Preparing for Bioterrorism: the Alfred P. Sloan Foundation's Leadership

Home , Michael Osterholm, Safe America Foundation

Editor: Mary Beth Hansen Associate Editor: Jackie Fox Assistant Editor: Molly D’Esopo Cover design, interior design, and layout: Davia Lilly Index: Karen Martin

First edition: December 2012

Published in the United States by Center for Biosecurity of UPMC 621 East Pratt Street, Suite 210 Baltimore, Maryland, USA, 21202

ISBN-13: 978-0615706825 ISBN-10: 0615706827 LCCN: 2012918441

The full text is available in PDF format on the Center for Biosecurity of UPMC website: www.upmc-biosecurity.org

Printed in the United States by CreateSpace www.creatspace.com Preparing for Bioterrorism

The Alfred P. Sloan Foundation’s Leadership in Biosecurity

Gigi Kwik Gronvall Center for Biosecurity of UPMC

Foreword by D. A. Henderson

Afterword by Tom Inglesby

Contributing author Madeline Drexler This book is dedicated to Ralph Gomory and Paula Olsiewski, with gratitude for their vision, leadership, and dedication.

f Preparing for Bioterrorism: The Alfred P. Sloan Foundation’s Leadership in Biosecurity

Foreword...... xi D. A. Henderson

Preface...... xvii Gigi Kwik Gronvall

Acknowledgments...... xxiii

Introduction: Finding a Sustainable Approach to Biosecurity ...... 1

Chapter 1: Building Civilian Preparedness and Readiness...... 9

Preparing for a Threat Beyond the Battlefield...... 13 The Center for Biosecurity of UPMC

Showing Americans How to Prepare for Terrorism...... 23 The Advertising Council’s READY Campaign

A Learning and Exchange Forum for Big City Emergency Managers...... 27 The Council for Excellence in Government’s Forum for Big City Emergency Managers

A Framework for Mass Casualty Response ...... 29 George Washington University’s MaHIM System

Children as Targets of Terrorism...... 32 Center for Disaster Preparedness Guidelines

Preparing the Disability Community for Disaster...... 35 The National Organization on Disability’s Emergency Preparedness Initiative Organizing Medical Volunteers for Disaster Response...... 37 The Civilian Medical Reserve Corps

Chapter 2: Organizing to Counter Bioterrorism...... 42

Coordinating Federal Government Responsibility for Bioterrorism ...... 45 The Wye River Workshop

Working Through Foreign Policy Ramifications of Bioterrorism...... 48 Atlantic Storm and Black ICE International Bioterrorism Exercises

Learning from Aum Shinrikyo...... 55 Danzig and Colleagues Report on Aum’s Use of Biological and Chemical Weapons

Assessing the US Government’s Bio-Response Capabilities ...... 58 The WMD Center’s Bio-Response Report Card

Chapter 3: Criminalizing Bioterrorism...... 63

An International Criminal Law Approach to Bioterrorism...... 65 The Airlie House Workshop

Teaching the World’s Police about Bioterrorism ...... 69 Interpol’s Work on Bioterrorism Prevention and Response

Chapter 4: Responsible Stewardship of Powerful Biotechnologies...... 73

Preventing the Misuse of Science...... 78 The Fink Report

International Oversight of Dual-Use Research...... 83 The Center for International Security Studies’ Biological Research Security System

Options for Governance of Gene Synthesis...... 86 Rational Guidance to Limit Access to Mail Order Pathogens Educating Scientists about Dual-Use Science...... 91 Deliberative Seminars for Scientists Worldwide

Setting International Priorities for Biosafety and Biosecurity...... 94 The International Council for the Life Sciences

A Global Culture of Responsibility in the Life Sciences...... 96 WHO Guidance on Responsible Life Sciences Research

Chapter 5: Public Health Law for the 21st Century...... 99

Modernizing Public Health Powers...... 102 The Cantigny Conference on State Emergency Public Health Powers and the Bioterrorism Threat

Fortifying Essential Public Health Powers...... 105 The Model State Emergency Health Powers Act

Protecting Good Samaritan Organizations...... 109 Liability Protections for Organizations that Assist in Disaster Response

Building Bioterrorism and Public Health Law into Law School Curricula...... 112 The Pacific McGeorge School of Law’s Curriculum Updates

Chapter 6: Preparing Businesses for Terrorism and Other Emergencies...... 115

Developing Standards for Business Preparedness...... 116 A Framework for Voluntary Preparedness

Business Planning for Pandemic Influenza...... 119 CIDRAP’s National Summit and Business Source

Measuring the Value of Corporate Preparedness ...... 122 New York University’s InterCEP

Understanding the Barriers to Corporate Preparedness ...... 125 A Study of Human Continuity Preparedness Chapter 7: Making Buildings Safe...... 128

Using Air Filtration to Make Buildings More Secure ...... 130 Updated Guidelines and Training for Building Owners and Managers

Expert Consensus on Practical Steps to Make Buildings Safer...... 134 The Working Group on Reduction of Exposure to Infectious Agents During a Covert Bioterrorism Attack

Chapter 8: Using Disease Surveillance for Early Warning...... 138

Building a Flexible Platform for Syndromic Surveillance Software...... 141 The New York Academy of Medicine’s SaTScan Program

Applying the Language of Science to Problems in Biosecurity ...... 144 DIMACS’s Research Program on Computational and Mathematical Epidemiology

Disease Surveillance in Real Time...... 146 Expanded Data Collection Capacity for RODS

Chapter 9: Strengthening Preparedness for Pandemic Influenza...... 148

Learning from the 1918 Influenza Pandemic...... 151 John Barry’s Historical Study of the 1918 Flu Pandemic

A Billion Decision Makers...... 155 A Fresh Look at Pandemic Modeling Assumptions

Preventing Flu Transmission in Families...... 157 A Controlled Study of Flu Prevention Measures in Families

Evaluating the Nation’s Response to the 2009 H1N1 Flu Pandemic...... 159 CIDRAP’s Assessment of Flu Vaccine Efficacy Chapter 10: Preparing New Yorkers for Terrorism and Other Disasters ...... 164

Are You Ready, New York?...... 166 The New York City Public Advocate’s Ready Campaign

Teaching New Yorkers about Preparedness...... 169 World Cares Center Disaster Preparedness Fair

Sampling the Environment...... 171 The NYPD Increases BioWatch Effectiveness

Training Building and Service Workers for Terrorism Response...... 173 New York Safe and Secure Training Program Curriculum

Afterword...... 175 Tom Inglesby

Table of Abbreviations...... 179

Notes...... 183

Selected Bibliography...... 225

Appendix...... 233 Sloan Foundation Biosecurity Grants, 2000-2010

Index...... 249 Foreword

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D. A. Henderson

n September 11, 2001, terrorists on suicide missions flew planes into the World Trade Center and the Pentagon. A stunned, O appalled country had only begun to pick up the pieces when desperately ill patients with a strange pneumonia like disease were reported first from Florida, then New York and New Jersey, and, finally, Washington, DC. Anthrax organisms were found in a white powder in some letters. Immediately, white powders, wherever they were found, became suspect. Public health laboratories were swamped with thousands of samples from all parts of the country samples that were not at all dangerous: powdered sugar from doughnuts, powdered cleaning preparations, and white cosmetic powders. Suspicious samples resulted in buildings being evacuated and employees “decontaminated” with water from fire hoses and showers. Information about what was occurring, even for government officials, had

xi Preparing for Bioterrorism to be gleaned from fragmentary reports on CNN and local television. There were no clinicians who had experience in treating cases of inhalation anthrax. Major cities had no plans for implementing public health measures in response to a biological attack. In short, the country was unprepared to deal with biological weapons. Although the country was caught unprepared, there was one deeply interested organization, the Sloan Foundation, which had already made a major commitment in October 2000 to take on the mission of reducing the threat of bioterrorism. The practical initiatives they supported over ten years transformed complacency into meaningful programs. That story is the essence of this book. The Sloan funded work along with the development of federally supported programs have fostered a significant change in a country that is still all too prone to rapidly forget and put aside unpleasant memories of past catastrophes.

My own concerns about bioterrorism began in the 1990s. At that time, fears of terrorism were stoked by Aum Shinrikyo’s chemical attack on the Tokyo subway, by the 1993 bombing of the World Trade Center, and by the startling revelation that the Soviet Union had been actively engaged in creating and perfecting biological weapons, including smallpox. President Clinton was sufficiently concerned that, in 1995, he issued a Presidential Decision Directive to all US government departments alerting them to the threat of terrorism and directing them to develop programs focused on national security. As a result, first responder teams began to be established in 120 major US cities, and funds were appropriated through the Departments of Defense and Justice to strengthen police, fire, and emergency rescue operations. But no funds were directed to casualty care or public health

xii Foreword response. Indeed, no provisions were made at all to deal with the threat of biological weapons; the threat was ignored by most officials. In the public health and medical communities, there was antipathy toward any activity that dealt with biological weapons, even as fears of biological attacks targeting civilian populations grew. At the time, neither the CDC nor the NIH had programs related to biological weapons.

It was clear to me that to address this problem, there had to be discussion, education, and research on this subject to be conducted by a dedicated center then called the Center for Civilian Biodefense Studies, which I founded with three colleagues in 1998. The center was conceived as a joint enterprise of the schools of public health and medicine at Johns Hopkins University. John Bartlett, then chief of the Division of Infectious Diseases, fully supported the initiative. Dr. Bartlett was also president of the Infectious Diseases Society of America (IDSA). As such, he was able to arrange on short notice a special symposium at the society’s national meeting in September 1997. It attracted an exceptionally large audience. The central question we posed at the symposium was this:

If late one night you were summoned to the emergency room as the infectious disease consultant on call and asked to deal with a dying patient with a rapidly progressing severe pneumonia or one covered with pustular lesions, would you recognize the patient with anthrax or smallpox? Bear in mind that this might be one of the first cases of a developing epidemic. Would you know what to do in treating the patient or preventing spread of the disease?

Symposium participants quickly understood that they would be wholly unprepared for such a scenario. Although much was being invested in a

xiii Preparing for Bioterrorism national program for first responders, medical and public health practitioners, the true first responders to bioterrorism, had been overlooked in planning, funding, and education.

The center had important work to do, but there was no support to be found. Foundations interested in public health turned us away because they were not interested in work related to terrorism or in the morally repugnant topic of biological weapons. Foundations focused on national security related topics thought our work belonged in the public health and health policy domains. Academic institutions did not welcome discussion of and research on biological weapons. We invited other institutions comparable to Hopkins to join us in this effort and were turned down by all.

After the IDSA special symposium, my center colleagues and I traveled the country to give invited presentations at other meetings and conferences. We next decided to convene a national symposium on bioterrorism, specifically targeted to the public health and medical communities. Nothing like this had been held before, and we wondered how we would fill a hall that seated 1,000 people. Notices and publicity began in November 1998, only eleven weeks before the symposium. The center was new and unknown, and interest in the subject itself was uncertain. However, one week before it was to begin, we found we had to turn people away. Nevertheless, despite the success of the symposium, foundations continued to turn down our proposals and resources began to run out.

That changed after a personal meeting in New York with Ralph Gomory, then president of the Sloan Foundation. It was immediately clear that we shared similar concerns. He invited me to submit a proposal, and we submitted a generous one that was fully funded within weeks. One of the

xiv Foreword

Hopkins center’s first joint efforts with Sloan was the simulated exercise Dark Winter. It was dramatically effective in acquainting key political leadership with the potentially dire consequences of a smallpox virus attack. Senator Sam Nunn played an especially important role in the exercise and then took it upon himself to brief both House and Senate leadership on the implications of a biological weapons attack. The last briefing in the Senate occurred in early September 2001, just days before 9/11.

After 9/11 and the anthrax letters that followed, the US government acted quickly. In November 2001, a new Office of Public Health Emergency Preparedness was created in the Office of the Secretary of HHS. Two months later, a special appropriation of more than $3 billion was provided to HHS to develop a program for civilian preparedness and response to a serious biological threat posed by a terrorist or by nature.

Soon after, others joined the Sloan Foundation and the center in the effort to build US biosecurity. It has been a long road from complacency to where we are today, and much has been accomplished along the way. Unquestionably, the country is better prepared now to deal with a biological weapons attack and with other large scale hazardous events.

But I should temper that statement and rewrite the sentence to say “was better prepared.” In 2012, as this book is being written, federal budgets for public health preparedness are once again being significantly reduced for states, counties, hospitals, and the CDC. Public health laboratories are losing staff; epidemiologist positions have been cut; community liaisons who help mobilize schools, industries, and health departments are leaving. Memories of events like the anthrax attacks, Hurricane Katrina, pandemic influenza, and SARS are fading rapidly.

xv Preparing for Bioterrorism

The Sloan Foundation fostered significant change. The major milestones in that history are recounted in this book. Sloan played a major role in laying the foundation for the nascent field of biosecurity and supported most of the key players who nurtured its development over the decade that followed the 2001 attacks. The nation should capitalize on the gifts of progress afforded by Sloan’s generous ten year investment by continuing the good work that has been started and expanding on the achievements already realized. There remains much yet to be done to ensure our preparedness for future threats and disasters that threaten US biosecurity. We should build on the work recounted here and defend vigorously against anything that will undermine these accomplishments.

D. A. Henderson, MD, MPH, is a distinguished scholar at the Center for Biosecurity of UPMC and professor of public health and medicine at the University of Pittsburgh. He is dean emeritus and professor of health policy and management at the Johns Hopkins School of Public Health and the founding director (1998) of the Johns Hopkins Center for Civilian Biodefense Strategies.

xvi Preface

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Gigi Kwik Gronvall

nfluenza, smallpox, cholera, and other infectious diseases have been a factor in warfare for centuries, but disease as a weapon has a much Ishorter history. It was not until advances in cell culture and fermentation allowed mass production that lethal pathogens could be added to the armaments of nations, starting with the first state sponsored biological weapons program in Germany in World War I. Afterward, biological warfare programs proliferated, culminating in the 1960s as the United States, the United Kingdom, Germany, France, the Soviet Union, and other nations directed teams of scientists to weaponize pathogens and devise the means to deliver them in combat. Those offensive biological weapons programs had a defensive side as well: Soldiers were vaccinated, fitted with gas masks, and administered antibiotics to protect them from the weaponized pathogens of enemy nations. The focus

xvii Preparing for Bioterrorism on defending troops against biological weapons remained sharp even after 1969, when President Richard Nixon declared that the United States would unilaterally disarm its biological weapons program, and after 1972, when the Biological Weapons Convention was signed in Geneva.

It was not until the 1990s that the possibility of biological terrorism, carried out by individual actors instead of the armies of nations, began to be widely recognized. Just as advances in microbial cell culture and vaccinology laid the groundwork at the turn of the twentieth century for development of offensive national biological weapons programs, advances in genetic engineering, biotechnology, cell culture, and aerosol technologies paved the way for terrorist use of biological weapons.

Weapons development that had previously required teams of scientists suddenly required only small groups or even an individual with the right laboratory skills and equipment. The attack range broadened as well. When nations attack nations, troops are most often the targets. When terrorists attack, civilians are often the targets. Once it became apparent that civilians were at risk, it was clear that the United States had a biological security deficit: Civilians were vulnerable to bioterrorist attack and the US government was not organized to protect or respond.

The biosecurity deficit was the motivation behind the Sloan Foundation’s entry to the field. Ralph Gomory, president of the foundation, brought on Paula Olsiewski to direct Sloan’s biosecurity program, which had as its mission the achievement of bioterrorism preparedness. Over the life of the program, which ran from 2000 to 2010, the Sloan Foundation awarded over $44 million to more than 150 grantees. The grantees, in turn, engaged and supported hundreds of experts, researchers, and other motivated people to

xviii Preface study, formulate, promulgate, enact, and rally for major gains in biosecurity and the nation’s preparedness.

This book describes selected individual achievements of Sloan grantees to show the results of the foundation’s leadership, commitment, and investments in national and international biosecurity. The story it tells illustrates how the Sloan Foundation’s vision and its grantees’ dedication and innovation left the nation demonstrably better prepared to face a biological weapons attack in 2012 than it was in 2000 before Sloan got involved.

Over its ten years in the field, Sloan awarded its biosecurity grants in ten loosely defined topic areas. Instead of trying to chronicle all of those grants, we chose a representative sample of grants from each area that, considered together, would tell the story of Sloan’s major achievements in accomplishing its biosecurity mission. The goal of the book is to illustrate how biosecurity changed over the course of ten years in areas that were crucial to building civilian preparedness. Sloan grants were awarded to define and develop preparedness for civilian populations vulnerable to terrorist attacks, to update public health laws, to improve public building filtration, to prepare businesses for major epidemics, and to address many other aspects of biosecurity preparedness.

I gathered the material for the history presented here through independent research, interviews with Ralph Gomory and Paula Olswieski, and reviews of ten years’ worth of grant proposals and grant reports submitted to the Sloan Foundation. Even more history was gathered from personal interviews with grantees who gave generously of their time in recounting their experiences with the Sloan Foundation and their Sloan supported projects. For that, I owe thanks to: Ron Atlas, Edward Baker, Joseph Barbera, John Barry, Al

xix Preparing for Bioterrorism

Berman, Bruce Blythe, Harvey Brickman, David Buckeridge, Kathy Crosby, Rosemarie Curran, Malcolm Dando, Richard Danzig, Elizabeth Davis, Richard Falkenrath, David Franz, Robert Friedman, Michele Garfinkel, Larry Gostin, Richard Hatchett, D. A. Henderson, Jo Husbands, Tom Inglesby, Leslie Gielow Jacobs, Lynn Jennings, Barry Kellman, Joanne Kelly, Lynne Kidder, Randy Larsen, Richard Larson, Gene Matthews, Farzad Mostashari, Ron Noble, Lisa Orloff, Michael Osterholm, Rosalie Philips, William Raisch, Brian Rappert, Irwin Redlener, Fred Roberts, Don Schmidt, John Steinbruner, Mitchell Stern, Laura Streichert, Terence Taylor, Robert Ursano, and Michael Wagner. All took time out of demanding schedules to talk at length with me or with contributing author Madeline Drexler. Our interviews covered their work, its legacy and contribution to US preparedness, and their ideas about what should come next. Many provided careful review of the book section that described their project and offered valuable feedback.

Judging from those conversations alone, Sloan picked the right people, all of whom spoke highly of the foundation. The portrait of the foundation that emerged from these conversations was one of a nimble, open minded organization extraordinarily able and willing to adapt to rapidly changing political and scientific landscapes.

The way Sloan worked gave grantees remarkable freedom and the ability to be as influential as possible in shaping the nation’s biopreparedness. It was exciting to put all of the pieces together and be able to see the whole history at once. This is a history of a new field and a new, important commitment to civilian preparedness. It is also an illustration of what foundations contribute to American society that the US government and capital investors with particular agendas cannot. Foundations provide invaluable independence.

xx Preface

We have included an appendix at the end of the book that lists all of the Sloan Foundation’s grantees over its decade in biosecurity. It is an impressive array. Sloan was able to “punch above its weight” because the foundation was dedicated to the mission of US biosecurity and chose and supported similarly dedicated grantees. We are all better for the Sloan Foundation’s leadership and investment.

Gigi Kwik Gronvall, PhD, an immunologist by training, has been a scholar in biosecurity since 2000, when she was a National Research Council postdoctoral associate at USAMRIID in Fort Detrick, Maryland. She became a member of the Johns Hopkins Center for Civilian Biodefense Studies in 2001, and has been a senior associate with the Center for Biosecurity of UPMC since its inception in 2003.

xxi Acknowledgments

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his book would not have been possible without the support and lively encouragement of Paula Olsiewski, who gave generously of T her time to reflect on the history of the biosecurity program and her most memorable experiences as director. Ralph Gomory gave generously of his time as well in an extended interview that could serve as a master class in leading and influencing large organizations. He insisted that this book describe not just the foundation’s contributions to biosecurity, but also the work that remains to improve civilian preparedness. That the many stories of individual Sloan efforts came together as a book is a testament to the talent and creativity of many of my colleagues, to whom I am grateful and indebted. D. A. Henderson, Randy Larsen, Joe Fitzgerald, Anita Cicero, and Tom Inglesby each read the completed manuscript with a critical eye and offered sage advice based on long experience. Monica Schoch Spana and Jennifer Nuzzo read the Center for Biosecurity and disease surveillance sections, respectively, and offered their valuable insights to help

xxiii Preparing for Bioterrorism make each better. Michael Mair and Penny Hitchcock reviewed the chapter on buildings and offered useful suggestions. I am grateful for the attention to detail, thought, and suggestions made by all reviewers.

Contributing author Madeline Drexler drew out many interesting and revealing quotes in this volume and drafted several of the sections. Yolanda Wolf, Paula Olsiewski’s assistant, gathered and helped us organize the hundreds of grant proposals, project reports, articles, and government reports that we used to compile this history. She was instrumental in helping us launch this project.

I had a strong team behind me at the Center for Biosecurity, and I owe many thanks to my center colleagues. Tanna Liggins, as always, helped keep me organized. Kim Biasucci and Maria Jasen were very helpful in the beginning as we organized mountains of files and details gathered from Sloan’s offices in New York. Crystal Franco, Tara Kirk Sell, Sam Wollner, Ryan Morhard, Kunal Rambhia, and Matt Watson served as the fact check team, chasing down and confirming myriad details and citations. Molly D’Esopo and Jackie Fox, both thoughtful and careful readers, provided valuable suggestions, skilled editing, and any other help needed through all stages of manuscript development. Ryan Morhard read the manuscript and offered the valuable feedback of someone who is new to, but up and coming in the field. Graphic designer Davia Lilly created the design and produced the book through layout and typesetting, bringing the book to life.

I was especially lucky to work with Mary Beth Hansen as editor. She shaped the book concept, organized and coordinated the team, and directed and kept on track all of the systems and processes that took this book from idea to finished product. She worked closely with me throughout to shape

xxiv Acknowledgments the narrative and refine the text. In addition to her talents as editor, she also contributed enthusiastic encouragement and appreciation throughout, which kept the project fun and made it a delightful experience (surprisingly).

Finally, I would like to thank my husband and sons Jesper, Casper, and Felix who inspire me and bring me joy every day.

xxv Introduction

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Finding a Sustainable Approach to Biosecurity

Sloan Foundation initiatives called attention to the threat of bioterrorism, paved the way for new directions in research, led to new and practical response capabilities, and helped point the US government in the right policy direction.

n October 2000, the Alfred P. Sloan Foundation took on the mission of reducing the threat of bioterrorism. Over the ten years that followed, the Ifoundation triggered fundamental improvements in US preparedness for bioterrorism and naturally occurring diseases. The investments in preparedness were prescient, as the first were made before the anthrax letter attacks in October 2001, and over time, they established the Sloan Foundation

1 Preparing for Bioterrorism as the primary US and international catalyst for innovative thinking and action in biosecurity. This book describes key projects, campaigns, and organizations underwritten by Sloan during its decade in biosecurity and shows how the foundation influenced and shaped the field. The individual projects recounted illustrate how Sloan’s work helped to shift thinking about biosecurity by affirming it as a societal responsibility that extended beyond the bounds of the military alone. The project descriptions also illustrate how the foundation’s work led to creation of a multidisciplinary professional field of research and practice in biosecurity. In all, this book shows how the nation is more prepared now than it was in 2000 to face natural or deliberate infectious disease threats, an achievement that the Sloan Foundation’s support helped bring about. In 2000, when the Sloan Foundation started its work in biosecurity, civilian biodefense was a nascent concept. Though the consequences of bioterrorism could be terrible numerous deaths, widespread illness, societal and economic disruption, loss of trust in the government community, state, and local preparedness planning was minimal. Most US government biodefense expertise resided in the military and was focused on defending troops from biological warfare because the threat to civilians had not yet been recognized. Relatively few people in the government were thinking about what would happen if a terrorist used anthrax to attack a US city or if smallpox re emerged as a weapon after having been eradicated from the natural world.

Lack of US government preparedness was the prime motivator that moved Ralph E. Gomory, president of the Sloan Foundation from 1989 to 2007, to adopt biosecurity as a mission. In fall 2000, Gomory heard a US government

2 Finding a Sustainable Approach to Biosecurity official describe the national strategy to defend against a bioterrorist attack, the centerpiece of which was developing a vaccine from scratch, and then mobilizing rapidly to vaccinate the threatened population. Gomory had no experience in developing or delivering vaccines he came to the Sloan Foundation from IBM, where he had been director of research and then senior vice president for science and technology, but his long experience with a large research organization told him that the government strategy was wishful thinking. He decided that the Sloan Foundation had to act to reduce the threat of bioterrorism.1 He was already convinced that biological weapons would be a problem in the future because this threat was the result of technological change, and biotechnologies were getting increasingly easier to misuse: “This new technology, widely diffused, will get into the hands of extremist groups.”2

Gomory tapped Paula Olsiewski, a biochemist and president of a technology consulting company, to direct Sloan’s new biosecurity initiative. Olsiewski saw herself as a connector who could “engage as many people as possible to work on different parts of the problem.”3 As such, she reached across institutional boundaries to convene experts who had never met but were natural allies because their work had the common goal of protecting citizens. She introduced building engineers to police officials, legal scholars to public health officials, and business owners to laboratory scientists. She organized working dinners where people discovered they had common cause with experts from diverse fields and ended up as close collaborators.

Gomory’s approach to biosecurity was to “try everything” that could address the problem.1 Unlike government funders, Sloan did not issue requests for proposals and then wait for good ideas to come to them.

3 Preparing for Bioterrorism

Olsiewski searched for people to pursue projects in the areas that she and Gomory decided were important. The foundation did not dictate projects for grantees or require adherence to specific project deliverables. Instead, Gomory and Olsiewski found people who were passionate about their work, shared Sloan’s goal of reducing the threat of bioterrorism, understood the changing conditions of the field and the political landscape, and were nimble enough to adjust projects as needed. The foundation’s review process was swift and efficient, and numerous projects were funded to see what could work. Gomory and Olsiewski believed that even if an approach was not successful, important lessons could be learned from the experience and applied to other efforts.

From the beginning, it was clear that civilian resilience to bioterrorism would improve only if established institutions and professional communities came to understand and accept new roles in national security.1 Through targeted grants, Sloan raised awareness of the consequences of bioterrorism for many professional communities and brought experts from multiple disciplines into the field. This was particularly important for healthcare and public health practitioners on the front lines, who would be the first to see victims who were sick with unusual infectious diseases.

Other professions also had to take on new roles to meet the challenges of biosecurity. Sloan funded education programs for scientists and scholarly analyses to encourage life scientists to examine how their training and work could be misused to create biological weapons. Business leaders and building owners were engaged in discussions of ways to protect building occupants from biological agents by improving HVAC systems, planning for pandemic flu, or devising systems to deliver vaccines to employees. Recognizing that law

4 Finding a Sustainable Approach to Biosecurity enforcement organizations had limited knowledge about bioterrorism, Sloan funded education programs that encouraged scientists and law enforcement officials to work together, which built trust between the two groups. Finally, Sloan supported many projects designed to reach and engage those policymakers well positioned to influence civilian biodefense policy and make badly needed reforms to public health law and public health preparedness.

The Sloan Foundation jump started interest in civilian biodefense among many previously uninvolved professions and brought those groups together to create a vibrant multidisciplinary field. After 9/11 and the anthrax letters, the fact that Sloan was already investing in biosecurity helped to propel initiatives forward on a nationwide scale and provided a community for those who were interested in contributing their expertise. The foundation funded numerous conferences and events where people shared ideas and learned from one another. Those exchanges led to cross pollination of ideas. In 2000, there were no national conversations about civilian biodefense; by 2003 there was a peer reviewed journal dedicated to biodefense and biosecurity,4 and now there are a variety of annual conferences and meetings.

Sloan’s goal of reducing the threat of bioterrorism was ambitious, but the foundation’s approach was pragmatic. Gomory and Olsiewski were interested in solutions that took advantage of existing systems and solutions that people could implement on their own. For example, for influenza preparedness, Sloan invested in studies to determine whether wearing masks or maintaining distance from social contacts could decrease the spread of flu. They funded projects that assessed whether HVAC filtering systems already installed in commercial buildings could be converted from potential pathogen distributors to pathogen filters. Sloan also wanted to harness information

5 Preparing for Bioterrorism already being collected about numbers of hospitalizations, over the counter drug purchases, and school absenteeism to find indications of a bioweapons attack. This commonsense approach guided the foundation to choose projects focused on developing sustainable, affordable ways to protect the US population.

Responsibility for biosecurity is now largely vested in the Department of Homeland Security (DHS), the Federal Bureau of Investigation (FBI), and the Department of Health and Human Services (HHS) and its internal agencies the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), and the Food and Drug Administration (FDA) in addition to programs headed by the Department of Defense (DOD). These agencies are responsible for preparedness, response, and recovery, which entails planning response; detecting a biological attack; developing, procuring, stockpiling, and delivering medical countermeasures; communicating with the public; preparing hospitals; attributing an attack; and leading recovery after an event.

Change has occurred in officials’ attitudes and beliefs about the public’s response to terrorism and disasters. Fears of public panic have been replaced by confidence in the wisdom of giving people as much information as possible about the dangers they face and the actions they can take to protect themselves, their families, and their communities. That confidence is grounded in results of research sponsored by Sloan and others demonstrating that fears of public panic were unfounded. That research also made clear that giving the public as much information as possible is essential because people could be on their own for hours or even days after a disaster and would need to know what to do during the time before official responders arrive.5 This

6 Finding a Sustainable Approach to Biosecurity attitudinal sea change has produced a widespread commitment to engaging the public in planning and response.

Sloan funding gave researchers the independence they needed to seek creative solutions to biosecurity problems and to criticize government decisions. Sloan funding made some projects easier, if not possible in the first place. The foundation funded projects that the government probably would not have funded during the decade of the foundation’s involvement or now as budgets are shrinking across all levels of government. The foundation was more flexible and responsive than government funding agencies can be. And, importantly, Sloan funded work that called attention to areas neglected for many years by the US government.

The Sloan Foundation closed its biosecurity program in 2010 after many successes. During its decade in the field, Sloan awarded more than $44 million in grants to individual researchers, organizations, universities, and government offices. Over that period, US government funding for biodefense grew from $50 million in 2000 to more than $1 billion in 2010.6 Many of the ideas and practices developed by Sloan grantees, such as civilian preparedness, have been institutionalized, and biosecurity as a multidisciplinary field has been firmly established.

The Sloan program ended during an economic downturn, when budget cuts began to threaten progress in biosecurity. The effects can be seen in cuts to the US public health system that are undermining preparedness systems set up after 9/11. When public health systems are working, they are largely invisible, but as political commitment to those systems wanes and funding is cut, the nation’s ability to protect people from the consequences of any type of epidemic will be severely weakened. That will be noticed.

7 Preparing for Bioterrorism

Sloan’s legacy is impressive. Beyond all advances in preparedness, a field of practice and research exists that did not in 2000. A substantial body of knowledge has been created. Leaders emerged who are now mentoring and educating the next generation. Laws and public policy have been created or modernized. Many of the programs spearheaded with Sloan Foundation funding will endure and expand. The pursuit of this mission must continue.

In describing this mission, Gomory said that “reducing the threat from bioterrorism is difficult, expensive, and perhaps unruly. But it has to be done. Bioterrorism is something you cannot wish away.”1 Sloan Foundation initiatives called attention to the threat of bioterrorism, paved the way for new directions in research, led to new and practical response capabilities, and helped point the US government in the right policy direction. As the threat of bioterrorism continues to evolve and change, pushed along by international politics and trends in the biological sciences, the field needs a new infusion of energy and support such as the Sloan Foundation provided for so long. The next chapter in this unruly endeavor remains to be written.

