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«Title of Document: STRUCTURING BIODEFENSE: LEGACIES AND CURRENT POLICY CHOICES Stacy M. Okutani, Doctor of Philosophy, 2007 Directed By: Professor ...»

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Stacy M. Okutani, Doctor of Philosophy, 2007

Directed By: Professor John D. Steinbruner

School of Public Policy

Policies are usually initiated in response to specific circumstances, but they do

not become effective unless they are embedded in operating institutions.

Understanding the historical process through which policies evolve is essential for assessing their character and their consequence. This study is a detailed history of the US bioweapons program from its inception to the present. It is an original analysis based on archival documents and scientific reports. The issue is, does the application of national security measures such as the classification of scientific programs improve biodefense?

Initial organization of the US bioweapons program as a secret, military program that performed threat assessment work (1941-1969) led to the development and stockpiling of biological weapons for deterrence, but few medical defenses. A strategic review in 1969 concluded that bioweapons were not useful for legitimate military missions and did not enhance US deterrence. It also concluded that proliferation threatened the US. To reduce proliferation, the US destroyed its bioweapons arsenal and enforced the norm against bioweapons acquisition by signing the Biological and Toxin Weapons Convention (BWC) in 1972. Subsequent organization of the US biodefense program was as an unclassified military medical research program. This work at the US Army Medical Research Institute of Infectious Diseases (USAMRIID) improved medical countermeasures without a concomitant classified, offensive program. However, in response to the terrorist attacks of 2001, the US is again imposing secrecy over important aspects of its biodefense work, including its threat assessment work. Based on the analysis here, current policy will increase the risk to US security by both enlarging the threat space and reducing defensive options.


By Stacy M. Okutani Dissertation submitted to the Faculty of the Graduate School of the University of Maryland, College Park, in partial fulfillment of the requirements for the degree of Doctor of Philosophy

Advisory Committee:

Professor John D. Steinbruner, Chair Doctor D.A. Henderson Professor Peter B. Jahrling Professor Dennis Pirages, Dean’s Representative Professor Robert H. Sprinkle © Copyright by Stacy M. Ok

–  –  –

So much intervenes in the course of developing an idea, especially when that course takes years. Something about the process requires time spent in speculation, misery, inspiration, and plain hard work – possibly in equal amounts. As Virginia Woolf wrote, “If anything comes through in spite of all this, it is a miracle, and no book is born entire and uncrippled as it was conceived.” For the miracle of this dissertation’s completion, I want to thank those who helped shape my thinking and those who tempered the hard times with their friendship.

The University of Maryland welcomed me with a University Fellowship when I started the Ph.D. program. In this way, I was able to devote my time to finishing the coursework and exploring dissertation topics. More than any other, Professor John Steinbruner broadened the scope of my understanding of security challenges and our options for meeting them. For their time and patience in their teaching, I am grateful to Dean Steve Fetter, Professor Tom Schelling, Professor I. Mac Destler, Professor Carmen Reinhart, Professor David Crocker, Professor Kori Schake, and Professor Peter Reuter.

After completing my coursework, I was fortunate to work at the Center for International and Security Studies at Maryland (CISSM) where I could explore other aspects of the topic. My work at CISSM was on the Advanced Methods of Cooperative Security Project, which is supported with generous funding from the John D. and Catherine T. MacArthur Foundation and the Sloan Foundation. For the past few years at CISSM, I was able to develop the ideas in this dissertation and have

–  –  –

Milton Leitenberg.

I am enormously grateful to the members of my committee. Professor John Steinbruner is an inspiration: without his intellectual guidance and support, I could not have written any part of this, much less the whole. Dr. D.A. Henderson and Professor Peter B. Jahrling were immensely helpful throughout the course of my work, always available to talk and provide me with a good contact to help deepen my understanding. Professor Robert Sprinkle provided good counsel from beginning to end. Professor Sam Joseph taught me all I know about microbiology. Finally, I want to thank Professor Dennis Pirages for being willing to jump in as my Dean’s Representative when Professor Joseph retired.

The University of Maryland’s libraries were a joy to explore and the staff always knowledgeable and helpful. I am grateful to Janice Goldblum, an archivist at the National Academy of Sciences (NAS). In both the University’s libraries and at the NAS archives I discovered neglected documents rich with promise. Finally, the Bioethics library at Georgetown University was a particular pleasure: in one small, beautiful room one could explore the full range of this topic.

With great humor and kindness, my friends helped make this travel endurable:

Aziza Nazarova, Jennifer Hill, Jeffrey Lewis, Tim Gulden, Chuck Thornton, Kevin DeWitt Jones, and Chris Thompson. Many thanks to you and to others.

My family suffered patiently with me through this. My parents, Verna and Bob Maynard, waited and never expressed the concerns they must have felt, providing me the unconditional support and love they always have. I am deeply

–  –  –

really good laugh! My brother, Ken, set the intellectual bar high. And my father, Brian, has always kept alive the question, “why?” – sustaining the curiosity one must have to pursue any topic.

I am thankful to Noel Gunther and his family, particularly Ed, Irene, Marc, and Estelle. We’ve been through so much together and they have been an important part of my life throughout this time. What I cherish most in the world I would not have without them.

My two sons, Noah and Aaron, have grown over these years: with them, I am blessed well beyond deserving.

