[House Hearing, 114 Congress]
[From the U.S. Government Publishing Office]
EXAMINING THE U.S. PUBLIC HEALTH RESPONSE TO THE ZIKA VIRUS
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED FOURTEENTH CONGRESS
SECOND SESSION
__________
MARCH 2, 2016
__________
Serial No. 114-124
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
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COMMITTEE ON ENERGY AND COMMERCE
FRED UPTON, Michigan
Chairman
JOE BARTON, Texas FRANK PALLONE, Jr., New Jersey
Chairman Emeritus Ranking Member
ED WHITFIELD, Kentucky BOBBY L. RUSH, Illinois
JOHN SHIMKUS, Illinois ANNA G. ESHOO, California
JOSEPH R. PITTS, Pennsylvania ELIOT L. ENGEL, New York
GREG WALDEN, Oregon GENE GREEN, Texas
TIM MURPHY, Pennsylvania DIANA DeGETTE, Colorado
MICHAEL C. BURGESS, Texas LOIS CAPPS, California
MARSHA BLACKBURN, Tennessee MICHAEL F. DOYLE, Pennsylvania
Vice Chairman JANICE D. SCHAKOWSKY, Illinois
STEVE SCALISE, Louisiana G.K. BUTTERFIELD, North Carolina
ROBERT E. LATTA, Ohio DORIS O. MATSUI, California
CATHY McMORRIS RODGERS, Washington KATHY CASTOR, Florida
GREGG HARPER, Mississippi JOHN P. SARBANES, Maryland
LEONARD LANCE, New Jersey JERRY McNERNEY, California
BRETT GUTHRIE, Kentucky PETER WELCH, Vermont
PETE OLSON, Texas BEN RAY LUJAN, New Mexico
DAVID B. McKINLEY, West Virginia PAUL TONKO, New York
MIKE POMPEO, Kansas JOHN A. YARMUTH, Kentucky
ADAM KINZINGER, Illinois YVETTE D. CLARKE, New York
H. MORGAN GRIFFITH, Virginia DAVID LOEBSACK, Iowa
GUS M. BILIRAKIS, Florida KURT SCHRADER, Oregon
BILL JOHNSON, Ohio JOSEPH P. KENNEDY, III,
BILLY LONG, Missouri Massachusetts
RENEE L. ELLMERS, North Carolina TONY CARDENAS, California
LARRY BUCSHON, Indiana
BILL FLORES, Texas
SUSAN W. BROOKS, Indiana
MARKWAYNE MULLIN, Oklahoma
RICHARD HUDSON, North Carolina
CHRIS COLLINS, New York
KEVIN CRAMER, North Dakota
Subcommittee on Oversight and Investigations
TIM MURPHY, Pennsylvania
Chairman
DAVID B. McKINLEY, West Virginia DIANA DeGETTE, Colorado
Vice Chairman Ranking Member
MICHAEL C. BURGESS, Texas JANICE D. SCHAKOWSKY, Illinois
MARSHA BLACKBURN, Tennessee KATHY CASTOR, Florida
H. MORGAN GRIFFITH, Virginia PAUL TONKO, New York
LARRY BUCSHON, Indiana JOHN A. YARMUTH, Kentucky
BILL FLORES, Texas YVETTE D. CLARKE, New York
SUSAN W. BROOKS, Indiana JOSEPH P. KENNEDY, III,
MARKWAYNE MULLIN, Oklahoma Massachusetts
RICHARD HUDSON, North Carolina GENE GREEN, Texas
CHRIS COLLINS, New York PETER WELCH, Vermont
KEVIN CRAMER, North Dakota FRANK PALLONE, Jr., New Jersey (ex
JOE BARTON, Texas officio)
FRED UPTON, Michigan (ex officio)
C O N T E N T S
----------
Page
Hon. Tim Murphy, a Representative in Congress from the
Commonwealth of Pennsylvania, opening statement................ 1
Prepared statement........................................... 3
Hon. Kathy Castor, a Representative in Congress from the State of
Florida, opening statement..................................... 5
Hon. Michael C. Burgess, a Representative in Congress from the
State of Texas, opening statement.............................. 5
Hon. Fred Upton, a Representative in Congress from the state of
Michigan, prepared statement................................... 143
Witnesses
Nicole Lurie, M.D., Assistant Secretary for Preparedness and
Response, U.S. Department of Health and Human Services......... 8
Prepared statement........................................... 11
Answers to submitted questions 144
Thomas Frieden, M.D., Director, Centers for Disease Control and
Prevention..................................................... 21
Prepared statement........................................... 23
Answers to submitted questions............................... 148
Anthony Fauci, M.D., Director, National Institute of Allergy and
Infectious Diseases, National Institutes of Health............. 31
Prepared statement........................................... 33
Answers to submitted questions............................... 155
Luciana Borio, M.D., Assistant Commissioner, Counterterrorism
Policy, U.S. Food and Drug Administration...................... 44
Prepared statement........................................... 46
Answers to submitted questions............................... 159
Timothy Persons, Ph.D., Chief Scientist, U.S. Government
Accountability Office.......................................... 55
Prepared statement \1\
Peter Hotez, M.D., Ph.D., Dean, National School of Tropical
Medicine, Baylor College of Medicine, President, Sabin Vaccine
Institute, and Texas Children's Hospital Endowed Chair in
Tropical Pediatrics............................................ 78
Prepared statement........................................... 80
Answers to submitted questions............................... 167
Lawrence O. Gostin, J.D., Linda D. and Timothy J. O'Neill
Professor of Global Health Law, Georgetown University Law
Center......................................................... 90
Prepared statement........................................... 92
Answers to submitted questions............................... 171
Joseph Conlon, M.S., Technical Advisor, American Mosquito Control
Association.................................................... 105
Prepared statement........................................... 108
Answers to submitted questions............................... 181
Jeanne Sheffield, M.D., Director, Division of Maternal-Fetal
Medicine, Johns Hopkins School of Medicine..................... 122
Prepared statement........................................... 124
Answers to submitted questions............................... 187
----------
\1\ Mr. Person's testimony is available at: http://
docs.house.gov/meetings/if/if02/20160302/104594/hhrg-114-if02-
wstate-personst-20160302.pdf.
EXAMINING THE U.S. PUBLIC HEALTH RESPONSE TO THE ZIKA VIRUS
----------
WEDNESDAY, MARCH 2, 2016
House of Representatives,
Subcommittee on Oversight and Investigations,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 10:15 a.m., in
room 2322 Rayburn House Office Building, Hon. Tim Murphy
(chairman of the subcommittee) presiding.
Members present: Representatives Murphy, Burgess, Griffith,
Brooks, Mullin, Hudson, Collins, Cramer, Castor, Tonko, Clarke,
Kennedy, Welch, and Pallone (ex officio).
Also present: Representative Bilirakis.
Staff present: Brittany Havens, Oversight Associate,
Oversight and Investigations; Charles Ingebretson, Chief
Counsel, Oversight and Investigations; Tim Pataki, Professional
Staff Member; Chris Santini, Policy Coordinator, Oversight and
Investigations; Alan Slobodin, Deputy Chief Counsel, Oversight
and Investigations; Sam Spector, Counsel, Oversight and
Investigations; Dylan Vorbach, Deputy Press Secretary;
Christine Brennan, Minority Press Secretary; Jeff Carroll,
Minority Staff Director; Waverly Gordon, Minority Professional
Staff Member; Ryan Gottschall, Minority GAO Detailee; Chris
Knauer, Minority Oversight Staff Director; Una Lee, Minority
Chief Oversight Counsel; Elizabeth Letter, Minority
Professional Staff Member; Andrew Souvall, Minority Director of
Communications, Outreach and Member Services; and Kimberlee
Trzeciak, Minority Health Policy Advisor.
OPENING STATEMENT OF HON. TIM MURPHY, A REPRESENTATIVE IN
CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA
Mr. Murphy. Good morning. We are here for the subcommittee
on Oversight and Investigations for the Committee on Energy and
Commerce for a hearing called ``Examining the U.S. Public
Health Response to the Zika virus.''
This morning we'll be examining this other public health
crisis affecting the Western Hemisphere, that Zika virus. This
virus of mosquito-borne pathogen is currently rampaging through
South and Central America, and in total has spread to more than
48 countries and territories.
While as of late February there have been no known locally-
acquired mosquito-borne cases reported in the Continental U.S.,
over 100 travel-associated Zika virus cases have been
identified in over 20 states. Outside of the 50 states local
mosquito-borne transmissions have been reported in Puerto Rico,
the U.S. Virgin Islands, and American Samoa. Public health
officials in the U.S. are bracing for the time when Zika passes
from a traveler with Zika in his or her blood to a local
mosquito, and then to another person.
Only about one and five people with Zika infection exhibit
symptoms, most of which are mild and flu-like. Of greater
concern is growing evidence of a link between Zika infection
and microcephaly, a congenital birth defect in infants born to
infected mothers, as well as Guillain-Barre Syndrome, an immune
disorder that can result in temporary paralysis. On this basis,
the World Health Organization recently declared Zika a public
health emergency of international concern.
The virus may also be transmitted through blood
transfusions and sex, leaving the Center for Disease Control to
issue interim guidelines for prevention of sexual transmission,
and the Food and Drug Administration to take steps to reduce
the risk to the U.S. blood supply.
Thus far, there has been only one reported case in the U.S.
of a child born with microcephaly to a mother with travel-
associated Zika virus. However, other pregnant American women
have become infected with Zika. Our understanding of how the
virus may impact a developing child during pregnancy is nearly
non-existent. We can, however, reasonably assume that a virus
affecting development of the brain on a large scale leading to
microcephaly in the first trimester will also impact
significant developmental functions for infants, toddlers, and
children exposed to the Zika virus. These include my concerns
for developmental disorders of difficulty with learning,
primary sensory and sensory integration, memory, attention,
concentration, behavior, mood, language, motor, and others.
Given all of the unknowns the importance of acting now to
protect pregnant women and women of reproductive age from
exposure to Zika virus cannot be overstated. However, we must
be equally concerned with protecting infants and children with
developing brains and not wait 5 to 10 years for symptoms to
appear before we take action to protect, to track, and to
treat.
To help prepare for and respond to Zika, the Administration
recently requested Congress provide over $1.8 billion in
emergency funding. The request includes support to states, U.S.
territories, the International Community for Mosquito Control,
virus testing, and expanding surveillance and response
activities. It also supports efforts to build upon existing
resources to develop a vaccine for Zika.
While the Administration's request has worthy aims, it's
one-off emergency funding approach like the $6 billion for
Ebola emergency funding demonstrates a reactionary posture
towards public health preparedness rather than a strategic one.
We want a strategic posture.
On February 12th, this subcommittee held a hearing
examining the federal government's preparedness for biological
threats focused on the finding of the Blue Ribbon Study Panel
on Biodefense. The panel concluded that the federal government
is ill prepared to handle future biological threats, an
alarming conclusion because since 2002 infectious disease
outbreaks, epidemics, and pandemics have emerged with
increasing frequency, and Zika is just the latest example of
this trend.
The Administration's response to Zika raises very serious
questions. There are no commercially available diagnostic tests
for Zika, nor has a vaccine been developed. In the absence of
these measures, mosquito control is the nation's critical
defense. However, mosquito control in the U.S. is a patchwork
of 700 mosquito abatement districts depending on the state,
county, and city funding and personnel with varying
capabilities. This unorganized hodgepodge could leave the U.S.
vulnerable to a rapid outbreak of Zika. The Administration has
not explained how its emergency request will address issues
with vector control. We want to work with the Administration to
solve that problem.
Public Health Departments and the CDC are using two Zika
diagnostic tests only available for U.S. labs. As the
Government Accountability Office testimony makes clear, these
tests have serious limitations, including the ability to either
detect Zika or to be able to distinguish Zika from other
viruses.
In addition, the confirmatory testing for Zika detection is
used only by CDC and a few labs, is cumbersome and not suitable
for screening a large number of individuals. This very limited
capacity for confirmatory testing is very troubling when we
consider the expected surge and the demand for Zika testing as
we reach the warmer months. Again, the Administration must
explain its plan to address this testing capacity issue.
Once again as with Ebola, we are assured that Zika will not
be a significant problem in the U.S., and while Dr. Anthony
Fauci of NIH has stated that it is unlikely the U.S. will have
a major Zika outbreak, other experts differ. In his written
testimony to this committee, Dr. Peter Hotez of Baylor School
of Medicine notes the experience of Texas showed a Dengue
outbreak occurred in the poorest areas of Houston and other
Gulf Coast cities vulnerable to Zika.
This morning we'll be taking testimony from a panel of
federal witnesses and experts, including the Assistant
Secretary for Preparedness and Response at HHS, the Director of
CDC, the Director of the National Institute of Allergy and
Infectious Diseases at NIH, the Acting Chief Scientists of FDA,
as well as the Chief Scientist of the GAO. Welcome. We will
then hear from a second panel featuring specialists in tropical
and maternal fetal medicine, mosquito control, and global
health law.
I want to thank all our witnesses for joining us this
morning and look forward to hearing your testimonies.
I now recognize, since Ms. DeGette is not here, we're
promoting her to the Ranking Member Pro Tempe of the
subcommittee, Ms. Castor of Florida, for 5 minutes.
[The statement of Mr. Murphy follows:]
Prepared statement of Hon. Tim Murphy
This morning, we will be examining a public health crisis
afflicting the Western Hemisphere. The Zika virus, a mosquito-
borne pathogen rampaging through South and Central America,
advances menacingly toward the U.S. The Zika virus has spread
to more than 48 countries and territories. While as of late
February there had been no known locally acquired mosquito-
borne cases reported in the continental U.S. states, over 100
travel-associated Zika virus disease cases have been identified
in over 20 states. Outside of the 50 states, local mosquito-
borne transmission has been reported in Puerto Rico, the U.S.
Virgin Islands, and American Samoa. Public health officials in
the U.S. are bracing for the time when Zika passes from a
traveler with Zika in his or her blood to a local mosquito, and
then to another person.
Only about one in five people with Zika infection exhibit
symptoms, most of which are mild and flu-like. Of greater
concern is growing evidence of a link between Zika infection
and microcephaly, a congenital birth defect in infants born to
infected mothers, as well as Guillain-Barre AE1 Syndrome, an
immune disorder that can result in temporary paralysis. On this
basis, the World Health Organization recently declared Zika a
``public health emergency of international concern.''
The virus may also be transmitted through blood
transfusions and sex, leading the Centers for Disease Control
(CDC) to issue interim guidelines for prevention of sexual
transmission and the Food and Drug Administration (FDA) to take
steps to reduce the risk to the U.S. blood supply. Thus far,
there has been only one reported case in the U.S. of a child
born with microcephaly to a mother with travel-associated Zika
virus; however, other pregnant American women have become
infected with Zika. Our understanding of how the virus may
impact a developing child during pregnancy is nearly non-
existent. Given all of the unknowns, the importance of acting
now to protect pregnant women and women of reproductive age
from exposure to Zika virus cannot be overstated.
To help prepare for and respond to Zika, the Administration
recently requested Congress to provide over $1.8 billion in
emergency funding. The request includes support to states, U.S.
territories, and the international community for mosquito
control, virus testing, and expanding surveillance and response
activities. It also supports efforts to build upon existing
resources to develop a vaccine for Zika.
While the Administration's request has worthy aims, its
one-off emergency funding approach, like the $6 billion for
Ebola emergency funding, demonstrates a reactionary posture
towards public health preparedness rather than a strategic one.
On February 12th, this Subcommittee held a hearing examining
the federal government's preparedness for biological threats,
focused on the findings of the Blue Ribbon Study Panel on
Biodefense. The panel concluded that the federal government is
ill-prepared to handle future biological threats--an alarming
conclusion because, since 2002, infectious disease outbreaks,
epidemics, and pandemics have emerged with increasing
frequency. Zika is just the latest example of this trend.
The Administration's response to Zika raises very serious
questions. There are no commercially available diagnostic tests
for Zika, nor has a vaccine been developed. In the absence of
these measures, mosquito control is the nation's critical
defense. However, mosquito control in the U.S. is a patchwork
of 700 mosquito-abatement districts dependent on state, county,
or city funding and personnel, with varying capabilities. This
unorganized hodgepodge could leave the U.S. vulnerable to a
rapid outbreak of Zika. The Administration has not explained
how its emergency request will address issues with vector
control.
Public health departments and the CDC are using two Zika
diagnostic tests only available for U.S. labs. As the
Government Accountability Office's testimony (GAO) makes clear,
these tests have serious limitations, including the ability to
either detect Zika or to be able to distinguish Zika from other
viruses. In addition, the confirmatory testing for Zika
detection is used only by CDC and a few labs, is cumbersome,
and not suitable for screening a large number of individuals.
This very limited capacity for confirmatory testing is very
troubling when we consider the expected surge in the demand for
Zika testing as we reach the warmer months. Again, the
Administration must explain its plan is to address the testing
capacity issue.
Once again, as with Ebola, we are assured that Zika will
not be a significant problem in the U.S. While Dr. Anthony
Fauci of the NIH has stated that it is unlikely that the U.S.
will have a major Zika outbreak, another expert differs. In his
written testimony to the committee, Dr. Peter Hotez, of Baylor
School of Medicine, notes that the experiences of Texas showed
dengue outbreaks occurred in the poorest areas of Houston and
other Gulf Coast cities vulnerable to Zika.
This morning we will be taking testimony from a panel of
federal witnesses, including the Assistant Secretary for
Preparedness and Response at HHS, the Director of CDC, the
Director of the National Institute of Allergy and Infectious
Diseases at NIH, the Acting Chief Scientist of FDA, as well as
the Chief Scientist of the GAO.
We will then hear from a second panel featuring specialists
in tropical and maternal-fetal medicine, mosquito control, and
global health law. I would like to thank all of our witnesses
for joining us this morning.
I now recognize the Ranking Member of the Subcommittee, Ms.
DeGette, for her opening statement.
OPENING STATEMENT OF HON. KATHY CASTOR, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF FLORIDA
Ms. Castor. Well, thank you, Mr. Chairman, for calling this
important hearing, and I want to thank all of our expert
witnesses who are here today for everything that you do to keep
American families healthy and safe.
So many of my neighbors across the State of Florida, and
the Gulf Coast, and Puerto Rico are very concerned with the
impacts of the Zika virus. We want our states and our
communities to be well prepared and we want to better
understand the impacts of the virus.
