«Title of Document: STRUCTURING BIODEFENSE: LEGACIES AND CURRENT POLICY CHOICES Stacy M. Okutani, Doctor of Philosophy, 2007 Directed By: Professor ...»
Title of Document: STRUCTURING BIODEFENSE: LEGACIES
AND CURRENT POLICY CHOICES
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.
STRUCTURING BIODEFENSE: LEGACIES AND CURRENT POLICY CHOICESBy 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
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
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
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
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
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
An Overview of USAMRIID’s Work
vii Drug Development and Drug Screening
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
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
A National Program
The Road Ahead
Appendix A: USAMRIID Research Summary
Anthrax Toxin Studies
The Role of Plasmids
Other Vaccine Studies
Studies of Modes of Vaccination
Clinical Trials (LVS)
Acquisition of Host Resistance
Phase II and Phase I whole cell vaccines
Rocky Mountain Spotted Fever
Melioidosis and Glanders
Yellow Fever Virus
Venezuelan Equine Encephalitis (VEE)
New Vaccine Testing
Control of an Epizootic
In utero Viral Transmission
Rift Valley Fever Virus
ix Vaccine Combinations
Synthetic Peptides for Vaccine Development
Attenuated Vaccine Studies
Korean Hemorrhagic Fever Virus (Hantaan)
Cross Protection and Subunit Vaccines
Botulinum Immune Plasma (Equine and Human)
Immunology and Therapy
Prophylaxis and Therapy
Staphylococcal Enterotoxin B (SEB)
Appendix B: USAMRIID FY1969-FY1990 Pathogenesis Studies
Appendix C: USAMRIID FY69-FY90 Vaccine & Therapy Studies
Appendix D: USAMRIID FY1969-FY1990 Detection Studies
TABLESTable 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
FIGURESFigure 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
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.