
facilities, patients suspected to be ill with Ebola wait, often for
days, for symptoms to present; inevitably there are individuals that
are ill with Ebola as well as many individuals who have other diseases
with Ebola-like symptoms (e.g., malaria). While waiting in these areas,
the latter often become infected with Ebola from those that are
actually ill with the disease. Rapid tests would allow for a quicker
discernment of those very ill with Ebola in these waiting areas, thus
reducing the spread of Ebola to those who are not ill with the disease.
However, the current rapid tests in development require a high amount
of virus to be present in a person's blood, far more than the longer,
standard polymerase chain reaction tests require.
CDC is partnering with companies to review and assess experimental
new tests so that these technologies can be refined and produced
quickly in the United States, thereby streamlining the procurement
process and speeding deployment of new products to West Africa. The
deployment process from the United States to the outbreak region can be
undertaken as quickly as three to 5 days. However, transportation and
distribution in the affected countries remains a significant challenge.
Question 4. How will the distribution of Ebola medical
countermeasures, both vaccines and therapeutics, be prioritized when
they become available?
Answer 4. CDC would not be making a determination of prioritizing
investigational therapeutics; however, the Department of Health and
Human Services is in ongoing discussions with global partners such as
WHO on this issue.
No specific therapeutics for patients with EVD are approved.
Furthermore, CDC cannot influence the requests made by clinicians for
investigational new drugs or therapies for emergency or compassionate
use. To ensure efficacy and safety, controlled clinical trials need to
be implemented.
Several investigational Ebola vaccine candidates have been
developed. NIH has begun initial clinical studies to assess the safety
and immune response of a candidate vaccine to prevent EVD. The
Department of Defense (DoD) has also begun clinical studies for a
different candidate vaccine. In addition, two companies, Tekmira and
BioCryst Pharmaceuticals, received funding from the DoD to develop
potential drugs to treat Ebola. BioCryst, with NIH support, is working
to develop an antiviral drug to treat Ebola; the first phase of (human)
safety testing is expected to begin later this year.
Question 5. Please outline in detail how CDC is partnering with
USAID and DoD in the training and deployment of medical personnel for
the countries impacted by the current Ebola outbreak?
Answer 5. In response to this unprecedented humanitarian crisis,
CDC created a first-ever domestic Ebola Treatment Unit Safety Training
Course. This course provides both didactic as well as extensive hands-
on education regarding the multiple complex issues faced by care
providers when working in Ebola Treatment Units (ETUs). The course was
designed specifically for U.S. personnel deploying to provide care in
ETUs within West Africa. We have worked closely with the Department of
Defense to ensure that their personnel who require this training are
enrolled in this course. We have offered technical advice regarding the
Department of Defense's mission to establish an ETU safety training
course in-country and have shared CDC's ETU Safety Training course
curriculum materials. We have also hosted several discussions with DoD
regarding additional training coordination in Liberia. USAID has
established a website where persons interested in deploying to provide
care in ETU's may register. Links are provided on this website to the
registration page for the CDC ETU Safety Training Course.
Question 6. There have been media reports that U.S. health care
facilities that have provided treatment to patients infected with Ebola
in the United States have had difficulty in disposing of the medical
waste associated with this treatment. Please outline in detail how CDC
is working with individual health care facilities, and other Federal
and State partners, to resolve the issue of proper disposal of medical
waste associated with the treatment of Ebola patients in the United
States.
Answer 6. CDC, in collaboration with the U.S. Department of
Transportation (USDOT) and the Occupational Safety and Health
Administration (OSHA), have issued guidance on the disposal of medical
waste from patients with Ebola to help States and hospitals coordinate
for safe management of waste. Ebola-associated waste disposal is
subject to State and local regulations. Notably, Ebola-associated waste
that has been appropriately inactivated or incinerated is no longer
infectious.
Medical waste generated in the care of patients with known or
suspected EVD is subject to procedures set forth by local, State and
Federal regulations. Basic principles for spills of blood and other
potentially infectious materials are outlined in the OSHA Bloodborne
Pathogen standard, 29 CFR 1910.1030. Medical waste contaminated with
Ebola virus is a Category A infectious substance regulated as a
hazardous material under USDOT's Hazardous Materials Regulations (HMR;
49 CFR, Parts 171-180). The HMR apply to any material USDOT determines
is capable of posing an unreasonable risk to health, safety, and
property when transported in commerce. For offsite commercial transport
of Ebola-associated medical waste, strict compliance with the HMR is
required.
The inactivation or incineration of Ebola-associated medical waste
within a hospital system may be subject to State, local and OSHA
regulations.
Onsite inactivation
Ebola-associated medical waste can be inactivated
through the use of appropriate autoclaves. Other methods of
inactivation (e.g., chemical inactivation) have not been
standardized and would need to consider worker safety issues,
as well as the potential for triggering other Federal safety
regulations.
Onsite incineration
Ebola-associated medical waste can be incinerated. The
products of incineration are not infectious and can be
transported and disposed of in accordance with standard
protocols for hospital waste disposal.
Question 7. Who at the National Security Council is responsible for
coordinating the inter-agency response to the Ebola outbreak in West
Africa? Is this individual responsible for coordinating the inter-
agency response for domestic Ebola efforts as well? If not, who is?
Answer 7. The U.S. Government response to the Ebola epidemic in
West Africa is a whole-of-government effort that draws on the
capabilities and expertise of numerous government departments and
agencies. Similar to other crisis response and humanitarian emergencies
around the world, USAID leads and coordinates the U.S. response in the
field. Many agencies are working closely on domestic Ebola preparedness
and response, including HHS, CDC, and DHS, in coordination with the
Assistant to the President for Homeland Security and Counterterrorism.
senator kirk
Question 1. The CDC has determined that $30 million was needed for
additional response efforts. It is estimated that this outbreak could
last another 12-18 months. Will more assistance be needed or do you
anticipate the $30 million covering the next year and a half?
Answer 1. Congress appropriated $30 million for CDC through the
continuing resolution. These resources will support CDC for period of
the continuing resolution, allowing us to ramp up efforts to contain
the spread of this virus. More than half of the funds are expected to
directly support staff, travel, security and related expenses. A
portion of the funds will be provided to the affected area to assist
with basic public health infrastructure, such as laboratory and
surveillance capacity, and improvements in outbreak management and
infection control. The remaining funds will be used for other aspects
of strengthening the public health response such as laboratory
supplies/equipment and other urgent needs to enable a rapid and
flexible response to an unprecedented global epidemic. CDC is working
to identify our potential resource needs for the rest of the fiscal
year, and possibly further, as we deal with this evolving public health
emergency.
Question 2. With all the different agencies involved, which one is
leading the efforts against Ebola? What coordinated efforts are
happening between the agencies? What are other nations doing to
contribute?
Answer 2. Within the West Africa region affected by the Ebola
outbreak, USAID continues to lead the United States' overseas response,
while CDC, the Department of Defense, Department of State, and other
Federal Departments and Agencies are supporting the whole-of-government
approach to this national security priority. USAID has deployed a DART
to coordinate planning, operations, logistics and other components of
the interagency effort. CDC staff is working with Ministries of Health
to improve surveillance, contact tracing, laboratory capacity,
emergency operations planning and other critical capabilities.
HHS, and in particular CDC, is working closely with the World
Health Organization (WHO), the United Nations, the Ministries of Health
in affected countries, and other international partners to respond to
the current Ebola outbreak in West Africa. The Ebola epidemic reminds
us that our global efforts to build the capacity to prevent, detect,
and rapidly respond to infectious disease threats like EVD have never
been more vital. In February 2014, CDC came together with nations
around the world to launch the GHSA as a 5-year effort to accelerate
action. On September 26, 2014, President Obama met with leaders of 40
nations as well as top Administration officials to advance progress in
the GHSA.
CDC receives regular updates of morbidity and mortality to evaluate
the spread of the disease and combines this information with reports
from CDC's staff deployed to the area. Hundreds of CDC staff members
have provided logistics, staffing, communication, analytics,
management, and other support functions for the response. CDC continues
to commit significant staffing and financial resources to the
international Ebola response both on the ground in West Africa and
through its domestic EOC.
CDC has activated its EOC to help coordinate technical assistance
and control activities with partners. CDC supports countries in
establishing their own national and sub-national EOCs. Each of the
three West African countries at the center of the epidemic now has an
Incident Manager, reporting to the President of the country, to lead
efforts.
To date, more than 35 donor countries have contributed and pledged
upwards of $690 million to the response. Highlights include:
Following the announcement of the Joint Force Command, the
United Kingdom, which had previously committed to establish a hospital
in Sierra Leone to care for infected health workers, announced that it
will stand up 700 Ebola treatment beds in Sierra Leone and establish a
military command center there.
France has announced additional resources and that it will
provide a hospital facility in Guinea.
Germany has pledged to build additional Ebola treatment
units, will provide C-160 transport aircraft to support the air bridge
in West Africa, and is mobilizing volunteers to support the response.
The World Bank has committed $400 million and the African
Development Bank has committed $150 million.
The European Union has committed to providing $180 million
and to expanding its response effort.
The IMF Executive Board approved $130 million expansion of
zero-interest loans for the three affected West African nations.
South Africa has committed to build and staff an Ebola
Treatment Unit as well.