In Florida, CDC has confirmed the Zika case count is now up
to 44 cases. All of these cases are travel-related, so there
are no locally-acquired cases in Florida. Overwhelmingly,
people who have traveled to Brazil and Latin America to visit
family and friends, or travel on business or for pleasure have
contracted the virus and have brought it back. Fortunately, the
Zika symptoms are not severe but there is a great concern for
emerging evidence to support the association between Zika and
microcephaly in infants born to mothers who contracted the Zika
virus during pregnancy.
I'm also especially concerned with the American citizens in
Puerto Rico because we now have 117 confirmed cases. It is the
most affected area in the United States, and the CDC predicts a
sharp rise. Again, family and friends who travel back and forth
from Puerto Rico to the U.S. want to know what the impacts are
and how they can be better prepared, especially as spring and
summer approach. That's going to bring larger and more active
mosquito populations. The U.S. must be prepared to quickly
address local transmission within Puerto Rico, the Gulf Coast,
and the entire United States.
I'm also particularly concerned with the weakening of our
public health infrastructure across the country. After the
Great Recession, I saw very significant cuts in the State of
Florida, but Florida is not alone. We have those cuts and
weakenings to public health departments and public health
infrastructure. And I think Ebola was something of a wake-up
call, but the Zika virus and other viruses, diseases, we've got
to be better prepared. I agree with Chairman Murphy, a much
more robust prevention strategy would be in our best interest.
For the Zika virus, addressing the crisis requires a
multidimensional response, including accelerating the research,
development, and procurement of vaccines and diagnostics,
providing emergency assistance to states. Thank you, CDC, for
what you've done in responding quickly to the State of
Florida's request, and we've got to enhance our surveillance
capacity.
Thank you, again. I look forward to your testimony. I yield
back.
Mr. Murphy. Thank you. Now we'll take Mr. Upton's
testimony, and for the record recognize Dr. Burgess for 5
minutes.
OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF TEXAS
Mr. Burgess. Thank you, Chairman, thank you for the
recognition, thank you for having this hearing this morning,
thanks to our witnesses. We always learn so much when we have a
panel like this in front of us, and today I'm sure will be no
exception.
This virus continues to spread through the Americas and it
really has become clear that this is a direct threat to our
public health and our public safety. So I'm in contact with
people back in my state, and my county health officials, and
one of the things that they've expressed to me is concern over
the flexibility and the scalability of federal aid at the state
level, so I'm actually interested in hearing from our panel
about that this morning. Obviously, I share that concern. It is
important that state and local agencies, as well as the local
docs on the ground have the ability to fight what they need to
fight and not have barriers from us at the federal level.
You know, Ebola happened in our backyard in north Texas,
and many ways we thought we were prepared, but in some ways we
turned out not to be prepared. So I guess I'm interested this
morning; yes, I want the reassurances that we're prepared, but
I really also want to hear what were the Lessons Learned when
we went through the Ebola crisis in September and October of
2014, and what is the applicability of those lessons to what's
going on on the ground today. A variety of other questions
concerning the testing and the development of tests for this
illness. And, obviously, I'm terribly interested, Dr. Fauci, in
the pathogenesis of the illness as it affects pregnancies, both
miscarriages and infants who are born affected, and very
interested in learning the status of the vaccine development.
Thank you, Mr. Chairman. I will yield back my time.
Mr. Murphy. Anybody else on our side wish to take any time?
If not, Mr. Pallone on his way but what we'll do is we will
begin our testimony, or begin that process. When he comes in,
we may interrupt after one of you speak.
Let me introduce the panel, start off with this. We have
Dr. Nicole Lurie, Assistant Secretary for Preparedness and
Response with the Department of Health and Human Services; Dr.
Thomas Frieden, Director of the Centers for Disease Control and
Prevention; Dr. Anthony Fauci, Director of the National
Institute of Allergies and Infectious Diseases at NIH; Doctor,
is it Luciano or Luciana?
Dr. Borio. Luciana.
Mr. Murphy. Luciana Borio, Acting Chief Scientist at FDA;
and Dr. Timothy Persons, Chief Scientist at the U.S. Government
Accountability Office. Welcome everyone for being here.
You're aware that the committee is holding an investigative
hearing and when so doing has the practice of taking testimony
under oath. Do any of you have any objections to taking
testimony under oath? Seeing no objections, the Chair then
advises you that under the rules of the House and the rules of
the committee you're entitled to be advised by counsel. Do any
of you desire to be advised by counsel during your testimony
today?
Dr. Borio. No.
Mr. Murphy. No one wants that, so in that case would you
all please rise, raise your right hand. I'll swear you in.
[Witnesses sworn.]
Mr. Murphy. Thank you. You are now all under oath and
subject to the penalties set forth in Title 18, Section 1001 of
the United States Code. We'll have you give a 5-minute opening
statement. Mr. Pallone, do you want to give yours now or do you
want to wait until we do some of the panel? We can go right to
your opening statement.
Mr. Pallone. It's up to you.
Mr. Murphy. Well, let's make a smooth transition. If you're
ready, we'll do that now, and then I'll call on Dr. Lurie. We
just did the swearing in so you're aware of what we did. So Mr.
Pallone is recognized for 5 minutes.
Mr. Pallone. Thank you, Mr. Chairman, and the witnesses
today for joining us to discuss the Zika virus and what the
federal government is doing to respond to the threat.
Zika represents a serious threat to global health and
security and we must address that threat decisively both at
home and abroad. It's suspected of causing a multitude of
devastating birth defects, most notably microcephaly, a
condition which babies are born with severe brain defects. In
adults, the virus has been associated with Guillain-Barre AE1
Syndrome which can result in paralysis and even death. Although
scientists are not able to say definitively that Zika is the
cause, evidence is mounting each day to support a causal
relationship between the virus and these serious health
conditions.
The Zika virus is spreading explosively through the
Americas with active local transmission in 31 countries and
territories. The Pan American Health Organization predicts that
the virus will eventually spread to every country in the
Americas except perhaps Canada and Chile.
The crisis in Puerto Rico could become particularly severe
as Zika is expected to infect one in five Puerto Ricans, and
given the territory's debt crisis and inability to fund even
the most basic health services robust assistance from the
federal government will be absolutely crucial to contain the
virus and protect as many pregnant women as possible.
As spring and summer approaches we must also be prepared to
address local transmission of Zika within the Continental
United States, particularly in southern states where the
mosquitoes that carry the disease are common.
As Dr. Hotez on our second panel has previously noted,
``Local transmission of Zika in the U.S. will likely
disproportionately affect poor neighborhoods in the southern
states where inadequate window screening, standing water, and
imperfect waste disposal provide ideal mosquito breeding
grounds, and addressing Zika will require a multidimensional
public health response. It must include accelerating research,
development, and procurement of vaccines and diagnostics,
providing emergency assistance to states and the U.S.
territories, and enhancing our surveillance capacity to track
the Zika virus in people and in mosquitoes.''
The Administration has requested emergency funding to
address each of these components, and I look forward to hearing
more about the details of this request today. Unfortunately,
the Republican chairs of the House Appropriations Committee
have declined to fund the Administration's request and have,
instead, called upon the agencies to divert unobligated Ebola
funds. I believe this decision is shortsighted and would
increase health risks both at home and abroad.
As our witnesses will make clear today, Ebola remains and
will continue to remain a threat to human health for the
foreseeable future. It could reemerge at any point, and as
we've seen it can cause outbreaks that decimate economies,
trigger widespread panic, and result in a tragic loss of human
life.
NIH is using its Ebola funds to conduct essential ongoing
research including the development of an Ebola vaccine, and CDC
is continuing to conduct its global efforts to combat the Ebola
Virus on the ground. Shortchanging these efforts would damage
our ability to effectively respond to both Zika and Ebola, as
well as to any future threats. The remaining Ebola funds are
largely committed to the global health security agenda, a
multi-year effort to keep Americans safe by strengthening the
capacity of developing countries to prevent, detect, and
respond to emerging epidemics.
Let's not forget how Ebola managed to spiral out of
control. To build an effective global system for containing
infectious disease we must make sure that the poorest and most
vulnerable countries have the surveillance capacity to identify
outbreaks and respond quickly, and fighting Zika will not be
easy. Like Ebola, it thrives in impoverished communities and
its heaviest burden falls on vulnerable populations least able
to respond. The disease is difficult to track as most people
infected with Zika experience no symptoms, and the research
agenda is extensive given how little we know about the disease.
But I'm confident that our federal agencies are up to the task
as long as Congress does its part and provides the necessary
resources. And I hope that all my colleagues on both sides of
the aisle recognize the importance of these investments and
that we'll be able to work together in a bipartisan manner to
address the Zika threat in the coming weeks.
Thank you, Mr. Chairman. I yield back.
Mr. Murphy. Thank you. Now we'll go and proceed with the
testimony. We'll start with you, Dr. Lurie. You know how this
works; watch your lights and try and keep it at 5 minutes.
Thank you very much. You may proceed.
STATEMENT OF NICOLE LURIE, M.D., ASSISTANT SECRETARY FOR
PREPAREDNESS AND RESPONSE, U.S. DEPARTMENT OF HEALTH AND HUMAN
SERVICES; THOMAS FRIEDEN, M.D., DIRECTOR, CENTERS FOR DISEASE
CONTROL AND PREVENTION; ANTHONY FAUCI, M.D., DIRECTOR, NATIONAL
INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES, NATIONAL
INSTITUTES OF HEALTH; LUCIANA BORIO, M.D., ASSISTANT
COMMISSIONER, COUNTERTERRORISM POLICY, U.S. FOOD AND DRUG
ADMINISTRATION; TIMOTHY PERSONS, Ph.D., CHIEF SCIENTIST, U.S.
GOVERNMENT ACCOUNTABILITY OFFICE
STATEMENT OF NICOLE LURIE
Dr. Lurie. Thanks. Good morning, Chairman Murphy, Ms.
Castor, and distinguished members of the subcommittee. I'm Dr.
Nicole Lurie, the Assistant Secretary for Preparedness and
Response, and thank you for the opportunity to talk to you
today about yet another emerging threat, the Zika virus.
While we don't yet know everything we need to know about
Zika, as a primary care physician and as a mom, I know how
deeply concerning what we're all learning is. As you know, ASPR
was established almost a decade ago by the Pandemic and All
Hazards Preparedness Act in part to overhaul the government's
approach to emergencies that threatens the public's health,
whether naturally occurring or manmade. Since that time and
with the support of Congress including many of you, ASPR has
done just that, developing a flexible set of capabilities to
quickly adapt to challenging threats, including Ebola, MURS,
and now Zika virus.
Since early reports of the potential link between Zika
virus and microcephaly, HHS has taken proactive and as
scientific evidence has mounted increasingly targeted actions
to protect the American people. Today I'll highlight three
areas in which ASPR's work is critical.
First, our central role is to coordinate across HHS and
beyond ensuring that all components have the latest information
and best scientific evidence to inform key decision making, and
that all are driving toward the same goals.
Second, ASPR has a mandate to develop the most promising
medical countermeasures through the Biomedical Advanced
Research and Development Authority or BARDA. I know this
committee is aware of how successful BARDA has been producing
22 licensed products and support nearly 200 countermeasure
candidates over the years.
Third, ASPR is clearing longstanding obstacles to progress
in this area, such as agreements on virus sample sharing and
close collaboration with regional and international partners.
You should know that well before the first case of Zika in the
U.S. in early January, I convened the HHS Disaster Leadership
Group to coordinate our preparedness efforts. This group is
made up of leaders from across HHS including CDC, NIH, and FDA,
and it ensures that the department's senior leaders have shared
awareness and the ability to make timely, informed, and
coordinated decisions during emergencies. We've convened this
group for every emergency and it will continue to meet
throughout this crisis.
Similarly, on December 2nd of last year I directed the
Public Health and Medical Countermeasure Enterprise or PHEMCE
to conduct a comprehensive review of its portfolio to identify
candidate products with the potential to stop transmission of
Zika.
This committee is well aware that the best ideas for
medical countermeasures won't translate into the drugs,
vaccines, diagnostics we need without investment. The BARDA
component of ASPR is tasked with transitioning promising
medical countermeasures through advanced development and across
the so called valley of death toward FDA approval. In the case
of Zika we've established three countermeasure priorities,
vaccines, diagnostics that can detect both acute and previous
infections, and insuring a blood supply that's safe by
developing blood screening tests for Zika, and techniques for
virus inactivation in blood.
Because access to virus samples is critical for developing
diagnostics and vaccines, we've worked across government to
successfully establish sample sharing and vaccine development
agreements, including with Panama and Brazil, respectively.
We've also established a mechanism to address international
requests for assistance because we recognize that health
security knows no borders.
While we move forward aggressively to prepare for the
threat of Zika, many of our efforts will depend on new
resources. The Emergency Supplemental Request includes funds
for CDC, which is responsible for the bulk of the public health
response, for medical countermeasure development, and for
contingencies that may arise over the course of the response.
For countermeasures we've been successful in moving from a
reactive model of preparedness to a proactive one, building on
strong day to day systems and a flexible set of capabilities to
do this. The same goes for state and local health departments
which is why preparedness for all hazards is so important.
A lesson from both H1N1 and Ebola was the need for flexible
funding to insure that we can move quickly as other departments
can so that something that starts as a crisis does not become a
full-blown emergency. The contingency fund included in the
President's supplemental request addresses this overarching
need; enabling us, if needed, to make emergency procurements or
quickly take other actions that become necessary but that we
cannot currently anticipate.
In sum, HHS has mounted a proactive and coordinated
response to the Zika virus, building on Lessons Learned from
previous challenges, and the domestic preparedness
infrastructure we've worked so hard to establish. Congressional
approval of the Administration's funding request will provide
critical resources to improve our ability to prevent, detect,
respond, and rapidly adjust to Zika and other emerging vector-
borne infectious diseases.
Thank you again for inviting me here. I look forward to
your questions.
[The statement of Dr. Lurie follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Murphy. Thank you, Dr. Lurie.
Now, Dr. Frieden, you're recognized for 5 minutes.
STATEMENT OF TOM FRIEDEN
Dr. Frieden. Thank you very much, Chairman Murphy,
Representative Castor, and members of the subcommittee.
At the outset, I want to make a few key points. First,
we're literally still discovering new things every day about
Zika. CDC has about 600 staff currently working on this
response. We're activated at Level 1, the highest level of our
emergency operations center. We have staff in Brazil, Colombia,
Puerto Rico, and other parts of the world looking at and
learning from a developing situation.
Zika is new, and new diseases can be scary particularly
when they affect the most vulnerable among us. And it's also
particularly scary because in Puerto Rico today cases are
doubling every week. By April we're likely to see widespread
transmission in Puerto Rico, and by June, mosquito season is
likely to start in parts of the U.S. where the mosquito that
can spread Zika is present. There's a limited window of
opportunity to take action. When we look at chikungunya which
affected Puerto Rico, started in 2014, within 2 months it was
all over the island, within 8 months one out of four adults
were infected. If that pattern is followed with Zika we could
see hundreds of thousands of infections by the end of the year.
CDC is working 24/7 to respond to this, learning more about
the link with microcephaly, Guillain-Barre AE1 Syndrome,
improving diagnostics, looking at ways to optimize vector
control with current tools. This is the latest in a series of
unpredicted and unpredictable health threats. What is
predictable is that there will be more health threats, and
that's why it's so important that we continue to improve the
ability of countries around the world to find, stop, and
prevent health threats.
Now, first, what do we know about Zika? You've outlined,
Mr. Chairman, other members some of the key facts here. It's
been around since 1947. We didn't know it could cause outbreaks
until 2007. It was thought to cause mostly mild disease. It
spread primarily by the Aedes aegypti mosquito. This is the
cockroach of mosquitoes. It lives indoors, it lives in the
shade, it is hard to kill, and it's very effective at spreading
diseases. That's why Dengue and Chikungunya and other diseases
spread by it can spread so explosively.
What is really new and unprecedented is the link to
microcephaly. It's been more than 50 years since a pathogen
causing microcephaly or other severe birth defects was
identified that would do so on such a broad level. And as far
as we know, never before has there been a mosquito-borne cause
of a severe fetal malformation.
The link to Guillain-Barre AE1 Syndrome looks increasingly
certain. Studies published this week, if replicated would
basically prove that link, and it wouldn't be surprising. We've
seen Guillain-Barre AE1 Syndrome after a wide variety of
infections. But microcephaly, the complication of microcephaly
is truly unanticipated, potentially catastrophic, and
permanent, the very definition of the need for an emergency
supplemental response.
Fundamentally, there are four different patterns of spread.
First, among travelers, some of them pregnant. And we have 40
million people going to and from Zika-affected areas each year.
Second, sexual partners. This is why we issued guidance to
reduce the risk of sexual transmission. Third, possible cases
and clusters in parts of the U.S. that have the mosquito
vectors present. That's why we need to scale up our support for
those entities. Fourth, areas likely to have widespread
transmission around the world, and especially in parts of the
U.S., including Puerto Rico, that have had large outbreaks of
Dengue.
The supplemental is critically important for CDC to respond
as part of a whole of government response. The request of CDC
is for $828 million in three categories: urgent support for
Puerto Rico, a response in the Continental U.S., and
international support, as well.
There are many very concerning diseases out there whether
it's Ebola, SARS, MURS, or the next HIV. We can't let down our
guard. Supplemental funding is essential for us to do several
things, including reducing the risk to pregnant women by
finding out more and doing more especially in Puerto Rico and
other areas where it may spread widely, by finding where
mosquitoes are spreading in the U.S., and better controlling
them, by establishing a registry for birth defects and
improving the monitoring of pregnant women, by supporting
states and territories directly to improve prevention and
management of cases, diagnosis of patients, increased
laboratory capacity, and implement key interventions. This is a
critically important and urgent need, and I look forward to
answering your questions. And thank you for the invitation to
appear before you today.
[The statement of Dr. Frieden follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Murphy. Thank you, Dr. Frieden.
Dr. Fauci, you're recognized for five minutes.
STATEMENT OF ANTHONY FAUCI
Dr. Fauci. Mr. Chairman, Ms. Castor, members of the
committee, first I want to thank you for giving me the
opportunity to discuss with you today the role of the National
Institute of Allergy and Infectious Diseases and the NIH in
general in the research endeavor to address this. As you know,
the NIH is part of a multi-component aspect of the Department
of Health and Human Services, and we're responsible primarily
for the research for the development of countermeasures.
As I have told this committee in past hearings, the dual
mandate of the Institute is somewhat unique among NIH
institutes because although we, like others, have the
responsibility of developing a robust basic and clinical
protocol and agenda in all of the areas for which we're
responsible, for us it happens to be infectious diseases,
microbiology, and immunology. However, we also have the unique
dual mandate of being able to respond very rapidly to emerging
threats. And as a matter of fact, that's exactly what we're
doing right now.
