[Senate Hearing 115-720]
[From the U.S. Government Publishing Office]
S. Hrg. 115-720
FACING 21ST CENTURY PUBLIC
HEALTH THREATS:
OUR NATION'S PREPAREDNESS
AND RESPONSE CAPABILITIES, PART II
=======================================================================
HEARING
OF THE
COMMITTEE ON HEALTH, EDUCATION,
LABOR, AND PENSIONS
UNITED STATES SENATE
ONE HUNDRED FIFTEENTH CONGRESS
SECOND SESSION
ON
EXAMINING FACING 21ST CENTURY PUBLIC HEALTH THREATS, FOCUSING ON OUR
NATION'S PREPAREDNESS AND RESPONSE CAPABILITIES
__________
JANUARY 23, 2018
__________
Printed for the use of the Committee on Health, Education, Labor, and
Pensions
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Available via the World Wide Web: http://www.govinfo.gov
___________
U.S. GOVERNMENT PUBLISHING OFFICE
28-514 PDF WASHINGTON : 2019
COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS
LAMAR ALEXANDER, Tennessee, Chairman
MICHAEL B. ENZI, Wyoming PATTY MURRAY, Washington
RICHARD BURR, North Carolina BERNARD SANDERS (I), Vermont
JOHNNY ISAKSON, Georgia ROBERT P. CASEY, JR., Pennsylvania
RAND PAUL, Kentucky MICHAEL F. BENNET, Colorado
SUSAN M. COLLINS, Maine TAMMY BALDWIN, Wisconsin
BILL CASSIDY, M.D., Louisiana CHRISTOPHER S. MURPHY, Connecticut
TODD YOUNG, Indiana ELIZABETH WARREN, Massachusetts
ORRIN G. HATCH, Utah TIM KAINE, Virginia
PAT ROBERTS, Kansas MAGGIE HASSAN, New Hampshire
LISA MURKOWSKI, Alaska TINA SMITH, Minnesota
TIM SCOTT, South Carolina DOUG JONES, Alabama
David P. Cleary, Republican Staff Director
Lindsey Ward Seidman, Republican Deputy Staff Director
Evan Schatz, Democratic Staff Director
John Righter, Democratic Deputy Staff Director
C O N T E N T S
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STATEMENTS
TUESDAY, JANUARY 23, 2018
Page
Committee Members
Alexander, Hon. Lamar, Chairman, Committee on Health, Education,
Labor, and Pensions, Opening Statement......................... 1
Burr, Hon. Richard, a U.S. Senator from the State of North
Carolina, Opening Statement.................................... 2
Casey, Hon. Robert P., Jr., a U.S. Senator from the State of
Pennsylvania, Opening Statement................................ 3
Witnesses--Panel I
Inglesby, Tom, MD, Director, Center for Health Security, Johns
Hopkins Bloomberg School of Public Health, Baltimore, MD....... 6
Prepared statement........................................... 8
Dreyzehner, John J., MD, MPH, FACOEM, Commissioner, Tennessee
Department of Health, Nashville, TN............................ 13
Prepared statement........................................... 15
MacGregor, Brent, Senior Vice President, Commercial Operations,
Seqirus, Co-Chair, Alliance for Biosecurity, Summit, NJ........ 18
Prepared statement........................................... 20
Krug, Steven, MD, FAAP, Head, Pediatric Emergency Medicine, Ann &
Robert H. Lurie Children's Hospital of Chicago, Professor of
Pediatrics, Northwestern University Feinberg School of
Medicine, Chair, Disaster Preparedness Advisory Council,
American Academy of Pediatrics, Chicago, IL.................... 23
Prepared statement........................................... 25
Additional Material
Roberts, Hon. Pat:
Gen. (Ret.) Richard B. Myers, Prepared Statement............ 59
FACING 21ST CENTURY PUBLIC
HEALTH THREATS:
OUR NATION'S PREPAREDNESS
AND RESPONSE CAPABILITIES, PART II
----------
Tuesday, January 23, 2018
U.S. Senate,
Committee on Health, Education, Labor, and Pensions,
Washington, DC.
The Committee met, pursuant to notice, at 10:05 a.m. in
room SD-430, Dirksen Senate Office Building, Hon. Richard Burr,
presiding.
Present: Senators Alexander, Burr [presiding], Isakson,
Cassidy, Young, Roberts, Casey, Baldwin, Murphy, Warren, Kaine,
Hassan, Smith, and Jones.
Opening Statement of Senator Alexander
Senator Burr [presiding]. I would like to call the hearing
to order.
First off, I would like to recognize the Chairman of the
Committee for a statement.
The Chairman. Thank you, Senator Burr, and Senator Casey,
and Members of the Committee.
I want to thank Senator Burr for chairing the hearing
today, and Senator Casey for serving as Ranking Member at
Senator Murray's request. They have both been real leaders on
this subject.
Senator Burr was the original author of the first passage
of the Pandemic and All-Hazards Preparedness Act in 2006. The
law helps protect us from the full range of public health
threats: from natural disasters, to bioterror attacks, to
outbreaks of infectious diseases.
Then in 2013, Senators Burr and Casey led the bipartisan
authorization of the Pandemic and All-Hazards Act. Many Members
of this Committee contributed at that time, some of whom are
still on the Committee including Senators Enzi, and Bennet,
Isakson, Warren, Hatch, Roberts, and others.
Now, the bill needs to be reauthorized for a second time
and today's hearing is the second we have had this year.
Last week, we heard from the Administration on
recommendations in advance of the reauthorization of the Act
including from the Assistant Secretary for Preparedness and
Response, the Food and Drug Administration, and the Centers for
Disease Control and Prevention.
In the middle of the flu season, it is critical that we
reauthorize the Act before many of its provisions expire in
September. I hope we will do this in a bipartisan way and I
expect that. That has been the tradition with the law and with
this Committee on almost all of our major bills.
People are not as aware of the devastation of, for example,
the flu, and I mentioned the flu season. I believe the figures
are that between 12,000 and 50,000 Americans die of flu every
year. Dr. Collins has talked to us about the expediting of a
universal flu vaccine, which he sees soon.
Tennessee has seen heartbreaking stories already this
winter as the flu spread across this state and this country. In
our state already in this season, a pregnant woman and three
children in Tennessee have died of the flu.
The Act provides a public health preparedness framework
that enables us to be prepared and able to respond to public
health threats by ensuring that we have enough medicines to
protect Americans, and to ensure our hospitals and state and
local health departments are prepared to respond to public
health emergencies.
Thanks to all our witnesses for coming here today,
especially Dr. Dreyzehner, who has come from Tennessee.
Thank you, Senator Burr.
Statement of Senator Burr
Senator Burr. Thank you, Chairman Alexander.
This morning, we are holding a hearing entitled, ``Facing
21st Century Public Health Threats: Our Nation's Preparedness
and Response Capabilities.''
We will hear from Dr. Tom Inglesby, Director of the Center
for Health Security at Johns Hopkins Bloomberg School of Public
Health; Dr. John Dreyzehner, Commissioner of the Tennessee
Department of Health; Brent MacGregor, Senior Vice President of
Commercial Operations for Seqirus and Co-Chair of the Alliance
for Biosecurity, Summit; and Dr. Steven Krug, Head of Pediatric
Emergency Medicine at Lurie Children's Hospital in Chicago.
Senator Casey and I will have an opening statement, and
then we will hear from the witnesses, and then Members will
have up to 5 minutes for questions.
I am pleased to chair this second hearing to inform our
work on PAHPA. I would like to thank the Chairman, once again,
for giving the opportunity to Senator Casey and I to lead the
discussion.
Today, we will hear from some individuals with firsthand
knowledge of the challenges we face in combating public health
threats, and their ideas on how to move forward.
Since the last PAHPA reauthorization, the emergency
preparedness and response framework has been tested by the
emergence of pandemic flu, multiple natural disasters, and an
Ebola breakout and a Zika virus.
The lessons learned in these events come from individuals,
like those sitting before us today, and their efforts to
protect and to save lives.
The last hurricane season resulted in three major storms
devastating many communities and raising new questions about
our ability to manage and withstand multiple periods of
response.
The emergence of Zika emphasized the need for improved data
collection and surveillance to inform and protect as many
mothers and babies as possible. Further, the Ebola breakout in
2014 highlighted the need for an ASPR that brings both the
knowledge of the potential damage that can be brought by these
threats and a deep understanding of the effort undertaken for
research, development, and procurement of medical
countermeasures.
I look forward to learning more about the opportunities and
barriers each of you see to better leverage innovative
technologies to solve these problems.
Whether it is the challenge in the development of a
vaccine, the information crucial to a public health department
in the midst of a crisis, the infrastructure a doctor needs to
rapidly care for patients, or improvements to the ways these
policies complement one another, your experiences reminds us
that we cannot let up on these efforts or lose sight of the
urgency this mission demands.
We must not get distracted by making changes to the laws
that are outside of our focus of perfecting PAHPA, improving
and strengthening our policies and programs to make them more
effective now and in the future.
I look forward to the insight each witness can provide.
Now I would turn to Senator Casey for any remarks he would
like to make.
Statement of Senator Casey
Senator Casey. Thank you, Senator Burr.
I want to thank Senator Burr for his years of work on these
issues.
I want to thank, as well, the leaders of this Committee,
Chairman Alexander and Ranking Member Murray, for this
opportunity.
Also, of course, I want to thank our witnesses for bringing
their experience and work to these issues, and for joining us
today.
This is our second hearing on this topic and the focus, of
course, is our Nation's preparedness to combat public health
threats as we look toward reauthorizing the Pandemic and All-
Hazards Preparedness Act later this year.
Now, more than ever, we must continue to build our Nation's
resiliency to help security threats. The threats that face our
Nation today are increasing in both frequency and intensity. It
is critical to foster and advance innovation and drugs,
devices, and diagnostics.
Yet, when we are considering an emerging infectious
disease, or an engineered bioweapon that has yet to be seen by
man, or the response to a natural disaster like a hurricane, we
do not and will not have a vaccine or a countermeasure to
protect us from these scenarios.
In addition to supporting biomedical innovations, we must
also strengthen our hospitals and our public health
professionals, our frontline of defense against these health
threats.
We must ensure that we give our communities the necessary
tools and support they need to be ready when, not if, the next
emergency strikes. By all accounts, we have come a long way.
I spoke at the last hearing about the success of the
Hospital Preparedness Program, the so called HPP and PHEP, the
Public Health Emergency Preparedness Program in the context of
a train derailment in Pennsylvania. One of many examples we
could cite.
But these grants for these programs also facilitate
preparedness activities that help hospitals and public health
systems with more regular occurrences.
For example, when subzero temperatures caused bursting
pipes in St. Vincent Hospital in Erie, Pennsylvania--and Erie
got hit worse than anyplace with snow this year--the hospital
contacted the local emergency management agency and also the
regional healthcare coalition, created through HPP funding, who
assisted in the response in that circumstance.
Yet, the funding for these preparedness programs has
decreased from PAHPA to PAHPRA with appropriations falling
behind authorized levels, spiking only in the response to Ebola
and Zika.
The impact of funding reductions means a decrease in the
amount of time that hospitals and medical staff have to plan
and train for an emergency; and the loss of thousands of public
health jobs, and the reduction in emergency managers and public
health lab technicians.
It is very dangerous to wait for a threat to emerge to try
to pass emergency funding bills. We must be proactive, not
reactive.
How can we improve our healthcare system preparedness and
our public health capacities, and thereby improve our
situational awareness in an emergency?
Can we work toward a precision public health using better
data to more efficiently guide responses in emergencies to help
benefit our communities? I think we can.
For example, it was reported by the publication ``Nature,''
when domestic transmission of the Zika virus was confirmed in
the United States, the entire country was not declared at-risk.
Instead, precise surveillance defined two at-risk areas of
Miami-Dade County neighborhoods measuring less than 2.5 square
miles. This allowed for the targeting of resources to these
regions.
Building on that experience, we can expand surveillance to
illuminate causes of disease and spark opportunities for
prevention.
At last week's hearing, we also heard from Assistant
Secretary Kadlec about the use of emPOWER, the emPOWER program,
to identify and treat at-risk individuals requiring
electricity-dependent medical and assistive equipment. Yet, he
also identified a weakness. This system only pulls in Medicare
data, not Medicaid and not TRICARE data.
How do we ensure that we are acting on the data
appropriately to protect these vulnerable individuals?
The tragic death of 12 seniors at a nursing home during
Hurricane Irma in September highlights that more needs to be
done to protect our most vulnerable citizens. In fact, most of
our citizens have additional characteristics that make them
more vulnerable during a public health emergency. This includes
our children, our parents, our rural communities, individuals
who have limited English proficiency, individuals with
disabilities and, of course, individuals with chronic illnesses
and more.
We must do better to help our communities to prepare for
potential health security threats. We must continue to invest
in innovative biotechnologies and we must also improve our non-
pharmaceutical interventions.
I am looking forward to the hearing, for the witnesses'
testimony, and for how we can continue to prepare our hospitals
and health systems to ensure equal consideration of all of our
constituents.
Senator Burr, thank you very much.
Senator Burr. Thank you, Senator Casey.
I am pleased that we have our four witnesses here today and
I thank each of you for taking the time to be here. I would
like to introduce all four.
First, I would like to introduce Dr. Tom Inglesby. Dr.
Inglesby is the Director of the Center for Health Security at
Johns Hopkins Bloomberg School of Public Health.
He is internationally recognized for his work as a writer
with numerous publications focusing on public health
preparedness, pandemic, and emerging infectious disease, as
well as the prevention of, and response to, biologic threats.
Dr. Inglesby, welcome.
I will now turn to Senator Alexander for an introduction.
The Chairman. Thank you, Senator Burr.
I would like to welcome Dr. John Dreyzehner, who is surely
the tallest Commissioner of Health in our history, maybe in the
country.
He has served as Commissioner of the Tennessee Department
of Health in Nashville since 2011. He has significant
experience responding to state and local public health
emergencies including infectious diseases like Zika, and
natural disasters such as the wildfires that devastated eastern
Tennessee in 2016.
Today, he will provide important insights into our Nation's
preparedness and response capabilities at the state and local
level, what is working, where we can improve, and where we can
protect and save more lives.
Dr. Dreyzehner is a physician with more than 25 years of
service. As Commissioner of Health, he helps to protect
Tennesseans from public health threats.
I appreciate his leadership in Tennessee and we welcome him
to the Committee.
Senator Burr. John, I am sure if you were a little younger,
there are a couple of Tennessee basketball teams that would
probably recruit you tomorrow given their record this year.
The Chairman. Well, one of them is doing better.
Senator Burr. Next, I would like to introduce Mr. Brent
MacGregor. He is the Senior Vice President for Commercial
Operations at Seqirus, the second largest flu vaccine company
in the world.
Seqirus is an example of the success that can be achieved
through public-private partnerships to ensure that we are
better prepared for the threats that face us.
Their facility in Holly Springs, North Carolina is one of
three advanced manufacturing facilities in the country with the
capability to rapidly respond in the event of a pandemic flu
outbreak.
Mr. MacGregor is also the Co-Chair of the Alliance for
Biosecurity. The Alliance works to promote the critical
partnerships between the Government, industry, and other
stakeholders to advance and encourage the development of
medical countermeasures.
Brent, welcome.
Finally, Dr. Steven Krug. Dr. Krug is the Head of Pediatric
Emergency Medicine at the Lurie Children's Hospital of Chicago.
Dr. Krug is also a Professor of Pediatrics at Northwestern
University Feinberg School of Medicine, and serves as the Chair
of the American Academy of Pediatrics Disaster Preparedness
Advisory Council.
Dr. Krug, welcome.
With that, I will turn to you, Dr. Inglesby, and you can
lead off for up to 5 minutes of testimony.
STATEMENT OF TOM INGLESBY, M.D., DIRECTOR, CENTER FOR HEALTH
SECURITY, JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH,
BALTIMORE, MD
Dr. Inglesby. Thank you.
Senator Burr, Senator Casey, Members of the Committee.
Thank you for the chance to speak today about these
important issues.
My name is Tom Inglesby, and I am the Director of the
Center for Health Security at the Johns Hopkins Bloomberg
School of Public Health where I am a Professor of Medicine and
Public Health. Our Center's mission is to protect peoples'
health from epidemics and disasters, and to build resilient
communities.
I will provide a brief overview of key areas that Center
colleagues and I consider vital to our Nation's preparedness
and response capabilities. The opinions expressed here are my
own and do not necessarily reflect the views of Johns Hopkins
University.
The U.S. faces a range of major public health threats, any
of which could occur without much warning. These include
natural disasters, technological accidents, mass shootings and
bombings, chemical spills and potential use of chemical
weapons, radiation and nuclear threats, and biological threats.
Biological threats, whether they are natural like H7N9 in
China, or accidental such as an epidemic viral strain released
from a lab, or deliberate like small pox or anthrax are of a
particular concern, and thus, a big focus of my comments today.
Biological threats could range from modest in size up to those
capable of posing global, catastrophic risks.
What more can be done to prepare for these threats?
First, we need to strengthen the healthcare system's
preparedness. That is, the capacity to care for high numbers of
sick or injured in an emergency.
While there has been substantial progress in preparing for
small disasters in the country, the Nation is not ready to
provide medical care in large catastrophes or big epidemics of
contagious disease.
The APSR Hospital Preparedness Program, or HPP, has been
helping fund and build these capabilities at the state and
local level. But significant resource constraints limit what
HPP can do. Its budget has decreased more than 50 percent since
it started in 2002. That trend should be reversed.
New initiatives, like establishing regional disaster
resource hospitals, could be a strong, new, additional
component in improving medical preparedness.
Second, we need to strengthen the ability of our public
health system to detect and respond to threats.
Since 2001, there have been serious efforts at the CDC, and
state and local levels, to provide early warning of new
outbreaks, provide lab diagnostics, investigate and contain
outbreaks, communicate to the public, ensure biosafety and
biosecurity, and much more.
There has been good, forward movement, but there is too
much to do and not enough trained professionals to do the work.
Public health relies on funding from the CDC's Public Health
Emergency Preparedness grants, or PHEP.
That funding has been reduced by nearly 30 percent since
2002 even though public health crises have not declined. PHEP
should be strongly supported.
In addition, I believe that a public health emergency
contingency fund should be established, which would allow
rapid, public health response funding in emergencies.
Third, we need to move ahead in medical countermeasure
development. There has been good progress, but many priorities
remain including sustained funding in research, development,
and manufacturing and acquisition of countermeasures;
transitioning to new flu vaccine technologies; and setting more
ambitious targets for rapid development of products in
emergencies so that they are ready in the course of a given
pandemic or epidemic.
Fourth, the U.S. needs to recognize threats that could
inadvertently emerge from biological research.
After the U.S. moratorium on potential pandemic pathogen
research was lifted last month, researchers can now again apply
for funding to study, for example, ways of making the world's
most lethal viruses, like H5N1 bird flu, respiratory
transmissible like seasonal flu.
In the worst case, this could lead to the accidental or
deliberate release of a novel strain of virus that could cause
an epidemic or even a pandemic.
I do not believe the benefits of this work are worth the
risks, but if it is going to go ahead, I would advise there be
high transparency in the program and serious dialog among
concerned governments internationally on how to proceed.
Finally, we should fund the Global Health Security Agenda,
or GHSA. In 2014, the U.S. helped launch GHSA with a billion
dollar commitment to help countries prevent, detect, and
respond to infectious disease threats.
Since then, the CDC and USAID have been working in 39
countries, leading programs to stop antimicrobial resistance,
increase lab and surveillance capabilities, strengthen public
health workforces, and much more.
But at this point, U.S. funding for GHSA is ending soon. If
we pull away from the GHSA, other countries will likely do the
same. We should continue to support it. It is the most
effective program we have to contain international outbreaks at
their sources overseas.
Improving our Nation's preparedness and response capacity
is a daunting, complex endeavor, but I am confident it is an
achievable goal if we focus our efforts on these initiatives.
I appreciate the Committee's time and I welcome your
questions.
[The prepared statement of Dr. Inglesby follows:]
prepared statement of tom inglesby
Chairman Alexander, Ranking Member Murray, and Members of the
Committee, thank you for the chance to speak with you today about
Facing 21st Century Public Health Threats: Our Nation's Preparedness
and Response Capabilities.
My name is Tom Inglesby. I'm the Director of the Center for Health
Security of the Johns Hopkins Bloomberg School of Public Health and a
Professor of Public Health and Medicine at the school. The opinions
expressed herein are my own and do not necessarily reflect the views of
The Johns Hopkins University. Our Center's mission is to protect
people's health from epidemics and disasters and build resilience in
communities. We study the organizations, systems, and tools needed to
prepare and respond, and work to help translate what we find into
stronger programs and policies.
I will provide comments on the kinds of threats that the country
faces, health care system preparedness, public health needs, medical
countermeasure development, potential pandemic pathogen research and
the global health security agenda.
Public Health Threats to the Country
The country faces a range of potential sudden, major public health
threats, any of which could occur without much warning: natural
disasters including major hurricanes, earthquakes, fires and mudslides;
technological accidents; mass shootings and bombings; chemical spills
and the use of chemical weapons, such as we saw on horrific scale in
Syria; radiation and nuclear threats; and, biological threats, either
natural, accidental or deliberate. I will say more about biological
threats given the particular kinds of threats they pose.
We have seen signs of what natural epidemics can do in recent
years. We saw what damage Ebola could do when it got into cities in
West Africa, what MERS did in S Korea when it arrived there, how Zika
could transmit congenital deformities by mosquito. And health agencies
around the world are tracking H7N9 in China, the most serious of avian
influenza potential threats to emerge in years, with case fatality
rates on the order of 40 percent. If H7N9 ever evolved into a virus
capable of sustained human to human transmission, it is hard to
describe how devastating that would be to the world.
We are also now in an era where there is incredible power in
biotechnology and science. This power is almost entirely for the good,
with the development of new medicines, better agriculture, improvements
to the economy, and more. But with every new technology we need to
acknowledge the potential downsides of accidental or deliberate misuse.
It is now possible to engineer new traits into old viruses. For
example, it is becoming possible to take the lethality of one virus and
combine it with the contagious qualities of another virus. And, last
week scientists published research showing how they synthetically could
create horsepox, a close viral relative of smallpox. We don't have the
oversight system we need to fully understand or manage these kinds of
developments yet, either in the U.S. or internationally. Whatever we do
about this, we need to ensure that we don't slow down science that
drives so many good things forward. But we also can't ignore that new
risks are becoming possible.
Even without the advent of new science, there are the known
deliberate biological threats including anthrax and smallpox. The
government's own modelling has shown repeatedly how severe the impact
could be in the event of larger scale biological weapons use in the
U.S., and there is continued urgency in preparing for these
possibilities.
There is a broad range of potential consequences from biological
threats. Some are common and of a more modest scale. On the other end
of the spectrum, some conceivable scenarios could even pose globally
catastrophic biological risks, with lasting damage to countries and
societies around the world.
Given the range of biological scenarios and possible consequences,
the forthcoming White House National Biodefense Strategy will be of
great importance in helping to set national priorities, assign agency
responsibilities, and identify funding requirements.
Health Care System Preparedness
An essential component of medical preparedness is the capacity to
care for high numbers of sick or injured in the event of an emergency.
And while there has been substantial progress in preparing for smaller
disasters, the Nation is not ready to provide medical care in large
catastrophes or big epidemics of contagious disease.
For smaller events, there is evidence that preparedness has gotten
better. We saw this with the response to the Boston marathon bombing in
which 264 were injured and treated at 27 hospitals-- all victims who
made it to the hospital survived. The health care and EMS response to
the Las Vegas shootings was also considered to be effective in
providing trauma care. Hospitals, for the most part, do well in normal
flu season, handle smaller outbreaks, and they provide good care for
the victims of car and bus accidents. The Assistant Secretary for
Preparedness and Response (ASPR) Hospital Preparedness Program (HPP)
has been working to help fund and build these capabilities.