Others, including China, Cuba, India, Japan, Canada,
Sweden, Australia, Norway, Switzerland, South Korea, Thailand, Ghana,
Malaysia, Denmark, Spain, Ireland and the African Union, are providing
significant financial and in-kind support.
senator enzi
Question 1. In previous communications with CDC, it was indicated
that there are only a few facilities specially equipped to deal with
highly contagious diseases, such as Emory University Hospital in
Atlanta. What will be the policy for treatment of patients diagnosed
within the United States? Will they be transported to these facilities
or cared for onsite or in other designated facilities?
Answer 1. CDC is working with additional hospitals to ready their
facilities for additional patients with Ebola. Any U.S. hospital should
be prepared to identify, assess and isolate a patient with Ebola. CDC
developed guidance documents and checklists to help U.S. hospitals
prepare for, test, and treat patients with Ebola, and works to keep the
health care system informed of new developments. CDC uses its Health
Alert Network (HAN) to provide information and guidance to U.S.
healthcare workers and hospitals regarding Ebola. CDC distributed a HAN
notice August 1, 2014, and five updates have followed. The most recent
HAN notice about Ebola was distributed on October 2, 2014.
CDC created plans outlining its course of action for when a
laboratory-confirmed Ebola diagnosis occurs in the United States. The
operational plans include assistance to State, tribal, territorial and
local officials and the domestic health care community, and leverage
CDC's expertise and resources in epidemiology, surveillance,
coordination of laboratory testing, health promotion and communication,
healthcare and infection control, traveler health and screening.
CDC's response to a diagnosed case follows three key public health
tenants--prevention, detection and response. The concept of prevention
focuses on actions which can affect the spread of the disease.
Detection centers on activities to find the disease through
surveillance and contact tracing. CDC's response efforts include its
agency-wide incident management and response capabilities in support of
domestic requirements.
CDC has redoubled its efforts to educate American health care
workers about how to isolate patients and how to protect themselves
from infection, including developing and disseminating resources,
hosting informational calls, and creating trainings. CDC has:
Hosted Clinician Outreach and Community Activity calls for
clinical professionals to provide information about what U.S. hospitals
need to know to prepare for Ebola.
Created guidance about Ebola for clinicians in U.S. health
care settings.
Posted a Medscape Expert Commentary for healthcare
providers whose patients are travelers with concerns about Ebola. The
commentary includes information about the Ebola outbreak in West
Africa, the transmission Ebola virus, and how to talk to travelers
about their risk.
Created guidance for U.S. healthcare workers on
``Infection Prevention and Control Recommendations for Hospitalized
Patients with Known or Suspected Ebola Hemorrhagic Fever in U.S.
Hospitals.''
Developed a checklist for hospitals to aid in Ebola
preparedness, which can be found on the CDC website.
Built a Safety Training Course for Healthcare Workers
Going to West Africa in Response to the 2014 Ebola Outbreak. The
primary purpose of the course is to ensure that clinicians intending to
provide medical care to patients with Ebola have sufficient knowledge
of the disease and its transmission routes to work safely and
efficiently in a well-designed Ebola Treatment Unit (ETU).
Collated the Top 10 Ebola Response Planning Tips: Ebola
Readiness Self-Assessment for State and Local Public Health Officials
to help guide planning and readiness for Ebola response at State and
local levels and assist health officials in assessing their
jurisdictions' level of readiness for a potential Ebola response.
Question 2. What steps are being taken by CDC to ensure adequate
coordination across agencies to, identify any new cases of Ebola
quickly, facilitate treatment, and to contain any spread of the
disease? Please identify all of the agencies involved, the departments
that are working on them, the steps taken to ensure coordination, and
the plans for updating Congress on the activities.
Question 3. Since the beginning of the Ebola outbreak in West
Africa, the CDC continually indicated a low probability of a case
occurring in the United States. What are the CDC screening and
monitoring processes for travelers who are likely to come into contact
with the Ebola virus? Please identify the specific steps involved,
coordinating agencies, and the data used to make claims of the low
probability of occurrence in the United States.
Answer 2 and 3. Although the risk of an Ebola outbreak in the
United States is very low, HHS and its sister Departments are taking
steps to protect Americans from the Ebola virus. To ensure the United
States is prepared to respond to an Ebola epidemic, the CDC has
detailed response plans in place for once an Ebola case is confirmed to
respond to Ebola cases in the United States. The plans include:
instructions to rapidly disseminate information about the Ebola case(s)
to key public health, health care system, and emergency management
partner organizations; providing current information to State, local,
and territorial public health departments; and coordinating critical
issues management regarding State and local needs for the CDC EOC
incident manager and other response task force teams. CDC has also
developed a web-based document, for use in State and local planning
that identifies rapidly emerging CDC guidelines for public health
preparedness national standards regarding Ebola.
Additional CDC efforts include:
Preparing providers, hospitals, State and local health
departments and others involved in public health preparedness and
response for the possibility of an Ebola case in the United States,
including guidance documents on the identification and treatment of an
Ebola patient, infection control guidelines, laboratory testing and
other recommendations necessary to protect U.S. health care workers and
the general public. Over the coming days and weeks, CDC will be working
with other Federal, State, and local governments and private
organizations to strengthen U.S. readiness for detecting and preventing
additional cases of Ebola in this country. These efforts include the
entry screening at U.S. ports of entry and enhanced outreach to
healthcare workers and hospitals to improve their infection control
practices and policies.
Providing funding and assistance to State and local health
departments for all-hazards preparedness, including an infectious
disease outbreak. This funding and assistance helps public health
departments develop capabilities that are applicable to responding to
many public health threats.
Developing guidance for laboratory technicians and other
health care personnel who collect or handle specimens in the United
States.
Working closely with DHS's CBP and other partners at U.S.
ports of entry to conduct enhanced entry screening to identify
travelers who show signs of infectious disease. CBP is conducting entry
screening at five U.S. airports (New York-JFK, Washington-Dulles,
Newark, Chicago-O'Hare, and Atlanta), that receive 94 percent of
travelers from the Ebola-affected nations of Guinea, Liberia, and
Sierra Leone, as of October 11, 2014. If a potentially sick traveler is
identified during or after a flight, the traveler will be immediately
isolated, and CDC will conduct an investigation and work with the
airline, Federal partners, and State and local health departments to
notify them and take any necessary public health action. Entry
screening is part of a layered process that includes exit screening and
standard public health practices, such as patient isolation and contact
tracing in countries with Ebola outbreaks. Successful containment of
the recent Ebola outbreaks in Nigeria and the Democratic Republic of
Congo demonstrate the effectiveness of this approach.
Assisting with exit screening and communication efforts in
West Africa to prevent sick travelers from boarding commercial planes,
buses, trains, or ships. CDC also has issued interim guidance about
Ebola virus infection for airline flight crews, cleaning personnel, and
cargo personnel.
In addition to CDC's efforts relating to prevention, detection, and
response, FDA is investigating what types of medical products could be
used to address the Ebola epidemic in West Africa and in the United
States. Currently, there are no treatments or vaccines that have been
shown to be safe or effective against the Ebola virus, and products
currently under development are in the very early stages of
investigation. FDA is using its regulatory mechanisms to enable access
to investigational medical products to facilitate appropriate access to
investigational Ebola medical products under an appropriate regulatory
mechanism to support preparedness and response efforts to help protect
people of the United States from the Ebola virus.
Additionally, under the FDA's Emergency Use Authorization (EUA)
authority, FDA can allow the use of an unapproved medical product--or
an unapproved use of an approved medical product--for a larger
population during certain types of emergencies, when, in addition to
other factors, there is no adequate, approved, and available
alternative. FDA has authorized the use of an Ebola diagnostic test,
developed by DoD, under an EUA to detect the Ebola virus in
laboratories designated by DoD. This test has been made available to 14
laboratories within the United States to support the rapid diagnosis of
any suspected cases of Ebola infection and to monitor patients already
infected with the Ebola virus. These sites are located close to ports-
of-entry where travelers from West Africa frequently arrive in the
United States or in locations where infected U.S. patients are
currently being treated. In addition, FDA has issued EUAs authorizing
the use of Ebola diagnostic tests developed by CDC and is working with
U.S. and non-U.S. commercial diagnostic test developers to clarify EUA
regulatory requirements and provide support in order to increase the
supply of available diagnostic tests for Ebola infection in the United
States and West Africa.
NIH and Biomedical Advanced Research and Development Authority
(BARDA), along with DoD, are supporting the development and
manufacturing of early stage Ebola vaccine and therapeutic candidates.
Key animal challenge efficacy studies and human safety and
immunogenicity studies are or will be underway in the United States and
other countries for several of these candidates. The results of these
initial human safety studies will inform expanded clinical studies in
affected African countries early next year. Scaled up manufacturing of
several of these product candidates has started as well to achieve
commercial scale manufacturing capacity next year.
Response by Anthony S. Fauci, M.D. and Robin A. Robinson, Ph.D. to
Questions of Senator Casey, Senator Bennet, Senator Whitehouse, Senator
Baldwin, Senator Warren, Senator Alexander, Senator Moran, Senator
Shelby, Senator Cochran, Senator Burr, and Senator Kirk \1\
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\1\ Note: Content accurate as of October 15, 2014. Responses do not
reflect enactment of the $238 million for NIH in emergency funding to
support clinical trials in response to the Ebola Epidemic.