I had the opportunity and the privilege to write this
perspective in the New England Journal of Medicine in January
in which I said exactly what Mr. Chairman said in his opening
statements, that this is yet again another threat, another
arbovirus threat. If you historically over the last couple of
decades we had West Nile, we have chikungunya, we have dengue,
and now we have Zika. And as Tom said just a few moments ago,
we're going to have others, so it's very important for us to
have as part of the overall effort a research component to be
able to develop the response. And as shown on this slide it's
multifaceted. We do everything from basic research to
fundamental clinical research and clinical trials. We do
provide, not very well appreciated, the research resources for
pharmaceutical companies, as well as for academics who want to
get into the field of studying this disease, and we're already
negotiating with a number of them.
The bottom line of it all, and the end game is to develop
diagnostics, therapeutics, and vaccines. I just want to spend a
minute or so going through some of the things that we are now
addressing.
First, natural history. We were discussing just a couple of
moments ago, it's very important to understand the true natural
history, not only of the disease, symptomatic versus
asymptomatic. Can an asymptomatic person who's infected and
pregnant actually have a baby who is a microcephalic baby, or a
baby that has a congenital defect? We need to study that. we
also need to have cohort studies to understand how this has
evolved. What we call pathogenesis of disease is trying to
understand how this disease evolves. We did this with Ebola, we
did this with HIV, and we're planning to do that with Zika.
Another is the fundamental basic research. We know an awful
lot about viruses like HIV, like chikungunya, like dengue. We
need to know a lot more about Zika. Luckily, it's related to
some of those diseases.
Also, the immune response. We don't understand a lot about
the immune response. The immune response is generally helpful.
We know with dengue that immune response can actually enhance
disease. We need to know the protection against Zika, and
whether or not there are any deleterious effects. And also, we
need to establish animal models.
You mentioned vector control. We do have basic research
collaborations with pharmaceutical companies and individual
investigators looking at novel ways to have vector control.
You've heard of several of these such as Wolbachia infection of
mosquitoes or genetic modification of mosquitoes.
Also in diagnostics, the CDC has taken the role in
developing and now distributing widely some of the diagnostics
that are available, but we still need high specific, easy to
perform diagnostics that can tell an important question. To
tell if someone is infected is relatively easy. We do a PCR,
it's highly specific. The question that is really on everyone's
mind is, have I been infected and if so, how long ago? And that
is something that needs specificity because the current
available antibody tests tend to cross-react with diseases that
are prevalent in these societies, particularly dengue.
Now the issue that we're really concentrating much of our
effort on is the issue of vaccines, and we now do have a couple
of candidates that we're looking at putting into a Phase 1
trial, hopefully by the end of this summer and early fall,
which will take a couple of months to determine if, in fact,
they're safe and do they induce an immune response that will
allow us to go to the next phase of the response, which is an
efficacy phase. And we have a number of candidates that I'll be
happy to talk to the group about during the question period.
One I want to bring up in particular, and that is why we
have what we call vaccine platforms, things that we have
experience with. An example is, we developed a vaccine for West
Nile virus several years ago. It was safe, and it induced a
good immune response. Unfortunately, there was no company that
was particularly interested in partnering with us. I don't
think we're going to have that problem now because we have a
number of companies that are interested. But what we've done is
we've taken that DNA platform and done a very simple thing;
we've pulled out the gene of West Nile and we stuck in the gene
of Zika, and we're going to be starting a Phase 1 trial, as I
mentioned, hopefully. And then finally, we have our screening
assays for the development of therapeutics we're going to be
looking at because, obviously, therapeutics are a very
important part.
So I'll close with this last slide, reiterating what Dr.
Frieden, and Dr. Lurie, and I said, that these threats will
continue to confront us. And I want to thank the committee for
your interest and support of us during these periods. Thank
you.
[The statement of Dr. Fauci follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Murphy. Thank you, Dr. Fauci.
Dr. Borio, you're recognized for 5 minutes.
STATEMENT OF LUCIANA BORIO
Dr. Borio. Good morning, Chairman Murphy, Representative
Castor, and members of the subcommittee. Thank you for the
opportunity to discuss the FDA's actions to respond to the Zika
virus outbreak.
FDA is working closely with our partners to help minimize
the impact of yet another tragic outbreak. Last month I had the
privilege of traveling to Brazil, my country of birth, with a
small HHS delegation to meet with the Brazilian Minister of
Health and several of his senior officials. The engagement was
extremely productive. In particular, FDA and ANVISA,
Brazilian's National Regulatory Agency, committed to working
very closely and reach convergence in the areas of vaccine
development and diagnostic tests.
FDA is working to help protect the safety of our nation's
blood supply, to facilitate the development and availability of
blood donor screening and clinical diagnostic tests, to support
the development and investigation of vaccines and therapies, to
review a proposal for the use of innovative strategy involving
genetically engineered mosquitoes to enhance vector control,
and to protect the public from fraudulent products. To help
mitigate the risk of Zika transmission from blood transfusions,
FDA issued guidance recommending important measures to keep our
nation's blood supply safe. And just yesterday, FDA issued new
guidance with recommendations to reduce a risk of transmission
of Zika by human cellular and tissue-based products are used in
medical procedures.
I'm happy to report that last week we issued the first
emergency use authorization for a test developed by the CDC. We
continue to work very interactively with the CDC and several
diagnostic companies, several diagnostic companies to support
development of additional tests.
The association between Zika, microcephaly, and other pro-
pregnancy outcomes results in a very serious and challenging
situation for pregnant women who test positive for Zika virus
infection. Just last week, CDC reported that among nine
pregnant travelers with laboratory confirmed Zika virus
infection there were two early pregnancy losses, two elective
terminations, and one infant with severe microcephaly at birth.
It is not difficult to imagine the fear, uncertainty, and
anguish these women and their families likely experienced;
therefore, it is essential that diagnostic tests for Zika virus
provide accurate results.
In recent weeks we have seen an increased interest by
clinical laboratories to develop their own tests for Zika. We
share the goal of expanding the availability of good tests, and
to support these efforts FDA developed simple templates that
developers can use to submit data to the FDA for expedited
review, but FDA is urging developers to work with us to insure
that their tests meet the standards for accuracy and precision.
And I need to make clear that FDA will not hesitate to take
appropriate action to prevent the use of tests that did not
meet our standards.
FDA is actively engaged with NIH and BARDA to help
accelerate the development of vaccines, and as we did during
the Ebola epidemic we will do all we can to facilitate access
to investigation of vaccines through appropriate clinical
trials as quickly and safely as possible.
Finally, we are reviewing a proposal for a field trial to
determine whether the release of a genetically engineered line
of Aedes aegypti mosquitoes will suppress the local Aedes
aegypti mosquito population in the release area of Key Haven,
Florida. We are preparing to very soon release for public
comment a Draft Environmental Assessment regarding the
potential impacts of this proposed field trial.
In closing, FDA is deeply engaged and fully committed to
sustaining our aggressive response activities to mitigate the
impact of Zika. Thank you.
[The statement of Dr. Borio follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Murphy. Thank you, Dr. Borio.
Now, Dr. Persons is recognized for 5 minutes.
STATEMENT OF TIMOTHY PERSONS
Mr. Persons. Thank you, Mr. Chairman, Ms. Castor, and
members of the subcommittee. I'm pleased to be here today to
discuss GAO's preliminary observations on Zika virus disease.
I'll summarize our findings of the four topics you asked us to
examine; specifically, one, the epidemiology and transmission
of Zika including what's known about its link to microcephaly
and neurological diseases. Two, the current diagnostic and
testing methods for Zika. Three, the methods for mosquito
control. And, four, the proposed federal research agenda as it
relates to Zika virus and disease.
With regard to epidemiology and transmission, while several
countries noted over here on this graphic have reported
outbreaks of Zika virus disease, unanswered questions remain
regarding the epidemiology and transmission of the disease.
Accurate information on the incidents of Zika is lacking. Five
primary reasons for this are first, about 80 percent of persons
who are infected do not show clinical symptoms resulting in
potentially significant underestimation of the true incidence
of infection. Second, since many of the remaining 20 percent of
those who manifest clinical symptoms may not go to a physician
because the symptoms are mild, the true incidence of disease is
potentially significantly under-reported. Third, an accurate
count of the number of cases of Zika virus disease requires a
consistent standardized international case definition; however,
at the moment different countries have different definitions,
thus complicating epidemiological analysis and research.
Fourth, on February 1st of this year the World Health
Organization acknowledged that there was no international
standard surveillance case definition for microcephaly.
Problems with changing case definitions, lack of sufficient
information on underlying causes of brain pathology, and lack
of baseline data make it difficult to accurately determine the
increase of microcephaly in Brazil, and how much stems from the
Zika virus. And fifth, the lack of approved diagnostic tests
complicates our understanding of the virus and may hinder our
response to the current outbreak.
With regard to detection and testing, currently no
commercially available test exists for Zika, as the Chairman
pointed out. The FDA recently issued an emergency use
authorization for an antibody-based test for the Zika virus;
however, the main limitation is the inability to differentiate
between infection with Zika and infection with other closely
related flaviviruses such as dengue. Since closely related
flaviviruses such as dengue may also be present in regions
where Zika has broken out, the use of this test could
incorrectly identify non-Zika virus associated infections, thus
risking extra burden on laboratory and health care systems, and
distorting epidemiological analyses.
With regard to mosquito control, because Zika virus disease
cannot yet be prevented by drugs or vaccines, controlling the
vector remains a critical factor in mitigating the spread of
the virus, and hence disease. GAO identified three categories
of mosquito control. First, standing water treatment. Second,
insecticides. And third, emerging technologies.
The WHO determined that maintaining vector control after a
disease subsides is complicated by dwindling resources. In the
United States, vector control methods are under state and local
jurisdictions which determine the method to use by local needs
and factors. Emerging control technologies include the use of
biologicals, genetically modified mosquitoes, and auto
dissemination traps. According to the scientific literature
these technologies show some promise in studies and field
trials but would need to be part of an overarching integrated
mosquito control strategy.
With regard to the federal research agenda, the NIH and CDC
have identified several high priority areas for research; for
example, linkages between Zika and microcephaly, improving
diagnostic tests and vaccine development. Efforts in these
areas are necessarily ambitious but agencies may face
challenges in implementing this agenda. For example, given the
number of known cases in the U.S. is so few, NIH and CDC may
have to rely on the cooperation of other countries to account
for a sufficient number of cases to carry on the proposed
research. However, data from other countries may differ because
of differing definitions of Zika virus disease and
microcephaly.
Turning to vaccine development, NIH officials told us that
given their experience with the development of a vaccine for
dengue fever, a vaccine for Zika could be ready in 3 to 4
years. Zika virus disease poses new challenge to vaccine
development testing especially on pregnant women for whom
several barriers to developing and testing vaccines exist.
Overcoming these barriers may extend the time for vaccine
testing and approval, and the information we have from NIH in
our prior work suggests that developing a Zika virus vaccine
may take longer than currently anticipated.
In conclusion, GAO's past work including, for example, our
recent analysis on Swine Enteric Coronavirus Disease outbreaks
in pigs has shown some similarities such as a lack of validated
diagnostic tests, immature mechanisms for reporting the disease
and no approved vaccine. These preliminary observations on the
Zika virus point to a persistent and urgent need for a
proactive, agile, integrated, and coordinated set of programs
in research and development including epidemiological studies,
mosquito control, testing capabilities, modeling and
simulation, and vaccine development, especially in light of
other emerging diseases such as chikungunya and dengue which
spread via the same mosquito vectors as Zika, and which also
pose a risk to human health.
Mr. Chairman, Ms. Castor, members of the subcommittee, this
concludes my prepared remarks. I'd be happy to respond to any
questions that you or other members may have at this time.
Thank you.
[Mr. Person's written statement has been retained in
committee files and can be found at: http://docs.house.gov/
meetings/if/if02/20160302/104594/hhrg-114-if02-wstate-personst-
20160302.pdf.]
Mr. Murphy. Thank you. I thank all the panel for your
information. Now we'll begin questioning. I'll begin with 5
minutes myself.
Dr. Lurie, under the Pandemics and All Hazards Preparedness
Act and its reauthorization, the Assistant Secretary for
Preparedness response was create a lead federal official for
coordinating these health emergencies. My understanding,
Secretary Burwell designated you as Lead Federal Official for
coordinating the response with Flint and Ebola. Am I correct?
[No response.]
Mr. Murphy. Has she named you the Lead Federal Official for
the Zika response?
Dr. Lurie. So in terms of the Zika response, ASPR's role as
it usually is, is to coordinate for her and on her behalf
policy issues and other issues related to the Zika response.
ASPR is very actively fulfilling that role, as you heard in my
testimony. As part of that role, the CDC has primary
responsibility for the operational public health response, and
Dr. Frieden has the lead for that.
Mr. Murphy. So is that how it's going to break down, the
Lead Federal Official will be Dr. Frieden, and not you, or do
we----
Dr. Lurie. ASPR has coordinating responsibility on behalf
of the Secretary for this. The primary response is an
operational public health response and that's what CDC does day
in and day out.
Mr. Murphy. We just want to make sure we have some sense of
how this is working out.
Dr. Lurie. Yes, absolutely.
Mr. Murphy. Dr. Persons, what are the concerns associated
with the assay recently authorized by the FDA for emergency
use?
Mr. Persons. Yes, thanks, Mr. Chairman. The test is called
the MAC-ELISA test. Its main concern is just its cross-
reactivity with other flaviviruses, as other witnesses have
pointed out. So you can tell that you have a related flavivirus
but you cannot have the specificity to say you have Zika with
assurance, unless or until you have the RT PCR basis to back
you up and do that.
Mr. Murphy. But is all this going to put an extra burden on
the labs and health care systems, and will that distort some of
our analysis then if we can't fully do that?
Mr. Persons. That is, indeed, a risk to the system.
Mr. Murphy. Dr. Frieden, do you want to comment on that,
too?
Dr. Frieden. Just to clarify, the IGM that was FBUA
approved by FDA in wonderful excellent time with good
collaboration, that test we believe is accurate, particularly
in people less likely to have been exposed to dengue. There is
a second test that we do which is a neutralization assay, a
PRNT on the IGM positive, so we would in some cases, depending
on the combination of the IGM and the PRNT be able to say we
believe it is definitively Zika. In other cases we can say only
that it's a flavivirus that may or may not----
Mr. Murphy. So we can get a false positive if they've been
exposed to dengue. Is that what happens, Dr. Borio?
Dr. Borio. Well, just for clarity, is that the emergency
authorization is not just for the ELISA test, the one that
causes the cross-activity. The authorization is for the ELISA
test and a confirmatory test done at CDC. We will have very
high standards for the UA.
Mr. Murphy. I'm aware of that, and you had elaborated this
point, too. I just want to find out if we have enough capacity
in our public health labs and health care system to handle what
the GAO is concerned about with this emergency response. If we
don't, we need to know that as Congress.
Dr. Frieden. So we are concerned about the capacity in
terms of the number of tests. Our laboratories have been
working around the clock for the PCR. We've produced more than
370,000 of them. We think that's ample for the MAC-ELISA. We're
up around 100,000 level. It could be that in some places, in
some areas individuals who want to be tested will not be able
to be tested until we further scale up production and roll out
validation of the state labs.
Mr. Murphy. Let me make sure I understand this. So if we're
also currently trying to develop a vaccine and some people who
have been exposed to Zika virus will be immune to it. And is
that the avenue? I guess, Dr. Fauci, this is your area. Is that
the avenue by which will help us determine a vaccine, if some
people have developed their own immunity? Does that give us
some other ideas of where to go with this? Am I down the right
road there?
Dr. Fauci. Yes. I think in a vaccine trial it depends on
what stage of the trial. When you're in a Phase 1 trial those
are people who are completely normal. That's the thing I was
mentioning that would start at the end of the summer. When you
get into a trial in the field in Brazil, obviously you're going
to want to know people who were pre-exposed, as well as people
who were not exposed as a subgroup of the study. The
fundamental study will be to determine the extended safety and
some degree of efficacy in a Phase 2A2B. As a subset of that
group, you'd want to know what the response would be in those
who were previously exposed, perhaps asymptomatically, versus
those who were never exposed.
Mr. Murphy. And so where we are now, we don't have the
capacity and you're asking Congress for help because we just
don't have the capacity to handle this. Right, Dr. Frieden?
Dr. Frieden. There are many things that we will not be able
to do or do at scale without the emergency supplemental.
Mr. Murphy. And this will delay our responsiveness and
detection in developing a vaccine until we get this level
higher? We all agree with that?
Dr. Fauci. Agreed.
Mr. Murphy. Thank you. Ms. Castor, recognize you for 5
minutes.
Ms. Castor. Thank you. The Zika outbreak began in Brazil
nearly a year ago, and it's rapidly spread across the Americas.
I'm very concerned by the virus' recent arrival in Puerto Rico
and its rapid spread there. News reports earlier this week said
there are well over 100 confirmed cases of Zika in Puerto Rico,
and that the number is almost sure to rise over the next few
weeks.
Dr. Frieden, can you give us an update on the situation in
Puerto Rico? What should we expect to see there in the coming
weeks? And then could you go into greater detail on the current
diagnostic tools in Puerto Rico, and whether or not they differ
in Brazil and across the Americas?
Dr. Frieden. Thank you very much. In Puerto Rico we have
basically the 1-2 punch of Zika and similar viruses. We have
the mosquito that can spread the virus, and we have a human
environment without screens and air conditioning widely
available that lead to explosive spread of viruses spread by
this mosquito. So as I mentioned earlier, we have chikungunya
which spreads by the same mosquito. One out of four adults
became infected with it within 8 months of the introduction of
that virus to the island.
In terms of the diagnostic tests, the tests are the same
but they perform differently in different places depending on
what the individuals there have been exposed to. So first off,
as Dr. Fauci mentioned, the test for active infection, that's
straightforward and accurate, so if someone is sick, they have
fever, then between the onset of symptoms or maybe a day or two
before until about four to seven days after symptom onset, that
test will be positive and it's definitive. But past that period
it's much more challenging to determine whether someone was
previously infected with Zika. That requires looking at
antibodies, and the EUA that the FDA approved on Friday allows
us to do that in a way that looks at the IGM or short-term
antibody response which may become positive within the first
week, and stay positive for some as yet undetermined period of
time, it could be months. And then to confirm that with a test
that actually grows the virus and sees if it is inhibited by
the patient's own serum, the neutralization assay. So it's an
algorithm-based testing. CDC has a dengue branch in Puerto
Rico. We currently have all 50 of our people from that branch
plus another 25 from the rest of CDC on the island now working
hard on every aspect of the response.