In larger scale infectious diseases emergencies, most U.S. health
care systems would not do well. It was quite evident how difficult it
was to care for even one hospitalized Ebola patient, let alone to
consider how a hospital would handle a larger scale infectious disease
emergency. The ASPR program to build 10 regional biocontainment units
(BCUs) was smart, and we should build on that capacity. But it is
important to know that most of these units can handle only a couple of
patients at a time. More broadly, there is no surge plan for taking
care of larger numbers of patients with contagious, potentially lethal
infectious diseases. If hospitals do need to take care of patients with
contagious infectious diseases, there could be major disruptions to the
regular operations of their systems. They will need to protect against
that, or could put at risk their normal work of taking care of heart
attacks, delivering babies, performing surgeries, and more.
If you consider what would be required to manage the ill in a flu
pandemic or smallpox or after a sizable anthrax event, it is clear that
hospitals do not have that capability-- they are simply not equipped
for those larger events, and they are living too close to the margins
with just in time inventories to be able to surge.
In larger events, a responding hospital would need to be part of a
larger entity that connects hospitals to each other and to other key
parts of the system--a system called Health Care Coalition. HPP has
funded the creation of these coalitions around the country, and they
largely comprise of hospitals, public health, EMS. In places where they
don't already, coalitions should also include minute clinics, surgi-
clinics, pharmacies, mental health and dialysis centers. We saw in the
response to Hurricane Sandy just how much medical care is delivered in
the community outside of hospitals themselves, so these kinds of
organizations need to be prepared to respond in emergencies too. With
the hurricanes of last fall, we also saw how much the affected
communities relied on the assistance of ASPR, the emergency personnel
it led, and the emergency medical assets it helped to provide.
On a national level, for planning for major epidemics and
disasters, we should build on the strengths we see in Level 1 Trauma
Centers and the BCUs to create what could be called specialized
Disaster Resource Hospitals (DRH). These would be designated facilities
with special national and regional responsibilities to prepare for
disasters and epidemics. They would have more reserve in the system,
better trained people, resources to support a larger mission, and could
serve as resources to other hospitals. Many would be academic medical
centers, probably already Level 1 Trauma Centers, probably many would
be the existing BCUs, because they are already organized to take on
high end risks and problems that smaller hospitals in system can't
manage.
There are other actions we can take to improve our health care
response. Doctors and nurses should be able to take their healthcare
credentials acrosslines in order to facilitate response to a regional
or national emergency.
We should also be able to rapidly deploy clinicians internationally
in new outbreaks. We had substantial difficulty doing that in Ebola. It
would be good for ASPR to work with CDC, State Department, USAID, DoD
and other partners as needed to develop a plan delineating under what
conditions, with what personnel, and how clinicians would be officially
deployed internationally from the U.S. in the event of a pandemic or
other emergency of international concern. Early deployment of clinical
experts could help outbreaks overseas from becoming out of control and
spreading.
The U.S. government should put in place a plan for conducting
research during public health emergencies to study new medicines,
vaccines, and other clinical and public health interventions to gauge
whether they are effective and safe. We have seen in past epidemic
responses that a number of new products and efforts are tried, but not
necessarily in careful ways that create the evidence needed to
determine effectiveness and safety. Clinical trial designs that help us
answer those questions should be worked out ahead of any crisis.
Overall, we need a stronger approach to prepare for the most
serious catastrophes that could hurt the country. We need planning for
the most consequential of the FEMA national planning scenarios. In the
dozen years since these scenarios were issued, we have not made a lot
of progress in the health care system in being able to respond
effectively to many of the threats detailed in those scenarios. A vivid
example of this was Hurricane Maria that destroyed the basic
infrastructure that we need to provide medical care to victims.
In terms of resources, the HPP budget of $250M is down from $515M
at its inception. This is worrisome, given what we have learned about
how hard it is to prepare to provide mass care for the range of
emergencies experienced by Americans. The HPP program should be
supported at a higher level, and other avenues of funding should be
explored for funding a new DRH program. Possible additional Federal
funding avenues to explore include adding a modest amount of additional
reimbursement for each Medicare and Medicaid admission to DRHs. This
could help reduce the uncertainties surrounding annual appropriations
for preparedness that come through the annual HPP program. In any
event, ASPR and its mission to build national preparedness, including
the hospital preparedness program and the medical countermeasure
enterprise, need to be strongly supported.
Public Health Preparedness
Another national pillar for preparedness is the capacity of our
public health system to detect and respond to public health crises.
Since 2001, there has been a major effort at CDC and around the country
at a state and local level to build programs that would help provide
early warning of new outbreaks, provide laboratory diagnostics,
investigate and help contain outbreaks, communicate risk to the public,
ensure biosafety and biosecurity practices and more.
A great deal of progress has been made, and there is a committed
cadre of public health officials working on these issues around the
country to protect Americans during times of public health crisis. But
there is too much to do and not enough trained professionals to do it.
The public health workforce has been reduced by budget pressures by
tens of thousands in the last decade. This is the same public health
workforce that every day deals with urgencies like the opioid crisis, a
nasty seasonal flu season, outbreaks of diseases like measles or
norovirus in a school or meningitis on a college campus or legionella
in an apartment building, medicine and vaccine shortages, HIV,
hepatitis, tuberculosis, the safety of water supplies, and so much
more. The National Health Security Preparedness Index, which measures
state by state capacities in key areas of public health, shows an
average state score of 6.8/10, with substantial variation around the
country.
Public health agencies critically rely on funding from the Public
Health Emergency Preparedness Program (PHEP) program administered by
the CDC to prepare for emergencies. That funding has been reduced to
$660M from $940M in 2002, and yet the public health crises faced by
Americans have not commensurately declined. Early in 2018, the
Administration proposed substantial cuts to PHEP grants. Congress
didn't go along with those cuts. I am hopeful that this year, the
Administration will recognize the role of the PHEP program and public
health grants in preparing the country for disasters and epidemics that
befall our communities. There should be more funding for public health
preparedness for emergencies, not less. If current funding goes down or
away, public health jobs are cut, key labs don't get supported,
outbreak investigations will be slowed, disease surveillance programs
will suffer, along with the rest of what public health provides every
day and in emergencies.
Some have asked whether there should be changes made regarding
which states and cities should receive HPP and PHEP funding based on
some new determination of risks. We haven't seen evidence that serious
changes to the programs' formulas would provide meaningful benefit or
that the current formula is flawed (currently there are already risk-
based considerations in both formulas). Funding formulas that lean too
heavily on risks from prior natural disasters ignore both universal
risks, such as an influenza pandemic or other outbreaks, and
unpredictable threats such as acts of terrorism and mass shootings.
Because disasters can occur anywhere in the U.S., preparedness should
occur broadly around the country.
Within CDC too there are essential public health preparedness
programs that should be noted, including the programs that provide
support and technical preparedness assistance to states and locals
public health agencies; the Biosafety and Select Agent and Toxin
program; the Strategic National Stockpile of meds and vaccines we will
need in crises; a range of critical disease surveillance programs; and,
the Emergency Operations Division which is the nerve center for CDC's
deployments around the U.S. and the world. These programs need to
continue to be supported.
There is a new proposed element in public health preparedness that
should be supported--a Public Health Emergency Contingency Fund. We saw
during the initial response to Zika that it took more than 230 days to
get emergency appropriations for that epidemic. A way to address this
would be to create a new Fund that allows rapid access funds in the
aftermath of an emergency. Such a fund should supplement and not
supplant existing public health and preparedness grants which are
needed in order to have a public health essential workforce, labs, and
infrastructure in the first place, and to prepare for the range of
disasters and epidemics that could arise. A Public Health Emergency
Contingency Fund would allow rapid initiation of responses to acute
emergencies so that families and children wouldn't have to wait for a
special appropriation before help could start. Resources from that fund
could be made available immediately following a public health emergency
declaration, with reporting requirements to Congress following the
initial emergency period and an automatic process to replenish funds
when depleted. A balance of $500 million to $1 billion would be
appropriate based on past emergency appropriations for Zika, Ebola, and
H1N1. It would be enough to get the emergency response started for
public health, the healthcare system, and for initiation of medical
countermeasure development, but may not be sufficient for the extended
response, which would need to come through emergency congressional
appropriations.
Medical Countermeasure Development
Another essential component of the country's medical and public
health preparedness is the capacity to make medical countermeasures to
respond to threats. As of 15 years ago, there was no national approach
to medicine or vaccine acquisition for civilian needs in emergencies.
Since then, there has been substantial progress. There are now: a
research program at NIH; an advanced development program at BARDA; an
FDA program dedicated to medical countermeasure approval and regulatory
science; engagement of the biopharma companies which develop and
manufacture needed products; and, a substantial stockpile of medicines
in the National Pharmaceutical Stockpile.
But we need to keep strengthening and sustaining this medical
countermeasure research, development and stockpiling system. It is a
very challenging mission primarily because of the complexity of the
science and the breadth of the needs. It is also difficult because--
outside of the U.S. government and sometimes other governments or
international organizations----there are no commercial markets for most
of these products. So the country relies on this system to prepare for
a range of biological, chemical and radiological threats.
There are a number of things about medical countermeasure
development that are worth special mention. We have to press forward on
new approaches to flu vaccine. We certainly need to forge ahead as
rapidly as is possible in the development of a universal flu vaccine
which could provide broad coverage to the range of flu threats that
could face the country. But our best flu scientists say that there are
major technical challenges in that pursuit, and that it will take time
to develop a universal flu vaccine, no matter how we approach it. So in
the meantime, we need to do all we can to improve the flu vaccine
approaches that are now available.
For instance, we still rely on eggs to produce annual flu vaccine
as we have for years. We do this even though we have the technology to
produce vaccine using modern recombinant techniques. Using new
production approaches would allow us to accelerate our response in the
event of a flu pandemic. It would also lessen the chances the vaccine
strains could drift to become less effective in the manufacturing
process as can happen in the process that relies on eggs.
In the event of the onset of a pandemic flu, the USG working with
its biopharma company partners have a plan that will take 5 to 6 months
to begin delivering the needed flu vaccine for that pandemic. We should
continue to exercise and support that plan and work to accelerate that
timeline. But at least in the case of flu, we do have targets and an
exercised process to go from new pandemic discovery to vaccine
manufacturing in 6 month timeline. We don't have that kind of process
for epidemics that might be caused by other pathogens.
For example, during the Ebola outbreak in West Africa, a new Ebola
candidate vaccine was developed, but it took so long that it was not
available until after the outbreak was over. And in some ways, we were
better positioned to respond to Ebola than we would be for many other
diseases--there had been substantial science efforts related to early
Ebola countermeasure development in DOD and NIH programs for years. For
other infectious diseases, we would be further behind at the start, and
it could take much longer than it did for Ebola.
As per the November 2016 PCAST report to the President on How to
Protect Against Biological Attack recommended, the country should set a
national target of 6 months or less for developing a new medicine or
vaccine for major epidemics and pandemics beyond pandemic influenza. To
do that would require people, systems and infrastructure dedicated to
that goal within government, and a budget to go with that. Right now
when new epidemics emerge that require a sudden start of a new MCM
program (e.g. Zika), it is almost guaranteed to be a long, uncertain,
and complicated process with no clear or well worked-out pathways. In
the case of Zika, a major company that was developing the vaccine
ultimately dropped out of the process, in part because of the
challenges of working with the government.
Potential Pandemic Pathogen Research
It is also important for the medical and public health preparedness
community to pay attention to the kinds of new threats that could
inadvertently come from biological research. For example, it was
announced last month that the USG moratorium for funding potential
pandemic pathogen (PPP) research is over. It is possible once again to
apply for USG funding to study ways of making the world's most lethal
viruses (like H5N1), respiratory transmissible (like seasonal flu). In
the worst case, this could lead to the accidental or deliberate release
of a novel strain of virus that could cause an epidemic, or even a
pandemic. I don't believe the benefits of this kind of research are
worth the risks of doing it. But since the end of the moratorium has
occurred, I would make a number of recommendations regarding this
program.
There should be transparency in how the government approaches this
research. Agencies that fund this work should make their processes
public. What PPP experiments are being proposed? How were risks and
benefits determined, what experiments were approved, and which were
denied? What kind of biosafety and biosecurity will be required to do
this work? There should be clarity regarding the special review process
that has been established to handle this research. How will it work?
Who will be involved? How to avoid conflicts? Are there red-lines that
should not be crossed by scientists?
What will the international approach be? It is good that U.S. has
taken a lead in formulating new PPP framework given that the USG
provided the majority of government funding to date for this kind of
work. Since the USG has acknowledged there are high risks in PPP, what
will USG do internationally to help establish norms for this? What will
our reaction be if we learn that other countries are pursuing PPP
research? I disagree that the U.S. should be pursuing this work, but if
the U.S. is going to do it, then it should be working to engage other
countries to try to establish rules of the road regarding under what
conditions it will be done.
Global Health Security Agenda
A final element to note in medical and public health preparedness
is the importance of international programs in preventing the emergence
of major outbreaks that have the chance to spread to the U.S.. In 2014,
the U.S. helped to launch the Global Health Security Agenda (GHSA) to
improve the capacity of countries around the world to prevent, detect
and respond to infectious disease threats. One lesson from Ebola was
that we have to do more to help countries control infectious diseases.
Because of that experience and because so many other countries were
having trouble building basic capacity to detect and respond to
infectious diseases, the U.S. made a $1Billion commitment to the GHSA
for a period of 5 years. Other countries have also been big supporters
of this effort. South Korea has pledged to spend $100 million to build
capacities in 13 countries. Japan and Australia have pledged $40
million and $100 million, respectively.
With U.S. GHSA funds, the CDC and USAID have been working to
improve these capabilities in 39 countries around the world. These
programs work to diminish antimicrobial resistance, increase laboratory
and surveillance capacities, improve vaccination rates, strengthen the
public health workforce, and much more.
But at this point the future of the GHSA is uncertain. Even though
a number of senior officials in the Administration have voiced support
for the GHSA, and signed onto a declaration to extend the GHSA for
another 5 years, U.S. funding for the initiative is ending soon, and no
commitment for future financial support has been made. Without any sign
that funding will be continued, CDC has notified countries that it will
begin planning to shut down those programs. And if we pull away from
the GHSA in this way, other countries that provide funding and
technical assistance will also likely do the same.
U.S. leadership in the GHSA not only has the advantage of improving
the capabilities of countries to prevent, detect and respond to
infectious diseases. It is also, as U.S. Secretary of State Tillerson
said last year, vital to U.S. national security interests. If
vulnerable countries (many of which are either politically or
financially unstable) do not have the capacity to quickly cope with
disease outbreaks, those outbreaks are more likely to spread
internationally, including to the U.S.. The GHSA is a powerful tool for
helping to ensure that global gaps in health security are addressed
before disease outbreaks occur. To continue the pace of U.S. efforts
for the GHSA set by the original U.S. investment and programs, an
estimated $100M to $200M annually would be needed. It is important for
the United States to commit to support the GHSA to help protect the
Nation and the rest of the world from epidemic disease. Over time, as
countries build their own capabilities, the need for the U.S. and other
national commitments should diminish. But at this time, GHSA remains a
central element in building international capability to prevent, detect
and respond to epidemic diseases.
______
Senator Burr. Thank you, doctor.
John.
STATEMENT OF JOHN J. DREYZEHNER, M.D., MPH, FACOEM,
COMMISSIONER, TENNESSEE DEPARTMENT OF HEALTH, NASHVILLE, TN
Dr. Dreyzehner. Good morning, Chairman Alexander, Senator
Burr, Senator Casey, and distinguished Committee Members.
Thank you for this opportunity to appear before the
Committee and to discuss an initiative of significant
importance to the common defense of this country; a strong,
agile, and resilient public health and medical preparedness and
response system.
It is an honor to be here.
Senator Alexander said I am a physician. I am the
Commissioner of the Health in Tennessee. I was a local health
director in central Appalachia for a decade before that and an
Air Force flight surgeon for many years before that as well.
The thoughts I will be sharing with you today are my own,
but I am confident that they are shared by my public health
colleagues across the country who strive every day to prepare
and respond to threats of all kinds. These threats may be
infectious disease outbreaks like measles, food borne illness,
and our annual epidemic of seasonal influenza that can, like
this year, unpredictably test our Nation's response readiness
and surge capacity.
These threats can be also large scale national or global
events like an influenza pandemic, Ebola, Zika, the opioid
epidemic, or acts of terrorism.
Public health also mobilizes, as you know, during natural
disasters like winter storms, hurricanes, tornadoes, floods,
wildfires as Senator Alexander mentioned, and other extreme
weather events. Unfortunately, seldom does a public health
jurisdiction of any size go more than a few years without
experiencing it.
As well, through mechanisms like the Emergency Management
Assistance Compact, or EMAC, even unaffected jurisdictions are
frequently called upon to assist neighbors.
Public health, and emergency preparedness response and
recovery, is a responsibility, discipline, and service that we
have to get right. Lives, as well as physical and economic
health, depend on it. It is something we, in public health, do
every day. It is a matter of local resiliency. All disasters
play out locally and it is also a matter of national security.
In the few moments that we have together, I would like to
share my perspective with you, having been directly involved in
the planning, implementation, and execution roles at all levels
both in the military and civilian capacity over 25 years. Let
me start with a simple question.
What is health and medical emergency preparedness response
and recovery?
At root, it is not stuff, or equipment, or plans. It is
people. Shelters do not staff themselves. A fire truck cannot
put out a fire without firefighters. And people, like public
health nurses or firefighters, cannot be hired and trained
after the alarm sounds. They need to be there, ready to go,
before the threat ever emerges if they are to be effective in
responding to it. Preparedness is about the people involved and
their interconnected networks.
To be truly prepared, we need three key things.
One, trained people, some with local knowledge and all
connected by relationships built on trust;
Two, expertise and leadership at all levels, local, state,
and Federal, and;
Three, communication and shared situational awareness among
responding leaders, people on the ground, and experts.
Trying to create these three things after an event begins
takes the one commodity that is most precious in an emergency:
time. We do not have time to create this network after the
event starts.
In a way, the public health, and emergency preparedness,
response and recovery network is like afor a performer. It has
to be in place before the show starts, anchored, inspected and
in good shape to do the job.
Many people think equipment or supplies are the net, but if
you remember nothing else from my testimony today, I would like
you to remember this. People, not things, are the net. People
are the net. The anchors matter, but it is the people that run
the response. The relationships, the knowledge, and the trust
created over time are what strengthen the cords, hold them
together, and keep them adaptable and resilient. The more that
cords and nodes on the net degrade or unravel, the less capable
the net is for what we need it to do at our most vulnerable
times.
Things like durable medical equipment, medical
countermeasures, and communications infrastructure are
essential anchors for the net. Without them, the network of
people cannot be as effective, but the people are the net.
Our accomplishments and successes in preparedness response
and recovery over the last 15 years, which I have illustrated
in my written remarks, can be directly attributed, I believe,
to the Pandemic and All-Hazards Preparedness Act.
This Act, both in its initial and first authorization form,
was transformative relative to public health and healthcare
preparedness, and has provided the requisite direction
authorities, the authorization of resources, and the cadence of
accountability that has become part of the culture of public
health, and enable us to do our job in the best way possible.
As you consider PAHPA reauthorization, PHEP and HPP
priorities and resources must be lined up with the demands of
an ever expanding threat environment, given our frontline of
defense and safety net ability. The scale and speed it needs to
protect the public's health and safety are critical to this
ability.
Congress, and especially this Committee, should be
applauded for its continued work on laws like PAHPA that give
states, territories, localities, and tribes the resources and
tools needed to stay vigilant at this critical post and get the
job done. These funds are not duplicative of emergency
management and Homeland Security, as you know, but
complementary and essential. Sometimes, depending on the
hazard, public health is the only responder.
What we ultimately need as a Nation to ensure a strong
safety net is consistent, reliable, and sufficient funding to
keep the people, the net, their knowledge, their networks, and
their trust intact.
Thank you, again, for the opportunity to speak with you
today about this fundamental issue and for caring about
preserving our ability to respond to any hazard or threat for
generations to come.
I appreciate the opportunity to present to you. Thank you.
I am happy to take questions.
[The prepared statement of Dr. Dreyzehner follows:]
prepared statement of john dreyzehner
Chairman Alexander, Ranking Member Murray, Senators Burr and Casey,
and distinguished Committee Members. Thank you for this opportunity to
appear before this Committee today to discuss an issue of significant
importance to the common defense of the country--a strong, agile, and
resilient public health and medical preparedness and response system.
It is an honor to be here. The thoughts I will be sharing with you
today are my own, but I am confident that they are shared by my public
health colleagues across the country who strive every day to prepare
for and respond to threats of all kinds. These threats may be
infectious disease outbreaks like measles, food borne illness, and our
annual epidemic of seasonal influenza that can, like this year,
unpredictably test our Nation's response readiness and surge capacity.
These threats can also be large scale national or global events like an
influenza pandemic, Ebola, Zika, the opioid epidemic, or acts of
terrorism. Public health also mobilizes during natural disasters such
as winter storms, hurricanes, tornados, floods, wildfires, and other
extreme weather events that, unfortunately, seldom does a public health
jurisdiction of any size go more than a few years without experiencing.
Through mechanisms like the Emergency Management Assistance Compact, or
EMAC, even unaffected jurisdictions are frequently called upon to
assist neighbors.
Public health and medical emergency preparedness, response, and
recovery is a responsibility, discipline, and service that we must get
right; lives, as well as physical and economic health depend on it. It
is something we in public health do every day, it is a matter of local
resiliency, as all disasters play out locally, and it is a matter of
national security. In the few moments we have together, I would like to
share my perspective with you, having been directly involved in
planning, implementation, and execution roles at all levels, both in a
military and civilian capacity, for over 50 years.
Let me start with a simple question: ``What is health and medical
emergency preparedness, response, and recovery?'' At root, it's not
``stuff'' or equipment or plans. It's people. Shelters don't staff
themselves. A fire truck can't put out a fire without firefighters, and
people, like public health nurses or firefighters, can't be hired and
trained after the alarm sounds. They need to be there, ready to go
before the threat ever emerges if they are to be effective in
responding to it.
Preparedness is about the people involved: It is about their
interconnected networks. To be truly prepared we need three key things:
(1) Trained people, some with local knowledge, and all connected by
relationships built on trust, (2) Expertise and leadership, at all
levels; local, state, and Federal and (3) Communication and shared
situational awareness among the responding leaders and experts. Trying
to create these three things after an event begins takes the one
commodity that is most precious in an emergency: Time. We don't have
time to create this network once the event starts.
In a way, the public health and medical emergency preparedness
response and recovery network is like a safety net for a performer--it
has to be in place before the show starts, anchored, inspected, and in
good shape for it to do its job. Many people think equipment or
supplies are the net, but if you remember nothing else from my
testimony today, please remember this: people, not things, are the net.
The relationships, knowledge, and trust created over time are what
strengthen the cords, hold them together and keep them adaptable and
resilient. The more the cords and nodes on the net degrade or unravel,
the less capable the net is for what we need it to do at our most
vulnerable times. Things, like durable equipment, medical
countermeasures, and communications infrastructure, are essential
anchors for the net. Without them, the network of people can't be as
effective, but it's the people who are the net.
Our accomplishments and successes in preparedness, response, and
recovery over the last 15 years (illustrated in my written remarks) can
be directly attributed to the Pandemic and All Hazards Preparedness
Act. This Act, both in its initial and first reauthorization form, was
transformative relative to public health and healthcare preparedness
and has provided the requisite direction, authorities, authorization of
resources, and cadence of accountability that have become part of the
culture of public health and enable us to do our job in the best way
possible.
As you consider PAHPA reauthorization, PHEP and HPP1 priorities and
resources must line up with the demands of an ever-expanding threat
environment and give our frontline of defense and safety net the
ability, the scale, and the speed it needs to protect the public's
health and safety. Congress, and especially this Committee, should be
applauded for its continued work on laws like PAHPA that give states,
territories, localities, and tribes the resources and tools needed to
stay vigilant at this critical post and get the job done when needed.
These funds are not duplicative of emergency management and Homeland
Security, but complementary and essential. Sometimes, depending on the
hazard, public health is the only responder.
What we ultimately need as a nation to ensure a strong safety net
is consistent, reliable, and sufficient funding to keep the people, the
net--their knowledge, networks, and trust--intact.
1 Public Health Emergency Preparedness (PHEP) Cooperative Agreement
& Hospital Preparedness Program (HPP)
Thank you again for the opportunity to speak with you today about
this fundamental issue and for caring about preserving our ability to
respond to any hazard or threat for generations to come.