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senator casey
Question. In addition to vaccines and treatments that are specific
to Ebola, are there any broad antiviral products being considered for
development, that could be used against either Ebola or other known
novel viruses?
Answer. Guided by our Strategic Plan and priorities, the National
Institute of Allergy and Infectious Diseases (NIAID) supports the
fundamental research needed to better understand infectious agents in
order to develop broad-spectrum antibiotics and antivirals--drugs that
can prevent or treat diseases caused by multiple types of bacteria or
viruses. In addition, NIAID has intensified its efforts to develop new
technologies that can be broadly applied to more efficiently develop
diagnostics and vaccines against a wide variety of infectious agents,
including pandemic influenza viruses, methicillin-resistant
Staphylococcus aureus (MRSA),
extensively drug-resistant Mycobacterium tuberculosis, dengue,
chikungunya, and filoviruses such as Ebola.
NIAID is funding BioCryst Pharmaceuticals to develop and test
BCX4430, a novel drug with broad-spectrum antiviral activity including
against Ebola viruses. To date, BCX4430 has shown some activity in
animal infection models for Ebola and Marburg viruses. A Phase I trial
is expected to begin in late 2014 or early 2015. NIAID is also funding
in vivo studies of brincidofovir, a broad-spectrum antiviral developed
by Chimerix, Inc., for use against other viral diseases, including
smallpox. In addition, NIAID offers in vitro testing as part of its
suite of preclinical research services available to the scientific
community and private industry to test products for antiviral activity
against Ebola viruses. NIAID is using this screening program to assist
investigators who have antiviral candidates that may be effective
against Ebola viruses.
Intramural scientists at NIAID's Rocky Mountain Laboratories (RML)
in Hamilton, MT, are working on therapeutics that might be effective
against all hemorrhagic fever viruses including the filoviruses Ebola
and Marburg and the arenavirus Lassa. Ribavirin, a drug currently used
to treat hemorrhagic fever viruses such as Lassa virus, is being
examined for its potential use in combination therapy to treat Ebola
virus infection. NIAID intramural scientists are investigating broad
antiviral therapies that target host cell proteins essential to viral
replication. One such antiviral currently being evaluated for hepatitis
C treatment has shown activity against Ebola virus in vitro and will be
further assessed. NIAID scientists also have screened a small
collection of broad-spectrum antivirals that are in development against
influenza and other RNA viruses; this screening has generated two
potential lead compounds for further evaluation.
NIAID's pursuit of broad-spectrum therapies effective against
entire classes of pathogens aims to maximize the investment in research
on emerging and re-emerging infectious diseases. NIAID will continue to
pursue broad-spectrum antiviral drugs for use against a variety of
viruses including Ebola virus.
Senator Bennet
Question 1. There are many charities and volunteers here that want
to help end this outbreak and care deeply about the outcome. For
example, in my home State, the Centennial-based Project CURE has been
working with local volunteers and high schools, like Valor Christian
High School in Highlands Ranch, to send medical supplies to West
Africa. They have already sent 4 large containers of supplies for
medical workers there. They want to know that their government is
showing a coordinated response to this effort, and that their work will
not be in vain. Can you give them and other volunteers across the
country some peace of mind that their work is helping and you all are
doing everything you can to coordinate an effective response to this
outbreak?
Answer 1. NIAID defers to other witnesses.
Question 2. Given the emergence of Ebola as a significant public
health threat--and the level of funds understandably being allocated in
response--I am concerned about our ability to respond to other
emergencies, such as pandemic influenza, which are far more common
threats. In particular, I'm concerned that we are jumping from crisis
to crisis and failing to adequately budget for rapid response
capabilities to public health pandemics, like Ebola, pandemic
influenza, and MERS. Just earlier this month, for instance, a DHS OIG
report highlighted that our pandemic influenza stockpiles have not been
effectively managed, and I'm concerned that we may be falling behind on
these other types of preparedness issues. How are you assuring that we
are adequately prepared and not compromising our ability to rapidly
respond to address other public health crises, like pandemic influenza,
in addition to emerging threats like Ebola?
Answer 2. NIAID has a dual mandate that balances research on
current biomedical challenges with the capacity to respond quickly to
emerging and re-emerging infectious threats. Since the 2001 anthrax
attacks, with the support of the Congress, NIAID has vastly expanded
its research portfolio in biodefense and naturally emerging and re-
emerging infectious diseases, focusing its efforts on pathogens that
pose high risks to public health and national security, including
pandemic influenza, MRSA, Mycobacterium tuberculosis, dengue,
chikungunya, and filoviruses such as Ebola.
To improve our preparedness for numerous infectious threats,
whether naturally occurring or deliberately introduced, NIAID has
adopted a flexible strategy to encourage the development of broad
spectrum therapeutics effective against whole classes of pathogens. To
encourage this process, NIAID ``de-risks'' the development of new and
improved therapeutics by providing early stage research resources to
academia, biotechnology firms, and industry. For example, NIAID offers
in vitro and in vivo screening and evaluation of candidate
countermeasures against a broad array of infectious pathogens including
bacteria, fungi, viruses, and parasites. These preclinical research
services, coupled with NIAID's strong support for basic and applied
research, have enhanced our ability to ultimately address a variety of
global infectious disease threats.
NIAID research includes the development of new and improved
vaccines against a variety of infectious disease threats to global
public health. As part of this effort, the NIAID Vaccine Research
Center (VRC) is pursuing design strategies to facilitate the
development of vaccines for emerging public health threats such as
Middle East Respiratory Syndrome (MERS), chikungunya, pandemic
influenza, and Ebola viruses. The VRC is currently applying the results
of its longstanding preclinical vaccine research program to accelerate
clinical studies of a chimpanzee adenovirus-based Ebola vaccine
candidate developed in collaboration with GlaxoSmithKline. Phase I
clinical studies of this vaccine are ongoing at the National Institutes
of Health Clinical Center, and additional studies are planned for sites
around the world.
In response to the public health threats posed by seasonal and
pandemic influenza, NIAID VRC and extramural researchers are engaged in
a broad range of basic and applied research on influenza virus. NIAID
is supporting research and development of new therapies, diagnostics,
and vaccines for both seasonal and pandemic influenza strains. For
example, during the 2009 H1N1 influenza pandemic, VRC researchers
utilized advanced genetic sequencing and gene-based vaccine technology
platforms to develop and test an experimental 2009 pandemic H1N1
influenza vaccine within 4 months. In addition, NIAID-supported
clinical research units quickly determined the safe and effective doses
of the 2009 H1N1 influenza vaccine for the elderly, children with
asthma, and individuals with compromised immune systems.
The development of a ``universal'' influenza vaccine is a key goal
of the NIAID infectious diseases research program. A ``universal''
influenza vaccine would induce a potent immune response to the common
elements of the influenza virus that undergo few changes from season to
season and from strain to strain. Such a vaccine could protect against
multiple strains of the virus over several years and help provide
protection in the event of an influenza pandemic. NIAID VRC and
extramural researchers are working with the conserved stem region of
influenza proteins to stimulate broader, more universal protection
against multiple influenza strains and to develop nanoparticle vaccine
platforms to improve the potency and breadth of influenza protection.
NIAID remains committed to fulfilling its dual mandate to balance
research on infectious and immune-related diseases with the capability
to mobilize a rapid response to newly emerging and re-emerging
infectious diseases.
senator whitehouse
Question. The severity of the current Ebola outbreak has led to the
use of still-experimental treatments, such as ZMapp--which Dr. Brantly
received. How can we encourage the development of treatments and
vaccines that treat incredibly deadly, but rare diseases, like Ebola?
How have our Federal health care agencies, including NIH, CDC, and FDA,
coordinated to help expand access to experimental treatments in a safe
and ethical way?
Answer. The 2001 anthrax attacks underscored the importance of a
national strategy for the development of medical countermeasures to
combat deadly infectious disease threats, whether man-made or naturally
occurring. Since that time, NIAID has greatly accelerated its
biodefense research program to rapidly respond to known and possible
future threats. NIAID supports basic research, identification of drug
and vaccine targets, preclinical testing, and clinical trials in order
to move candidate medical countermeasures along the product development
pipeline. Critical to this effort are NIAID's public-private
partnerships with organizations including non-profits, academic
institutions, and biotechnology and pharmaceutical companies.
Equally important to the development of medical countermeasures for
deadly diseases such as anthrax, smallpox, and Ebola virus disease, is
NIAID's collaboration with Federal agencies such as the Centers for
Disease Control and Prevention, the Food and Drug Administration (FDA),
the Biomedical Advanced Research and Development Authority (BARDA), and
the Department of Defense (DoD). For example, NIAID coordinates with
its partners through the Public Health Emergency Medical
Countermeasures Enterprise to ensure that the results of NIAID-
supported research can be translated rapidly into safe and effective
medical countermeasures. In particular, NIAID transitions the advanced
research and development of high-priority medical countermeasures to
BARDA, with the goal of FDA approval, licensure, clearance, or
emergency use authorization and, if appropriate, possible inclusion in
the Strategic National Stockpile.