8 CHAPTER 1

Building Civilian Preparedness and Readiness

Until the 1990s, most US biodefense expertise, research, planning, and preparedness were concentrated in the military, and civilian preparedness was overlooked.

t has long been clear that biological weapons posed a threat far beyond the battlefield because they could be used to target large numbers I of civilians. The potential results of their use were demonstrated in the 1950s and 1960s when, as part of the former US offensive biological weapons program, the US military tested the spread of microbes in cities and subway systems and projected potentially staggering levels of mortality and morbidity.7,8 Despite the threat to civilians, responsibility for biodefense rested with the military in the decades after the 1969 US unilateral disarmament of biological weapons and the 1972 Biological Weapons Convention (BWC). Until the late 1990s, in fact, most US biodefense expertise, research, planning, and

9 Preparing for Bioterrorism preparedness were concentrated in the US military, which focuses on force protection, and civilian preparedness was overlooked.9 In the 1990s, civilian vulnerability and the need for preparedness were both made clear when defectors from the former Soviet Union and Iraq revealed the existence of biological weapons programs in both countries, in violation of the BWC.10-12 The former Soviet Union’s program was vast, employing more than 60,000 people in dozens of facilities.13 When Russia’s steep economic decline occurred in the 1990s and scientists, along with many others, lost their jobs, leading security experts began to worry that nations and terrorist groups would be able to purchase from unemployed Russian experts the materials and expertise needed to make biological weapons.14 Another event that raised concern was the 1995 Aum Shinrikyo subway attack in Tokyo, which led to revelations that the Japanese cult had explored use of biological weapons.15,16 Those events exposed the reality of the bioweapons threat, and the 1993 attack on the World Trade Center in New York and the 1995 terrorist bombing in Oklahoma City made clear that the United States was also vulnerable to violent extremism.

At the same time, great advances in the biomedical sciences were occurring: the Human Genome Project was launched, the medical potential of stem cells was discovered, fMRIs to explore brain function were developed, and genetic engineering gained ground.17 Although such advances were generally applauded, they also prompted worries that, in the wrong hands, the growing power of science could be misapplied with calamitous effect. This fear was supported by a 1993 Office of Technology Assessment report that stated that the lethality of a biological weapon could mirror the consequences of a nuclear attack.18 Popular culture was stoking fear about the

10 Building Civilian Preparedness and Readiness dark side of biology, too, with movies like 1995’s Outbreak, about an Ebola like epidemic,19 and the 1997 novel The Cobra Event, about a lone bioweaponeer who sparks an epidemic with a genetically engineered smallpox virus.20 The Cobra Event is said to have inspired President Clinton to call for analysis of the biological weapons threat and US preparedness.21,22

The growing recognition of civilian vulnerability was accompanied by the growing realization that US cities and states and the federal government were not organized to manage and withstand outbreaks of unusual infectious diseases and the potential widespread epidemics that could follow a bioweapons attack. Public health departments were understaffed, underfunded, and unconnected to hospitals.23 Hospitals did not have the surge capacity needed to triage and treat a sudden large influx of patients. Most US clinicians had never seen a patient suffering from anthrax or smallpox and may not have recognized the signs and symptoms. Members of the public were not included in emergency us cities and states and the planning and response. And many officials federal government were considered the public a problem to be not organized to manage managed one prone to irrational fear, panic, and withstand outbreaks of and civil unrest.24 unusual infectious diseases and the potential widespread As the threat of a bioattack seemed to be epidemics that could follow growing, the nation was not at all ready to a bioweapons attack. respond neither to bioterrorism nor to any type of widespread epidemic. Against this backdrop, the Sloan Foundation launched its biosecurity program in 2000.

The foundation entered the field recognizing that civilians were not aware of the threat or prepared for an attack and that the US government was not

11 Preparing for Bioterrorism doing enough to prepare. By focusing on biosecurity, the Sloan Foundation hoped to spur US government action while also helping ordinary people and professionals with relevant expertise gain awareness and get involved in emergency planning.

The Sloan Foundation gave its first biosecurity grant to the Center for Civilian Biodefense Studies at Johns Hopkins University, an academic policy center focused primarily on preparedness and grounded in public health, medicine, and the life sciences. Early on, the foundation also funded the READY campaign, now run by DHS, to provide practical information that people needed to protect themselves. Sloan supported other important preparedness initiatives, including projects that promoted strategic thinking about national biopreparedness, brought together emergency managers from big cities to share best practices, raised awareness of the terrorist threat to children, and developed guidance for working with the disability community in emergencies. The foundation funded hospital planning efforts to improve communications and expand levels of care and facilitated planning for a volunteer civilian medical reserve corps that could respond in emergencies.

In 2012, civilian preparedness is much better than it was in the 1990s. The 9/11 terrorist attacks and the anthrax letter attacks that followed underscored the need for preparedness and reinforced the importance of Sloan’s biosecurity program. Now, a little more than a decade later, medical and public health professionals are demonstrably more prepared for epidemic response. The skills needed to communicate with the public during emergencies have been identified and practiced, and the public is now widely acknowledged as central to emergency preparedness. President Obama and other government leaders have described the public as key to US

12 Building Civilian Preparedness and Readiness resilience to a catastrophic health event.25,26 Hindsight makes clear that the Sloan Foundation was connected to much of the biopreparedness work and progress of the past decade.

Preparing for a Threat Beyond the Battlefield

The Center for Biosecurity of UPMC

When the Johns Hopkins Center for Civilian Biodefense Studies now the Center for Biosecurity of UPMC was formed in 1998, it was one of the few organizations with the mission of improving the country’s preparedness for bioterrorism and the only one with substantive expertise in medicine and public health. D. A. Henderson, who led the World Health Organization’s (WHO) smallpox eradication program from 1967 to 1977, founded the center because he thought that most parts of the federal government did not fully understand the nature of bioterrorism. Evidence of that misunderstanding was the US government’s emphasis on traditional first responder organizations rather than public health or medical institutions as key to bioterrorism preparedness.27 Henderson knew that the most likely first responders to a biological attack would be healthcare providers: emergency room physicians and nurses, family doctors, infectious disease specialists, infection control practitioners, epidemiologists, and laboratory

13 Preparing for Bioterrorism experts. He was concerned that professionals in those disciplines were not engaged in bioterrorism preparedness, leaving the nation unready to face the consequences.28

The reason most health professionals and life scientists were not engaged, according to Henderson, was because the notion of biological weapons was anathema to them. Many were convinced that biodefense measures were unnecessary for the United States. This conviction stemmed from an absolute belief in the moral repugnance of biological weapons and a belief that no one would use them. Others believed that such weapons would be too difficult to make.29 These positions were challenged when the Soviet and Iraqi bioweapons programs were revealed in the 1990s, and then again when the terrorist threat to the United States was brought home with the 1993 World Trade Center bombing and the 1995 Oklahoma City bombing.

Henderson recruited Tara O’Toole, an occupational health physician and former Assistant Secretary of Energy for Environment, Safety, and Health, to be deputy director. He also recruited Tom Inglesby, an infectious diseases doctor, and Monica Schoch Spana, a medical anthropologist, early on as well. Though Henderson and his colleagues began to see the old taboos against discussing biodefense waning, it was still a shock when, in February 1999, nearly 1,000 people accepted the center’s invitation to attend the first of its kind National Symposium on Medical and Public Health Response to Bioterrorism, a two day conference cosponsored by the center, HHS, and the Infectious Diseases Society of America. Some who wanted to attend had to be turned away for lack of space.30 Donna Shalala, Secretary of HHS, told the assembled group of Congressional staff and medical, public health, government, intelligence, and military experts that, with bioterrorism, “the

14 Building Civilian Preparedness and Readiness public health and medical communities stand directly on the front lines. How well we respond to a threat or attack will depend on the preparedness of our public health and medical communities.”31 She also announced President Clinton’s proposed increase of $72 million in funding to HHS for bioterrorism preparedness.31

As interest in the medical and public health communities began to build, the center also began hosting professional conferences to describe the threat of bioterrorism, discuss medical care for smallpox or anthrax patients (diseases that had been encountered by only a handful of practicing physicians), and recommend policies to guide the roles and responsibilities of health professionals in the aftermath of a bioterrorist attack.

Around that time, the Journal of the Most policymakers did not American Medical Association (JAMA) began understand how a publishing a series of center led papers on the bioterrorism attack would medical and public health management of the unfold, the responses that principal biological threat agents, beginning would be required, or the with anthrax and smallpox and followed by decisions that leaders would have to make. papers on plague, botulinum toxin, tularemia, and viral hemorrhagic fevers.32-37 The guidelines for medical and public health management of each agent were developed in consensus with experts convened by the center, in what became known as the Working Group on Civilian Biodefense. The 1999 guidance for anthrax developed by this group became foundational for clinical management of the 2001 anthrax attack victims. Much of what this working group anticipated for such an event was substantiated during the response to the 2001 anthrax attacks. New

15 Preparing for Bioterrorism information gained from that experience led to additional, updated clinical guidance on anthrax from the working group in 2002.38

Yet in 1999 and 2000, before the value of these efforts was widely recognized, funding the center’s activities proved difficult. Even though infectious disease experts and concerned government officials were encouraging, the center’s mission was too security oriented for traditional health foundations and too health focused for those concerned about security. Civilian biodefense was not yet a professional field of practice.

That changed after Gomory heard a US government presentation in the fall of 2000 that he said “didn’t add up.”1 In that presentation, an official described the national strategy to defend against a bioterrorist attack as one reliant on developing a vaccine from scratch after an attack a process that typically takes many years and mobilizing to administer the vaccine broadly. Observed Gomory, “That didn’t look to me like a ‘defense.’ And it was pretty clear that the [weapons] could be deadly.”1 When he learned of Henderson’s center, Gomory asked for a meeting in New York. That meeting resulted in a relationship that lasted more than a decade, during which time the Sloan Foundation provided substantial support for the center’s work. In making its first biosecurity grant to the center, Gomory said that he hoped to “catalyze the creation of a national program of civilian biodefense.”39

In the history of the Sloan biosecurity program, the relationship between the foundation and the center, the recipient of its largest total grants, was unique. Gomory considered the advancement of a center devoted to biosecurity as one of the most successful accomplishments of the Sloan program.1 It allowed a group of people passionate about the problem of bioweapons to work full time on solutions. A dedicated center could employ

16 Building Civilian Preparedness and Readiness a variety of methods and approaches to influence policymakers, inform the public, and achieve Gomory’s desired goal of a prepared nation. “You want to give grants to people who want to get there,” Gomory said, “not to people who don’t have their hearts in the effort. It was obvious D. A. really wanted to get there.”1

The Sloan grant allowed the center to more than double the size of its staff, adding scientists, physicians, and other experts to pursue biodefense and public health policy work as their profession. In 2003, the center was recruited by UPMC (the University of Pittsburgh Medical Center) to collaborate with the UPMC healthcare system and the University of Pittsburgh Schools of Medicine and Public Health. In 2012, it is still the largest and longest serving think tank focused on biosecurity. Many projects undertaken by the center over the years have focused on improving preparedness, but the center has also addressed many of the same issues in biosecurity that were of concern to the Sloan Foundation: responsible stewardship of biological research (chapter 4), pandemic influenza preparedness (chapter 9), business preparedness (chapter 6), disease surveillance (chapter 8), and protecting building occupants from bioterrorism (chapter 7).

One barrier to advancing civilian preparedness was that most policymakers did not understand how a bioterrorism attack would unfold, the responses that would be required, or the decisions that leaders would have to make. To overcome that, one of the first projects the center embarked on was the tabletop exercise Dark Winter, held at Andrews Air Force Base in the summer of 2001. In that exercise, former senior government officials played the roles of members of the White House National Security Council reacting to a fictitious smallpox attack in the United States. The center designed, wrote, and produced

17 Preparing for Bioterrorism the scenario in collaboration with Analytic Services, Inc. (ANSER), the Center for Strategic and International Studies (CSIS), and the Oklahoma National Memorial Institute for the Prevention of Terrorism. The exercise demonstrated fundamentals of epidemiology and emphasized that if a contagious disease such as smallpox is not contained with public health measures, including vaccination, it will continue to spread.40

Dark Winter also made obvious the limited options for response available to leaders. As a result of the exercise, the participants learned that they wanted more situational awareness of the attack and its consequences such as the numbers of sick and dead people and the locations of hospitalized survivors but the fragmented US healthcare system was not networked to provide such data. They also learned that hospitals and public health departments would be central to the response, but they were poorly resourced to handle a surge of patients. Smallpox vaccine could probably protect against death and possibly disease if administered within three days of exposure, but stockpiles were grossly insufficient to stop an epidemic.35

Former Senator Sam Nunn, who played the US president during the exercise, showed how important leadership would be in a crisis when he observed that “the federal government has to have cooperation from the American people. There is no federal force out there that can require 300 million people to take steps they don’t want to take.”40 Dark Winter was the first exercise of its kind, and it prompted both a Congressional hearing and increased concern about US preparedness.40

That the American public could have a positive, consequential role in the disaster planning and response is now backed by empirical evidence; has been affirmed by the US president,26 the director of the Federal Emergency

18 Building Civilian Preparedness and Readiness

Management Agency (FEMA),25 and other government officials; and seems completely obvious today. However, today’s view of the public’s role represents a sea change in attitude. When the center began its work, many policy leaders and major planning documents viewed the public as a problem to manage, even as a “panicky mob” that would engage in antisocial, violent actions that the government had to be able to anticipate.24

Since its inception, the center has done a significant amount of work demonstrating that this view of the public is wrong. These efforts have been led by medical anthropologist Monica Schoch Spana. Schoch Spana directed the February 2003 conference The Public as an Asset, Not a Problem: A Summit on Leadership During Bioterrorism, which she followed with several scholarly articles, a series of workshops, and publication of the handbook Leading During Bioattacks and Epidemics with the Public’s Trust and Help: A Manual for Mayors, Governors, and Top Health Officials.41 The manual provided government leaders with guidance on anticipating and averting governing pitfalls that arise during epidemics and best practices for safeguarding the public’s trust and cooperation. The center Many leaders viewed the distributed 10,000 manuals to the offices of public as a problem to manage, a “panicky mob” that would mayors, governors, county executives, and engage in antisocial, violent public health departments nationwide. The actions that the government manual was endorsed by the US Conference of had to anticipate. Mayors’ homeland security task force and the American Public Health Association. Building on this momentum, in 2007 the center convened a blue ribbon panel for the Working Group on Community Engagement in Public Health Emergency Planning to advise elected officials and health and safety authorities on why and how to involve the community

19 Preparing for Bioterrorism in disaster related policymaking.42 The report’s principles and practices are reflected in the 2008 national guidance to health departments on engaging vulnerable populations in pandemic flu planning,43 the 2009 National Health Security Strategy,44 and CDC’s 2011 public health preparedness grant guidance and performance measures for state and local health departments.45

The center has specialized in convening experts and facilitating in depth discussion to address problems in preparedness. For example, in 2005 the center partnered with the WHO Communicable Disease Surveillance and Response Office in Lyon, France, to bring together experts in biosafety, infectious diseases, public health, and the biosciences to discuss challenges presented by the 2003 SARS outbreak and the growing threat of H5N1 influenza.

Center experts have provided real time advice to government and health leaders during infectious disease crises, such as the 2003 SARS epidemic and the 2009 H1N1 pandemic, and have worked to transform the lessons observed during an event into policies beneficial for the next infectious disease emergency. In March 2012, after the 2009 influenza pandemic subsided, the center convened a meeting in Washington, DC, that invited leaders to review the most important medical and public health lessons learned from the experience with the pandemic and to consider policy implications for future outbreaks.46 Over the years, the center’s staff has published dozens of scholarly analyses of issues ranging from medical countermeasures to building safety and policy papers on topics ranging from legislation affecting public health to laboratory security. They have provided Congressional testimony, instituted a Congressional seminar series on biological and nuclear security with the Senate Caucus on WMD Terrorism as an honorary co host,

20 Building Civilian Preparedness and Readiness and provided real time expert advice to Congressional staff. The center’s crosscutting analysis of the federal budget for civilian preparedness, published annually since 2001, has been the only analysis of its kind and is relied on by government agencies and the media.47

The center has also nurtured biodefense as a professional field. From 2001 through 2009, the center hosted nearly thirty dinner meetings that invited members of the biosecurity community (policymakers, scientists, medical and public health officials and practitioners) to meet informally for expert presentations and off the record discussion of important and cutting edge issues. The staff published Biodefense Quarterly, which kept approximately 2,000 subscribers apprised of factual biodefense information, and offered summer courses in biodefense at the Johns Hopkins School of Public Health.

In 2003, the center teamed with Mary Ann Liebert, Inc., to create the peer reviewed journal Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science to provide the first forum for scholarly publication in the field and to advance knowledge and practice.4 Center for Biosecurity staff have editorial responsibility for the journal, which ranks in the top ten journals in the world in international relations. With Sloan support, the center also publishes an electronic daily newsletter, Biosecurity News Today, and the twice monthly Clinicians’ Biosecurity News, both designed to keep the biodefense community and medical and public health communities up to date on developments in the field.

As the field of biosecurity has grown, a number of subspecialties have emerged. In response, the center has increasingly convened large meetings that bring together members of those subspecialty communities to exchange information, identify priorities, and set goals. As an example, for the October

21 Preparing for Bioterrorism

2011 Sloan funded meeting, Charting the Future of Biosecurity, the center invited federal officials, top scientists, private sector executives, members of the press, and other influential leaders in the field to take stock of the progress made in biosecurity since 2001 and recommend priorities for the decade ahead.

Sloan Foundation support has allowed the Center for Biosecurity to address an array of topics that constitute biosecurity and civilian biodefense. It has helped the center be nimble able to respond quickly to events and provide critical information and consultation in real time and has provided stability when center experts have gone on to serve in government. D. A. Henderson was asked to establish the HHS Office of Public Health Preparedness shortly after the 9/11 attacks, and the center’s second director, Tara O’Toole, was appointed DHS Under Secretary for Science and Technology in 2009. Center alumni have gone on to serve important roles in the FDA, HHS, DHS, DOD, and the Intelligence Advanced Research Projects Agency (IARPA).

Throughout its history, the center has conducted independent research and analysis, convened professional groups to address complex problems, and engaged the government policy community, all in service to its mission of increasing resilience to biological threats. Sloan Foundation support has allowed the center to remain an independent voice calling for action and needed changes in civilian preparedness.

22 Building Civilian Preparedness and Readiness

Showing Americans How to Prepare for Terrorism

The Advertising Council’s READY Campaign

Where can people find information about how to protect their families after a terrorist attack? According to focus research conducted in July 2002,48 people were anxious about terrorism but did not know what to do or how to create emergency preparedness plans for themselves and their families.48 That research, conducted by the Advertising Council (Ad Council) and funded by the Sloan Foundation, found that Americans were “hungry for leadership and action, to be told what to do to be more prepared, to be assured that this preparedness can make a difference” and “to take responsibility upon themselves.”48

The public’s desire for preparedness information prompted three way collaboration among the Ad Council, the Sloan Foundation, and the White House Office of Homeland Security to produce a multimedia public education campaign. The READY campaign was developed in just seven months and formally launched in February 2003.

The Ad Council was a logical choice. This private nonprofit organization conducts more than twenty such campaigns each year with various federal

23 Preparing for Bioterrorism

agencies, and their campaigns are memorable: “Friends Don’t Let Friends Drive Drunk,” “Take a Bite Out of Crime,” and “A Mind Is a Terrible Thing to Waste” are instantly recognizable, and one of their first, “Loose Lips Sink Ships,” is iconic of the WWII era.49

The READY campaign encouraged people to take simple, life saving actions, such as making an emergency supply kit, creating a family communication plan, and becoming informed about different types of terrorism they might face. According to Kathy The READY campaign Crosby, the Ad Council’s senior vice president encouraged people to take simple, life saving actions. and group campaign director at the time, and now director of health communication and education at the FDA Center for Tobacco Products, “The point we were trying to make was that until help arrives, you’re your own first responder, so be there to protect your family.”50

The campaign took its name from remarks by Tom Ridge, then secretary of the fledgling DHS, recalled Crosby: “One of the very first things we heard him say was, ‘Terrorism forces us to make a choice. We can be afraid. Or we can be ready.’”50 That became the signature line for the campaign, which Ridge formally launched on February 19, 2003.51,52

The campaign brochure, “Preparing Makes Sense. Get Ready Now,” summarized the threats from biological and chemical weapons, nuclear blasts, radiation discharges, and dirty bombs.53 It offered sensible, straightforward advice, such as: “While there are many things that might make you more comfortable, think first about fresh water, food and clean air,” and “Consider two kits. In one, put everything you will need to stay where you are and make it on your own. The other should be a lightweight, smaller version you

24 Building Civilian Preparedness and Readiness can take with you if you have to get away.”53 Other campaign components included a website (http://www.ready.gov), TV and radio public service announcements (PSAs), and a toll free phone number (1 800 BE READY) that people could call for information.

The READY campaign became one of the Ad Council’s most successful campaigns. When it debuted, it generated more than 1,700 media stories.54 More than 2.8 million brochures were downloaded from the campaign’s website during its first ten months online.54 In addition, the Ad Council secured a commitment of $17 million in outdoor advertising for the campaign and $90 $100 million in space for a shortened copy of the brochure in the Yellow Pages.54 In the first six weeks after launch, there was $4.2 million in donated media. More than 100 million people had seen or read about the READY campaign within the first ten days of the launch.54

Public awareness of the campaign’s messages peaked at approximately 70 percent between April and June 2003. Between February 2003 and February 2004, a behavior shift occurred as the proportion of Americans who stocked emergency supplies climbed from 26 percent to 33 percent. Those who created a family emergency plan increased from 17 percent to 27 percent. Among parents with children younger than eighteen years, the number who prepared jumped from 28 percent to 40 percent. Finally, those who remembered a READY PSA were much more likely to have stocked emergency supplies, made a family emergency plan, and searched out more information on preparedness.54

As years passed with no subsequent attacks on US soil, the READY campaign’s mission changed. After Sloan funding ended in 2003, and as DHS took over, the campaign evolved to address all types of emergencies,

25 Preparing for Bioterrorism from terrorism to natural disasters. Today, its three primary audiences are the general public, businesses, and schools. Information presented on the READY website has been translated into twelve languages. At the same time, more than a decade after 9/11, Americans have slacked off in personal preparedness.50 “We’ve seen a flattening of the behavioral metrics,” Crosby said. “Complacency has set in. We’re still trying to figure out how to break through that. Unless the problem goes away, there will always be a need to get the preparedness message out there.”50 The national READY campaign is still going strong, though, and has inspired other groups to carry its messages forward; those groups include the Boy Scouts and Girl Scouts of America, both of which now have emergency preparedness badges.54,55

The Sloan Foundation’s early work in the wake of the 9/11 attacks paved the way for this ongoing civilian awareness initiative. As Crosby explains:

Sloan recognized in 2002 that there was a window of opportunity because there was not yet a formal DHS, so there was no funding for public education. They saw a void in the market and they were willing to put themselves and the Sloan Foundation out there to solve the problem. They had the utter belief that the Sloan Foundation could and should make a difference in preparedness.50

Major General Bruce Lawlor, Ridge’s chief of staff, concurred, when he told the New York Times in February 2003 that “the foundation has been absolutely essential to what we did.”56

26 Building Civilian Preparedness and Readiness

A Learning and Exchange Forum for Big City Emergency Managers

The Council for Excellence in Government’s Forum for Big City Emergency Managers

Part of a city emergency manager’s job description is planning for hurricanes, tornadoes, earthquakes, blackouts, terrorism attacks, and just about any other type of disaster imaginable. In big cities, though, the job is even more complex. If a storm surge hit New York City, for example, it could displace millions of people. Where would they go? Depending on the size of the storm, it could take months, even years, to repair all the property damage. FEMA could provide trailers for temporary housing, but they are designed to be placed ten households per acre, and Manhattan is about twenty times more densely populated.57

Given the unique disaster planning needs of big cities, it made sense for their emergency managers to have a way to compare notes and share best practices. Recognizing that, the Sloan Foundation sponsored a first of its kind meeting in October 2004 for the emergency managers of Los Angeles, Chicago, New York, and the District of Columbia to gather and have an opportunity to speak frankly about the demands and challenges of their jobs. That successful first meeting led the foundation to provide funding for the

27 Preparing for Bioterrorism

Council for Excellence in Government to formalize over two years a “learning and exchange forum” for big city emergency managers. When the first forum was held in Washington, DC, in 2005, participants addressed public preparedness plans and campaigns, critical infrastructure protections, and mass warning systems.

The emergency managers found the exchange valuable, said Lynn Jennings, then executive vice president of the Council on Excellence in Government: “The cities are the cutting edge in how they approach emergency management, and how they leverage resources. Learning from one another really serves them well.”58 The Big City Managers group also opened a channel through which DHS could connect with big cities vulnerable to attack. Once the Sloan funding ended, management of the group transitioned to an independent, nonprofit organization called Big City Emergency Managers, Inc. (with Lynn Jennings as executive director of the new organization).

BCEM is now composed of fifteen jurisdictions that represent almost 30 percent of the nation’s population.59 The group’s mission is to support emergency management operations in the nation’s largest, most at risk metropolitan jurisdictions, so the country is better able to prevent, protect against, mitigate, prepare for, respond to, and recover from major incidents and catastrophic emergencies. They receive no government assistance, relying instead on corporate partners that include Target, ESRI, Sprint, and ICF.59 When BCEM meets twice a year, the group is briefed about major events that have occurred. For example, the Washington, DC, emergency manager has given a detailed presentation on the 2008 inauguration, and the New York City manager has briefed the group on the 2009 emergency landing of an airplane in the Hudson River. Participants also share details of new projects:

28 Building Civilian Preparedness and Readiness

Joe Bruno, emergency manager for New York City, presented the city’s 2007 competition for the best post disaster urban housing designs, which was initiated in recognition of the inadequacy of FEMA trailers.57

“Learning what’s new and innovative makes this meeting worthwhile to the participants,” explained Lynn Jennings. Particularly in times of budget shortfalls, the participants need creative ideas about how to sustain programs and build energy around them. As far as the emergency managers themselves, added Jennings, “They are so committed to what they do, it makes a huge difference.”58

A Framework for Mass Casualty Response

George Washington University’s MaHIM System

When Robert Stevens, a photography editor for a Florida tabloid, died of inhalational anthrax on October 5, 2001, his death was initially declared an isolated incident.60,61 That judgment was quickly proven wrong as additional anthrax filled letters were mailed to the offices of news media outlets and two US senators. After hearing the news, Joseph Barbera, co director of the Institute for Crisis, Disaster, and Risk Management at George Washington University (GWU), activated the Washington, DC, Hospital Association communications system. Daily conference calls were held for clinicians

29 Preparing for Bioterrorism

and health authorities to discuss patient care, the value of nasal swabs in diagnosing anthrax, patient response to treatment, and resources that would be needed if the number of victims grew.23 Although hospitals and public health departments were overwhelmed at the time, the anthrax event was mostly over within two months. In all, five people died of inhalational anthrax, eleven others recovered, five were treated for cutaneous anthrax, and 32,000 people were prescribed antibiotics.62,63

During those two months, according to Barbera, “there was a lack of any understanding of how to organize and how to manage a major incident that crossed multiple jurisdictions and multiple disciplines.”64 Barbera thought pre event organization would have made delivery of health care go more smoothly.

Because plans were not already in place, Barbera noted, public confidence in authority was undermined. This was evident in the public’s response to the nasal swab tests and to the provision of ciprofloxacin (cipro) to Capitol Hill staff but not to Brentwood postal workers. Pre event organization would The CDC directed care of the postal workers have made delivery of health care go more smoothly. and did not recommend the nasal swab test because it was thought to produce misleading results; CDC recommended the antibiotic doxycycline because it was as effective as cipro and more readily available. Although both approaches were based on scientific evidence, some attributed the differences to a double standard: An anonymous government official remarked that “it became an issue of poor black folks versus rich white folks.”23

After the anthrax attacks, getting hospitals and the public health system better prepared became a federal priority, which led to the 2002 launch of

30 Building Civilian Preparedness and Readiness the Hospital Preparedness Program (HPP). The HPP is an HHS initiative to improve surge capacity and hospital preparedness for public health emergencies. At the same time, the Sloan Foundation funded Joe Barbera and his GWU colleague Anthony G. Macintyre to develop the Medical and Health Incident Management (MaHIM) system, a project designed to help hospitals improve their emergency planning.

MaHIM so named to evoke the word mayhem, which describes Barbera’s and Macintyre’s assessment of the medical and public health response to the 2001 anthrax attacks was designed as a framework for mass casualty response. The MaHIM planning system describes each operational function that emergency management and the public health and medical sectors must address to manage mass casualty incidents. Barbera and Macintyre extrapolated from business management principles in conceptualizing MaHIM. They also built on the principles of incident command used to create a flexible organizational framework to help people who do not normally work together to cooperate in an emergency. First responders know incident command systems well. MaHIM described a structure that could take hospitals from an organic reaction to public health emergencies to proactive planning in which specific emergency hospital functions were identified and planned for in advance.65

MaHIM provided the intellectual foundation for the Medical Surge Capacity and Capability (MSCC) Handbook, which was funded and endorsed by HHS.66 The handbook describes six tiers of emergency management for individual hospitals through the federal government. The handbook was published in 2004, updated in 2007, and is still widely used by hospital planners.

31 Preparing for Bioterrorism

Hospitals are much better prepared for emergencies in 2012 than they were in 2001. By providing more than $4.5 billion to hospitals since its inception, the HPP has been the main impetus for improvement.67 One of the most significant developments has been the nationwide formulation of healthcare coalitions, which have improved collaboration and networking among individual hospitals as well as among hospitals, public health departments, and emergency management and response agencies.68 But progress remains uneven, and there is more work to be done. Barbera described the remaining need: “The one thing we don’t have to worry about in the United States is having intelligent, knowledgeable public health personnel and medical personnel. What we need is a system that allows them to maximize their capabilities.”64

Children as Targets of Terrorism

Center for Disaster Preparedness Guidelines

Just weeks after the September 2004 Beslan massacre, in which Chechen separatists targeted a Russian school and killed 186 children, there were reports of a computer disk found in Iraq that contained building layouts and security plans for American schools in California, Florida, Georgia, Michigan, New Jersey, and Oregon.69 Until that time, targeting children was unheard of.

32 Building Civilian Preparedness and Readiness

They were seen as the unfortunate collateral victims of terrorism, not the targets. A shift to targeting children could cause widespread societal grief and reverse even the staunchest national “no negotiation” policies.

In 2005, in light of this emerging, unthinkable threat, the National Center for Disaster Preparedness (NCDP), under the direction of Irwin Redlener, received a grant from the Sloan Foundation to develop preparedness models, guidelines for emergency responders, and treatment protocols to address the unique physical and emotional needs of child targets of a terrorist attack. NCDP is housed at the Columbia University Mailman School of Public Health and is an academically based interdisciplinary research and policy analysis center focused on the nation’s capacity to prevent and respond to terrorism and major disasters.

“In 2001, we had awoken to the specter of terrorism as a real potential in our lives,” said Redlener, a pediatrician and principal investigator for the Sloan funded study. “Whatever distance we were mentally keeping [from thinking about tragedy] … was shattered. And once that door was opened, what else could happen?”70

During the six month project, NCDP staff reviewed national, state, and local laws pertaining to children and terrorism and assessed the potential for violence at child centric destinations, such as schools, playgrounds, buses, colleges, and universities. They met with legislators whose committee memberships placed them in influential positions for this issue and with officials at the US Department of Education and the New York Police Department (NYPD). NCDP also hosted an October 2005 meeting, Working Group on Children as Intended Targets of Terrorism, in which participants discussed prevention and preparedness for child targeted terrorism and

33 Preparing for Bioterrorism

health system response. The report from the meeting concluded that current medical and public health systems were not prepared for an attack on children and suggested that several important steps be taken to remedy that situation. The authors called for enhanced security at child centric facilities People don’t like to think and for training to teach first responders how about it or plan for it, but to recognize and treat the unique effects of children are highly violence and terrorism on children. The report vulnerable. also noted the need to determine the most efficient treatment models for post traumatic stress disorder in children.70 Redlener distributed the findings to members of Congress, the White House, and experts in the intelligence community.71

Children make up 25 percent of the US population.72 Concern about whether the nation was prepared for an attack that targeted them prompted formation of the bipartisan National Commission on Children and Disasters, which was appointed in 2008 by President George W. Bush and established under the Kids in Disasters Wellbeing, Safety, and Health Act of 2007.72 In 2010, the commission completed its work, issuing a report on major deficiencies in emergency preparedness for children.72

Redlener, a member of the commission, had hoped to establish a dedicated program focused on children as targets of terrorism, but he encountered many obstacles: “There’s a reflexive aversion to the topic,” he explained. “People don’t like to think about it, and people don’t plan for it. Children are still highly vulnerable.”70

34 Building Civilian Preparedness and Readiness

Preparing the Disability Community for Disaster

The National Organization on Disability’s Emergency Preparedness Initiative

Two months after the 9/11 terrorist attacks, the National Organization on Disability (NOD) launched the Emergency Preparedness Initiative (EPI). Before that, NOD had focused on employment and education issues in its mission to promote access in all aspects of life for the fifty four million disabled Americans.73 Even though there had been a great deal of progress at that point, “9/11 woke people up to the reality that for people with disabilities, the opening of access they had been experiencing might close in a moment during a disaster,” according to Elizabeth Davis, EPI’s first director and current director of EAD & Associates, LLC.74

EPI had a two fold purpose. First, it aimed to bring people with disabilities into the emergency planning process to offer their insights, direct knowledge, and resourcefulness. Second, EPI sought to ensure that the needs of people with disabilities would be addressed in a disaster. If first responders could make effective decisions during a crisis, then the effects of a disaster could be minimized.75 “Individuals with disabilities have to be problem solvers and creative solution finders on a daily basis, overcoming barriers and finding

35 Preparing for Bioterrorism

solutions so the next person doesn’t experience what they went through. Well, why not bring that same moxie into emergency management?” asked Davis.74 But first, people needed information.