–  –  –



Table of Contents

List of Tables and Figures

Chapter 1: Management of the Bioterrorist Threat

The Approach

Broader Issues

A Brief History Lesson

Secrecy vs. Transparency

Chapter 2: Creating the Logic of Biodefense

Pre-War BW Attitudes

Paradigm Shift: The WBC Committee and the Feasibility of Bioweapons............ 28 Establishing the Threat

Technical Fesibility

Choosing a Response

The War Research Service (1942-1944)

Research and Development


The Chemical Warfare Service

The Army Surgeon General’s Office

DEF Committee: 1944-1948

War’s End


Chapter 3: Developing the Offense

The Late 1940s

The DEF Committee: Publication Issues

The DEF Committee: The Future of BW Work in Peacetime

BW Policy Evolution

Bioweapons Development and Testing: 1950-1969

Medical Defenses against BW

The 1969 Choice to Disarm

The Biological Weapons Convention


Chapter 4: Relying on Defense

USAMRIID: 1969-1990


An Overview of USAMRIID’s Work

Vaccine Research

vii Drug Development and Drug Screening


Basic Research

Biodefense Work Under Transparency Rules

Scientific publication at USAMRIID

International Cooperation: Validation of Technologies and Medicines........... 116 No Open-Air Testing in the Public Domain

Limiting Threat Assessment

National Security and the Question of Past Offensive Work


Chapter 5: The Regression of BW Strategy

Evolution of Biodefense Policy: 1989-2004

Critical Events and US Responses

Access Controls on Select Agents

Oversight of Research

Current Strategy

Department of Defense

Health and Human Services: Response, Recovery & Countermeasures.......... 140 Department of Homeland Security: Threat Awareness & Surveillance........... 143 Characteristics of the Current Strategy

Chapter 6: Choice and Consequence

The Past as Future?

BW are Feasible, Powerful, Inexpensive and Easily Hidden

Advances in Technology make new BW possible

Intelligence Collection not Sufficient

Investigation of the Offense is Necessary to prepare Defenses

Necessary to Investigate the Nature and Extent of US Vulnerability............... 157 BW Research and Publication Requires Classification & Access Controls..... 158 BW Use Not Governed by Moral Considerations or International Agreements

Deterrence Not Feasible

Which History?

A National Program

International Cooperation

The Road Ahead

Appendix A: USAMRIID Research Summary


Anthrax Toxin Studies

The Role of Plasmids

Virulence Testing

Vaccine Studies


Challenge Tests

viii Detection


Vaccine Interactions

Skin Test

Other Vaccine Studies

Studies of Modes of Vaccination

Drug Interactions

Clinical Trials (LVS)


Acquisition of Host Resistance

Nonspecific Resistance

Passive Transfer


Q Fever

Phase II and Phase I whole cell vaccines

CMR Vaccine

Subunit Vaccines

Vaccine Combinations


Virulence Studies

Rocky Mountain Spotted Fever

Vaccine Studies




Melioidosis and Glanders

Yellow Fever Virus

Vaccine Studies


Basic Studies

Influenza Virus

Venezuelan Equine Encephalitis (VEE)

Vaccine Studies

Vaccine Combinations

New Vaccine Testing


Virulence Testing

Vaccine Production

Antiviral Testing

Control of an Epizootic

In utero Viral Transmission

Radiation Challenge

Immunological Responses


Rift Valley Fever Virus

Vaccine Research

ix Vaccine Combinations

Synthetic Peptides for Vaccine Development

Attenuated Vaccine Studies

Antiviral Therapies


Aerosol Tests

Basic Research

Transmission Studies


Korean Hemorrhagic Fever Virus (Hantaan)

Machupo Virus

Cross Protection and Subunit Vaccines


Basic Research

Junin Virus

Vaccine Research

Cross Protection



Basic Research

Lassa Virus

Vaccine Research


Basic Research

Botulinum Toxin


Challenge Studies

Toxin Production

Botulinum Immune Plasma (Equine and Human)

Immunology and Therapy




Challenge Tests

Prophylaxis and Therapy


Staphylococcal Enterotoxin B (SEB)

Toxoid Studies

Toxin Preparation



Basic Research


Appendix B: USAMRIID FY1969-FY1990 Pathogenesis Studies

Appendix C: USAMRIID FY69-FY90 Vaccine & Therapy Studies

Appendix D: USAMRIID FY1969-FY1990 Detection Studies

x Glossary


–  –  –


Table 1: WRS Research projects: 1942-1944………………………………………..43 Table 2: Biological Weapons and Biodefenses (1944-1969)………………………..85 Table 3: Funding at USAMRIID by Area…………………………………………..101 Table 4: Category A Agents………………………………………………………..148 Table 5: Comparison of Presumptions……………………………………………..153 Table 6: Balance of Readiness as of 1969………………………………………….162


Figure 1: The War Research Service (structure)……………………………………..42 Figure 2: The Concept of Munitions Command (1962)…….…………………….…77 Figure 3: USAMRIID Funding: FY1969-FY1990…………………………………101 Figure 4: USAMRIID Work Years and Publications………………………………115

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Biological weapons are excellent terrorist weapons, but are not effective for legitimate military missions. That was the original judgment of the US in the first few decades of the twentieth century. During World War II, the accuracy of that assessment was challenged through an intense BW R&D program that grew through the 1950s and 1960s. The original justification for the US BW program was defense against presumed enemy BW programs: the result was a stockpile of biological weapons. Driving this outcome was the argument that understanding of offensive BW potential was critical to development of defenses. However, when the US terminated its BW program in 1969, it had not produced or stockpiled adequate medical countermeasures. Current policy in reaction to the 2001 terrorist events is applying the same logic – and expecting the opposite outcome. Instead, US policy should evolve out of the predominantly open and defensive medical research program that has existed since 1969 to manage the bioweapons threat. That was a robust, unclassified scientific R&D program based at the US Army Medical Research Institute of Infectious Diseases (USAMRIID): it developed important medical defense against the most virulent bioagents known.

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