Efforts to date have included early stage development of a smallpox
vaccine candidate and two smallpox drug candidates to complement the
vaccines that currently exist, as well as anthrax vaccine and
therapeutic candidates.
In response to the current Ebola outbreak in West Africa, the NIAID
Vaccine Research Center (VRC) worked closely with FDA colleagues to
expeditiously move CAd3, an Ebola candidate vaccine developed by the
NIAID VRC and GlaxoSmithKline, into clinical studies while still
maintaining rigorous safety, ethical, and regulatory standards.
Proactive communication and partnership enabled FDA to review VRC's
Investigational New Drug (IND) application in less than 1 week, leading
to acceleration of the clinical study start date. Ongoing discussions
among NIAID VRC, BARDA, and industry partner GlaxoSmithKline will
accelerate development of CAd3 through additional vaccine manufacturing
and clinical trials to further determine safety and immune response. In
addition, the NIAID VRC is collaborating with the DoD Walter Reed Army
Institute of Research on plans to evaluate safety and immunogenicity of
the candidate vaccine in healthy adults in Uganda.
NIAID will continue its longstanding investment in research to
develop tools to prevent, diagnose, treat, and control deadly diseases
such as Ebola. To effectively bring a concept from the earliest stages
of basic research to a finished product requires that we rigorously
evaluate safety and efficacy along the product development pipeline and
leverage public-private partnerships between academia, non-profit
organizations, private industry, and government agencies around the
world.
senator baldwin
Question 1. Dr. Fauci, one of your NIH colleagues and an Ebola
expert recently argued that scientists must share data, like diagnosis
and detection data, with their colleagues in real-time to improve the
public health response to the Ebola outbreak. Can you please explain
why this is so critical, what is NIH's role in this data exchange, and
how similar information sharing has helped address prior outbreaks like
influenza and SARS?
Answer 1. The National Institutes of Health (NIH) has a
longstanding commitment to make scientific data publicly available in a
timely manner. This was exemplified by the Human Genome Project, an
international research project that required rapid and comprehensive
data release during its mapping and sequencing of the full human
genome. Recently, NIH has expanded this commitment to sharing important
genomic data by implementing a policy requiring NIH-funded large scale
genome projects to include data sharing plans. For the past 10 years,
NIAID has endorsed this commitment, and contributes to several publicly
accessible and searchable international data bases, such as NIH's
GenBank, a collection of all publicly available DNA sequences.
Publicly released data, including datasets generated and released
by NIAID, serve as critical resources for scientists around the world,
and are essential to enable the advancement of research and
surveillance of infectious diseases. For example, in early April 2009,
a novel influenza virus was isolated from a patient in California; by
the end of April 2009, the genome of the H1N1 influenza virus was
sequenced and the data released into the public domain. The genetic
characterization of this virus revealed that it was a novel strain,
gave clues to its drug sensitivity and resistance, and was instrumental
in production of effective diagnostics and vaccines used in the
subsequent 2009 H1N1 influenza pandemic. Ongoing NIAID sequencing
efforts and resources seek to provide additional information about the
Ebola virus strain currently circulating in West Africa. This
information, shared in real-time, can help researchers to understand
how the virus is transmitted and causes disease, as well as guide
strategies for developing new therapeutics, vaccines, and diagnostics.
Although there is no rapid, point-of-care diagnostic test for Ebola
virus currently available, real-time data sharing is an increasingly
important aspect of collaborative research and could critically
influence both patient care and epidemic management of the current
Ebola virus outbreak. The ability to rapidly and accurately detect and
report the presence of Ebola virus in blood samples would allow
healthcare providers to more quickly isolate and care for patients with
Ebola virus disease. Importantly, rapid diagnosis and reporting would
also help to identify patients who have symptoms consistent with Ebola
virus disease but actually have a disease caused by another pathogen.
Upon testing negative for Ebola, these patients could minimize their
contact with Ebola patients and be given appropriate treatment for
their disease. In addition, real-time data sharing is critical to
guiding the public health response because it allows for a more
accurate understanding of sources of infection, new outbreak locations,
and the scope and rate of transmission. Rapid data sharing is also
important for assessing the utility of diagnostic tests and the
significance of viral gene mutations. Established diagnostic assays
that detect specific gene sequences of a virus may not be as effective
in detecting viruses with genetic variants. Real-time generation and
sharing of genetic sequence data, including mutations, is crucial to
ensuring these molecular diagnostic tests remain valid.
Question 2. Dr. Fauci, in the absence of an approved therapeutic
treatment for Ebola, can you please discuss the importance of highly
effective and efficient diagnostics in controlling this outbreak, and
what steps we are taking to develop and implement such tools? In
August, the FDA authorized the emergency use of a diagnostic test
developed by the Department of Defense in the affected region. Can you
provide an update on how this test is working and being used on the
ground?
Answer 2. Accurate and accessible diagnostics for Ebola virus
infection are needed for the rapid identification and treatment of
patients in the current Ebola outbreak because the symptoms of Ebola
can be easily mistaken for other common causes of fever in West Africa,
such as malaria. Point-of-care, or onsite, Ebola virus diagnostics are
particularly valuable as they allow caregivers to quickly identify
infected patients in order to isolate them and minimize additional
exposures to the virus.
NIAID provides resources for investigators developing Ebola
diagnostics. With NIAID support, Corgenix Medical Corporation is
developing rapid immunodiagnostics for Ebola virus using genomic
technology to produce recombinant viral proteins. NIAID is advancing
development of additional diagnostics, including those using novel
technologies such as microfluidics, optofluidics and nanophotonics,
which are capable of detecting multiple viruses including Ebola. Such
innovative approaches can provide information critical to the creation
of point-of-care diagnostics that could be distributed and used in
areas where Ebola virus outbreaks occur. In addition, intramural
scientists from NIAID's Rocky Mountain Laboratories in Hamilton, MT,
and NIAID's Integrated Research Facility in Frederick, MD, have
responded to the ongoing epidemic in West Africa by providing technical
diagnostic support on the ground in Liberia.
NIAID defers to CDC regarding the emergency use of diagnostics in
West Africa.
Question 3. The President recently outlined a comprehensive
response to combat this epidemic that includes the efforts of an
estimated 3,000 U.S. forces and a strong partnership with the United
Nations and our other international partners. The first cases of Ebola
were reported in March; it is now October and the Ebola crisis is only
worsening. Why did we not initiate this response in March? In
hindsight, what should have been the United States' first action item
when cases were first reported, and what can we learn from this to
prevent the world from seeing such tragedy again?
Answer 3. NIAID defers to other witnesses.
senator warren
Question 1. Fighting epidemics in developing countries presents
unique challenges. Despite all the attention that's being paid to the
Ebola outbreak, serious health problems have gripped these countries
for years. In Liberia, for example, 17 percent of deaths are due to
Malaria, and Sierra Leone has one of highest rates of infant and
maternal mortality in the world. Countries currently dealing with Ebola
have a poor healthcare infrastructure and very few healthcare workers--
and are barely able to provide basic care, much less handle an
epidemic.
How would long-term investments to improve the basic healthcare
infrastructure of developing nations help to improve our ability to
respond to new outbreaks and epidemics?
How are the United States and international aid organizations
helping to take care of health care needs besides Ebola in the epidemic
regions?
Answer 1. NIAID defers to other witnesses regarding investments to
improve basic healthcare infrastructure of developing nations, and
regarding how United States and international organizations are helping
to take care of health care needs besides Ebola in the epidemic
regions.
Question 2. Each time a new disease or disease threat appears, we
see a spike in public attention and an avalanche of government support
to address the immediate crisis. Congress has no problem spending
billions of dollars combating SARS, pandemic flus, MERS, and now Ebola,
one outbreak at a time. When there is a crisis, of course we should
act. But over the same time period, Congress has slashed the purchasing
power of America's flagship research agencies--the agencies that do the
work to make sure that we are ready for these crises before they occur.
The National Institutes of Health has nearly 25 percent less
purchasing power today than it did a decade ago. When asked last week
about Ebola vaccine development, Francis Collins said, ``If we had just
been able to have basically equivalent purchasing power over these 10
years, we would have been at least a year ahead of where we are now.''
After years of stable reserve fund support, the budget for BARDA is now
subject to the tumultuous appropriations process. A company in
Cambridge, MA, received a Department of Defense grant in 2010 to
develop an Ebola treatment, and the company developed a drug with
promising trials. We still don't know if that treatment might be
effective because the funding was cut in 2012 because of shrinking
Federal support.
How can investments in basic research and in development help to
prepare our Nation to deal with known and unknown contagious disease
threats?
Answer 2. NIAID is the lead institute at NIH for conducting and
supporting basic research on biodefense, including chemical,
biological, radiological, and nuclear threats as well as emerging and
re-emerging infectious diseases. Basic research supported by NIAID
contributes to a comprehensive understanding of the scientific and
medical aspects of these potential threat agents and informs the
development of medical countermeasures.
The NIAID research portfolio includes basic research to understand
the biology, immune response, and pathogenesis of potential bioterror
agents and emerging and re-emerging infectious diseases, including
plague, smallpox, Ebola virus disease, and influenza. This research
provides insight into how these agents cause disease and reveals
potential targets for the development of medical countermeasures to
diagnose, treat, and prevent disease. NIAID also supports
translational-research and product-development efforts to capitalize on
basic research discoveries and to advance candidate medical
countermeasures through the product development pipeline. These efforts
help to ensure our Nation's preparedness to respond to public health
threats posed by emerging and re-emerging diseases.
