[House Hearing, 114 Congress]
[From the U.S. Government Publishing Office]
STRATEGIC PERSPECTIVES OF THE BIOTERRORISM
THREAT
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON
EMERGENCY PREPAREDNESS,
RESPONSE, AND COMMUNICATIONS
ONE HUNDRED FOURTEENTH CONGRESS
FIRST SESSION
__________
APRIL 22, 2015
__________
Serial No. 114-14
__________
Printed for the use of the Committee on Homeland Security
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Available via the World Wide Web: http://www.gpo.gov/fdsys/
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COMMITTEE ON HOMELAND SECURITY
Michael T. McCaul, Texas, Chairman
Lamar Smith, Texas Bennie G. Thompson, Mississippi
Peter T. King, New York Loretta Sanchez, California
Mike Rogers, Alabama Sheila Jackson Lee, Texas
Candice S. Miller, Michigan, Vice James R. Langevin, Rhode Island
Chair Brian Higgins, New York
Jeff Duncan, South Carolina Cedric L. Richmond, Louisiana
Tom Marino, Pennsylvania William R. Keating, Massachusetts
Patrick Meehan, Pennsylvania Donald M. Payne, Jr., New Jersey
Lou Barletta, Pennsylvania Filemon Vela, Texas
Scott Perry, Pennsylvania Bonnie Watson Coleman, New Jersey
Curt Clawson, Florida Kathleen M. Rice, New York
John Katko, New York Norma J. Torres, California
Will Hurd, Texas
Earl L. ``Buddy'' Carter, Georgia
Mark Walker, North Carolina
Barry Loudermilk, Georgia
Martha McSally, Arizona
John Ratcliffe, Texas
Brendan P. Shields, Staff Director
Joan V. O'Hara, General Counsel
Michael S. Twinchek, Chief Clerk
I. Lanier Avant, Minority Staff Director
------
SUBCOMMITTEE ON EMERGENCY PREPAREDNESS, RESPONSE, AND COMMUNICATIONS
Martha McSally, Arizona, Chairman
Tom Marino, Pennsylvania Donald M. Payne, Jr., New Jersey
Patrick Meehan, Pennsylvania Bonnie Watson Coleman, New Jersey
Mark Walker, North Carolina Kathleen M. Rice, New York
Barry Loudermilk, Georgia Bennie G. Thompson, Mississippi
Michael T. McCaul, Texas (ex (ex officio)
officio)
Kerry A. Kinirons, Subcommittee Staff Director
Deborah Jordan, Subcommittee Clerk
Moira Bergin, Minority Subcommittee Staff Director
C O N T E N T S
----------
Page
Statements
The Honorable Martha McSally, a Representative in Congress From
the State of Arizona, and Chairman, Subcommittee on Emergency
Preparedness, Response, and Communications:
Oral Statement................................................. 1
Prepared Statement............................................. 3
The Honorable Donald M. Payne, Jr., a Representative in Congress
From the State of New Jersey, and Ranking Member, Subcommittee
on Emergency Preparedness, Response, and Communications:
Oral Statement................................................. 4
Prepared Statement............................................. 6
The Honorable Bennie G. Thompson, a Representative in Congress
From the State of Mississippi, and Ranking Member, Committee on
Homeland Security:
Prepared Statement............................................. 6
Witnesses
Hon. Jim Talent, Former Senator From the State of Missouri:
Oral Statement................................................. 8
Prepared Statement............................................. 10
Mr. Charles B. Cairns, M.D., Interim Dean, Health Sciences
Center, University of Arizona College of Medicine:
Oral Statement................................................. 14
Prepared Statement............................................. 15
Ms. Marisa Raphael, Deputy Commissioner, Office of Emergency
Planning and Response, New York City Department of Health and
Mental Hygiene:
Oral Statement................................................. 21
Prepared Statement............................................. 23
STRATEGIC PERSPECTIVES OF THE BIOTERRORISM THREAT
----------
Wednesday, April 22, 2015
U.S. House of Representatives,
Subcommittee on Emergency Preparedness, Response,
and Communications,
Committee on Homeland Security,
Washington, DC.
The subcommittee met, pursuant to call, at 10:07 a.m., in
Room 311, Cannon House Office Building, Hon. Martha McSally
[Chairman of the subcommittee] presiding.
Present: Representatives McSally, Walker, Payne, and Rice.
Ms. McSally. The Subcommittee on Emergency Preparedness,
Response, and Communication will come to order.
The subcommittee is meeting today to receive testimony
regarding the bioterrorism threat.
Before I recognize myself for an opening statement, I want
to acknowledge a special guest of the subcommittee today. I am
pleased to have my goddaughter, Clare, joining us. She is
shadowing me all day today to see what it is like to be serving
in the House of Representatives.
I now recognize myself for an opening statement.
This morning, the Subcommittee on Emergency Preparedness,
Response, and Communications will continue its examination of
preparedness for the CBRN attacks to the homeland, with a focus
on the threat of bioterrorism. It is what I hope will be the
first conversation of many that this subcommittee will hold on
biodefense. I intend for us to really dig into all aspects of
biopreparedness, both for terrorism and pandemics or other
emerging infectious diseases.
We received a Classified briefing last week on the threat
of biological and chemical terrorism. How we prevent and
prepare for WMD terrorism is a key area of oversight for the
full Committee on Homeland Security, as it is for this
subcommittee. Our Nation's capacity to mitigate the impacts of
all types of biological events is a top National security
priority.
Though many of us are new to this subcommittee or to
Congress, we are not new to the issue of biodefense. I have
personal interest in this area. I have a biology degree from
the Air Force Academy, by the way, but I deployed six times,
though, to combat zones during my military service, four of
those deployments after 9/11. I was deployed to Saudi Arabia in
the Middle East during the anthrax scare of 2001. I can tell
you, in the military, we even were not prepared to deal with
this threat at that time.
On subsequent deployments, I personally received a number
of vaccines, to include the anthrax vaccine, smallpox, and we
were on continuous antibiotics on my last deployment to
Afghanistan. So, as we were responding militarily, we were
poking and prodding all of our troops, making sure, you know,
that we were ready to go for any of the common threats we
thought were out there.
But that makes me wonder, just like when we talked about
the chemical terrorism threat, obviously we can't have that be
going on for everybody at home, so what do we need to do, you
know, to protect the homeland and our society? So that is why
it is imperative that we have a system in place and we exercise
it, to detect and communicate and respond to this threat, to
include the distribution of medical countermeasures.
We understand an attack using biological agents or weapons
is a low-probability but high-consequence event. A bio-attack
could cause illness or death in hundreds of thousands of
people, overwhelm our public health capabilities, and have an
economic impact of over $1 trillion per incident. Furthermore,
we know there would be a myriad of significant societal and
political consequences.
We also understand, thanks to experts such as those that
are appearing today before us, that bioterrorist attacks are an
urgent and a continuing threat. The Director of National
Intelligence testified in February that weapons of mass
destruction continue to be a major threat to security of the
United States. He noted that biological and chemical materials
and technologies, as well as personnel with expertise to use
and design them, move easily in the economy. The DNI also
stated that infectious disease continues to threaten our
security, that a more crowded and interconnected world is
increasing the opportunities for human and animal diseases to
emerge and spread globally.
The hearing this subcommittee held last month highlighted
challenges related to mass-casualty management as it pertains
to a chemical event. Bio would be equally as challenging, with
the added problem of illness taking days or weeks to present
symptoms sometimes.
Because of the legitimate and important life sciences
reasons to do research with biological agents, we may not
always be able to stop our enemies from developing a biological
weapon. Therefore, we must have a robust preparedness and
response infrastructure in place. The ability of our health
system to respond is of critical importance.
There has been a lot of solid work in assessing
biopreparedness over the years, and I am very grateful to
Senator Talent, co-chair of the WMD Commission, for being here
to share this history and discuss why we seem to be almost
stuck in place and time, unable to take steps toward change and
enhancing our resiliency in this area.
In preparing for today's hearing, I reviewed this history,
and I am honestly surprised and actually shocked that some of
the recommendations made 6 or 8 years ago have not been
implemented and that, even after the Ebola response, if we can
call it that, we cannot seem to identify the Federal official,
the one Federal official, who has the responsibility and the
authority to coordinate the dozen or so senior officials whose
responsibility it is for biological preparedness and defense.
It is just baffling to me.
Beyond today's hearing, we will look at disease
surveillance, detection, diagnosis, and reporting; we will
receive a report from the formidable Blue Ribbon Study Panel on
Biodefense, which plans to issue recommendations for changes to
U.S. law and policy later on this year; and we will dive deeper
into roles and responsibilities in the biodefense space.
But today is all about the threat. Last year, General
Clapper stated that the intelligence community assessed that
Syria's biological warfare program, ``might have advanced
beyond the research and development stage and might be capable
of limited agent production''.
In addition to the concern of the Syrian regime using
biological weapons, we must also be concerned about ISIS and
its affiliates getting ahold of them. As I have stated before,
ISIS is better-resourced, more brutal, and more organized than
any terrorist organization to date. We know they have an
interest in using chemical and biological weapons. In fact, a
laptop reportedly retrieved from an ISIS hideout in Syria last
year contained plans for weaponizing bubonic plague and a
document discussing the advantages of using biological weapons.
We have a very distinguished panel of witnesses here today
to discuss this threat. I am hoping to hear from each of you. I
want to know what keeps you up at night. How can we best
position the Federal Government to respond to the threat of a
biological attack?
[The statement of Chairman McSally follows:]
Statement of Chairman Martha McSally
April 22, 2015
This morning, the Subcommittee on Emergency Preparedness, Response,
and Communications will continue its examination of preparedness for
CBRN attacks to the homeland, with a focus on the threat of
bioterrorism. It is what I hope will be the first conversation of many
that this subcommittee will hold on biodefense. I intend for us to
really dig into all aspects of bio preparedness, both for terrorism and
pandemics or other emerging infectious diseases. We received a
Classified briefing last week on the threat of biological and chemical
terrorism. How we prevent and prepare for WMD terrorism is a key area
of oversight for the full Committee on Homeland Security as it is for
this subcommittee. Our Nation's capacity to mitigate the impacts of all
types of biological events is a top National security priority.
Though many of us are new to this subcommittee or to Congress, we
are not new to the issue of biodefense. I have a personal interest in
this area and a background in biology. I deployed six times to combat
zones during my military service, with four of those deployments
occurring after September 11. I was deployed in the Middle East during
the Anthrax scare in 2001, and I can tell you that even we in the
military weren't prepared for that. On subsequent deployments, I
received a number of vaccines to counter biological agents and on my
last deployment to Afghanistan they had us taking antibiotics every day
to counter the potential for biological attacks on troops.
Obviously, we can't have everyone in America taking similar
precautions every day. That is why it is imperative to have a system in
place and exercised to detect, communicate, and respond to these
threats, including the distribution of medical countermeasures. We
understand that an attack using biological agents or weapons is a low-
probability, high-consequence event. A bio attack could cause illness
or death in hundreds of thousands of people, overwhelm our public
health capabilities, and have an economic impact of over one trillion
dollars per incident. Furthermore, we know there would be myriad
significant societal and political consequences. We also understand,
thanks to experts such as and including those before us today, that
bioterrorist attacks are an urgent and continuing threat.
The Director of National Intelligence testified in February that
weapons of mass destruction continue to be a major threat to the
security of the United States. He noted that biological and chemical
materials and technologies, as well as personnel with the expertise to
use and design them, move easily in the economy. The DNI also stated
that infectious disease continues to threaten our security and that a
more crowded and interconnected world is increasing the opportunities
for human and animal diseases to emerge and spread globally.
The hearing this subcommittee held last month highlighted
challenges related to mass casualty management as it pertains to a
major chemical event. Bio would be equally as challenging, with the
added problem of illness that takes days or weeks to present symptoms.
Because of the legitimate and important life-sciences reasons to do
research with biological agents, we may not always be able to stop our
enemies from developing a biological weapon. Therefore, we must have a
robust preparedness and response infrastructure in place. The ability
of our health system to respond is of critical importance.
There has been a lot of solid work in assessing bio preparedness
over the years and I'm very grateful to Senator Talent, co-chair of the
WMD commission, for being here to share this history and discuss why we
seem to be almost stuck in place--unable to take steps toward change
and enhanced resiliency in this area.
In preparing for today's hearing, I've reviewed this history and I
am honestly surprised that some of the recommendations made 6 and 8
years ago have not been implemented, and that even after the Ebola
response we cannot seem to identify the Federal official who has the
responsibility and authority to coordinate the dozen or so senior
officials with responsibility for biological preparedness and defense.
It's just baffling.
Beyond today's hearing, we'll look at disease surveillance,
detection, diagnosis, and reporting. We'll receive a report from the
formidable Blue Ribbon Study Panel on Biodefense, which plans to issue
recommendations for changes to U.S. law and policy later this year. And
we will dive deeper into roles and responsibilities in the biodefense
space.
But today is all about the threat. Last year, General Clapper
stated that the intelligence community assessed that Syria's biological
warfare program ``might have advanced beyond the research and
development stage and might be capable of limited agent production.''
In addition to the concern of the Syrian regime using biological
weapons, we must also be concerned about ISIS getting ahold of them.
As I have stated before, ISIS is better resourced, more brutal, and
more organized than any terrorist group to date. We know that they have
an interest in using chemical and biological weapons. In fact, a laptop
reportedly retrieved from an ISIS hideout in Syria last year contained
plans for weaponizing bubonic plague and a document discussing the
advantages of using biological weapons.
We have a very distinguished panel of witnesses here today. I am
hoping to hear from each of you: What keeps you up at night? How can we
best position the Federal Government to respond to the threat of a
biological attack?
Ms. McSally. Before I get to the panel, the Chairman now
recognizes the gentleman from New Jersey, Mr. Payne, for an
opening statement.
Mr. Payne. Good morning.
I want to thank Chairman McSally for continuing this
subcommittee's work on ensuring that we understand and are
prepared to respond to the threats posed by bioterrorism.
Just over a year ago, this subcommittee examined the
history of bioterrorism threats, how bio-threats are evolving,
and whether the Federal Government is doing what it needs to to
prevent and effectively respond to acts of bioterrorism. The
message from the hearing was clear: When it comes to
biodefense, there is a leadership vacuum.
