[House Hearing, 113 Congress]
[From the U.S. Government Publishing Office]
BIOTERRORISM: ASSESSING THE THREAT
=======================================================================
HEARING
before the
SUBCOMMITTEE ON EMERGENCY
PREPAREDNESS, RESPONSE,
AND COMMUNICATIONS
of the
COMMITTEE ON HOMELAND SECURITY
HOUSE OF REPRESENTATIVES
ONE HUNDRED THIRTEENTH CONGRESS
SECOND SESSION
__________
FEBRUARY 11, 2014
__________
Serial No. 113-51
__________
Printed for the use of the Committee on Homeland Security
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Available via the World Wide Web: http://www.gpo.gov/fdsys/
__________
U.S. GOVERNMENT PRINTING OFFICE
88-168 PDF WASHINGTON : 2014
-----------------------------------------------------------------------
For sale by the Superintendent of Documents, U.S. Government Printing
Office Internet: bookstore.gpo.gov Phone: toll free (866) 512-1800;
DC area (202) 512-1800 Fax: (202) 512-2250 Mail: Stop SSOP,
Washington, DC 20402-0001
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
Paul C. Broun, Georgia Yvette D. Clarke, New York
Candice S. Miller, Michigan, Vice Brian Higgins, New York
Chair Cedric L. Richmond, Louisiana
Patrick Meehan, Pennsylvania William R. Keating, Massachusetts
Jeff Duncan, South Carolina Ron Barber, Arizona
Tom Marino, Pennsylvania Dondald M. Payne, Jr., New Jersey
Jason Chaffetz, Utah Beto O'Rourke, Texas
Steven M. Palazzo, Mississippi Tulsi Gabbard, Hawaii
Lou Barletta, Pennsylvania Filemon Vela, Texas
Richard Hudson, North Carolina Steven A. Horsford, Nevada
Steve Daines, Montana Eric Swalwell, California
Susan W. Brooks, Indiana
Scott Perry, Pennsylvania
Mark Sanford, South Carolina
Vacancy
Vacancy, Staff Director
Michael Geffroy, Deputy Staff Director/Chief Counsel
Michael S. Twinchek, Chief Clerk
I. Lanier Avant, Minority Staff Director
------
SUBCOMMITTEE ON EMERGENCY PREPAREDNESS, RESPONSE, AND COMMUNICATIONS
Susan W. Brooks, Indiana, Chairwoman
Peter T. King, New York Donald M. Payne, Jr., New Jersey
Steven M. Palazzo, Mississippi, Yvette D. Clarke, New York
Vice Chair Brian Higgins, New York
Scott Perry, Pennsylvania Bennie G. Thompson, Mississippi
Mark Sanford, South Carolina (ex officio)
Michael T. McCaul, Texas (ex
officio)
Eric B. Heighberger, Subcommittee Staff Director
Deborah Jordan, Subcommittee Clerk
C O N T E N T S
----------
Page
Statements
The Honorable Susan W. Brooks, a Representative in Congress From
the State of Indiana, and Chairwoman, Subcommittee on Emergency
Preparedness, Response, and Communications..................... 1
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................................................. 3
Prepared Statement............................................. 4
The Honorable Bennie G. Thompson, a Representative in Congress
From the State of Mississippi, and Ranking Member, Committee on
Homeland Security:
Prepared Statement............................................. 5
Witnesses
Dr. Robert P. Kadlec, Former Special Assistant to the President
for Biodefense:
Oral Statement................................................. 7
Prepared Statement............................................. 8
Dr. Tom Inglesby, CEO and Director, UPMC Center for Health
Security:
Oral Statement................................................. 13
Prepared Statement............................................. 15
Dr. Leonard A. Cole, Director, Terror Medicine and Security,
Department of Emergency Medicine, Rutgers New Jersey Medical
School:
Oral Statement................................................. 19
Prepared Statement............................................. 21
For the Record
The Honorable Susan W. Brooks, a Representative in Congress From
the State of Indiana, and Chairwoman, Subcommittee on Emergency
Preparedness, Response, and Communications:
Bio-Response Report Card....................................... 34
Appendix
Questions From Honorable Steven M. Palazzo for Robert P. Kadlec.. 41
Questions From Honorable Steven M. Palazzo for Tom Inglesby...... 41
Questions From Honorable Steven M. Palazzo for Leonard A. Cole... 42
BIOTERRORISM: ASSESSING THE THREAT
----------
Tuesday, February 11, 2014
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 10:05 a.m., in
Room 311, Cannon House Office Building, Hon. Susan W. Brooks
[Chairwoman of the subcommittee] presiding.
Present: Representatives Brooks, King, Palazzo, Perry,
Sanford, Payne, Clarke, Higgins, and Thompson (ex officio).
Also present: Representative Pascrell.
Mrs. Brooks. The Subcommittee on Emergency Preparedness,
Response, and Communications will come to order. The
subcommittee is meeting today to receive testimony on the
threat of bioterrorism.
Mr. Payne. Madam Chairwoman, I ask unanimous consent that
the gentleman from New Jersey, Mr. Pascrell, be allowed to sit
for the purpose of questioning the witnesses at our hearing
today.
Mrs. Brooks. Without objection, so ordered.
Today's hearing is part of the oversight work this
subcommittee has conducted and will be conducting on
bioterrorism and the Department of Homeland Security's
biosurveillance capabilities. As a former U.S. Attorney for the
Southern District of the Indiana appointed in October 2001, I
was involved in the National response and alert surrounding the
anthrax attacks in 2001. We know that while it has been more
than a decade, we still need to be reminded that these attacks
killed 5 people and sickened at least 20 others. These attacks
showed us both the physical and psychological impacts of a
bioterrorism event and they were a reminder that a small amount
of a biological agent can have a large impact.
In his 2003 report, ``Catastrophic Bioterrorism, What is to
Be Done,'' Richard Danzig noted that the 1 gram of anthrax,
which I might note is about a sugar-packet size, was sent to
Senator Leahy, it contained a trillion spores, an amount that
if effectively dispersed, could kill thousands of people and
could cause great economic damage. I don't say this to be an
alarmist, but we must be aware of all of the threats that we
face. I fear that over the course of time, people have lost
sight of the potential impacts of such an attack and why we
must remain vigilant and prepared, and because of this, I think
this hearing is very important to, again, talk about this
threat and what we are doing about it.
In addition to this hearing, the subcommittee is also doing
several other activities surrounding bioterrorism and
biosurveillance. At the request of Ranking Member Payne and
myself, as well as the Chairman and Ranking Member of the full
committee, the GAO is conducting a review of the National
Biosurveillance Integration Center to determine whether the
NBIC is working to its potential, whether it is providing value
to the Federal participants and whether it continues to be
worthy of our vital National security dollars. The subcommittee
is also continuing its oversight of the BioWatch program, the
Office of Health Affairs' flagship program designed to detect
aerosolized bioterror agents.
BioWatch is at a crossroads, and Members may recall that
this subcommittee requested a GAO review of the program in
112th Congress, which was released in September 2012. Among its
recommendations was that the Department complete an analysis of
alternatives for the Generation III, or Gen-3, system to
determine whether or not this approach is the right way to go,
and the Institute for Defense Analysis completed this analysis
and delivered the results to the Department late last year. It
is my understanding that the Department is currently reviewing
the AOA and considering options for the future of the program.
I urge them, and as we will discuss with Secretary Johnson
who will be before us tomorrow, before the full committee, to
thoughtfully consider the results of the AOA to determine the
most appropriate path forward for the BioWatch program. I look
forward to receiving testimony from the Department on this
issue in the near future.
As the foundation of this future work, we are meeting today
to receive an update on the bioterrorism threat, and we know
the threat is real. In testimony before this subcommittee in
the 112th Congress, former Senator Jim Talent, vice chair of
the WMD Commission reminded us of the Commission's finding that
it was likely that there would be an WMD attack somewhere in
the world by the end of 2013 and that, in their judgment, the
attack was more likely to be biological.
Bioweapons can be developed surreptitiously, transported
with relative ease and deployed insidiously over time.
Obviously, as we all know, the attack in Syria was just that
sort of an attack, with respect to an attack that the WMD
Commission predicted.
We have no reason to believe that the threat has changed
since that testimony. In materials prepared for his appearance
before the House Intelligence Committee just last week,
Director of National Intelligence, James Clapper, noted that
the intelligence community remains focused on the proliferation
of chemical and biological warfare-related materials and
development of WMD delivery systems.
In addition to nation-state actors, the intelligence
community has also judged that groups like al-Qaeda and its
affiliates are intent on conducting CBRN attacks against the
United States. So, I am pleased that we will be receiving
testimony from such a distinguished panel of witnesses today to
put this threat into perspective. I will note for the Members
that we are planning to follow up this hearing with a
Classified briefing on the threat later this month, and with
that, I look forward to the testimony and our discussion here
this morning.
The Chairwoman now recognizes the gentleman from New
Jersey, our Ranking Member, Mr. Payne, for any opening
statement he may have.
Mr. Payne. Good morning. First, I would like to thank
Chairwoman Brooks for holding the hearing today on the threats
posed by bioterrorism. I would also like to thank Chairwoman
Brooks for allowing my friend and my colleague, my mentor from
the Garden State, Congressman Bill Pascrell, to participate in
today's important hearing. As a former Member of the committee
and a leader on bioterrorism issues, I know we will benefit
from his expertise.
I commend Mr.--I commend both Mr. Pascrell and Mr. King,
the lead sponsors on the WMD Prevention and Preparedness Act,
for their efforts to comprehensively address the threats that
are posed by weapons of mass destruction, particularly
biological weapons. I admire their bipartisan effort and their
persistence in championing this legislation that will implement
many of the recommendations of the bipartisan WMD Commission. I
look forward to doing my part to help advance the bill.
As a freshman Member, I appreciate this opportunity to
explore threats posed by weapons, weaponized pathogens, and
what we can do as legislators to address them. During my
preparation for this hearing, two things stuck out to me.
First, without a special assistant to the President for
biodefense, there does not appear to be a unified coordinated
effort for addressing these threats posed by biological
weapons.
Second, we are not where we need to be with respect to
caring for children in the event of a biological attack.
To my first point, it seems that the Federal effort to
address bioterrorism ebbs and flows. In December 2009,
President Obama signed an Executive Order that outlined a
process for the Federal Government to deliver medical
countermeasures. Shortly after the administration created a
Federal working group tasked with designating this high-risk
Tier 1 biological select agents and toxins, the release in July
2012 of National strategy on biosurveillance--biosurveillance
that emphasized the need to coordinate among Federal, State,
and local governments, the private sector was a really positive
step.
However, since that time, specifics on how to carry out the
strategy have not been forthcoming. As a result, efforts
continue to be disjointed. I am not alone in reaching this
conclusion. GAO stated in its testimony before this
subcommittee in 2012 that the National biosurveillance efforts
continue to be without a system to determine current resources,
ask assessed risk, and prioritize investment. This mission is
too critical to be without a coordinated and consistent Federal
framework.
To my second point, I am concerned, as a Nation, we have
not done enough to ensure in the event of a biological attack,
children get the care that they need. It is well-understood
that as a population, children may experience biological
reactions to weaponized pathogens more quickly than adults.
There is a very healthy and active debate about the development
and provision of countermeasures to children.
Last April, the GAO reported that 40 percent of
countermeasures in the strategic National stockpile were not
approved for the use on children. I understand that last--I
understand that last year, the President's Commission for the
study on biological--bioethical issues released a report
entitled, ``Safeguarding Children, Pediatric Countermeasures
Research'' to make recommendations about carrying out research
for medical countermeasures for children.
Aside from the question of developing and stockpiling
countermeasures for children, there is the matter of treating
children in such a disaster. I am concerned that in recent
years, the advent of the Federal support for public health such
as a termination of funding for the Metropolitan Medical
Response System and its vital programs, local public health
personnel do not have the training necessary to treat the
unique needs of children who have been exposed to weaponized
pathogens. I look forward to learning more about these issues
from our witnesses.
I want to thank the witnesses for being here today, and I
look forward to their testimony, and I yield back. But Madam
Chairwoman, before I yield back--that was in the script, but
before I yield back, you know, I had a situation when I was
president of the Newark Municipal Council that an envelope was
mailed to my home and mailed to several other council members
during our tenure, and one of my children's jobs is to get the
mail. Luckily, this day, my wife picked the mail up and a
powdery substance had been mailed to my home and several other
council members. The other council members, it was mailed to
City Hall, but this one was mailed to my home.
So, you know, I have an experience with what this could
potentially be and mean to citizens that we are here to protect
and serve, so I just wanted to add that, that this is very,
very important work we are doing and the witnesses and very
personal to me and what it means to children. Thank you.
[The statement of Ranking Member Payne follows:]
Statement of Ranking Member Donald M. Payne, Jr.
February 11, 2014
As a former Member of the Committee, and a leader on bioterrorism
issues, I know we will all benefit from his expertise. I commend both
Mr. Pascrell and Mr. King--the lead sponsors of ``the WMD Prevention
and Preparedness Act''--for their efforts to comprehensively address
the threats posed by Weapons of Mass Destruction--particularly
biological weapons. I admire their bipartisan effort--and persistence--
in championing legislation that will implement many of the
recommendations of the bipartisan WMD Commission. I look forward to
doing my part to help advance the bill.
As a Freshman Member, I appreciate this opportunity to explore the
threats posed by weaponized pathogens and what we can do, as
legislators, to address them. During my preparation for this hearing,
two things stuck out to me. First, without a special assistant to the
President for biodefense, there does not appear to be a unified,
coordinated effort for addressing the threats posed by biological
weapons. Second, we are not where we need to be with respect to caring
for children in the event of a biological attack.
To my first point, it seems that the Federal effort to address bio-
terrorism ebbs and flows. In December 2009, President Obama signed an
Executive Order that outlined a process for the Federal Government to
deliver medical countermeasures. Shortly thereafter, the administration
created a Federal working group tasked with designating the highest
risk or ``Tier 1'' biological select agents and toxins.
The release, in July 2012, of a National Strategy on
Biosurveillance that emphasized the need to coordinate among Federal,
State, and local governments and the private sector was a positive
step. However, since that time, specifics on how to carry out the
Strategy have not been forthcoming. As a result, efforts continue to be
disjointed.
I am not alone in reaching this conclusion, GAO stated in its
testimony before this subcommittee in 2012 that National
biosurveillance efforts continue to be without a system to determine
current resources, assess risk, and prioritize investments. This
mission is too critical to be without a coordinated and consistent
Federal framework.
To my second point, I am concerned that, as a Nation, we have not
done enough to ensure that, in the event of a biological attack,
children get the care they need. It is well-understood that, as a
population, children may experience biological reactions to weaponized
pathogens more quickly than adults.
There is a very healthy and active debate about the development and
provision of countermeasures to children. Last April, the GAO reported
that 40 percent of the countermeasures in the Strategic National
Stockpile were not approved for use on children. I understand that,
last year, the President's Commission for the Study of Bioethical
Issues released a report entitled Safeguarding Children: Pediatric
Countermeasure Research, to make recommendations about carrying out
research for medical countermeasures for children. Aside from the
questions of developing and stockpiling countermeasures for children,
there is the matter of treating children in such a disaster.
I am concerned that, in recent years, the advent of less Federal
support for public health--such as the termination of funding for the
Metropolitan Medical Response System and other vital programs--local
public health personnel do not have the training necessary to treat the
unique needs of children who have been exposed to weaponized pathogens.
