U.S. GOVERNMENT PRINTING OFFICE

57–119 cc WASHINGTON : 2000

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

For sale by the U.S. Government Printing Office

Superintendent of Documents, Congressional Sales Office, Washington, DC 20402

ISBN 0–16–060194–0
(II)

COMMITTEE ON APPROPRIATIONS

TED STEVENS, Alaska, Chairman

THAD COCHRAN, Mississippi

ARLEN SPECTER, Pennsylvania

PETE V. DOMENICI, New Mexico

CHRISTOPHER S. BOND, Missouri

SLADE GORTON, Washington

MITCH MCCONNELL, Kentucky

CONRAD BURNS, Montana

RICHARD C. SHELBY, Alabama

JUDD GREGG, New Hampshire

ROBERT F. BENNETT, Utah

BEN NIGHTHORSE CAMPBELL, Colorado

LARRY CRAIG, Idaho

KAY BAILEY HUTCHISON, Texas

JON KYL, Arizona

ROBERT C. BYRD, West Virginia

DANIEL K. INOUYE, Hawaii

ERNEST F. HOLLINGS, South Carolina

PATRICK J. LEAHY, Vermont

FRANK R. LAUTENBERG, New Jersey

TOM HARKIN, Iowa

BARBARA A. MIKULSKI, Maryland

HARRY REID, Nevada

HERB KOHL, Wisconsin

PATTY MURRAY, Washington

BYRON L. DORGAN, North Dakota

DIANNE FEINSTEIN, California

RICHARD J. DURBIN, Illinois

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

SLADE GORTON, Washington

JUDD GREGG, New Hampshire

LARRY CRAIG, Idaho

KAY BAILEY HUTCHISON, Texas

TED STEVENS, Alaska

JON KYL, Arizona

TOM HARKIN, Iowa

ERNEST F. HOLLINGS, South Carolina

DANIEL K. INOUYE, Hawaii

HARRY REID, Nevada

HERB KOHL, Wisconsin

PATTY MURRAY, Washington

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

FRANK H. MURKOWSKI, Alaska

JAMES M. JEFFORDS, Vermont

BEN NIGHTHORSE CAMPBELL, Colorado

LARRY E. CRAIG, Idaho

TIM HUTCHINSON, Arkansas

JOHN D. ROCKEFELLER IV, West Virginia

BOB GRAHAM, Forida

DANIEL K. AKAKA, Hawaii

PAUL WELLSTONE, Minnesota

PATTY MURRAY, Washington

CHARLES BATTAGLIA, Staff Director

JIM GOTTLIEB, Minority Chief Counsel/Staff Director
(III)

CONTENTS

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
Page

IV

Statement of Robert C. Myers, M.D., chief operating officer and director,

Bioport Corp ......................................................................................................... 48

Prepared statement .......................................................................................... 50

Coordinate existing programs ................................................................................. 53
(1)

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.
2

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
3

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.
4

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
5

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.
6

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.
7

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:

Requirement

Fiscal years—

1998 1999 2000

Funds expended or committed ................................................................................... $6,100 $41,320 1 $1,056,842

Full-time Equivalent Employee (FTEE) ........................................................................ 1.15 2.29 2.29

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 sup-
8

port, 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
9

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?
10

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
11

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 reinvigo-
12

rating 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 highconsequence 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
13

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
14

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 antibacterial 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
15

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 inhouse 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 re-
16

sults. 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
17

1See 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).

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.

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
18

2We recognize that some agents are communicable and could be spread without a weapon or

device.

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

—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 worstpossible 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.
19

3The 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. 4For the purposes of our work, we define terrorist(s) as a non-state actor not provided with

a state-developed weapon.

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.

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-assetvulnerability 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
20

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.

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.

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
21

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).
22

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.
23

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?
24

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 counterterrorism 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 agen-
25

cies. 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
26

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.
27

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
28

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.
29

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
30

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 CommitteeLabor 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
31

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;
32

—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.
33

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/
34

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
35

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-ofaffairs 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
36

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.
(37)

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
38

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 boatmounted 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.
39

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. 123

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 oper-
40

ated 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 in-
41

tractability 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:

1Orient JM. Chemical and biological warfare: should defenses be researched and deployed?

JAMA. 1989;262:644–648. 2Sidel 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. 4WHO Group of Consultants. Health Aspects of Chemical and Biological Weapons. Geneva,

Switzerland: World Health Organization; 1970. 5Zilinskas 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. 7Kadlec RP, Zelicoff AP, Vrtis AM. Biological weapons control: prospects and implications for

the future. JAMA. 1997;278:351–356. 8Danzig R, Berkowsky PB. Why should we be concerned about biological warfare? JAMA.

1997;278:431–432. 9Ferguson JR. Biological weapons and the US law. JAMA. 1997;278:357–360.

10Franz DR, Jahrling PB, Friedlander AM, et al. Clinical recognition and management of patients exposed to biological warfare agents. JAMA. 1997;278:399–411.
42

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. 12Toeroek 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. 13Kovalic 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. 15Lederberg J. The control of chemical and biological weapons. Stanford J Int Stud.

1972;7:22–44. 16Protocol 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. 18Kadivar 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. 19Tucker 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. 21Pomeransev 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. 22Lederberg J. Infection emergent (editorial for theme issue). JAMA 1996;275:243–245 23Miller 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
43

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
44

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.

2W. 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 weap-
45

ons 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 em-
46

ployed 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
47

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
48

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 com-
49

pany 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
50

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,
51

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.
52

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.
53

Pregnancy Category C: Animal reproduction studies have not been conducted with llllll. It is also not known whether llllll can

cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. llllll 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.
54

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.
55

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 Eu-
56

rope, 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.
57

[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.]

Æ