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[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
57-119 CC                    WASHINGTON : 2000

_______________________________________________________________________
            For sale by the U.S. Government Printing Office
Superintendent of Documents, Congressional Sales Office, Washington, DC 
                                 20402
                           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

                              ----------                              
                                                                   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

                              ----------                              

                        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.
---------------------------------------------------------------------------
    \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
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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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