[Senate Hearing 106-352]
[From the U.S. Government Publishing Office]
S. Hrg. 106-352
BIOTERRORISM--DOMESTIC WEAPONS
OF MASS DESTRUCTION
=======================================================================
JOINT HEARING
before the
SUBCOMMITTEE ON
LABOR, HEALTH AND HUMAN SERVICES,
AND EDUCATION, AND RELATED AGENCIES
COMMITTEE ON APPROPRIATIONS
and the
COMMITTEE ON VETERANS' AFFAIRS
UNITED STATES SENATE
ONE HUNDRED SIXTH CONGRESS
FIRST SESSION
__________
SPECIAL HEARING
__________
Printed for the use of the Committees on Appropriations and Veterans'
Affairs
Available via the World Wide Web: http://www.access.gpo.gov/congress/
senate
______
U.S. GOVERNMENT PRINTING OFFICE
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_______________________________________________________________________
For sale by the U.S. Government Printing Office
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ISBN 0-16-060194-0
COMMITTEE ON APPROPRIATIONS
TED STEVENS, Alaska, Chairman
THAD COCHRAN, Mississippi ROBERT C. BYRD, West Virginia
ARLEN SPECTER, Pennsylvania DANIEL K. INOUYE, Hawaii
PETE V. DOMENICI, New Mexico ERNEST F. HOLLINGS, South Carolina
CHRISTOPHER S. BOND, Missouri PATRICK J. LEAHY, Vermont
SLADE GORTON, Washington FRANK R. LAUTENBERG, New Jersey
MITCH McCONNELL, Kentucky TOM HARKIN, Iowa
CONRAD BURNS, Montana BARBARA A. MIKULSKI, Maryland
RICHARD C. SHELBY, Alabama HARRY REID, Nevada
JUDD GREGG, New Hampshire HERB KOHL, Wisconsin
ROBERT F. BENNETT, Utah PATTY MURRAY, Washington
BEN NIGHTHORSE CAMPBELL, Colorado BYRON L. DORGAN, North Dakota
LARRY CRAIG, Idaho DIANNE FEINSTEIN, California
KAY BAILEY HUTCHISON, Texas RICHARD J. DURBIN, Illinois
JON KYL, Arizona
Steven J. Cortese, Staff Director
Lisa Sutherland, Deputy Staff Director
James H. English, Minority Staff Director
------
Subcommittee on Labor, Health and Human Services, and Education, and
Related Agencies
ARLEN SPECTER, Pennsylvania, Chairman
THAD COCHRAN, Mississippi TOM HARKIN, Iowa
SLADE GORTON, Washington ERNEST F. HOLLINGS, South Carolina
JUDD GREGG, New Hampshire DANIEL K. INOUYE, Hawaii
LARRY CRAIG, Idaho HARRY REID, Nevada
KAY BAILEY HUTCHISON, Texas HERB KOHL, Wisconsin
TED STEVENS, Alaska PATTY MURRAY, Washington
JON KYL, Arizona DIANNE FEINSTEIN, California
ROBERT C. BYRD, West Virginia
(Ex officio)
Professional Staff
Bettilou Taylor
Mary Dietrich
Jim Sourwine
Aura Dunn
Ellen Murray (Minority)
Administrative Support
Kevin Johnson
Carole Geagley (Minority)
------
COMMITTEE ON VETERANS' AFFAIRS
ARLEN SPECTER, Pennsylvania, Chairman
STROM THURMOND, South Carolina JOHN D. ROCKEFELLER IV, West
FRANK H. MURKOWSKI, Alaska Virginia
JAMES M. JEFFORDS, Vermont BOB GRAHAM, Forida
BEN NIGHTHORSE CAMPBELL, Colorado DANIEL K. AKAKA, Hawaii
LARRY E. CRAIG, Idaho PAUL WELLSTONE, Minnesota
TIM HUTCHINSON, Arkansas PATTY MURRAY, Washington
Charles Battaglia, Staff Director
Jim Gottlieb, Minority Chief Counsel/Staff Director
C O N T E N T S
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Page
Statement of Kenneth W. Kizer, M.D., Under Secretary for Health,
Department of Veterans' Affairs................................ 1
Statement of Margaret A. Hamburg, M.D., Assistant Secretary for
Planning and Evaluation, Department of Health and Human
Services....................................................... 1
Statement of Henry L. Hinton, Jr., Assistant Comptroller General
for National Security and International Affairs, General
Accounting Office.............................................. 1
Opening statement of Senator Arlen Specter....................... 1
Opening statement of Senator Ben Nighthorse Campbell............. 2
Opening statement of Senator John D. Rockefeller IV.............. 3
Prepared statement of Senator Dianne Feinstein................... 5
Summary statement of Dr. Kenneth W. Kizer........................ 6
Draft Responses of Hon. Kenneth W. Kizer to Questions Submitted
by Senator Arlen Spector, Chairman, Committee on Veterans'
Affairs........................................................ 7
Responses of Hon. Kenneth W. Kizer to Questions Submitted by
Senator Robert C. Byrd, Committee on Appropriations............ 9
Summary statement of Margaret A. Hamburg, M.D.................... 10
Prepared statement........................................... 12
Summary statement of Henry L. Hinton, Jr......................... 15
Prepared statement........................................... 17
The foreign and domestic terrorism threat in the United
States................................................. 18
Threat and risk assessments can help define requirements
and prioritize and focus program investments........... 19
Our ongoing work examining the biological and chemical
terrorist threat....................................... 19
Preliminary observations on HHS' public health
initiatives related to bioterrorism.................... 20
Appendix I--Related GAO Products......................... 21
GAO reports...................................................... 22
Responses to Questions Submitted to Dr. Hamburg by Senator
Specter........................................................ 24
NSC Tasking Concerning Bioterrorism Preparedness (1998)...... 25
Consultation on Anthrax Vaccines (January 15,1998)........... 25
Inter-Departmental Working Group on Response to a Weapon of
Mass Destruction (1998).................................... 25
Five Year Inter-Agency Counter-Terrorism and Technology Crime
Plan Working Group 4: Crisis/Consequence Planning and
Management................................................. 25
Five Year Inter-Agency Counter-Terrorism and Technology Crime
Plan Working Group 5: Preventing and Responding to
Terrorism Involving Nuclear, Biological & Chemical (NBC)
Weapons.................................................... 25
Biological threats............................................... 25
Letter to Jacob J. Lew, Director, OMB, from Senator Arlen Specter 30
Letter to Senator Arlen Specter, from Jacob J. Lew, Director, OMB 30
Draft prepared statement of Kenneth W. Kizer..................... 31
Statement of Joshua Lederberg, M.D., president-emeritus and
Sackler Foundation scholar, Rockefeller University, New York
City........................................................... 37
Prepared statement........................................... 39
From Epilogue Biological Weapons--Limiting the Threat:
MIT Press 1999......................................... 42
Statement of Donald A. Henderson, M.D., M.P.H., director, Center
for Civilian Biodefense, the Johns Hopkins University.......... 44
Prepared statement........................................... 46
The unique nature of the biological threat............... 46
Responses following a Bioweapons Attack.................. 47
The national initiative.................................. 47
A look to the future..................................... 48
Statement of Robert C. Myers, M.D., chief operating officer and
director, Bioport Corp......................................... 48
Prepared statement........................................... 50
Coordinate existing programs..................................... 53
BIOTERRORISM--DOMESTIC WEAPONS OF MASS DESTRUCTION
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TUESDAY, MARCH 16, 1999
U.S. Senate, Subcommittee on Labor, Health and
Human Services, and Education, and Related
Agencies, Committee on Appropriations, and
Committee on Veterans' Affairs,
Washington, DC.
The subcommittee and Committee met jointly at 9:33 a.m., in
room SD-106, Dirksen Senate Office Building, Hon. Arlen Specter
(chairman) presiding.
Present: Senators Specter, Stevens, Kyl, Campbell, and
Rockefeller.
DEPARTMENT OF VETERANS' AFFAIRS
STATEMENT OF KENNETH W. KIZER, M.D., UNDER SECRETARY
FOR HEALTH
DEPARTMENT OF HEALTH AND HUMAN SERVICES
STATEMENT OF MARGARET A. HAMBURG, M.D., ASSISTANT
SECRETARY FOR PLANNING AND EVALUATION
GENERAL ACCOUNTING OFFICE
STATEMENT OF HENRY L. HINTON, JR., ASSISTANT
COMPTROLLER GENERAL FOR NATIONAL SECURITY
AND INTERNATIONAL AFFAIRS
opening statement of senator arlen specter
Senator Specter. Good morning, ladies and gentlemen. This
joint hearing of the Veterans' Affairs Committee and the
Appropriations Subcommittee on Labor, Health and Human Services
will now proceed.
Our subject this morning is domestic weapons of mass
destruction. The issue of weapons of mass destruction is one of
overwhelming importance in America today and, for that matter,
throughout the world. As we speak, the Senate is considering
legislation which would establish a national missile defense
for rogue terrorist nations.
The question of biological warfare and chemical warfare has
been one of enormous importance as it applies to the domestic
scene. Congress has appropriated very large sums of money to
the FBI on counterterrorism. There is a commission now at work
to deal with the governmental organization on weapons of mass
destruction.
Legislation was inserted into the 1996 defense
authorization bill, at a time when I chaired the Intelligence
Committee, to take a fresh look at the 96 separate agencies
which deal with weapons of mass destruction. High on the list
is the question of what happens domestically, where
responsibility has been lodged with the Department of Health
and Human Services and the Department of Justice and the
Veterans Administration.
Today, we are going to make inquiries into what line of
preparedness there is at the present time and what ought to be
done. This hearing is held in coordination with the work of the
Commission on Weapons of Mass Destruction chaired by former CIA
Director John Deutch to try to get some insights to see what
more ought to be done or how our organization ought to be
structured to take appropriate stock of this very, very serious
problem.
Today we have six distinguished witnesses and our lead
witness is Dr. Kenneth W. Kizer, Under Secretary for Health in
the U.S. Department of Veterans Affairs. As the chief executive
officer of the VA Administration and the highest ranking
physician in the Federal Government, Dr. Kizer oversees the 173
VA hospitals and administers a medical budget of $17 billion,
not enough, but a starting point.
Dr. Kizer, let me put a pointed, specific question to you
as to the role of the Veterans Administration in dealing with
the issue of weapons of mass destruction on the domestic level.
Before I do, we have Senator Campbell with us. Senator
Campbell, would you care to make an opening statement?
opening statement of senator ben nighthorse campbell
Senator Campbell. Thanks, Mr. Chairman. I have a conflict,
so I will have to run in a few minutes. But I am very
interested in this hearing.
Coincidentally, just a few months ago we had three families
in Colorado Springs, which is our second largest city in
Colorado, that received letters and packages with warnings that
the package contained anthrax. I cannot imagine anybody sending
a package where they would label it on the outside, but that
did happen. It did throw a big scare into our local response
teams, our HAZMAT teams out there.
As we move along, I know it will not be strictly in the
purview of this Committee, but I would like to--I would hope
that as you do move along we do some exploration with other
committees about how we are going to interact with the Federal
Government and local teams.
Some firemen came in this morning, in fact, and they were
telling this about these packages last fall. The firemen that
were in this morning, they described themselves as test rats.
They said they get so little help from the Federal Government
that when there is any kind of a terrorist threat, when they
have to go out they go out totally unequipped with knowledge or
equipment and it is kind of by hook or crook. If some die they
must have the wrong equipment. If they manage to survive the
thing, then they must have the right equipment.
That is a pretty tragic way to respond to any kind of a
threat of some of these biological weapons. So as we do move
along I would hope this Committee would look into some
interaction with other committees on seeing if we cannot
provide some Federal assistance to those local teams.
Thank you, Mr. Chairman.
Senator Specter. Thank you very much, Senator Campbell.
Our distinguished ranking member, Senator Rockefeller, for
an opening statement.
opening statement of senator john d. rockefeller, iv
Senator Rockefeller. Thank you, Mr. Chairman, very much.
I do not know who Daniel Greenberg is, but he probably
ought to move to Oregon as quickly as possible, because this
has to be one of the most ridiculous articles I have ever read
in my life--his op-ed piece in this morning's Washington Post--
in which he blithely dismisses the subject that a lot of people
worry about, in a childlike way. He may be a scientist. I have
no idea. But I think he should move to Oregon.
I think that it is a serious problem and I think that----
Senator Specter. How far is Oregon from West Virginia,
Senator?
Senator Rockefeller. Oregon is a long way from West
Virginia, a long way from West Virginia, and may it ever remain
so.
I think the potential for exaggeration, which is, of
course, what he emphasizes--that this concern is all
exaggerated--obviously, in anything of this sort, the potential
for exaggeration is high because it is speculative. On the
other hand, it is extremely real. It has always occurred to me,
just in the nature of common sense, that entrepreneurial or
ideological terrorism, biological or chemical, is a part of
what we are facing in this country and is as great a threat or
greater than the threat that the Soviet Union posed to us.
Ebola, smallpox, anthrax, all of these things, whether they
are imagined or not, are there and have the potential to bring
unspeakable horrors upon this country.
So I am glad that the administration has taken this threat
seriously, or appears to be. It is an enormously complicated
matter, the coordination of a response. I think in the
Department of Defense I counted 19 separate divisions which
deal with this, and I think in HHS I counted 10. So that is two
agencies, 29 defense groups.
So, we are undertaking, as Senator Campbell has just
indicated, a very difficult thing, in which States and their
agencies have to try to cooperate on this. It is fascinating to
me and very depressing that only about half of the public
health facilities in this country even have the computers with
which to try to do the best they can to communicate with CDC,
which by definition, therefore, would be an impossibility. We
are way, way, way behind in our efforts to deal with
bioterrorism in whatever form.
I think generally people would agree that one of the
biggest challenges is fortifying our medical system, including
improving our laboratory capability and vaccine stockpiling.
Most U.S. hospitals, including VA hospitals, are not
necessarily prepared to treat patients contaminated by chemical
or biological agents, and we can discuss that.
I think our medical system must be merged with grassroots
public health offices, at least half of which are virtually
unprepared to deal with anything of this sort, even to
communicate about it.
Our challenge is to build upon the existing public health
system and infrastructure to vastly improve the medical
response, and, of course, that is going to be very difficult.
In preparing for an act of bioterrorism, we are going to have
to spend plenty of money.
I do not want to make a long statement, but I want to make
four points, four important points for me:
First, how are we going to ensure that our emergency room
doctors and other frontline health professionals--assuming that
they themselves were not affected by some kind of attack--will
be trained to recognize and treat germ warfare diseases?
In other words, somebody walks in with a biological attack,
which may not show up for a week or two, and has respiratory
problems, coughing, sneezing, and other things. Is that going
to be diagnosed? Are our medical people prepared to diagnose
what may appear to be something quite different and is not, but
in the meantime, is communicable?
Second, given the vast differences between dealing with the
release of chemical weapons versus biological weapons, how can
we simultaneously and successfully pursue remedies to each of
these two?
Third, shortages of vaccines pose a potentially very
dangerous situation, and that, of course, is especially true in
the case of smallpox. I thought that counterposing Daniel
Greenberg's dribblings in this morning's Washington Post was a
slightly more interesting article in the New York Times, which
said that perhaps resurrection of the study of smallpox and
things of that sort could potentially be very useful.
Fourth, what can be done to ensure that there is close
coordination between, as Senator Campbell indicated, major
government players at all levels? We live with this in the
Canaan Valley in West Virginia because we have the highest
concentration of chemicals in that area of any place in the
country, and we are constantly on alert because we have high
populations surrounding very, very difficult chemical
situations.
We are very practiced at it and very good at it, and people
come from all around the country to look at how we prepare for
this. But of course, that kind of potential disaster is nothing
like what we are talking about here.
One more idea, Mr. Chairman, and that is, when you have
such a complex and such a high profile issue, involving so
many, there is often need for a strong national civilian
coordination of the many competing agencies, coordination that
continues from one administration to the next, that is not
Republican or Democrat, is not Bush or Clinton. It just goes
forward.
I have a lot of concerns that we do not have that situation
in place now. We have, I think, a very good person who is in
charge of doing it for this administration. Does that mechanism
continue or is there a better mechanism? One solution would be
creation of a domestic terrorism response advisory board, and I
would like to have the views of witnesses on that, as a
permanent entity to provide overall national guidance. This
would be fashioned on the model of the Presidential Foreign
Intelligence Advisory Board, which I think people think has
worked fairly well.
I thank the chairman.
prepared statement of senator dianne feinstein
Dianne Feinstein asks that I insert a statement in the
record, and who am I to say no.
Senator Specter. Without objection, it will be submitted.
[The statement follows:]
Prepared Statement of Senator Dianne Feinstein
Thank you, Chairman Specter and Ranking Minority Member Harkin for
holding today's hearing on biological terrorism.
I look forward to hearing today's testimony because I believe many
of us are very concerned about how prepared our nation might be for
these biological threats. Any threat of terrorism is a great cause of
concern. Biological terrorism has its own unique dimensions because
biological agents can do great harm with small quantities; they can be
relatively easily concealed and delivered; they can spread quickly; and
their symptoms can take days to develop and are difficult for health
care workers to diagnose.
As a former mayor who had to worry about prompt emergency responses
to crises of all kinds--from accidents to fires, from AIDS to
earthquakes--I am particularly concerned about the readiness of our
traditional emergency response teams to deal with biological exposures.
No one is immune from this form of terrorism. These agents can be
put into our water, our food, our heating and cooling systems. In
Washington, there have been anthrax scares at the State Department, the
Washington Post, NBC News, the Old Executive Office Building, and here
in the Congress.
But these scares are not confined to Washington. There has been a
virtual rash of them in California: in schools, a nightclub, an office
building, a courthouse and a department store. The Washington Post
reported on January 11, with a dateline of Los Angeles:
A wave of hoaxes involving the lethal bacteria is spreading
across Southern California and turning up in states nationwide.
It is a fad so alarming, so costly and so confounding to police
and public health officials that some almost sound wistful for
the days when they had to contend only with phony bomb scares.
Since late last year, nearly two dozen anthrax threats have
been reported just in greater Los Angeles.
Most experts caution that we are not prepared. For example, at a
conference last year, Dr. Donald Henderson, an expert from Johns
Hopkins University who will testify today, said:
The U.S. lacks the infrastructure, planning and fundin . . .
U.S. efforts to deal with biological weapons used against a
civilian population are only two years old. These actions are
only marginally funded and marginally supported.
Similarly, the December 30, 1998 Los Angeles Times reported:
Recent anthrax threats in Southern California dramatically
underscore the lack of a comprehensive national plan to guide
health agencies responding to biological or chemical terrorism.
. . .
I welcome the budget proposal from the Administration to improve
our ability to respond to biological terrorism. I look forward to
working with you, Mr. Chairman, and the Administration to put adequate
resources into this effort and to reassure the American people that we
can anticipate, detect and respond effectively in hopes that a strong
defense can deter these egregious acts.
Senator Specter. Senator Kyl, do you care to make an
opening statement?
Senator Kyl. No, Mr. Chairman. Thank you.
Summary statement of Dr. Kenneth W. Kizer
Senator Specter. We had just begun to pose a question to
you, Dr. Kizer. I asked the question instead of calling on you
for an opening statement because I am advised that the Office
of Management and Budget has not cleared your statement. So let
us begin with a generalized description of the role which the
Veterans Administration has pursuant to Presidential Decision
Directive 62, issued by President Clinton on May 18, 1998,
which ordered Federal agencies to expand steps to protect
against biological and other conventional domestic attacks.
Dr. Kizer. Thank you, Mr. Chairman, and good morning,
members of the Committee. I am pleased to appear before you
this morning to talk about both current and potential roles for
the Department of Veterans Affairs in Federal emergency
management in general and with regard to weapons of mass
destruction in particular.
As you noted already, I do not have a cleared formal
statement, so what I would like to offer here at the outset is
both a general response as well as a personal reflection based
on some 25 years, or so, of experience in disaster planning and
emergency management. That includes specific experience as a
fireman, as a naval officer involved particularly in some of
these areas, as an emergency physician, as a medical
toxicologist, as a public health official, and as one who has
managed a number of infectious disease emergencies or
epidemics, as well as the largest pesticide poisoning epidemic
in North American history.
In brief, I believe this country is woefully unprepared for
a terrorist incident involving weapons of mass destruction, and
I believe, regretfully, that this lack of preparedness
translates, or would translate, should such occur today, into
unnecessary loss of life and suffering. I think, however, there
is much that could be done in the near term to better prepare
us for such an inevitable event.
I would note for the record that, at least in my mind, just
as there is no doubt that floods and earthquakes and hurricanes
and tornadoes and other such natural disasters will strike the
United States in the future, there is no question in my mind
that a terrorist event involving weapons of mass destruction
will occur in the United States, and the real question is
really only a matter of when and where such will occur and to
what extent we are prepared.
Having offered that perspective, in more specific response
to your question, I would note that the Department of Veterans
Affairs today provides a supportive role to other agencies in
Federal emergency management plans. We also have a specific
role in managing some pharmaceutical caches that might be
needed in the event of a relevant chemical incident. Let me
leave it at that for the moment.
ADDITIONAL COMMITTEE QUESTIONS
Senator Specter. All right, thank you very much, Dr. Kizer.
We will return to you during the more extended question and
answer session.
There will be some additional questions which will be
submitted for your response in the record.
[The following questions were not asked at the hearing, but
were submitted to the Department for response subsequent to the
hearing:]
Draft Responses of Hon. Kenneth W. Kizer to Questions Submitted by
Senator Arlen Spector, Chairman, Committee on Veterans' Affairs
Question. What is VA's current role in assisting localities in
preparing for, and participating in, a medical response to WMD
incidents? Do you believe that VA resources have been adequately
incorporated into the overall Federal plan to assist localities? What
areas do you envision VA playing a larger role?
Answer. The current WMD preparedness role of VA was assigned by
PDD-62, which tasked PHS, working with VA, to ensure adequate
stockpiles of antidotes and other necessary pharmaceuticals nationwide
and to train medical personnel in NDMS hospitals. PHS has provided
funding for four pharmaceutical caches, and there is a provision in the
HHS fiscal year 2000 budget for up to $1 million to be transferred to
VA for NDMS training. Also, under the Federal Response Plan, Emergency
Support Function No. 8, Health and Medical, VA is prepared to respond
to WMD incidents as well as any other local and regional disasters.
VA's potential for an expanded WMD role has not received
appropriate attention. VA, with its institutional capabilities and
infrastructure, could be assigned a larger role in this regard.
VA, with the nation's largest fully integrated healthcare system,
can uniquely contribute to WMD initiatives in the following areas:
--Use of pharmaceutical infrastructure for procurement, management,
and storage.
--Training of health professionals
--Medical and clinical capability
--Coordination with state and local agencies
--Provision of logistical and other support for other federal
agencies
--Research
Question. What funding is VA receiving for its WMD related
activities? What is the source of this funding? How is this funding
expressed in terms of full-time equivalent (FTE) employees? Is funding
increasing for VA involvement in WMD activities? In what areas do you
see a funding shortfall?