Ten months after the hearing, that leadership vacuum became
publicly apparent as the Federal Government struggled to
effectively coordinate its response to the U.S. Ebola case.
Despite billions of dollars of investment in developing
capabilities to prevent and respond to bioterror events, the
lack of comprehensive Federal strategy effectively coordinated
by someone at the highest level of Government undermines every
dollar we spend.
That is why, last Congress, I supported the WMD Prevention
and Preparedness Act, which was introduced by my colleague from
New Jersey, Congressman Bill Pascrell, and the former Chairman
of Homeland Security, the Honorable Peter King. That
legislation would have implemented recommendations that were
made in 2008, WMD Commission Report, and, importantly,
reestablished the position of Special Assistant to the
President on Biodefense. Although the bill did not move in this
committee last Congress, I am hopeful that it will be
reintroduced and that the lessons learned from the Ebola crisis
last fall will incentivize this committee and Congress to act
on it.
As I have observed throughout my tenure in Congress, the
attention of this body and its Federal partners ebbs and flows
from crisis to crisis. I hope that we address the
biopreparedness gaps we have observed last year before we
become complacent and the next crisis shocks us back into
action.
Along those lines, I am interested to hear Senator Talent's
views on the threats posed by bioterrorism and the potential of
lone-wolf actors and how we should prioritize our efforts with
respect to addressing bio-threats.
Despite some challenges at the Federal level, I am
encouraged to hear about efforts local public health
departments are undertaking to ensure that they will be able to
protect the public should a bio-event occur.
Additionally, I would like to commend Deputy Commissioner
Raphael on New York City's successful response to the Ebola
case last fall. I am interested in understanding how the city
became prepared to respond so effectively and whether
information shared by the Federal Government was consistent,
coordinated, and useful.
Before an Ebola case was diagnosed in the United States,
New York City was working to improve its bio-response
capabilities by testing its plans to rapidly deploy
countermeasures following an anthrax attack in its largest no-
notice emergency response exercise to date. I am interested in
learning about how lessons learned from previous exercises
informed the plans tested last summer, what New York City
learned from the August exercise, and whether the lessons
learned are being shared with neighboring jurisdictions.
Finally, I would note that our counterparts on the
Appropriations Committee are in the process of drafting the
fiscal year 2016 funding bill as we speak. I would be remiss if
I did not take the opportunity to highlight the important role
grant programs like the Urban Areas Security Initiative, also
known as UASI, have played in developing local capabilities to
prepare to respond to bio-threats. I urge our colleagues to
provide robust funding for UASI and to consider restoring
funding for reduced or expired grant programs that bolster
medical response capabilities, such as the Metropolitan Medical
Response System.
I would like to thank the witnesses for being here today,
and I look forward to your testimony.
With that, Madam Chairman, I yield back.
[The statement of Ranking Member Payne follows:]
Statement of Ranking Member Donald M. Payne, Jr.
April 22, 2015
I want to thank Chairman McSally for continuing the subcommittee's
work on ensuring that we understand--and are prepared to respond to--
the threats posed by bioterrorism. Just over a year ago, this
subcommittee examined the history of bioterrorism threats, how bio-
threats are evolving, and whether the Federal Government is doing what
it needs to do to prevent and effectively respond to acts of
bioterrorism.
The message from that hearing was clear: When it comes to
biodefense, there is a leadership vacuum. Ten months after the hearing,
that leadership vacuum became publicly apparent as the Federal
Government struggled to effectively coordinate its response to the U.S.
Ebola cases.
Despite billions of dollars of investment in developing
capabilities to prevent and respond to a bioterror event, the lack of a
comprehensive Federal strategy effectively coordinated by someone at
the highest level of Government undermines every dollar we spend.
That is why last Congress, I supported the WMD Prevention and
Preparedness Act, which was introduced by my New Jersey Colleague,
Congressman Bill Pascrell, and former Chairman Peter King. That
legislation would have implemented the recommendations made in the 2008
WMD Commission Report and, importantly, re-established the position of
Special Assistant to the President on Biodefense. Although the bill did
not move in this committee last Congress, I am hopeful that it will be
reintroduced, and that the lessons learned from the Ebola crisis last
fall will incentivize this committee and Congress to act on it.
As I have observed throughout my tenure in Congress, the attention
of this body and its Federal partners ebbs and flows from crisis to
crisis, and I hope that we address the bio-preparedness gaps we
observed last year before we become complacent and the next crisis
shocks us back into action.
Along those lines, I am interested to hear Senator Talent's views
on the threats posed by bioterrorism, the potential of lone-wolf
actors, and how we should prioritize our efforts with respect to
addressing bio-threats. Despite some challenges at the Federal level, I
am encouraged to hear about efforts local public health departments are
undertaking to ensure that they will be able to protect the public
should a bio-event occur.
Initially, I would like to commend Deputy Commissioner Raphael on
New York City's successful response to the Ebola case last fall, and I
will be interested in understanding how the city became prepared to
respond so effectively and whether information shared by the Federal
Government was consistent, coordinated, and useful.
Before an Ebola case was diagnosed in the United States, New York
City was working to improve is bio-response capabilities by testing its
plans to rapidly deploy countermeasures following an anthrax attack in
its largest, no-notice emergency response exercise to date. I am
interested in learning about how lessons learned from previous
exercises informed the plans tested last summer, what New York City
learned from the August exercise, and whether the lessons learned are
being shared with neighboring jurisdictions.
Finally, I would note that our counterparts on the Appropriations
Committee are in the process of drafting the fiscal year 2016 funding
bills as we speak. I would be remiss if I did not take this opportunity
to highlight the important role grant programs like the Urban Area
Security Initiative have played in developing local capabilities to
prepare for and respond to bio-threats.
I urge our colleagues to provide robust funding for UASI and to
consider restoring funding for reduced or expired grant programs that
bolstered medical response capabilities, such as the Metropolitan
Medical Response system.
Ms. McSally. Great. Thank you.
Other Members of the subcommittee are reminded that opening
statements may be submitted for the record.
[The statement of Ranking Member Thompson follows:]
Statement of Ranking Member Bennie G. Thompson
April 22, 2015
Last month, this subcommittee examined efforts to bolster the
ability of Federal, State, and local governments to respond to chemical
terrorism. I am pleased that the subcommittee is now taking the
opportunity to assess bio-terrorism threats and our ability to prevent
and respond to such attacks.
One of the key recommendations that the 9/11 Commission made to
Congress was to address the grave threat posed by the proliferation of
weapons of mass destruction. Accordingly, when I was Chairman of this
committee, we authorized the Commission for the Prevention of Weapons
of Mass Destruction Proliferation and Terrorism, or the WMD Commission,
on which Senator Talent--who is here with us today--served as vice
chair.
In 2008, the WMD Commission issued a report making a series of
recommendations to address WMD threats, particularly bioterrorism.
Unfortunately, the Federal Government has been slow to respond.
In 2010, a WMD Commission progress report gave the U.S. Government
an ``F'' for failing to do enough to prevent a biological attack on the
United States or to be able to respond effectively in the event of a
biological attack.
In 2011, the WMD Center found that the United States was still
unprepared to detect and respond to a large-scale biological attack,
despite upwards of $60 billion invested in developing those
capabilities. The Federal Government's failure to implement appropriate
policies and build the robust governance infrastructure necessary to
tackle biological threats came to a head last fall when an Ebola victim
sought treatment in a Texas hospital.
In addition to public concern, evolving guidance regarding
appropriate PPE for hospital staff, and inconsistent quarantine polices
at the State and local level, it was unclear who in the Federal
Government was in charge of developing, and coordinating the
implementation of, policies to contain the virus and ensure that the
sick could be treated safely.
The response structure was seemingly lacking. Nevertheless,
although the Federal response to a low number of Ebola cases in the
United States was somewhat stilted, it was successful. I worry,
however, that we would not be so lucky in the event of a biological
attack. It has been nearly 7 years since the WMD Commission released
its report and recommendations, and 3 years since the WMD Center
released its damning report card of our National Bio-Response
Capabilities.
During that time, Congressman Pascrell and former Chairman King
have introduced the WMD Prevention and Preparedness Act, which would
implement many of the WMD Commission's recommendations, three times.
Unfortunately, the bill has never been enacted. In the absence of a
comprehensive legislative remedy to our bioterrorism capability gaps, I
will be interested in learning whether our witnesses believe we have
made any progress in improving our response to bio-threats over the
past several years. I am also interested to know how State and local
governments address bioterrorism threats.
Ms. McSally. We are pleased to have a very distinguished
panel before us today on this important topic.
Senator Jim Talent has been active in public policy for the
past 30 years, including representing Missouri in both the U.S.
Senate and the U.S. House of Representatives.
Following his service in the Senate, Senator Talent served
as the co-chair of the Commission on the Prevention of Weapons
of Mass Destruction Proliferation and Terrorism. Following the
expiration of the WMD Commission's authorization in 2009,
Senator Talent joined Senator Graham, the chairman of the WMD
Commission, in establishing the Bipartisan WMD Terrorism
Research Center.
Senator Talent is also a senior fellow and director of the
National Security 2020 Project at the American Enterprise
Institute. Senator Talent has a B.A. from Washington University
in St. Louis and a J.D. from the University Chicago Law School.
Dr. Charles, or ``Chuck,'' Cairns is an interim dean at the
University of Arizona College of Medicine in my district and
the assistant vice president of the Arizona Health Sciences
Center. He previously served as a chair of the Department of
Emergency Medicine at the University of North Carolina and as
director of emergency research at the Duke Clinical Research
Institute.
Dr. Cairns has been a clinician, educator, investigator,
and leader in emergency care, focused upon the host responses
of individual patients and populations to acute medical
conditions. Dr. Cairns was principal investigator of the
National Collaborative for Bio-Preparedness and the director of
the U.S. Critical Illness and Injury Trials Group. He has
published over 150 scientific articles and reviews and has
received numerous awards and honors.
Dr. Cairns is an honors graduate of Dartmouth College and
the University of North Carolina. He completed an emergency
medicine residency and EMF research fellowship at the Harbor-
UCLA Medical Center. Dr. Cairns is board-certified in emergency
medicine and a fellow of the American College of Emergency
Physicians, the American Academy of Emergency Medicine, and the
American Heart Association.
I now yield to the Ranking Member to introduce our third
witness.
Mr. Payne. Thank you, Madam Chairman.
It is my distinct honor to introduce Marisa Raphael, who is
the deputy commissioner of the Office of Emergency Preparedness
and Response at the New York City Department of Health and
Mental Hygiene.
Ms. Raphael's responsibilities include directing and
coordinating all operational, all administrative aspects of the
department's emergency preparedness and response activities,
including overseeing the coordination of public health
emergency preparedness planning for New York City's health care
system. In other capacities at the Office of Emergency
Preparedness and Response, Ms. Raphael has overseen emergency
planning exercises and training and countermeasures planning.
Ms. Raphael received her master's of public health from the
University of Michigan. She also attended the Harvard Kennedy
School of Government Senior Executives in State and Local
Government Program and Harvard's National Preparedness
Leadership Initiative.
Welcome.
Ms. McSally. Thank you.
Welcome to all the witness.
The witnesses' full written statements will appear in the
record.
The Chairman now recognizes Senator Talent for 5 minutes.
STATEMENT OF HON. JIM TALENT, FORMER SENATOR FROM THE STATE OF
MISSOURI
Mr. Talent. Thank you, Madam Chairman.
I want to thank you and the Ranking Member and all the
Members of the subcommittee for your interest in this subject.
It is personally quite encouraging to me because I do have a
history with it, and you are right in believing that it does
present a very grave threat and that we are not responding as
well as we could.
I am going to summarize very briefly. I know you probably
have a lot of questions and it will help you more to ask
questions than for us just to talk.
A little bit on the history, and I know the subcommittee is
aware of it, so I will be brief. Senator Graham and I were
asked in 2007 to co-chair the Task Force on WMD Proliferation
and Terrorism. We met with Senator Reid, the Majority leader in
the Senate at the time, and he urged us to consider the mandate
to be a broad one, to identify the areas where we felt Congress
needed to know something that had not been highlighted enough,
and to tell it to the Congress, you know, without any varnish
on it, just to say it as it was. So we did that.
As we began our work, we decided to focus on the nuclear
and the bio-threat. As we continued through our initial
deliberations, the bio-threat kept emerging in the minds of
everybody on the Commission, most of whom were nuclear experts,
by the way, as actually the graver threat of the two--which, of
course, is not to downgrade the danger of the use of a nuclear
device against us--for several reasons.
One, the bio-threat is potentially as destructive as the
use of a nuclear device. You have had the briefing; you know
that. Second, we had direct intelligence that al-Qaeda was
aware of the potential of a bio-threat. They had a lab in
Afghanistan. They were trying to develop it. Third, we thought
that acquiring and deploying a bioweapon was actually more
within their capabilities than acquiring and deploying a
nuclear device because advances in life science, which have
done so much to, you know, improve the quality of human life,
also have lowered the bar for the production and deployment of
the bioweapon.
Now, it used to be that was only within the ability of a
nation-state to do this. It was developed originally and then
discarded as a battlefield weapon. But, now, if you can recruit
a competent life scientist and get a lab at a cost of several
hundred thousand dollars, it is entirely plausible that that
life scientist can isolate and weaponize a deadly bio-agent. We
said in the report, I think, that we were less concerned about
the terrorists becoming biologists than we were concerned about
biologists becoming terrorists.
So we said that in the report. We made a number of
recommendations. Congress then asked us to come back and do
another report on the status of our recommendations. This was
the first one. We did the second one. In the course of doing
that one, we focused on the issue of preparedness for a bio-
attack, and, again, for a couple reasons, one of which is,
obviously, if there is an attack, we want to limit the loss of
life as much as possible. The second was our feeling that, to
the extent that we can really prepare and harden the target, if
you will, we could actually deter such an attack. We can make
bioweapons no longer weapons of mass destruction.
So we issued the second report. Then, at the urging of the
other commissioners, Senator Graham and I formed a nonprofit,
which did the first ever--and, I think, the only one, to this
date--end-to-end strategic study of all the links in what we
call the chain of resilience. We recruited the best experts to
formulate the right questions so that we knew what metrics we
could use in judging the resiliency of the system, and we
recruited another set of experts to answer those questions.