I look forward to learning more about these issues from our witnesses.
Mrs. Brooks. Thank you, Congressman Payne, and thanks for
reminding me that we also had an incident when I was U.S.
Attorney a couple--I think on more than one occasion where
letters were mailed to our office as Federal employees and with
powder and the office had to go through the emergency
procedures and HAZMAT teams were called to test it and so
forth, and so--and you know, we just saw very recently what
happened in Sochi, or I am sorry, at the Super Bowl, rather,
with hotels, with powder being sent to various hotels, and so,
I think you reminded us of the psychological impact and the
fear that doing something as simple as going and getting the
mail can have on your family, so thank you for sharing that.
Members are reminded that additional statements may be
submitted for the record.
[The statement of Ranking Member Thompson follows:]
Statement of Ranking Member Bennie G. Thompson
February 11, 2014
I understand that Congressman Pascrell and Congressman King plan to
reintroduce the WMD Prevention and Preparedness Act today. I commend
both of them on their efforts to improve WMD preparedness, response,
and recovery in a bipartisan manner.
Their bill has been approved by the full committee twice. With any
luck, maybe the third time will be the charm, and this critical
legislation will finally get due consideration by the full House.
Enactment of this measure will strengthen our Nation's homeland
security posture in very meaningful ways--particularly in the area of
bio-defense.
Over the past 10 years, we have invested over $60 billion in bio-
security programs. Nevertheless, most of the assessments I have seen
indicate that the United States is not where it needs to be with
respect to preventing and responding to a large-scale biological
attack. The legislation authored by Mr. Pascrell and Mr. King would
begin the effort of building a robust biodefense enterprise.
In addition, it would ensure that first responders have the
committed and collaborative Federal partner needed to address the
unique issues of a potential WMD attack.
Importantly, the bill reauthorizes the Metropolitan Medical
Response System (MMRS). This critical grant program has not been funded
since 2011, and its authorization has lapsed. The MMRS reauthorization
language included in this bill would provide grants to metropolitan
areas to bolster medical surge capacity, strengthen capabilities, and
improve biological response and decontamination activities.
State and local public health departments have been hit hard by
budget cuts, and they need MMRS. I am committed to seeing the WMD bill
become law, but I know there are obstacles in its path. As we work to
resolve those issues, I hope that the legislation can be the
springboard for discussion, and that it will keep the issue of
biodefense and WMD on the front burner. I thank the witnesses for being
here, and I look forward to their testimony.
Mrs. Brooks. We are pleased this morning to have a very
distinguished panel before us on this important topic. Dr.
Robert Kadlec served 26 years as an officer and physician in
the United States Air Force where he held senior positions in
the Executive and Legislative branches. Until January 2009, Dr.
Kadlec served as the special assistant to the President and
senior director for biodefense policy on the Homeland Security
Council. While on the Homeland Security Council, Dr. Kadlec
drafted the National Biodefense Policy for the 21st Century,
which became Homeland Security Presidential Policy Directive
10. He was also the staff director of the Senate Committee on
Health, Education, Labor, and Pension's Subcommittee for
Bioterrorism and Public Health Preparedness.
Next is Dr. Tom Inglesby, who is the director of the UPMC
Center for Health Security. He serves as a co-chair of the
National Health Security Preparedness Index Initiative and has
also been a chair or a member of a number of National Academy
of Sciences committees. He is coeditor-in-chief of the journal
Biosecurity and Bioterrorism: Biodefense Strategy, Practice and
Science and is an associate professor of medicine and public
health at the University of Pittsburgh Schools of Medicine and
Public Health. I now yield to the Ranking Member to introduce
our next witness.
Mr. Payne. Thank you, Madam Chairwoman. I am pleased to
introduce Dr. Leonard Cole, an expert on bioterrorism and on
terror medicine. Dr. Cole is an adjunct professor at the
University of Medicine and Dentistry of New Jersey, where he is
the director on the program of terror medicine and security,
which is part of the University's centers for biodefense. Dr.
Cole serves on the advisory board of the International
Institute of Counterterrorism and is a trustee of the
Washington Institute for Near East Policy.
He has written numerous articles for professional journals
as well as general publications, including The New York Times,
Washington Post, Scientific American, and the Sciences.
Let's see. Dr. Cole received a BA with the highest honors
from University of California at Berkley. He holds a master's
degree and Ph.D. in political science from Columbia University
and a doctorate from the University of Pennsylvania School of
Dental Medicine, which in 2008 awarded him its alumni award of
merit. We are happy to have him testify before us, the
committee today.
Mrs. Brooks. Thank you. Just to remind you as witnesses
before us, it is a green, yellow, red light, and the green will
go on when you begin testifying and the yellow light comes on
when you have a minute left in your testimony, and so if you
could do your best to wrap up in that last minute, that would
be terrific so we can hear from all of you.
So the full written statements will appear in the record,
and we appreciate the time and effort that went into preparing
those full written statements, and the Chairwoman now
recognizes Dr. Kadlec for 5 minutes.
STATEMENT OF ROBERT P. KADLEC, FORMER SPECIAL ASSISTANT TO THE
PRESIDENT FOR BIODEFENSE
Dr. Kadlec. Thank you, Madam Chairwoman Brooks and Ranking
Member Payne. It is a privilege to appear before you today, and
Members of the subcommittee, to talk about this serious
National security issue. It doesn't receive the kind of
attention or consideration that it deserves. I would like to
commend the committee for taking the time and effort to raise
awareness and inform the public about it.
Congress plays a vital leadership role through hearings
like this authorizing important programs and appropriating
sufficient funds to ensure the means to protect America and
Americans from this threat. The risk of BW's attacks is not an
easy problem to talk about. Frankly, it scares people. The
deliberate use of biological agents or toxins is as distinct
from natural diseases and highlights a fundamental principle
not found in nature, the efforts of a thinking enemy to inflict
death, incapacitation, or economic loss by confounding
diagnosis and frustrating treatment.
Adversaries who use BW are intent on creating conditions
that are not found in nature, aerosolizing overwhelming doses
to infect large numbers of people with agents that are more
virulent than natural strains and resistant to common forms of
treatment.
Conflating deliberate and natural infectious diseases
implies that by addressing the more common natural problem, the
solution will be sufficient to address the BW threat. It is
not. To confront this threat effectively requires an
understanding of its fundamental principle, and I am afraid we
have not done so yet. It is a threat that could result in a
significant loss of life, severe economic losses, and cause
social instability and forever change our way of life. Simply
stated, BW can kill as many people or more than the nuclear
weapon. The technological barriers to achieve this potential
are significantly less for nuclear weapons. Graham Allison, the
founding dean of Harvard's John F. Kennedy School of Government
and a leader and an expert on nuclear proliferation said,
``Nuclear terrorism is a preventable catastrophe, and the
reason it is preventable is because the material to make a
nuclear bomb can't be made by terrorists. Can I prevent
terrorists from getting it into their hands anthrax or other
pathogens? No. Even our best efforts can't do that. The fact
that it has not yet happened may be luck that is undoubtedly
assisted by the efforts of the U.S. military intelligence
community disrupting terrorist groups.''
Madam Chairwoman, I think you noted the testimony by
national--Director of National Intelligence, James Clapper,
that starkly conveyed the reality that we find ourselves in.
The global trends emerging for the risk of BW are alarming, and
in addition to those that he outlined in terms of the dual-use
nature of this technology diffusing globally, complicating this
picture is the discipline of synthetic biology. The World
Health Organization has assessed that advances in synthetic
biology now permits adversaries to recreate pathogens no longer
found in nature such as smallpox. General Clapper also noted
that elements of serious BW program might have progressed
beyond research and development, and might have achieved
limited agent production. In an environment where a variety of
radical Islamic groups, some aligned with al-Qaeda, the risk
that 1 or 2 kilograms of anthrax could fall into the hands of
terrorists should motivate us significantly to improve our
preparedness.
During my tenure as a special assistant to the President,
we evaluated and modeled the human and economic impact that a
couple of grams, kilograms of anthrax could have on a major
metropolitan area. Such an attack could threaten millions, kill
several hundred thousand, and result in a direct economic
impact of greater than $1 trillion.
As good as our intelligence is, it can never be perfect.
The 2005 Commission on the Intelligence Capabilities of the
United States regarding WMD characterized the biological threat
has the greatest intelligence challenge. According to a senior
CIA official interviewed for that report, we don't know more
about the BW threat than we did 5 years ago, and 5 years from
now, we will know even less.
Our intelligence was less than perfect in identifying the
al-Qaeda clandestine BW weapons laboratory in Afghanistan prior
to the invasion of the United States in the 2002. The
possibility and probability that al-Qaeda may still harbor the
strategic intent and may still pursue BW capabilities to attack
the United States should be sufficient impetus. The risk of
surprise is great and more preparedness, not less, is our
greatest insurance policy. It requires a champion in Congress
and in the White House and continued support of programs like
BioWatch, the biothreat risk assessment, National Biodefense
Analysis and Countermeasures Center, as well as programs at HHS
for biosurveillance, BARDA, BioShield, and Strategic National
Stockpile.
Finally, it also requires promoting vaccinations of first
responders against the most likely biological threats and means
for home medical kids to protect first responders and their
families. The risk of bioattacks in the United States is an
uncertain yet imminent reality. It requires a credible and
rapid means to detect, mitigate such attacks, and equally
credible means to attribute and hold those accountable. I thank
you for this opportunity and look forward to your questions.
[The prepared statement of Dr. Kadlec follows:]
Prepared Statement of Robert P. Kadlec
February 11, 2014
Madame Chairwoman Brooks and Ranking Member Payne it is a privilege
and honor to appear before you and Members of this subcommittee to talk
about a very important National security issue: Bioterrorism and
biological warfare. It is a subject that has not received the kind of
attention or consideration that it deserves and I would like to commend
the committee for taking the time and effort to raise awareness and
inform the public about it. Congress plays a vital role in confronting
this threat through hearings like this, authorizing important programs,
and appropriating the necessary funds to ensure we have the means and
medical countermeasures to deter and if necessary protect America and
Americans from this threat.
Talking about the threat I am always reminded of the sage words of
Dr. Joshua Lederberg, Nobel Prize-winning microbiologist who said ``I
am very worried about this (bioterrorism) but hardly dare to mention it
for fear of putting an evil idea in someone's head.'' His words
resonant constantly with me and serve as a practical warning. But, the
practical reality argues that in a democracy we must talk about these
otherwise unspeakable threats in a responsible way to inform, not to
incite. If no one talks about the risks of biowarfare (BW) or
bioterrorism (BT); few in Government will think about it, much less act
to do the necessary things to protect America and Americans.
The risk of deliberate biological attacks is not an easy problem to
talk about. Frankly, it scares people. In today's public discourse, we
usually hear the risk embedded in the phrase natural, accidental, and
deliberate disease threats.
Somehow if we cloak it with other infectious disease threats that
emerge from Mother Nature it is easier to contemplate or accept. We do
ourselves, however, a great disservice by doing so.
The deliberate use of biological agents or toxins to achieve
strategic military and political objectives invokes a fundamental
principle not found in nature--the efforts of a thinking enemy to use
biological agents to inflict death, incapacitation, or economic loss by
using biological agents to confound diagnosis and frustrate treatment.
The military or terrorist intent is to create conditions that are not
found in nature or with natural disease epidemiology: Aerosolizing
overwhelming doses of infectious agents to infect large numbers of
people simultaneously with agents that are not naturally endemic and
are likely to have been engineered to be more virulent than natural
strains and resistant to common forms of treatment.
Conflating deliberate and natural disease threats somehow implies
that by addressing the more common Mother Nature problem, the solution
will be sufficient to address the deliberate biological threat. It is
not. To understand this threat and confront it effectively is to
understand this fundamental principle. I am afraid, we as a Nation and
Government do not fully comprehend the kind of threat we are talking
about today.
Fortunately, unlike cyber attacks which occur with some frequency
and have received media notoriety, deliberate biological attacks have
been very few and far between. It is, however, a threat that could
result in enormous loss of life, severe economic losses, cause social
instability, and forever change our way of life. Simply stated,
biological weapons have the power to kill as many or more people as a
nuclear weapon. The technological barriers to achieve this potential
are significantly less than for nuclear weapons. The fact it has not
happened yet may be more a matter of luck and the superb efforts of the
U.S. military and intelligence community than restraint or
unwillingness on the part of terrorists.
The trends emerging around the potential threat of deliberate use
of biological agents are alarming. The dual-use means to cultivate,
grow, and produce biological agents in quantities sufficient for
nefarious use has grown smaller and more efficient, harder to locate,
and diffused globally. This technology and know-how are increasingly
becoming available to wider group of potential adversaries. In the
past, BW was a capability reserved for nations, now it is a potential
weapon for terrorist groups and disaffected individuals. Complicating
this picture is the discipline of synthetic biology. The World Health
Organization has assessed that advances in synthetic biology now
permits adversaries to recreate pathogens no longer found in nature
such as smallpox. It is conceivable in the not-too-distant future that
someone could design and produce a new pathogen never seen before.
One way to consider the seriousness of the threat is to observe
what Congress has said and done. Congress has mandated commissions,
enacted laws, and appropriated funds going back to the late 1990's
highlighting the risks from deliberate use of biological agents. In
1999, Senators Gary Hart and Warren Rudman highlighted the risk in
their report entitled ``A New World Coming: American Security in the
21st Century.'' It noted that the increase in information technology
and biotechnology will cause new vulnerabilities for the United States
and that the proliferation of chemical, biological, and potentially
nuclear weapons that will empower and embolden both state and not-state
actors to threaten or act against the United States.
In 2004, Congress passed the Project BioShield Act (Pub. L. No.
108-276) that appropriated $5.6 billion to create a guaranteed market
for the acquisition of medical countermeasures against chemical,
biological, radiological, and nuclear threats. An essential provision
of that law was directed the Department of Homeland Security (DHS) to
determine which biological threats pose a priority threat in order to
prioritize medical countermeasure development and acquisition. DHS uses
the Integrated Terrorism Risk Assessment findings to determine which
CBRN agents present a greater risk based on the relative risk ranking
against the U.S. population sufficient to affect National security.
Specifically, for the highest-ranked agents, DHS evaluates the
intelligence and threat information and develops and models a highly-
plausible consequence scenario taking into account acquisition,
production, dissemination efficacy, source strength, and meteorological
conditions. This model is used to derive an estimate of the number of
potentially exposed individuals at various levels of exposure, which
becomes part of the Material Threat Assessment. The estimates are
provided to the Department of Health and Human Services (HHS), which
conducts its Public Health Consequence Modeling to determine the public
health impacts.
DHS has issued about a dozen Material Threat Assessments for
biological threat agents that have served as the basis for advanced
development and acquisition of medical countermeasures by HHS. As
mandated by law, the United States is currently researching,
developing, producing, and stockpiling medical countermeasures against
a variety of biological agents such as anthrax, botulinum toxin,
smallpox, and other agents viewed as a credible BW or BT threat.
Project BioShield funding acquires the medical countermeasures that
create a powerful deterrent against this threat.
The 2008 Weapons of Mass Destruction Commission chaired by Senators
Bob Graham and Jim Talent further highlighted growing trends in the
spread of enabling technology and led to their principle finding that
the risk of a WMD attack was rising and that the terrorist use of
biological weapons was greater than the likelihood of terrorists
building or obtaining a nuclear device. Their Commission recommended
greater efforts to both prevent and respond to this threat. Their
periodic report cards indicate that we have achieved much but still
have far to go in our preparedness efforts.