Ms. Castor. Dr. Fauci, Dr. Borio, do you want to add
anything on the diagnostics?
Dr. Fauci. No, but we will do better. As Dr. Frieden said,
this is what we have right now, but we are all of us trying
very hard to develop a much more specific test that would
answer the question directly that everyone is concerned with.
But for what we have now, that's what we're talking about.
Dr. Lurie. I would only add that we've been really
approached by a whole array of companies who are now actively
working to develop their own diagnostic tests. We're in a
position to provide them support and to work closely in
collaboration with FDA to make a smooth, easy path if those
diagnostics are effective.
Ms. Castor. Thank you. And, Dr. Frieden, Puerto Rico has
seen recent outbreaks of other related infectious diseases in
Puerto Rico. What have those outbreaks taught us about Puerto
Rico's public health infrastructure and its capacity to
respond?
Dr. Frieden. Well, I think it's fair to say that mosquito
control, the capacity is very limited. In addition, the
challenges of controlling this mosquito are very great so even
though there have been efforts to reduce spread of dengue and
chikungunya, they have had very little, if any, impact on the
actual disease spread.
Ms. Castor. I understand that the FDA has issued guidance
on blood donation calling on blood banks in areas where Zika is
locally transmitted to import blood from regions without an
outbreak, instead of using local donations. Dr. Borio, what
does that mean for Puerto Rico? Does it affect their ability to
provide medical care to their residents?
Dr. Borio. So FDA's guidance meets an important public
health need, which is to keep the nation's blood supply safe.
In areas with active transmission, the guidance does require
whole blood and blood components to be imported from areas
without active virus transmission until a diagnostic test that
can be used to screen the blood supply is available. So there
is a potential that our guidance could impact in theory the
supply of blood to areas of active transmission.
That being said, that should not be the case in Puerto Rico
because we have been working very closely with our partners,
Puerto Rico health officials, CDC, and Dr. Lurie's office to
mitigate the impact of our guidance. And Dr. Lurie may have
more to add on that.
Ms. Castor. Well, I note that the President's emergency
budget request includes $225 million for grants in technical
assistance for Puerto Rico and other U.S. territories facing
Zika outbreaks. Is that going to get to the heart of the
matter?
Dr. Frieden. That is crucially important for us to be able
to mount a robust response, and the sooner the better.
Ms. Castor. Thank you very much. Thank you, Mr. Chairman.
Mr. Murphy. Yes, just a follow-up. Would you say that
Florida and Texas are probably some of our highest risk states?
Dr. Frieden. Yes, we've seen clusters of dengue and
chikungunya in Florida or Texas, and because of the presence of
the vector we anticipate that these could be areas where we
might see clusters of local transmission.
Mr. Murphy. OK.
Ms. Castor. In fact, Mr. Chairman, there was recently a map
published in the national newspaper and it had Florida in
bright red, so it's definitely gotten everyone's attention, so
this is very timely. Thank you.
Mr. Murphy. I will then recognize the doctor from Texas to
follow up there. Dr. Burgess, you're recognized for 5 minutes.
Mr. Burgess. Thank you. And again, thanks to our panel for
being here today, and we always do learn so much when you come
in to talk with us.
So, Dr. Frieden, let me just ask you, after talking to my
folks on the ground back in Denton County yesterday, what
constraints has the CDC placed on states when it comes to the
expenditure of preparedness Ebola dollars to combat Zika?
Dr. Frieden. We have several different funding streams
available that includes the Public Health Emergency
Preparedness dollars. Those I believe but would have to
confirm, we have indicated to states that they can use for the
Zika response.
Mr. Burgess. Those dollars should be able to travel freely
between missions?
Dr. Frieden. That's the PHEP, the Public Health Emergency
Preparedness grants. For the Ebola dollars, I would have to get
back to you.
Mr. Burgess. And please do, because that is important. And
we're hearing stuff about funding. I get that. It always come
up in this subcommittee, and I'm not immune to that. But, Dr.
Frieden, let me just ask you, the travel restrictions, Tier 2
travel advisory right now for countries in the Caribbean and
Central America, and South America. Is that correct?
Dr. Frieden. Yes.
Mr. Burgess. What is the reluctance to go to Tier 3
restrictions?
Dr. Frieden. There's not really a reluctance. It's a
question of what's appropriate to the circumstances. We're not
saying that nobody should go; we're saying that women who are
pregnant should consider not going. And similarly in other
situations.
Mr. Burgess. You're asking us for more money. OK, I get
that, and you're saying it's an emergency. I might believe you
more that it's an emergency if you would be willing to say and
we really don't want you to go down there. The State
Department, when I talk to them they say oh, we rely entirely
on the CDC, but they're also not assigning women of
reproductive age to those outposts. So there's kind of a
disconnect there.
Dr. Frieden. What we feel is we need to give people
information and allow them to make the choices. We've heard of
situations where someone is going back for a funeral or a very
important personal event, and so we say you shouldn't go, but
we also say we understand there are some circumstances in which
women will go. And in those circumstances we provide the
information on how they can best protect themselves with
mosquito repellant and other means.
Mr. Burgess. Again, it just seems logical that nonessential
travel really should be circumspect right now.
Dr. Fauci, let me just ask you a question, because going
back several years to what was called the Swine Flu outbreak,
and we talked on several occasions during that. I remember the
conference call that occurred during March Madness of 2009, and
I remember talking to you during the August recess about the
availability for the vaccine was a few weeks away. It wasn't
quite going to be there for the start of school, but it would
be a week or two after, so the middle of September. So that's a
6-month time frame if I'm doing my math correctly that you were
able to identify the genetic sequence of the virus, reverse
engineer a vaccine, test it, assure its safety and efficacy,
and get it to school teachers on the second week of school.
That's pretty impressive.
Dr. Fauci. Right.
Mr. Burgess. And why are we different with this? Is this
just because it's a different virus?
Dr. Fauci. Yes. Well, what you have with influenza was a
strain change and a production to have over 150 million doses
available over that period of time. What we're talking about
right now, as I mentioned, and if I may, let me just clarify--
--
Mr. Burgess. Sure.
Dr. Fauci [continuing]. What is a feasible time frame
within the context of there are always vicissitudes when you're
dealing. So we have this couple of candidates, two or three
that are likely going to go into a Phase 1 trial in 2016. The
one I mentioned as a prototype because it seems to be
temporally ahead of the others, is one that we think by the end
of the summer we'll have enough, and we have our own pilot
plant where we're making doses. We're working very closely with
the FDA colleagues on trying to make sure we get that same
smooth transition that they helped us with when we went into
the Phase 1 trial with Ebola. So let's say we start at the end
of the summer/the beginning of the fall, it's likely it will
take a few months, similar to the Ebola Phase 1 where you know
if it's safe and it can induce an immune response.
In 2017, likely in the first couple of months, if the
epidemic is still raging in South America, that's very
important for a vaccine trial.
Mr. Burgess. Sure.
Dr. Fauci. Because we're now in a trial, not a
distribution. We'll likely get an answer of its efficacy very
quickly. When I say quickly, I say 8 to 10 months, at which
point then you make a decision, you look at the data and you
decide what kind of regulatory decision or not you're going to
make.
Remember with Ebola, by the time we were ready to go with
the vaccine the cases due to the CDC and other efforts had gone
all the way down, and there were very few cases to be able to
prove efficacy. I don't think we're going to see that because
nobody anticipates that this outbreak is going to just
disappear in Brazil.
Mr. Burgess. Correct.
Mr. Murphy. Thank you.
Mr. Burgess. Well, I do appreciate that, and I've got a
number of questions. And certainly after communicating with my
folks back home, this is going to be an ongoing evolving
difficulty, and I really would appreciate the ability to
interact with all of you as things develop. Thank you, Mr.
Chairman.
Mr. Murphy. Thank you. The gentleman's time has expired.
Recognize Mr. Pallone for 5 minutes.
Mr. Pallone. Thank you, Mr. Chairman.
I'm going to talk about the money, too. The President
submitted the $1.9 billion request for Zika that directs funds
to areas that the agencies have identified as priorities. But,
of course, the House Republicans have thus far declined to fund
the Administration's request; instead, calling upon the
agencies to divert unobligated Ebola funds to finance the Zika
response. And I believe this decision is ill-advised, and it
will force federal agencies to either compromise the critical
work that they're doing in other areas, or shortchange the
federal response to Zika and Ebola. So let me ask questions in
this regard.
Dr. Frieden, can you explain to us what you plan to do with
the agency's remaining Ebola funds?
Dr. Frieden. Ebola is not over. As of today, 84 CDC top
staff are in West Africa responding to the Ebola outbreak. Last
month labs in West Africa tested approximately 10,000 samples
for Ebola. It was only in January that we had the most recent
Ebola case in Sierra Leone, so we're still actively responding
and tracking. And as you noted in your remarks, the Ebola
supplemental funds also directed CDC to work over a 5-year
period to strengthen the systems around the world that could
find, stop, and prevent other health threats such as Zika
before they spread widely so that we can learn more rapidly
about them and protect Americans more effectively.
Mr. Pallone. All right. Let me go to Dr. Fauci, same
questions. What do you expect to do with the Agency's remaining
Ebola funds, and why is it important that the Agency complete
this work?
Dr. Fauci. Well, the NIH was given $238 million from the
Ebola supplement. We only have less than $10 million left. We
have about $9 million left, and we have ongoing studies, both
the survivor study, as well as the next phase of the vaccine
study, so quite frankly, Mr. Pallone, we don't have any Ebola
money to switch over. Right now what I'm doing in anticipation
of hopefully the approval of the supplement, is I'm moving
money from other areas right now to get a start on the things
that I just mentioned to Dr. Burgess; namely, the vaccine and
other components. So we're using money that we have to shift
around from other places. We don't have any really substantial
money that's left on Ebola.
Mr. Pallone. So let me ask both of you, Dr. Frieden or Dr.
Fauci, if Congress does not move quickly to fund the Zika
supplemental the way the President has requested, how will the
agencies meet the demands of fighting the Zika epidemic? How
will this affect the other work that you do?
Dr. Frieden. Well, first off we're already drastically
scaling back the work we're doing on other diseases, such as
dengue and tick-borne disease because we're devoting those
staff to the Zika response, even the area of birth defects
which usually considered to be an area that would respond to an
emergency. We've been pulling staff to work on this who would
otherwise be working on a series of other challenges in that
field.
And without the supplemental we won't be able to most
effectively reduce the threat against pregnant women by
learning more and doing more to protect them. We won't be able
to rapidly improve our awareness of where the mosquito
populations are in the U.S., and to control them before
mosquito season. We won't be able to establish a robust birth
defects registry to further understand this, or initiate and
follow-up on critical studies to understand key unknowns, such
as for babies born to mothers with infection who don't have
microcephaly, do they have other severe problems? That's going
to be a many month and many year undertaking that has to be
started now or we'll lose the opportunity to do it most
effectively. And we won't be able to support states and
territories in their ability to rapidly increase their
effectiveness here to the extent that we would like to.
Mr. Pallone. Dr. Fauci, do you want to add to that?
Dr. Fauci. Yes, Mr. Pallone. Ditto what Dr. Frieden said
about not being able to do several of the things that I showed
on the slide of our research agenda. But one of the additional
things that also worries me about not getting the supplement is
that we are now starting to forge partnerships with the
pharmaceutical companies that are getting quite interested in,
and they're linked to BARDA, and we're all working together to
try and push to develop products.
If it turns out we don't get the supplement, we will be
viewed as an unreliable partner, and we don't want that because
we had that, you might remember, when we were doing the
biodefense issues years and years ago where we would start
partnering with the pharmaceutical companies, and when it
looked like we weren't going to get a particular amount of
partnership money, they pulled back. And that would be the
worst thing in the world for us, is to have the pharmaceutical
companies think we're not a reliable partner.
Mr. Pallone. Thank you, gentlemen.
Mr. Murphy. Thank you. Now recognize Mr. Griffith for 5
minutes.
Mr. Griffith. Thank you, Mr. Chairman.
Dr. Borio, as you mentioned in your opening the FDA is
currently considering an application for a field trial with
genetically engineered mosquitoes that would take place in the
Florida Keys. Can you update us on where it stands today with
your agency, and when you expect the Florida field trial to
start? And I'm going to leap forward in an attempt to save a
little bit of time because you know we're limited. Does the FDA
have sufficient legal authority to expedite the review process
for this product given the current Zika emergency? And if not,
what additional authorities are needed?
Dr. Borio. We do have the authorities, and we are
expediting the review of this. And like I said, very soon we
hope to release for public comment the Environmental Assessment
and associated findings.
Mr. Griffith. Do you have the ability since there's an
emergency to truncate or eliminate the public comment before
you do the field trials, particularly in light of the fact that
the particular modification of the mosquito has been tested in
a number of countries in tropical environments?
Dr. Borio. Mr. Griffith, it's very important for us to go
through the process and include the period of public comment.
We need to give the public an opportunity to comment on the
Environmental Assessment given the significant attention that
this novel technology has generated, especially in the
communities for the proposed sites. So it is true that there
have been many field releases done, especially in Brazil. I
learned more about them when I was there last week. The data
seems to be promising in terms of reducing the mosquito
populations in those small field trials, but we need to go
through our process. And we are greatly expediting the process.
Mr. Griffith. In light of the concerns in the Commonwealth
of Puerto Rico, is it possible to expand, do you have the
authority to expand and maybe look at a field site not only in
Florida, but also in Puerto Rico? And since you have not yet
opened the public comment you're going to go through that
process, have public comment there, as well?
Dr. Borio. So if the company and public health authorities
in Puerto Rico are interested in that, we would be very
supportive of the process. So the geography might be a little
bit different from the field trial that is being proposed, so
the company would have to submit the assessment for that--
anything that may be different for the new field trial. But we
will look to create efficiencies as much as possible.
Mr. Griffith. As I understand it, it's been a multiple
year, I want to say 4 but don't hold me to that, years in
getting to this point. Would they have to go through that same
process in Puerto Rico, or is there some way that we could
shorten that time period up extensively so the tests could be
going simultaneously?
Dr. Borio. I understand that's the case, and what I can
tell you is that this is being greatly expedited now. And I
believe that where we are today in the process, that it would
not be a protracted process to be able to rapidly assess the
request for a field trial elsewhere.
Mr. Griffith. All right, I do appreciate that.
Dr. Fauci and Dr. Frieden, you all have been involved
somewhat in this with the genetically engineered mosquito. How
is your agency assisting the company that's developed this
novel technology? It looks like it's trials of 5,000 people,
lots of mosquitoes. Looks like it's been about 90 percent
effective in some of the areas it's been tried in.
Dr. Frieden. We have a number of vector control experts who
have consulted with the company and others, listened to them as
well as provided our input. I think one of the challenges is
the issue of scalability. These particular mosquitoes don't fly
very far, so you may have to release millions upon millions of
them every short distance in order to get the knockdown.
The other thing that's very important to understand is,
this mosquito is so tricky that even when we've seen very large
knockdowns in mosquito populations, we haven't necessarily seen
commensurate reductions in human infections, so it'll be
important to look at both of those factors.
Mr. Griffith. And while it could just be other factors. I
do know in one situation some of the disease that they carry
was knocked down substantially, but there may have been some
other factor involved. It's hard to eliminate all the other
factors, as well. I do appreciate that, as well.
I do think it's something we ought to look at. It's pretty
exciting stuff, and it's got to be a whole lot easier to
release millions of mosquitoes than it is to go door to door
with pesticides. Did you have something you want to say,
doctor?
Dr. Fauci. Yes. Actually, we've been negotiating and
discussing with Oxytech, the company that involved with that.
Mr. Griffith. Yes.
Dr. Fauci. And looking at trying to make sure we correlate
what Dr. Frieden was saying, the decrease in mosquitoes with
actually a decrease in disease because it may be that that we
don't really have that exact correlate. You really want to
prove that before you start doing a massive thing, because
scalability is really going to be a major problem. And you
don't want to scale up unless you know it works.
Mr. Griffith. And I have a follow-up question for you
that's off subject, but U.S. Pharmacopeia is looking at allergy
injections for folks and trying to change some of those rules,
and they may have some right. But have they consulted with you
about that?
Dr. Fauci. Nothing to do with Zika.
Mr. Griffith. Nothing to do with Zika. But since you're
involved with the Institute of Allergy and Infectious Diseases,
I thought I'd ask.
Dr. Fauci. I'm sorry. I was taken by surprise with that.
Mr. Griffith. But they have not consulted----
Dr. Fauci. Not to my knowledge. They may have consulted
with my staff, but not directly with me.
Mr. Murphy. If you need to think about that, you can get
back to him on a time. Thank you. Now recognize Ms. Clarke for
5 minutes.
Ms. Clarke. Thank you very much, Mr. Chairman. I thank our
panelists today. It's good to see you again, Dr. Frieden.
This question is for Dr. Frieden, Dr. Lurie, and Dr. Fauci.
Just as a bit of background, it's my understanding that the
majority of people infected with the Zika virus will remain
asymptomatic. However, 20 percent of those infected will
experience symptoms which range from fever to GBS, which can
leave persons paralyzed.
Though so far there have been no local transmission of the
virus in the Continental U.S., does CDC expect to see local
transmission in the U.S. as the mosquito population increases
this summer? While the mosquitoes that carry Zika are common in
southern states, they can range as far north as my home
district of Brooklyn, New York. Your location, as well as lack
of access to air conditioning increases one's chance of coming
in contact with the virus, as was pointed out by Dr. Frieden in
discussing the situation in Puerto Rico.
Many of my constituents living in the Brownsville section
of my district in Brooklyn are very low income, and likewise
the low income communities of the south has some of the highest
concentrations of poverty in the United States, and tend to
lack access to air conditioning. In the south not only do these
communities lack access to air conditioning, but they also lack
access to health insurance as many southern governors have
chosen not to expand Medicaid coverage under the ACA. If they
do get sick with the Zika virus, having access to care may
become problematic. The bottom line is that economically
distressed Americans will likely be the ones most impacted by
the spread of Zika were that to manifest.
With that in mind here's my question. What are we going to
do to assist low income and disadvantaged communities to
prevent being infected in the first place, as well as spread
the word of the virus in their communities especially since
Zika can be sexually transmitted?
Dr. Frieden. Thank you very much. Our primary concern or
most urgent concern is places like Puerto Rico which are likely
to see widespread transmission. In addition, we're advising
pregnant women and their sexual partners to use condoms if the
sexual partner has come from an area where there has been Zika
transmission.