Then we issued this report, the ``Bio-Response Report
Card.'' We tried to be fairly nuanced, to issue grades across a
spectrum of different kinds of potential attacks. We did that
in 2011.
My time is running out. I will just say, you have focused,
I think, your subcommittee on the areas that concerned us the
most.
We are not stockpiling as well as we should. We have made
some progress since then. But, to the extent that we can
stockpile against the most likely agents, then we force anybody
who is actually planning this to try and come up with agents
that are harder for them to come up with, so we raise the bar.
FDA has made some progress in trying to develop the technology
to be able to go from bug to drug quickly, but they need to
work harder on that.
I was also--two more things, very briefly. I may run just a
little bit over. But one of them--I was personally concerned
with our distribution system very much. I am going to be very
eager to hear what the deputy commissioner has to say because,
to me, as a representative and a public official, the idea of
these drugs being available and us not having an adequate
system for dispensing them to people, think of the panic, think
of what would happen to the social fabric if people knew they
needed these countermeasures for their families and they
couldn't get them. I mean, I don't want to think what would
happen under those circumstances.
Finally, Senator Graham and I felt free, having served in
this body, to be very clear and direct about recommendations
regarding changing the way the Government approaches this in
both the Executive and the Legislative branch. Leadership is
too fragmented, and, if anything, Madam Chairman, to be fair to
the Executive branch, it is worse here than it is over there.
We all know the problem. We know it is difficult to solve.
I was a Chairman myself. I am not underestimating that. But we
need to make an effort. If I had the Speaker and the Leader
here and the Majority and Democratic leaders of the Senate
here, I would tell them exactly the same thing.
So I hope that a movement towards that comes out of this.
Bob and I understand that Congress is not an obstacle in this
kind of thing; Congress can be a tremendous influencer for good
in the workings of the Executive branch. But Congress has to be
able to operate, and it can't with this jurisdictional setup.
I ran a little bit over, but not bad for a former Senator,
though. I mean----
Ms. McSally. Very impressive, actually.
Mr. Talent. Thank you so much.
[The prepared statement of Hon. Talent follows:]
Prepared Statement of Hon. Jim Talent
April 22, 2015
Madame Chairman, Ranking Member Payne, and Members of the
subcommittee, it's a pleasure for me to appear before you today, and
quite encouraging to me personally that you are holding a hearing on
this subject. Congress cannot pay too much attention to the fact that
we live in an era of information technology which has, unfortunately,
greatly increased the danger to the United States and the world of
asymmetric weapons: Weapons which have a destructive potential that is
highly disproportionate to the power and resources it requires to
develop and deploy them. Of the asymmetric dangers we face, the threat
of a bio-attack is, in my judgment, one of the greatest and gravest.
I will address that subject later in my testimony. First I want to
describe how I came to be familiar with this issue.
One of the recommendations of the 9/11 Commission was that Congress
focus on the danger of weapons of mass destruction proliferating to
terrorist groups. So in 2007 Congress created a Commission to study the
danger and report on measures that could be taken to minimize it. I was
asked to co-chair the Commission with Senator Bob Graham of Florida.
There were a total of 9 members on our bi-partisan Commission.
Shortly after our Commission was formed, we met with Senator Harry
Reid at his request. Senator Reid explained his interest in the subject
of our work, and encouraged us to highlight clearly those aspects of
the WMD terrorism threat which we believed were the most significant;
he urged us in the strongest terms to tell us what we thought Congress
most needed to know about the danger. We did so in a Report released at
the end of 2008 called ``World at Risk.''
Early in our deliberations, Senator Graham and I decided to focus
on the threat posed by nuclear and biological weapons, and if anything
to give the bio-threat greater emphasis. There were two primary reasons
for that:
First, we knew that the terrorists had pursued bio-weapons in the
past. Former CIA director George Tenet noted in his memoir that in
connection with their planning of the 9/11 attacks, al-Qaeda launched a
concerted effort to obtain and weaponize anthrax to use in a mass
attack. They set up a biological laboratory for that purpose in
Afghanistan and hired Yazid Sufaat, a former Malaysian Army officer who
had been trained in microbiology at California State University,
Sacramento. Fortunately, their efforts were derailed by the American
invasion of Afghanistan, but the record showed that they were aware of
the potential of bio-weapons for their purposes. Others such as al-
Qaeda of the Arabian Peninsula (AQAP) have expressed similar intent.
Second, we judged that it was probably easier for them to secure a
bio-weapon than a nuclear weapon. Before the information revolution, it
required the resources of a nation-state to develop and deliver a bio-
weapon. But the tremendous advances in life science over the last few
decades, which have done so much to advance the quality of human life,
have had the ironic side effect of reducing the barriers to developing
a bio-weapon. Disease-causing microbes--anthrax is an example--are
readily available in nature, or they can be acquired from a sick
person. A skilled biologist, with a laboratory costing no more than
several hundred thousand dollars, is capable of isolating and
weaponizing a particularly deadly form of such a microbe. As we said in
our Report,
``We accept the validity of current intelligence estimates about the
current rudimentary nature of terrorist capabilities in the area of
biological weapons but caution that the terrorists are trying to
upgrade their capabilities and could do so by recruiting skilled
scientists. In this regard, the biological threat is greater than the
nuclear; the acquisition of deadly pathogens, and their weaponization
and dissemination in aerosol form, would entail fewer technical hurdles
than the theft of production of weapons-grade uranium or plutonium and
its assembly into an improvised nuclear device.''
There are other secondary but nevertheless significant reasons why
bio-weapons might be even more attractive than nuclear weapons to
terrorist groups. Such weapons are relatively easy to transport without
detection; they can cause as many or more deaths than a tactical
nuclear weapon; they can be more easily stockpiled, making it possible
to hit several targets in succession; and--depending on the biological
agent used--it is entirely possible that terrorists could launch such
an attack and escape the area before the authorities even knew that an
attack had occurred. The symptoms of anthrax (and many other diseases
capable of being used as bio-weapons), do not manifest for several days
after exposure and can easily, in the early stages, be mistaken for
influenza and other naturally-occurring diseases.
The aim of the terrorists is not just to kill, but to create as
much fear as possible. As we saw last year during the Ebola outbreak,
societies are susceptible to panic over even natural epidemics. The
subcommittee can well imagine the effect in a large city if large
numbers of people became ill or died because terrorists had weaponized
a deadly pathogen and spread it through urban neighborhoods or in the
transportation system. The Department of Homeland Security, Office of
Science & Technology has modeled the effects of a potential anthrax
attack on a city like New York; I invite the subcommittee's attention
to their conclusions.
So we knew the terrorists had the motivation to get biological
weapons, and we were quite concerned that advances in life sciences
would bring development of such weapons increasingly within their
capabilities. I was particularly influenced by Senator Graham's opinion
in this regard; as a former Intelligence Committee Chairman, he had and
has extensive experience with how the terrorists think and plan. Even
though most of the Commission members were experts primarily in nuclear
proliferation, they fully agreed to highlight the bio-threat and put
our recommendations in that regard first in the Report.
Of course we did not devalue the danger of nuclear proliferation to
terrorists; it is a real threat, and our Report made a number of
recommendations for minimizing it.
After we released ``World at Risk'', the bipartisan Congressional
leadership extended the life of our Commission and asked us
specifically to report on the status of our recommendations and, more
generally, the extent and effectiveness of our Government's efforts to
prevent and/or prepare a WMD terrorist attack. We issued a second
Report in January 2010 in the form of a report card. We gave a range of
grades, some of them quite high; but in the crucial area of
preparedness to respond to a bio-attack, we gave the Government an
``F''.
Preparedness for a biological attack, or for that matter a
naturally-occurring epidemic, means having a well-developed
infrastructure which can:
detect and diagnose a biological event,
communicate effectively and in real time the nature and
spread of disease,
stockpile and distribute medical countermeasures,
treat large numbers of afflicted people, and
(where necessary) remediate the environment in areas that
have been exposed.
During our final meeting, the commissioners encouraged Senator
Graham and me to continue our work as a not-for-profit organization.
Along with our executive director at the WMD Commission, Randy Larsen,
we created the Bipartisan WMD Terrorism Research Center (WMD Center).
We also brought in Lynne Kidder, who was (and still is) a co-chair of
the Institute of Medicine's Forum on Medical and Public Health
Preparedness for Catastrophic Events.
Senator Graham and I decided that the most helpful project for the
WMD Center would be a thorough, end-to-end assessment of the country's
state of preparedness for a major biological event, either natural or
because of an attack. No government or private organization had ever
accomplished such an assessment.
We recruited a distinguished group of 11 senior advisors including:
The former deputy commissioner of FDA, the director of the American
Medical Association's Center for Disaster Medicine and Emergency
Response, a former special assistant to the President for biodefense in
both the Clinton and Bush (43) administrations, a retired major general
who had led medical countermeasure development for DoD, the vice
president and director of RAND Health, and the former chief legal
advisor to the Centers for Disease Control and Prevention.
These senior advisors wrote the questions that needed to be
answered to determine America's preparedness for bio-response. A
separate consulting team of subject-matter experts then did extensive
research to answer these questions.
Senator Graham and I and our staff at the WMD Center used this
information to assign the grades.
A copy of the Report Card has been distributed to the subcommittee
and staff. I invite your attention to our findings. Though I will not
attempt to detail all of them here, I want to make a general
observation and then comment on several of the findings which in my
view are the most important.
While every effort should be made to prevent a bio-attack, we
cannot plan on the assumption that those efforts will be successful
forever. The struggle against terrorism is long-term, and as long as it
lasts, there is a good chance, for the reasons I've noted, that at
least some of the terrorist groups will continue to try to acquire and
deploy a bioweapon. Our first Report noted that they may well be
successful. The efforts we make now to prepare will be crucial to
limiting the impact of such an attack; with a swift and effective
response, the loss of life and collateral effects can be drastically
reduced.
Of course any loss of life because of a bio-attack would be tragic.
But the better hardened we are, the more likely it is that a bio-attack
will not be a weapon of mass destruction, and the less likely it is
that the terrorists will choose to use it. In other words, preparedness
can be a form of prevention. This is a point Senator Graham has often
made, and rightly so. We may actually be able to deter such an attack
if it is clear that we are as prepared as possible to respond to it.
I want to note several specific aspects of the WMD Commission
Report Card (January, 2010) and the WMD Center Report Card (October,
2011).
First and foremost, the lack of sufficient medical countermeasures
(MCMs) in our Strategic Nation Stockpile (SNS), and the lack of a
system to quickly develop and produce MCMs during a crisis was our No.
1 concern in 2011 and remains so today. This is a complex problem with
many key elements: Basic science (NIH), advanced development (BARDA),
and regulatory science (FDA). As we said in the WMD Center Report Card,
``A bio-response enterprise without adequate medical countermeasure is
like an Army without bullets--it may look good on a parade ground, but
has minimal value for National security.''
The recent Ebola virus outbreak highlighted that unless
countermeasures are immediately available, including diagnostics tests
that can be used by clinicians who are evaluating suspected cases,
therapeutics to treat cases and vaccines to protect health care workers
and others at risk, we are left with fairly primitive means to respond
to and contain such events.
The challenge is not unmanageable. The list of bio-threat agents
for which we should have a diagnostics tests, therapeutics, and
vaccines for is about a dozen. To date, our stockpile contains
countermeasures for only 3 or 4. The entity in the U.S. Government
responsible for developing and producing these countermeasures, the
Biomedical Advanced Research and Development Authority (BARDA) at the
Department of Health and Human Services has been chronically
underfunded. Originally authorized by Congress in 2006 to receive about
a $1 billion annually, it has received one-quarter to half of that
amount. As we witnessed with the Ebola outbreak, it is too late to
develop countermeasures after an outbreak or attack has happened.
There have been some bright spots and progress. Thanks to the
efforts of Dr. Luciana Borio at FDA, we have made significant progress
in regulatory science since 2011, some of which was seen in the Ebola
response last year when new diagnostics were approved by FDA in a
matter of days. We have also seen a shift in strategy regarding MCMs in
a move away from ``one-bug, one-drug'' to a more flexible, rapid
response. However, as we noted in the WMD Commission Report, if we
continue to fund BARDA at a fraction of its actual requirements, we
cannot expect to dig ourselves out of this preparedness hole.
Second, at the time of our WMD Center Report Card, we had no
reliable means to dispense the countermeasures quickly. A number of
cities had experimented with various distribution systems, but the
process was not National and was not moving quickly enough. This is a
shortfall I find particularly worrisome; the prospect of what will
happen if there is an attack, and our people know there are
countermeasures but can't get access to them. This is an essential,
underappreciated and under-valued element of a response. We may be
confronted with a situation where we have countermeasures but can't get
them to the people who need them, when they need them.
Third, our Report Card noted that there had been some significant
progress in improving the public health infrastructure in the various
States, though our overall evaluation was that the medical system was
not capable of managing the surge in demand that would be created by a
major biological event. At the time we issued our Report Card, the
budgetary stresses of the Federal Government were just beginning to
take their toll on the public health system, particularly at the State
and local level. I fear that funding reductions since then have
undermined such progress as had been made at the time we were writing.
Finally, there are significant shortfalls in how both the Executive
and Legislative branches are organized to deal with this issue. Today
there are more than two dozen Presidentially-Appointed, Senate-
Confirmed individuals with some responsibility for bio-defense, but
none of them has bio-defense for a full-time job and no one is in
charge. This virtually guarantees a fragmented response. The
administration appointed a WMD Coordinator, to oversee the general WMD
proliferation issue; that was an improvement. But since the departure
of Elizabeth Sherwood Randall from the NSC to become the deputy
secretary of Energy, that position has remained vacant. Ideally, there
should be a special assistant to the President devoted full-time to the
bio-threat (both man-made and naturally-occurring), as existed during
the both the Clinton and Bush (43) administrations.
The Congressional oversight structure is also far too fragmented.
Again, a number of committees have responsibility for pieces of the
effort. It's difficult even to determine exactly how many committees
and subcommittees are involved. Senator Graham and I are both well
aware of the difficulties inherent in restructuring and unifying
Congressional oversight. But we also know the vital contribution
Congress can make in this area, if it is organized in a way that allows
the full weight of Congressional influence to be brought to bear. It
would be well worth a major effort by the bipartisan leadership, joined
by Chairs and Ranking Members, to unify oversight to just a few
committees with clearly-defined areas of authority.