State and territorial public health departments play a critical
role in national security and have increased their individual and
collective capacity, capabilities, and impact over the last 15 years to
manage the consequences of local, regional, and national emergencies
more effectively, saving lives and preventing or reducing injury and
illness. These accomplishments are due, in large part, to the
leadership, strategy and policy provided, and the investments by the
Federal Government in state and local partners, to build and sustain a
strong public health and medical preparedness system--both a front-line
defense and a safety net. Our accomplishments and successes can be
directly attributed to the Pandemic and All Hazards Preparedness Act.
This Act, both in its initial and first reauthorization form, was
transformational as it pertains to public health and healthcare
preparedness and has provided the requisite direction, authorities, and
authorization of resources to enable us to do our job in the best way
possible.
In Tennessee, our front line of defense and safety net is very
adaptable. We have deployed it recently for fires, floods, for winter
storms, wind and tornado events, and to provide mutual aid to
neighboring states and those as far away as the US Virgin Islands. The
list continues with other hazards like Ebola, Zika, measles and mumps
outbreaks, foodborne illnesses, the fungal meningitis associated with
contaminated compounded injectable drugs which I will come back to in a
few moments, and ``white powder'' incidents. These are real and often
different threats requiring flexible and adaptable response
capabilities. In each instance, the strength of our system is tested,
and each time we assess our performance with a commitment to learn from
each and every experience and to make improvements so that our actions
will be even stronger the next time.
Among other features, the Pandemic and All Hazards Preparedness Act
created and authorized two critically important, aligned and
coordinated programs: The Public Health Emergency Preparedness Program
administered by the CDC and the Hospital Preparedness Program
administered by the HHS Assistant Secretary for Preparedness and
Response. These two programs are the bedrock for state and local public
health preparedness and response providing essential cooperative
agreement funding as well as guidance and technical assistance. They
not only enable jurisdictions to plan, train and exercise, but also to
purchase laboratory and communications equipment, medical
countermeasures, and personal protective equipment for first
responders. More importantly, it allows public health departments to
hire and retain a skilled workforce and to make a long-term investment
in ``people'' such as epidemiologists, laboratory technicians, nurses,
environmental health specialists and other subject matter experts. It
is the people, their networks, expertise, and relationships built on
trust that are truly the safety net.
Eighty-one percent of Tennessee's Public Health Emergency
Preparedness (PHEP) program award goes to personnel costs. I realize
this is not an appropriations Committee hearing today but I would be
remiss if I did not mention that the aforementioned funding is
essential, but not sufficient. The primary source for state and local
public health preparedness has been cut by about one-third (from $940
million in 2002 to $667 million in 2017) and hospital emergency
preparedness funds have been cut in half ($514 million in 2003 to $254
million in 2017). These reductions have degraded the safety net and our
resiliency as a nation in the face of these ongoing and increasing
threats. This is a high value investment in the health, safety, and
security of our homeland, and returning to these earlier levels of
funding is a relatively small investment that could reap billions of
dollars in savings given the potentially high cost it could take to
respond to an unmitigated disaster or pandemic. Having the resources to
get it right rapidly at the local level is far more effective and less
costly than a poorly coordinated response that would require Federal
intervention. As you consider PAHPA reauthorization, funding
authorization levels for both PHEP and HPP must line up with resource
demands of today and into the future to sufficiently handle the ever-
expanding threat environment and to give our frontline of defense and
safety net the ability, the scale and the speed it needs to protect the
public's health. It is important to understand that public health
emergency preparedness and response infrastructure is people. One can
think of it in terms of three tiers of public health responders: (1)
Emergency preparedness professionals, (2) those who have deep emergency
preparedness training but whose daily duties are more in line with
traditional public health work, and (3) all other public health
professionals like public health nurses who stand ready to assist when
needed. Each of these tiers, while they may have differing levels of
direct involvement in responding to threats, are all essential to
enabling a fully functional net and all must work together when needs
arise to support each other.
Using just two examples in my own State of Tennessee, a strong
public health response was crucial in saving lives during the 2016 wild
fires in Sevier County that impacted the beautiful town of Gatlinburg.
In addition to staffing shelters, providing vaccines and care, tracking
down and accounting for missing persons, providing for the decedents,
assuring food safety, testing water, staffing of local, regional, and
state emergency operations centers around the clock, the Tennessee
Department of Health (TDH) trailers served as the communications hub
for multiple other agencies including the hospital, EMS, and 911
system. We were all part of the same team, and having the proper
resources deployed at the right place and time saved lives and
property.
During the fungal meningitis outbreak of 2012 that led to 751 cases
across 20 states, with 64 total deaths nationwide, the TDH leveraged a
PHEP-funded communication system called the Tennessee Countermeasure
Response Network to integrate public health in this unprecedented
response that included public health and healthcare sectors. It was
Tennessee's leadership that pinpointed the source of the outbreak and
helped to identify patients at risk. Relationships and trust built
between TDH and Tennessee healthcare providers and other public health
agencies and, most critically, the relationships between public health
nurses and the victims of this terrible event themselves, enabled a
swift and coordinated response. The outbreak response was concluded in
4 months (though the suffering of the victims in some cases continues),
and the rapid identification and response eliminated further exposure
and cases.
These incidents could have been far worse if it were not for the
preparedness efforts of the public health and medical systems.
Similarly, I am confident that my colleagues like Dr. John Wiesman in
Washington State when responding to the tragic train derailment last
December or Danny Staley in North Carolina recently responding to
extreme winter weather, do not want to know how their experiences could
have evolved without the critical support from the Federal Government
for public health preparedness efforts. Each of these examples, and I
can certainly provide you with many more, demonstrates a return on the
investment. That being said, we must also remember that the system
built on passionate, compassionate public health professionals can
degrade quickly if not maintained and the investment continually
renewed.
In closing, allow me to reemphasize the point that the Pandemic and
All Hazards Preparedness Act (PAHPA) is the mechanism that undergirds
the Federal, state, and local governments in these efforts. It is an
extremely important and proven piece of legislation that is responsible
for transforming public health preparedness over what is approaching
two decades and is paramount as it pertains to our ability to protect
the public's health from a constant, challenging, and changing threat
landscape. Congress, and especially this Committee, should be applauded
for its continued work on laws like PAHPA that give states,
territories, localities, and tribes the resources and tools needed to
get the job done. These funds are not duplicative of emergency
management and Homeland Security, but complementary and essential.
As you consider suggestions for the refinement and enhancement of
PAHPA, I respectfully submit the following principles to consider:
Preparedness Programs should be nationwide and extreme
care should be given not to change the funding formula or criteria that
would result in reduced or eliminated funding to jurisdictions thus
compromising their preparedness and response capacity and capability;
all states and localities need their neighbors to be as strong as they
are,
I mentioned previously Preparedness Programs should be
authorized at sufficient funding levels to strengthen and maintain
support for public health infrastructure and workforce; to retain this
highly trained and effective workforce, they need to have some
reasonable certainty regarding continuity in the Nation's need and wish
for their professional activities; these people form the core of the
safety net,
We need a viable Immediate Response Fund allowing for the
timely infusion of additional resources to support surge when existing
capacity is or will soon be exceeded. This principle is well understood
and used routinely by other first responders dealing with natural
disasters. A current fund already exists but is not truly funded. The
practice community would gladly work with the Committee and others to
identify those ``triggers and guardrails'' to be expressed in statute
possibly through this reauthorization cycle that will give Congress the
necessary comfort and confidence of stewardship to then appropriate
reasonable and necessary funds for future use, and
Strengthen the Public Health Emergency Medical
Countermeasures Enterprise (PHEMCE) strategy and implementation plan
process to require coordination with state and local entities to ensure
the products being developed reach the end users in a timely and well-
coordinated manner.
Thank you again for your attention today and for caring deeply
about our Nation's emergency preparedness, response, and recovery
system for today and tomorrow.
______
Senator Burr. Thank you, John.
Brent, the floor is yours.
STATEMENT OF BRENT MACGREGOR, SENIOR VICE PRESIDENT, COMMERCIAL
OPERATIONS, SEQIRUS; CO-CHAIR, ALLIANCE FOR BIOSECURITY,
SUMMIT, NJ
Mr. MacGregor. Good morning, Senator Burr, Senator Casey,
and Members of the Committee.
My name is Brent MacGregor and I am the Senior Vice
President of Commercial Operations for Seqirus.
I appreciate the opportunity to appear before you today as
you prepare to consider the second reauthorization of the
Pandemic and All-Hazards Preparedness Act.
I would like to focus my remarks on the importance of
preparedness against pandemic influenza and the critical role
played by the Biomedical Advanced Research and Development
Authority, BARDA, and its industry partners.
There are three issues that I would like to highlight from
my written testimony.
First, that pandemic influenza is one of the most urgent
public health threats we face as a Nation and must be a
priority of HHS's biodefense enterprise.
Second, BARDA's pandemic influenza program must finally be
authorized in this year's PAHPA legislation.
Third, that Congress must provide sustained, and
predictable, MCM funding to strengthen partnerships with the
private sector and ensure our Nation's preparedness.
Now, regarding my first point, preparing against pandemic
influenza, this is critical to our national and economic
security. Seqirus is proud of the partnership we have with
BARDA to supply one-third of the Nation's vaccine needs when
the next pandemic strikes.
Thanks to the leadership of Senator Burr and Senator Casey,
and Members of this Committee, and the dedicated team at BARDA,
our state-of-the-art vaccine production facility in Holly
Springs, North Carolina is one of the best examples of a
successful public-private partnership in biodefense.
Second, regarding BARDA's pandemic influenza program,
despite representing the ``P'' in PAHPA, authorized funding for
pandemic influenza has never been included in the legislation.
As a result, funding for critical BARDA activities, such as
vaccine stockpiling, advanced research and development, has
been largely episodic since 2009. Emergency supplemental funds
provided during the 2005 and the 2009 pandemics are now fully
exhausted.
Having a program authorized by Congress will provide a
clear signal to the private sector that the U.S. Government is
committed to preparing against pandemic threats in the future.
BARDA's most recent 5-year budget outlined $630 million in
pandemic influenza funding needs for Fiscal Year 2019 alone. We
believe an annual authorization level of at least $535 million
is needed to support HHS's most critical pandemic influenza
activities.
Finally, regarding sustained and predictable MCM funding,
over the last 12 years, this enterprise has greatly improved
our Nation's security. And while BARDA has improved its
communication with industry partners, better reporting from the
Government could provide more end to end certainty in the MCM
development process.
Procurement funding provided by the Project BioShield
Special Reserve Fund, the Strategic National Stockpile, and
BARDA's pandemic influenza program provides manufacturers in
the market certainty after investing for many years in R&D.
Because there is no commercial market for MCM's, companies
like Seqirus can only rely on the commitments provided by HHS
to make investments in MCM research. Unfortunately, over the
last several years, the private sector has become more
skeptical of the Government's commitment to biodefense. The
lack of multiyear funding for the SRF has created uncertainty
in the long term sustainability of MSM programs. Public-private
partnerships must be sustained over time through a demonstrated
commitment by the Federal Government.
There are dozens of companies, both large and small, that
have committed to BARDA's mission and made significant new
investments in MCM development. Reauthorization of PAHPA's
authorities and a renewed commitment to MCM funding will ensure
these investments yield even more FDA approved medical
countermeasures.
Seqirus strongly supports the PAHPA reauthorization
priorities identified by the Alliance for Biosecurity, to which
I am privileged to be a co-chair, and by the Biotechnology
Innovation Organization, or BIO.
I would like to thank Members of this Committee, and in
particular, Senator Burr, for their commitment to reauthorizing
PAHPA in a timely manner. Seqirus believes tremendous progress
has been made to ensure Americans are better protected against
the threat of pandemic influenza, and we are excited about the
future of our partnership with BARDA.
We strongly encourage the Committee to formally authorize
BARDA's pandemic influenza program. This is a critical
opportunity for Congress to ensure BARDA has the resources it
needs to prepare against one of the most predictable threats we
face as a Nation.
I look forward to serving as a resource for this Committee
during the PAHPA reauthorization process.
I am happy to answer any questions you may have, and I
thank you for inviting me here today.
[The prepared statement of Mr. MacGregor follows:]
prepared statement of brent macgregor
Good morning Mr. Chairman, Ranking Member Murray, and Members of
the Committee. My name is Brent MacGregor and I am the Senior Vice
President of Commercial Operations for Seqirus. I appreciate the
opportunity to appear before you today as you prepare to consider the
second reauthorization of the Pandemic and All Hazards Preparedness Act
(PAHPA). I would like to focus my remarks on the importance of
preparedness against pandemic influenza and the critical role played by
the Biomedical Advanced Research and Development Authority (BARDA) and
its industry partners.
Seqirus is a global leader in the development and manufacturing of
influenza vaccines. With extensive research and production expertise
and facilities in the U.S., U.K. and Australia, Seqirus is a committed
partner in pandemic preparedness and a major contributor to the
prevention and control of influenza globally. Seqirus' influenza
vaccine business comprises a workforce of over 3,000 employees,
significant manufacturing capacity, a commercial presence in 20
countries, and product and geographic diversity. We are the only
influenza vaccines manufacturer with the flexibility of two scaled up
production technologies, including, cell-based vaccines.
Our long-established parent company, CSL Limited, has a rich
heritage in influenza dating back to the Spanish flu pandemic. As you
may know, this year marks the 100th anniversary of the 1918 pandemic,
which killed more than 50 million people and represents one of the
deadliest natural disasters in human history. It is especially timely
for this Committee to be considering how the U.S. can be better
prepared against pandemic influenza in the future.
I would like to highlight Seqirus' state-of-the-art vaccine
production facility in Holly Springs, North Carolina. Thanks to the
leadership of Senator Burr, Members of this Committee, and the
dedicated team at BARDA, we believe the Holly Springs facility is one
of the best examples of a public-private partnership envisioned by the
authors of PAHPA when it was originally signed into law in 2006.
I would also like to highlight Seqirus' proprietary adjuvant MF59
which boosts response, and broadens vaccine match as well as enabling
dose-sparing of vaccine antigen. MF59 is a cornerstone of broader
access to pandemic influenza vaccines and part of BARDA's pandemic
preparedness and response stockpiling strategy. We believe it is
critical to manage MF59 as a long term asset within the pandemic
preparedness enterprise which means that it needs a life cycle
management strategy consistent with industry standards.
We are currently working with BARDA to manufacture candidate
vaccines against the H7N9 strain circulating in China. Last week,
testifying before this committee, the Assistant Secretary for
Preparedness and Response, Dr. Kadlec, highlighted his concern with the
ominous trends that they are seeing with the evolution of the H7N9
strain.
Seqirus believes it is critical that PAHPA be reauthorized in a
timely manner to ensure BARDA has the resources it needs to continue
its unique national security mission at the Department of Health and
Human Services (HHS). We also strongly believe that the Committee's
reauthorization of PAHPA should finally include an authorization of
BARDA's pandemic influenza program. Despite representing the ``P'' in
PAHPA, authorized funding for pandemic influenza preparedness has never
been included this legislation.
Similar to medical countermeasures against chemical, biological,
radiological, and nuclear (CBRN) threats, there is no commercial market
for pandemic influenza vaccines. Seqirus relies on our partnership with
the U.S. Government to make continued investments in research,
development, infrastructure, and vaccine production. Authorizing
BARDA's pandemic influenza program and providing robust, sustained
annual funding for the program would send a clear signal to the private
sector that the United States is committed to preparedness against
pandemic influenza.
Seqirus also supports the PAHPA reauthorization priorities
identified by the Alliance for Biosecurity, to which I am privileged to
be a Co-Chair, and by the Biotechnology Innovation Organization (BIO).
These priorities include multi-year funding for the Project BioShield
Special Reserve Fund (SRF) and increased funding for BARDA's advanced
research and development programs, including for emerging infectious
diseases and antibiotics. Finally, I would like to thank the members of
this committee for all the work they have done to support HHS'
preparedness enterprise since the last PAHPA reauthorization, including
making important changes to BARDA's contracting process in last year's
21st Century Cures Act.
PAHPA has been a success since it was first passed by Congress in
2006. The biodefense enterprise created at HHS over the last 12 years
has greatly improved our Nation's security. From the perspective of a
manufacturer, this enterprise has made it more attractive to invest in
partnerships with the U.S. Government. However, there are areas where
the medical countermeasure (MCM) enterprise could be improved.
At the beginning of this process, industry partners with the
National Institutes of Health (NIH) to conduct basic research and
discovery. These public and private investments often yield promising
MCM candidates which can progress to advanced development with BARDA.
While BARDA has improved its communication with industry partners to
ensure smooth transitions, better coordination and communication within
the government could improve the ability to provide end-to-end
certainty to government partners. In recent years, BARDA has focused on
the promise of platform technologies which can speed up development
timelines and provide rapid response capabilities in an outbreak.
Because there is no commercial market for MCMs, the procurement
funding provided by the Project BioShield Special Reserve Fund (SRF),
the Strategic National Stockpile (SNS) and BARDA's pandemic influenza
program provides manufacturers with market certainty after investing
for many years in research and development. However, the lack of multi-
year funding has created uncertainty in the long term sustainability of
some medical countermeasures programs. And importantly, the Food and
Drug Administration's (FDA) dedication to addressing the unique
challenges of MCM development has given companies confidence that MCM
candidates can ultimately gain licensure. FDA approval is an important
milestone for companies and a key public health goal for the
government.
Of course, this process is not perfect and can certainly be
improved. The overall structure created by PAHPA has enabled dynamic
public-private partnerships to thrive, but these partnerships must be
sustained over time through a demonstrated commitment by the Federal
Government.
Seqirus is just one example of how a partnership with BARDA could
be successful in the pandemic influenza space. There are dozens of
other companies--both large and small--that have committed to BARDA's
mission and made significant new investments in MCM development.
Reauthorization of PAHPA's authorities and a renewed commitment to MCM
development funding will ensure these investments yield even more
approved MCMs.
The Threat of Pandemic Influenza
As Members of this Committee know well, one of the most urgent
public health threats we face as a nation is pandemic influenza, a
constantly changing global viral threat. It is often forgotten that the
2009 H1N1 pandemic, a relatively mild pandemic, killed more than 12,000
Americans and hospitalized 300,000 more. The cost to our citizens, our
economy, and our security was incredibly high. It is not a matter of
if, but when, the next pandemic strikes.
Pandemic influenza is not just a public health threat; it is indeed
a national security threat. Ensuring we are prepared to respond to an
influenza pandemic is critical to our national and economic security.
The World Bank has estimated that a severe global influenza pandemic
could cost nearly 5 percent of global GDP.
To be ready when a pandemic is declared, we have to invest in R&D
for new and better influenza vaccines, to invest in, and sustain, the
manufacturing surge capacity to rapidly produce more than 600 million
doses of matched virus--two for every American, and we have to maintain
stockpiles of vaccine against circulating pre-pandemic strains so we
can protect first responders and essential personnel during the time it
takes to manufacture matched vaccine.
Pandemic influenza is related to seasonal influenza, but is also
different in many significant ways. Most importantly, new pandemic
influenza strains show up across the globe in real-time, emerging from
animal to human transmission of strains new to our immune system.
Because there is no commercial market to develop vaccines against these
new pandemic strains, the U.S. Government must work with private sector
partners to ensure vaccines against these strains are available if an
outbreak occurs. This process of developing pandemic influenza vaccines
requires a robust partnership between the government and the private
sector. We are proud of our decade-long partnership with BARDA to
ensure the United States is prepared to respond to a pandemic influenza
outbreak.
Unfortunately, funding for preparedness against pandemic influenza
threats has been episodic since 2009. The vast majority of funding
provided to the Department of Health and Human Services (HHS) for
pandemic influenza was in emergency supplemental legislation during the
2004, 2005, and 2009 outbreaks. These emergency funds helped stand up
critical response efforts at HHS, but are now fully exhausted. Since
that time, annual funding for HHS' pandemic influenza readiness
programs have dramatically declined. It is critical that our domestic
influenza manufacturing capabilities are strengthened and sustained,
and private sector partners see a renewed commitment from Congress and
HHS.
Seqirus' Pandemic Influenza Partnership With BARDA
In 2007, BARDA partnered with Seqirus (then Novartis) in the
construction of a new influenza vaccine manufacturing facility in Holly
Springs, North Carolina. Seqirus currently has several contracts with
HHS to (1) complete advance stage development of antigen-sparing
capability for pandemic influenza vaccination; (2) facilitate domestic
vaccine capability with more rapid response and with greater surge
capacity in the event of an influenza pandemic; (3) stockpile pandemic
vaccine supplies; and (4) develop a synthetic influenza seed process
for rapid pandemic response.
The Holly Springs facility will quickly surge domestic production
capacity of pandemic influenza vaccine to combat public health
emergencies. The facility has been designed to provide pandemic
vaccines to protect one third of the US population, within 6 months of
the declaration of a pandemic.
The facility employs approximately 500 high-skilled workers to
produce both pandemic and seasonal influenza vaccines using innovative
cell culture-based manufacturing technologies. We believe Holly Springs
is one of the most successful public-private partnerships between
industry and BARDA. The total investment in the facility committed by
both Seqirus and BARDA has now surpassed $1 billion. The innovations
developed at Holly Springs--like new, cell-based flu vaccines--are
critical to improving U.S. preparedness.
Seqirus is a Leader in the Development of Innovative, Cell-Based
Vaccines Technologies
How well flu vaccines work can vary from season to season. One of
the main factors that impact flu vaccine effectiveness is the ``match''
between the viruses that the flu vaccine is designed to protect
against, and the flu viruses spreading in the community.
How closely the vaccine is ``matched'' to circulating strains can
be impacted by changes in the circulating viruses between the time the
influenza vaccine was manufactured and the public is vaccinated, as
well as changes that can take place in the influenza vaccine production
process.
The majority of currently available influenza vaccines globally are
manufactured using egg-based technology, and work reasonably well.
However, the viruses used by manufacturers to start the production
process can undergo changes when optimized for growth in eggs. When
this occurs, the resulting vaccine may not be as closely matched to the
circulating virus as would be preferred, which can reduce the level of
protection against influenza infection.
The influenza vaccine industry is pursuing several new technologies
to improve vaccine effectiveness. One of the new technologies used by
Seqirus is a cell-based influenza vaccine manufactured in the United
States. Cell-based influenza vaccines are not subject to egg-adaptation
issues, and may therefore be more closely matched to circulating
viruses. We believe the use of cell-based influenza vaccines in future
flu seasons and flu pandemics has the potential to significantly
improve vaccine effectiveness, and as a result, save more lives.
PAHPA Reauthorization Must Include BARDA's Pandemic Influenza Program
Over the last 13 years, Congress has passed three separate
emergency supplemental bills providing $13.2 billion in funding to
respond to the threat of pandemic influenza. This funding sustained HHS
programs to develop and purchase flu vaccines, antivirals, and
necessary medical supplies. The funding also supported the construction
and renovation of manufacturing facilities for the production of
pandemic influenza vaccines to secure sufficient supplies for the U.S.
population.
For more than a decade, HHS has relied on and drawn down balances
from supplemental appropriations bills to fund pandemic preparedness.
These balances are now exhausted. Since the passage of these three
emergency supplemental bills, sustained resources for HHS' pandemic flu
readiness programs have dramatically declined. This has led to an aging
stockpile that doesn't match currently circulating strains, critical
adjuvants such as our MF59 that are expired, domestic manufacturing
capabilities that must be sustained, and private sector partners who
aren't sure if HHS is committed to this partnership that is so critical
to the Nation's readiness.
In order to successfully prepare against a future influenza
pandemic, Seqirus believes Congress should finally enact a permanent
authorization of BARDA's pandemic influenza program in the
reauthorization of PAHPA. This authorization is necessary to support
research and development of new influenza technologies, regularly test
and evaluate rapid response capabilities for known and new pandemic
threats, and maintain influenza stockpiles of vaccine and therapies.
Having a program authorized by Congress will also provide a clear
signal to the private sector that the U.S. Government is committed to
preparing against pandemic threats.
BARDA's most recent 5-year budget outlined $630 million in pandemic
influenza funding needs for Fiscal Year 2019 alone. We believe an
annual authorization level of at least $535 million is needed to
support HHS' most critical pandemic influenza activities. These
activities include pandemic vaccine stockpile maintenance, diagnostic
research, infrastructure improvements, universal flu vaccines research,
and flu therapeutic research.