Answer. The Department of Veterans Affairs in compliance with Title
38 United States Code 530 submitted its first ``Annual Report on
Program and Expenditures for Domestic Response to Weapons of Mass
Destruction'' to the Committee on Veterans Affairs. This report
indicated the following:
------------------------------------------------------------------------
Fiscal years--
Requirement -------------------------------------
1998 1999 2000
------------------------------------------------------------------------
Funds expended or committed....... $6,100 $41,320 \1\ $1,056,842
Full-time Equivalent Employee 1.15 2.29 2.29
(FTEE)...........................
Source of Funds................... ( \2\ ) ( \2\ ) ( \3\ )
Anticipated Funds................. N/A N/A N/A
Anticipated Personnel Shortfall... N/A N/A N/A
------------------------------------------------------------------------
\1\ The Office of Management and Budget (OMB) has approved $1,000,000
for the Department of Health and Human Services, Public Health Service
(PHS) to fund a WMD training program with VA designated as the lead
training organization. PHS has the discretion to reimburse VA up to
$1,000,000 for expenses incurred in conducting a WMD training program
for non-federal hospitals participating in the National Disaster
Medical System.
\2\ Veterans Health Administration.
\3\ Veterans Health Administration/Public Health Service.
Question. I understand that VA already collaborates with local
hospitals and emergency medical personnel through its involvement in
the National Disaster Medical System (NDMS). Explain VA's involvement
in NDMS as it relates to planning and preparing for a WMD incident. Is
this existing structure being expanded upon to provide more in-depth
training and planning services?
Answer. Under PDD-62, VA is preparing to provide WIND response
training to NDMS hospitals utilizing the 40 VA Area Emergency Managers
(AEMs) located throughout the nation's major population centers. These
AEMs are already responsible for the maintenance of 1,545 MOUs with
NDMS hospitals that commit staffed acute care beds to the system during
a disaster, and regularly participate with local, regional, and state
emergency medical planners in the coordination for mutual support,
training, and exercises. Some AEMs have proactively initiated VA
medical center and community training for WMD. The Emergency Management
Strategic Healthcare Group (EMSHG) has supported pre-positioned assets
for ``special events'' such as the 1996 Summer Olympics, the Economic
Summit of the Eight, the 1996 Republican and Democratic Conventions,
the President's State of the Union addresses, and the recent Papal
Visit. Before the Papal visit, EMSHG conducted a seminar in St. Louis
on WMD patient reception and treatment for the civilian hospitals. VA
will also participate in support of the NATO 50 meeting here in
Washington in April. VA medical centers and the AEMs have become part
of the local health care systems, creating a solid base upon which VA
can build an enhanced role specifically related to WMD.
VHA's existing emergency management infrastructure can be expanded
to accommodate new roles if additional resources are provided, in order
to ensure that our first and primary mission of caring for veterans is
not compromised.
Question. In a joint VA, DOD, HHS, and FEMA report to Congress on
the Federal role in preparing for a medical response to a WMD incident
delivered in July 1998, it is recommended that VA identify the medical
shortfalls in the NDMS and coordinate the actions of NDMS partners to
address the shortfalls. What shortfalls have you found? How are you
coordinating with the NDMS partners to address these shortfalls?
Answer. These recommendations of the report to Congress were
preceded by a recommendation, deleted in the final report, to
accomplish a nationwide assessment, including decontamination and
quarantine requirements, of the medical system's capability to receive
and treat WMD casualties, to include NDMS hospitals. This initiative
was also included in VA's initial fiscal year 2000 budget request, but
deleted in the passback. No other agency has requested or funded this
recommendation. Consequently, no assessment has been made.
Question. I recently sent letters to 19 mayors across the country
inquiring about any role they envision VA playing in the event of a WMD
incident. VA was mentioned, by some, as being a possible contributor in
the areas of pharmaceutical stockpiling, incident-site casualty
treatment, and post-incident casualty treatment. Furthermore, in
testimony before the Labor-HHS Appropriations Subcommittee, testimony
from an International Association of Fire Chiefs representative urged
Congress to consider VA for an important role in these same matters. Do
you agree with these assessments?
Answer. Yes. I believe VA has significant untapped capabilities
that could support the federal government's capability to respond to
WMD incidents. VA facilities are geographically dispersed in
essentially all of the nation's major metropolitan areas. We have long-
established relationships with 85 percent of the nation's medical
schools and some 1,200 universities and colleges overall. Because we
are part of local health care systems, we have established
relationships with the local emergency medical services systems. We
already participate in much of the state and local emergency planning
activities, as well as coordinate training programs and exercises. In a
word, there already exists a solid base upon which VA can build an
enhanced role specifically related to WMD.
As I noted earlier, VA manages four pharmaceutical caches for the
NMRTs, but beyond this, VHA's infrastructure certainly lends itself to
increasing such support in terms of procurement, storage, and
management of pharmaceuticals at multiple sites for ready distribution
wherever needed. In fact, in recognition of the key role a VA facility
can play to address WMD preparedness planning, the Office of the
Attending Physician of the U.S. Capitol signed a Memorandum of
Understanding with VA in September 1998 to provide for the procurement,
maintenance, and storage of a customized WMD cache, to be kept at the
Washington VAMC (which also is one of the NMRT sites).
In this same vein, Public Law 104-201 directs and funds HHS to
develop 125 local emergency medical systems, or Metropolitan Medical
Strike Teams (MMSTs) in selected cities across the United States.
Currently, 22 MMSTs exist in various stages of implementation. It has
become apparent by the requests for support to VA's PBM/SHG and EMSHG
that the strike teams do not have the infrastructure and training in
place to facilitate the purchase, maintenance, and distribution of the
WMD-related medical caches.
Moreover, I note that while VA's role and potential to support the
national response to WMD has not been widely recognized within the
federal government, I am advised that in cities where VA facilities
have routinely been actively involved in local discussions, local HHS-
led Disaster Medical Assistance Teams (DMATs) typically view VA as an
important resource for training and logistical assistance.
Thus, I believe that VA's role could be enhanced, at minimum, to
formally and proactively provide expertise and service to the expanding
network of MMSTs and DMATs, rather than as a ``resource of last
resort.'' And beyond assistance with matters related to
pharmaceuticals, these same VA assets could be drawn upon to improve
the federal government's preparedness for WMD incidents in five
additional areas--i.e., in terms of (1) training; (2) medical and
clinical capability; (3) coordination with state and local agencies;
(4) provision of logistical and other support for other federal
agencies; and (5) research.
Question. Currently, HHS provides VA money to purchase and store
pharmaceutical stockpiles for use by specialized teams responding to
WMD attacks. I note that these stockpiles are contained at only four
sites: Washington, DC; Los Angeles; Denver; and Winston-Salem. Why only
four sites? Shouldn't there be additional stockpiles available to
prevent delays in delivering necessary treatment? What is the plan to
collect and administer pharmaceuticals in a coordinated and timely
fashion? Is there sufficient quantity of appropriate antibiotics and
vaccines at these sites?
Answer. The four current sites are to support the four National
Medical Response Teams (NMRTs) that have been developed by the
Department of Health and Human Services (HHS) for response to a
chemical/biological incident. Except for the team in Washington, DC,
these are deployable teams and, while they would be available for a
local response, have been developed primarily for a response to a WMD
event occurring in another city. As such, the pharmaceutical supplies
that are stored by VA in these locations would be deployed with the
teams. VA has agreed to deliver the pharmaceutical cache to the
respective NMRT within two hours of notification.
In my opinion, there should be additional stockpiles, and I
understand that HHS is placing stockpiles in major cities, especially
where the Metropolitan Medical Strike Teams (MMSTs) are being
developed. VA has not been requested to support HHS in this effort. In
my view, at a minimum, every major city needs to have sufficient
quantities of pharmaceuticals to meet local requirements, given their
population at risk, especially for first responders to include hospital
emergency rooms that will be providing initial care to these victims.
This is especially true for a chemical attack where the window of
opportunity for providing life-saving or life-sustaining care is very
small. The immediate effects of the majority of these agents are such
that there will be insufficient time for these supplies to be delivered
from remote locations. I should add that these concerns extend to not
only pharmaceutical supplies, but also equipment, such as respirators
required for care of hospitalized victims.
To our knowledge, other than that established by VA for the caches
to support the NMRTs, there is no plan in effect to administer and
collect necessary pharmaceuticals in a timely manner that may be placed
in other cities. For the four caches directly managed by VA, there is a
centralized management system for ordering, shipping, storing,
transport, inventory control, inspection, update and rotation of
potency dated pharmaceutical items and medical supplies.
VA did not have a role in determining the items, nor the
quantities, which are contained in the caches. The requirements were
provided to VA from HHS. There is a very limited amount of antibiotics
and no vaccines contained in these caches.
Question. New York City's Chem-Bio Handbook recommends that, for
post exposure treatment to anthrax, an individual receive a four-week
supply of 500 mg ciprofloxacin or 100 mg doxycycline, taken twice
daily, followed by an anthrax vaccine immunization. I note that at each
of the four stockpile caches, there is only enough ciprofloxacin and
doxycycline to provide a four-week supply to 80 people, and no mention
of any anthrax vaccine. How do you explain such a limited supply of
these antibiotics given what may be an overwhelming demand for them in
the event of an anthrax attack?
Answer. VA did not play a part in the development of the caches.
These requirements were provided from HHS to VA. However, it should be
recognized that the caches were developed not to provide for, or
augment, an individual city's requirements over an extended period of
time, but to be used for an immediate response to a terrorist event by
the respective NMRT. Follow-up treatment and maintenance medications
would have to come from another source.
______
Responses of Hon. Kenneth W. Kizer to Questions Submitted by Senator
Robert C. Byrd, Committee on Appropriations
Question. Dr. Kizer, has there been an increase in funding for the
West Virginia Emergency Management Operation according to the Weapons
of Mass Destruction (WMD) threat? Does the Veterans Health
Administration (VHA) have plans to reduce the number of full-time-
equivalent employees associated with this effort for the West Virginia
Emergency Management Operation?
Answer. No additional funds have been provided for the West
Virginia Emergency Management operation for its functions relating to
Weapons of Mass Destruction threats. Currently, we have no plans to
reduce the level of employment at this center. However, a new Chief
Consultant has recently been hired for this program, and she will be
reviewing current program needs and VHA requirements and a recent VA
Inspector General (VAOIG) report on our Emergency Management Strategic
Healthcare Group (headquartered at Martinsburg, West Virginia.) This
review may result in restructuring recommendations to better meet
anticipated VA mission requirements.
Question. Dr. Kizer, will the VHA allocate more funding within the
current budget to improve the internal medical emergency management
operation? Can it be assumed that more funding will be required beyond
the current operational levels? If so, how much funding is required to
make the operation truly viable?
Answer. The VHA allocation for this program is currently
$7,046,000. This level of funding allows VHA to fulfill current
emergency management responsibilities.
Question. Dr. Kizer, I am seriously concerned about reports that
have reached me which indicate that the West Virginia Emergency
Management Operations, which is located on the campus of the
Martinsburg VA Medical Center, is being slated for cuts at a time when
many believe that such programs should receive increased emphasis. What
can you tell me about this, Dr. Kizer? Please elaborate for the record.
Answer. Again, a new Chief Consultant has just been hired to review
program needs and VHA requirements and the VAOIG report mentioned
above, and she will recommend an appropriate organizational structure.
The Chief Consultant will continue to be based at the Martinsburg VA
Medical Center location, which is the headquarters operation for VHA's
national emergency preparedness efforts.
Summary statement of Margaret A. Hamburg, M.D.
Senator Specter. Our next witness is Dr. Margaret A.
Hamburg, Assistant Secretary for Planning and Evaluation at the
Department of Health and Human Services, principal adviser to
the Secretary on policy development and coordination and
implementation, including the HHS effort on bioterrorism.
We welcome you, Madam Secretary, and look forward to your
testimony.
Dr. Hamburg. Thank you, Mr. Chairman and members of the
Committee, for the opportunity to testify. The Department
welcomes your interest in our efforts to address the threat of
bioterrorism.
I am joined by colleagues who have responsibility for
implementing various parts of our initiative. After I briefly
outline the overall strategic approach, we would be pleased to
answer questions.
Bioterrorism presents a special set of challenges. Unlike a
bomb or a discrete chemical exposure, a terrorist incident
involving a biological agent may not be detected or even
suspected until people begin to present with serious illness.
This may occur at considerable and varying remove from the site
of initial exposure, both in terms of onset of disease and
geographic location. Spreading circles of infectious disease
can significantly extend the damage.
In addition, many of the potential biological agents cause
diseases not commonly seen here or routinely dealt with by our
medical system. Hence, the population generally has little or
no immunity, medical providers are not familiar with the
diagnosis and treatment, and scientific research has not been a
major focus.
For these reasons, the sound strategy for addressing
bioterrorism will be quite different from one that targets the
other types of terrorist acts. Our initiative addresses five
distinct but related areas: deterrence of biological terrorism;
strengthening the public health infrastructure for disease
surveillance; medical and public health response; development
of a national pharmaceutical stockpile; and research and
development.
First, deterrence. The CDC has the responsibility to
regulate the shipment of certain hazardous biological organisms
and toxins. Regulations require that all facilities sending or
receiving shipments of select agents register with the CDC,
maintain records of such transfers, and otherwise document
their compliance. CDC also fosters safe design and secure
operation of laboratories that handle select agents.
If an act of bioterrorism occurs, rapid detection and
response rests critically on the existence of a robust
infrastructure for public health surveillance. How quickly an
exposure is detected, analyzed, understood and addressed will
hold dramatic implications for the extent and severity of
disease, suffering, and societal disruption.
CDC is working to upgrade public health capacity at every
level to address the threat of bioterrorism. The emphasis areas
are preparedness, planning by State and local health
departments, and education and training of the medical
community, improved reporting of cases of unusual illness or
suspicious patterns of disease, epidemiological analysis of
outbreaks to identify the source and mode of transmission,
laboratory identification and characterization of the agents
involved, and efficient communications among all players.
Much of the initial responsibility for effective response
to a bioterrorism attack rests with local governments, with
expanding support from State and Federal agencies. Health
systems almost inevitably will be called on to provide such
critical tasks as mass patient care, mass immunization or
prophylactic drug treatment, mass fatality management,
infection control, and decontamination of the environment.
PDD-62 designates HHS as the lead Federal agency to plan
and prepare for a national response to medical emergencies
arising from the terrorist use of weapons of mass destruction.
Our Office of Emergency Preparedness works closely with other
agencies to ensure that plans for managing these medical
emergencies are well integrated with other emergency response
systems.
In addition, OEP contracts with local governments for the
creation of metropolitan medical response systems to focus on
the chem-bio threat. There are 27 municipalities already on
board and we hope to bring the total up to 47 this year and 67
in fiscal year 2000. OEP is also working to strengthen its four
national medical response teams and the national disaster
medical system overall.
A bioterrorism incident would likely require rapid access
to quantities of pharmaceuticals that would not be readily
available in any given location and argues strongly for the
creation of a national stockpile for civilian use. The CDC has
been charged with this activity and the initial focus will be
on acquiring antibiotics for treating anthrax, plague, and
tularemia, botulinum antitoxin, enhancing the utility of the
existing supply of smallpox vaccine, and developing a cache of
drugs and equipment for countering chemical attacks. As threats
shift and as R and D yields new products, we would expect to
modify the stockpile contents as appropriate.
Clearly, our ability to detect and counter bioterrorism
depends greatly on medical science and technology. The NIH is
reinvigorating its research on infectious organisms likely to
be used in terrorist acts, including pathogenesis, immune
responses, and genomics. In turn, this work will facilitate
development of new rapid diagnostic methods, new antiviral and-
or antibiotic therapies, and new vaccines. Of note, the
Department will place a major emphasis on developing improved
vaccines for two serious and high-consequence bioterrorism
threats, anthrax and smallpox.
The development of new or improved diagnostics,
antibiotics, antivirals, and vaccines must go hand in hand with
efforts to streamline the regulatory process. FDA will work
closely with sponsors and manufacturers to ensure effective and
timely reviews of investigational new products.
In conclusion, Mr. Chairman, I believe that the Department
is making important progress to protect the health of this
Nation from the threat of bioterrorism. Funding for this
initiative this fiscal year totals $158 million. The
President's request for fiscal year 2000 includes $230 million
to continue to expand and strengthen the activities begun this
year.
prepared statement
The medical and the public health communities clearly have
the skill and the will needed for this task. We seek your help
in ensuring that they also have the means. Thank you.
Senator Specter. Thank you very much, Dr. Hamburg.
[The statement follows:]
Prepared Statement of Margaret A. Hamburg
Mr. Chairman and members of the Committee, thank you for the
opportunity to testify today. I am accompanied by colleagues who have
responsibility for implementing various parts of our anti-bioterrorism
initiative: James Hughes, M.D., Director of the National Center for
Infectious Diseases, Centers for Disease Control and Prevention; Robert
Knouss, M.D., Director of the Office of Emergency Preparedness, Office
of the Assistant Secretary for Public Health and Science; John Taylor,
Esq., Senior Advisor for Regulatory Policy, Food and Drug
Administration; and Anthony Fauci, M.D., Director of the National
Institute for Allergy and Infectious Diseases, National Institutes of
Health. The Department of Health and Human Services (DHHS) welcomes
your interest in our efforts to develop effective counter-measures for
possible uses of biological weapons against the civilian population.
I will outline for you the overall strategic approach that DHHS is
pursuing in our anti-bioterrorism activities--emphasizing our efforts
to strengthen the public health infrastructure for infectious disease
surveillance related to potential bioterrorism agents and our efforts
to enhance capabilities for medical and public health response should a
bioterrorist attack occur. Following that, my colleagues and I will be
pleased to respond to questions.
I begin by noting that bioterrorism presents a special set of
challenges to our emergency preparedness systems, public health
organizations, and consequence management capability. Unlike a bomb or
discrete chemical exposure, a terrorist incident involving a biological
agent may not be detected or even suspected until people begin to
present with serious illness. This may occur at considerable and
varying distance from the site of initial exposure, both in terms of
onset of disease (incubation periods can vary) and geographic location
(e.g., if exposure occurs in a transportation terminal, people can
spread out widely before becoming ill).
With a bioterrorist event, there is also the possibility of
concentric, spreading circles of communicable disease exposure,
extending significantly the damage caused by the agent released. This
kind of threat will also dramatically increase the level of public fear
and potential for major civil disruption.
Increasing the urgency of the need for our nation to prepare for
the potential threat of bioterrorism is the fact that the agents most
likely to be used in this type of attack are pathogens not commonly
experienced in this country or routinely dealt with by our medical
system. This has a number of significant implications: (1) the
population generally has little or no immunity to the pathogen and
hence is more vulnerable (e.g., no longer vaccinated against smallpox);
(2) medical providers generally are not familiar with the diagnosis and
treatment of these disorders (which they may even fail to initially
recognize); and (3) routine scientific research into the pathogenesis
and treatment of certain of these disease conditions has been at very
low levels compared to other agents of infection because they have not
been perceived to be high priority or because they require levels of
biological containment that are not available at most research centers.
For these reasons, a sound strategy for addressing bioterrorism will be
quite different from one that targets other types of terrorist acts.
The DHHS initiative features activities in five distinct but
related areas: Deterrence of biological terrorism; Surveillance for
unusual outbreaks of illness; Medical and public health response;
Development of a national pharmaceutical stockpile; Research and
development.
I will comment briefly on each.
Deterrence.--The Centers for Disease Control and Prevention (CDC)
has the responsibility mandated by the Antiterrorism and Effective
Death Penalty Act of 1996 to regulate the shipment of certain hazardous
biological organisms and toxins (hereinafter called ``select agents'').
Organizations such as research universities, pharmaceutical
manufacturers, and microbiological archives often have occasion, as
part of their routine work, to send or receive samples of dangerous
pathogens or toxins. DHHS regulations (42 CFR 72.6) require that all
facilities sending or receiving shipments of select agents register
with the CDC, maintain records of such transfers, and otherwise
document their compliance. CDC's administration of the select agent
rule is part of the Administration's multi-agency effort, led by the
Department of Justice, to combat terrorism.
CDC also fosters safe design and secure operation of laboratories
that handle select agents. This involves consultation with laboratory
officials to help ensure that new, renovated, or proposed facilities
meet standard guidelines for the infectious organisms that will be
handled. Development of guidelines and training materials for use by
laboratory personnel and provision of technical assistance to states as
requested regarding their inspection programs for BSL 3 facilities also
are part of CDC's responsibilities..
Surveillance.--Terrorist use of biological weapons against the
civilian population is likely to be surreptitious. Absent an explosion,
other immediate evidence of an attack, or notification of authorities
by a perpetrator that an attack has been made (i.e., people have been
exposed), the first responders will be health-care workers rather than
fire or police personnel (as would be expected for a conventional
emergency response scenario). The first indication that a silent attack
has occurred probably will be an outbreak of some uncommon illness or
an abrupt, significant increase in the incidence of commonly observed
symptoms. How quickly the outbreak is detected, analyzed, understood,
and addressed will determine the timeliness and effectiveness of the
medical and public health response and hence the extent and severity of
the impact upon the health and well-being of the affected community.
For example, most infectious agents have an incubation period
measured in days or weeks. A silent release of a biological agent
capable of producing a highly communicable disease, therefore, could
afflict hundreds--if not thousands--of individuals over a wide
geographic area during a period of several weeks before the need for a
full medical and public health response could be identified and the
response designed and mounted.
CDC is working to upgrade public health capability to counter
bioterrorism through complementary, simultaneous improvements in the
bioterrorism-related expertise, facilities, and procedures of state and
local health departments and within the CDC itself. The emphasis areas
are (a) preparedness planning by state and local health departments;
(b) prompt reporting of cases of illness that might have been caused by
terrorists; (c) epidemiological analysis of outbreaks to identify the
source and mode of transmission; (d) laboratory identification and
characterization of the agents causing the outbreaks; and (e)
electronic communications among public health officials regarding
occurrences of outbreaks and responses to them. CDC recently issued a
competitive program announcement soliciting applications for
cooperative-agreement awards whereby states and major metropolitan
health departments can receive financial and technical assistance to
effect desired improvements in one or more of the five emphasis areas.
CDC will make these awards this summer.
Medical and Public Health Response.--Much of the initial burden and
responsibility for providing an effective response by medical and
public health professionals to a terrorist attack of any kind rests
with the local governments, with support from state and federal
agencies. Local public health systems almost inevitably will be called
on to provide protective and responsive measures for the affected
populations, including:
--mass patient care--including the establishment of auxiliary,
temporary treatment facilities or procedures for the movement
of overflow patients to other geographic areas for care;
--in the case of a bioterrorist event, mass immunization or
prophylactic drug treatment for groups known to be exposed,
groups who may have been exposed, and populations not already
exposed but at risk of exposure from secondary transmission
and/or the environment;
--mass fatality management to provide respectful and safe disposition
of the deceased, including animals; and
--decontamination of the environment.
Presidential Decision Directive 62 designates DHHS as the lead
federal agency to plan and prepare for a national response to medical
emergencies arising from the terrorist use of weapons of mass
destruction. Within DHHS, this responsibility rests with the Office of
Emergency Preparedness (OEP) within the Office of Public Health and
Science.
