[House Hearing, 108 Congress]
[From the U.S. Government Publishing Office]
TOWARDS A NATIONAL BIODEFENSE STRATEGY
=======================================================================
HEARING
of the
SELECT COMMITTEE ON HOMELAND SECURITY
HOUSE OF REPRESENTATIVES
ONE HUNDRED EIGHTH CONGRESS
SECOND SESSION
__________
JUNE 3, 2004
__________
Serial No. 108-50
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Printed for the use of the Select Committee on Homeland Security
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SELECT COMMITTEE ON HOMELAND SECURITY
Christopher Cox, California, Chairman
Jennifer Dunn, Washington Jim Turner, Texas, Ranking Member
C.W. Bill Young, Florida Bennie G. Thompson, Mississippi
Don Young, Alaska Loretta Sanchez, California
F. James Sensenbrenner, Jr., Edward J. Markey, Massachusetts
Wisconsin Norman D. Dicks, Washington
W.J. (Billy) Tauzin, Louisiana Barney Frank, Massachusetts
David Dreier, California Jane Harman, California
Duncan Hunter, California Benjamin L. Cardin, Maryland
Harold Rogers, Kentucky Louise McIntosh Slaughter, New
Sherwood Boehlert, New York York
Lamar S. Smith, Texas Peter A. DeFazio, Oregon
Curt Weldon, Pennsylvania Nita M. Lowey, New York
Christopher Shays, Connecticut Robert E. Andrews, New Jersey
Porter J. Goss, Florida Eleanor Holmes Norton, District of
Dave Camp, Michigan Columbia
Lincoln Diaz-Balart, Florida Zoe Lofgren, California
Bob Goodlatte, Virginia Karen McCarthy, Missouri
Ernest J. Istook, Jr., Oklahoma Sheila Jackson-Lee, Texas
Peter T. King, New York Bill Pascrell, Jr., North Carolina
John Linder, Georgia Donna M. Christensen, U.S. Virgin
John B. Shadegg, Arizona Islands
Mark E. Souder, Indiana Bob Etheridge, North Carolina
Mac Thornberry, Texas Ken Lucas, Kentucky
Jim Gibbons, Nevada James R. Langevin, Rhode Island
Kay Granger, Texas Kendrick B. Meek, Florida
Pete Sessions, Texas
John E. Sweeney, New York
John Gannon, Chief of Staff
Stephen DeVine, Deputy Staff Director and General Counsel
Thomas Dilenge, Chief Counsel and Policy Director
David H. Schanzer, Democrat Staff Director
Mark T. Magee, Democrat Deputy Staff Director
Michael S. Twinchek, Chief Clerk
(II)
C O N T E N T S
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Page
STATEMENTS
The Honorable Christopher Cox, a Representative in Congress From
the State of California, and Chairman, Select Committee on
Homeland Security.............................................. 1
The Honorable Jim Turner, a Representative in Congress From the
State of Texas, and Ranking Member, Select Committee on
Homeland Security.............................................. 3
The Honorable Dave Camp, a Representative in Congress From the
State of Michigan.............................................. 5
The Honorable Donna M. Christensen, a Delegate in Congress From
the U.S. Virgin Islands........................................ 25
The Honorable Norman D. Dicks, a Representative in Congress From
the State of Washington........................................ 28
The Honorable Jennifer Dunn, a Representative in Congress From
the State of Washington........................................ 32
The Honorable Bob Goodlatte, a Representative in Congress From
the State of Virginia.......................................... 49
The Honorable James R. Langevin, a Representative in Congress
From the State of Rhode Island................................. 30
The Honorable Sheila Jackson-Lee, a Representative in Congress
From the State of Texas........................................ 32
The Honorable Christopher Shays, a Representative in Congress
From the State of Connecticut.................................. 22
WITNESSES
Panel I
The Honorable Penrose ``Parney'' Albright, Assistant Secretary
for Science and Technology, Department of Homeland Security
Oral Statement................................................. 5
Prepared Statement............................................. 8
Dr. Anthony Fauci, Director of the National Institute of Allergy
and Infectious Diseases Department of Health and Human Services
Oral Statement................................................. 13
Prepared Statement............................................. 16
Accompanied by: Dr. William F. Raub, Principal Deputy Assistant
Secretary, Office of the Assistant Secretary for Public Health
Emergency Preparedness
Oral Statement................................................. 26
Major General Lester Martinez-Lopez, Commanding General, U.S.
Army Medical Research and Materiel Command, Fort Detrick,
Maryland
Oral Statement................................................. 12
Panel II
Dr. Shelley A. Hearne, Executive Director, Trust for the
America's Health
Oral Statement................................................. 41
Prepared Statement............................................. 43
Dr. Anna Johnson-Winegar, Private Consultant
Oral Statement................................................. 37
Prepared Statement............................................. 38
APPENDIX
Questions and Responses for the Record:
The Honorable Penrose C. Albright.............................. 57
Dr. Anthony S. Fauci........................................... 80
Dr. Shelley Hearne............................................. 64
Major General Lester Martinex-Lopez............................ 73
Dr. Anna Johnson-Winegar....................................... 75
TOWARDS A NATIONAL BIODEFENSE STRATEGY
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Thursday, June 3, 2004
House of Representatives,
Select Committee on Homeland Security,
Washington, DC.
The committee met, pursuant to call, at 1:13 p.m., in Room
345, Cannon House Office Building, Hon. Christopher Cox
[chairman of the committee] presiding.
Present: Representatives Cox, Dunn, Barton, Shays, Camp,
Goodlatte, Linder, Thornberry, Turner, Dicks, Lowey, McCarthy,
Jackson Lee, Christensen, Lucas, Langevin, and Meek.
Chairman Cox. The Select Committee on Homeland Security
will come to order. The committee is meeting today to hear
testimony on the development of a national biodefense strategy.
In order to allow us to hear from our witnesses more quickly, I
would ask members to waive or limit the duration of oral
opening statements. Those who are present within 5 minutes of
the gavel and waive their opening statement will be allotted 3
additional minutes for questioning the panel. If the members
have written statements, they may be included in the hearing
record.
I want to thank our distinguished panelists for appearing
before us this afternoon.
The biothreat is particularly worrisome because we know so
little about terrorist capabilities. We don't know nearly as
much as we would like about their motivations and their
intentions to employ biological weapons. Yet, we also know that
a bioattack could result in a catastrophic loss of life. The
Department of Homeland Security must have experienced analysts
to assess the threat on a continuing basis, and must play a
leading role in coordinating the development of antidotes and
countermeasures to the most virulent agents we face today and
that we will face tomorrow.
As the President stated soon after 9/11, disease has long
been the deadliest enemy of mankind. Infectious diseases make
no distinctions among people and recognize no borders. We have
fought the causes and consequences of disease throughout
history, and must continue to do so with every available means.
Of course, this goes triply if those diseases are being spread
intentionally rather than by mother nature.
Under President Bush's leadership, we have stood up the new
Department of Homeland Security, substantially increasing
biosecurity through the passage of the Bioterrorism
Preparedness Act of 2002, and we have begun implementation of
the latest Presidential directive on biosecurity, HSPD-10. We
have also dramatically increased funding for biodefense
research, surveillance, preparedness, and response activities.
The House and now the Senate have also passed the project
BioShield Act, which hopefully soon will go to the President's
desk for signature. This bipartisan legislation is an
investment to incentivize development of the counter-measures
by the private sector and speed up biodefense research. It is
only one of many initiatives the President has proposed and
fully supported to counter the continued biothreat.
The serious and continuing threat to our citizens is real.
The President's and Congress' commitment to reducing it is
today greater than ever. The good news is that our investments
in biodefense will have significant application to naturally-
occurring infectious diseases that can, with little warning,
wreak havoc on mankind without regard to borders or social
class.
The science and technology revolution in which we are now
involved offers unprecedented hope, if we are smart enough, to
exploit the opportunities before us. Over the past year, DHS's
highly capable science and technology directorate has
implemented biowatch in approximately 30 cities. The
President's commitment to building a strong biodefense is clear
in the fiscal year 2005 budget proposal. R&D biodefense
spending in the science and technology directorate alone is
slated for a 42 percent increase over fiscal year 2004 levels.
The S&T directorate and its current management has enjoyed the
enthusiastic support of both the Executive and Legislative
Branches. And we expect this to continue.
That said, we must all recognize that the time has come to
develop and implement a clear national strategy for biodefense
that will allow us to focus on priorities, to discipline our
spending, and to permit measurement toward concrete goals. The
strategy presented by the President in the Homeland Security
Presidential Directive 10, Biodefense for the 21st Century,
defines the missions, sets the priorities, and assigns roles to
key Federal partners. It gives the Department of Homeland
Security specific responsibilities to coordinate these efforts.
The committee will conduct rigorous oversight of DHS's efforts
to develop a concrete strategy to implement this new directive.
The panel before us represents the primary Federal partners
assigned to mitigate the biothreat. As our committee moves to
complete the first authorization bill for the Department of
Homeland Security, we will be especially vigilant in assessing
DHS efforts to craft a biodefense strategy.
We must address the paramount need to prioritize research
goals and objectives in consultation with the widest range of
U.S. government and outside experts. As this committee so often
stresses, credible intelligence will be a key factor in this
prioritizing. I look forward to hearing the steps our witnesses
have taken to work with the IAIP directorate and other elements
of the intelligence community to incorporate our best
intelligence into your planning for biodefense R&D and to levy
new requirements to improve that intelligence. I also look
forward to hearing the progress you have made in surveillance,
detection, and diagnosis of bioterrorist threat agencies.
Finally, we know only too well that an effective biodefense
strategy must include unprecedented cooperation among Federal
agencies. The Department of Homeland Security along with the
Department of Health and Human Services and the Department of
Defense, must coordinate their resources as never before to
defeat the biothreat. Close coordination among these Federal
departments will be increasingly important to develop the
scientific expertise and R&D capabilities to meet the threat of
new and more virulent agents in the year ahead.
I, again, thank our distinguished witnesses for taking the
time to be with us this afternoon. And at this time, I would
yield to the gentleman from Texas, Mr. Turner, for his opening
statement.
Mr. Turner. Thank you, Mr. Chairman. It is good to have all
of our witnesses here today to talk about this very, very
important subject to Homeland Security.
I want to thank all of our witnesses for their presence,
Dr. Albright, Dr. Fauci, welcome back to our committee. We look
forward to hearing from both of you once again. General
Martinez and Dr. Raub, thank you so much for your presence here
today. I also want to thank Dr. Shelley Hearne, who will appear
momentarily to give us perspective on biodefense preparedness
as well as Dr. Anna Johnson-Winegar, who has years of
experience as a researcher and administrator of biological
defense programs.
It was one year ago that this committee held hearings on
Project Bio-Shield. Following such consideration, we, along
with our House colleagues, moved quickly to approve the bill,
sending it to the Senate. Its final passage out of the Senate
just two weeks ago is, in my judgment, long overdue, and I
think once again, illustrates for us the fact that, in my
judgment, we have lost the sense of urgency that we need to
have for protecting the homeland that we all felt in the wake
of the 9/11 attacks. The sense of urgency must be regained. I
think we all understand that our terrorist enemies who are
fully capable of striking again and looking for opportunities
to do so.
Fortunately, we have made some progress in preparing our
Nation to combat a bio-terrorism attack. We do have a large
strategic national stockpile of antibiotics and medical
supplies. Public servants such as Dr. Fauci have worked hard to
develop new vaccines, drugs, diagnostic devices, all of which
we need in the defense against bio-terrorism.
Our Department of Homeland Security has deployed new
sensors to detect airborne pathogens in our major cities, and
the Department of Defense has long made the protection of
troops from chemical and biological weapons a priority of its
research and procurement programs.
Despite this good news, there is clear evidence that we
need to do a whole lot more. We need to move much faster in
protecting our Nation against the threat of bio-terrorism. Let
me cite a few examples.
It took us 2-1/2 years after the anthrax attacks to develop
a strategy for bio-terrorism, a strategy that was released just
a few weeks ago by the administration in the form of a
Presidential directive. In reviewing this document, it appears
from our briefings on the subject that it sets forth broad
strategic goals and assigns specific tasks to specific
agencies. It does not, however, seem to identify specific
objectives, establish time frames for achieving those
objectives, allocate resources, or clearly define the roles of
the Federal, state, and local agencies in bio-terrorism
prevention, preparedness, and response. In order to get this
job done, this degree of detail must be attached to and
provided as a part of this strategic plan to deal with the
bioterrorist threat.
Another example of our failure is that we still have not
secured our national stocks of dangerous pathogens and the
laboratories that house them, despite a requirement to do so in
the 2002 Bioterrorism Preparedness Act.
While expanded research is essential to improving our
biodefense, it also brings more opportunities for the
accidental or intentional escape of pathogens from legitimate
facilities. The administration should fully implement the
select agent regulations mandated by Congress as soon as
possible.
Another example of a shortcoming I think that still exists:
While we have enough smallpox vaccine, from what I understand,
to vaccinate every man, woman, and child in the Nation, it
appears to me that it is still an open question as to whether
or not we could vaccinate our population quickly enough if a
smallpox outbreak occurred. The administration's goal of
vaccinating 500,000 health care workers and first responders
has not been met. The last time I checked, we had vaccinated
under 50,000 people. And 40 percent of the States report that
they are unable to vaccinate their populations within 10 days
of an outbreak. The goals of the national smallpox vaccination
program have not been achieved, and it is not clear how the
administration is attempting to get that program back on track.
In addition to the deficiencies in smallpox preparation,
the trust for America's health reports that only two States are
actually prepared to distribute the supplies that currently
reside in the national stockpile. To prepare our Nation for a
bioterrorist attack, every State and community in the country
should have detailed plans outlining how the necessary
medicines will be transported, where the medicines will be
distributed, and who will be operating those distribution
centers.
Finally, Mr. Chairman, we need to acknowledge that while
Project BioShield is a good first step, it is unlikely to
provide the full range of countermeasures we need to prepare
this Nation for a bioterrorist attack. We must take steps to
ensure that the private sector and, if necessary, the Federal
government can rapidly produce the counter-measures we need to
combat the unknown, the resistant, or the bioengineered
pathogens that could be used against us in a future bioterror
attack.
That is why I, along with 34 other Members of the House,
recently introduced H.R. 4258, the Rapid Cures Act, to begin
the process of building a national capability to respond more
quickly to bioterrorism threats. And I hope that each of our
witnesses will take a look at that legislation and advise me
regarding your opinion and the merits of it.
The legislation recognizes that it may never be possible to
produce every medical countermeasure we need through Project
BioShield, and that the growing power of biotechnology can
render a pathogen like anthrax or smallpox immune to the
vaccines and drugs that we do have on hand. We need to develop
the mechanisms to go from bug to drug or the identification of
a pathogen to the development of a countermeasure to combat it
in as little as a few months or even weeks rather than the
current 18-year average for drug development. Personally, I
cannot think of another research goal that would bring more
benefits to the security of this country and to the public
health of this country than achieving this objective. I am
interested in hearing from our witnesses today on this
proposal.
Mr. Chairman, bioterrorism is arguably the most significant
threat we face, and I thank you for calling the hearing today
to allow us to examine how we best move forward to develop a
bioterrorism strategy for our nation.
Thank you, Mr. Chairman.
Chairman Cox. I thank the gentleman.
The gentleman from Connecticut, the chairman of the
Subcommittee on National Security of the Committee on
Government Reform and Oversight, is recognized for purposes of
an opening statement.
Mr. Shays. I have no opening statement. I will just have
questions. Thank you.
Chairman Cox. The gentleman from Michigan.
Mr. Camp. I am fine.
Ms. McCarthy. I yield back.
Chairman Cox. Does any member wish to be recognized for
purposes of an opening statement? If not, the Chair will now
call up testimony from the first panel. Let me remind witnesses
that under our committee rules they should strive to limit
their opening remarks to 5 minutes. Each witness's entire
written statement will appear in the record. We will also allow
the entire panel to testify before questioning any witnesses.
Chairman Cox. The Chair now recognizes our first witness,
the Honorable Penrose ``Parney'' Albright, Assistant Secretary
for Science and Technology, the Department of Homeland
Security, to testify. Secretary Albright, welcome back to the
Committee on Homeland Security.
STATEMENT OF THE HONORABLE PENROSE ``Parney'' ALBRIGHT
Dr. Albright. Thank you, Chairman Cox. And good afternoon,
Chairman, Congressman Turner, and the other distinguished
members of the committee. I am pleased to appear before you
today to discuss the progress of the science and technology
directorate of the Department of Homeland Security, that it is
making in the Nation's effort to prevent, protect against,
respond to, and recover from acts of bioterrorism against the
American people.
President Bush has made strengthening the Nation's defenses
against biological weapons a critical national priority. And,
as the Chairman just pointed out, this has resulted in a joint
Homeland Security Presidential directive, along with the
National Security Council, entitled Biodefense for the 21st
Century, that provides a comprehensive framework for our
Nation's biodefense.
The Department of Homeland Security, through the science
and technology directorate, has explicit responsibilities in
this integrated national effort.
I want to briefly address how we work with the Department
of Homeland Security's information, analysis, and
infrastructure protection directorate and how their work is
linked to the S&T directorate's work. The IAIP directorate
assesses collected intelligence and information about threats
and vulnerabilities from other agencies, and then takes
preventative and protective action. They are partners in the
total agencies to obtain, assess, and disseminate information
regarding potential threats to America from terrorist actions.
These threats and vulnerability assessments are inputs into the
strategy and research, development, testing and evaluation
activities of the science and technology directorate, and
further inform S&T's interactions with the broader research and
development community.
The Presidential directive, Biodefense for the 21st
Century, outlines four essential pillars of the Nation's
biodefense program and provides specific directives to further
strengthen the significant gains that have been put in place in
the past 3 years.
The four pillars of the program are:
First, threat awareness, which includes biological weapons-
related intelligence, vulnerability assessments, and
anticipation of future threats. And then, prevention and
protection, surveillance and detection, and response and
recovery.
The Department of Homeland Security and S&T directorate
have a role and responsibility in each of these four pillars of
the national biodefense program. Our contributions and planned
activities include providing a continuing all-WMD assessment
effort within the science and technology directorate. This work
is being performed for IAIP. The first reports describing the
capabilities of 20 terrorist groups in biological, chemical,
radiological, nuclear, cyber, and advanced explosives threats
areas have been completed and delivered to IAIP.
Furthermore, the S&T directorate has embedded a team of WMD
scientific experts to provide technical assistance to IAIP
analysts, and is installing a knowledge information tool within
IAIP to enable easy access to reports and all the supporting
data and information.
The S&T directorate has established a national biodefense
analysis and countermeasure center, or NBACC, with the missions
of threat characterization, forensics and attribution, and the
establishment of a knowledge center in the biological area. The
S&T directorate is further coordinating with the Departments of
Defense, Health and Human Services, and Agriculture to
establish a national interagency biodefense campus at Fort
Detrick. The S&T directorate addresses the full range of
biological threats, but the initial emphasis is on active
defense against high consequence threats, those that can
inflict damage that would significantly challenge this Nation's
immediate ability to respond.
In addressing these biological threats, the S&T directorate
has the leadership role in several key areas and partners with
lead agencies in others. Those areas in which the S&T
directorate provides significant leadership are, first,
providing an overall end-to-end understanding of an integrated
biodefense so as to guide the Secretary and the rest of the
Department in its responsibility to coordinate the Nation's
efforts to deter, detect, and respond to biological acts of
terrorism.
We also provide scientific support, as I mentioned earlier,
to the intelligence community and IAIP in prioritizing the
biothreats. We are, again, as the Chairman noted, developing
and have implemented early warning and detection systems to
permit timely response to mitigate the consequences of the
biological attack. And we conduct technical forensics to
analyze and interpret materials recovered from an attack to
support attribution.
DHS also supports our partnering departments and agencies
where they are leads in other key areas of an integrated
biodefense. The Department of Health and Human Services on
medical countermeasures and mass casualty response, USDA on
agriculture, USDA and HHS on food security, and the
Environmental Protection Agency on decontamination and on water
security.
The Presidential directive HSPD-10, as well as other HSPDs,
identify national objectives and priorities and departmental
agency roles in addressing those particular national priorities
in the biodefense arena. The S&T directorate has been and
continues to be an active participant in interagency
activities. We participated in the joint NSC/HSC biodefense
end-to-end study, which led directly to HSPD-10, and this was
followed by an interagency review conducted under the aegis of
the NSC/HSC for fiscal year 2006 to 2010 science and technology
needs to support the national biodefense strategy as
articulated in HSPD-10.
This and other inputs including those from the
counterproliferation technology coordinating committee, the
National Science and Technology Council's weapons of mass
destruction medical countermeasures committee, and its
associated subcommittees, and various HHS-led risk management
meetings which help guide medical countermeasure procurements,
are being documented in the national strategic plan for
Homeland Security science and technology.
The weapons of mass destruction medical countermeasures
subcommittee provides an interagency forum for discussing and
prioritizing medical countermeasure needs to be pursued under
BioShield, and an HSC-led interagency biosurveillance committee
provides a forum for coordinating and integrating the multiple
activities in this area to provide an integrated biowarning and
situational awareness system.
And then at other levels of coordination, there are strong
bilateral efforts around key elements of the strategy. For
example, examples include strong and frequent collaborations on
BioShield with HHS, the development of a coordinated civilian
and military surveillance and detection system with DOD, and
the development and execution of a national strategy for
agricultural biosecurity with the USDA.
The needs in three areas of this integrative biodefense
have turned out to be so great to have generated Presidential
initiatives. And there are three of them. These three
initiatives are: BioShield, which we have already heard quite a
bit about. One important point to make about that is that the
S&T directorate played a significant role in determining which
agents constitute material threats and in developing the
scenarios to inform decisions on the quantity of
countermeasures required. We have certified one material
threat, which is anthrax, have two additional underway, and
three more are pending.
We also play a key role in the biosurveillance initiative
in terms of first operating the biowatch system, deploying the
second generation system to significantly expand the number of
detectors in the highest threat cities and key facilities, and
in developing advanced detection systems.
And then in addition, the S&T directorate is bringing
significant contributions and end-to-end studies of key
agricultural and food threats through the development of
advanced diagnostics and through R&D conducted jointly with
USDA at Plum Island Animal Disease Center.
Thus, the science and technology programs conducted within
the Department of Homeland Security fully support the national
biodefense program as stated in HSPD-10 and other Homeland
Security Presidential directives. Moreover, they are conducted
in an act of collaboration with other Federal departments and
agencies having a role in meeting this national priority, and
are focused on reducing the threat of a biological attack
against the Nation's population and its agricultural and food
critical infrastructures, and supports a science-based
forensics and attribution capability.
This concludes my prepared statement. With the committee's
permission, I request that my formal statement be submitted for
the record.
Mr. Chairman, Congressman Turner, and members of the
committee, I thank you for the opportunity to appear before you
today and look forward to your questions.
Chairman Cox. Thank you, Secretary Albright. Your written
statement has been entered into the record.
[The statement of Dr. Albright follows:]
Prepared Opening Statement of Dr. Penrose C. Albright
Good afternoon Chairman Cox, Congressman Turner, and distinguished
members of the Committee. I am pleased to appear before you today to
discuss the progress the Science and Technology Directorate of the
Department of Homeland Security is making in the nation's efforts to
prevent, protect against, respond to, and recover from, acts of
bioterrorism against the American people.
President Bush has made strengthening the nation's defenses against
biological weapons a critical national priority. Although significant
progress has been made to protect America, President Bush instructed
Federal departments and agencies to review their efforts and find
better ways to secure America from bioattacks.
This review resulted in a joint Homeland Security Presidential
Directive (HSPD-10)/National Security Presidential Directive (NSPD-33)
entitled Biodefense for the 21st Century. that provides a comprehensive
framework for our nation's biodefense. This directive builds upon past
accomplishments, specifies roles and responsibilities, and integrates
the programs and efforts of various communities--national security,
medical, public health, intelligence, diplomatic, agricultural and law
enforcement--into a sustained and focused effort against biological
weapons threats.
The Department of Homeland Security (DHS) and the Science and
Technology (S&T) Directorate have explicit responsibilities in this
integrated national effort. In particular, I want to highlight the
strategy, planning and accomplishments to date of S&T in the area of
biodefense, and the essential collaborations with key Federal partners,
including those represented here today.
BIODEFENSE
Before I speak directly to the biodefense efforts of the S&T
Directorate, I want to briefly address the role of the DHS's
Information Analysis and Infrastructure Protection Directorate, and how
their work is linked to the S&T Directorate. The Information Analysis
and Infrastructure Protection (IAIP) Directorate assesses intelligence
and information about threats and vulnerabilities from other agencies
and takes preventative and protective action. They are partners in the
total interagency efforts to obtain, assess and disseminate information
regarding potential threats to America from terrorist actions. These
threat and vulnerability assessments are inputs into the strategy and
research, development, testing and evaluation (RDT&E) activities of the
Science and Technology Directorate. For example, agriculture and food
are two of the multiple critical infrastructure sectors identified by
Homeland Security Presidential Directive 7.As such, they fall within
the domain of the IAIP Directorate; they also are within the domain of
concern for biological threats.
Mission and Objectives:
The presidential directive Biodefense for the 21st Century outlines
four essential pillars of the nation's biodefense program and provides
specific directives to further strengthen the significant gains put in
place in the past three years. Specific direction to departments and
agencies to conduct this biodefense program is contained in a
classified version of the directive and is not provided in the present
document. However, the four pillars of the program are:
Threat Awareness, which includes biological weapons-
related intelligence, vulnerability assessments, and
anticipation of future threats. New initiatives will improve
our ability to collect, analyze, and disseminate intelligence
on biological weapons and their potential users.
Prevention and Protection, which includes interdiction
and critical infrastructure protection. New initiatives will
improve our ability to detect, interdict, and seize weapons
technologies and materials to disrupt the proliferation trade,
and to pursue proliferators through strengthened law
enforcement cooperation, including through such mechanisms as
Interpol.
Surveillance and Detection, which includes attack
warning and attribution. New initiatives will further
strengthen the biosurveillance capabilities being put in place
in fiscal year 2005.
Response and Recovery, which includes response
planning, mass casualty care, risk communication, medical
countermeasures, and decontamination. New initiatives will
strengthen our ability to provide mass casualty care and to
decontaminate the site of an attack.
The Department of Homeland Security has a role and responsibility
in each of these four pillars of the national biodefense program. The
S&T Directorate has the responsibility to lead the Department's RDT&E
activities to support the national biodefense objectives and the
Department's mission.
Accomplishments and Planned Activities:
Dr. Charles E. McQueary, Under Secretary for Science and
Technology, has previously testified before the U.S. House of
Representatives, Appropriations Subcommittee on Homeland Security; the
U.S. House of Representatives, Subcommittee on Cybersecurity, Science,
and Research and Development; and the U.S. House of Representatives,
Science Committee. The accomplishments to date and planned activities
for FY 2005 of the Science and Technology Directorate and its RDT&E
related to biological threats have been described in the written
testimony for the record for those hearings and I will not repeat here
the details already provided in those fora. However, there are some
specific accomplishments and planned activities I want to describe
because they illustrate the integrated efforts within the Department of
Homeland Security and other Federal departments and agencies.
The Science and Technology Directorate contributes to each of the
key areas of the national biodefense program. Our contributions and
planned activities include:
The S&T Directorate is funding a continuing all-WMD
assessment effort. The program focuses on determining the
capabilities of state and non-state terrorist groups to develop
and deliver or deploy any chemical/biological/radiological/
nuclear/explosives (CBRNE) agent within the United States. This
work is being performed for IAIP; and the first reports,
describing the capabilities of 20 Tier 0 and Tier 1 groups in
biological, chemical, radiological, nuclear, cyber, and
advanced explosives (or energetics) threat areas, have already
been completed and delivered to IAIP. Furthermore, the S&T
Directorate is in the process of embedding a team of WMD
scientific experts to provide technical assistance to IAIP
analysts and is installing a pilot Knowledge Information Tool,
which enables access to the reports and all of the supporting
data and information. .
The S&T Directorate has established the National
Biodefense Analysis and Countermeasures Center (NBACC), with
the missions of threat characterization, forensics and
attribution, and bio-knowledge. In order to fulfill these
missions, the NBACC is comprised of three centers: the Bio
Threat Characterization Center (BTCC), the National
BioForensics Center (NBFAC) and the Biosecurity Knowledge
Center (BKC). These components will provide a scientific basis
to understanding the biological threat and become part of a
data and telecommunications network enabling information
sharing and threat and vulnerability analysis among a diverse
set of users.
The S&T Directorate is coordinating with the
Departments of Defense, Health and Human Services, and
Agriculture to establish the proposed National Interagency
Biodefense Campus at Ft. Detrick. The NBACC is proposed to
include the BTCC, focusing on threat characterization, and
NBFAC, which provides interagency forensic capability. The
synergy at this center will allow for integrated biodefense
research programs across the government, better address the
priorities established in the President's directive and provide
scientific rigor to threat and vulnerability assessments for
IAIP.
The S&T Directorate has developed and implemented a
Threat-Vulnerability Integration System prototype at IAIP. That
system provides advanced information discovery, analysis, and
visualization tools to IAIP analysts and will be used in
concert with the Threat-Vulnerability Mapping System. Such
advanced tools can be applied to the biodefense problem
specifically or all-WMD analysis in general. To ensure use of
these systems is optimized, the S&T Directorate has detailed
technical personnel to IAIP.
The S&T Directorate addresses the full range of biological threats,
but the initial emphasis in on active defense against high consequence
threats- those that can inflict damage which would significantly
challenge this Nation's immediate ability to respond, i.e. thousands or
tens of thousands of serious casualties and/or economic losses in the
tens of billions of dollars or higher. Such threats include large
outdoor and indoor aerosolized releases of non-contagious and
contagious pathogens, contamination of selected bulk food supplies,
foreign animal diseases, highly virulent plant diseases, engineered
threats, multiple small attacks, and zoonotic diseases.
In addressing these activities, the S&T Directorate has a
leadership role in several key areas and partners with lead agencies in
others. Those areas in which DHS provides significant leadership are:
Providing an overall end-to-end understanding of an
integrated biodefense, so as to guide the Secretary and the
rest of the Department in its responsibility to coordinate the
Nation's efforts to deter, detect, and response to biological
acts of terrorism
Providing scientific support to the intelligence
community and IAIP in prioritizing the bio-threats
Developing early warning and detection systems to
permit timely response to mitigate the consequence of a
biological attack
Conducting technical forensics to analyze and
interpret materials recovered from an attack to support
attribution
Operation of the Plum Island Animal Disease Center to
support both research and development (R&D) and operational
response to foreign animal diseases such as foot and mouth
disease.