A 2003 2004 Sloan Foundation grant met that need by providing NOD the funding to build the EPI website that was launched on July 15, 2003. The website featured new research and government reports on emergency preparedness for people with disabilities, information about useful equipment and technologies, an electronic bulletin board to encourage information sharing among emergency management planners, and video clips that demonstrated best practices in areas such as special needs planning, evacuation techniques for people with 9/11 woke people up to the reality that, for people with disabilities, disabilities, and other relevant topics. the opening of access they had The website was designed for the been experiencing could close disability community and as a resource in a moment during a disaster. for emergency planners and the disaster response community. “The publications turned out to be wildly successful, not just with advocacy organizations and people with disabilities, but with community outreach officers in emergency management and with partner organizations that had a role in disasters, such as local Red Cross chapters,” observed Davis. “It penetrated to stakeholders from both sides of the community, which was part of EPI’s original goal.”74

EPI continued to advocate for the inclusion of people with disabilities in planning for all phases of the disaster lifecycle. The organization’s goal was to promote consideration of the disability community in general so, for instance, disaster engineers and architects would be able to design and rebuild fully accessible buildings during the recovery and rebuilding phase of

36 Building Civilian Preparedness and Readiness a disaster. “If you have a destructive event, whether natural or man made, and you need to completely rebuild, then you should embrace the opportunity to build back better than what it was before,” said Davis, “and this includes making the built environment accessible for all people.”74

Indeed, as a testament to the success of the initiative, in 2011 the Emergency Preparedness Initiative spun off and was launched as a self sufficient 501(c)(3) not for profit organization called EPI Global. Elizabeth Davis is on the new organization’s board of directors. More work is needed to improve preparedness for people with disabilities, but by building on the successes of EPI under NOD, EPI Global hopes to find renewed commitment of support as it expands its program areas.

Organizing Medical Volunteers for Disaster Response

The Civilian Medical Reserve Corps

The Medical Reserve Corps (MRC) recruits, manages, trains, and activates medical professionals and other volunteers for disaster response duty. Today, there are more than 200,000 MRC volunteers coordinated by the HHS Office of the Surgeon General. During disasters such as Hurricanes Gustav and Ike

37 Preparing for Bioterrorism in 2008, MRC volunteers have administered tetanus shots and performed medical evaluations; in nonemergency times, they have volunteered at health fairs to perform hypertension screening and give flu shots. Now celebrating its ten year anniversary, the MRC was launched as a demonstration project in July 2002,76 but it was born in the immediate aftermath of the 9/11 terrorist attacks.

On the day of the attacks on the World Trade Center, Dr. Richard Hatchett was working at the Memorial Sloan Kettering Cancer Center’s emergency room for cancer patients. The next day, he and many other medical professionals in New York City made their way downtown to see if help was needed at the various triage posts that sprung up spontaneously around Ground Zero. Eventually, Hatchett made his way to Stuyvesant High School, four blocks from where the towers stood.

The medical volunteers at Stuyvesant kept pace with the fast moving events in the days after 9/11. As the number of volunteers grew, so did the size and organization of the small triage area established in the lobby of the high school. When tractor trailer trucks started delivering supplies, the group created a supply depot. When volunteers came to feed rescue workers, the group set up a cafeteria area. And when massage therapists with massage beds showed up, the medical volunteers found a place for them to work. When narcotics and other valuable medicines arrived, the group developed its own volunteer security force for what came to be known as the “Stuyvesant Triage Center.” Hatchett described the situation as “a constant influx of resources and material,” and said that he “was running around making sure that everyone had what they needed to keep the thing functional.”77 The New York

38 Building Civilian Preparedness and Readiness police and fire departments and the Office of Emergency Management were present but too busy to provide oversight or direction.

Hatchett recalled that “people were traumatized, but the ability to do something productive and as part of a group was transformational. Even though it was so desperately sad and terrible, the work we were doing together was also life affirming. These people who did not know each other drew together and turned Stuyvesant into a four floor field hospital overnight.”77 There were no survivors who needed care, so the volunteers took care of the medical needs of the search and rescue workers: They maintained the eye washing stations necessary because of the dust and debris in the air, they treated minor injuries, and they provided care to responders who developed respiratory problems and chest pain.

The organic volunteer effort was a success, but there were challenges. Specifically, Hatchett notes, there were security, credentialing, and organizational issues, as well as problems in communicating with official responders. This prompted him to e mail several Stuyvesant volunteers later that month to say “that if the other shoe drops and this happens again, we need to be better organized.”77 The group started meeting and came up with the idea of creating a civilian MRC that would be able to connect with the official government response.

Soon after, Hatchett was introduced to the Sloan Foundation’s Gomory and Olsiewski, who gave him a small grant to defray the expenses of developing the MRC concept. That funding allowed the group to move its work space from a bar to an office in the New York University math department. There the group developed its proposal for a Civilian Medical

39 Preparing for Bioterrorism

Reserve Corps. When it was finished, Olsiewski helped to bring the concept to the appropriate people in Albany and Washington, DC.

At that point, Hatchett was receiving some “tacit pressure” at work to wrap up his volunteer activities so he could take on increased clinical responsibilities. When he got the message not long after that the vice president’s office was on the phone, he just People were traumatized, but the ability to do something assumed it was an executive of the Memorial productive and as part of a Sloan Kettering Cancer Center. It wasn’t. A group was transformational; representative of the office of Vice President the work we were doing Dick Cheney was on the phone, inviting together was life affirming. Hatchett to Washington, DC, to brief the project to high level officials. After President Bush mentioned the project in his 2002 State of the Union address, the civilian MRC was launched. The corps “creates a highly distributed capability that communities have used,” explained Hatchett, “and the more they use it, the more it becomes part of local community response capability.”77

The project had significant professional consequences for Hatchett, who was invited to embark on a career in government to help establish a national MRC. Now he is chief medical officer and deputy director at BARDA, the agency that develops and purchases the vaccines, drugs, therapies, and diagnostic tools that are needed for public health medical emergencies, including bioterrorism.

Although Hatchett thinks we are much better prepared for emergencies than we were ten years ago, he also thinks misinformation about communities’ reactions to crisis still abounds. “Communities respond in a very affirmative way to disasters,” he explained, and because governments

40 Building Civilian Preparedness and Readiness often fear the eruption of disorder, they often “create the crisis they are most afraid of by clamping down on spontaneous community action.” If governments were to both understand and leverage that response, claimed Hatchett, “we could have much better use of spontaneous volunteers. The more structure there is in which to receive and accommodate volunteers, the better off we are.”77

41 CHAPTER 2

Organizing to Counter Bioterrorism

One of the biggest challenges may be forging working partnerships among groups and professionals who interact only rarely, if at all.

iological weapons have often been grouped with other nontraditional but unrelated security threats. In the 1950s, biological weapons were commonly grouped with chemical and radiological threats (CBR) or B 78 nuclear and chemical threats (NBC). More recently, biological weapons have been categorized as weapons of mass destruction (WMD), along with nuclear, chemical, and radiological weapons (dirty bombs).79 Although lumping together these very different methods of attack may be useful in some ways for example, they are all threats to civilian populations doing so can also be misleading because preventing and/or responding to these dissimilar threats requires vastly different approaches, expertise, and organization.28 Yet, even

42 Organizing to Counter Bioterrorism as the US government was expanding its efforts in bioterrorism preparedness after 2001, the distinct challenges and requirements of bioterrorism were not generally understood.80 Without that understanding, US government preparedness would falter. In contrast to “lights and sirens” events, an act of bioterrorism could take days to declare itself, remaining undetected until the sick began to present in doctors’ offices and emergency rooms. The scale of an anthrax attack, for example, could range from focused and limited, as happened with the letters used in 2001, to a wide area dispersal, as would happen with an aerosol release.11 The aftermath could unfold for an unpredictable number of days or weeks, with the number of casualties rising over time. Victims could be geographically dispersed, spreading over an area of unpredictable boundaries. Attributing a bioterrorism attack could be difficult: It took years to attribute both the 2001 anthrax attack81 and the 1984 salmonella salad bar attack in Oregon.82 Preparedness requires attention to numerous factors and variables, including the unique characteristics of the many biological agents that could be used as weapons.83

Complicating preparedness further is that it requires coordination across many government agencies and the collaborative effort of experts from many different professions. As a result, one of the biggest challenges may be that of forging and maintaining numerous working partnerships among groups and professionals who may interact only rarely, if at all.28,84 For biopreparedness and response, medical and public health professionals have to coordinate; homeland security, the FBI, and local law enforcement have to cooperate; and public and private entities have to collaborate all have expertise relevant to biopreparedness. Longstanding tensions have to be overcome, such as

43 Preparing for Bioterrorism

those between security and law enforcement and between healthcare and public health. A good example: Disease outbreak investigation, an important function of public health, cannot be carried out without information about where infected people have been and who they have been with. People may not want to provide information if doing so could reveal criminal activity or illegal immigration status to law enforcement officials, even if they are interested only in identifying the source of a biological attack. Many such concerns have to be addressed.

This chapter describes key Sloan Foundation funded projects that fostered new thinking about and organizational approaches to bioterrorism preparedness. One was a 2003 workshop Preparing for bioterrorism is that gathered experts and leaders from an ongoing process that various parts of the US government and requires sustained attention and funding, continuous work, academia and provided them the time and persistent monitoring. and space needed to think through the challenges of biopreparedness and then identify and assign essential roles and responsibilities. Sloan also funded two important international scenario exercises, Atlantic Storm and Black ICE, that helped world leaders understand the ways in which large scale bioterrorism differs from other, more familiar types of terrorism and crises. In those exercises, leaders had to build new partnerships among nations and had to facilitate cooperation between security and health agencies to stem the dangerous disease outbreaks threatening their countries. The groundbreaking research on Aum Shinrikyo that Sloan funded yielded important new information about how and why a terrorist organization would turn to bioterrorism, which, in turn, informed counterterrorism. Finally, Sloan

44 Organizing to Counter Bioterrorism provided seed money for the WMD Center, whose members examined the progress of US bioterrorism preparedness from 2001 to 2011 and issued a report card that called the attention of Congress and the national media to areas where more effort and greater investment were needed.

All of these efforts, along with the work of many others in the field, helped advance bioterrorism preparedness in the decade after the anthrax letter attacks in 2001. All demonstrate that preparing for bioterrorism is an ongoing process that requires sustained attention and funding, continuous work, and persistent monitoring to ensure that improvements are made.

Coordinating Federal Government Responsibility for Bioterrorism

The Wye River Workshop

Responding to a biological attack is not the job of just one government agency. Instead, at the federal level, many agencies and departments may have a role in response: CDC, DHS, DOD, EPA, FDA, HHS, NIH, and the Departments of Agriculture (USDA), Commerce (DOC), Justice (DOJ), and State (DOS). Not surprisingly, their responsibilities overlap.47,85

45 Preparing for Bioterrorism

The organizational challenges in coordinating bioterrorism preparedness across all of these government entities are formidable, as was noted by Richard Danzig, former secretary of the Navy and a scholar on civilian biodefense, in his 2003 report Catastrophic Bioterrorism What Is To Be Done? In that report, Danzig described US government agencies as operating “now like independent fingers, each poking at a problem, while the hand is unable to grasp the task in totality.”86 David Franz, former commander of the US Army Medical Research Institute of Infectious Diseases (USAMRIID), was concerned as well. Both were well aware of the complexities of bioterrorism preparedness and the ways it differs from preparedness for a natural disease outbreak or other types of terrorism. To describe one of the essential differences, Danzig articulated the idea of “reload.”

When we talk about terrorists’ acquiring a nuclear weapon, we’re talking about just that they’re acquiring a weapon. . . . With biological weapons, we’re talking about acquiring the ability to produce weapons. So if you acquire the ability to produce 100 grams of anthrax, you can keep doing that. You really have to think about biology as potentially the subject of a campaign, where somebody keeps attacking, rather than a one shot incident.8

In other words, if one bioweapon attack is detected, it should be assumed that others either have occurred or may occur.86 Effective planning depends on thorough examination of such matters as reload to create what Danzig calls “a common, systemic, operational understanding” of how to respond.86

Accomplishing the intergovernmental coordination necessary to identify and think through those types of problems has been extraordinarily difficult.

46 Organizing to Counter Bioterrorism

Danzig and Franz thought that experts and officials needed face to face meeting time for in depth, off the record discussions in which they could think together about the new challenges of bioterrorism and the best courses of action. Leaders of government agencies could agree on how to frame problems, identify sources of expertise, and set collective priorities.

In October 2003, Danzig and Franz convened a two day Sloan funded meeting at a conference center on the Wye River in Maryland. They brought together forty five senior leaders from the White House, DOD, HHS, and academia to discuss post attack environmental recovery, operational management, mass casualty care, and nontraditional biological threats.

The purpose of the meeting was summarized by the organizers in their report to the Sloan Foundation: “We have no legitimacy beyond the power of the ideas we present. We may catalyze action only insofar as some agreed ideas are evocative for all or at least most of us.”87 Several valuable actions followed from that meeting. For example, DHS decided to fund a National Academy of Sciences panel to assess normal environmental levels of anthrax and then determine appropriate safety standards based on that assessment.88 More broadly, the Wye workshop and other facilitated discussions inside and outside the government sharpened participants’ views on the most pressing issues in biopreparedness and helped them achieve broad consensus on priorities.

47 Preparing for Bioterrorism

Working Through Foreign Policy Ramifications of Bioterrorism

Atlantic Storm and Black ICE International Bioterrorism Exercises

Disease knows no borders. This oft repeated truism about contagious disease outbreaks also applies to disease caused by biological weapons because even noncommunicable diseases, such as anthrax, can be spread worldwide in a matter of days via jet travel. Consider the case of a person exposed and infected in New York who can then travel to just about anywhere in the world within 24 hours postexposure well before an attack may be detected and not show signs of infection until hours or even days after landing. Multiply that scenario by the numbers of people who fly out of New York’s airports in a day, and it becomes clear that a biological attack in one city could quickly become a global problem.

Also clear is that bioterrorism response planning must be an international effort to be effective, and it must, to the greatest degree possible, begin well in advance of a crisis. The complexities that attend international sharing of medical resources, managing movement of people across national borders, and coordinating logistics and communication strategies require thought, planning, coordination, and investment.

48 Organizing to Counter Bioterrorism

One proven method to help leaders recognize and work through the complicated international issues and decisions is a tabletop exercise based on a fictional but plausible bioterrorism scenario. Participants play specific roles in the scenario and are asked to interact with other players to decide how best to manage the crisis at hand and to work together on decisions. Leaders can develop a better understanding of what they will face and may have to do in a real crisis. After the scenario is played out, the participants engage as themselves in a “hotwash” discussion to evaluate their own and others’ actions and offer their views on what could be done to prepare better in the future.

In 2005, the Sloan Foundation, along with the Nuclear Threat Initiative and the German Marshall Fund, supported the international bioterrorism exercise Atlantic Storm.89 The exercise was organized, scripted, and hosted by the Center for Biosecurity of UPMC, the Center for Transatlantic Relations of Johns Hopkins University, and the Transatlantic Biosecurity Network, a group of international experts in transatlantic and European security affairs.

The fictitious Atlantic Storm scenario placed eight heads of government from Europe and Canada, along with the director of the WHO and the president of the European Commission, in the United States for a transatlantic summit with the US president. While the leaders were at the summit, news broke that a small number of people in several European countries were infected with smallpox. Because smallpox has been eradicated from the natural world for decades, its appearance signaled that a biological attack had occurred. The scenario called for the world leaders to stay together to plan how the United States, Canada, and Europe could coordinate their responses to this global threat. Playing the US president, former Secretary of State

49 Preparing for Bioterrorism

Madeleine Albright chaired the proceedings in which the former and current officials playing the scenario’s world leaders grappled with strategies to contain the disease and apprehend the terrorists responsible for the attack.89

The exercise was held in real time, which meant that participants reacted to the beginning stage of an outbreak when information was most uncertain and changing most rapidly. Over the course of the exercise, the reported number of smallpox cases rose from fifty one Issues of biodefense are in four European countries at nine o’clock in equally rooted in public health and foreign policy the morning to 3,320 reported cases throughout because of the nature of Europe and North America at one thirty in biology and disease. the afternoon, with projections indicating the possibility of 660,000 cases worldwide within thirty days.89 The rapid rise in cases was not because the disease was spreading quickly; instead, the increase in case numbers demonstrated that the full extent of the attack would take time to determine accurately.

The participants also received information about the approximate numbers of smallpox vaccine doses possessed by their respective countries. Although some nations, including the United States, had enough smallpox vaccine for 100 percent of its residents, smallpox vaccine was a scarce resource globally: Even some of the wealthiest European countries did not have enough to contain an epidemic, and many countries around the world had (and still have) no smallpox vaccine. The stark differences in preparedness from one country to another forced the Atlantic Storm participants to confront the dilemma of which countries to prioritize for receipt of vaccine and other medical resources.89 That discussion gave rise to questions about whether previously agreed upon treaties, including the Schengen Agreement, which

50 Organizing to Counter Bioterrorism allows EU citizens to freely cross from one EU nation to another,90 could be maintained under intense political pressure to close borders, ostensibly to halt the spread of disease.91

Atlantic Storm focused on the foreign policy ramifications of a major epidemic, but every effort was made to ground the smallpox epidemiology firmly in past experience. D. A. Henderson, leader of the WHO smallpox eradication effort from 1966 to 1977, and the center’s researchers and analysts based the exercise’s epidemiological assumptions about the spread of smallpox on the data and practical experiences of the eradication program.92

The exercise opened leaders’ eyes to the unique characteristics of bioterrorism. Leaders were shocked and dismayed to discover that the tools needed to counter the threat, such as vaccine and diagnostic tests, were either not available or were in short supply. Also concerning was the lack of coordinated systems to provide situational awareness.89 As a result of the considerable attention it received in the international media, the exercise opened the eyes of many others as well. More than forty original reports were filed in news outlets around the world. BBC provided in depth coverage, ABC’s Nightline ran a two night feature hosted by Ted Koppel, and National Public Radio delivered a seven minute broadcast.93

No appropriate political tools or organizations were available to manage the crisis either. Jan Eliasson, who played the Swedish prime minister in between his real life appointments as Sweden’s ambassador to the United States and president of the United Nations (UN) General Assembly, described the situation: “We live in a time of new threats. . . . What we now see is that health and security go together, so we have to combine them, and I think the

51 Preparing for Bioterrorism lesson we should draw from this . . . is that we don’t have the organizational structures to deal with the new threats.”89

Indeed, as Atlantic Storm world leaders hunted for a unifying expert authority that could manage both political and medical exigencies and priorities, they turned to the WHO. Their logic was understandable: The WHO is a specialized UN agency that acts as a coordinating authority on international public health. However, the agency is underfunded and understaffed, particularly for meeting global needs on a scale such as the one played out in this exercise. Gro Harlem Brundtland, the former WHO director general who played that role in the exercise, neatly summed up the problem with relying on the WHO: “The budget of the WHO has very considerable limitations. It’s like a middle sized hospital in England in total resources. . . . If leaders at this level are realizing that you have a crisis and that you need the WHO . . . they also will [have to] support, with extra budgetary resources, what’s necessary.”89

The participants’ desire to rely on the WHO to coordinate response to an international bioterrorism event helped spur planning for another tabletop exercise, Black ICE, which took place in Montreux, Switzerland, on September 7 8, 2006, and was cohosted by the US and Swiss governments.94 Black ICE was designed, developed, conducted, and evaluated by Applied Marine Technology, Inc., and funded by the Nuclear Threat Initiative and the Sloan Foundation. The name for the exercise is based on the acronym for International Coordination Exercise, and it refers to a smooth layer of ice that appears to be just water on a road’s surface it looks harmless but is treacherous.94 The exercise was meant to provide greater clarity about the roles and responsibilities of international organizations after a biological

52 Organizing to Counter Bioterrorism attack. A senior US State Department official told a reporter that “many countries had unrealistic expectations about what international organisations could do.”95 Black ICE convened senior officials from twelve international organizations, including the WHO, the International Federation of Red Cross and Red Crescent Societies (IFRC), the International Maritime Organization (IMO), International Criminal Police Organization (Interpol), the North Atlantic Treaty Organization (NATO), the Pan European regional security body Organization for Security and Cooperation in Europe (OSCE), and the UN Department for Disarmament Affairs (UN DDA). Other groups that would play a role in caring for the sick, distributing countermeasures, or apprehending the perpetrators of an international biological attack were included as well. All participants were senior level officials who “could call their entire organization’s resources into action.”94 To keep the focus primarily on international organizations and their respective roles, participants did not include individual countries. The United States and Switzerland were cohosts but did not have a role in the scenario.

Like Atlantic Storm, Black ICE was a tabletop exercise about a smallpox attack, in which self infected terrorists ensured spread. Unlike Atlantic Storm, which focused on the time immediately following recognition of an attack, the two day Black ICE exercise covered the first six weeks after a fictional attack.

The biggest lesson drawn from the Black ICE exercise was the great need for multisectoral engagement.94 In other words, the exercise demonstrated the need for international humanitarian and health focused organizations to work with security and military organizations. The exercise also emphasized the need for nations to increase their attention to preparing for bioterrorism.

53 Preparing for Bioterrorism

Because international organizations have finite resources, countries have to increase their national capacity to prevent and respond to bioterrorism.94 After the exercise, the senior US State Department official who told a reporter that countries had unrealistic expectations added that many bioterrorism coordinators in Europe had never met each other before the exercise.95

The success of Black ICE led to Black ICE II, which was also hosted by the US and Swiss governments and held in Montreux, Switzerland, but employed a scenario based on an attack with plague.96 Black ICE, Atlantic Storm, and other international exercises can expose gaps in international preparedness for biological terrorism or natural disease epidemics. They also make clear the proper lens through which to view biodefense, as Marc Ostfield from the US State Department explained when he wrote that most people understand that issues of biodefense are rooted in public health, when actually “they are equally fundamentally rooted in foreign policy because of the nature of biology and disease.”97

54 Organizing to Counter Bioterrorism

Learning from Aum Shinrikyo

Danzig and Colleagues Report on Aum’s Use of Biological and Chemical Weapons

On March 20, 1995, a chemical attack with sarin gas in the Tokyo subway system killed thirteen people and caused six thousand others to seek treatment. The group responsible for the attack was Aum Shinrikyo, a Japanese apocalyptic cult. Chizuo Matsumoto had formed the group a decade earlier as a peaceful yoga school promising a path to spiritual enlightenment. Over time, though, Matsumoto led the sect in a violent direction, and Aum Shinrikyo (Aum) grew progressively more radical, dangerous, and dedicated to using chemical and biological weapons.16

Aum’s use of biological science techniques offered a rarely available view of a terrorist group’s attempts to acquire and use chemical and biological weapons. After the successful sarin gas attack, it was discovered that the group was attempting to develop a biological weapon with either anthrax or botulism; fortunately, those efforts failed utterly.16 Investigators later found at least one reason for the failure: Aum used a vaccine strain of Bacillus anthracis instead of a lethal strain.98

The case of Aum Shinrikyo has since served as a kind of Rorschach test for biosecurity experts. Those who believed the dangers of biological weapons

55 Preparing for Bioterrorism were exaggerated after 2001 saw Aum’s failure as evidence that bioweapons are too hard to come by and too difficult to use and confirmed that chemical weapons and explosives were much more accessible for misuse.99,100 Others interpreted Aum’s intentions and attempts as a harbinger of terrorist acts to come.16,21

Firsthand knowledge of what actually occurred with Aum and the reasons why a terrorist group might turn to biological weapons were scarce, and it has been difficult to know the stumbling blocks that a terrorist group might encounter in trying to develop a bioweapon. The Aum experience offered the possibility of insight into both. Even the circumstances that led to the group’s acquisition of a vaccine strain of B. anthracis were not known. It was difficult to imagine that the group did not know the type of strain needed to create a weapon. This error led some to wonder whether Aum got cold feet.

In 2008, thirteen years after the sarin gas attack, Richard Danzig, former secretary of the Navy and current chairman of the board of the Center for a New American Security, secured funding from the Sloan Foundation to pursue answers to the many questions surrounding the cult’s actions and experiences. Danzig also wanted to find the lessons in the Aum Shinrikyo experience that might inform current and future counterterrorism efforts. His investigation uncovered evidence that the cult’s successes and its failings were both “greater than had been previously realized.”16

In July 2011, Danzig and colleagues Marc Sageman, Terrance Leighton, Lloyd Hough, Hidemi Yuki, Rui Kotani, and Zachary M. Hosford published their findings in the report Aum Shinrikyo: Insights into How Terrorists Develop Biological and Chemical Weapons.16 The report is based on interviews with incarcerated Aum members, some of whom are on death row. It describes the

56 Organizing to Counter Bioterrorism early days of the Aum movement, the group’s embrace of violence, and its tests of biological and chemical weaponry.

The interviews did reveal some information about Aum’s use of an anthrax vaccine strain, though Seiichi Endo, who was in charge of the biological weapons effort, declined to be interviewed. It seemed, for instance, that Endo did not want to order anthrax bacteria from a commercial company because it would be traceable by police authorities. Instead, it is believed, he hoped to use genetic engineering to create a lethal anthrax strain from two different less regulated vaccine strains Sterne and Pasteur that have complementary genetic elements required for lethality. Combining these bacteria may have been a more difficult task in 1993 than today, but Endo also did not test his results rigorously before proceeding with an attack. He also tried to use botulism as a weapon but encountered problems with contaminated fermenters.16 Ultimately, the person in charge of the group’s chemical weapons effort was more successful.

Danzig and colleagues concluded that chemical weapons may be more accessible to terrorists than biological weapons, but dissemination of either would probably be challenging for a terrorist group.16 They also concluded that police pursuit, even if intermittent or just anticipated, may slow down terrorists in the future. Even though police pursuit of the Aum sect was lax, the group attended to what the police were doing and changed course or shut down operations when they suspected they were being pursued.16

Aum’s efforts were hindered by compartmentalization as well. The cult’s leaders worked alone on developing biological and chemical weapons, which helped keep the work secret, but that insular approach cut off access to people who might have had the skills needed to make more successful

57 Preparing for Bioterrorism weapons. Danzig expects this will be a problem for other terrorist groups: “Terrorists need time; time will be used for trial and error . . . [T]rial and error entail risk [of discovery], . . . but Aum found paths to WMD, and other terrorists are likely to do the same.”16

Finally, Danzig and colleagues offered a caveat regarding Aum’s significant failures: “When we encounter terrorist pursuit of these weapons, the failures may be less a source of comfort than a warning of activity that, if persistently pursued, may result in success.”16 Danzig’s description suggests that the beliefs and activities of groups like Aum Shinrikyo are perhaps most akin to Russian roulette. They may follow “notions that are bizarre, concepts that are sterile, [but] then one of those chambers turns out to be loaded.”101

Assessing the US Government’s Bio-Response Capabilities

The WMD Center’s Bio-Response Report Card

In 2004, the National Commission on Terrorist Attacks Upon the United States (also known as the 9/11 Commission) urged the US government to prevent the proliferation of WMD, writing that “the greatest danger of another catastrophic attack in the United States will materialize if the world’s

58 Organizing to Counter Bioterrorism most dangerous terrorists acquire the world’s most dangerous weapons.”102 In response, the US Congress created the Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism, also known as the WMD Commission, in 2008. The nine member bipartisan commission was led by former Senator Bob Graham (D FL) and former Senator Jim Talent (R MO). The commission was charged with examining US vulnerabilities to nuclear, biological, and chemical weapons and identifying the actions needed to reduce that threat.

The group interviewed more than 250 counterterrorism and intelligence experts in the United States and abroad, and their report, World at Risk, issued a strong warning for the US government and allies: “Unless the world community acts decisively and with great urgency, it is more likely than not that a weapon of mass destruction will be used in a terrorist attack somewhere in the world by the end of 2013.”103 In 2008, that was only five years in the future.

Although the WMD Commission was concerned about the proliferation of nuclear weapons, it stressed that “to date, the US government has invested the largest portion of its nonproliferation efforts and diplomatic capital in preventing nuclear terrorism. Only by elevating the priority of preventing bioterrorism will it be possible to substantially improve US and global security.”103 The commission was concerned about the proliferation of advanced biological technologies, which are necessary for gains in medicine and public health, but could be misused to create biological weapons. The group was also concerned about the security of dangerous pathogens in US laboratories: During the time when the commission was conducting

59 Preparing for Bioterrorism

its research, the FBI declared Bruce Ivins, an army scientist, to be solely responsible for the 2001 anthrax letter attacks.104

World at Risk presented thirteen recommended domestic and international measures to prevent bioterrorism and strengthen the nuclear nonproliferation regime. The report also highlighted areas in need of greater, more efficient, and more organized US government effort to The greatest danger of counter WMD threats. A year later, in 2009, another catastrophic Congress reauthorized the commission for attack in the United States an additional year, “to assist Congress and will materialize if the world’s most dangerous the Administration to improve understanding terrorists acquire the of its findings and turn its concrete world’s most dangerous recommendations into actions.”105 At the end weapons. of its final year of work, the commission produced a report card in which it assigned grades to the government’s efforts to address recommendations made in World at Risk.105 Results were mixed. The government received some A’s, some B’s, and some C’s for its efforts to strengthen the nuclear nonproliferation regime, reinvigorate the BWC, develop a national strategy for bioforensics, and strengthen domestic and global disease surveillance networks.

The government got an F for its effort to “enhance the nation’s capabilities for rapid response to prevent biological attacks from inflicting mass casualties” and to “reform congressional oversight to better address intelligence, homeland security, and crosscutting twenty first century national security missions.” The number of committees and subcommittees that oversee DHS is estimated to be somewhere between 82 and 108, and virtually no progress had been made since consolidation was first recommended by

60 Organizing to Counter Bioterrorism the 9/11 commission in 2004.105 In reaction to the report card, there were headlines and hearings,106-109 but it was clear that the problems highlighted by the report card were not going to be fixed easily or swiftly and that continued oversight and monitoring was needed to make sure the government was working steadily on the problems identified by the commission.

Senators Bob Graham and Jim Talent wanted to continue that monitoring effort, as did Randy Larsen, who was executive director of the WMD Commission in its second year and the former chairman of the Department of Military Strategy The problems highlighted in the report card were and Operations at the National War College. The not going to be fixed Sloan Foundation gave them seed funding to easily or swiftly. transition from a commission to a not for profit research and education center. They brought on Lynne Kidder, former senior vice president of Business Executives for National Security, and together launched the Bipartisan WMD Terrorism Research Center (WMD Center). In looking at the nation’s preparedness for a biological event, the group focused on US capacity for detection, development, and delivery of medical countermeasures; attribution; and environmental recovery.

In October 2011, ten years after the anthrax letter attacks, the WMD Center gave the government a different kind of report card, noting that “since 2001, the US government has spent more than $65 billion on biodefense, and yet it has done so without an end to end, strategic assessment of the nation’s bio response capabilities.” They designed a report card to fill that strategic assessment gap.110

Drawing on a team of advisors and outside experts, the Bipartisan WMD Terrorism Research Center’s Bio Response Report Card offers a detailed

61 Preparing for Bioterrorism assessment of whether, for instance, the government’s efforts to develop medical countermeasures meets the public’s expectations, and whether the trend is going in the right direction. The report also gives a sense of scale to the government’s efforts in that the group evaluated the ability to respond to a small scale noncontagious outbreak versus a large scale outbreak caused by a drug resistant pathogen or a global contagious epidemic. Larsen explains: “Defining categories of attack big and small was important and new. Before, if you were talking about a biological attack, one person might mean a limited attack like the anthrax letters, and another person might mean a large scale aerosol attack with a contagious disease. The government is not equally prepared to respond to both events.”111

In the end, the government’s grades again were mixed B’s, C’s, D’s with F’s as the size of the attack and the complexity of the response grew. The WMD Center recommended that efforts to raise D’s to C’s will provide the best return on investment to help the nation prepare.