A more unified chain of command within Congress and the Executive
Branch would allow the development of relationships and expertise over
time, and a more strategic approach by the top-level political
authorities, that Senator Graham and I believed essential to the
success of this vital effort.
A final word. Our Report Card was issued 3\1/2\ years ago. Some of
our findings may be outdated, though given the problems I have noted
above, I fear that in most areas our preparedness has declined rather
than improved. In any case, the questions we developed, and asked, are
still the right questions for you to ask as you do your vital work in
this area. That was one of our purposes in doing the Report Card: to
give decision makers tools for understanding the global state of our
preparedness to respond to a biological event. I urge the subcommittee
to continue its emphasis on the urgency of this danger, and to use the
questions we asked as a starting point for understand what must be
done.
Ms. McSally. Thanks, Senator Talent.
The Chairman now recognizes Dr. Cairns for 5 minutes.
STATEMENT OF CHARLES B. CAIRNS, M.D., INTERIM DEAN, HEALTH
SCIENCES CENTER, UNIVERSITY OF ARIZONA COLLEGE OF MEDICINE
Dr. Cairns. Thank you very much, Chairman McSally and
Ranking Member Payne, for this opportunity to provide
testimony.
The National Collaborative for Bio-Preparedness and the
U.S. Critical Illness and Injury Trials Group, both are
designed to improve the surveillance, the detection, and the
response to and recovery from biological events. The overall
goal of these programs is to intervene early enough during the
bio-event to save lives. There is a National need for timely
intervention in bio-events in order to save lives.
As an emergency physician, I know that timely diagnosis and
clinical intervention save lives. I have been involved in a
State-wide system of heart-attack care that utilizes emergency
medical services, including EMTs and paramedics, to rapidly
diagnose and deliver appropriate treatment. This system has
been replicated across the country and has been proven to save
lives.
Thus, we have shown that we can provide timely, life-saving
interventions for anyone, anywhere, anytime, on a State-wide
basis. We need to extend these systems Nationally and apply
them to biological threats, whether they are due to
bioterrorism or natural disease outbreaks.
So the NCBP system was designed to provide rapid
recognition of clinically significant biological events, with
the mission to provide more effective decision making in health
and emergency responses at the Federal, State, and local level.
Last fall, NCBP released an operational system capable of
real-time analysis of streaming health data. Users can search
by clinical symptoms, syndromes, free text within health
records, and incorporate data on hospital resources, weather,
critical infrastructure, and internet searches. The NCBP
architecture can now support the integration of virtually any
data source for simultaneous analysis and layered geographical
visualization.
Now, while the system was originally developed as a tool to
detect incidents of bioterrorism for use by analysts within the
Department of Homeland Security National Biosurveillance
Integration Center, DHS now appreciates the system offers the
opportunity to collaborate with State and local officials in
sectors such as public health preparedness, health care,
infrastructure protection, and agriculture. This collaboration
provides more sensitive and specific insights than DHS
attempting to monitor the Nation single-handedly.
For example, local jurisdictions have a difficult time
correlating DHS BioWatch environmental measures data to
clinical data. Local officials are challenged to take action in
the event of a biological attack without a keen understanding
of whether people will become ill. The NCBP system is designed
to provide this important perspective and to support the
decisions necessary to deploy public health countermeasures.
I suggest Congress support the efforts of the NBIC program
to provide NCBP information to local officials.
EMS data, emergency medical services data, has turned out
to be most timely and consistent. We have shown that EMS
records can detect flu outbreaks earlier than the standard
hospital- and laboratory-based approaches. Indeed, we have
shown that free text analysis of EMS records can readily
identify patients at risk for emerging infections. If Texas had
been part of the NCBP system, it likely would have rapidly
detected that initial case of Ebola in Dallas last September.
With adequate funding, NCBP will incorporate additional
States, implement additional analytic and visualization tools
and other data types, as well as engage new local, State, and
Federal users.
But there is also a National need for a rapid, effective
clinical response system in bio-events. During public health
emergencies, reliable patient data are needed to identify
groups at high risk for severe illness and death and to assess
the impact of the event on critical health care resources. Yet
experience with influenza and Ebola indicate that real-time
clinical data aggregation, analysis, and reporting remain a
strategic vulnerability.
Many of these logical challenges stem from the distributed,
even silent, approach we have to emergency preparedness, as
delineated by Senator Talent. The good example is, yet again,
our response to Ebola. There was no preparedness on how to
collect data longitudinally as to whether the medical
conditions of the patients presenting were similar, whether
medical countermeasures worked, or if any of those measures had
any toxicity or interacted with other therapies, or even if
they had any effect on long-term outcomes.
The U.S. Critical Illness and Injury Trials Group Program
on Emergency Preparedness, which has been supported by ASPR,
has been partnering with DHS and HHS agencies to begin to
foster collaboration and build new capacities for data
collection and research in order to address key questions of a
successful response and address these challenges to the chain
of resiliency. Failure to aggressively extend, support, and
fund this initiative will amount to yet another potential
failure of imagination for the next outbreak or act of
bioterrorism.
Thank you again for the opportunity to testify today, Madam
Chairman.
[The statement of Dr. Cairns follows:]
Prepared Statement of Charles B. Cairns
April 22, 2015
introduction
Chairman McSally and Ranking Member Payne, my name is Dr. Charles
Cairns and it is an honor to be providing this testimony. I currently
serve as the interim dean of the College of Medicine, professor of
Emergency Medicine, and vice president of clinical research of the
University of Arizona.
Prior to Arizona, I served as the chair of the Department of
Emergency Medicine at the University of North Carolina and as director
of Emergency Research at the Duke Clinical Research Institute of Duke
University.
I have served as the principal investigator of the National
Collaborative for Bio-preparedness and as the director of the United
States Critical Illness and Injury Trials Group.
In both of these programs, the Government has invested in improving
its surveillance and detection capability in support of, and enabling
of more efficient response to and recovery from biological events. The
overall goal is to intervene early enough during a bio-event to save
lives.
national need: timely intervention
As an emergency physician, I know that timely diagnosis and
clinical intervention can save lives--both for individual patients and
across populations and geographies. I have been involved in the
development and implementation of a State-wide system of heart attack
care that has resulted in having a rapidly diagnosis and treatment plan
for every emergency medical services agency in every county of North
Carolina every day. The system integrates the State-wide 9-1-1 system
with pre-hospital technology to diagnose heart attacks with destination
plans to deliver heart attack patients directly to the right health
care resource or hospital (Mears, et al, Curr Opin Crit Care 2009). The
result of this system has been to have a plan to rapidly diagnose every
heart attack in the State and rapidly deliver life-saving care. This
system has been shown to save lives (Glickman, et al, Ann Emerg Med
2012) and has been replicated across the country.
Thus, we have proven that we can effectively develop and implement
systems that can provide timely, life-saving interventions for anyone,
anywhere, anytime (Cairns, et al, Ann Emerg Med 2012) and to extend
these systems to biological threats.
national collaborative for bio-preparedness
The National Collaborative for Bio-Preparedness (NCBP) is a system
designed to provide rapid recognition of clinically significant
biological events, whether they are due to disease outbreaks,
contaminations or poisonings due to either natural causes or terrorism.
(Arasaratnam M, et al. Online J Public Health Inform, 2013). NCBP
utilizes a web-based system (https://ncbp.bioprep.us/) of near real-
time data collection, automated assessment and analysis to detect
relevant disease conditions and symptoms. The system is designed to
meet the bio-surveillance needs of key local and regional stakeholders
while providing awareness and transparency of events to State and
National decision makers. In addition, the NCBP system is providing
information on critical health care infrastructure and relevant
interventional needs and care resources. Thus, rapid recognition of
events can be matched to the necessary resources on a timely and
geographically relevant basis, providing a context of when local or
State resources are insufficient to match the needs of the affected
population.
The NCBP is a project sponsored by the U.S. Department of Homeland
Security (DHS) through a cooperative agreement with the University of
North Carolina at Chapel Hill (UNC). Begun in 2010, the NCBP mission is
to:
``Enable its users to recognize events occurring in the biosphere that
have significance to the health and security of people and
infrastructure in users' jurisdictions, leading to more effective
decision making in health and emergency response at the Federal, State
and Local level.''
On September 15, 2014, NCBP released an operational data
visualization and analytics system capable of real-time analysis of
streaming health data to detect meaningful changes in the data and
visualizing the information in a geographic format. The system also
enables users to search records by clinical symptoms, user-defined
syndromes, and free text within the health records. The system has been
developed using human health data from Emergency Medical Services
(EMS),
9-1-1, Emergency Department (ED) and Poison Control Centers, with
incorporation of State-wide hospital bed and resource availability,
live weather data, critical infrastructure (schools, roads, hospitals,
Federal facilities) and internet search feeds (Google searches). NCBP
architecture can now support the integration of virtually any data
source for simultaneous analysis and layered visualization to provide
greater insight and fidelity for the Nation's preparedness resources
and decision makers.
NCBP is unique in offering near real-time clinical data and custom
analytics that generate signals and communicate them to users as the
analysis occurs, with the goal of providing warnings of significant
anomalies, in time to inform decision makers and support a response.
The system is available to users 24/7/365.
The system was originally developed for analysts within DHS'
National Biosurveillance Integration Center (NBIC), the project's
sponsor, as a tool to detect incidences of bioterrorism. However, DHS
appreciates that the system offers the opportunity to collaborate with
State and local officials in the sectors of public health preparedness,
human health, infrastructure protection, and agriculture. This
collaboration provides more sensitive and specific insights, and thus a
higher level of security for the Nation, than DHS attempting to monitor
the Nation singlehandedly. NCBP is therefore offering the system to
State and local officials and infrastructure owners who can contribute
to the system's development and design.
For example, DHS has operated the Nation's environmental detection
system for bioterror events, known as BioWatch. To date, local BioWatch
jurisdictions have a difficult time correlating these environmental
measurements to clinical data. In other words, local officials are not
in the position to take action with public health countermeasures
needed in the event of biological attack without a keen understanding
of whether people and animals are becoming ill or are likely to become
ill. The NCBP system and the US Critical Illness and Injury Trials
(USCIIT) Group are designed to provide this important perspective and
to support the decisions necessary to deploy public health
countermeasures. Local jurisdictions have long recognized this need for
clinical context to the BioWatch signals and I suggest Congress support
the efforts of the DHS NBIC program to provide NCBP information to
them. Local officials are the ones making the decision to deploy public
health countermeasures and thus, Federal agencies should be providing
local officials the information needed for effective decision support.
Among various sources of human health data, data from Emergency
Medical Services (EMS) has turned out to be the most timely and
consistent. These near real-time data are entered by trained providers
utilizing standardized forms and our group has pioneered the
development of these systems, especially for EMS (Mears, et al, Prehosp
Emerg Care 2010). EMS data is population-based and is gathered by local
EMS professionals who record emergency health data in free text, and
they transmit it daily to the NCBP data center partner. NCBP currently
incorporates every EMS call in NC, SC, and (soon) WV, MS, IN, and AZ
into its analysis, most within 24 hours. EMS data are acquired in a
Nationally-standardized format National EMS Information System
(NEMSIS), containing patient complaints, provider assessment, time
stamps, and the geocoding that enables geospatial analysis. As a result
of this standardization, EMS data will be the most expedient source for
NCBP to expand rapidly to other States.
In 2015, NCBP is entering the phase of development for expansion of
the system toward a Nation-wide network of biosurveillance users, in
order to provide ultimate value to the Federal Government, and enables
a wide network of State and local users to contribute to the Nation's
biopreparedness. With adequate funding, NCBP will incorporate
additional States, implement additional analytic and visualization
tools, add other data types (such as animal health and agricultural
data) and engage new users from those disciplines. The goal for NCBP is
to transition the system into a self-sustaining, not-for-profit entity
to provide service to the Federal Government.
national need: a rapid, effective clinical response system
The appropriate treatment of critically ill or injured patients can
vary minute-to-minute. Thus, timely access to reliable data is one of
the foundations of contemporary intensive care. It follows then that
optimal responses during public health emergencies, for both clinicians
and decision makers, would benefit from comprehensive, real-time event
reporting. This should include physiological patient data that are
needed to provide immediate insight into the impact of the event on
critical health care resources and to identify groups with high risk
for morbidity and mortality.
Importantly, this reporting should include the highly granular
patient data that is needed to: (1) Characterize clinical features, (2)
provide immediate insight into the impact of the event on critical
health care resources (e.g., mechanical ventilation, dialysis,
medication availability), (3) assess health care staffing availability
and training/educational needs, (4) identify groups of patients with
high risk for morbidity and mortality, and (5) determine the efficacy
and safety of treatment and medical countermeasures. Recent experiences
globally, however, indicate that real-time clinical data aggregation,
analysis, and reporting remain a strategic vulnerability during public
health emergencies. (Lurie, et al. N Engl J Med 2013).
The United States Critical Illness and Injury Trials Group (http://
www.usciitg.org) through its Program for Emergency Preparedness
(USCIITG-PREP) aims to significantly enhance the National capability to
rapidly glean crucial information regarding the clinical course of
acute illness and injury and guide clinical resource requirements
during emergent events:
Real-time collection of clinical data by a coordinating
center during a regional or National public health emergency;
Rapid analysis of clinical data to address key analytic
outcomes, answering both clinical and operational questions:
What was the nature of the clinical insult and the
resulting phenotype?
As a clinical responder, what, if anything, did you have
to do differently?
Did clinical diagnostics, countermeasures, and therapies
work as expected?
What was the operational impact on the patient and care
setting?
Was there anything essential needed that you did not get?
What is the best/worst case that could happen next time?
Timely dissemination of event-related information to inform
front-line treatment of disease and resource allocation,
assuring patient confidentiality, data security, and strict
version control.