The intelligence community annually reports to Congress on the
threats confronting the Nation. I note that Director of National
Intelligence James Clapper and other senior intelligence officials
testified before the House and Senate Intelligence Committees in
January of this year. Their annual assessment identifies the greatest
National security threats. General Clapper stated:
``Nation-state efforts to develop or acquire weapons of mass
destruction (WMD) and their delivery systems constitute a major threat
to the security of the United States, deployed troops, and allies. We
are focused on the threat and destabilizing effects of nuclear
proliferation, proliferation of chemical and biological warfare (CBW)-
related materials, and development of WMD delivery systems. The time
when only a few states had access to the most dangerous technologies is
past. Biological and chemical materials and technologies, almost always
dual-use, move easily in the globalized economy, as do personnel with
scientific expertise to design and use them. The latest discoveries in
the life sciences also diffuse globally and rapidly.''
He also noted note that elements of Syria's biological weapons
program might have progressed beyond research and development and might
have achieved limited agent production. In an environment where a
variety of radical Islamic groups are fighting the Syrian government,
the risk that 1 or 2 kilograms of anthrax could fall into the hands of
terrorists should make us pay serious attention. During my tenure as
the special assistant to the President for biodefense policy in the
Bush administration, we evaluated and modeled the human and economic
impact that a couple of kilograms of anthrax could have on a major
metropolitan area.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
In addition to Congress and the intelligence community's
perspectives, I would like to offer you a more personal evaluation of
the threat as it has evolved during my professional career. I come to
you as an accidental tourist as it pertains to the subject of
bioterrorism and biological warfare. My introduction came some 24 years
ago when I was a young officer and physician assigned to the Joint
Special Operations Command at Fort Bragg on the eve of the Iraqi
invasion of Kuwait. I was pressed to serve as an advisor on these
issues to then Major General Wayne A. Downing.
At that time, the U.S. military was marginally prepared to confront
a regional power that possessed chemical and biological weapons. The
military lacked the necessary protective equipment, detectors, and
medical countermeasures including vaccines and antibiotics against the
immediate threats posed by Iraq. Congress played a vital role in
rectifying those shortfalls and our military is better prepared.
While the United States was victorious in 1991, the scale and scope
of Iraq's biological weapons program remained elusive despite the most
intrusive inspection and monitoring regime ever conceived and
implemented by the United Nations Special Commission (UNSCOM). I
experienced this first-hand, as I served as a UNSCOM biological arms
inspector in 1994, 1996, and 1998. It was only after the defection of
Saddam Hussein's son, Hussein Kamel, did UNSCOM and the world learn of
the extent of Iraq's biological weapons. Even so, UNSCOM was never able
to fully account for or verify the destruction or elimination of the
biological weapons Iraq possessed or the precursors (seed stock) that
were used as part of the program.
The events in Iraq and the coincident dissolution of the Former
Soviet Union signified an important milestone in historical trend of
biological warfare. Previous to the 1990's, biological weapons were
capabilities limited to advanced nations and indeed superpowers. The
defections of high-level officials from the Soviet BW program
illuminated the size and sophistication of a program that involved an
estimated 30,000 scientists and workers and 2 dozen large-scale
facilities. The Soviets manufactured metric tons of anthrax and
smallpox to be used in war with the United States. Despite the enormous
scale and scope of the Soviet program, the disturbing fact is the U.S.
intelligence community knew little of its existence. Once again
Congress played a vital role in efforts to prevent the risk of
proliferation of nuclear and biological weapons with Soviet Threat
Reduction Act of 1991.
From Fort Bragg I was assigned to the Pentagon Office of the
Secretary of Defense for Counter-proliferation Policy that was
established after the first Gulf War. There, I witnessed the efforts to
ascertain the truth behind the former Soviet Union's BW effort. The
Trilateral Process between the United States, United Kingdom, and
Russia stalled and the government of Russia never provided a full
accounting of its BW program. The fate of these agents and associated
weapons was never satisfactorily resolved. The enigma of the Russian
program is only magnified when President Putin recently called for
exploiting new and emerging technologies to rearm Russia and mentioned
the development of genetic weapons as means ``for achieving political
and strategic goals.''
The revelations from the Former Soviet Union and Iraq all occurred
as the advances in biotechnology and molecular biology marched on in
the background. The dual-use means (both the enabling technology and
the know-how) continue to increase and diffuse around the globe. The
means are available for any nation with modest pharmaceutical
manufacturing capacity to achieve a capability with lethal equivalence
to nuclear weapons.
The concern that non-state actors could divert legitimate
biological process and equipment was realized when the Japanese cult
Aum Shinrikyo surprised the Japanese government and the world by
perpetrating a chemical nerve agent (sarin) attack in the Tokyo subway
system in 1995. While the manifestation of the Aum's intentions was a
nerve agent attack, Japanese law enforcement investigations uncovered
Aum's efforts to develop, produce, and disseminate botulinum toxin and
anthrax. The cult tried several times, fortunately unsuccessfully, to
disseminate botulinum toxin and anthrax. One attempted anthrax attack
targeted the U.S. naval installation at Yokohama. Probably, the
greatest limitation to their effort was obtaining a virulent strain of
anthrax to affect their plan. In the end they were the cult that
``could not spray straight.'' Their incompetence was fortunate for us,
but the story is not reassuring. The cult's efforts to develop both
chemical and biological weapons went unnoticed by Japanese civilian
authorities and U.S. intelligence agencies.
Following the attacks of September 11, I was recalled for service
back into the Pentagon and was there when the initial reports about
inhalational anthrax cases were first reported by the media. The
National psyche after the traumatic attacks at the World Trade Center
and the Pentagon was fragile and the anthrax letter attacks dealt
another significant blow striking fear in every American heart about
what could come next. Little did we know that the perpetrator was not
al-Qaeda but a deranged scientist.
This fear, however, and the uncertainty about the identity and
motives of the perpetrator(s) was enhanced when U.S. forces who invaded
Afghanistan uncovered a laboratory built by al-Qaeda to research,
develop, and produce anthrax (Agent X). According to the 2005
Commission on the Intelligence Capabilities of the United States
Regarding Weapons of Mass Destruction:
``al-Qa'ida's biological program was further along, particularly with
regard to Agent X, than pre-war intelligence indicated. The program was
extensive, well-organized, and operated for two years before September
11, but intelligence insights into the program were limited. The
program involved several sites in Afghanistan. Two of these sites
contained commercial equipment and were operated by individuals with
special training. Documents found indicated that while al-Qa'ida's
primary interest was Agent X, the group had considered acquiring a
variety of other biological agents. The documents obtained at the
training camp included scientific articles and handwritten notes
pertaining to Agent X.
``Reporting supports the hypothesis that al-Qa'ida had acquired several
biological agents possibly as early as 1999, and had the necessary
equipment to enable limited, basic production of Agent X. Other
reporting indicates that al-Qa'ida had succeeded in isolating cultures
of Agent X. Nevertheless, outstanding questions remain about the extent
of biological research and development in pre-war Afghanistan,
including about the reliability of the reporting described above.''
The possibility that al-Qaeda then and now may still harbor the
strategic intent and pursued capabilities to attack the United States
with biological weapons is a lingering concern that should not be
ignored.
In 2003 and 2004, I deployed to Iraq four times looking for proof
of Saddam's BW program and the existence of smallpox virus cultures. It
was difficult challenge under the tactical circumstances we encountered
and operated in. Despite finding clandestine biological laboratories
run by the Iraqi Intelligence Services, the true nature of the work and
relevance to Iraq's offensive BW effort was never ascertained. Here
again, despite owning the territory, apprehending and interviewing many
but not all the key personalities involved, and exhaustive field
investigations, the ability to uncover the truth about Iraq's BW
program was never accomplished.
The limitations of intelligence were formally noted by the 2005
Commission on the Intelligence Capabilities of the United States
Regarding Weapons of Mass Destruction. According to a senior CIA
official interviewed for that report: ``We don't know more about the
biological weapons threat than we did five years ago, and five years
from now we will know even less.'' That statement may seem astonishing
but it reflects the challenge our intelligence community faces in light
of the global diffusion of technology that enables practically anyone
with a biology degree the means to create a biological weapon.
The risk for surprise is great. Relying entirely on intelligence
assessments fails to understand the complex threat our intelligence
community confronts. Understanding and preparing for the future
biological threat will take more than intelligence. I highlight the
vital contributing role of the National Biodefense Analysis and
Countermeasure Center and two of its component entities.
The National Bioforensic Analysis Center conducts
bioforensic analysis of evidence from a biocrime or terrorist
attack to attain a ``biological fingerprint'' to help
investigators identify perpetrators and determine the origin
and method of attack. It is the lead Federal facility to
conduct and facilitate the technical forensic analysis and
interpretation of materials recovered following a biological
attack in support of the FBI.
The National Biological Threat Characterization Center
conducts studies and laboratory experiments to fill information
gaps to better understand current and future biological
threats; to assess vulnerabilities and conduct risk
assessments; and to determine potential impacts to guide the
development of countermeasures such as detectors, drugs,
vaccines, and decontamination technologies.
These Centers provide critical insights and information that help
the U.S. biodefense enterprise understand current and emerging threats.
In the case of the anthrax letters, the forerunner to the National
Bioforensic Analysis Center contributed significantly to the
investigation that led to the identification of the perpetrator of
those attacks. Bioforensics can play an important part in a BW
deterrent strategy that links timely and accurate attribution with the
credible threat of retribution to any perpetrator.
The Threat Characterization Center tests whether the hypothetical
threats are real. Using valid scientific methods performing research
and conducting experiments, the researchers there help bound a
potential infinite risk with scientific data. They help advance the
understanding of what really constitutes a threat.
I would conclude with the observation that the risk of biological
attacks on the United States with biological agents is an uncertain,
imminent reality. Our ability to predict or know when this threat will
manifest itself is severely limited by the capabilities of our
intelligence services and the wide array of potential perpetrators who
could conduct such attacks. Biological weapons could inflict grievous
harm on America, equal to and potentially greater than nuclear weapons,
and any investments to defend against them is a modest insurance policy
against an uncertain future. Our best defense remains a robust defense:
A credible and rapid means to detect and mitigate such attacks and
equally credible means to attribute and hold those accountable. I thank
you for this opportunity and look forward to assisting you further in
your efforts on this subject.
Mrs. Brooks. Thank you.
The Chairwoman now recognizes Dr. Inglesby for 5 minutes.
STATEMENT OF TOM INGLESBY, CEO AND DIRECTOR, UPMC CENTER FOR
HEALTH SECURITY
Dr. Inglesby. Madam Chairwoman, Ranking Member Payne,
Members of the subcommittee, thank you so much for the
opportunity to speak to you today about bioterrorism. The
Nation faces a number of major biological threats, rising
levels of multi-drug anti-microbial resistance, possible
pandemics of influenza, SARS, and MERS, a lab accident in which
engineered pathogens could start an epidemic, but among the
most serious of these facing the Nation is of course
bioterrorism. My three messages for the committee today are:
(1) The capability to create and use biological weapons exists
widely in the world; (2) the consequences of such weapons could
be major loss of life and societal disruption; and (3) while
progress has been made, a great deal needs to be done to build
and sustain preparedness for this threat.
The know-how to make biological weapons is now in the reach
of groups or individuals with the right scientific background.
Components for making biological weapons are on eBay, equipment
for disseminating them is in hardware stores and agricultural
supply stores. The technology is dual-use. It has both good and
dangerous practical purposes in the world. It can't be locked
away. There may be no obvious signal of bioweapons development,
and we shouldn't expect to have warning regarding its use in
the future.
The anthrax events of 2001 were shocking for the country.
Letters carrying anthrax spores sickened or killed people in a
number of States. Doctors were unfamiliar with the disease,
major parts of Government were shut down, the source couldn't
be identified. Communication from Government was very unsteady.
People were afraid of their own mail. Nothing like this had
happened before in our country or in any country.
It is important for this committee to know that a future
biological weapons attack in the United States could look quite
different from 2001 in terms of the size of attack, the form,
and the numbers affected. Future events are unlikely to come
with warnings that tell people to start antibiotics or get out
of a building. It is more likely that the first signs of a
bioterror attack will be sick people appearing in emergency
rooms.
In addition, what we learn from the 1960s U.S. bioweapons
program is that bioweapons don't cause normal infectious
disease. As Dr. Kadlec said, they cause disease that was faster
and more resistant to treatment.
A lot has been done in the last 13, 14 years to improve our
preparedness for bioterrorism. In my written testimony, I have
described some of things that the Federal agencies and at the
State and local level are doing, some of the valuable work
being done there, but there is a great deal to do going forward
to make us better-prepared. Here are some of the steps I would
recommend:
We need to support public health preparedness programs and
medical preparedness programs through the CDC PHEP program and
ASPR HPP programs. These are programs that benefit the front
lines responding to bioterrorism, and they have been cut
sharply in recent years. We should make good use of the new
National Health Security Preparedness Index. Congress and the
administration have been calling for new features of
accountability, and I think this index will help along those
lines in the future.
We absolutely need to sustain BioShield, BARDA, and the FDA
program that we need to develop medicines and vaccines against
biological threats. That process is generally working and is
crucial. We need to move ahead on biosurveillance by doing a
number of things. We need to set up programs that gather
information from where people are getting sick in hospitals and
clinics. To some extent that is going on, but we could do a
better job using electronic health records that are being built
across the country. We absolutely need to coordinate across
Federal agencies. Critical information is being collected in a
variety of Federal agencies, and it is very important to
collect that and make that viewable by all.
We need to sustain well-performing laboratories. When you
ask practitioners what kind of information they value the most
in surveillance, they always say laboratory information because
it is the most reliable. Of course, we need reliable diagnostic
tools to tell us when something is going on.
Finally, we need to work together internationally. Our
partners need the same protections that we do here in the
United States, from pandemics, from anti-microbial resistance,
and from bioterrorism, so we should work particularly hard on
building this kind of global health security going forward.
Thank you again for the chance to speak to you today, and I
look forward to your questions.
[The prepared statement of Dr. Inglesby follows:]
Prepared Statement of Tom Inglesby
February 11, 2014
Madame Chairwoman, Ranking Member Payne, and Members of the
subcommittee, thank you for the chance to speak to you today on issues
regarding the threat of bioterrorism.
My name is Tom Inglesby. I am the director and CEO of the UPMC
Center for Health Security of the University of Pittsburgh Medical
Center (UPMC) and associate professor of medicine and public health at
the University of Pittsburgh. I'm an infectious disease physician by
training.
The Center for Health Security is an independent, nonprofit
organization of UPMC. Our center's mission is to protect people from
the consequences of epidemics and disasters and to build resilience in
communities against these challenges. My colleagues and I have been
working on issues related to preparedness for bioterrorism and other
major threats for the last 15 years.
There are a number of major biological threats that confront the
Nation. Among these are the rising levels of antimicrobial resistance
in American hospitals leading to increasing numbers of untreatable
infections; the prospect of new pandemics of influenza or other novel
emerging infections like SARS or MERS; the possibility of a laboratory
accident in which engineered contagious pathogens cause epidemic
disease; and, of course the issue prompting today's hearing, the
potential for the use of biological weapons in acts of terrorism. There
are many commonalities between bioterrorism and these other biological
threats, and there are also aspects of the bioterrorism threat that
require specific, major planning and action.
My three main messages for the committee are the following:
The capability to create and use biological weapons exists
widely in the world.