Conclusion
We believe tremendous progress has been made to ensure Americans
are better protected against the threat of pandemic influenza, and
Seqirus is excited about the future of our partnership with BARDA.
I would like to thank Members of this Committee, and in particular
Senator Burr, for their commitment to reauthorizing PAHPA in a timely
manner. This is a critical opportunity for Congress to ensure BARDA has
the resources it needs to prepare against of the most predictable
threats we face as a Nation.
I look forward to serving as a resource for this Committee during
the PAHPA reauthorization process, and I am happy to answer any
questions you may have today. Thank you.
______
Senator Burr. Brent, thank you for that testimony.
Steven, the floor is yours.
STATEMENT OF STEVEN KRUG, M.D., FAAP, HEAD, PEDIATRIC EMERGENCY
MEDICINE, ANN AND ROBERT H. LURIE CHILDREN'S HOSPITAL OF
CHICAGO; PROFESSOR OF PEDIATRICS, NORTHWESTERN UNIVERSITY
FEINBERG SCHOOL OF MEDICINE; CHAIR, DISASTER PREPAREDNESS
ADVISORY COUNCIL, AMERICAN ACADEMY OF PEDIATRICS, CHICAGO, IL
Dr. Krug. Good morning, Chairman Burr, Ranking Member
Casey, distinguished Members and staff of the HELP Committee.
I am Dr. Steve Krug. I am the Head of the Division of
Emergency Medicine at the Ann and Robert H. Lurie Children's
Hospital, Chicago and Professor of Pediatrics at the
Northwestern University Feinberg School of Medicine. I am the
Chair of the American Academy of Pediatrics Disaster
Preparedness Advisory Council. And on behalf of the 66,000
Members of the AAP, thank you for holding today's hearing and
for inviting me.
I have also been privileged to serve on Federal Advisory
Committees and presently as the Chair of the HSS National
Biodefense Science Board, now known as the NPRSB. My comments
today, however, are as a private citizen and as a member and
leader within the Academy.
I applaud the work of this Committee for strengthen and
improving our Nation's public health and medical preparedness
with the Pandemic and All-Hazards Preparedness Reauthorization
Act of 2013. In particular, I must thank you for the first-ever
provisions for children in the last reauthorization. Those
changes have helped to make the needs of children a much higher
priority in emergency planning and response.
As we heard last week from ASPR, CDC, and FDA leadership,
each agency has a vital and distinct role to play in ensuring
that our healthcare system is better prepared to meet the needs
of all Americans including, of course, children during and
after a disaster.
The leaders of these Federal agencies--and the countless
hardworking, dedicated Federal employees that they oversee--
really are the backbone of our Nation's 24/7 Federal emergency
readiness and response capacity.
By most accounts, the frequency, severity, and cost of
disasters and emergencies are increasing, meaning that they
will remain a significant threat to the health and safety of
our communities and our Nation.
As such, maintaining and expanding the Federal Government's
strategic focus on all hazard approaches that address both
routine and health security related needs is critical. This
will require continuing engagement of all stakeholders
including public health, medical and mental health services,
academia, industry, and day to day emergency and trauma
services.
Foundational elements core to preparedness, including the
HRSA Medical Emergency Services for Children program and our
Nation's children's hospitals, must also be strong and engaged.
It is evident that healthcare, and other systems that are
regularly tested, will be the most reliable and effective
during a response. Regular exercises and drills, along with
continuing education for care providers and first responders,
are necessary in order to be ready for all populations when a
disaster strikes. This is especially important if we hope to be
ready to meet the unique needs of children.
At a population level, we should strive for a healthier and
more resilient community pre-disaster as this will reduce the
burden on the healthcare system during and after disasters.
This means ensuring access to affordable healthcare and
preventative services, and reducing healthcare disparities in
all populations.
Financial drivers in today's healthcare environment are not
aligned with the need for facilities to be prepared for public
health emergencies. Cost reduction measures have resulted in a
leaner stockpile of supplies, medications, and equipment and a
substantially smaller workforce with daily operations,
particularly inpatient operations functioning much closer to
full capacity.
This has promoted emergency department overcrowding, that
is where I work, and poor surge capacity during seasonal
epidemics and pandemics, like the one we are going through
right now. The surge capacity gap is particularly precarious
within pediatrics.
Current disaster planning does not adequately integrate
primary care. These clinicians, who largely operate as small,
private sector businesses, provide vital services before,
during, and then after disasters. In the absence of mechanisms
to provide assistance to impacted providers and disrupted
practices, many have been forced to leave.
Given this, it is not hard to see why so many communities
have struggled to respond and why so many never fully recover
after a disaster. Community resilience relies heavily upon the
resilience of the healthcare sector. It is a key pillar.
Children account for 25 percent of the population and their
unique vulnerabilities mean that preparedness and response
activities at all levels must account for their needs. Children
are not little adults.
I concur with the comments of my esteemed colleagues here,
but I would offer three additional thoughts in terms of
recommendations.
First, reauthorize and strengthen the HHS National Advisory
Committee on Children and Disasters with subject matter experts
from the public and private sector, the NACCD has provided
insightful reports with cogent recommendations to improve
healthcare preparedness for children.
Two, authorize the CDC Children's Preparedness Unit, which
has proven to be an invaluable resource to the CDC, the
pediatrician community, schools, and other child-serving
institutions during recent emergencies, such as Ebola and Zika.
This unit is a best practice example of an effective public and
private sector partnership that has brought tremendous value to
preparedness.
Finally, to reiterate comments that have been made already,
let us maintain the HPP and PHEP grant programs as distinct,
nationwide programs with strong pediatric performance measures,
and with increased funding.
As disasters and universal risks, such as influenza, can
occur anywhere in the Nation, it is essential that all
jurisdictions have a baseline level of preparedness aided by
each of these programs.
I want to thank the Committee for the opportunity to
testify and I look forward to your questions.
[The prepared statement of Dr. Krug follows:]
prepared statement of steven e. krug
Chairman Alexander and Ranking Member Murray, thank you for the
opportunity to speak here today about our Nation's preparedness and
response capabilities. My name is Dr. Steven Krug. I am head of the
Division of Emergency Medicine at Ann & Robert H. Lurie Children's
Hospital of Chicago and Professor of Pediatrics at Northwestern
University Feinberg School of Medicine in Chicago, IL. I am board
certified in Pediatrics and Pediatric Emergency Medicine. I am here
today in an official capacity representing the American Academy of
Pediatrics where I serve as chair of its Disaster Preparedness Advisory
Council. The American Academy of Pediatrics (AAP) is a non-profit
professional membership organization of 66,000 primary care
pediatricians and medical and surgical pediatric subspecialists
dedicated to health and well-being of children.
By way of additional background, I also serve as chair of the
Assistant Secretary for Preparedness and Response (ASPR) National
Biodefense Science Board, now referred to as the National Preparedness
and Response Science Board (NPRSB). Additionally, I am a member of the
Food and Drug Administration's Pediatric Advisory Committee Ethics
Subcommittee. I am not representing either of these entities here
today.
I applaud the work of this committee for strengthening and
improving our Nation's public health and medical preparedness with the
Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) of
2013. In particular, AAP thanks the leadership of Members of this
Committee for including first-ever provisions for children in the last
reauthorization. Those changes have helped to make the needs of
children in emergency planning and response a higher priority in our
Federal agencies.
As we heard last week from Drs. Bob Kadlec, Stephen Redd, and Scott
Gottlieb, each of our key Federal health care agencies--ASPR, the
Centers for Disease Control and Prevention (CDC), and the Food and Drug
Administration (FDA)--has an important and distinct role to play in
ensuring our public health and medical sectors are better prepared to
meet the needs of all Americans, including, of course, children before,
during, and after a disaster. The leaders of these Federal agencies,
present and past, and the countless hard-working, dedicated Federal
employees they oversee serve as the backbone of our Nation's 24/7
emergency readiness and response capacity and deserve much credit for
their work on behalf of all Americans. AAP values its close partnership
with these Federal agencies and others and we look forward to
continuing to work collaboratively with them.
By most accounts, the frequency, severity, and cost of disasters
and emergencies are increasing, meaning they will remain a significant
threat to the health and safety of communities and our Nation. As such,
maintaining and expanding the Federal Government's strategic focus on
multi-and all-hazard approaches that address both routine and health
security related needs is critical. This means continuing to engage all
stakeholders, including public health, medical, mental and behavioral
health services, academia, industry, and day-to-day emergency medical
and trauma services in strengthening ``foundational'' programs core to
preparedness. \1\ Emergency Medical Services (EMS), trauma and burn
centers, and our Nation's children's hospitals must be strong and
engaged.
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\1\ National Preparedness and Response Science Board. ASPR Future
Strategies Report. March 30, 2015. http://www.phe.gov/Preparedness/
legal/boards/nprsb/recommendations/Documents/aspr-fswg-
report03162015.pdf
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Healthcare systems that are regularly tested may be the most
effective and reliable in a response. In a sense, the concepts of
preparedness and response are actually interchangeable. The Centers for
Medicare and Medicaid Services (CMS) Emergency Preparedness Rule which
sets national emergency preparedness requirements for Medicare and
Medicaid-participating providers and suppliers is critically important
for ensuring adequate planning for both natural and man-made disasters,
and coordination with Federal, state, tribal, regional, and local
emergency preparedness systems. However, investments in preparedness,
maintenance of a stable workforce, and sustainment of core response
capabilities can be challenging. Major reductions in Federal spending
on public health and medical preparedness as well as intermittent
surges around specific disasters or spikes in seasonal influenza like
we are currently experiencing combine to adversely impact the
preparedness of the Nation.
Physician and health care professional workforce burnout and
inability to practice self-care in the face of a disaster, one in which
health care providers and their families may have personally
experienced injury or loss, must be addressed as part of medical
preparedness and response.
At a population level, we should strive for healthier communities
pre-disaster which will reduce the burden on the health care system
during and after a disaster. This means ensuring access to affordable
medical and mental or behavioral health care and preventive services
and reducing or eliminating health care disparities in all populations.
Ensuring the Health of Children in Disasters
Children account for twenty-five percent of the population and
their unique vulnerabilities mean that preparedness and response
activities should account for their distinct needs. Children are not
little adults and the factors a state, city, hospital, or community
must consider when planning for children may differ when considering
the care needs of infants versus preschool-aged children versus
adolescents. Additionally, children spend much of their day separated
from their parents at school or in child care, making issues of
preparedness planning in these settings, including training exercises
and drills, mechanisms for child tracking and timely family
reunification, and, consent for treatment, if needed, particularly
important.
At the Federal level, AAP remains concerned about the
appropriateness of the current statutory definition of and references
to ``at-risk individuals'' throughout PAHPA. According to ASPR, at-risk
individuals are children, older adults, pregnant women, and individuals
who may need additional response assistance. This includes but is not
limited to individuals with disabilities, individuals who live in
institutional settings, individuals from diverse cultures, individuals
who have limited English proficiency or are non-English speaking,
individuals who are transportation disadvantaged, individuals
experiencing homelessness, individuals who have chronic medical
disorders, and individuals who have pharmacological dependency. By some
estimates, this could amount to fifty percent of the total population.
The expertise needed to successfully plan for and respond to a
public health emergency involving a person with a pharmacological
dependency is very different from that of a child or of a pregnant
woman. Given the discretion allowed under current requirements for
states and cities in the CDC's Public Health Emergency Preparedness
Program (PHEP), a jurisdiction can ``check the box'' by including one
of these categories in disaster drills and exercises. In fact, in a
PHEP Impact Assessment conducted in 2014, of the select PHEP
capabilities reported on, the two poorest performing measures were
those that directly related to children: Did the grantee have a
sufficient plan for vulnerable populations (55 percent) and did the
grantee have patient tracking capability for family reunification (47
percent). By contrast, all other measures were met 73 to 100 percent of
the time.
AAP would urge Federal agencies including ASPR to move away from
generic terms like ``at risk'' or ``vulnerable'' populations. When
agencies or grantees are forced to address this broad category, the
subpopulations contained within may be overlooked. We would suggest
that ASPR consider creating a position of Director of Pediatric
Preparedness and Response who is empowered and adequately resourced to
work within ASPR, with its grantees, and with HHS partner agencies to
improve our Nation's preparedness and response for children.
Healthcare System Preparedness, Response, Recovery, and Resilience
At baseline, our health care delivery system is fragile,
decentralized, frequently uncoordinated, and regional. Financial
drivers in the health care system are not aligned with the need for
facilities to be prepared for emergencies and surges in the number and
acuity of patients seeking care. Cost-reduction efforts within health
care systems have led to skilled staffing shortages and leaner
stockpiles of routine supplies, medications, and key equipment. This
environment has caused hospital inpatient facilities to operate much
closer to full capacity and emergency department overcrowding, driven
largely by inadequate inpatient capacity, leads to poor surge capacity.
So, when disasters occur, it's not hard to see why many communities
struggle to respond and why some may never recover.
Changes to the economic environment are creating serious challenges
for scientific research and innovation and are reducing public health
system stability. In addition, the health care sector is in a State of
rapid change, with adaptations underway to health care delivery models,
health care systems, and health care financing. In this State of rapid
change and uncertainty, with decreasing funds and increasing fiscal
pressures, economic or service delivery disengagement by public and
private sector safety net providers and other partners critical to
health security (e.g., health departments, hospitals, academic medical
centers, biotechnology and pharmaceutical industries) is reported from
the field. In addition to the effect of economic change on individual
sectors, these same stressors have the potential to further harm
relationships among the various components of the larger system
including Federal-state-local-private sector interactions. These
relationships are critical to an effective response. \2\
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\2\ Ibid.
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With respect to children, the majority of ill and injured children
seek care at the closest emergency department in their community.
Eighty-nine percent of children in the emergency care system are seen
in non-children's hospitals. \3\ It is critical that all EDs have the
appropriate resources and staff to provide effective emergency care for
children but many see few pediatric patients per day--roughly 50
percent of U.S. emergency departments provide care for fewer than ten
children per day. On a nationwide level, AAP, along with the American
College of Emergency Physicians, the Emergency Nurses Association, and
other professional societies, issued guidelines on the care of children
in the emergency department to aid all emergency departments in what to
prioritize for children.
---------------------------------------------------------------------------
\3\ Emergency Medical Services for Children National Resource
Center. National Pediatric Readiness Project. Available: http://
pediatricreadiness.org/About--PRP/
---------------------------------------------------------------------------
AAP thanks Senators Orrin Hatch and Bob Casey for their strong
leadership on the Federal Emergency Medical Services for Children, or
EMSC, Program, the only Federal program that focuses specifically on
improving the pediatric components of the Emergency Medical Services
(EMS) system. Under the leadership of the EMSC Program at the Health
Resources and Services Administration, in partnership with several
professional societies, we now have the National Pediatric Readiness
Project, a multi-phase quality improvement initiative to ensure that
all U.S. emergency departments have the essential guidelines and
resources in place to provide effective emergency care to children.
Of the 4,146 emergency departments that participated in the 2013
National Pediatric Readiness assessment, the overall hospital Pediatric
Readiness score was 69 percent but only 47 percent of participants
responded that they have a disaster preparedness plan in place that
addressed the unique needs of children. \4\ The project found that the
presence of a Physician and Nurse Pediatric Emergency Care Coordinator
(PECC) was associated with a higher Pediatric Readiness score compared
with no PECC. The potential for improving patient outcomes based on the
findings of the National Pediatric Readiness Project is great. These
findings also have important implications for the Hospital Preparedness
Program (HPP) and ASPR's broader healthcare system preparedness
efforts.
---------------------------------------------------------------------------
\4\ Gausche-Hill, M., Ely, M., Schmuhl, P. A National Assessment
of Pediatric Readiness of Emergency Departments. JAMA Pediatr
.2015;169(6 :)527-534 .doi:10.1001/jamapediatrics.2015.138
---------------------------------------------------------------------------
In order for the medical care system to respond, recover, and
ultimately be resilient, preparedness planning must include not just
public health and hospitals but also the primary care medical delivery
system. While that system is largely in the private sector, it cannot
be ignored. Primary care providers, such as pediatricians, are on the
front lines of all emergencies. The administration of vaccines,
provision of anticipatory guidance and appropriate screenings, and the
counseling of patients and families are some of the vital functions of
primary care, the continuity of which are all highly relevant to public
health emergencies.
While the opportunity exists to improve further upon present
disaster planning and response capabilities, we must also focus on
recovery and the components of resiliency. Community resilience relies
heavily upon the resilience the healthcare sector, a key pillar. As
such, the Federal Government should support the ability of patients to
return to their regular source of local medical care. After a disaster,
medical offices and equipment are often damaged, and loss of power can
lead to spoilage of vaccine doses. Lack of usable or safe office space
and staff, housing, water, power, and telephone service have repeatedly
hindered physician efforts in reestablishing practices. Further, local
physicians may find themselves competing for patients with free or
temporary clinics set up in the aftermath of the disaster. In the face
of these circumstances, many physicians are forced to close their
practices and leave the community. The Federal Government should
develop formal incentives and assistance programs to provide
systematic, long-term, financial stability to private physician
practices after disaster strikes. \5\, \6\ Collaboration between ASPR
and the Centers for Medicare and Medicaid Services (CMS) is critical.
As the Federal agency responsible for payment for medical services and
for ensuring families affected by disasters seamlessly continue their
insurance coverage under Medicaid and CHIP or become newly eligible for
Medicaid or CHIP because of a disaster, CMS and ASPR must work closely
together.
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\5\ National Preparedness and Response Board. Assistant Secretary
for Preparedness and Response (ASPR) Future Strategies Report.
\6\ National Biodefense Science Board. Community Health Resilience
Report.
---------------------------------------------------------------------------
After an emergency, physicians are often eager to provide medical
assistance to affected communities. While the National Disaster Medical
System (NDMS) has an important role to play in our Nation's emergency
medical response, it lacks the size and quantity of needed specialists
to reach all communities that are or could be affected by disasters.
AAP encourages ASPR to consider a more efficient infrastructure so
that, in event of an emergency, physicians eager to provide volunteer
medical services have a way to do so quickly.
Medical Countermeasures for Children
Significant strides have been made over the past ten to 15 years to
develop medical countermeasures (MCMs) to address potential disaster
hazards, including chemical, biological, radiologic, and nuclear
threats. \7\ Yet, major gaps still remain related to MCMs for children,
a population highly vulnerable to the effects of exposure to such
threats, because of their physiology and developmental differences from
adults. Many vaccines and pharmaceuticals approved for use by adults as
MCMs do not yet have pediatric formulations, dosing information, or
safety information. As a result, the Nation's stockpiles and caches
where pharmacotherapeutic and other MCMs are stored are less prepared
to address the needs of children compared with those of adults in the
event of a disaster.
---------------------------------------------------------------------------
\7\ American Academy of Pediatrics DISASTER PREPAREDNESS ADVISORY
COUNCIL. Medical Countermeasures for Children in Public Health
Emergencies, Disasters, or Terrorism. Pediatrics, originally published
online January 4, 2016; DOI: 10.1542/peds.2015-4273
---------------------------------------------------------------------------
Congress made important changes in the last PAHPA reauthorization
to Emergency Use Authorizations (EUAs) that allow an EUA to be issued
for preparedness purposes.
The Strategic National Stockpile (SNS) is currently underfunded to
support the necessary stockpiling and replacement of MCMs as well as to
support research, development, and procurement of pediatric MCMs. We
must ensure that the SNS is adequately funded to meet these needs and
that safety and dosing for children are considered. \8\
---------------------------------------------------------------------------
\8\ Ibid.
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Recommendations for the Next Reauthorization of the Pandemic and All-
Hazards Preparedness Act
Reauthorize and Strengthen the HHS National Advisory
Committee on Children and Disasters--AAP notes the important
contributions of the HHS National Advisory Committee on Children and
Disasters (NACCD) since this committee created it under PAHPRA in 2013.
The NACCD contains numerous subject matter experts from the public and
private sector. It has provided HHS with several thoughtful reports
with recommendations for healthcare preparedness for children, surge
capacity, strategies for human services and child-serving institutions,
and a joint report with the NPRSB on youth leadership and resilience.
AAP strongly supports the reauthorization of the NACCD and asks
Congress to align the NACCD with the NPRSB by making it permanent and
resourced. AAP has recommendations for additional areas of expertise
that would be helpful to add to the NACCD such as mental or behavioral
health, children and youth with special health care needs, schools and
child care, trauma and critical care, among others. It is our hope that
the ASPR will utilize the expertise of the NACCD and the NPRSB to
enhance its preparedness and response efforts.
Authorize the CDC Children's Preparedness Unit--AAP asks
Congress to authorize the Children's Preparedness Unit (CPU) at CDC.
The CPU has proven to be an invaluable resource to the CDC, the
pediatrician community, schools, and other child-serving institutions
during recent emergencies such as Ebola and Zika. The CPU is an
internal team of experts within CDC with a background in pediatrics,
behavioral science, child psychology, epidemiology, biostatistics,
health communications, and more that is providing leadership and
technical assistance, training, and consultation with the CDC and to
Federal, state, and local public health entities to improve
preparedness and response for children including under the PHEP
Program. Members of the CPU have been activated or utilized as part of
a CDC emergency response and, as Dr. Redd noted to this committee, they
leverage public-private partnerships to address gaps in emergency
preparedness and response for children.
Funding for Public Health and Medical System Preparedness
and Response--HPP and PHEP are key to the foundational capabilities of
healthcare and public health preparedness, respectively. These
critically important Federal programs must be resourced at sufficient
levels to ensure every community is prepared for disasters. HPP's
highest level of appropriation was $515 million, yet the program has
eroded to only $255 million, a vastly insufficient level given the task
of preparing the healthcare system for a surge of patients, continuity
of operations, and recovery. As Dr. Kadlec noted before the committee
last week, we have a roughly $3.3 trillion health care system, so a
Federal investment of only about $250 million is not realistic if we
are to have a truly prepared and resilient health care system. AAP
urges Congress to authorize HPP at a minimum of $474 million, the level
authorized in the PAHPA legislation of 2006. PHEP, currently funded at
$660 million, should be authorized at a minimum of $824 million, the
level authorized in the 2006 PAHPA bill. Federal funding is crucial to
maintaining state, local, and territorial public health preparedness
capacity. Even small fluctuations in funding--such as the 2016 transfer
of $44 million from PHEP for the Federal Zika response--have major
impacts on workforce, training and readiness. \9\
\9\ https://www.naccho.org/uploads/downloadable-resources/Impact-
of-the-Redirection-of-PHEP-Funding-to-Support-Zika-Response.pdf
---------------------------------------------------------------------------
We cannot let happen again what transpired during the Zika response
where Federal agencies' ability to respond was hampered by delays in
congressional action on emergency funding. A pre-approved standing fund
for short-term scale-up of rapid, emergency response is necessary. Such
a fund should be administered by the HHS Secretary and should
supplement and not supplant existing, base public health and
preparedness funds. Funding should not come at the expense of other
health programs, either from discretionary health spending or by
transfer. Such a fund should serve as an interim bridge between
underlying capacity-building funds and emergency supplemental funds, if
needed. While such a fund should have sufficient resources, it cannot
be viewed as a substitute for future supplemental emergency funding.
Public Health and Medical System Preparedness are
Distinct and They Should Be nationwide with Strong Pediatric
Considerations--Because disasters can happen anywhere in the country
and universal risks such as influenza pandemics and mass shootings
exist, it is essential that all jurisdictions have a baseline level of
preparedness aided by the HPP and PHEP programs. Performance measures
for both programs must include meaningful metrics that assess a
jurisdiction's preparedness to identify and meet the needs of children.
Given the important role pediatricians play in the response and long-
term recovery and resilience of communities, pediatricians should be
integrated into all health care coalitions to help serve as pediatric
subject matter experts and to help integrate pediatric components into
planning, including drills and exercises. While HPP and PHEP should
continue to be aligned and coordinated, they must remain as separate,
distinct programs. The two programs serve a different but complementary
purpose: PHEP builds the capacity of state, local, and territorial
health departments and laboratories to prevent, detect, and respond to
emergencies, while HPP prepares the healthcare delivery system to
provide essential care to patients by ensuring continuity of care
during disasters. Both programs are needed to save lives and protect
the public from emergency-related illnesses and injuries.