OEP seeks to develop complementary medical response capabilities at
local and national levels. It works closely with other agencies--
especially the relevant components of the Department of Defense (DOD),
the Department of Justice, the Department of Veterans Affairs, the
Federal Emergency Management Agency, and others--with a view toward
ensuring that plans for managing the medical consequences of terrorist
acts are well integrated with other emergency response systems. To
date, the anti-terrorism focus across the federal government has been
on the prospect of nuclear or chemical attacks. Future preparedness
efforts must focus on the prospect of bioterrorism as well.
In particular, OEP contracts with local governments for the
creation of Metropolitan Medical Response Systems (MMRSs) and, within
these agreements, is placing new emphasis on preparedness for mass
patient care and other consequences of biological terrorism. Also, OEP
is working to strengthen its four National Medical Response Teams and
the National Disaster Medical System overall with respect to the
bioterrorism threat so that they can augment local capabilities as
needed in the event of an attack. To date, OEP has contracted with 27
municipalities to develop MMRSs. Another 8 MMRSs are to be initiated
this year; plans to fund 12 more with redirected fiscal year (FY)1999
funds have been provided to the Subcommittee (bringing the total to
47); and the budget request for fiscal year 2000 includes $16.5 million
for contracts with an additional 20 cities for MMRSs--bringing the
total to 67. The long term goal is to establish MMRSs in all 120
metropolitan areas specified in The Response to Weapons of Mass
Destruction Act of 1997.
National Pharmaceutical Stockpile.--A release of biological, and
some chemical, weapons of mass destruction will require rapid access to
quantities of pharmaceutical antidotes, antibiotics and/or vaccines
that will not be readily available in the locations in which they would
be needed unless special stockpiles are created. Because no one can
anticipate exactly where a terrorist will strike and each local
government does not have the resources to create sufficient stockpiles
on its own, special stockpiles must be created and maintained as a
national resource.
The initial focus will be on acquiring antibiotics useful in
treating anthrax, plague, and tularemia; enhancing the utility of the
existing supply of smallpox vaccine; and developing a cache of drugs
and equipment for countering chemical attacks. Once research and
development have yielded improved vaccines against anthrax and smallpox
and new antiviral drugs effective against smallpox, they will be
included in the stockpile.
CDC has responsibility for developing the stockpile. Fifty one (51)
million dollars has been appropriated for this purpose this fiscal
year, and a comparable sum is requested for fiscal year 2000.
Research and Development.--Capability to detect and counter
bioterrorism depends to a substantial degree on the state of relevant
medical science and technology. Without rapid techniques for accurate
identification of pathogens and assessment of their antibiotic
sensitivity, planning for the medical and public health response will
be compromised significantly. Without efficacious prophylactic and
therapeutic agents, even the best planned responses are likely to fail.
The current base of science and technology is strong in some areas
(e.g., certain classes of anti- bacterial drugs) and weak in others
(e.g., rapid diagnostics, anti-viral drugs, and vaccines). Strong,
sustained research and development in relevant scientific disciplines
is the only proven way to remedy such deficiencies in knowledge and
technology.
The National Institutes of Health (NIH) is reinvigorating its
research related to the pathogenesis of--and host immune responses to--
infectious organisms likely to be used in terrorist acts--e.g., the
organisms that cause anthrax, tularemia, and plague. This research
would be greatly facilitated by the acquisition of genome sequence
information on these and related pathogens. The results of such
genomics research--coupled with other pathological, immunological,
biochemical, and microbiological information--are expected to
facilitate pursuit of a variety of critical goals including the
development of rapid diagnostic methods for the most likely biological
weapons, the development of antiviral therapies for smallpox and Ebola
virus, and the development of new vaccines for anthrax, cholera, and
smallpox. NIH also will undertake an array of basic and targeted
studies oriented toward development of new or improved methods to
diagnose chemical exposures and determine their effects upon the
nervous system.
Building upon the rapid advances of recent years in the molecular
and cell biology of infectious organisms, the Department has requested
$30 million in fiscal year 2000 specifically for developing improved
vaccines for the highest priority bioterrorism threats: anthrax and
smallpox.
Other DHHS agencies are engaged in relevant research and
development as well. CDC, as part of the surveillance initiative I
described earlier, is expanding its in-house Rapid Toxic Screen project
to develop methods for measuring, within 48 hours, toxicants in human
blood or urine samples. The goal over the next three years is to devise
methods to identify and measure 150 different toxins and to achieve an
in-house analytic capacity of 200 samples per day. As new methods come
on line, CDC will disseminate them to state and local laboratories as
appropriate for incorporation into their analytic repertoires. Also,
FDA proposes to expand its research on detection and characterization
of toxins that might be used by terrorists.
Looking more generally at the entire civilian medical response to
chemical and biological terrorism, DHHS contracted in May, 1997 with
the National Academy of Sciences' Institute of Medicine (IOM) to
provide specific recommendations for priority research and development
activities to improve that response. The IOM's report, delivered this
past January, examines a wide range of research and development needs--
including not only the medical response areas described above but also
topics such as environmental detection of chemical or biological
agents, personal protective clothing and equipment, and
decontamination. My colleagues and I have found this to be an excellent
and helpful study; and the Office of Science and Technology within the
Executive Office of the President is using the IOM report as its
framework for assessing and coordinating counter-terrorism-related
research and development throughout the Executive Branch.
Expedited Regulatory Review.--The development of new or improved
diagnostics, antibiotics, antivirals, and vaccines needed to combat
bioterrorism must go hand in hand with efforts to streamline the
regulatory process that new products must undergo successfully to be
approved for marketing. FDA will work closely with sponsors and
manufacturers to ensure effective and timely reviews of investigational
new products. For example, NIH has created an Anthrax Vaccine Working
Group, which brings together representatives of the NIH, FDA, and DOD
to advance research and development relevant to developing a new
anthrax vaccine. Also, FDA intends to accelerate the pace and increase
the efficiency of its reviews by ensuring the availability of experts
to guide sponsors through the regulatory process not only for new
products but also for new uses of existing products.
In conclusion, Mr. Chairman, I believe that DHHS is off to a good
start toward protecting this nation from those who would use biological
weapons against the civilian population. Thanks to the leadership of
President Clinton and the strong support of the Congress, the funding
for the anti-bioterrorism initiative this fiscal year totals $158
million. Moreover, the President's request for fiscal year 2000
includes $230 million to continue, expand, and strengthen the
activities begun this year. The medical and public health communities
clearly have the skill and the will needed for this task. We seek your
help in ensuring that they also have the means.
Summary statement of Henry L. Hinton, Jr.
Senator Specter. Our next witness is Mr. Henry Hinton,
Assistant Comptroller General for National Security and
International Affairs at the General Accounting Office. He is
responsible for GAO's work at the Department of Defense and
State, as well as U.S. intelligence and foreign aid services.
Senator Rockefeller and I, last June 17, requested GAO to
do a study of the anthrax immunity program. We thank you for
the results. Shortly thereafter, on July 1, Senator Rockefeller
and I again requested a GAO study on the administration's
threat assessment of biological and chemical agents.
Mr. Hinton, thank you for joining us. Again, both of those
reports are available, and we look forward to your testimony.
Mr. Hinton. Thank you, Mr. Chairman. I am pleased to be
here to discuss our ongoing work and preliminary observations
on the biological terrorist threat and some aspects of HHS'
bioterrorism initiative.
My comments this morning, Mr. Chairman, will address four
issues: First, the intelligence agencies' judgments about the
threat; second, the importance and benefit of threat and risk
assessments; third, some preliminary observations about our
ongoing work on the science behind the biological and chemical
terrorist threat; and finally, I will provide some of our
observations on the public health initiatives that deal with
the new national pharmaceutical stockpile.
Let me turn to the threat. The U.S. intelligence community
continuously assesses both the foreign origin and the domestic
terrorist threat to the United States and notes that overall
conventional explosives and firearms continue to be the weapons
of choice for terrorists. Terrorists are less likely to use
biological and chemical weapons than conventional explosives,
at least partly because they are difficult to weaponize and the
results are unpredictable.
However, some groups and individuals of concern are showing
interest in biological and chemical agents. The possibility
that terrorists may use biological and chemical materials may
increase over the next decade, according to intelligence
agencies.
We have previously reported on the value of using sound
threat and risk assessments performed by a multidisciplinary
team of experts for focusing programs and investments to combat
terrorism. Without such assessments using sound inputs and a
team of experts, there is little or no assurance that the
programs and spending are focused in the right areas and in the
right amounts.
As you mentioned, Mr. Chairman, we are looking into the
scientific and practical feasibility of a terrorist or
terrorist group improvising a biological weapon or device
outside a state-run laboratory and program, successfully and
effectively disseminating biological agents, and causing mass
casualties. Much of the information we have obtained is
classified and in the early stages of our evaluation.
Overall, our work to date suggests that, for the most part,
there are serious challenges at various stages of the process
for a terrorist group or individual to successfully cause mass
casualties with biological agents. For example, a terrorist
group or individual generally would need a relatively high
degree of sophistication to successfully and effectively
process, improvise a device or weapon, and disseminate
biological agents to cause mass casualties.
HHS has not performed a formal, sound threat and risk
assessment with a multidisciplinary team of experts to derive,
prioritize, or rank in accordance with the most likely threats
the Nation would face the specific items it plans to have in
its pharmaceutical stockpile. Also, we note that several of the
items HHS plans to procure seem to be geared toward the worst
possible consequences from a public health perspective and do
not match the intelligence agencies' judgments on the more
likely biological and chemical agents a terrorist group or
individual might use as explained to us.
prepared statement
Last, it is unclear from HHS' 1999 operating plan whether
and to what extent the Department has fully considered the
long-term costs, benefits, and return on investment of creating
and sustaining the production and inventory infrastructure for
such an initiative.
Mr. Chairman, that concludes my opening statement and I
stand ready to address your questions.
Senator Specter. Thank you very much, Mr. Hinton.
[The statement follows:]
Prepared Statement of Henry L. Hinton, Jr.
Mr. Chairman and Members of the Committee and Subcommittee: I am
pleased to be here to discuss our ongoing work and preliminary
observations on the biological terrorist threat and some aspects of the
Department of Health and Human Services' (HHS) bioterrorism initiative.
As you know, our ongoing work was requested by you in your capacity as
the Chairman and Senator Rockefeller as Ranking Minority Member of the
Senate Veterans Affairs Committee; Congressman Shays as the Chairman of
the House Government Reform Committee, Subcommittee on National
Security, Veterans Affairs, and International Relations; and
Congressman Skelton as Ranking Minority Member of the House Armed
Services Committee. Over the past 3 years, we have studied and reported
on a number of issues concerning federal agencies' programs and
activities to combat terrorism. A list of related GAO reports and
testimonies is in appendix I.
It is frightening to think that a lone terrorist or terrorist group
might be able to improvise a biological weapon or use other means to
spread anthrax, smallpox, or other biological agents to cause mass
casualties and overwhelm the health care system in the United States.
There is no question that it would be unconscionable not to prepare to
respond to, if not be able to prevent, such an incident. But some very
important questions should be asked and answered as an integral part of
any federal decision to invest in medical countermeasures or
preparedness initiatives. This is one of those few areas in which
national security and public health issues clearly intersect. It is
also an area in which many disciplines of expertise must come together
to perform the challenging tasks of assessing an emerging threat and
focusing our investments on the most appropriate countermeasures and
preparedness efforts.
My testimony will address four issues. First, I will briefly
discuss intelligence agencies' judgments about the threat of terrorism.
Second, I will highlight the importance and benefits of threat and risk
assessments to provide a sound basis for targeting the nation's
investments in combating terrorism--a widely recognized sound business
practice we have discussed in our reports and testimonies.\1\ Third, I
will share some preliminary observations from our ongoing work on the
science behind the biological and chemical terrorist threat, with some
focus on biological agents. Finally, I will provide some of our overall
observations on public health initiatives that deal with a new national
pharmaceutical stockpile and the basis for selecting items to research,
produce, procure, and stockpile for civilian defense against terrorism.
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\1\ See Combating Terrorism: Spending on Governmentwide Programs
Requires Better Management and Coordination (GAO/NSIAD-98-39, Dec. 1,
1997); Combating Terrorism: Threat and Risk Assessments Can Help
Prioritize and Target Program Investments (GAO/NSIAD-98-74, Apr. 9,
1998); and Combating Terrorism: Observations on Federal Spending to
Combat Terrorism (GAO/T-NSIAD/GGD-99-107, Mar. 11, 1999).
---------------------------------------------------------------------------
summary
The U.S. intelligence community continuously assesses both the
foreign-origin and the domestic terrorist threat to the United States
and notes that, overall, conventional explosives and firearms continue
to be the weapons of choice for terrorists. Terrorists are less likely
to use biological and chemical weapons than conventional explosives, at
least partly because they are difficult to weaponize and the results
are unpredictable. However, some groups and individuals of concern are
showing interest in biological and chemical agents. The possibility
that terrorists may use biological and chemical materials may increase
over the next decade, according to intelligence agencies. While
biological and chemical terrorism is still an emerging threat, many
agencies have initiated programs and activities--with Congress' support
and funding--to combat and prepare for this threat.
We have previously reported on the value of a new, post-Cold War
approach of using sound threat and risk assessments performed by a
multidisciplinary team of experts for focusing programs and investments
to combat terrorism. Without such assessments using sound inputs and a
multidisciplinary team of experts, there is little or no assurance that
programs and spending are focused in the right areas in the right
amounts.
We are looking into the scientific and practical feasibility of a
terrorist or terrorist group improvising a biological weapon or device
outside a state-run laboratory and program, successfully and
effectively disseminating biological agents, and causing mass
casualties.\2\ Much of the information we have obtained is sensitive,
classified, and in the early stages of evaluation. Overall, our work to
date suggests that, for the most part, there are serious challenges at
various stages of the process for a terrorist group or individual to
successfully cause mass casualties with an improvised biological or
chemical weapon or device. More specifically, our preliminary
observations are that
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\2\ We recognize that some agents are communicable and could be
spread without a weapon or device.
---------------------------------------------------------------------------
--a terrorist group or individual generally would need a relatively
high degree of sophistication to successfully and effectively
process, improvise a device or weapon, and disseminate
biological agents to cause mass casualties;
--a weapon could be made with less sophistication, but it would not
likely cause mass casualties;
--some biological agents are very difficult to obtain and others are
difficult to produce; and
--effective dissemination of biological agents can be disrupted by
environmental (e.g., pollution) and meteorological (e.g., sun,
rain, mist, wind) conditions.
For its part of domestic preparedness initiatives for combating
terrorism, HHS received about $160 million in fiscal year 1999. These
funds are intended for a variety of related preparedness efforts,
including research and development and a new national stockpile for
pharmaceuticals, millions of doses of vaccines for smallpox and
anthrax, antidotes for chemical agents, and other items. For fiscal
year 2000, HHS has requested $230 million for public health initiatives
for dealing with bioterrorism. Our preliminary observations follow:
--HHS has not yet performed a documented, formal, methodologically
sound threat and risk assessment with a multidisciplinary team
of experts to derive, prioritize, or rank--in accordance with
the most likely threats the nation will face--the specific
items it plans to have researched, developed, produced, and
stockpiled.
--Several of the items HHS plans to procure seem to be geared toward
the worst-possible consequences from a public health
perspective and do not match intelligence agencies' judgments
on the more likely biological and chemical agents a terrorist
group or individual might use.
--It is unclear from the HHS fiscal year 1999 operating plan whether
and to what extent the Department has fully considered the
long-term costs, benefits, and return on investment of creating
and sustaining the production and inventory infrastructure for
such an initiative.
the foreign and domestic terrorism threat in the united states
The bombings of the World Trade Center in 1993 and the federal
building in Oklahoma City, Oklahoma, in 1995, along with the use of a
nerve agent in the Tokyo subway in 1995, have elevated concerns about
terrorism in the United States--particularly terrorists' use of
chemical and biological weapons. The U.S. intelligence community, which
includes the Central Intelligence Agency, the Defense Intelligence
Agency, the National Security Agency, the Federal Bureau of
Investigation, and others, has continuously assessed the foreign-origin
and domestic terrorist threats to the United States. According to
intelligence agencies, conventional explosives and firearms continue to
be the weapons of choice for terrorists. Terrorists are less likely to
use chemical and biological weapons, at least partly because they are
more difficult to weaponize and the results are unpredictable. However,
some groups and individuals of concern are showing interest in chemical
and biological weapons. According to the FBI, there were 4 confirmed
incidents of terrorism in the United States in 1992, compared with 12
in 1993, zero in 1994, 1 in 1995, 3 in 1996, and 2 in 1997. These
incidents involved the use of conventional weapons.
threat and risk assessments can help define requirements and prioritize
and focus program investments
We have pointed out that sound threat and risk assessments can be
used to define and prioritize requirements and properly focus programs
and investments in combating terrorism. Soundly established
requirements could help ensure that specific programs and initiatives
and related expenditures are justified and targeted, given the threat
and risk of validated terrorist attack scenarios as assessed by a
multidisciplinary team of experts.
Several public and private sector organizations use formal,
qualitative threat and risk assessments to manage risk and identify and
prioritize their requirements and expenditures. For example, the
Defense Threat Reduction Agency, the Department of Energy, and the
Federal Aviation Administration use such assessments in their programs.
In addition, the President's Commission on Critical Infrastructure
Protection \3\ recommended in its final report that threat and risk
assessments be performed on the nation's critical infrastructures, such
as telecommunications, electric power, and banking and finance systems.
In fact, the Federal Emergency Management Agency strongly endorses the
concept of risk assessment, as it is the key to predisaster hazard
mitigation--the foundation of emergency management. Moreover, the
Department of Energy has stated that domestic preparedness program
equipment purchases should be delayed until a risk assessment is
completed to ensure that appropriate equipment is obtained.
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\3\ The Commission, a government-private sector body established in
1996, was to develop a national strategy to protect the nation's
critical infrastructures from physical and computer-based threats.
---------------------------------------------------------------------------
Threat and risk assessments are grounded in a new, post-Cold War
approach to thinking about and dealing with security issues called risk
management. Risk management is the deliberate process of understanding
``risk''--the likelihood that a threat will harm an asset with some
severity of consequences--and deciding on and implementing actions to
reduce it. Risk management principles acknowledge that (1) while risk
generally cannot be eliminated it can be reduced by enhancing
protection from validated and credible threats and (2) although many
threats are possible, some are more likely to occur than others. Threat
and risk assessment is a deliberate, analytical approach that results
in a prioritized list of risks (i.e., threat-asset-vulnerability
combinations) that can be used to select countermeasures to create a
certain level of protection or preparedness. Generally, because threats
are dynamic and countermeasures may become outdated, it is sound
practice to periodically reassess threat and risk.
The critical first step in a sound threat and risk assessment
process is the threat analysis. The analysis should identify and
evaluate each threat in terms of capability and intent to attack an
asset, the likelihood of a successful attack, and its consequences. To
perform a realistic threat assessment, a multidisciplinary team of
experts would require valid foreign and domestic threat data from the
intelligence community and law enforcement. The intelligence
community's threat reporting on foreign-origin terrorism is often
general and, without clarification, could be difficult to use. However,
a multidisciplinary team of experts can use the best available
intelligence information on foreign-origin and domestic threats to
develop threat scenarios. The intelligence community could then compare
the threat scenarios to its threat reporting and validate or adjust the
scenarios with respect to their realism and likelihood of occurrence as
appropriate.
our ongoing work examining the biological and chemical terrorist threat
On the basis of information we obtained and analyzed to date, a
terrorist group or individual \4\ would generally need a relatively
high degree of sophistication to successfully and effectively process,
improvise a device or weapon, and disseminate biological agents to
cause mass casualties. John Lauder, Special Assistant to the Director
of Central Intelligence for Nonproliferation, recently testified that
``the preparation and effective use of biological weapons by both
potentially hostile states and by non-state actors, including
terrorists, is harder than some popular literature seems to suggest.''
\5\ Because we are in an open forum and our work is sensitive and
preliminary in nature, my discussion will remain limited.
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\4\ For the purposes of our work, we define terrorist(s) as a non-
state actor not provided with a state-developed weapon.
\5\ Unclassified statement by Special Assistant to the Director of
Central Intelligence for Nonproliferation on the Worldwide Biological
Warfare Threat to the House Permanent Select Committee on Intelligence,
March 3, 1999.
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Our ongoing synthesis of information and technical data from
recognized experts suggests that some exotic biological agents--such as
smallpox--are difficult to obtain, and others--such as plague--are
difficult to produce. Processing biological agents for effective
dissemination to cause mass casualties requires specific, detailed
knowledge and specialized equipment. Moreover, improvising a device or
weapon that can effectively disseminate biological agents to cause mass
casualties requires certain items that are not readily available. In
addition, successful and effective dissemination of biological agents
in the right form requires the proper environmental and meteorological
conditions and appropriate energy sources.
That is not to say that casualties would not occur if less
sophisticated means were used. For example, if an agent were dispersed
in a less effective form using less effective equipment, some
casualties might occur. However, under these circumstances, the
potential incident would be less likely to cause mass casualties. What
we have learned is that capability is a critical factor. Terrorists
have to handle risk, overcome production difficulties, and effectively
disseminate a biological agent to cause mass casualties. We continue to
gather and evaluate data on these matters and plan to report to our
requesters this summer.
preliminary observations on hhs' public health initiatives related to
bioterrorism
On June 8, 1998, the President forwarded to Congress a fiscal year
1999 budget amendment that included a proposal to (1) build--for the
first time--a civilian stockpile of antidotes and vaccines to respond
to a large-scale biological or chemical attack, (2) improve the public
health surveillance system to detect biological or chemical agents
rapidly and analyze resulting disease outbreaks, (3) provide
specialized equipment and training to states and localities for
responding to a biological or chemical incident, and (4) expand the
National Institutes of Health's research into vaccines and therapies.
The Omnibus Consolidated and Emergency Supplemental Appropriations Act
(Public Law 105-277) included $51 million for the Centers for Disease
Control and Prevention to begin developing a pharmaceutical and vaccine
stockpile for civilian populations. The act also required that HHS
submit an operating plan to the House and Senate Committees on
Appropriations before obligating the funds. The fiscal year 2000
request for HHS' bioterrorism initiative is $230 million, including $52
million for the Centers for Disease Control and Prevention to continue
procurement of a national stockpile.
Our preliminary work suggests that an ad hoc interagency health
care group led by HHS has not yet performed a formal, documented threat
and risk assessment to establish its list of biological and chemical
terrorist threat agents against which it should stockpile. In fact,
several of the items HHS plans to procure do not match intelligence
agencies' judgments, as explained to us, on the most likely chemical
and biological agents a terrorist group or individual might use.
According to HHS officials, the group identified its list through a
process of evolutionary consensus among federal and nonfederal health
experts. Because HHS did not document its process or methodology, we
have difficulty evaluating its soundness and comprehensiveness.
According to HHS officials, the interagency participants identified
the list based on:
--agent characteristics such as transmissibility and stability,
--likely impact on population (i.e., can it cause mass casualties),
--availability of treatment, and
--whether the agent could be weaponized.
The group chose four biological agents for HHS' stockpiling
initiatives--inhalation anthrax, pneumonic plague, smallpox, and
tularemia (a bacteria)--because of their ability to affect large
numbers of people (create mass casualties) and tax the medical system.