NIAID's basic research investment helps inform development of
products that can gain Food and Drug Administration (FDA) approval,
licensure, clearance, or emergency use authorization and, if
appropriate, be considered for inclusion in the Strategic National
Stockpile. If candidate countermeasures show promise in proof-of-
concept animal studies or early human testing, NIAID transitions these
candidates to the Biomedical Advanced Research and Development
Authority (BARDA) for advanced development. Examples of recent
successful transitions from NIAID to BARDA include vaccines and
therapies for anthrax and pandemic influenza--a next-generation
treatment for chemical exposure; two smallpox antiviral drugs; and, in
partnership with DoD, the candidate Ebola therapeutic ZMapp. NIAID also
supported clinical trials, advanced development, and manufacturing
services leading up to the BARDA's procurement of Bavarian Nordic's
smallpox vaccine, IMVAMUNE, which has been accepted into the Strategic
National Stockpile. Results from recent NIAID studies have supported
the procurement of NEUPOGEN and Leukine for the Strategic National
Stockpile to treat Acute Radiation Syndrome. The progress of these
successful products into advanced development and procurement to ensure
the Nation's preparedness would not have been possible without NIH/
NIAID's important investments in basic and applied research on
biodefense and emerging and re-emerging diseases.
senator alexander
Question 1. You mentioned that you have an arrangement with the
Broad Institute in Boston, MA to track the genetic changes of the
virus. Please describe this arrangement and how it allows you to track
the genetic changes of the virus as the outbreak continues, including
changes that could result in increased transmissibility or other
changes with respect to the virus. Are there plans for additional
arrangements to facilitate further study of the Ebola virus circulating
in the current outbreak in West Africa in order to inform research on
vaccines, treatments, diagnostics, including point-of-care, as well as
any characteristics of the virus that could improve our public health
response?
Answer 1. For the last 10 years, NIAID has supported the Genomic
Center for Infectious Diseases at the Broad Institute to genetically
characterize viruses that cause infectious diseases such as dengue
fever and Lassa fever. Their work has expanded to include the genomic
sequencing and analysis of Ebola viruses isolated from patients in West
Africa. One project, the results of which were recently published in
Science magazine, characterized nearly 100 Ebola virus genomes from
patients in Sierra Leone, allowing researchers a clearer view of how
the virus can change over the course of an epidemic. The researchers at
the Broad Institute currently are leveraging existing partnerships in
Sierra Leone and Nigeria to obtain additional samples for genomic
sequencing and analysis.
Findings from these studies will inform investigations into the
species of Ebola virus causing the current outbreak. The goal of these
investigations is to identify and track genetic variations over time
and at multiple locations and to monitor potential genetic signals of
transmissibility or other changes in the biology of the virus. The
research team at the Broad Institute also has allowed the scientific
community immediate access to its findings by releasing the full-length
genome sequences on the National Institute of Health's National Center
for Biotechnology Information (NCBI) genome sequence data bank. This
data sharing encourages collaboration among the global scientific and
public health communities to accelerate discoveries about Ebola virus
transmissibility and adaptation. NIAID will continue to support the
efforts of the Broad Institute in enhancing and guiding strategies for
Ebola therapeutics, vaccines, and diagnostics.
Question 2. NIAID and BARDA are funding studies and clinical trials
for several candidates for Ebola therapies and vaccines. How are you
coordinating together to ensure the smooth transition of promising
candidates from the earlier phase research supported by NIH to some of
the later advanced research and development supported by BARDA? How are
you coordinating with the Department of Defense on the research
supported by them? Please also describe your coordination with the Food
and Drug Administration with respect to these drug and vaccine
candidates.
Answer 2. A core component of NIAID's mission is to conduct and
support basic and applied research on potential biothreat agents,
including newly emerging and re-emerging infectious agents such as
Ebola virus. NIAID aims for our basic research investment to inform
development of products that can gain Food and Drug Administration
(FDA) approval, licensure, clearance, or emergency use authorization
and, if appropriate, be considered for inclusion in the Strategic
National Stockpile. If candidate medical countermeasures against
biothreats show promise in proof-of-concept animal studies or early
human testing, NIAID transitions these candidates to BARDA for advanced
development. NIAID's longstanding and successful collaborations with
BARDA, FDA, CDC, and the Department of Defense (DoD) are critical to
accelerating efforts to develop treatments and vaccines for Ebola virus
disease.
In partnership with BARDA, DoD, and FDA, and others, NIAID is
working to accelerate the development of medical countermeasures for
Ebola virus. NIAID has worked closely with FDA to advance testing of
the CAd3 Ebola vaccine candidate developed by NIAID in partnership with
GlaxoSmithKline. This candidate uses a chimpanzee virus as a carrier to
introduce Ebola virus genes into the body in order to stimulate an
immune response. NIAID is currently conducting Phase I clinical trials
of the CAd3 candidate vaccine at the National Institutes of Health
Clinical Center in Bethesda, MD and additional testing at the
University of Maryland and Emory University. Proactive communication
and partnership enabled FDA to review NIAID's Vaccine Research Center's
Investigational New Drug (IND) application in less than 1 week, leading
to acceleration of the clinical study start date. CAd3 will also be
evaluated in the United Kingdom and the West African country of Mali,
and further clinical trials are under consideration should the vaccine
prove safe and indicate an ability to generate an immune response.
NIAID and DoD are currently coordinating efforts to accelerate the
production of two Ebola vaccine candidates. NIAID and DoD are
collaborating with NewLink Genetics on an investigational recombinant
vesicular stomatitis virus (VSV)-based vaccine candidate developed and
licensed by the Public Health Agency of Canada. NIAID has worked with
FDA to enable this candidate to begin Phase I safety studies in the
fall of 2014 at Walter Reed Army Institute of Research in Silver
Spring, MD, and at the NIH Clinical Center in Bethesda, MD. Another
project aims to produce a vaccine candidate based on an existing rabies
vaccine that could protect against Ebola and rabies, important diseases
in certain regions in Africa. NIAID and DoD are partnering with
researchers at Thomas Jefferson University to produce sufficient
quantities of this candidate to begin clinical testing in early 2015.
In addition, NIAID is partnering with DoD and BARDA to advance the
development and testing of the Ebola therapeutic candidate ZMapp.
ZMapp, developed by Mapp Biopharmaceutical, Inc., with support from
NIAID and DoD, is a combination of three monoclonal antibodies that can
protect monkeys from death due to Ebola virus when administered up to 5
days after infection. NIAID is working closely with partners at DoD,
BARDA, and FDA to help determine whether ZMapp is safe and effective.
BARDA currently is working with Mapp Biopharmaceuticals to accelerate
the manufacturing of more ZMapp for additional testing.
NIAID is an active participant in the Public Health Emergency
Medical Countermeasure Enterprise (PHEMCE), an interagency effort led
by the Department of Health and Human Service's Office of the Assistant
Secretary for Preparedness and Response that coordinates Federal
activities to increase preparedness against chemical, biological,
radiological, and nuclear threats, including Ebola viruses. As an
active member of the PHEMCE, NIAID participates in multiple teams and
committees to ensure coordination of scientific activity with PHEMCE
partners, including BARDA, FDA, and DoD. In addition, NIAID
participates in the Ebola Medical Countermeasures Senior Steering
Group, coordinated by the White House Office of Science and Technology
Policy. Senior staff from all agencies participating in the Ebola
response meet twice weekly to discuss medical countermeasures for Ebola
virus in the context of the U.S. response to the Ebola epidemic.
NIAID will continue to play an active role in the PHEMCE and work
with BARDA, DoD, FDA, and other partners to advance the development of
diagnostics, therapeutics, and vaccines for Ebola virus.
senator moran
Blood Transfusions
Question 1. Dr. Fauci, the World Health Organization has endorsed
the use of blood transfusions from recovered Ebola patients into sick
patients; however there doesn't appear to be much scientific
information showing that this works. What is your professional judgment
on this form of treatment?
Answer 1. The ability to safely and effectively prevent and treat
Ebola virus infection is a longstanding priority of the National
Institute of Allergy and Infectious Diseases (NIAID). However, it is
important to balance the urgency to deploy investigational medical
countermeasures in an emergency such as the current Ebola outbreak with
the need to ensure the safety, determine the efficacy of candidate
therapeutics, and avoid inadvertent harm. NIAID will do this with
careful attention to safety, established scientific principles, ethical
considerations, and the urgent, pressing needs of the affected
populations.
Some patients infected with Ebola and hospitalized in facilities
across the United States and affected countries in West Africa received
so-called ``convalescent serum'' in addition to other medical care. The
rationale behind use of convalescent serum is that it contains
antibodies generated by the immune system of an Ebola survivor during
the course of infection. These antibodies may help newly infected
patients to fight Ebola virus. However, more must be known about the
safety and effectiveness of plasma (``convalescent serum'')
transfusions from those who have recovered from Ebola virus infection.