Children with Special Healthcare Needs--The HHS emPOWER
map allows every hospital, first responder, electric company, and
community member to use the map to find the monthly total of Medicare
beneficiaries with electricity-dependent equipment claims at the U.S.
State, territory, county, and zip code level and turn on ``real-time''
natural hazard and NOAA severe weather tracking services to identify
areas and populations that may be impacted and are at risk for
prolonged power outages. This technology has the potential to save the
lives of over 2.5 million Medicare beneficiaries who rely upon
electricity-dependent medical and assistive equipment, such as
ventilators and wheel chairs, and cardiac devices in our communities.
However, emPOWER is currently limited to Medicare beneficiaries. AAP
urges ASPR and HHS to conduct feasibility testing for piloting how
emPOWER could be expanded to the Medicaid program so that millions of
children and youth, including those with special health care needs can
benefit from this technology.
______
Senator Burr. Dr. Krug, thank you.
As evidenced by the fact that I am not sure that we have
had, in the past, a pediatrician before in PAHPA related
hearings, it shows that we understand the need to get it right.
I might say it is probably one of the most challenging
areas because it is hard to incorporate pediatrics in the
cutting edge technologies that, on one side, we are pushing
that that will always be a challenge to us and we need more
subject matter experts to help us navigate through that.
I will recognize Members for up to 5 minutes starting with
myself and move on a seniority basis.
Mr. MacGregor, Seqirus has worked for many years to make us
better prepared in the event of an outbreak of pandemic flu.
The facilities in Holly Springs, North Carolina are both a
promise and a partnership between your company and the Federal
Government that, if needed, we can flip a switch from the
manufacturing of vaccines for seasonal flu to the manufacturing
for pandemic flu.
What are the lessons learned from this partnership? And,
how can we improve the partnership?
Mr. MacGregor. Thank you for the question.
I think the lessons we have learned thus far that the
partnership has been a very good one since the very beginning.
What has happened, really, in recent years is the commitment
that has been made, and for which Seqirus and its predecessor
companies have delivered, the funding has not kept up with what
we believe is the threat going forward.
So whereas there was a period of time, and even though the
funding for a pandemic flu, BioShield was not part of the
original PAHPA legislation, there was emergency funds,
supplemental funds that were provided for flu.
I think the big lesson we have learned since that time is
as the funding has declined to very low levels, particularly
since 2009, you start to question the commitment. And while we
put a commitment forward, a partnership forward with BARDA, I
think sometimes we feel that with the funding that is dedicated
or earmarked for pandemic flu suggests that there is not a
seriousness or as serious an interest taken to this particular
threat going forward. I think that is one of the lessons we
have learned.
I think communication, ongoing communication is another
lesson we have taken. I think, for the most part, the
communication between BARDA and our company, and BARDA and
other companies that are in partnership with the Government,
has been good, but there is always opportunity for improvement
across the spectrum from NIAID all the way to the SNS.
It is not bad. There is still room for improvement there in
harmonizing how it works across that entire spectrum.
Senator Burr. The jurisdictional lines were a little
difficult at the beginning.
Mr. MacGregor. Yes.
Senator Burr. But I think we have gone through a lot of
that.
I hope that my colleagues on this Committee will remember
this year's flu season, the severity of it. We do not know yet,
but as we get smarter at projecting what the threat is going to
be, this is a great example that we are not smart enough to get
it better than 32 percent right based upon the current numbers.
And that we have got to look at technology that allows us to
address seasonal flu in a way that encompasses all of the above
options that might happen.
You mentioned BARDA. BARDA works to advance new and
innovative technologies to better combat public health threats
and has been extremely successful in advancing innovative
approaches to the development of medical countermeasures such
as platform technology.
What do you see as the greatest challenges to bringing
these new, and innovative, technologies through the medical
countermeasure pipeline?
Mr. MacGregor. Well, I think one example of what you
mentioned, Senator Burr, is new and innovative platform
technologies and the plant in Holly Springs is an example of
this. This is cell-based technology in Holly Springs. It is not
the more conventional egg-based which, I think, most people are
aware.
The interaction with BARDA has been very strong in not only
allowing us to continue to advance the effectiveness of cell-
based technology--most recently through the partnership through
efforts to improve the yields of cell-based technology that
cannot only benefit in a pandemic setting--but actually will
potentially benefit in a seasonal setting as well.
The benefit that ideally will come will not only be,
hopefully, in vaccines coming sooner to market, but the other
promise we hope with cell-based technology as an example of a
platform--technology that is invested in by the Government--is
that it offers the potential of providing a better match in the
event of a mismatch season, as we are experiencing this year.
Senator Burr. Tom, let me turn to you, if I can.
Innovations and information technology have drastically
improved our biosurveillance and situational awareness
capabilities to monitor, detect, and identify public health
threats in as timely a fashion as is possible. Though this
potential exists, the Federal Government lags behind in its
ability to leverage these technologies.
How can we improve the Federal programs to create a more
cohesive and real time surveillance capability for public
health threats? And just as an aside to that, do you believe
that we use enough open source information outside of the
mechanisms we have set up domestically and internationally?
Dr. Inglesby. Sir, that is a very good question. People
have been working on that for a long time.
There are many surveillance systems in the country right
now that are aimed at that goal. They are not all brought
together under one roof, which would be very difficult to do. I
know it has been a goal of the Federal Government to try and
consolidate and bring those systems together.
One of the things that we could do better is to get more
information out of the healthcare system, to public health,
during emergencies. We have a lot of advances in Electronic
Health Records, but for the most part, public health agencies
do not have any resources or analytics to be able to see what
is going on in healthcare records around the country.
If we could do more to bridge that divide between public
health and medicine, that is where a lot of the information,
that is where the signals are going to come in during outbreaks
from doctors and nurses seeing unusual things and feeding that
information to public health, getting laboratory diagnostics,
getting that information together.
I think closing that divide a little bit and also bringing
together unusual sources of information like what is going on
in the animal systems, combine that with human systems. Being
able to trace back foods when big food outbreaks arise; that is
a very difficult challenge for us right now.
Senator Burr. We are much better at a lot of it than we
were a number of years ago.
Dr. Inglesby. Much better, but a lot of challenges.
Senator Burr. John is on the frontline and I feel confident
that mechanisms are in place for that transmission of
information. All we need is one breakdown.
It does make one wonder, in the overall scheme of things,
why we are not layering on top of that a review of scripts
written on a daily basis that gives us either confirmation of
what we are hearing from the public health arena, or
potentially a sign of an outbreak of something that we pick up
in prescriptions that were administered the day before.
The unusual thing is that gives us great clarity as far as
the geographical location of something all the way down the
nine digit ZIP Code.
It seems like it is all of the above that we have to do.
Senator Casey.
Senator Casey. Thank you, Senator Burr.
Dr. Inglesby and Dr. Dreyzehner, I will start with you.
Senator Burr talked about the flu this year. We are told
that more than 17,700 cases of the flu have been confirmed just
in Pennsylvania. Thirty-two people, including one child, have
passed away because of that.
While this is a particularly bad flu season, it does not
come close to what we would see on a much larger scale in an
infectious disease emergency or, of course, a pandemic flu
scenario. Our healthcare sector is already near capacity with
this flu season. So we are woefully unprepared to respond to a
mass casualty, biological event.
For both Dr. Inglesby and Dr. Dreyzehner, I would ask, how
can we begin to prepare hospitals--let us just focus on
hospitals--for a mass casualty, biological event?
I know that is a lot to bite off, but as best you can.
Dr. Dreyzehner. Thank you for the question, Senator. I
certainly welcome Dr. Inglesby's comments as well.
I think as has been said, fully funding PHEP and HPP to its
prior levels would be hugely helpful. I think Dr. Krug made
some really important points in terms of the financial
incentives of the current system's just-in-time for supplies
and for staffing. There is limited surge capacity and we are
seeing that in Tennessee right now.
In fact, I had a call with our hospitals a couple of weeks
ago. I have another call tomorrow. Some of the challenges that
are----
This is a flu season that, I think, is more severe than we
typically see. As, I think, Senator Burr pointed out, we do not
know exactly what this will look like in comparison to other
flu seasons.
I think one thing is true, we are reporting more. Many
states are reporting all deaths. Our state is reporting child
and pregnancy deaths. As Senator Alexander pointed out, we have
already had several tragic preventable deaths.
As people hear about those things, there is a perception of
greater severity. And when there is a perception of greater
severity, people frequently visit places like emergency rooms.
One of the things we have been doing is messaging around,
``If you are ill, you may need to call your healthcare
provider, but you may not need to go to an emergency room.'' So
all those kinds of things are a part of what we deal with in a
flu season where there is a heightened awareness.
In terms of assuring that we are prepared, the amount of
funding available to the HPP grant has been inadequate, really,
for some time. And, I think as you pointed out in your
comments, there is a need to bolster that.
I do not think it takes a great deal more, but certainly
returning to earlier funding levels would be extremely helpful.
Senator Casey. Dr. Inglesby.
Dr. Inglesby. Yes, I would agree with everything he said.
I would add that, going back to the beginning of the
hearing, the more that we can develop our flu vaccine
technologies, universal flu vaccine being the ultimate goal,
but modernization and rapid acceleration of the process being
the interim goal, the less we will have sick people in
hospitals. But in the meantime, we need a strong healthcare
system preparedness program through HPP.
There could be other facets of that program, like having
more regional centers, that could shoulder more responsibility
in crises, take care of more contagious patients. We have a
Level One trauma center system in the United States that works
very well, but we do not have anything like that for infectious
disease. That could be a model.
We have built biocontainment units in places around the
country in response to Ebola, but most of those containment
units can only take care of one, or two, or three patients at
most. So if we want to try and raise the level of preparedness,
we might think about creating some regional strength.
But at most hospitals, they are going to need to be able to
take care of patients. They are going to need proficiency,
personal protective equipment, and relationships with the other
hospitals, and the public health agencies, and the surgery
clinics, and the medi-clinics where people are getting cared
for in the community.
It is a network of care as opposed to only relying on the
major, acute care hospitals and have to distribute that burden
out to the community when there are major epidemics of flu or
even pandemics of flu.
Senator Casey. You mentioned, and I know I am going to be
out of time in a moment, but I might come back to it after we
have other questions.
But the Level One trauma center model, that is my word not
yours, how do you think we incentivize that in the context of
what, I think, in your testimony on Page 3, you refer to as,
``specialized Disaster Resource Hospitals,'' another acronym,
DRH?
I might ask you that question. I am out of time, but then I
will come back later to Dr. Krug to add his comments on it.
Dr. Inglesby. I think the way you would incentivize it is
you could have some kind of competition for it, but you would
have to provide resources for it because there is no, as we
have said already here today, there is no ``give'' in the
system. Hospitals are running very small margins, so they are
not going to be able to build large entities or programs
outside of the usual programs unless the Government says, ``We
want you to do this, and here is how.''
Senator Casey. Thanks very much.
Senator Burr. Senator Isakson.
Senator Isakson. Thank you, Chairman Burr.
Dr. Inglesby, you wrote of the national security agenda,
the Global Health Security Agenda in your comments that was
established in 2014.
Where is it housed today?
Dr. Inglesby. It is in multiple agencies of Government,
particularly the CDC and USAID.
Senator Isakson. Who is the quarterback for it?
Dr. Inglesby. The quarterback for it, I think you would
say, is the USAID and CDC directors.
Senator Isakson. Who are integrally involved.
Dr. Inglesby. Yes.
Senator Isakson. In fact, when the Ebola outbreak took
place, and you referred to some places around the United States
that had containment areas already built and things like that.
Dr. Inglesby. Yes.
Senator Isakson. From a modest standpoint, we were able to
meet the threat at Emory University at NIH and a couple of
other places with those first Samaritans, those first doctors
who came back from, I think, Liberia which is where it broke
out.
Dr. Inglesby. Right.
Senator Isakson. That was enough at the time. But how much
of that do you think should be built in preparation or to
anticipate needing to have something like that happen again,
maybe not for Ebola, but for some other infectious disease?
Dr. Inglesby. Well, I think Emory was a national leader in
that program, and I think if you were to speak to the leaders
in that program, they would say that it would be difficult for
them to take care of more than one or two patients in the
current units.
I think we need to get better cost information about how
much those units cost. It would be difficult to scale those by
orders of magnitude by 10 or 100, but I think we could build
more capacity in the systems, share the lessons that have been
learned in those units, see if we can spread that
responsibility out a bit further, because right now, it is a
pretty small number of units that can care for any patients
with that.
Senator Isakson. As in most cases, capital and money is the
secret.
Dr. Inglesby. And training, yes, exactly. Capital, money,
training, and specialized people.
Senator Isakson. You talked in your testimony about a
contingency fund or you recommended having some sort of a
contingency planning funding for that.
Do you have any recommendations of where that ought to be
and how much it ought to be?
Dr. Inglesby. The contingency fund?
Senator Isakson. Yes.
Dr. Inglesby. If you base contingency funding on what we
have spent in other infectious disease emergencies, we
typically have spent at least $500 million to $1 billion as a
country in response to things like H9N1, Ebola, Zika, sometimes
much more. And so, a fund that was somewhere in that range.
I think public health agencies, and others outside of our
center, have called for a $2 billion contingency fund. That is
closer to what FEMA uses for its disaster relief funding. I
think that would provide a lot of acceleration in the public
health response and emergencies.
Senator Isakson. And because biological threats and disease
threats do not recognize national boundaries or oceans as
barriers, it is something the whole world community has really
got to participate in together. Right?
Dr. Inglesby. Yes, absolutely.
Senator Isakson. And CDC is great at coordinating things
like that and so is USAID, and they did a great job on the
Ebola.
But that would be where the international agenda ought to
coalesce a game plan and a contingency fund?
Dr. Inglesby. Yes. I think the way the Global Health
Security Agenda has worked, and one of its successes, is that
it brings in different parts of government, including the
finance sides of government and the security sides of
government.
In the U.S., it is bigger than the CDC and USAID. There is
participation by security, and by finance and economics, and
that is the model they are trying to get other countries to
represent as well.
Senator Isakson. Mr. MacGregor.
Mr. MacGregor. Yes.
Senator Isakson. Does the plant in North Carolina
manufacture the flu vaccine?
Mr. MacGregor. Yes.
Senator Isakson. How are we doing on that? Do we still have
enough, given the current epidemic that is going on?
Mr. MacGregor. Yes. We have been constantly enhancing the
capability in that plant. So from a seasonal perspective, just
looking at it from a seasonal perspective, we more than tripled
our capacity into the market this year on a seasonal
perspective.
That plant is also responsible, as I mentioned, in
delivering one-third of the requirement in the event of a
pandemic and responding within a 6-month period.
Senator Isakson. And you are cell-based?
Mr. MacGregor. It is cell-based. That is correct.
Senator Isakson. What is the shelf life of that vaccine?
Mr. MacGregor. Well, the shelf life of the vaccine from a
pandemic perspective, the antigen is 5 years. Unfortunately, we
do have antigen that is in the stockpile right now that is
older than that from an egg and from a cell perspective. But
that is the state of affairs right now as far as our cell-based
vaccine is concerned. We also have to promise----
By the way, Senator, as I said, it offers the potential of
being a better match in the event of a mismatched strain, so as
an alternative form of manufacturing and the reason for the
initial public-private partnership. That is some of the promise
that our company is trying to deliver on, on behalf of the
government.
Senator Isakson. Thank you very much.
Thanks to all of you for your testimony.
Senator Burr. Thank you.
Senator Hassan.
Senator Hassan. Thank you, Senator Burr.
Senator Casey, thank you for your leadership on this issue.
To our panelists, good morning, and thank you for being
here.
Dr. Inglesby, I wanted to start with a question for you.
As we all know, Puerto Rico was recently devastated by
Hurricane Maria and the island is still trying to rebuild from
the disaster. The effects of that disaster are obviously
widespread.
Hospitals in New Hampshire, and around the country, are
dealing with, among other effects, medical product and
equipment shortages such as I.v. saline bags because the storm
devastated some of the manufacturers on the island.
So Doctor, what does this shortage say about our overall
preparedness in the case of a future event or other types of
emergencies where medical supplies cannot be easily
replenished? What can we do here in Congress with this issue
when we reauthorize PAHPA?
Dr. Inglesby. Senator Hassan, yes, I agree with you
completely that the Puerto Rico hurricanes and other storms
have revealed how vulnerable our supply systems are.
One possibility to consider would be whether there are some
critical supplies, such as saline bags, if they are single
sourced to a part of the world, or some active products, or
pharmaceuticals, if they are single sourced, whether or not
they should be included in the national pharmaceutical
stockpile.
That is not how the stockpile is configured or resourced
now, so there would need to be additional resources for an
additional mission.
But the stockpile has a great success in acquiring
medicines and being able to deliver them to localities. So that
would be one possibility if there were an additional purpose
and funding for the stockpile.
Senator Burr. Senator, can I interject?
Senator Hassan. Sure, yes.
Senator Burr. The time will not count against you.
Holly Springs is a great example, and the other two
facilities, that when faced with a pandemic, we actually became
visionary.
Senator Hassan. Yes.
Senator Burr. And we thought, ``What can we do to meet what
we do not know?''
We went into a partnership with three different companies
where we funded three-quarters of the facility of the plant,
but with a condition written into it that at any point, we
could turn it into what is in the Nation's best interest. And
all three owners knew that and participated in it.
So it may be a model that we look at as we identify other
things, but we have shown a degree of vision in the past.
Senator Hassan. I think that is very helpful and I think
the example of what happened on Puerto Rico after Maria really
helps us focus on one of the next things we should be doing.
I also wanted to ask all of you, and I think I would start
the question with you, Dr. Dreyzehner. I loved what you said
about preparedness and response being about people and time,
and obviously both demand resources.
New Hampshire uses its hospital preparedness funding to
support a single statewide healthcare coalition that works to
bring together public health and emergency management
professionals to assure that the healthcare system preparedness
is there across the spectrum of care from hospitals, to
homecare, to long term care and beyond.
New Hampshire, like other states, relies on this funding to
help make sure it is prepared for all kinds of emergencies,
mass casualty incidents to hurricanes. Unfortunately, like many
other states, New Hampshire has seen a significant decrease in
hospital preparedness funding in recent years.
We do not know when the next emergency will happen or what
precisely it is going to entail, so we need to make sure that
the coalition in New Hampshire is not only collaborating
regularly, but training regularly. It is hard to do that,
though, when funding is dramatically reduced.
So I will start with you, Dr. Dreyzehner, but from all of
you, do you agree that we need to increase investments in the
hospital preparedness program and that it should continue to
fund those efforts in all states?
Dr. Dreyzehner.
Dr. Dreyzehner. So thank you for the question, Senator. I
would say absolutely yes, if you think about who responds.
In my written testimony, I talk about three tiers.
Senator Hassan. Yes.
Dr. Dreyzehner. Professionals, people who do this every
day. We have people that are highly trained and they are called
upon if there is an actual emergency, like one you described,
but they typically have different duties on a day to day basis.
For example, one of our emergency coordinators in Tennessee
actually directs our Board of Emergency Medical Services.
Senator Hassan. Right.
Dr. Dreyzehner. But when we have an emergency, she is in
the State Operation Center.
Then we have this third tier, which is kind of everybody
else and the people that you are talking about. They are the
public health nurses. They are the clinicians in the hospital.
They are hospital nurses. They are people who are called upon
whenever there is a need to surge.
Their training in training, and exercising, and actually
responding, creating the relationships, the knowhow, ``What do
I do?'' ``Where do I go?'' ``Who do I talk to?'' Those are the
critical things. Those are the relationships built on trust
that the HPP funding really helps solidify.
Unfortunately, when you reduce that funding, that is one of
the first things that goes. Right? You try to preserve the
positions. You try to preserve some of the things you have
invested in, but the more fungible assets are the very things
you need more of. And I think you spoke to those very
eloquently.
Senator Hassan. Well, thank you. Just in the interest of
time, I will ask the other three panelists any thing you would
disagree with or add to what Dr. Dreyzehner just said about the
funding?
Dr. Krug. Just a point. It is about people.
The earlier question about how do we get the hospitals
better prepared. They have to train and if you do not have
trained people, your response will not be effective. That has
been shown in many other industries, including healthcare.
With the focus evolving from hospitals to healthcare
coalitions, which is actually, I think, an appropriate move, it
is not just the hospitals that need to be trained. It is the
entire community that needs to be trained.
As an emergency physician, can I just do a brief pivot?
Senator Hassan. Yes.
Dr. Krug. After oxygen, the elixir of life in how we care
for patients is saline.
Senator Hassan. Yes.
Dr. Krug. So whether you have sepsis, because of a high-
consequence infectious disease, or you have been in an
explosion, or a bus crash, if you do not have saline, you lose
lives.
So there could be nothing more fundamental to our emergency
response, after oxygen, than saline.
Senator Hassan. Well, I thank you.
Senator, I know I am over. I will just submit for Dr. Krug,
a question about behavioral health needs, especially for
children in disasters. The trauma that disasters impose on our
children concerns me greatly.
Senator Hassan. Last, just thank you for pointing out the
importance of focusing on special needs populations. I am the
mother of a special needs young man, and I thank you for
raising that in your testimony very much.
Dr. Krug. Thank you.
Senator Hassan. Thank you, Senator Burr.
Senator Burr. Thank you.
Senator Smith.
Senator Smith. Thank you very much, Senator Burr, and
Senator Casey, and to the other Members of this Committee for
your work and focus on emergency preparedness, and also to our
testifiers here today.
In 2015, when I was Lieutenant Governor, and Minnesota was
hit by an avian flu outbreak, which ended up costing somewhere
in the neighborhood of $1 billion, it was the largest and most
expensive animal disease response in the history, I think, of
this country. Of course, it hit poultry growers incredibly
hard.
Dr. Dreyzehner, I was really relating to what you were
talking about how this safety net that we have is about people
and not stuff because certainly as we responded to this
catastrophe, we needed stuff. But we also really needed the
people and the relationships that made our response work and
function incredibly quickly, which was such an important part
of it.
I am quite interested in this idea of a One Health approach
and how we can build that kind of approach into our thinking
about emergency preparedness. I know that Senator Young from
Indiana has raised this question just last week and probably, I
have only been here for 2 weeks, so he has probably been
talking about it for much longer. But raise this question of
whether we need additional approaches or resources to do this.
So maybe I would like to just turn to Dr. Inglesby and also
Dr. Dreyzehner. Could you talk a little bit about what tweaks
you think we might need to the PAHPA legislation, and the
PAHPRA legislation to address this question, this One Health
approach, what we ought to be doing better there?
Dr. Inglesby. Yes. First of all, I completely agree with
the values and principles of One Health and think you are
absolutely right that there are strong connections between
animal and human health disease surveillance, outbreaks,
zoonoses.
I do think that those principles, you will find those
principles in Federal agencies. People believe there is a lot
of acceptance and belief in One Health.
But I think you are also right that it is not really housed
in a particular program. There are not large efforts underway
to try and bring One Health together.
I do think that there is a national biodefense strategy
that is now being written, or completed, by the White House and
its purpose is to bring together animal health, plant health,
and human health for biodefense. This is the first time a
strategy has been written that way.
I do think that there was a lot of coming together in the
agencies over the last year on this and I think it is improving
animal surveillance systems. We do not have strong animal
surveillance. If you talk about shortages in the workforce, the
human health, public health workforce is strapped and the
animal public health workforce is even more strapped.
Taking a look at those things, I am not sure that would be
in the scope of PAHPA or not, but we do not have a lot of
information coming from our animal systems. We do not have
enough information and it does not crossover into human health
very easily. So trying to create the bridges between the
systems, that would be a good step.
Senator Smith. Thank you very much.
Dr. Dreyzehner.
Dr. Dreyzehner. Yes, thank you for that great question.
I think if I can make this point. As public health
professionals, we think about primary prevention of flu,
stopping it in the first place as a vaccine, as non-
pharmaceutical interventions.
But I think we have to look ourselves and we have to think
about, well, how do you primarily prevent the flu from ever
occurring in the human population or another disease, for
example, Ebola, occurring in the human population?