On the basis of our discussions with HHS officials, it is unclear
to us whether and to what extent intelligence agencies' official
written threat analyses were used in their process. According to the
Joint Security Commission's 1994 report on Redefining Security, without
documented threat information, countermeasures are often based on
worst-case scenarios. Valid, current, and documented threat information
is crucial to ensuring that countermeasures or programs are not based
solely on worst-case scenarios and are therefore out of balance with
the threat. While HHS officials told us that they obtained information
from various experts, including intelligence analysts, the ad hoc
interagency group making the decisions comprised representatives only
from the health and medical community. As a result, we have not seen
any evidence that the group's process has incorporated the many
disciplines of knowledge and expertise or divergent thinking that is
warranted to establish sound requirements for such a complex and
challenging threat and to focus on appropriate medical preparedness
countermeasures.
As required in the appropriations act I mentioned earlier, HHS
prepared an operating plan for its fiscal year 1999 bioterrorism
initiative. The plan discusses numerous activities on which the fiscal
year 1999 appropriations will be spent within four areas:
--deterrence of biological terrorism,
--surveillance for unusual outbreaks of illness,
--medical and public health responses, and
--research and development.
We have reviewed the unclassified version of the operating plan. On
the basis of our review of the plan, it is unclear whether and to what
extent HHS has fully considered the long-term costs, benefits, and
return on investment of establishing the production and inventory
infrastructure for such an initiative. The reason I raise the issue of
return on investment is that, until a valid threat and risk assessment
is performed, we question whether stockpiling for the items on the
current HHS list is the best approach for investing in medical
preparedness. In addition, the HHS plan does not clearly address issues
surrounding (1) the long-term costs of maintaining an inventory of
items with a shelf life or (2) the safety and efficacy of expedited
regulatory review of new drugs and vaccines.
conclusions
We see many challenges ahead for HHS as it continues to decide how
to target its investments for this emerging threat. Many frightening
possible scenarios can be generated. But the daunting task before the
nation is to assess--to the best of its ability--the emerging threat
with the best available knowledge and expertise across the many
disciplines involved. The United States cannot fund all the
possibilities that have dire consequences. By focusing investments on
worst-case possibilities, the government may be missing the more likely
threats the country will face. With the right threat and risk
assessment process, participants, inputs, and methodology, the nation
can have greater confidence that it is investing in the right items in
the right amounts. Even within the lower end of the threat spectrum--
where the biological and chemical terrorist threat currently lies--the
threats can still be ranked and prioritized in terms of their
likelihood and severity of consequences. A sound threat and risk
assessment could provide a cohesive roadmap to justify and target
spending for medical and other countermeasures to deal with a
biological and/or chemical terrorist threat.
appendix i--related gao products
Combating Terrorism: Observations on Federal Spending to Combat
Terrorism (GAO/T-NSIAD/GGD-99-107, Mar. 11, 1999).
Combating Terrorism: FBI's Use of Federal Funds for
Counterterrorism-Related Activities (FYs 1995-98) (GAO/GGD-99-7, Nov.
20, 1998).
Combating Terrorism: Opportunities to Improve Domestic Preparedness
Program Focus and Efficiency (GAO/NSIAD-99-3, Nov. 12, 1998).
Combating Terrorism: Observations on the Nunn-Lugar-Domenici
Domestic Preparedness Program (GAO/T-NSIAD-99-16, Oct. 2, 1998).
Combating Terrorism: Observations on Crosscutting Issues (GAO/T-
NSIAD-98-164, Apr. 23, 1998).
Combating Terrorism: Threat and Risk Assessments Can Help
Prioritize and Target Program Investments (GAO/NSIAD-98-74, Apr. 9,
1998).
Combating Terrorism: Spending on Governmentwide Programs Requires
Better Management and Coordination (GAO/NSIAD-98-39, Dec. 1, 1997).
Combating Terrorism: Efforts to Protect U.S. Forces in Turkey and
the Middle East (GAO/T-NSIAD-98-44, Oct. 28, 1997).
Combating Terrorism: Federal Agencies' Efforts to Implement
National Policy and Strategy (GAO/NSIAD-97-254, Sept. 26, 1997).
Combating Terrorism: Status of DOD Efforts to Protect Its Forces
Overseas (GAO/NSIAD-97-207, July 21, 1997).
Chemical Weapons Stockpile: Changes Needed in the Management
Structure of Emergency Preparedness Program (GAO/NSIAD-97-91, June 11,
1997).
State Department: Efforts to Reduce Visa Fraud (GAO/T-NSIAD-97-167,
May 20, 1997).
Aviation Security: FAA's Procurement of Explosives Detection
Devices (GAO/RCED-97-111R, May 1, 1997).
Aviation Security: Commercially Available Advanced Explosives
Detection Devices (GAO/RCED-97-119R, Apr. 24, 1997).
Terrorism and Drug Trafficking: Responsibilities for Developing
Explosives and Narcotics Detection Technologies (GAO/NSIAD-97-95, Apr.
15, 1997).
Federal Law Enforcement: Investigative Authority and Personnel at
13 Agencies (GAO/GGD-96-154, Sept. 30, 1996).
Aviation Security: Urgent Issues Need to Be Addressed (GAO/T-RCED/
NSIAD-96-151, Sept. 11, 1996).
Terrorism and Drug Trafficking: Technologies for Detecting
Explosives and Narcotics (GAO/NSIAD/RCED-96-252, Sept. 4, 1996).
Aviation Security: Immediate Action Needed to Improve Security
(GAO/T-RCED/NSIAD-96-237, Aug. 1, 1996).
Passports and Visas: Status of Efforts to Reduce Fraud (GAO/NSIAD-
96-99, May 9, 1996).
Terrorism and Drug Trafficking: Threats and Roles of Explosives and
Narcotics Detection Technology (GAO/NSIAD/RCED-96-76BR, Mar. 27, 1996).
Nuclear Nonproliferation: Status of U.S. Efforts to Improve Nuclear
Material Controls in Newly Independent States (GAO/NSIAD/RCED-96-89,
Mar. 8, 1996).
Aviation Security: Additional Actions Needed to Meet Domestic and
International Challenges (GAO/RCED-94-38, Jan. 27, 1994).
Nuclear Security: Improving Correction of Security Deficiencies at
DOE's Weapons Facilities (GAO/RCED-93-10, Nov. 16, 1992).
Nuclear Security: Weak Internal Controls Hamper Oversight of DOE's
Security Program (GAO/RCED-92-146, June 29, 1992).
Electricity Supply: Efforts Underway to Improve Federal Electrical
Disruption Preparedness (GAO/RCED-92-125, Apr. 20, 1992).
Economic Sanctions: Effectiveness as Tools of Foreign Policy (GAO/
NSIAD-92-106, Feb. 19, 1992).
State Department: Management Weaknesses in the Security
Construction Program (GAO/NSIAD-92-2, Nov. 29, 1991).
Chemical Weapons: Physical Security for the U.S. Chemical Stockpile
(GAO/NSIAD-91-200, May 15, 1991).
State Department: Status of the Diplomatic Security Construction
Program (GAO/NSIAD-91-143BR, Feb. 20, 1991).
GAO reports
Senator Specter. We had some reports from GAO which had
gone to the Committee on Health, Education, and Labor,
Subcommittee on Public Health, not to us. We had a draft report
also. Can you give me an approximation as to when GAO will
conclude the studies which Senator Rockefeller and I have
requested?
Mr. Hinton. Later this spring, Mr. Chairman, probably
around the May-June timeframe.
Senator Specter. May-June timeframe?
Mr. Hinton. Yes, sir.
Senator Specter. Well, to the extent you can expedite that,
we would very much appreciate it.
Mr. Hinton. Yes, sir, we certainly will try to.
Senator Specter. Dr. Hamburg, there is very heavy
classification, as reported to me, on the number of agents
which constitute biological threats. This subject came up at an
earlier hearing conducted by the Veterans Affairs Committee and
we have been trying to move to declassify. In the interest of
caution, I will not say how many biological threat agents there
are, but there is an approved vaccine, as I am advised, for
only one, that is anthrax, and there are activities with FDA--
only two other of six potential vaccines have been licensed.
The four remaining are investigational drugs.
There are a large number of biological threats for which
the United States has no vaccines. So that when someone makes
the comment, as Senator Rockefeller alluded to earlier, that
there is no threat, it is hard to understand how that could see
print.
But what is the assessment of HHS as to our ability to
start to develop vaccines for this very large number of
biological threat agents?
Dr. Hamburg. We see it as a very significant responsibility
of the Department, of course working with our colleagues in
other parts of the administration, the Department of Defense
critically, and with private industry----
Senator Specter. Well, is the research being done
principally by the National Institutes of Health or are there
other agencies hard at work on the scientific research work?
Dr. Hamburg. The NIH has played and will continue to play
an important role, a growing role. DOD, particularly through
USAMRIID, has a long history of research in this area and is
actively engaged. Other parts of the administration are also
involved in important aspects of our research agenda.
Senator Specter. Who is pulling it all together? That is
one of the issues----
Dr. Hamburg. Right.
Senator Specter [continuing]. Which Chairman Deutch and I
are looking at on weapons of mass destruction. Who is pulling
it all together?
Dr. Hamburg. In terms of coordination of the overall
research agenda, both identifying the goals and action plans
for implementation, the Office of Science and Technology Policy
in the White House is coordinating with the NSC that effort.
Senator Specter. That is the agency headed by Mr. Dick
Clarke?
Dr. Hamburg. Dick Clarke is coordinating the overall
counterterrorism activities. The Office of Science and
Technology Policy is part of the Executive Office of the
President, but it is not part of the NSC. It is the science
adviser to the President's Office. The NSC and OSTP are working
in coordination, with OSTP having the designated lead on the
biomedical research agenda.
Senator Specter. To what extent is private industry
participating? I had a talk with Admiral Crowe and we are going
to have on our second panel Mr. Robert C. Myers from the
BioPort Corporation, which is developing a vaccine for anthrax
or is manufacturing, producing a vaccine for anthrax. According
to Admiral Crowe, private industry is not really pursuing this
issue because of their liability problems.
It is a remarkable situation that for anthrax, a known
threat where the Department of Defense has announced a plan to
inoculate all the servicemen, that there is only one source of
supply. Question: To what extent to your knowledge is the
private sector really digging into this problem?
Dr. Hamburg. Well, we are increasingly trying to engage the
private sector. But as you point out, the liability issues are
enormous.
Senator Specter. Increasingly trying to engage the private
sector, but what is the private sector doing, if you know?
Dr. Hamburg. Through contracts within DOD, there are
relationships with private pharmaceutical companies to pursue
development of a number of vaccine products.
Senator Specter. Dr. Hamburg, would you supply in writing
to this Committee the following information: Specifically, what
is being done in the private sector? What companies are working
on what vaccines, and what is the stage of progress? What
evidence do you have, if any, that other companies are not
pursuing this subject because of concern for civil liability?
Specifically, what is the role of the White House Office of
Science that you have referred to? What is happening with NIH?
We can bring Dr. Varmus in separately, but since you are in
charge of this we would appreciate it if you would take a look
at that for us. What specifically is NIH doing, and could they
do more?
The subcommittee on HHS took the lead in increasing their
allocation by some $2 billion and this ought to be on the front
burner. I would like to know precisely what they are doing in
this line as you evaluate it, and also what the Department of
Defense is doing.
[The information follows:]
Responses to Questions Submitted to Dr. Hamburg by Senator Specter
Question. Specifically, what is being done in the private sector?
What companies are working on what vaccines, and what is the stage of
progress?
Answer. At the present time, Bioport is the only private sector
company producing a licensed vaccine for a pathogen (anthrax) that
could potentially be used as a biological weapon. DynPort, under
contract to the Department of Defense, is in the early stages of
developing a cell-culture based smallpox vaccine; this work has not yet
entered the phase of human clinical trials. Several smaller companies
have ongoing research and development programs on agents that also have
the potential to be weaponized, but none of these efforts has
progressed beyond the stage of pre-clinical testing in animal models.
Question. What evidence do you have, if any, that other companies
are not pursuing this subject because of concern for civil liability?
Answer. While manufacturers and researchers are not required to
share their rationale for the products they choose either to develop or
not develop, there are incentives and deterrents that will influence
their decisions. Incentives include the likelihood that a product will
generate a profit, proceed successfully through the stages of
development, and be accepted by consumers and health providers. The
deterrents include, but may not be limited to, the cost of development,
length of time for development, and liability issues.
Manufacturers may view significant off-label use as a potential
liability. When a product is developed and licensed for one indication
and a manufacturer is approached about an off-label use of the product,
as in the case of vaccination to protect against a biological agent
used in bioterrorism, the manufacturer may view the latter use as a
potential liability since such use is not supported by adequate
clinical data.
The liability issue is particularly significant with regard to the
development and use of vaccines. The reason vaccines may be specially
vulnerable relate to the issue of mandatory vaccination because, unlike
other drugs prescribed for a disease from which an individual already
suffers, vaccines are given to otherwise healthy individuals. The
person being immunized may not be aware of the severity of the diseases
that the vaccine is designed to prevent, leaving them more apprehensive
of being vaccinated and less tolerant of adverse reactions associated
with vaccination. This set of circumstances may result in the loss of
public confidence in vaccines, thus increasing the likelihood of
litigation against vaccine manufacturers.
Question. Specifically, what is the role of the White House Office
of Science that you have referred to?
Answer. The Office of Science and Technology Policy (OSTP), a
component of the Executive Office of the President, is coordinating an
interagency effort to develop a unified, government-wide research and
development agenda to improve counter-terrorism capabilities.
Development of new and improved vaccines is a category of special
interest. OSTP does not presume to direct the efforts of NIH or other
agencies. Rather, OSTP facilitates communications among agencies on
topics of common interest. With respect to vaccine development
specifically, OSTP has helped DOD and DHHS identify complementary
interests and expertise and avoid undue duplication of effort.
Question. What is happening with NIH? What specifically is NIH
doing, and could they do more?
Answer. Several NIH Institutes are engaged in basic research on
infectious agents--including several viruses, strains of bacteria and
toxins--that have been identified as potential agents for use in
bioterrorist attacks. In addition, the National Institute of Allergy
and Infectious Diseases (NIAID) conducts and supports research on the
development of therapeutics and vaccines for pre-and post-exposure
prophylaxis and treatment, as well as diagnostics, for a wide variety
of infectious agents, including several of those identified as
potential biological weapons.
At the present time, NIH (primarily NIAID) maintains active
research programs on anthrax, smallpox, plague, tularemia,
Staphylococcal enterotoxins, viral encephalitides, and viral
hemorrhagic fevers. The major emphasis, however, is on smallpox and
anthrax. In this connection, NIAID recently formed working groups on
smallpox and anthrax vaccines to coordinate the development and testing
of potential second-generation vaccines. In addition to these efforts,
NIH has participated in the following interagency activities related to
bioterrorism:
nsc tasking concerning bioterrorism preparedness (1998)
Interagency collaboration in the development of a research agenda
for the rapid development of diagnostic tools, treatments and vaccines
for diseases caused by bioengineered agents.
Agencies: DHHS (OEP, NIH, CDC, and FDA) DoD, DoE, VA, and OSTP.
consultation on anthrax vaccines (january 15,1998)
Agencies: DHHS (NIH [NIAID, NIDR, & NICHD] and FDA), DoD.
inter-departmental working group on response to a weapon of mass
destruction (1998)
Use of unapproved pharmaceuticals for WMD response.
Agencies: DHHS (OEP, FDA, NIH, & CDC), DoD, and VA.
five year inter-agency counter-terrorism and technology crime plan
working group 4: crisis/consequence planning and management
Agencies: DHHS, DOJ, FBI, ATE, FEMA, DOE, NRC, EPA, DOS, NSA, DOC,
DOT, FAA, OSTP, CIA, Treasury, VA, DOI.
five year inter-agency counter-terrorism and technology crime plan
working group 5: preventing and responding to terrorism involving
nuclear, biological & chemical (nbc) weapons
Agencies: DHHS, DOJ, FBI, ATE, FEMA, DOE, NRC, EPA, DOS, NSA, DOC,
DOT, FAA, OSTP, CIA, Treasury, VA, DOI.
Recently, NIAID, participating in the National Security Council's
tasking on the R&D aspects of bioterrorism preparedness, developed a
research program to provide effective defense measures for the civilian
population. The research plan addresses both short and long-term
activities targeted at the design, development, evaluation, and
approval of defensive measures against possible bioterrorist events.
The essentials of this plan include design/testing of diagnostics,
design/development/clinical evaluation of both therapies and vaccines,
and basic research and infrastructure.
Question. What is DOD doing?
Other than the collaboration between NIH and the U.S. Army Medical
Research Institute of Infectious Diseases (USAMRIID) on projects
involving anthrax and smallpox, DHHS is not in a position to speak to
DOD's activities in vaccine development. The Committee may wish to
contact DOD directly--e.g. Colonel Gerald Parker, Commander, USAMRIID,
who is a highly knowledgeable about DOD activities related to
preparation against bioterrorism threats.
Biological threats
Senator Specter. We will pursue with the Department of
Defense the issue of declassification of these biological
threats, because in my judgment the American people have a
right to know what is happening here so that there be an
appropriate response. I appreciate what the three of you have
testified to, but I do not think there is anywhere near an
appropriate response, and that is because the public is
uninformed.
Senator Rockefeller.
Senator Rockefeller. Mr. Chairman, just commenting on your
statement, I am not sure that is the reason--that the public is
uninformed. I think, of course, the public is uninformed,
because actually GAO kind of brushes this thing aside, or
appears to.
You have, if you count up all of the agencies at the State,
local, and Federal levels, probably some 35 different agencies
that need to coordinate, or parts, subsets, of agencies that
need to coordinate.
I think, generally speaking, the public does not spend a
lot of time thinking about bioterrorism. But I think it is
precisely that that makes it more important for us to do so.
Dr. Hamburg, let me just put this to you. Dr. Henderson,
who appears later, said that the production of smallpox vaccine
stopped in 1980, with the exception of the one that the
chairman referred to, and that that was kind of a perfect time
for others, rogue nations, et cetera, to start producing it.
Smallpox is considered a thing of the past. GAO dismisses it as
being unimportant because some other agency has not declared it
to be important.
It does not occur to me that anything is unimportant when
it comes to either chemical or biological weapons, but
everything needs to be inventoried, everything needs to be
taken seriously.
We have, now, what--6 or 7 million doses of smallpox?
Dr. Hamburg. Usable doses, yes.
Senator Rockefeller. Yes, and it would take a year or two
to get us to the point where we could begin to disseminate
those, for production? Not the 6 or 7 million doses, but to
make the necessary amounts?
Dr. Hamburg. With the smallpox vaccine there are two
important issues. One is the use of the existing smallpox
vaccine supply, which as you know is limited to somewhere
around 6 million usable doses.
But there is also the issue of, if we are going to expand
capacity, should we not actually build on advances in
biomedical science and produce an improved, better, safer, more
efficacious vaccine? And that would require an investment of
dollars and several years of research and development. But I
think that there is widespread agreement within the scientific
community that we need to invest in the creation of a second
generation smallpox vaccine, that, while the risk of smallpox
may be relatively low, the consequences of an exposure to
smallpox in this Nation and around the world would be truly
catastrophic.
We need to prepare against the threat of bioterrorism. To
not do so I think would be irresponsible. It is a highly lethal
disease. We know that smallpox has been used in various efforts
to finally weaponize it as a bioweapon. There is no available
treatment, limited supplies of vaccine. We have a population in
this country and internationally that is essentially totally
vulnerable, immunologically naive because we no longer
vaccinate against smallpox and we do not have naturally
occurring disease.
It is communicable person to person in a highly contagious
way, requiring for appropriate infection control very strict
respiratory isolation. A few cases would rapidly overwhelm our
health care capacity to achieve that kind of respiratory
isolation, virtually ensuring the ongoing spread.
So that I think, given the implications of what even a
small smallpox exposure could mean in terms of taking a disease
that is presently not a threat to the human population in terms
of naturally occurring disease and making it again potentially
endemic around the world, we believe that we have to prepare in
a very serious and aggressive way.
Senator Rockefeller. For everything, right?
Dr. Hamburg. Clearly, with limited resources and competing
priorities----
Senator Rockefeller. But the theory is we would like to?
Dr. Hamburg. Yes.
Senator Rockefeller. It would just seem to me that it would
be reasonably clear if we were not preparing to do something
about smallpox, that others, then, who have ill will for us,
would understand that and make the necessary accommodations.
Dr. Hamburg. Given that in certain arenas we have limited
medical tools available at the present time, we have to look to
the future. Perhaps we will not always make the right choices,
but we have to make certain research and development
investments now so that we can be prepared to protect the
health of the public.
Senator Rockefeller. A quick question for you and a quick
question for Dr. Kizer. This coordination thing is staggering.
I mean, 50 percent of the public health agencies not having the
computers to communicate with CDC is embarrassing, shocking,
all the rest of it.
You know, we have all of these agencies and all of these
problems and potentially a lot of time or potentially not a lot
of time to prepare. Is there a best way of doing this--I mean,
how does one gather so many agencies into a coordinated attack
in something called government in the United States,
philosophically as well as literally?
Dr. Hamburg. It certainly is a challenge, and in this
particular arena it requires bringing together communities of
professionals that historically have not worked closely
together. Public health and the medical community have not been
colleagues with the intelligence community and the law
enforcement community in an ongoing way.
I think the threat of bioterrorism really requires that we
all work together and forge these new partnerships. The issues
of collaboration and the effective utilization of limited
resources to really address the most significant threats before
us is one that we need to continue to work on, and I think that
there are many, many examples of fragmentation of programs that
would be greatly strengthened if we could coordinate.
I do think it is critically important to point out--and it
will not surprise you, since I am representing public health
and medicine for the Department of Health and Human Services--
that the role of public health and medicine in addressing the
threat of bioterrorism in particular has been dramatically
underappreciated and underdeveloped because there has been the
continuing framing of the so-called ``chem-bio'' threat as
though it was one unified issue.
But I think that, as I hope I indicated in my testimony,
the paradigm of bioterrorism is really very different, and
public health and medicine will be the front-line responders,
and the investments in increasing the robustness of the public
health infrastructure for disease surveillance will not only
greatly benefit our efforts to prepare against bioterrorism,
but also against a range of naturally occurring infectious
diseases that represent very serious concerns.
Senator Rockefeller. Do public health agencies out there
see this as a serious threat, or do they see it as sort of an
unfunded mandate coming down on them from the Federal
Government, something that they choose not to have to deal with
because they do not have the resources to do it and we are not
probably going to give them to them?
Dr. Hamburg. I think there is growing concern and there is
a real desire on the part of local public health departments
and State and local governments to really begin the
preparedness, planning, the investments in building the public
health infrastructure, the medical consequence management
capacity, and of course the concerns about having the medical
tools we need to treat and prevent disease.
We have gotten enormous response to the requests for
proposals that have gone out from the CDC just recently around
the new money in the fiscal year 1999 budget. It should be
noted that fiscal year 1999 is the first year that our
Department did receive targeted moneys for bioterrorism. But
there is an enormous desire to engage on this issue.