DHS also supports our partnering departments and agencies with
their leads in other key areas of an integrated biodefense: the
Department of Health and Human Services (HHS) on medical
countermeasures and mass casualty response; the U.S. Department of
Agriculture (USDA) on agriculture; USDA and HHS on food security and
the Environmental Protection Agency (EPA) on decontamination and on
water security.
Interagency Collaboration:
The previously mentioned presidential directive Biodefense for the
21st Century, as well as other Homeland Security Presidential
Directives (HSPDs) including HSPD-9, Defense of United States
Agriculture and Food; HSPD-8, National Preparedness; HSPD-4, National
Strategy to Combat Weapons of Mass Destruction; and HSPD-7, Critical
Infrastructure Identification, Prioritization, and Protection,
identifies national objectives and priorities, and departmental and
agencies? roles in addressing these national objectives.
The S&T Directorate has been, and continues to be an active
participant in these interagency activities as illustrated by our
participation in the biodefense program. At the highest level, the
joint National Security Council-Homeland Security Council (NSC-HSC)
Biodefense End-to-End Study and the ensuing HSPD-10/NSPD-33 (Biodefense
for the 21st Century) laid out the overall strategy, department and
agency roles, as well as specific objectives and called for periodic
reviews to plan, monitor and revise implementation. This was followed
by an interagency review, conducted under the aegis of the NSC-HSC, of
specific FY 2006-FY 2010 science and technology needs to support the
national biodefense strategy as articulated in HSPD-10. This and other
inputs such as those from the Counterproliferation Technology
Coordination Committee (CTCC), the National Science and Technology
Council's Weapons of Mass Destruction Medical Countermeasures Committee
(WMD-MCM) and its associated subcommittees, and HHS--led risk
management meetings which help guide medical countermeasures
procurement activities are being documented in the National Strategic
Plan for Homeland Security Science and Technology as required in the
Homeland Security Act of 2002.
The Weapons of Mass Destruction Medical Countermeasures
Subcommittee (WMD-MCM) provides an interagency forum for discussing and
prioritizing medical countermeasure needs to be pursued under BioShield
and an HSC led interagency Biosurveillance Committee provides a forum
for coordinating and integrating the multiple activities in this area
to provide an integrated biowarning and situational awareness system.
At still the next level of coordination, there are strong bilateral
efforts around key elements of the strategy. Examples of this
coordination including strong and frequent collaborations on Bioshield
(HHS/DHS), the development of coordinated civilian and military
surveillance and detection systems (DHS/DoD) and the development and
execution of a National Strategy for Agricultural Biosecurity (DHS/
USDA).
Presidential Initiatives:
The needs in three areas of this integrated biodefense turned out
to be so great as to have generated Presidential Initiatives to address
them. These three initiatives are:
BioShield: which seeks to speed development and use of new
biomedical countermeasures by creating a guaranteed market for these
`orphan drugs' and removing some of the barriers to their development
and emergency use. DHS's S&T Directorate plays a significant role in
this in determining which agents constitute ``material threats'' and in
developing scenarios that inform decisions on the quantity of
countermeasures required. We have certified one ``material threat''
(anthrax), have two additional underway, and three more are pending.
Biosurveillance Initiative: which seeks to enhance systems that
monitor the Nation's health (human, animal and plant) and its
environment (air, food, water) and to integrate these with intelligence
data to provide early detection of an attack and the situational
understanding needed to guide an effective response. The S&T
Directorate plays a major role in the Biosurveillance Initiative in
operating its 1st Generation BioWatch System, in deploying a 2nd
Generation system which significantly expands the number of collectors
in the highest threat cities and at key facilities (e.g. transportation
systems), and in developing advanced detection systems to further
increase the capabilities. We are also designing the information system
that will be use to integrate health and environmental monitoring
information from the sector specific agencies with intelligence data
from the IAIP Directorate. Implementation of this system will actually
be initiated by the IAIP Directorate in FY 2005, but the S&T
Directorate will continue to supply subject matter expertise in
biological threat and defense.
Food and Agricultural Initiative: which seeks to enhance the
security of our agricultural and food infrastructures. DHS activities
in this area are led by the IAIP Directorate--but the S&T Directorate
brings significant contributions in end-to-end studies of key
agricultural and food threats, through the development of advanced
diagnostics, and through R&D conducted jointly with USDA at the Plum
Island Animal Disease Center.
CONCLUSION
The Science and Technology Directorate's programs conducted within
the Department of Homeland Security fully support the national
biodefense program as stated in the presidential directive Biodefense
for the 21st Century, and other Homeland Security Presidential
Directives. Moreover, they are conducted in an active collaboration
with other Federal departments and agencies having a role in meeting
this national priority, and are focused on reducing the threat of a
biological attack against this nation's population and its agriculture
and food critical infrastructures, and supports a science-based
forensics and attribution capability.
This concludes my prepared statement. With the Committee's
permission, I request my formal statement be submitted for the record.
Mr. Chairman, Congressman Turner, and Members of the Committee, I thank
you for the opportunity to appear before you and I will be happy to
answer any questions that you may have.
Chairman Cox. Our next witness is Major General Lester
Martinez-Lopez, commanding general, U.S. Army Medical Research
and Materiel Command, at Fort Detrick, Maryland. Your written
statement will also be entered into the record, and we welcome
your oral testimony. General, welcome.
STATEMENT OF MAJOR GENERAL LESTER MARTINEZ-LOPEZ
General Martinez-Lopez. Mr. Chairman, distinguished members
of the committee, thank you for the opportunity to briefly
discuss the national interagency biodefense campus that is
being planned at Fort Detrick, Maryland.
As commanding general of the United States Army Medical
Research and Materiel Command as Fort Detrick, I am responsible
for delivering the best medical solutions for today and
tomorrow to enhance, protect, and treat the warfighter on point
for the Nation. This responsibility includes the protection
against biological weapons.
Today, Fort Detrick is embarking upon a vision to become
the home of the national interagency biodefense campus.
As the anthrax attacks demonstrated, the new biothreat
respects no borders and knows no boundaries. Our homeland is at
continual risk. After the attacks, many turned to Fort Detrick
for answers because throughout its history, Fort Detrick has
contributed scientific breakthroughs and medical solutions for
their Armed Forces and the Nation. With Fort Detrick's United
States Army Medical Research Institute of Infectious Diseases,
expertise has a cornerstone, and in partnership with the
National Institute of Health, the Department of Homeland
Security, and the Department of Agriculture, I believe the
National Interagency Biodefense Campus will be the Nation's
primary center for development of defenses against biological
terrorist attacks. These four agencies, complementary
facilities, programs, and expertise in the context of the
national biodefense campus will comprise the cycle of discovery
for the badly needed medical solutions against this biothreat.
To take this campus concept from a vision to a reality,
senior leaders from participating Federal agencies met in late
May 2002. We developed a strategy, established combined
facility working groups, and explore areas of research
collaboration. One month later, the National Biodefense
Interagency Coordinated Committee was established. This
interagency work led to the completion of the National
Interagency Biodefense Campus master plan. With your help, the
National Institute of Food Allergies and Infectious Diseases
will break ground for its new facility this year. The National
Biosecurity Analysis and Countermeasures Center, NBACC, of the
Department of Homeland Security, will shortly follow, and, as
you may know, the Department of Agriculture planned pathogen
laboratory is already at the Fort Detrick campus.
Let me share with you what each of these partnering
organizations will bring to the table. For 34 years, USAMRMC
has safely handled the world's deadliest pathogens and is home
to most of the Nation's experts in infectious aerosol as well
as biological threats. These world-renowned professionals have
also crossed the globe to investigate or support infectious
disease outbreaks and have provided training in how to respond
to incidents. The USAMRMC Building itself has an aerobiology
lab, biosafety labs two, three, and four, and has the only
biosafety level four patient care suite in the Nation.
The National Institute of Allergies and Infectious Diseases
brings incredible expertise and resources from their previous
efforts to understand, treat, and ultimately prevent a myriad
of infectious immunologic and allergic diseases that threaten
hundreds of millions of people worldwide. The Department of
Homeland Security will establish a center that will conduct
research to better understand classical as well as new and
emerging biological threats to humans, plants, and animals. And
in support of the FBI and other Federal agencies, a second
center will provide validated authoritative forensic analysis.
Finally, the Fort Detrick's foreign disease with science
research unit of the United States Department of Agriculture
will continue its work on pathogen detection and identification
of crop protection. In addition, the National Cancer Institute
already has a large campus at Fort Detrick. Although their
mission is direct research aimed at identifying the causes and
treatment for cancer, their facilities and scientific expertise
will complement and augment the biodefense campus work. The
campus will mass research facilities, knowledge and expertise,
creating a brain trust of civilian and military scientists in a
way that will minimize duplication of effort, technology and
facilities, while identifying ways to improve the ability of
the labs to produce science, technology, and products that are
faster, better, and cheaper.
The campus will share a common infrastructure and support
requirements, such as roadways, libraries, cafeteria,
regulatory and quality assurance offices, and will share
securities, biosafety, and biosurety responsibility. We are
also looking at cost saving mechanisms such as enhanced use
lease for a central utility plan. We are making real progress
every day toward division of the national interagency
biodefense campus at Fort Detrick, and will be--which that will
be a collaborative center of excellence for our Nation. All
partners have established good working relationships, and the
community is supportive. I am excited to be part of this bright
future.
Mr. Chairman, this concludes my remarks, and I will be
pleased to answer your questions.
Chairman Cox. Thank you, General.
Chairman Cox. Our next witness is Dr. Anthony Fauci,
director of the National Institute of Allergy and Infectious
Diseases, the Department of Health and Human Services, NIH.
Thank you, Dr. Fauci. Welcome back.
STATEMENT OF DR. ANTHONY FAUCI
Dr. Fauci. Thank you very much, Chairman Cox, Mr. Turner,
members of the committee, I appreciate the opportunity to again
appear before you as I did about this time last year.
I was asked by committee staff to briefly address three
areas of the NIH research response to the threat of
bioterrorism. And those are a summary, which I will give
shortly, of the biodefense research activities, how we
coordinate these research activities among agencies, and,
finally, how the research and development priorities are based
on threat assessment.
Chairman Cox. Dr. Fauci, if you would suspend just for a
moment. We have had two bells indicating that there is a vote
on the floor. I would propose that we go forward with your oral
testimony. And Dr. Raub, we will recognize you, but my
understanding is that you do not have a formal statement. That
will permit members to return following floor votes to begin
questioning the panel. So I want members to be alert to remain
for the formal testimony. And Dr. Fauci, I want you to not be
bothered by the buzzers that probably will continue to
interrupt your testimony.
Dr. Fauci. Will do.
Chairman Cox. Please proceed.
Dr. Fauci. At your pleasure. Okay. Next slide.
Again, just historically, as referred to by you and Mr.
Turner, about a year ago when I discussed with this committee
the strategic plan that we had brought up in response to being
able to execute the mandate of doing the research necessary to
develop appropriate countermeasures for biodefense threats, we
put together a strategic plan, which I briefly outlined for you
at the time, and also we put together a research agenda for
Category A, and Category B and C agents.
Since that time, we have now put together a progress report
on both of those. And I would recommend to you and your staff,
if you get the opportunity, to page through those. It is
available on the Web, in which we outline not only the
accomplishments that have occurred since that time, but also a
supplementation of where we will be going in the future. So let
me briefly outline some of that for you.
The first that I alluded to last year was the need for
building up both our human capital and our physical
infrastructure to be able to do the research necessary to
develop these countermeasures. Since that time, significant
progress has been made. We now have the funding that has been
disbursed for the development of two national biocontainment
laboratories or BSL-4s, one in Texas and one in Boston; nine
additional regional biocontainment laboratories, or BSL-3s.
And, importantly, again, I discussed with the committee last
year the need to get the best and the brightest of the
infectious diseases, microbiology, and immunology scientific
community involved in the biodefense effort. By the awarding of
our regional centers of excellence for biodefense and emerging
infectious diseases, eight in number, in fact, I believe we
have succeeded in that, because we have the best of our
established and now younger people coming into the field.
And, finally, there have been four new facilities that are
government-owned, one going up right now in construction on the
NIH campus, a BSL-3. Dr. Martinez-Lopez referred to the BSL-4
that we are going to be collaborating with on the campus in
Fort Detrick as well as the BSL-3 in Rockville and the BSL-4 in
the Rocky Mountain Laboratories in Hamilton, Montana.
What about the research? I put the slide together to show
you the continuum of the fundamental basic research in concept
development of which we have been quite successful. I will give
you some examples, but I will be happy to discuss this during
the questioning period. In addition, several products already
have gone from the preclinical and the animal model up through
phase one and into phase two, and right now we are pushing the
envelope as we promised towards the development of these three
types of products, diagnostics, therapeutics, and vaccine. And
as you know, as we discussed last time, it is at this point
where Project BioShield will kick in.
What about these countermeasure developments? Significant
progress has been made in smallpox, the development of a safer,
not reactogenic smallpox vaccine. In other words, the Modified
Vaccinia Ankara that I mentioned to you, we had to prove that
it was effective in animals at the same time we are proving it
is safe in humans. Both of those things have gone on. A couple
studies have been completed. We have shown in a monkey model
and in a mouse model that it protects these animals from
challenge with either smallpox or its equivalent. And this is
an important issue with regard to the FDA's ``two animal rule''
for approval.
With regard to anthrax, we are well into the clinical
trials of the recombinant protective antigen, contracts have
been let, and we are on our way to getting that into the
stockpile.
Also, since we spoke last, we now have an Ebola vaccine
that protects monkeys that is now in a phase one clinical trial
in humans started on the NIH campus in November of 2003. We
also made advances in therapeutics. We are testing a
therapeutic against smallpox as well as, based on the
pathophysiology of anthrax, ways in which we can block the
actual toxin. We know we have very good antibiotics against
anthrax, we know we can block the toxin in people with advanced
diseases, and some in-roads that have been made in diagnostics
in the arena of smallpox as well as anthrax.
Let me briefly address the question regarding coordination
of biodefense activities. There are three levels. At the NIH,
as you are aware, the NIAID is by far the lead institute in
executing the research in bioterror agents. But there are other
institutes that are involved also at NIH, and I chair a
committee that is called the NIH Biodefense Research
Coordinating Committee, in which we coordinate among the NIH
institutes.
At the level of the Department, the coordination falls
under the auspices of the Office of the Assistant Secretary for
Public Health Emergency Preparedness, where the NIH, the FDA,
and the CDC are coordinated. And at the Federal Government
level, it is coordinated at the White House by the Homeland
Security Council and the National Security Council. And these
are the Federal agencies involved. Predominantly, DHS, HHS, and
DOD, which are represented here at this hearing, as well as
other relevant agencies.
And, finally, the question was asked: How do we establish
the research and development priorities based on threat
assessment? The first was the CDC category A, B, and C agent
designation, which we have made the foundation for the research
direction that we put into our original strategic plan. Right
now, currently the Department of Homeland Security has taken
the lead in providing us with continual threat assessments, and
we rely heavily on the Department to work with us in a
collaborative way so that we can direct our research toward the
appropriate groups. That is my formal statement, Mr. Chairman.
I would be happy to answer questions later.
Chairman Cox. Thank you, Dr. Fauci.
[The statement of Dr. Fauci follows:]
The NIH Biomedical Research Response to the Threat of Bioterrorism
Prepared Statement of Anthony S. Fauci, M.D
Mr. Chairman and Members of the Committee, thank you for the
opportunity to speak with you today about the role of the National
Institutes of Health (NIH) in the execution of our national biodefense
research strategy.
The destruction of the World Trade Center, the attacks on the
Pentagon and an airliner over Pennsylvania, and the anthrax attacks in
the fall of 2001 clearly exposed the vulnerability of the United States
to acts of terrorism. In particular, the anthrax attacks made it very
clear that the possibility of the use by terrorists of deadly pathogens
or biological toxins such as those that cause anthrax, smallpox or
botulism represents a serious threat to our Nation and the world. The
Administration and Congress responded aggressively to this threat by
significantly increasing funding for biodefense preparedness and
research.
The National Institute of Allergy and Infectious Diseases (NIAID)
is a component of NIH and a leading federal agency for biomedical
research concerning potential agents of bioterrorism that directly
affect human health. NIH, and particularly NIAID, has devoted the
increased biodefense research funding to an aggressive, broadly based
research program designed to provide the American people with medical
countermeasures, i.e. vaccines, therapeutics, and diagnostics against a
range of bioterrorist threats. My remarks today will specifically
address three aspects of our biodefense research activities. I will
first describe the NIH biodefense research program, including a few
examples of our recent accomplishments. Next, I will summarize how NIH
biodefense research is coordinated with research carried out by other
Federal agencies. I will close by discussing how NIH is informed about
and responds to new bioterror threats that might arise.
NIH Biodefense Research
The NIH research agenda for defense against bioterrorism was
developed through a comprehensive and systematic strategic planning
process. In February 2002, we convened the Blue Ribbon Panel on
Bioterrorism and Its Implications for Biomedical Research, with
membership composed of distinguished researchers from academic centers,
private industry, government civilian agencies, and the military. Three
key documents were developed based on this panel's advice and on
extensive discussions with other Federal agencies: the NIAID Strategic
Plan for Biodefense Research, the NIAID Research Agenda for CDC
Category A Agents (for those agents that pose the gravest threat), and
the NIAID Research Agenda for CDC Category B and C Agents (agents whose
biological properties make them more difficult to deploy or less likely
to cause widespread harm). The Strategic Plan provides a blueprint for
the conduct of basic research on microbes and host immune defenses, as
well as targeted, milestone-driven development of drugs, vaccines,
diagnostics and other interventions that would be needed in the event
of a bioterror attack. The two biodefense research agendas describe
short-term, intermediate, and long-term goals for research on the wide
variety of agents that could be used to conduct such an attack.
NIH has moved rapidly to execute its biodefense strategic plan and
significant progress toward reaching many of the goals set forth in the
research agendas has already been made, as described in two recent
progress reports. With regard to basic research, which is needed to
understand more about how pathogens interact with human hosts, NIAID-
supported researchers and their international colleagues have
completely sequenced the genomes of representative bacteria considered
to be bioterror threats, including multiple strains of the anthrax
bacterium, as well as at least one strain of every potential viral and
protozoan bioterror pathogen. Another NIAID program is supporting
studies of the human innate immune system, which is comprised of
broadly active ``first responder'' cells and other non-specific
mechanisms that are the first line of defense against infection. The
development of methods to boost innate immune responses could lead to
fast-acting countermeasures to mitigate the effects of a wide variety
of bioterror pathogens or toxins; in addition, manipulation of the
innate immune system could lead the way towards the development of
powerful adjuvants that can be used to increase the potency and
effectiveness of vaccines.
NIH also has moved aggressively to expand national biodefense
research capabilities by investing in several research infrastructure
development programs, including manpower and facilities. For example,
NIAID recently funded eight Regional Centers of Excellence for
Biodefense and Emerging Infectious Diseases Research. This nationwide
network of multidisciplinary academic centers will conduct wide-ranging
research on infectious diseases that could be used in bioterrorism, and
will develop diagnostics, therapeutics and vaccines needed for
biodefense. In addition, these Centers will serve as the training
ground for future generations of biodefense researchers. The Centers
also partner with State and local public health agencies to ensure the
strongest coordinated response to a bioterrorist event. In addition,
NIAID is supporting the construction of two National Biocontainment
Laboratories (NBLs), which will include facilities built to Biosafety
Level 4 standards and will therefore be capable of safely containing
any pathogen, as well as nine Regional Biocontainment Laboratories
(RBLs) with Biosafety Level 3 facilities. These high-level research
laboratories will provide the secure space needed to carry out the
nation's expanded biodefense research program in a setting of safety
for both biodefense workers and the surrounding community. Other
ongoing projects will expand intramural facilities at Bethesda and
Rockville, Maryland, at our Rocky Mountain Laboratories in Hamilton,
Montana, and in Frederick, Maryland.
The ultimate goal of all NIH biodefense research is the creation of
new and effective medical countermeasures, including vaccines,
therapeutics, and diagnostics against potential bioterror agents.
Substantial progress toward this goal has already been achieved. In the
area of therapeutics, for example, NIAID-supported scientists have
identified a drug that may prove useful in treating both smallpox and
the complications of smallpox vaccination. This agent, called
cidofovir, is approved by the FDA for treating viral eye infections in
HIV-infected patients. NIAID studies also are investigating the use of
antibodies that can bind to and block the action of toxins produced by
the anthrax bacterium, as well as botulinum toxin.
New and improved strategies for the development of vaccines against
smallpox, anthrax and other potential bioterror agents are being
vigorously pursued, with the objective of adding them to the Strategic
National Stockpile (SNS) as quickly as possible. For example, NIAID is
supporting and overseeing the rapid development of the next-generation
anthrax vaccine known as recombinant protective antigen, or rPA.
Clinical trials of rPA are ongoing; results to date build on findings
in animal studies that suggest the vaccine is safe and capable of
evoking a robust immune response. Researchers also will test, in
animals, whether protection against anthrax can be enhanced by
receiving the rPA vaccine in addition to antibiotic therapy following
exposure to anthrax spores. This development effort is on track for
Project BioShield to award contracts this year to achieve the goal of
adding 75 million doses of rPA vaccine to the SNS to protect 25 million
U.S. citizens.
NIAID-supported researchers also are testing several new smallpox
vaccines that may prove at least as effective as the current smallpox
vaccine, and can be used by a broader population, including those who
are immunocompromised. One of these, modified vaccinia Ankara (MVA), is
based on a strain of the vaccinia virus that replicates less robustly
than the traditional Dryvax vaccinia virus, and which is also known to
cause fewer side effects. Human trials of MVA vaccines are under way at
NIH and elsewhere. Encouragingly, recent studies by NIAID intramural
scientists and their colleagues have shown that MVA protects monkeys
and mice from smallpox-like viruses. NIH also has launched the first
human trial of a vaccine designed to prevent infection with Ebola
virus. The trial vaccine is made from parts of the viral DNA, and is
similar in design to other investigational vaccines that hold promise
for controlling such diseases as AIDS, SARS, and infection with West
Nile virus.
Coordination of Biodefense Research
Although NIH is a leading agency in government-sponsored biomedical
biodefense research on agents that directly affect humans, it is by no
means the only agency involved; the Centers for Disease Control and
Prevention (CDC), the Food and Drug Administration (FDA), the
Department of Defense (DoD), the Department of Homeland Security (DHS),
the Department of Agriculture (USDA), and other governmental
organizations also play important roles. Coordination among the various
agencies involved is therefore extremely important. In broad terms, the
NIH biodefense research agenda and activities are coordinated at three
distinct levels: within NIH, within DHHS, and across the government as
a whole.
Within NIH, NIAID is responsible for the bulk of NIH-sponsored
biodefense research; other NIH institutes, however, also make
significant contributions. The focal point for trans-NIH coordination
and planning of biodefense activities is the NIH Biodefense Research
Coordinating Committee. I am Chairman of this committee, which meets at
least quarterly or more often, as needed. It is administered by the
NIAID Office of Biodefense Research, which also serves as liaison
office for NIH contacts with other federal agencies such as DoD and DHS
regarding biodefense research and response.
At the level of the Department of Health and Human Services (DHHS),
coordination of biodefense research between the CDC, NIH, FDA and other
agencies within DHHS is the responsibility of the DHHS Office of the
Assistant Secretary for Public Health Emergency Preparedness (ASPHEP).
The ASPHEP Office of Research and Development Coordination holds
periodic meetings with all governmental stakeholders in the development
of medical countermeasures.
Members of my staff also meet regularly with the research community
at Fort Detrick and the U.S. Army Medical Research and Material
Command. Through such meetings, synergy in research and mutual support
leading to the development of new drugs, vaccines, and diagnostic tests
for the nation are achieved. My staff also holds meetings periodically
with the Defense Threat Reduction Agency and the Defense Advanced
Research Projects Agency, two important entities within the research
infrastructure in the DoD.
At the highest level, coordination of biodefense research is
carried out by the White House, and in particular the Homeland Security
Council, now led by Frances Townsend, and the National Security
Council. In addition, the Committee on Homeland and National Security
of the National Science and Technology Advisory Council also
participates, especially through its Weapons of Mass Destruction
Medical Countermeasures Subcommittee.
Although these three levels describe the basic structure through
which the Nation's biodefense research programs are formally
coordinated, NIH, as the lead biodefense research agency, collaborates
daily with the other federal agencies and is party to a large number of
interagency programs, informal contacts, and communication mechanisms
that significantly contribute to the efficiency and effectiveness with
which biodefense research is carried out across the U.S. government.
Threat Assessment and the Research Response
We developed the NIAID Strategic Plan for Biodefense Research and
the two research agendas based on an overall threat assessment
formulated by CDC in close cooperation with the intelligence community.
Category A agents are the most dangerous microbes and toxins; these
include anthrax, smallpox, plague, botulism, tularemia, and hemorrhagic
fevers caused by viruses such as Ebola. These agents were given the
highest priority because they a) are relatively easily disseminated or
transmitted from person to person; b) result in high mortality rates
with the potential for major public health impact; c) would likely
cause significant social disruption; and d) require special action for
public health preparedness. Category B agents are in the second tier of
priority. They are agents that a) are moderately easy to disseminate,
b) result in moderate morbidity and low mortality rate, and c) require
specific enhancements of national diagnostic capacity and disease
surveillance systems. Category C Agents have the next highest priority.
They include emerging pathogens that could be engineered for mass
dissemination in the future because of their availability, ease of
production and dissemination, and potential for high morbidity and
mortality rates and major health impact.
To receive information about new threats that may arise, we work
closely with DHS, which provides threat assessments concerning issues
germane to our research. Because new infectious disease challenges
emerge naturally on a regular basis, NIH has considerable experience in
rapidly mobilizing research resources to confront new infectious
disease threats. This experience serves us well when called upon to
adjust our research priorities in response to new intelligence
information.
In closing, I am confident that the biomedical research agenda we
have formulated concerning potential agents of bioterrorism is well
conceived, and will rapidly lead to new and improved medical
countermeasures against agents of bioterrorism. I am also very pleased
with the degree of coordination and cooperation between NIH and other
federal agencies involved in carrying out biodefense research.
I appreciate this opportunity to testify before you today, and I
would be pleased to answer any questions that you may have.
Chairman Cox. And I would like at this point to welcome our
accompanying witness, Dr. William Raub, principal deputy
assistant secretary for public health emergency preparedness at
the Department of Health and Human Services. We understand that
you will be available to take member questions as a member of
this panel. Members are advised that there are two votes on the
floor, a motion to construct conferees on the highway bill, and
the Cox resolution concerning human rights in the Peoples
Republic of China. All members are encouraged to vote aye on
that. We will return as quickly as we can upon the conclusion
of votes on the floor.
[Recess.]
Chairman Cox. Welcome back. Our members will be returning
episodically from the floor. The committee is reconstituted.
I will begin with my questions for the panel by thanking
you for your outstanding testimony and for being with us today
on a very important topic. The Department of Homeland Security,
Department of Health and Human Services, and the Department of
Defense, as we just heard, are working together to establish a
joint research facility at Fort Detrick, National Interagency
Biodefense Campus.
For the record, may I ask which agency of the Federal
Government is in charge of this?
Dr. Albright. Can I take that? Okay.
Chairman Cox. Whoever answers the question.
Dr. Albright. Whoever goes first, I guess, gets the ticket.
Yes, we are in charge. I think what the National Biodefense
Campus is really aimed at doing is providing a venue where each
agency that is operating within the confines of its running
lanes, for example, the responsibilities that have been
assigned to it by the national biodefense strategy, for
example, can operate in a collaborative environment. So I think
it's a mistake to say that any one person is in charge of the
campus. So, for example, we are in charge of NBACC, Dr. Fauci
has responsibilities for what NIAD is operating up there, and
General Martinez-Lopez will be responsible for USAMRIID, and of
course works within the U.S. Army for the facility that
actually will house the site.
The idea behind the campus is that you have several groups
of people at USAMRIID, at NBACC, and at NIAD who are addressing
different aspects of the bioterrorism problem. And, therefore,
it is important, and in our view, beneficial to have an
environment where these people are eating together in the same
cafeteria, their kids are in the same day care center, they are
going to the same seminars, there are some potential shared
assets such as animal facilities, for example, that you know
can avoid duplication.
But, basically, when we talk about the Center, it is really
aimed at promoting a professionally collaborative environment
where, again, people who are working different parts of the
problem can freely intermingle and share ideas.
Chairman Cox. Is USAMRIID providing the technical staff to
support the DHS capability, or is DHS providing its staff and
only utilizing the laboratory space?
Dr. Albright. What is happening right this second is we
provide staff, but we are utilizing USAMRIID space. As you are
well aware, we have a construction proposal in our 2004 and
2005 budget to actually build a building that would be right
across the street from USAMRIID, but right now we are utilizing
USAMRIID spaces.
Chairman Cox. Perhaps then I should have asked if you could
very succinctly summarize the roles of these three agencies in
a sort of one-line mission statement.
Dr. Albright. Okay. NBACC's primary--the Department of
Homeland Security's primary function up there is threat
characterization and assessment. NIAD, of course, conducts
fundamental research and development activities. USAMRIID does
much of the same, but is focused on the warfighter. And I would
invite--.
General Martinez-Lopez. Mr. Chairman, if I may, also the
Department of Agriculture is part of the partnership, and they
bring about some of the knowledge on the crop pathogens which
also can be--agroterrorism is part of the biothreat. And they
are looking, and some of the technology and some of the basic
science is very similar. So what we want to do is leverage all
the knowledge from all the four partners, and also NCI. Even
though, you know, the National Cancer Institute is really just
looking at cancer and treatment and that kind of stuff, but
they are developing vaccines against cancer, they are
developing new basic science and understanding of how cells
behave. And that knowledge is critical to us. And so having all
that knowledge, all the--science still is about people, sir. I
mean, science is not about technology, science is about great
scientists that are doing the discovery and putting it in that
context. So if you create the right environment for them to
really collaborate and talk and share the knowledge, I think we
can advance that much further.