The consequences of the use of such weapons could be
substantial loss of life and societal disruption.
While substantial progress has been made in past years,
there is a great deal that needs to be done to prepare to
respond to bioterrorism.
I'll elaborate on these messages in my testimony.
the capability to make biological weapons
The interest in biological weapons has been age-old in the world,
as has been the capability to use them. Biological weapons have been
used at various times in recorded human history at levels of
sophistication consistent with the time. In ancient times, biological
weapons were crude. In modern times, they became sophisticated and
highly lethal. In the 1960s, the capacity to make, disseminate, test,
and evaluate biological weapons was transformed. At that time, the U.S.
Government funded vast programs to develop biological weapons using
science and technology that was cutting-edge for those years. In those
programs, they discovered how to make aerosols more stable in the
environment; how to make particles float further; how to grow pathogens
in high quantities; how to disseminate bacteria and viruses without
inactivating them; and, much more. At the same time, other countries in
the world were also studying biological weapons with their own
dedicated, highly-funded programs.
In 1969, President Nixon unilaterally ended the U.S. offensive
program. Then in 1972 he signed the Biological Weapons Convention
saying that the United States already had enough seeds of its own
destruction. That treaty led to the end of the U.S. offensive program
and to the end of any country admitting it had a bioweapons development
program, even though a number of countries were discovered to have had
clandestine BW programs in the years since.
Now 40-some years after the signing of that treaty, the technology
and know-how that was once the domain of governments, is now within
reach of small groups of scientists around the world, even individual
scientists with the right backgrounds. The methods for making aerosols
stay airborne are widely available. The tools for making pathogens in
high quantities in fermenters are on ebay. The recipes for making
stable formulations of pathogens are on the internet. The equipment for
disseminating these weapons is in hardware or agricultural supply
stores. This information and technology is almost entirely dual-use--in
the sense that it has both legitimate and dangerous uses in the world.
It can't be locked away, and it wouldn't be in our interest to do so.
I understand that this committee will soon have a Classified
hearing on the threat assessment. That will be important in giving you
the U.S. Government assessment regarding what specific countries and
groups are doing now with respect to research or development or
stockpiling of biological weapons. All I will say related to this is
that the workforce of scientists with microbiology and related relevant
backgrounds that have enough knowledge to turn information and
technology into bioweapons is countless and global. While particular
threat briefings should help direct focus regarding specific terrorist
groups' or countries' immediate interests in pursuing biological
weapons, it is critical to understand that a country or group could
change its direction on biological weapons in short order, quite
possibly without any obvious signal. The former Soviet Union had a
massive BW program for decades that was not visible to the outside.
Given that small groups or even individuals are capable of making
biological weapons and using them, we should expect not to have
advanced warning regarding the development and their use.
In summary, the know-how and capability to create and use
biological weapons exists widely in the world. This will only grow with
time as the tools and techniques of biotechnology become more broadly
disseminated, less expensive, and valuable to growing economies
globally.
the consequences of biological weapons
The anthrax events of 2001 were shocking for the country. Letters
carrying anthrax spores were sent to a number of people in different
cities. Hospitals, doctors, and nurses at the time were largely
unfamiliar with the disease. Elements of all three branches of
Government were each affected and closed at some point. Buildings had
to be evacuated for prolonged periods. Cases appeared over weeks in
different places. A number of people were sickened and killed. The
source of the anthrax could not be identified. The communication about
it from our own Government was often uncertain and changing. The media
coverage was constant. People were afraid of their own mail. Nothing
like this had happened before in our country or any country.
A great deal has been done to improve our ability to recognize and
respond to biological weapons events since that time. I will say more
about that below. But it is important for this committee to know that a
future biological weapons attack on the United States could look quite
different that the 2001 anthrax incident--in terms of size of attack,
form, and the numbers affected.
The anthrax letters of 2001 came with a warning in them, which
allowed some people to begin taking protective antibiotics and initiate
evacuation. Future events are unlikely to come with warnings like that.
It is more likely that the first sign of a bioterror attack will be
sick people appearing in clinics and emergency rooms. And while the
anthrax letters of 2001 came through the mail, future bioterrorism
attacks could come in many different kinds of form. There are many
means of creating aerosols. And there are clearly other means of using
biological weapons against the public.
We also need to understand that the scope of future bioweapons
events could be far, far greater that what we saw in 2001. In 2009, the
U.S. National Security Council said: ``The effective dissemination of a
lethal biological agent within an unprotected population could place at
risk the lives of hundreds of thousands of people. The unmitigated
consequences of such an event could overwhelm our public health
capabilities, potentially causing an untold number of deaths. The
economic cost could exceed $1 trillion for each such incident.'' The
use of such weapons could lead to substantial loss of life and great
societal disruption. Even with a small or modest-sized attack, the
social and economic impact would be significant.
build our ability to respond
In the last 10 years, progress in preparedness has been made in a
number of areas. There are now a cadre of Government officials, public
health experts, doctors, nurses, and scientists who have become
knowledgeable and skilled in thinking through and planning for
biological terrorism. That community of experts in and out of
Government didn't exist in 2001. There are also a series of major
biopreparedness programs across the U.S. Government, some of which I
will cite here. HHS/ASPR has funded hospital preparedness programs
around the country and runs valuable programs like the National
Disaster Medical System. NIH has a basic research program for
biodefense. BARDA has developed a number of medications and vaccines
that could be critical in future bio responses. CDC has funded State
and local public health agencies to prepare for bioterrorism (among
other crises and disasters) and it oversees laboratory research in this
area, manages a strategic National stockpile of medications for use in
an emergency, and has an Emergency Operations Center that is a model
for other health agencies around the world. DHS has created a risk
assessment and threat characterization process to help guide planning.
FDA has created an office that deals explicitly with the regulation and
approval of products only to be used in the event of bioterrorism,
pandemics, or other urgencies or emergencies. The DOD and DOS have
important programs dedicated to addressing the issue overseas through
science and technology as well as cooperative threat reduction. Taken
together, these efforts, combined with the substantial hard work of
State and local public health agencies, hospitals, emergency management
and civic organizations, have put the country on a better footing in
its ability to respond to major biothreats.
Our Center's 2013 study of the U.S. Federal biodefense funding
found that 90 percent of the biodefense budget served additional
purposes beyond biodefense. The good news in that number is that these
additional purposes are valuable such as public health agency
preparedness for disasters, hospital planning for crises, and research
that improves our response to infectious diseases. The down side of
that 90 percent number is that there has been an inflated sense of what
is actually been spent on biodefense; that effort is not nearly as big
as it looks at first pass.
The more work that is done in this field, the more it becomes clear
what we still need to prepare for to respond to bioterrorism and to
sustain the preparations that have been made to date. What follows are
my recommendations for what we need to pay particular attention to in
the years ahead in terms of biopreparedness.
strengthen medical and public health preparedness
In the event of bioterrorism, the people who would be on the front
lines responding are largely comprised of public health, medical, and
hospital professionals. They will be the ones most likely to discover
that something has gone wrong and to initiate laboratory testing for
what is behind it. They are the ones who will be called to rapidly
investigate what is happening, and where and how the bioterrorism
occurred. Following an act of bioterrorism, there may be no
announcement, and there is likely to be no ``site'' that can be
cordoned off--just sick people appearing in emergency rooms and
clinics. Public health and medical leaders will be asked to advise our
political leaders on the right course of action for administering
prophylactic care to prevent illness, for treating those who are sick,
for identifying those at greatest risk of falling ill. And they will be
the ones who are providing medical care within hospitals.
Given the importance to bioterrorism preparedness of these
professionals and the agencies and institutions in which they work,
their work needs to be supported. Funding for the public health
emergency preparedness program (PHEP), which funds State and local
health agencies to prepare for bioterrorism and other disasters, has
been cut by more than $100 million in the last 5 years. In addition,
funding support for the National hospital preparedness program fell 33%
last year, and is down nearly 50% from its inception. I'm really
concerned about these reductions and trends, and how this sharp decline
in funding will weaken these programs. In fact, we are already seeing a
dramatic reduction in total per capita funding for emergency
preparedness in the States, which will inevitably results in a
reduction in our capability to respond when emergencies strike.
It is worth calling your attention to the National Health Security
Preparedness Index that was launched in December by 20 collaborating
organizations. This is a first-of-its-kind index that has as its
purpose the measurement of the level of National and State health
security preparedness. It uses 128 indicators that gauge State
capacities and capabilities in the domains of health surveillance,
incident and information management, countermeasure management,
community planning and engagement, and surge management. Based on those
indicators, scores are calculated that State and local preparedness
communities and National policy makers can use to judge how well
prepared we are, and how to continue to strengthen the collective
efforts. The overall score for the country in December was 7.2 out of
10, with varying results in the States around the country. This score
shows that we have built some capacity in a number of realms. But it
also makes clear how much more we need to do. To make these scores
improve will require focus and more resources. If, on the other hand,
resources for these key National programs continue to slide, then I am
concerned that index scores in the coming years will decline. We
shouldn't let that happen.
Another critical element of our public health and medical
preparedness is the development of medicines and vaccines for use
following a biological attack. Development of these products is a
complex, sometimes decade-long process with inherent risks of failure,
as is the case with drug and vaccine development more broadly. It is
difficult to persuade the major pharmaceutical companies to engage in
this effort because of the uncertainties of Government policy and
action, and because of the opportunity costs associated with doing this
work as opposed to other more economically-valuable opportunities. A
variety of programs and policies have been established over the years
to try to deal with this challenge. Earlier critical steps to deal with
this were the creation of the BioShield fund and the establishment of
the BARDA advanced research and development program. The loss of the
multi-year BioShield fund has been a setback for the USG effort to
develop countermeasures. It creates new uncertainty for the private
sector. The single-year BioShield appropriation for fiscal year 2014 is
about equivalent to half of what had been available annually in years
prior.
On the other hand, there has been a positive change in the way
BARDA is now funded. In past years, advanced development at BARDA had
been funded by diverting BioShield funds, which was not how the funds
were intended. Fiscal year 2014 is the first year since fiscal year
2008 that BARDA advanced research and development has received funds
from Congress directly and not from BioShield. It is important that
BARDA continue to receive appropriations that are separate and distinct
from BioShield. The purposes of BioShield and BARDA are distinct and
should be funded accordingly.
Another major contributor to success in the program to develop
countermeasures is the FDA program, established explicitly to support
the regulatory process for these medicines and vaccines. This has been
a highly successful program and should continue to get strong support.
It is worth underscoring again in the context of countermeasure
development that we really need to come to grips with what was learned
in the bioweapons programs from the 1960s. From those programs we
learned that some biological weapons did not cause illness in the same
patterns as naturally-occurring infectious diseases. Among other
things, they caused illness on an accelerated time course, and they had
the ability to overwhelm traditional treatment strategies. As we
continue to improve and build our countermeasure development efforts
and broader planning efforts, we need to make sure our planning for
today takes into account what we learned from those earlier years.
make wise investments in biosurveillance
The U.S. Government definition of biosurveillance comes from
Homeland Security Presidential Directive 21. There it is defined as
``the process of active data-gathering with appropriate analysis and
interpretation of biosphere data that might relate to disease activity
and threats to human or animal health--whether infectious, toxic,
metabolic, or otherwise, and regardless of intentional or natural
origin--in order to achieve early warning of health threats, early
detection of health events, and overall situational awareness of
disease activity.''
We need biosurveillance systems to help us detect and understand
new outbreaks and to discover specific signals related to bioterrorism
or other health events. There are many information needs that would
immediately and urgently arise following an act of bioterrorism: How
many people are sick? By what means is the disease spreading? What are
the risk factors and how do we control them? What public health
interventions are working? Are treatments working safely and
effectively? And many other related questions. We need systems that can
answers these questions.
To do this requires good information systems, analytic capability
and health expertise. At the Federal level, that means sharing
information across the agencies quickly. Information that can bear
directly on outbreak discovery and control can come from public health,
the agricultural sector, commerce, private industry, overseas disease
surveillance networks, and many other channels. Programs like NBIC that
are intended to share and organize that information across Federal
agencies and with State and local partners are critical. We should also
support innovation and research into whether we can use social media
and mobile technologies to identify outbreaks early.
At the local level, public health leaders also need information
systems that give them insight into what is happening within hospitals
during outbreaks. This requires collaboration between medical
institutions and public health agencies in ways that helps them
identify new patterns of disease in outbreaks, and gauges the
effectiveness and safety of medicines and vaccines in automated, rapid
fashion.
Disease surveillance also requires good laboratory diagnostics.
When you ask public health officials what kind of surveillance
information they place highest value on, they consistently tell you
that laboratory data is the most prized because it provides definitive
diagnosis of an illness or an outbreak. Laboratory diagnoses of serious
infectious diseases that are made in a clinic or a hospital are not
always automatically transmitted to public health officials who would
be responsible for communicating about them to the public and to
political leaders. We also need to continue to push ahead to develop
rapid diagnostic tests for bioterrorism-related and other infectious
diseases, recognizing that there is no commercial market for these
products, so they will need continued Government development support
and Government purchase.
A few words on environmental surveillance. I understand you will be
holding a future hearing on this issue. So I will only comment here to
say that there is a clear need for environmental surveillance, but it
has to work in the real-world situation where it will reside. If State
and local public health agencies are to be part of the system (and they
have expertise and tools that are needed for these systems to work),
then they need to understand and believe in the value and the
effectiveness of these systems. If State and local leaders don't have
the confidence to take action following an environmental surveillance
alarm when it goes off, then that is not a well-functioning system. So
in addition to all the development, testing, and evaluation of these
environmental systems, a continued examination and testing of how they
are actually working in places around the country is critical.
improve global health security
The work we need to do to prepare for bioterrorism has much in
common with the work we need to do to respond to pandemic influenza,
emerging infectious diseases, and antimicrobial resistance,
particularly as we work with our international partners around the
world on these challenges.
Each of these problems requires a workforce that knows how to
recognize new outbreaks and new patterns of infectious disease. Each of
them depends on scientific research to improve our understanding. Each
of these issues could cause serious response challenges in the medical
and public health communities. And in each of these realms, we have to
cope with the reality that markets themselves have not been enough to
create the new medicines, vaccines, and diagnostics that are needed.
The required preparations and responses to these issues are the same
for our international partners as they are for us. It is important to
see the ways in which working together on them makes sense and can
create valuable synergy.
In conclusion, there has been consistent progress in recent years
in our efforts to prepare for bioterrorism and related threats. But
there remains a great deal of critical work to be done. Over the last
decade, we have witnessed a slow but steady decline in attention to
bioterrorism preparedness issues, in part because we haven't
experienced another bioterror attack since 2001. But we have no
reason--from a technical perspective or consequence management
perspective--to let our guard down. I thank you for holding this
hearing to address these issues. The efforts of this committee as well
as other efforts in Congress can help to ensure we make continued
forward progress in areas of great National importance in preparing for
bioterrorism.
Mrs. Brooks. Thank you, Dr. Inglesby.
The Chairwoman now recognizes Dr. Cole for 5 minutes.
STATEMENT OF LEONARD A. COLE, DIRECTOR, TERROR MEDICINE AND
SECURITY, DEPARTMENT OF EMERGENCY MEDICINE, RUTGERS NEW JERSEY
MEDICAL SCHOOL
Dr. Cole. Thank you. Chairwoman Brooks, Ranking Member
Payne, distinguished Members of this subcommittee, and of the
larger and full Homeland Security Committee, thank you for
inviting me to speak on the threat posed by bioterrorism to the
American homeland and elsewhere. I am grateful as well to the
full committee's Chairman McCaul and Ranking Member Thompson
for their leadership on Homeland Security. Since I see he has
come back, I must also recognize the Congressman who, on many--
for many reasons I have huge regard for, and in the neighboring
county--represents people in the neighboring county to the one
I live in, so we need you on our side.