Working with the Office of the Assistant Secretary for Preparedness
and Response (HHS/ASPR), leading professional organizations, and the
Homeland Security Information Network (HSIN), USCIITG-PREP has been
developing mechanisms for rapid clinical data collection, analysis, and
dissemination of findings during public health emergencies. Pre-event
work on protocols, data collection processes, rapid analysis
techniques, and means to quickly disseminate findings to stakeholders
are all crucial to making clinical science networks effective at
enhancing the response. The USCIIT Group will leverage existing
infrastructure to both strengthen pre-event operational science
capabilities and provide timely data and situational awareness across
the emergency care continuum during public health emergencies. Critical
illness and injury professional organizations will use this rapid
dissemination plan to inform their membership, in aggregate
representing over 150,000 front-line clinicians, thereby saving lives
and minimizing suffering based on the timely accurate guidance gleaned
from operational science.
Furthermore, optimal outcomes in response to public health
emergencies require rapid feedback on how well medical countermeasures
(MCM) work to protect and treat affected individuals and their
families. This information is used by clinicians in the field to guide
therapy and by public health agencies responsible for mobilizing the
necessary resources at both the regional and National levels. The
overarching goal of USCIITG-PREP is to facilitate development of MCM's
to protect against threats, specifically, select public health
emergencies. USCIITG-PREP is working to develop and implement
strategies to assess, evaluate, and monitor medical countermeasure
safety, performance, and patient compliance in response to a public
health emergency. The communication systems, infrastructure, data
analysis and reporting algorithms, and sample collection and processing
protocols that USCIITG-PREP develops for seasonal influenza could be
applied directly to protect against other threat agents, including
pandemic influenza (such as 2009 pH1N1), emerging respiratory viruses
(such as H7N9, MERS-CoV, Ebola), and other biothreats agents such as
inhalational anthrax. This work is also important because USCIITG-PREP
uniquely catalyzes communication and builds infrastructure across the
care continuum (prehospital, emergency department, intensive care
units, rehab, adult and pediatric), linking HHS agencies, academic
medical centers, community medical centers, critical illness and injury
professional organizations, and industry. The USCIITG-PREP Steering
Committee includes representatives from FDA, NIH, CDC, ASPR, and BARDA.
united states critical illness and injury trials group
The United States Critical Illness and Injury Trials (USCIIT) Group
serves as a ``network of networks'', with the dual missions to foster
investigator-initiated hypothesis testing and to develop
recommendations for strategic plans at a national level. (Cobb JP, et
al. J Trauma 2009; Blum, et al. Chest 2013). To these ends, the USCIIT
Group provides a venue for investigator communications, supports a
multi-society task force for research strategic planning, catalyzes HHS
inter-agency dialog for endorsement of transforming initiatives (e.g.,
NIH-ASPR-FDA-CDC-BARDA), and fosters innovative, multidisciplinary,
multicenter studies the results of which will improve clinical care and
preparedness (Cobb, Crit Care Med 2009; Deutschman CS, Crit Care Med
2012). The USCIIT Group is endorsed by all major U.S. critical illness
and injury professional organizations spanning the specialties of
anesthesiology, emergency medicine, internal medicine, nursing,
pediatrics, pharmacy and nutrition, surgery and trauma, and respiratory
and physical therapy. The USCIIT Group has grown to include over 200
investigators across more than 30 academic and community hospitals.
Collectively, USCIIT Group investigators have enrolled over 10,000
patients in studies during the last four years. For more details,
please visit the USCIIT Group web page at www.usciitg.org.
The USCIIT Group organizes some of its investigator-initiated
projects (now numbering more than 50) into several, large-scale,
collaborative programs, consistent with the recent consensus strategic
plan for critical illness and injury research in the United States.
Program for Prevention of Organ Failures (USCIITG-PROOF).--
Efforts to prevent organ failure are hampered by three
barriers: (i) Compartmentalization of care (emergency
department, operating room, ICU, etc.), (ii) the difficulty of
identifying early those at risk, and (iii) lack of proven,
effective preventative interventions. Building on the success
of the Lung Injury Prevention Study (USCIITG-LIPS),\1\ the
unique, multidisciplinary, USCIIT Group network, and CTSA-
funded infrastructure, USCIITG-PROOF addresses all three
barriers simultaneously through rapid cycle, multicenter
clinical trials that span clinical domains to test a variety of
interventions that prevent organ failure in those at risk.
---------------------------------------------------------------------------
\1\ Mears GD, Pratt D, Glickman SW, Brice JH, Glickman LT, Cabanas
JG, and Cairns CB. The North Carolina EMS Data System: a comprehensive
integrated emergency medical services quality improvement program.
Prehosp Emerg Care, 14, 85-94. 2010.
---------------------------------------------------------------------------
Program for Critical Illness Outcomes (USCIITG-CIOS).--Care
delivered in intensive care units is high-intensity, high-cost,
and has tremendous geographic and organ-specific variation.
Little is known about which ICU organizational and structural
factors are associated with high-quality care and optimized
outcomes. To determine which of these factors are most strongly
associated with high-quality critical care, USCIITG-CIOS
enrolled 66,400 patients across 69 ICU's in the United
States.\2\ CIOS-2 planning is underway with grant submissions
planned for this calendar year. There are numerous new
collaborative opportunities for ancillary studies for those
interested (we're especially interested in supporting new
investigators).
---------------------------------------------------------------------------
\2\ Blum JE, Morris PE, Martin GS, Gong MN, Bhagwanjee S, Cairns
CB, Cobb JP: U.S. Critical Illness and Injury Trials Group. Chest. 2013
Mar 1;143(3):808-13.
---------------------------------------------------------------------------
Program for Early ICU Rehabilitation (USCIITG-PEIR) and
USCIITG-Burn.--Physical therapists, respiratory therapists,
speech language pathologists, and occupational therapists are
essential for coordinating rehabilitation of critically ill or
injured patients. Early rehabilitation can help to ameliorate
and even avoid severe deconditioning associated with post-ICU
syndrome (PICS), which presents as long-term physical,
cognitive, and mental health problems after severe critical
illness or injury. USCIITG-PEIR seeks to identify areas of
heterogeneity of care and to improve early rehabilitation for
critically-ill or injured patients. Funded by the DOD, USCIITG-
PEIR collaborates with USCIITG-Burn to actively enroll patients
in a multi-center, randomized controlled clinical trial to
measure the effect of early rehabilitation on hospital stay,
muscle loss, and functional outcomes in burn patients with
acute respiratory failure.
Program for Emergency Preparedness (USCIITG-PREP).--There
are insufficient capabilities internal to HHS to rapidly
collect clinical data to inform decision makers and key end-
users in public health emergencies, especially on illness
severity and physiology. The USCIITG-PREP Group was funded by
the Office of the Assistant Secretary for Preparedness and
Response (ASPR/HHS) to create an electronic Core Data Set for
public health emergencies.\3\ Version 1 of the data set was
tested and validated across 12 clinical sites (HHS contract,
Rapid Assessment of Acute Illness and Injury to Enhance the
U.S. Response to Public Health Emergencies) with data analysis
and dissemination within 24 hours of data collection. USCIITG-
PREP is seeking support to operationalize data set capabilities
at the National level, including IRB innovations to insure
patient safety and protect privacy during emergent events as
well as data analysis and rapid dissemination plans.
---------------------------------------------------------------------------
\3\ Laurie N, Manolio T, Patterson AP, Collins F, Frieden T.
Research as a part of public health emergency response. N Engl J Med.
2013 Mar 28;368(13):1251-54.
---------------------------------------------------------------------------
USCIITG-PREP PULSE Project.--USCIITG-PREP has been supported
by ASPR to convene internet forums to address preparedness and
response for threats to public health. The goal is to get near
real-time feedback from USCIITG critical care volunteers
distributed across the United States. For example, some parts
of the country are experiencing a shortage of normal saline and
others a resurgence of severe respiratory failure from H1N1;
other regions are not. This new tool is designed for USCIITG-
PREP to document this variance in experience and assess health
system stress. For USCIITG-PREP and ASPR to keeps its fingers
on the ``pulse'' of a potential threat, feedback from our
investigators in the form of answers to a few questions, say
weekly, would be extremely helpful. Thus, we've called this
internet-based tool ``USCIITG-PREP Pulse'', or simply Pulse,
for short. After a successful pilot project on saline
shortages, we are compiling a list of additional investigators/
members who are interested in participating in Pulse. The
project is sensitive to investigator time with the expected
response burden for each forum will be minimal (less than 10
questions). We also expect that use of the tool will quickly
evolve, making the response network more efficient and robust,
and the Pulse tool easier and easier to use.
USCIITG-PREP Medical Countermeasures Project.--Optimal
outcomes in response to public health emergencies require rapid
feedback on how well MCM's work to protect and/or treat
affected individuals and their families. This information is
used by clinicians in the field to guide therapy and by public
health agencies responsible for mobilizing the necessary
resources at both the regional and National levels. The
overarching goal of USCIITG-PREP is to facilitate development
of MCM's to protect against threats, specifically, select
public health emergencies. The overarching goal of this FDA
proposal is to develop and implement strategies to assess,
evaluate, and monitor medical countermeasure safety,
performance, and patient compliance in response to a public
health emergency. Influenza was chosen as the prototypic test
case for this FDA proposal as it is one of the most predictable
and serious public health threats. Moreover, the communication
systems, infrastructure, data analysis and reporting
algorithms, and sample collection and processing protocols that
USCIITG-PREP develops for seasonal influenza could be applied
directly to protect against other threat agents, including
pandemic influenza (such as 2009 pH1N1), emerging respiratory
viruses (such as H7N9 or MERS-CoV, Ebola), and other biothreats
agents such as inhalational anthrax. This work is also
important because USCIITG-PREP uniquely catalyzes communication
and builds infrastructure across the care continuum
(prehospital to rehab, adult and pediatric), linking HHS
agencies, academic medical centers, community medical centers,
critical illness and injury professional organizations, and
industry. The USCIITG-PREP Steering Committee includes
representatives from FDA, NIH, CDC, ASPR, and BARDA.
national need: cooperation and collaboration
None of these initiatives will be successful ultimately, without
the full cooperation and collaboration across Federal agencies, the
States, and local governments. However, the current climate is not
necessarily one of collaboration and cooperation. The reasons for this
are multi-factorial and probably rooted in interagency claims of
primacy and in segregated budget lines and Congressional oversight. The
Nation's biodefense effort requires high-level direction and
coordination from The White House. In past years, the various
initiatives and programs of the Nation's biodefense apparatus were
overseen and coordinated directly by The White House, through a Special
Assistant to the President for Biodefense. This position was vacated in
2009 and has not been filled. I would urge the Congress to unify its
oversight of these biodefense programs so that money is spent more
wisely and the agencies are working on behalf of each other rather than
in competition.
This lack of programmatic unity is most felt at the State and local
level, which is the tip of the spear for the Nation's biodefense. It
will be the hospital systems and EMS agencies that will first detect
abnormalities in illness patterns. These same health care institutions
will be expected to deliver life-saving care in real time, currently
without the perspective of what resources will need to be available and
consumed during such an event. Local emergency managers will need to
execute their contingency plans well before any Federal disaster is
declared or FEMA shows up.
conclusion
The programs I have described above are important examples of
programs that capitalize on local health and safety officials and
practitioners' information and awareness to inform the Federal
agencies. I encourage Congress to ensure that any biodefense program
take into account the capabilities and the responsibilities of local
and State institutions, which must be weaved into the fabric of
National preparedness.
Thank you for the opportunity to testify before the subcommittee
today.
References
Mears G, Glickman SW, Moore F, Cairns CB: Data based integration of
critical illness and injury patient care from EMS to emergency
department to intensive care unit. Curr Opin Crit Care 2009
Aug;15(4):284-9.
Glickman SW, Greiner MA, Lin L, Curtis LH, Cairns CB, Granger CB,
Peterson ED: Assessment of Temporal Trends in Mortality With
Implementation of a Statewide ST-Segment Elevation Myocardial
Infarction (STEMI) Regionalization Program. Ann Emerg Med. 2012
Apr;59(4):243-252.
Cairns CB, Glickman SW: Time Makes a Difference to Everyone,
Everywhere: The Need for Effective Regionalization of Emergency and
Critical Care. Ann Emerg Med. 2012 Nov;60(5):638-40.
Arasaratnam M, Potenziani D, Hoit M, Jenkins C, and Cairns CB.
National Collaborative on Biopreparedness. Online J Public Health
Inform, 5, e198. 2013.
Cobb JP, Cairns CB, Bulger E, et al. The United States critical
illness and injury trials group: an introduction. J Trauma 2009;67(2
Suppl):S159-160.
Cobb JP, Ognibene FP, Ingbar DH, et al. Forging a critical
alliance: Addressing the research needs of the United States critical
illness and injury community. Critical Care Medicine 2009;37(12):3158-
3160.
Deutschman CS, Ahrens T, Cairns CB, et al. Multisociety Task Force
for Critical Care Research: key issues and recommendations. Critical
Care Medicine 2012;40(1):254-260.
Ms. McSally. Thank you, Dr. Cairns.
The Chairman now recognizes Ms. Raphael for 5 minutes.
STATEMENT OF MARISA RAPHAEL, DEPUTY COMMISSIONER, OFFICE OF
EMERGENCY PLANNING AND RESPONSE, NEW YORK CITY DEPARTMENT OF
HEALTH AND MENTAL HYGIENE
Ms. Raphael. Good morning, Chairman McSally, Ranking Member
Payne, and Members of the subcommittee. On behalf of Mayor Bill
de Blasio and Health Commissioner Mary Bassett, thank you for
the opportunity to testify on New York City's efforts to
prepare for and respond to public health emergencies.
I am here today to discuss the vital role that public
health plays in detecting and responding to emergencies, the
importance of Federal public health and health care
preparedness funding, and examples of how these investments
have increased preparedness.
Our Nation's public health and health care infrastructure
play a critical role in protecting our citizens by quickly
detecting acts of bioterrorism or naturally-occurring
outbreaks, containing the spread of disease, and mitigating the
health impacts of emergencies.
The department currently receives Federal emergency
preparedness funding from the CDC Public Health Emergency
Preparedness program, the ASPR Hospital Preparedness Program,
and the Department of Homeland Security Urban Areas Security
Initiative. As a result, the department's public health and
health care emergency response capabilities have been expanded,
and we have made vital investments in planned development,
training and exercises, and skilled and experienced personnel.
I want to thank the committee and subcommittee for their
continued recognition of the need for these critical Federal
programs.