Chairman Cox. If there is no other comment on that, open
opportunity to comment, then let me ask about NBACC, the
National Biodefense Analysis and Countermeasure Center, which
has been established within the S&T directorate to be the
operationally focused technical biodefense analysis center
within Homeland Security.
First, how is DHS organizing NBACC to fulfill this mission?
Second, what is the gap in biodefense capabilities that NBACC
is filling?
Dr. Albright. I hope I can answer both those questions at
the same time by telling you how we are organized. There are
sort of two key capabilities that will be developed at NBACC.
There is something called the National Bioforensics Analysis
Center. This is a capability that we are doing jointly with the
FBI. The original motivation for it was the fact that after the
anthrax attacks, the FBI needed a place to do analysis on
contaminated mailboxes and that sort of thing. So there was a
need to have a national capability to analyze, to be able to
hold and analyze evidence that is collected associated with
bioterrorism, and ultimately to perform the appropriate
analysis so that we can attribute the attack. And that of
course is a very technical area that doesn't really exist in
the Federal Government today, or it exists in a fairly
disconnected way.
The second key capability is the biological threat
characterization center. And what it will do is conduct
laboratory experiments and studies to fill important gaps in
our knowledge regarding the risks from specific high
consequence pathogens. For example, one might be concerned
about the reality behind certain emerging threats, engineered
pathogens, for example. It is important to be able to do
experiments to verify whether or not these pathogens in fact
can be engineered without affecting their function. So, for
example, one might be concerned about a particular threat and
doing a genetic modification to it that increases its virulence
in some manner. These are living organisms, after all, and you
just don't fool around with the genes of these things without
having impacts elsewhere.
It may be possible to do such a thing, but it also has an
effect on its liability and nature, for example, or in your
ability to weaponize it, or on a whole lot of other factors.
So a large part of what this center is intended to do is
provide an environment where we can do sensitive work like
that, to first analyze and understand what the potential
emerging threats are. And that is, of course, an analytic
effort. It is paper studies and that sort of thing. And then,
if necessary, to understand the realities of those threats so
that the people who generate the medical countermeasures at
NIAD, for example, can respond appropriately.
Chairman Cox. I thank you very much. My time has expired. I
have other questions on biowatch, biosurveillance, basic
research, and so on, and possibly I will get a chance to ask
another round. But at this point, I yield to the Ranking
Member, the gentleman from Texas, Mr. Turner.
Mr. Turner. Thank you, Mr. Chairman.
Dr. Fauci, you know of my interest in trying to shorten the
drug and vaccine development timetable. And I have also shared
with you my concern, which I know you share, about the trends
in the pharmaceutical industry away from production of
antibiotics toward the more lifestyle drugs that are more
profitable. Give me some sense of the kind of investments
through your grant programs or internal activities, the degree
and the amount of emphasis that we are placing on trying to
shorten this drug development, vaccine development time frame,
which I believe is so vital to dealing with the bioengineered
threats that we know will be out there in the future.
Dr. Fauci. Yes, thank you for the question, Mr. Turner. The
issue of the development of new antibiotics, particularly
antibiotics against drug-resistant microbes, is a threat that
really transcends biodefense and is involved even in our
natural interaction at the level of treating people at
hospitals. The NIAID has a major investment in antibiotic
development, particularly in the arena of antibiotic resistance
to the tune of in fiscal 2005 an estimate of about 185, $187
million.
I look upon this in the same manner as we discussed on
several occasions regarding other countermeasures, where there
is a push and there is a pull. And the push is the amount of
investment that you put into research to identify new targets.
One of the things that we have invested in--and the biodefense
research agenda has really enabled that--has been the ability
to rapidly sequence microbes, things that took a year and a
half years ago, now you can do in a day or two. And that allows
you identify the various multiple targets of vulnerability for
an antimicrobial.
So the investment in basic research allows us to do that.
The problem that we face, as you yourself just mentioned, is
that the companies that are involved in the actual making of
that antibiotic have other fish to fry many times. They have
other drugs to make that people will use for a lifetime as
opposed to an antibiotic which most courses are 10 days to two
weeks, and then you stop using it. Or, there is the development
of resistance, which makes that antibiotic ultimately unusable.
Dr. Fauci. We have also enhanced and made available our
clinical trial networks to be able to have those companies use
our networks to test drugs. What we don't have--and are working
towards--is to develop the same sort of positive incentives for
companies to get involved in an arena of development that is
not intuitively profitable for them, and the ways that we have
done that is to try and partner with them to give them the
comfort that we will be with them in the long run. We will
partner to try and push the process of research and development
further towards the actual advanced development so that their
risk in getting involved is somewhat decreased, around the same
broad general philosophy of what we are trying to do with
Project BioShield.
Mr. Turner. How much would you say that we are investing
today in that effort to push that issue forward in the same
manner that--we obviously have made a tremendous investment and
commitment financially in BioShield to take care of the end.
How much are we investing right here in the middle where we
need to, I think, make an investment and have, I hope, national
commitment to get this done?
Dr. Fauci. We are progressively now, over the last year and
a half, putting a relatively larger proportion of that $185-
some-odd million that we spend on antibiotic development to
push into that. I can't give you a specific number except that
when we do our projected planning of what the portfolio is
going to look like, we are ever torquing more towards pushing
it towards that development. So we don't have a number, but we
are gradually being able to do that over the past year and a
half to 2 years and will continue that in the future.
Mr. Turner. So it seems we may have a little time to deal
with this, but the uncertainty of it tells me that this is
clearly an area where we need to stay out in front and on the
cutting edge. And I don't know, General Martinez, if you can
share with us if there is any similar effort going on within
the Department of Defense to be able to do this. Do you have a
parallel effort to the ones that Dr. Fauci refers to within
DOD?
General Martinez-Lopez. Sir, actually we do. But the good
news is that we are in partnership with NIH. So the effort is a
joint effort trying to--it is not compete the same industry--
trying to foster the total industry forward. So from my view, I
am talking more from the tactical level, but what I see is that
there is really an effort in the Department, in the two
Departments, to really advance this cause, and it is a concern
to both of us.
Mr. Turner. Thank you. I think my time is up.
Chairman Cox. The gentleman from Connecticut, Mr. Shays, is
recognized for, if I am not mistaken, 8 minutes.
Mr. Shays. Thank you very much, Mr. Chairman. And,
gentlemen, welcome, and thank you for your service to our
country.
I want to know how do you keep biodefense research and
procurement in sync with the threat? I see four blank faces,
and I am going to start with whoever wants to jump in. The
question is how do you keep biodefense research and procurement
in sync with the threat? The threat exists right now. I am
hearing that some things will not be resolved for 9 years, and
I want to know how we get it more in sync.
Dr. Fauci. It is an iterative process of modifying your
research direction, but there is a fundamental basic research
endeavor that really translates to any threat. Let me just give
you an example. The example of the sequencing of virtually
every microbe on the threat list, more than one strain of every
microbe on the threat list. This allows us to respond to the
possibility of there being a deliberate mutation, a deliberate
genetic modification of that microbe. We have a given threat
list. Sometimes a countermeasure will take years. We try to
close that window as much as we possibly can, but we can't do
the impossible. Sometimes things just take a couple of years.
But if you look at the threat assessment that we had in front
of this committee a year ago when we were talking about the
vulnerabilities with smallpox, with Ebola and with anthrax and
look a year later, I would say, Mr. Shays, that the amount of
progress that has been made to close the gap of that threat is
the fastest that I have ever seen in any public health
endeavor.
And we continually reassess the threat assessment, as I
mentioned in my opening statement, by our partnering with the
Department of Homeland Security which keeps us reassessed of
whether the threats are changing.
Mr. Shays. I would like to hear answers from others. Thank
you for your answer.
Dr. Albright. I guess I would make the same point Dr. Fauci
made, and that is I think there is a fairly clear understanding
of the threat, and as he pointed out we work closely with him
as the threat evolves, but you cannot--to say it perhaps more
succinctly, you can't command science, you can't deliver things
instantly. So there is a certain amount of research that is
required to develop countermeasures, and that just takes time
to do.
Mr. Shays. Anyone else? The answer is the same?
General Martinez-Lopez. Yes, sir.
Mr. Shays. The issue of botulitum antitoxin, how far are we
away?
Dr. Fauci. We have botulism antitoxin. We don't have enough
for a massive attack. There are two avenues that are going on
simultaneously. One are the stores that were actually under the
purview of the Department of Defense of horse plasma that has
been converted to--.
Mr. Shays. I am just curious to know how far are we to
having the supplies that we need for a serious outbreak?
Dr. Fauci. It would probably take--right now if there were
an attack involving thousands of individuals, we have enough
right now. If there is an attack that involves hundreds of
thousands of individuals, we are probably a couple of years
away from that.
Mr. Shays. More than 2 years certainly?
Dr. Fauci. Yes.
Mr. Shays. Three, four, five?
Dr. Fauci. I would say probably around 3 to 4 years away
from that.
Mr. Shays. I had heard 9 years; so that is inaccurate?
Dr. Fauci. Again, the question gets asked in multiple
different way ways. It really depends if you are talking about
enough to feel comfortable that in even the most massive
threat, then you are talking 9 or 10 years or maybe even
longer. If you are talking about expanding it to the point
where we have a reasonable level of comfort that even a
modestly big attack you can go to, then I think you are talking
3 to 4 years.
Mr. Shays. Why aren't we on three shifts to deal with this
issue? I mean, really, why aren't we on three shifts? Why is it
going to take 2 to 3 years to basically deal with the threat?
And I want to know why we aren't having people who work 24
hours a day, three shifts, just get it done? Is there an
answer?
Dr. Fauci. I think the answer is the reality of the
situation of the prioritization of things that need to be done
right now, given the manpower that is involved, given the
resources we have, I think if we did that there might be a
disproportional amount to a real threat, but one of many
threats. So I would like to see--I mean, as someone who is
involved in the research on this, I would have to say if I had
my way, as it were, and you can never have your way all the
time, I would have 24-hour shifts on everything.
Mr. Shays. But with all due respect, that is what your
testimony should be. Your testimony should be before this
committee, this is what we need. If we don't deliver, then it
is our fault. If you don't tell us, then it is your fault. And
I know you have a tremendous task, but I have had 50 hearings
on the terrorist threat in my subcommittee, and I am surprised
that we seem to think it is a 9-to-5 kind of effort, 2 to 3
years. If it is a serious outbreak, 4 to 5, maybe 9. It doesn't
make me feel very comfortable.
One of the things that I am uncomfortable about is there is
a lack of interagency cooperations and communications between
DHS, DOD, HHS, CDC, NIH, as it relates to this issue of
BioShield, and I want to know what is going to break through so
we don't have people going in different directions. What does
this committee need to do to force you to have better
interaction?
Dr. Albright. I guess I am not sure how much better we
could interact than the way we do. We have multiple
coordinating mechanisms that exist. For example, in BioShield
in particular, there is--as the legislation was being proposed,
the way that we set up a medical countermeasures working group
with a number of activities designed around prioritizing and
even developing procurement strategies for the various
pathogens of interest. So, for example, I co-chair with HHS the
procurements acquisitionSec.
Mr. Shays. Is it your testimony that you disagree and that
there is very good coordination? Is that your testimony?
Dr. Albright. Yes, it is.
Mr. Shays. Because we are going to have testimony that says
that is not true.
Dr. Albright. I would say there is excellent coordination.
In fact, I see Tony at least once a month, I would say.
Mr. Shays. Is that a lot?
Dr. Albright. For senior leadership to run into each other?
Yes, sir, I would say so. I have people on my staff who
interact with HHS on a daily basis.
Mr. Shays. Why does DOD, General Martinez-Lopez, pursue its
own efforts, separate from HHS, that parallel; and why is it
that DOD does not have to have the same regimen dealing with
children and the elderly that we require from HHS?
General Martinez-Lopez. Sir, let me see if I got the
question right. When we develop a vaccine, are you saying that
we don't have the same requirements for children?
Mr. Shays. Right.
General Martinez-Lopez. We are trying to get the FDA
approval, and if this is a strategy that is unique to the
Department of Defense, that it is going to be only used for
warfighters, then obviously the FDA may only license that
product for an age group, both males and females. But quite
often, like with--but right now as we move into the future,
sir, many of the products, for example, the RPA, the next
generation anthrax vaccine, one of our products has been--.
Mr. Shays. General, let me be clear, though. What you
develop is not just for the military.
General Martinez-Lopez. Correct.
Mr. Shays. And what makes me nervous is you don't follow
the same regimen, and yet in the end what you do may be used
for elderly and children.
General Martinez-Lopez. The good news, sir, is right now,
as an example, the RPA vaccine, that is a new generation
anthrax vaccine, was developed initially by the Department of
Defense. Now it is being followed by NIH, and when it is
licensed it is going to be licensed for both, for general
population. So this is an effort where the interagency--in the
old days, the Department would have followed probably just a
warfighter FDA licensing. Now we are going to be looking at a
more general population licensing because the interagencies are
working on those issues. There will be countermeasures that
will be unique to the Department of Defense because their
strategy may be different the way we approach a particular
disease. In those cases I don't know how we are going to pursue
that--.
Mr. Shays. I would thank you all for your service. I know
you are trying to do the best you are doing. I just would
conclude by saying when I hear 2 or 3 years, if there is an
outbreak before, the question that is going to be asked of us
is, why wasn't this an around-the-clock effort? And it isn't.
And that is what of concern.
Thank you, Mr. Chairman.
Chairman Cox. The gentleman's time is expired.
The gentlelady from the Virgin Islands, Dr. Christensen, is
recognized for 8 minutes.
Mrs. Christensen. Thank you, Mr. Chairman. And welcome to
the panelists.
I share some of those concerns, and when other areas'
directors, agencies, come before this committee, we are always
very concerned with, one, the slow pace of the readiness and
preparedness, the often lack of clear lines of responsibility
and the lack of institutionalized coordination. We hear about
coordination that takes place, but it seems to be very informal
and dependent on the people in place, and we would like to see
that more concretized so we know that it will continue
regardless of who is there and who is working in these areas.
Dr. Fauci, I promised you a question, because we have
gotten into this before, during the BioShield hearings. Do you
have any indication from within the Department that the same
emphasis that is being placed on research is being put in the
public health preparedness and any thoughts on just how
effective all of this wonderful research can be and the
wonderful counteragents deployed and utilized when they are
needed, if our public health infrastructure, the facilities,
the staff, the training, is not adequate and in place?
Dr. Fauci. Mrs. Christensen, I could answer the research
part, but I would have to ask Dr. Raub to answer the public
health preparedness, because that is not something I am
responsible for. The research is going at a very rapid rate and
I might, if you would allow me to, just comment about what was
just said by yourself, saying the slowness of the pace and what
Mr. Shays mentioned about--.
Mrs. Christensen. Coordination.
Dr. Fauci. How can we increase this pace.
Mrs. Christensen. Not too long, though.
Dr. Fauci. No. It is going to be real short. When you are
doing research, there are things you can't push because the
science doesn't go to your demand. And that is something that
really needs to be understood. You can't demand the science to
give you a discovery.
The other thing is that even when you are making a product,
for example, botulism antitoxin, there are two ways to make it.
You vaccinate a horse or you try to develop a monoclonal
antibody. A monoclonal antibody takes years to develop and to
develop correctly. You vaccinate a horse, it takes 3 to 4
months before the next boost, another 4 to 5 months before the
next boost, and another 4 to 5 months before the next boost
before you get a titer even high enough to bleed the horse. So
you could stand there and watch that horse 24 hours a day, but
it is not going to have that horse make antibodies anymore
quickly. So there are constraints that we have.
Mrs. Christensen. I will come back to that, too. But go
ahead, Dr. Raub, please.
Mr. Raub. Thank you. The emphasis on strengthening State
and local public health preparedness is every bit as high a
priority as the investment in research and development. We have
a program of cooperative agreements with all of the States,
some major cities, and the territories. One part of that flows
through the Centers for Disease Control and Prevention, aimed
at State and local health departments. The other part flows
through the Health Resources and Services Administration,
focused on hospitals and other health care entities.
We have provided a little over a billion dollars in fiscal
year 2002, about $1.5 billion last year, and we will award
about another $1.5 billion this year. In shaping those
cooperative agreements, we have tried to balance broad
investments, strengthening public health overall, such as the
addition of epidemiologists, the improvement of communication
systems, the improvement of laboratories, with things that are
highly specific either to bioterrorism or other aspects of
public health emergencies, and we will continue that emphasis.
We are gratified by the strong response of our State and local
partners, and it will continue to be a major emphasis for us.
Mrs. Christensen. The administration has requested $150
million less for public health and hospital preparedness grants
for fiscal year 2005. How can we justify cutting? I also
notice, I think I read this week that $480 million was just
released for hospitals, and you said at one point $5 billion.
Have the States and territories indicated what their level of
funding need might be, and how well are we meeting what they
have projected their needs are? Because my understanding is
that in the hospitals and emergency rooms the staffing is
really overstretched, and maybe there are two States out of the
whole Nation that can be considered relatively prepared.
Mr. Raub. I think it is fair to say that, if asked, every
one of our State or local colleagues would say that, if more
moneys were available, they could use it intelligently.
Nonetheless, substantial investments are being made and much of
that is at a pace or above what many of them are able to
accommodate because of limitations in their procurement
systems, hiring freezes, and the like, and we have continued to
work with them to try to accelerate some of those investments.
Looking to the future, the fiscal 2005 budget proposes a
continued substantial investment. Some of the offset you
described is not to take it away from the problem but rather to
orient it on another facet; namely, increasing our capabilities
for biosurveillance as well as increasing our capabilities for
quarantines. So it is a matter of the typical set of choices
that go along with the development of any budget, but we
believe the aggregate package continues to be strong and will
remain among our highest priorities.
Mrs. Christensen. Dr. Fauci, you talked about the long time
frame to developing vaccines, that it is relatively long, we
can't just demand and it is going to be there. In light of
that--and we have talked about BioShield--we have had many
hearings on that--our Ranking Member mentioned fast cures.
Wouldn't it be better for us to focus more of our time and
investment on more basic, more generic all-hazard type research
to shorten the time frame to develop a countermeasure, rather
than, as we are doing in BioShield, preparing to meet agents,
some of which we know or we think are likely to be agents, some
of which we have no idea on, so when a new agent shows up, we
are not going to be able to respond quickly enough to develop a
countermeasure? Wouldn't it be better for us to focus on the
fast cures approach?
Dr. Fauci. The fast-cures approach can be either specific
for a microbe or it could be more generic. In fact, at the
testimony last year, I introduced a concept--and we are
following up on that--of trying to develop much more generic
antimicrobials against a whole range of microbes, as opposed to
going through each individual specific microbe.
The same holds true for vaccination to be able to more
generically or globally up-regulate the body's immune system by
dealing with the innate immune system so that it could respond
across a wide range of microbes.
I do agree with what Mr. Turner said, that we should try,
particularly with the combination of both screening and then,
as soon as you get a ``hit'' as we call it, to try to develop
very rapidly at least a couple of antimicrobials against all
the known threats and use your knowledge of the genomic makeup
of the microbes to be able to target.
So there are two general approaches that I believe Mr.
Turner was referring to. One is a screening approach, which is
more amenable to the rapid approach that he is talking about.
And then there is the targeted development, which may not be as
rapid but ultimately would also get you good results. I think
if you accelerate both of those, the time frame from when you
started until the time that you actually have a countermeasure
against a microbe will be shortened.
Mrs. Christensen. Is that 8 minutes or 5?
Chairman Cox. That is 8 minutes. The gentlelady's time is
expired.
Mrs. Christensen. Okay. I will be back. Thank you.
Chairman Cox. The gentleman from Washington, Mr. Dicks, is
recognized for 5 minutes.
Mr. Dicks. The gentleman from Connecticut, Mr. Shays,
pointed out that if we were truly treating this as a wartime
setting, we would be going 24 hours a day. I can remember in my
hometown of Bremerton, Washington when they were overhauling
and repairing ships during World War II, that they went 24
hours a day, 7 days a week. The President came out there twice
to exhort the workers to do more, to do it faster, to restore
these ships that had been damaged to the Pacific fleet. And I
too share Mr. Shays' concern that this is a very leisurely pace
that we are talking. And the cutting of $150 million for these
grants again is a demonstration. Can anybody here tell us that
public health agencies across the country and hospitals are
prepared to deal with a biological attack of some sort? I
certainly don't hear that from my doctors and from my clinics
out in the State of Washington. We probably do better because
we have a few military hospitals there, Madigan and Bremerton
Naval Hospital, but I share this same concern that we are doing
this at a one-shift-a-day approach. And I just wonder whether
we are going to get this job done and get the country truly
prepared.
There was one question here I am going to ask all of you.
What are the two or three largest obstacles to true terrorism
preparedness in the United States? I would like each of you to
take a shot at that. Is it money? Is it commitment? What is it?
The Congress? What is blocking you from moving out and getting
this job done?
Dr. Fauci. From a research standpoint--and I would like to
in my answer very briefly address your justifiable concern, Mr.
Dicks, about the slowness of the pace--if we had a product that
we needed to make available by manufacturing it, then you put
the 24-hour shifts in and make it.
During World War II they were making bullets, they were
making tanks. They knew how to make the tanks. When you are
dealing with research, there are questions that need to be
answered and knowledge that needs to be gained that isn't
necessarily as amenable to the 24-hour approach. Once you get a
product, then I say put the afterburners on and go after the
24-hour approach.
So my part of the answer to your question to the four of us
is that when you are dealing with research, knowledge is one of
the major stumbling blocks, and that is why you do research to
develop the concepts so that you can get the countermeasures.
So from my standpoint that is it. We have been given--.
Mr. Dicks. So the biggest obstacle from your perspective is
a lack of knowledge on how to prepare the countermeasures that
we need?
Dr. Fauci. Precisely. From a research standpoint. I am not
talking about public health. Others can answer that. But from a
research standpoint, it is our race to get the knowledge to be
able to develop the countermeasures that we don't have.
Mr. Dicks. Dr. Raub.
Mr. Raub. Complementing that on the public health
preparedness side, I would say the greatest challenge is
getting and keeping agreement on the threats and priorities of
the threats. I will give you an example of that. When we began
our investments 2 years ago in the increased State and local
preparedness, one of the benchmarks we set out and asked all of
the States to address was to have an epidemiologist for every
municipal area within a State that had 500,000 or more people.
Virtually every one of the States has achieved that because
they and we agree that it is fundamental to public health
preparedness.
Other aspects such as the ability to receive an emergency
case report around the clock, 24-7, has been aggressively
implemented by some States but not others. And I think it is
not so much they don't know how, but rather they don't perceive
the emergency threat in the same way that other States do, or,
frankly, to the degree that some of us do.
So part of our continuing challenge is trying to ensure
that communication to get the emphasis on both broad
enhancement of public health but also the more sharpened aspect
of emergency response. And that is a continuing challenge,
especially the further you are outside the Beltway, and
sometimes the threat doesn't seem as acute, and we will
continue to labor at that.
Mr. Dicks. General?
General Martinez-Lopez. Sir, I think I agree with Dr.
Fauci. But something else that is a second-level obstacle is
sometimes we rely--we have labs all over the country, and the
way the scientists go about their business is by reading the
articles that are published. It takes us almost a year or 2
years to publish those articles. In order to compress the
cycle, what you want to do is to bring those guys together,
either to conferences, or, like in the biodefense campus, to a
single place where now, having coffee, they can discuss a
particular project or a particular problem they have, and that
way you can compress the cycle.
And I think one of the things that the biodefense campus is
going to allow us to do is exactly that: Bring different
agencies, different people approaching the same problem from
different angles, and put them together. And we hope that by
doing that alone, obviously we are going to foster more
structure collaboration, but by doing that we can really
compress the cycle and, at the other end, with better products.
Mr. Dicks. Secretary Albright?
Dr. Albright. I think I agree with Dr. Fauci's point as
well. And I think the basic obstacle fundamentally is time. I
think it is not resources. I think this administration has
devoted fairly significant resources over the last couple of
years to basic research, to threat characterization, to
procurement of countermeasures should they be available. I
think the real issue is having the time to develop and the
knowledge to develop those countermeasures, making the research
work.
Where we have countermeasures, we are, I think, to use your
term, we are going 24-7. A good example is the very first
procurement that is going to come out under the BioShield is
the RPA procurement, and in the meantime we are maximizing--as
part of that we are going to maximize production of the AVA
vaccine, the existing vaccine, until RPA comes on board. So I
think you cannot command discovery, as I think Dr. Fauci said,
and I think that is the real issue.
Mr. Dicks. Thank you.
Chairman Cox. Mr. Langevin is recognized for 5 minutes.
Mr. Langevin. Thank you, Mr. Chairman.
And, gentlemen, I would like to thank you for
participating, being here today. Certainly your insights and
expertise have been extremely helpful as we wrestle with some
very difficult issues.
In particular, I just want to welcome Dr. Raub here today,
with whom I had the pleasure of participating recently in a
recent exercise of the National Defense University where
Members and agency experts were confronted with a disturbing
scenario involving multiple bioweapons attacks across the
country. So thank you for being here. The exercise that we were
involved with was certainly enlightening and provided a rather
chilling reminder of how far we still have to go to ensure that
we are adequately prepared to respond to such an attack.
One of the problems that we confronted during the exercise,
which involved multiple, nearly simultaneous anthrax attacks on
various cities, was determining how to allocate limited
stockpiles of drugs when there may not be enough for every
person affected. In addition, it became clear that finding
adequate personnel to distribute the drugs once they arrived
and appropriate locations for distribution would be a major
hurdle.
So what I would like to ask is, in terms of stockpile, can
members of the panel address adequacy of our current stockpile
and what plans, if any, are in place to increase it so that we
would have sufficient product on hand in the event of multiple
simultaneous attacks or even one attack of great magnitude? And
also has consideration been given to working with Canada and
other countries to quickly get additional drugs to the right
place should the need arise?
Mr. Raub. Thank you, sir. I will start off, and others may
want to add here. The current Strategic National Stockpile--and
I will focus specifically on antibiotics not only because that
is the major part of it but that was the focus of the exercise
in which you and I and others engaged--that stockpile is enough
for 13 million individuals for a 60-day course of treatment.
Plans are underway beginning this year and going through fiscal
year 2006 increase that stockpile to the order of 60 million
treatment courses for 60 days, recognizing that we need a
broader capacity.
Mr. Langevin. That will take place over how much time?
Mr. Raub. Between through now and fiscal 06 as our
proposals are considered.
The second part of that, as you indicated, is one of our
weakest links right now is getting the material from the
airport or wherever we deliver it into people's mouths. All of
our public health components around the country know how to set
up and operate a point of dispensing, and many do it routinely
for childhood vaccination or for outbreaks such as meningitis,
but none of these communities has ever been challenged to do it
on a very broad scale in a very short period of time. And it is
our new understanding of the anthrax threat in particular,
where an area of square miles could be covered, and we would
not know who was exposed, but we would have to start antibiotic
treatment while we figure that out, that becomes a major
challenge.
That is the thrust of this recent plan announced by the
Department for a Cities Ready Initiative to focus on 21 major
cities in collaboration with our colleagues in Homeland
Security, the United States Postal Service, and others, to make
more robust the metropolitan capability to deliver and dispense
antibiotics locally, to supplement that with Federal resources
as needed, including those of the U.S. Postal Service, and in
general to get the more rapid penetration that would give us
time to understand better the nature of the exposure and to go
on with the longer-term public health measures.
The final part of this is to encourage more local
deployment of antibiotics for the immediate needs of the
community, especially for medical personnel, for fire, police,
transportation operators, and others--that there would be
enough material on hand immediately to ensure some stable
function of that infrastructure while the larger response was
being readied.
Mr. Langevin. Anyone else?
Dr. Albright. Well, another issue that generated a great
deal of discussion at the exercise was the question of
information sharing with the public at large as well as State
and local officials and specific industries or sectors that
might be particularly affected. We all agreed at the outset
that in any crisis like a bioterror attack that it was critical
that those who needed information would receive it in a calm,
detailed, and coordinated manner basically, obviously, to
engender trust, minimize panic, and ensure cooperation and
assistance of those in a position to help. What we couldn't get
a clear sense of is whose responsibility such communications
are going to be or are.
My sense is that both a public information and education
campaign as well as information sharing among jurisdictions and
industry sectors should be coordinated through the DHS so that
there is one clear voice speaking to Americans and one defined
clearinghouse of information flowing to and from various
stakeholders.
So I would like to ask the panelists to describe their
understanding of the procedures and protocols currently in
place for communicating with State and local governments, the
private sector, and the public in the event of a bioterror
attack; and do you feel these mechanisms are adequately defined
and understood among all relevant agencies; and is there a plan
in place for what information to share at what time; and are
the basic elements of a public information campaign already in
place so that it could be quickly implemented in an emergency?
Dr. Albright. There are several aspects to that. There is
sharing with the local public health officials, which I will
defer the answer to that to Dr. Raub.
In terms of communication strategy, the department has been
fairly proactive in developing a suite of communications
strategies, I guess is the right word, for a wide variety of
events--radiological, nuclear, biological--but I would say that
is work that is just now--it is not mature yet. Exactly how to
communicate to the public what the risk is, how to keep the
issues surrounding--what precisely the response of the public
should be if a particular event were to occur, for example, a
radiological or biological attack, is something we are working,
for example, with the National Academies on. It is an area that
we are focused, but it is a work in progress.
Mr. Langevin. Where along that process are you right now?
Dr. Albright. Excuse me?
Mr. Langevin. In terms of a timeline, where are you in that
process to having--.
Dr. Albright. We are proactively--as I said, we have a
contract in place with the National Academies of Sciences to--
and I believe that has been underway for several months--to
develop communication strategies in these various areas. I
believe it is a 1-year contract, but I am not certain of that.
This is actually being operated under our public affairs shop,
and I will certainly be happy to get back to you after the
hearing with more information on that if you wish.
Mr. Langevin. Yes, I would like that. Thank you.
Dr. Raub.
Mr. Raub. If I could just add quickly that your question
has several facets, and I won't try to touch all of them, but
at the national level under Homeland Security Presidential
Directive No.5, any event involving two or more of the Federal
agencies looks to Secretary Ridge to be the coordinator of
those activities, including the coordinator of the
communication aspects of it.