The Bio Response Report Card laid the groundwork for future report cards and ongoing evaluation of biopreparedness progress, but the successes required to raise those grades will not be achieved overnight. While the government is doing that important work, the WMD Center is going to turn its attention to state and local preparedness and will come back to re evaluate the federal efforts in a few years, when, according to Lynne Kidder, it will be a good time to take another look.111

62 CHAPTER 3

Criminalizing Bioterrorism

If an individual developed a biological weapon, would that person be guilty of a crime? In 2001, not necessarily.

iological weapons development is prohibited by the BWC.112 All 165 nations that signed the treaty agreed that they will not develop or stockpile biological agents or toxins “of types and in quantities that B 112 have no justification for prophylactic, protective or other peaceful purposes.” Therefore, if a nation were to develop biological weapons, it would violate international law. But what if an individual developed a biological weapon would that person be guilty of a crime? In 2001, the answer was “not necessarily.” The BWC was the only legal commitment most nations had regarding biological weapons, and when it was originally signed in 1972, it was thought that individuals would

63 Preparing for Bioterrorism develop biological weapons only at the behest of a government, not acting as individual non state actors.113 In 2001, if non state actors were arrested after committing a bioterrorist attack, they could be charged with murder or attempted murder, but the activities they would have engaged in before an attack weaponizing pathogens or distributing equipment critical to making a bioweapon might not have been illegal in most nations.114 Without the laws to declare certain activities off limits, law enforcement authorities may not have been able to stop an attack before it occurred. Moreover, many law enforcement agencies were either only slightly aware of the threat of bioterrorism or did not know whether action could be taken to prevent such a crime.

The necessity for a more uniform legal approach to non state actors gained prominence in early 2004, when Abdul Qadeer Khan (or “A.Q. Khan”), the designer of Pakistan’s nuclear program, was revealed to have provided designs and centrifuge technology to aid nuclear weapons programs in Iran, Libya, and North Korea.115 In response, in April 2004, the UN Security Council adopted UN Security Council Resolution 1540 (UNSCR 1540), which states that the “proliferation of nuclear, chemical and biological weapons, as well as their means of delivery, constitutes a threat to international peace and security.”116 The resolution required all UN member states to modify their internal legislation to make it illegal for an individual or non state actor to gain access to biological, chemical, and nuclear weapons, related materials, or the means of delivering those weapons.

Now, in 2012, law enforcement officials worldwide have a much greater ability to interdict and prosecute individuals for biological crimes, including during the planning stages, and they have much greater awareness of the

64 Criminalizing Bioterrorism threat of bioterrorism. This chapter describes Sloan Foundation efforts that helped bring about this important change. The foundation funded an international workshop that addressed criminalization of bioterrorism and an Interpol led project that initiated education and training for law enforcement agents around the world. UNSCR 1540 provided additional incentives for nations to engage with Interpol on the Sloan supported projects. This work is now considered so important to global law enforcement that Interpol member countries continue to fund and support that work on their own.

An International Criminal Law Approach to Bioterrorism

The Airlie House Workshop

“In 2012, it seems kind of silly to be talking about making bioterrorism a crime, it is such a given,” noted Barry Kellman, director of the International Weapons Control Center at the DePaul University College of Law, in a February 2012 interview, “but at the time [in 2001] it was not at all viewed that way. Bioterrorism was not criminalized in most countries.”117 Instead of being seen as a crime, Kellman explained, a biological weapon was considered a violation of an arms control treaty and, therefore, a political matter. “This

65 Preparing for Bioterrorism becomes an enormous problem when dealing with non state actors, as terrorists do not care about arms control agreements.”117

This problem was addressed in May 2002, when the DePaul International Human Rights Law Institute and the Global Security Institute gathered fifty people at the Airlie House outside Washington, DC, for the multi day Workshop on Biological Terrorism: An International Criminal Law Approach.118 The Sloan Foundation sponsored the workshop, which started with the premise that to prevent bioterrorism, law enforcement tools were needed to investigate and interdict terrorist preparations. The goal was to stimulate discussion of legal initiatives that could eventually become part of a convention or treaty to prevent bioterrorism and aid law enforcement in bringing bioterrorists to justice.

Given that acquisition of biological weapons by non state actors would be an international problem, the workshop was international, with participants from Jordan, Italy, Georgia, Argentina, Brazil, Ukraine, Russia, India, Zimbabwe, the United States, and other nations. Academic and policy centers were represented, as were international organizations such as the Red Cross and Interpol. During the meeting, participants focused on topics that included smuggling, customs enforcement, and law enforcement investigations intended to prevent a biological crime from being committed.

Part of the agenda focused on discussion of the “Draft Model Convention on the Prohibition and Prevention of Biological Terrorism,” written by Kellman, which put forth the notion that states should criminalize the hostile use of biological agents, develop a licensing system for legitimate biological activities with dangerous pathogens, establish an international mechanism to

66 Criminalizing Bioterrorism promulgate biosafety and biosecurity standards, and strengthen international information gathering to thwart illegal activity.119

In April 2003, the Sloan and MacArthur Foundations funded a second workshop, Preventing Disease Weaponization: Strengthening Law Enforcement and National Legislation, which was organized and chaired by Kellman.120 Fifty participants Terrorists do not from all over the world came to the Palais des Nations care about arms control agreements. in Geneva, Switzerland, to discuss and formulate strategies to promote “bio criminalization,” which referred to making the development of biological weapons a crime in national codes of law.120 According to Kellman, bio criminalization next appeared on the international agenda of the 2003 BWC Expert Meeting focused on “National mechanisms to establish and maintain the security and oversight of pathogenic micro organisms and toxins” that took place in August 2003.121

Kellman continued his work on this issue by delivering more than one hundred briefings on bio criminalization to international organizations, NGOs, and officials from the United States and other governments. These briefings and the discussions they sparked helped shift the international approach to bioterrorism away from arms control to emphasize criminal law instead. That shift was one of the key objectives of the Airlie workshop. The criminalization effort dovetailed with the broader UNSCR 1540, as 1540 required all nations to have in place legislation to respond to non state actors. As Kellman explained, “The ideas in [UN Security Council Resolution] 1540 and the ideas we were talking about were precisely synonymous. . . . 1540 was advocated by people who were at the Airlie House workshop. . . . The fact that the Security Council took that action was an incentive” for nations

67 Preparing for Bioterrorism to criminalize bioterrorism and to become more aware of the threat of bioterrorism.117

After the May 2002 Airlie workshop, Kellman went to Lyon, France, to meet with Interpol’s secretary general, Ron Noble. They agreed that laws were needed to criminalize bioterrorism and that another critical need was greater police awareness of the threat and what could be done about it. Noble and Kellman joined forces to establish what became the Interpol police training program. Kellman continued to work closely with the Interpol team and participated in Interpol led workshops in Africa, Asia, the Americas, and Ukraine. In collaboration with the McGeorge School of Law, Kellman also led Sloan funded workshops on bio criminalization in Nairobi, Moscow, and Brussels.117,122,123

Kellman cautioned that although substantial progress has been made, the work on this issue is not complete because laws are useless without people trained to prosecute and enforce them. Training must be entrenched and constant because people retire and move on. Nonetheless, Kellman observed, “We have much better infrastructure and laws than we had a decade ago.”117

68 Criminalizing Bioterrorism

Teaching the World’s Police about Bioterrorism

Interpol’s Work on Bioterrorism Prevention and Response

With 190 member nations, Interpol is the world’s largest international police organization.124 The organization’s mission is to facilitate global police coordination.124 Interpol does not make arrests, and there is no jail at the member headquarters in Lyon, France. Rather, Interpol helps law enforcement agencies from all over the world track transnational criminals and provides extensive databases of individual criminals and crime trends to member nations. Interpol has been an invaluable resource to law enforcement agencies worldwide in their investigations of art thefts, child pornography, endangered animal trafficking, financial crimes, and, starting in 2005, bioterrorism.122

Interpol’s bioterrorism awareness efforts were launched in March 2005 with the largely Sloan Foundation funded Global Conference on Preventing Bioterrorism125 in Lyon. This conference was the largest international gathering of police that had ever been held. It was attended by more than 500 senior officials and experts from 155 countries and 16 international organizations.125

In his opening remarks, Ron Noble said of bioterrorism: “There is no criminal threat with greater potential danger to all countries, regions, and

69 Preparing for Bioterrorism

people in the world than the threat of bioterrorism. And there is no crime area where the police generally have as little training as they do in preventing or responding to bioterrorist attacks.”126 The meeting attendees agreed to an Interpol program to improve that situation.

The Sloan Foundation’s support allowed Interpol to develop its capacity to counter bioterrorism by raising awareness among law enforcement agencies all over the world, developing police training programs, and strengthening law enforcement for biological crimes. Interpol created a dedicated bioterrorism unit responsible for developing a plan to bolster national and international capacity to counter the threat of bioterrorism.122

There is no criminal To raise awareness, Interpol drafted its threat with greater Bioterrorism Incident Response Guide in 2007, potential danger to all which has been revised and updated several countries, regions, and times, and created an e learning module and people in the world than the threat materials for police academies. Interpol also of bioterrorism. held nine week long regional workshops on bioterrorism prevention and response throughout Asia, Africa, the Middle East, Eastern Europe, and Latin America. “At the regional workshops, we brought together the scientific community, health and regulatory agencies, and law enforcement,” said Noble, and they made sure that the participants “knew one another’s names and phone numbers and e mail addresses.”127

According to Noble, Interpol was acutely sensitive to the concerns of scientists who might worry that the police would perceive their legitimate work as criminal. He offered assurances that police recognized that the scientific community could best manage its own work, and asked the

70 Criminalizing Bioterrorism scientists to be aware of “this other community out there that could attempt to use [science] for really bad purposes.”127 Interpol’s workshops enhanced cooperation and understanding between law enforcement and scientific research centers in member countries.

Interpol also conducted four multi country tabletop exercises involving law enforcement, public health, and customs personnel. In 2010, Interpol cosponsored a fifth tabletop exercise with the Netherlands. The tabletop exercises centered on hypothetical bioterrorism scenarios involving the spread of plague and monkeypox at international sporting events and airports. As of September 2011, approximately 586 police officers from 130 countries have been trained or have taken part in the tabletop exercises.

Interpol has done this work as police budgets for dealing with everyday crime are under increasing pressure, explained Mitchell Stern, Interpol’s CBRNE (chemical, biological, radiological, nuclear, and explosives) program manager.

If you are a police officer working on the African plain, you might be more focused on cattle rustling. If you’re an officer working in a high murder jurisdiction, you are focused on homicide. . . . If someone comes along and says, “Bioterrorism is something you have to pay attention to, but it will take a lot of training and equipment before you can even do the investigation,” a working police executive will nod and say, “I see your point, but I have someone who just stole 150 head of cattle.”128

To support police organizations that do not have the resources to devote to bioterrorism, Interpol established in house capacity to provide technical

71 Preparing for Bioterrorism assistance and back up to police officials who have questions. Interpol offers practical suggestions for law enforcement agencies as well, said Stern: “If you know who is selling castor beans in your jurisdiction, you can set up a benign tripwire program for someone who might seek to distill ricin from those castor beans.”128

Today, the program that began with Sloan Foundation support is funded through mandatory and voluntary contributions from member countries and other agencies, such as the FBI and the US State Department. Interpol’s accomplishments and the continuation of the training program are substantial achievements, but there is always more to do. In addition to continued training, more needs to be accomplished in the realm of the law itself. Not all nations, for instance, now have the laws needed to prosecute bioterrorism in its planning stages, and not all have serious penalties for conspiracy to commit biological crimes. Ultimately, though, explained Noble, “We are better prepared than we were in 2001, and better prepared than we’ve ever been.”127

72 CHAPTER 4

Responsible Stewardship of Powerful Biotechnologies

The dual use nature of biology greatly complicates strategies to prevent the development of biological weapons.

he life sciences are inherently “dual use” in that a great deal of the scientific knowledge, materials, and techniques required for T legitimate, beneficent biological research could also be used to make a biological weapon. As an example, laboratory research conducted to uncover critical information about how a pathogen manipulates the human immune system to cause disease could be exploited to make a disease harder to treat.129 This dual use nature of biology greatly complicates strategies to prevent development of biological weapons. Bioweapons development cannot be prevented using the same strategies developed to prevent nuclear terrorism

73 Preparing for Bioterrorism because, unlike highly enriched uranium, the building blocks of biological weapons are globally accessible. Pathogens can be harvested from sick people and animals, found in laboratory freezers, and collected in the natural environment.130 Like most information on biological research, information on how to find and genetically manipulate pathogens is widely available on the Internet, and training in legitimate life sciences research yields skills equally useful for development of biological weapons.

Fortunately, and despite the wide accessibility of biological information and materials, countries rarely suggest they have biological weapons,131 and there is no evidence that terrorist groups have subverted cutting edge biological science to make biological weapons. The potential, however, remains, and with the rapidly accelerating power of biological technologies, the consequences of misuse could increase over time.132 Technologically advanced dual use research in aerosol technologies, synthetic viruses, or even antibiotic resistance could make a natural pathogen into a much more deadly weapon.132

The dual use dilemma of the life sciences was brought to policymakers’ attention in 2001 following publication of a study done by a group of Australian researchers133 who added a single gene, IL 4, to mousepox virus, a cousin of the human smallpox virus. The addition of that gene made the mousepox virus so much more pathogenic that it killed even the vaccinated mice. While it is not clear that adding IL 4 to smallpox virus would amplify the lethality of the virus in humans,134 the implications were troubling. A popular cliché among infectious disease experts is that “Mother Nature is the worst bioterrorist,”135,136 but the mousepox experiment demonstrated that it

74 Responsible Stewardship of Powerful Biotechnologies is indeed possible for a thinking enemy to make something worse than what could evolve naturally.

When published in 2001, the mousepox experiment also exposed the fragility of biodefense planning that relied on rapid development and deployment of vaccines. If an engineered smallpox virus were impervious to vaccine, there would be no defense that could save lives if the virus were used as a weapon. Creating a new vaccine or other type of medical countermeasure could take eight to ten years and could cost more than $800 million.137

Even worse, in 2001, most people under the age of thirty would not have had any immunity to smallpox, which kills 30 percent of its victims, because vaccination stopped in 1972 in the United States. People who had been vaccinated in the past but had not received booster The question of how shots since the 1970s would have had incomplete to manage the dual protection at best.138 There were powerful reasons use dilemma is far to prevent the misapplication of dual use scientific from resolved. knowledge, difficult as that may have been, without harming legitimate science. Misuse could threaten the health and lives of many innocent civilians.

Recognizing the inherently high stakes of dual use science, the Sloan Foundation funded a number of projects that sought ways to govern the life sciences responsibly without hindering essential, legitimate research. Sloan supported a National Academy of Sciences (NAS) committee in 2002 03 to consider the problem of dual use science; the resulting report (“the Fink Report”) is considered the seminal reference in the field.139 The foundation also funded a University of Maryland (UMD) to develop a prototypical mechanism for international governance of dual use science. While UMD’s

75 Preparing for Bioterrorism

oversight system did not gain wide support among scientists, it did prompt the scientific community to develop a mechanism for self governance. The approach could not be a traditional “command and control” regulatory system because the dual use nature of the life sciences makes it almost impossible to precisely define “allowed” versus “prohibited” scientific activities. Moreover, the life sciences are international, change rapidly, and require in depth scientific expertise to evaluate risks. Due in part to The building blocks Sloan’s efforts, there now exists a National Science of biological weapons Advisory Board for Biosecurity (NSABB) to advise the are globally accessible pathogens. US government on matters related to dual use research and its publication. Sloan’s investment in synthetic biology, which continues, also yielded US government guidance for gene synthesis companies that need to screen orders for the genetic sequences of dangerous pathogens.140

Despite more than a decade of focused and thoughtful work on the issue, the question of how to manage the dual use dilemma of the life sciences is far from resolved. Since the results of the mousepox study were published in 2001, several other controversial papers have been published: a June 2002 paper described how a smallpox virus gene inactivated part of the human immune system,141 and an August 2002 paper described re creation of polio virus through chemical synthesis.142 In 2005, researchers published the genetic sequence of the 1918 pandemic influenza virus,143 prompting fear of regeneration of that virus. Most recently, in 2011 12, two researchers sought to publish results of their studies of whether and how the H5N1 influenza virus (a “bird flu” virus) could become more transmissible.144 In response to the H5N1 influenza studies, the NSABB took the unprecedented step

76 Responsible Stewardship of Powerful Biotechnologies of recommending against publication, then reversed course after several months of heated debate in the global scientific community.145 The H5N1 study controversy was the likely impetus for the United States Government Policy for Oversight of Life Sciences Dual Use Research of Concern,146 which was released on March 29, 2012. This new policy requires US government funding agencies to review all proposed and funded projects to identify dual use concerns and propose risk mitigation plans that could include voluntary redaction or classification of research publications.146

Even with screening and oversight, the questions of whether a paper should be published and who is authorized to make that decision will probably continue to be contentious. It is virtually impossible to know in advance which study results may be useful to a terrorist, leaving open to debate the degree of threat posed by many scientific papers. Many learned people may agree that specific research poses a dual use threat, but they may disagree about overriding public health or scientific value that would make it worthwhile to publish a paper in the open literature despite any potential threat.

Although it may not be possible to have a readily codified system of oversight for dual use research, there is a clear need to educate scientists about the dual use dilemma (and about biosafety). Before proceeding with scientific work, scientists should always consider the possibility that research results could be misused147 and should always be able to explain laboratory safety procedures when asked.148 To shore up education for scientists, the Sloan Foundation funded researchers from the English Universities of Bradford and Exeter to deliver seminars for scientists around the world. Sloan also provided support for the WHO to develop international guidance on

77 Preparing for Bioterrorism biosafety and dual use considerations and underwrote efforts to create the International Council for the Life Sciences to help scientists and policymakers increase biosafety in Central Asia, the Middle East, and North Africa.

Like all education initiatives, the task of educating scientists must be continued indefinitely to update established scientists and engage new scientists. The Sloan Foundation’s investments have produced important results, and it is crucial for the government and professional associations to continue this work.

Preventing the Misuse of Science

The Fink Report

In 2001, when the Sloan Foundation awarded a grant to the NAS to explore ways to prevent destructive applications of research in biotechnology, the dual use nature of biological research was not a concern of most life scientists. Biological weapons were the stuff of movies, fiction, and the distant past.19,20,149 The US bioweapons program was dismantled long before most of today’s graduate students, postdoctoral fellows, and assistant professors in the life sciences were born.150 The idea of using scientific research results to do harm or to gain greater understanding of how to wield pathogens as weapons was anathema to scientists. That tacit moral boundary was proved illusory,

78 Responsible Stewardship of Powerful Biotechnologies though, when the extent of the former Soviet Union’s bioweapons program was revealed. As concerns about bioterrorism grew, so did concerns that life scientists were inadvertently providing information that could be of use to bioweaponeers.28

In 2001, the Sloan Foundation provided support to help launch the Committee on Research Standards and Practices to Prevent the Destructive Application of Biotechnology, chaired by Gerald R. Fink, then professor of genetics at the Whitehead Institute for Biomedical Research at the Massachusetts Institute of Technology (MIT). Composed of life scientists, social scientists, lawyers, and bioethicists, the committee met between April 2002 and January 2003.139

The idea for a project to review existing US oversight of “potentially dangerous biotechnology research . . . to prevent the destructive application of biotechnology research while still enabling legitimate research to be conducted”139 actually emerged before 9/11 How do you avoid making and the anthrax letters. Jo L. Husbands, now a science and security into senior project director for the NAS Board on a zero sum game? Life Sciences, recalls that the NAS assumed the study committee “would have the luxury of thinking this through quietly, presenting it, disseminating it, and talking with our international colleagues, because it’s a tough problem. Then all of a sudden, we were in the headlights.”151

Committee member and University of Louisville professor of biology Ronald Atlas explained: “We were dealing with a crisis situation. In responding to the threat of bioterrorism, the government was considering draconian measures actions like banning foreign scientists, banning foreign

79 Preparing for Bioterrorism students from study in the life sciences, requiring government clearance to publish. Back then, there were those who argued that the scientific community just could not be trusted.”152 The fear that the government might act in a way that scientists would not like was echoed by Parney Albright, then a senior official in the White House Office of Science and Technology Policy and now director of Lawrence Livermore National Laboratory. In a 2003 forum, he said that “the science community ought to come up with a process before the public demands the government do it for them, and that will be driven by the rate at which controversial papers hit the streets.”153

In October 2003, the National Research Council published Biotechnology Research in an Age of Terrorism. The document widely known as the Fink Report is considered foundational in the evolving discussion of science and national security. “The report showed that the scientific community recognized that this was a legitimate issue and was prepared to think through, in practical ways, what might be done,” said Husbands. “The idea was, how do you avoid making science and security into a zero sum game?”139

The committee described an initial set of seven types of experiments of concern that, while not prohibited, would merit review and discussion before being undertaken or published in detail. Such experiments would do at least one of the following: 1. Demonstrate how to render a vaccine ineffective. 2. Confer resistance to therapeutically useful antibiotics or antiviral agents. 3. Enhance the virulence of a pathogen or render a nonpathogen virulent. 4. Increase a pathogen’s transmissibility. 5. Alter the host range of a pathogen.

80 Responsible Stewardship of Powerful Biotechnologies

6. Enable the evasion of diagnostic and/or detection modalities. 7. Enable the weaponization of a biological agent or toxin.139

In addition to recommending creation of programs to educate scientists about the dual use dilemma and their responsibility to reduce risks, the committee identified opportunities for review of scientific experiments and results throughout the research life cycle. This was to ensure responsible oversight of scientific advances that have the potential for dangerous misapplication.139 The committee also called for creation of the NSABB to propose guidance and leadership for research oversight. Finally, the group recommended extending all US efforts in this realm to the global life sciences community.139

The US government swiftly adopted some of the Fink Report’s key recommendations. The NSABB was created to offer advice, guidance, and leadership for the proposed system of review and oversight. Established in 2004 as a federal advisory committee, the NSABB has been chartered continuously at two year intervals by the secretary of HHS. The NSABB has offered guidance for handling dual use research of concern (DURC), a modified form of the Fink Report’s experiments of concern, and has provided input on the publication of several papers, including one on the reconstruction of the 1918 influenza virus154 and others that explored whether H5N1 could become transmissible among humans.155-157

Today, the Sloan funded Fink Report continues to shape thought and policy, “but we’re a long way from a substantial culture change,” admitted Husbands, who observed:

There is still a general lack of awareness in the life sciences

81 Preparing for Bioterrorism

community about possible security risks. Most life scientists genuinely believe that their work is about the benefits for humanity, broadly drawn. The concept that their research could have a dark side is difficult for people to accept. And there is a deep concern that this will mean increased regulation, at a time when, at least in the United States and most of the developed world, increased regulatory burden makes it harder and harder to actually do your science.151

US government actions taken after the 2011 12 controversies surrounding H5N1 experiments may prompt creation of a dual use research oversight system, the need for which was noted in the Fink Report. On March 29, 2012, the US government issued a policy for DURC oversight that requires federal government funding agencies to review all proposed and funded projects for DURC potential and propose risk mitigation plans for DURC research. Risk mitigation plans could include classifying or redacting information that might otherwise be published in the open scientific literature.146

It may be impossible to know whether efforts to prevent subversion of the life sciences are effective without what has been termed “extraordinary visibility” into the actions of a bioterrorist.147 According to the Fink committee, biological scientists have an “affirmative moral duty to avoid contributing to the advancement of biowarfare or bioterrorism.”139 In short, scientists should do what they can to prevent misuse of their work.

82 Responsible Stewardship of Powerful Biotechnologies

International Oversight of Dual-Use Research

The Center for International Security Studies’ Biological Research Security System

Biological scientists in the United States have laws, requirements, and regulations to follow, but there are no international authorities or regulations that govern their experiments unless they work on live smallpox virus.158 To work with smallpox, scientists must receive permission from a WHO special committee of experts.159 Because smallpox was eradicated from the natural world, this controlled system is to provide confidence that research is scientifically justified and conducted in a safe and secure manner.158,160 Smallpox is a special case, but biological research with other dangerous pathogens could also be vulnerable to accident or misuse. That recognition led to the question of whether an international regulatory system similar to that governing smallpox research should be applied to bioscience research more broadly. John Steinbruner, director of the Center for International Security Studies at Maryland (CISSM), argued that it should, and the Sloan Foundation funded his work to develop an international framework to provide “systematic protection against misapplications of biotechnology.”161

As Steinbruner and colleagues Elisa D. Harris, Nancy Gallagher, and Stacy Okutani wrote in Controlling Dangerous Pathogens,162 the monograph

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that concluded their study, there are many benefits to be gained from advances in biotechnology, but there may also be grave dangers. “Hundreds of millions of lives might be enhanced, salvaged, manipulated, degraded, or terminated depending on how the same basic knowledge is applied. Little of that potential has yet been accomplished, but none of it can be dismissed as fantasy.”162 They argued that the optimal time to establish a regulatory system to protect society from those grave dangers is before any harmful powers of biology become commonplace.

The researchers’ Sloan funded work began before 9/11, when they began to examine existing rules and laws governing biological research in the United States and other nations, particularly the United Kingdom. Steinbruner and colleagues then conducted a series of workshops Governance of science around the world to explore the best ways to manage must be based on global public health interests, the risks of powerful biotechnologies, and they rather than national developed a network of scientists, arms control security interests. experts, information specialists, lawyers, regulators, and institutional experts to inform their draft oversight plan. In 2007, Steinbruner’s group finalized the prototype Biological Research Security System (BRSS).162 If implemented, they hoped it would protect the global population from any dangers of bioscience advances so “judgments are based on social consequences, not just scientific merit.”163

Designed to encompass all biological research around the globe, the BRSS would require licensure for all biological scientists and peer review of all projects before they began. Projects would be placed into one of three categories based on the level of danger and degree of oversight required to assure safety; most research would require little oversight.164 Local

84 Responsible Stewardship of Powerful Biotechnologies consultation, within a university, for example, would be recommended for low concern activities; national consultation would be required for research involving specific dangerous pathogens; and international consultation would be required for work “with the potential to create agents significantly more consequential than those currently known.”164 The group made a BRSS software package available for research centers that want to collect and analyze information about their biological research activities and have projects reviewed for dual use concerns.165

The prototype BRSS was controversial and was not embraced by the scientific community. In 2003, Ron Atlas, then president of the American Society for Microbiology, said that requiring scientists, institutions, and even experiments to be licensed “would have a devastating, chilling impact on biomedical research.”166 Some questioned whether it would be feasible to establish a global regulatory regime when one had never been established in a nation,166 and many favored self governance or an institution based approach to mitigating risks of dual use biological science.132,167

Although many scientists did not agree with Steinbruner’s approach, Olsiewski believes the group was able to “move the conversation,”168 by showing that other approaches to research oversight, including those recommended by the NSABB, seemed more reasonable once compared with Steinbruner’s BRSS.169

Although he believes that American scientists will not accept greater oversight, Steinbruner is hopeful about the international scientific community. In meetings and workshops held in Africa, East Asia, Russia, and the Middle East, non US scientists have not reacted as negatively as US scientists to the idea of greater oversight. Despite US resistance, Steinbruner

85 Preparing for Bioterrorism thinks oversight is inevitable170 and stresses that scientists “should anticipate that systematic oversight is going to be a requirement, work it out so it is not done in the wrong way―do it yourselves rather than having it done to you by upset and angry people.”170 Steinbruner has continued to recommend his oversight framework after the 2011 2012 controversy surrounding publication of the H5N1 papers, and he continues to emphasize that governance of science must be dominated by global public health interests rather than national security interests.171

Options for Governance of Gene Synthesis

Rational Guidance to Limit Access to Mail Order Pathogens

In July 2002, Eckard Wimmer, distinguished professor at the State University of New York at Stony Brook, associate professor Aniko V. Paul, and then postdoctoral fellow Jeronimo Cello made headlines when they created a polio virus from scratch.142 In their Science magazine article, they described how they painstakingly strung together sixty base pair pieces of DNA, purchased from a made to order DNA supplier, to build DNA molecules encoding the ~7,500 base pair virus. Once the DNA was transcribed into RNA and translated into proteins in a test tube, they had infectious polio virus. It took three years to perform this work. In a follow up interview in the

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New York Times, Wimmer noted, “You no longer need the real thing in order to make the virus and propagate it.”172

The publication immediately caused alarm among policymakers, especially when it became widely known that the genetic information for polio virus, as with most other viruses, is freely available on the Internet. As Wimmer reflected, “It was immediately predicted correctly that a similar method could be used to synthesize any virus, including smallpox. . . . Moreover, the question arises as to whether a virus whose ‘formula’ genome sequence is known can ever be eradicated.”173 He described the paper as a wake up call.173

Less than two years after the poliovirus paper was published, a research team based in the J. Craig Venter Institute ( JCVI) published its de novo synthesis of the 5,386 bp bacteriophage X174 (polio was 7,500 bp), which took them just two weeks.174 A little over one year later, another research team published an article about its resurrection of the Spanish influenza virus by chemical synthesis.143 Then, in 2010, J. Craig Venter and colleagues synthesized an entire bacterial genome and “booted up” a synthetic cell.175 Venter described the cell as “the first self replicating species we’ve had on the planet whose parent is a computer. . . . This is a philosophical advance as much as a technical advance.”176 The philosophical questions are likely to continue, especially if George Church from Harvard University and his colleagues from Pennsylvania State University are successful in developing the technologies required to change the 400,000 sites where an elephant genome differs from a woolly mammoth and bring an extinct animal back to life.177-179

These demonstrations of the power and speed of new technologies are coming from world class laboratories. Creating a viable pathogen from scratch is not technologically simple, and assembling the genetic material is

87 Preparing for Bioterrorism just the first step in a complicated process. However, that process is now as difficult as it will ever be, and the tools needed to make both the short pieces of DNA that characterized the polio work and gene length DNA pieces of 52,000 bp are increasingly accessible. The number of companies providing those services is growing, and the price is falling as demand increases. DNA is needed for basic research, vaccine development, and development of other biotechnology products, including biofuels.180,181

Creating effective regulations that do not hinder positive uses of a rapidly evolving technology requires careful thought. To support that effort, the Sloan Foundation provided funding for commercial suppliers, government leaders, and other stakeholders to work together for nearly two years to examine the best options for governance. The group included Robert Friedman from JCVI; Michele Garfinkel, then of JCVI and now at the European Molecular Biology Organization (EMBO); Drew Endy, then at MIT, now at Stanford; and Gerald Epstein, formerly at CSIS, and now at DHS. The group assessed the current state of the technology, then identified risks and benefits to society and formulated options for governance.182 Their final report, issued in October 2007, offered an array of policy options for regulating gene synthesis and described the advantages and disadvantages of each option.182,183

The policy interventions focused on commercial firms that sell synthetic DNA, the owners of laboratory “benchtop” DNA synthesizers, and DNA users and their research institutions. The group considered government regulations, self governance options for commercial suppliers, screening software to detect suspicious synthesis orders, and greater institutional review of synthesis orders by researchers. As Friedman explained: “Somebody

88 Responsible Stewardship of Powerful Biotechnologies had to take the time to look through each potential intervention point for opportunities to reduce risk.”184

By 2006, the US government was interested in changing regulation of synthetic biology. The NSABB was asked to examine the security issues related to synthesis of regulated pathogens (“select agents”) to provide advice on “whether current United States Government (USG) policies and regulations adequately cover the de novo synthesis of select agents or whether additional biosecurity measures are necessary.”185 Commercial gene foundries were proactive in considering the risks from gene synthesis and formed two international industry associations to develop standards for screening customer orders.186,187 The governance of gene synthesis was also a major focus at some synthetic biology users’ conferences, which also drew Sloan support.

The discussions and identification creating a viable pathogen of oversight options led to government from scratch is not action. On October 13, 2010, HHS released technologically simple, but that process is now as Screening Framework Guidance for Providers difficult as it will ever be. of Synthetic Double Stranded DNA,140 which asks suppliers of double stranded DNA to screen orders against GenBank, the NIH genetic sequence database that is an annotated collection of all publicly available DNA sequences. The guidance calls for suppliers to screen customers as well, to ensure compliance with US trade restrictions and export controls. If sequence screening determines that a customer has requested genetic material available only to those with clearance to work with select agents, then the customer must be in compliance with select agent regulations.