As the largest point of entry in the United States, New
York City recognizes the increased likelihood that a naturally-
occurring disease in any area of the world can quickly spread
to New York City.
In July 2014, New York City began a highly coordinated and
expensive multi-agency and multi-jurisdictional response to
Ebola. To prepare, we addressed hospital readiness, risk
communication, increased lab capacity, and community
engagement. We began developing detailed plans for disease
surveillance and managing a person under investigation, and our
public health surveillance staff investigated hundreds of
suspect cases. The public health lab quickly became proficient
in testing for and rapidly diagnosing Ebola in record time.
The city chose to focus on readying Bellevue Hospital as
New York City's primary Ebola treatment center. Bellevue's
quarantine and isolation unit had been supported over the past
decade through HPP funding, and, therefore, we could focus on
enhancing existing capabilities. When the first confirmed Ebola
case in New York City was identified, we were in a strong
position to respond.
One of the biggest challenges we currently face is
maintaining a permanent state of readiness among city agencies
in the health care system. This brings us back to the original
impetus for the Federal preparedness funds: September 11 and
the subsequent anthrax attacks.
The receipt of letters tainted with anthrax in 2001 led to
a State and local requirement to develop mass prophylactic
capabilities. The primary method of rapidly dispensing
medication in response to a wide-spread aerosolized anthrax
attack is through points of dispensing, or PODs, which are
temporary emergency sites established to provide free
medication to large numbers of people.
Years of planning, training, and exercises culminated in
August 2014, when the department conducted the largest no-
notice exercise on record, the Rapid Activation for Mass
Prophylaxis Exercise, or RAMPEx. This exercise involved
notifying and mobilizing over 1,500 city employees and setting
up and opening 30 PODs simultaneously.
RAMPEx tested all components of our mass prophylaxis
response and definitively demonstrated our ability to rapidly
open 30 PODs city-wide in less than 8 hours, with some ready
within 6 hours.
RAMPEx also helped identify critical planning gaps and
solutions. First, all PODs are ready to open 4 hours before
medication from CDC's Strategic National Stockpile would
arrive. To address this gap, the department has requested that
SNS assets be forward-deployed to New York City and other high-
threat, high-density urban areas that have demonstrated an
ability to stand up PODs faster than SNS medications can be
delivered.
Second, we have not met our POD staffing goals. City-wide
prophylaxis distribution requires 33,000 POD staff to support
48 hours of dispensing operations. New York City has made great
efforts to recruit, pretrain, and assign staff to a POD site
close to home. We are advocating for non-mission-critical
Federal staff who live locally to be similarly identified and
trained to support POD operations.
Our successful Ebola response and medical countermeasure
exercise are a direct result of a decade of Federal investments
in local preparedness. However, the greatest danger to our
progress is the decline in Federal funding. While overall
preparedness funding should be increased, allocations should
also be based on risk to reflect the scale-of-threat impact to
high-density urban areas and complexity of response.
The department relies on dedicated Federal funding streams
to build and maintain critical public health and health care
capabilities. Significant cuts in funding jeopardize our
existing capabilities. PHEP funding for New York City has
decreased 35 percent from its peak in fiscal year 2005, which
has led to a 47 percent reduction in the public health
preparedness workforce, compromising our ability to detect and
respond to disease outbreaks.
I am reading as fast as I can, but I may run a little over.
Similarly, drastic cuts of nearly 40 percent to HPP have
impeded health care-sector preparedness and response efforts.
There are 55 hospitals, 259 long-term-care facilities, 303
primary care centers, 50 urgent care centers, and 101 dialysis
centers in New York City. Preparing a health care system of
this size and complexity requires significant resources.
In the immediate months following a particular emergency,
jurisdictions have occasionally received one-time funding. New
York City is thankful to have received funds to address our
Ebola response. However, singular funding allocations are not
an adequate substitute for sufficient and sustained base
funding.
There is also a critical need for a real-time funding
mechanism to support public health emergency response, not just
preparedness efforts. Currently, we must use Federal
preparedness funds to cover response costs. Federal budgets
designed to support public health and health care system
preparedness and response capabilities must be increased and
sustained.
Chairman McSally and Ranking Member Payne, thank you for
inviting me to testify today. We are grateful for your
continued support, and I look forward to your questions.
[The prepared statement of Ms. Raphael follows:]
Prepared Statement of Marisa Raphael
April 22, 2015
Good morning Chairman McSally, Ranking Member Payne, and Members of
the subcommittee. I am Marisa Raphael, deputy commissioner for the
Office of Emergency Preparedness and Response at the New York City
Department of Health and Mental Hygiene. Our mission is to promote New
York City's ability to prevent, prepare for, respond to, and recover
from public health emergencies. I have been privileged to serve in a
leadership role in this field for more than a decade. On behalf of
Mayor Bill de Blasio and Health Commissioner Mary Bassett, thank you
for the opportunity to testify on New York City's efforts to prepare
for and respond to emergencies with public health and medical
consequences.
public health and emergency preparedness
I am here today to discuss the vital role that public health plays
in detecting and responding to emergencies, the importance of Federal
public health and health care preparedness funding, and examples of how
these investments have increased preparedness. I will focus on our most
recent and on-going Ebola response and the Rapid Activation and
Mobilization Point of Dispensing Exercise, called RAMPEx, which the
Health Department conducted in August 2014.
Our Nation's public health and health care infrastructure play a
critical role in protecting our citizens by quickly detecting acts of
bioterrorism or naturally-occurring outbreaks, containing the spread of
disease, and otherwise mitigating the public health impacts of
emergencies. State and local health departments along with their local
health care systems play equally vital roles as that of first responder
agencies--we prevent illness and save lives. The Department currently
receives Federal emergency preparedness funding from the Centers for
Disease Control and Prevention (CDC) Public Health Emergency
Preparedness program (PHEP), the Assistant Secretary for Preparedness
and Response (ASPR) Hospital Preparedness Program (HPP) cooperative
agreements, and the Department of Homeland Security Urban Area Security
Initiative (UASI) grant awards. As a result, the Department's public
health and health care emergency response capabilities have been
expanded, and we have made vital investments in plan development,
training and exercises, supplies and equipment, and skilled and
experienced personnel to respond to a broad range of emergencies. In
New York City, a perpetual target for terrorism, focal point for
disease outbreaks, and victim of natural disasters, these investments
have been critical to shoring up our public health and health care
system. I want to thank the committee and subcommittee for their
continued interest and recognition of the need for these critical
Federal programs.
ebola in new york city
As the largest point of entry in the United States, we recognize
the increased likelihood that a naturally-occurring disease in any area
of the world can quickly spread to New York City. This was demonstrated
during our recent and on-going response to Ebola. Beginning in July
2014, when it became apparent that cases of Ebola were increasing in
West Africa and that an individual with Ebola would likely reach New
York City, the city activated a highly-detailed, coordinated, and
expensive multi-agency and multi-jurisdictional effort. The Mayor
convened interagency preparedness meetings to discuss various scenarios
and ensure our health care system and first responders were aware of
their roles and familiar with protocols. I would be remiss to not
mention the over 20 agencies, including the NYC Health and Hospitals
Corporation (HHC), FDNY, NYPD, and NYC Office of Emergency Management
that worked hand-in-hand with our team at Health and City Hall to
ensure a coordinated response. Each city agency dispensed invaluable
expertise and leadership and I cannot emphasize enough how critical
coordination is in the face of threats like this.
To give you a sense of our preparation at the Health Department, we
addressed hospital readiness, risk communication and emergency
transport, increased lab capacity, and community engagement. The Health
Department began developing detailed plans for disease surveillance,
emphasizing early detection, isolation and rapid notification, as well
as plans to manage a person under investigation. Our public health
surveillance and epidemiology staff investigated hundreds of suspect
cases; the Public Health Laboratory quickly became proficient in
testing for Ebola to facilitate rapid diagnosis and delivered test
results in record time. We also prioritized community engagement,
distributing over 100,000 ``Am I at Risk?'' palm cards and speaking at
over 115 public events to address the public health concerns of New
York City's diverse communities. For example, our Commissioner
personally went out into West African immigrant communities and other
vulnerable areas of the city to begin a dialogue about, not only of the
risks of infection, but also discussing issues of tolerance to ensure
immigrants were being treated fairly.
Most notably, HHC proactively conducted extensive staff training at
each of its 11 hospitals, to be prepared to receive and screen
individuals potentially exposed to the disease. Additionally, the city
chose to focus on readying Bellevue Hospital as the primary NYC Ebola
treatment center. Bellevue was selected because its ``quarantine and
isolation'' unit has been supported over the past decade through HPP
funding and we could focus on enhancing existing capabilities by
further training staff and hiring additional personnel, as well as
outfitting of isolation rooms to properly handle additional electrical
and laboratory capacity. The fact that Bellevue was the sole facility
ready to receive and treat an Ebola patient when that capacity was
actually needed--and that it did so with successful outcome for the
patient and all the personnel who care for and supported the patient--
is merely part of the remarkable preparedness and response work
overseen by Dr. Raju, HHC's president.
Years of planning made possible through the previously-mentioned
funding gave the city the capacity to quickly prepare and respond to
the Ebola threat. On October 23, 2014, when the first confirmed case in
New York City was identified the city was in a strong position to
respond because of these Federal dollars. Nonetheless, funding is still
needed to reimburse the city for the costs incurred in transporting,
screening, treating, and monitoring persons with or potentially exposed
to Ebola.
mass prophylaxis capability and rampex
One of the biggest challenges we currently face is maintaining a
permanent state of readiness among city agencies and the health care
system. This brings us back to the original impetus for the Federal
preparedness funds--the September 11 attacks and the subsequent anthrax
attacks.
The receipt of letters tainted with anthrax in multiple cities in
2001 led to a State and local requirement to develop mass prophylaxis
capabilities. PHEP funds support State and local health departments to
develop and execute plans for the mass dispensing of medication in
response to a biological attack. In the case of a wide-spread,
aerosolized attack, all potentially exposed people must begin taking
antibiotics within 48 hours to prevent illness and death. While 48
hours is the target, modeling has shown that the more rapidly
medication is provided to the public, the more lives will be saved. The
primary method of rapidly dispensing medication is through Points of
Dispensing, or PODs, which are temporary emergency sites established to
provide free medication to large numbers of people to prevent them from
becoming sick. Years of planning, training, and exercises as well as
our investment in a team of experienced, highly-skilled Health
Department emergency managers culminated on August 1, 2014, when the
Health Department conducted the largest no-notice emergency response
exercise on record: The Rapid Activation for Mass Prophylaxis Exercise,
or RAMPEx. This exercise involved notifying and mobilizing over 1,500
city employees and setting up and opening 30 PODs simultaneously, and
was funded by UASI.
RAMPEx tested all components of our mass prophylaxis response to an
aerosolized anthrax attack from the mobilization of our Receipt, Stage,
and Store (RSS) warehouse, to the coordination of our command and
control center and mobilization of PODs. RAMPEx definitively
demonstrated our ability to rapidly open 30 PODs city-wide in less than
8 hours, with some fully set up, staffed, and ready to open within 6
hours.
RAMPEx helped identify critical planning gaps and solutions. First,
all PODs were ready to open up to 4 hours before medications from CDC's
Strategic National Stockpile (SNS) would arrive at New York City
warehouses. In an effort to close this gap, the Health Department has
requested that SNS assets be forward-deployed in reasonable and useful
quantities to NYC and other high-threat, high-density urban areas that
have demonstrated an ability to stand up PODs faster than SNS
medications can be delivered. The consequence of the failure to
forward-deploy SNS assets may ultimately be measured in the numbers of
lives lost because of delayed access to medication.
Second, we have not met our POD staffing goals for both leadership
and general staff. In NYC alone, city-wide prophylaxis distribution
will require 33,000 POD staff to support 48 hours of dispensing
operations. In anticipation of ``role abandonment'' or failure to
report, NYC has made great efforts to recruit, pre-train, and assign
staff to a POD site close to home. We are advocating for non-mission-
critical Federal staff, who live locally, to be similarly pre-
identified and pre-trained to support POD operations. There are many
areas in which Federal staff could be utilized to augment local
response efforts during a large-scale emergency, PODs being one such
opportunity.
RAMPEx demonstrated New York City's extensive medical
countermeasure capabilities and high level of readiness for this type
of scenario, and the importance of Federal preparedness funding to
sustain such efforts.
importance of federal emergency preparedness funding
Our successful Ebola response and medical countermeasure exercise
are a direct result of a decade of Federal investments in local
preparedness. However, the greatest danger to our progress is the
decline in Federal emergency preparedness funding. Preparedness is an
on-going effort that must be sustained over time. While the overall
emergency preparedness and response funding should be increased,
funding allocations should also be based on risk to reflect the scale
of threat, impact to high-density urban areas, and complexity of
response. These funds support the development, maintenance, testing,
and continued improvement of these public health and health care
capabilities and without these funds, lives would be lost.
Federal funds have allowed us to build critical capabilities so
that when faced with public health emergencies, we have the tools
necessary to protect the public. The Department relies on the dedicated
emergency preparedness Federal funding streams of PHEP, HPP, and UASI
to build and maintain these critical public health and health care
capabilities. Significant cuts to the PHEP award, combined with similar
cuts to the HPP award jeopardize NYC's, and other State and local
jurisdictions' existing capabilities and impede planning to address
known gaps. I will speak to the cuts New York City has endured
specifically.
PHEP funding for New York City has decreased 35% from its peak in
fiscal year 2005, which has led to a 47% reduction in our public health
preparedness and response workforce. The erosion of a skilled,
dedicated workforce including epidemiologists, laboratory technicians,
and preparedness planners threatens to compromise our ability to detect
and respond to disease outbreaks. In New York City, for example, the
cuts have reduced the ability of the Public Health Lab to respond to
after-hours lab testing needs, which is critical to the 24/7 response
needed for bioterrorism incidents and public health emergencies such as
pandemic influenza and Ebola.
Similarly, drastic cuts of nearly 40% to HPP have impeded
preparedness and response efforts necessary to shore up our Nation's
health care sector. Health care system preparedness is essential to
responding to all types of public health emergencies. During the recent
Ebola response, every hospital had to be ready to identify, isolate,
and stabilize any patient with potential Ebola disease and a handful of
hospitals had to be ready to provide intensive treatment for a
confirmed Ebola patient. There are 55 hospitals, 259 long-term care
facilities, 303 primary care centers, 50 urgent care centers, and 101
dialysis centers in New York City. Preparing a health care system of
this size and complexity requires significant resources, and as the
funding has declined, NYC's ability to fully prepare its health care
system has been compromised.