At the local level, those cooperative agreements that I
mentioned in responding to Mrs. Christensen before include a
component on public communication, and we have asked each of
the State and local health departments to prepare themselves
not only on their own, but in conjunction with the emergency
management officials and their political leadership and others,
to have the capabilities to, as you say, apprise the public
actively in a firm but low-key way to not only let them know
what is happening but also to enlist their cooperation; because
if we are at a major response such as something requiring rapid
distribution of antibiotics or vaccination of a large group of
people, no matter how good our medical or public health
capabilities are, if we don't have cooperation from the public,
and instead we have civil disorder or chaos, it just makes that
medical delivery almost impossible. Those are just two aspects
of it but this continues to be a major concern and emphasis for
us.
Ms. Dunn. [Presiding] The gentleman's time has expired. I
thank the gentleman. Next we will call on the gentlewoman from
Texas, Ms. Jackson-Lee.
Ms. Jackson-Lee. Thank you, Madam Chairperson. I thank the
witnesses for their presentation as well.
Let me try to characterize the attitude that I have or the
sense of concern that I have, using one or two anecdotal
stories or at least reflections on the week's recent events,
first being the pronouncement by the Attorney General just last
week, during the week of memorializing and honoring our fallen
soldiers, of a terror alert or at least a terror pronouncement.
I am not sure what it was intending to do. But for those of us
in our communities, our local districts, it was confusing at
best because, obviously, it was a stand-alone activity by the
Department of Justice and the FBI Director, and only later did
Secretary Ridge either suggest that he gave his approval--but I
can assure you that those on the homefront, which is what I
believe the Homeland Security Department and this committee is
to be about, we are certainly concerned about the inside-the-
Beltway, but our work is really outside the Beltway, and really
that announcement fell on deafened ears, jaded minds, and
people basically ignored it. That was the context in which it
was received.
Just as an aside that is not really pertaining to your
business, yesterday we were debating a constitutional amendment
dealing with the potential of losing 218 Members of Congress,
maybe all at one time. And the reason why I raise that with you
is that even that monumental debate did not warrant this body
giving it more than 30 minutes a side to talk about what would
happen if we did not have this Congress in place or government
in place.
I only use these examples to say that I am equally
concerned that many think of terror as airplanes flying into
buildings and have not yet understood the potential biological,
chemical, or radiological weapons, except for the fact of the
terminology ``dirty bombs.'' At least the public understands
that, but I don't know if they perceive that it will come in
Cleveland, Ohio, or Houston, Texas, or some rural hamlet or
village or suburban location.
And that is my frustration where we are today. I think this
is an important hearing, but I would like to raise these
points, but I would ask any of you to join in, but specifically
I would like Dr. Albright and Dr. Raub to answer these
questions, and they build upon my colleagues' concern, and that
is about our public health and hospital infrastructure. But I
also want to speak specifically to local clinics, health
clinics.
Many of us are advocates of local community health clinics,
and my concern is when you use the term ``local,'' are we
reaching as far into the infrastructure as those local clinics?
My first question is, enunciate for me or give me an
understanding--and I am going to give you all the questions at
once--what are the accountability standards that have been put
in place? Where are they? Are they posted up on a wall? Does
each medical director have them or public director have them?
Do the city and county directors have them? And what is the
guidance being given? Is there a 1-800 number or emergency
number that someone can call to immediately grab hold onto the
instructions? We can talk about large intent, but if they are
not transferrable, they are not working.
On the outsourcing do we have a firewall--when we talk
about outsourcing, production of biodefense agents, do we have
a firewall to protect the Nation against sabotage of production
of those biodefense agents, or are we randomly outsourcing with
no indication at all?
The last question deals with what I started out with, my
local community health clinics. Are they in any way connected?
And I am sure you will say connected to their major body,
whether it is State or local; but are they connected? Is there
some way of having tentacles to that embedded community clinic
that is somewhere in someone's community, whether it be rural
or urban? And I would appreciate it if you can attack this
question with a vengeance.
Let me just for a moment--and I know I am on this last
point here--you have a problem called BioWatch, Detect to
Treat, and there was an incident in Houston, tularemia, where
it did not work. I think you are aware of it, and I don't want
to go on long with the question, but if you can comment on
that, and if not, I will welcome that in writing. But Dr. Raub
and Dr. Albright, and others who may want to join in. Thank
you.
Mr. Raub. With respect to your first question about
accountability standards and guidance, the cooperative
agreements that I mentioned before from both of the agencies
include items that we call critical benchmarks. These are
milestones on the road to preparedness, but things that are to
receive the highest priority and things that we believe can be
and should be achieved in a short period of time.
Ms. Jackson-Lee. Are you speaking about standards? That is
what I asked about, accountability standards. You are talking
about benchmarks.
Mr. Raub. Well, some of them are quantitative now. Others
are our first estimate, because we are not sure exactly what
the final standard should be. I gave the example before of 1
epidemiologist for every metropolitan area of 500,000 people or
more. We think that is a good starting number. We don't know
that that is the precise standard that ought to hold for all
time, but it was a near-term target that we believed every
State could and should achieve, and we will continue to make
that kind of emphasis.
As these cooperative agreements go on, we will sharpen and
build on those critical benchmarks, trying to make them more
precise and more quantitative and closing in on standards, as
you would describe it, because I share your view that we need
to be communicating as clearly as we can about what we are all
trying to achieve.
With respect to the emergency response, every one of the
State health departments is well connected to the Centers for
Disease Control and Prevention and knows how in the face of an
emergency or even any uncertainty to make the contacts at CDC
to get the kind of technical assistance they need. CDC in turn
is well connected not only with our Office of the Secretary but
with colleagues in the FBI. We are well connected with the
Operation Center at the Department of Homeland Security, and we
like to think we are getting better and better at providing
that kind of emergency assistance and response.
Ms. Jackson-Lee. Dr. Albright.
Dr. Albright. What I can comment on is on your question
about the BioWatch incident in Houston. Actually I think that
is an example of the system first working quite well and a good
example of interagency cooperation and cooperation between
Federal and local public health entities.
First let me state what actually happened. The BioWatch
system that was in Houston in fact did detect tularemia and in
fact it was tularemia. The system did work. The pathogen was
later sequenced at CDC and was confirmed to be that. They were
very weak hits. When the incident occurred, what we immediately
did was to begin coordinating with CDC in two specific areas.
The first was in the arena of a public announcement. So in
terms of public affairs, we worked jointly with CDC to craft
some--frankly, some talking points for the local public health
officials should they decide that they needed it.
The second thing we did, very importantly, was again
working with CDC and the local public health people, was we
increased disease surveillance in the area. So we had these
very weak hits of tularemia in the system. We then--CDC
actually and the local public health authorities notified the
local clinics to--essentially if they got a certain set of
symptoms, to rule out tularemia was basically the instructions
they got, and thereby substantially increased our ability to
detect the disease, which, if detected, is eminently treatable.
So what it was, was a very good example of our ability to
work very closely with CDC and HHS on an event such as this.
Then secondly, our ability jointly at the Federal level to work
with the public health authorities locally. They were basically
told that they were in charge of the incident, and they were
put in charge of the incident. And I have to tell you, I don't
think they believed it until we actually did it, that they were
allowed to run it. They were allowed to run the public affairs
aspects of it. They were allowed toSec. they interacted with
their local medical community directly.
Ms. Jackson-Lee. They waited several days to determine that
that was what the substance was or what the item was.
Dr. Albright. Excuse me. What actually happened was, the
way we get the hits in tularemia is through a very robust
analysis. This was not a false alarm. No one thought it was a
false alarm at the time. And all I can say is that the
subsequent analysis just confirmed something that we really
knew to be true on the ground, I believe the local public
health people knew to be true on the ground as well.
Mr. Raub. Let me just add as somebody who spent many hours
in the Operation Center those several days, as Dr. Albright
indicated, we had a true positive. It turned out to be
environmental noise, not a terrorist attack, and frankly we
thought it was environmental noise. The officials in the city
of Houston, in Harris County in the State of Texas, could not
have performed better in our judgment in terms of the very
deliberate way they proceeded in the face of the uncertainty
but the likelihood that we had something that was an
environmental cause rather than a terrorist attack.
Nonetheless, the surveillance efforts they put in place as a
precaution were a model, I think, of what other cities might
do. And from my perspective I viewed that as some of that State
and local money at work manifesting itself in a demonstration
that they are indeed moving to heightened preparedness.
Ms. Dunn. The gentlelady's time has expired.
The ranking member of the committee, Mr. Turner of Texas,
has an additional question.
Mr. Turner. I won't take a question because I think we need
to move to the next panel. But I want to make a request and
maybe, Dr. Fauci, if you could do this for us it would help us
as a committee. You have heard people on both sides of the
aisle talk about their sense that we are not doing this 24-7,
that we are not making the kind of commitment that we need to
make, and so it would be helpful to us if you could prepare for
us and perhaps give us a briefing outside of the hearings, just
a briefing with members that are interested and staff, on the
total dollars that we are currently spending and the kind of
grants and other activities that are ongoing through your
agency and any others that you have to bring in, which I am
sure you are aware of, to a accomplish the goals of that rapid-
cures act that we have introduced, so we can get a sense of how
great a commitment are we making to this basic research that is
necessary to shorten this time frame and the right options on
how to do it.
The other presentation I would request from you to present
perhaps in the same fashion to the staff and the members who
are interested in a briefing setting is the amount of money
that we are committing to finding the countermeasures to the
various pathogens that we know we are worried about and maybe
do the class A, the class B, the class C. Let us just see the
dollars that we are spending, the grants, the total efforts
that we are making in those areas to give us a sense of that.
And then the final one is a request that you are familiar
with, I think, that came from staff as they were trying to look
into the financial management review procedures that you use
before you enter into a contract with a private sector company
to do some work for you; because, as you know, there is some
information out there now that this biotech company, VaxGen,
that has over $100 million in government contracts, that there
may be some evidence of accounting irregularities there, and I
think they have been threatened with having their name delisted
from NASDAQ, and it has given us concern.
If you could provide us a briefing about that issue so that
we can have some assurance that when you are granting these
multimillion-dollar contracts, that we are giving them to
companies that are not going to go bust on us.
Dr. Fauci. I would be happy to do all three of those
requests, Mr. Turner, and I will have my staff work with your
staff to set up the briefing times as soon as we possibly can.
Mr. Turner. Thank you. Thank you, Madam Chairman.
Ms. Dunn. Thank you. And thank you very much, gentlemen,
for appearing before us today. It has been very useful and we
appreciate your coming here.
The Chair would like to ask the second panel to be seated,
please.
We welcome our new panel. Thank you for being with us
today. Let me remind you that if you could keep your opening
statement to 5 minutes, your written statement will certainly
appear in the record, and as a result we would be able to allow
our members to have time for questioning. Thank you very much.
Ms. Dunn. Why don't we start with Dr. Johnson Winegar, and
then we also welcome and we will hear next from Dr. Shelley
Hearne.
STATEMENT OF ANNA JOHNSON-WINEGAR, PRIVATE CONSULTANT
Ms. Johnson-Winegar. Thank you, Madam Chairman, and other
members of the committee, for the opportunity to appear before
you today to address this extremely critical topic that I have
thought about for essentially most of my professional career.
Just to set the stage, I wanted to inform you that I have
previously served as the Deputy Assistant to the Secretary of
Defense for Chemical and Biological Programs, and recently
retired from that position. I do have a Ph.D. in microbiology
and I am currently a private consultant in those general areas.
When I think about the area of biodefense and bioterrorism,
I feel very strongly that a comprehensive approach is required
to address the full spectrum of things that can go on. First
and foremost, I feel it important that we must significantly
increase our resources in the areas of intelligence and threat
assessment. In my opinion, unfortunately, our expertise in this
area is indeed quite limited.
Another important area that I think is quite overlooked is
that of biodetectors. The current biodetectors that we have are
characterized by the scientific community as detect-to-treat
rather than detect-to-warn, and this is due to the lag time
between collection of samples and identification of the
pathogen. And while this is a good first-step approach, without
more definitive intelligence, the cost to establish and
maintain a sufficient number of these biodetectors throughout
the United States is prohibitive.
And I think that perhaps even more importantly than working
on improvements in biodetector technology, for I do believe the
improvements will come incrementally, is the need for a concept
of operations. In other words, what happens when the alarm goes
off? Who makes the decisions? Where are the supplies that we
needed? And finally, after a potential attack, there is the
whole problem of residual contamination and clean-up.
I think that much more emphasis needs to be placed on new
decontaminants that are environmentally friendly, safe to use
on humans, and sensitive electronic equipment, ones that can be
disbursed over large areas, ones that work quickly and are
inexpensive.
And, finally, any robust science and technology program
that addresses bioterrorism and biodefense needs all of these
aspects, plus medical countermeasures.
Realizing the lack of a commercial market and poor
incentives for the industry has been one of the problems in
getting the pharmaceutical firms to develop the drugs and
vaccines that we need. I think a lot of information has been
provided by the earlier panels on the work that is going on in
what I characterize as basic research, and there is the
BioShield legislation to address the procurement of these
items. However, I feel that there is a major gap in the
advanced development areas. We need additional work done on
validated animal models. We need a lot more work done in both
preclinical and clinical trials so that before these products
come to market, we are sure that they are both safe and
effective.
I would call your attention to the recent report by the
Institute of Medicine on giving full measure to medical
countermeasures in which they describe a number of problems
associated with the current approach and they make specific
recommendations for alternatives. I firmly believe that a
vigorous effort must be made to shorten the time frame to
develop new medical countermeasures.
Clearly the Department of Defense has invested for many
years in the area of medical countermeasures. Now the budget of
the Department of Health and Human Service has increased
dramatically, now providing over $1-1/2 billion. This indeed
dwarfs the investment made by the Department of Defense, and it
has initiated an obvious shift from DOD to HHS as the primary
funder in biological research against terrorists' use of
biological agents.
However, the history of NIH has been one of investigator-
initiated research rather than one that is based on threats or
driven by requirements. While the NIH has traditionally been
strong in basic research, they have much less attention on
product development and licensing of new products.
I think that we all agree that bioterrorism is a major
threat to us, and I think the priorities need to be established
across the various Federal agencies, all the way from analysis
of the threat and a true prioritization of the vast array of
projects that could be funded. Not every project of purely
scientific interest deserves funding. Measures of effectiveness
must be established and publicized. Areas of common interest to
the individual departments must be leveraged to shorten the
timelines. Formal communication and collaboration must be
established that transcends the particular individuals involved
in the programs. Budgets must be aligned. Senior officials must
be held accountable, and results are imperative.
I would be happy to answer any questions that the committee
members may have.
Mr. Turner. [Presiding] Thank you, Dr. Winegar.
[The statement of Dr. Winegar follows:]
Prepared Statement of Dr. Anna Johnson-Winegar
INTRODUCTION
Mr. Chairman and distinguished committee members, I am Dr. Anna
Johnson-Winegar. Thank you for the opportunity to appear before you
today to address this extremely critical topic. I am the former Deputy
Assistant to the Secretary of Defense for Chemical and Biological
Defense Programs, having served in that position from October 1999
until my retirement in June 2003 after 37 years with the Department of
Defense. I have a PhD in microbiology and I am currently engaged in
private consulting in the general areas of chemical and biological
defense, biotechnology, medical product research and development, and
other related areas for both government and commercial clients.
I am here today to discuss my thoughts on how the United States is
proceeding toward developing a comprehensive biodefense strategy. I
think we are all aware that the tragic events of September 11th and the
anthrax cases in the fall of 2001, as well as more recent incidents
with ricin have greatly heightened the public's awareness of the threat
of biological terrorism. The creation of the department of Homeland
Security last year was a major step in raising the level of importance
of all aspects of security for the people of the United States. The
focus of today's hearing, and the basis for my remarks deals
specifically with the threat of bioterrorism- one aspect of the broader
threat of weapons of mass destruction (WMD).
A COMPREHENSIVE APPROACH IS REQUIRED
When addressing the full spectrum of a potential attack with a
biological agent, it is helpful to identify responses across a
continuum. Clearly, long before any such incident, we must
significantly increase our resources in the areas of intelligence and
threat assessment. Unfortunately, our expertise in this area is quite
limited. While there have been modest efforts to capture information
from employees who worked in the U.S. offensive biological warfare
program that was cancelled by President Nixon in 1969, much of their
understanding of how to make a biological organism a weapon has been
lost. Among the goals of the National Biodefense Analysis and
Countermeasures Center (NBACC) is support for intelligence activities
and characterization of biological threats. This will take years of
hard work to establish core capabilities and build a strong cadre of
personnel. This group will also be challenged by the need to think
creatively. The use of the postal system to deliver anthrax spores is
but one example of how little our current defensive program understands
the broad range of possibilities for biological terrorism.
In the time immediately preceding a biological attack, the best
approach is a detection and warning system. Current bio-detectors are
characterized by the scientific community as ``detect to treat'' rather
than ``detect to warn''. This is due to the lag time between collection
of appropriate samples and identification of potential pathogens. The
BioWatch program, currently set up in approximately 30 cities in the
U.S. makes use of environmental monitoring in specific locations. While
this is a first-step approach, without more definitive intelligence,
the cost to establish and maintain a sufficient number of biodetectors
throughout the United States is prohibitive. Current detector systems
use triggers that respond to increased particles in the air, followed
by laboratory analysis of samples that are collected by one of several
means. Current identification systems rely on specific antibodies or
nucleic acid probes to identify' the specific agent. Obviously then,
these systems are limited in their capability since, by design, one
must know what you are looking for in advance. More research is
desperately needed on generic systems that can act as a first alert.
Some approaches toward these types of systems include receptor based
technology and living cells that may respond to any number of toxins,
chemicals, or biological agents. The level of sensitivity and
specificity for biodetectors still needs improvement. While some assays
are very sensitive, others are not yet at the level of being able to
detect small doses which can cause human illness.
However, perhaps even more important than improvements in detector
technology (for they will come incrementally), is the need for a
concept of operations. Assuming one had a ``perfect'' biodetection
system-i.e., one that had the ultimate degree of sensitivity, an
absolute ability to distinguish false positives and false negatives,
and one that could operate without fail for long periods of time, the
question still remains: Who is responsible for analyzing the
information, what is the chain of command for disseminating the
information, and what response can be taken? True, for some of the
biological threats, prompt initiation of antibiotics may be effective
in preventing onset of disease. For others, post exposure vaccination
may be appropriate; however, sufficient pre-clinical and clinical data
are needed before this approach can be advocated on a large scale.
Finally, there are still many agents on the threat list for which there
is no treatment, and therefore, a ``detect to treat'' approach is
doomed to failure.
Another approach at protection following an alarm, is that of
individual and collective protection. This is the approach used by the
DOD to protect military members in chemical-biological environments.
While it may be impractical to provide the entire population of this
country with protective masks, this is indeed the approach taken by
Israel. It seems apparent that more work is needed in the areas of
improved physical protection for the citizens of this country.
Finally, following a potential terrorist attack with a biological
agent, there is the problem of residual contamination and clean-up.
This has turned out to be a major problem in sufficiently cleaning
facilities that were contaminated with anthrax spores. New
decontaminants are needed that are environmentally friendly, safe to
use on humans and sensitive electronic equipment, can be dispersed over
large areas (both open and enclosed, work quickly, and are inexpensive.
It would be desirable to have one decontaminant that is effective for
both chemical agents as well as biological agents (specifically anthrax
spores).
A robust science and technology program is needed that covers all
aspects mentioned above-i.e. intelligence, detection, individual and
collective protection, and decontamination. Medical countermeasures are
the final component of a comprehensive approach and will be discussed
in the following section of my statement.
MEDICAL COUNTERMEASURES FOR BIOLOGICAL AGENTS
A significant effort is being undertaken to improve the status of
medical countermeasures for biological agents. This issue first
received a high priority within the Department of Defense during
Operation Desert Shield/Desert Storm. The leadership of the Department,
as well as the nation as a whole, came to realize that we went into
that conflict with only one vaccine licensed by the Food and Drug
Administration. The anthrax vaccine had been approved in 1970, and had
been is limited use by at-risk laboratory workers, some veterinarians,
and a few commercial industries (wool mills).
Surge capacity for large quantities of this vaccine was an
immediate need, however, the pharmaceutical industry was not able to
respond. Further, there were no products available that had been
specifically licensed for treatment of anthrax (which means indicating
that on the product label and package insert). Animal studies conducted
by the DOD were instrumental in providing data to show that
administration of antibiotics post exposure were effective (under the
controlled conditions of the experiments). Subsequently, several
antibiotics have now been approved by the FDA for treatment of anthrax.
However, post-exposure use of anthrax vaccine is not yet approved by
the FDA and such treatment must be conducted under the rules of
Investigational New Drugs. Beyond anthrax, there were almost no
products available for immunization or treatment except very limited
quantities of a toxoid for Cl.botulinum, and even more limited supplies
of antitoxin for treatment. Realizing the lack of a commercial market
and poor incentives for the industry, the DOD undertook a number of
different studies to address the problem. Meetings with industry raised
their specific concerns, namely: indemnification and liability; long-
term commitment of government funds; setting priorities for vaccine
production (i.e. balancing current marketable products versus
developing a stockpile of vaccine for limited use); needs for
additional studies to validate animal models and conduct necessary pre-
clinical trials; expenses associated with larger clinical trials, even
if only to establish safety and immunogenicity of a new product; and
bio-safety and bio-security concerns. The concept of a Government
Owned-Contractor Operated (GOCO) vaccine facility was supported within
the DOD budget request in the mid-1990's, but was subsequently
withdrawn in favor of an approach that relies upon private industry to
meet the vaccine needs of the DOD. This Joint Vaccine Acquisition
Program (JVAP) has been in place for over five years, and no new
products have been licensed. The recent report by the prestigious
Institute of Medicine entitled ``Giving Full Measure to Medical
Countermeasues'' describes problems associated with the current
approach and recommends alternatives for both the research and
development aspects of a biodefense program as well as procurement
issues. A vigorous effort must be made to shorten the time frame for
new medical countermeasures.
In the time since the Gulf War (now more than 10 years), we still
have no new medical countermeasures licensed and available. (I am
discounting the additional quantities of smallpox vaccine since that
was not a result of new research and development). Now, the budget of
the Department of Health and Human Services has been increased
dramatically, providing over $1.6 B in fiscal year 2004. This dwarfs
the investment made by the DOD, and it has initiated an obvious shift
from DOD to HHS (NIH and NIAID) as the primary funders for biomedical
research against terrorist use of biological agents. However, the
history of NIH has been one of investigator initiated research rather
than one that is threat based or driven by requirements. Further, the
NIH has traditionally been strongest in basic research, with much less
attention on product development; clinical trials, and licensing of new
products. New regulations on handling select agents may deter some
academic institutions (the traditional strength of NIH grants) from
working in this area. It will take years for some of the basic research
that is just getting started to pay off. It will be important to
maintain the momentum that has been started.
THE ROAD AHEAD
Realizing that the threat of bioterrorism or use of biological
agents by a traditional adversary could cause irreparable damage is a
most dramatic incentive to the various Departments of the government to
coordinate and find accelerated ways to address the problem in the
shortest amount of time possible. The Department of Homeland Security
has the lead in most areas of the science and technology programs, with
the Department of Health and Human Services having the lead in medical
countermeasures. The role for the Department of Defense is still
unclear in many aspects, but it is obvious that much of the knowledge
we have today is resident within the DOD. It is essential that we do
not waste time reinventing the wheel, or repeating work simply because
of parochial interests.
First priority should be given to a thorough analysis of the threat
and a prioritization within the vast array of projects that could be
funded. Not every project of purely scientific interest deserves
funding. Measures of effectiveness must be established and publicized.
Areas of common interest to the individual Departments must be
leveraged to shorten time lines. Formal communication and
collaborations must be established that transcend individuals involved
in the programs. Budgets must be aligned to avoid duplication. Senior
officials must be held accountable. Results are imperative. The future
welfare of our country depends on it.
Mr. Turner. Dr. Hearne.
STATEMENT OF DR. SHELLEY A. HEARNE, EXECUTIVE DIRECTOR, TRUST
FOR THE AMERICA'S HEALTH
Dr. Hearne. I hope to be just as efficient in covering all
these bases.
Good afternoon and thank you for holding this hearing on a
very important issue. I am Shelley Hearne, the executive
director of Trust for America's Health, a nonprofit,
nonpartisan organization dedicated to preventing epidemics and
protecting people.
Everyone in this room knows full well about the threats and
concerns of bioterrorism. Certainly the Hill has experienced
many of those attacks in person with ricin and anthrax. What is
important to remember is that the 2001 attacks were a
relatively minor event that absolutely overwhelmed our public
health system. They overwhelmed our labs. They besieged our few
epidemiologists out there and they revealed that most States
don't have a bioterrorism plan. In my home State of New Jersey,
postal workers and others were told to go find their personal
doctor and to get the antibiotic Cipro if you had a doctor,
because the local health agencies were not prepared to do
delivery and emergency distribution of those supplies. This was
not the American public health system's finest hour.
The good news we had in that event is that it was a strain
that was not drug resistant and it was also responding to a
widely available antibiotic.
But having stockpiles of medicines and vaccines will not
protect us without a fully functional public health system that
includes those disease-tracking systems that can quickly pick
up an event and have the labs that can do the biological and
chemical testing to figure out what that agent may be and--
critically--the public health workforce who knows how to
rapidly respond.
It is the teamwork between the pharmaceuticals and the
public health system that is going to prevent a pandemic
epidemic. Its only bottom line is--I will show my older days as
an aging jock here--but your team is only good as your weakest
player, and the problem is that the public health system has
been sitting on the bench for decades now with neglect.
After those 2001 attacks, the administration and Congress
recognized those public health gaps and quickly responded by
investing nearly $2 billion to jump-start the Nation's
bioterrorism preparedness efforts. The question now is, are we
better prepared? And the answer is, not yet.
Our recent report that the Trust put out found that States
are only modestly better prepared to respond to a health
emergency. We have seen some very good progress in the area of
communications in developing those initial plans and making
sure even that the bioterrorist leaders were getting connected
to homeland security frontline responders. But our report also
showed there is enormous room for improvement. We examined 10
key indicators in every State, looking at how well prepared
they are. We found that almost 75 percent had scores of 5 or
lower.
Let me run through some of the particularly serious
shortcomings we found. We found that only two States had
achieved full readiness, or the green status, to receive,
distribute, or administer emergency vaccinations and antidotes
from the Strategic National Stockpile. Since then, another
State has joined the ranks, but we have also heard reports that
as many as six States have actually regressed in their current
status. We found that only six States had sufficient laboratory
capacities to deal with a major public health emergency.
Ms. Hearne. We also found an enormous public health
workforce crisis, particularly with epidemiologists,
environmental specialists needed for chemical events and other
trained experts
Other initiatives such as the U.S. Postal Service are
intriguing ones that we need to consider, but they do not
address the dire absence of needed public health professionals.
Bottom line is the decisions about pediatric doses, for
instance, need to be made by a doctor and not a delivery man at
the door.
Nearly 66 percent of these States, which are facing budget
crisis, have also cut funding for their public health
activities. This finding seriously dilutes the impact of the
Federal investments that have been made for bioterrorism.
To be battle-ready with our public health defenses at all
levels--Federal, State, and the local levels--it is going to
take years of a sustained commitment, funding, and oversight.
The Trust for America's Health is recommending the
following actions:
One is that HHS has informed Congress about plans to
redirect $55 million of State and local bioterrorism
preparedness funds to new initiatives, including the 21 high-
risk cities, and plans to activate the U.S. Postal Service for
stockpile delivery. Under that proposal, every State will
receive a cut of over $1 million. Shifting money from one
preparedness initiative to another is not the solution today
for nationwide bioterrorism readiness, especially when we are
finding that all States have still significant areas of
vulnerability. The House Labor-HHS Appropriations Subcommittee
should be urged to continue the funding to State and local
preparedness initiatives and find additional dollars to fund
that city readiness initiative.
In addition, it has been noted earlier that the proposed
2005 budget does have an 11 percent cut to the State and local
preparedness activities. The bottom line is that our biological
defenses are far too important to shortchange at this point,
and in fact what we recommend is that an independent review is
conducted to look at current expenditure needs and also to
ensure that systems of accountability are being put in place.
Lastly, I would like to point out that very important
initiatives have been raised recently, such as BioSense,
BioShield, BioWatch, but one of the concerns that is being
raised today is that there really is no bio game plan. The
Trust is worried that many overlapping jurisdictions, lack of
coordination amongst the various Federal agencies; that there
is no plan between the multitude of these interagency
initiatives; that we need to have a clear leader in charge;
that a bio game plan is a critical element so that we
understand the different parts and ensure that teamwork.
Certainly terrorism thrives on uncertainty, and we don't
know what the next attack may be, if it is smallpox, sarin gas
or a small radiologic explosion. We must continue to invest in
these important programs like BioShield, but you cannot accept
that vaccinating the public is the solution unless you have
that equal rapid response, highly trained, well-equipped Public
Health Service to rapidly detect, manage, and contain all
health emergencies. It is the team work that we need in the
United States, and I hope that through this committee's work we
can continue to urge that progress and direction. Thank you.
Mr. Shays. [Presiding] Thank you, Doctor.
[The statement of Ms. Hearne follows:]
Prepared Statement of Dr. Shelley Hearne
Good afternoon. I am Dr. Shelley Hearne, Executive Director of
Trust for America's Health (TFAH), a non-profit, non-partisan
organization dedicated to saving lives by protecting the health of
every community and working to make disease prevention a national
priority. I would like to thank Chairman Cox, Ranking Member Turner and
the entire Select Committee on Homeland Security for holding this
important and timely hearing. On behalf of Trust for America's Health,
I appreciate the opportunity to testify about the role public health
plays with respect to homeland security, particularly in the event of a
biological, chemical or radiological terrorism event.
Since September 11, our nation has faced a series of dramatic
wakeup calls with respect to the state of public health preparedness
and we have repeatedly seen that the country is ill-prepared to respond
to a large-scale health emergency. The 2001 anthrax crisis was a
relatively minor event, yet it overwhelmed the nation's limited public
health laboratory capacity, besieged epidemiology investigators, and
revealed that no emergency pharmaceutical distribution system existed.
In my home state of New Jersey, postal workers and others who were
potentially exposed to anthrax were told to go visit their personal
doctor to obtain the antibiotic Cipro, since the local heath agencies
did not have the ability to distribute emergency supplies. This was not
the American public health system's finest hour.
The good news was that this strain of anthrax was not drug
resistant and was treatable with a widely available antibiotic.
However, having stockpiles of effective medicines or vaccines will not
protect us without a functional public health system that includes
disease tracking systems to quickly detect an attack, labs that can
identify the biological or chemical agent, and a trained public health
workforce that can rapidly respond.