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Some hoped the US government would impose stricter controls on DNA synthesis by, for instance, regulating oligos, which are single stranded pieces of DNA. George Church, a professor at Harvard Medical School and a leader in synthetic biology research, wrote years ago that all DNA synthesis should be more regulated, that the sales of the machines and supplies should be limited to licensed buyers, and that “all use of reagents and oligos would be automatically tracked and accountable (as is done for nuclear regulations).”188 An NAS committee described a possible screening system that might eventually be useful for predicting the danger, or pathogenicity, of a sequence.189

However, stricter regulations would be difficult to put into practice without imposing greater burdens on US scientists performing legitimate research.190 Gene synthesis is an international business, and companies outside the United States are not subject to US regulations. If it becomes too onerous to go through commercial suppliers, scientists may make the genes they need themselves, obviating the usefulness of regulation of commercial suppliers. A 2010 presidential commission examined the current approach to governance in synthetic biology more broadly and did not recommend increased controls at this time.191,192

Ensuring that regulation and guidance keep pace with rapid advances in DNA synthesis is a challenge, especially given the international availability of the technologies. By delineating all policy options shaped by scientific and security expertise, the Sloan funded governance project successfully steered US government policy in a rational direction.

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Educating Scientists about Dual-Use Science

Deliberative Seminars for Scientists Worldwide

Brian Rappert, a sociology professor at the University of Exeter, England, and Malcolm Dando, a biologist, international security professor, and arms control expert at the University of Bradford, England, have circled the globe to engage scientists and policymakers directly in conversations about mitigating the risks of dual use biotechnology.

Rappert and Dando began their work in 2005 in the United Kingdom with a series of modified focus groups that they called “deliberative seminars”; the seminars were funded by the Sloan Foundation. The pair’s discussions with British life science researchers generally indicated that the scientists were not aware of and had not considered policymakers’ concerns about dual use security issues.193 Rappert and Dando questioned why scientists were not engaged in political discussions of dual use issues that required their input and affected their work, and they found that the subject was not part of scientists’ education or training. Dando realized that “it would be very, very rare to meet any practicing life scientist who knew anything at all about the issues of concern to people like me who had contact with the security community.”194 Scientists may not have been concerned, but policymakers were, and the deliberative seminars proved useful for sparking dialogue

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and understanding across professional lines. The pair’s experience with the seminars led Rappert and Dando to develop educational modules that could be incorporated into science education.

In a recent interview, Rappert said they have visited fifteen countries, including China, India, Israel, Japan, Kenya, the Netherlands, South Africa, Finland, and the Ukraine, where they have conducted more than 130 seminars on dual use concerns and held numerous meetings with government and professional policymakers.193 Rappert described the seminars as having “a two fold purpose: to inform participants about current life science security debates and to generate discussion about how research findings should be communicated, whether experiments Strengthening norms against should be subject to institutional oversight, misuse of biological science requires ongoing commitment. and how the funding of research is being affected by concerns about biothreats.”195 The pair has reached more than 3,000 scientists through global seminars and a website that offers training materials, articles, and books on dual use issues.195 They built the website with colleagues at the University of Bradford to make publications and additional resources on the topic widely accessible.

It has long been recognized that life scientists should be more aware of security issues and that dual use science should be part of their education. The first recommendation of the 2004 Fink Report was for “national and international professional societies and related organizations and institutions [to] create programs to educate scientists about the nature of the dual use dilemma in biotechnology and their responsibilities to mitigate its risks.”139 In 2009, the National Security Council affirmed that “life scientists are best positioned to develop, document, and reinforce norms regarding the

92 Responsible Stewardship of Powerful Biotechnologies beneficial intent of their contribution to the global community” and that it would be part of the US strategy for prevention of biological threats to assist “professional societies and other representatives of the life sciences community in the development of relevant educational and training materials” for scientists.196 It requires a lot of persuasion and work, though, to translate a general consensus that education is a desirable goal into the action required to accomplish that goal, and each country has specific needs. Rappert concurred: “Each country requires specific action. You need to assess country by country what might work. It can’t be done alone by governments; it has to be done in collaboration with practitioners and professional organizations.”193

Strengthening norms against misuse of biological science requires ongoing commitment to educating scientists in order to reach each new generation of researchers in every country and to keep practicing scientists up to date. Dando agreed: “Given the multitude of possible ways in which the life sciences can be misused in the future, I’m more and more coming to the opinion that strengthening the norm amongst practicing scientists is going to be one of the major restraints on misuse. We just can’t rely on laws.”194 Rappert pointed out reason to hope that biosecurity education could become part of global science education: “Thirty years ago, the idea of biosafety training was met with resistance from many quarters. That attitude changed over time. How can we elicit the same change with biosecurity?”193

Rappert’s and Dando’s work in engaging scientists and policymakers internationally did help spur BWC action. In 2011, dual use education was discussed by the 165 States Parties of the BWC during the Seventh Review Conference. Working with several states they visited as part of their Sloan

93 Preparing for Bioterrorism work, particularly Switzerland and Japan, Rappert and Dando helped secure a broad base of support for education initiatives.197 The BWC had discussed the need for biosecurity education in 2005 and again in 2008,198 but in the Final Declaration of the 2011 meeting, it was agreed that the topics of education, awareness raising, and training programs for scientists were important enough to be standing agenda items in the yearly intersessional meetings. Working in collaboration with governments and nongovernmental organizations, Rappert and Dando continue to push for meaningful biosecurity education activities and programs.

Setting International Priorities for Biosafety and Biosecurity

The International Council for the Life Sciences

The International Council for the Life Sciences (ICLS) began in December 2005 as a nonprofit, nonpartisan organization specializing in international biosafety and biosecurity, but focused mainly on the Middle East and North Africa (MENA) and in Central Asia and Russia. A grant from the Sloan Foundation allowed the organization to branch off the International Institute for Strategic Sciences to become a freestanding, membership based organization.

94 Responsible Stewardship of Powerful Biotechnologies

The first major event for ICLS was the 2007 Biosafety and Biosecurity International Conference (BBIC) in Abu Dhabi,199 which drew more than one hundred scientists and policymakers from twenty six countries.200 This conference began what came to be known as the “BBIC process,” in which ICLS serves as secretariat, but priorities for action are set by a region’s scientists and policymakers.200 The first priority for the Abu Dhabi meeting was to develop a regional biosecurity strategy for shared food and water resources.200 Despite political differences, all MENA nations have common problems with food and waterborne diseases, especially shigella. “If you find the area of convergence of interest of these nations, then you can broaden that to expand to areas of interest that have more global benefits,”201 explained Terry Taylor, president of ICLS. “The objective is to improve their processes for dealing with a broad spectrum of biological risks.”201

The BBIC process continued in Casablanca in April 2009, with a conference funded by the Kingdom of Morocco’s ministry of education and Jordan’s Royal Scientific Society.202 One of the important outcomes of this meeting was the creation of the Moroccan biosafety organization in November 2009.202 Jordan was the site of the 2011 BBIC, and the 2013 BBIC in Lebanon is being planned. In addition, the BBIC process includes technical workshops, assistance with development of national biosafety associations, advisory panels, and biosafety training. Each of the conferences has a theme; for 2011 it was affordable biosafety.203

The work done to bring the technical and political leaders of this region together is not easily accomplished by any government. “Sloan should be commended for being farsighted and seeing that this process had benefits,” according to Taylor.201 Having a record of involvement on both technical

95 Preparing for Bioterrorism and political levels has allowed the BBIC process to continue over the years in times of greater political tensions. If anything, the political tensions have increased the desirability and importance of the BBIC process.

ICLS is now applying its skill in consensus building to a new topic synthetic genomics. In a Sloan funded effort, the group is helping different synthetic genomics professional associations develop and refine codes of conduct for responsible research.201

A Global Culture of Responsibility in the Life Sciences

WHO Guidance on Responsible Life Sciences Research

As the public health arm of the United Nations, the WHO provides global leadership on health concerns and technical assistance for member states in fighting disease and constructing sound health policies. Traditionally, the WHO had not led global discussions of biological weapons and divisive security issues. The organization’s 1970 report Health Aspects of Chemical and Biological Weapons was not updated until 2004. This followed a 2002 World Health Assembly ruling (WHA55.16) that the WHO does indeed have responsibilities in a biological incident, “whether it is characterized as a

96 Responsible Stewardship of Powerful Biotechnologies natural occurrence, accidental release or a deliberate act,” and urged member states to treat any deliberate use of a biological agent as a global health threat.204

WHA55.16 instructed the WHO to provide technical assistance to member states on biosecurity issues, but it was the Sloan Foundation’s investment that enabled the WHO to help build member states’ capacity to promote a culture of responsibility in the life sciences. The six year project, Responsible Life Science Research for Global Health Security, promoted a three pillar approach to building public health capacity: research excellence, sound ethics, and increased laboratory biosafety and biosecurity.205

Starting in 2004, Sloan Foundation support allowed the WHO to enhance its in house capacity to provide guidance and technical support to member states and establish contacts on global health There is no single security in the six regional WHO offices. In solution or system that 2005, the WHO began pursuing a Sloan funded will suit all countries effort to develop a working paper on dual use and all laboratories. issues in biotechnology: “Life Science Research Opportunities and Risks for Public Health: Mapping the Issues.”206 Next came the 2006 report Scientific Working Group on Life Science Research and Global Health Security: Report of the First Meeting, which outlined priority areas for WHO guidance, including raising awareness, advancing preparedness, assessing risk, building capacity, and overseeing research.207

In 2007, the WHO held a meeting in Bangkok to bring together representatives from Asian Pacific countries and research experts in the life sciences. The meeting had several purposes: increase countries’ understanding of the public health risks posed by advances in the life

97 Preparing for Bioterrorism sciences and options for risk management; exchange information about and experience with related policies and best practices; identify countries’ needs and priorities; and draft recommendations for research policy and management.208

In addition, the WHO and the US NSABB cosponsored an International Roundtable on Dual Use Life Sciences Research in February 2007.209 The aim of this meeting was to start a dialogue about the management of dual use research among scientists from Australia, Argentina, Bulgaria, Georgia, India, Israel, Morocco, the Netherlands, the People’s Republic of China, Poland, Spain, Switzerland, Uganda, and the UK and representatives from international organizations and scientific societies. The roundtable objectives included determining what various countries were already doing in this area and promulgating NSABB draft work products that included criteria for identifying DURC, elements of a code of conduct, and methods for the appropriate communication of dual use research.

The culmination of the WHO’s Sloan funded multiyear, multifaceted project was publication of the report Responsible Life Sciences Research for Global Health Security: A Guidance Document.205 Intended for a worldwide audience of life science researchers, laboratory managers, and research institution officials, the document includes a self assessment questionnaire for the WHO member states to evaluate their strengths and weaknesses in preparedness. As “there is no single solution or system that will suit all countries and all laboratories,”205 the guidance steers the member states into crafting biosecurity solutions that can work for their unique situations.

98 CHAPTER 5

Public Health Law for the 21st Century

Public health law was neglected and did not keep pace with societal change over time.

n the United States, 1952 was the worst year for polio.210 More than 57,000 patients filled hospital wards; most were infants and children. Of I the stricken, 3,000 died and 21,000 were left permanently paralyzed.210 The imagery of polio iron lungs, the airtight chambers that forced patients’ diaphragms to expand and contract so they could breathe, and March of Dimes posters featuring children in leg braces Laws just atrophied 211 because there was no inspired widespread fear. But all of that changed need for them. when a polio vaccine became available. Mass trials of vaccine began in the United States in 1954, and by 1965, fewer than one hundred cases were reported.212,213 The last US epidemic, which occurred in 1979, was an anomaly:

99 Preparing for Bioterrorism polio struck in an Amish community whose members refused the vaccine that was by then part of the routine childhood immunization schedule.213 Gaining control of polio entailed a massive public health effort, but once the threat was eliminated, public health visibility in the realm of infectious diseases decreased, and some laws that public health officials depended on atrophied.214 Public health officials and workers still had to be able to isolate sick people to protect the healthy from contagious disease, and they still had to be able to order tuberculosis patients to take their medication or be jailed for noncompliance.215,216 With polio gone, though, so were the once routine signs that declared swimming pools closed, prohibited public gatherings, or restricted travel “By Order of the Board of Health.210,211

After the polio epidemic ended, public health law was neglected and did not keep pace with societal change over time. Decades after the polio era of the 1950s, some states still had laws on their books that granted public health officials tremendous powers to restrict travel, institute quarantine, and order compulsory medical treatment. However, there was no guarantee that those laws would be upheld in an emergency, especially given the Warren Court’s reforms of due process and civil liberties in the 1960s, which opened to challenge the existing broad public health powers.217

In a recent interview, Gene Matthews, who served as chief legal advisor to the CDC from 1979 to 2004,214 suggested that political skill withered along with public health law after the 1950s. He pointed out that public health officials had to be well connected in local politics and politically astute to mount successful mass vaccination campaigns, cancel sporting events, close public facilities, or declare quarantines in the name of disease control. In comparing then and now, Matthews observed that “there was this rich linkage

100 Public Health Law for the 21st Century between the law and public health and between public health and politics, and [then] we went into this era of what’s called ‘narrow public health.’”214,218 Explaining further, Matthews added, “We wear white coats, and we do not get dirty with what goes on at the city council, at the county commissioner’s office, at the state capital, and anything happening across the Potomac River, so all those laws just atrophied because there was no need for them.”214

Thus, by 2001 only a handful of states had revised the outdated public health laws on their books,219 leaving open the possibility that in the event of a health emergency such as a bioterrorism attack, officials would be left without the legal tools needed for response. They could, for instance, find themselves without the legal authority to act quickly and without hindrance to protect the uninfected, treat the infected, prevent the spread of disease, and manage the consequences.

A fortuitous turn of events in late 2000 helped correct this situation. Paula Olsiewski had joined the Sloan Foundation as director of the biosecurity program and began inquiring about the nation’s biosecurity needs. After talking with Matthews, Larry Gostin from Georgetown University, and other leaders in the field, she made the foundation’s first grants in this area to support projects aimed at updating public health law. As a result, the Sloan Foundation was instrumental in remedying the neglect of public health law that occurred after the end of the polio era and ensuring that laws were updated to meet twenty first century public health needs.

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Modernizing Public Health Powers

The Cantigny Conference on State Emergency Public Health Powers and the Bioterrorism Threat

In January 2001, Olsiewski called Gene Matthews, then chief legal advisor at CDC (now director of the Southeastern Regional Center of the Network for Public Health Law), to ask what help the agency needed to prepare for a bioterrorist attack. At that time, Matthews had on his desk an internal report indicating that at least half of the fifty United States had not updated their emergency preparedness laws since 1930.214 Matthews’s reply to Olsiewski, therefore, was, “We’ve got a problem with these state laws. Nobody knows how to quarantine, and they don’t know if they have the authority. How would they implement them in an emergency situation? We need to educate, and we need to get some people together and talk about it.”214

Olsiewski agreed, and her first grant as director of the Sloan Foundation’s biosecurity program was to underwrite the April 2001 Cantigny Conference on State Emergency Public Health Powers and the Bioterrorism Threat. The conference was sponsored by CDC, the American Bar Association Standing Committee on Law and National Security, and the National Strategy Forum. It brought together groups that had not traditionally worked with each other: public health attorneys, national security attorneys, public health officers,

102 Public Health Law for the 21st Century members of the national defense community, academics, and experts from nonprofit organizations.220

The conference had four objectives: (1) identify public health powers that would be needed in a bioterrorism event, (2) assess the status of current emergency health powers, (3) determine the gaps in such powers, and (4) develop a framework for future action.220 Over the two day meeting, participants agreed that many legal authorities for responding to an emergency existed, but many had to be re examined, especially those laws that had been passed fifty to eighty years earlier. They also observed that public health officers in many states could be unaware of the legal authorities they had and lack access to expert legal advice. The conference participants emphasized that, for all states and In at least half of the fifty jurisdictions, the procedures for rapid public united states, emergency health decision making had to be tested and preparedness laws were not rehearsed to be effective in an emergency. updated between 1930 and 2001. At the close of the session, the Cantigny conference participants declared the actions they would personally take to promote the conference objectives, such as analyzing their state’s emergency powers laws or drafting executive orders that political leaders could use in an emergency.220

The April 2001 Cantigny conference was followed not long after by 9/11 and the anthrax letters. The day after the first anthrax case was reported, Matthews read that many state legislators were planning to convene the following January (2002) to enact tough new legislation about bioterrorism. “But we had all been thinking about how we get public health statutes revised,” he explained. “We needed to channel that energy in a direction

103 Preparing for Bioterrorism beneficial for public health.”220 Matthews immediately called Larry Gostin at Georgetown University. Gostin was working on a Sloan funded project to address legal aspects of bioterrorism preparedness and response.

Gostin told Matthews that he had already started compiling a database of all state laws related to emergency powers.221 Matthews replied that they would need to use that data to create model legislation before the end of the year before the state legislators convened in January 2002 if their work were going to have any impact on policy. Then, Matthews recollected, “Larry [Gostin] asked, ‘What should be the organizing structure?’ and I said, ‘Let’s follow that outline in Appendix A to the Cantigny Report.’”222

The Cantigny conference participants had already detailed a long list of public health powers that would be needed in a bioterrorism event. That list became “Appendix A” of the conference report.220 Those necessary powers included: collection of records and data from hospitals, pharmacies, workplaces, and the like; control of property, to include the ability to close facilities or use them temporarily to provide medical care; management of people, to include instituting isolation or quarantine; and access to communications and public relations, to include the ability to establish a command center. The Cantigny list of public health powers needed in an emergency thus became the basis for the 2001 Model State Emergency Health Powers Act.223

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Fortifying Essential Public Health Powers

The Model State Emergency Health Powers Act

In spring 2001, Larry Gostin, global health law professor at Georgetown University and director of the Centers for Law and the Public’s Health at Georgetown and Johns Hopkins Universities, initiated what was to be a three year Sloan funded project to address legal aspects of bioterrorism. Gostin and his colleagues intended to use the year one Sloan funding to draft model legislation that would give state and local public health officials appropriate legal powers in a bioterrorism emergency. The tragedies of 9/11 and the subsequent anthrax attacks dramatically sped up the project’s timeline: States were demanding it, and CDC needed model legislation quickly because of the great concern about biosecurity that followed the anthrax attacks.

Within weeks, the team charged with drafting the legislation at the Centers for Law and the Public’s Health put forward its first version of the Model State Emergency Health Powers Act (MSEHPA). The draft act drew from three primary sources: proceedings from the Cantigny conference;220 experience with an earlier effort to develop a broad model public health law, which produced the Turning Point Model State Public Health Act;221 and data on existing state laws that already had been collected by the centers. Once

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MSEHPA became public in October 2001, the centers received and addressed hundreds of comments before publishing it on December 21, 2001.223,224

MSEHPA gave policymakers a menu of options for granting states the power to conduct five basic public health functions in an emergency: preparedness, surveillance, management of property, protection of people, and public information and Within ten years of msehpa, 225 twenty six states and the communication. The model act also district of columbia had used the term “public health emergency,” crafted “public health which was defined as an imminent threat emergencies” into their laws. that “poses a high probability of . . . a large number of deaths in the affected population; a large number of serious or long term disabilities in the affected population; or widespread exposure to an infectious or toxic agent that poses a significant risk of substantial future harm to a large number of people in the affected population.”223 The drafters’ definition was formulated carefully to trigger public health authorities necessary for a rapid public health response to such threats as anthrax, smallpox, or flu, but to avoid triggering those authorities for other serious but not acute public health threats, such as HIV.224

MSEHPA authorizes timely disease reporting and data collection and exchange. During a public health emergency, state and local officials are authorized to use and appropriate property as necessary for the care, treatment, and housing of patients. They are also empowered to provide care, testing, treatment, and vaccination to people who are sick or have been exposed to a contagious disease and to separate infected people from the population at large to interrupt disease transmission. At the same time, the act

106 Public Health Law for the 21st Century recognizes that a state’s ability to respond to a public health emergency must respect people’s dignity and rights.225

The model act was extraordinarily successful. Within five years, thirty nine states had passed bills related to MSEHPA.224 Within ten years, by 2011, twenty six states and the District of Columbia had crafted “public health emergencies” into their laws.224 The Turning Point Model State Public Health Act, a tool for state, local, and tribal governments to use in assessing their public health laws and identifying areas in need of update and improvement, had a section based on MSEHPA.221 On the federal level, HHS was vested with similar “public health emergency” declaration authority through the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.226 Other nations, including the United Kingdom, Canada, China, India, Australia, and New Zealand, introduced similar legislation. In 2007, the WHO’s updated International Health Regulations integrated themes from MSEHPA in its definition of a “public health emergency of international concern.”224 Most recently, the Institute of Medicine praised MSEHPA in its June 2011 report For the Public’s Health: Revitalizing Law and Policy to Meet New Challenges and recommended that state and local governments continue to review existing public health laws and modernize them as necessary.227

Not everyone applauded the act, though. MSEHPA triggered public debate about the proper balance between personal rights and the common good.228 Critics objected to compulsory powers to vaccinate, test, medically treat, isolate, and quarantine, even though, in fact, all are standard public health powers. As Gostin wrote in Health Affairs in 2002, “The MSEHPA was designed to defend personal as well as collective interests. But in a country so tied to rights rhetoric on both sides of the political spectrum, any proposal

107 Preparing for Bioterrorism that has the appearance of strengthening governmental authority was bound to travel in tumultuous political waters.”225 Gostin, who had his American Civil Liberties Union (ACLU) membership card torn up, on television, by the head of that organization, observed that “there was a complete failure to understand the model act, because it actually had very strong safeguards of individual rights while still protecting public health.”229 All told, though, critics were a tiny minority in the response to the many experts who have described these changes to public health law as ranking “among the most significant public health law reforms in history.”224

Gostin acknowledged that if the US experiences another public health emergency like the 2001 anthrax attacks, response would not be perfect, but it would be much better because of MSEHPA: “The model public health law requires preparedness training, which has been funded by the federal government. It gives states more power but also tells them that they must exercise that power within the rule of law. To me, all that suggests that we would have a more effective and more civilized way of dealing with an emergency.”229

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Protecting Good Samaritan Organizations

Liability Protections for Organizations that Assist in Disaster Response

Most states have Good Samaritan laws to provide legal protections for people acting in good faith who provide assistance in an emergency, and in some states, these protections extend to licensed healthcare practitioners. However, most Good Samaritan laws do not protect organizations, including businesses and nonprofits, that assist the government in responding to a disaster. This leaves “significant gaps of liability exposure”230 that could inhibit organizations from providing assistance in a public health emergency.

Why would an organization need Good Samaritan protection? Because, for instance, a church that offers its facilities for shelter could face liability exposure for disease transmission or other injuries that occur in that shelter, as could an organization that provides food to emergency workers if the workers get sick.230 Even an organization like the Red Cross would need liability protection should volunteers deployed in a disease emergency get sick.231 In 2006, with a grant to the North Carolina Institute for Public Health at the University of North Carolina Gillings School of Global Public Health, the Sloan Foundation helped fill this gap in preparedness by supporting establishment of the Good Samaritan Entity Liability Protection Initiative.232

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With this funding, Gene Matthews and Edward Baker, director of the North Carolina Institute for Public Health, created templates that outlined key elements of Good Samaritan liability protection for businesses and nonprofits like the Red Cross that participate in emergency response.230 These protections are triggered only when a state declares an emergency, they apply only to emergency activities conducted in coordination with a state agency, and they cover pre event planning and training activities that take place before an emergency is declared.230

The initiative’s team worked with members of other public health organizations, including the American Public Health Association (APHA), the Association of State and Territorial Health Officials (ASTHO), the National Association of County and City Health Officials (NACCHO), and the CDC,230 but it was a series of reports from There is still no federal policy for Good Samaritan the organization Trust for America’s Health liability protection. (TFAH) that called the most attention to the issue.233 Beginning in 2007, TFAH added liability protection to the list of preparedness indicators that the organization used in Ready or Not? Protecting the Public’s Health from Diseases, Disasters, and Bioterrorism,233 its annual assessment of states’ public health preparedness. Once TFAH reported that many states did not have the appropriate level of Good Samaritan liability protections in place, change occurred. By 2009, thirty three states and the District of Columbia had either enacted the liability laws for entities or made a formal determination that their existing laws provided such protection.234

There remains a gap in protection from liability exposure, though, because there is still no federal policy that accords Good Samaritan liability

110 Public Health Law for the 21st Century protections. This means that a nationwide business that was willing to assist the government in a disaster would have to establish different policies in every state instead of relying on a nationwide policy. What has been proposed is a way to ease concerns about liability but still allow claims to be settled. As was described in TFAH’s 2009 report,234 the federal government could apply the provisions of the Robert T. Stafford Disaster Relief and Emergency Assistance Act (Stafford Act) to create a national standard for liability protection. The Stafford Act allows the federal government to pay certain costs related to state emergency activities, which means that a lawsuit filed against an organization acting in good faith could be resolved through a state’s administrative torts claim mechanism, and the federal government could then reimburse the state for any costs incurred.234 A federal solution would allow nationwide businesses to have nationwide policies to help the government in a bioterrorism emergency. This important next step in legal preparedness could encourage companies to help the government in the immediate response to an event and could prompt large companies to participate in drills and training with government partners.

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Building Bioterrorism and Public Health Law into Law School Curricula

The Pacific McGeorge School of Law’s Curriculum Updates

In March 2003, the University of the Pacific McGeorge School of Law held the Sloan funded two day workshop Creating a Model Syllabus for Bioterrorism and Public Health Law. “Bioterrorism and national security were certainly on people’s mind,” observed law professor Leslie Gielow Jacobs, director of the Capital Center for Public Law and Policy, who organized the meeting with her colleagues J. Clark Kelso and law school dean Elizabeth Rindskopf Parker.235 Since 2003, SARS, pandemic flu, and ongoing concern about smallpox and other pathogens have kept biosecurity issues salient in public health law and have confirmed the relevance of the conference. Explained Jacobs: “The importance of the subjects discussed in this conference has become more obvious because of the wars, claims of bioterrorism, concerns about dual use research and civil liberties, and the intersection between individual rights and the right of the state to protect national security.”235

Law professors, lawyers, and public health practitioners from around the country attended the workshop,236 which aimed to encourage and

112 Public Health Law for the 21st Century facilitate teaching and scholarship in the nation’s law schools related to bioterrorism and public health.237 Participants created four model syllabi and sets of teaching problems, all still posted on the McGeorge bioterrorism website.237 The model syllabi are composed of discrete units so professors can incorporate public health law materials into other regular courses in the law school curriculum, including constitutional law, criminal law, and torts.

In June 2003, Jacobs compiled the four class teaching module “Bioterrorism, Infectious Diseases and Constitutional Rights,” which is still available by request at the same McGeorge website. The module covers constitutional implications of quarantine and vaccination and free speech and national security limits on disseminating dangerous information. It was distributed to all American Bar Association law schools. It is important to think about legal issues and legal McGeorge encouraged law schools to use structures before the workshop materials in their courses, and emergencies happen. nineteen schools have requested information on the curriculum. In 2003, the McGeorge participants worked on creating the National Security Law Section that was inaugurated in January 2004 within the Association of American Law Schools.235 In 2004, McGeorge also published the first issue of the Journal of National Security Law and Policy, which has published articles on laws pertaining to bioterrorism and infectious disease.238

Jacobs believes that graduates who work in policymaking positions will have an advantage if they understand biosecurity and public health issues. She believes that efforts to update law school curricula to include these issues “developed awareness that people took home that likely caused them

113 Preparing for Bioterrorism to infuse public health issues into their law school teaching. The message delivered and received was that it’s important to think about legal issues and legal structures before emergencies happen.”235 This, too, is an important part of modernizing public health law for the twenty first century.

114 CHAPTER 6

Preparing Businesses for Terrorism and Other Emergencies

The private sector has a major role to play in government planning for emergencies.

ith control of an estimated 85 percent of critical infrastructure in the United States, the private sector drives the US W economy.239 Yet growing risks from terrorism, natural disasters, technological crises, and other sources have made businesses increasingly vulnerable to disruption.240 For this reason alone, the private sector has a major role to play in government planning for emergencies. After 9/11, businesses and other private sector organizations increasingly acknowledged the need for organization wide emergency management and business continuity programs.241 In the United States, in the years since, hurricanes and tornadoes in the South and Southeast, wildfires in the

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Southwest, and a blackout in the Northeast have all served to underscore this need. Corporate preparedness using an all hazards approach can reduce the devastation of such wide scale catastrophes and help protect profitability.

Persuading businesses to adopt preparedness measures is not an easy sell, as investments in preparedness must serve the bottom line.242 The Sloan Foundation’s interest in strengthening the response of civilian institutions to disasters led to the development of financial incentives to prod corporate preparedness. To accomplish that, businesses and policymakers needed reliable data to make the financial case, a set of criteria that defines preparedness, and an objective measurement that confirms criteria have been met.

Developing Standards for Business Preparedness

A Framework for Voluntary Preparedness

On August 3, 2007, Implementing Recommendations of the 9/11 Commission Act of 2007 was signed into law.243 Title IX of the act called for creation of a voluntary business preparedness standards program to both promote preparedness and establish a measurable standard to

116 Preparing Businesses for Terrorism and Other Emergencies gauge a company’s preparedness. The law gave DHS the lead on building this program, but it also called specifically for private sector input for implementation.

The process for choosing a suitable national standard was immediately contentious. Two organizations had already formulated business continuity or preparedness standards.244 There was some competition between them, as each wanted to be seen as having the standards most broadly applicable to the nation’s businesses. Paula Olsiewski, with help from Bruce Blythe, CEO of Crisis Management International, and Bill Raisch, director of the International Center for Enterprise Preparedness (InterCEP) at NYU, brought together representatives from standards organizations and experts in business preparedness to find points of consensus. That meeting took place in October 2007, when representatives from three major standards organizations the American National Standards Institute (ANSI), the National Fire Protection Association (NFPA), and ASIS International met at the Sloan Foundation offices in New York with emergency response experts from Walmart, Goodyear Tire and Rubber Company, Target, Home Depot, and business continuity firms. “We brought together the Hatfields and McCoys,” Blythe said.245

During the meeting, a small group was asked to write a consensus report that could serve as private sector input for DHS. “Framework for Voluntary Preparedness” was written by Marc H. Siegel, Al Berman, Donald L. Schmidt, and Carol Fox, representatives from ASIS International, Disaster Recovery Institute International, NFPA, and the Risk and Insurance Management Society, Inc.246

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The authors identified core elements of preparedness in established regulations with which businesses already complied. This meant a company could work to comply with the standard it preferred, and if core elements were satisfied, then preparedness performance could be improved. The authors thought that “. . . greater resiliency success will be achieved if businesses are given the freedom and flexibility to determine how they will improve preparedness in a way that best fits their respective business models.”246 According to Al Berman, one of the Greater success will be report’s authors, this approach would give DHS achieved if businesses are some early success, as many large companies given the freedom and would find that they were already in compliance, flexibility to determine how they will improve and they would push compliance down to their preparedness. suppliers.247 For the program to be successful, this type of push would be essential because there was no tangible incentive or tax credit written in the legislation to reward businesses for compliance. Berman suggests there are additional barriers to participation, as companies may be reluctant to reveal vulnerabilities in the event of litigation, a concern echoed in an InterCEP report on the legal concerns of voluntary business preparedness standards.242,247

Some elements of the Sloan sponsored report are mirrored in PS Prep, the voluntary private sector preparedness program DHS announced on June 15, 2010.248,249 PS Prep allows companies to choose from several applicable standards from NFPA, the British Standards Institution, or ASIS International. Don Schmidt, another of the report’s authors, suggests that in the time since the 9/11 Commission issued its recommendations, the original concern about what could have been done to save more lives has waned, though companies

118 Preparing Businesses for Terrorism and Other Emergencies may be more aware of the need for preparedness.250 Although the program has been slow to gain momentum, it is now starting to certify companies. In March 2012, AT&T was the first company certified under the DHS program, and Secretary Janet Napolitano has urged other companies to follow that lead.251

Business Planning for Pandemic Influenza

CIDRAP’s National Summit and Business Source

In February 2006, more than 300 business leaders from 200 companies braved cold Minneapolis temperatures to attend the two day meeting Business Planning for Pandemic Influenza: A National Summit. The goal of the event was to “give business leaders an opportunity to learn from experts about the risk of pandemic influenza and help figure out how their industries can prepare for it.”252 The summit was organized by Center for Infectious Disease Research and Policy and sponsored by the Sloan Foundation and the US and Minnesota chambers of commerce.