In 2012, and again last year, I was privileged to address
the Subcommittee on Counterterrorism and Intelligence during
which I referenced the 2012 paper titled, ``WMD Terrorism.''
The paper was produced by the Aspen Institute's Homeland
Security WMD Working Group of which I was a member. One of the
paper's conclusions, still valid, is that bioterrorism remains
a continuing and serious threat.
In the wake of last April's Boston Marathon bombings,
Ricin-laced letters were mailed to several public officials,
including one to President Obama. Just last week, Israel's
Supreme Court upheld an indictment against a detained
Palestinian operative for al-Qaeda who was charged with
developing biological weapons under the direction of the
organization's leader, Ayman al-Zawahiri.
Since the anthrax attacks in 2001, the U.S. Government has
spent more than $60 billion on biosecurity programs. They range
from enhancing methods of disease detection to developing more
effective antibiotics, vaccines, and other countermeasures.
Despite progress in the Nation's preparedness and response
capabilities, deficiencies remain. I cite three here that I
think warrant particular attention. The first is the need for
expanded education and training throughout the medical
community. The level of preparedness for a biological assault
varies from one location to another. Where drills are conducted
frequently and in realistic settings, optimal outcomes are more
likely. The effective medical response at the Boston bombings
was credited not only to the availability of excellent
personnel and hospitals, but to the high quality of pre-event
drills.
These exercises included mock biological attacks. In many
locations, budget pressures and human inertia have resulted in
cutbacks in the frequency and quality of exercises. Failure to
maintain proper levels of education and training diminishes the
likelihood of a successful medical outcome at an actual
incident.
A second area of concern relates to the special needs of
children, and I reference as well the concerns of
Representative Payne, Ranking Member Payne on this issue, the
special needs of children during a biological attack. Children
are particularly vulnerable to biological agents because of
their more rapid respiratory rate, greater skin permeability,
and lower fluid reserve than that of adults, yet medical
response plans typically are adult-specific and do not include
allowances for these differences. Compounding this concern, a
2013 article cited studies showing that most physicians feel
unprepared to address a bioterrorism attack. These studies
included a survey of Michigan pediatricians who were deemed
``overwhelmingly underprepared to deal with an event.''
The third issue that deserves particular attention is the
need for legislation that directly addresses the threat of
biological and other weapons of mass destruction. I understand
that Representatives Pascrell and King are reintroducing the
WMD Preparedness and Response Act. Although previous
incarnations of the bill have drawn unanimous endorsement from
the House Committee on Homeland Security, it is not yet law.
Regarding the biothreat, the act would heighten laboratory
security, help create uniform standards for handling dangerous
biological agents, and support appointment of a special
assistant to the President to coordinate biodefense policy. The
proponents of this bill deserve high praise, and I wish them
every success toward its enactment.
In concluding, I note that it is no more possible to
completely eliminate bioterrorism than it is to completely
eliminate infectious disease. Still, enhancing security
measures reduces the portals of opportunity for a would-be
perpetrator. Further making biological terrorism more difficult
to actuate is bound to discourage individuals and groups from
even trying. Diminishing the threat is surely a worthy goal
shared by people of good will everywhere. Thank you.
[The prepared statement of Dr. Cole follows:]
Prepared Statement of Leonard A. Cole \1\
---------------------------------------------------------------------------
\1\ Unless otherwise indicated the views expressed here are my own
and not representative of any institution.
---------------------------------------------------------------------------
February 11, 2014
Chairman Brooks, Ranking Member Payne, distinguished Members of
this subcommittee, thank you for inviting me to speak on the threat
posed by bioterrorism to the American homeland and elsewhere. I am
grateful as well to the full committee's Chairman McCaul and Ranking
Member Thompson for their leadership on homeland security. In 2012 and
again last year, I was privileged to address the Subcommittee on
Counterterrorism and Intelligence during which I referenced a 2012
paper titled WMD Terrorism. The paper was produced by the Aspen
Institute's Homeland Security WMD Working Group, of which I was a
member. One of the paper's conclusions, still valid, is that
bioterrorism remains a continuing and serious threat.
Pathogenic microorganisms and toxins such as anthrax bacteria or
botulinum toxin are relatively easy to acquire and grow. Disseminating
anthrax can be as simple as sending dried spores through the U.S. mail,
which is exactly what happened in the weeks following the 9/11 attacks.
About half-a-dozen anthrax letters infected at least 22 people, 5 of
whom died. Spores were later found to have leaked from the letters
during mail processing and delivery. As a result, scores of buildings
including U.S. House and Senate office buildings had become
contaminated and were shut down--some for several years. More than
30,000 people at risk of exposure received prophylactic antibiotic
treatment.
The bio-threat continues. In the wake of last April's Boston
Marathon bombings, ricin-laced letters were mailed to several public
officials, including one to President Obama. Just last week, Israel's
Supreme Court upheld an indictment against a detained Palestinian
operative for al-Qaeda, who was charged with developing biological
weapons under direction of the organization's leader, Ayman al-
Zawahiri.
Since bacteria and viruses reproduce and multiply, unlike any other
weapon they can make an environment more dangerous with the passage of
time. If resistant to medical countermeasures they could kill many
thousands. Yet much can be done to minimize this risk. Since the
anthrax attacks in 2001, the U.S. Government has spent more than $60
billion on biosecurity programs. They range from enhancing methods of
disease detection to developing more effective antibiotics, vaccines,
and other countermeasures. Despite progress in the Nation's
preparedness and response capabilities, deficiencies remain. I cite
three here that I think warrant particular attention.
The first is the need for expanded education and training
throughout the medical community.\2\ The level of preparedness for a
biological assault varies from one location to another. Where drills
are conducted frequently and in realistic settings, optimal outcomes
are more likely. The effective medical response at the Boston bombings
was credited not only to the availability of excellent personnel and
hospitals but to the high quality of pre-event drills. Those exercises
included mock biological attacks.
---------------------------------------------------------------------------
\2\ A course on Terror Medicine is being taught this semester at
Rutgers New Jersey Medical School, to my knowledge the first such
course at an American medical school.
---------------------------------------------------------------------------
In many locations budget pressures and human inertia have resulted
in cutbacks in the frequency and quality of exercises. Failure to
maintain proper levels of education and training diminishes the
likelihood of a successful medical outcome at an actual incident.
A second area of concern relates to the special needs of children
during a biological attack. On its website, the American Academy of
Pediatrics notes that children are particularly vulnerable to
biological agents because of their more rapid respiratory rate, greater
skin permeability, and lower fluid reserve than that of adults. Yet
medical response plans typically are adult-specific and do not include
allowances for these differences.
Children comprise 23 percent of the population. Making a diagnosis
in this group can be complicated especially among the very young who
are unable to describe their symptoms or discuss how they might have
been exposed.
Compounding this concern, a 2013 article cited studies showing that
most physicians feel unprepared to address a bioterrorism attack. The
studies included a survey of Michigan pediatricians, 85 percent of whom
had never participated in a bioterrorism training exercise. The authors
of the survey concluded that these pediatricians were ``overwhelmingly
underprepared to deal with an event.''\3\
---------------------------------------------------------------------------
\3\ Following are links to references about preparedness and the
vulnerability of children to a biological attack: http://
journals.lww.com/smajournalonline/Fulltext/2013/01000/Prepared-
ness_of_Rural_Physicians_for_Bioterrorist.7.aspx; http://www.aap.org/
en-us/advocacy-and-policy/aap-health-initiatives/Children-and-
Disasters/Pages/Biological-Terrorism-and-Agents.aspx; http://
globalbiodefense.com/2013/02/05/bioterrorism-preparedness-the-
forgotten-patient-population/#sthash.X9whD34M.dpuf; http://
www.ncbi.nlm.nih.gov/pubmed/19194343.
---------------------------------------------------------------------------
The third issue that deserves particular attention is the need for
legislation that directly addresses the threat of biological and other
weapons of mass destruction. I understand that Representatives Pascrell
and King are reintroducing the WMD Preparedness and Response Act,
versions of which they have sponsored in the past. Although previous
incarnations of the bill have drawn unanimous endorsement from the
House Committee on Homeland Security Committee, it is not yet law.
In 2008 the bipartisan WMD Commission called for measures now part
of the bill including the establishment of a National strategy to
counter the threat of weapons of mass destruction. Regarding the bio-
threat, the act would heighten laboratory security, help create uniform
standards for handling dangerous biological agents, and support
appointment of a special assistant to the President to coordinate
biodefense policy. The proponents of this bill deserve high praise, and
I wish them every success toward its enactment.
In concluding I note that it is no more possible to completely
eliminate bioterrorism as a threat than to completely eliminate
infectious disease. Still, enhancing security measures reduces the
portals of opportunity for a would-be perpetrator. Further, making
biological terrorism more difficult to actuate is bound to discourage
individuals and groups from even trying. Diminishing the threat is
surely a worthy goal shared by people of good will everywhere.
Mrs. Brooks. Thank you, Dr. Cole.
At this time, the Chairwoman is now just pleased to
recognize Congressman Pascrell, and so pleased that you could
be here because of your extensive work on this issue, and so we
appreciate you taking time out of your calendar to make sure
you can be here today. As much time as you may consume.
Mr. Pascrell. Madam Chairwoman, it is an honor to be here,
and with our Ranking Member, and it is good to hear the experts
that you have called and assembled here. I am very, very
familiar with Dr. Cole, and we have been at this a long time,
at least it seems a long time anyway.
We have to go back to 9/11 reports to the Congress of the
United States, and this is the one area, Madam Chairwoman, this
is the one area that we have been absolutely negligent. We have
not done near enough to address the issues which the 9/11
Commission laid before us. I articulated it to the ``nth''
degree.
As a Member, original Member of the Homeland Security, we
tried to do our best to implement the recommendations of the
9/11 Commission. They weren't all implemented immediately, as
we well know. This has a long, long history, unfortunately, but
I don't sense, Madam Chairwoman, the urgency about this, and I
think our three--I did read Dr. Inglesby's testimony, they have
all basically said the same thing, too, about that issue. Why
isn't it that we are not addressing it? I mean, we spent over
$60 billion, and so like a lot of money we spent in Homeland
Security that went for naught because if we don't have a
coordination of agencies, then nothing is going to work. This
is serious business, regardless of which part of this, you
know, we are talking about. So I want to thank you and Ranking
Member Payne for allowing me to say a few words today.
We are going to reintroduce, Peter King and myself, the
Weapons of Mass Destruction Preparedness and Prevention Act
today. For the past three Congresses, I worked with Mr. King to
enact this much-needed legislation, to establish comprehensive
protection and response in addressing a threat of weapons of
mass destruction. This wide-ranging bill addresses all aspects
of our preparedness frame-working. It touches upon prevention,
protection. Prevention, you have heard our witnesses talk about
education, tremendously lacking, directed only to one subgroup
and not to the entire population, particularly to our kids; the
protection of our population and what responses we have, God
forbid, when any--whether it is chemical, biological,
radiological, or nuclear attacks occur, what do we do? Are we
prepared? You have heard what our witnesses said.
So, we have a long way to go. Then finally, recovery. How
do we recover from such a dastardly situation? Are we prepared
to recover? We live in a very important and critical age. It
has brought us some terrible things, but it is also hope for
the future that not only we can prevent these things--and it is
never going to be seamless, we know that. I am glad you are
bold enough and brave enough to say that. Most relevant, I
think, to the topic to today's discussion, this legislation
requires a new top-down strategy from the White House for a
better intergovernmental approach, meeting the need for Nation-
wide monitoring of biological threats. That is, I think, very
paramount to our efforts. We may--we need to make this issue a
priority.
Remember, we created the Talent/Graham Weapons of Mass
Destruction Commission because of the extreme gravity of this
threat, particularly from a biological attack. Madam
Chairwoman, that is a long time ago we did that. After 12
years, we still do not have a comprehensive strategy. Versions
of the WMD Prevention and Preparedness Act have passed out of
this committee twice, but unfortunately, it never made it to
the floor.
When you guys were the Majority, when we guys were, so I
mean, there is enough concern around here to go around.
Meanwhile, there does not appear to be any momentum in this
administration to tackle the pressing issue of terrorism,
bioterrorism. I was encouraged to see that the White House
released the National Strategy on Biosurveillance in July 2012.
It fell short on substance. The strategy was far from what
Congressman King and I envisioned in the WMD bill. I hoped--I
had hoped that the implementation plan, which was supposed to
be released by December 2012 would fill the gaps. It still
hasn't been released. That is totally unacceptable. I mean,
this is either a priority or it is not, and when everything is
a priority, nothing is a priority.
I am pleased that Mr. King has agreed to work with me on
this by introducing the measure today. I think this is a matter
of life and death. It has been over 2 years since the WMD
Center, the successor to the WMD Commission released its ``Bio-
Response Report Card.'' You look at that report card, and you
have to wonder, and it would scare legislators, so think about
what it will do the public. It has been made public. I don't
know if anybody ever read the darn thing.
In the absence of progress on robust legislative
initiatives, such as this bipartisan bill, little has changed.
Doctor, can I just ask Dr. Cole?
Mrs. Brooks. Absolutely.
Mr. Pascrell. Dr. Cole, I am highly concerned, as all three
of you are, with the continued lack of progress in our
preparedness. The WMD Prevention and Preparedness Act calls for
a comprehensive strategy across the entire Federal Government
to counter bio threats. What is the current level of
coordination between agencies on these issues as you see it and
how do you believe we can improve it? Because I think that is
at the core of us moving and getting out of our quicksand here.
Dr. Cole. I wish I had a very good answer for this. I do
not. In part, I am not part of the Governmental apparatus and
the day-to-day affairs of interagency cooperation. I am aware
of several initiatives that are being directed at this problem,
certainly in the Health and Human Services Department and
advances in BioShield in particular. I don't know how one can
raise the level of consciousness to an appropriate degree. A
lot of this is psychological. We can all imagine, God forbid
that it should happen, that if there were a major biological
incident in the next week, 1 minute after the word got out that
this was the case, there would be attention around the country
and would be again revved up.
My short answer has to be that holding hearings like this
with prominent spokespersons reminding everybody of the
importance of this issue can only be to the good. As I said in
any remarks, I think it is terrific that you and Representative
King are going to be reintroducing the WMD bill.
Mr. Pascrell. Well, we are not going to be discouraged. You
know, we don't give up. We are not smart enough to give up.
Would either two gentleman like to jump in and briefly respond
to that? I would appreciate it.
Dr. Kadlec. Well, I may have a little more insight than Dr.
Cole other than to say that it really does take some leadership
at the very top to basically drive this problem. In my
experience, and I had the title, was basically, you know,
working the issue 24/7, 365. I think that is really what it
takes, and it basically is more than just an individual. It
takes, you know, literally the President to make this a
priority. I will just highlight his making the nuclear
terrorism issue a priority has made a difference, has mobilized
not only the world, but the U.S. Government to work against
that problem, and clearly this is a similar nature that
requires the same kind of attention and commitment, too.
Mr. Pascrell. Dr. Inglesby.