Well, doing things around the animal sources are critical.
So the example you gave of avian influenza and stamping out
avian influenza in poultry, we also have to make sure we circle
the workers and we circle their families because that is
primary prevention of a potential novel influenza strain in the
human population.
One Health is, I think, an essential perspective and, I
think, from my perspective, I would say from the Association of
State and Territorial Health Officials' perspective, a deep
interest in that.
Be very happy to work with you on crafting in PAHPA how to,
specifically as Dr. Inglesby mentioned, bring agriculture
professionals, public health professionals, the veterinary, the
health world together to do a better job of keeping animal
diseases in animal populations and not allowing transfer into
human beings. Make one other point.
If somebody had come to Congress years ago and said, ``We
need some money to teach people how to properly prepare bush
meat in Africa because we know they are going to eat it and how
to properly gather fruit that may have been defecated on by
bats.'' I think that would have been a pretty hard sell.
But when you consider all the money that we have spent on
the Ebola outbreak that emanated from those practices, and lack
of education around that risk, it would have been a relatively
small investment.
Senator Smith. Thank you very much, and I look very much
forward to working with this Committee and Senator Young on
this issue of One Health. I appreciate it.
I know I am out of time, but I might also just submit later
to Dr. Krug. I am very interested in this question of how we
respond to what is another epidemic seriously affecting
children, which is the opioid epidemic especially in Indian
country.
That will be for a later time, but I would very much
appreciate your thoughts on that.
Senator Burr. Senator Roberts.
Senator Roberts. Thank you, Mr. Chairman.
I want to thank this Committee, both the ranking Member and
our distinguished Chairman, for focusing on this issue.
Last month, over in the Agriculture Committee, we held a
hearing on safeguarding American agriculture in a globalized
world. Dr. Inglesby, you really hit the nail on the head with
your comments.
One of our witnesses was General Richard Myers, four-star,
President of Kansas State University, home of the now under
construction National Bio and Agro-Defense Facility. We call it
NBAF, for short. You can see why.
In his testimony, General Myers noted that because there
were two Homeland Security Presidential Directives, HSPD's, in
2004--that has been some time ago--one for people, one for
animals, there does not seem to be as strong of a focus at the
executive level on crops, and livestock, and food. He suggested
reasons why this is surprising.
I will enter his full testimony in the record at this
point, if that is all right, Mr. Chairman.
Senator Burr. Without objection.
Senator Roberts. Thank you.
[The following information can be found on page 59 in
Additional Material]
Senator Roberts. His reasons are, one, essentially every
country that ever developed an offensive bioweapons program,
including the U.S., created weapons targeting agriculture as
well as people.
I would just like to insert at this time that we have had a
lot of interest in this by former Senators Sam Nunn and Dick
Lugar, the old Nunn-Lugar program on pandemic threats; and also
by Tom Ridge and Joe Lieberman with regards to agro-terrorism.
I, myself, was in charge, at one time, of Nunn-Lugar
funding as a Member of the Armed Services Committee. It was
called the Emerging Threat subcommittee; went to a place called
Obolensk, which is just north and west of Moscow thereby seeing
one of the secret cities. We are not allowed in there now, of
course, but we were then because they needed the money. We were
focusing on security.
But in touring that area, I was a little stunned--not a
little stunned--I was really stunned with regards to vast
warehouses of pathogens that they were making ready with
regards to attacking a country's food supply.
We ran an exercise at that particular time. It was called
crimson sky. I think it was sort of a misnomer because you do
not want to burn carcasses or anything like that. But it was
hoof and mouth disease.
By the time Texas figured out that they would put a stop
order from shipping cattle to Oklahoma, or Oklahoma would then
to Texas say, ``Do not ship any cattle in,'' in Kansas, and
Nebraska, and South Dakota, and North Dakota, we had an
epidemic on our hands.
We had to terminate thousands, if not millions, of cattle.
All of our exports stopped. I mean, all of our exports stopped.
There was a run on grocery stores all throughout the country.
People finally discovered their food did not come from grocery
stores.
It took us years to get back to a situation where we could
literally feed not only this country, but a very troubled and
hungry world. That was quite an experience for me and that is
when we started on NBAF.
The General said first, as I have indicated, every country
that ever developed an offensive bioweapons program also
targeted agriculture.
Two, almost every pandemic threat today is a zoonotic
disease that can spread from animals to people. Among the
bioterror threats for which the Department of Homeland Security
has issued a material threat determination, all except for
small pox, are zoonotic, meaning they reach humans through
animals.
The foreign animal disease threats could really devastate
public health, as well, according to General Myers' testimony.
Until NBAF is operational in the next four to 5 years, I regret
that it is taking that long, there is no U.S. laboratory where
livestock research can be conducted on Nipah and Ebola, swine
being a host animal for both.
Mr. Chairman, I would like to work with you and all of our
colleagues on this reauthorization, to ensure we are addressing
and preparing for zoonotic threats.
I see I have 25 seconds to ask Dr. Inglesby if he would
like to respond.
ASPR is responsible for leading the public health emergency
medical countermeasure enterprise. This is supposed to be where
all the coordinating agencies--the Department of Defense, the
V.A., Agriculture, Homeland Security, along with all the first
responders that are involved, along with HHS--to update our
strategy and to implement our plan annually.
From your perspective, are we doing the job?
Dr. Inglesby. I think we have a lot more work to do in the
realm of agriculture, food, and crop safety.
I completely agree with what you said about the importance
of animal vaccines, the shortage, with the lack of animal
vaccines to protect herds against some of the most serious
threats on the planet.
I agree with what you said about the threat to agriculture
which, I think, both animal and plants, I think, have been
relatively neglected over the last 15 years as we have begun to
do other things around biological defense.
How to organize that in the government? I do not have a
strong sense of how that should be organized. I do think it is
complicated in that the USDA is responsible for the promotion
of food and the business of food, and it is difficult, and
perhaps could be difficult, to have all that protection of food
in the same exact place.
But I have seen signs of life in the last 6 months around
those programs that I had not seen in the last five or 10
years. So perhaps the program is becoming much stronger.
Senator Roberts. Well, Secretary Perdue and the Agriculture
Research Service, obviously, would run NBAF. The construction
of it is the Department of Homeland Security. In fact, they are
responsible for any attack on the United States.
It has been very difficult to focus on this. Some years
back on the Intelligence Committee, of which my distinguished
friend is the Chairman, we were able to determine that what
keeps you up at night that at least in the top ten was an
attack on our food supply.
That is not the case today. I am talking with our CIA
Director Mike Pompeo, who happens to be from Kansas. And so, we
are trying to, at least, reassess that threat and I think it is
a very real one.
I thank you all for your service.
I am over time. I yield back. Thank you, Mr. Chairman.
Senator Burr. Senator Roberts, you did not disappoint me. I
knew there was going to be a question somewhere in that
dissertation.
[Laughter.]
Senator Burr. Senator Baldwin.
Senator Baldwin. Thank you, Chairman Burr and Ranking
Member Casey.
This discussion today is important and timely. It brought
into focus the sobering fact that we have experienced at least
one health emergency every year in the 5-years that I have been
serving on this Committee, from Ebola to Zika to the hurricanes
this year.
I was serving, previously, in the House of Representatives
during the 2009 H1N1 pandemic and also in 2004, when we saw a
dangerous shortage of influenza vaccines due, in part, to our
insufficient domestic production capabilities.
We are also in the middle of a particularly severe and
deadly seasonal flu year. So I wanted to focus especially on
our readiness for a pandemic flu outbreak.
I am concerned with the lack of sustained and predictable
funding for the pandemic vaccine stockpile, and I am committed
to working with my colleagues to advance a specific
authorization for pandemic flu activities.
Mr. MacGregor, in your testimony, I was troubled that our
pandemic flu stockpile does not match the current strains of
influenza and is full of expired vaccine components due to
underfunding. And it is especially concerning as we have the
H7N9 bird flu circulating in China that continues evolve in
ways that has the potential to trigger a global pandemic.
Are we adequately prepared for an outbreak of pandemic flu
that could strike in the near term? And how would a pandemic in
the middle of this severe seasonal flu season complicate our
vaccine readiness?
Mr. MacGregor. Thank you for the question, Senator.
I think at the start of your statement, you immediately
gave part of what would be my answer. I think your question and
your comment about the stockpile, as it exists today, is a
result of the underfunding that has occurred, particularly
since 2009.
So with the funds that were provided, supplemental balances
or emergency funds that were provided up to 2009, from 2005
through to 2009, it allowed for the building up of a stockpile
of various pandemic strains, pre-pandemic strains allowing us
to test and to understand how to manufacture. And this was, I
think, a good partnership with BARDA and was fundamental to our
preparation at that time.
Since then, the funding has really dropped off, as you
commented and that is really what is behind the point I was
making. There is product that sits in the stockpile today that
was manufactured quite some time ago, in some cases, seven, 8
years ago.
Our ability, and the ability of the government, to
replenish the stockpile, whether it be with antigen, or whether
it be with adjuvant, which is also in the stockpile, has been
diminished by the lack of sustainable funding to support BARDA
and its efforts.
I would say in answer to your questions, because of that I
do not believe we sit in a great state of readiness today. You
do mention the H7N9 and we are, in fact, working with BARDA on
developing an H7N9, as I imagine some other partners are as
well.
Senator Baldwin. Okay.
Mr. MacGregor. But we need that sustainable funding going
forward in order to enhance our readiness.
Senator Baldwin. This next question is both for you, Mr.
MacGregor, and Dr. Inglesby.
My home State of Wisconsin has long been a leader in
medical innovations that help grow our economy. Not only are we
home to a world renowned flu scientist working to develop a
universal vaccine, but we are also the hub for biomedical
companies producing new technologies.
Stratatech, a company in Madison, Wisconsin is producing a
new, regenerative skin technology to treat severe burns through
a contract with BARDA to develop their tissue as a medical
countermeasure. Instead of painful skin grafts, they are
producing living tissue designed to mimic human skin and
promote tissue regeneration.
Dr. Inglesby and Mr. MacGregor, can you discuss why it is
important to maintain our Federal investment in medical
countermeasure research and development to foster innovation
that keeps pace with the evolving and increasing chemical and
biological threats?
Why do we not start with you, Dr. Inglesby?
Dr. Inglesby. I think the reason why it is so important to
continue investment is that for problems, like the one you
described for patients with burns, for pandemic influenza, for
other kinds of outbreaks, there is not necessarily a commercial
market for those products.
Companies face a very difficult challenge, planning, a lot
of uncertainty. If the Government can provide more clarity,
both in the early phases in the research and in the development
phase--and then potentially in the acquisition phase if that is
the role for the government for a particular product--companies
can then plan, can decide to make investments in this space as
opposed to other commercially valuable opportunities that they
might pursue otherwise.
I think it is going to continue to be a very important role
for the government to play for products that we want that are
not otherwise produced by the commercial markets.
Mr. MacGregor. I would certainly echo that comment from Dr.
Inglesby.
It is a mechanism that needs to exist to have companies,
innovative companies--like the one you mentioned and others
that are Members of the Alliance for Biosecurity and more
broadly bio--to be able to continue innovating in this space.
There needs to be sustainable funding in this space.
The last comment I would make, just to add, it is
interesting to hear from a number of colleagues in this space
that, when you look at institutional investors and the like,
where there used to be more of an attraction for them when the
funding was more certain, that attraction has gone away. Little
to no value is placed on MCM work in the current context
because of the lack of sustainable funding.
Senator Burr. Senator Cassidy.
Senator Cassidy. Thank you, gentlemen. I enjoyed your
testimony, all of you. A couple of things. I enjoyed it so much
because you agree with me. One of you spoke about the need to
have healthcare professionals be able to go across lines and
have liability protection. I was a practicing physician when
Katrina hit. There was an orthopedist at the New Orleans
Airport. The FEMA people would not allow him to set somebody's
broken bones because he was from out of state and they were
concerned about liability. So I think we need a Good Samaritan,
which our Governors can say, ``Listen, if you are from out of
state and you are in good standing with your state, you have
blanket protection.'' But I do think we need that on a Federal
level as opposed to the patchwork. I will say that. I have
introduced a bill with Senator King entitled the Good Samaritan
Health Professionals Act that would do so. Second, I think Drs.
Krug and Inglesby, you spoke Dr. Dreyzehner, of the need to
have a public health emergency fund. Senator Schatz and I have
introduced something such as that would, just as FEMA has
dollars, it does not need a special appropriation, but rather
can go and when an emergency hits, the dollars are
appropriated, and it cannot be encumbered and put in escrow by
another effort. Those dollars are there. Still have
accountability. To get a second trunch, you have to come back
to Congress and get approval. GAO will make sure they do it.
But we also take care of contracting because the CDC director
said of Ebola, he had to get ten signoffs on travel vouchers
for people to go over to West Africa and that slowed the
response. He had to contract with NGO's for them to contract to
get transportation for people and goods. We are trying to
circumvent that and again, Senator Schatz and I have put
something together as regard to that. Now, let me hit on some
stuff which perhaps is a little bit more provocative. Dr.
Inglesby, you speak about the need to maintain this
international network. Theoretically, World Health is doing
that. I am not sure we are getting bang for our buck with World
Health. Now, you probably have relationships with them, so I do
not mean to put you in a bad position. But if we are funding
internationally World Health and the CDC is having to do it
separately, that does not seem, in a time of scarce resources,
wise use of resources. Thoughts?
Dr. Inglesby. Yes, so the World Health Organization has
some of the best experts in the world on diseases around the
world, and they are kind of the normative agency for setting
policy, and guidance around the world, looked up to it in the
world. But they are not a strong, operational agency. They do
not have resources to go and train the world or build labs
around the world. They have some money for that, but their
budget is constrained as well. They depend on donations.
Senator Cassidy. If they had the money, do they have the
capability of doing it?
Dr. Inglesby. Not right now.
Senator Cassidy. So, that seems like we are having to
supplant an international organization with a Centers for
Disease Control. I understand why we are doing it, but it
almost seems like we are compensating for something which
should have the responsibility already.
Dr. Inglesby. Well, what I would say is that the CDC and
about 65 other countries are all contributing in some way, some
of them with a lot of money, some of them with just their
experts. But the Global Health Security Agenda was a way of
getting a large consortium of countries go out and help.
Senator Cassidy. I get that and I am not objecting to it
except insofar as it seems like World Health should be doing
that. Let me move on.
Dr. Inglesby. Okay.
Senator Cassidy. Now, you mentioned about having regional
areas of expertise. Let me go back to my formative experience
with Hurricane Katrina. When the fecal material hit the fan, it
just overwhelmed everything. Now, when I went to Haiti as a
private citizen after the earthquake there, I was struck that
the Israelis came in and they just plopped down a hospital,
unfolded it, and every capability they needed was there in a
field hospital. I almost think since a public health emergency
could happen in Baton Rouge, Shreveport, or Topeka, or you name
it, how does every region have that kind of expertise? As
opposed to a public health hospital that may sit up in your
local V.A., which is already a government facility. Boom. ``We
commandeered. We are taking it over.'' It almost seems a better
way to respond because then you would truly have expertise that
is deployable in a moment. Any thoughts on that?
Dr. Inglesby. I do think that we should be able to rely on
the local institutions. So V.A.'s are a great source of
strength in some cities. But the National Disaster Medical
System and the DMAT teams, I think, are some of the teams that
responded to Katrina, they responded to Harvey.
Senator Cassidy. Let us go back to Ebola, which is very
specialized. You had to take off your booties in a correct
fashion or else you were exposed. This happened to the nurse in
Dallas.
Dr. Inglesby. Right. So the U.S. was not prepared to send
doctors and nurses to Ebola. We sent public health specialists,
but they did not take care of patients. They were not allowed
to take care of patients.
Senator Cassidy. But my point is, would it be better to
have that sort of expertise that truly could go to a community
and boom. ``We are going to be the expeditionary force.'' I am
sitting next to a Marine.
The healthcare expeditionary force that is going to be able
to manage this and we do not have to have a lot of in-service
because these people are hitting the door right now. We will
give you in-service, but in the meantime, we will provide
direct care and that way, whether it is Baton Rouge or Topeka
or New York, we know that we have expertise deployed.
Dr. Inglesby. Yes, I do think it would be very valuable. We
have something like that on a much smaller scale called the
DMAT teams.
Senator Cassidy. Yes, but DMAT is more generic.
Dr. Inglesby. Fair enough. I agree with you.
Yes, I do not think we have infectious disease-oriented, or
Ebola, or contagious disease-oriented teams like the ones you
are talking about. And I think nationally and internationally,
it would be good for us to be able to build those teams.
Senator Cassidy. I yield back. Thank you.
Senator Burr. I would like the record to show that North
Carolina tried to deliver to Louisiana after Katrina a portable
hospital.
Senator Cassidy. Yes.
Senator Burr. And it was the Governor who would not sign
the liability agreement. That put that hospital in Mississippi.
So we have this incredible surge capacity, I am learning
about. It is just we have hurdles in the way.
Senator Cassidy. Right.
Senator Burr. That will stop it dead in its tracks if it
ever starts the motion of addressing collectively the problem.
So these are things we can work out.
Senator Cassidy. And let me just say we, in Louisiana,
continue to be indebted to other DMAT's around the Nation who
just so generously deployed. I cannot tell you the gratitude we
feel.
Senator Burr. Senator Kaine.
Senator Kaine. Thank you, Mr. Chair, and thanks to the
witnesses.
An observation and then I want each of you to address a
workforce question. So the observation is this.
When we reached a deal yesterday so the Government would
open, there are really two components to the deal. One, a
guarantee of a debate and vote around permanent protection for
Dreamers, which is very important.
But the second half of it was, we have to get out of
continuing resolution mania and get back to real budgeting
again to fund these priorities and others.
One of the funding questions that we are now grappling with
is the question of budgetary caps because of votes of earlier
congresses that would impose such caps. When the caps were
imposed, they were imposed equally on defense and non-defense.
All of your testimony, and the testimony of the equivalent
panel last week, are about national security. This is national
security.
I just came from a closed hearing about America's nuclear
posture in the Armed Services Committee national security, but
you are national security too.
One of the proposals floating around is that we would
increase caps on the defense accounts but not on the non-
defense accounts. You guys are non-defense, so you are national
security, but you are not defense.
The Lynchburg, Virginia economy is based pretty heavily on
companies that build nuclear reactors that go into carriers and
subs. But those are under the control of the Department of
Energy, not DOD. So that is a non-defense expenditure.
The point that I am making is as we grapple with these
caps, it would be foolish to raise defense caps and non-defense
caps because if we are not raising caps appropriately to fund
emergency response, or we are not raising caps appropriately to
fund the DOE programs that build nuclear reactors, we are not
taking care of our national security.
That is my observation.
Second, workforce. The quote, Dr. Dreyzehner, in your
testimony, written and verbal, it is about people. It is about
people. And one of the things I love about this Committee is it
is Health, Education, Labor, and Pensions. So PAHPA is within
our Health jurisdiction, but in the Education jurisdiction, we
are having a set of hearings about approaching the rewrite of
the Higher Education Act. Programs like public loan service
forgiveness. This is on the education side.
You all approach your jobs from different backgrounds and
expertise, but share any concerns you have about the current
public health workforce in this country as you look forward
because we might be able to do something about that, not just
in PAHPA. We might be able to do some things about that as we
grapple with the Higher Education Act rewrite.
If you want to start, Dr. Krug.
Dr. Krug. Thank you. Thank you for the great question.
As has already been said, this is about people. Yes, we do
need more ``stuff,'' but we really need more people. The budget
environment today constrains the number of people that you can
employ, which is why there is this just-in-time thing going on
in healthcare, which is why we do not have a lot of capacity.
But in the end, there are not enough nurses, as an example,
to staff all of the hospitals or all of the clinics. And some
of those limitations are greater in certain communities than
others. I will defer to my public health colleague, but I
believe there is a public health workforce issue as well.
What we need to do through education, and maybe through
some incentives, is to direct more of our future, young people,
toward these important careers because these are careers where,
in addition to taking home a paycheck, you are making a
difference. You are serving the community. You are serving the
public. You may not be a special Government employee, but you
are still making a difference.
I think if we can redirect the flow, we will be better
prepared to deal with a calamity.
Senator Kaine. Others who would like to address it? Mr.
MacGregor and then Dr. Dreyzehner.
Mr. MacGregor. We will go down the line quickly.
Senator Kaine. Yes.
Mr. MacGregor. I think my main response in this would be
some of the strain that comes on public health, as referenced
by my colleagues up here, is the need to respond in an
emergency.
I feel that a big part of the reauthorization discussion,
the notion of sustainable funding really has, at its core, the
avoidance of having to respond in an emergency that puts an
undue strain on the public health system.
It has a bit drifted from your question about workforce,
but I just wanted to make that particular point, because I
think it gets to the sustainability question.
Senator Kaine. Thank you. Dr. Dreyzehner.
Dr. Dreyzehner. Thank you, Senator. A very important
question.
I think Mr. MacGregor said in his comments about medical
countermeasures and the certainty around having a market for
those. Dr. Krug mentioned that folks who are engaged in this
area are highly committed, passionate, compassionate people,
but they need certainty in the profession being there tomorrow.
That has not been the case for the last 15 years.
There have been a lot of question marks raised about,
``Will the area that I have devoted my life to, when called
upon, be there?''
Really after 9/11 and anthrax, we developed our current, I
think, more modern, more responsive, higher capacity public
health and healthcare preparedness infrastructure.
But those professions that have evolved around that, many
of them are now becoming senior, many of them are retiring.
People are making decisions as to whether they want to enter
the field, ``Will there be a profession for me if I decide to
enter the field or to stay in it?'' So all those things are
really important.
Sustaining and maintaining funding is very important, not
pulling at the last minute to redirect it to some other
priority is really important. You referenced that briefly.
I absolutely think your points are really important. I
think the threat to the public health workforce is they are
going to decide to go to something else and possibly they will
retrain into healthcare where there is a little bit more
stability. They have other options, but they really like these
jobs.
These jobs are good jobs. They are important jobs in the
areas where they exist, both in rural and urban environments. I
think the Nation's national security would be well served to
recognize the passion of these professionals, the experience
that they have gained, the relationships that they have built,
and the lives and property that they have saved in the last 15
years since this regime, PAHPA one and two, were reauthorized.
Senator Kaine. Mr. Chairman, might I ask Dr. Inglesby to
respond briefly? Thank you.
Dr. Inglesby. Yes, I would just echo the comments and say
that the public health emergency preparedness program that
supports so much of the public health workforce has come down
pretty substantially since its start. Thousands of jobs have
been eliminated in public health since we began this effort
back after 9/11.
I think there is great excitement in the field. Young
people want to work on these issues, both in medicine, nursing,
and public health. They leave schools with pretty substantial
loans. There are some loan forgiveness programs which need to
be attended to, to draw people into the field.
But for the most part, I think people will come to these
jobs if there is a field there, if there is support there. And
right now, a lot of this money does come from the Federal
Government. It supports jobs directly.
I think continuing these programs would help ensure that we
have a workforce.
Senator Kaine. Thank you for that.
Thank you, Mr. Chair.
Senator Burr. Senator Young.
Senator Young. Well, thank you, Chairman, and Ranking
Member for this second in a series of hearings on a very
important topic, public health threats.
I would like to turn to a topic of insurance for pandemics.
I will be asking a question of each of you related to this
topic.
But by way of background, in our last hearing, we heard
Admiral Redd who, of course, is from the Centers for Disease
Control and Prevention. He said that our strategy to address
zoonotic diseases, those that spread from animals to people
such as Ebola and the avian influenza, has been a reactive
strategy.
It made me think. Are there any strategies that might take
us from a reactive stance to a, to use a modern term, proactive
one?
I found that last year, the World Bank launched the first
pandemic bond to quickly finance public health emergencies. You
may be familiar with this. So financing emergencies like
pandemic influenza strains, something called corona viruses,
filo viruses like Ebola, and others.
According to the World Bank, their pandemic emergency
financing facility would provide over $500 million of coverage
against pandemics in just the next 5 years.
My question to you is do you think Congress should
experiment in the creation of similar financing structures like
the pandemic emergency financing facility, or some other type
of insurance mechanism to protect against pandemics?