In the immediate months following a particular emergency,
jurisdictions have occasionally received one-time funding to supplement
the PHEP and HPP grants. New York City is thankful to have received
such an allocation for our Ebola response. However, these singular
funding allocations are not an adequate substitute for sufficient and
sustained base funding. There is also a critical need for a real-time
funding mechanism to support public health emergency response.
Currently, we must use Federal preparedness funds to cover response
costs, however with decreasing budgets that are already allotted to
preparedness projects, this is unrealistic. Generally speaking, Federal
budgets designed to support public health and health care system
preparedness and response capabilities must be increased and sustained;
this is as true for New York City as it is for localities Nation-wide,
particularly dense urban centers.
Chairman McSally and Ranking Member Payne, thank you once again for
inviting me to testify today. We are grateful for your and your
colleagues' work to protect our citizens. I look forward to your
questions.
Ms. McSally. Thank you, Ms. Raphael.
The Chairman now recognizes myself for 5 minutes for
questions.
I appreciate all the testimony and the expertise at the
table here.
Senator Talent, I want to start with you. I mentioned in my
opening statement about the threat coming, potentially, from
ISIS and, you know, those that are inspired by ISIS. Obviously,
we have foreign fighters that are flowing in and out of the
area. We have home-grown, lone-wolf--but we had somebody
testify saying they prefer to call them ``stray dogs'' instead
of ``lone wolf'' in one of our previous hearings. But, also,
obviously, the capability is right there in Iraq and Syria, the
potentiality.
I learned in my military career, obviously, threat equals
intent and capability. So you have to have those two together.
I think we can all agree that extremist organizations out there
certainly would want to have the intent if they could, so the
issue related to the threat is the capability.
In order to have that capability, you must be able to
isolate, weaponize, and then disperse the agent. So, of those
three steps, which do you think is the biggest challenge or
barrier for extremists out there, both organized and inspired,
less organized, so that we can try and get a good sense of what
we are dealing with in the threat?
Mr. Talent. My understanding of the science--and I will
certainly invite Dr. Cairns and the deputy commissioner to
weigh in here--is that probably, of the three, the weaponizing
it would be the most difficult but, nevertheless, within the
capability of a fairly wide range of professionals in life
science. So, really, the issue is can they have a long enough
period of sanctuary where they can plan, recruit, get the
necessary lab facilities so that the experts that they have can
isolate and weaponize.
That is one of the things that concerns me. Because we are
seeing areas now--you mentioned Iraq, Syria, but Yemen--there
are places in North Africa, which you are more well aware of
than I, where they may have the necessary time and the
necessary sanctuary to be able to develop this. So that is my
concern.
You know, you said it at the beginning, and correct, it is
a low-probability but very highly destructive event if it were
to occur. The problem is, when you keep running risk and the
risk continues to grow, even gradually, you know, eventually,
the bullet is in the chamber, if you will. This is really what
concerns me.
So I am concerned that the risk that they will be able to
acquire it is growing because they are spreading, they are
getting more sophisticated, and the logic of this, from their
strategic point of view, is, I think, very strong.
Ms. McSally. Thank you. Yeah, no, I agree; the ungoverned
spaces that are continuing to grow around the world provide
that space for this kind of activity to happen. If we don't
have partners in the region to be able to provide governance
and oversight of those activities, that is where the threat can
continue to grow, I think, so----
Mr. Talent. I don't want to take your 5 minutes----
Ms. McSally. Yeah.
Mr. Talent [continuing]. But whoever did----and we know who
the FBI thinks sent the letter here, for example.
Ms. McSally. Right.
Mr. Talent. Well, if that had been put into the heating and
air conditioning system instead of sent in a letter with a
warning note----
Ms. McSally. Right.
Mr. Talent [continuing]. I mean, the destruction would have
been much, much greater, and the damage.
Ms. McSally. Thank you.
Dr. Cairns, in Ms. Raphael's testimony, she talked about
the preparedness of New York City related to the Ebola crisis.
We often talk about New York City as a potential target area,
and we have talked about it even in the chemical threat. So it
seems the preparedness and the efforts that you took are very
admirable.
Do you see, Dr. Cairns, that type of preparedness around
the country? I would think other cities, other smaller cities,
you know, even Phoenix or Tucson, other places, would not have
had that same capability or response. Have we spread the
lessons learned from the Ebola event to other areas so that we
can learn from their preparedness?
Dr. Cairns. Well, thank you very much for the question.
I think that the deputy commissioner outlined what is a
best practice, in terms of response to these kinds of entities.
So, no, I don't think Tucson and Phoenix would have that same
experience, nor would they have those resources.
So we need to incorporate, of course, the learnings from
New York City, but we have to think about: How do we have a
dedicated isolation unit the way Bellevue was set up? Our
hospitals are overwhelmed now, so having that dedicated space
just in case is just a luxury we haven't been able to invest
in. Then how do we deal with other issues that involve the
populations outside--Tucson, Phoenix, or any number of Western
States? How do we make a difference for everywhere for anything
at anytime, I think, would be one of our big challenges.
Ms. McSally. Great. Thank you.
My time has expired. We might have time for a couple rounds
of questions here, but I want to now recognize Ranking Member
Payne for 5 minutes.
Mr. Payne. Thank you, Madam Chairman.
You know, if you could describe some of the lessons learned
from the Ebola cases in the United States last year and how
they might apply to a biological attack scenario, Dr. Cairns.
Dr. Cairns. Thank you very much for the question.
I think some of the lessons we learned from Ebola is that
we need to be prepared to be able to collect data rapidly, have
a system in place to understand the place of countermeasures,
and then look at the effect of countermeasures on both
individual patients and as a collective. We currently don't
have that system in place. So I think the first lesson is we
need to be prepared not only for operational experiences but
also to better understand the impact and value of our
countermeasures.
I think another key lesson is that it has been very
difficult. It has been my experience, working with DHS and HHS
across multiple agencies on how we might develop that, both
across the clinical groups, professional organizations, and
coordinate with the rest of the world, that it became very
difficult. Frankly, we had more interactions on a standardized
case form with our clinical trial groups in Canada, New
Zealand, Australia, and the Europeans and the World Health
Organization than we did within the United States.
So I think we really need to start addressing this as a
National priority and be prepared to get timely information,
effective assessment to countermeasures, and a system to
deliver those countermeasures to the patients that would
benefit most.
Mr. Payne. Thank you.
Senator Talent.
Mr. Talent. I was discouraged by several aspects of the
Ebola response.
In our last report, we actually gave the best grade for our
Government's preparedness to communicate, both among health
care professionals, to the public, and within the Government.
That seemed, to me, to be a major failure. This was a small-
scale event. I mean, it is important to think of this in terms
of from small-scale noncontagious to large-scale contagious. So
that was very distressing.
I don't--we established an Assistant Secretary for
Preparedness and Response, who I had hoped was the one
coordinating all this, and didn't see the Assistant Secretary
for Preparedness and Response. So there were malfunctions
there.
What we are seeing here is, when we have, as in New York,
unified authority which sets priorities, we have good use of
dollars, you know, we spotlight the weaknesses, we know what we
need to do. When we don't have that, we have problems on the
ground that we didn't expect, and we are not sure what to do
about it.
So I think, again, it points back to the need for a greater
unit of leaderships either in a person or in a small group of
people who are able to look at the whole picture from the
Federal point of view, identify what needs to be done, and have
the authority to act when the crisis arises.
Mr. Payne. Thank you.
Ms. Raphael.
Ms. Raphael. So I think I want to make three key points.
So one is just how resource-intensive this kind of response
is. I think sometimes we slip in to referring to Ebola as past
tense, but our reality is this is still going on. We have hit
the 2,300 mark in terms of number of people monitored. We are
monitoring over 190 people on any given day. So this is an
incredibly resource-intensive response. We have been using over
a thousand of our staff. Many millions of dollars have been
expended on the part of the city.
I think one of the key challenges is maintaining a
permanent state of readiness. I can't stress enough how the
success of our response was really built on all of the
capabilities that we have developed over the last decade. We
would not have had the response we had if we hadn't had those
investments in basic surveillance, labs, communications
capabilities.
Obviously, the health care system played a critical role in
this response. They are required to also have a baseline level
of readiness, not only for Ebola but for any emerging
infectious disease. So continuing to invest in the preparedness
and readiness of the health care system is critical.
Then, finally, we are dependent on the Federal Government
for consistent guidance that is based on best practices that we
can all look to and be on the same page.
Mr. Payne. Thank you.
You know, that harkens back to my point and being adamant
about, you know, the Commission's report that talked about
reestablishing the position of special assistant to the
President on biodefense. The coordination that you speak of
would be enhanced by someone that that was their job and their
due diligence every single day, to advise the President.
Senator Talent, in your testimony, you stressed that the
Government's preparedness for biological attacks received an F
in your 2010 report. You specifically mentioned the lack of
sufficient medical countermeasures as your No. 1 concern.
What can the Government and private sector do right now to
improve preparedness for biological incidents?
Mr. Talent. I think this should be a focus of the
subcommittee, in part because this is the one area, one link in
the chain where it is really Federally dominated, right? I
mean, you all have control, as a jurisdictional matter, over
what FDA is doing, what BARDA is doing, what HHS is doing.
So I think we have to improve the stockpile. We ought to do
for other biological agents what we have done for smallpox and,
to some extent, for anthrax; and then continue to support FDA.
They are moving in the direction of having the resident
capacity to be able to respond and come up with new drugs
quickly.
I think it is also very important--one of the things Ebola
showed us is diagnostics is hugely important. We have to put
effort into being able to diagnose quickly. If you can't do
that, you can't respond.
I would also say to you that it is important that the drugs
that we stockpile, that we take into account the need of
particular populations--the elderly, women who are pregnant,
children--because countermeasures that will work with young,
healthy people may be too much for them. So I think that is
definitely an area where we ought to move.
Again, this unifying responsibility--I just leaned over to
Dr. Cairns a minute ago because he said, how can we have an
isolation unit the way they do in Bellevue? Well, you all know,
as all of us do who have served here, VA has a lot of excess
capacity, right? So if we had a sort of unified leadership
response, this is an area you would at least like to look into:
Could we use some of the VA's excess capacity to supply--and it
is all throughout the country, too, right, or at least through
a lot of places.
But, at least as of the time we did our report, VA wasn't
really even involved in the Federal response. Again, I think
the problem is there is no special assistant and then, within
the Congress, there is no way to move in a unified way to send
a signal from the highest level of political authority.
Mr. Payne. Okay.
Well, Madam Chairman, I see my time is up, so I will yield
back.
Ms. McSally. We should be able to come back to you, though.
The Chairman recognizes Mr. Walker from North Carolina.
Mr. Walker. Thank you, Madam Chairman.
I wanted to follow up on what my colleague was just talking
about. I am married to a family nurse practitioner who works in
a Level 1 trauma center, but, over the last month, she spent
about five or six shifts on a trauma helicopter as their chief
trauma nurse and really works a lot with these first responders
on different issues. These are really the salt-of-the-earth
people who face and run into situations without asking
questions, whatever it might be. I particularly am concerned
about, are we looking out for these guys in the best capacity?
In driving to my question for both Dr. Cairns and former
Senator Talent, the medical community seems to have a knowledge
or understanding--or they are getting there--of what is going
on, of what they might be facing, yet it seems the larger
communities, whether you want to call it awareness or the
action steps or whatever, it just seems like the threat isn't
really understood or appreciated to that level.
My question is, what is it that can be done from local
communities, out of our positions here in Congress? What is it
that you see would be not just awareness--we talk so much about
awareness--but what are the action steps that we could take to
bring some of the awareness?
I would address that to both of you gentlemen.
Mr. Talent. It is tough. The Chairman mentioned, you know,
you don't want to panic people, but you want them to be aware
of the threat.
A couple of small steps. I mean, we could do a better job
within this body of making sure that Members are aware. Now,
obviously, the Members of this subcommittee and the committee
are more aware. I am not so sure that your colleagues who are
not sitting here are aware. I said to the Chair before the
hearing: We do a lousy job of orientation on National security
issues in general for new Members coming into this body. As the
Members know more--because you all network so much back home;
you talk to your press--I think that would help a lot.
HHS, as of the time we did our report, they had some
websites, they were doing some things. As we said, we felt a
little bit better about communications. But my sense is it has
probably declined, and I think the funding cuts are one of the
reasons.
I mean, one of my real concerns--I agree with the deputy
commissioner on this. When we issued our report, it was just
when the funding cuts for public health were coming into play,
and it is hard for me to believe that any link in this chain
has gotten better given what has happened to the budget
situation.
Mr. Walker. Okay.
Mr. Cairns.
Dr. Cairns. Again, thank you for that question.
Indeed, one of the things that we think is very important,
Congressman, is for first responders to be integrated into the
system. So we developed the NCBP system based on the
experiences and the perspectives of EMTs and paramedics and
increasingly are trying to reach out to highway patrol, police,
and fire so that they at least have the information needed to
both understand a situation they might be going into as well as
contribute information that can be integrated into the larger
collective.
They are just a critical component of our Nation's health
care system. They clearly are going to be not just the tip of
the spear, but they are first in time, in getting an
understanding. They need to be protected.
Mr. Walker. Sure.
Dr. Cairns. They need to be aware.
Mr. Walker. I had a meeting this morning where I found out
for the first time a piece of legislation--I believe it is H.R.
1300 that is out there that would specifically allow first
responders to some of the vaccines in our medical database. Do
you agree with that? Do you approve of that? Or what would your
position be?
Dr. Cairns. I would approve of that; in fact, a movement
towards community paramedicine, where we take advantage of the
prehospital care system and EMS system to help take care of
patients every day--people who are in assisted living
facilities, people who have to have care at home, those special
populations that Senator Talent referred to. Why not utilize
these people and their expertise and their interaction with the
community to facilitate every-day care?
So, most certainly, giving them an option to participate in
a response, I think, would be a valuable adjunct.