Dr. Inglesby. I agree. Well, I think the first dilemma for
all of us is that the functions of biodefense are really going
to have to reside in different agencies. It is very hard to
imagine at an implementation-level point that we gather because
HHS has to do certain things, CDC has to do certain things,
DOD, et cetera, so there is going to be challenge for
coordination, so it is really important what you pointed out. I
think the people actually leading those programs, their
personalities and their ability to stay on the issue is really
fundamental. I think we do both when Bob was in office and now,
I think there are a lot of very impressive people running those
programs, but obviously we could always get--we need to improve
coordination.
Mr. Pascrell. Madam--Thank you. Madam Chairwoman, I don't
know if we have to work backwards for folks to understand how
devastating any of these attacks could be on a small level and
a large level. We--we need to get--make sure that there is a
sense of urgency on this administration and future
administrations about this very critical issue, and I applaud
you for what you are doing, both of you, in order to get this
in front of the public again, because if we don't address it,
we saw what happened on what we would consider to be,
relatively speaking, smaller attacks.
I mean, when you--when you look at what could happen in
what we call ``Oil Alley,'' the New Jersey Turnpike up in
through the Elizabeth area, which is--FBI has called probably
the most dangerous area in the entire country, I mean, you have
a catastrophic incident there, you will put immediately 1.5
million people in jeopardy. I don't know how better to say it.
I mean, if that doesn't make you think about what the heck we
are doing, nothing will. Our bill won't, discussions won't,
this is serious business, and I thank you for your work.
Mrs. Brooks. Well, I thank you, Congressman Pascrell, for
your leadership, for you and Congressman King continuing to
fight this battle Congress after Congress, and I assure you
that this committee and--will continue to fight the battle as
well. Thank you for pointing out the Bio-Response Report Card,
which while it was in our materials, it shows--and while we are
all used to A through F grades, there are no As on this report
card. There are a lot of Fs on the report card, a lot of Ds,
such as medical countermeasure development and approval
process, such as medical countermeasure availability, and
medical management, all of the things that our witnesses have
talked about, and so it is--it is clear that we are not yet
prepared and that we have a long way to go, even though there
have been, you know folks like yourselves working on this for
quite sometime.
So, we appreciate, we look forward to working with you on
movement of your bill and with hopeful passage and very much
appreciate your leadership in this Congress. Thank you.
At this time, I will recognize myself for 5 minutes of
questioning, and I want to build a bit on some of the points
that have already been made. Again, talking a bit about the
coordination. Because there is no leadership, a biodefense
advisor as you were, Dr. Kadlec, to President Bush, there is,
at this time, not a person singularly responsible for this.
The GAO testified before the subcommittee in April 2011
that development of medical countermeasures for biological and
other threats is a complicated business, and as I just brought
up with this biodefense report card, we are really not doing
well on that--on that measure. The business starts with a
declaration by Department of Homeland Security that a virus or
bacteria or chemical or other agent is a material threat. It
then becomes incumbent, as you said, Dr. Inglesby, upon HHS to
work with industry to develop pharmaceuticals that can help
meet the threat. GAO has reported that the coordination between
DHS and HHS has not been optimal and could benefit from
clarification between the two agencies on time frames,
milestones, and written procedures.
This is a question for the entire panel: How do you think
these agencies are working? What should we be doing to
encourage or require DHS to be doing to facilitate the smooth
transition of threat information to HHS to assist with this
counterdevelopment, development process? Because, as we have
seen from this report card, we are simply not prepared.
So, I would like to start out with you, Dr. Kadlec, and
then each of the panel to talk about our preparedness and the
coordination between those agencies, and working also with
industry.
Dr. Kadlec. Certainly. There exists within the enterprise,
if you will, this Public Health Emergency Medical
Countermeasures Enterprise, PHEMCE, which is really a way to
convene the interagency group at levels below the White House
levels. While I think that is effective in terms of what is a
polite coordination, the question is, is whether or not the
priorities that have been outlined by DHS have been effectively
acted upon by HHS, and quite frankly, that is not a polite
conversation that has to happen, and clearly, I think, has to
go a level above.
To think about how you could effectively maybe encourage,
or coerce better coordination, you have the report card that
you identify doesn't get into details that have been
identified, but I do know that there have been 12 agents on
them, material threat determinations have been made, and it may
be helpful to have a report card issued each year that looks at
the progress against those 12 different agents. I through you
would find that probably you will find some real progress in
one area, or maybe two, but not much progress in other areas.
So I think the question is, is I think that is one way to
monitor this effort. I do believe that in some ways the role of
the White House reigns supreme here, and while we are fixated
on the idea of a senior leader in that position, I also think
that one of the important roles of the Government is really
with the Office of Management and Budget, and they were our
greatest ally to basically have these kinds of conversations
with the interagency, subject to the progress or nonprogress
that has been made.
So I think in some ways it really does require good
oversight by Congress, and certainly transparency in terms of
the progress that is being obtained, as well as leaders inside
and outside the process to ensure that it is met.
Mrs. Brooks. Thank you for those suggestions. Dr. Inglesby.
Dr. Inglesby. Yes, this is a really complicated process,
and I think it has been evolving--I am sorry. Thank you. It is
a very complicated process. It has been evolving, I think, in
the right direction, albeit not as fast as we would like over
the years. I think that my sense from the outside is that DHS
and HHS are communicating better about the risk assessment
process than before.
I don't know that the risk assessment process is what is
rate limiting right now as much as is resource and decisions,
terrible decisions that have to be made between do we develop
this versus this versus this. At some point, I think the whole
process run into a resource dilemma. If you took what they are
being asked to do and gave it to the private sector, the
private sector developing its own medicines and vaccines could
not do in terms of resource what we have asked the Government
to do, to make new medicines and vaccines.
So I think overall there is a resource limitation. I do
think, at Bob's idea of looking at what of the 12 things that
are material threat determinations, how much progress we have
made on those, always thinking about whether or not we need to
elevate something new as a new material threat. I think that is
a very logical way to go, and we have much further to go on all
those things, but my sense is that, in the end, that is largely
what we are able to make available, given budget austerity.
Mrs. Brooks. Thank you very much. Dr. Cole.
Dr. Cole. The situation, as I hear it being discussed, and
I have thought about it myself, reminds me of the dilemma that
was posed some years back, not too many years ago, before there
was a Director of National Intelligence. There was not one
single person with an authority even to convene the various
intelligence agencies.
Now, the 16 or so intelligence agencies are part of an
umbrella that is directed by an individual, a capable
individual, we always hope to be capable, and I would think
that same importance should be applied to this. Now, Bob Kadlec
made some remarks, and I think perhaps he is being overly
modest, but he can refer to his own experience about the
advantage not only of having a single coordinator, but one who
is stationed in the White House and therefore draws the
prestige of the Presidency in the White House when he or she
were to call meetings to gather together to come to some kind
of coordinated and coherent policy.
Mrs. Brooks. Thank you very much. I now recognize Ranking
Member Mr. Payne from New Jersey for questions.
Mr. Payne. Thank you, Madam Chairwoman.
Dr. Cole, as I indicated in my opening statement, I am
concerned about the 40 percent of countermeasures in the
Strategic National Stockpile are not approved for children.
That gives me great reason for pause, and what are our greatest
challenges to developing countermeasures for children?
Dr. Cole. Well, I think this relates to some of what I
referred to before as raising the issue of concern in
appropriate quarters. I would be happy to think of the White
House having a coordinator who could then underscore the
importance of the filling some other gaps as well, but
particularly this one as it applies to children, and which you
so appropriately made reference to.
Now, this is not just your or my concern. The various
pediatric associations, I believe it is the American Academy of
Pediatrics has made a very clear concern about this. In terms
of how this would be approached in the National Strategic
Stockpile, that would be just one element in terms of helping
to prepare better defenses and responses on behalf of children,
and that would include, as I referenced, medical training,
appropriate individuals being informed, local public health
authorities, right through what is placed into our stockpile
for defenses.
Mr. Payne. Dr. Inglesby.
Dr. Inglesby. Well, I certainly agree with your judgment
that we need to do more for the pediatric population. I think
Dr. Cole's comments are very logical and sensible. I think part
of that education comes from what HHS is trying to do with
hospitals in the hospital preparedness program and what we are
doing to prepare kids--prepare for kids' illnesses and injuries
at the hospital level. I do think the countermeasure
development program needs to much more carefully incorporate
pediatric needs. The dilemmas are not just financial there, but
they are ethical. I know that you-all know very well how
difficult it is to develop a medicine for a child that would
only be used in the event of a National emergency.
I mean, the ethics systems that we have now require us to
only test medicines in kids when they can have a direct benefit
and--so, it poses a new and very difficult problem that the
President's Bioethics Commission took on very well. That
doesn't get us out of having to spend much more thought and
time and resource on the problem, so I do agree with you and
think we should.
Mr. Payne. Dr. Kadlec.
Dr. Kadlec. Sir, I would just endorse the comments made by
Dr. Cole and Dr. Inglesby. I do believe the ethical issues are
certainly significant and no trivial matter. I do believe there
is an element of priority though, and focus on this to
understand that in some ways we have a very significant
obligation to those most vulnerable in our society to protect
them, and I think in some ways that is a reminder that needs to
pervade the whole effort, whether it be the policies, whether
it be the programmatics, the advanced development, the
procurements, as well as the FDA testing that goes around this
to ensure that we do keep an eye to that problem.
It is not an easy problem and certainly one that would
benefit from some more resources, but I do believe more
attention, and, as you pointed out, sir, very eloquently, the
realization that we have this very significant obligation to
these children.
Mr. Payne. Okay. I would just like to ask each one of you:
How can Government in our part and industry efforts improve to
better protect our children?
I hear the ethical issue, which seems like it is probably
pretty difficult to get around that. But what can we do to work
with industry to protect our children from these dangerous
bioagents?
Dr. Kadlec. Well, I will just give you a tangible one. I
think, in terms of the annual--or the--they are not frequent,
but I think the notion that the frequent requests for proposals
that come from the Government--I can't recall one that
specifically calls out the children in any form or fashion. It
would seem to me that would be an appropriate thing to do, to
identify particular products or product preparations that would
be more amenable for children.
I just note that in some ways some antibiotics that we have
in the Strategic National Stockpile are not formulated in a way
that would be easy to give to the children--for either the
parents to give or the children to accept. So I think that is
one little example of what you could do practically to address
that.
Mr. Payne. So be more specific in the RFP.
Dr. Kadlec. As well as have specific RFPs for pediatric
preparations.
Dr. Inglesby. I think that is a good idea. I think maybe
another thing to consider is whether or not we should be more
explicit in our requirement-setting process.
Because the Government really is driven by requirements
and, if we formally establish in some way some requirement for
pediatric formulations, then that would drive work and
direction.
I am not sure I have a proposal on how to do that. But to
the extent that it is not happening now, we should consider
doing that.
Dr. Cole. I have the strange thought that, (A), because we
are talking about children, there would be much greater
sensitivity to this issue as there would be about our treatment
and concern for children across the board.
By creating this consciousness of disparity in terms of
preparation and capabilities for response with children, in a
way, that is a vehicle to alert the entire population and
answer some of the questions that have been raised, in general,
about our concern for preparedness.
Or I guess in a sentence I can say, if we are very
concerned about the welfare of our children in this area,
bioprotection, then, surely, if we are going to take steps to
advance that kind of capability on behalf of children, the
indirect effect as well would be to raise consciousness about
the concerns we have for the biothreat, in general.
Mr. Payne. Thank you.
Thank you, Madam Chairwoman. Thank you for your indulgence.
Mrs. Brooks. Thank you. Very, very important question.
I yield 5 minutes to the gentlelady from New York. Thank
you for being here.
Ms. Clarke. Thank you so much, Madam Chairwoman.
I thank our experts this morning, and just wanted to sort
of concur with Congressman Pascrell because part of his
motivation for his legislation spoke about the petrocorridor
and how a bioterrorism attack would impact the immediate
population of about 1 million or more residents in New Jersey.
Being his neighbor to the north, coming from New York City,
I could see such an event having catastrophic consequences. So
I think that this subject matter is something that requires far
more attention. I want to thank the leadership here for holding
this hearing today.
My first question is to Dr. Kadlec. In 2011, you testified
at a joint hearing before the subcommittee on the WMD
Prevention and Preparedness Act of 2011 and, at the time, you
observed that we had spent about $50 billion on biodefense and
that there are legitimate questions as to whether we spent too
much in certain areas or overlooked others.
So my question is: Has Federal visibility of biodefense
investments improved? If so, how so? If not, how can we get a
better idea of where our dollars have been invested and how to
prioritize and coordinate future spending?
Dr. Kadlec. Thank you, ma'am, for that question. I think
the answer is there has been some improvements and, again, they
are kind of buried deep in the bureaucracy.
But one of the issues that occurred, I think, early on in
the tenure of the Obama administration was to demand a cross-
cutting budget analysis by OMB.
I don't know if that has ever been shared with Congress,
but it would certainly be illustrative, maybe, of a better idea
of where the money is going and how it is flowing. I think,
quite frankly, whether we have spent too much or too little,
the question is whether we have spent effectively. That is a
big issue, and I will use one example.
One of the great things that Congress did collectively in a
bipartisan fashion in 2004 is create the Strategic Reserve
Fund, which is also known as BioShield and Project BioShield.
With it, it understood very clearly the necessary incentives to
have industry basically come to the table and work actively in
this space, particularly for countermeasures that don't have
commercial--if you will, commercial benefit to their
shareholders and to their companies. So that is something that
has gone forward.
With the reauthorization of that and with the
reauthorization of the Pandemic and All-Hazards Preparedness
Act, again, Congress said, ``Instead of a 10-year outlay, we
will give you a 5-year outlay of approximately $2.6 billion.''
The challenge is to kind-of get the Government as it stands to
appropriate that money and to ask for that money in
Presidential budgets and appropriations to--again, to reaffirm
the commitment of the Government around it.
So in some ways it is not that we haven't put the money on
the table; it is how we put the money on the table and what
reassurances we have. That is just one example.
I think there are many other examples where we have been
penny-wise and pound-foolish, in hospital preparedness programs
where the budget was cut a third this year, or in the
metropolitan medical response programs that Representative
Payne highlighted.
So I think the thing is that, as the attention to this
issue has kind of waned--and Representative Payne talked about
the ebbs and flows; it happens in many levels and many
different fashions--that is one where we just need to have a
consistent level of sustainable funding to ensure that the
preparedness that we achieve is something that we can continue
and build upon.
Ms. Clarke. Thank you for your response.
Clearly, the ebb and flow of this does not bode well when
you want to remain protected and have a robust infrastructure
to deliver.
As I said, I am from New York City and, when you have over
8 million people that have to be attended to in an event, it
becomes very challenging if your hospital infrastructure gets
overwhelmed and it does not have the capacity. So I can
appreciate your response about the funding.
Dr. Inglesby, in your testimony, you note that, over the
past 10 years, through significant investment, a cadre of
people with expertise and planning for biological terrorism has
emerged and a series of major biopreparedness programs have
been launched.
In your opinion, are these programs effectively coordinated
across various levels of Government and with the private
sector?
Dr. Inglesby. Well, in an enterprise as big as biodefense,
I think coordination could always be better and I think
communication with industry could always be better. Sometimes I
think it is a common refrain to hear from industry that they
don't know enough about what the Government wants or in what
form it wants it.
So that is a challenge, and it is a challenge for the
Federal officials who want to communicate with industry, but
also are worried about procurement rules and the way that that
operates.