There is, of course, confusion in the profession about how
real is this concern, how adequately can we in fact prepare.
There are some who want to throw up their arms and say it is
hopeless. There are others who want to roll up their sleeves
and try to work on it.
But I think that we have made important strides forward,
but we have a long way to go.
Senator Rockefeller. Thank you, Dr. Hamburg, and please say
hi to your father for me.
Dr. Hamburg. Thank you.
Senator Rockefeller. He happens to be one of the great men
in America, so I had to say that.
Dr. Kizer, you referred to having had some experience in
this, and I remember in--I think it was 1982 or 1983 or 1984--
and I think actually it was in Oregon or someplace like that--
that there was a cult group that contaminated water supplies,
trying to win a local election or something. Is that what you
were referring to?
Dr. Kizer. No, that sounds like something that would happen
in West Virginia.
Dr. Hamburg. It happened in Oregon, actually.
Dr. Kizer. Yes.
Senator Rockefeller. You cannot say ``ORR-e-gon.'' You have
to say ``ORR-e-gin.'' You get in trouble.
Dr. Kizer. As a former Oregonian, I will have to discuss
your relocation plan at a later time.
Senator Rockefeller. Actually, I meant to say Vancouver.
Dr. Kizer. The incident I referred to, in response to your
question, involved the contamination of watermelons with the
pesticide aldecarb in 1985. That involved many States in the
West and ultimately over 1,100 people were poisoned and about a
half a dozen deaths resulted from it.
Senator Rockefeller. My time has run out, but I am actually
determined to prevail on this point. Well, I will have to
prevail later, but there was an incident in 1982 or 1983 when
there was a cult group, whose name I cannot pronounce.
Dr. Hamburg. Rajneeshi.
Senator Rockefeller. Yes.
Dr. Hamburg. In Oregon, and they used salmonella to
contaminate----
Senator Rockefeller. That was it.
Dr. Hamburg [continuing]. A salad bar, in the hopes of----
Senator Rockefeller. Also, they attempted to get into the
water system, and, I thought, were successful.
Dr. Hamburg. I am not aware of that.
Senator Rockefeller. They did not, OK. But in any event,
the point is, things can happen, even in this country. It does
not have to be in the Tokyo subway.
In terms of emergency care, Dr. Kizer, you have a
background in ER yourself. VA has very strict rules about which
services they provide to veterans. Only now will VA be able to
provide a uniform benefit package for all veterans, which may
include emergency care. With your own background as an
emergency medicine physician, how would you rate VA's capacity
at this point in terms of emergency care?
Dr. Kizer. The VA has not historically been, nor is it at
present, known for its expertise in acute trauma care. Most of
our patients have medical problems, and I would rate its
capability of dealing with complex medical problems as much
higher than dealing with the typical knife and gun club trauma
that you see in ER and some other places that I have worked in
the past.
That--well, let me leave it at that. I was going to take it
to where I think you might have been going, but I will defer to
see whether you do.
Senator Rockefeller. No, because my time has long since run
out. But I appreciate your answer on that.
Thank you, Mr. Chairman.
Senator Specter. Thank you very much, Senator Rockefeller.
Picking up on a couple of comments from Senator
Rockefeller--put the lights off. We are going to move on to the
next panel. I just want to make a couple of concluding remarks.
The issue of public awareness in my judgment is always the
dominant force to get governmental action. If the people are
aroused and these stories appear in the media, there is more of
a focus of attention. I have already instructed staff to
prepare a letter for my signature to the Secretary of Defense,
Bill Cohen, outlining at least my views about the public
disclosure and the declassification.
Senator Rockefeller puts his finger on the key spot that
our Commission on Weapons of Mass Destruction is dealing with,
where should the central authority be. We are debating the
Office of the Vice President versus some special office in the
national security administration. My own view is that it takes
somebody like the Vice President, with that kind of clout, to
bring all these agencies together. But of course he has to have
the support of the President. But recently Presidents and Vice
Presidents have been close together. Those are items we are
going to be working on.
Dr. Kizer, just one word as to your situation. We thank you
for your forceful advocacy for the veterans budget. There is
just a glimmering, with OMB not approving your testimony today
and the internal battles as to how much the veterans budget is
going to be, that this is a fight which may have to be elevated
to Congress. Members may have to take a hand here.
I do not want to get involved in your discussions within
the executive branch to any extent that you do not want to
mention them, but would you care to offer any explanation as to
why OMB did not approve your statement and what is happening
with respect to our efforts to have a significant increase in
the veterans budget?
Dr. Kizer. I think those are two separate issues. I am not
sure that I can comment on why OMB was reluctant to concur with
the testimony that we had offered, and I would offer that
opportunity to them to explain that, should that be
appropriate. As far as----
Senator Specter. We are going to offer them the opportunity
to explain it, too, and to include a copy of the statement they
would not approve, so we can see why they would not approve it.
Coincidentally, we will look at the statement.
[The information follows:]
U.S. Senate,
Committee on Veterans' Affairs,
Washington, DC, March 24, 1999.
Hon. Jacob J. Lew,
Director, Office of Management and Budget,
Executive Office Building, Washington, DC.
Dear Mr. Lew: On March 16, 1999, I chaired a joint Veterans'
Affairs Committee-Labor HHS Subcommittee hearing to examine the roles
and preparedness of the Department of Health and Human Services and the
Department of Veterans Affairs (VA) to respond to a domestic chemical
or biological weapons attack. I invited Undersecretary for Health, Dr.
Kenneth W. Kizer, to testify on VA's behalf. Attached, you will find a
copy of the letter of invitation sent to Dr. Kizer.
Much to my disappointment, Dr. Kizer showed up at the hearing with
no prepared written testimony. OMB cleared a redacted version of Dr.
Kizer's proposed testimony which would have provided insight on the
greater role VA could bring to bear on the issue of a domestic WMD
attack. I directed Dr. Kizer to provide me a copy of OMB's pass-back
and found it stifling.
The issue of medical preparedness and response to a domestic attack
by a chemical or biological agent is critical to the country's well-
being. That is why I am at a loss as to why OMB is interfering in a
Congressional inquiry into this matter.
I look forward to your response.
Sincerely,
Arlen Specter.
Executive Office of the President,
Office of Management and Budget,
Washington, DC, May 13, 1999.
Hon. Arlen Specter,
Chairman, Committee on Veterans Affairs,
U.S. Senate, Washington, DC.
Dear Mr. Chairman: I am writing to respond to your letter of March
24, 1999, inquiring about the Office of Management and Budget (OMB)
clearance of testimony prepared for Dr. Kenneth Kizer of the Department
of Veterans Affairs (VA) for a March 16, 1999, joint hearing of the
Labor-HHS Appropriations Subcommittee and the Committee on Veterans'
Affairs on the roles of VA and the Department of Health and Human
Services (HHS) in medical preparedness and response to a domestic
attack by a chemical or biological agent.
I want to assure you that this issue is very important to the
Administration. The Administration is concerned that adversaries will
increasingly rely on unconventional strategies, such as attacks with
weapons of mass destruction (WMD), to offset U.S. military superiority.
Armed with these weapons, terrorists could inflict tremendous harm.
While the Administration is working to deter and prevent such assaults,
we must also be ready to manage the consequences of a WMD attack.
Therefore, the counterterrorism activities of Federal agencies are the
subject of a formal analysis each year in the preparation of the
President's Budget. In addition, OMB participates in extensive
interagency working groups throughout the year, led by the National
Security Council, that address WMD preparedness issues. We believe it
is very important that relevant testimony prepared for the Congress
reflect this interagency process and present a coordinated
Administration position.
OMB's clearance process is designed to ensure that the Congress
receives coordinated testimony from the Executive Branch that
accurately reflects Administration positions. The clearance process, as
it currently operates, was essentially developed during the Roosevelt
Presidency in the 1930s and established in its current form in 1939.
The basic purpose of the central clearance process has remained the
same during each of the subsequent Administrations--ensure that
Presidential policies are reflected accurately before the Congress.
OMB received Dr. Kizer's draft testimony the day before the hearing
and circulated it to concerned agencies to ensure that it was
coordinated within the Administration and accurately reflected
Presidential policies. After reviewing the edits proposed by the
agencies, OMB asked VA to make changes to the testimony. After
receiving the requested edits, VA staff informed OMB the evening before
the hearing that the edits were unacceptable to Dr. Kizer and that he
had decided to appear without a written statement. The staff at OMB
acted properly, within the time available, to make sure the Congress
would receive testimony accurately reflecting the President's policies.
I hope this answers your question.
Sincerely,
Jacob J. Lew,
Director.
______
Draft Prepared Statement of Kenneth W. Kizer
Mr. Chairman and Members of the Committees: I am pleased to appear
before you today to discuss current and potential roles for the
Department of Veterans Affairs (VA) in emergency management, in
general, and incidents involving weapons of mass destruction (WMD), in
particular.
At the outset, though, I want to commend you for calling this
hearing to address the vitally important issue of WMD preparedness
planning and for your leadership in recognizing the important role that
VA could play in the domestic response to terrorist uses of WMD.
background
Before addressing issues related to WMD, let me first review VA's
current emergency management roles and functions. VA was first formally
assigned a federal emergency management role in 1982, when Public Law
97-174 tasked VA with ensuring the availability of health care for
eligible veterans, military personnel, and the public during Department
of Defense (DOD) contingencies, and natural, manmade, or technological
emergencies. Within VA, the Veterans Health Administration (VHA) has
responsibility for this emergency management function, and this is
generally referred to as VHA's fourth mission. Within VHA, the
Emergency Management Strategic Healthcare Group (EMSHG)--formerly the
Emergency Management Preparedness Office (EMPO)--has lead
responsibility for this mission.
EMSHG staff are charged with fulfilling several statutory or other
mandated missions. With its headquarters located on the grounds of the
VA Medical Center in Martinsburg, WV, a budget for fiscal year 1998 of
about $7.6 million, and personnel located throughout the nation's major
population and transportation centers, the EMSHG staff currently plan,
coordinate, administer, and execute VHA's participation in six
interrelated emergency management functions. These functions are:
--developing guidance to ensure continuity of operations for
individual VA medical centers, and, more recently, VHA's
Veterans Integrated Service Networks (VISNs).
--providing back-up medical care for DOD personnel in wartime;
--participating in the National Disaster Medical System (NDMS);
--participating in the Federal Response Plan for natural and man-made
disasters;
--responding to natural and technological hazards; and
--participating in the Federal Government's continuity of government
program.
Specific VHA mission responsibilities include the following:
VA Contingencies.--Through planning and coordination, EMSHG Area
Emergency Management (AEM) personnel act to ensure continuity of
operations at VA medical facilities during emergency conditions. AEM
staff responsibilities also involve, prior to emergency conditions,
developing, managing, and reviewing plans for disasters and
evacuations, and coordinating mutual aid agreements for patient
transfers
DOD Contingencies.--Since 1982, under Public Law 97-174, VA is the
primary backup to the DOD healthcare system during times of war or
other emergencies involving military personnel. In this regard, VA
maintains plans to allocate up to 25 percent of its staffed operating
beds for DOD personnel (casualties) within 72 hours of being alerted of
DOD's need for such capacity. More specifically, 68 VA medical centers
are designated as Primary Receiving Centers; these Primary Receiving
Centers are tasked with being prepared to receive DOD patients and
execute plans for early release and/or movement of VA patients to other
VA Medical Centers designated as Secondary Support Centers. Other VA
Medical Centers provide DOD installation support as needed. EMSHG
maintains data on the availability of VA beds and would coordinate the
receiving and transfer of DOD patients if needed.
National Disaster Medical System.--Under an interagency agreement
signed in 1984, VA, DOD, the Department of Health and Human Services
(HHS), and the Federal Emergency Management Agency (FEMA) are partners
in administering and overseeing the NDMS, which is a joint effort
between the federal and private sectors to provide backup to civilian
health care in the event of disasters. NDMS maintains memoranda of
agreement with civilian hospitals to provide staffed, acute care
hospital beds for treating large numbers of patients as a result of
major peacetime disasters, as well as additional backup during a
military contingency. VA participates fully in NDMS. VHA
representatives meet regularly with the other agency partners for
planning and coordination. Overall policy is set by the NDMS Senior
Policy Group, of which I am a member.
Federal Response Plan.--Under Public Law 93-288, enacted in 1992,
VA assists state and local governments in responding to disasters, and
increasingly events requiring security coordination. VA may be tasked
to provide engineering services, mass care and sheltering, resources
support, health and medical services, and urban search and rescue.
Planning and coordination of VA participation is performed by EMSHG
headquarters staff, with assistance from field staff as needed. Both
headquarters and field staff are subject to deployment to disaster
sites to assist FEMA and HHS in providing disaster relief. Clinical
staff from other VHA elements may also be deployed to such sites.
Support for these staff is prodded by EMSHG.
Since Hurricane Andrew in August 1992, VA has provided direct
health and medical services in response to 19 mayor domestic disasters
that have included earthquakes, hurricanes, floods, ice storms, and the
bombing of the federal building in Oklahoma City, as well as special
events involving the pre-positioning of medical assets for response to
potential terrorist incidents. These events have included the 1996
Summer Olympics, the Economic Summit of the Eight, the 1996 Republican
and Democratic Conventions, the recent Papal visit, and the President's
State of the Union addresses. Over the past nine years, this support
has involved the deployment of over 1,000 VA healthcare personnel, and
the provision of substantial amounts of medical supplies and equipment,
as well as use of VA facilities. Important to note is that with the
abolition of the Public Health Service's direct care capability and
with the devolution of military health care in recent years, VA has
increasingly been looked to as the federal government's primary and
principle response asset for disasters requiring a medical response.
Natural and Technological Hazards.--Under Executive Order 12657
(November 1988), VA responds to natural and technological hazards as a
participant in the Federal Radiological Emergency Response Plan and is
tasked, along with DOD, to respond to accidents at nuclear power
stations and accidents involving radiological threats or injuries.
EMSHG is responsible for planning and coordinating VA's participation
to meet federal emergency management requirements and to provide
coordination for federal deployments of VA medical assets.
Continuity of Government.--Under Executive Order 12656 (November
1988), EMSHG maintains VA-specific relocation sites in support of the
continuity of government program during national emergencies. EMSHG
staff assist in the maintenance of a relocation site in Martinsburg and
necessary communication facilities for use by VA top management in the
event these are needed to continue Federal government functions during
a major national emergency.
va involvement in weapons of mass destruction preparedness planning
VA has been involved--both directly and indirectly--in weapons of
mass destruction (WMD) planning since Presidential Decision Directive
#39 was published in June 1995. This Directive established the crisis
and consequence aspects of WMD incidents and included funds for HHS to
purchase pharmaceuticals in support of four National Medical Response
Teams (NMRTs) sponsored by the Public Health Service (PHS). VA
currently stores and maintains four identical pharmaceutical caches for
the NMRTs in Washington, DC; Winston-Salem, North Carolina; Denver,
Colorado; and Long Beach, California.
Presidential decision directive #62
Since May 1998, VA has regularly participated in WMD planning in
accordance with Presidential Decision Directive #62 (PDD-62),
``Combating Terrorism.'' Included among the elements of this directive
was a tasking to HHS, working with VA, to ensure adequate stockpiles of
antidotes and other necessary pharmaceuticals nationwide and to train
medical personnel in NDMS hospitals. To date, there have been no HHS
requests under PDD-62 for additional pharmaceutical storage by VA at
sites other than the existing four NRMTs.
With respect to training, PDD-62 tasks HHS, working with VA, to
train medical personnel about WMD in NDMS hospitals. Currently, EMSHG
has initiated the development of a WMD training program for selected
NDMS hospitals this fiscal year. The training program is targeted for
implementation in fiscal year 2000. Of note, in fiscal year 2000, HHS
has the discretion to reimburse VA up to $1,000,000 for expenses
incurred in conducting the WMD training program for hospitals
participating in NDMS. The following table summarizes VA activities
specifically related to WMD planning.
----------------------------------------------------------------------------------------------------------------
Fiscal years--
--------------------------------------------
1998 1999 2000 (projected)
----------------------------------------------------------------------------------------------------------------
Funds expended or committed, excluding salaries.................... $6,100 $41,320 \1\ $1,056,842
Fulltime equivalent employees...................................... 1.15 2.29 2.29
----------------------------------------------------------------------------------------------------------------
\1\ Includes the $1,000,000 HHS reimbursement.
There are significant considerations still to be addressed,
however, regarding VA's potential to assist in WMD-related training
efforts. For example, at this time I am not aware of any provisions for
funding necessary decontamination and personal protective equipment at
civilian hospitals, which are essential components of training for
these incidents. Without such equipment, hospitals will be unable to
accept ``walk-in patients'' who are contaminated, because to do so
would imperil their staff and patients already one site. Clearly,
``hands on'' would greatly enhance readiness. Given that VA is
developing the training program, addressing this matter would
significantly improve our efforts in this regard.
va activities and role in pharmaceutical procurement
In addition to developing the WMD training program for NDMS
hospitals, EMSHG has assisted selected VA Medical Centers in WMD
training initiatives. VA Area Emergency Managers also have been
participating in state and local planning and preparation for WMD
response in their role as community and mutual support coordinators.
For example, at the request of HHS, VA recently provided training on
treatment of WMD victims to selected hospitals in St. Louis prior to
the Papal visit. VHA is currently involved in planning and coordination
for the NATO-50 meeting in Washington, DC, where we will support the
pharmaceutical cache pre-positioning and other medical support
responsibilities in accordance with the 1992 Federal Response Plan.
Important to note, however, is that training for all VA medical
centers--just as with training for all NDMS hospitals--needs to be
improved to assure baseline medical capabilities for WMD readiness.
With respect to pharmaceutical stockpiles, VA operates under an
interagency agreement with HHS (attachment A). EMSHG works with VHA's
Pharmacy Benefits Management Strategic Healthcare Group (PBM/SHG),
Emergency Pharmacy Service to procure, inventory, store, manage, and
distribute pharmaceuticals, nationally. The contents of the medical
caches is determined by HHS; VA procures and then manages the caches.
PBM/SHG, working with the National Acquisition Center, purchases
from select vendors the pharmaceutical and medical supplies, as
identified and directed by HHS. VA has responsibility to replenish
these items, as needed, based on usage and/or potency longevity and to
store the cache in a manner that ensures conformity to FDA and
manufacturer storage regulations and recommendations. When deployment
of a cache is required, PBM/SHG coordinates logistical matters with
EMSHG. A copy of the general responsibilities of the Emergency Pharmacy
Service responsibilities and of the storage and maintenance policy for
the medical caches is found at attachment B.
wmd preparedness planning and va's future role
In your letter of invitation to appear at this joint hearing, you
noted that you wished to explore VA potential for an expanded WMD role.
I welcome the opportunity to discuss this with you, since I believe
that VHA's potential utility and value in this regard has not received
appropriate attention. Since becoming Under Secretary, I have
undertaken various relevant efforts--to the extent possible within
budgetary and management constraints--to improve VA's institutional
capabilities and infrastructure in ways that would both enhance VA's
contributions to the federal government's efforts to address WMD
preparedness and enhance VA's ability to manage its current patient
portfolio.
In this regard, I must emphasize that VA's medical care budget is
dedicated to providing care for veterans. Consequently, as we noted in
a previous report to Congress in response to Public Law 105-114, if VA
is to assume any expanded role in WMD planning, it must be accompanied
by additional resources to ensure that our first and primary mission of
caring for veterans is not compromised.
Notwithstanding these resource issues, however, I think it is
relevant to point out that VA can uniquely contribute in incremental
ways to the federal effort to prepare for possible terrorist incidents
involving WMD. In the area of physician training and expertise, for
example, the federal government can leverage VA's major role in health
professional training. As you know, each year more than half of all
medical students and a third of postgraduate physicians in training
(i.e., residents) receive some of their training at VA facilities. In
addition, more than 40 other types of healthcare professionals receive
training at VA medical centers every year. In this vein, during the
past three years I have utilized this aspect of VA's mission to expand
physician training slots that will increase the number of individuals
with appropriate expertise in those disciplines necessary to address
WMD preparedness, as well as to better address existing and projected
needs in related areas involving veterans care.
Specifically, I directed that VA establish and support a new
Medical Toxicology Special Fellowship (the expertise most pertinent to
WMD incidents); this was initiated last year. In academic year (AY)
1997-98, VA supported 1 fellow; in AY 1998-99, there are 6 fellows.
Additionally, Occupational and Environmental Medicine is the
Accreditation Council of Graduate Medical Education-approved residency
program providing the most relevant expertise, and in AY 1995-96 VA
supported 4.25 positions in this specialty. In AY 1997-98, we supported
8.25 positions in Occupational and Environmental Medicine (AY 1996-97
was a transition year). In AY 1998-99, this number has grown to 14.37
positions.
Within VHA's primary medical care mission, I believe there lies
significant untapped potential for us to support the federal
government's capability to respond to WMD incidents. VA facilities are
geographically dispersed in essentially all of the nation's major
metropolitan areas. We have long-established relationships with 85
percent of the nation's medical schools and some 1,200 universities and
colleges overall. Because we are part of local health care systems, we
have established relationships with the local emergency medical
services systems. We already participate in much of the state and local
emergency planning activities, as well as coordinate training programs
and exercises. In a word, there already exists a solid base upon which
VA can build an expanded role specifically related to WMD.
As I noted earlier, VA manages four pharmaceutical caches for the
NMRTs, but beyond this, VHA's infrastructure certainly lends itself to
increasing such support in terms of procurement, storage, and
management of pharmaceuticals at multiple sites for ready distribution
wherever needed. In fact, in recognition of the key role a VA facility
can play to address WMD preparedness planning, the Office of the
Attending Physician of the U.S. Capitol signed a Memorandum of
Understanding with VA in September 1998 to provide for the procurement,
maintenance, and storage of a customized WMD cache, to be kept at the
Washington VAMC (which also is one of the NMRT sites).
In this same vein, Public Law 104-201 directs and funds HHS to
develop 125 local emergency medical systems, or Metropolitan Medical
Strike Teams (MMSTs) in selected cities across the United States.
Currently, 22 MMSTs exist in various stages of implementation. It has
become apparent by the requests for support to PBM/SHG and EMSHG that
the strike teams do not have the infrastructure and training in place
to facilitate the purchase, maintenance, and distribution of the WMD-
related medical caches.
Moreover, I note that while VA's role and potential to support the
national response to WMD has not been widely recognized within the
federal government, I am advised that in cities where VA facilities
have routinely been actively involved in local discussions, local HHS-
led Disaster Medical Assistance Teams (DMATs) teams typically view VA
as an important resource for training and logistical assistance.
Thus, I believe that VA's role could be enhanced, at minimum, to
formally and proactively provide expertise and service to the expanding
network of MMSTs and DMATs, rather than as a ``resource of last
resort.'' And beyond assistance with matters related to
pharmaceuticals, these same VA assets can be drawn upon to improve the
federal government's preparedness for WMD incidents in terms of
training; medical and clinical capability; coordination with state and
local agencies; provision of logistical and other support for other
federal agencies; and research.
conclusion
In closing, I would like to offer my personal observations on the
current state-of-affairs for WMD readiness in the United States based
on my experience as an emergency physician, medical toxicologist,
public health official and as the former director of Emergency Medical
Services for the State of California. In brief, this country is
woefully unprepared for a terrorist incident involving WMD.