Can I make one comment about medical countermeasures?
Mr. Walker. Sure.
Dr. Cairns. I do believe the FDA is making progress. In
fact, they have supported the U.S. Critical Illness and Injury
Trials Group to try to come up with ways to be proactive in
data collection and assessment of medical countermeasures.
So continuing to work with ASPR, FDA, as well as Homeland
Security, in order to empower and embrace the effective
countermeasures for use by paramedics, EMTs, and first
responders, I think, should also be a priority.
Mr. Walker. Senator, did you want to add anything to that
as far as----
Mr. Talent. I think, in terms of communication, one of the
things I always believed is that people will pay more attention
if there is something they can do. So, I mean, to the extent
that we can give advice to people about how maybe they could
prepare, again, you want to be careful.
I think I would start with some of the bigger cities that
are at a higher risk and give people an idea--and, generally, I
think, when you are talking about management of these things,
you are working through local authorities, as in New York.
Okay? So the logical way to approach it would be to have a best
practices out there; let other cities, maybe in order to get
funding, present plans, one of which ought to include public
awareness and also would include protecting local responders,
taking advantage of resources outside of the traditional
medical system--because if we get a big event, there is just no
way that the surge capability of the hospital is going to be
able to deal with it. I think they have estimated hospitals can
surge to, like, 20 percent, something like that, and you could
have many, many times that.
As far as FDA is concerned--and I just don't know because
it has been, like, 3 or 4 years--have they used--now I don't
want to ask the question. They were considering approving new
drugs based on animal testing, which we thought was important,
but, as of that time, they hadn't ever done it. I don't know if
that is being pursued, but it is a question I would ask if I
were you.
Mr. Walker. Thank you, Madam Chairman. I yield back.
Ms. McSally. Great. Thank you.
You guys up for a second round here of questions while we
have our distinguished panel here?
So I believe in one of the testimonies or some of the
background we talked about there is about maybe 15 different
agents that potentially we think could be used for
bioterrorism, but we really only have countermeasures available
for about 2 or 3 of them.
What is the barrier for us to be able to have, you know,
the countermeasures for the other 12? Is it a resource issue
only? Is it a political will or a biological solution? I just
want to get a sense of what are our barriers.
Because I agree with Senator Talent that we are talking
about the threat today, but the one way to reduce the threat is
to be prepared. One way to be prepared, obviously, is to have
those countermeasures in place.
So, Dr. Cairns, what is the barrier to having
countermeasures available for the rest of those so that the bad
guys would have to go further down the list developing
capabilities?
Dr. Cairns. Well, we need to emphasize the development of
these countermeasures. We have to facilitate pathways,
including animal testing, that then can be applied in like
clinical scenarios. Frankly, that is one of the things we have
just developed with FDA, in conjunction with ASPR, is a way to
think about how to do that for one of those key agents on that
list.
But we also have to think about how we can rapidly adapt to
changes either in virulence of a particular organism or the
emergence of something we have known about for a long time like
Ebola. So being prepared about how we not only test and
reassess the value of those countermeasures, but to have it as
a priority to have them developed.
There were so many countermeasures available for Ebola, for
example, yet we didn't test any efficacy on most of these, and
yet that program could be vital in the future. Imagine all the
rest of the 15 agents on that list and how we might actually
apply them to people who need them.
Ms. McSally. Great.
Senator Talent, do you have----
Mr. Talent. Yeah, I think part of the issue is, as I
understand it, okay, NIH does a lot of the basic science. HHS
is supposed to coordinate setting priorities and requirements,
and then BARDA is supposed to actually develop the
countermeasures. I think there has been a lack of, again,
coordination in decision making about what are we going to
focus on, you know, decisions about when animal testing is good
enough--I don't want to get into the science of it.
Then BARDA has been underfunded. It is being funded at a
fraction of what it needs. You know, I know we don't just throw
dollars at a system that is not working otherwise, but I think
we are going to have to do more in terms of funding there.
Since that is the one aspect of this that is the complete
Federal responsibility, really--I mean, if you don't have the
countermeasures, you can have all the rest of it done--it is
like an army without bullets, I think I said in the testimony.
Ms. McSally. Great. Thank you.
In the fiscally-constrained environment that we are in, I
am always going to be asking what is doable. Like, you know, as
we talked in the back earlier, Senator Talent, like, what is
the low-hanging fruit that is actually doable in this fiscal
environment, in this divided Government, that we could maybe
get some bipartisan agreement on and to address some things
incrementally. I mean, we have a whole host of challenges, some
of which have been brought up today, some we haven't even
touched on.
But what do you think, Senator Talent, is actually doable
in this environment, that this subcommittee could move through
in a bipartisan way and get signed by this President, that
isn't, you know, significant resources? We have to make that
case, certainly, to our colleagues and others, but I also want
to get something done and not have the perfect be the enemy of
the good.
Mr. Talent. Well, I do think--and Mr. Payne mentioned
this--fixing the authority situation. I am not sure how to go
about it from an Executive branch point of view. I would
support the legislation you all have sponsored. At the same
time, it is not the best thing in the world in legislation to
tell the President how he has to organize his own staff. But I
support what you are doing because I think it is so urgent.
So, just as a practical matter, this might be an
opportunity for the leadership or your Chair and Ranking Member
to go talk to the chief of the staff, if you haven't done it,
and just say, ``Hey, how come you haven't done this?''
I mean, the President is personally, obviously, aware of
this. He has talked about it in his National security strategy.
He has responded personally and taken a lot of initiative on
cyber, for example. That is clearly something he is interested
in. So I think sometimes it is just making somebody personally
aware of it.
I would look at how you can empower all these tremendous
assets we have out there--local health departments, first
responders. They have such a tradition of partnership and
mutual aid anyway. I would ask people like the deputy
commissioner, are there issues relating to potential liability
that has hampered you in New York, for example, in
distribution? Are the big box retailers--I don't know how many
you have in New York--but are they not--so I would look at some
of the non-money things.
Then, in terms of what you are doing with the money, I
would focus on two things: Offering funding to localities that
come up with really good plans for distribution and managing
surges; and fixing the stockpiling issue. That is going to take
more money. I know it is hard, but--and it is going to take
consistency, too. You know, it is hard when you are planning
this and then one year it is here and the next year it is here.
So speak to the appropriators and get them to be consistent in
funding. Good luck with that, right?
Ms. McSally. Yeah, thanks. Thanks a lot. We will get right
on that.
So it seemed to me also that just sharing information is
important, that when we have best practices or lessons
learned--in the military, we would call them lessons
identified, because it seems like we constantly are identifying
issues but we are not learning them--how do we share them
across both, you know, the levels of Government and how do we
share them across metropolitan areas?
That should not be very costly, just being able to share
information.
Ms. Raphael or Dr. Cairns, do you have any comments on--it
seems to me we could do that kind-of on the cheap, you know,
just setting up procedures to collaborate and share
information.
Ms. Raphael. Sure. So, I mean, I think New York City
certainly recognizes that we outresource many jurisdictions and
we are much further along in our planning. So we always welcome
the opportunity to present on our work, share our work. We see
a lot of what we are doing as really a National model. So we
take that very seriously. We just spent last week at an annual
preparedness summit, where we did a number of presentations and
had a lot of interest in the work we are doing.
I have, over many years now, stressed to both CDC and ASPR
that they have a very particular perspective, in terms of who
is strong in what, and that they should really be sharing that
information. They are assessing, essentially--they have a
viewpoint of where each jurisdiction is in their capability
development. I think they could be doing more to match those
that are stronger in certain capabilities with those that are
weaker. But it is only the Federal Government that I think has
that higher level of perspective.
Ms. McSally. Dr. Cairns.
Dr. Cairns. I agree that we need to share information and,
frankly, need to share data, not just with local groups and the
Federal Government but across the Federal Government.
The National Biosurveillance Integration Center, for
example, has been kind-of pigeonholed into looking at open-
source data, and my understanding is that they are not getting
data from the CDC BioSense Program, for example. So having data
shared across Federal agencies and made available to State and
local officials who have this responsibility to respond and
understand the situation and employ countermeasures would be a
very valuable step forward.
Speaking of the VA, you know, I think there is a real
opportunity to utilize the VA system and VA data, which is
standardized and available across the country, but those data
aren't integrated into the system either.
So I think having shared data, shared information, and a
collective response to this issue of preparedness as well as
countermeasures would be a very valuable first step.
Ms. McSally. Great.
Senator Talent, final comments on that?
Mr. Talent. Just 30 seconds. We haven't mentioned
remediation here with the last link in the chain. Anthrax is
the classic one. That could be an area, also, where the Federal
Government--we all could act pretty much as a Government.
I mean, I have often thought that this capacity ought to be
resident maybe in DOD or the Reserves because they do so much
anyway in terms of chem-bio, in terms of battlefield
preparation. It is not fair to task all these localities to
come up with their own remediation when you really only need,
like, one team that can go in and do it.
I bet that could be done pretty inexpensively, too. I
wouldn't just add it without any funding, but we need the
ability to come in and clean up. You know how long it took them
to clean up the Hart Building after Senator Daschle's office
got--it took 6 months, I think, or longer.
So that is another area you could explore.
Ms. McSally. Great. Thank you.
You just reminded me--I know we are out of time here, but
the use of the National Guard, is that a part of, Ms. Raphael,
your planning for distribution?
Ms. Raphael. So, just to note, we did use the National
Guard for our Hurricane Sandy response. They were a prominent
part of our response, but it is not currently our plan. So
something that has been drilled in State and locals from very
early on is that you need to be ready to prepare at that level.
You know, yes, Federal Government will provide assistance, but
don't, sort-of, bank on that on the first hours. So all of our
staffing is sort of local-based.
That said, the two things we are really asking of Federal
Government is, No. 1, to give us access to their non-mission-
critical staff that are locally-based. As I mentioned, we need
a lot of staff to run these PODs. We need to run them in 48
hours and get meds into people as quickly as possible. So that
is something we have been really pushing for.
Then the other thing we are completely dependent on the
Federal Government for is the Strategic National Stockpile. We
are in a position where our distribution plans are so advanced
that we are ready to open before the medications arrive. We
will literally be ready, public standing at the door, and we
will not have the medication. That is just a huge problem.
Ms. McSally. Okay. Great. Thank you.
My time is very expired, so I will hand it over to Mr.
Payne now.
Mr. Payne. Thank you, Madam Chairman.
Deputy Commissioner Raphael, I understand that the RAMPEx
began with a fictitious BioWatch Actionable Result, or BAR.
What happens after a BAR? Does the Federal Government provide
adequate support in evaluating how to respond to a BAR?
Ms. Raphael. Funny you should ask that. So, you know, we,
sort of, got these BioWatch filters and were told: Okay, figure
out what you are going to do with them. So, we have no funding,
so we have figured out, sort-of, at the local level what we
would do if there was a positive hit.
Something we have been asking of the Federal Government for
literally years is for there to be some sort of interagency
working group among all the different Federal agencies so we
could understand what every Federal agency's role is. Because
it is not clear to us exactly what the Federal Government would
do in the case of there being a positive result.
We know what we will do as a city. Obviously, requesting
and receiving the SNS as quickly as possible will be a key
component to that. But in regards to some of the remediation
issues, a lot of those issues are really outstanding, and we
really need the Federal Government's help.
Mr. Payne. Thank you.
Also, during the Ebola crisis last fall, you know, State
and local public health organizations and hospitals were
bombarded with guidance materials and updated protocols.
Can you talk about what worked and what needed improvement
with respect to the Federal Government's efforts to push
guidance and other information out to the local and public
health organizations?
Ms. Raphael. So I think one thing that would be helpful, to
the extent possible, is having some sort of State and local
representation on some of these guidance discussions so that
there is an understanding of what it would mean on the ground
in terms of implementation, or at least having more of a heads-
up in terms of what is coming.
Because I think a huge challenge for us was constantly
changing guidance on a regular basis. Here we were, trying to
implement a response, be flexible, be nimble, and then the
guidance would change the next day.
So I think, you know, having thoughtful guidance coming
out, with appropriate input into the process.
Mr. Payne. Okay.
Just one last question to Ms. Raphael. I felt like you
weren't given much opportunity, so I am going to focus down
your alley for a bit.
But, you know, in your testimony, you discussed the
planning for role abandonment--basically, workers not showing
up to operate the PODs. What can the Federal Government do to
help prevent role abandonment?
Ms. Raphael. Give us money.
So I think the most important----
Mr. Payne. Never mind.
Ms. Raphael. No, I mean, continue to provide us with
funding.
I think the No. 1 investment for us as New York City--you
know, I think we have been held up as a best practice. The
reason why our planning is so advanced is because we have
dedicated staff that are working on this every day.
Some of the advancements include pre-identifying and pre-
assigning every single health department staff to a POD role,
to a POD site. They know exactly what POD location they are
going to. They are assigned based on their home address so that
they can walk there if mass transit goes down.
We pre-developed, sort-of, phase one PODs, where we have
pre-identified the first 30 through 80 PODs that would open up.
Everyone knows what those are; the police department knows what
they are. We literally hit a switch, and it happens.
So I think we just really need sustained funding to
maintain this capability. If the funding goes down more or goes
away, we will not have this capability.
Mr. Payne. Thank you.
You know, just in wrapping up, you know, those are the type
of examples that deserve funding. If, you know, you are being
that conscientious and that dedicated to it, those best
practices and the things that you are doing in New York City
should be held up as an example of what and how to do this and,
based on your success rate, all should be part of the factor in
funding, I believe.
So thank you to all of the witnesses today.
Madam Chairman, I yield back.
Ms. McSally. Thank you, Mr. Payne.
I thank all the witnesses here today and your testimony.
This is the start of a discussion with this subcommittee. For
sure, there is a lot more work to be done, and I think we will
be probably following up with you, additional questions on
individuals we can meet with or in our other role of oversight,
in addition to hearings on legislation to address some of these
issues.
So I really appreciate your testimony today and your
expertise and what you are doing to address this threat.
Members of the subcommittee may have additional questions
for you in writing, and so we will pass those on to you if they
do. Pursuant to committee rule 7(e), the hearing record will be
open for 10 days for those questions.
Without objection, the subcommittee stands adjourned.
[Whereupon, at 11:17 a.m., the subcommittee was adjourned.]
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