I would say that I am worried about the support of some of
the critical programs. You mentioned the budget a moment ago. I
think the number $60 billion--in our center, we put out an
annual analysis of the biodefense budget. So that number is
about in line with what we have calculated that has been spent
over time.
But it is a misunderstood number because more than 90
percent of that money is also being spent--it is being spent in
the name of biodefense, but it is actually being used for many
other purposes, which isn't necessarily a bad thing. It is
often a good thing. It's dual-use purposes for research or for
preparedness.
But some people will swing around the number like a
bludgeon and say, ``We've spent $60 billion,'' but, in reality,
what we have spent for biodefense in a dedicated way has been
much smaller, much, much smaller.
I am worried that some of the key programs that biodefense
planning depends on--the CDC programs, the hospital
preparedness programs, the BARDA and BioShield programs--are
under a lot of pressure and that, if we continue to erode those
problems we will absolutely see a decrease in capability.
So it is important for Congress particularly to know what
those key programs are and think a lot about that as they
consider their funding choices in the year ahead.
Ms. Clarke. In both of your responses, I kind of get the
feeling that, if you don't use it and maintain it, you lose it,
and I think that that is something that we have to be very
conscious of as we address these threats that are very present
and ever present in our civil society.
I yield back, Madam Chairwoman, and thank you.
Mrs. Brooks. Thank you.
At this time we will begin the second round of questioning.
As I noted in my opening statement, this hearing is part of a
series that we plan on taking on of oversight activities on the
Federal biosurveillance efforts, particularly BioWatch and
NBIC.
Tomorrow, Secretary Johnson comes before the full
committee. I am interested in your perspective, specifically on
BioWatch, on thoughts with respect to Gen-3, and the NBIC.
Are these initiatives that we are investing significant
dollars around the country, are they working, or what changes
would you recommend to the new Secretary or to the committee?
Dr. Kadlec? I would love to hear from all of you.
Dr. Kadlec. Thank you, Madam Chairwoman.
So subject to the BioWatch program, I have an intimate
understanding of the program, having been in the White House at
the time of its creation.
I would just point out that the intent of that program was
simply to provide public health officials early warning to the
risk of a large-scale release of a biological agent. I think
that remains as a consistent threat that goes on.
The idea was, though, spiral development of the program as
it went on. When the program was first deployed, it was very
rudimentary and the idea was that, over time, improvements
could be made in an incremental way.
I think there was a decision made--an investment decision
made that I think, quite frankly, in retrospect, wasn't
probably the wisest one.
We basically took a lot of that investment money and put it
against the next generation of BioWatch detectors, and we know
the rest of story there at least right now.
So I think, in some ways, BioWatch deserves improvements.
BioWatch can be improved by things improving the chronological,
if you will, assessment that it can provide when a release
occurs. It can also increase the density of collectors.
Certainly there can be improvements subject to the time at
which these collectors can be sensed in terms of looking for
particles in the atmosphere that could at least trigger a
warning or at least an alert to go pull the filters earlier.
So I think there are very substantive things that can be
done now. To the idea of an automated system down the road,
clearly that is the idealized end-state and clearly that is
something that is worthwhile.
But I think sometimes the discussion to date has been a
trade-off between environmental detectors and improved clinical
diagnosis and the answer is, you can't have either without the
other.
So the idea that there is somehow a competing idea out
there for clinical diagnostics, point-of-care diagnostics, for
example, I think is something that is necessary and invaluable,
but you can't eliminate the idea of an environmental detector.
I think it is something that we have to continue to work on.
I noticed the idea of anti-ballistic missile defense was
one that came in the 1960s and it only occurred decades later
in terms of its realization, not because we gave up on it, but
we continued to work on it and find the technology to make it
work effectively. So, with that, I will just end my comments.
Mrs. Brooks. Thank you.
Dr. Inglesby.
Dr. Inglesby. On the two issues, the first on the NBIC
program, I think NBIC has had a challenging history. It has had
multiple directors over the years and a change in course a
number of times.
I would say that I am really pleased with how NBIC has
changed over the last year. I think it has garnered a lot more
respect in the interagency. I think it has a very strong
director.
I know that they have weekly conference calls where all the
Federal agencies that are doing biosurveillance get on the
phone every week, I think every Friday. I think they have a
requirement now that they can convene that group within 60
minutes at the White House's request, and have done so.
I haven't been on the calls; so, I can't speak--you will
have to ask the users whether it is valuable to them. But I do
think that they have really evolved in a positive direction and
are very purposeful and recognize their role as a coordinating
entity.
They do a number of other things that are more innovation
and local, ground-up surveillance work that I think are pilot
projects. But I think their fundamental core is around
coordination and I think it is moving in the right direction.
On BioWatch, I do think there is a role for environmental
surveillance and I agree with Dr. Kadlec that it should not be
zero-sum with clinical diagnostics, which are also vital.
I think the problem with BioWatch in a general sense is
that the public health community, which it was built, as Bob
says, to inform, in many places don't have a lot of confidence
or at least have confidence that they should take action based
upon the results. That exists for a number of different
reasons, and I am sure the AOA, which I have not seen, probably
will go into that.
But I think--if we are going to continue to invest in the
BioWatch program or even expand it, I think the public health
departments--it is their laboratorians and health officials
that are being asked to both do work around it and then trust
the results and take action based on it and, if they don't
trust it, then they won't act on it and then this will not be a
useful investment.
So I think we do have to at a fundamental level build it in
concert with that community so that they trust it, understand
it and will act on it if there is useful information.
Mrs. Brooks. Thank you.
Dr. Cole.
Dr. Cole. I would like to comment and add perhaps in the
area of BioWatch to the otherwise excellent remarks that we
have just heard.
The way I look at it is that the BioWatch ideal is to
create a situation that would identify a dangerous biological
agent at some location before somebody has symptoms, before
anybody actually would be going to a doctor or finding out what
would be bothering them or, putting it another way, before the
ideal environmental surveillance capability would exist and, in
some respects, already does exist, we were all canaries in the
coal mine.
The first way you would identify that there had been a
biological attack, unless you had advanced warning from the
perpetrator, which is unlikely, would be when people start
getting sick.
So I very much feel the ideal ought to be respected and
that, yes, there have been disappointments in both the speed
and the reliability of the detection mechanisms as they have
progressed.
But, by all means, I think to forgo continuing efforts to
develop research and engineering efforts would be a terrible
loss to what I think is an appropriate and attainable end
result that we all want, namely, to have effective
identification of suspicious organisms when they are actually
in the environment and before anybody becomes ill.
Mrs. Brooks. Thank you so much for that comment.
At this time I would ask unanimous consent to submit to the
record the Bio-Response Report Card that we spoke of earlier.
Without objection, so ordered.
[The information follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mrs. Brooks. At this time, I recognize the gentleman from
New Jersey, Mr. Payne, for questions.
Mr. Payne. Thank you, Madam Chairwoman.
Just to stay on that topic with the report card, you
pointed out the Ds and the Fs. I know, when I brought my report
card home and it looked like that, my father would say it is
unacceptable. So to that vein, this is absolutely unacceptable,
what we see before us.
Mrs. Brooks. I doubt that ever happened, Mr. Payne.
Mr. Payne. The WMD Center Bio-Response Report Card, which
we are talking about, released in 2011 gave the Nation a D for
its ability to detect and diagnose large-scale attacks, as we
have been discussing.
Since 2011, do you think the Nation has made any progress
in that category? If so, how, Dr. Kadlec?
Dr. Kadlec. Well, sir, I think the progress is negative at
this point. Quite frankly, there are just a lot of--obviously,
the economic situation we find ourselves in has put a lot of
pressure on a lot of these programs.
I think the attention has moved to other areas, quite
frankly, without the kind of oversight from the White House and
certainly involvement like your committee's. I think no one is
disinterested, but have forgotten about it. We are far away
from the events of 2001.
So what I am concerned about is that, as time continues to
move forward, many of these fundamental capabilities will ebb
away, to use your ebb-and-flow analogy. So I have deep concern
about that.
It is very hard to believe that, in today's world, we could
be so vulnerable and become more vulnerable than we may be
today, but I am very worried about very simple things.
I think Representative Clarke mentioned about the
infrastructure--the public health infrastructure. Even though
we may have things in the Strategic National Stockpile, we may
not be able to get them to the people who need them in time
because we don't have the infrastructure and the logistics
supply chain in place to do this.
So I am very concerned about this, and I am just so glad
that this committee has taken upon itself, along with
Representatives King and Pascrell, trying to get the visibility
of this issue where it is supposed to be, in the front and
center of our National security and homeland security
discussions.
Mr. Payne. Dr. Inglesby, the Nation received another D for
its ability to determine the source of a biological event.
Do you think we have made any progress since 2011 in that
respect and, if so, how?
Dr. Inglesby. I do think that we are continuing to improve,
as a whole, microbial science. So we are getting--we do learn
more about pathogens and what differentiates them.
I think the problem with biological weapons is that, even
if we know exactly what beaker a pathogen is made in, someone
could make it in this room and then launch it in India and we
wouldn't know that it came from this room.
We may be able to say that it is very much like another
bacteria in the same beaker, but you can't attribute a
geographic spot to the bacteria itself. So that is always going
to be a challenge that lives with us.
It is very different from watching where a missile came
from on a map or ballistics from a particular gun. Bacteria can
be multiplied. They start in one beaker. They can be put in
someone's pocket and moved to another place. I think that is
going to be a fundamental challenge for us and we are going to
have to rely on different kinds of things to figure out the
source.
Mr. Payne. Dr. Cole, how do you think we can improve around
these issues our capabilities?
Dr. Cole. Well, the bottom line obviously is continuing
research and development. I would add this, though, to the
general conversation.
Before 9/11 in 2001, there was very, very little thought
about a multiple number of airplanes being hijacked and crashed
into buildings virtually at the same time, simultaneously.
Before the anthrax letters were sent, there were very, very
few people and none in the United States Government that I am
aware of who had actually projected among the many possible
means of delivery of a biological agent as a weapon sending
spores through the mail.
By coincidence, about 8 or 10 months before the actual
anthrax letters were sent there was an experiment up in Canada
and it did indicate that these spores could spread and leak
from envelopes, but nothing on a large-scale measure as what we
faced, which I guess answers--is a very unfortunate answer, but
an accurate one.
We don't know altogether how and in what manner the next
attack on us--whether biological or otherwise--could be. It
could well be in a manner that none of us have imagined or been
creative about. So we do need generic bases for concern.
So on that basis, I would--in picking up with what Dr.
Inglesby just said, I wouldn't worry as much about the source.
Yes, it is not nice to get a D or certainly an F in any course
you take.
I would be much more interested in what we can do about
intercepting once the source or once the distribution or the
release of biological agents have taken place.
So I am very much concerned about response--preparedness
for response as well as identification early on where the
material came from.
Mr. Payne. Thank you, sir.
Mrs. Brooks. Thank you.
The Chairwoman now recognizes the gentlelady from New York
for questions.
Ms. Clarke. Thank you very much, Madam Chairwoman.
Picking up on Dr. Cole's last comment, I would like to ask
Dr. Kadlec--there are numerous and unique challenges related to
detecting and responding to a WMD attack, especially bioterror
attacks.
What do you think that Congress can do to ensure that first
responders, emergency services personnel are effectively
prepared to respond during a biological attack? How can these
people be best utilized during a response?
Dr. Kadlec. Thank you for that question.
I would just simply say we need to protect our first
responders and their families. Simple as that. We have the
means to do so today in many respects in terms of vaccines that
we have in our stockpile as well as the ability to basically
develop antibiotic kits that can be kept at home safely and
securely to ensure that, should there be an emergency requiring
our first responders and every first responder to respond--
because, as we heard from Representative Pascrell, these are
not going to be small events, potentially.
These are going to be very large events affecting several
hundred thousand--millions of people, in New York, 8 million.
So you would like to believe that every fireman, every
policemen, every public health worker, every sanitation worker
who is going to be needed to man pods, maybe every postal
worker who in some jurisdictions are going to deliver
antibiotics to the general public, have the means to protect
themselves and their family and the confidence they can go out
into that environment and do their duty without concern for
themselves or their family members.
Ms. Clarke. So old habits die hard. One of the challenges
around the 9/11 event is that the instinct of the responder is
to go and respond irregardless of what the dangers may be to
that individual.
What type of measures need to be put in place to really do
the type of behavior modification that enables our responders
to do their work effectively and not have the ripple effects
that we have seen as a result of just their instincts?
Dr. Kadlec. Thank you, ma'am.
I would just recall Dr. Cole's comments early on in his
statement about the vital importance of education and training.
That is transformational in the sense of how we would raise
awareness and, if you will, give our first responders and the
public, in general, information they could use in those kind of
circumstances.
I think one of the great issues--and it was talked about
earlier--are the psychological effects of biological warfare
insofar as, in some ways, they prey on the worst ruminations of
people's minds.
In some ways, you can dispel a lot of those concerns and at
least inform people in a way that they do have control of their
environment and there are things substantively they can do to
protect themselves and their families.
Ms. Clarke. My question to you would be--and to the entire
panel is: Is there evidence in the training academies across
this Nation from the municipal on up that this type of
adjustment is being made?
You know, as we sit here, graduating classes, the training
that is taking place, you know, are they playing from the old
playbook or have you seen an integration of practices that
would protect them?
Dr. Kadlec. Well, ma'am, I can't comment broadly, other
than to say that I believe--in the professional education and
training areas, particularly within the medical public health
areas, I don't believe that they are institutionalized in a way
that bring the best practices to care for people in a WMD
environment.
I think there were some earnest efforts after 9/11. Those
efforts haven't been sustained. They have become somewhat
fragmented. They are not part of the course load of any given
curricula, I believe, in any profession, whether it be
physicians, nurses.
I would just say that EMS is probably the best position to
date. They have generally instituted many of these ideas and
curricula changes.
But I believe that we are far from where we need to be in
basically having everyone have a basis of understanding of what
to do in a disaster, whether it be a WMD event or even a
natural event, for that matter.
Ms. Clarke. Dr. Cole.
Dr. Cole. If I could add something, it is sort of an
advertisement plug, I guess.
At the school at which I am an adjunct professor of
emergency medicine, there is a course being taught for the
first time, to my knowledge, in any American medical school on
terror medicine, which deals with the unique aspects and
distinctive aspects that apply to responding to a terror event.
Now, there is a lot of overlap with disaster medicine and
emergency medicine. But when one looks carefully, there are a
whole series of issues, including how one has to deal with a
biological agent used for hostile purposes, that would not
apply otherwise.
So, yes, there are spots. But to your question, which is
very important--why and how widespread is training
appropriate?--I don't think we know. I don't think there has
been an adequate recent survey on what is being taught, if
anything, about these areas.
But I did refer in my oral statement and written remarks to
the fact that a recent poll of hundreds of pediatricians in the
State of Michigan--after the surveyors looked at this, they
concluded that 85 percent of them had not had any serious
training and that, in general, these people were totally
unprepared for a biological event.
Ms. Clarke. Thank you very much, Madam Chairwoman.
Mrs. Brooks. Thank you, as always, for your concern for our
first responders. I very much appreciate that.
I have one last question that I would ask each of you to
help us, which I think would also help Congressman Pascrell and
Congressman King.
As we try to elevate the importance of this continued
discussion and focus on bioterrorism, how can we do a better
job in describing what the impact is?
So when you are educating people, whether it is in
classrooms or whether it's at a dinner party, about
bioterrorism, do you have a way to help us describe what a
horrific significant impact a bioterrorism attack would have on
our country and our citizens?