The driving force behind this event was CIDRAP director Michael Osterholm, who is well known for his efforts to get the nation prepared for pandemic flu and bioterrorism. In addition to his academic publications, he wrote Living Terrors,253 a layperson’s guide to biological terrorism

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preparedness, and, on January 24, 2006, he was Oprah Winfrey’s guest for a full hour to discuss pandemic influenza.254 His focus on getting the business community prepared was made clear when he testified before the House Committee on International Relations in 2005:

We can no longer assume that business continuity plans for both our multinational companies and small businesses, largely based on the concept of a regional event of a limited duration, will approximate the actual impact and consequence of an influenza pandemic. Rather, I believe an influenza pandemic will be like a twelve to eighteen month global blizzard that will ultimately change the world as we know it. This will occur even if we experience a mild worldwide pandemic of millions of deaths, rather than many millions of deaths.255

CIDRAP’s business preparedness summit sparked wide interest, attracting representatives from such companies as IBM, Pfizer, Koch Industries, Cisco Systems, DuPont, JP Morgan, Mattel, Travelers, and Walmart, who heard presentations from Michael Leavitt, then secretary If you’ve seen one of HHS; author John Barry; newsman Ted Koppel; pandemic, you’ve seen one pandemic. and former HHS Secretary Tommy Thompson. Subgroups met to discuss continuity planning for specific industries, such as healthcare, manufacturing, transportation, warehousing, and energy. As Osterholm noted at the time, “I think it’s the first conference of its kind to bring together all the various industry sectors to actually work toward determining and addressing current gaps in planning” for the business community.256

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Not surprisingly, the summit attendees were concerned about the effect of pandemic influenza on their businesses. A survey taken during the conference found that 84 percent of respondents “definitely believed a pandemic would disrupt their supply chains.”257 Still, 21 percent had not started planning, and 59 percent said their companies had started working on the issue but did not yet have a plan in place.257

Over the next four years, Osterholm and CIDRAP, with support from the Sloan Foundation, deepened their commitment to helping the nation’s businesses prepare for influenza. CIDRAP Business Source was formed, with US editorial board members that included the Chamber of Commerce, Deloitte & Touche, and International SOS.258 They sent regular newsletters to business executives, held additional flu summits in 2007 and 2009, hosted webinars, and released reports on the pandemic threat to the nation’s power supply. Their recommendations for businesses included: (1) develop a flu emergency operations team with two deep redundancy; (2) educate employees to stay home if they are sick; (3) investigate the preparedness planning of suppliers and contractors; and (4) think ahead about how to satisfy Sarbanes Oxley disclosures during a pandemic.259

Business leaders feared an imminent and devastating H5N1 pandemic, but when H1N1 emerged in 2009, it was relatively mild for most people. Interest in business preparedness for flu waned. On June 2, 2011, the decision was made to suspend the business outreach for flu, although the need for planning remains. As Osterholm warned in his newsletter, “If you’ve seen one pandemic, you’ve seen one pandemic. The 2009 H1N1 pandemic has been declared over. But the emergence of another pandemic remains a threat.”260

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Measuring the Value of Corporate Preparedness

New York University’s InterCEP

InterCEP is the world’s first major academic center dedicated to business continuity and crisis management. The center was established at New York University in 2004 and is directed by Bill Raisch, who served as a private sector preparedness advisor to the 9/11 Commission.

In 2005, with a three year Sloan grant, InterCEP started making the business case for preparedness by identifying economic incentives that would motivate large and small companies to plan for maintaining operations after an attack. To that end, InterCEP focused on what could be done in the legal, insurance, rating agency, and regulatory realms to help businesses and ensure the safety and continuity of critical supply chains. Their work and the work of others paved the way for a 2007 law243 that requires DHS to support development of the voluntary certification program for all hazards business emergency preparedness that became the DHS PS Prep program.

In the business world, the InterCEP initiative was both novel and challenging, explained Raisch:

Corporations are about business, and business is about making profits. . . . The profit motive is the physics of the business

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environment. We can only do so much with jingles and calls to the heart. Without a clear, ongoing business case, the sustaining [preparedness] effort is not going to be there. So we’ve always emphasized the internal business case: What impact does preparedness have on revenue, on expenses, on the balance sheet, and on protecting assets and decreasing liabilities?261

To develop legal incentives for corporate preparedness, InterCEP examined the risks of insufficient planning and proposed a strategy to curb legal liability. Applying the legal principle of “affirmative defense,” a company that has prepared for disaster before an emergency may be able to reduce its liability by offering proof of that preparation after the crisis has passed. With Sloan Foundation support, InterCEP convened a series of roundtables for lawyers from leading corporations, trial attorneys, and others to clarify the legal rationale for corporate preparedness and the value of the affirmative defense approach.

To develop insurance incentives, InterCEP sought to link preparedness to benefits in insurance underwriting, pricing, and policy terms. With Sloan support, InterCEP convened roundtables with insurance underwriters, brokers, and corporate risk managers. Since insurance companies have no standard measures of preparedness, there is no actuarial data that can be used to determine whether better prepared firms incur fewer business losses.262 The situation is particularly acute for medium sized businesses. Although larger corporations can meet with insurance underwriters and argue that their preparations have minimized their potential for loss and should result in a more favorable insurance premium, small to medium sized businesses need

123 Preparing for Bioterrorism data to demonstrate the difference between a company that is prepared and one that is not.261

For rating agency incentives, InterCEP examined whether business preparedness helped companies meet debt obligations after a crisis. The goal was to link preparedness with a firm’s credit rating and cost of capital. A goal of InterCEP was realized in early 2008, when Standard and Poor’s (S&P) announced a new policy to include an assessment of “enterprise risk management” (ERM) in its rating of all corporations.263 ERM requires a firm to address all of its risks on a firm wide basis. Management from the 3,000 plus firms rated by S&P in the United States must now present and discuss their ERM practices at meetings with ratings analysts.264

Though the DHS PS Prep certification program is still in its early stages, it has the potential to make corporations more resilient to disasters by defining a common metric for preparedness. After all, Raisch explained, corporate preparedness is not easy to discern from the outside.

You can walk into a building with a clipboard, look up at the ceiling, and see the sprinkler systems. But you can’t necessarily just look at a three ring binder and say, “OK, you’ve done the exercises, your people know about preparedness.” Who knows what’s in the binder and what the binder is about? This is where a standard set of industry based criteria are essential. A third party can come in and say, “Yep, we’ve done the audit, and we’ve found that you are prepared to this standard set of criteria, and we certify that.”261

Looking back on his Sloan supported endeavors, Raisch considers the development of metrics to be his biggest achievement because “measurement

124 Preparing Businesses for Terrorism and Other Emergencies allows for the accumulation of data that will inform management of the value of preparedness. We have also created a robust community around this a community of both thought and action.”261

Understanding the Barriers to Corporate Preparedness

A Study of Human Continuity Preparedness

Terrorists have a history of targeting workplaces. The World Trade Center in New York and the Pentagon in Washington, DC, were attacked on 9/11. The US Postal Service, US Congress, and major media centers in New York City and Florida were targeted in the October 2001 anthrax letter attacks. The Alfred P. Murrah Federal Building in Oklahoma City was bombed in 1995. Transportation systems that are the workplaces for some and the means of getting to work for others have also been attacked: the Moscow subway in March 2010, the London subway in July 2005, and the Madrid commuter train system in March 2004. Robert J. Ursano, director of the Center for the Study of Traumatic Stress (CSTS) at the Uniformed Services University of the Health Sciences, agrees that work settings are vulnerable: “As terrorists will continue to focus their efforts on vulnerable targets with the greatest potential for

125 Preparing for Bioterrorism impact on society, the workplace is likely to continue to be the site of future attacks.”265

Despite this threat, most businesses are not prepared for the consequences of a terrorist attack. Some larger businesses have continuity or crisis management plans, but it is not clear how well those plans are exercised, or whether the psychological and behavioral consequences of terrorism have been given enough attention. With funding from the Sloan Foundation, CSTS embarked on a project to understand the barriers to corporate preparedness.

Ursano and his colleagues interviewed managers and leaders in large US corporations “to systematically explore the present status of human terrorism preparedness in the workplace.”265 Business continuity plans tend to focus on supply chains and contractors, but Ursano and his colleagues wanted to find what is being done to promote “human continuity,” which refers to “sustaining the health, safety and the ability to perform of individuals in a corporation, organization, group or community after a critical incident, disaster or terrorist attack.”266 An assessment of human continuity examines such factors as employee willingness to come to work after an event and workplace resources that could be offered to foster resilience and rapid recovery for employees.

CSTS also held a Sloan funded workshop in June 2006 that gathered more than seventy professionals from the public and private sectors to educate them about the psychological consequences of disaster, terrorism, and bioterrorism and the need for human continuity planning.267

Through their interviews with people throughout the corporate structure, including C class executives, human resources and employee relations

126 Preparing Businesses for Terrorism and Other Emergencies professionals, and occupational health services staff, Ursano’s team identified several barriers. For instance, the researchers noted that corporate security officers are often concerned only with the day to day security needs of a company, though they should also be charged with building “a community of safety” that will enhance a company’s ability to function during and after a terrorist attack.265 The researchers also observed that medical directors and occupational health professionals are often not involved in corporate decision making. This practice inhibits a company’s ability to plan for the health implications of terrorism, “especially bioterrorism and infectious disease outbreaks with population health implications.”265 Finally, Ursano’s team asserted that, to be effective, exhortations to “get prepared” must be translated “into the defining event language of a specific corporation’s histor[ical] experience with a disaster or critical event,” such as a natural disaster, a disease outbreak, or social unrest.265

127 CHAPTER 7

Making Buildings Safe

Buildings could serve as a first line of defense against biological attacks.

any US workers spend a great deal of their lives inside temperature controlled commercial buildings, breathing M circulated and filtered air. Circulating air improves indoor air quality and makes the environment more comfortable for building occupants, but if that circulation allowed biological agents to spread throughout a building, it could also make the occupants more vulnerable to the effects of a biological attack. Air circulation may have contributed to the spread of anthrax spores in 2001 when an envelope containing anthrax spores was opened in the Hart Senate Office Building and people on several floors and in adjacent office suites were exposed. If the heating, ventilation, and air conditioning (HVAC) systems of large commercial buildings were

128 Making Buildings Safe manipulated to intentionally expose occupants to a biological attack, mass casualties could result. In a 2002 Washington Post op ed piece, Ralph Gomory, Richard Garwin, and Matthew Meselson asserted that HVAC systems, if properly configured, Investing in better air in commercial buildings would might be able to protect building provide benefits even in the occupants instead of facilitating the absence of an attack. spread of dangerous pathogens. They argued that HVAC systems configured to filter pathogens from the air could become “not a conduit for, but a defense against, bioterrorist attack.”268 If exposure to dangerous pathogens could be reduced, then illness and possibly deaths could also be averted or decreased.

Investing in better air in commercial buildings would provide benefits even in the absence of an attack, because enhanced air filtration standards could boost energy efficiency, lower maintenance costs, improve indoor air quality, and, presumably, improve occupants’ general health. Some studies have suggested that as many as 15 million office workers in the United States suffer from “sick building syndrome,” a series of nonspecific symptoms that include headache, fatigue, and upper respiratory complaints that “appear to be linked to time spent in a building, but no specific illness or cause can be identified.”269,270 Although the causes of sick building syndrome are varied and often unknown, it has been attributed to improper air ventilation and to chemical and biological contaminants.270

The Sloan Foundation continues to focus on protecting health and examining the role of biological contaminants in the indoor environments in homes, hospitals, and public buildings, and shaping the emerging field

129 Preparing for Bioterrorism of “indoor ecology.”271 Reducing natural threats like sick building syndrome will help many on a routine basis, and reducing exposure to pathogens could diminish the consequences of exposure to a biological weapon. As there would be less need to treat victims of a biological attack if building filtration were successful, these engineering methods are an important complement to medical preparedness. As Gomory said, “The threat is here, the threat is only going to get worse as our knowledge of how to construct DNA improves, and the cheapness of doing it improves. And yet, the stuff is filterable. And it’s bound to be, because it’s that big. So you can defend against it, but not by traditional medical methods.”1

Using Air Filtration to Make Buildings More Secure

Updated Guidelines and Training for Building Owners and Managers

Better filtered air could theoretically reduce the consequences of a bioterrorist attack and curb the spread of ordinary infections. However, the practicality and feasibility of augmenting the HVAC systems of existing buildings had to be examined. In 2002, the Sloan Foundation launched a major collaboration with the American Society of Heating, Refrigerating

130 Making Buildings Safe and Air Conditioning Engineers (ASHRAE), a 50,000 member professional organization that provides influential guidance to the industry. Sloan’s direct involvement began when Gomory contacted John L. Tishman, then chairman of the board and chief executive officer of Tishman Realty & Construction Company, based in Manhattan. The company’s senior vice president, Harvey Brickman (now retired), was asked to investigate the efficiency of filters in averting the effects of a biological attack to determine whether filtration devices were effective and readily available.

A mechanical engineer by training, Brickman found that such filters were effective, readily available, and might even be cost effective for some buildings. “ASHRAE looked into all aspects of this problem, including filtration, arrangement of systems, where the vulnerable points were, when you should run your system, when you shouldn’t run your system,” Brickman recalled. “The problem is more than just filtration. It’s how you operate your systems, how you design your systems and how you assess risk.”272

This research helped establish pragmatic guidance for upgrading air filtration. Air filters are rated with a minimum efficiency reporting value (MERV). MERV ratings range from 1 to 20; filters rated 17 or higher are known as HEPA filters (HEPA stands for high efficiency particulate arresting). HEPA filters, which are expensive, are used in hospital operating rooms, clean rooms of silicon chip manufacturers, and other environments with strict air quality control requirements. Yet in conventional settings, filters with MERV ratings of 13 to 16 can remove most pathogens, often without major changes to a building’s air handling system or significant extra costs.273

Brickman worked with ASHRAE to translate the findings into practical advice that was disseminated through a 2004 Sloan supported satellite

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A White-Knuckle Ride broadcast, “Homeland Security for Buildings.”274 to the 27th Floor Sloan also funded a 2006 satellite broadcast and To understand the issue better herself, simultaneous webcast on “Multiple Benefits Paula Olsiewski arranged to see an Solutions for Enhanced Building Security.” That HVAC system up close. Brickman took program reached approximately 20,000 building her to an office building under construction in Times Square. She professionals, “one of the largest audiences ever for 272 donned a hardhat, stepped into an an ASHRAE webcast,” according to Brickman. outside hoist, and was lifted to the With Sloan support, Brickman also convened a twenty-seventh floor in a white- knuckle ride. luncheon at which building engineers and managers

Later that day, Olsiewski and were invited to meet with members of the NYPD Brickman spoke with the building’s so the two groups could exchange information. operations manager. “He asked us, ‘If I The goals were to provide NYPD with expertise on install more efficient air filters buildings and get building engineers to think more everywhere, what will my cost be?’” about security. “The supervisors in charge of the Brickman said. “We did a quick calculation and told him it would be in homeland security division of the police department the range of $30,000 a year.” were interested and engaged,” Brickman explained.

“He said, ‘This is an 800,000 square “They wanted to know what an air-conditioning foot building. I spend millions of system really does. What are its components? How dollars a year maintaining and can attacks affect it? How can building operators cleaning it, and $30,000 is a drop in mitigate the effects of a terrorist attack or accidental the bucket.’” spill?”272 Ultimately, the management company retrofitted all its buildings in New Brickman believes that making buildings safe York City with upgraded filters. As will require more research and training. “Right one of its officials later told Olsiewski, now, the best thing any group can do is to educate “It was a no-brainer.” and advise builders who are contemplating construction or are trying to retrofit a building. It

132 Making Buildings Safe means updating information and making sure, either through ASHRAE or through the Building Owners and Managers Association [BOMA], that it gets to the people who make these critical decisions.”272 To that end, Sloan funded ASHRAE’s 2009 white paper, “Guideline for the Risk Management of Public Health and Safety in Buildings,”273 which offers guidance for evaluating, designing, and implementing measures to reduce risks in new and existing structures.

According to Brickman, much remains to be done to strengthen buildings against bioterrorism. “One of the major deficiencies today is the location of outside air inlets in buildings, which is very hard to correct once a building is constructed. If the outside air intake is at ground level, someone can come up and throw something in it and contaminate the whole building.”272 In some structures, the problem is the ventilation system itself.

Today, it is difficult to gauge the long term effect of these efforts, partly because building owners are reluctant to publicize information about security for fear that doing so would help criminals circumvent the measures. “I do know that new buildings most likely have MERV 14 16 filters,” said Brickman. “Disseminating the information with Sloan’s assistance did a lot to publicize the problem and persuade people to take action. But unfortunately, retrofitting older buildings lags behind. The problem is money. We can’t force people to do things that are in their own best interests. But we can tell them what the benefits are and hope that they comply.”272

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Expert Consensus on Practical Steps to Make Buildings Safer

The Working Group on Reduction of Exposure to Infectious Agents During a Covert Bioterrorism Attack

The Sloan Foundation enlisted the Center for Biosecurity of UPMC to establish expert consensus on ways to protect building occupants from a terrorist attack with an aerosolized biological agent.

In 2005, after completing an extensive review of reports on air filtration published in the forty years prior, the center convened the Working Group on Reduction of Exposure to Infectious Agents During a Covert Bioterrorism Attack.275 Participants included experts in an array of specialties air filtration, building ventilation and pressurization, air conditioning and air distribution, biosecurity, building design and operation, building decontamination and restoration, economics, medicine, public health, and public policy who represented private industry and academic institutions, the US General Services Administration, the US Postal Service, the Environmental Protection Agency (EPA), the National Institute of Standards and Technology, and the CDC.

134 Making Buildings Safe

The working group focused on identifying and agreeing on a set of actions that commercial building owners and operators could take to improve building safety using “currently available off the shelf technologies” that could be implemented immediately for modest expense.275 The 2006 report “Improving Performance of HVAC Systems to Reduce Exposure to Aerosolized Infectious Agents in Buildings: Recommendations to Reduce Risks Posed by Biological Attacks”275 included the group’s recommendations.

The most straightforward and important of the recommendations was that commercial HVAC systems be fitted with filters that have higher MERV ratings. ASHRAE recommends a minimum MERV rating of 6 for filters used in commercial buildings. That size will remove less than 20 percent of particles in the same size range as anthrax spores. Alternatively, a MERV 13 filter could remove more than 95 percent of those particles for only slightly greater operating cost.275

Because inadequate installation and maintenance renders the air filtration systems in many buildings considerably less If there were a bioterrorist effective than design specifications call for, attack, which side of the filter the working group also recommended that would you want to be on? commercial HVAC systems be configured and operated to work as intended. To that end, the group advised that building operators seal, caulk, and replace gaskets in air handling systems and change filters according to manufacturer recommendations. The group also noted the importance of regular commissioning and recommissioning of buildings to test and repair HVAC systems and ensure proper functioning. All of these actions should improve air quality and HVAC functioning, but they are not always taken. In fact, most commercial buildings have never been

135 Preparing for Bioterrorism commissioned. The working group attributed this to a lack of standardized training programs and continuing education for building operators.

Directly applicable to the goal of mitigating the consequences of a biological attack was the working group’s commonsense recommendation that filters be installed on outdoor air intakes to limit the damage from a release of a biological weapon directly into an air handling system.

The group’s final recommendation called for establishment of “[a] lead government agency for indoor air quality, to include biological hazards.”275 Various government efforts have been made to protect building occupants from a biological attack, including the Immune Building Program (started at DARPA—the Defense Advanced Research Projects Agency—and moved to DTRA—the Defense Threat Reduction Agency)276 and guidance for building owners from HHS.277 Many government agencies have research programs and responsibilities related to the indoor environment—DOD, DOE, DHS, EPA, HHS—but none has the clear lead or primary responsibility.

Generating consensus among experts was just the first step, though. People who build commercial buildings or operate them needed to be informed of these inexpensive preventive measures that could save many lives. In September 2007, Tom Inglesby (now CEO of the Center for Biosecurity) met with the Real Estate Roundtable (RER) to inform its members about the working group’s conclusions. He was accompanied by a White House representative who briefed the group about the bioterrorism threat. RER members collectively hold portfolios of “5 billion square feet of office, retail and industrial properties valued at more than $1 trillion; over 1.5 million apartment units; and in excess of 1.3 million hotel rooms.”278

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In 2008, the center launched the website Protecting Building Occupants from Biological Attacks (http://www.upmc biosecurity.org/buildings) to provide practical recommendations for building owners and information about the costs and benefits of implementing HVAC improvements. The site also points end users to numerous sources of additional information.

In addition to improving biosecurity, the measures recommended by the working group could save energy and reduce costs for building owners, which could increase the likelihood of their adoption. Commissioning buildings, for example, can lead to considerable energy savings.279 Figures from Lawrence Berkeley National Laboratory indicate that if commissioning buildings were a national requirement, the following benefits could be realized: more than 20,000 new jobs for trained workers, up to $30 billion annual savings from reduced energy costs by 2030, and annual reductions of greenhouse gas emissions of about 340 megatons of carbon dioxide.280

Although the economics and the energy savings are important, the Sloan Foundation is primarily focused on protecting health by finding ways to reduce the effects of biological contaminants in the indoor environments of homes, hospitals, and public buildings.271 Natural threats, such as those thought to cause sick building syndrome, may affect many people, but given the modest cost of protection, the threat of bioterrorism should be prepared for as well. Owners have that responsibility to the people who work in their commercial buildings. After all, asked Gomory, “If there were a bioterrorist attack, which side of the filter would you want to be on?”1

137 CHAPTER 8

Using Disease Surveillance for Early Warning

Public health officials have wanted to mine indirect early warning signs of an outbreak since 1993.

rise in purchases of over the counter painkillers. An uptick in 911 calls for ambulances or in calls from parents alerting schools of A children’s absences. Together, those events could mean that an infectious disease outbreak is under way. Public health officials have wanted to mine these types of indirect early warning signs of an outbreak ever since 1993, when information about stores running out of antidiarrheal medications might have alerted Milwaukee health officials to an outbreak of waterborne disease weeks before a laboratory confirmed case.281 Yet before “syndromic surveillance” began in earnest, such data were not always collected, organized, or reported, and they were not available to alert public health officials about emerging disease trends.

138 Using Disease Surveillance for Early Warning

Syndromic surveillance gained ground after the 2001 anthrax attacks. Officials wanted early warning that a bioterrorist attack was in progress so medical countermeasures could be deployed. New syndromic surveillance systems were created, including the BioSense system mandated by the Public Health Security and Bioterrorism Public health practitioners are Preparedness and Response Act of 2002282 using these systems to support and other systems in New York City and “situational awareness” or near real time monitoring several large US cities.283-285 These systems of a public health event. were put in place because, for public health purposes, it made intuitive sense to track such data as emergency room admission codes and pharmacy purchases, though at the time there was little evidence to suggest those efforts would lead to earlier and better public health decisions in mitigating an outbreak.286

In September 2002, the National Syndromic Surveillance Conference was hosted by the New York Academy of Medicine, the CDC, and the New York City Department of Health and Mental Hygiene (NYC DHMH), with generous support from the Sloan Foundation.287 Two years later, Sloan awarded a grant to the Tufts Health Care Institute to provide administrative support for development of the International Society for Disease Surveillance (ISDS), “dedicated to the improvement of population health by advancing the field of disease surveillance.”287 The conference, now annual, has completed its tenth year and is still hosted by ISDS.287

The field of syndromic surveillance has supported monitoring for all hazards, which may include events such as the BP oil spill or increases in the incidence of chronic diseases, not just infectious disease outbreaks and bioterrorism. Most syndromic surveillance systems were initially designed

139 Preparing for Bioterrorism to detect outbreaks rapidly, but public health practitioners are increasingly using these systems to support “situational awareness” or near real time monitoring of the evolution of a public health event. This evolution occurred because it was found that in the context of outbreak detection and management, syndromic surveillance is mainly useful for the characterization and management of a recognized outbreak.288 David Buckeridge, president of ISDS, observed that the field is still evolving and growing: “The evidence base needs to continue to be built, and the knowledge needs to be translated into practice.”289 Farzad Mostashari, NYC DHMH assistant commissioner at the time, notes that syndromic surveillance has been useful for determining that cases of severe disease are not indicative of a large epidemic or an attack.290

ISDS continues to make significant contributions to public health surveillance of all types and to work toward ensuring that syndromic surveillance remains an effective tool for assessing the public’s health. Recent efforts include strong advocacy to ensure that public health information is included in the electronic health record system called for in the Healthcare Reform Act of 2010 and development of the Distribute Project for influenza syndromic surveillance to provide comprehensive situational awareness of influenza like illness.291,292

140 Using Disease Surveillance for Early Warning

Building a Flexible Platform for Syndromic Surveillance Software

The New York Academy of Medicine’s SaTScan Program

In 2002, the Sloan Foundation awarded a grant to the New York Academy of Medicine (NYAM) to work with the NYC DHMH and the University of Connecticut to develop a syndromic surveillance software system for tracking potential disease outbreaks and to make the technology user friendly for state and local health departments. Farzad Mostashari, then NYC DHMH assistant commissioner, was principal investigator. (Mostashari is now national coordinator for health information technology at HHS.)

The software they developed, called SaTScan (“Software for the spatial, temporal, and space time scan statistics”) was originally developed by Martin Kulldorff and Information Management Services, Inc., with support from the National Cancer Institute, to detect clusters of cancer. NYAM and NYC DHMH modified the statistical approach to conduct surveillance for West Nile virus, influenza, and bioterrorism. Their goal was to produce a flexible software platform on which to build a comprehensive system for outbreak detection and syndromic surveillance.

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In 2002, NYC DHMH analyzed ambulance dispatch and emergency department visit data on every day of the year for spatial and temporal aberrations.293 The department also analyzed data on subway worker absenteeism and sales of both prescription and over the counter medications.294 In October 2002, a refined version of the software was released as a free downloadable program.295 Today, the program can still be downloaded free of charge from the SaTScan website (http://www.satscan. org), and the NYC DHMH still maintains a link to the website.296

The outbreak detection software and analytic methods developed for SaTScan were used by leading practitioners and researchers in the field, including the Johns Hopkins University Applied Physics Laboratory and the University of Pittsburgh Real Time Outbreak It wasn’t bioterrorism Detection System (RODS) laboratory.297 Sloan that made people engage gave Mostashari a second grant in 2003 to refine with this; it was helping them solve daily problems the software’s bioterrorism surveillance capability like flu surveillance. by incorporating data from pharmacy sales and BioWatch, the federal system of sensors and lab based analyses for detecting bioterrorism agents. Mostashari and his colleagues made the software easy to use for health departments that had never employed these methods and released an improved version in October 2003.295 In December of that year, the NYAM launched a website that served as a “town hall” for the expanding international syndromic surveillance community.

The Sloan grant helped catapult syndromic surveillance from a cumbersome research method to a mainstream technology in public health. In 2008, Mostashari published findings from a survey of public health officials in

142 Using Disease Surveillance for Early Warning fifty nine state, territorial, and selected large local jurisdictions in the United States indicating that 83 percent of the respondents conducted syndromic surveillance.284 In a recent interview, he estimated that today, approximately 90 percent of state health departments rely on the technology. Emergency department visits are the most commonly used data source for surveillance, but others include clinic visits, calls to poison control centers, 911 emergency medical service calls, medication purchases, and school absenteeism. “It’s almost ubiquitous now,” Mostashari said, “but it wasn’t bioterrorism that made people engage with this; it was helping them solve daily problems like flu surveillance.”290 Impressive as that progress may be, Mostashari thinks much more work is needed, especially in collecting clinical specimens for laboratory diagnosis once there is a signal that an outbreak is under way.

When syndromic surveillance was getting off the ground, some practitioners questioned whether high tech surveillance for bioterrorism was a public health priority, and Mostashari conceded that the early skepticism was justified: “The question is, are these tools useful daily. Because if they’re not useful daily, they won’t be useful for bioterrorism events.” In an ideal world, he added, “Routine clinical care would help provide an understanding of population patterns, and situational awareness of what’s happening in the community would in turn be fed back in to clinical care.”290

The Sloan grant allowed researchers to develop new science, not out of whole cloth, but by fostering connections between different fields. Future support of syndromic surveillance should also draw on that approach, Mostashari said. “What a philanthropic organization or government entity gives to a grantee is not just money. It’s support, visibility, and flexibility.”290

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Applying the Language of Science to Problems in Biosecurity

DIMACS’s Research Program on Computational and Mathematical Epidemiology

Interdisciplinary collaborations have become a hallmark of security oriented research, according to Fred S. Roberts, a mathematics professor at Rutgers and, since 1996, director of the Center for Discrete Mathematics and Theoretical Computer Science (DIMACS).298 The problems are complex and evolving, and solving them requires many types of technical expertise. For example, persistent problems in biosecurity, such as modeling the potential spread of deliberately dispersed pathogens, developing successful vaccination strategies, and predicting the evolution of pathogens, require the expertise of biologists, epidemiologists, public health experts, mathematicians, and computational modelers.

Roberts described DIMACS as a center that tries “to get different people with different backgrounds talking to each other to do things that aren’t traditional.”299 DIMACS itself is a collaboration among researchers from Rutgers, AT&T, Alcatel Lucent Bell Labs, IBM Research, Microsoft Research, and other academic and industrial centers. Roberts’s efforts to apply mathematics, which he calls “the language of science,”300 to complex problems

144 Using Disease Surveillance for Early Warning in biosecurity and intelligence at DIMACS led to its designation as a Center for Excellence by DHS.301

In summer 2002, DIMACS brought together more than one hundred experts in epidemiology, infectious diseases, and mathematics for the first national conference on mathematical contributions to biodefense.301 That Sloan funded conference, organized by Roberts and DIMACS colleague Simon Levin of Princeton University, kicked off a Special Focus on Computational and Mathematical Epidemiology research program. A major goal was to involve more mathematicians (especially graduate students and postdocs who might focus on this area in their careers) in work on public health problems, so the conference started with a tutorial on infectious diseases and how public health epidemiologists track disease spread.

This special focus research program began as a five year project and was extended to eight years, during which time it gave rise to working groups on such topics as the analogies between computer viruses and biological viruses, ways to use mathematical methods to more quickly detect adverse events caused by new medical countermeasures, spatiotemporal and network modeling of disease spread, and mathematical methods for comparing vaccination strategies. Working group members included experts from international academic centers, government, and private industry.

While important mathematical and security work for biodefense has continued, as has education for graduate students and postdocs, there are challenges ahead, mostly related to analyzing massive amounts of data and developing new tools for data analysis.302 It is a complex task to ensure that false positives indicating the occurrence of a bioattack, for instance are avoided, while at the same time ensuring that false negatives do not slip by

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undetected. In the end, the goal of this effort is to devise new approaches to providing the most accurate information possible for leaders.