Furthermore, there are parts of the U.S. that have a
secondary vector, the albopictus mosquito, the tiger mosquito
is much more widely distributed, but it appears to be much less
effective at spreading Zika. So unlike aegypti, which bites
multiple people, bites only humans, lives indoors, albopictus
is less of a threat. It appears that it can spread Zika, and
dengue, and other viruses but much less efficiently than the
other virus. So our goal with the supplemental funding would be
to provide resources for states and local communities to both
reduce the risk of mosquito-borne transmission where that is at
higher risk, and also to respond to cases so that people who
come back with Zika minimize their chances of being bitten by a
mosquito, and thereby initiating a chain of transmission.
Ms. Clarke. And my hope is that there will be a lot of
public information, education, particularly as the summer hits,
especially in a place like New York where you have that
international mix and blend of individuals.
Dr. Fauci and Dr. Frieden, the CDC expects to see local
transmissions of the Zika virus at some point in the
Continental U.S. Currently, the south has the highest number of
people living with HIV in the United States, over 40 percent of
those living in the south are HIV positive. I'd like to know
how the Zika virus impacts with those living with HIV? Do we
expect to see some more serious symptoms in HIV positive
individuals who are infected with Zika? Do we have a sense of
that yet?
Dr. Frieden. I'll let Dr. Fauci continue, but I would say
the primary issue we see at this point is to pregnant women
regardless of HIV status with the risk of birth defects.
Dr. Fauci. Yes. If you look at the historical analogies
with other flaviviruses, we have not seen a serious difference
at all in an HIV infected versus non-HIV infected person with
that kind of--however, I'm glad you brought that point up, Ms.
Clarke, because that's part of natural history studies. When
you do natural history studies of cohorts you will be able to
get subgroups of that who are HIV positive or not, and actually
definitively answer your question, as opposed to saying our
impression is that there really is not. But just to reiterate
what Dr. Frieden said, we really focus on the pregnant women.
That's the real target issue here.
Ms. Clarke. Very well. Mr. Chairman, I yield back.
Mr. Murphy. The gentlewoman yields back. Now recognize Mr.
Hudson for 5 minutes.
Mr. Hudson. Thank you, Mr. Chairman, and thank you to the
panel for this very informative discussion.
It was mentioned that there are clusters of dengue in
Florida and Texas. It got me thinking, just in terms of folks
coming across our southern border. There's been a lot of
discussion about different diseases and other public health
concerns.
Dr. Frieden, is this also a concern that folks coming
across the border could be bringing Zika with them? Is that
something we're looking at?
Dr. Frieden. Well, on the one hand we know that Zika and
other diseases do spread largely because of human migration.
But, in fact, there are 40 million Americans or 40 million
people from the U.S. who travel to Zika-affected areas each
year and then travel back, and so the number on the border
crossing will be a very minute proportion of that.
What we have seen is in some communities that are
essentially across the border, for example, Brownsville and
Matamoros in Texas, when dengue spread it spread in both parts,
but it spread eight times more in Matamoros because it was more
crowded and had less access to air conditioning.
Mr. Hudson. I understand. Dr. Lurie, what role will
mosquito or vector control play in our response to Zika?
Dr. Lurie. Well a we talk about this paradigm of prevent,
detect, respond, prevention is key, so mosquito vector control
has got to underpin our efforts for the foreseeable future for
Zika, and also for other vector-borne diseases.
Mr. Hudson. Well, there are currently 700 mosquito control
districts across the United States at the state and local
level. What role should the federal government play in mosquito
control?
Dr. Frieden. One of the areas that we would like to enhance
and for which we need supplemental funding is to better
understand the capacity of mosquito control districts, and to
support improvement of that capacity, and better linkage of the
mosquito control districts with the health departments and
environmental departments, whatever is most effective within
that state or county. They often bridge multiple counties and
they may not always be well integrated, but in effective vector
control programs for vector-borne disease you may need an
integration of the public health staff and the mosquito control
staff to identify the places or even the houses to target. And
that's really important, and one of the areas that we want to
urgently improve.
Mr. Hudson. When you talk about houses to target are you
talking about spraying insecticide?
Dr. Frieden. Yes.
Mr. Hudson. Is that the effective way to----
Dr. Frieden. Both insecticide and what's called larvicide
that kills the developing mosquito.
Mr. Hudson. OK. Well, because the mosquito that carries
Zika breeds in small pools of water often indoors near houses,
aggressive trash cleanup and removal is something that's been
talked about as one of the most effective ways. Do you envision
a federal role in terms of trash cleanup and those sort of
things, or is it more information----
Dr. Frieden. No. I mean, we really want to support state
and local entities with technical guidance. We also recognize
that reduction in breeding sites, cleanups is important, it's
high profile, but it's very difficult, as you pointed out with
mosquitoes that can breed in the amount of water of a bottle
cap. It can be extremely difficult to be effective, so it is a
component of integrated vector control strategies. We do think
that is a state and local responsibility, but we have, I
believe, a responsibility to provide technical guidance, best
practices, and catalytic funding to try to improve that,
especially when something as unanticipated and potentially
devastating as Zika is upon us.
Mr. Hudson. So the funding request doesn't cover any of
those type activities. It's more just the coordination and
information?
Dr. Frieden. We would have some support for local vector
control, mostly along the lines of rapidly surging in if
there's an area that's not able to do it, and for a particular
cluster by establishing rapid response teams, sharing best
practices, identifying resources that can be shared among
jurisdictions.
At CDC more than 60 percent of our funding or thereabouts
goes out to state and local entities. We exist to support the
front lines at the state and local government, but what we do
at CDC is to develop the tools, the science, the things like
the test kits for Zika that we then distribute to and support
local entities to use.
Mr. Hudson. Makes sense. Is it possible to predict or
anticipate using surveillance or other means what the next
emerging infectious disease would be?
Dr. Frieden. There are many people who would tell you yes.
My own belief is probably not, because there are so many
possibilities. Just to give you a sense, I just returned from a
trip to Africa looking at some of our programs there. I've
recently spoken with our teams in India. They've identified two
tick-borne viral hemorrhagic fevers, this is Congo Crimean
Hemorrhagic Fever and Kyasanur Forest Disease that are much
more widely distributed than anyone knew before. So whether
we're going to have now a tick that could bite you and you
could have a bleeding disease that kills you, I don't know if
that's going to come next. But no one, I think, would have
predicted that H1N1 would have come from Mexico, or MURS from
the Middle East, or Ebola widely distributed in West Africa, or
Zika causing birth defects.
Mr. Hudson. Thank you. Mr. Chairman, I'm out of time. I
yield back.
Mr. Murphy. Thank you. Now recognize Mr. Tonko for 5
minutes.
Mr. Tonko. Thank you, Mr. Chairman. Thank you to our
witnesses for providing very valuable information.
I'm encouraged by our government's rapid response to the
Zika virus, and the assistance we have provided and are
continuing to provide in the areas most affected by the
outbreak. This in my opinion underscores one of the most
important messages we hear every time we have a hearing on
disease outbreak, and that is that we have to be prepared for
what we can't predict.
So with that in mind, Dr. Frieden, how is our response on
Zika, and our continued response on Ebola preparing us for the
next emerging threats?
Dr. Frieden. We use the framework of prevention, detection,
response. Those are three core areas of what we need to do both
in this country and around the world. Prevention may be things
like better vaccines or reduced risk of spread of Ebola and
other diseases in hospitals. Detection is about laboratory
networks, as well as disease detectives or epidemiologists, and
tracking systems so we know how common certain conditions are
and can quickly detect an increase, whether it's in
microcephaly or other conditions. And response, the ability to
have rapid response teams that can be on the ground within
hours or days and have the tools needed to assess the situation
and mitigate to the greatest extent science allows.
Mr. Tonko. Thank you. And how are we assisting our state
and local health departments in their preparedness, and
certainly their response efforts? What can we do to coordinate
the response across all levels of government?
Dr. Frieden. There are many aspects of the response which
are critically important to be coordinated. For example, we
provide diagnostic tests, we work with health care providers,
we inform of the latest scientific evidence about it. And with
the supplemental request we would be able to be much more
robust and involving many parts of state government around the
U.S., and within states strengthening the hands of state and
local health departments in their ability to provide services,
education, information, and interventions to address the spread
of Zika, and to reduce the risk.
Dr. Lurie. If I might----
Mr. Tonko. Sure, Dr. Lurie.
Dr. Lurie [continuing]. Add that one of the most important
components of this is being sure that our day-to-day public
health system is strong so that it can do this detection. If
you start from a low level each time and we build and then let
it decay it doesn't really make any sense. Our country has a
pretty good history of national attention deficit disorder when
it comes to preparedness and maintaining a strong public health
infrastructure, and a strong preparedness system is going to be
key both for this outbreak and for all the questions about how
we are going to deal with the next outbreak. Those day to day
systems are critical.
Mr. Tonko. Thank you. And it seems as though keeping each
one of those independent bodies strong and functioning then
provides for a better sense of coordination. And infectious
diseases that are threats out there need to be addressed in a
way that addresses individual states and individual nations. No
one can escape some of those impacts, so I think coordination
is important. And the key to containing those infectious
diseases is to contain them at their source, I would think. So
the coordination here, I agree, is very important.
Dr. Lurie. Yes. No, thank you for that, and that's the job
of my office, to do that coordination.
One of the things that we also do is think about Lessons
Learned from other outbreaks. And as I said earlier, one of the
things that has characterized challenges in our response
whether it was to H1 or to Ebola is that Congress was very
generous in providing supplemental funds, but we can't move out
quickly and prevent a crisis before it becomes an emergency
unless we have some kind of a contingency fund to be able to
get going at the beginning.
We've shortened the time dramatically between when Congress
is able to approve funding and when we can get it out the door,
but each one of those things still creates a lag. I work with
FEMA all the time, and you know that when a Presidential
emergency is declared and the Stafford Act is activated, money
moves right away. At HHS, we don't have that kind of a response
fund to respond to public health emergencies, and that's
something that I think we're very focused on.
Mr. Tonko. OK. That's good information to have. And
finally, Dr. Frieden, how does our assistance in Latin American
countries as they grapple with Zika help keep America safer,
Americans safer?
Dr. Frieden. The more quickly we can understand Zika from
our work in Latin America and the Caribbean the better for
those countries and the better for Americans. This is where
it's spreading now, this is where the evidence is. That's why
we have teams on the ground in Brazil and Colombia, and we're
working side by side in partnership with those countries and
others. We disseminated our diagnostic test to countries around
the world, and we learn together so we're safer together.
Mr. Tonko. Thank you very much. Mr. Chair, I yield back.
Mr. Murphy. Thank you. Now recognize Mr. Collins for 5
minutes.
Mr. Collins. Thank you, Mr. Chairman. I want to thank the
panel.
I've just got a couple of questions. Certainly, in the
past, whether it was dengue fever or West Nile, the threat was
there, but nothing like what we potentially have here with Zika
and the link to the microcephaly. So if a woman is tested and
she tests positive, I'm trying to--is there a treatment today?
There isn't, so for a pregnant woman to be diagnosed with Zika
is a very bad, stunningly bad day for her, her family, and the
potential of which----
Dr. Frieden. That's why we've worked very closely with the
American College of Obstetricians and Gynecologists. We've
provided detailed guidance in conjunction with ACOG. They've
sent that out to their members as well, and we provided
information so that as soon as we know more information we
provide that to clinicians, as well as women.
Mr. Collins. So here's a question. We do know, there's been
some studies done that there's some women that have a history
of breast cancer in their families, and some women will decide
to forego the test for fear of what the test will show,
especially if there may not be a treatment. So if you're a
pregnant woman and there is no treatment if you test positive,
there are women who just for their own sanity would opt to not
be tested.
Dr. Frieden. We leave that up to the pregnant woman and
her----
Mr. Collins. Well, I know, but----
Dr. Frieden [continuing]. Clinician, but we do find that
there's a great desire on the part of pregnant women to be
tested. And it's not that there's nothing that can be done. For
example, we would want to insure that that infant were
delivered in a facility that has advanced care capacity to
provide the intensive support that it might need. Dr. Fauci?
Dr. Fauci. Actually, just to confirm that what we're
seeing, the anxiety associated with people who are traveling
there, there is a great need to know. We're not seeing denial.
There are people who really want to know as much information as
we can give them. And as Dr. Frieden said, we leave the
individual response to that information up to the individual
and their physician, but they are really very much in desire of
information, which is what we're trying to get them. This
relates to the answer to the question about ultimately getting
a highly specific and sensitive test to tell you if, in fact,
you were infected.
Mr. Collins. So to lead to that, now I'm assuming the rapid
tests that people are looking at are all antibody tests pretty
much.
Dr. Fauci. Well, as we said you have to ask are you
infected now? That's not an antibody test, that's a molecular
PCR test. The test that people are more in desire of, they go
and come back and say I know that 80 percent are likely
asymptomatic, so I don't know if I were infected or not.
Mr. Collins. What was your----
Dr. Fauci. They want to know an antibody test. Right?
Mr. Collins. That's correct. So I'm assuming the industry
is looking at the rapid tests, are in fact antibody tests.
They're not going to pick it up pre-antibody but----
Dr. Fauci. Right.
Mr. Collins. I'm assuming that's what's being done.
Dr. Fauci. A lot of activity is trying to develop an
antibody test that's highly specific for Zika and doesn't
cross-react with other similar viruses.
Mr. Collins. All right. So like in HIV where you've got
some false positives, there's the Western Blot that will look
for P24 protein or something like that.
Dr. Fauci. Right.
Mr. Collins. Is there such a protein in Zika?
Dr. Fauci. You could actually--in fact, Dr. Frieden will
just explain it, so why don't you go ahead about the----
Dr. Frieden. There are several proteins in Zika that are
specific to Zika. However, they're not that dissimilar from
similar proteins with dengue and Yellow Fever, so there can be
cross-reactivity. But we can give as of today a definitive
diagnostic result to a person with prior infection in some
circumstances. In other circumstances where there's more cross-
reactivity in the serum it's more difficult.
Mr. Collins. But I was hearing from GAO or others that some
of these confirmatory tests, they are not widely available.
Dr. Frieden. Right.
Dr. Fauci. What you can do to make it specific is that you
can actually--and this is what our grantees are working on
right now, is that if you look at the molecule for dengue,
which is the most likely bad actor of cross-reactivity, and you
look at the molecule of Zika, you could mutate out of Zika
those components that are common between Zika and dengue and
still have a protein that's left that the only thing it has is
things that are highly specific to Zika. That's what we're
working on right now. We don't have that, but that's----
Mr. Collins. So now one last question in the last few
seconds. If somebody has antibody, they progress to that state,
they do a PCR test. Wouldn't the PCR test still identify the--
--
Dr. Lurie. No.
Dr. Fauci. No. The virus is gone within days of infection,
within 7 to 10 days it's gone. So once the virus is cleared you
could do PCR all you want, you won't get anything.
Mr. Collins. Interesting. All right. Well, thank you for
that update, especially on what we ultimately need is--I mean,
if there's possibly some treatment if someone tests positive.
Appreciate the information.
Mr. Murphy. Thank you. The gentleman's time has expired.
Now recognize Mrs. Brooks of Indiana for 5 minutes.
Mrs. Brooks. Thank you, Mr. Chairman, and thank you so much
for holding this important hearing.
I think what you were just talking about, Dr. Fauci and Dr.
Lurie, I'm curious about what is BARDA, and HHS, and NIH doing
to support and facilitate these platform-based technologies
that you're referring to against the known and emerging
threats? You've kind of talked about it a little bit, but what
are you actually doing to support platform technologies? Dr.
Lurie, you want to start?
Dr. Lurie. Sure, great question. So, back in 2010 when we
took a look at the countermeasure industry and decided to
pivot, we decided to move away from one bug/one drug to these
platform technologies, so we are actually now engaged with a
host of vaccine development companies, we have open
solicitations to work with them. We are providing technical
assistance on the use of platforms specifically. The same thing
with diagnostics and tests in that regard. We built these
Centers for Advanced Development and Manufacturing. One of them
is in your home state, and they also are positioned to use
various platform technologies to make vaccines so that when a
candidate is ready they would be the kind of place that you
could actually do the scale up, development, the pilot lot
manufacturing, and potentially even with technology transfer be
able to, when they're ready, manufacture large volumes of
vaccines. So Dr. Fauci's group and mine are working extremely
actively, talk every day to be sure these hand-offs are ready
and the platforms are ready.
Mrs. Brooks. Thank you. Dr. Fauci, anything else you want
to add to that?
Dr. Fauci. Yes. Actually some examples, just for your
information. You have the DNA platform which we've worked with
BARDA on. We have the vector platform, the VSV vector where you
insert the gene of a particular virus. We did it with Ebola,
we're doing it right now with Zika. You have nanoparticles,
ferrite nanoparticles so there are all things that can be
transferred across all infections, and that's what we mean by a
platform, something that you could say this is the way we're
going to go, and we're going to stick in the appropriate
infection. Once you have those and you have a good solid group
of platforms you're going to cut down very, very significantly
the amount of time it takes to go after a particular infection.
Mrs. Brooks. And is there anything we need to be doing to
encourage this so it does go faster?
Dr. Fauci. Yes. I think that we need some money.
Mrs. Brooks. Let me ask Dr. Lurie about money. Speaking of
money.
Dr. Lurie. Yes.
Mrs. Brooks. I'm confused because the President requested
just $350 million for the special reserve fund for FY 2017, and
the language that was included in the President's request would
expand the allowable use for the SRF. This was a reduction in
funds, if I'm not mistaken. It was a reduction in funds for the
SRF, and so how is it that the President can put that in his
budget, reduce those funds, and yet we're still needing to do
all of these things we need to do with respect to other threats
like anthrax or smallpox?
Dr. Lurie. So there's no question at all that the funding
is critically important. You know, BARDA gets----
Mrs. Brooks. But, Dr. Lurie, why did the President request
a reduced amount of funding?
Dr. Lurie. Because it provided additional flexibility for
advanced research and development funds so that we could move
forward with those platforms. Right now the Special Reserve
Funds are limited to being able to purchase things that are
material threats on the material threat determination, and our
pretty profound need right now is in the advanced research and
development area.
Mrs. Brooks. And so you're not concerned about the level of
funding with respect to material threats.
Dr. Lurie. Oh, we----
Mrs. Brooks. You believe it's sufficient?
Dr. Lurie. No, we are always concerned that we can do the
job we need to do for the American people and having enough
money to be able to procure for bio threats. As you know, in
the multi-year budget we've got a 5-year projection of what it
is that we need. We believe that for Fiscal Year '16 or '17,
sorry, that we have sufficient funds to procure the
countermeasures that will be ready.