Anyone want to jump in to give us the elevator speech, so
to speak, to help us explain the importance of this topic as to
what the impact might be? Dr. Kadlec.
Dr. Kadlec. Well, I would just simply say the elevator
speech I would use is basically the United States demonstrated
in the 1950s and 1960s the plausibility of this form of
warfare.
It became so significant in our concerns that we tried to
eliminate it as an acceptable form of warfare by basically
engaging in a treaty with a number of nation-states, the
Biologic Weapons Convention, and certainly our worst fears were
realized when we recognized that other nations could assume
this capability and certainly terrorists.
So we have empowered now individuals, groups of
individuals, with the ability to kill as many people as a
nuclear weapon and they can do so at a fraction of the cost
without the technical burdens or liabilities associated with
nuclear weapons.
I think that should be a chilling--chilling story for any
person who lives in a major metropolitan area, like
Representative Clarke, or in the corridor, as Representative
Payne, or Madam Chairwoman, even in Indianapolis.
I believe that no part of the country could be spared from
this, and I think that is the issue that has to be conveyed, is
that we are all vulnerable.
The fact of the matter is that there are substantive things
that we can do to reduce our vulnerability. We can't eliminate
it. We can reduce our vulnerability in a way that would
basically at least make this a manageable risk, not an
unmanageable risk, as it is today.
Mrs. Brooks. Thank you.
Dr. Inglesby.
Dr. Inglesby. I guess in my elevator speech I would say it
is important for those who don't remember it to recall that a
series of letters containing anthrax which led to less than 10
deaths nearly paralyzed our Federal Government and put the
Nation on edge for months and that those bioattacks were
delivered in the crudest imaginable form and that technology
now exists to create and to disseminate biological weapons on a
scale that is far, far greater than what we experienced in
2001.
Our strongest defense is to become resilient and prepared
for those kinds of attacks. It is in our capability to do that,
but we have to actually plan for it and do it.
Mrs. Brooks. Thank you very much, Dr. Cole.
Dr. Cole. If this were a very long elevator ride----
Mrs. Brooks. I understand you have a train to catch; so, it
may have to be a short elevator ride.
Dr. Cole. Not only would I incorporate--or try to synopsize
what we just heard from Dr. Kadlec and Dr. Inglesby, I would
make two additional points.
One is that, unlike any other weapon, we are all familiar
at some level with the effects of infectious disease. All of us
have had colds. Many have had flu and others.
One can remember--certainly in my own family, in my own
mind, I can remember some very serious consequences, maybe not
critical, but enough to know that this is not a pleasant thing.
Can one then imagine becoming infected by something that
was intended to cause you not only to become ill, but possibly
to die? There is a culture kind of connection to this, to
biologicals, that we don't have in another areas of hostility
and weaponry.
Second, I would speak to the moral question, the moral
issue. The Biological Weapons Convention treaty that prohibits
the use or even the development or stockpiling of biological
weapons was first put on the table in 1972, and it contains a
unique phrase that I think all of us ought to treasure as to
its wording: ``The use of these kinds of weapons''--and I am
quoting from this convention--``is repugnant to the conscience
of mankind.''
That was the first treaty that ever used that kind of
language, that really elevated the moral and ethical issue to
the point where it has, I think, a personal and a psychological
effect, because it was the forerunner of then continuing usage
of ethics and morality in other treaties as well.
So I would emphasize those points, particularly the
familiarity we all have with moderately effective biological
agents, and then how important it is for us as a society to be
aware of how awful this kind of thing is, which, in effect,
indirectly can minimize the likelihood of its use.
Even those societies, civilizations, countries that have no
moral compunctions about using biological weapons would then
understand that, for many in the world, whatever the purpose of
their aggressiveness or bad behavior would be, it would be so
repulsive that it could act as an additional deterrent to them
wanting to use it in the first place.
Thank you.
Mrs. Brooks. Thank you very much. I think that is an
appropriate way to conclude today's hearing.
I want to thank each you for dedicating your careers to
this incredibly important topic to our country and to mankind,
as you so eloquently stated, Dr. Cole. I want to thank the
staff for getting such incredible witnesses before the
subcommittee.
We will do our best to continue to move this discussion
forward. The Members of the subcommittee may have additional
questions for you and will ask you to respond to these
questions in writing.
Pursuant to Committee Rule 7(e), the hearing record would
be open for 10 days.
Without objection, the subcommittee stands adjourned.
[Whereupon, at 11:40 a.m., the subcommittee was adjourned.]
A P P E N D I X
----------
Questions From Honorable Steven M. Palazzo for Robert P. Kadlec
Question 1. Our country has been subjected to numerous, potentially
catastrophic biohazard exposures in recent years in our agricultural
industry; the outbreak of the H1N1 (Swine Flu) and the H5N1 (Bird Flu)
viruses come to mind. Fortunately, none of these exposures have
resulted in any large-scale damage.
However, agro-terrorism, which is the malicious use of plant or
animal pathogens to cause devastating disease in the agricultural
sector, is a concern. But it doesn't stop there. Natural or accidental
biological events can have the same devastating impacts as those which
are intentionally caused.
To give you a scenario, in 2001, Foot & Mouth Disease affected
9,000 farms in the United Kingdom and required the destruction of more
than 4 million cows. USDA researchers believe that a similar outbreak
in the United States would cost taxpayers up to $60 billion. Given the
relative size of the United States to the United Kingdom, this could
result in the need to destroy 20 million head of cattle in a short
period of time with little advance notice.
Does the Federal Government have a plan in place and the attendant
resources to handle a disaster of this magnitude? Please identify with
specificity this plan and those dedicated resources of people and
equipment. Specifically, how would the decomposing and potentially
infectious carcasses be disposed of? How quickly would this response
occur, and what would its effectiveness be?
Answer. Response was not received at the time of publication.
Question 2. What is the Federal Government's response plan for a
large-scale avian influenza outbreak in the poultry industry?
Specifically, how would the diseased and infectious birds be disposed
of? How quickly would this response occur, and what would its
effectiveness be?
Answer. Response was not received at the time of publication.
Question 3. When a natural or man-caused biological event occurs in
the homeland and that affects our livestock or other agricultural
interest, we need to ensure we have a comprehensive, pre-planned, pre-
resourced, and pre-positioned response plan in place.
What recommendations would you make to FEMA to ensure our
agricultural interests are protected and that we are prepared to
respond in the event of a agro-terrorist attack or an epidemic?
Answer. Response was not received at the time of publication.
Questions From Honorable Steven M. Palazzo for Tom Inglesby
Question 1. Our country has been subjected to numerous, potentially
catastrophic biohazard exposures in recent years in our agricultural
industry; the outbreak of the H1N1 (Swine Flu) and the H5N1 (Bird Flu)
viruses come to mind. Fortunately, none of these exposures have
resulted in any large scale damage.
However, agro-terrorism, which is the malicious use of plant or
animal pathogens to cause devastating disease in the agricultural
sector, is a concern. But it doesn't stop there. Natural or accidental
biological events can have the same devastating impacts as those which
are intentionally caused.
To give you a scenario, in 2001, Foot & Mouth Disease affected
9,000 farms in the United Kingdom and required the destruction of more
than 4 million cows. USDA researchers believe that a similar outbreak
in the United States would cost taxpayers up to $60 billion. Given the
relative size of the United States to the United Kingdom, this could
result in the need to destroy 20 million head of cattle in a short
period of time with little advance notice.
Does the Federal Government have a plan in place and the attendant
resources to handle a disaster of this magnitude? Please identify with
specificity this plan and those dedicated resources of people and
equipment. Specifically, how would the decomposing and potentially
infectious carcasses be disposed of? How quickly would this response
occur, and what would its effectiveness be?
Question 2. What is the Federal Government's response plan for a
large-scale avian influenza outbreak in the poultry industry?
Specifically, how would the diseased and infectious birds be disposed
of? How quickly would this response occur, and what would its
effectiveness be?
Question 3. When a natural or man-caused biological event occurs in
the homeland and that affects our livestock or other agricultural
interest, we need to ensure we have a comprehensive, pre-planned, pre-
resourced, and pre-positioned response plan in place.
What recommendations would you make to FEMA to ensure our
agricultural interests are protected and that we are prepared to
respond in the event of a agro-terrorist attack or an epidemic?
Answer. Belated thank you for the follow-up email and the questions
from Congressman Palazzo. Those are all very important questions, and I
would have liked to have been able to address them.
But unfortunately neither I nor my colleagues at the UPMC Center
for Health Security have the expertise or backgrounds to be able to
answer those questions competently. Our Center has a focus preventing
and responding to threats to human health, and we don't have animal
health experts on staff. I am sorry that I am not of any assistance in
responding to them.
Questions From Honorable Steven M. Palazzo for Leonard A. Cole
Question 1. Our country has been subjected to numerous, potentially
catastrophic biohazard exposures in recent years in our agricultural
industry; the outbreak of the H1N1 (Swine Flu) and the H5N1 (Bird Flu)
viruses come to mind. Fortunately, none of these exposures have
resulted in any large scale damage.
However, agro-terrorism, which is the malicious use of plant or
animal pathogens to cause devastating disease in the agricultural
sector, is a concern. But it doesn't stop there. Natural or accidental
biological events can have the same devastating impacts as those which
are intentionally caused.
To give you a scenario, in 2001, Foot & Mouth Disease affected
9,000 farms in the United Kingdom and required the destruction of more
than 4 million cows. USDA researchers believe that a similar outbreak
in the United States would cost taxpayers up to $60 billion. Given the
relative size of the United States to the United Kingdom, this could
result in the need to destroy 20 million head of cattle in a short
period of time with little advance notice.
Does the Federal Government have a plan in place and the attendant
resources to handle a disaster of [great] magnitude? Specifically, how
would the decomposing and potentially infectious carcasses be disposed
of? How quickly would this response occur, and what would its
effectiveness be?
Answer.* Since the United States has not experienced a catastrophic
outbreak of Foot and Mouth Disease or other livestock disease in recent
memory, response plans are based largely on extrapolations from routine
disposal methods and lessons from major outbreaks elsewhere,
specifically in Europe and Taiwan. A review by the U.S. Department of
Agriculture (USDA) indicates four principal methods of disposal of
infectious carcasses: Burial (on-site), incineration, rendering
(conversion to other products), and composting (breakdown into
fertilizer).
---------------------------------------------------------------------------
* [Note.--My bioterrorism expertise is largely focused on the
direct effects on people, not plants or animals. In providing answers
to the questions I have searched Government websites and other
literature. I also benefited from conversation with veterinary expert
Dr. Sandra San Miguel, Associate Dean of Engagement at Purdue
University. Before addressing the posed questions, I note that
protection regarding any outbreak of animal disease involves layers of
interested parties. Federal law requires that serious animal diseases,
such as Foot and Mouth Disease, be reported immediately. Federal
oversight is largely under the purview of the U.S. Department of
Agriculture (USDA) and its Animal and Plant Health Inspection Service
(APHIS). States also maintain agencies responsible for oversight and
control of animal disease outbreaks.
For livestock events involving reportable diseases the emergency
response is Federal first (led by APHIS), and then local assistance is
used. For responses involving natural emergencies (flood, tornado,
etc.) the response usually goes local first. If local resources become
exhausted Federal aid is sought.
Personal and economic interests buttress the likelihood of early
reporting. The following parties are positioned and obliged to report
disease as soon as recognized: Veterinarians, farmers, slaughter
facilities, truckers and other transporters, Federal and State plant
inspectors, even 4-H youngsters--in short, everyone in the livestock
industry. Given this array, Dr. San Miguel believes that any clinical
signs of disease would be recognized quickly. However, before such
signs are visible, an infected animal may already have been exposed to
other animals.]
---------------------------------------------------------------------------
Strengths and limitations are associated with each method. Burial
of numerous carcasses in large pits can be relatively quick, though
inadequate protective treatment and insulation (with chemicals and
barriers) around the pit risks soil and groundwater pollution.
Contained incineration can be effective but the number and
availability of enclosed incinerators is limited. Open-air burning,
while quick, contaminates surrounding air. Rendering and composting
requires transporting numerous carcasses perhaps to distant facilities,
which also are limited in numbers. Carcass disposal options are more
fully reviewed in a 2004 report by the National Agricultural
Biosecurity Center at Kansas State University. (https://krex.k-
state.edu/dspace/handle/2097/662)
I am unaware of a Federal plan to dispose of carcasses explicitly
resulting from a catastrophic disease outbreak. Oversight
responsibility for this would fall to the USDA's Animal and Plant
Health Inspection Service. The response presumably would be a ramping
up of existing methods as suggested by an observation in a USDA
publication: ``Past experiences of epidemic disease outbreaks in Taiwan
and Europe indicate that use of several disposal methods in combination
may be required to deal with catastrophic mortality disposal.''
(``Swine Carcass Disposal Options for Routine and Catastrophic
Mortality,'' Council for Agricultural Science and Technology (CAST),
Issue Paper No. 39, U.S. Department of Agriculture, July 2008.)
Question 2. What is the Federal Government's response plan for a
large-scale avian influenza outbreak in the poultry industry?
Specifically, how would the diseased and infectious birds be disposed
of? How quickly would this response occur, and what would its
effectiveness be?
Answer. Unlike for livestock, and particularly large animals,
disposal of birds infected with avian influenza should not include
burial. The virus is highly contagious and burial and land containment
cannot be sufficiently controlled to preclude its spread to other birds
or mammals. Thus, incineration is the method of choice. But because of
the virus's high infectivity potential, transporting birds to standard
apparatus such as solid municipal waste incinerators or autoclaves is
not advised. Rather, portable (truck driven) ``refractory walled'' fire
boxes are deemed the most suitable to dispose of suspect bird
carcasses. (Avian Influenza Bird Carcass Disposal, Disposal of Culled
Birds and Dead Wild Birds at Remote Locations, USDA Animal Welfare
Information Center, http://www.airburners.com/DATA-FILES_Print/AB-
Bird_Flu_%20Carcass_Disposal-v0306d.pdf)
The speed and effectiveness of disposal, like response capabilities
in other areas of disaster management, doubtless vary from one location
to another. Some areas will have quicker access to the required
equipment, more appropriate personnel, and perhaps have undertaken more
frequent and realistic preparedness exercises.
Question 3. When a natural or man-caused biological event occurs in
the homeland and that affects our livestock or other agricultural
interest, we need to ensure we have a comprehensive, pre-planned, pre-
resourced, and pre-positioned response plan in place.
What recommendations would you make to FEMA to ensure our
agricultural interests are protected and that we are prepared to
respond in the event of a agro-terrorist attack or an epidemic?
Answer. For every disease of concern, the USDA's Animal and Plant
Health Inspection Service (APHIS) has plans in place including
provision of medications, euthanasia, and personnel protection. The
Federal Emergency Management Agency (FEMA) should be working with APHIS
in furtherance of these and other response methods. According to Dr.
San Miguel, this cooperation exists at the State level in Indiana and
elsewhere.
For example, the lead oversight agency in Iowa is the State's
Department of Agriculture and Land Stewardship (IDALS), which includes
a network of 330 veterinary and animal health professionals trained to
respond to disease emergencies in the State. The IDALS response plans
explicitly include working with the Federal DOA-APHIS. (http://
www.cfsph.iastate.edu/Animal_Response/English/pdf/A4_SPN-
_BusinessOverview.pdf)
Gauging cooperation at the Federal level between DOA-APHIS and FEMA
would require further inquiries into activities of the two agencies and
of other relevant bodies.
[all]