Blood and plasma transfusions have been used as treatment against
many infectious diseases, and the scientific rationale behind
``convalescent serum'' therapy suggests that it could be a potential
treatment for Ebola virus infection. However, there are limited data
from patients who have undergone this procedure, and further research
is required before a determination is made that this therapy is a safe
and effective treatment for Ebola virus infection.
Note that an alternative mechanism to deliver antibodies that may
help to treat the Ebola virus would be to artificially manufacture
these antibodies and deliver them as a drug. This is the principle on
which the therapeutic candidate ZMapp, a combination of three
monoclonal antibodies, is based. A drug like ZMapp contains only the
most potent neutralizing antibodies and its manufacture is standardized
and regulated. The Department of Health and Human Services is
vigorously supporting manufacturing and further evaluation of ZMapp.
Question 2. Is there the necessary infrastructure in-country to
make sure this technique is done safely? I am particularly concerned
that Liberia, Guinea, and Sierra Leone do not have the proper blood
screening procedures in place to ensure that they will not be spreading
other diseases, like HIV.
Answer 2. Proper blood screening from donors and blood typing of
donors and recipients are essential for safe transfusions and to avoid
dangerous transfusion reactions. In order to safely implement blood
transfusions to treat Ebola in West Africa, there must be an
infrastructure capable of identifying survivors, collecting their
blood, identifying blood type of donor and recipient, and processing
the blood to screen it for other infectious agents common to the
region, such as malaria and hepatitis C. The limited health care
infrastructures in the nations seriously affected by Ebola would make
it challenging to ensure that blood transfusions were consistently
administered safely and to collect data appropriate for clinical
research on this intervention.
Trial Infrastructure
Question 3. Dr. Fauci, the World Health Organization announced that
it would accelerate the use of experimental therapies and vaccines to
contain the expanding Ebola epidemic. In addition, it has endorsed the
controversial treatment of blood transfusions. As these treatments are
deployed, how do we tell whether they are effective? Is there
infrastructure in place to track effectiveness?
Answer 3. NIAID is committed to working with partners to evaluate
candidate drugs and vaccines for safety and efficacy. The U.S.
Government, working in partnership with industry, has an established
mechanism for testing and reviewing the safety and efficacy of
potential medical interventions. Randomized controlled clinical trials
remain the ``gold standard'' for the evaluation of candidate drugs and
vaccines because they represent the most efficient way to prove
efficacy and lack of an unexpected harmful effect.
It is important to balance the urgency to deploy investigational
medical countermeasures in an emergency such as the current Ebola
outbreak with the need to ensure the maximal safety and to determine
the efficacy of candidate Ebola therapeutics. Blood transfusions, other
Ebola-specific, blood-related products such as plasma from convalescent
patients or processed serum from either convalescent patients or
hyperimmune serum from vaccinated individuals, and other candidate
interventions will be considered as potential experimental Ebola
therapeutics. These potential therapies will undergo the same rigorous
testing and evaluation with regards to safety and efficacy as other
candidate Ebola treatments. As these treatments are deployed for
emergency use and clinical evaluation, NIAID will continue to work with
its partners, including non-profit organizations, biotechnology and
pharmaceutical companies, Federal agencies such as the Centers for
Disease Control and Prevention, the Biomedical Advanced Research and
Development Authority, and the Food and Drug Administration, to support
the clinical trials infrastructure necessary to determine the safety
and effectiveness of medical countermeasures for Ebola.
senator shelby
Ebola Drug Candidate
Question 1. A university in my State is pioneering a drug, with
your support at NIAID, that would reactivate the body's immune system
after Ebola or other viruses deactivate it. What promise do you see in
this line of drug discovery?
Answer 1. NIAID supports a broad portfolio of basic research to
better understand Ebola viruses and applied research to develop
diagnostics, therapeutics, and vaccines against Ebola viruses. This
research includes efforts to design and develop drugs to treat Ebola
virus disease that would inhibit viral replication and its deleterious
effects on the human immune system. One promising approach is the
development of nucleoside derivative drugs. These drugs interfere with
the reproductive process of the virus and may have activity against a
broad spectrum of viruses. NIAID currently is supporting preclinical
studies on promising drugs for the treatment of Ebola, and nucleoside
derivatives are among the candidates that may enter clinical testing to
evaluate their safety and markers of efficacy in the near future.
In complement to NIAID's ongoing development of drugs that directly
target Ebola viruses, NIAID is supporting research that may provide
significant insights into the mechanisms that govern the immune
response to viruses. These insights could be used to design highly
effective and long-lasting vaccines and inform studies on the
development of novel therapeutic interventions that would enhance human
responses to viral infections. NIAID will continue to support promising
approaches to the development of drugs to treat Ebola virus disease and
enhance the immune response to combat Ebola virus infection.
NIH Research on Ebola
Question 2. Dr. Fauci, NIH has several Ebola vaccines and therapies
in development. Could you talk about the prospects for these treatments
and give your professional judgment on which is the most promising
approach?
Answer 2. NIAID supports and conducts basic, translational, and
clinical research on novel therapeutics and vaccines targeting emerging
and re-emerging infectious diseases, including Ebola viruses. The
ongoing NIAID response to the current Ebola outbreak focuses on working
with non-profit, private industry, and government partners around the
world to advance the development of medical countermeasures against the
disease, including evaluating the use of drugs licensed or approved to
treat non-Ebola diseases as a potential treatment for patients infected
with Ebola. This approach has led to the generation of multiple
therapeutic and vaccine candidates across the different stages of the
product development pipeline.
While NIAID is an active participant in the global effort to
address the public health emergency in West Africa, it is important to
recognize that we are still in the early stages of understanding how
infection with the Ebola virus can be treated and prevented. The most
promising therapeutic and vaccine approaches will be identified through
further research, including evaluation of candidates at the preclinical
and clinical stages.
Some of the candidate vaccines and therapeutics currently in
development with NIAID support are described below.
Vaccines. The NIAID Vaccine Research Center collaborated with the
pharmaceutical company GlaxoSmithKline to develop an experimental
vaccine based on Chimpanzee Adenovirus 3. The vaccine candidate has
shown promising results in animal models against two Ebola virus
species, including the Zaire Ebola species responsible for the current
outbreak. A small Phase I study to examine the safety and ability of
this candidate vaccine to induce an immune response in humans began on
September 2, 2014, at the NIH Clinical Center in Bethesda, MD, with
results anticipated by the end of the calendar year. Additionally, NIH
is collaborating with DoD and NewLink Genetics on Phase I safety
studies of another vaccine candidate based on a recombinant vesicular
stomatitis virus.
An additional vaccine candidate being developed by a team of NIAID
intramural scientists and Thomas Jefferson University investigators is
based on an existing licensed rabies vaccine and aims to protect
against Ebola and rabies viruses. The vaccine is currently undergoing
preclinical testing and NIAID is partnering with DoD to produce
sufficient quantities of the vaccine candidate to begin clinical
testing in 2015.
Therapeutics. A combination of three antibodies known as ZMapp has
been shown to protect monkeys from death due to Ebola virus when
administered up to 5 days after infection. ZMapp was developed by Mapp
Biopharmaceutical, Inc., with support from NIAID and DoD. NIAID's
preclinical services are now being used to provide preliminary safety
data to support the use of ZMapp for clinical trials in humans.
NIAID also has funded BioCryst Pharmaceuticals to develop and test
BCX4430, a novel drug that interferes with the reproductive process of
the virus. BCX4430 has activity against a broad spectrum of viruses and
has shown some activity in animals against infection by Ebola virus and
the related Marburg virus. Additionally, NIAID scientists are working
on therapeutics that may be effective against multiple hemorrhagic
fever viruses including Ebola and Marburg filoviruses and the
arenavirus Lassa. Ribavirin, a drug currently used to treat viral
hemorrhagic fevers such as Lassa fever, is being examined for its
potential use in combination therapy to treat Ebola virus infection.
Candidate therapeutics are being considered for future clinical
trials to evaluate their safety and efficacy. NIAID will continue to
work with biopharmaceutical companies and public health agencies around
the world to advance development of promising candidates and increase
access to safe and effective medical countermeasures for Ebola virus
disease as quickly as possible.
senator cochran
Response from International Community
Question 1. Thank you for coming in today to describe efforts by
the U.S. Government to respond to the Ebola outbreak in West Africa. I
am hopeful that the United States can play a leadership role in
addressing this humanitarian crisis, but I am also curious about the
contributions of international organizations and our partner nations.
Will you please describe efforts by the international community to stop
the Ebola epidemic?
Answer 1. NIAID defers to colleagues coordinating the Ebola
outbreak response.
Ebola Protection and Control
Question 2. Do you believe the additional $88 million that has been
requested by the President to respond to this Ebola crisis will provide
you with the resources required to protect against the potential spread
of Ebola in the United States and to address needs abroad?
Answer 2. NIAID defers to recipients of supplemental funding.
Capacity for Drugs or Vaccines
Question 3. Do you believe the capacity we have to approve,
produce, and distribute drugs and vaccines here in the United States is
sufficient to contain an infectious disease such as Ebola should it
make its way here to the United States?
Answer 3. NIAID defers to other witnesses.
Prioritization of Funding
Question 4. Dr. Robinson and Dr. Fauci, NIH receives approximately
$1.7 billion per year for biodefense and emerging infectious diseases
and BARDA receives $415 million. How does HHS prioritize the
utilization of this funding to address known and emerging threats?