Mrs. Brooks. Thank you. Dr. Frieden, I'm very concerned
about the stockpiling, the strategic national stockpile, and
could you talk to me about things that BARDA, CDC can do to
improve the effectiveness, the coordination of the strategic
national stockpile because I don't think we're ready.
Dr. Frieden. Well, we've been optimizing the stockpile for
some time. We're able to deliver----
Mrs. Brooks. What does that mean?
Dr. Frieden. We're able to now deliver products to more
places more quickly. We're also looking at how to get as much
protection for our dollar as possible in terms of the mix of
products in the stockpile. And we're also looking at the
different threats that we may face to make sure that we have a
balanced portfolio to be able to address those that might be
the greatest risk to Americans.
Mrs. Brooks. Based on the hospitals and the folks I talked
to back home we seem to lurch from crisis to crisis and I'm
very concerned that we are still not ready. Thank you, I yield
back.
Mr. Murphy. Gentlewoman yields back. Now recognize Mr.
Bilirakis of Florida for five minutes.
Mr. Bilirakis. Thank you very much, Mr. Chairman. Thanks
for allowing me to participate in this subcommittee. Appreciate
it and thanks for holding the hearing.
The Zika outbreak like global issues especially pressing in
Florida and other Gulf States given that these locations are
vulnerable to the spread of Zika. In Florida we already have
two cases in Hillsborough County, one of the counties that I
represent.
A question for Dr. Borio. You mentioned innovation
strategies being proposed to help suppress virus-carrying
mosquitoes. It is my understanding that FDA is currently
considering an application for a field trial with genetically
engineered mosquitoes in Florida. The question is, could you
update us on where the field trial application stands today,
and when the earliest starting date could be?
Dr. Borio. Thank you. So we are working to soon release for
public comment the Draft Environmental Assessment that the
company developed. We work closely with EPA and CDC in
reviewing the materials, so hopefully very soon it will be
released. Once we have an opportunity to review the comments we
receive from the public, then we'll make a final decision
regarding the application. We're expediting the process. It's
part of our Emerging Infectious Disease Task Force in response
to Zika, so our--the reviewers involved in this technology are
part of our Emergency Response Task Force, so we're doing
everything we can to move this as expeditiously as we can.
Mr. Bilirakis. Well, give me an estimate.
Dr. Borio. Yes. I'm unable to give an estimate at this time
because it really will depend a little bit on the volume and
interest from the public. We are working those----
Mr. Bilirakis. Well, I'm sure there's a great deal of
interest based on what my constituents tell me.
Dr. Borio. Yes, it has been an area of tremendous interest,
and including some opposition. I think, you know, what we don't
right now is where the public stands in the setting of Zika and
the new developments associated with Zika. So we're doing
everything we can to move this very quickly. We're
collaborating across government with CDC and EPA. We'll learn a
great deal about this technology also during my visit to Brazil
last week, last month, so what I can tell you right now is that
we are prepared to move very quickly on this.
Mr. Bilirakis. Thank you. Next question. You mention FDA's
emergency use of authorization referencing diagnostic tests.
Would FDA be able to use an emergency use authorization to
advance the use of this technology should the Secretary declare
a public health emergency? So if you can answer that question.
Dr. Borio. Our EUA authority is currently limited to human
products, not to animal products. And this technology is
regulated under our animal drug regulations, so it's separate,
so we do not have currently authorities on emergency
authorization for animal drugs.
Mr. Bilirakis. OK, next question. Are there other
innovative products or strategies being proposed that you're
aware of, and able to discuss at this time?
Dr. Borio. I would like to defer those answers to my
colleagues from CDC.
Mr. Bilirakis. Please, please, please.
Dr. Frieden. There are a variety of other mosquito control
approaches that are being considered. One is simply to optimize
our currently available products. And we think there's
considerable progress that we could make by doing that,
different ways of applying different combinations of products,
different ways of assessing mosquito populations after the
application of these products. That's very important and needs
to be done.
In addition, there are new tools that are exciting. One of
them is the genetically modified mosquitoes that you mentioned.
Another is Wolbachia, a bacteria that infects mosquitoes and
then can reduce their life expectancy and their ability to
spread disease. This has been done on a pilot basis. But,
again, the question about all of them are are they scalable,
will they reduce human disease, are they practically
implemented? And NIH is doing work in this area, as well.
Mr. Bilirakis. Anyone else wish to comment on this? Thank
you.
Right now there are three tests I understand for detecting
Zika during different stages of infection. It is my
understanding that Florida and a few other jurisdictions are
able to utilize the RT PCR test to detect infection. However,
given that those who are infected often don't show symptoms, it
seems crucial that we are able to disseminate diagnostic
capabilities such as the antibody testing to state and local
authorities. So what hurdles do we face in increasing access to
these diagnostic tests nationwide?
Dr. Frieden. We're working around the clock to do that.
Mr. Bilirakis. Yes, go ahead.
Dr. Frieden. Excuse me. We've already produced 375,000 of
the realtime PCR. We've got roughly 15 to 20 states already
approved for use of that. Now with the IGM EUA just last
Friday, we expect to have another 15 or 20 states approved for
that. That's where most of the returning travelers live and
we'll continue to produce them. We've been able to accelerate
our production capacity at CDC so that we can increase the
proportion of the need that's met, but we recognize that there
may be a period of weeks or a month or two where people who
want the test can't get it. We're in active discussions as is
BARDA and other parts to encourage the private sector to do
more in this area. But right now, the CDC developed a test
which scientists at CDC spent years working on, is the best
thing out there in terms of what's available. And we're working
around the clock to make it more widely available.
Mr. Bilirakis. All right. Well, thank you very much, Mr.
Chairman. I appreciate it. I yield back.
Mr. Murphy. I know we're done with this. I know Ms. Clarke
has 1 minute. She'd like to ask one more question for 1 minute.
Ms. Clarke. Thank you, Mr. Chairman. Thank you for your
indulgence.
Clearly, there's still a lot more to learn about the Zika
virus. No doubt the public health response to Zika virus will
be complex and require coordination at the global, regional,
and national level. While the response to Zika may evolve, one
thing is clear; governments and international organizations
must commit to funding and providing access to comprehensive
reproductive health services to meet the needs of communities
during this public health emergency and far beyond.
Preventing pregnancy and the spread of the disease is
desired by women in their childbearing age as has been
suggested already in Brazil during this outbreak. As a follow-
up to Congressman Collins' line of questioning, what more can
the CDC be doing, or what else can Congress do to support the
CDC to help women prevent unintended pregnancies, if so
desired, and prevent continued spread of this disease through
possible sexual transmission?
Dr. Frieden. Thank you. As you noted, about half of the
pregnancies in the U.S., and about two-thirds of pregnancies in
Puerto Rico are unintended. We do not issue advice to women on
whether or not to get pregnant. We don't think that's our role.
We do provide information so that women, their families, and
their providers can make a decision about whether to use
effective contraception. We provide guidelines for which
methods of contraception are most effective, and how those
might be used. This is basically the approach that we're
taking, is providing information.
Mr. Murphy. Thank you. Dr. Burgess would like 1 minute.
Mr. Burgess. And, Dr. Frieden, if we can just talk one
second about the spraying issue. You and I have talked about
this a lot in the past, straight spraying, aerial spraying.
Obviously for this mosquito it is a little bit different, and
as I understand it, it's backpacks and going into yards and
gardens. So is the CDC developing any guidance for our local
public health offices as to what they can and cannot do, or can
and cannot expect? As far as local spraying, is it always going
to require consent to go on property? Do people need to
identify when they have an ill person at home so that those
areas can be perhaps on heightened surveillance?
Dr. Frieden. We've looked at all of these issues and
compared experiences across jurisdictions. We have a public
health law project which provides information and advice to
jurisdictions on models and what's possible in different
places. I do think that there are ways to optimize current
mosquito control practices, and that's one of the things that
we need to rapidly accelerate, and for which the supplemental
request would be used.
Mr. Burgess. Do people have the ability to actually get the
insecticide themselves and use it in their homes if they don't
want the CDC coming in with backpacks?
Dr. Frieden. The CDC wouldn't go in with backpacks, but
this a thing that we're looking at quite actively. It depends
on mosquito resistance. We're currently doing studies in Puerto
Rico to see which products the mosquitos are resistant to, and
we found that for some there's 100 percent resistance, for
others they're largely susceptible. And it'll depend on what
those results are for whether that could be done in exactly
what you mentioned, showing people here's where you need to
spray. Here are the products that work, is one approach that
we're considering.
Mr. Burgess. Thank you. Thank you, Chairman.
Mr. Murphy. I want to thank this panel for your work. We
have a second panel coming up here. As you know, other members
may have questions for you, so I ask members to submit the
questions and then please respond in a prompt manner. I'm sure
we'll be following up with all of you by phone, by visits, by
other hearings. This is critically important for our nation's
health, so thank you so much for attending today.
And while this panel is stepping away and we're preparing
the next panel to come to the table, I'll begin the
introductions of Panel Two.
We have with us today Dr. Peter Hotez, the Dean of the
National School of Tropical Medicine at Baylor. He's also
President of the Sabin Vaccine Institute and Endowed Chair in
Tropical Pediatrics at Texas Children's Hospital. Second, we
have Lawrence Gostin, Linda D. and Timothy J. O'Neill Professor
of Global Health Law at Georgetown University Law Center. Next
we have Joseph Conlon, Technical Advisor to the American
Mosquito Control Association, and Dr. Jeanne Sheffield,
Director of the Division of Maternal-Fetal Medicine at the
Johns Hopkins School of Medicine. And as soon as we have our
panel seated; again, it'll be Dr. Hotez, Lawrence Gostin,
Joseph Conlon, and Dr. Jeanne Sheffield, I'll begin with some
of the parts here.
Let me just say to the panelists, you are aware that the
committee is holding an investigative hearing. When doing so it
has the practice of taking testimony under oath, so if you
could all please be seated, I'll swear you in. Do any of you
have any objections to testifying under oath? Seeing no
objections, the Chair then advises you that under the rules of
the House and the rules of the committee you are entitled to be
advised by counsel. Do any of you desire to be advised by
counsel during testimony today? No, say no then.
In that case if you would please rise and raise your right
hand, I'll swear you in.[Panel sworn.]
Mr. Murphy. Thank you. All the panelists have affirmed
that, so now you're under oath and subject to the penalties set
forth in Title 18, Section 1001 of the United States Code.
We will now ask each of you to give a 5-minute summary of
your opening statement. Dr. Hotez, you are recognized first.
Please make sure you're turned on, bring the mic close to you,
and watch for the red light. Thank you.
STATEMENT OF PETER HOTEZ, M.D., Ph.D., DEAN, NATIONAL SCHOOL OF
TROPICAL MEDICINE, BAYLOR COLLEGE OF MEDICINE, PRESIDENT, SABIN
VACCINE INSTITUTE, AND TEXAS CHILDREN'S HOSPITAL ENDOWED CHAIR
IN TROPICAL PEDIATRICS; LAWRENCE O. GOSTIN, J.D., LINDA D. AND
TIMOTHY J. O'NEILL PROFESSOR OF GLOBAL HEALTH LAW, GEORGETOWN
UNIVERSITY LAW CENTER; JOSEPH CONLON, M.S., TECHNICAL ADVISOR,
AMERICAN MOSQUITO CONTROL ASSOCIATION; JEANNE SHEFFIELD, M.D.,
DIRECTOR, DIVISION OF MATERNAL-FETAL MEDICINE, JOHNS HOPKINS
SCHOOL OF MEDICINE
STATEMENT OF PETER HOTEZ
Dr. Hotez. Mr. Chairman, Representative Castor, and members
of the subcommittee, I thank you for giving me the opportunity
to speak today. I'm Dean of the National School of Tropical
Medicine at Baylor College of Medicine. I also head a product
development partnership that makes neglected tropical disease
vaccines that the big pharmaceutical companies won't make
because they're vaccines for the diseases of the poorest
people.
For my remarks about Zika today, I want to focus on my
perspective living and working in the Gulf Coast of the United
States, and our unique vulnerability to Zika epidemics, and why
I believe that this spring or summer Zika could begin affecting
pregnant women living in economically distressed areas of
Texas, Louisiana, Mississippi, Alabama, and Florida. And why I
worry that by the end of this year we could see microcephaly
cases appearing on the Gulf Coast. I also want to talk a little
bit about some of the hurdles in vaccine development if there's
time.
The reason I'm concerned particularly about the Gulf Coast
is because the Gulf Coast is unique in that it's the only part
of the United States with the possible exception of Tucson,
Arizona that has the Aedes aegypti mosquito. That's the
mosquito that's now mostly responsible for transmission all
over Latin America and the Caribbean, so it's Aedes aegypti
that we mostly have to be concerned about. But my other reason
I'm concerned about the Gulf Coast, and one not really being
talked about enough is extreme poverty. I mean, the reason why
we're seeing Zika in Pernambuco State and Recife in Brazil is
because that's the poorest area, one of the poorest areas of
Brazil. It is the epicenter, not just of Zika, but all of
Brazil's neglected tropical diseases. It's where we see
lymphatic filariasis, that's where we see schistosomiasis. And
the reason there's so much Zika there is when you--and it
doesn't take much to understand it. You an just view one of the
poor communities, you see no window screens, holes in the
window screens, but it's also the environmental degradation
around the area. You see discarded tires, you see plastic
containers filled with water, and all of those factors combine
to make the perfect storm, and why Pernambuco is such a deadly
place in terms of microcephaly cases and Zika.
It's the same reason why I'm very worried about Haiti. I
know we're mostly focusing on the United States, but I'd just
like to make the point that I think Haiti is going to be
decimated by Zika. UNICEF estimates there's 264,000 pregnant
women every year in Haiti, so we could be looking at more than
100,000, maybe 200,000 pregnant women with Zika in their first
or second trimester. We could be looking at tens of thousands
of cases of microcephaly in Haiti, in a country that basically
has no health system. So this is a humanitarian catastrophe
that's unfolding in front of our eyes, and I really don't see
any significant global action right now happening in Haiti.
And the reason I'm particularly worried about the U.S. Gulf
Coast, dengue actually caused outbreaks in Houston in 2003,
2004, and 2005. That was worked on by our National School of
Tropical Medicine. The reasons are clear, we have Aedes
aegypti, but where this is most happening are in the poor areas
of Houston, so the historic African American wards like the
Fifth Ward in Houston where I can take you there just a minute
off the highway. This is not hard to find, and what I'll show
you are dilapidated housings with no window screens, holes in
the window screens. You'll see discarded tires all along the
side of the road filled with organic debris and water, and the
Aedes aegypti mosquito likes nothing more than discarded tires
along the side of the road.
Right now our Harris County Mosquito Control Division is
finding Aedes aegypti mosquitoes. Those numbers are going to
start to climb beginning April and into May, and I'm quite
worried that we won't learn that there's going to be a Zika
outbreak until we start seeing microcephaly cases towards the
end of the year. So what do we need to do about this?
First of all, I think the U.S. Government needs a more
active role in coordinating what's going on in Haiti, or what's
not going on in Haiti, working with the Organization of
American States and WHO. Remember this is a disease we can
fight. Between 1947 and 1962 we eradicated the Aedes aegypti
mosquito from the Western Hemisphere for most of Latin America.
We did it by old-fashioned mosquito control programs and being
aggressive by draining water sources. The Aedes aegypti
mosquito was eradicated in 18 Latin American countries and
resulted in dramatic reductions in dengue and yellow fever.
Equally important, we need a coordinated response to combat
the threat of Zika on the Gulf Coast. This means surveillance
of mosquitos and Zika detection. Beyond mosquito control we
need to collect the garbage, we need to get rid of the
discarded tires and standing water in poor neighborhoods,
provide pregnant women living in poverty with adequate screens
for their homes. This approach goes beyond the health sector
and beyond the remits of the CDC. It could require involvement
of Housing and Urban Development, EPA, even Homeland Security.
Remember, even if a few babies are born with microcephaly on
the Gulf Coast it will be talked about in the same context as
Katrina, it will be talked about in the same context as the BP
Oil spills; so, therefore, I urge this committee to
aggressively pursue policies to protect that region. Thank you.
[The statement of Dr. Hotez follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Murphy. Thank you, doctor. Your time has expired. We'll
come back to you.
Professor Gostin, you're recognized next for five minutes.
STATEMENT OF LAWRENCE GOSTIN
Mr. Gostin. Thank you, Mr. Chairman Murphy, Representative
Castor, and the House subcommittee. I'm going to discuss four
is very briefly. First is the President's supplemental
appropriation. Secondly, how we continually under-invest and
the financing of these kinds of ongoing threats. Third, our
public health measures like travel isolation, quarantine. And
fourth is child, maternal, and reproductive services.
First in terms of the President's appropriation which I
strongly support. So why act now? Well first, as you've heard
from the first panel, there's a clear and present danger to the
United States and our hemisphere. The United States is the
global health leader, humanitarian leader, and we are the major
leader in our own hemisphere in the Americas and the Caribbean.
We also have our own domestic homeland to protect.
We remember when Ebola arose here in Dallas and other
places, how ill-prepared we were, and the public would not
accept that. Ebola taught us a vital lesson to act quickly, act
decisively, mobilize funding, and attack the hazard as its
source. There have been four global commissions since Ebola. I
was a member of two of them, and they have strongly urged us to
act and act now.
I remember during the Ebola appropriations and when the
President sent military forces and the Department of Defense
into West Africa. I was on PBS News Hour and they asked me what
I thought, and I said I was very proud of America, and I think
we need to be proud of America now in our response to Zika.
Should we take Ebola funding for Zika? I think we should
not. We would be robbing Peter to pay Paul. This is still a
major threat in West Africa. We promised to rebuild and
strengthen the decimated health system in West Africa, and
America's word is its bond, and its leadership should never be
placed in doubt. And that should be on a bipartisan basis, in
my opinion.
Zika, moreover, has a deep moral as well as a health
dimension. I'm a public health ethicist, and if you had a
hearing, for example, nine months from now and there was a
mother with a microcephalic child here and we failed to act
decisively now, I think the American public would find that
unacceptable.
From financing, we have continually underestimated our
financing needs. I was a member of the National Academy of
Science's Global Health Risk Framework Commission. They said
that an Ebola epidemic, a SARS epidemic, an influenza epidemic,
and now Zika could affect up to 10 percent of global GDP in the
affected areas, and the commission suggested that there was an
estimated $60 billion loss to GDP every year expected with $6
trillion in the 20th century, in the 21st century. With that,
the President's $1.8 billion supplemental appropriation to me
looks modest and would reap great benefits. I would also
support a contingency fund so that we don't have to mobilize
funds in the midst of an epidemic.