There is, however, much that can and should be done in the near
term to better prepare us for such an inevitable event. As VA's Under
Secretary for Health, I know the assets, expertise, and potential
capabilities VA can offer to address WMD readiness; they are
significant, though too often unrecognized and overlooked--or under
appreciated. This is unfortunate, since just as there is no doubt that
floods, earthquakes, hurricanes, tornadoes, and other natural disasters
will strike the United States in the future, there is no question in my
mind that a terrorist event involving WMD will occur in the United
States. It is only a matter of when, where, and whether we will be
prepared.
Dr. Kizer. As far as the budget, we continue to work with
all involved parties to see that we have the resources to
provide care to the many men and women who rely on the system
for that care.
Senator Specter. Well, we will pursue that generalized
answer on another occasion.
We thank you very much, Dr. Kizer, Dr. Hamburg, and Mr.
Hinton. Mr. Hinton, you had your hand up a moment ago, just a
finger. Did you want to make another statement?
Mr. Hinton. Yes, sir. I would like to just offer a couple
comments in response to Senator Rockefeller's comments just a
few minutes ago. This is an important area that we have been
following over the last couple of years, and we have watched
the funding go up, and the Federal response to this problem has
been very, very significant. The message that I want to convey
is our message is not that we should stop funding in this area.
What we see missing from the picture--and it kind of goes
to the government's machinery, its response to the problem
here--is that we have not seen threat and risk assessments that
would kind of take you through each of the threats that we
have, the likelihood and vulnerability around the threats, and
a prioritization of what we need to be focusing the Federal
machinery and the resources on, so we make sure we get to the
highest priority parts of that threat list.
We have not seen that yet, and that has been an observation
that we have had across the full spectrum of Federal programs
and activities that have also been growing.
The second point that I would leave with you is that we
provided a classified report, Mr. Chairman, to the Congress in
December of this past year that raised some very significant
command and control issues that I would want to make sure the
Committee is aware of and make sure that you all have a copy of
that before I depart.
Senator Specter. Thank you very much, Mr. Hinton, Dr.
Hamburg, and Dr. Kizer.
We are going to move now to----
Senator Rockefeller. Mr. Chairman, could I just make a
comment on that?
So what you are saying, Mr. Hinton, is that you want all
the ducks to be in order? You want No. 1 threat, No. 2 threat,
No. 3 threat, and No. 13 threat, all of them put in strict
uniform order, and then you want a nice blueprint for how this
vast array of agencies is going to coordinate, before we start
to take, to go more seriously into how we are going to protect
ourselves?
Mr. Hinton. No, sir, not----
Senator Rockefeller. I love the idea of waiting 2 years, if
nothing happens. But do you contemplate such certainty on that?
Mr. Hinton. Senator, no, I do not see the detailed
accounting in that way. What I am suggesting here is that we
are bringing the complete apparatus, to include the
intelligence communities, to bear in helping think through what
the top priorities may be that we need to target that can cause
the mass casualties we may be concerned about.
It is that type of analysis that we have not seen done,
that would help us make sure we are not letting anything that
we need to be dealing with fall through the cracks.
Senator Specter. Thank you very much, Mr. Hinton. We are
going to have to move ahead to the next panel. We have to
conclude this hearing in advance of 11 o'clock. So we thank you
all very much.
NONDEPARTMENTAL WITNESSES
STATEMENT OF JOSHUA LEDERBERG, M.D., PRESIDENT-EMERITUS
AND SACKLER FOUNDATION SCHOLAR, ROCKEFELLER
UNIVERSITY, NEW YORK CITY
Senator Specter. We would now like to turn to Mr. Joshua
Ledberg----
Senator Rockefeller. Lederberg.
Senator Specter. Dr. Joshua Lederberg, Dr. Donald
Henderson, and Dr. Robert Myers. Our first witness on the
second panel, Dr. Lederberg, is President Emeritus and Sackler
Foundation Scholar of the Rockefeller University of New York
City. No wonder Senator Rockefeller was so particularized about
pronunciation.
Senator Rockefeller. Pronounce the name correctly. He is a
Nobel Laureate.
Senator Specter. I quite agree with your preeminence, Dr.
Lederberg. I would try to pronounce everybody's name correctly
even if they are not of your status.
Educated at Columbia and Yale, pioneered the discovery of
genetic recombination of bacteria. In 1958, Dr. Lederberg was
awarded the Nobel Prize in Medicine at the age of 33.
Thank you for joining us. Director Deutch sends you special
greetings. We look forward to your testimony.
Dr. Lederberg. Thank you, Chairman Specter, Senators. Let
me say right off I applaud your remarks at the beginning and
the very bipartisan spirit with which they are given. My own
may be preaching to the choir, but there are a few points I
would like to emphasize.
First of all, before there is an aspiring reporter who
wants to win a Pulitzer Prize for an astounding revelation, let
me put it on the record, what everybody knows. I do consult
quite widely in the biotechnology and the pharmaceutical
industry and for SAIC, all of which would like to play a role
in biodefense. I have also been for 30 years activistically
involved in trying to deal with the threats of emerging
infections and bioweapons.
The dissolution of the Soviet Empire and the refinement of
our own military technology have vastly altered the security
environment of the United States. Our forces in place have
obliged our potential adversaries to avoid confrontation on
discernible battlefields and to seek asymmetric strategies to
avoid defeat upon head-on collision with us.
Biological weapons, germs, deployed against symbolic
targets, troop barracks, and real valued ones like ports of
assembly and cities, are almost ideally suited for that aim--
post-modernist warfare.
With respect to major bio attacks by state interests, our
principal bulwark remains deterrence. The main challenge is the
credibility of our resolve to respond and the cementing of a
global coalition dedicated to the enforcement of BW
disarmament. That requires more work to win the minds and
hearts of our friends as well as to define and lay down the law
for the culprits. These may be the most vital steps, but they
are an arena probably beyond the scope of these hearings.
But deterrence is futile against unattributable groups or
crazies. BW can be delivered by clandestine vehicles, man or
truck or boat-mounted sprayers, and can use prepositioned
stockpiles measured in pounds, not tons. A major attack might
hide below our radar screen of epidemic awareness for hours, if
not days. Who then could be the target for our revenge in a
deterrence mode?
Undeviating reliance on deterrence also leaves us open to
provocation and disinformation from culprits and third parties
to elicit responses that might discredit our legitimacy or even
to catalyze war between tensely positioned states. Consider the
interference with the peace process in Israel on the part of
Hamas and its use of terrorism.
Nevertheless, it is smaller groups who are most likely to
resort to BW, even if they lack access to unlimited resources
from a mobilized state sponsor. Such smaller groups, which I
will define as operating on a budget of a million dollars or
less, still have readily achievable, although limited,
capabilities.
Not enough attention has been paid to soft kill of urban
targets, even while there has been some hyperbole about the
ease of a hard kill of a city. For example, no one can dispute
the feasibility of a scenario which could achieve 1,000 to
10,000 mortal casualties in a metropolitan area, far short of
destroying the entire city, as is sometimes advertised.
What has been underestimated grossly is the terror that
this would induce while the seeds of infection were germinating
and spreading. In the wake of such an attack, even if the
ultimate casualties added up to ``only'' 1,000 or 10,000,
100,000 to a million would be at risk, even according to the
most rational calculus, because who would know who was infected
and who was not. This could be amplified further by rumor and
panic soon after the earliest cases came to notice.
Hence, even such--and I put this in quotes--``limited''
attacks demand preparations for managing situational awareness,
diagnosis, prophylaxis, and treatment for up to a million
people--a staggering number and an event that cannot possibly
be managed without a great deal of prior care, attention,
mobilization, exercises, prepositioned stockpiles. It will be
very difficult to know exactly who has been exposed in time to
intervene and many more people would have to be cared for, many
more people would have to be treated, than will in the end
succumb, than will in the end have actually been exposed.
To deal with these issues, the public health infrastructure
is the most important component. But this has to be designed
and exercised to coordinate with all other elements of
emergency management--public information, law enforcement, and
if need be on such a scale, support from forces that can be
mobilized under military discipline. Besides the structural
arrangements would be provision for materiel, diagnostics,
antidotes, hospital support equipment, including improvised
beds, shelter, isolation, and so forth.
A brutal calculus might infer that this is demanding an
investment of thousands of dollars per life actually saved, and
this has to be qualified further by the unlikelihood that such
attacks will really eventuate, or we do not know the
likelihood. My answer is that this scale of investment is
within the bounds of other prophylactic programs, but also that
the penalty of a successful attack goes beyond the lives lost.
It will be an example for others, inviting multiplied problems.
It will discredit the sensitivity and competence of government.
The secondary damage from chaos and panic may exceed the
primary kill, including, may I say, the deterioration of the
taxes that can be collected on uninhabitable properties.
The secondary gains from a preparedness program include a
form of deterrence against culprits by offering less obviously
naked targets. Hence their incentive to use this mode of attack
would be greatly lessened to the extent that we are in fact
prepared for it.
Senator Specter. Dr. Lederberg, could you summarize the
balance of your statement, and your full statement will be made
a part of the record.
Dr. Lederberg. Yes.
prepared statement
Navy Secretary Danzig has characterized bioweapons as
weapons of mass disruption, and for this most likely level of
attack that is the appropriate perspective and should guide our
priorities in allocating the resources for the defense of our
cities.
Thank you very much.
Senator Specter. Thank you very much, Dr. Lederberg.
[The statement follows:]
Prepared Statement of Joshua Lederberg
This writing is adapted from my introduction and epilogue to
``Biological Weapons: Limiting the Threat'' MIT Press 1999 edited by
Joshua Lederberg.
The transcendence of BW over medicine and public health, private
criminal acts, terrorism, interstate warfare, and international law
directed at the elimination of BW, makes this one of the most intricate
topics of discourse, poses very difficult security problems, and opens
some novel challenges in the ethical domain. (See Table 1.)
That same transcendence confounds efforts to organize governmental
and intergovernmental measures of control: health authorities will need
to negotiate with the military, with law enforcement, with
environmental managers. And all will have to cope with how to enhance
security without imposing intolerable stresses on personal liberties
and on freedom of travel and of commerce.
The topic of biological warfare (BW) had last been covered
systematically by JAMA, as part of a discourse on weapons of mass
destruction, in August 1989. \1\ \2\ \3\ We recall that 1989 marked the
bicentennials of the American presidency and of the French Revolution.
By year's end, perhaps not by pure coincidence, 1989 also marked the
collapse of the Soviet Empire, and with that the end of the cold war.
The Biological Weapons Convention (BWC) had been in place since 1972;
nevertheless, compliance on the part of great states, notably Russia,
with that convention was the centerpiece anxiety in 1989. United States
national policy was likewise concentrated on the defense of our troops
in tactical combat settings.
Medical interests, notably symbolized by the World Health
Organization's pleas \4\ had played a significant role in the
diplomatic priority given to the BWC, and then to concern for its
enforcement. Since 1989, the Persian Gulf War, the escaltion of
terrorism, and a recrudescence of many infections have added new
dimensions to concerns for the malicious incitement of disease. Iraq
was proven to have developed and militarized a repertoire of BW agents,
notably anthrax spores.\5\ Terrorists achieved new levels of violence
in New York, Oklahoma City, and Tokyo and operated on ever more
incomprehensible and unpredictable rationales. Having deployed chemical
weapons in Tokyo and dabbled in BW, terrorists would soon be attempting
to deploy BW on an increasing scale. It is not difficult to find
recipes for home-brew botulinum toxin on the World Wide Web; terrorists
justify this with the proposition that every citizen should have the
parity of power with government. Meanwhile, the growth of biotechnology
has great promise for new modes of diagnosis and therapy, but if left
unchecked, advances in biotechnology will allow for even more
troublesome microbiological agents of destruction.
This volume then touches on a set of timely concerns that unite
national security and public health, concerns that cry out for well-
articulated convergence of the human community worldwide. Various
articles in this issue touch on the historical,\6\ diplomatic,\7\ \8\
and legal background; \9\ on modalities of diagnosis and management;
\10\ \11\ and on case studies of small-scale BW attacks that have
already been perpetrated, though amateurish in design and ending with
limited malefaction.\12\ \13\
While BW is widely regarded as the absolute perversion of medical
science, the problematics of invoking humanitarian regulation of means
of warfare are well understood.\14\ \15\ Resort to warfare is tied to
the use of any means necessary for the survival of the state, including
organized violence. It is mainly the peacetime behavior of states that
can be regulated by international law, and this has evolved toward
greater coherence and impact in an interdependent global economy. Even
in the thrall of violent combat, states will also be deterred when
there is a firm international resove: Iraq did not, after all, use its
massive stockpiles of anthrax in the Gulf War.\5\
The 20th Century has seen the exercise of massive violence on an
immense scale, even without major resort to BW. What distinguishes BW
is the understanding that its habitual practice would be ruinous to
personal security and civil order perhaps more grievously than any
other weapon likely to get in the hands of disgruntled individuals or
rogue states. One sine qua non for the elimination of BW is its utter
delegitimation; in the language of the Geneva Protocol of 1925, it must
remain ``justly condemned by the general opinion of the civilized
world.'' \16\
As a matter of international law, any debate has already been
settled by the wide adoption of the 1972 BWC: the abnegation of
biological weapons is approaching the status of a norm of international
behavior, going beyond a mere contract for mutual compliance. When an
international consensus can be achieved and sustained, as happened
after Iraq's invasion of Kuwait, severe sanctions can be imposed by the
international community. The task is to build that moral consensus \17\
and give it sustainability and priority over more transient aspects of
perceived national interest, like commercial advantage or access to
resources. We are happily less burdened by the choosing up of sides of
the cold war and the strange bedfellows that process engendered. There
is much to answer for in the nonchalance exhibited by most of the world
when Iraq used chemical weapons in its wars against Iran and its own
Kurd dissidents.\18\
Writing 50 years ago,\20\ Vannevar Bush remarked, in puzzling why
BW had not been deployed at the height of World War II: ``Without a
shadow of a doubt there is something in man's make-up that causes him
to hesitate when at the point of bringing war to his enemy by poisoning
him or his cattle and crops or spreading disease. Even Hitler drew back
from this. Whether it is because of some old taboo ingrained into the
fiber of the race. . . . The human race shrinks and raws back when the
subject is broached. It always has, and it probably always will.'' Bush
could not offer these as reliable reassurances; and he surely played a
large role in instituting and maintaining what became the US offensive
BW development program. That started during World War II, and escalated
in the cold war competition with the Soviet Union until 1969, with
President Nixon's unilateral abnegation. In due course that was
followed by the successful negotiation of the BW Convention of 1972,
and its coming into force internationally in 1975.
Scrupulous adherence to the BWC on our own side, coming to the bar
with clean hands, is of course an absolute prerequisite to the moral
platform of BW prohibition. There is no more powerful instrument for
that credibility than self-inspection. In free societies, that
responsibility will largely devolve on well informed scientific and
medical professionals. That community also has deep-seated ties with
compeers even in some authoritarian states, bonds that should be
cultivated to develop common ground even against obstacles of parochial
interest.
Unlike nuclear weapons, the capability for BW is unlikely to be
reliably contained by any degree of legal prohibition and formal
verification. The facilities required for producing and dispensing BW
agents are modest, easily concealable, and almost indistinguishable
from licit production of pharmaceuticals and vaccines. The same holds
for the underlying technical knowledge, which is part and parcel of
medical research and education. The potential for grave enhancement
\21\ of virulence and intractability of pathogens for BW use goes hand
in hand with the advances of biotechnology for human life-enhancement.
Verification still plays a role, as part of a lawful process of
investigation and indictment of malefactors. But the key to
consolidation of the law on BW is its rigorous enforcement, and this
will require a consensus even among our friends and allies that has yet
to be achieved--partly out of the expectationthat the U.S. will always
bear the onus as enforcer of last resort. Moral conviction and discreet
technical education about the implications of leaving BW unchecked then
go hand in hand.
As for the smaller and more marginal states, we should anticipate
some ambivalence about foregoing weapons that might mitigate the
overwhelming military power of a super-state. To enlist their
unreserved cooperation in denying the use of BW, we should be far more
proactive in mobilizing our health technology to stamp out rampant
infectious disease globally. \22\ Tuberculosis remains the earth's
prime killer, and malaria with hundreds of millions of infected people
the greatest drain on human vitality. It is scandalous that these
coexist with a technology that will soon have plotted the entire human
genome. Lacking robust technical solutions to the malevolent use of BW,
we have little to call upon besides this common moral ground to prevent
attack.
If despite deterrence, law, and moral suasion, the means of attack
cannot be forsworn, there remains the obligation to be prepared to
blunt them. Physicians and local health services, along with police and
firefighter first-responders are in the front lines to deal with health
emergencies. This is the same apparatus needed to deal with natural
disease outbreaks: recall Legionella, Influenza A-H5N1, and Escherichia
coli O157:H7 of recent vintage. The local responders also need to be
trained in exercises entailing support from the Public Health Service
and, if need be, military personnel. While BW attacks may be widely
dispersed, far more than trauma from explosives or chemicals they are
amenable to medical intervention: provided diagnosis is timely and
resources can be mobilized. In many cases, there may be little or no
advance warning. Vigilance in understanding the fate of victims near
the dose-epicenter might provide an alert for the much larger cohorts
likely to receive smaller doses and exhibit longer incubation times--a
window of opportunity for treatment.
Several artiles in this issue point to recent progress, and a long
way still to go, in the coordination of resources among a host of U.S.
governmental agencies: federal, state, and local.\11\ \19\ Recent press
reports also speak to a rising tide of attention by responsible
officials.\23\
In view of the rapid dispersal of people via jet aircraft, and the
globalization of commerce, including foodstuffs, that coordination
needs to be extended to a global venue. This scarcely exists at all at
the present time, although the WHO has energetic programs to deal with
influenza and HIV, and could be the nucleus of more extensive disease
surveillance. With the growing recognition that BW is a strategic
weapon, directed most effectively at large urban populations,
cooperative public health measures might well reach the agenda of our
security alliances like NATO. Military force protection against BW (and
CW) is fairly advanced--with the dissemination of vaccines, antidotes
and masks: these weapons are not likely to confer great tactical
advantage to the perpetrator. Civil populations, near actual and
potential theaters of combat or clandestine attack--and that no longer
excludes our homeland--deserve comparable protection, if only to reduce
the temptations for the aggressors, and soften the dilemmas and
collateral harm of retaliation.
references
Those for JAMA 1997 should be recast to refer:
\1\ Orient JM. Chemical and biological warfare: should defenses be
researched and deployed? JAMA. 1989;262:644-648.
\2\ Sidel VW. Weapons of mass destruction: the greatest threat to
public health. JAMA. 1989;262:680-682.
\3\ Huxsoll DL, Parrott CD, Patrick WC III. Medicine in defense
against biological warfare. JAMA. 1989;262:677-679.
\4\ WHO Group of Consultants. Health Aspects of Chemical and
Biological Weapons. Geneva, Switzerland: World Health Organization;
1970.
\5\ Zilinskas RA. Iraq's biological weapons: the past as future.
JAMA. 1997;278:418-424.
\6\ Christopher GW, Cieslak TJ, Pavlin JA, Eitzen EM Jr.Biological
warfare: a historical perspective. JAMA. 1997;278:412-417.
\7\ Kadlec RP, Zelicoff AP, Vrtis AM. Biological weapons control:
prospects and implications for the future. JAMA. 1997;278:351-356.
\8\ Danzig R, Berkowsky PB. Why should we be concerned about
biological warfare? JAMA. 1997;278:431-432.
\9\ Ferguson JR. Biological weapons and the US law. JAMA.
1997;278:357-360.
\10\ Franz DR, Jahrling PB, Friedlander AM, et al. Clinical
recognition and management of patients exposed to biological warfare
agents. JAMA. 1997;278:399-411.
\11\ Holloway HC, Norwood AE, Fullerton CS, Engel CC, Ursano RJ.
The threat of biological weapons: prophylaxis and mitigation of
psychological and social consequences. JAMA. 1997;278:425-427.
\12\ Toeroek TJ, Tauxe RV, Wise RP et al. A large community
outbreak of salmonellosis caused by intentional contamination of
restaurant salad bars. JAMA. 1997;278:389-395.
\13\ Kovalic SA, Kimura A, Simons SL, Slutsker L, Barth S, Haley
CE. An outbreak of Shigella dysenteriae type 2 among laboratory workers
due to intentional food contamination. JAMA. 1997;278:396-398.
\14\ Bull H. The Control of the Arms Race. New York, NY: Praeger
for the Institute for Strategic Studies; 1961.
\15\ Lederberg J. The control of chemical and biological weapons.
Stanford J Int Stud. 1972;7:22-44.
\16\ Protocol for the Prohibition of the Use in War of
Asphyxiating, Poisonous or Other Gases, and of Bacteriological Methods
of Warfare, (Geneva Protocol), 1925. Available at: www.opcw.nl.
\17\ Cole LJ. The Eleventh Plague: The Politics of Biological and
Chemical Warfare. New York, NY: WH Freeman; 1996.
\18\ Kadivar H, Adams SC. Treatment of chemical and biological
warfare injuries: insights derived from the 1984 Iraqi attack on
Majnoon Island. Mil Med. 1991;156:171-177.
\19\ Tucker JB. National health and medical services response to
incidents of biological and chemical terrorism. JAMA. 1997;278:362-368.
\20\ Bush, V. Modern Arms and Free Men. pp. 142, 146. New York:
Simon and Schuster. 1949.
\21\ Pomeransev AP., Staritsin NA., Mockov YV., Marinin LI.
Expression of cereolysine ab genes in Bacillus anthracis vaccine strain
ensures protection against experimental hemolytic anthrax infection
Vaccine. 1997;15:1846-1850.
\22\ Lederberg J. Infection emergent (editorial for theme issue).
JAMA 1996;275:243-245
\23\ Miller J., Broad WJ. Clinton Expected to Back Plan to Deter
Terrorist Attack New York Times, April 26, 1998 (p. 1).
table 1.--germs as arms: basic issues
BW vs CW: living germs vs chemicals germs might self-amplify and spread
germs are biological unstable: could mutate to higher virulence
Underlying science is unalterably dual use licit defensive exploration
targetted against natural disease
Likewise production up to point of weaponization vaccines vs. BW
agents?
Facilities moderate scale; few external signatures easily concealed or
masked by licit programs
Weapons: potent, but unfamiliar and unreliable in military context
Tactical defense is easy: physical barriers (masks, suits)
Latent period up to 36 hours. Disease may be treatable Hence focus on
civil health preparedness
Hardly understood until now, these are *strategic* weapons. . . . At
same time, accessible to small powers . . . or groups Seen as
answer to a Superpower self confident about the ``revolution in
military affairs''.