Regardless of your thoughts on that, if there are other
proactive strategies that you think we should turn to first, if
you could volunteer that to me, I would appreciate it. We will
start with Dr. Inglesby, please.
Dr. Inglesby. I very much respect what the World Bank has
done with the pandemic bonds. I have not studied it enough to
understand whether there would be some value in doing that in
the United States. It is an interesting and new question. I
have not heard that before, so maybe I can get back to you with
thoughts on that.
I think one alternative, which is less complicated but we
talked about already, would be to establish a contingency fund
that would only be used in the event of emergencies declared by
either Congress of the Secretary of Health. We would have a
fund that would be ready to go. It is kind of like an insurance
policy. It would not be called insurance, but a fund available
for rapid response.
Senator Young. Thank you. Actually, I have done work like
this, new financing mechanisms, related to a number of fields
from healthcare to social policies. So I respectfully am of the
opinion, this would not be all that complicated. It would be a
way to capitalize a fund like those that have been invoked
earlier. But thank you very much, doctor. Yes.
Dr. Dreyzehner. Well, I would echo Dr. Inglesby's comments.
I think I am not sure I know what insurance means anymore,
but the idea that, I think, funding is up in HPP back to their
prior levels is insurance to make sure that people that need to
be there when the balloon goes up are there and able to do what
they do.
I think the contingency fund could be a very important
piece of insuring that the unknown unknowns are insured against
and they will certainly occur.
I would just echo what Dr. Inglesby said and I would say
that our best insurance is making sure that we have adequate
people, and relationships, and networks, and experts available
at a moment's notice to respond.
Senator Young. Thank you. Mr. MacGregor.
Mr. MacGregor. I would just add as well that if mechanisms
such as these----
When you first mentioned it, I always thought more of in
the event of protecting against the cost of pandemic once it
hits. I would be more inclined toward financing mechanisms
that, again, allow us to be more prepared in advance and not
having to deal with the tragic aftermath.
Maybe just maybe what World Bank is proposing is something
that could be more of a global kind of effort that cannot only
benefit the U.S., but can benefit other countries as well. And
by benefiting other countries, it actually contributes to
preparedness we can have here.
Senator Young. Thank you. Doctor.
Dr. Krug. It is good to be last. I agree with all of the
comments made by my colleagues. I would offer two, hopefully
helpful, perspectives.
First of all, as one of the Members stated, if we could
mitigate the problem and avoid the disease, that would solve a
lot of problems, and so, that gets back to proactive
vaccinations. And also locally and at a global level, looking
at those vectors and trying to identify early on and prevent
those diseases before they spread.
In the end, it is pretty clear to me, and I know you guys
get this, that there is not money to go around to make this all
work. We have all told you we need to improve funding for the
core elements of the process because if you want to do it for
less, that is what you are going to get. You are going to get
less and that is what we are seeing today.
It is long overdue for a discussion with the public about
the threats that we face, the reality of our resources, and how
we can collectively make a difference. I think most Americans
share some common values and I think our collective survival
and making America stronger is something that most people would
want to do.
In the end, there are not enough resources when the cavalry
arrives, whether it is the state, local, or Federal Government
to meet the needs of everybody in a town, a city, and whatnot.
If citizens were better prepared, if we began a discussion
about the values and the culture with personal readiness and
with the strong helping the weak, helping your neighbor, making
sure that is okay, then we would not have to rescue everybody.
Maybe we would be rescuing a few fewer, because there are going
to be citizens who cannot do that for a variety of important
reasons.
But if we can get back to the culture that, I think, I grew
up with when I was in grade school where that seemed to be a
value, I think that would help us both with this and probably
with some other issues as well.
Senator Young. Well, I thank you all. I threw a novel
concept at you. If you have any additional thoughts that you
would like to followup with my office about later, I would be
appreciative.
Mr. Chairman, I would just note that point on community is
something that has been invoked consistently, whether we are
talking about the opioid epidemic, or social pathologies, the
need for more community to help address a range of public
issues that we are dealing with; so not an easy one to tackle,
but an important reminder.
Thank you.
Senator Burr. Senator Warren.
Senator Warren. Thank you, Mr. Chairman.
When a public health emergency hits, the headlines are all
about what is happening on a minute by minute, hour by hour
basis. You do not get news alerts on your phone about the years
of hard work that went into making the response to the disaster
actually work when everything was on the line; so all the
drills, the dry runs, the training. But I understand. These are
the investments that we have to make in our Nation's
preparedness and our response capabilities if we are going to
be ready when an emergency strikes.
I want to talk about one specific type of investment today,
and that is investing in the therapies, or the medical
countermeasures, that save lives when disaster strikes; so
vaccines for anthrax, or Ebola, or influenza; products to
protect us from radiation exposure; next generation
antibiotics.
In 2004, Congress established a program called BioShield,
and I think Senator Burr referred to this earlier and Senator
Baldwin. I just want to dig in a little bit about this program.
The idea was to accelerate development of medical
countermeasures by investing in biomedical research.
Now, Dr. Inglesby, you are an expert on biosecurity. When a
company develops a new drug or device, usually they go out and
get a lot of funding from private investors.
Why do medical countermeasures need public investment from
a program like Project BioShield?
Dr. Inglesby. Senator, the reason why companies need that
kind of support from the Government is because the products
that we are trying to make for pandemics, like an anthrax
vaccine or an Ebola vaccine that you referred to, they do not
have a commercial market.
Senator Warren. We hope.
Dr. Inglesby. We hope.
Even in the event of a pandemic, it is going to be
difficult for people to access those funds without the help of
government. They are going to be in stockpiles. So what we need
is sustained investment in those companies to get them to do
this work.
Senator Warren. So let us talk about that sustained
investment.
When Project BioShield was created, it got $5.6 billion in
guaranteed funding over 10 years. It was called an advance
appropriation, and that means that Congress decided, in
advance, that it was going to spend that amount of money. They
did not come back every year during that 10 year period to
decide whether or not they would actually put the money in as
promised.
Now that changed in 2013 when the initial 10 year
commitment ran out and Project BioShield has had to get its
funds set aside on a yearly basis, just like everyone else,
through the appropriations process.
Mr. MacGregor, you work in the biosecurity field at a
company that makes flu vaccines. The authorization levels for
Project BioShield, that is what Congress said we could spend on
it, have stayed exactly the same since 2013.
Is that right?
Mr. MacGregor. Yes, since 2013. I mean, the authorization.
Senator Warren. So authorization, I am going to go to this.
Mr. MacGregor. Yes.
Senator Warren. The authorization stays the same, but
appropriations levels, did Congress actually get that money out
the door to you?
Mr. MacGregor. No.
Senator Warren. No.
Mr. MacGregor. So for BioShield, I think the authorization
is $2.8 from Fiscal Year 2014 and about $1.5 billion was
actually appropriated. So there was a shortfall relative to
what had been experienced in the initial period.
Senator Warren. That is a pretty significant shortfall.
Mr. MacGregor. Yes.
Senator Warren. All right.
What does that mean for companies like yours that are
trying to make decisions about researching and developing these
kinds of countermeasures?
Mr. MacGregor. Well, it calls into question again what the
commitment is and I think for a lot of companies, it is very
difficult in this space to do long term planning and to
forecast in a way you would typically forecast, granted, in a
commercial space. So it makes it very difficult to plan.
I think as well what has happened with this uncertainty,
and I know I mentioned it before, but during that initial 10
year period, I think there was a lot of private investment.
There was a lot of institutional investment in companies that
were in the MCM space because there was a value that was seen
there.
I have heard from a number of colleagues that investment,
that pool of investment, has really dried up. And, in actual
fact, there is really very little of any value that the market
puts in the MCM space.
Senator Warren. So this really worries me. You are telling
me it is a market that only works if the Federal Government
makes the investment and that the yearly appropriations process
is not working in this field. I think that is what I am gearing
from the two of you.
It just seems to me that keeping our Nation safe from these
kinds of threats, it is one of the most important investments
we can make. You cannot make up ground overnight on this, but
you cannot do it once the threat is at your doorstep. We have
to be in this for the long haul.
As this Committee works to reauthorize PAHPA, I hope that
we can discuss the importance of providing robust, stable
funding to researchers who are working to help us avert the
next public health emergency.
Thank you, Mr. Chairman.
Senator Burr. Thank you, Senator Warren.
Let me just say to colleagues, I think Senator Casey and I
have been in the trenches for a long time. We have written more
letters to appropriators.
The definitive change was when Presidential budgets did not
ask for the full BioShield money; a pivotal point. It was that
lack of request. And unfortunately up here, as Senator Casey
and I have found, even our letters to appropriators would not
get them to fill a hole bigger than what the Presidential
budget request was, and we have seen this steady decline.
But I think I can say on behalf of the Chairman, who is an
appropriator, that this Committee has always said that we ought
to appropriate at reauthorization levels.
You probably hit on the key thing that was, I think, the
toughest thing to recognize, and that is: where is the Federal
Government's responsibility at creating the incentive for
people to create something that there is not a commercial
market for?
I will say, though, hiding in the back of the room, is one
of the authors who now works for the ASPR, and she has
feverishly been writing notes. So everything you have said
today is going to find its way back.
But I will tell you how difficult this was. When this was
originally designed, trying to find somebody to be the
spokesperson for disaster, we had to create a new position
called the Assistant Secretary for Preparedness because nobody
wanted to raise their hand and be in charge.
This is something that this Committee has got to be
absolutely vigilant on from a standpoint of what the needs are
because, I would say, that Mr. MacGregor is a great example. If
this dries up, who wants to be in the vaccine space? The same
reason that we have a shortage of antibiotics today, who wants
to be in the antibiotic space? It is millions, and millions,
and millions of dollars in development.
It is not only addressing this, I would tell you it is
technologically trying to come into the 21st century. And our
regulatory and reimbursement, as you look at gene-based
platforms that may cure genetic defects in children on one
side, and diseases that we have not been able to cure today
that we can cure tomorrow.
How do you reimburse for that? You cannot do it based upon
how much you have put into it. You have to look at it from a
standpoint of how much we are saving over the life of living
with that disease. This is foreign to government, but it is
something that we have to tackle in a bipartisan way to get it
done.
Senator Casey and I have just a couple more questions, and
if Senator Warren has some, I will stick around as long as we
need to.
Dr. Krug, identifying emerging public health threats is
critical in determining how to prevent, treat, and mitigate its
effect. One of the best tools that we have to gain this
information is the diagnostic test.
In the midst of combating Ebola and Zika, determining the
individuals in need of treatment helped to inform providers,
and those on the frontlines, of the outbreak.
How do rapid, point of care diagnostics work to better
inform providers working and are preparing for these public
health emergencies?
Dr. Krug. Thank you. That is a great question. They help
immeasurably.
Imagine, for a moment, that you are in a scenario with
multiple sick victims. And, I think, as one of my colleagues
pointed out, your Ebola treatment center can maybe take care
of, at most, three patients. Which of those three patients are
you going to admit to the Ebola treatment unit?
With the older technology that we have with diagnostic
testing, which took over 24 hours back when we dealt with Ebola
as a treatment center, we had no other choice but to treat
those patients until we knew for sure that they did not have
the disease.
Fortunately, it came during a time of the year where we
were not operating at peak hospital operating capacity. If that
was today, I would not know what to do with this problem,
because I would not know who to treat. And by treating somebody
who might not actually have the disease and need the treatment,
essentially prevent somebody else who needs that same treatment
area and ICU bed, and that ICU care team meeting their need.
Both in a hospital setting, but also in the field, these
diagnostics are terribly important. I mean, in the field the
resources are more limited and so the fundamental decisions
made in that setting are also vital.
Senator Burr. Tom, I want to turn to you since Dr. Krug
mentioned Ebola.
Is this statement correct? ``We learned enough with the
Ebola crisis to understand our limitations, but we have done
nothing to increase our capacity if it were to happen
tomorrow.''
Dr. Inglesby. I think at a high level, that is probably
true. There have been some lessons that have been built into
the system, but we have not really changed resources that are
available for the mission.
Senator Burr. But we learned enough to know that we have
no, or very little, surge capacity for an infectious disease of
that magnitude.
Dr. Inglesby. That is true.
Senator Burr. Okay. Dr. Krug, let me come back to you.
From a pediatric standpoint, there have been a number of
news reports, I do not know the accuracy of them, that suggest
that young adults taking Tamiflu have had hallucinations.
How challenging does that make the avenue to try to expand
these new treatments to the pediatric population?
Dr. Krug. Well, thanks to that.
Senator Burr. And the acceptance by parents.
Dr. Krug. Yes, thank you. You have hit the nail squarely on
the head.
It is not just Tamiflu. In fact, the bigger issue is with
vaccination. Because with the exception of maybe a glass of
water, there are probably going to be side effects associated
with almost anything, potentially anything, that you prescribe
or give to a patient. Whether you use something or not is,
hopefully, driven by evidence and that risk-benefit ratio of
positive effects versus side effects.
Thanks in part to social media, everything that occurs that
maybe did not occur the way it should have, and reports of
adults who are having hallucinations with Tamiflu, make their
way to places. And so that the average family that I care for
that has a smart phone, they already know about this.
When I try and advise them that their child should have
something, and it is driven by CDC guidance and the guidance
from the American Academy of Pediatrics, they say to me, ``But
doctor, this medication will cause my child to have four
heads.'' And it is like, ``Well, I am not even sure that is
true and if it is true, the likelihood of bad occurrence from
the disease is probably much more likely than those four heads
that you are worried about.'' So the point is that does make it
more difficult.
I will say that the partnership that we have been able to
have, and it is not just the American Academy of Pediatrics.
There are other specialty societies as well in terms of
partnering with a group like the CDC and getting out guidance,
not only to practitioners, but information to families. So that
at least on a reliable Website, there is, perhaps, counter
information that makes it clear that if your child has an
underlying medical problem, and they are in their first day of
illness with the flu that Tamiflu is probably a good idea.
Senator Burr. The challenging thing is to fulfill your
wishes, which is increased pediatric indication, you have to
have children willing to join clinical trials. And that means a
parent that is willing to allow a child to do that.
We have done some unusual things by emergency use order,
but I think you would agree with me that when you take somebody
who is physically different than what a dose or a drug might
have been approved for, you just do not know the reaction you
are going to get.
There is a real interest in the Committee to make sure that
pediatric indications are a normal process in the future.
Dr. Krug. And it should be part of the process. There are
ethical concerns whenever you are going to enroll a child in a
trial. The concerns that you have to address are substantially
greater than adults. And so, again, we are calling on this
other hat that I have.
A very interesting discussion was, since we do not know if
it was going to work, ``Should we try and test the anthrax
vaccine in children before an anthrax event occurs?'' This was
back when anthrax was high on the radar screen.
In the end, we deferred to the Presidential Commission on
Bioethics, which essentially came to the conclusion that it was
probably not ethical to do that.
So that is the dilemma. How do you do that? Again, in an
industry where it is tough to convince people to develop things
for which there is no market, the market is even smaller for
children. And the risk to the industry to do something in
children is substantially greater. So it is a steeper hill to
climb.
Senator Burr. Yes. Brent, I want to turn to you just real
quick.
I think it is safe to say that countermeasures are
difficult things to develop. Those human efficacious studies
are not feasible in some countermeasures. So the FDA finally,
in 2015, set the way forward with the animal rule.
My question is this, what are the challenges in
successfully bringing forward a medical countermeasure by
relying on the animal rule as the pathway?
Mr. MacGregor. Well, it is a different approach for it to
take from what we are accustomed to. And so, you are reliant on
the data you generate from that rule being something that you
have to extrapolate to being of use in humans.
I think it is beneficial in the sense that it allows us to
bring medical countermeasures forward. So in that regard, it is
good.
It is a rule that we have had, as an industry, to adapt to
going forward, but I think as an industry, we are doing it. So
it has been a good step forward.
Senator Burr. Senator Casey.
Senator Casey. Mr. Chairman, thank you very much.
I wanted to continue on the topic of children. I know we
are almost out of time here. But Dr. Krug, in the last
reauthorization, we were able to put in place a new,
National Advisory Committee on Children and Disasters, and
appreciate your work and your testimony today.
The only question I have for you is, what are the areas of
our preparedness planning where you see the greatest need for
more attention to the needs of children?
I know you have answered different parts of this, but at
least my wrap up would be there.
Dr. Krug. Well, arguably in all facets. And again, we have
made tremendous progress and the National Advisory Committee
has certainly contributed in that direction.
From a healthcare perspective--and that is a narrow
perspective because the whole process is bigger than
healthcare--the healthcare industry is primarily put together
to take care of somebody like me. Somebody not a child,
somebody with underlying medical problems, toward the end of
their life, I hope not.
The point is that with the exception of the facilities, and
there are a smaller number that sort of specialize in children,
the rest of the system does not. There is nothing wrong with
it. That is how it works on a day to day basis.
We can build these specialty centers of greatness for
disaster response, but every community, every institution,
every clinic--because that is where the care may need to be
provided--needs to be prepared to take care of all comers in
the community. And that also, then, includes children.
In current operations, if you have a sick child, you put
them in an ambulance and you send them to the children's
hospital. Well, that is not going to work, first of all, if the
children's hospital has been disabled by the event, or the
nature of the disaster does not permit transportation, or
everything is fine but they are already full to the gills.
So the challenge that we have, and the good thing is
everybody likes children, so that is our little thing in our
pocket. We have to get everybody better prepared to take care
of children and one of the most important ways to get there is
through training. Drilling and training, I think, would make us
better in caring for all populations, and certainly for
children.
Senator Casey. Thanks very much.
Thanks, Mr. Chairman.
Senator Burr. Thank you, Senator Casey.
Thank you to our witnesses. I do want to highlight, just
once again. In 24 years, I have done a lot of hearings. I found
it almost impossible to have an agency witness at the table who
testified and the private panel comes up second, and get an
agency person to stay in the room to listen to the private
sector.
This may be the first time I have looked and we have not
had a government witness, but we have had agency folks who have
attended to hear what the Members and the private sector say
about the reauthorization of a program.
That is unusual. I hope it is a trend that is going to
become the norm and not the exception. And I say that as a
message to go back because I think your testimony is not only
valuable to us, it is valuable to the agencies that are
affected by the issues that you are here to talk about.
So I want you to know today, they got heard not just by us,
but by the agency itself.
I thank all four of you for your willingness to be here
today and for the insight that you have provided to the
Committee.
The hearing record will remain open for 10 days. Members
may submit additional information within that time, if they
would like.
[The information referred to follows]
ADDITIONAL MATERIAL
prepared statement of richard b. myers \1\
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\1\ General (Ret.), 15th Chairman of the Joint Chiefs of Staff
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Chairman Roberts, Ranking Member Stabenow, and distinguished
Members of the Committee, I am honored to appear before you today on
behalf of Kansas State University (K-State) for this hearing entitled,
``Safeguarding American Agriculture in a Globalized World.''
THREATS AND CONSEQUENCES
Food insecurity is an ever increasing global problem as delineated
in a 2015 assessment by the intelligence community. \2\ Hungry people
are not happy people. America still feeds the world, so there is an
urgent need to protect America's food crops, food animals, and food
supply from naturally occurring and intentionally delivered biological
threats. Either could be devastating.
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\2\ Intelligence Community Assessment: Global Food Security, ICA
2015-04; September 2015
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One of the early discoveries when our troops went into Afghanistan
in 2002 was a list of 16 pathogens al-Qaeda was planning to use as
bioweapons. Only 6 of them targeted people. Another 6 were pathogens of
livestock and poultry and 4 were crop pathogens. So, al-Qaeda wasn't
just planning to attack people with biological weapons; they were going
after agriculture and food as well.
al-Qaeda has always had a goal of destroying the U.S. economy, so
bioweapons targeting crops, livestock and poultry is consistent with
that objective. Moreover, natural infectious disease outbreaks could
lead to the same outcome.
Consider the United Nations (UN) Food and Agriculture Organization
(FAO) assessment that ``just 15 crop plants provide 90 percent of the
world's food energy intake, with three--wheat, rice, and maize--making
up two-thirds of this.'' \3\ Ninety percent makes the protection of
food crops rather significant.
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\3\ See United Nations Food and Agriculture Organization: http://
www.fao.org/docrep/u8480e/u8480e07.htm
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If wheat, rice, or corn are targeted successfully by al Qaeda or
other bioterrorists or if there's a natural disease outbreak that
devastates the global supply of any one of the three, the world will be
in big trouble. The Wheat State takes such matters seriously.
Although it didn't turn out to be a global disaster, the pathogen
Wheat Blast hitting Bangladesh in 2016 certainly wreaked havoc there.
Wheat Blast can kill 100 percent of crops, and it likely got to
Bangladesh in a shipment of grain from South America where it's
endemic. The outcomes were devastating in areas of the country where it
occurred, and even though infected fields were burned, there was a
recurrence in 2017; the new outbreak spread to India too. The U.S.
should consider restricting grain shipments here from South America to
avoid a similar outcome.
With livestock, the Porcine Epidemic Diarrhea virus (PEDv) foreign
animal disease (FAD) outbreak in the U.S. in 2013 highlighted
biosecurity problems here that must be addressed. It resulted in over 8
million baby pigs dying, and significant financial losses incurred by
producers drove up the cost of pork markedly. It's suspected PEDv came
to the U.S. in feed products from China, but the FBI still hasn't
confirmed whether the virus got here by accident or intentionally.
There are reasons to suspect the latter. Either way, the impacts were
substantial, and PEDv is now an enduring endemic problem to deal with
in the U.S., not a FAD threat.
There are innumerable FAD threats that the U.S. must worry about
today, and the top-line FAD concerns are those currently projected to
be worked on in the U.S. Department of Homeland Security's (DHS's)
$1.25 billion National Bio and Agro-defense Facility (NBAF) under
construction on the K-State campus. These include the livestock-only
threats, African Swine Fever (ASF), Classical Swine Fever (CSF), and
Foot and Mouth Disease (FMD), along with the zoonotic threats, Rift
Valley Fever (RVF), Japanese Encephalitis (JE), Nipah virus, and Ebola
virus. Any of these and innumerable other FADs could ravage America's
agricultural infrastructure, food supply, and economy if they hit the
U.S. Furthermore, zoonotic FADs could devastate public health as well,
and until NBAF is operational in 2022/23, there's no U.S. laboratory
where livestock research can be conducted on Nipah and Ebola.
FOUNDATIONAL EFFORTS
Defense of U.S. Agriculture and Food--Homeland Security
Presidential Directive/HSPD-94
Delineating the federal role in bio/agrodefense post-09/11,
President Bush issued Homeland Security Presidential Directive/HSPD-9,
on January 30, 2004 to establish: ``a national policy to defend the
agriculture and food system against terrorist attacks, major disasters,
and other emergencies.'' \4\ Along with a number of other systems vital
to U.S. survival and prosperity, the agriculture and food sector was
appropriately noted to be ``critical infrastructure.'' \5\
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\4\ Homeland Security Presidential Directive/HSPD-9--Defense of
United States Agriculture and Food; Jan. 30, 2004
\5\ As delineated in Section 1016(e) of the USA PATRIOT Act of
2001 [42 U.S.C. 5195c(e)]
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HSPD-9 Roles and Responsibilities:
A defined chain of command is critical to accomplish any national
security mission. That's true for bio/agrodefense--defending the
homeland agriculture and food system--just as it is for every other
aspect of national defense. The leadership roles per HSPD-9 are as
follows:
Secretary of Homeland Security. As established in HSPD-7,
\6\ the Secretary of the Department of Homeland Security (DHS) ``is
responsible for coordinating the overall national effort to enhance the
protection of critical infrastructure and key resources of the United
States.''
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\6\ Homeland Security Presidential Directive/HSPD-7--Critical
Infrastructure Identification, Prioritization, and Protection, December
17, 2003
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Secretaries of Agriculture, Health and Human Services and
the Administrator of the Environmental Protection Agency. The two
Secretaries and the Administrator ``will perform their responsibilities
as Sector-Specific Agencies as delineated in HSPD-7:'' \7\
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\7\ Homeland Security Presidential Directive/HSPD-7--Critical
Infrastructure Identification, Prioritization, and Protection, December
17, 2003
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For the U.S. Department of Agriculture (USDA), sector-
specific responsibilities mean agriculture and food (meat, poultry, and
egg products);
For the Department of Health and Human Services (DHHS),
it means public health, healthcare, and food (other than meat, poultry,
and egg products); and
For the Environmental Protection Agency, sector-specific
means drinking water and water treatment systems.