Answer 4. NIAID is the lead institute at NIH for conducting and
supporting basic and applied research on biodefense, including
chemical, biological, and radiological/nuclear threats, and emerging
and re-emerging infectious diseases. This research provides the
foundation for developing medical products and strategies to diagnose,
treat, and prevent a wide range of biodefense threats and infectious
diseases, whether those diseases emerge naturally or are deliberately
introduced as an act of bioterrorism.
Since the 2001 anthrax attacks, with the support of the U.S.
Congress, NIAID has vastly expanded its research portfolio in
biodefense and emerging and re-emerging infectious diseases. NIAID's
biodefense research is guided by its Strategic Plan for Biodefense
Research, which has been developed and updated in consultation with
biodefense research experts. NIAID's research also aligns with the
priorities of the interagency Public Health Emergency Medical
Countermeasures Enterprise (PHEMCE). NIAID's pathogen priority list is
periodically reviewed and is subject to revision in conjunction with
our Federal partners, including the Department of Homeland Security,
which determines threat assessments, the Centers for Disease Control
and Prevention, which prepares for and responds to emerging pathogen
threats in the United States, and the Biomedical Advanced Research and
Development Authority, with which we collaborate to transition
promising medical countermeasures for advanced development.
Guided by our Strategic Plan and priorities, NIAID supports the
fundamental research needed to better understand infectious agents in
order to develop broad-spectrum antibiotics and antivirals--drugs that
can prevent or treat diseases caused by multiple types of bacteria or
viruses. In addition, NIAID has intensified its efforts to develop new
technologies that can be broadly applied to more efficiently develop
diagnostics and vaccines against a wide variety of infectious agents,
including pandemic influenza viruses, MRSA, extensively drug-resistant
Mycobacterium tuberculosis, dengue, chikungunya, and filoviruses such
as Ebola.
NIAID's biodefense research portfolio includes investigator-
initiated research as well as targeted research initiatives to
capitalize on new scientific opportunities, provide critical research
resources, and stimulate research in high-priority areas. All NIAID
research, whether investigator-initiated or solicited, undergoes peer
review. Scientific experts evaluate the scientific and technical merit
of proposed research, and funding decisions are based on scientific and
technical merit of proposed projects, availability of funds, and
relevance to program priorities. NIAID's research funding process
provides the flexibility needed to respond rapidly to address known and
emerging disease threats.
senator burr
Question 1. How is NIAID structuring the clinical trials with
respect to both Ebola vaccine and therapeutic candidates, including
with respect to enrolling clinical trial participants in West Africa?
Are there aspects of the current Ebola clinical trials that are unique
given the state of the outbreak overseas?
Answer 1. NIAID is consulting with experts around the world to plan
clinical trials of Ebola medical countermeasures that will enroll
participants in West Africa. An important part of these ongoing
discussions is an evaluation of whether candidate vaccines and
therapeutics are available in sufficient quantities for testing and
whether early clinical testing has indicated they are safe and can
generate the desired response.
With respect to vaccines, the NIAID Vaccine Research Center (VRC)
plays a leading role in the evaluation of safety and immunogenicity of
candidate Ebola vaccines. Currently, the VRC is conducting and
supporting Phase I clinical trials of CAd3, an experimental vaccine
developed by NIAID and GlaxoSmithKline which has shown promising
results in animal models against two Ebola virus species, including the
Zaire Ebola species responsible for the current outbreak in West
Africa. NIAID and GlaxoSmithKline plan to share doses of the vaccine
candidate with an international consortium comprising Oxford
University, the Wellcome Trust, and the World Health Organization in
order to enable other planned clinical trials. With respect to
therapeutics, only limited clinical use of Ebola therapeutic candidates
under expanded access mechanisms has occurred so far. Plans for
systematic clinical testing are under active discussion at this time.
Aspects of the planned Ebola clinical trials unique to this
outbreak include the rapid establishment of complex technology transfer
arrangements, the facilitation of expedited regulatory reviews, and the
extraordinary deployment of NIAID resources and infrastructure to
safely provide clinical materials to international partners. NIAID is
committed to advancing candidate Ebola vaccines and therapeutics while
ensuring the maximal safety of clinical trial participants.
Question 2. Are there vaccine and therapeutic candidates that we
should be pursuing that are not already in the pipeline?
Answer 2. There are a number of promising vaccine and therapeutic
candidates for Ebola virus currently in the development pipeline, and
additional approaches are constantly being investigated and considered
for further development. NIAID employs multiple approaches to identify
and develop potential Ebola virus medical countermeasures. NIAID
supports a strong foundation of basic research to better understand
Ebola virus and to identify biological targets to inform the
development of diagnostics, therapeutics, and vaccines. NIAID is
actively examining these targets to assess scientific concepts and to
advance promising approaches along the development pipeline.
NIAID employs a multifaceted and interdisciplinary approach to
ensure a robust pipeline of candidate medical countermeasures for Ebola
virus. In collaboration with our partners in government and industry,
we will continue to evaluate novel ideas and pursue promising
candidates. Currently NIAID is actively engaging scientists around the
world who have come forward to discuss their candidate Ebola
diagnostics, therapeutics, and vaccines. NIAID also makes resources
available to academic and industry researchers, such as in vitro and in
vivo screening, to help evaluate potential medical countermeasures and
advance promising candidates. For example, since 2011, over 30
different vaccines, formulations, or dosing schedules against
filoviruses, the virus family that includes Ebola viruses, have been
evaluated using NIAID's preclinical services. Seven qualified for
further testing and five are currently in the product development
pipeline. NIAID is fully committed to engaging its resources to
identify and evaluate promising vaccines and therapeutics.
senator kirk
Question 1. Dr. Fauci and Dr. Robinson, are there medical
countermeasures in development to support the current Ebola outbreaks?
I believe that Ebola was identified as ``threat sufficient'' to affect
national security in 2006. How does HHS prioritize investments to
address known and emerging threats?
Answer 1. NIAID defers to other witnesses on HHS prioritization of
investments.
NIAID supports a broad portfolio of intramural and extramural basic
research to better understand Ebola viruses and applied research to
develop diagnostics, therapeutics, and vaccines against Ebola viruses.
NIAID has supported a number of medical countermeasures currently in
development. As described below, medical countermeasures for Ebola
virus disease currently in advanced development include therapeutic
candidates ZMapp, CMX001 (brincidofovir), BCX4430, T-705 (favipiravir),
TKM-Ebola, and vaccine candidates CAd3 and VSV-EBOV. It is important to
note that these products are still in development and have not been
shown to be safe and effective in Ebola patients. So far, only limited
clinical use of these products under expanded access mechanisms has
occurred in patients with documented or suspected Ebola virus
infection.
Vaccines
CAd3. The NIAID Vaccine Research Center and pharmaceutical company
GlaxoSmithKline have developed an experimental vaccine that uses the
chimpanzee adenovirus 3 (CAd3) as a vector to introduce Ebola virus
genes into the body, stimulating an immune response. This vaccine
candidate has shown promising results in animal models against two
Ebola virus species, including the Zaire Ebola species responsible for
the current outbreak in West Africa. A small Phase I study to examine
the safety and ability of this candidate to generate an immune response
began on September 2, 2014, at the National Institutes of Health (NIH)
Clinical Center in Bethesda, MD. Results from the study are anticipated
by the end of 2014, and will help inform future development of the
vaccine.
VSV-EBOV. The Public Health Agency of Canada has developed VSV-
EBOV, an investigational recombinant vesicular stomatitis virus Ebola
vaccine subsequently licensed to NewLink Genetics. NIAID is
collaborating with DoD in support of efforts by NewLink Genetics to
conduct Phase I safety studies for VSV-EBOV. These studies are planned
for the fall of 2014 at Walter Reed Army Institute of Research in
Silver Spring, MD, and the NIH Clinical Center in Bethesda, MD.
Therapeutics
ZMapp. NIAID supported Mapp Biopharmaceutical, Inc., to develop MB-
003, a combination of three antibodies that provides some protection
from Ebola virus disease in monkeys when administered within 48 hours
of exposure. An optimized product derived from MB-003, known as ZMapp,
has protected monkeys from death due to Ebola virus up to 5 days after
infection. NIAID's preclinical services are now being used to gather
safety data for the use of ZMapp in clinical trials. ZMapp was recently
administered to several patients with Ebola virus disease as an
experimental treatment, although it is not possible at this time to
determine whether ZMapp benefited these patients. BARDA is implementing
plans to optimize and accelerate the manufacturing of ZMapp so that
clinical safety and efficacy testing can proceed as soon as possible.
NIAID will continue to work closely with partners at BARDA, DoD, and
FDA to advance development and testing of this therapeutic candidate.
CMX001 (brincidofovir). NIAID is evaluating therapeutics in
development or licensed for the treatment of other diseases for
activity against Ebola virus. One of these investigational agents is
brincidofovir, an antiviral originally targeting smallpox that has had
NIAID support for parts of the development program conducted by
Chimerix, Inc. Currently, brincidofovir is in advanced clinical testing
for use against cytomegalovirus and adenovirus infections. In vitro
screening suggested some activity against Ebola virus and the candidate
is now undergoing NIAID-funded in vivo testing against Ebola virus
disease.