Capabilities can scarcely be denied remedial and intelligence focus on
intentions
______
From Epilogue Biological Weapons--Limiting the Threat: MIT Press 1999
(By Joshua Lederberg)
As these works were being assembled, our policy perspectives were
informed by new happenings and governmental reactions. Saddam Hussein
renewed his harassment of the UNSCOM inspectors seeking closure on
Iraq's programs in BW and other weapons of mass destruction. Final
rupture ensued, and with it renewed attacks on relevant Iraqi
facilities on the part of the U.S. That escalation might be a
deterrent/warning, or it might provoke unrasoned responses, including
the use of BW if the regime inferred it had nothing more to lose. The
dilemma persists how to invoke punishment on deviant autocrats without
injuring captive populations even more severely. Nor is this forum the
place to look beyond violence to the causes of belligerency. At one
level, we knew the danger that violence will beget violence. At
another, the history of nations has shown how the most violent
exemplars, like Nazi Germany and Imperial Japan could eventually be
pacified (and become models of pacific constraint and economic
success)--at terrible cost to themselves and others. Democracies who
regard themselves as humane will be torn, and sometimes self-deterred
by such considerations, probably more than by threats of forceful
retaliation. Saddam may not know this well enough to refrain from
launching terrorist reactions; and there is always the cloak of fringe
zealots acting on their own initiative.
This is the story line for the vicious bomb attacks on U. S.
embassies in Kenya and Tanzania on August 8, 1998, attributed to Usama
bin Ladin. Bernard Lewis \1\ has retrieved bin Ladin's formal
declaration of war against the United States and its citizens from the
Arabic press. His aim is the expulsion of U.S. interests from the holy
Arabian peninsula. In the process, hundreds of native Africans were
injured or killed: this may go even beyond casual disregard of
uninvolved bystanders--it conveys the message that diplomatic relations
of any country with the U.S. entail a lethal liability.
This atmosphere has not triggered acute defensive precautionary
mobilization beyond routine travel advisories. However, past months
have witnessed a growing concern expressed in public pronouncements and
official actions. Secretary William Cohen's foreword \2\ is also
reflected in President Clinton's Annapolis speech (May 22, 1998): ``. .
. three new initiatives--the first broadly directed at combatting
terrorism; the other two addressing two potential threats from
terroriss and hostile nations, attacks on our computer networks and
other critical systems upon which our society depends, and attacks
using biological weapons.
. . . We will work to upgrade our public health systems for
detection and warning, to aid our preparedness against terrorism, and
to help us cope with infectious diseases that arise in nature. We will
train and equip local authorities throughout the nation to deal with an
emergency involving weapons of mass destruction, creating stockpiles of
medicines and vaccines to protect our civilian population against the
kind of biological agents our adversaries are most likely to obtain or
develop. And we will pursue research and development to create the next
generation of vaccines, medicines and diagnostic tools. The Human
Genome Project will be very, very important in this regard. And again,
it will aid us also in fighting infectious diseases.
. . . To make these three initiatives work we must have the
concerted efforts of a whole range of federal agencies--from the Armed
Forces to law enforcement to intelligence to public health. I am
appointing a National Coordinator for Security, Infrastructure
Protection, and Counterterrorism, to bring the full force of all our
resources to bear swiftly and effectively.''
These decisions are reflected in Presidential Decision Directive
[PDD-62], and the appointment of Richard Clarke of the National
Security Council as the coordinator. Inter-agency discussions with
regard to allocation of responsibility and budget are continuing.
Significant announcements include the assignment of backup
responsibilities to the National Guard [Cohen \2\]. The U.S. Atlantic
Command (ACOM) already bears operational responsibility for ``Homeland
Defense'', a theme much discussed in recent months, and it may be given
further tasks in this arena. Not least is planning for the security of
our ports of embarkation, the logistic chokepoints for maritime buildup
and supply of any U.S force projection overseas.
Then, the Department of Justice will take over the training of
local emergency responders to function safely and effectively in
contaminated environments. Acting on its own, and impelled by past
experiences like the attack on the World Trade Towers in 1993, New York
City has already mounted an extensive program that will be a model for
others.\3\ In addition the FBI will establish a National Domestic
Preparedness Office--a canonical shopping window for enquiries and
appeals from local officials otherwise perplexed where to turn for
assistance from the complex federal establishment. These proposals go a
long way to meeting the criteria set out in a thoughtful paper by three
recent members of the Clinton administration, Ashton Carter, John
Deutch and Philip Zelikow.\4\ They remark, however ``. . . one should
not place faith in czars. Real power still resides in the executive
departments that have people, equipment, money, and the capacity to get
things done.'' These requirements have been elaborated in further
detail by Richard Falkenrath and his colleagues.\5\
Efforts to engage the Congress have been partly successful, but
predictably face some resistance as ``budget-busting'' when incremental
funding is sought. While there is substantial verbal endorsement of the
priority that should be assigned to domestic bio-defense as an element
of national security, it still fares poorly in competition with the
long established traditional military concerns, the end of the Cold War
notwithstanding.
The R&D requirements for bio-defense are barely touched upon in the
current volume. They range from the most far-reaching innovations that
will be called upon to deal with exotic viral infections to banal items
like inexpensive, citizen-adapted protective masks. Protocols for the
management of infectious disease were not designed nor validated for
mass casualty settings, where for example available antibiotics are in
short supply and rational schemes for extending those supplies will be
desprately called for. Nor have our FDA and other regulatory and
ethical regimes been confronted with emergent crises where thousands or
millions of lives may be at stake, awaiting resolution of bureaucratic
contradictions. Some of these matters have been given initial study by
the Institute of Medicine.\6\
The delegation of responsibility to public authorities, and if so
which ones, should be deliberated during times of peace, and informed
consent conferred or denied; this cannot be achieved in the midst of
crisis.
Among the triumphs of medical science and international cooperation
in this century has been the global eradication of smallpox. Once among
the major killers of humankind, smallpox has been eliminated from
circulation by concerted programs of vaccination. The last
authenticated case of naturally spread disease occurred in 1977; and
the WHO officially declared eradication in 1979. Since then, accepted
doctrine and general practice has been the abandonment of routine
vaccination: the scourge had been lifted, no further precautions were
needed. In consequence we now have, globally, a whole generation of
humans with no history of exposure either to smallpox virus or to the
protective vaccine. This is unprecedented in human experience, though
it may be likened to the condition of Western Hemisphere natives prior
to the European exploration and conquest. With recent rumor and
defectors' reports of unabated experimentation with smallpox as a
weapon, in defiance of the BW treaty, anxieties about our consequent
vulnerability have been heightened. Outbreaks have happened before, and
they could probably be contained--but only if vaccine stocks (now all
but depleted) are refreshed and prepositioned.\7\ This would not be
very expensive; equally valuable and an important complement would be
anti-viral medication if that could be materialized with renewed R&D.
My personal concern about the blight of biological weaponry, and
the subversion of medical technology to the intentional spread of
plagues, gos back many years. In 1970, I had occasion to address the
United Nations Committee on Disarmament in Geneva, focussed on arms
control as an important remedial device.\8\ The treaty has been in
place since 1975; it is now deeply embedded in the law of nations. The
issue now is its enforcement, which depends on the institutionalized
acknowledgment of and respect for that law, which is not to hide the
problematics of focussing on a weapon rather than what is being fought
over. BW is a special weapon, with implications for civility of life
that set it apart from many other kinds of violence. Most of the other
arguments remain hardly altered, except for the burgeoning realization
of what biotechnology could bring us, for good or for evil.
footnotes
\1\ B. Lewis, ``License to kill,'' Foreign Affairs, Vol.77, No. 6.
(1998), pp. 14-19.
\2\ W. Cohen, ``Foreword,''--this volume.
\3\ Richard A. Falkenrath, Robert D. Newman, and Bradley A. Thayer,
``America's Achilles' Heel: nuclear, biological, and chemical terrorism
and covert attack,'' BCSIA Studies in International Security
(Cambridge, Mass.: The MIT Press, 1998).
\4\ Judith Miller and William J. Broad, ``New York girding for
grim fear: deadly germ attack by terrorists.'' New York Times, (June
19, 1998).
\5\ A. Carter, J. Deutch, and P. Zelikow, ``Catastrophic
Terrorism,'' Foreign Affairs, Vol. 77, No. 6. (1998), pp. 80-94.
\6\ Institute of Medicine, ``Improving civilian medical responses
to chemical or biological terrorist incidents. Interim Report''
National Research Council, Washington. 1998.
\7\ Joel G. Breman and D. A. Henderson, ``Poxvirus dilemmas--
Monkeypox, Smallpox, and Biologic Terrorism,'' New England Journal of
Medicine, Vol. 339 (1998), pp. 556-559.
\8\ Joshua Lederberg, ``Address to Conference of the Committee on
Disarmament, August 5, 1970.'' Congressional Record, (Sept. 11, 1970),
pp E-8123-8124.
STATEMENT OF DONALD A. HENDERSON, M.D., M.P.H.,
DIRECTOR, CENTER FOR CIVILIAN BIODEFENSE,
THE JOHNS HOPKINS UNIVERSITY
Senator Specter. We now turn to Dr. Donald Henderson,
Director of the Center for Civilian Biodefense at Johns Hopkins
University. He previously served as the Associate Director of
the White House Science Office and the Senior Science Adviser
to the Secretary of Health and Human Services.
Welcome, Dr. Henderson, and we look forward to your
testimony.
Dr. Henderson. Thank you very much, Mr. Chairman and
members of the Committee. I am really very pleased that you
have taken the interest you have in this subject, which I think
is a very important one.
My involvement in this whole field began in the Science
Office in 1990 and has continued actively ever since.
Throughout this period we have seen an escalating concern about
the threat of weapons of mass destruction. But until recently,
in the many meetings that I have participated in discussions
about the implications of that threat and its possible
scenarios have been confined primarily to those in the
military, diplomatic, law enforcement, intelligence, and arms
reduction communities.
Only recently have the civilian medical and public health
communities begun to be engaged in examining the principal
challenges posed by the threat. This has been a serious
oversight.
So far, indeed, virtually all Federal efforts in strategic
planning and training have been directed toward crisis
management following a chemical release or an explosion and
utilizing first responders, the fire, police, and emergency
rescue workers. These groups do perform an important function
and progress has been made in meeting this threat.
But a bioterrorism event presents an entirely different
scenario. Unlike an explosive or chemical event, the bioweapons
release will be silent and almost certainly undetected. Not
until days or weeks later will patients begin appearing in
emergency rooms and physicians' offices with symptoms of a
strange disease which none of those seeing the patients have
ever seen before. There will be no sudden alarm calling for
action within minutes to hours on the part of ``first
responders,'' and in fact the first responders will not be fire
and law enforcement staff at all.
Special measures will be needed for patient diagnosis, for
care, for hospitalization, for obtaining the laboratory
confirmation, for providing vaccine and perhaps antibiotics to
large proportions of the population. We will need trained
epidemiologists to identify where and when infection occurred
so as to identify how and by whom it might have been spread,
and we will have public administrators who will be challenged
to undertake emergency management of a problem in an
environment where, as Dr. Lederberg has said, the potential for
panic is high.
In brief, the personnel that are required, the skills they
must have, and the strategies to be employed could hardly be
more different than those required for a chemical or explosive
event. The prevailing assumptions which persist even today,
that chemical and biological threats are so similar that they
can be readily handled by multipurpose chem-bio experts, I
think is as patently ridiculous as to assume that the athletes
playing for the Washington Redskins are interchangeable with
the Baltimore Orioles.
I was pleased last year when the Committee took cognizance
of these challenges and appropriated to HHS and to CDC funds
for planning, for strengthening the infectious disease
surveillance network, and for enhancing the capacity of Federal
and State laboratories. It is an important but modest sum of
money, considering the needs of a fragile public health
infrastructure extending over 50 States and 120 cities, none of
whom are really strong at this particular point in time.
I would suggest to you that an augmented full-time cadre of
professionals at this level, the State and local level, would
represent for biological weapons a counterpart to the National
Guard Rapid Assessment and Initial Detection teams, which are
really more for chemical weapons. But the augmented
capabilities to deal with such a bioterrorist event would not
be on a standby basis, to be employed only in the case of
emergency. Rather, they would be there working day by day, with
the opportunity to deal with new and emerging infections and
antibiotic resistance.
I should note that a risk assessment process has been in
progress for nearly a year to identify which agents of
potentially thousands are the most critical and for which we
need to be prepared. Two in particular stand out as being of
exceptional concern, smallpox and anthrax. Both are associated
with high case fatality rates when dispersed as an aerosol. For
smallpox we are talking about 30 percent, for anthrax 80
percent.
It is the view of our Hopkins group that reserve stockpiles
both of anthrax and smallpox vaccines should be produced and
antibiotics should be made available to deal with anthrax and
with other agents as appropriate.
prepared statement
To come back to the point that I think that biologists,
especially those in medicine and public health, are as critical
to confronting the problems of biological weapons as are
physicists and dealing with nuclear threats. They are sorely
needed now to participate in a complex planning process, which
you have identified, to blend together a very diverse array of
institutions and talents in a way we have never done before,
both public and private, in some sort of coherent plan. I
believe it can be done.
Thank you.
Senator Specter. Thank you very much, Dr. Henderson.
[The statement follows:]
Prepared Statement of Donald A. Henderson
Good morning, Mr. Chairman and members of the Subcommittee. I am
Dr. D.A. Henderson, Professor of Epidemiology and International Health
and Director of the Center for Civilian Biodefense Studies at Johns
Hopkins University. My involvement in counter terrorism activities date
back to 1990-93 when I served as a Science Adviser to President Bush. I
sustained this interest during my tenure as Deputy Assistant Secretary
and Senior Science Advisor in the Department of Health and Human
Services. I continue to serve on a variety of consultant panels to the
DOD and the intelligence community.
This Committee has explicitly enunciated its own concerns with
respect to bioterrorism. I share those concerns and am grateful for the
support provided in helping us at Johns Hopkins to establish an
academic center intended to catalyze a civilian planning and
development program to deal with this vexing problem.
As this Committee is aware, this decade has been marked by
escalating concerns about the threat of weapons of mass destruction. At
first, discussions about the implications of this threat and its
possible scenarios were confined primarily to those in the military,
diplomatic, law enforcement and intelligence communities and to those
concerned with arms reduction issues. Only recently have the civilian
medical and public health communities begun to be engaged in examining
the practical challenges posed by this threat.
the unique nature of the biological threat
Of the weapons of mass destruction, the biological ones are the
most greatly feared but the country is least well prepared to deal with
them. So far, virtually all federal efforts in strategic planning and
training have been directed toward crisis management after a chemical
release or an explosion. Should such an event occur, plans
appropriately call for so-called ``first responders''--fire, police,
and emergency rescue workers--to proceed to the scene. There, with the
FBI assuming lead responsibility, they are expected to stabilize the
situation, to deal with casualties, to decontaminate, and to collect
evidence for identification of a perpetrator. This is an important
function and progress has been made in training and in developing such
as the Metropolitan Medical Response Systems. Success in this effort
must be attributed, in part, to the fact that spills or releases of
hazardous materials, explosions, fires and other civil emergencies are
not uncommon events.
A bioterrorist event presents an entirely different scenario, one
that is alien to civil authorities. Epidemics of serious diseases such
as are anticipated are wholly unknown to American cities. Unlike an
explosive or chemical event, the bioweapons release would be silent and
almost certainly undetected. The aerosol cloud would be invisible,
odorless and tasteless. It would behave much like a gas in penetrating
interior areas. No one would know until days or weeks later that anyone
had been infected. Then, patients would begin appearing in emergency
rooms and physicians' offices with symptoms of a strange disease that
few physicians had ever seen. There would be no sudden alarm calling
for action within minutes to hours on the part of ``first responders''.
In fact, the ``first responders'' would not be fire and law enforcement
staff but public health and medical personnel.
responses following a bioweapons attack
Special measures would be needed for patient diagnosis, care and
hospitalization, for obtaining laboratory confirmation regarding the
identity of microbes unknown to most laboratories, for providing
vaccine and perhaps antibiotics to large portions of the population,
and for identifying and possibly quarantining patients. Trained
epidemiologists would be needed to identify where and when infection
had occurred, so as to identify how and by whom it may have been
spread. Public health administrators would be challenged to undertake
emergency management of a problem alien to their experience, in a
public environment where epidemics of pestilential disease are unknown,
and in an environment where the potential for panic is high.
In brief, the personnel that are required, the skills that they
must have and the strategies to be employed could hardly be more
different. The prevailing assumptions that chemical and biological
threats are generically so similar that they can be readily handled by
multi-purpose ``chembio'' experts is as patently ridiculous as to
assume that the athletes playing on the Washington Redskins football
team would be interchangeable with the Baltimore Orioles baseball club.
First responders to a biological weapons incident are emergency
room physicians and nurses, family physicians, infectious disease
specialists, infection control practitioners, epidemiologists, hospital
and public health administrators, and laboratory experts. Until very
recently, none of these groups had been meaningfully involved in
assessing risks, nor in planning for appropriate civilian responses,
nor in training, nor in defining research and development needs.
the national initiative
I was extremely pleased last year when the Committee took
cognizance of these practical challenges in coping with bioterrorism
and appropriated to HHS for fiscal year 1999, the sum of $133 million
of which $51 million is intended for an emergency stockpile of
antibiotics and vaccines. Other funds were allocated to the CDC,
primarily for planning purposes, for the strengthening of the
infectious disease surveillance network and for enhancing the capacity
of federal and state laboratories. This was an important but still
modest sum of money, considering the needs of a fragile public health
infrastructure extending over 50 states and at least 120 major cities
but it is an important beginning.
The provision of funds to HHS is consonant with the belief that one
of the most critical elements for coping with bioterrorism is to
strengthen the public health and infectious disease infrastructure. An
augmented full-time cadre of professionals at the state and local level
would represent, for biological weapons, a counterpart to the National
Guard Rapid Assessment and Initial Detection Teams for chemical
weapons. However, the augmented capabilities to deal with a
bioterrorist event would not be on a standby status to be employed only
in the case of an emergency. Rather, they would simultaneously serve to
strengthen efforts directed toward dealing with such as new and
emerging infections and food-borne diseases.
The sum of $1 million was identified for the Johns Hopkins Civilian
Biodefense Studies Center. With these funds, a working group comprised
of experts from federal, state and local institutions as well as
academia have undertaken comprehensive reviews to identify the
organisms that pose the most serious threats and that warrant special
training of personnel in their identification and control and, as
necessary, the development of relevant stockpiles of vaccines and
antibiotics.
Two organisms in particular were identified as being of exceptional
concern--smallpox and anthrax. Both are associated with high case
fatality rates when dispersed as an aerosol. For smallpox, it is 30
percent; for anthrax, above 80 percent. Both have other advantages in
that they can be grown reasonably easily and in large quantities and
are sturdy organisms that are resistant to destruction. They are thus
especially suited to aerosol dissemination to reach large areas and
numbers of people. The working group supported the view that reserve
stockpiles both of anthrax and smallpox vaccines should be produced and
that a stockpile of antibiotics should be created to deal with anthrax.
The group believed that the possible development of second generation
vaccines for both diseases should be explored as a matter of urgency.
Documents setting forth the consensus views of these experts should be
published in a major national publication within the next few months.
Other documents detailing the threat and response for at least four
other agents will follow.
Over the past year, personnel from the Hopkins Center have made
more than 50 presentations, on the request of professional
organizations and hospitals, to acquaint them with the realities of the
threat of bioterrorism and to discuss initiatives that need to be
taken. On 16-17 February, a National Symposium, sponsored by the
Hopkins Center, HHS and 12 other sponsoring organizations, took place
in Washington. It was the first of its kind directed to a public health
and medical audience. The response was so great that registration had
to be closed 10 days before the Symposium convened. At this time, I
believe it is reasonable to conclude that there is a markedly
heightened concern and desire on the part of the medical and public
health community to take a far more active role in the nation's
preparedness.
a look to the future
Biologists, especially those in medicine and public health, are as
critical to confronting the problems posed by biological weapons as are
physicists in dealing with nuclear threats and chemists with chemical
weapons. There is a need to expand the discussion regarding issues both
at national and local levels, to recruit the interest and commitment of
scientists in devising strategy, in undertaking needed research and in
the complex planning process which is needed to blend together the very
diverse array of institutions, both public and private in coherent
local, state and federal plans.
Plans for dealing with large numbers of patients, including those
who require isolation will have to be elaborated on a regional basis
and plans developed for emergency care facilities, for decontamination
procedures, for dispensing rapidly large quantities of vaccine and
antibiotics, for rapid and secure communications, for informing the
media in a timely manner, for provision of mental health services and
for emergency mortuaries.
Developing the experts and expertise will require a major
educational effort, given the variety of specialists that are needed
and the now virtual absence of knowledgeable and experienced
specialists. There is a need to train primary care physicians and
emergency room personnel in early recognition of the most important
disease threats. Infectious disease specialists and hospital
epidemiologists must also become versed in case recognition and in
steps to take if a suspicious case is detected. There is a need for
trained laboratory directors and key staff in laboratories with
designated responsibilities for lab diagnoses. More over, state and
local health officers and epidemiologists require training in, among
other things, detection, surveillance and management of epidemic
disease. Such an effort will require the full participation of
professional organizations as well as those in the public sector and in
academia.
Last but not least, it will be important to recruit the help of the
medical and public health community in longer term measures that may
prevent acts of terrorism. This would include strengthening the
provisions of the Biological Weapons Convention Treaty and expanding
our intelligence capabilities so as to anticipate and perhaps interdict
terrorists. The fostering of international cooperative research
programs to encourage openness and dialogue as is now being done with
Russian laboratories is also important.
The possible role of the medical community in educating peoples and
policymakers everywhere about the dread realities of bioterrorism has
also been proposed as a parallel effort to an earlier initiative that
proved so effective in clarifying the disastrous consequences of a
nuclear war.
(For further information see: ``The Looming Threat of
Bioterrorism'' in Science, 26 February 1999, pages 1279-1283.)
STATEMENT OF ROBERT C. MYERS, M.D., CHIEF OPERATING
OFFICER AND DIRECTOR, BIOPORT CORP.
Senator Specter. We turn now to Dr. Robert C. Myers, Chief
Operating Officer of BioPort Corporation, successor to the one
company which produces anthrax vaccine. Dr. Myers was in charge
of the State of Michigan's Division of Biological Products.
We appreciate your being here, Dr. Myers, and look forward
to your testimony.
Dr. Myers. Thank you very much, Mr. Chairman and members of
the Committees.
I am the Chief Operating Officer of BioPort Corporation,
the only FDA-licensed manufacturer of anthrax vaccine. I
commend you to devoting today's hearings to bioterrorism and
America's response to this critical issue. It is an honor to
share my experience with you, an extended experience in
biodefense vaccine development and manufacture.
I bring a somewhat unique perspective on the use of
vaccines to combat bioterrorism. Unlike my colleagues, you have
probably never heard my name before. That is no surprise. We do
our work quietly. We try not to make waves.
The Defense Department came to us in 1990 to accelerate the
production of anthrax and botulism vaccines in support of
Desert Shield. I have been in Lansing for 21 years and for most
of that time we were being asked to address the emergency need
of one vaccine or another. For the last 10, it has been making
sure there is anthrax vaccine to protect American troops being
sent in harm's way.