Thus, DHS was named to lead bio/agrodefense, with USDA, DHHS, and
EPA supporting. Other departments and agencies also provide support
with the HSPD-9 requirements that follow.
HSPD-9 Requirements:
``Awareness and Warning'' \8\ . Knowing what's happening
over-the-horizon--beyond U.S. borders--is vital if America is to be
prepared to confront emerging biological threats; if the U.S. is to
respond quickly and decisively to defeat the threat.
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\8\ Homeland Security Presidential Directive/HSPD-9--Defense of
United States Agriculture and Food; Jan. 30, 2004
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HSPD-9 required the development of ``robust,
comprehensive, and fully coordinated surveillance and monitoring
systems'' for diseases of animals, plants, wildlife and people along
with threats to food and water quality. This system was to include
nationwide diagnostic networks for ``food, veterinary, plant health and
water quality.'' The Department of the Interior (DOI), USDA, DHHS, EPA
and other departments and agencies would develop the systems.
HSPD-9 required ``intelligence operations and analysis
capabilities focusing on agriculture, food, and water sectors.'' This
would be led by the Attorney General/ Department of Justice (DOJ), DHS,
and the Central Intelligence Agency (CIA) in coordination with USDA,
DHHS, and EPA.
HSPD-9 required the creation of ``a new biological threat
awareness capacity that will enhance detection and characterization of
an attack.'' DHS was to coordinate with USDA, DHHS, EPA and other
departments and agencies to carry this out.
``Vulnerability Assessments''. HSPD-9 mandated
``vulnerability assessments of the agriculture and food sectors'' and
the identification of ``requirements for the National Infrastructure
Protection Plan'' that was to be updated every 2 years. The assessments
would be done by USDA, DHHS, and DHS, with DHS responsible for the plan
every 2 years.
``Mitigation Strategies''. HSPD-99 required:
The prioritization, development, and implementation of
``mitigation strategies to protect vulnerable critical nodes of
production or processing from the introduction of diseases, pests, or
poisonous agents.'' \9\ This was a responsibility of DHS and DOJ
working with USDA, DHHS, EPA, and other departments and agencies.
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\9\ Homeland Security Presidential Directive/HSPD-9--Defense of
United States Agriculture and Food; Jan. 30, 2004
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The development of ``common screening and inspection
procedures for agriculture and food items entering the United States''
and maximizing ``effective domestic inspection activities for food
items within the United States.'' This was a responsibility of USDA,
DHHS, and DHS.
``Response Planning and Recovery''. HSPD-9 required:
Ensuring ``that the combined federal, state, and local
response capabilities are adequate to respond quickly and effectively
to a terrorist attack, major disease outbreak, or other disaster
affecting the national agriculture or food infrastructure.'' This was a
responsibility of DHS in coordination with USDA, DHHS, DOJ, and EPA.
Developing ``a coordinated agriculture and food-specific
standardized response plan that will be integrated into the National
Response Plan.'' This was a responsibility of DHS in coordination with
USDA, DHHS, DOJ and EPA.
Enhancing ``recovery systems that are able to stabilize
agriculture production, the food supply, and the economy, rapidly
remove and effectively dispose of contaminated agriculture and food
products or infected plants and animals, and decontaminate premises.''
This was a responsibility of USDA and DHHS in coordination with DHS and
EPA.
Making ``recommendations to the Homeland Security
Council, within 120 days of the date of this directive, for the use of
existing, and the creation of new, financial risk management tools
encouraging self-protection for agriculture and food enterprises
vulnerable to losses due to terrorism.'' This was a responsibility of
USDA.
Working with state and local governments and the private
sector to develop:
``A National Veterinary Stockpile (NVS) containing
sufficient amounts of animal vaccine, antiviral, or therapeutic
products to appropriately respond to the most damaging animal
diseases affecting human health and the economy and that will
be capable of deployment within 24 hours of an outbreak.''
``A National Plant Disease Recovery System (NPDRS)
capable of responding to a high-consequence plant disease with
pest control measures and the use of resistant seed varieties
within a single growing season to sustain a reasonable level of
production for economically important crops.''
Both were requirements of USDA in coordination with DHS and in
consultation with DHHS and EPA.
``Outreach and Professional Development''. HSPD-9 specified that
the Secretaries shall:
Work ``with appropriate private sector entities to
establish an effective information sharing and analysis mechanism for
agriculture and food.'' This was a responsibility of DHS in
coordination with USDA, DHHS and other appropriate departments and
agencies.
Support ``the development of and promote higher education
programs for the protection of animal, plant, and public health.'' \10\
This was a responsibility of USDA and DHHS in consultation with DHS and
the Department of Education (ED).
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\10\ Homeland Security Presidential Directive/HSPD-9--Defense of
United States Agriculture and Food; Jan. 30, 2004
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Support the development of and promotion of ``a higher
education program to address protection of the food supply.'' This was
a responsibility of USDA and DHHS in consultation with DHS and ED.
Establish ``opportunities for professional development
and specialized training in agriculture and food protection, such as
internships, fellowships, and other postgraduate opportunities that
provide for homeland security professional workforce needs.'' This was
a responsibility of USDA and DHHS.
``Research and Development''. HSPD-9 required:
Accelerating and expanding ``development of current and
new countermeasures against the intentional introduction or natural
occurrence of catastrophic animal, plant, and zoonotic diseases.'' This
was a responsibility of DHS, USDA, DHHS, EPA and other appropriate
departments and agencies in consultation with the Director of the
Office of Science and Technology Policy (OSTP), with DHS coordinating
the efforts.
Developing ``a plan to provide safe, secure, and state-
of-the-art agriculture biocontainment laboratories that research and
develop diagnostic capabilities for foreign animal and zoonotic
diseases.''This was a responsibility of USDA and DHS; DHS constructing
the National Bio and Agro-defense Facility (NBAF) meets this
requirement.
Establishing ``university-based centers of excellence in
agriculture and food security.''This was a responsibility of DHS in
consultation with USDA and DHHS, but funding for these centers has been
terminated by DHS.
The summary above does not include all the details in HSPD-9, but
it does note departments and agencies responsible for each requirement.
For almost every task, there were multiple departments and agencies
involved which would make every task very complex. Nonetheless, all six
requirements are vitally important to protecting U.S. agriculture and
food.
Separating HSPD-9 from HSPD-10--Bioterrorism for the 21st Century
\11\
\11\ Homeland Security Presidential Directive/HSPD-10--Biodefense
for the 21st Century, April 28, 2004
As already noted, HSPD-9--protecting agriculture and food from
bioterrorism--was signed on January 30, 2004, while HSPD-10--protecting
people from bioterrorism--was finalized on April 28, 2004. There were
likely sound reasons in 2004 to separate bioweapon threats to people
from bioweapon threats to agriculture and food, but the result of that
over the past decade and a half is that agriculture and food have
received minimal biodefense attention or funding.
That's surprising for at least two reasons: (1) Essentially every
country that ever developed an offensive bioweapons program, including
the U.S., created weapons targeting agriculture as well as people; and
(2) almost every pandemic threat today is a zoonotic disease that can
spread from animals to people. As a result, significant federal funding
should be focused on confronting and stopping these threats in the
animal host; that's not being done.
The only statement regarding agriculture and food in HSPD-10
referenced ``new programs to secure and defend our agriculture and food
systems against biological contamination.'' \12\ That's basically
delineating a food safety role as a small part of HSPD-10. And, in
fact, it was HSPD-7 that outlined homeland security obligations
regarding food safety. \13\ Responsibilities for meat, poultry, and egg
products went to USDA; the agency responsible for inspecting those
processing activities. Inspections for everything other than meat,
poultry, and egg products is the responsibility of the Food and Drug
Administration (FDA); a component within DHHS.
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\12\ Homeland Security Presidential Directive/HSPD-10--Biodefense
for the 21st Century, April 28, 2004
\13\ Homeland Security Presidential Directive/HSPD-7--Critical
Infrastructure Identification, Prioritization, and Protection, December
17, 2003
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That might actually explain some of the disparities between HSPD-9
and HSPD-10, e.g., why HSPD-10 specifies ``increased funding for
bioterrorism research within DHHS by thirty-fold''to protect human
health, while USDA got nothing for bio/agroterrorism research within
HSPD-9 to protect plant and animal health. Food was delineated by food
processing responsibilities for USDA and DHHS/FDA, with little focus on
safeguarding agriculture pre-harvest activities, i.e., protecting food
crops or food animals from infectious diseases or bioweapons. Thus,
USDA and DHHS have nearly equal roles in HSPD-9 (with DHS leading),
while DHHS has an appropriately dominant role in HSPD-10 (also with DHS
leading) with USDA having a minor food safety role.
Infectious diseases and biological weapons target living things,
people, plants, and animals. As noted above, bioweapon programs
commonly included pathogens of plants and animals, not just people.
Why? Because food-deprived or starving people are generally less fit to
fight and more likely to surrender.
Evidently, al Qaeda knew this, since their bioweapons list included
10 pathogens targeting animals and plants, and only 6 targeting people.
U.S. Bio/Agrodefense Status Today
U.S. biodefense efforts have been lacking for decades as pointed
out in multiple reports; first by the Commission on the Prevention of
Weapons of Mass Destruction (WMD) Proliferation and Terrorism, \14\,
\15\ and then by the bipartisan Blue Ribbon Study Panel on Biodefense.
\16\, \17\ The Commission looked at all WMD threats, and in their 2010
report card, biological risks received a failing grade; an ``F.'' All
four citations concentrated on biothreats to people, although the Blue
Ribbon reports referenced threats to animals, primarily from a ``One
Health'' perspective. The 2015 Blue Ribbon \18\ report highlighted
thirty-three major shortcomings requiring urgent attention by
Washington, DC policymakers. The top three most problematic were: (1)
no national leader; (2) no strategic plan; and (3) no dedicated budget.
Unfortunately, none of these shortcomings have yet been corrected.
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\14\ The Clock is Ticking: A Progress Report on America's
Preparedness to Prevent Weapons of Mass Destruction Proliferation and
Terrorism; Commission on the Prevention of Weapons of Mass Destruction
Proliferation and Terrorism, October 21, 2009
\15\ Prevention of WMD Proliferation and Terrorism Report Card;
Commission on the Prevention of Weapons of Mass Destruction
Proliferation and Terrorism, January, 2010
\16\ A National Blueprint for Biodefense: Leadership and Major
Reform Needed to Optimize Efforts; A Bipartisan Report of the Blue
Ribbon Study Panel on Biodefense, October 2015
\17\ Biodefense Indicators: One Year Later, Events Outpacing
Federal Efforts to Defend the Nation; A Bipartisan Report of the Blue
Ribbon Study Panel on Biodefense, December 2016
\18\ A National Blueprint for Biodefense: Leadership and Major
Reform Needed to Optimize Efforts; A Bipartisan Report of the Blue
Ribbon Study Panel on Biodefense, October 2015
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Since few elements dealt with agriculture, K-State raised the bio/
agrodefense issue with Blue Ribbon Panel Members. That led to a Panel
hearing on the K-State campus on January 26, 2017. The outcome of that
was a special focus report entitled, ``Defense of Animal Agriculture.''
\19\ Since Senator Lieberman will be covering Blue Ribbon reports, the
only other issue that should be noted from the hearing at K-State is
that defense of plant agriculture was discussed as well. It's our
understanding those threats will be addressed in a separate report.
\19\ Special Focus: Defense of Animal Agriculture; Bipartisan
Report of the Blue Ribbon Study Panel on Biodefense, October 2015
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Bio/Agrodefense Focus at K-State
As the Committee knows, protecting U.S. agriculture is a mission of
America's land-grant universities; that began in 1862 when President
Lincoln signed the Morrill Act. As someone relatively new to land-grant
administration--but someone with a lifelong commitment to national
defense --I'm convinced that the Nation's land-grant universities can
and should play a significant role in U.S. bio/agrodefense. These
institutions participate in protecting agriculture and food in their
states each and every day.
Thus, we would encourage the Committee to integrate the land-grant
universities into whatever solutions are developed. K-State stands
ready to participate on the national team and lead when asked or when
necessary. Protecting America's agriculture and food infrastructure is
too important not to.
K-State is not new to this realm. Back in 1999 with encouragement
from the Chairman of this Committee, K-State developed a 100-page
``Homeland Defense Food Safety, Security, and Emergency Preparedness
Program'' \20\ that detailed how to protect America's food crops, food
animals, and food supply from biothreats. Later that year, K-State's
President Jon Wefald testified before the U.S. Senate's Emerging
Threats Subcommittee regarding the ``Agricultural Biological Weapons
Threat'' \21\ facing America. That Senate subcommitee was also chaired
by Kansas Senator Pat Roberts.
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\20\ Homeland Defense Food Safety, Security, and Emergency
Preparedness Program, March 22, 1999. See:http://www.k-State.edu/nbaf/
documents/1999-Homeland-Defense-Program.pdf
\21\ Agricultural Biological Weapons Threat, October 27, 1999.
See: http://www.k-State.edu/nbaf/documents/1999-US-Senate-Testimony.pdf
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The ``Big Purple Book,'' as the 1999 program became known,
documented the need for a biocontainment facility capable of conducting
R&D on biothreats to food crops, food animals, and the food supply.
Prior to September 11th and the anthrax attacks in 2001, little
traction was gained for the need to build it. Post-09/11/2001, state
and federal funding was obtained, and the Biosecurity Research
Institute (BRI) at Pat Roberts Hall (PRH) became a reality.
The BRI/PRH is located immediately adjacent to the NBAF site and it
includes five BSL-3Ag rooms that can be configured for research with
cattle, pigs, sheep, goats and poultry. Work has been done on numerous
species to date, including white-tailed deer in 2017 to determine their
susceptibility to RVF. In addition to BSL-3Ag labs, the BRI/PRH has
dedicated BSL-3 space for conducting research on crop and food
pathogens. Wheat Blast R&D has been ongoing since 2009 and food safety
research began soon thereafter. The latter included studies for the
Army whereby eight 1-ton grinds of hamburger were done in October 2011
to validate whether food pathogens could be detected at the end of a
commercial process. The breadth of food-related biocontainment R&D
conducted under one roof makes the BRI/PRH unique-in-the-world.
K-State jump-started NBAF research in the BRI/PRH on RVF in 2013,
JE in 2014, CSF in 2015, and ASF in 2016. We were able to do this
because the State of Kansas agreed to fund $35 million for NBAF
research in the BRI/PRH as part of our ``best and final offer'' for
NBAF during the site selection competition. Research and development
(R&D) continues on all four of these FADs, but the Kansas funding
commitment will end in fiscal year 2019 when the last $5 million is
appropriated. The majority of the research is conducted by K-State
faculty, staff and students, but collaborators from the U.S. Department
of Agriculture's (USDA's) Center for Grain and Animal Health Research
(CGAHR) in Manhattan participate on some of the NBAF-related FAD
projects. Moreover, CGAHR conducts other USDA BSL-3/3Ag biocontainment
research in K-State's BRI/PRH as well. Going forward, federal support
is needed for R&D on RVF, JE, CSF, and ASF to help mitigate these
threats to U.S. animal health and public health.
Until NBAF is fully operational in 2022/23, USDA has no
biocontainment facilities where R&D can be conducted on zoonotic FADs.
Moreover, DHS stopped funding CSF and ASF research in 2017 at the Plum
Island Animal Disease Center (PIADC); an antiquated facility unsafe for
work with zoonotic diseases. Consequently, training the NBAF R&D
workforce is highly reliant on the BRI/PRH until the new DHS facility
becomes operational.
PROPOSED PATH FORWARD
The importance of implementing the requirements outlined in HSPD-9
\22\ to safeguarding American agriculture in a globalized world cannot
be overstated. They are all critically important, but strides made to
implement them in the early years have eroded today.
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\22\ Homeland Security Presidential Directive/HSPD-9--Defense of
United States Agriculture and Food; Jan. 30, 2004
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K-State believes that statutory authorization--with clearly
delineated and enforceable accountability--along with the appropriation
of funds to support the following key provisions in HSPD-9 will advance
this crucial humanitarian and economic mission.
(1) Enhance Intelligence Operations and Analysis Capabilities--
Leverage ``awareness and warning''intelligence information to conduct
federal, state, and local agriculture and food ``vulnerability
assessments.'' Advanced warning of over-the-horizon biothreats is
vital, but today, the U.S. is often minimally aware and insufficiently
warned. One reason appears to be insufficient numbers of bio/
agrodefense subject matter experts (SMEs)--veterinarians, animal
scientists, crop scientists, plant pathologists, etc.--with high-level
security clearances to assess classified intelligence.
(a) Security Clearances--Increase the number of food crop, food
animal, and food supply SMEs with high-level security clearances (TS-
SCI) to monitor bio/agrodefense threats worldwide.
(b) Sensitive Compartmented Information Facilities (SCIFs)--
Increase the number of SCIFs with secure communications that have
agriculture/food SME analysts and/or cleared SME advisors with TS-SCI
clearances.
(c) USDA Clearances--Increase the number of USDA personnel with TS-
SCI clearances. It's unknown how many bio/agrodefense SMEs there are
within the intelligence agencies, but there are nowhere near enough
within USDA. Conversations in 2016 with the USDA's chief scientist and
a USDA intelligence analyst confirmed their frustrations with an
inability to convey critical classified information within USDA to make
it actionable. This creates huge federal impediments to safeguarding
agriculture, particularly when DHS stopped meeting their HSPD-9
responsibilities in 2016/17. Undertaking ``vulnerability assessments,''
\23\ developing ``mitigation strategies,'' conducting ``response
planning and recovery,'' and defining time-critical ``research and
development'' strategies are virtually impossible when there is limited
awareness and no warning. This must be rectified immediately.
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\23\ Homeland Security Presidential Directive/HSPD-9--Defense of
United States Agriculture and Food; Jan. 30, 2004
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(d) Intelligence Fusion Centers (IFCs)--Increase the number of
state IFCs with agriculture and food SMEs with TS-SCI clearances. The
Kansas IFC (KIFC) appears to be the only such center of over 70
nationwide that has a biothreat team with cleared SMEs capable of
assessing the full range of biohazards to food crops, food animals, the
food supply, and people. These include a DVM and PhDs from K-State and
MDs from the University of Kansas Medical Center as well as SMEs from
multiple state agencies. These SMEs allow the KIFC to assess global
intelligence for the purpose of preventing bioterrorism attacks and
preparing for natural infectious disease events emerging globally.
Thus, the KIFC focuses ``left of boom'' (prior to an attack or
outbreak) rather than ``right of boom'' (after the event) like other
fusion centers. This model should be emulated beyond Kansas, because it
allows state-specific planning with regard to ``vulnerability
assessments, mitigation strategies, and response planning and
recovery.''
(2) Emerging FAD Threats--Exploit ``awareness and
warning''telligence information regarding newly emerging biothreats to
establish bio/agrodefense ``mitigation strategies''at USDA CGAHR prior
to NBAF becoming operational and fund ``research and development''in
the BRI/PRH.
(3) Zoonotic Animal Disease Research--Establish federal threat
``mitigation strategies'' \24\ for zoonotic FADs at USDA CGAHR prior to
NBAF becoming operational and fund RVF and JE ``research and
development''in the BRI/PRH.
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\24\ Homeland Security Presidential Directive/HSPD-9--Defense of
United States Agriculture and Food; Jan. 30, 2004
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(4) Non-Zoonotic Foreign Animal Disease Research--Expedite federal
threat ``mitigation strategies''for non-zoonotic FADs by moving the
research portfolios for ASF and CSF from USDA PIADC to CGAHR and
funding ASF and CSF ``research and development''in the BRI/PRH until
NBAF becomes operational.
(5) Private-Sector Outreach--Enhance private-sector ``outreach and
professional development''by leveraging the Nation's land-grant
universities that interact routinely with private-sector agriculture
producers and food processors nationwide.
An implementation problem for HSPD-9 was the expectation that the
Federal Government would be able ``to establish an effective
information sharing and analysis mechanism''with private-sector
agriculture producers and food processors. Having the Federal
Government show up at the door is likely to be viewed with distrust and
skepticism. In some instances, State Government might be a somewhat
better alternative, but this is an area where the Nation's land-grant
universities could serve as the facilitators/trusted brokers.
(6) Higher Education Programs--Support the development of higher
education programs as called for in HSPD-9 ``outreach and professional
development.''
(a)
For Capacity Building--`In veterinary medicine, public health, and
agriculture.''
(b) For Protection--``Of the food supply.''
(7) Surveillance Systems--Increase support for ``awareness and
warning'' surveillance systems to provide early detection of U.S.
disease outbreaks.
(a) For Food Animals--the National Animal Health Laboratory Network
(NAHLN)
(b) For Food Crops--the National Plant Diagnostic Network (NPDN)
(c) For Wildlife--Unknown
(8) Agriculture Response and Recovery--Support agriculture/food
``response planning and recovery''systems for the purpose of
reestablishing full operations following infectious disease outbreaks.
(a) For Food Animals--By utilizing and expanding the USDA National
Veterinary Stockpile (antigen bank) as called for in HSPD-9 ``response
planning and recovery''and endorsed by livestock producer groups and
animal health companies.
(b) For Food Crops--By designing a National Plant Disease Recovery
System as called for in HSPD-9 ``response planning and recovery'' and
endorsed by crop producer groups and related stakeholders.
(9) FAD Advance Development and Manufacturing (ADM)--Improve
``response planning and recovery'' \25\ by creating FAD ADM
capabilities for producing vaccines and other countermeasures against
livestock-only and zoonotic FADs similar to ADM capabilities for human
infectious diseases.
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\25\ Homeland Security Presidential Directive/HSPD-9-- Defense of
United States Agriculture and Food; Jan. 30, 2004
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(10) Screening/Inspecting Agriculture and Food Items--Validate
existing screening technology ``mitigation strategies'' and develop
new/improved technologies.
(11) National Livestock Readiness Program (NLRP)--Ensure DHS in
standing up the NLRP to help meet the requirements of the fiscal year
2017 ``Securing Agriculture and Food Act'' (Public Law 114-328) in
support of HSPD-9.
(12) National Biodefense Strategy (NBS)--Confirm that the NBS --
Section 1086, fiscal year 2017 National Defense Authorization Act
(Public Law 114-328) -- includes agriculture (animal health and plant
health) and that bio/agrodefense components are adequate and
implemented effectively.
(13) Biodefense Leadership--Support the Blue Ribbon Study Panel on
Biodefense's proposal to centralize bio/agrodefense leadership.
BIO/AGRODEFENSE BOTTOM LINE
The bottom line today regarding bio/agrodefense is that ``the clock
is ticking'' \26\ as stressed by the WMD Commission back in 2009. Much
must be done to safeguard American agriculture in a globalized world--
the U.S. agriculture and food critical infrastructure is not well
protected from potentially catastrophic biological events.
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\26\ The Clock is Ticking: A Progress Report on America's
Preparedness to Prevent Weapons of Mass Destruction Proliferation and
Terrorism; Commission on the Prevention of Weapons of Mass Destruction
Proliferation and Terrorism, October 21, 2009
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Bioterrorist attacks on America's food crops and/or food animals
could devastate the U.S. economy, and the global economy wouldn't be
far behind. America still feeds the world. Natural disease outbreaks
could lead to similar outcomes.
Food shortages in the U.S. may not occur immediately, or ever,
depending on the effectiveness of the attack or the magnitude of the
outbreak. Nonetheless, there could still be hugely problematic outcomes
for America and the world.
Well-conceived Presidential Directives have not gotten the job
done; neither did the Patriot Act nor the Homeland Security Act that
preceded the directives. Key components of American critical
infrastructure--agriculture and food--are vulnerable to terrorist
attacks with bioweapons and undeliberate infectious disease outbreaks,
and the U.S. is unprepared to confront these threats. \27\
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\27\ Bodin, Madeline; ``U.S. Remains Unprepared for Agricultural
Disease Outbreaks,'' Emergency Management, November 13, 2017
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Congress must act before it's too late.
______
Senator Burr. This hearing is adjourned.
[Whereupon, at 12:10 p.m., the hearing was adjourned.]
[all]