As Americans we have long taken special pride that our nation has
set the pace for disease prevention and control worldwide. But today,
the nation's public health system is being stretched to the breaking
point.
Congressional approval of $5.6 billion for Project Bioshield
represents one step forward toward better bioterrorism preparedness in
America.
Smallpox is a good example of how important it is to have both
effective countermeasures and a competent public health system. The
Department of Health and Human Services (DHHS) invested wisely in
expanding and enhancing the nation's smallpox vaccine supply. In the
event of an outbreak, the strategy is to ``ring inoculate.'' Executing
this strategy requires astute clinicians to notify public health
officials or disease surveillance systems capable of detecting a
possible smallpox event, labs that are able to rapidly test and confirm
smallpox cases, and deployment of rapid response teams who can deduce
who has been exposed and inoculate anyone possibly exposed. If managed
correctly, a smallpox event could be caught early and contained. The
team work of pharmaceuticals and public health could prevent a global
pandemic. But a team is only as good as its weakest player.
The Nation's Current State of Public Health Preparedness
Unfortunately, due to decades of neglect, America's public health
system has been sitting on the bench. Following the terrorist attacks
of 2001, the Administration and Congress recognized that significant
gaps in public health made the nation vulnerable to attack and
responded quickly and appropriately by investing nearly $2 billion to
help jump start our nation's bioterrorism preparedness efforts. The
infusion of funds into the public health system was sorely needed and
most welcome. Yet, two years of bioterror funding cannot make up for
decades of underinvestment in the nation's public health system.While
progress has been made in state and local preparedness for public
health emergencies, much more remains to be done.
Six months ago, TFAH released a state-by-state report, assessing
whether or not the nation was better prepared for another terrorist
attack or other major health emergency given the $2 billion federal
bioterror investment over the last two years.
The short answer is: ``not yet.''
Our report, Ready or Not? Protecting the Public's Health in the Age
of Bioterrorism, found that states are only moderately better prepared
to respond to health emergencies than they were prior to September 11.
We found that some good progress has been made in most states to
improve communications with the public and between health agencies.
Every state had at least an initial plan on paper of how to mobilize
public health resources in the event of a terrorist attack.
However, the report also found that there is much room for
improvement. The report examines 10 key indicators to assess areas of
improvement and areas of ongoing vulnerability in our nation's effort
to prepare against bioterrorism and other large-scale health crises. We
found that nearly 75 percent of states earned positive marks for only
half (five) or fewer of the 10 possible indicators.
Some of the most serious shortcomings include:
In December 2003, only two states had achieved full
readiness or ``green'' status with respect to receiving,
distributing, and administering emergency vaccinations and
antidotes from the Strategic National Stockpile. Since then,
another state has joined their ranks. At the same time however,
six states have reportedly regressed with respect to their
stockpile status. Moreover, there is confusion and uncertainty
about the roles and responsibilities of federal agencies,
including the Departments of Homeland Security (DHS) and
Veterans Affairs (DVA) and the Centers for Disease Control and
Prevention (CDC).
Only six states report that they have sufficient
laboratory facilities should a major public health emergency
occur, such as a mass mailing of anthrax, simultaneous release
of sarin gas in U.S. subways, or even a potential outbreak of
plague. These findings build on those of an earlier TFAH
report, Public Health Laboratories: Unprepared and Overwhelmed.
This study found that even fewer state public health
laboratories had the ability to detect chemical weapons in its
citizenry. The Association of Public Health Laboratories
(APHL), found that only eight state public health laboratories
have a chemical terrorism emergency response plan in place.
This observation is even more alarming in light of the ricin
incident on Capitol Hill earlier this year.
There is a serious public health workforce crisis,
including a shortage of epidemiologists and other trained
experts. Rather than recruiting and training a new public
health workforce, which requires a serious investment of time
and money, many states had planned on mobilizing National Guard
personnel in the event of a health emergency to deliver
medicine and equipment from the Strategic National Stockpile.
Yet, as we have recently seen, these troops may be deployed
elsewhere, leaving millions of Americans vulnerable during a
public health emergency. Alternative initiatives, such as using
the U.S. Postal Service, are intriguing, but fail to address
the dire need for more public health professionals. Decisions
about pediatric doses, for instance, need to be made by a
doctor, not the delivery man at the door.
Nearly 66 percent of states, facing budget crises,
have cut funding for public health activities. This seriously
dilutes the impact of the federal government's investment in
bioterror preparedness.
Since TFAH released its report in December, similar national
investigations have confirmed our findings. In February 2004, the
General Accounting Office (GAO) issued a report detailing the
preparedness gaps nationally, including the discovery that no state had
completed all CDC program requirements. Just days ago, the RAND
Institute found that in California--a state that TFAH had ranked as one
of the best prepared in the nation--there was enormous variability in
city and local public health readiness.
What Can the U.S. Do Now to Better Prepare for a Bioterror or Chemical
Terrorism Event?
The American public health community has a solid understanding of
the many actions that should be taken to make our country more safe and
secure. However, achieving a battle-ready public health defense at the
federal, state and local levels will take years of sustained
commitment, funding and oversight.
To stop the hemorrhaging of the nation's public health
infrastructure and to achieve the optimum all-hazards approach to
public health preparedness, TFAH recommends that Congress take the
following actions:
Despite a number of reports suggesting that states are
only modestly better prepared to handle a terrorist attack, CDC
funding for state and local preparedness capacity is in danger.
The Secretary of Health and Human Services has informed the
House Labor Health and Human Service (LHHS) Appropriations
Subcommittee that he intends to redirect $55 million dollars,
that had been allocated previously to state and local
bioterrorism preparedness efforts, to support instead targeted
improvements in 21 specific cities and the U.S Postal Service
Strategic National Stockpile initiative. Under the proposal,
almost every state will sustain a cut of over $1 million. Sec.
To protect all Americans, TFAH believes that there is a need to
increase funding to enhance the readiness of targeted cities, while
maintaining key CDC bioterrorism preparedness programs. However, we do
not believe that the Cities Preparedness Initiative should jeopardize
the health and security of the rest of the nation, especially since
report after report indicates the country is still underprepared. The
House Appropriations Subcommittee on Homeland Security denied a similar
request to reprogram fiscal year 2004 funds away from the Department's
Metropolitan Medical Response System (MMRS), and we hope that the House
LHHS Appropriations Subcommittee will follow suit and continue to fund
the state and local preparedness grants at their appropriated levels
and find additional dollars to fund the CDC's Cities Readiness
Initiative.
In addition, the CDC's fiscal year 2005 budget for
state and local bioterrorism preparedness programs is slated to
receive an 11 percent cut or a $105 million reduction. Even in
this tight fiscal year, Congress must restore the fiscal year
2005 funding; otherwise further readiness efforts at the state
and local levels will be derailed. TFAH recommends that
Congress make a long-term investment in biosecurity and
authorize an independent review to determine whether current
expenditures are sufficient. Experts note that at a minimum,
the nation requires a $1 billion annual commitment for the next
several years in order to achieve the appropriate level of
biosecurity.
To assure that this investment is well-spent, CDC, in consultation
with state and local health officials and outside experts, including
those from other federal agencies like the Departments of Defense and
Homeland Security, must define measurable standards for comprehensive
preparedness that all state and major local health departments should
meet.
The Administration and Congress have addressed
bioterrorism threats by developing and funding innovative
programs such as Bio-Sense, BioShield and BioWatch. TFAH
remains concerned that there is no overarching federal
``BioGame Plan.'' We worry that there are overlapping
jurisdictions, lack of coordination among various federal
agencies, and no plan for intra--and inter-agency training or
rapid deployment of resources in the event of an attack.
Congress should identify a lead agency to develop and oversee a
comprehensive BioGame Plan that clearly delineates the roles
and responsibilities of each federal agency and its state and
local counterparts.
The President, in consultation with Congress, should
convene a White House summit that will develop a concrete
vision for the future of the American public health system and
the resources needed to make it a reality. This summit should
consider how our country can build a robust, integrated public
health infrastructure. TFAH believes that such a summit could
craft a blueprint for a public health system that is designed
to meet both America's current and emerging health threats. The
discussion must include how to develop a public health system
for the 21st century--the summit should address all aspects
essential to public health, such as bioterrorism, chemical, and
radiological preparedness, known and emerging infectious
diseases and chronic disease prevention and control. At the
same time, we believe the summit should foster a long-overdue
dialogue about the resources required to implement needed
changes and guarantee accountability at every level of the
public health system.
Terrorism thrives on uncertainty. We don't know when or where the
next attack might be launched or whether it will be smallpox, Sarin gas
or a small nuclear device. While we must continue to invest in
defensive programs like BioShield, we cannot expect to vaccinate
Americans against all threats unless we have a nimble, highly-trained,
well-equipped public health defense that can rapidly detect, contain
and respond to all health emergencies. That is the team work the United
States needs. That is the team work Americans deserve.
Once again, thank you for allowing Trust for America's Health the
opportunity to contribute to the policy debate on homeland security and
public health. I am happy to answer any questions.
Mr. Shays. We will start out with the Ranking Member of the
committee, Mr. Turner.
Mr. Turner. Thank you, Mr. Chairman.
Dr. Hearne, you certainly articulate one of the greatest
problems that we have in terms of dealing with bioterrorism,
and that is that we don't have the public health infrastructure
to really respond. One of the administration's programs that
was announced in late 2002 was this national effort to
vaccinate 500,000 health care workers for smallpox, and that
was supposed to be followed by the vaccination of 10 million
first responders.
We know we are 18 months away from the announcement of that
program, and neither of those goals have been anywhere near
achieved. I think there is about 40,000 or so people that have
been vaccinated under the program, and there may be various
reasons for it. But bottom line is, do you think we are
prepared to deal with an attack of smallpox in this country? I
know we heard Secretary Thompson say he thought we were
prepared. And are we prepared to deal with an anthrax attack in
this country? And can we distribute a stockpile that they tell
us is out there in the event there is such an attack?
Dr. Hearne. These are challenging issues, and certainly
frightening ones to discuss and talk about. We are better
prepared, and in the event of a smallpox, anthrax, or even an
unexpected event--because that is the reality of terrorism, you
don't know what is going to be thrown over the transom--we have
seen some important improvements.
I do think in the specific instance that you asked with
smallpox, we probably are a bit more vigilant. We would catch
it early, which is really the most critical part of smallpox.
We are not in a position or a policy to be able to vaccinate
the entire country. We must pick it up quickly and do that ring
inoculation, try to squeeze and contain smallpox.
Could we do as good a job as we should? I don't think so. I
suspect we would have far more cases than if we were fully
prepared as we should be, and that is where we need to see
these stronger investments. We don't know where a smallpox
would hit. And while you might want to target certain cities
and heighten that capability, the reality is we need to have
that vigilance across the board and improve our ability to
rapidly respond at all levels in this country, and that has not
been a priority and a response that we have seen yet today at
the level that we would like.
Mr. Turner. So is the answer yes or no? Could we respond
adequately? Are we anywhere close to being adequately prepared
to deal with even anthrax?
Ms. Hearne. We are better prepared for anthrax. You want a
yes or no? Not yet. We would do our best, and it would be
certainly better than it was pre-9/11, but it is not as good as
it should be.
Mr. Turner. Do you have any indications that the
administration is going to request the kind of funding that you
believe would be necessary to get us prepared to deal with
either anthrax or smallpox?
Dr. Hearne. Let me make a very important point. Public
health probably is the weakest link in homeland security today,
and public health has also been the Cinderella issue of this
country for over 20 years. This has been benign neglect,
really, by many administrations. And recently this has been the
most critical investment that we have had in public health in,
as I have noted, decades.
Is it enough? No. And part of the issue is that it needs
both a sustained and long-term commitment, but it
simultaneously needs to have a much better set of performance
measures and accountability so that people can be in a better
position to answer those questions that you are asking, Mr.
Turner, are we better prepared, where are our gaps, and what do
we need to do? And that comes with not just money, but it also
comes with the accountability metrics that are long overdue.
Mr. Turner. Dr. Winegar, is project BioShield an adequate
response to the bioterrorist threat?
Dr. Hearne. It is one piece of the triad here. You know, as
my testimony was pointing out, the ability to have drugs as a
countermeasure are invaluable, but without the ability to
deliver or have the brains at the head of the system that can
both pick up an event and can rapidly determine who needs what,
how to cover our population, it really doesn't matter what
drugs you have, because those will be wasted countermeasures
without the ability to do right and adequately protect the
public's health.
Mr. Turner. Dr. Winegar.
Ms. Johnson-Winegar. I agree that certainly BioShield is
one component of an overall strategy, but as a stand-alone
effort, it is not enough. And I wanted to reiterate the comment
that I made before. I still think that there is a gap between
the work that is going on as basic research and the procurement
of items, and, as I have understood the legislation, that
indeed is procurement of items that are not licensed but that
have the potential to be licensed. And I think that that is
where there is a large gap that really needs to be addressed.
And that is the appropriate types of animal models and the
appropriate clinical trials that, if necessary, address
pediatric populations, elderly populations, populations with
individuals who have an immuno-compromised system or other
health problems that may prevent them from taking a vaccine
that may be perfectly acceptable for normal healthy people in a
limited age range.
So I think it is a step in the right direction, but as a
stand-alone, it is certainly not the end-all, be-all.
Mr. Turner. Thank you. Thank you, Mr. Chairman.
Mr. Goodlatte. [Presiding] I thank the gentleman.
It is my pleasure to recognize the gentleman from
Connecticut Mr.Sec. ays.
Mr. Shays. Thank you very much. I want to thank both of you
for being here. Dr. Hearne, it is, I think, a very important
statement that you made that you said public health is the
weakest link in our war against terror, and I just hope that
that doesn't get lost on people.
I want to know, Dr. Winegar, if you agree as well. You no
longer work for Defense now. You can be totally candid.
Ms. Johnson-Winegar. I have always tried to be candid with
you, sir.
Mr. Shays. But you have no restraints, there are no
restraints?
Ms. Johnson-Winegar. I think public health is one of the
major elements of a comprehensive defense. To say that it is
the weakest link is perhaps a bit further than I would like to
go. And I would like to say that the whole area of biodefense
has been the ugly stepchild for many years. I personally fought
many, many battles within the Department of Defense to try to
get us a sufficient amount of funding, and while we all know
that funding isn't the total answerSec.
Mr. Shays. But given what you said, it is the ugly
stepchild, so is there anything more ugly? I mean, is there
another issue--the weakest link means it is the weakest link.
It may be relatively good or not, but it is the weakest link.
What do you think is the weakest link if it is not this?
Ms. Johnson-Winegar. I think intelligence is the weakest
link.
Mr. Shays. Okay, fair enough. Well, we have identified two
pretty weak links. Okay. And thank you for that answer.
I want to ask both of you how you have the capability to
match the threat. And before you respond to that, I want to
know if you believe bioterrorism is a legitimate concern that
our country needs to defend against. We will just keep going
back and forth. I will start with you, Dr. Hearne.
Dr. Hearne. Absolutely, it is a significant concern. We
have already had a number of reminders of that. While they have
not been major events, I don't think anyone on thisSec.
Mr. Shays. So the bottom line is yes?
Dr. Hearne. Yes.
Mr. Shays. And, Dr. Winegar?
Ms. Johnson-Winegar. Yes, I agree.
Mr. Shays. Do you believe that we are matching--I think I
know the answer to this--is the capability matching the threat?
And I think both of you have said no, but let me ask this
question: Does that say to you that this needs to be more than
a 9:00 to 5:00 effort or an 8:00 to 6:00 effort, that it may
need to be, you know, 24 hours a day until we get to at least a
certain level?
And I will start with you, Dr. Hearne.
Dr. Hearne. You are probably starting with me because I am
nodding my head vigorously. Absolutely it should be 24-7. We
had that lesson with public health agencies. People would call
on a Friday evening to report a possible case. There was no one
answering the phone. That has been a major change since 9/11.
We have gotten our agencies up to 24-7, response capability,
but simultaneously we are actually hearing stories now that
with budget cuts both at the State and Federal level and also
at some of the local entities, those actual 24-7 response
capabilities are being threatened.
Mr. Shays. But how about the capability for making sure
that we have the antidotes to certain biological agents?
Dr. Hearne. The Strategic National Stockpile has enormously
expanded and improved our ability to have readiness on that
scale. The issue is with the stockpile being ready, are the
States ready to receive those materials and do the distribution
that would be needed in a major event.
Mr. Shays. Well, we had testimony that said we are 2 to 3
years away, and under a really significant event, we may be 4-
plus years away. So should we just decide that should be the
time schedule, or should we speed it up?
Dr. Hearne. We absolutely could speed this up, and it is
really an issue of going back to my premise that this has been
the weakest link, that it has been the Cinderella agency in
most States. It has not been a priority. And given if this were
put up higher on the radar screen and given the top level of
commitment by key policymakers, you could turn around these
gaps in a very rapid time period.
Mr. Shays. Thank you.
Dr. Winegar.
Ms. Johnson-Winegar. I absolutely agree, and while some of
the comments that were made earlier on how fast a particular
research project can proceed are constraints on time, I too am
quite dismayed by the long periods of time, and I would like to
go on the record as saying that my estimate of when we will
have sufficient antidotes for clostridium botulinum is in the
10-plus years away.
Mr. Shays. Nine was what I had heard, and I was surprised
that we were being told less. One of the dangers in the
Department is they want people not to be afraid, but my view is
since September 11th, we need to make sure that people are told
the truth, and particularly Members of Congress so we are not--
I am just interested--was I given 5 or 8 minutes? Ten minutes.
Would you mind if I had 1 more minute? Do you need to get a
plane?
Mrs. Christensen. Go ahead.
Mr. Goodlatte. Without objection, the gentleman is
recognized.
Mr. Shays. I wanted to just ask that last question, which I
forgot. And it was my wrap-up question. So thank you. Just
totally forgot it. Thank you for your kindness, Doctor.
Mr. Goodlatte. I thank the gentleman.
It is now my pleasure to recognize the gentlewoman from the
Virgin Islands.
Mrs. Christensen. Thank you. I will see if I can get
through this quickly, and then maybe Chris will remember his
question.
But thank you for being here and for bringing the message
that you bring, because we need some echoing of that message
every time we talk about health and biodefense.
You know, I am concerned about the shifting of the funds
from our everyday needs in public health to homeland security,
which is obviously a priority and we need to ensure that we
have the proper defense preparation, the ability to respond to
bioterrorism. But the funding for public health preparedness in
bioterrorism usually means--it has begun to mean taking away
from some of the other functions. And given these concerns and
our experience up to date, isn't it possible to not shift but
make bioterrorism funding really dual use? What would either of
you say about that and the approach that we should be taking?
Dr. Hearne. Ideally, if we are smart on these investments,
we do create a system that is all-hazards approach, whether it
is a terrorist event or Mother Nature throwing the unexpected
at us, like SARS, like avian flu. You don't know what is going
to hit, but they can all be of equal consequence.
You need to make sure that those investments are there,
and, unfortunately, we have been shifting dollars, so that
while we cover one flank, we are leaving our other exposed and
quite vulnerable to unexpected events.
We are hearing stories all across the country of things
like restaurant inspections. It may sound real sexy, but one
that could be a form of food agricultural terrorism. But, two,
it is a major event that goes on in this country that is
preventable; and that is the bottom line if public health does
its job. It is keeping people from getting sick in the first
place, whether it is bioterrorism or those other everyday
health risks.
One of the things that we ask is we shouldn't be robbing
Peter to pay Paul here, and the cities initiative isn't a very
important one. I don't mean to take anything away from it. It
is just that we shouldn't be taking money from one place to the
other when they are both underfunded as currently seen.
What in fact I think we really need to do here is stop for
a moment and really take a look at we have not modernized our
public health system really since the day it did its job back
in the 1800s in stopping cholera and typhoid and yellow fever.
Those were extraordinary investments that made a difference.
We are in a very different place today. We have got very
different sets of threats. Anthrax or asthma, chemical weapons
or cancer. We actually could have a much smarter public health
system that could do its job in preventing all of those
diseases much more effectively with probably not huge amounts
of dollars, but we haven't set it up that way.
And in fact, one of the recommendations that we have in
this report here is calling on Congress and the administration
to host a national summit on modernizing, creating that 21st
century public health defense, because there isn't a lot of
money out there. But we could be doing a lot more, a lot
better, smarter, safer, swifter, and we just need to take that
time out and figure out how to put those pieces together,
because there is a win here. We are just keeping it off the
radar screen.
Mrs. Christensen. Did you want to add anything?
Ms. Johnson-Winegar. I certainly agree with those points,
and I would like to call your attention to the fact that many
of the things that are on the threat list or thought of as
bioterror agents also occur in other ways, and I will go back
to Congressman Shays' example of botulinum toxin. Botulinum
toxin is found in food poisoning, and we need to leverage what
we have learned about treating those types of cases and
diagnosing them and apply that to the use of the toxins as a
biothreat. Now, of course there are going to be differences,
but I think there needs to be a much greater collaboration and
leveraging of the work that is done in the endemic disease, the
emerging infectious diseases, with those things that are in the
bioterrorist realm.
Mrs. Christensen. Thank you. You know, when we visited
several sites around the country and talked to first
responders, several who had done exercises in responding to a
simulated terrorist threat, we didn't find that public health
and hospitals were really fully a part of the first responder
team, and I was wondering what are you seeing.
Dr. Hearne. That may be one of the areas of most
improvement out there. We hear across the board that for the
first time ever, public health leaders know who their
counterparts are in Homeland Security, in law enforcement, even
EMS, which is a little surprising, you would have thought.
Clearly, though, there is also room for improvement. We
have been hearing surprising reports. The RAND Institute, for
instance, just put out a report a few days ago that looked
intensively in California and actually found that public health
departments knew their minority populations less than the
police departments.
Now, what was interesting--we can take that a little
further, but one of the things that was coming out of that is
that public health has actually not been as engaged with
disadvantaged populations as it could be and should be and
particularly in the event of a bioterrorism outbreak, that the
lack of those connections to key populations may be a
significant problem.
So while there have been some very interesting new
connections being made, some of the basic arenas that public
health has been presumed to be doing well actually need to be
improved.
Mrs. Christensen. Thank you. And I thank you for alluding
to the issue of minority populations, which I am sure you know
is one of great concern to me.
Thank you, Mr. Chairman.
Mr. Goodlatte. I thank the gentlewoman, and it is my
pleasure now to recognize the gentlewoman from Texas, Ms.
Jackson-Lee.
Ms. Jackson-Lee. I thank the distinguished Chairman, and I
thank the committee for this hearing. I laid out a scenario in
the previous panel, just to suggest that all of us can do well
by taking what we are doing more seriously, and I appreciate
the work of both of you on this issue and the years of
commitment.
My relaying of the anecdotal story regarding the
pronouncement of the Attorney General was just to suggest that
I think that 99.9 percent of Americans went about their daily
business; and it is twofold, probably a tribute to how far we
have come and what Americans believe we have done on their
behalf. And maybe the other point is the lack of completeness
in understanding of how much more we need to do.
So I think these hearings are important, because if
Congress has any role it is oversight, and sometimes our
oversight is not pretty. It has to be probative. It has to be
provocative. And I say that because I want to compliment the
Texans who were engaged in the work of dealing with the
tularemia, and I don't want to take anything away from them,
because Texas certainly has the advantage of having the likes
of the Texas Medical Center. But also there are rural aspects
of Texas that are not connected to such a fine network that is
found maybe in Harris County, Houston, Austin, where the head
of the Department of Health is, and of course connected to the
Texas Medical Center.
So here is my point of questions, and I want to use, Dr.
Hearne, your statement, and I would welcome the input of both
of you. But my question goes back to the example of smallpox
and the fact that we need to have--if we use that as an
example, if I understand, you are suggesting that we need
public health officials. We need to have astute clinicians to
notify public health officials, or disease surveillance systems
capable of detecting possible smallpox. We need labs that can
rapidly test to confirm smallpox cases. We need deployment of
rapid response teams who can deduce, and we need a working
pharmaceutical network as well.
There are many elements that I am concerned that, although
good intentioned and we have made progress, I want to be
provocative, I want to be piercing, because we will have no
time to be that in time of crisis, and I do believe that we are
still geared to looking for the airplane coming into our
neighborhood. And we hear the word bioterrorism, we hear the
word radiological attack or a chemical attack. I am not sure if
we fully comprehend. And if we comprehend it in Texas, if I
might use this as a laboratory, it is only because we live with
refineries, and we live in what has been labeled the oil
capital of the world. We have lived with natural gas and oil
for many years. We have lived with our refineries and their
fires, but no one can comprehend what it means to release a
dirty bomb. No one can comprehend a purposeful attack on those
refineries, short of an accident which is what you are used to.
So what I am trying to determine, we have made advancement
in legislation that was passed soon after 9/11. We are now
dealing with BioShield. I am not comfortable in even what we
have gotten out of this hearing, with all due respect and
appreciation of our fine public officials in Washington. I am
not comfortable that we have a circumstance, if you will,
that--or a set of circumstances that really have given us
standards, has a network that is connected. Maybe I am
connected in the fourth largest in the Nation. I am lucky, but
I might be not be connected in a poor neighborhood in the
fortieth largest city in the Nation, and I may not be connected
50 miles down the road, which turns rural as soon as you leave
outside of the borders of Houston, you are in rural Texas.
So if you can give me the bad news and the roadmap to get
from the bad news to where we are--and I know that some members
already asked that--that would be helpful to us, because I just
think that we are treading light waters and being polite. And
let me just say, not criticizing any of the witnesses, because
you have been forthright, but give us a roadmap of where we
need to be going and who we need to be touching on these
issues.
Dr. Hearne. It is hard sometimes to tell the truth. Mr.
Turner was trying to get me to say, yes or no, are we prepared?
I don't particularly like sitting in this hot seat, having
to--.
Ms. Jackson-Lee. We will give you immunity. How about that?
Ms. Hearne. If only it would cover smallpox and--here's the
reality. We have a long ways to go. Your home State, Texas, if
I remember right, scored 4 out of our 10 indicators. You can go
back and take a look at where those gaps are, and there is a
lot of work to be done in Texas, things like there is not
sufficient laboratory capacity, there aren't enough workers. In
fact, the budgets have been severely cut of the Texas Public
Health Department. They tried to shut down their cancer
registry and their birth defects registry. Birth defect is the
number one cause of infant mortality in that State. That is
just an example of the challenges that have been going on in
that health department, let alone having to think about
bioterrorism. It is not pretty what has been going on on a lot
of these fronts, and it is an issue of priorities and care.
But your question, in part, was you play the role of
oversight and your job is to ask those tough questions and to
make sure things are being covered that people may not always
want to talk about.
Well, one of the issues, to push back to the table of the
panel before, of Federal authorities was where are those
measures accountability. Dr. Raub mentioned, as an example,
they had a metric of 1 epidemiologist per 500,000 people. Well,
they have never actually collected that information. HHS and
CDC does not know if there are now 1 epidemiologist per
500,000, and in fact the benchmarks that HHS were producing
aren't the ones that CDC are going to put out, but CDC still
hasn't put it out and we are 3 years out in this bioterrorism
program.
Accountability has not been the strongest suit of these
types of issues, and it actually has been one of the benefits
of Homeland Security's partnership with HHS, is that it has
brought a greater sense of urgency and push for accountability.
But I actually think that this would be just the type of issue
to turn back to Congress and say where are those measures, how
are we matching up? And the reality is our group put out this
report on its 10 indicators, because we were filling a gap to
answer just the questions we were getting in every office on
the Hill of, well, so how better off are we, and is our job
done? Because many people do believe with this important
investment that has gone on the last few years, that we are
taken care of. But the reality is we have a very long ways to
go. But we have not set up what are those targets, what are
those benchmarks, and what does every citizen in this country
have the right to anticipate in terms of the protections and
preparedness that they should have.
So I in some ways would appreciate to turn that back to
Congress and to have that oversight role. It would be extremely
helpful, because I think there are some significant cultural
quality changes that need to take place in how we do health
protection, and I am talking about the public health side in
this country which has not had oversight, and it hasn't had
really anyone caring about it before. And that is long overdue.
Ms. Jackson-Lee. So your solution, or at least your
suggestion, is that we intensify our oversight hearings and
begin to probe into the State's structure or begin to probe HHS
as to the accountability standards? Because I guess I am still
looking for the list of accountability standards. Can someone
point to me, can I go to the Web page, can I go somewhere and
see their accountability standards, besides the very fine work
that you have done? Does the government have an assessment on
Iowa or Georgia or Mississippi or Texas or New York in terms of
where they are? And then say categorically, you know what, they
are at zero; they are not even talking to each other; we have
got emergency relief for that State that is at zero, because
that is where homeland security is?
Dr. Hearne. No.
Ms. Jackson-Lee. That is--.
Dr. Hearne. Soon to come. But we have been hearing that for
over a year now. There are benchmarks of expectations, but
there are not performance standards set yet. CDC is in the
process right now of--after several iterations, is trying to
develop those performance standards. It is currently piloting
those performance standards in, I believe, five States and
hopes to roll them out soon; but, again, we are at a point
where the States are waiting on their 2004 guidance and still
hasn't gotten it. And we are here in June of 2004.
Again, let me just--just to give a sense, public health is
not rocket science. There are some very basic things that we
have been doing since the 1800s but we are just not doing very
well anymore. To set those benchmarks is critical but we need
to have the impetus and energy and push to make sure that we
are achieving those and that that accountability and commitment
to hitting those marks are there.
Ms. Jackson-Lee. Thank you. So oversight is crucial. Thank
you.
Chairman Cox. [Presiding] The gentlelady's time is expired.
Dr. Hearne, Dr. Johnson-Winegar, I just have one question for
each of you. Dr. Hearne, earlier we went into BioWatch; the
BioWatch program, to oversimplify, starts with EPA collection,
moves on to CDC analysis, and then, if necessary, to FBI
investigation. There are other moving parts, but that is the
superstructure.
And I want to ask whether, Dr. Hearne, you think that this
is an appropriate role, particularly assuming that it grows in
terms of scope and complexity for EPA.
Dr. Hearne. I should probably confess my training is
actually as an environmental toxicologist.
Chairman Cox. Your focus on these areas is the reason I ask
you this question.
Dr. Hearne. One of the problems that we have right now in
this arena is that there are many different agencies, many
different programs evolving, developing, and unfortunately
there is an enormous lack of coordination and clear
authorities.