We have worked closely with the FDA to get a quality
vaccine up and running, and we have worked closely with the
Army to build and test a stockpile of vaccine to meet an
important DOD force protection requirement. In short, when it
comes to both development and manufacture of biodefense
vaccines, I know what it is about because I have done it. Now
BioPort is the only company to manufacture a vaccine placed in
routine use to protect against biowarfare.
What you have heard today should keep you awake at night.
Tomorrow's biowarfare threats are today's responsibilities.
Those threats are more real than some would like to think.
Anthrax, as Dr. Henderson has pointed out, almost uniformly
fatal. Smallpox, the entire world is susceptible and it is
highly contagious. There are several others in the second
string.
Heightening its threat, anthrax is a low tech bioweapon. It
is easy to get, it is easy to grow--the recent hoax of choice.
No one should question the potential for hoax to become reality
sooner rather than later. As you have pointed out, Mr.
Chairman, America just is not ready for that yet.
However, we have the power and knowledge to apply resources
to diminish these threats to our safety, both here and abroad.
But there is much to be done: intelligence, deterrence,
detection, coordination, decontamination, containment,
treatment.
It is complex to even think about from the perspective of a
vaccine manufacturer. We have had an FDA-licensed anthrax
vaccine since 1970, and just because it is old does not mean it
is not good. How old are tetanus and diphtheria vaccines? We
can be ready with a vaccine for anthrax. We have a good one
now. We just do not have enough.
But we are not ready with large amounts of smallpox
vaccine, and I believe it will take longer than the 3 or so
years that some people are suggesting it will take to get a
stockpile in place. A new smallpox vaccine, a new anthrax
vaccine, or any other defense vaccine for that matter, faces
serious challenge to licensure.
There has been little interest up until now from major
pharmaceutical companies. The demonstration of both safety and
effectiveness poses challenging issues for these unique
vaccines. Critical manufacturing infrastructure will have to be
fully developed and FDA licensed. This does not happen
overnight. The stockpile will have to be generated and, as
importantly, both the manufacturing sites and the stockpile
storage sites will have to be protected against attack.
There will be criticism. Certainly the safety of a vaccine
must be assured. Our experience with anthrax vaccine provides a
perfect example of a safe vaccine that is still being
criticized. It baffles me that someone going to the Middle East
would actually refuse protection from a disease that is always
fatal. You get inhalational anthrax, you do not get better; you
die.
Vaccines given by injection do not get any safer than the
anthrax vaccine. The side effects--a sore arm, a slight fever--
occur less frequently than they do with common childhood
vaccinations.
Bioterrorism is serious and demands that America take
action. There is an enormous amount of work to be done and that
work comes at a cost, both in time and money. But the greater
cost is in failing to act in an informed, responsible, and
reasonable manner.
I would be remiss if I walked away from this table without
saying what some may perceive as controversial and self-
serving. You are faced with choices that require almost
unlimited resources, but your resources are limited. I strongly
recommend that you focus those limited resources carefully. As
far as vaccines go, take the FDA-licensed anthrax vaccine,
manufacture it in greater quantities, and get it on the shelf
and stockpiled for the civilian population now. Then get moving
on smallpox vaccine now.
prepared statement
We are nowhere where we should be in protecting against
what we once thought was eradicated from the face of this
Earth. Concentrate America's vaccine-making resources where
they are most needed and where they will do the most good.
Tomorrow's biowarfare threats are indeed today's
responsibilities.
Thank you. I would be happy to answer any questions.
Senator Specter. Thank you very much, Dr. Myers.
[The statement follows:]
Prepared Statement of Robert C. Myers
My name is Robert C. Myers and I am the Chief Operating Officer of
BioPort Corporation. While I am not at the center of the policy and
scientific discussions on how we move forward to best protect America
against the scourge of biowarfare agents that could be used by
terrorists and rogue nations, I am well qualified to speak to the
development and manufacture of vaccines to provide the most effective
shield of protection against this horrible sword of deranged
aggression. Let me briefly explain.
As you probably know, BioPort manufactures the only FDA-licensed
anthrax vaccine in the world. We are also making and testing a vaccine,
under an approved Investigational New Drug (IND) sponsored by the
Surgeon General, to protect against five different types of botulism,
one of the most potent toxins known to man, a toxin that causes a
miserable death by muscle paralysis. It is probably next on the threat
list behind anthrax and the rapidly emerging threat of smallpox. I have
been leading the Lansing, Michigan, facility's efforts to make, test
and provide these vaccines to the Department of Defense for the last
decade or so. Being at the front line of providing protection against
these two weapons of mass destruction, we have grappled with the
challenges that must be overcome to develop, make available and
stockpile vaccines for which there is no market in the natural world--
vaccines whose only market is derived as a response to the world of
religious and political zealots and aggressor nations. These challenges
can be overcome. I sincerely believe that the fastest and best approach
to overcoming them is by first applying what we have learned up to now
and then building on this.
The explosion of technological advances in medicine in the last
decade have been thrilling to observe, especially in the area of new
approaches to specifically stimulate the body's immune system to
protect against and even treat all sorts of disease and sicknesses. At
the same time, it has become alarmingly apparent that the likely near
term threat is not based on burgeoning new technology but, rather, the
evil and calculated use of organisms already known to nature. Most
likely is anthrax. I say this because the organism is readily
available, it can be easily grown to hugely destructive proportions in
small, easily concealed labs, and weaponization techniques are well
known, albeit not so easy to accomplish. Much less likely is smallpox
because it is not readily available and its preparation as a biological
weapon requires much more sophistication than that for anthrax.
Nevertheless, because smallpox is highly contagious and probably most
of the world is now susceptible, it is a potential biowarfare agent of
serious concern.
There exist similar challenges to the further development and
manufacture of new vaccines for anthrax, smallpox and, for that matter,
any other biodefense vaccine. The first challenge is the challenge of
interest. In this decade there have been few, if any, major
pharmaceutical companies interested in developing and manufacturing
defense vaccines. Their lack of interest was clearly established by
their absence at the bidding table for the most wide-sweeping defense
vaccine contract ever awarded by the Department of Defense--the Joint
Vaccine Acquisition Program (JVAP). This program, to develop and
license up to eighteen vaccines against important biological warfare
agents and expected to take ten or more years at a funding of perhaps
half a billion dollars, was well publicized, yet no major
pharmaceutical company applied. I don't blame them. Such an effort is
immense, will probably take longer and cost more than expected, and
profits will be limited to that allowable by federal government
regulations. With no clear second, more profitable market, there is
little financial motivation to participate. Additionally, cumbersome
government regulations and serious concerns about the government's
ability to protect proprietary information probably cause large firms
to shy away. There also is the greater likelihood of being subjected to
an intrusive inspection under the Biological Weapons Convention, a
likelihood made greater by the fact that those who make defense
vaccines usually have the organisms, technology and many of the tools
necessary to make the toxic and infectious components of biowarfare
weapons. Under this scenario, important company proprietary information
could and probably would literally ``walk out the door'' with the
inspectors' records.
Perhaps most importantly, working on these vaccines could put a
company's public image at risk. Consider the potential consequences for
a large company, if it were making the anthrax vaccine--a vaccine that
has been shown to be among the safest vaccines in the world. The
unfounded adverse publicity surrounding this vaccine is great and it
makes no sense for these companies to risk their reputations, be forced
to defend frivolous litigation, or even experience product boycotts as
a result of participating in a program such as JVAP.
Another challenge is embedded in the technical base of research and
early development of any biodefense vaccine. In 1996, I was part of a
team of organizations, led by Battelle Memorial Institute, which came
together to compete for the JVAP award. We researched potential
biodefense vaccines, which were being developed at the time. We found
the science in the research and development of new vaccines to be
generally excellent, with the proof of concept (the demonstration that
a vaccine can be made and that it does protect against a target
organism) well established for several. However, we often found that
some of these vaccines were not as far down the path of development as
the scientists would have liked us to believe. This challenge--the need
for further testing, etc.--should be easily addressed by focusing on
the real goal: on-the-shelf stockpiles of FDA licensed products. In
addition to good science, the process also demands that specialists in
manufacturing development, clinical trials, quality assurance,
engineering and regulatory compliance be involved now. Full integration
of these specialists, from the initial stages of each vaccine
development project, is essential.
Once a vaccine product is ready to be tested in humans, there are
special challenges for biodefense products that have yet to be
addressed. Human Subjects Review Boards--those bodies that review and
approve clinical studies from perspectives that include medical
ethics--will have to determine the ethical acceptability of human
studies of new vaccines that are only of hypothetical benefit--i.e.,
the vaccine's real benefit lies in a hypothetical situation that has
not yet occurred--most likely a terrorist act. The approval of clinical
trials under these circumstances is not a trivial matter as the
circumstances of exposure are fundamentally different for civilian men,
women and children than for service personnel whom we know are at risk
of exposure to these horrific biological agents in battlefield
conditions. I do not yet see a clear path to overcoming this ethical
challenge. I am not an expert in this area and will leave this issue to
the medical ethicists among us.
There are also special challenges to demonstrating both the
effectiveness and safety of biodefense vaccines. For most of the
vaccines that need to be developed, there is insufficient natural
disease anywhere on this planet to demonstrate directly in humans that
a given biodefense vaccine protects against disease. To overcome this
challenge, animal and perhaps cell culture models of protection will
have to be developed. These ``models of effectiveness'' will have to
identify and demonstrate that there is a measurable, immunological
marker that correlates well with protection. This marker must also be
measurable in humans and be confirmed in human clinical trials as a
surrogate marker of protection in lieu of the impossible direct
vaccination of human, followed by exposure to the disease-causing
organism. These studies must be accepted as valid by the scientific and
medical communities, the FDA and ultimately the general public if any
new vaccine is to have a place in preventing one of the terrible
diseases that could be unleashed by a terrorist action.
The adequate demonstration of safety in humans is also a special
challenge for biodefense vaccines. For these vaccines, we may have to
change our view of the way safety is established. Human studies may
have to be larger and more highly conclusive. I say this because the
ongoing safety surveillance that occurs with most vaccines will be
absent. Ongoing safety is routinely demonstrated for most vaccines
because most vaccines are used regularly. In all likelihood, biodefense
vaccines will not be generally administered; they will be used only in
response to a terrorist or rogue nation biowarfare attack. Absent the
ongoing safety surveillance, the scope and magnitude of human clinical
trials may need to be expanded to increase the certainty that any
biodefense vaccine we might use will be safe if and when it has to be
used.
Other aspects of demonstration of clinical safety are also
challenging. Unlike the services, where the recipients of biodefense
products can reasonably be described as an adult population, exposure
to a terrorist attack would include all age groups--babies, children,
adolescents, adults and the aged. I see as formidable the challenge of
planning and completing the necessary studies to confirm safety
conclusively in specific age groups.
Further, the current experience with BioPort's very safe anthrax
vaccine and the evolving FDA policy changes for all vaccines require
that special studies be conducted that have not been traditionally
required for vaccines in the past. These studies include evaluation in
accepted models of the potential for toxicity to the fetus, fertility
in both men and women, and perhaps even carcinogenicity. I would be the
first to tell you that these studies are of questionable need
scientifically for these vaccines. Unlike drugs, present vaccines
largely exert their effect by stimulating the human immune system to
respond specifically in one or more ways to a disease-causing organism.
It is this stimulation of the immune system that later protects the
individual against disease, when exposed to the organism. Also, unlike
drugs, this ongoing immune response is the only lasting trace of the
vaccine. There is no goal to sustain a certain level of the vaccine's
ingredients, as is usually required of drug and other medicines. This
continued exposure to drugs to treat medical conditions--often for
one's entire life--is the basic reason why such studies are entirely
appropriate for drugs and much less so for many vaccines. For decades
we have vaccinated babies, children, adults and the elderly against
tetanus without over this extended period of time finding any
suggestion of specific fetal toxicity, impairment of fertility or
cancer. In fact, in much of the world today pregnant women are
intentionally vaccinated against tetanus to prevent neonatal tetanus in
their babies, a disease still of serious concern in less developed
parts of the world. Few if any vaccines have been examined in the ways
for which anthrax vaccine is being specifically criticized today. In
fact, two of the most recently licensed vaccines--vaccines for
Hepatitis A and Hepatitis B--have not been fully evaluated for their
effect on pregnancy. These vaccines are each made by two large
pharmaceutical companies (a total of four products). The prescribing
information for these four products each contains the same statement.
Pregnancy Category C: Animal reproduction studies have not been
conducted with ____________. It is also not known whether
____________ can cause fetal harm when administered to a
pregnant woman or can affect reproduction capacity.
____________ should be given to a pregnant woman only if
clearly needed.
Remember, these hepatitis vaccines are among the newest, high-tech
recombinant vaccines available today. All four contain the same
statement that accompanies the anthrax vaccine, although only anthrax
has received serious criticism. In fact, there are at least 25 FDA-
licensed vaccines that carry the same statement. The fact that a
vaccine has not been studied for its affect on fertility, the fetus and
cancer does not mean that there are effects. It simply means that it
hasn't been studied. This point is often lost in the din of criticism
of anthrax vaccine in the popular press and I expect that new
biodefense vaccines could easily become targets of such criticism as
well. Some of these issues on safety are just plain baffling to me. I
have received many doses of anthrax vaccine through the years. During
this time, my wife and I have been honored by the miraculous gift of
life three times. And I now have a three-year old grandson as well. If
the anthrax vaccine were available today, I would have absolutely no
reservation in administering it to my wife, grandson and three
daughters, including my eldest who is of childbearing age.
Security will also be a challenge. As we improve our preparedness
to combat bioterrorism, our preparation measures themselves will become
targets of terrorist attack. Suppose we have a smallpox vaccine
stockpile and a manufacturing capability. Suppose a terrorist group has
smallpox as a weapon. While a successful terrorist action becomes more
difficult, it is still possible and maybe simple. A bomb to the
stockpile, a bomb to the manufacturing facility and a release of
smallpox to a major city. A deadly one, two three combination. Funding
for adequate security must be included in this program if the threat is
to be optimally minimized. Included in these security measures and to
prevent against natural disaster, there should be two or more
geographical separate manufacturing facilities and two or more
facilities for storage of the manufactured vaccine.
We collectively, all of us here today have a tremendous
opportunity, responsibility and obligation to minimize exposure and
risk to our citizens. Bioterrorism is a serious situation that demands
that America take the offensive. There is an enormous amount of work to
be done, and that work comes at a cost--both in time and in money--but
the greater cost is in failing to act in an informed, responsible and
reasonable manner.
I was invited here today to give my perspective and I would be
remiss if I walked away from this table without saying what some may
perceive as controversial and self-serving. You are faced with choices
that require unlimited resources but your resources ARE limited. I
strongly recommend that you focus those limited resources on those
areas of bioterrorism in which we are most vulnerable. Specifically,
take the FDA-licensed anthrax vaccine, manufacture it in greater
quantities and get it on the shelf and available to the civilian
population now. Then, get moving on smallpox. Now. We are nowhere near
where we should be in fighting what we once thought was eradicated from
the face of the earth. Concentrate America's resources where they are
most needed and where they will do the most good.
Tomorrow's biowarfare threats are indeed today's responsibilities.
Thank you.
Coordinate existing programs
Senator Specter. Let me start with a question to you, Dr.
Lederberg. As I say, we are running very close on time. We are
going to have to conclude before 11. You outline an
overwhelming problem which we all recognize, and great details
as to what needs to be done. What is your suggestion as to how
we structure the Federal Government to put somebody in charge
who would have the clout to bring all of these disparate groups
together and to provide the articulation for the public to get
the kind of funding?
Dr. Lederberg. Senator, I have been wrestling with that
problem at the philosophical level that you were engaging in
earlier for at least 5 years and trying to press for that kind
of coordinated response. There are severe inherent problems
that you recognize better than anyone.
For one thing, I might add, is where would the
congressional responsibility for that coordination lodge? Are
you going to carve out areas that now are scattered among five
or six defense committees and have one super committee take a
unique responsibility for it? It is not just a question of
reorganizing the executive branch.
Because we are dealing with preparing for standby capacity
in large measure, I do not think we want to reinvent forces
that would be waiting and performing no other function. So I
think making the most effective use of existing public health
resources, law enforcement resources, defense resources, and
extending their training is important. So I do not favor having
a single operating agency that has its own staff, troops, and
so forth. I think we do have to find a way to coordinate
existing programs.
Senator Specter. How do you do the coordination then?
Dr. Lederberg. Well, that is very, very difficult. Without
having a centralized budget, you then have mostly powers of
executive persuasion, let me call it--it is a phrase I just
invented--to try to modulate the behavior of individual
departments. I think there does need to be a very strong focus.
The only place in government that now exists that is
remotely related to it is the one that is being used, is the
National Security Council, which can call on the secretaries of
other departments. It does not actually have a lot of executive
clout because it does not have the budget, and I do not think
we would want it to have the overall budget that would be
involved.
So I think the strong backing of the President, the
designation of an officer in the National Security Council, and
then a more or less standing committee representing the
different departments.
Senator Specter. Would you prefer someone else in the NSC
to the Vice President?
Dr. Lederberg. I would say, unless you are going to greatly
enlarge the Vice President's staff and create a new office in
government which is not in the Constitution as the
responsibilities of the Vice President, I would think the
National Security Council would be the natural lodging. Perhaps
the Vice President in some administrations----
Senator Specter. Let me turn to Dr. Henderson, because of
the time limit, with the same question. You went through a long
litany of what needs to be done. How would you make it happen?
You have been in the White House. You have had extensive
governmental experience. What is your best recommendation?
Dr. Henderson. Well, I think Dr. Lederberg has outlined a
lot of the considerations certainly which have occurred to me
as well. I think there is a lot that can be done from the White
House perspective if indeed you have got strong leadership
there and good support from the Office of the President, there
is a lot that can be done--and goodwill. I think my feeling
would be that this would be the logical locus.
Senator Specter. The Vice President?
Dr. Henderson. Well, I think that I have never seen the
Vice President's office function in this way, but it is quite
possible that that is the way to go. I think something in that
area, however, is important.
Senator Specter. My yellow light is on.
Dr. Myers, I want to ask you a question about companies
which will develop vaccines. You identify anthrax. Why is there
only one producer of anthrax? How do we get moving on smallpox?
Is there some way to stimulate the private sector to dig into
this issue, or are they too worried about product liability
issues?
Dr. Myers. I am not sure how to stimulate the private
sector, but it has been clear through the years that the
private sector has had very little interest in working on
defense vaccines. Probably that was more clearly established in
the proposal by the DOD called the Joint Vaccine Acquisition
Program, which was widely advertised. It concerned the
development of some 18 biodefense vaccine products, a 5- to 10-
year program with an estimated budget of $500 million. Not a
single major manufacturer of pharmaceuticals applied.
I think besides the liability there is issues of
profitability, there is issues of working with government. You
call it getting ducks in a row here in Washington. In Michigan
we call it herding cats. It really is not easy to work with
government.
But as importantly as anything, why would a company risk
its reputation when it has lines of vitamins that are worth
half a billion dollars in sales a year, risk its reputation to
be involved in defense vaccines when this issue is so uncertain
and has drawn such criticism?
Senator Specter. Thank you very much, Dr. Myers.
Senator Rockefeller.
Senator Rockefeller. Thank you.
Dr. Lederberg and Dr. Henderson, I think one thing is
instructive when people do not take these potential threats
seriously. I think it is the cult group Aum Shinrikyo which did
its number in the Tokyo subway. What I think is less well
known--but among the biological and chemical fraternity, they
would know--is that that group tried, before they resorted to a
chemical weapon, they tried very hard to use biological
weapons, by introducing one into an exhaust system of
automobiles which they were going to send around town, and the
other with an aerosol approach from the top of a couple of
buildings in downtown Tokyo.
They did not happen to work, and so they resorted to the
chemical in the subway. But the fact that they did not work is
really, I think, relatively unimportant, because making
something like that work is, it seems to me, in the high realm
of probability. The effect of that, it seems to me, would be
extraordinary.
Dr. Lederberg, I guess this is the question I would want to
ask you and Dr. Henderson: In the event of something of that
sort, let us say, in smallpox, what would be the effect on a
city the size of Seattle, let us say?
Dr. Lederberg. I am going to defer to Dr. Henderson on
anything to do with smallpox.
Dr. Henderson. Yes, I had 11 years experience with smallpox
and I know it only too well. This is a disease which is, I
would say, one of the most horrible diseases that one could
possibly ever see. I have certainly seen many in hospitals,
with a 30-percent death rate, a disfiguring disease, painful,
very miserable disease.
It does generate a great deal of fear, tremendous fear,
tremendous anxiety. So when we have seen outbreaks occurring in
Europe, one in Yugoslavia in 1972, the countries around simply
close their borders immediately this was discovered and
permitted nothing to go across borders. It is a reaction which
is very extreme.
This is what I think we would expect to see in our own
cities. We have worked out a scenario looking at this, trying
to estimate what would happen, and we would foresee enormous
difficulties. Particularly, this is a more communicable disease
than we had even thought about ourselves until we worked
through the European experience. December through April we were
getting 10 cases for every 1 every 2 weeks. In other words, it
is multiplying tenfold every 2 weeks.
With the movement of people and travel, one can assume that
it is not going to be a nice little localized outbreak in one
city, but it is very rapidly going to involve many cities,
States. There is going to be a tremendous demand for vaccine.
Whether it is warranted or not, the demand will be there, and I
think we will use up vaccine very quickly.
At this point you begin to get a spiraling problem with
more cases, suspect cases, more demand for vaccine, no vaccine
available, nothing you can do. You can see the scenario that is
unrolling. It does not take a lot of cases, I think, to do
this.
I think we have got a lot to be concerned with smallpox.
Senator Rockefeller. Is it not true that--although this
does not have any enormous moment for the present--but it is
interesting that back in the Middle Ages, in the case of the
plague or smallpox or other things, that where walled cities
were under attack and plagues broke out, as people died they
threw the bodies over the walls so that they could land at the
feet of the enemy, because even they understood that there was
an incubation period or something, and afterwards it was
something that could spread very rapidly?
Dr. Lederberg. That happened in 1436 in Kaffa, a Genoese
fort on the coast of the Black Sea.
Senator Rockefeller. Is there not some thought that in
fact, that then carried on to the great plague, that that may
have been one part of the genesis of the great plague?
Dr. Henderson. That was the beginning of it, that is
correct.
I think with smallpox over the years we have been--
countries have been much more concerned about this, more
fearful of it, than any other disease. In fact, Britain until
the early eighties maintained four hospitals on a standby
basis, to be opened only if cases of smallpox came into
Britain. Germany built two new ones in the 1960's simply for
that purpose.
So that there is great concern about this disease, and in
fact even a small outbreak I think would generate some real
serious problems so far as civil disorder was concerned.
Senator Rockefeller. I am always impressed when
distinguished people are willing to come long distances for
relatively short hearings. Thank you both, all of you, very
much.
Senator Specter. Thank you very much, Dr. Lederberg, Dr.
Henderson, Dr. Myers. We very much appreciate your being here.
Conclusion of hearing
That concludes our hearing, the subcommittee and Committee
will stand in recess subject to the call of the Chair.
[Whereupon, at 10:57 a.m., Tuesday, March 16, the hearing
was concluded, and the subcommittee and Committee were
recessed, to reconvene subject to the call of the Chair.]
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