Third are public health measures. I believe that the CDC
was absolutely right in its travel advisory for pregnant women.
In fact, the CDC went further than the World Health
Organization. I think it was right to do that. I think any of
us if we had a daughter who asked us if she were pregnant
should she go to a Zika-affected country, we would tell her
what the CDC is telling her, that she should consider
postponing that travel. But I would not go further and have
travel restrictions or bars, isolations, quarantines, or border
controls, some of which were used during Ebola, some
successfully, but many not. I think there would also be
Constitutional challenges appropriately to many of those
measures.
And then, finally, I believe that we need to be very
attentive to child, maternal, and reproductive services. Pope
Francis supported the use of contraception particularly in
relation to Zika. We have women in the United States and in
Puerto Rico that need reproductive services and health care
services for them and their children, and we shouldn't let them
down if they're under-insured or uninsured.
So I thank you, Mr. Chairman and the committee for your
clear recognition of this health threat facing the United
States and the Americas, and for your leadership in this
regard.
[The statement of Mr. Gostin follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Murphy. Thank you, Professor.
Now we're going to turn to Mr. Conlon, who I also
understand was an entomologist in the United States Navy for a
couple of decades.
Mr. Conlon. Indeed.
Mr. Murphy. So thank you.
STATEMENT OF JOSEPH CONLON
Mr. Conlon. Thank you. Good morning, Mr. Chairman and
members of the subcommittee, Representative Castor. My name is
Joseph Conlon. I'm a retired U.S. Navy Medical Entomologist and
I serve as the Technical Advisor for the American Mosquito
Control Association, and I welcome this opportunity to provide
a mosquito control perspective to the deliberations of this
committee.
The recent introduction and spread of Zika virus in the
Western Hemisphere has reawakened in the United States an
appreciation of mosquitoes as not just nuisances, but
transmitters of devastating diseases. And I use the term
``reawakened'' advisedly for mosquito-borne diseases such as
malaria, dengue, yellow fever were once quite common in the
United States and, indeed, played a major part in shaping our
nation's destiny. These diseases no longer claim victims in the
United States as a matter of course largely due to the
exemplary efforts of organized mosquito control agencies in
conjunction with an enlightened and effective public health
infrastructure. But even more mosquito-borne diseases are a
mere 7-hour flight from our shores, and our public health
agencies must be prepared to meet these challenges that they
will eventually present.
Zika virus is thought to be primarily transmitted from
human to human by the bite of an infected Aedes aegypti and
possibly Aedes albopictus species of mosquitoes. Of these,
Aedes aegypti has been primarily responsible for transmitting
the disease due, in part, to its preference by humans both day
and night and its predilection for biting the lower extremities
out of sight. Moreover, females frequently take multiple
partial blood meals often from different individual humans, not
only increasing the likelihood of feeding on an infectious
human, but also leading to single infectious females
potentially feeding on and infecting multiple humans within a
relatively short time period. This is unique.
Both Aedes aegypti and Aedes albopictus, the Asian Tiger
mosquito are notoriously difficult to kill and/or prevent. They
live inside our houses under furniture, beds, in closets. Their
eggs can withstand months of drying and their young can develop
in water containers as small as a discarded soda bottle cap.
Virtually any collection of stagnant water in containers, tree
holes, leaf axles, et cetera can serve as an egg-laying habitat
for these species. Thus, draining wet areas does not prevent
their development around our homes and yards.
Aedes aegypti has been found in isolated areas of
California and along the southern tier of states up into
Georgia and South Carolina. Aedes albopictus is a bit more
cold-hardy and its range includes those states but extends
northward to Illinois and New York. States within this range
have excellent integrated mosquito control programs in some
areas, but mosquito control outside of their jurisdictions is
spotty. Indeed, many potential ports of entry throughout the
United States have limited or no mosquito control available and
there is a pressing need for funding to establish sustainable
mosquito control programs in these areas if outbreaks are to be
contained.
Successful mosquito control is based first and foremost on
a comprehensive knowledge of the vector in order to exploit its
vulnerabilities. All prevention and control strategies are
based on this knowledge; however, the cryptic nature of Aedes
aegypti makes normal surveillance and control strategies
problematic. This demands that mosquito control in the 734
established districts and over 1,100 municipal programs be
improved in the following seven areas: improved mosquito
surveillance tools for adult Aedes aegypti; availability of
pesticide resistance testing kits and accurate rapid diagnostic
tests for arboviral agents and trapped mosquitoes; faster
communications about protocols between public health
laboratories and mosquito control programs; funding to
underwrite new data call-ins that might influence a pesticide
registrant's decision to keep proven products on the market;
funding for field validation of new control modalities such as
lethal overtraps; intracellular controls using Wolbachia;
genetically modified mosquitoes; new active ingredients such as
dopamine receptor agonists to name a few. We also need a
national strategy to elicit sustained public participation in
removing and draining containers used by Aedes aegypti as
position sites. Also identifying areas at risk of Zika
transmission, assisting to the extent possible any federal
programs, underwriting the startup of new vector control
programs in impoverished areas at risk.
The federal government has several mechanisms available to
help these needs if funds already authorized were to be
appropriated. Three in particular come to mind. First, the
expanded laboratory capacity program of CDC for funding
increases in arboviral testing capacities. Second, the Mosquito
Abatement for Safety and Health Act by which local governments
could receive matching federal funds up to $100,000 for the
establishment and/or enhancement of mosquito abatement
programs, and $100 million total for building sustainable
programs where they do not exist. The funding for this was
authorized but never appropriated. Third, the Food Quality
Protection Act which authorizes the use of federal funds when
the cost of new data for public health pesticides was more than
their producers could afford putting their registration at
risk.
The national capacity to control mosquito-borne disease at
present and in the future will largely depend on the extent to
which these support programs or their functional equivalent in
the President's February 22nd Emergency Supplemental Fund
Request are implemented. Increased tourism, travel, and trade
make continual introductions of exotic diseases carried by
mosquitoes virtually inevitable. Resources for prevention and
control programs must be made available and employed so that
future cases of exotic diseases can be contained and eliminated
before their establishment and spread.
The President's recent request for emergency supplemental
funding for Zika prevention and control tangibly addresses our
acknowledgment of current shortfalls in mosquito-borne disease
control capability and seeks avenues to remedy them towards our
shared goal of protecting the American people from exotic
diseases. The American Mosquito Control Association agrees. Our
citizenry deserves no less. Thank you.
[The statement of Mr. Conlon follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Murphy. Thank you, Mr. Conlon.
Dr. Sheffield, you're recognized for 5 minutes.
STATEMENT OF JEANNE SHEFFIELD
Dr. Sheffield. Thank you. Chairman Murphy, Ms. Castor and
representatives, I'd like to thank you for the opportunity
today to testify before you on the effects of Zika virus in
pregnant women and how clinicians are responding to this virus
threatening the United States and the rest of the Americas.
The Zika virus epidemic is a unique situation. It is a mild
disease in adults in most cases, of little consequence to date
other than the uncommon but potentially devastating
complication of Guillain-Barre AE1 Syndrome. However, maternal
Zika infection during pregnancy can have enormous consequences
to the developing fetus. Zika has received international
attention predominantly because of its effect on the developing
fetus, specifically the association with microcephaly,
significant effects on brain growth and development, and ocular
abnormalities. Thus, much of the focus so far of current
efforts has been on the management of the at-risk patients.
You've heard extensive testimony about the origin of this
virus and its spread over the last six decades, so I won't
repeat myself or repeat that information for the sake of time.
While the Continental United States has not identified a case
of local transmission of Zika, there is a growing number of
confirmed travel-related cases, several of these in pregnant
women as we've heard about. While transmission of Zika virus is
primarily through the infected mosquito, transmission may also
rarely occur through infected blood in laboratory accidents,
vertical transmission from a pregnant mother to the fetus has
been confirmed, and finally cases of sexual transmission of
Zika from an infected person to an uninfected sexual partner is
increasingly being documented.
Data regarding Zika virus infection in pregnancy are
limited, and it is imperative that resources are directed to
elucidating the pathophysiology of the infection on pregnancy,
rate of fetal transmission, influence of timing in infection
and relation to pregnancy on fetal manifestations of the
disease, and long-term consequences of fetal infection. While
it is unknown at this time if pregnant women are more
susceptible to Zika virus, the disease itself does not appear
any worse in pregnant women compared to non-pregnant women.
Zika infects pregnant women in any trimester, and the virus has
been found in multiple different tissues from fetal losses,
amniotic fluid, the placenta, and the brain of infected
neonates.
The Brazilian outbreak of virus was associated with a
significant rise in microcephaly. Microcephaly itself is
diagnosed when the head is significantly smaller than what
would be expected for the sex and gestational age of the
infant. There are many causes of microcephaly, average rate is
about 2 to 12 per 10,000 live births in the United States.
There are multiple etiologies or multiple causes, chromosomal
abnormalities, genetic abnormalities, toxin exposures such as
mercury, alcohol exposure during pregnancy, and in the case of
Zika, also other infections such as cytomegalovirus and
rubella.
The reason microcephaly develops in association with Zika
is currently under investigation. Infants with microcephaly can
have multiple long-term complications depending on the severity
of the microcephaly and the associated abnormalities: seizures,
developmental delay, including speech and motor abnormalities
are just a few of these complications. There is no known cure,
and treatments are very limited depending on what the etiology
is of the microcephaly. Significant resources are going to have
to be focused on the long-term care of these affected infants.
Since the microcephaly association was first noted several
months ago, we now know that there's multiple other
abnormalities, and I've detailed these in my written testimony.
Soon after the association of Zika virus infection and fetal
microcephaly was identified, the Centers for Disease Control
and Prevention set up a health alert and brought together
subject matter experts including arbovirus virologists, public
health personnel, and obstetrics and gynecologists with
expertise in infectious disease and pregnancy. While data were
very limited at that time, interim guidelines were rapidly
developed to inform physicians caring for pregnant women,
management strategies were disseminated, and educational
materials describing preventative measures were made widely
available not just to physicians but to the general public.
These guidelines have been updated several times as new
information has been elucidated. As was mentioned, the American
College of OBGYN and also the Society for Maternal-Fetal
Medicine have played a very integral part in the development
and dissemination of this information, and I will be glad to
answer any questions related to the management of these
patients.
Zika virus infection is now a notifiable disease allowing
for better surveillance of disease burden. The CDC has
developed a pregnancy registry with confirmed Zika infection in
the United States. They actually released a report on Friday
that was briefly mentioned earlier detailing the initial
results of 257 Zika tests performed for pregnant women in the
report, 3 percent were positive. The nine women that were
positive, two electively terminated, two had a miscarriage or
first trimester loss, one delivered an infant with severe
microcephaly, and two pregnancies are ongoing, two pregnancies
have delivered and so far there are no known effects to the
infant. One woman was infected in a third trimester and
delivered a healthy infant. So while this initial report is an
important first step, much more is needed for the physician to
be able to effectively counsel pregnant women at risk for
infection. Support for both national and international research
targeting key populations such as pregnant women is imperative.
Until effective treatments and/or a vaccine are developed,
prevention of maternal infection is necessary to prevent the
devastating consequences of fetal infection. Thank you.
[The statement of Dr. Sheffield follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Murphy. Thank you, doctor. I'll now recognize myself
for 5 minutes of questions.
First, Dr. Sheffield, has any of the medical academies or
the AMA come out with any recommendations with regard to asking
mothers and keep ing the record if they have traveled to any
areas where Zika virus is known?
Dr. Sheffield. I think that's actually a superb question,
and we talked about it quite extensively. My hospital, Johns
Hopkins, we have developed a very comprehensive screening tool
with a list of the countries and territories that are currently
affected, and we are trying to spread this information out to
multiple other centers. When I talk to other colleagues from
around the country they are doing the same thing. So very
similar to Ebola, we're working on a screening questionnaire.
Mr. Murphy. So would you say at this point, should it be a
standard that OBGYNs and pediatricians ask that question of
mothers, if they have traveled to during pregnancy?
Dr. Sheffield. Absolutely.
Mr. Murphy. And with regard to that, and this is whether or
not they had symptoms, just if they traveled there or nearby.
Dr. Sheffield. Whether they traveled. The pregnant women
regardless of symptoms require testing.
Mr. Murphy. Even if in second or third trimester, of
travel.
Dr. Sheffield. Yes, sir.
Mr. Murphy. I mean, I know myself as a psychologist, worked
for many years with developmentally delayed children that
there's a lot of long-term intellectual motor and sensory
complications. I must admit, I'm also concerned that
regardless, because we don't know yet all the route of what
happened to this virus with the developing brain, that I wonder
even if an infant or a young child is also infected with the
Zika virus, the outcome on the brain, we simply don't know
that. Am I correct?
Dr. Sheffield. I think that is actually one of the big
concerns, is that even if you're infected in the third
trimester, have no evidence at delivery of microcephaly or
neurologic abnormalities, the long-term follow-up of these
babies is imperative because we don't know what the long-term
consequences are going to be.
Mr. Murphy. That's correct. I agree with you there.
Dr. Hotez, you've been critical what you call the
narrative. We've been mostly hearing from the U.S. Government
that the Continental U.S. is a wealthy place with few of the
risk factors contributing to the rapid spread of the arbovirus
infection such as Zika, dengue, and chikungunya in Latin
America and the Caribbean. But as a specialist in tropical
disease based in a major Gulf Coast urban center, why do you
disagree with that narrative that we shouldn't worry as much?
Dr. Hotez. Thank you for that question. The reason is we
have poor people in this country, we have 20 million Americans
that live at half the U.S. poverty level. We now have 1.65
million families that live on less than $2 a day according to
the University of Michigan Center for Poverty. And what we're
finding is something very interesting about the world's
neglected diseases, that currently most of the world's
neglected diseases, which include Zika, are actually found in
wealthy G20 countries, but it's the poor living among the
wealthy that account to it for this. So the G20 countries
account for most of the world's worm infections, and dengue,
and chagas disease, and leishmaniasis. We have 12 million
Americans now living with a neglected tropical disease in the
United States, most of them in the American south, most living
along the Gulf Coast. For all the reasons that I mentioned in
my previous testimony that we know that poor areas are
particularly vulnerable. I have pictures.
Mr. Murphy. But even with that, I only have a minute, 50
seconds. I want to ask, and then we can look at those later.
But even so, I don't know how far these mosquitoes may travel
in their lifetime, get a wind. Do we have any idea? Mr. Conlon,
is it miles?
Mr. Conlon. Not in the case of Aedes aegypti and Aedes
albopictus. Their ranges are about 100 to 200 meters from where
they actually breed.
Mr. Murphy. I see. And along these lines, too, does anyone
know if the virus can live in the water in which they breed,
and can the virus be transmitted for an adult to offspring?
Just to help the American public understand this. Does anybody
know?
Mr. Conlon. To my knowledge, it can't reside in water.
However, it is vertically transmitted from the mosquito, the
adult mosquito to their offspring, so they're born with it.
Mr. Murphy. That's disturbing, too. In your testimony, Mr.
Conlon, you also observed that malaria and yellow fever, both
mosquito-borne diseases were once quite prevalent, but that
today they no longer claim victims due to the efforts of the
Organized Mosquito Control Agencies. How is this accomplished?
And the infrastructure given is pretty disjointed. How can we
improve that?
Mr. Conlon. Well, as Dr. Hotez mentioned, there are many
places in the United States that do have socioeconomic
conditions that are conducive to the spread of these types of
diseases. Those conditions were quite evident back in the past
in places like Norfolk, places like Louisiana, all throughout
Louisiana. There were a number of different areas that these
got transmitted. Dengue fever was first discovered in
Philadelphia, Pennsylvania, so we should not rely upon the
south to be the potential breeding ground for these things, but
anywhere that poverty occurs where you've got difficulties in
trash removal, you've got certain socioeconomic conditions
conducive to keeping water containers inside. Those can really
hurt.
I want to emphasize, though, that mosquito control is
conducted on an integrated basis and we should not think that
there is any silver bullet for this. We've got to utilize all
the tools that are at our disposal in order to keep these
diseases from establishing. We need a number of different
modalities.
Mr. Murphy. Thank you. I'm out of time. Now turn to Ms.
Castor for 5 minutes.
Ms. Castor. Thank you. Well, thank you all very much. In
addition to the previous panel, you all have really given
everyone a wake-up call about what has to be done. And I'm more
convinced than ever that we've got to move this supplemental
appropriation, and it can't get bogged down in the typical
congressional budget battles. We need to move it as quickly as
possible.
And, Dr. Gostin, I wanted to thank you for emphasizing the
moral imperative for the Congress to act quickly. And Dr.
Hotez, I think you're absolutely right to raise the issue of
Haiti right now and the consequences because there hasn't been
much discussion about Haiti. And I think they are particularly
at risk. I think we can do better in mobilizing the
international aid community and religious community that have
so many initiatives there.
I want to focus back on pregnant women because it appears
that the impact and the connection to microcephaly came as
something of an unwelcomed surprise. Dr. Sheffield, you've been
very involved in drafting the guidelines for the CDC, the
Society of Maternal-Fetal Medicine, and ACOG. Can you go into
greater detail on the science and what we know?
Dr. Sheffield. So when the guidelines were first drafted--
very soon after the reports initially came out about the
microcephaly, they called a group of people together, and we
freely admitted--I was not a Zika expert at the time. I knew
very little actually about the Zika virus infection. However,
the group of us had done a lot of work over the years with
other infections and how it affects pregnancy, such as
cytomegalovirus, and so the group of us that came together at
the request of the CDC kind of looked at what data was
available to us with the understanding of what happens with
other viruses, and drafted just the original, the initial
guidelines, which have subsequently been updated every time new
data comes out. But the guidelines initially, if you look back
a couple of months ago when they first came out, they were
essentially screen everybody that traveled, and we talked a
little bit about how to screen, the diagnostic tools that we've
already talked about earlier today, and then ultrasound looking
for actual fetal abnormalities, particularly in the head.
Ms. Castor. What's going on here? With other infectious
diseases in maternal health, what--are there any other diseases
where we've seen similar impacts to the fetus or child that
would develop microcephaly?
Dr. Sheffield. This virus is fascinating because this virus
is very neurotropic. It likes the brain, it likes the fetal
brain and nervous tissue obviously in adults since we're
talking about Guillain-Barre AE1 Syndrome, but it is very
neurotropic. There aren't a lot of other viruses that affect
the developing fetus that is so specific to the nervous system,
or to the brain. There are other viruses such as rubella, one
of the most devastating viruses out there that cause multiple
fetal abnormalities, but it causes abnormalities in multiple
different systems. Same with some of the other viruses and
parasites that will affect a pregnant woman. This one so far
has been very, very focused on brain and neurologic
abnormalities.