BCX4430. NIAID has funded BioCryst Pharmaceuticals to develop and
test BCX4430, a novel drug that interferes with the reproductive
process of the virus and has activity against a broad spectrum of
viruses. In preclinical testing, BCX4430 has shown some activity in
animals against infection by Ebola virus and the related Marburg virus.
A Phase I clinical trial of this drug is expected to begin in late 2014
or early 2015.
T-705 (favipiravir). NIAID funded early screening of T-705, or
favipiravir, a broad-spectrum antiviral against RNA viruses. T-705 is
owned by Toyama Chemical of Japan and licensed by MediVector for
development in the United States. This drug is licensed in Japan for
pandemic influenza; in the United States, it is undergoing DoD-
supported Phase III clinical trials for use against influenza. Pilot
studies funded by DoD are underway to test the effectiveness of
favipiravir against Ebola virus in nonhuman primates.
TKM-Ebola. DoD has supported development of TKM-Ebola by Tekmira
Pharmaceuticals. TKM-Ebola is a small, inhibitory RNA molecule that
interferes with Ebola virus replication. Tekmira Pharmaceuticals began
Phase I trials of TKM-Ebola in January 2014. The trial in healthy
uninfected volunteers is currently on a partial clinical hold; however,
the FDA has allowed use of TKM-Ebola under an expanded access mechanism
in individuals with suspected or confirmed Ebola virus infection.
Question 2. Dr. Bell and Dr. Fauci, with all the different agencies
involved, which one is leading the efforts against Ebola? What
coordinated efforts are happening between the agencies? What are other
nations doing to contribute?
Answer 2. NIH supports foundational research and facilitates
interagency partnerships that lead to the development of new and
improved medical countermeasures for biodefense and emerging and re-
emerging infectious diseases. NIAID is the lead component of the NIH
for research and development of medical countermeasures against Ebola
virus. Basic and applied research supported by NIAID contributes to a
comprehensive understanding of the scientific and medical aspects of
Ebola virus and aims to advance development of diagnostics,
therapeutics, and vaccines against this deadly disease. Critical to
these efforts are NIAID's collaborations with other Federal entities,
particularly CDC, FDA, BARDA, and DoD.
NIAID has responded to the current Ebola virus outbreak in West
Africa by leveraging longstanding and productive partnerships to
accelerate ongoing research efforts. For example, NIAID is working
closely with partners at DoD, BARDA, and FDA, along with the product
developer, Mapp Biopharmaceutical, Inc., to advance development and
testing of this Ebola therapeutic candidate ZMapp to determine whether
it is safe and effective. ZMapp is a combination of three antibodies
developed with support from NIAID and DoD. ZMapp has shown promising
results in studies with monkeys, and NIAID is partnering with BARDA and
FDA to accelerate manufacturing and additional testing of ZMapp. NIAID
will continue to work closely with BARDA to transition additional
therapeutic candidates for advanced development as appropriate. NIAID's
ongoing coordination with FDA will help to advance promising
therapeutics into clinical testing to determine their safety and
efficacy.
In addition, NIAID and DoD are coordinating efforts to accelerate
the production of Ebola vaccine candidates. One project aims to
generate immunity to Ebola and rabies viruses using a vaccine candidate
based on an existing rabies vaccine. NIAID and DoD are currently
partnering with researchers at Thomas Jefferson University to produce
sufficient quantities of the candidate to begin clinical testing in
early 2015. NIAID and DoD also are collaborating with NewLink Genetics
on an investigational recombinant vesicular stomatitis virus (VSV)-
based vaccine candidate developed by the Public Health Agency of Canada
and licensed to NewLink Genetics. This candidate has begun Phase I
safety studies in fall 2014 at Walter Reed Army Institute of Research
in Silver Spring, MD, and at the NIH Clinical Center in Bethesda, MD.
NIAID will work closely with FDA to evaluate the safety and
immunogenicity data from this trial as well as from NIAID's ongoing
Phase I clinical trial of the chimpanzee adenovirus-based Ebola vaccine
(CAd3), developed in collaboration with GlaxoSmithKline.
NIH also participates in the Ebola Medical Countermeasures Senior
Steering Group, led by the White House Office of Science and Technology
Policy and comprising senior staff from all Federal agencies
participating in Ebola response activities. Through this and other
mechanisms, NIAID will continue its efforts to accelerate the
development of safe and effective countermeasures against Ebola virus
by leveraging existing partnerships with industry and other Federal
agencies including CDC, FDA, BARDA, and DoD.
NIAID defers to other witnesses regarding which Agency is leading
efforts against Ebola and other nations' contributions against Ebola.
Response to Questions of Senator Casey and Senator Warren by
Ishmael Alfred Charles
senator casey
Question 1. You stated that stigma surrounding Ebola is a problem
for combating the current outbreak. What message do you think needs to
be articulated to help fight that stigma?
Answer 1. Well over the period with the current outbreak we have
practically seen how stigmas and discrimination have torn apart more
people almost as much as the outbreak. At community level, it is
important to use our religious leaders and community volunteers to
preach about acceptance and the fact that those who have survived Ebola
cannot transfer the virus or cannot get anyone sick. Also at the
regional and international level people need to get more education on
how Ebola spreads, for example in the United States, institutions like
CDC and NIH need to engage the wider society that Ebola is not an
African outbreak. It can take place anywhere. It is more serious in
Africa because of the bad leadership and poor health infrastructures
and system. Also that Ebola does not spread by merely seeing someone
but only through bodily contact, as the lack of sufficient information
is also creating more confusion.
Stigma is degrading attitude of the society that brings not only
shame and disgrace, but also discredits a person or a group because of
an attribute to an outbreak like Ebola.
Stigma leads to people not being treated with dignity and respect
and promotes hate and disunity which is socially unacceptable.
Question 1a. Which people in local communities do you feel would be
best able to communicate that message?
Answer 1a. There are community stakeholders who also are the
opinion leaders of the community.
The following are examples: Religious leader (e.g., Imam, Pastors
and Rev. Fr.), Traditional Heads, popular sports/soccer players,
musicians/comedians and influential personalities.
Question 2. In your testimony, you stated that schools in Sierra
Leone are closed indefinitely, while the illiteracy rate is 70 percent.
How can the international community help affected countries fill in
this education gap for their children and improve literacy?
Answer 2. Prior to the Ebola outbreak, the basic survival of the
ordinary citizen was difficult. The outbreak has undoubtedly compounded
the already worse situations.
The cost of the basic school or learning materials increased just
before the outbreak and the outbreak has stopped all economic
activities such as trading and movement. Schools are closed to avoid
contact among pupils and students.
The following interventions may help:
(1) Take care of the education of the orphans of Ebola victims.
(2) Help the government to provide affordable education at all
levels for the citizens (e.g., Free tuition for secondary schools and
reduction in college and university fees.)
(3) Reintroduce school feeding programs in primary schools to
augment the post Ebola recovery.
(4) Support the universities directly with their needs including
subsidies.
Clearly we realized that in a post conflict country only recovering
from the aftermath of the war has not helped the situation at all.
Schooling was badly disrupted and it has only further damaged the
educational development of the country, a country with 70 percent
illiteracy. Schools have closed indefinitely, and this is exposing many
young girls to teenage pregnancy and further increasing the burden. My
suggestion is for us to ensure that these children who will be pregnant
after Ebola will need to be enrolled in a special school to ensure that
they don't become drop outs.
Also there is a need for a recap type of school. Post war era, we
had a schooling program called Remedial term, which was an accelerated
learning and teaching program. We will need a similar program in the
post Ebola era, so that the school pupils will be able to recap and
catch up with what they have lost.
senator warren
Question 1. Fighting epidemics in developing countries presents
unique challenges. Despite all the attention that's being paid to the
Ebola outbreak, serious health problems have gripped these countries
for years. In Liberia, for example, 17 percent of deaths are due to
Malaria, and Sierra Leone has one of highest rates of infant and
maternal mortality in the world. Countries currently dealing with Ebola
have a poor healthcare infrastructure and very few healthcare workers--
and are barely able to provide basic care, much less handle an
epidemic.
How would long term investments to improve the basic healthcare
infrastructure of developing nations help to improve our ability to
respond to new outbreaks and epidemics?
Answer 1. Any attempt to address the health care problems in
developing countries, like Sierra Leone should focus on sustainable
infrastructure and a strong system that is in rhythm with international
best practice(s).
Our current health care facilities including the Infrastructure do
not address the needs/demands of most of the recent outbreaks and
epidemics.
In addition to the substandard provisions, there are no improving
systems that will implement and monitor the effective and efficient use
of the health care facilities.
The following are recommended:
1. Establishment of a Centre for Diseases Control (CDC) in every
country, especially those that were badly affected by Ebola.
2. Strengthening of health care systems.
3. Ensure a vibrant disease surveillance network within West
Africa.
Question 2. How are the United States and international aid
organizations helping to take care of health care needs besides Ebola
in the epidemic regions?
Answer 2. The international aid organizations and U.S.
organizations are helping in diverse ways which include provision of
food and nonfood items to people as hunger and starvation is on the
increase. This support is not enough, hence there is a huge need for
more support to the community people across the country, especially in
the badly hit areas of the country.
[Whereupon, at 5:45 p.m., the hearing was adjourned.]