Disease Surveillance in Real Time

Expanded Data Collection Capacity for RODS

In 1999, two years before the anthrax attacks, Jeremy Espino, “Rich” Fu Chiang Tsui, and Michael Wagner started the Real Time Outbreak and Disease Surveillance (RODS) Laboratory “to investigate methods for real time detection and assessment of disease outbreaks.”303 This syndromic surveillance system collected data Hours count, and detection has to occur from emergency departments and hospitals early to allow time for in western Pennsylvania; the data included response and treatment. patients’ symptoms, age, gender, address, and test results.304 Started with funds from the National Library of Medicine, RODS aimed to make surveillance data collection automatic by eliminating reliance on care providers to fill out and submit forms by hand and to relieve hospitals of the burden of sending data manually to health departments. Their goal, explained Wagner, now director of RODS, was to be able “to analyze patterns and ask whether there is something unusual compared to the usual.”305

146 Using Disease Surveillance for Early Warning

After the 2001 anthrax attacks, the RODS system was examined as a national model for syndromic surveillance; President Bush even visited the laboratory in February 2002.306 The system was used in areas outside of Pennsylvania as well, including Salt Lake City, Utah, for the 2002 Winter Olympics, where it linked and gathered data from thirty hospitals and walk in clinics to monitor for a possible bioterrorist attack. Although RODS did not detect bioterrorism, it did catch an influenza outbreak in its data stream.305,307

In December 2002, the software was made publicly available at no cost to health departments nationwide. Now it is one of the most commonly used systems in the country, and it is used outside the United States as well.308

Sloan recognized the potential of this system, and in 2003, a Sloan funded project made the RODS system more powerful by allowing the researchers to expand pharmacy data collection from twenty three retailers to 33 percent of all product sales nationwide. “There’s a torrent of information being collected routinely in real time. Over the counter sales of pharmaceuticals contain information very relevant to outbreaks of disease,” explained Wagner.305 For bioterrorism, “hours count, and detection needs to occur very early to allow time for response and treatment to occur.”309

147 CHAPTER 9

Strengthening Preparedness for Pandemic Influenza

How able are we to respond to a pandemic? How can people protect themselves and their families when a vaccine is not available?

hen H5N1 avian influenza emerged in Hong Kong in 1997, public health officials around the world were alarmed. Of W eighteen people reportedly infected, six died.310 Although it appeared that H5N1 could not be transmitted from one person to another, and that all known infections had occurred through contact with infected birds, experts worried about the future of the virus. Influenza viruses routinely evolve and combine with other influenza viruses, creating new strains. If the H5N1 virus were to evolve to become contagious, it could spark a global pandemic. Worse, the greater than 30 percent mortality rate seen

148 Strengthening Preparedness for Pandemic Influenza in the 1997 outbreak would vastly exceed the devastation caused by the 1918 pandemic virus that killed approximately 2.5 percent of those infected.311 In years after the 1997 Hong Kong outbreak, there were major outbreaks in poultry, but the virus rarely crossed over to humans. When it did, it was deadly: By 2005, nearly one hundred people had been diagnosed with confirmed cases of avian influenza, and half had died.310 With every case, there were more opportunities for the virus to adapt and to become both contagious and more deadly. In 2012, H5N1 continues to cause human infections in a number of countries around the world, including Indonesia, Vietnam, Bangladesh, and Cambodia. The case fatality rate for the more than 600 WHO confirmed cases is greater than 50 percent.312 Fortunately, the virus has not evolved to become transmissible between people.

By 2004, the possibility of an avian influenza pandemic appeared to be increasing, and pandemic planning in national governments and the WHO took on new urgency, focused mostly on the problem of how to get vaccine made as quickly as possible.313 If the H5N1 influenza virus started spreading from person to person, there would be a race to develop, test, and manufacture a new vaccine, but there was not nearly enough manufacturing capacity to produce vaccine for everyone who would need it. An assessment of the time needed to produce a new vaccine suggested that the maximum number of H5N1 vaccine doses that could be hoped for globally was only 300 million, a little less than the population of the United States.314 A lack of vaccine manufacturing capacity was not a new problem, but in a lethal pandemic, it could have especially damaging consequences.

What a vaccine shortage could look like in the United States became clear during the 2004 05 flu season. The UK based company Chiron, one of the

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two manufacturers that supplied vaccine to the US market, had contamination problems and was barred from exporting its vaccine. Other nations, including the United Kingdom, had contracted with additional vaccine manufacturers to avoid severe shortages. In the United States, Without vaccine, our main supply was cut by nearly 50 percent.315 Elderly defenses will be non pharmacological and chronically ill people waited in line for interventions. hours for the chance to be vaccinated, and some people in vaccine priority groups were turned away. In some places, vaccine distributors became price gougers, charging $800 for a $60 vial of vaccine.316

Thankfully, the flu season was moderate that year. Some people in priority groups did not receive the vaccine as they had in previous years, but the consequences of the shortage were not as bad as they could have been.315 However, if the prevailing flu strain that year had been H5N1 or another pandemic virus that put more of the population at risk of serious illness, the flu season could have been disastrous. The best option for protection was vaccination, but it would have been available to relatively few people.

The fact that vaccine might not be widely available in a pandemic was the point of a 2006 Science magazine editorial by Stephen Morse from Columbia University, Richard Garwin from IBM Research Laboratories, and Paula Olsiewski, who argued that, without vaccine, “our main defenses will be non pharmacological interventions, such as hand washing, ‘respiratory etiquette,’ face masks, school closure, and social distancing or isolation [which] are ironically similar to the measures used in 1918 to combat the greatest of all known influenza pandemics.”317 The authors called for more research on actions that individuals could take to reduce their risk of infection.

150 Strengthening Preparedness for Pandemic Influenza

The Sloan Foundation’s funding for pandemic influenza related work expanded understanding of how influenza epidemics unfold, how well the public health system can respond, and what measures people can take to protect themselves. Sloan supported efforts to learn more about how the 1918 epidemic came about and to assess both the effectiveness of public health measures during the 2009 H1N1 pandemic and the value of nonpharmacological measures, including surgical masks, school closures, and social distancing. The work that resulted provides insights important for managing not only the next flu epidemic, but also for informing public health responses to many other contagious biological threats, whether emerging or intentional.

Learning from the 1918 Influenza Pandemic

John Barry’s Historical Study of the 1918 Flu Pandemic

The catastrophic influenza pandemic of 1918 took place before there were vaccines to prevent infection, before genetic analysis existed to determine how the virus was mutating over time, and before events could be preserved in real time for future analysis. Understanding the genetic makeup of the virus could be important to understanding what makes some influenza viruses especially dangerous and, potentially, to predicting new pandemics as

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they are emerging. Understanding what worked to slow transmission in the absence of vaccine such as quarantine or school closures may help today’s decision makers develop sensible plans for managing an epidemic when it occurs. Remarkably, genetic study is possible because researchers have a handful of viral samples retrieved from victims Flu vaccine production buried in the Alaskan permafrost and some samples cannot beat the speed of a pandemic. stored for decades at the Armed Forces Institute of Pathology.311 However, answers to questions about what worked to slow transmission are to be found only through study of the historical record, an effort undertaken by acclaimed author John Barry.

Barry, a distinguished scholar at Tulane and Xavier universities, raised public consciousness of the events of 1918 in his bestselling 2004 book, The Great Influenza: The Epic Story of the Deadliest Plague in History.318 With Sloan Foundation encouragement and funding, he then turned to the historical archives to uncover more information that could inform modern pandemic planning. His research, still ongoing, has informed the scientific debate about what made the 1918 influenza virus so dangerous and how a future flu pandemic could emerge.

It has long been understood, for instance, that there were three different waves of influenza infections in 1918; that is, three distinct outbreaks occurred in the span of one year, all caused by the same virus. However, the first wave outbreak was mild, while the second and third waves were deadly. The stark difference has led some researchers to hypothesize that the first wave of illness may have been caused by a different virus altogether.311,319

This debate cannot be settled in the laboratory because there are no known samples of the first wave virus, so Barry undertook a comprehensive

152 Strengthening Preparedness for Pandemic Influenza quantitative analysis of 1918 records from thirty seven US Army camps as well as some British military and civilian records. He found that populations that experienced first wave outbreaks were largely protected from illness and death in the second wave. That finding strongly suggests an immunizing effect that would occur only if the same virus caused all of the influenza like illnesses in all three waves.320

The implications of this finding are important. In a modern pandemic, a mild first wave might protect much of the population from a deadlier version of the same virus. The time between discovery of a first wave and emergence of a deadlier second wave may be enough to produce a protective vaccine for those not infected in the first wave, who may be susceptible to the second wave virus. Sustained change in On the social front, Barry’s examination of people’s normal behavior the use of quarantine, the most extreme form is less reliable than the of nonpharmacological intervention, continues; protection of a vaccine. however, he notes that “the data strongly suggest it’s useless except under very special circumstances.”321,322 His historical research also yielded important lessons for leaders who may hesitate to be completely candid in communicating risks to the public. Barry has argued that the modern notion of risk communication “implies that the truth is being managed,” and that “the truth should not be managed, it should be told.”321 History supports this notion. During the 1918 pandemic, panic resulted when authorities offered no information or, worse, false reassurances. As Barry has explained, “Although a false alarm can be damaging, it is not nearly as damaging as silence the type of silence that makes people believe the truth

153 Preparing for Bioterrorism is being withheld. That is how trust disintegrates and how rumors passed in the streets in 1918, passed over Internet blogs today take hold and grow.”323

Barry’s work indicates that direct public communication and some nonpharmacological interventions may have an effect, but sustained change in people’s normal behavior is less reliable than the protection of a vaccine. Unfortunately, flu vaccine production cannot beat the speed of a pandemic. Recent research suggests, though, that it may be possible to produce a vaccine that will protect against all influenza viruses, thus eliminating the need to produce a new vaccine for each outbreak.324 “Had influenza been taken seriously for the past thirty years, we would probably have one by now,” Barry lamented. “No matter what happens over the next year or two, that’s one history lesson we need to learn.”325

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A Billion Decision Makers

A Fresh Look at Pandemic Modeling Assumptions

In 2003, concerns about an H5N1 avian influenza pandemic and the likelihood of vaccine shortages led the US government to look in earnest for data about nonpharmacological methods to prevent the spread of flu. Through the mathematical modeling work of the Models of Infectious Disease Agent Study (MIDAS), supported by the NIH, important public health policy questions were explored, such as the likely effectiveness of administering antivirals, isolating the sick at home, reducing work contacts, cancelling community events, or closing schools.326 The MIDAS work influenced policy decisions and formed the basis for some CDC flu guidance.

On the premise that some of the underlying assumptions for pandemic planning should be examined independently, in 2007 the Sloan Foundation funded Richard Larson of MIT to take a fresh look at flu preparedness and modeling. Larson is an expert in operations research, a field that combines mathematics, engineering, and management sciences to find the best solutions to complex decision making problems. Over the course of his career, Larson has sought answers to such diverse questions as how can a city make police patrols by car more effective, and what is the science of waiting in line. The

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search for commonsense solutions to everyday problems shapes the research questions of Larson’s field.

Flu is not a simple problem. As Larson put it, “With pandemic influenza, we are dealing with a worldwide problem involving decisions by literally billions of people.”327 In the early days of a pandemic, disease spread may be determined by the scientific characteristics of the virus. How well can it spread? How long can it remain infectious on a person’s hand? Once the Flu is not a simple problem. danger of the illness is recognized, many We are dealing with a worldwide decision makers come into play, such problem involving decisions as government officials who may cancel by literally billions of people. public gatherings or close schools, and people who change their behavior to see fewer friends, wear face masks, or cough into their elbows. Meanwhile, the scientific characteristics of the virus change as the virus evolves. Simple mathematical models cannot account for such a complex, stochastic global system, as “disease dynamics are partly under our individual and collective control. Any engineered system in anticipation of the flu must take this into account.”327

From complex models that iteratively reflect changes in people’s behavior, Larson extrapolated some lessons for decision makers. First, travel restrictions during a pandemic are futile because if they are not 100 percent effective, they will not stop the spread of disease. Second, nonmedical behavior changes are probably going to be effective, so social distancing something people will do anyway as they reduce nonessential personal contacts, but which should be actively encouraged by officials may limit the number of infected people and lower the peak of an epidemic.328

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Larson’s work has been incorporated into the BLOSSOMS (Blended Learning Open Source Science or Math Studies) Initiative, also funded by the Sloan Foundation, to educate high school students all over the world.329 Larson’s students have gone on to apply these modeling techniques to such diseases as malaria and polio.329 His work on flu continues as well. In a 2010 article, Larson emphasized that it is not just public health authorities who should work to limit the spread of disease. Those authorities “. . . must recognize that ordinary people at the individual, family, workplace, school, neighborhood, and community levels must be engaged in meeting the threat.”330 Social distancing, increased hygiene, and other nonmedical interventions “are key to empowering our citizenry to be the authors of their own survival in the event of a pandemic.”330

Preventing Flu Transmission in Families

A Controlled Study of Flu Prevention Measures in Families

Influenza spreads fairly easily among strangers, coworkers, and friends, but it spreads especially well in families. Estimates of the risk of household spread of flu have ranged from 10 percent to 40 percent in various epidemics.331-333 When flu spreads within households, illness leads to missed school days for children and missed work days for adults who may be caregivers or patients

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themselves. Without an effective vaccine, nonpharmacological measures must be taken to reduce transmission in families, prevent broader spread of flu, and minimize the disruption it causes.

Manfred S. Green, along with Michal Bromberg and Adi Libling, all from Tel Aviv University, Ramat Aviv Israel Center for Disease Control, wanted to explore ways in which family members could Estimates of the risk stay well, even when caring for a sick child. of household spread of flu have ranged from With support from the Sloan Foundation, Green 10 percent to 40 percent. and his collaborators conducted a randomized, controlled, unblinded study to test the effect of nonpharmacological methods, such as using surgical masks, washing hands, and isolating sick family members. Sick children were not asked to wear masks, but household members older than six were. If Green and colleagues could prove that these methods reduced flu transmission within a family, health agencies could recommend them for entire populations. Most important, perhaps, these measures could be implemented by anyone as safe, easy, inexpensive ways to reduce flu transmission. That could, theoretically, reduce reliance on drug development or vaccine supplies.

Green’s study was inconclusive. The number of families who agreed to participate was small, and not many participants used the masks.334 This is a common problem when studying influenza transmission. Even the surgical mask the simplest nonpharmacological intervention has never been proven to actually reduce transmission, and the CDC acknowledges there is little concrete evidence to support its use.335 Researchers have had a hard time proving the effectiveness of nonpharmacological measures in general, which may be the most important conclusion stemming from this study. The authors

158 Strengthening Preparedness for Pandemic Influenza explained that “the two main reasons given for non feasibility were the difficulty in isolating patients, especially young children, from their mothers and siblings, and the burden of following all the hygiene instructions.”334 In follow up conversations, participating families indicated that, even though they believed the preventive measures would help stop the spread of flu, they still did not follow the researchers’ instructions.334

As we prepare for the next influenza season, or the next pandemic, this conclusion is important. Even though parents may be convinced that wearing masks, washing hands, and isolating sick children from other household members will make a difference to their own health and the health of their families, such seemingly easy prevention methods may be difficult to put into practice. For influenza at least, such measures may not be practical for families, and other tools to prevent transmission need to be developed.

Evaluating the Nation’s Response to the 2009 H1N1 Flu Pandemic

CIDRAP’s Assessment of Flu Vaccine Efficacy

By the time a new influenza pandemic emerged in spring 2009, the US government had already done a great deal of planning and preparing for

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pandemic vaccine production, allocation, and distribution. HHS put forth strategic plans in 2005 to define the roles of federal, state, and local public health agencies.336 The government invested in domestic cell based vaccine manufacturing capacity, although it did not come online until 2011.337 The pandemicflu.gov website was established as a one stop shop for the public to find flu resources and information.338

When the 2009 H1N1 influenza pandemic put those plans to the test, there were surprises among them, the emergence of The H1N1 vaccine the pandemic in Mexico, instead of East Asia, was delayed and did not work as well as expected. as was expected. The timing of the pandemic made the US public health system go into overdrive. The seasonal influenza vaccine was already in production when a pandemic vaccine was needed, so two separate influenza vaccine campaigns were launched, each with its own public health messages. Finally, the estimates for how much vaccine could be available by October 2009 turned out to be overly optimistic.339 The H1N1 vaccine was initially in short supply and recommended only for specific priority groups.340

By the time the WHO declared the pandemic over in August 2010, some experts thought the response was a tremendous public health success, particularly because the vaccine development process was accelerated as much as possible and the H1N1 vaccine that was produced had the same safety profile as other flu vaccines.341 Others thought public health officials stoked fear in the face of what was perceived as a mild pandemic,342 even though the pandemic was anything but mild for children, young adults, and pregnant women, who disproportionately suffered from the disease.343,344 The mean age of death in the 2009 pandemic was estimated to be thirty

160 Strengthening Preparedness for Pandemic Influenza seven years, which is considerably closer to twenty seven years, the mean age of death in the 1918 pandemic, than to the mean age of death in other pandemics sixty five years in 1957, sixty two years in 1968, and seventy five years in normal flu seasons.345,346

While the 2009 H1N1 pandemic was still occurring, the Sloan Foundation moved quickly to support an evaluation of US response to the outbreak. The project’s goals were to document the public health response and identify lessons to improve planning and to apply in the next pandemic response. The University of Minnesota Center for Infectious Disease Research and Policy (CIDRAP) spent three months collecting real time information on vaccine manufacturing, allocation, distribution, and impact during the H1N1 pandemic in the United States and followed that effort with a one year Sloan funded project to review all aspects of pandemic influenza vaccine preparedness and response. Leading the study was CIDRAP’s director, Michael Osterholm, who has a distinguished career in public health and has written extensively about influenza vaccine preparedness.347-349

Although Osterholm and CIDRAP set out to assess the response to H1N1 influenza, their animating question shifted dramatically during the course of the project. They found, for instance, that despite accelerated production, the H1N1 vaccine was delayed and did not work as well as expected. A large, multicenter study found that the overall effectiveness of the 2009 H1N1 vaccine in the United States was just 56 percent.350 Most public health experts consider a flu vaccine successful if it is 70 percent to 90 percent effective.351 The 2009 H1N1 vaccine fell short of that measure, even though, as Osterholm noted, “This was the most closely matched strain in decades.”352

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That dubious success rate led the CIDRAP team to delve more deeply into the historical efficacy of flu vaccine. What they discovered surprised them. Their effort began with a search for randomized controlled trials that assessed “a relative reduction in influenza risk” after vaccination.353 They used more stringent inclusion criteria than had been used in the past by considering only studies of patients with laboratory confirmed flu (RT PCR or viral culture) as opposed to serology confirmed flu because serology is less accurate.354 Of the 5,707 articles they identified in their initial Medline scan of publications from the years 1967 to 2011, only thirty one met the CIDRAP team’s criteria for No company will invest studies measuring vaccine efficacy.353 the $800 million needed to bring a Osterholm’s team found that the efficacy new vaccine to market as long as the current vaccine is so of flu vaccines is about 59 percent in adults wholeheartedly endorsed younger than sixty five years. With 83 by public health officials. percent efficacy, live attenuated vaccine works well in children aged six months to seven years. Surprisingly, there is not much evidence in either direction of the efficacy of flu vaccine for older children and young adults or for the elderly. The team concluded that “current influenza vaccines can provide moderate protection, but it is greatly reduced or absent in some seasons.”355

Until recently, a major hurdle in assessing flu vaccine effectiveness has been methodology. Osterholm argues that many previous studies used erroneous outcome measures: “They were using serology for the trivalent vaccine, when we now know that serology grossly underestimates the number of infections among vaccinees.”355

In 2010, the US Advisory Committee on Immunization Practices (ACIP) established the first national universal seasonal influenza vaccination

162 Strengthening Preparedness for Pandemic Influenza recommendations, which advocate either annual trivalent inactivated vaccine for all people aged six months or older or live attenuated vaccine for healthy people aged two to forty nine years who are not pregnant.356 Even though Osterholm believes that, with such recommendations, public health officials have pushed universal flu vaccination in spite of mixed data, he does not want his criticisms to fuel anti vaccine sentiment because, on an individual level, some protection is better than no protection. However, he does not want people to lose sight of the need to develop better vaccines that are more effective for individuals and populations. It will be a real problem, he explained, “if ‘some protection’ gets in the way of developing better vaccines. People should still get vaccinated, but we have to understand that the impact will be limited.”355

Osterholm advocates greater investment in new vaccines, including further research into a universal vaccine that protects against all influenza viruses. There are several candidates in early stages of development, but, according to Osterholm, no company will invest the $800 million needed to bring a new vaccine to market as long as the current vaccine is so wholeheartedly endorsed by public health officials.137,352 Ultimately, Osterholm believes that “we have to demonstrate the shortcomings of the current vaccine to be in a position to motivate, financially and otherwise, research on better vaccines.”355

163 CHAPTER 10

Preparing New Yorkers for Terrorism and Other Disasters

Sloan Foundation work enhanced disaster preparedness and biosecurity in New York, for New York.

lfred P. Sloan, Jr., was a New Yorker. He grew up in Brooklyn and attended the Brooklyn Polytechnic Institute until he graduated at A age seventeen. He ran the General Motors Company from offices at 1775 Broadway at 57th Street, and he established the offices of the Alfred P. Sloan Foundation at 630 5th Avenue in Rockefeller Center, one of New York City’s most iconic landmarks. Sloan lived in a 5th Avenue apartment in the winter and summered on Long Island. The Sloan Kettering Institute for Cancer Research was established in New York in 1945 and was at the time one of the Sloan Foundation’s largest grants ($2.56 million).357 It is in keeping with that commitment to the city that the Sloan Foundation funded a substantial

164 Preparing New Yorkers for Terrorism and Other Disasters number of disaster preparedness and biosecurity projects that had the goal of improving civilian preparedness among New Yorkers. That goal is important not just because of the geographic connection, but also because the city is a major target of terrorism. The World Trade Center was bombed in 1993 and destroyed on September 11, 2001. In 2001, letters containing anthrax were sent to news outlets in Manhattan. Other attempted attacks have been thwarted, including a car bomb in Times Square in 2010. The foundation’s biosecurity grants in New York have served the dual purposes of responsible citizenship and helping a targeted city get prepared for bioterrorism.

In some cases, helping New York City prepare was a matter of introducing the right people to each other. This was the case on September 24, 2002, when then president Ralph Gomory and Paula Olsiewski hosted a dinner at the Rainbow Room in Rockefeller Plaza to introduce key members of the city’s engineering community to members of the NYPD Counter terrorism Bureau. The police had been advising building owners who wanted to adjust their HVAC systems to reduce the potential effects of bioterrorism and they needed assistance. The engineers were happy to help. The Rainbow Room dinner helped the two groups get to know each other and provided a forum for exchange of ideas about ways to protect building occupants. After that introduction, the NYPD tapped the engineers’ expertise for quite some time, and this area of work became one of the major components of the Sloan Foundation’s biosecurity program.

Many other biosecurity programs and projects funded by the Sloan Foundation had their genesis in New York City and delivered national benefit, including the civilian MRC, now a program of the federal government and

165 Preparing for Bioterrorism celebrating its tenth year; New York University’s InterCEP program, which devised incentives for widespread business preparedness; and SaTScan, the syndromic surveillance software developed by the New York City Department of Health and Mental Hygiene.

This chapter, however, focuses on Sloan Foundation work that enhanced disaster preparedness and biosecurity in New York, for New York.

Are You Ready, New York?

The New York City Public Advocate’s Ready Campaign

After September 11, 2001, and the anthrax letter attacks, the public wanted more information about the threat of terrorism, about actions the government was taking to prevent additional attacks, and about measures ordinary people could take to protect themselves and their families. Despite the public’s hunger for information, many public officials Your family’s safety believed that if they told all they knew or is in your hands. Are you ready? suspected about the seriousness of the threat, public fear would increase, social disorder could follow, and there would be political repercussions.358 The reverse turned out to be true. After widespread reports on the anthrax letters, theNew York Times reported that the US government was employing a “spin control”

166 Preparing New Yorkers for Terrorism and Other Disasters model of public information release by not telling all they knew about the seriousness of the threat in order to prevent a panic, and, “as a result, public trust . . . evaporated.”359

Public trust in all levels of government was strained. Betsy Gotbaum, who at the time was public advocate for the City of New York, confirmed that New Yorkers complained to her about gaps in communication in the city, about not knowing what the city government was doing to protect them, and about not having the information they needed to protect themselves and their families if another disaster happened.360 With Sloan Foundation support, she took action. In 2002, Gotbaum’s Preparedness Project for New York City published a printed guide and website to provide New Yorkers with detailed information about disaster preparedness.360

New York’s public advocate is an independently elected citywide official, next in line to the mayor a powerful position in the city. The position was originally intended as that of ombudsman to help New Yorkers cut through red tape and gain better access to government. Thought of by some as a watchdog and by others as a pest, the public advocate has enough power to make a lot of noise about a problem and get results. In this case, the office pushed for community wide preparedness efforts from the New York City government, while also raising New Yorkers’ awareness of what they could do to prepare themselves for disaster. As part of that effort, in summer 2002 the office published and distributed more than 50,000 copies of a basic disaster preparedness pamphlet to provide city residents with detailed information about disaster preparedness, bioterrorism, mental health and disasters, and children and disasters.360,361

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The success of those citywide efforts helped pave the way for the Sloan funded Ready New York campaign launched by New York City’s Office of Emergency Management (OEM) in 2003. Ready New York was an extensive, city specific guide, available in seven languages, that provided information about weather disasters, fires, earthquakes, terrorism, radiological exposure, disease epidemics, and biological events.362 The guide provided information for parents, families, seniors, and pet owners about preparedness and a variety of other topics, such as mental health. The OEM leveraged the work of the Ad Council and DHS by aligning its steps for preparedness with those in the federal guide, but the OEM tailored the city’s guidance to meet the specific needs of New Yorkers. It was the first such guide that the city had produced since the 1960s.363

Now, almost ten years later, Ready New York is a much more extensive effort. In a 2006 editorial, the New York Times praised the program because it “anticipates an impressive list of potential emergencies, with clear, helpful, multilingual directions on how to prepare and respond.”364 The project’s website provides multiple guides and planning tools, videos, interactive maps for planning post disaster meet ups, and numerous other resources.365 Preparedness guides are customized for a host of audiences and a host of disasters (floods, extreme heat, hurricanes, pandemic flu), and they are published in English, Spanish, Russian, Haitian, Arabic, Urdu, Korean, Bengali, Chinese, Polish, and French. The website reminds visitors that “your family’s safety is in your hands,” and asks, “Are you ready?”365

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Teaching New Yorkers about Preparedness

World Cares Center Disaster Preparedness Fair

In August 2004, New Yorkers’ fears of another terrorist attack were heightened by the Republican National Convention, which was to be held at Madison Square Garden from August 30 through September 2. Terror alerts were frequent and security was dialed up, “temporarily turning midtown Manhattan into an armed camp.”366 During the convention, the more than 10,000 police officers armed with rifles and deployed by the city to secure the area were a conspicuous addition to the US Secret Service, DHS, and FBI patrols.366 The ramped up security made people nervous.

Lisa Orloff, founder and executive director of the World Cares Center, confirms that even three years later, “people were still really angry about 9/11, the response, and the government’s response.”367 Orloff’s World Cares Center was formed not long after the 9/11 attacks by a group of New York City volunteers, who, according to the group’s website, “saw a need to bring together various agencies and community based organizations in a safe and collaborative environment.”368 The group established two September Space Community Resiliency Centers “to promote social, emotional and physical healing for the entire responder community.”369 In 2004, as the city prepared for the Republican National Convention, Orloff’s organization received many

169 Preparing for Bioterrorism calls and e mails from people asking for information, venting, and worrying about another terrorist attack.367

In response to the community’s concerns, and with funding from the Sloan Foundation, the World Cares Center held the September Spaces Disaster Preparedness Fair on August 13, 2004, to help community members learn about the preparedness work that officials were doing on their behalf and about how to prepare themselves and their families for disaster. Speakers included representatives of the New York Disaster Council Coalition, Disaster Spiritual Care Services New York, Citizens for NYC, the American Red Cross of Greater New York, the New York Department of Health and Mental Hygiene, the OEM, and the police department.370 Fair attendees received free “go bags” of emergency supplies and information that could help them survive a disaster. They also heard about World Care Center’s PERCS program (PERCS stands for plan, educate, respond, collaborate, and support), which focused on volunteering and ways to prepare for the psychological effects of helping survivors.370

“Our efforts were to make sure that the general public was aware of what was going on, that they heard it directly from officials, and that officials were hearing concerns directly from the public. It was important to us and our mission for the center,” explained Orloff,367 who started the organization after her experiences volunteering as a supply chain manager at the Jacob Javits Center in the days just after the 9/11 attacks. Since then, the World Cares Center has grown under her direction from a 100 percent city volunteer organization to a national organization that promotes collaborative disaster preparedness and recovery among community members and official responders.369 The World Cares Center has built on the experiences of

170 Preparing New Yorkers for Terrorism and Other Disasters running the September Spaces Community Resiliency Centers, which served more than 45,000 people in the first six years of operation to become a source of expertise in spontaneous disaster volunteer management.369

Thankfully, New York City has not seen another attack like 9/11. Nonetheless, the World Cares Center continues the work of connecting people with public officials for information, as with the Disaster Preparedness fair, and helps officials manage volunteers during disaster response. The center has provided local leaders in twenty seven states and two countries with just in time training on managing volunteers in disasters, and when Hurricane Irene hit New Jersey in 2011, they provided just in time training for more than 1,000 community volunteers and coordinated other relief organizations to “muck out” and remediate 595 homes.367,371

Sampling the Environment

The NYPD Increases BioWatch Effectiveness

New York City was the first US metropolitan area to receive BioWatch, the federal environmental monitoring system intended to detect pathogens in the air that would signal a large bioterrorist attack. The BioWatch program was announced in President Bush’s 2003 State of the Union address and was installed in New York only months later.

171 Preparing for Bioterrorism

The monitoring system places air sampling units where they will collect air particulates on a filter. The filters are collected and exchanged daily and analyzed for the presence of bioterrorism agents at the New York City Public Health Laboratory.

BioWatch has a number of limitations as a monitoring tool, but perhaps the most critical is the delay: Once filters are gathered from the monitors and analyzed for the presence of pathogens, it could take days before a “BioWatch Actionable Result” is detected. Patients may arrive at a hospital well before BioWatch has warned of an attack. Newer generations of BioWatch detectors require less time for sample analysis, making it possible that information signaling an attack could be acted on more rapidly.372

In 2007, the NYPD requested support from the Sloan Foundation to conduct a citywide needs assessment and requirements analysis for environmental monitoring of pathogens. The goal was to maximize the effectiveness of the BioWatch system by helping the NYPD determine the best locations for six new automated detector units. Richard Falkenrath, then NYPD’s deputy commissioner of counterterrorism, and colleagues asserted in a proposal to Sloan that “automated systems are the future, as they can do air sampling and lab testing in the field, delivering testing results in near real time, and cut down on cost and labor intensity.”373 They made the case that the city of New York could not wait until federally developed next generation systems became available. Sloan’s grant allowed them to do the best they could with the technology available.

172 Preparing New Yorkers for Terrorism and Other Disasters

Training Building and Service Workers for Terrorism Response

New York Safe and Secure Training Program Curriculum

“He can chat about the weather, deliver urgent packages, and help you when you’re locked out. But can your doorman keep out Al Qaeda?”374 So opened a June 24, 2002, New York Magazine article about a new program to train building service workers to recognize and respond to terrorism. The course, called NY Safe and Secure: Restoring a Sense of Well Being to the Citizens of New York City, provided instruction through the Thomas Shortman Training Fund on behalf of the Service Employees International Union (SEIU) Local 32BJ. The Sloan Foundation funded curriculum development, which was a collaborative effort of the city’s police and fire departments, OEM, John Jay College of Criminal Justice, and the Realty Advisory Board in partnership with the Real Estate Board of New York and the Council of NYC Cooperatives and Condominiums.

In a 2004 USA Today article announcing the program, NYPD Commissioner Raymond Kelly explained its logic: “The police and the building service workers are natural allies. . . . Both work around the clock, both are in the business of protecting people. This program gives us a powerful network of eyes and ears on the street.”375 The course strove to

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break terrorism down into “a combination of crimes that target civilian populations,”376 crimes familiar to doormen and other building service workers who have had to deal with rapists, robbers, and burglars. The specialized antiterrorism training helped refine the skills they had and taught them observational skills and how to effectively describe a perpetrator to the authorities.376

Training was completed initially by 28,000 doormen, superintendents, and porters in 3,500 New York City apartment buildings. Off duty police academy instructors taught the four hour session on how to Can your doorman 375 keep out Al Qaeda? spot and respond to potential terrorist threats. Mike Fishman, President of Local SEIU 32BJ, told New York Magazine, “We’d like to be the third leg, after fire and police. We’re in every building. . . . We’d like to coordinate citywide procedures like evacuation plans, even checklists on how to look for terrorist behavior.”374 Years later, NY Safe and Secure is still offered in the course catalog for the Thomas Shortman Training Fund, which provides free academic and training courses for building service workers who are eligible members of their SEIU Local 32BJ union.

174 Afterword

∂

Tom Inglesby

hen D. A. Henderson recruited me to work at the original biosecurity center, there was important work to be done, but W little funding, and little interest outside of our immediate circle. Enter the Sloan Foundation. D. A. was presenting his views on bioterrorism at a major meeting of scientists addressing the problems posed by biological weapons and bioterrorism an anomalous topic then considered something best left to the arms control community. Ralph Gomory was in the front row. After the meeting, Ralph asked D. A. what needed to be done with greatest priority. D. A. gave him a list of priorities and asked whether the Sloan Foundation might be interested in funding any of it. Ralph’s reply: “Do all of it.” This book describes what followed from that momentous meeting. “Do all of it” turned out to be the driving theme that animated Ralph and Paula Olsiewski and the foundation’s work in biosecurity for more than a decade. When they saw no path to solving a problem, they blazed new trails and found new grantees. When they found no science to answer key

175 Preparing for Bioterrorism questions, they rallied new scientists to the effort. They kept the larger goal of preparing the nation for bioterrorism in mind. They pressed people to move forward as quickly as they could to improve preparedness. I saw their commitment over the years firsthand. It was a combination of stubborn optimism and impatience for progress. What they helped build is remarkable.