This is one of those areas that both has the challenge of
where it fits, but I also would raise the issue of the concerns
of the investments in BioWatch, in part that many people from
the laboratory community have grave concerns about, is the best
investment given the high rate of false positives and that the
technology is not particularly accurate and ready to be rolling
it out, because the number of false positives activate a very
expensive and very costly response mechanism. And so one of the
challenges has been that each time a sensor picks up a
potential hit, its disconnect with the public health community
starts and activates a very large response that overwhelms the
system.
It is not working particularly well right now, and it is an
issue that needs to be given more thought and more counsel, in
part because we hear from so many points in the public health
system about their concerns on BioWatch.
At the same time, this is the challenge; we need to have
these new technologies but as currently configured, BioWatch
does not appear to be a highly effective program.
Chairman Cox. Given that the program itself has its own
challenges--and take that as a given--is the structure of it,
with EPA as collector, an appropriate structure from EPA's
standpoint?
Dr. Hearne. Well, I am sure EPA would say yes. Given--those
were all systems that were originally designed and are still
being used for air monitoring systems across the country for a
set of air pollutants that EPA is actually by law required to
be collecting.
So those are units that are already in place throughout the
major metropolitan areas collecting information. It is an idea
that is smart in terms of it is building on an existing
infrastructure rather than trying to reinvent the wheel. So, as
such, it makes sense that it has been built on EPA.
The problem is it has been done in a vacuum from the public
health and responders who need that information.
I guess it comes back to really the issue I brought up
before of we probably need to take that time out and take a
look at how all these different pieces most effectively can
work together and how we can have a smart and strategic public
health response rather than piecemeal parts spread out across
the jurisdictions.
Chairman Cox. Thank you, Dr.Sec. arne.
Dr. Winegar, I want to ask you with respect to bioterrorism
research in general what you think is the appropriate role down
the road for DOD, and how do we ensure that the expertise that
is resident within DOD is integrated with all else that is
going on, that it is not lost in this process? And what do you
see as the primary role for the Department of Homeland
Security, given that they won't be doing basic human health
research?
Ms. Johnson-Winegar. Well, as was mentioned earlier, I
think there is a role for everybody to play. DOD has
traditionally been the leader in the area of biodefense and
bioresearch. And while the individual scientists working at the
bench probably can do equally good work for the Department of
Homeland Security or the Department of Health and Human
Services as he or she can for the Department of Defense, it
would certainly help everyone, I think, to have a consolidated
approach and clear leadership in the area. And I fear that what
we have right now is fractured leadership, with the Department
of Homeland Security having the lead in some areas while
deferring the lead to HHS in the areas of medical
countermeasures and then HHS needing to collaborate and
communicate with DOD.
It is very confusing to the researcher in the field,
whether they are in academia or private industry: Do I go to
talk to Homeland Security, do I go to talk to NIH, do I go to
talk to the DOD? And basically what is happening is that people
are making the rounds and going to all of those agencies and
waiting for somebody to step up and say, yes, this is what we
are going to do; or, no, this is not what we are going to do.
It is confusing to the public and to the research community at
large, I feel.
Chairman Cox. And if you were free yourself to heal the
fracture, who would be in charge?
Ms. Johnson-Winegar. I think it has to be at some level
above all the departments, and so that in my mind clearly
points to the Homeland Security Council or the White House or
some other body that sits above the individual departments.
Chairman Cox. And is that true for operational decision
making as well?
Ms. Johnson-Winegar. I think that is important, yes,
because there are individual components that each of those
departments will be asked to execute, and they can't do that in
a vacuum. And while I will agree that they are making progress,
they still need some leadership in that whole area, I think.
Chairman Cox. So if I understand your testimony, you would
recommend that the Homeland Security Council be given line
management authority over all of these Cabinet departments?
Ms. Johnson-Winegar. At least for the interim, until things
are more established. And I think, in addition, the Homeland
Security Council needs to be augmented. It is my understanding
that in the whole area of bio, you can count the number of
people on one hand.
Chairman Cox. All right. I appreciate very much your
straightforward answers to my questions and appreciate very
much your expert testimony to our panel, and with that, I would
excuse this panel and adjourn our hearing. Thank you very much.
[Whereupon, at 4:15 p.m., the committee was adjourned.]
A P P E N D I X
----------
Material Submitted for the Record
Questions for the Record from Ranking Member Jim Turner for Dr. Penrose
C. Albright's Responses
National Biosecurity Analysis and Countermeasures Center
1. What is the mission of the National Biosecurity Analysis and
Countermeasures Center?
Response: The National Biodefense Analysis and Countermeasures
Center (NBACC) is the name of a facility proposed to be located at the
National Interagency Biodefense Campus at Ft. Detrick, MD.
NBACC will provide the nation with the scientific basis for
awareness of biological threats and attribution of their use against
the American public.
NBACC will be comprised of two centers to execute this mission:
The National Bioforensic Analysis Center (NBFAC) will
provide national capability to conduct forensic analysis of evidence
from bio-crimes and terrorism to attain a ``biological fingerprint'' to
identify perpetrators and determine the origin and method of attack.
The Biological Threat Characterization Center (BTTC) will
conduct systematic and rigorous research to understand current and
future biological threats, assess vulnerabilities, and determine
potential impacts to guide the development of countermeasures, such as
detectors, therapeutics, vaccines, and decontamination capabilitities.
NBACC is part of the Department of Homeland Security's (DHS's)
integrated national biodefense complex consisting of Plum Island Animal
Disease Center (PIADC); two University Centers of Excellence, the
University of Minnesota's National Center for Food Protection and
Defense and Texas A&M University's National Center for Foreign Animal
and Zoonotic Disease Defense; and the Biosecurity Knowledge Center
(BKC). Since Dr. Albright's testimony, the BKC has been established at
Lawrence Livermore National Laboratory to serve as a national data
resource network enabling information sharing and threat and
vulnerability analysis, including results of research conducted at the
NBACC facility.
2. How does it fit into the ``Biodefense for the 21st Century''
strategy announced by President Bush in April?
Response: The Presidential directive Biodefense for the 21st
Century (HSPD-10) outlines four essential pillars of the nation's
biodefense program. The four pillars are: threat awareness, prevention
and protection, surveillance and detection, and response and recovery.
The Department of Homeland Security has a role and responsibility in
each of these four pillars of the national biodefense program.
The two programs executed at NBACC will directly or indirectly
support each pillar.
The National Bioforensic Analysis Center was specifically
designated in Biodefense for the 21st Century as ``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 appropriate lead Federal agency.''
The Biological Threat Characterization Program will provide the
scientific basis to characterize biothreats as called for in the Threat
Awareness section of President Bush's directive which states, ``We are
building the flexibility and speed to characterize such (biological)
agents, assess existing defenses, and rapidly develop safe and
effective countermeasures.''
3. How will NBACC interact with the intelligence community? Will
the NBACC and the CIA develop concurrent threat assessments? How will
conflicting assessments be prioritized?
Response: The primary conduit for NBACC interaction with the
Intelligence Community is through the Information Analysis organization
within DHS's Information Analysis and Infrastructure Protection (IAIP)
Directorate.
While NBACC's mission is not to produce intelligence assessments,
NBACC will support the intelligence community by conducting scientific
studies and analyses to address gaps in our knowledge of current and
future biological threats. As appropriate, NBACC will also work with
operational directorates within DHS (such as those within IAIP) that
are responsible for disseminating vulnerability data and best practice
information to industry and to members of the protective community.
4. Which agency will be ``in charge'' of developing bioterror
threat assessments?
Response:
As described in Biodefense for the 21st Century, the Intelligence
Community is directed to ``collect, analyze, and disseminate
intelligence.''
NBACC will support this mission by providing science-based analysis
for characterizing the threat, assessing vulnerabilities, determining
potential impacts, and attributing their use.
Plans for the NBACC include conducting science-based threat
assessments of current and future biological threats. Center activities
might include determining the feasibility of genetic manipulation of
microorganisms to make them more harmful, and simulated ``red teaming''
or table top exercises using bioterror scenarios.
5. Can you provide us with a succinct list of activities that will
occur in NBACC laboratories, including those associated with ``science-
based threat assessment''?
Response: The programs conducted at NBACC will provide knowledge of
infectious properties of biological threat agents, potential means of
employment against our nation, effectiveness of countermeasures,
decontamination procedures, and forensics analyses so policy makers and
responders can use this information to develop policies, programs and
technologies to deter or defend against future attacks and save lives.
The Biological Threat Characterization Program will focus on:
(1) Developing systematic and rigorous methodology for risk
assessment of biothreats.
(2) Conducting targeted research and laboratory studies to
address specific knowledge gaps.
(3) Investing in infrastructure and procedures to support long-
term biodefense programs.
6. Will this work involve the study of genetically-engineered
pathogens and techniques for making existing pathogens resistant to
antibiotics and vaccines, more virulent, or otherwise more dangerous?
How will this work be overseen to ensure it does not violate our
international treaties against biological weapons or pose a safety
concern?
Response: The national biodefense effort across the U.S.Government
is focused on understanding the potential impact of and defense against
a terrorist use of biological agents.
The Biological Threat Characterization Center's mission is to
provide science-based analysis for characterizing the threat, assessing
vulnerabilities, and determining potential impacts to guide the
development of countermeasures. Research and laboratory studies will be
targeted to address specific knowledge gaps. This may include directed
studies to evaluate the potential consequences of specific genetically-
modified pathogens that exploit resistance to antibiotics and vaccines.
All work conducted by the BTCC will be for defensive purposes, as
permitted by the Biological Weapons Convention (BWC), and will be
consistent with existing U.S. policy and law.
The BWC compliance review process will be transparent within the
U.S. Government and coordinated with other Federal agencies, including
the Department of State to assure appropriate international authorities
are advised of BTCC activities as they become relevant to international
interests. In addition, criteria developed by the National Science
Advisory Board for Biosecurity, and will be considered as appropriate.
The Department of Homeland Security is developing formal processes
to review critical aspects of proposed projects for the BTCC, including
technical, safety, ethical, policy, and legal issues. This includes
plans to engage a standing committee within the National Academy of
Sciences to advise on the technical and scientific aspects of its
programs.
According to the Homeland Security Act, HHS is to work
collaboratively with DHS as it sets goals and policies for medical
countermeasures development. You have indicated in your testimony how
this is occurring. DHS is also working with USDA on developing
veterinary medical countermeasures to counteract agroterrorism.
7. Can you describe the difference between how these two inter-
agency countermeasures research programs are managed, and whether one
is working better than the other?
Response: The management for both medical and agricultural
countermeasures share a common programmatic framework, as strategic and
budget planning for both programs is the responsibility of the
Biological Countermeasures Portfolio within the Science and Technology
(S&T) Directorate of DHS. S&T also has a major role in inter-agency
coordination, which includes efforts in a number of venues that were
mentioned in the testimony before the committee (e.g., several Homeland
Security Presidential Directives, Counterproliferation Technology
Coordinating Committee, WMD-Medical Countermeasures Committee, National
Strategic Plan for Homeland Security Science and Technology, etc.).
Implementation and execution of individual program elements in S&T is
the responsibility of either the Office of Research and Development
(including NBACC, national laboratories, University Centers of
Excellence), the Homeland Security Advanced Research Programs Agency
(competitively awarded programs to the private sector, federal
laboratories, and universities), or the Systems Engineering and
Development (e.g., operational programs such as Bio-Watch).
The principal difference between how the two inter-agency
countermeasures programs are managed is an operational difference. As
specified by the Homeland Security Act of 2002, DHS S&T assumed
responsibility (`facilities and liabilities') for the Plum Island
Animal Disease Center in June 2003, and collaborates with the U.S.
Department of Agriculture (USDA, Agriculture Research Service, and
Animal and Plant Health Inspection Service) on a joint strategy for the
study of foreign animal diseases (e.g., foot-and-mouth disease). DHS
S&T and the Department of Health and Human Services (HHS) collaborate
on determining medical countermeasures but DHS S&T does not have
operational responsibility for any biomedical facility.
Both collaborative programs are working well in accordance with
each agency's roles and responsibilities; there is no basis for stating
`whether one [relationship] is working better than the other.'
According to the Homeland Security Act, HHS is to work
collaboratively with DHS as it sets goals and policies for medical
countermeasures development. You have indicated in your testimony how
this is occurring. DHS is also working with USDA on developing
veterinary medical countermeasures to counteract agroterrorism.
8. Can you describe the difference between how these two inter-
agency countermeasures research programs are managed, and whether one
is working better than the other?
Response: Question 8 in the original transmittal of these Questions
for the Record is a duplicate of Question 7 which has been answered
above.
9. How do threat information and vulnerability assessments
collected by DHS influence the research agendas, if at all?
Response: Threat characterization is an integral part of the S&T
strategic planning process. This strategic planning process is informed
by threat and vulnerability information available through the
Intelligence Community, law enforcement, and other sources. S&T uses
this threat information to identify knowledge gaps, against which
research, development, test, and evaluation (RDT&E) needs are
prioritized and translated into program execution strategies to fulfill
operational end-user requirements.
For example, in the biological countermeasures area, S&T is leading
a Biothreat Characterization Program for DHS, which will develop
methodologies for a quantitative risk assessment process to understand
biothreats, to perform targeted studies to address specific knowledge
gaps, and to invest in infrastructure and procedures to support
biodefense programs. The Biodefense Knowledge Center supports the
Biothreat Characterization Program by collecting biodefense related
information and expertise that is accessible on short time frames for
immediate response, and longer time frames for strategic analysis and
assessments.
The S&T Directorate is also engaged in understanding the broader
threat environment. One new effort, denoted all-Weapons of Mass
Destruction (WMD) Capability Assessment, is collecting and
disseminating information on the capabilities of various terrorist
groups, both state and non-state, to develop and deploy chemical,
biological, nuclear, radiological, cyber, and explosives agents. This
type of information will have a direct effect on establishing the
research and development agenda of S&T.
A second activity, known as the Nuclear Assessment Program and
transferred to DHS from the Department of Energy, has been analyzing
communicated nuclear threats since 1977 for such agencies as the
Federal Bureau of Investigation. Such information is now being used by
our Radiological/Nuclear Countermeasures portfolio to help guide its
research agenda.
10. Are NIH researchers and program managers given access to this
threat information or allowed to set their own research agendas based
on this information?
Response: Upper level NIH management, selected program managers,
and selected researchers with appropriate clearances and the need to
know are given access to threat information through a variety of
mechanisms ranging from interagency working groups to various threat
briefings. Examples of these interagency working groups include the
Homeland Security Council/National Security Council-led BioDefense End-
to-End Study and Counterproliferation Technology Coordinating Committee
Studies, and the Weapons of Mass Destruction Biomedical Countermeasures
Committee, a working group comprised of the Office of Science and
Technology Policy, Health and Human Services, Department of Homeland
Security, and the Department of Defense. This classified information,
along with unclassified but highly relevant information on current and
future threats, is then distilled by NIH management into an
unclassified research strategy and priorities. This strategy is
published to guide the activities of the broader NIH research
community. For additional details on the process NIH uses to
established research strategies and priorities, please contact NIH
directly.
11. Right now there is no treatment for ricin exposure--once
someone is exposed, they will die. And yet recent experience has shown
that it is relatively easy to gather materials and transmit the toxin
around the country. This is arguably a more serious threat than anthrax
because at least anthrax has a vaccine and a course of treatment. So
who has looked at this and determined it's not important to invest in a
ricin treatment? How is this decided?
Response: Actually, there has been work done on developing a
medical countermeasure for ricin exposure. The DoD completed efficacy
studies in rodents on recombinant ricin toxin A-chain vaccine
candidates and down-selected a lead candidate and an alternate. The
Joint Science and Technology Office for Chemical-Biological defense
predicts that a ricin vaccine candidate will be ready for transition to
advanced development in FY 2006.
It seems that thus far our biodefense strategy has largely been
driven by the nation's vulnerability to a mass-casualty attack, such as
terrorist use of smallpox or a large airborne anthrax release. This is
reflected in the categorization of agents on the A, B, and C priority
pathogen lists from Centers for Disease Control--with smallpox and
anthrax on the A list.
However, the anthrax letter attacks in October 2001 suggest we may
need to pay attention to small- and medium-sized attacks, too. The
Congressional Research Service has done such an assessment, and,
interestingly, anthrax and smallpox were not at the top of the list.
Instead, they determined glanders was the top concern, currently a
category B agent.
12. Are you aware of this assessment, and, if so, what do you think
of it? Does the current priority listing of pathogens need to be
reassessed? Has it been reassessed? Who would be responsible for such a
reassessment and when and how will it get done?
Response: Yes, we are aware of the Congressional Research Service
(CRS) assessment. We agree that small and moderate size biological
events also pose threats. However, more work would be needed to
determine if the current priority listing of pathogens should be
changed. As the CRS authors note on p. 53 of their study ``The approach
taken here is not the only valid approach, and different results may
occur if different criteria and weighting systems are chosen.'' Also,
an integrated national strategy must seek the difficult balance of
responses and associated resource investments against the range of
threats--from small scale events with more limited consequences to
moderate-to-large scale events with extensive consequences. Efforts to
date have been guided by threat prioritizations done by the Centers for
Disease Control and Prevention (CDC), the Department of Defense (DoD),
and the Intelligence Community. Threat lists are not static and should
be periodically reassessed to take into account new intelligence
information, advances in science and technology, and changes in
vulnerabilities and defensive concerns. Several such assessments are
currently ongoing. The CDC is reassessing its threat priority list and
DHS is conducting formal `material determinations of threat'' as part
of the BioShield process.
In addition, DHS is required to provide a formal risk assessment
every two years with the first due no later than January 2006. This
will be a structured review process involving a broad range of
intelligence experts, scientific experts, and analysts with `vetting'
before a still larger community.
Project Bioshield requires the Secretary of Homeland Security to
make a Material Threat Determination before a countermeasure can be
purchased. Such a determination process is now underway. The Secretary
of Health and Human Services then determines how the threat should be
addressed medically and whether an existing countermeasure program
qualifies for a contract.
13. What is the process for making a material threat determination?
How many have been completed to date?
Response: Material threat determinations are conducted by DHS to
determine major threats as part of the BioShield process. These
determinations draw on: available intelligence analysis of the intent
and capabilities of potential threat organizations; on technical
assessments of acquiring, producing, and disseminating the agents; and
on systems analyses of vulnerabilities, potential attack scenarios, and
resulting consequences of plausible attacks. These studies involve the
relevant experts across the intelligence, scientific and analysis
communities. To date, material threat determinations have been
completed for anthrax and for botulinum toxin.
Anthrax Vaccine
14. What is the justification for a new anthrax vaccine (rPA) when
there is already an FDA-approved vaccine (AVA) that has been used for
years by the military?
Response: The current vaccine has a significant limitation with
regard to manufacturing capacity (currently 6.6 million doses/year).
Furthermore, limitations regarding the AVA vaccine have been
articulated in the 2002 report, Anthrax Vaccine: Is It safe? Does It
Work? from the Institute of Medicine of the National Academy of
Sciences. The report concluded ``that a new [anthrax] vaccine,
developed according to more modern principles of vaccinology, is
urgently needed.'' The new anthrax vaccine should be more readily
produced and is anticipated to minimize some of the limitations
associated with AVA.
15. Is it true that the new vaccine is similar to the existing
vaccine in terms of safety, efficacy, and delivery? Please consider the
purpose and results of the CDC anthrax vaccine safety and efficacy
research program in your answer.
Response: AVA is licensed as a 6-dose (0, 2, 4 weeks and 6, 12, and
18 months) vaccine for pre-event only. The new rPA vaccine is
anticipated to be a 3-dose vaccine (schedule to be determined) and will
be licensed for both pre-event and post-event situations. There is no
data at this time to indicate a difference in safety or efficacy. The
CDC is supporting a study to examine whether the dosing schedule can be
reduced and the route of administration changed, but that study will
not be completed until 2007, although some preliminary data may be
available later this year.
16. Please explain why the development and purchase of rPA for the
stockpile is, at this time, a better investment than either a) purchase
of AVA for the stockpile, or b) research and development of an oral or
other advanced vaccine.
Response: Anthrax is a top WMD threat. There is an urgent
requirement (as determined by the interagency WMD Medical
Countermeasures subcommittee) for enough vaccine to protect 25 million
persons. If we were to rely on AVA alone, at current manufacturing
capacities, this could take over 20 years ((25 million people x 6
doses/person)/ 6.6 doses/year)). The current manufacturers of rPA
(under contracts with the National Institute of Allergy and Infectious
Diseases) have facilities with capacities up to100 million doses/year
and the current HHS Request for Proposals (proposals are currently
under review) requires that delivery of 25 million doses be
accomplished within 2 years of contract award. HHS awarded a contract
on November 4, 2004 for 75 million doses of rPA. Delivery to the
Strategic National Stockpile should begin mid-2005. It is likely that
there will be a significant cost savings with rPA compared to AVA.
The U.S. Government recognizes the need for the development of a
third generation anthrax vaccine with an improved delivery system that
is more compatible with a rapid public health emergency response.
However, delaying the acquisition program until the development and
availability of such a product is inconsistent with the national
security environment.
The Administration has announced that the Department of Homeland
Security will be leading the interagency effort to set national
preparedness goals and ensure we will reach them.
17. Does DHS have the capability to complete this task for
bioterrorism preparedness? How much work does it do with state and
local health departments on a daily basis?
Response: The President's Biodefense for the 21st Century states
``The Secretary of Homeland Security . . . is responsible for
coordinating domestic Federal operations to prepare for, respond to,
and recover from biological weapons attacks.'' DHS has a significant
portion of the capability to provide this coordination and is
increasing this capability where needed.
Public health biopreparedness and the associated interactions with
state and local health departments is the primary responsibility of the
Department for Health and Human Services.
Questions from Mrs. Kay Granger for Dr. Pensose C. Albright
1. As your agency proceeds to support the development of WMD
medical countermeasures, are you aware of, and what are you doing to
support, the development and deployment of radiological and nuclear
medical countermeasures?
Response: The Office of Science and Technology Policy (OSTP)
National Science and Technology Council, Weapons of Mass Destruction
Medical Countermeasures Subcommittee, Radiological and Nuclear Threat
Countermeasures Subgroup is the advisory committee that is providing
priorities and guidance to Project Bioshield in the area of anti-
radiation drugs. Procurement of some such drugs may be authorized using
funds from the Project BioShield appropriation, or funds of the
Strategic National Stockpile, which is managed by HHS. DHS participates
on this interagency group which is currently developing a national
acquisition strategy. Additionally, coordination of research and
development in the areas of both radioprotectants and radiation
treatment drugs is taking place on many levels including the
Counterproliferation Technology Coordinating Committee (CTCC). DHS
supports the development of radiological and nuclear medical
countermeasures by participation in the aforementioned activities but
does not directly provide funding for development efforts.
2. Q01994: As follow up, are you aware of a product, 5-
androstenediol, or ``HE-2100,'' that is currently the lead candidate
for the first radiation sickness drug, which has proven to repopulate
bone marrow destroyed by radiation exposure? If so, what are you doing
to help accelerate the approval and stockpiling of this or a similar
drug for the protection of the American people and the military?
Response: A number of potentially effective drugs for use as
radiological and nuclear medical countermeasures, including 5-
androstendediol, have been brought to our attention. As discussed
above, DHS S&T is supportive of the activities which lead to the
approval and stockpiling of anti-radiation drugs. In the specific case
of protection to the American military, the Armed Forces
Radiobiological Research Institute (AFRRI) is charged with conducting
research in the field of radiobiology and related matters essential to
the operational and medical support of the U.S. Department of Defense
and the military services. AFRRI has funded development and testing of
5-androstendediol and DHS S&T has been briefed on these results.
Questions from Mr. Bob Etheridge for Dr. Penrose C. Albright
The Administration included $250 million for a Biosurveillance
Initiative in its Fiscal Year 2005 budget request. Half of this project
will be managed by the Centers for Disease Control, and the other half
by the Department of Homeland Security. The Information Analysis
Directorate is supposed to have major responsibilities, but I
understand they have asked the Science and Technology Directorate to
develop the systems they will use.
Response: The FY 2005 President's Budget asks for $129M in DHS to
support the BioSurveillance Initiative. Of that $129M, $118M goes
directly to the Science and Technology Directorate to: expand the
BioWatch Program in the top threat cities; to pilot a BioWarning and
Incident Characterization System (BWICS) in two of the BioWatch cities;
to accelerate the development of next generation bio-detection systems;
and to initiate R&D on biological detection systems for protecting
critical food nodes. The remaining $11M of the $129M is to go to the
Information Analysis and Infrastructure Protection (IAIP) Directorate
for the development of a National Biosurveillance Integration
capability which will integrate state of health monitoring (human,
animal, and plant) with environmental monitoring (air, agriculture,
food and water), and with intelligence and threat data to enable the
earliest possible detection of an event and to help guide the response
to any such event. S&T has offered and is currently conducting the
design study for this information system, which will be transferred to
IAIP in FY 2005.
1. Has IAIP submitted this request to you, and when?
Response: By agreement of the Secretary's Office in February 2004,
S&T is sponsoring the design of the National Biosurveillance
Integration System (NBIS) to be completed in FY 2005. The statement of
work for this system was developed through an interagency process.
Quotations were reviewed by an interagency team and the design contract
was awarded. A Conceptual Design Review was held in September, a
Preliminary Design Review in October, and a Final Design Review in
December, 2004. Actual implementation of the design will be transferred
to IAIP in FY 2005.
2. When do you expect to begin working on DHS? plan for
implementing the biosurveillance initiative?
Response: As noted above, the DHS role in the Biosurveillance
Initiative consists of several elements, the planning for which has
been on-going for sometime now. We are in the process of piloting the
planned BioWatch expansion, with the pilot to be operational in New
York City this fiscal year and with deployment to the other top threat
BioWatch cities schedule for FY 2005 and early FY 2006. A systems
design phase for the BWICS element was `kicked off' this past summer.
The additional funding to accelerate the development of the next-
generation bio-detection program will be used to augment the 15 awards
that have recently been made, or are in process, in this area. The
requirements for the detection systems for critical food nodes are
currently being developed through analysis of representative food
contamination scenarios. And, we have awarded a contract for the design
of the National Biosurveillance Integration System (NBIS) and expect to
complete the design effort in December 2004.
3. Have you sketched out a role for state and local governments, or
even the private sector, in collecting information? Is any funding set
aside, to your knowledge, to include them?
Response: State and local governments play a significant role in
BioWatch and BWICS and a significant portion of the funding in these
programs will go to support them. The NBIS will integrate information
streams provided largely by other Federal Agencies in their respective
areas of responsibility, e.g., CDC will provide information related to
public health, USDA to agriculture. NBIS may also employ data streams
from other relevant sources.
4. Are you confident such a system can work?
Response: The Generation 1 BioWatch system has been operating
successfully for over a year. The key elements of this Generation 2
expansion have been demonstrated in the laboratory and are currently
being piloted. We are confident that they will work, though there will
be the usual lessons learned to optimize their performance.
The National Biosurveillance Integration System is a new endeavor,
with three main goals: to enable earlier detection of a biological
event; to provide situational awareness to better guide the response to
such an event; and, to facilitate the sharing of needed information at
the Federal, state, and local level. To accomplish this, NBIS
integrates new and emerging information streams from sector specific
agencies. There is little question that combined access to these
diverse information streams will significantly increase our situational
awareness and improve the sharing of information to at all levels. That
leaves the question of how much we can advance the detection timeline.
Studies over the past few years, including analyses against historical
data sets and limited field data have indicated that the use of non-
traditional indicators (e.g. emergency room chief complaints) can
significantly advance the detection timelines, as can the correlation
of diverse events (e.g the linkage of dead crows with West Nile
disease). Therefore, we fully expect that NBIS and the related sector
sources will provide an advance in the detection timeline and that this
advance will increase as we gain additional operational experience with
various algorithms and data sources against real world backgrounds.
Questions the Honorable Jim Turner for Dr. Shelley A. Hearne
1. Do we have a coherent biodefense strategy today? How should we
build one? What should the core elements be? How should its overall
goals and objectives be set? What might they look like?
The Administration and Congress have addressed bioterrorism threats
by developing and funding programs such as Bio-Sense, BioShield and
BioWatch. However, Trust for America's Health (TFAH) remains conceed
that there is no overarching federal ``BioGame Plan.'' We worry that
there are overlapping jurisdictions, lack of coordination among various
federal agencies, and no plan for intra- and interagency training or
rapid deployment of resources in the event of an attack. We believe
that Congress should identify a lead agency to develop and oversee a
comprehensive BioGame Plan that clearly delineates the roles and
responsibilities of each federal agency and. its state and local
counterparts.
The most important components of a national biodefense strategy for
public health should include:
Coordination among the agencies at the federal, state
and local level to insure a clear delineation of duties and
assure that system gaps are covered.
State specific bioterrorism plans that are routinely
exercised at the local, state and regional level with federal
accountability for performance.
All state public health laboratories must have minimum
capacities to respond, 24 hours a day/7 days a week, to the
full spectrum of public health emergencies, including
terrorism, without compromising critical and routine
investigations, such as testing drinking water or food
supplies.
Minimum standards for the public health workforce,
including specific targets per capita for specialists (i.e.,
one epidemiologist/500,OOO people); training requirements and
credentialing. With the growing workforce shortage, strategic
federal investments in the public health workforce are required
to protect the U.S. population from a wide range of health
threats.
Modem and up-to-date communications systems are vital.
As we learned with anthrax and SARS, communicating with a
shaken public is key to alleviating natural fears that arise
with an unexpected threat or an emerging illness. The Health
Alert Network (HAN), a federally coordinated system between the
CDC and state/local health departments, has the potential to
fill this current communications gap.
By using advanced technological tools, HAN will allow for real-time
coordination in situations where even seconds matter. The HAN plays a
vital role in the nation's state of readiness and timetables to
completion and activation must be accelerated.
Creation of a nationwide disease tracking command
center at CDC. Because of the current ``disease du jour''
(i.e., SARS one month, and Monkeypox the next), CDC risks
establishing dozens of different databases that are not
directly linked or integrated, and may in fact, be redundant.
This paradigm also limits the public health community's ability
to understand the interconnections between diseases and
possible causes. TFAH recommends that Congress provide the
mandate, resources and support to establish a centralized
disease tracking center within CDC. This would include tracking
animalborne diseases, chronic diseases, such as cancer and
asthma, events related to bioterrorism, and environmental
risks.