Ms. Castor. OK. So we're going to need extensive research
on all that, and that is just starting. Is that right?
Dr. Sheffield. Absolutely.
Ms. Castor. Is that how you would characterize it? So let's
drill down on the recommendations for maternal health. Because
in the Western Hemisphere, as Dr. Hotez says, we are so
interconnected, Florida to Brazil, and Latin America and
Colombia, and Puerto Rico, to Mexico, to Haiti. It's just
millions and millions of families, travelers where you're just
not going to be able to talk about travel bans of things like
that, so you've got to give folks the most constructive
recommendations. So talk about citizens of the U.S. and Puerto
Rico, what you're advising them right now if they are of
childbearing age and intend to get pregnant?
Dr. Sheffield. So right now myself as I'm sitting across
the table from one of my pregnant women that is considering
traveling and my colleagues across the country are all pretty
much following the ACOG, SMFM, and CDC guidelines, which is if
you have a pregnant woman that is interested in traveling to a
Zika affected area currently we, one, recommend against it. If
they do have to travel there is excellent education out there
about prevention of mosquito bites because if they do travel,
it all becomes prevention because, again, there is no
treatment, and there's no vaccine currently available. So for
right now it is prevention. So we spend a lot of time if they
do have to travel talking about preventative measures, and
there again is a lot of information on the CDC Web site for
that.
We also, if they come back from travel, and this is where a
lot of my patients are coming in, as two months ago they never
heard of Zika virus. They've all traveled down to an affected
area and they're coming back suddenly in a panic after seeing
everything that's happened. And those are the ones where we
have testing available. Again, not perfect as we've heard, but
it's what we have available, and then ultrasound or evaluation.
Ms. Castor. Could you name those specific areas so that we
have that?
Dr. Sheffield. The specific areas for the evaluation?
Ms. Castor. The travel to.
Dr. Sheffield. Oh, travel to. So the CDC has a linked Web
site of travel notice, and they keep updating it. Every time a
new country or a new territory comes up, they update that list.
Last I saw it was about 30 or so countries and territories, and
it's online. It's very easily accessible, and actually we
update it for our clinicians. We have the link right there in
clinic. They click on it, they pull it up, and they're able to
say OK, where did you travel? All right, you're on the list.
Ms. Castor. But Brazil.
Dr. Sheffield. Brazil, Colombia, Puerto Rico, though Cuba
is not on it, we actually have tested one patient that's
traveled from Cuba, so we're talking about the Caribbean.
Ms. Castor. And it's not going to be a static list. That
list is going to change.
Dr. Sheffield. No, it is frequently. It's actually
frequently updated as new countries are reporting.
Ms. Castor. Thank you.
Mr. Murphy. Thank you. Yes, that list is available on CDC's
Web site. It's quite extensive, throughout the Caribbean,
Central America, South America, Mexico. Other issues coming up,
too, for the summer Olympics, as well.
Mr. Collins, you're recognized for 5 minutes.
Mr. Collins. Thank you, Mr. Chairman. I want to thank the
panel as well. Maybe following up on Ms. Castor's comments.
I think what a lot of us are worried about is there is no
vaccine, and if somebody does test positive there's no
treatment, and it's somewhat disturbing but Dr. Sheffield, that
some women would even choose to terminate the pregnancy. But
picking up on that, education to me, because we're not going to
have a vaccine tomorrow or next week, and we'll have better
diagnostics before we're going to have vaccines and treatments.
So I'm thinking education, guidelines, pamphlet, with a sense
of urgency into the physicians' offices. I don't know how many
typical doctors right now have this information in their
waiting room, but a lot of times we think we're invincible,
from what I'm hearing. So a couple of questions: do we have
even an idea, a 25-year old woman who--she's got 15 years or
longer to be in her childbearing years. How long if she's
infected, so she gets the Zika virus, she's not pregnant. She
waits X period of time. Is that 1 year, 2 years, 10 years,
never? Do we have any idea?
Dr. Sheffield. So right now the guidance is if you travel
to an area you're not pregnant, we're recommending people wait
at least 4 weeks. The reason for that is the incubation period
is about up to 2 weeks. The viremic time period where the virus
can cross to the placenta and then to the fetus is somewhere
around 7 to 10 days.
Mr. Collins. Yes, but what I'm getting at is, OK, she's
tested positive. She's not pregnant. How long would a woman who
knows she's had the Zika virus, she was infected. Should she
wait to consider having children? Is it never, or is it 1 or 2
years? Do we have any guidelines in that area?
Dr. Sheffield. We don't. Right now we're saying about four
weeks, but that is based on, again, very, very limited data.
That's where we desperately need information coming out of
Brazil, and Colombia, and some of the U.S. studies that are---
Dr. Hotez. It'll be important to determine if Zika is going
by the same play book as something like dengue where the virus
is in your system for a couple of weeks, and then it's gone.
And that's probably the likely scenario. There is evidence
that, for instance, West Nile virus can sometimes persist in
the kidneys for periods of months or years, but that appears to
be an exception----
Mr. Collins. So even though someone may be antibody
positive, the virus, like you're saying with dengue, has
cleared the bloodstream. You're saying then at that point it's
to the best of your knowledge they would no longer be infecting
a fetus?
Dr. Sheffield. To the best of our knowledge, yes.
Dr. Hotez. Right.
Mr. Collins. That's very good news, actually, if there's
such a thing as good news here.
Dr. Hotez. It's about the only good news about this virus.
Mr. Collins. Yes. But if it clears, which is the difference
in HIV and some others, because it doesn't clear. Yes, sir?
Mr. Gostin. The other thing to consider is for women who
are considering getting pregnant but are not pregnant now, what
we tell them, because they won't necessarily go to their
physician's office. That's why, in addition to education in the
doctor's office, I think we need to do public health
information campaigns to advise young women about what their
risks are so that they can make well-informed decisions. And
this is particularly important with the Rio Olympics that are
looming, because although it will be the Southern Hemisphere's
winter, there still will be active transmission. And they'll be
coming then to the northern height of the summer where we could
then see local transmissions here. So those are all kinds of
things to consider in addition to the fact that, as you've all
said, you have so much interchange between Puerto Rico, other
U.S. territories.
Mr. Collins. So if there is one absolute, I'm assuming the
one absolute is a pregnant woman should not travel to those
areas, because you're saying they could be third trimester and
we don't know. So would that at least be a fair absolute;
you're pregnant. You just stay away?
Dr. Sheffield. I'm a physician. We never deal in absolute--
--
Mr. Collins. Well, sometimes you need absolutes.
Dr. Sheffield. But we do strongly recommend they not
travel.
Dr. Hotez. The problem will come and what happens in the
summer when the Gulf Coast of Texas or Florida becomes an area
included in the travel ban zone, and then we're going to----
Mr. Collins. That would be a nightmare.
Dr. Hotez. That would be a nightmare.
Mr. Collins. Total nightmare.
Dr. Hotez. That's a real----
Mr. Collins. But thank you for your testimony. This
education is absolutely critical for us, as well as the public.
And I want to thank the Chairman for holding this hearing, and
thank the witnesses for your testimony. I yield back.
Mr. Murphy. Thank you. Ms. Castor, going to recognize you
for an additional couple of minutes here, 5 minutes.
Ms. Castor. Thank you very much.
In some of the countries experiencing outbreaks many do not
have access to primary health services; that means limited
access to family planning, as well. Dr. Hotez, it's fairly
plain but would you explain to everyone why it is in the best
interest of Americans and American families that we tackle the
disease in Brazil, and in Puerto Rico, and other places in the
Western Hemisphere?
Dr. Hotez. Well, thank you for that question. I think
what's becoming clear is the Gulf Coast of the United States is
part of the same eco-zone that the Caribbean and Central
America is. There's a homogeneity there, especially in our
impoverished areas. I can take you through parts of the Fifth
Ward of Houston and you might think you're in Port Au Prince or
Tegucigalpa, and so we have to realize that what is happening
in Haiti and in Central America is the same vulnerability as
the Gulf Coast, and take that accordingly.
Ms. Castor. Dr. Gostin.
Mr. Gostin. Yes. It's a very good, actually, because one of
the things we've learned with SARS, with Ebola, with so many
novel infectious diseases, and it's more true, or at least as
much true with Zika is that we can't just be defensive in the
United States. You actually have to go to the source of the
infection; that, in other words, to protect ourselves we also
need to protect the people and the ecosystem, and the mosquito
population.
Ms. Castor. So what should we be doing, what should the
U.S. be doing to insure that women in these countries have
access to family planning services during this crisis?
Mr. Gostin. Well, I believe that for health reasons and for
moral reasons we should encourage it. There are particular
countries that have told women not to become pregnant for a
year, 2 years, and more. And as Pope Francis said, we need to
give them the tools to be able to achieve that goal. And, of
course, if they do have infants, then we need to give the
mother maternal health care, we need to give the child
services. I think it's very important. And, of course, it's
important in Puerto Rico because Puerto Rico is going through a
major financial crisis, bankruptcies. It's Medicaid system is
in shambles. And part of the President's appropriation request
is to support that and it seems to me that as a territory of
the United States it's very important. But also because of the
interchange of travel between people in Puerto Rico and the
United States.
Ms. Castor. Dr. Sheffield, give us the practical advice of
doctor to patient you would give on family planning in the
impacted areas.
Dr. Sheffield. So practically speaking, I am an advocate of
providing effective contraception in order to, as you
mentioned, provide a tool to prevent pregnancy if the woman so
desires, if she does have to travel to Zika-affected areas. So
if I have a woman that is not pregnant and is not interested in
becoming pregnant in the near future, we do talk contraception,
particularly if she is traveling down to Zika-affected areas.
Ms. Castor. And then there's also been the discovery that
Zika also poses a risk through sexual transmission, so it's not
just women. We must also target communications and resources to
men who may carry and spread the Zika virus. Dr. Sheffield,
what guidance would you offer to men traveling to areas with
active Zika transmission?
Dr. Sheffield. So this has kind of thrown a wrench in it in
our discussions over the last month or so. Now that sexual
transmission has been confirmed and we are discovering more and
more cases of sexual transmission, again all of them so far
have been male to female transmission as was mentioned earlier.
Our counseling right now is if you are a male who has a
pregnant female partner, when you come back from travel from a
Zika-affected area use condoms or actually abstain from sexual
practice; however, if you don't abstain, use condoms. And we're
using the word, consistently and correctly use the condoms, and
trying to prevent transmission. It may not be 100 percent
unless it's true abstinence, but it at least provides some
protection.
Ms. Castor. It's a very important message for the millions,
and millions, and millions of our neighbors who travel across
the Americas and in the Western Hemisphere, so thank you all
very much for your testimony today.
Mr. Murphy. Thank you. I want to follow up with a couple of
questions, as well. First of all, with regard to this you're
recommending, obviously, abstain from travel, abstain from
other contact here. Does anyone know if airlines, and cruise
ships, and travel agents are spreading that word, as well?
Professor Gostin?
Mr. Gostin. They have not yet, but what we saw with Ebola
was that even before governments were implementing policies,
the airline industry was doing that. This is a major financial
issue for the industry, as well, particularly again because of
the large travel to the Olympics and others, people canceling
their flights, so I think it's very important for the United
States Government and other governments to work with the
airline industry to make sure that they follow the best public
health advice.
Mr. Murphy. Certainly advise that. Mr. Conlon, with regard
to this, many times people travel to areas and then go to a
resort area. One would assume that there would be some
different sort of vector control there versus another part of
the community. Do you have any advice on that?
Mr. Conlon. In places in the Caribbean that do have vector
control capabilities in the resort areas, it tends to be rather
problematic, even more so than in the United States. I would
recommend that people, and particularly males that are going
into this area, utilize EPA registered repellants. They do work
against all these mosquitoes, and they just need to follow
label recommendations. But I would caution everyone to make
sure they're EPA registered. There's a lot of mosquito
repellant products out there that have rather iffy data sets
supporting them, so EPA has taken into consideration that
they're safe to use and they're effective at least four hours
when utilized properly. What you do is you reduce human
mosquito contact, no problem with the disease.
Mr. Murphy. So it isn't just the matter of looking at what
islands and countries to avoid, but it doesn't necessarily give
me confidence that even if it is a four or five star resort
that they necessarily have full vector control. And if you
still go there, to use some sort of mosquito repellant, so
there's multiple levels.
Mr. Conlon. Absolutely. And I would also say that if you're
going to a resort that's got an 18-story hotel you can find
Aedes aegypti at 18 stories. They go up through the elevator
shafts.
Mr. Murphy. OK. In your testimony you also noted the
American Mosquito Control Association is currently developing
guidelines specifically geared towards aegypti and albopictus.
What will these guidelines focus on, and when will they be
ready, and how do you see them being put to use?
Mr. Conlon. Well, hopefully, we're going to get them ready
by about April, but one can never know when you're talking
about dealing with volunteers. We're specifically going to try
to shift our control paradigms and our recommendations from
reactive, which is oftentimes larvicide. Larvicide are not
going to be the answer with this mosquito, primarily because we
generally use larvicide because the larvae are contained in a
small area, they're easy to get at, they're easy to kill, and
then they spread out as adults, and make it difficult for us to
deal with them with regard to adulticides. In the case of this
mosquito, though, larvicide are not going to be the answer
because they're occurring in the same area where the adults
are, so you might as well kill the adults in addition to. So
we're going to focus more on the adulticide issues, we're going
to focus more on trying to get community support, elicit
community support to get rid of the habitat. This is a human
problem. This not necessarily an Aedes aegypti problem. We're
creating the problem, and we need to be conversant in creating
the solution, as well.
Mr. Murphy. All right, thank you. Dr. Sheffield, what do we
know currently about the risk of a Zika infection passing from
an asymptomatic mother to a child during pregnancy? It can
still happen?
Dr. Sheffield. We think it can. There haven't been
excellent documented cases yet of an asymptomatic mother
passing to an infant, or passing to her fetus. That being said,
we are assuming that it could happen, and so the
recommendations are the same whether you're symptomatic or
asymptomatic.
Mr. Murphy. And, again, that's something the OB and the
pediatricians should always in screening questions, where have
you been? So how frequently should pregnant women who could
have had an asymptomatic Zika infection be tested for the
virus?
Dr. Sheffield. So right now when a pregnant woman comes
back from a Zika-affected area, we're doing the initial test.
We're doing the PCR, RT-PCR if she is symptomatic. If she is
asymptomatic, we are doing the IGM and the plaque-reducing
neutralizing antibody test. If that is negative, we still are
following up the fetus with serial ultrasounds. If the
ultrasound becomes abnormal, we will retest a mother that
initially tested negative, and we will offer amniocentesis to
test the fetus, also.
Mr. Murphy. And do we have the capacity to handle all those
tests?
Dr. Sheffield. Right now we have not been turned down on a
test. Maryland actually is able to do the test. It's the one of
the states that's able to do the test. However, when we start
rolling this out to all 50 states, I think that is a large
question, is if every pregnant woman who travels needs to be
tested at least once, do we have the capacity? And then you
start looking at the asymptomatic, or the symptomatic men and
testing. I think that is a concern.
Mr. Murphy. Is it possible also for the Zika virus to be
transmitted through a breast-feeding mother to her infant?
Dr. Sheffield. So that's an excellent question. For breast-
feeding mothers, so far they have found Zika RNA in the breast
milk, so we know that at some point the virus has made it to
the breast milk. That being said, there have been no cases of
transmission from breast milk. There also have not been active
virus identified from the breast milk, so we know that there's
parts of virus there. That's why the PCR comes back positive.
But as of right now we haven't found active virus in breast
milk.
Mr. Murphy. Well, I want to thank this panel and the
previous panel. This is very sobering and, quite frankly, very
frightening stories we have heard today about a very real
nightmare of the spread of Zika virus. And we don't have the
answers yet, we don't have the tests yet, we don't have the
solutions, and I don't even think we know all the consequences
yet of what this does to adults, to infants, and what we'll see
in the future with children, whether it is those who have been
affected in utero with the virus, or those who may have been
affected during early childhood, because we don't know what
that could do to the developing brain, as well. So we'll
monitor this very closely.
We thank you and the other panelists for your information
on this. So I'd like to thank the witnesses and the members who
have attended today. Thank you, Ms. Castor, for stepping in
here.
I remind all members they have 10 business days to submit
questions for the record. I ask that the witnesses all agree to
respond promptly to the questions. And with that, this hearing
is adjourned. Thank you.
[Whereupon, at 12:56 p.m., the subcommittee was adjourned.]
[Material submitted for inclusion in the record follows:]
Prepared statement of Hon. Fred Upton
Mr. Chairman, thank you for holding this hearing on the
U.S. public health response to the Zika virus.
Since January, bipartisan committee staff has been
examining our public health preparedness for Zika through
meetings with federal agencies, state health departments,
public laboratories, international organizations, experts in
tropical diseases and mosquito control, as well as other key
stakeholders.
While there has yet to be a confirmed case of mosquito-to-
human Zika transmission across the 50 states, this may only be
a matter of time. Meanwhile, we must confront the tragic
incidence of microcephaly in babies born to women that acquired
the infection from travel abroad. We must work diligently to
reduce the chance of sexual transmission as well as
contamination of the national blood supply.
Our understanding of the virus is growing by the day.
However, there are still many questions that remain to be
answered before we can be assured that we are doing our utmost
to protect the American people from this and future pandemics.
Of particular concern is the disorganization of mosquito
control systems and the limited capacity for lab testing to
diagnose Zika.
Zika is another example demonstrating the need for greater
preparedness. Zika is one of the emerging biological threats
that formed an important part of the inquiry of the Blue Ribbon
Study Panel on Biodefense, discussed at a hearing before this
Committee several weeks ago. The panel's findings should serve
as an urgent reminder of the need to build capacity--and
improve coordination--at all levels of government to address
present and future public health crises, whether of manmade or
natural origin.
The federal witnesses testifying before us this morning are
uniquely positioned to discuss how the federal response to Zika
has been formulated, expand upon the $1.9 billion requested of
Congress on February 22 under the emergency supplemental
appropriation, and address how it builds upon the lessons
learned from responses to past outbreaks, such as Ebola. Our
GAO witness will add his preliminary observations on the
contours of a successful domestic, regional, and global
response, and our second panel will feature non-government
perspectives that will assist us in identifying crucial
questions for further study.
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