Although there is agreement among public health experts on many of
the core elements of a well-prepared public health system, there are
still several critical goals and objectives that continue to need
discussion. Accordingly, TFAH recommends that the President, in
consultation with Congress and public health experts, should convene a
White House summit that will develop a concrete vision for a 21st
century American public health system and identify the resources needed
to make it a reality. TFAH believes that such a summit should create a
blueprint for a public health system that is designed to meet America's
current and emerging health threats.
Specifically, the summit should address all essential public health
concerns, including, bioterrorism, chemical, and radiological
preparedness, known and emerging infectious diseases and chronic
disease prevention and control. At the same time, we believe the summit
should foster a long-overdue dialogue about the human and financial
resources required to implement needed changes and to guarantee
accountability at every level of the public health system.
Your organization's December 2003 report, Ready or Not? Protecting
the Public's Health in the Age of Bioterrorism, found that ``only two
states are at the highest preparedness level required to receive and
distribute. . .supplies needed to provide . emergency vaccinations and
antidotes.'' But my understanding is that every state has to submit a
stockpile distribution plan to the federal government.
2. How accurate is this statistic? What is wrong with the state's
plans? Are they unworkable? Haven't they been exercised?
The Department of Homeland Security (DHS) and CDC evaluate the
states' Strategic National Stockpile (SNS) distribution capabilities
and assign them a preparedness rating of red, amber or green. A red
rating is the worst, while green is the best. In TFAH's report, ``Ready
or Not? Protecting the Public's Health in the Age ofBioterrorism,''
only two states had obtained green status as of November 2003. From
recent public reports, TFAH has learned that an additional state
(Louisiana) has now obtained green status, although our organization
has not conducted a formal review. There are also unsubstantiated
reports from government officials that several states have lost ground
recently in their SNS status, but TFAH does not have specific
quantitative information.
For TFAH's December 2004 state-by-state report on preparedness, we
will attempt to update the SNS information. For up-to-date accuracy,
TFAH would recommend that the Committee directly request CDC and DHS to
provide a tabulated chart on the number of states that have obtained
green, green minus, amber plus, amber, red plus and red status for the
SNS.
States have developed SNS distribution plans, which are reviewed
and . assessed by DHS through intensive on-site teams. DHS should be
applauded for establishing performance standards and evaluation
methods, which is an unusual practice in the public health field. The
challenge states are facing in preparedness for stockpile distribution
are numerous, ranging from lack of sufficient workforce to limited
funds. As noted in our testimony, many states had planned on tapping
their National Guard units for distribution, which may now be
unavailable due to deployment in Iraq and elsewhere. In other
instances, states have not done sufficient training or exercising with
respect to stockpile distribution. There have also been complaints that
as SNS responsibilities were transferred from CDC to DHS, there were
significant delays in funding, guidance and the ability for DHS
representatives to conduct evaluations.
You discussed in your testimony your concerns about a workforce
sbortage in distribution of the stockpile. We understand that the
Secretary's recent reprogramming request would include funding for 21
cities to employ the U.S. Postal Service to help disseminate
antibiotics in the case of a terrorist event.
3. Can you discus the pros and cons of this approach? Given the
traumatic experience of many postal workers during the 2001 anthrax
attacks, do you think they are prepared or even wiling to take on a
duty that might put them at risk?
By all indicators, this nation is unprepared on multiple levels for
a major bioterrorism attack. One critical weakness relates to how to
deliver vital medical materials, such as antibiotics, antidotes and
vaccines, to large segments of the population. Almost all states fail
to be fully prepared to receive the Strategic National Stockpile (SNS),
in large part because of a limited distribution capacity. In TFAH's
past reports, the enormous public health workforce shortage is cited as
a major factor for this preparedness shortcoming. Rather than making an
investment in revitalizing the diminished public health workforce, the
Administration is proposing a unique strategy to tap into the U.S.
Postal Service's delivery experience and network.
The ``pro'' argument for this approach is that it potentially
provides officials with a vast delivery network that is well-organized
and geographically familiar with the community. Given that many states
had developed distribution plans relying on National Guard Units, short
term alternatives are needed. But this approach has significant
vulnerabilities, which again highlights the need for a national
commitment to rebuild our public health workforce to sufficient levels,
rather than relying on stopgap measures.
The concerns about relying on the U.S. Postal System during a
bioterrorism event are multiple, particularly during broad scale
quarantine/isolation. Public health and emergency response experts are
gravely concerned about how the American public would respond during
this type of crisis; fears range from distrusting government
information/recommendations to civil unrest. Research, public opinion
polls and past experience highlight that ``trust'' is the most critical
factor influencing the public's response and that the healthcare
provider community is the most trusted resource. In the midst of a
major pandemic or bioterrorism event, response workers tasked with
distributing . medical supplies to isolated/quarantined homes will need
to be far more than deliverymen, but instead will need to be well-
trained, familiar with health issues and trusted.
TFAH cannot assess if U.S. Postal Service employees will be
prepared or willing to travel to potentially contaminated locations.
However, we would like to point out that even if provided with
extensive training, individuals inexperienced with infectious disease
may not respond rationally or well to a perceived health threat. The
HIV/AIDS crisis is a vivid reminder that despite widespread information
on the virus's transmission, many non-health care workers refused to
interact with infected individuals. In addition to transporting
critical medical supplies to homes, postal workers would be playing
dual roles--providing information about the health emergency and giving
assurance during a crisis. A family cordoned off from the world will
inevitably have specific questions about possible symptoms, doses for
children, elderly or immune-suppressed individuals, why isolation is
necessary, etc. These front line responders need to be well trained in
crisis management that builds on their fundamental health skills if a
system of quarantine and isolation is to work.
A better short term option would be to consider a network of home
health care providers, ambulance services, EMS and even pharmacists who
have better fundamental training in health matters. Or at a minimum, a
bioterror response plan should ensure that these health professionals
are integrated into an emergency response system. But in the long term,
a serious reinvestment is needed to refortify and bolster our nation's
public health workforce.
If current workforce demographic trends are left unchecked, they
will have an adverse affect on the capacity of state health agencies to
carry out their mission; including responsibilities that have continued
to expand since the events of September 11, 2001, and the ensuing
anthrax attacks. Hiring freezes at the state and local levels, due in
part to budget deficits and competition from higher-paying private
companies contribute to the workforce shortages.
TFAH supports legislation that has been proposed to begin to
address this critical public health need. The Public Health
Preparedness Workforce Development Act of 2004 is designed to alleviate
workforce shortages in federal, state and local government public
health agencies. The bill establishes two new programs for students
pursuing degrees in public health disciplines--a new scholarship
program and a loan repayment program.
Examples of disciplines related to public health that would be
covered by the legislation include: laboratory sciences, epidemiology,
environmental health, health communications, information sciences,
public administration, social work, and nursing.
Cuts in Preparedness Funding
4. If enacted, what will be the effect on bioterrorism preparedness
of the $105 million reduction in state and local bioterrorism capacity
grants?
The proposed funding cut of $1 05 million in state and local
capacity grants, (11 % from fiscal year 2004 appropriated levels), will
seriously erode state and local preparedness across the nation. The
cuts proposed for fiscal year 2005 will be especially hard-hitting
because, if enacted, the $105,000,000 reduction in state and local
preparedness dollars would follow the Department of Health and Human
Service's reprogramming of $55 million appropriated by Congress in
fiscal year 2004 for bioterrorism capacity grants to the CDC Cities
Readiness Initiative, Biosurvelliance Initiative and quarantine
acceleration efforts.
The reprogramming of these funds has resulted in a reduction of
$1.085 million for most states (please see attached chart of state-by-
state cuts resulting from the reprogramming), which significantly
weakens the ability of local and state public health officials to
respond to a health emergency. For example, according to the
Association of State and Territorial Health Officials (ASTHO), negative
effects of the reprogramming request may include: reductions in
workforce; delays in the creation of surge laboratory capacity;
elimination of planning activities for the Strategic National
Stockpile; cancellation of planned training events and statewide
exercises for a potential chemical attack; and discontinuation of the
implementation of the statewide Health Alert Network.
The proposed $105 million cut in fiscal year 2005 funding would be
nearly' double that of that of funds that were just reprogrammed away
from state and local capacity grants and the impact on public health
agencies to respond to a bioterror attack would be even more draconian.
That is why TFAH believes that even in these tight fiscal times,
Congress must restore the proposed $105 million cut. Otherwise further
readiness efforts at the state and local levels will be derailed. TFAH
recommends that Congress make a long-term investment in public health
preparedness and authorize an independent review to determine whether
current expenditures are sufficient. Experts note that at a minimum,
the nation requires a $1 billion annual commitment for the next several
years in order to achieve the appropriate level of public health
security .
To assure that this investment is well-spent,CDC, in consultation
with state and local health officials and outside experts, including
those from other federal agencies like the Departments of Defense and
Homeland Security, must define measurable standards for comprehensive
preparedness that all state and major local health departments should
meet.
The General Accounting Office has reported that no hospital funded
through federal preparedness grants is able to meet the benchmark of
serving a surge of at least 500 patients.
5. Why do we remain so far from effective mass casualty
preparedness? What will it take to get our hospitals up to a minimum
standard? What should that standard look like?
Based on input from the University of Pittsburgh's Center for
Biosecurity, at present, most hospitals in the U.S. would have great
difficulty dealing with 50 critically ill victims of a bioterrorist
attack, let alone 500. As was evident in Toronto hospitals during the
SARS outbreak last year, highly contagious diseases have tremendous
impact on hospital function, and in fact, hospitals caring for SARS
patients or victims of a bioterror attack with smallpox, for instance,
would be more likely to experience a decrease in overall capacity, not
an increase in capacity. Most hospitals have only the numbers of
doctors and nurses they need for routine purposes. If more doctors,
nurses paramedics, medical technicians, cafeteria workers, sanitation
workers, etc., were needed in crisis, hospitals would need to have
systems in place to bring on more staff from the community or
elsewhere.
Further complicating matters, in an actual event, many hospitals
may not be able to keep even their usual staffing commitments--regular
health care workers may be fearful of going to work or of leaving their
family members during such a crisis, or, as was the case in SARS, some
may become ill themselves from the disease at hand. Serious and
integrated planning would need to take place to create the kind of
emergency staffing systems needed to keep hospitals up and running in
the case of a bioterror event resulting in mass casualty.
Hospitals typically have sufficient medical supplies and
ventilators to serve routine needs, no excess. While the Strategic
National Stockpile (SNS) may be able to provide some of these key
supplies to hospitals in the time of crisis, most hospitals do not
currently know exactly what is in the SNS, how quickly or by what
mechanism they would receive components of the SNS, how decisions would
be made to allocate such components, etc. As noted earlier, few states
have reliable systems to distribute components of the stockpile to
hospitals.
Recognizing this vulnerability, Congress made important new funding
commitments for hospital preparedness over the last few years.
Unfortunately, these funds were divided across the hospital community
throughout the U.S. without consideration for risk and need, thereby
dangerously diluting the resources. Few U.S. hospitals have received
serious funding to prepare for bioterrorism. One major hospital in New
York City, located only blocks from the World Trade Center site,
received $40,000 in funding last year to address all of its
biopreparedness and terrorism preparedness needs. These days $40,000
would pay for about half of one senior nurse's salary.
Commensurate with this, hospital preparedness is treated in many
communities as an avocation, with work done after hours by a dedicated
few. To be able to cope with an event producing 500 or more victims,
hospitals need to develop preparedness programs built on reliable
systems that are testable, scaleable, and capable of ``dual use'' for
meeting a full spectrum of challenges. This will require a sustained
and more substantial funding stream with realistic guidance. Currently,
HRSA guidance covers a broad range of initiatives, but present funding
levels are unrealistic to accomplish few, if any.
One of the ongoing concerns that we have when trying to determine
state and local preparedness for a terrorism event is our focus on
biological readiness. Recent reports of a possible terrorism event seem
to suggest that a dirty bomb or chemical attack, similar to the recent
ricin attack in the Senate office buildings, are just as possible if
not more likely
6. Do you think we are prepared for a chemical or radiological
attack? If not, what do we need to do to become better prepard?
From a public health perspective, the U.S. is woefully unprepared
for a chemical or radiological attack. With respect to chemical
terrorism, a report issued by TFAH in June 2003 found that state public
health laboratories are ``dangerously unprepared'' to fulfill their
roles as first responders charged with identifying chemical agents used
in an attack. The report, ``Public Health Laboratories: Unprepared and
Overwhelmed,'' examined the capabilities of state public health
laboratories, a crucial component of our defense and response system,
and found that a majority of labs are in need of modernization and
stabilized funding support. Labs are responsible for identifying the
chemical weapons used in an attack, which then drives the critical
treatment, containment, and clean up decisions. The report found gaps
in planning, coordination, equipment, training, safeguards, workforce,
and environmental testing capacity for chemical agents.
TFAH's recommendations for improving public health lab capacity to
respond to a chemical or radiological attack include: .
Enhanced Capacity: By the end of 2004, each state
should have at a minimum, testing capabilities for priority
potential chemical and biological weapons agents.
Modem Communications: All state public health
laboratories must establish an effective communications network
incorporating clinical laboratories, hospitals and private labs
that evaluate patients directly.
More Expertise: Each state laboratory should have at
least two trained PhD-level microbiologists and one PhD-level
chemist to ensure effective biological, chemical and
environmental testing capacity.
Enhanced Federal Commitment: Federal funding for
improving the readiness of public health laboratories to
respond to biological, radiological and chemical attacks should
be $200 million in fiscal year 2005. This level of funding is
essential if labs are to have the ability to conduct clinical
testing for potentially dangerous chemicals, such as ricin,
cyanide, nerve agents and pesticides.
CDC Leadership: CDC must have the authority to ensure
capacity, collaboration and consistent methodology for clinical
testing for chemical exposures. The National Center for
Environmental Health should be supported to advance
methodologies, develop a training system and establish
performance measures for state laboratories. DHS should partner
with CDC and Environmental Protection Agency (EPA) to
prioritize chemical agents for environmental and clinical
laboratory methodologies.
Joint Training. Key federal agencies including DHS,
EPA, and CDC should collaborate to develop a joint training
exercise with states and first responders to prepare for
chemical attacks. The May 12, 2003 ``Topoff2'' emergency
response exercise had components to examine nuclear and
biological threats, but did not include a chemical scenario. To
date, there has not been a substantial training exercise to
test national and local readiness in the event of such an
attack.
Increasingly, there are some who see bioterrorism preparedness as a
trade-off. That is, funding for public health preparedness for
infectious diseases means less money for other functions, such as
community health, elderly care or obesity reduction plans. Focusing on
a new anthrax or tularemia vaccines means less of a focus 'on
tuberculosis or malaria.
7. Are there concerns real? Given our experience to date, is it
possible to make bioterrorism funding truly ``dual-use?'' What
can we do better to achieve an all-hazards approach?
The tragedies of September 11 and the subsequent anthrax attacks
shook the nation--and highlighted in the most dramatic way possible
that our country was not ready to respond to large scale health crises.
Even before the threats of bio--and chemical terrorism, the nation's
state and local health agencies were already stretched too thin trying
to manage everything from infectious disease outbreaks to preventing
chronic disease like cancer and asthma, with too few resources.
Over the course of the last year alone, local, state, and federal
health officials have responded--and contained--SARS, monkeypox, flu,
and West Nile virus outbreaks, and the recent ricin incident in the
Senate, while simultaneously working to prevent chronic diseases and
address the everyday health needs of all Americans.
TFAH believes that rather than concentrating solely on bioterrorism
or responding to each ``disease du jour'' crisis individually, public
health preparedness efforts must be focused on an ``all-hazards'' or
``dual-use'' approach. This approach would focus on strengthening the
fundamentals of our public health defenses, including laboratory
capabilities and communications and response procedures.
To achieve the optimum all-hazards approach to public health
preparedness, TFAH's specific recommendations include:
CDC must formally authorize states to use federal
preparedness funds to support an ``all-hazards'' approach to
preparedness that simultaneously addresses the potential for
biological, chemical, radiological and natural disease
outbreaks.
CDC, in consultation with state and local health
officials and outside experts, must define measurable standards
for comprehensive preparedness that all states and major local
health departments should meet.
Congress should provide long-term commitment and
oversight toward ensuring the nation achieves adequate and
sustainable public health security. As such, Congress should
authorize an independent review to assess whether current
expenditures--at the federal, state and local levels--are
sufficient.
Health security requirements must be established,
including mandates and accountability measures to ensure all
citizens are adequately protected.
CDC must be required to track state and local funding
and expenditures on critical public health functions,
particularly those involving federal support. Unfortunately,
there is mounting evidence to indicate that severe state budget
cuts dilute the impact of the federal preparedness investment.
Concerned that federal dollars should supplement--and not
supplant--state and local funding streams, Congress urged the
Health and Human Services Secretary to guard against such
actions, but this ``maintenance of effort'' needs to be
enforced.
CDC should independently verify that health emergency
performance standards are being met at the federal, state and
local levels.
As stated earlier, that is why TFAH also recommends that the White
House, in consultation with Congress, convene a national summit on the
future of public health to develop a cohesive and proactive approach to
public health protection.
The Administration has developed a Biowatch program, deployed in
cities throughout the country, and a new Bio-surveillance initiative,
which is to involve building complex new information systems both at
DDS and at the Centers for Disease Control, known as BioSense. The
concept of detecting a release as early as possible makes a lot of
sense in terms of protecting the public. But DDS itself admits that the
Biowatch system may be too costly and labor intensive. Some scientists
have suggested the syndromic surveillance, the basis of BioSense, has
not been proven to work.
8. Are these systems ready to be fielded, or do we need more
research and to develop better systems first? Are the resources we are
devoting to this system well spent?
The BioWatch Program is intended to provide early warning of a mass
pathogen release, which inherently makes sense in light that human
symptoms from bioterrorism may not appear for days after exposure.
Numerous questions have been raised about the program's inherent
efficacy, costs, the strategic siting of detectors, workforce needs and
the overall ability to coordinate responses with the local public
health agencies.
One major issue is the strategic location of the detectors.
Building upon the nation's existing air quality monitoring system, the
biopathogen detectors are reportedly combined with EPA's infrastructure
for tracking ambient air pollutants, such as ozone and nitrous oxides.
Efforts are underway to expand BioWatch to locations in all major
metropolitan statistical areas, but these locations do not generally
coincide with where a pathogenic agent would be released. For example,
EPA's air monitors are positioned on large building rooftops and
airport outdoor properties to capture ambient air pollutants. For
terrorists with high impact designs, pathogens are more likely to be
released in lower, more closely contained areas with dense populations.
For early warning purposes, BioWatch may have greater value positioned
in high target areas, such as subways, large arenas, and ventilation
systems for significant or landmark buildings. Already, its limited
applications come with a significant price tag: annual operating costs
are estimated at $1 million per city, after the initial $1 million
investment per location.
In addition, numerous laboratory issues abound with BioWatch.
First, the pathogen monitors are highly labor intensive, requiring
samples to be collected every 24 hours from the aerosol samplers and
are analyzed using a polymerase chair reaction (PCR) technique. Lab
capacity is already stretched thin in most state and local public
health agencies. We speculate, that in reality, BioWatch results may
take days to determine, raising questions about its early warning
capacity .
9. Are these the best we can do in detection, or are there other
options we should be considering?
Numerous federal and independent reports have noted the gaps in
basic public health preparedness, from laboratory capacity to rapid
response teams to disease surveillance systems. Significant
improvements are needed in public health preparedness that far
outweighs the potential benefits of the BioWatch programs. A cost
benefit analysis for preparedness would most likely reveal that more
lives would be saved by investing in state or the art disease
surveillance systems, adequate medical distribution systems, trained
and sufficient numbers of public health workers, strong communications
operations, and routine exercises for all hazards. While BioWatch is a
technological advance, its limited coverage and high labor and resource
costs, make it a questionable investment in light of greater
bioterrorism preparedness needs.
At this stage, BioWatch is of limited value and should be
revaluated in the context of the broader strategic needs of the
nation's bioterrorism defense.
The rapid increase in funding for biodefense has led to the
building of more biocontainment labs and many more researchers working
with these dangerous pathogens. It seems that this could lead to a
greater risk of theft or accidental release of these pathogens.
10. Are you concerned about the safety and security of these labs?
Are we doing enough to ensure the safety and security of biodefense
research in this country?
Although the safety and security of state public health labs is of
concern, there are additional overarching issues with respect to the
role of labs during a public health crisis. The nation's 2,000 state
and local public health laboratories, together with hospitals and local
health departments, would quite literally be 'front-line' defenders in
case of a terrorist attack. In our 2003 study, TFAH found that 30 years
of inadequate funding and the absence of federal oversight have
rendered public health laboratories unable to respond appropriately to
more traditional hazards, let alone acts of terrorism. An under-
prepared workforce, a shortage of trained laboratorians, and old, often
outdated facilities lacking the latest equipment, reagents and other
tools, render public health laboratories dangerously unprepared to
respond to a public health emergency. Public health specialists point
out that, while the technologies and expertise exist to manage
bioterror threats, laboratories lack the resources to access them.
Questions Mr. Ed Markey for Dr. Shelley A. Hearne
As you know, the only federal program that directly coordinates
local first responders to deal with a bioterror attack is the
Metropolitan Medical Response System. This program gives direct grants
to 125 US cities to coordinate fire, police, hospital and public health
officials for terror attacks with large numbers of casualties. However,
the President's fiscal year 2005 budget contains no money for the
program.
1. Do you agree with the Administration's efforts to eliminate
MMRS?
2. How important in your opinion is coordination among local
first responders--hospitals, fire, police and public health
officials--in mitigating the effects of a' bioterror attack in
an urban area?
The goal of Metropolitan Medical Response System (MMRS) is to
support local jurisdictions by enhancing and maintaining all-hazards
response capabilities with respect to a mass casualty incident,
including but not limited to, a terrorist attack during the early
hours. TFAH believes that the basic tenet of this program--enhancing
the coordination of activities between the major players involved in
responding to a mass casualty is critical and we applaud this
coordination where it is working well.
Questions from Mr. Bob Etheridge for Dr. Shelley A. Hearne
You have called for the federal government to define measurable
standards for comprehensive preparedness that all states and major
local health departments should meet for preparedness. This is exactly
what the interagency process the Department of Homeland Security is
supposed to manage.
1. How would you advice the Department to accomplish this task?
What would ``preparedness'' look like? How would we know we were
prepared until something happened and we could measure our response?
Over two years after the state bioterrorism preparedness program's
launch, at least three separate initiatives are underway throughout the
federal government to establish performance measures for readiness for
a major public health emergency. The Centers for Disease Control and
Prevention (CDC) is in the pilot phase of testing evidence-based
performance goals for states public health disaster preparedness. The
Department of Health and Human Services (HHS) has separately been
assessing potential benchmarks to evaluate state programs. The
Department of Homeland Security (DHS) recently embarked on a
comprehensive preparedness exercise which brought together experts
representing a wide variety of the ``preparedness'' world including
public health organizations. The goal of exercise was to create a
``universal task list'' for states and communities. According to public
health experts, the exercise was based on various scenarios that were
not well designed because they failed to accurately reflect what would
happen during a major health emergency. Throughout the exercise, goals
and public health roles were uncertain within the context of the
comprehensive preparedness initiative.
Unfortunately, states are implementing the third year of the grant
program without overall preparedness standards in place. Further, it
appears that DHS, HHS and CDC are not coordinating these efforts so
that state and local health departments would ultimately have one set
of measurable standards to abide by. TFAH would strongly recommend that
the CDC and HHS directly coordinate a performance measure system for
state and local preparedness, and subsequently build it in and test it
through DHS's comprehensive preparedness effort. Using realistic
biological, chemical or radiological scenarios, DHS could effectively
test public health readiness with the CDC/HHS performance measures.
HHS Reallocation of $59.4 million in State Emergency Preparedness Funds for FISCAL YEAR 2004
----------------------------------------------------------------------------------------------------------------
CDC FISCAL Redirected $ for Cities
YEAR 2003 Percent Cut Readiness Initiative TFAH BT
State Emergency Dollar Amount of From FISCAL ------------------------------- Preparedness
Preparedness Cut to State YEAR 2003 Score, Scale
Funds Funds of 1-10**
----------------------------------------------------------------------------------------------------------------
Alabama $14,056,645 -$1,085,000 -8% ................ ........... 6
----------------------------------------------------------------------------------------------------------------
Alaska 6,284,107 -1,085,000 -17 ................ ........... 3
----------------------------------------------------------------------------------------------------------------
Arizona 15,755,035 -1,085,000 -7 Phoenix $1,280,000 5
----------------------------------------------------------------------------------------------------------------
Arkansas 10,461,043 -1,085,000 -10 ................ ........... 2
----------------------------------------------------------------------------------------------------------------
California 55,589,662 -1,085,000 -2 Los A2,670,000 7
----------------------------------------------------------------------------------------------------------------
............ ................. ........... San Diego 1,220,000 ............
----------------------------------------------------------------------------------------------------------------
............ ................. ........... San Francisco 940,000 ............
----------------------------------------------------------------------------------------------------------------
Colorado 13,979,790 -1,085,000 -8 Denver 820,000 5
----------------------------------------------------------------------------------------------------------------
Connecticut 11,960,524 -1,085,000 -9 ................ ........... 4
----------------------------------------------------------------------------------------------------------------
Delaware 6,614,378 -1,085,000 -16 ................ ........... 5
----------------------------------------------------------------------------------------------------------------
District of Columbia 11,162,901 ................. No Cuts DC 830,000 3
to DC
----------------------------------------------------------------------------------------------------------------
Florida 38,181,999 -1,085,000 -3 Miami 710,000 7
----------------------------------------------------------------------------------------------------------------
Georgia 22,034,847 -1,085,000 -5 Atlanta 740,000 3
----------------------------------------------------------------------------------------------------------------
Hawaii 7,486,672 -1,085,000 -14 ................ ........... 4
----------------------------------------------------------------------------------------------------------------
Idaho 7,676,282 -1,085,000 -14 ................ ........... 3
----------------------------------------------------------------------------------------------------------------
Illinois 24,923,148 -1,085,000 -4 Chicago 2,150,000 5
----------------------------------------------------------------------------------------------------------------
Indiana 17,416,386 -1,085,000 -6 ................ ........... 4
----------------------------------------------------------------------------------------------------------------
Iowa 10,941,890 -1,085,000 -10 ................ ........... 3
----------------------------------------------------------------------------------------------------------------
Kansas 10,476,095 -1,085,000 -10 ................ ........... 3
----------------------------------------------------------------------------------------------------------------
Kentucky 13,245,815 -1,085,000 -8 ................ ........... 2
----------------------------------------------------------------------------------------------------------------
Louisiana 14,059,595 -1,085,000 -8 ................ ........... 5
----------------------------------------------------------------------------------------------------------------
Maine 7,603,092 -1,085,000 -14 ................ ........... 3
----------------------------------------------------------------------------------------------------------------
Maryland 15,915,365 -1,085,000 -7 ................ ........... 7
----------------------------------------------------------------------------------------------------------------
Massachusetts 17,972,524 -1,085,000 -6 Boston 840,000 5
----------------------------------------------------------------------------------------------------------------
Michigan 25,278,581 -1,085,000 -4 Detroit 1,030,000 3
----------------------------------------------------------------------------------------------------------------
Minnesota 15,101,600 -1,085,000 -7 Minneapolis 710,000 5
----------------------------------------------------------------------------------------------------------------
Mississippi 10,795,501 -1,085,000 -10 ................ ........... 2
----------------------------------------------------------------------------------------------------------------
Missouri 16,424,504 -1,085,000 -7 St. Louis 690,000 4
----------------------------------------------------------------------------------------------------------------
Montana 6,834,837 -1,085,000 -16 ................ ........... 3
----------------------------------------------------------------------------------------------------------------
Nebraska 8,485,811 -1,085,000 -13 ................ ........... 6
----------------------------------------------------------------------------------------------------------------
Nevada 9,251,219 -1,085,000 -12 Las Veg790,000 5
----------------------------------------------------------------------------------------------------------------
New Hampshire 7,552,202 -1,085,000 -14 ................ ........... 5
----------------------------------------------------------------------------------------------------------------
New Jersey 22,248,528 -1,085,000 -5 ................ ........... 5
----------------------------------------------------------------------------------------------------------------
New Mexico 8,710,551 -1,085,000 -12 ................ ........... 2
----------------------------------------------------------------------------------------------------------------
New York 27,794,404 -1,085,000 -4 NYC 5,100,000 6
----------------------------------------------------------------------------------------------------------------
North Carolina 21,630,396 -1,085,000 -5 ................ ........... 5
----------------------------------------------------------------------------------------------------------------
North Dakota 6,290,025 -1,085,000 -17 ................ ........... 5
----------------------------------------------------------------------------------------------------------------
Ohio 28,082,405 -1,085,000 -4 Cleveland 770,000 4
----------------------------------------------------------------------------------------------------------------
Oklahoma 12,031,404 -1,085,000 -9 ................ ........... 3
----------------------------------------------------------------------------------------------------------------
Oregon 12,039,235 -1,085,000 -9 ................ ........... 3
----------------------------------------------------------------------------------------------------------------
Pennsylvania 29,933,326 -1,085,000 -4 Philadelphia 1,350,000 3
----------------------------------------------------------------------------------------------------------------
............ ................. ........... Pittsburgh 690,000 ............
----------------------------------------------------------------------------------------------------------------
Rhode Island 7,147,493 -1,085,000 -15 ................ ........... 6
----------------------------------------------------------------------------------------------------------------
South Carolina 13,232,255 -1,085,000 -8 ................ ........... 4
----------------------------------------------------------------------------------------------------------------
South Dakota 6,536,811 -1,085,000 -17 ................ ........... 4
----------------------------------------------------------------------------------------------------------------
Tennessee 16,651,663 -1,085,000 -7 ................ ........... 7
----------------------------------------------------------------------------------------------------------------
Texas 48,310,184 -1,085,000 -2 Houston 1,650,000 4
----------------------------------------------------------------------------------------------------------------
............ ................. ........... Dallas 1,190,000 ............
----------------------------------------------------------------------------------------------------------------
Utah 9,618,011 -1,085,000 -11 ................ ........... 4
----------------------------------------------------------------------------------------------------------------
Vermont 6,242,254 -1,085,000 -17 ................ ........... 3
----------------------------------------------------------------------------------------------------------------
Virginia 19,584,849 -1,085,000 -6 ................ ........... 5
----------------------------------------------------------------------------------------------------------------
Washington 17,146,134 -1,085,000 -6 Seattle 830,000 6
----------------------------------------------------------------------------------------------------------------
West Virginia 8,649,835 -1,085,000 -13 ................ ........... 4
----------------------------------------------------------------------------------------------------------------
Wisconsin 15,955,629 -1,085,000 -7 ................ ........... 2
----------------------------------------------------------------------------------------------------------------
Wyoming 6,000,636 -1,085,000 -18 ................ ........... 4
----------------------------------------------------------------------------------------------------------------
** Source: TFAH's 12/03 Report, Ready or Not? Protecting the Public's Health in the Age of
Bioterrorism http://healthvamericans.org/state/bioterror/Bioterror.pdf
----------------------------------------------------------------------------------------------------------------
Responses to Questions for the Record from Major General Lester
Martinex-Lopez
USAMRMC Responses to Representative Cox's Select Committee Follow-
on Questions
Question: 1. How do threat information and vulnerability
assessments collected by DHS or DOD influence the research agendas, if
at all?
Answer: 1. Within the formal DOD process, the Joint Requirements
Office--CBRND (JRO-CBRND) integrates threat information and
vulnerability assessments from all sources and reviews the DoD CBD
Program. Results of these reviews, conducted with all Services
participating, are documented in the Joint Service Modernization and
Joint Service RDA Plans. These documents form the basis for the
consolidated Program Objectives Memorandum (POM). Once requirements for
warlighting capabilities are determined, doctrinal, training, or
organizational solutions (nonmaterial solutions) are explored, and when
these cannot fulfill the need, equipment or materiel solutions are
sought through the materiel acquisition process. Based upon such
capability-based analysis, research program strategies are assessed and
planning guidance is modified by the CB S&T manager at the Defense
Threat Reduction Agency to incorporate potential technological
opportunities and needs-based technology maturation efforts into the
Department's research agenda. Specifics of how threat information and
vulnerability assessments from DHS are incorporated in this process are
best directed to the JRO-CBRND.
In parallel to this official process, the interagency coordinating
mechanisms described in my response to your question number three also
act to shape the detailed research agenda.
Question: 2. Are MRMC researchers and program managers given access
to this threat information or allowed to set their own research agendas
based on this information?
Answer: 2. In medical CB S&T, MRMC researchers are provided with
threat information from multiple sources and this includes raw as well
as formal, finished intelligence. Formal intelligence information may
be restricted in distribution, but it does shape program and proposal
development. MRMC researchers are not allowed to set their own research
agendas based on threat information, although they do recommend
programs and develop competitive proposals based on such information.
Program management of medical CB S&T is the responsibility of DTRA,
which was assigned responsibility for management and integration of CBD
S&T on 22 April 2003. Program guidance in medical CB S&T is provided by
DTRA directly to program executors/performers. Guidance delivered to
program performers is developed from DTRA's coordination with JRO-CBRND
and the Joint Program Executive Office for CB Defense so that joint
Service capabilities and requirements and materiel development
strategies are appropriately addressed in developing research agendas.
MRMC researchers respond to guidance provided through the DTRA program
managers by participating in program development, developing research
proposals and executing those that are approved for funding. Final
coordination and impacts of proposed program expenditures are discussed
between the DTRA program office and MRMC, setting the path for science
program execution in the current budget year.
Question: 3. Do the National Institute of Allergy and Infectious
Diseases and USAMRIID coordinate on setting research agendas? How would
NIAID know whether USAMRIID is pursuing the same pathogen?
Anwser: 3. Using available intelligence, each agency will
internally develop and approve its own threat list and research agenda
based upon missions and responsibilities. We can expect some threats
will be unique to one agency and other threats will be shared. A
committee formed by the partners of the National Interagency Biodefense
Campus will review and discuss the lists, looking for unique and
overlapping threats. Unique threats will be the responsibility of the
specific agency; however, the expertise and facilities of other
agencies will be available to enhance execution of research and
operational programs to address the threats. For overlapping threats,
the involved agencies will discuss their approach to the threat,
allowing performance of different research and operational programs by
different agencies, thereby sharing cost while developing products that
will address the threats identified by more than one agency. Needless
duplication and redundancy will be avoided in scientific programs
through oversight and coordinating efforts of one or more scientific
and/or operational committee(s) formed by the partners of the National
Interagency Biodefense Campus. Each agency will develop its own
programs based upon its missions and responsibilities. The committee
will review the programs, looking for redundancy. If redundancy is
found, through a joint process, different aspects of the program will
be assigned to the agencies with the most expertise and superior
facilities in each area. This process will encourage collaboration and
mutual fulfillment of research and operational goals, ultimately
developing products that can be used by multiple agencies.
In addition to the forums and processes provided by the Interagency
Campus, other formal and informal coordination mechanisms will
continue. NIAID and USAMRMC leadership participate in activities of the
R&D Sub-Group of the Interagency Working Group on Weapons of Mass
Destruction Medical Countermeasures of the Chemical, Biological,
Radiological, and Nuclear Health Countermeasures Subcommittee of the
Homeland and National Security Committee of the National Science and
Technology Council. Additionally, USAMRMC's scientific workforce will
remain active in providing programmatic and scientific advice to NIAID,
and in responding to NIAID program announcements. NIAID program
leadership has visited our laboratories for program and scientific
briefings on a regular basis. These more formal interactions are
facilitated on a personal level by the prevalence of ex-military
scientists within the program leadership of NIAID, DHHS and DHS. In
addition, the DTRA Medical Chemical and Biological Defense Research
Program has initiated efforts to harmonize their science program with
leadership within the Biodefense Research Program of the NIAID.
Question: 4. Right now there is no treatment for Ricin exposure--
once someone is exposed, they will die. And yet recent experience has
shown that it is relatively easy to gather materials and transmit the
toxin around the country. This is arguably a more serious threat than
anthrax because at least anthrax has a vaccine and a course of
treatment. So who has looked at this and determined it's not important
to invest in a Ricin treatment? How is this decided?
Answer: 4. Although specific, FDA approved medical countermeasures
against ricin are not available at the present time, it is not
necessarily true that exposure leads to death. However, after signs/
symptoms appear, treatment for ricin aerosol exposure is limited to
supportive care to treat acute pulmonary edema and respiratory
distress. Supportive care for oral intoxication includes activated
charcoal administration and intravenous fluid and electrolyte
replacement. Although ricin has historically held a lower level
priority as a military threat, based on intelligence estimates and
doctrinal reliance on early detection, physical protection and rapid
decontamination, the resource intensive nature of such care, and
generally poor prognosis, has been a primary consideration in driving a
continuing research and development effort for medical countermeasures.
The best medical solution for populations at high risk to ricin
exposure would be vaccination because: (1) small amounts of vaccine can
provide safe and lasting protection against exposure to large amounts
of toxin; (2) vaccines require minimal space and logistical support;
and (3) vaccines can be administered easily and far in advance of
exposure. Although there is presently no approved human vaccine for
ricin, two experimental vaccines have been developed in the DoD Medical
Biological Defense Research Program (MBDRP). The candidates have not
been tested in humans and do not have current FDA IND status. USAMRIID
maintains approximately 30,000 troop effective doses of cGMP dGA
(deglycosylated A chain) vaccine candidate that has demonstrated a 90%
protection level against 1015 LD50 of aerosolized ricin toxin in non-
human primates. This earlier generation vaccine was developed at a time
when human efficacy testing would have been the only way to achieve
licensure, and has remained ``on-the-shelf'' for contingency use as an
investigational product. Although the advent of the FDA's ``two-animal
rule'' has technically opened the way for further development, the
manufacturing process of dGA is outdated and likely precludes further
advanced development A new generation ricin vaccine candidate is
presently under development under Defense Technology Objective (DTO)
CB.46. This candidate is produced by recombinant technology and is
projected for transition to the Joint Program Executive Officer for
Chemical and Biological Defense in FY2006.
Research on pretreatment or early treatment (hours to days before
or after exposure) has demonstrated initial proof of concept in animals
that large amounts of experimental antibodies given as a therapeutic
may mitigate ricin toxicity when the toxin is directly injected.
However, administration of pre-made antibodies is expected to be less
effective against ricin aerosol exposure. The ``window of opportunity''
for post-exposure treatment with antibodies is narrow because ricio
binds and is taken up rapidly by exposed cells lining the airways. An
acceleration of these efforts by the DOD would require better
definition of the military use for prophylactic antibodies (vs.
vaccination) and, as warranted, research and development to produce new
human therapeutic antibodies. Although lack of clear military utility
for such a therapeutic may limit the military investment in this
approach, the USAMRIID is available to partner with other funding
agencies is furthering this effort. The development and availability of
a ricin therapeutic would certainly have utility for U.S. military
personnel exposed to the threat, however a therapy would have even
greater applicability for medical defense in a civilian population
where the use of prophylactic vaccines may be more difficult to
justify.
Questions from the Honorable Jim Turner for Anna Johnson-Winegar
Question: 1. Do we have a coherent biodefense strategy today? How
should we build one? What should the core elements be? How should its
overall goals and objectives be set? What might they look like?
Answer: As of today (June 2004), this nation does not have a
coherent biodefense strategy in place. While there has been some effort
to develop parts of a comprehensive plan, the planning process has not
been inclusive, and the communication of what has been proffered has
fallen far short of what is needed. The United States does not need a
classified plan that is not available to or understood by the public;
this will not be effective in allaying fears and concerns. In order to
build a better plan, the administration, working with the appropriate
agencies and experts must reach out in a more proactive fashion.
Convening Blue Ribbon panels of experts is one step that can take
advantage of the various independent thinkers who have been dealing
with all aspects of biodefense. Additional Congressional hearings also
provide another forum for obtaining information, although these
sessions are often limited by time and the results are not well
publicized. The overall goals and plans for a biodefense strategy
should be developed in a consensus from the component parts. A
suggested list (although not comprehensive) would include the
intelligence community; medical community; policy experts;
communication specialists; and leaders in the scientific and
engineering fields. There should be a phased approach, identifying
those objectives that can be reached in the short term (less than one
year); mid-term (one to three years); and long term (greater than three
years). Periodic reports should be issued so that an unbiased,
professional analysis can be generated about the progress being made
and the availability of funding, personnel and facilities dedicated to
the plan.
Increasingly, there are some who see bioterrorism preparedness as a
trade-off. That is, funding for public health preparedness for
infectious diseases means less money for other functions, such as
community health, elderly care or obesity reduction plans. Focusing on
a new anthrax or tularemia vaccine means less of a focus on
tuberculosis or malaria.
Question: 2. Are these concerns real? Given our experience to date,
is it possible to make bioterrorism truly ``dual-use''? What can we do
better to achieve an all-hazards approach?
Answer: There must be a balance between the emphasis on infectious
diseases (both naturally occurring and bioterrorist disseminated) with
chronic diseases. The research needs of both communities have common
areas of interest and this is the path that must be pursued to make the
work truly ``dual-use''. One easy example is the need for basic
research that more clearly defines the immune system and its response
to pathogens (regardless of the source of the pathogen). Other examples
include development of generic drugs that can be used to treat a
variety of diseases (both acute and chronic), and development of more
rapid diagnostic systems.
Funding for public health preparedness for infectious diseases also
helps build the infrastructure that will be available to address other
concerns. As we learn more about how pathogens interact with the body
and how they enter the body (via aerosol dissemination or by mosquito
bite), we can apply this knowledge to a broader array of diseases. It
doesn't have to be one or the other! There is plenty of work to be done
and much can be useful in broad application.
To achieve a better all-hazards approach, we have to stop thinking
about one disease at a time. The threat list of bioterrorism agents IS
long enough, but the number of diseases on the naturally occurring
infectious list, added to those considered chronic is daunting. More
emphasis should be placed on multi-valent vaccines, non-specific immune
enhancers, and awareness of general health issues.
The Administration has developed a Biowatch program, deployed in
cities throughout the country, and a new biosurveillance initiative,
which is to involve building complex new information systems both at
DHS and at the Centers for Disease control, known as BioSense. The
concept of detecting a release as early as possible makes a lot of
sense in terms of protecting the public. But DHS itself admits that the
Biowatch system may be too costly and labor intensive. Some scientists
have suggested that syndromic surveillance, the basis of BioSense, has
not been proven to work.
Question: 3. Are these systems ready to be fielded, or do we need
more research and develop better systems first? Are the resources we
are devoting to this system well-spent?
Answer: The systems that are fielded today need substantial
improvement. First, they are point detectors. The design of these
systems only enables filter collection of air samples from a limited
area in the immediate vicinity of the collector. Therefore, it is
critical to place the detector system in the optimal location. Without
knowing where an attack may occur, this is simply a guess. There are a
number of computer projections that determine the minimal number of
systems needed to cover a given area (a city, or a military
installation), but the number in use today is far below the minimum for
each location. The systems are indeed labor intensive, and require
sophisticated laboratory analysis of the filters to determine presence
of a biological agent. Sustainment costs for these systems are very
high. The resources being spent on these systems is not well spent
since they are not fully developed, are prone to false positives,
require extensive quantities of consumable expensive reagents and are
not necessarily located in the right places.
Question: 4. Are these the best we can do in detection, or are
there other options we should be considering?
Answer: The systems in use today in the Biowatch program are among
the best available. However, the assays in use are based on specific
reagents, which, by definition, limit the scope of the system. In other
words, you have to know what you're looking for, then develop the right
reagents, and maintain the system accordingly. As the list of potential
I bioterrorist threats increases, more reagents must be developed and
added to the existing array. While the reagents available today cover
most of the highest probability threats, they are certainly not
comprehensive. In addition, the level of sensitivity needs to be
improved by several orders of magnitude to approach maximal
effectiveness. A bigger concern is the lack of absolute correlation
between competing systems developed by different laboratories. There is
currently no federal agency or organization that is the certifying
group for these types of reagents. When different results are obtained
(one positive, one negative), the credibility of detector systems comes
into question. More research is needed in stand-off detection for
biological agents. Approaches include various types of spectroscopy and
lasers to probe and interrogate potential agent clouds. These types of
systems are not ready for even preliminary fielding, but should be the
option of choice for future work.
With regard to biosurveillance, I agree that this has not yet been
proven to work. In concept, the idea is good, but it will be costly to
develop the information systems that can collect and coordinate the
input from private physicians, hospitals, schools, drug stores, and all
the other contributing elements. Since the possibility exists that the
first cases of a bioterrorist attack may show up in very dispersed
areas (i.e. assume the release of an agent in an airport with symptoms
not beginning for 24 hours), it will be critical for BioSense to
capture data from extensive geographical areas. While the CDC seems the
appropriate organization to collect and analyze the data, they are not
currently staffed to undertake this responsibility. Submission of data
to the system will be voluntary and there is no real mechanism to
monitor compliance. The costs associated with this type of passive
system have not been fully evaluated. Finally, issues of patient
confidentiality have not been suffiiently addressed.
In your testimony, you mentioned that even with perfect detectors,
we need a robust ``concept of operations'' to make that detector part
of a real working system that will improve our biosecurity. That seems
to be exactly what we lacked during the anthrax attacks. Once the
attack was detected here or in Florida, or New York, no one seemed to
know quite how to respond, or what to tell the public.
Question: 5. Do we have a better ``concept of operations'' today
behind our civilian biodetection systems, particularly Biowatch?
Answer: I believe we have made progress in establishing a better
concept of operations. Coordination with state and local officials has
been an important advance in our understanding of how results from
Biowatch would be reported and utilized throughout the nation. Various
training exercises have been completed which provide the foundation for
a comprehensive approach. These efforts must be continued so that
confidence in the systems can be improved.
Most biodefense programs before 9/11 were carried out by the
Department of Defense. You pointed out in your testimony that funding
for medical countermeasures has grown exponentially following 9/11, but
that this growth has primarily occurred at other agencies, NIAID now
has a $1.7 billion budget, far larger than USAMRIID's $66.3 million,
and even larger than DOD's entire chemical and biological defense
research budget, including medical and non-medical projects, of $359.3
in FY04.
Question: 6. Let's say you were back at DOD, but with a budget
of$7.3 billion, the combined NIAID and Bioshield budgets. What would
you do differently than we are doing today?
Answer: As you are aware, the NIAID and BioShield budgets encompass
only medical research and procurement of medical countermeasures. I
would reallocate more research funding into the non-medical components
of a comprehensive program. This would include more work on stand-off
biodetection; development of better decontamination solutions; and more
efforts in modeling and simulation to understand dispersion of
biological agents. There are many unanswered questions about aerosol
dissemination of biological agents. Much of the work today relies on
data generated 50 years ago or more, including estimates of the LD50
for humans (e.g., is the estimate of 10,000 anthrax spores the correct
LD50 for humans, or is it lower in some individuals?), early clinical
signs for many agents, and estimates about survivability of biological
agents in various delivery forms. In addition, I would rearrange the
emphasis of the medical funding to focus on development of appropriate
animal models and to expand the funding available for necessary
clinical trials for safety and immunogenicity of potential new
countermeasures. As I stated during the hearing, I think the NIAID
approach toward basic science that is investigator initiated will not
lead to many new products. Conversely, the BioShield legislation allows
for procurement of medical countermeasures that are near FDA licensure.
There is an obvious gap in the work since there is not any focus on
pivotal animal studies and development of surrogate markers to
establish immunity in humans. Making effective transitions from
laboratory scale basic research into production quantities of effective
countermeasures should be a high priority for developmental funding.
Government Owned- Contractor Operated Facilities
Question: 7. What is a GOCO facility for medical countermeasure
development?
Answer: During the first Gulf War (1990-91), the DOD needed larger
supplies of several medical countermeasures for biological agents,
primarily anthrax vaccine and botulinum toxoid. The only manufacturer
at the time (the Michigan Department of Public Health, subsequently
BioPort) had limited facilities and while they worked diligently to
increase production, they were unable to meet the needs of the United
States military, much less any Allies or coalition partners. The DOD
commissioned a special task force (code named Project Badger) that
contacted all commercial vaccine manufacturers to assess their interest
and willingness to produce extra doses of these critical vaccines. None
were responsive due to limited availability of facilities; concerns
about liability and indemnification; concerns about long-term funding
for the effort; concerns about safety; need for bio-containment
laboratories (BL-3 required) and lack of specialized, dedicated
equipment needed for these products. (There is an FDA regulation that
any product made from a spore-forming organism, such as Bacillus
anthracis or Clostridium botulinum must be produced in dedicated
equipment that can not be used subsequently for other vaccines). .
Ultimately, the Project Badger report recommended that DOD pursue
the option of establishing a stand-alone Vaccine Production Facility.
The best option appeared to be a facility that was government owned
(and funded), but .operated by contractors since DOD lacked sufficient
personnel to staff such a facility. The complete Project Badger report
has now been declassified and is available for your review. Following
the Project Badger recommendation, the Army developed costs, evaluated
potential locations, and ultimately, the DOD submitted a budget for a
VPF in the POM. A small amount of funding ($25 million) was
appropriated in FY02 for design studies, but after further review, the
project was deleted from the DOD budget request.
Question: 8. How would the use of this kind of facility differ from
the BioShield approach? How would it differ from the approach NIH is
taking to product development?
Answer: The GOCO approach requires construction of a stand alone
facility that will be owned by the government. Both the BioShield and
NIH approaches rely on use of existing industrial facilities. Although
the pharmaceutical firms seem opposed to the GOCO approach, citing the
availability of capacity already existing, this belies that fact that
each year industry has difficulty meeting existing market demands.
Recent shortages in tetanus, pertussis, and flu vaccines support the
perception that there is no excess capacity available for biodefense
vaccine work. While scheduling production runs of various products is
not a trivial exercise, the profitability and marketability of a
specific item seem to be high priorities. There is genuine concern that
the existing facilities will be taxed (at over 80% capacity) to meet
current needs for widely used products, ranging from influenza vaccine
to the childhood vaccines.
The GOCO approach also differs from current alternatives in that
both NIB and the BioShield approach require a specific solicitation for
each product. The RFP process is time consuming and mandates that
potential contractors spend time developing a proposal and negotiating
final specifications. In the GOCO approach, a long-term contract (10
years or more) is envisioned, with annual funding for the workforce
salaries, supplies, validation and licensing costs, etc. The actual
product(s) to be produced each year can be decided on as-needed basis,
rather than projecting far in advance. This provides much more
flexibility to the government. Also, by making a long-term commitment
to a GOCO, the government sends a strong signal about sustained support
for medical countermeasures for biological agents. Referring back to
the ``dual-use'' question above, the GOCO facility should be considered
a national asset. While development and production of bio-defense
products would be the first priority, this facility would be available
as a back-up to industry for either surge production of a particular
vaccine, or as an alternative should a current production facility be
closed for renovation or because of FDA violations identified during
routine inspections. Since the nation finds itself in a position where
there are fewer licensed vaccine manufacturers than ever before, and
since many products are made in only one facility (raising
vulnerability), the concept of a back-up facility should be considered
an attractive alternative.
The GOCO facility should be designed as a multi-functional
building, with several types of production suites (e.g., bacterial
fermentation; tissue culture in roller bottles; etc); pilot development
scale laboratories; common areas for bottling and storage of final
products; appropriate containment laboratories for animal testing of
candidate vaccines; and other required functions. The understanding is
that the facility would be totally regulated and inspected by the Food
and Drug Administration, thereby assuring high quality products with
external review. Validation of the facility and all the equipment and
processes is a complex process and could take several years after
completion and trial runs. The facility would not normally compete with
private industry, thus allaying their concerns about profit, but would
serve as an adjunct to the current concepts.
Question: 9. Should Congress still consider a GOCO facility?
Answer: While there are still issues to be resolved, such as which
department should be in charges of a GOCO facility, I firmly believe
this is the right approach for the government. The key features of a
GOCO facility include the following:
government control of production, availability, and
distribution
flexibility for emergency production technologies
meets national security priorities for bio-defense
vaccines
overcomes limited industry interest in bio-defense
products
existing government labs provide supporting research
and development
operating contractor would provide specialized
expertise in vaccine production and regulatory requirements
At the time of the original proposal in the early to mid 1990's, a
GOCO facility was estimated to cost only $125 million for construction.
The revised estimate prepared by the DOD in 2000 estimated $856.5
million for design and construction, with annual operating costs to be
added to this figure. As time passes, the costs will only increase, and
the nation will be at the mercy of the fragile, profit-motivated
pharmaceutical industry to make the bio-defense vaccines that are
needed. In my opinion, Congress should strongly consider appropriating
funds for a GOCO facility for bio-defense medical countermeasures.
The National Biosecurity Analysis and Countermeasures Center
(NBACC) at the Department of Homeland Security will be responsible for
assessing the threat of bioterrorism. I'm interested in hearing from
you about the mission of this institution.
Question: 10. What capabilities will NBACC bring that DOD did not
have during the last several decades? Is this a wholly new function, or
something of a duplication of national security functions, but for
homeland defense?
Answer: The Department of Defense program in biological defense
over the past decades (since 1969 when President Nixon ended the U.S.
offensive biological warfare program) has been purely defensive in
nature. It has been a reactive, not a proactive program. The
capabilities envisioned for NBACC position it to be more proactive in
conducting the appropriate kinds of studies and analyses to validate
threats and make more realistic predictions about the use of biological
agents. For example, the work done following the anthrax attacks in the
fall of 2001 on how the anthrax ,spores were released through the
letters and the mail sorting machines, as well as how effectively
radiation could be used to kin the spores in the mail, is work that
does not fall under the mission of the DOD biodefense program. Other
work needs to be completed on assessing the infective doses of some
biological agents via the respiratory route since current estimates are
based on outdated methods for enumerating organisms and assessing
viability. In addition, NBACC should assume the responsibility for
maintaining data bases with information on multiple strains of
organisms such as anthrax. The DNA sequencing of many pathogens is
underway, and NBACC should use this data in their forensic
responsibilities. While there may be some overlap between the national
security function of DOD and the NBACC mission, I believe the NBACC
mission surpasses the limited role of the DOD. Clearly, there must be a
coordination of efforts between these agencies, as well as the
intelligence community for NBACC to be successful.
Another issue I want to ask you about is how NBACC should carry out
its duties. There is significant concern about the potential for new
technologies in biology to be applied to create a more dangerous
bioterror threat. Many are concerned that these experiments should
never be tried, and, if they occur accidentally, the results kept
secret.
Question: 11. How exactly should NBACC assess the assessment of
this threat? Should NBACC attempt to create some of these more
dangerous pathogens, or refine techniques for weaponization? Is there a
situation where such experiments are legitimate?
Answer: Since there are no restrictions on terrorists, it would be
prudent for an organization such as NBACC to be able to analyze
experiments that have been reported in the open scientific literature
to determine widespread applicability. One immediate example that comes
to mind would be for NBACC to perform the studies that determine
whether currently available vaccines (such as anthrax vaccine) are
effective in protecting against all strains of the organism that exist
in nature. Following this, efforts should be made to obtain samples of
genetically modified organisms (such as that reported by the Soviets)
to test the effectiveness of our detectors and medical countermeasures.
In the absence of such confirmatory data, we are only deluding
ourselves about the breadth and depth of our protection. Reproducing
the laboratory work of others, and conducting some well controlled
experiments to evaluate the ease of production of new more potent
organisms are appropriate for the mission of NBACC, in my opinion.
There is a great deal of controversy in the scientific community
about restrictions on publishing data on biological agents. While the
``publish or perish'' philosophy exists in
Question: 15. Should we be worried about Russian biological
programs? Is there more the United States should be doing at former
bioweapons sites in the former Soviet Union?
Answer: I have limited knowledge of the activities the United
States is pursuing in the former Soviet Union, and would defer this
question to those with more expertise. However, my belief is that the
former Soviet Union (along with other counties) maintains a robust
research program in biological warfare. The limited program underway to
convert former bioweapons sites to peaceful objectives is slow due to
administrative issues and reluctance to accept new goals and
objectives. Retraining scientists and technicians will take a matter of
years, and the ultimate success of the program depends upon continued
financial support coupled with appropriate levels of monitoring for
safety and security. In my opinion, the individuals participating in
these programs can be motivated by financial security, the opportunity
to publish their findings in the open scientific literature, and the
opportunity to participate as equals in international scientific
conferences.
No Responses to the Following Questions have been Recieved:
Questions for the Record from Ranking Member Jim Turner, for Dr.
Anthony S. Fauci
1. The Administration's recent ``Biodefense for the 21st Century''
strategy document indicated that HHS is responsible for the
``anticipation of future threats?'' What will HHS do in this area and
how will it differ from the work at NBACC?
According the Homeland Security Act, HHS is to work collaboratively
with DHS as its sets goals and policies for medical countermeasures
development. You have indicated in your testimony how this is
occurring. DHS is also working with USDA on developing veterinary
medical countermeasures to counteract agroterrorism.
2. Can you describe the difference between how these two inter-
agency countermeasures research programs are managed, and whether one
is working better than the other?
3. How do threat information and vulnerability assessments
collected by DHS influence the research agendas, if at all?
4. Are NIH researchers and program managers given access to this
threat information or allowed to set their own research agendas based
on this information?
5. Do the National Institute of Allergy and Infectious Diseases and
USAMRIID coordinate on setting research agendas? How would NIAID know
whether USAMRIID is pursuing the same pathogen?
6. Right now there is no treatment for Ricin exposure-once someone
is exposed, they will die. And yet recent experience has shown that it
is relatively easy to gather materials and transmit the toxin around
the country. This is arguably a more serious threat than anthrax
because at least anthrax has a vaccine and a course of treatment. So
who has looked at this and determined it's not important to invest in a
Ricin treatment? How is this decided?
It seems that thus far our biodefense strategy has largely been
driven by the nation's vulnerability to a mass-casualty attack, such as
terrorist use of smallpox or a large airborne anthrax release. This is
reflected in the categorization of agents on the A, B, and C priority
pathogen lists from Centers for Disease Control--with smallpox and
anthrax on the A list.
However, the anthrax letter attacks in October, 2001 suggest we may
need to pay attention to small- and medium-sized attacks, too. The
Congressional Research Service has done such an assessment, and,
interestingly, anthrax and smallpox were not at the top of the list.
Instead, they determined glanders was the top concern, currently a
category B agent.
7. Are you aware of this assessment, and if so, what do you think
of it? Does the current priority listing of pathogens need to be
reassessed? Has it been reassessed? Who would be responsible for such a
reassessment and when and how will it get done?
Project Bioshield
8. Will the implementation of Project Bioshield change the way
NIAID spends its biodefense budget?
9. Will you continue to fund advanced development of
countermeasures, such as the new anthrax and smallpox vaccine projects,
or will you leave it to the guaranteed market under Bioshield to lead
to development?
Anthrax Vaccine
10. What is the justification for a new anthrax vaccine (rPA) when
there is already an FDA approved vaccine (A V A) that has been used for
years by the military?
11. Is it true that the new vaccine is similar to the existing
vaccine in terms of safety, efficacy, and delivery? Please consider the
purpose and results of the CDC anthrax vaccine safety and efficacy
research program in your answer.
12. Please explain why the development and purchase of rPA for the
stockpile is, at this time, a better investment than either (a)
purchase of A V A for the stockpile, or (b) research and development of
an oral or other advanced vaccine.
NIB has obligated nearly $750 million for the construction of new,
high security biodefense labs around the nation, so-called BSL-3 and
BSL-4 labs. In addition, the CDC, the Department of Agriculture, the
Department of Defense, the Department of Energy, and the Department of
Homeland Security are all planning to construct new facilities.
13. What study was conducted to determine our requirements for BSL
laboratory space? What were the conclusions of that study in terms of
how much space is needed?
14. Communities are rightly concerned about the possible escape of
a harmful pathogen from one of these labs. We need only reference the
recent escape of SARS from a Chinese research lab to know that it is
possible. What protocols are in place to protect communities from an
accidental release of a harmful or lethal pathogen?
Questions for the Record from Representative Nita Lowey for Dr. Anthony
S. Fauci
1. Can you please tell the Committee what is being done to support
the development and deployment of radiological medical countermeasures?
No response has been received.
It is my understanding that the Department of Health and Human
Services has issued two requests for information (RFI)--one from the
Centers for Disease Control and Prevention in February 2004 and one
from the National Institute of Allergy and Infectious Diseases in April
2004--regarding the development of radiological countermeasures.
2. Considering the Attorney General's recently mentioned threats,
can you please explain the need for two different RFIss rather than a
request for proposals (RFP)? No response has been received.