Numerous US government programs and systems have been established since 2000. Could many of them be stronger? Yes. Could they do all the country would need if a major biological weapons attack occurred? No. But we are much stronger than we were in 2000, and, if we sustain what has been built, we will be able to prevent a good share of the suffering and chaos that would have followed a major epidemic in 2000.

Unfortunately, the federal budget for biosecurity programs has been reduced in the last few years, largely as a result of budget deficits, broad cuts, and yes, some waning of concern as the specter of the 2001 attacks fades. In the case of funding for state and local public health preparedness, the cuts have been drastic and will lead to real reductions in capacity. Without question, such dramatic cuts to key biosecurity programs should be reversed. In general, though, as compared to the world before 9/11, federal support for biosecurity programs remains substantial and, with strategic direction, can make big differences in the country’s ability to cope with biological threats.

In the scientific community, discussions regarding the responsible conduct of the life sciences have evolved steadily since 2000. New policies being considered in response to recent H5N1 mammalian transmissibility research are, at the time of this writing, the most recent development in an ongoing dialogue among members of the policy, scientific, biosafety, and biosecurity communities in the US and abroad. Striking the right balance between

176 Afterword preserving scientific freedoms and minimizing the risk of inadvertent harm will require careful thought and consideration in the years ahead.

Taking stock of where we are now means recognizing as well that there are some other accomplishments that we should have achieved by now but have not. For instance, as a nation, we should already have acknowledged the essential role that the public health system and its agencies will play in a major infectious disease crisis and committed once and for all to funding that system and keeping it strong. We should have a broader armamentarium of new medicines and vaccines. Those are just two examples of important work still to be done.

As for the collective, extraordinary achievements in the field to date, those gains have many parents, but many of those successes had their genesis in the vision and support of the Alfred P. Sloan Foundation. The story recounted in this book illustrates the ways a foundation can take risks and try new approaches that government cannot. It shows that foundations can pursue problems of the people along paths that the private sector is less likely to follow.

Many big challenges lie ahead in biosecurity. How will we manage the risks that will attend new biotechnology discoveries without stifling or slowing scientific progress? How can we make sure that our approach to biosafety keeps pace with breakthroughs in pathogen engineering, for example? Given the globalization of biology, how do we come to multinational agreement on biological dangers and protections? How do we discover and develop the medicines and vaccines we need to protect people from the most dangerous pathogens? Can we sustain public health and hospital disaster response capacities as resources dwindle? Will we be able to discover novel epidemic

177 Preparing for Bioterrorism diseases before they have taken hold and spread widely in the world?

There are elements of all these problems that foundations are uniquely poised to address. Foundations provide independence from government grantees are unfettered and can say what they need to say. Foundations provide financial flexibility they do not get entangled by a congressional budget impasse. They offer freedom to innovate and to adapt our approaches to hard problems as new knowledge changes the dimensions of the problems or as crises arise.

The US is indebted to the Sloan Foundation for its generous investment in improving American preparedness. Sloan showed us how foundations can make safer the lives of so many. We can only hope that other foundations recognize the contributions they could make to US biosecurity in the next decade and beyond. Relatively small investments, if focused clearly and well, can produce remarkable good.

Tom Inglesby, MD, director of the Center for Biosecurity of UPMC, has been with the center since its inception in 2003 and was one of the founders of the Johns Hopkins Center for Civilian Biodefense Studies in 1998. He is an associate professor of medicine and public health at the University of Pittsburgh Schools of Medicine and Public Health.

178 Table of Abbreviations

ACIP Advisory Committee on Immunization Practices ACLU American Civil Liberties Union ANSI American National Standards Institute APHA American Public Health Association ASHRAE American Society of Heating, Refrigerating and Air-Conditioning Engineers ASTHO Association of State and Territorial Health Officials BARDA Biomedical Advanced Research and Development Authority BBIC Biosafety and Biosecurity International Conference BCEM Big City Emergency Managers BLOSSOMS Blended Learning Open Source Science or Math Studies BOMA Building Owners and Managers Association bp Base pairs BRSS Biological Research Security System BWC Biological Weapons Convention CBR Chemical, biological, and radiological CBRNE Chemical, biological, radiological, nuclear, and explosives CDC US Centers for Disease Control and Prevention CIDRAP Center for Infectious Disease Research and Policy CISSM Center for International Security Studies at Maryland

179 Preparing for Bioterrorism

CSIS Center for Strategic and International Studies DHS US Department of Homeland Security DIMACS Discrete Mathematics and Theoretical Computer Science DOC US Department of Commerce DOD US Department of Defense DOS US Department of State DURC Dual-use research of concern EMBO European Molecular Biology Organization EPI Emergency Preparedness Initiative ERM Enterprise risk management FBI US Federal Bureau of Investigation FDA US Food and Drug Administration FEMA Federal Emergency Management Agency GWU George Washington University HEPA High-efficiency particulate air (filter) HHS US Department of Health and Human Services HPP Hospital Preparedness Program HVAC Heating, ventilation, and air-conditioning IARPA Intelligence Advanced Research Projects Agency ICE International coordination exercise ICLS International Council for the Life Sciences IFRC International Federation of Red Cross and Red Crescent Societies IMO International Maritime Organization InterCEP International Center for Enterprise Preparedness ISDS International Society for Disease Surveillance JAMA Journal of the American Medical Association JCVI J. Craig Venter Institute

180 Abbreviations

MaHIM Medical and Health Incident Management MENA Middle East and North Africa MERV Minimum efficiency reporting value MIDAS Models of Infectious Disease Agent Study MIT Massachusetts Institute of Technology MRC Medical Reserve Corps MSCC Medical Surge Capacity and Capability MSEHPA Model State Emergency Health Powers Act NACCHO National Association of County and City Health Officials NAS National Academies of Science NATO North Atlantic Treaty Organization NCDP National Center for Disaster Preparedness NFPA National Fire Protection Association NGO Nongovernmental organization NIH National Institutes of Health NOD National Organization on Disability NSABB National Science Advisory Board for Biosecurity NYAM New York Academy of Medicine NYC DHMH New York City Department of Health and Mental Hygiene NYPD New York City Police Department OEM Office of Emergency Management OSCE Organization for Security and Cooperation in Europe PERCS Plan, educate, respond, collaborate, and support PSA Public service announcement RER Real Estate Roundtable RODS Real-Time Outbreak and Disease Surveillance S&P Standard and Poor’s

181 Preparing for Bioterrorism

SEIU Service Employees International Union TFAH Trust for America’s Health UMD University of Maryland UN United Nations UPMC University of Pittsburgh Medical Center USAMRIID US Army Medical Research Institute of Infectious Diseases USDA US Department of Agriculture USG United States government WHO World Health Organization WMD Weapons of mass destruction

182 Notes

1. Ralph Gomory, interview by Gigi Kwik Gronvall and Madeline Drexler, January 28, 2011. 2. Gomory R. Thinking the unthinkable . . . in order to deal with it. Richard Heffner’s Open Mind. April 10, 2003. http://www.thirteen. org/openmind/aging/thinking the unthinkable %E2%80%A6 in order to deal with it/1613/. Accessed July 27, 2012. 3. Paula Olsiewski, interview by Gigi Kwik Gronvall, February 14, 2012. 4. Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science. New Rochelle, NY: Mary Ann Liebert, Inc. http://www. biosecurityjournal.com. 5. Cowan R. Bird flu likely in US flocks soon: health secretary. Reuters. March 2, 2006. 6. Franco C, Sell TK. Federal agency biodefense funding, FY2010 FY2011. Biosecur Bioterror. 2010;8(2):129 149. 7. Martin JW, Christopher GW, Eitzen EM. History of biological weapons: from poisoned darts to intentional epidemics. In: Dembek ZF, ed. Medical Aspects of Biological Warfare. Washington, DC: Office of the Surgeon General, US Army; Borden Institute, Walter Reed Army Medical Center; 2007:1 20. 8. Hylton WS. Warning: there’s not nearly enough of this vaccine to go around. New York Times Magazine. October 26, 2011:26.

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9. Henderson DA. Smallpox: The Death of a Disease: The Inside Story of Eradicating a Worldwide Killer. Amherst, NY: Prometheus Books; 2009. 10. Alibek K, Handelman S. Biohazard: The Chilling True Story of the Largest Covert Biological Weapons Program in the World, Told from the Inside by the Man Who Ran It. New York, NY: Random House; 1999. 11. Preston R. Annals of war the bioweaponeers. New Yorker. March 9, 1998:52 65. 12. Crossette B. Experts dispute Iraq’s claim it ended germ war effort. New York Times. April 10, 1998. http://www.nytimes. com/1998/04/10/world/experts dispute iraq s claim it ended germ war effort.html. Accessed August 10, 2012. 13. Tucker JB. Biological weapons in the former Soviet Union: an interview with Dr. Kenneth Alibek. Nonproliferation Review. Spring/Summer 1999;6(3):1 10. http://cns.miis.edu/npr/pdfs/ alibek63.pdf. Accessed August 10, 2012. 14. Committee on Strengthening and Expanding the Department of Defense Cooperative Threat Program. Global Security Engagement: A New Model for Cooperative Threat Reduction. Washington, DC: National Academies Press; 2009. 15. Kaplan DE, Marshall A. The Cult at the End of the World: The Terrifying Story of the Aum Doomsday Cult, from the Subways of Tokyo to the Nuclear Arsenals of Russia. New York, NY: Crown Publishers; 1996. 16. Danzig RJ, Sageman M, Leighton T, et al. Aum Shinrikyo: Insights into How Terrorists Develop Biological and Chemical Weapons. Washington, DC: Center for a New American Security; July 2011. http://www.cnas.org/aumshinrikyo. Accessed September 10, 2012.

184 Notes

17. Peck P, Cox L. The top 10 medical advances of the decade. ABC News in collaboration with MedPage Today. December 19, 2009. http://abcnews.go.com/Health/Decade/genome hormones top 10 medical advances decade/story?id 9356853&page 7#. T5lIu7OLOQE. Accessed April 26, 2012. 18. US Office of Technology Assessment. Proliferation of Weapons of Mass Destruction: Assessing the Risks. OTA ISC 559. Washington, DC: Office of Technology Assessment; 1993. http://www.au.af.mil/ au/awc/awcgate/ota/9341.pdf. Accessed August 10, 2012. 19. Petersen W, Kopelson A, Katz G, et al. Outbreak. Warner Bros.; 1995. 20. Preston R. The Cobra Event: A Novel. New York, NY: Random House; 1997. 21. Miller J, Engelberg S, Broad WJ. Germs: Biological Weapons and America’s Secret War. New York, NY: Simon & Schuster; 2001. 22. Nash M. In Person; Where terrorism meets optimism. New York Times. November 24, 2002. http://www.nytimes.com/2002/11/24/ nyregion/in person where terrorism meets optimism.html. Accessed August 10, 2012. 23. Gursky E, Inglesby TV, O’Toole T. Anthrax 2001: observations on the medical and public health response. Biosecur Bioterror. 2003;1(2):97 110. 24. Schoch Spana M. The people’s role in U.S. national health security: past, present, and future. Biosecur Bioterror. 2012;10(1):77 88. 25. Leggiere P. FEMA: Fugate outlines first national preparedness goal. HSToday.us. October 12, 2011. http://www.hstoday.us/ channels/fema/single article page/fugate outlines first national preparedness goal/b26fb2b9e7045376c62eb125570af8b9.html. Accessed August 10, 2012.

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26. The White House. National Security Strategy. May 2010. http:// www.whitehouse.gov/sites/default/files/rss_viewer/national_ security_strategy.pdf. Accessed August 10, 2012. 27. D. A. Henderson, interview by Gigi Kwik Gronvall, March 5, 2012. 28. Henderson DA. The looming threat of bioterrorism. Science. 1999;283(5406):1279 1282. 29. Henderson DA. Bioterrorism as a public health threat. Emerg Infect Dis. 1998;4(3):488 492. 30. Center for Biosecurity of UPMC. National Symposium on Medical and Public Health Response to Bioterrorism. February 16, 1999. Washington, DC. http://www.upmc biosecurity.org/website/ events/1999_symposium 1/index.html. Accessed August 10, 2012. 31. Shalala DE. Bioterrorism: how prepared are we? Emerg Infect Dis. 1999;5(4):492 493. 32. Arnon SS, Schechter R, Inglesby TV, et al. Botulinum toxin as a biological weapon: medical and public health management. JAMA. 2001;285(8):1059 1070. 33. Borio L, Inglesby T, Peters CJ, et al. Hemorrhagic fever viruses as biological weapons: medical and public health management. JAMA. 2002;287(18):2391 2405. 34. Dennis DT, Inglesby TV, Henderson DA, et al. Tularemia as a biological weapon: medical and public health management. JAMA. 2001;285(21):2763 2773. 35. Henderson DA, Inglesby TV, Bartlett JG, et al. Smallpox as a biological weapon: medical and public health management. JAMA. 1999;281(22):2127 2137. 36. Inglesby TV, Dennis DT, Henderson DA, et al. Plague as a biological weapon: medical and public health management. JAMA. 2000;283(17):2281 2290.

186 Notes

37. Inglesby TV, Henderson DA, Bartlett JG, et al. Anthrax as a biological weapon: medical and public health management. JAMA. 1999;281(18):1735 1745. 38. Inglesby TV, O’Toole T, Henderson DA, et al. Anthrax as a biological weapon, 2002: updated recommendations for management. JAMA. 2002;287(17):2236 2252. 39. Alfred P. Sloan Foundation. 2000 Annual Report. http://www.sloan. org/fileadmin/media/files/annual_reports/2000_annual_report. pdf. Accessed September 10, 2012. 40. O’Toole T, Mair M, Inglesby TV. Shining light on “Dark Winter.” Clin Infect Dis. 2002;34(7):972 983. 41. Working Group on “Governance Dilemmas” in Bioterrorism Response. Leading during bioattacks and epidemics with the public’s trust and help. Biosecur Bioterror. 2004;2(1):25 40. 42. Schoch Spana M, Franco C, Nuzzo JB, Usenza C. Community engagement: leadership tool for catastrophic health events. Biosecur Bioterror. 2007;5(1):8 25. 43. Association for State and Territorial Health Officials. Executive summary. In: At Risk Populations and Pandemic Influenza: Planning Guidance for State, Territorial, Tribal, and Local Health Departments. August 2008. http://www.astho.org/Display/AssetDisplay. aspx?id 401. Accessed August 10, 2012. 44. US Department of Health and Human Services. National Health Security Strategy of the United States of America. December 2009. http://www.phe.gov/Preparedness/planning/authority/nhss/ strategy/Documents/nhss final.pdf. Accessed August 10, 2012.

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45. US Centers for Disease Control and Prevention, Office of Public Health Preparedness and Response. Public Health Preparedness Capabilities: National Standards for State and Local Planning. March 2011. http://www.cdc.gov/phpr/capabilities/. Accessed August 10, 2012. 46. Center for Biosecurity of UPMC. Conference Brief: The 2009 H1N1 Experience: Policy Implications for Future Infectious Disease Emergencies. http://www.upmc biosecurity.org/website/ events/2010_h1n1/index.html. Accessed August 10, 2012. 47. Franco C, Sell TK. Federal agency biodefense funding, FY2011 FY2012. Biosecur Bioterror. 2011;9(2):117 137. 48. Gellman B. Government is slow to offer safety plans: local, national offices have yet to disclose advice people could use in a terrorist attack. Washington Post. August 6, 2002. 49. Ad Council. Our Work: The Classics. http://www.adcouncil.org/ Our Work/The Classics. Accessed May 10, 2012. 50. Kathy Crosby, interview by Madeline Drexler, April 11, 2011. 51. Rhem KT. Ridge: “We can be afraid or we can be ready.” American Forces Press Service. February 19, 2003. 52. Clemetson L. Threats and responses: domestic security. Reshaping message on terror, Ridge urges calm with caution. New York Times. February 20, 2003. 53. US Department of Homeland Security. Preparing Makes Sense. Get Ready Now. [pamphlet] http://www.homelandsecurity.ms.gov/ docs/dhs_brochure.pdf. Accessed March 13, 2012. 54. Ad Council. “Ready” Campaign Final Report, Grants #2002 10 1 and #2003 6 1, to the Alfred P. Sloan Foundation and the Department of Homeland Security. February 19, 2004.

188 Notes

55. Girl Scouts of America. Be Prepared Emergency Preparedness Patch Program. http://www.gscnc.org/dhs.html. Accessed August 10, 2012. 56. Strom S. Threats and responses: protective devices; behind duct tape and sheeting, an unlikely proponent. New York Times. February 23, 2003. http://www.nytimes.com/2003/02/23/world/ threats responses protective devices behind duct tape sheeting unlikely.html. Accessed August 10, 2012. 57. Remarks by Mayor Bloomberg. Mayor Bloomberg and OEM Commissioner Bruno Announce “What if New York City …” Competition to Design Urban Housing for Use After a Disaster [video]. September 27, 2007. 58. Lynn Jennings, interview by Gigi Kwik Gronvall, February 15, 2012. 59. Big City Emergency Managers website. http://www.bigcityem.org/. Accessed March 8, 2012. 60. Canedy D, Wade N. Florida man dies of rare form of anthrax. New York Times. October 6, 2001. 61. Stolberg SG. A nation challenged: the disease; anthrax threats point to limits in health systems. New York Times. October 14, 2001. 62. Update: investigation of bioterrorism related anthrax, 2001. MMWR Morb Mortal Wkly Rep. 2001;50(45):1008 1010. 63. Belongia EA, Kieke B, Lynfield R, Davis JP, Besser RE. Demand for prophylaxis after bioterrorism related anthrax cases, 2001. Emerg Infect Dis. 2005;11(1):42 48. 64. Joseph Barbera, interview by Madeline Drexler, November 18, 2011.

189 Preparing for Bioterrorism

65. Barbera JA, Macintyre AG. Medical and Health Incident Management (MaHIM) System: A Comprehensive Functional System Description for Mass Casualty and Health Incident Management. Washington, DC: Institute for Crisis, Disaster, and Risk Management, George Washington University; October 2002. 66. Barbera JA, Macintyre AG. Medical Surge Capacity and Capability: A Management System for Integrating Medical and Health Resources During Large Scale Emergencies. 2d ed. Prepared under Contract Number 233 03 0028 for the US Department of Health and Human Services. 2007. 67. Franco C, Sell TK. Federal agency biodefense funding, FY2012 FY2013. Biosecur Bioterror. 2012;10(2):162 181. 68. Toner E, Waldhorn R, Franco C, et al. Hospitals Rising to the Challenge: The First Five Years of the Hospital Preparedness Program and Priorities Going Forward. Prepared by the Center for Biosecurity of UPMC for the US Department of Health and Human Services under Contract No. HHS100200800038C. 2009. 69. Bhatt S. Details about Seattle school found in Iraq. Seattle Times. October 21, 2004. 70. Irwin Redlener, interview by Madeline Drexler, September 7, 2011. 71. Redlener I. Are our children terrorist targets? San Francisco Chronicle. January 2, 2005. 72. National Commission on Children and Disasters. 2010 Report to the President and Congress. http://cybercemetery.unt.edu/archive/ nccd/20110427002908/http:/www.childrenanddisasters.acf.hhs.gov/ index.html. Accessed June 11, 2012. 73. National Organization on Disability website. http://nod.org/about_ us/. Accessed May 11, 2012.

190 Notes

74. Elizabeth Davis, interview by Madeline Drexler, November 29, 2011. 75. National Organization on Disability. What we do. Emergency Preparedness website. http://nod.org/what_we_do/consultation_ technical_assistance/emergency_preparedness/. Accessed May 11, 2012. 76. Middleton G. Medical Reserve Corps: engaging volunteers in public health preparedness and response. Biosecur Bioterror. 2008;6(4):359 360. 77. Richard Hatchett, interview by Gigi Kwik Gronvall, February 10, 2012. 78. Department of the Army. Soldier’s Manual for Defense Against CBR Attack. Field Manual 21 41. April 1953. 79. Clinton Letter on Weapons of Mass Destruction: Text of a Letter from the President to the Speaker of the House of Representatives and the President of the Senate. November 12, 1998. http://www. bu.edu/globalbeat/nuclear/Clinton111298.html. Accessed April 27, 2012. 80. O’Toole T, Inglesby TV. Toward biosecurity. Biosecur Bioterror. 2003;1(1):1 3. 81. Shane S. F.B.I., laying out evidence, closes anthrax case. New York Times. February 19, 2010. 82. Torok TJ, Tauxe RV, Wise RP, et al. A large community outbreak of salmonellosis caused by intentional contamination of restaurant salad bars. JAMA. 1997;278(5):389 395.

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83. Committee on Advances in Technology and the Prevention of Their Application to Next Generation Biowarfare Threats. National Research Council. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: National Academies Press; 2006. 84. Butler JC, Cohen ML, Friedman CR, Scripp RM, Watz CG. Collaboration between public health and law enforcement: new paradigms and partnerships for bioterrorism planning and response. Emerg Infect Dis. 2002;8(10):1152 1156. 85. Gottron F, Shea DA. Federal Efforts to Address the Threat of Bioterrorism: Selected Issues and Options for Congress. Washington, DC: Congressional Research Service; February 8, 2011. 86. Danzig R. Catastrophic Bioterrorism What Is To Be Done? Washington, DC: Center for Technology and National Security Policy, National Defense University; August 2003. 87. Danzig R, Franz D. Sloan Report on the meeting at Wye River conference center, 2003. 88. Committee on Standards and Policies for Decontaminating Public Facilities Affected by Exposure to Harmful Biological Agents: How Clean Is Safe? National Research Council. Reopening Public Facilities After a Biological Attack: A Decision Making Framework. Washington, DC: National Academies Press; 2005. 89. Smith BT, Inglesby TV, Brimmer E, et al. Navigating the storm: report and recommendations from the Atlantic Storm exercise. Biosecur Bioterror. 2005;3(3):256 267. 90. Schengen Borders Code. European Union Regulation No. 562/2006.

192 Notes

91. Center for Biosecurity of UPMC. Atlantic Storm pre scenario briefing: issues to consider. Atlantic Storm Interactive website http://www.atlantic storm.org/flash/pdf/issues_0900_b.pdf. Accessed April 27, 2012. 92. Center for Biosecurity of UPMC. Atlantic Storm Scenario Planning Assumptions Atlantic Storm Interactive website. http://www. atlantic storm.org/flash/pdf/assump_1600.pdf. Accessed April 27, 2012. 93. Center for Biosecurity of UPMC. Media coverage of Atlantic Storm. Atlantic Storm website. http://www.upmc biosecurity.org/website/ events/2005_atlanticstorm/press/media.html. Accessed July 27, 2012. 94. Lauritzen A, Quattrini F. Black ICE: Bioterrorism International Coordination Exercise. After Action Report. http://merln.ndu.edu/ archivepdf/wmd/State/79521.pdf. Accessed September 10, 2012. 95. Miks J. Bioterrorism in Asia. Diplomat. May 7, 2009. 96. Federal Authorities of the Swiss Confederation. International Bioterrorism Response Coordination Exercise (Black Ice II). Bern, September 9, 2009. 97. Ostfield ML. Strengthening biodefense internationally: illusion and reality. Biosecur Bioterror. 2008;6(3):261 267. 98. Keim P, Smith KL, Keys C, Takahashi H, Kurata T, Kaufmann A. Molecular investigation of the Aum Shinrikyo anthrax release in Kameido, Japan. J Clin Microbiol. 2001;39(12):4566 4567. 99. Leitenberg M. Aum Shinrikyo’s efforts to produce biological weapons: a case study in the serial propagation of misinformation. In: Taylor M, Horgan J, eds. The Future of Terrorism. London; Portland, OR: Frank Cass; 2000.

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100. Smithson AE, Levy L A. Ataxia: The Chemical and Biological Terrorism Threat and the US Response. Washington, DC: Henry L. Stimson Center; 2000. 101. Matishak M. Report: cult demonstrates chemical terrorism threat. Global Security Newswire. July 29, 2001. 102. National Commission on Terrorist Attacks upon the United States. The 9/11 Commission Report: Final Report of the National Commission on Terrorist Attacks upon the United States. New York, NY: Norton; 2004. 103. Graham B, Talent JM, Allison GT. World at Risk: The Report of the Commission on the Prevention of WMD Proliferation and Terrorism. Washington, DC: Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism; 2008. 104. U.S. officials declare researcher is anthrax killer. CNN. August 6, 2008. http://articles.cnn.com/2008 08 06/justice/anthrax. case_1_bruce ivins anthrax killer anthrax attacks?_s PM:CRIME. Accessed June 11, 2012. 105. Prevention of WMD Proliferation and Terrorism Report Card: An Assesment of the U.S. Government’s Progress in Protecting the United States from Weapons of Mass Destruction Proliferation and Terrorism. Washington, DC: Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism; January 26, 2010. 106. Hearing on the WMD Prevention and Preparedness Act of 2009. US Senate Homeland Security and Governmental Affairs Committee; 2009. 107. Arnaudo D. WMD Commission issues findings. Arms Control Today. 2009;39(1):33.

194 Notes

108. Morhard R. White House, Congress mobilize in response to WMD Commission biosecurity recommendations. Biosecur Bioterror. 2010:8(3):212 213. 109. Pascrell B, King PT. WMD threat real, must be addressed. (Special Report: homeland security). The Hill. May 21, 2010:1521 1568. 110. BiPartisan WMD Terrorism Research Center. Bio Response Report Card. Washington, DC. October 2011. 111. Randy Larsen and Lynne Kidder, interview by Gigi Kwik Gronvall, January 12, 2012. 112. Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on Their Destruction. http://www.unog. ch/80256EE600585943/(httpPages)/04FBBDD6315AC720C12571800 04B1B2F?OpenDocument. Accessed August 28, 2012. 113. Gronvall GK. A new role for scientists in the Biological Weapons Convention. Nat Biotechnol. 2005;23(10):1213 1216. 114. Kellman B. An international criminal law approach to bioterrorism. Harv J Law Public Policy. 2002;25(2):721. 115. Rohde D, Sanger DE. Key Pakistani is said to admit atom transfers. New York Times. February 2, 2004:A1. 116. United Nations Security Council Resolution 1540 (2004). 117. Barry Kellman, interview by Gigi Kwik Gronvall, February 7, 2012. 118. Global Security Institute. 2002 Annual Report. http://www. gsinstitute.org/gsi/pubs/gsi_ar_2002.pdf. Accessed April 14, 2012. 119. Kellman B. Draft Model Convention on the Prohibition and Prevention of Biological Terrorism. 2001. http://www.law.depaul. edu/centers_institutes/iwcc/pdf/draft_convention.pdf. Accessed April 27, 2012.

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120. Kellman B, Muthe Lindgren O. Preventing Disease Weaponization: Strengthening Law Enforcement and National Legislation. Geneva Workshop, April 2003. http://www.law.depaul.edu/centers_ institutes/iwcc/pdf/geneva_workshop_2003.pdf. Accessed April 12, 2012. 121. Biological Weapons Convention members begin new process: experts to meet in Geneva to discuss ways of strengthening national measures against biological weapons [press release]. Geneva, Switzerland: World Health Organization; August 18, 2003. http://www.un.org/News/Press/docs/2003/dc2882.doc.htm. Accessed April 27, 2012. 122. INTERPOL’s Bioterrorism Prevention Programme. INTERPOL website. https://www.interpol.int/Public/BioTerrorism/Prevention. asp. Accessed April 12, 2012. 123. Bioterrorism events and workshops. INTERPOL website https:// www.interpol.int/Public/BioTerrorism/Workshops/Default.asp. Accessed April 12, 2012. 124. About INTERPOL. Overview. INTERPOL website. http://www. interpol.int/About INTERPOL/Overview. Accessed April 12, 2012. 125. The 1st INTERPOL Global Conference on preventing bioterrorism. INTERPOL website https://www.interpol.int/Public/ BioTerrorism/Conferences/Conf01/default.asp. Accessed April 12, 2012. 126. Noble RK. Remarks made at 1st INTERPOL Global Conference on preventing bioterrorism; March 1 2, 2005; Lyon, France. https://www.interpol.int/Public/ICPO/speeches/ NobleBioTerrorism20050301.asp. Accessed August 20, 2012. 127. Ronald K. Noble, phone interview by Madeline Drexler, September 26, 2011.

196 Notes

128. Mitchell Stern, phone interview by Madeline Drexler, September 19, 2011. 129. Committee on a New Government University Partnership for Science and Security. National Research Council. Science and Security in a Post 9/11 World: A Report Based on Regional Discussions Between the Science and Security Communities. Washington, DC: National Academies Press; 2007. 130. Rambhia KJ, Ribner AS, Gronvall GK. Everywhere you look: select agent pathogens. Biosecur Bioterror. 2011;9(1):69 71. 131. Young A. Official: Israel will act if militants raid Syrian chemical or biological weapons stocks. International Business Times. July 23, 2012. http://www.ibtimes.com/articles/365816/20120723/syria wmds chemical biological.htm. Accessed July 27, 2012. 132. Kwik G, Fitzgerald J, Inglesby TV, O’Toole T. Biosecurity: responsible stewardship of bioscience in an age of catastrophic terrorism. Biosecur Bioterror. 2003;1(1):27 35. 133. Jackson RJ, Ramsay AJ, Christensen CD, Beaton S, Hall DF, Ramshaw IA. Expression of mouse interleukin 4 by a recombinant ectromelia virus suppresses cytolytic lymphocyte responses and overcomes genetic resistance to mousepox. J Virol. 2001;75(3):1205 1210. 134. Mullbacher A, Lobigs M. Creation of killer poxvirus could have been predicted. J Virol. 2001;75(18):8353 8355. 135. Neergaard L. Details of lab made bird flu won’t be revealed. Houston Chronicle. December 21, 2011. http://www.chron. com/news/article/Details of lab made bird flu won t be revealed 2414290.php. Accessed April 2, 2012. 136. Enserink M. Scientists chase fast moving and deadly global illness. Science. 2003;299(5614):1822.

197 Preparing for Bioterrorism

137. DiMasi JA, Hansen RW, Grabowski HG. The price of innovation: new estimates of drug development costs. J Health Econ. 2003;22(2):151 185. 138. Russell PK, Gronvall GK. U.S. medical countermeasure development since 2001: a long way yet to go. Biosecur Bioterror. 2012;10(1):66 76. 139. Committee on Research Standards and Practices to Prevent the Destructive Application of Biotechnology. National Research Council. Biotechnology Research in an Age of Terrorism. Washington, DC: National Academies Press; 2004. 140. Screening framework guidance for providers of synthetic double stranded DNA. Fed Register. 2010 Oct 13;75(197):62820 62832. http://www.gpo.gov/fdsys/pkg/FR 2010 10 13/html/2010 25728. htm. Accessed August 21, 2012. 141. Rosengard AM, Liu Y, Nie Z, Jimenez R. Variola virus immune evasion design: expression of a highly efficient inhibitor of human complement. Proc Natl Acad Sci U S A. 2002;99(13):8808 8813. 142. Cello J, Paul AV, Wimmer E. Chemical synthesis of poliovirus cDNA: generation of infectious virus in the absence of natural template. Science. 2002;297(5583):1016 1018. 143. Tumpey TM, Basler CF, Aguilar PV, et al. Characterization of the reconstructed 1918 Spanish influenza pandemic virus. Science. 2005;310(5745):77 80. 144. Roos R. H5N1 transmission experiment stirs concern. CIDRAP News. November 17, 2011. http://www.cidrap.umn.edu/cidrap/ content/influenza/avianflu/news/nov1711board.html. Accessed August 20, 2012.

198 Notes

145. Malakoff D. Breaking news: NSABB reverses position on flu papers. Science Insider. March 30 2012. http://news.sciencemag.org/ scienceinsider/2012/03/breaking news nsabb reverses pos.html. Accessed April 3, 2012. 146. United States Government Policy for Oversight of Life Sciences Dual Use Research of Concern. March 29, 2012. http://oba.od.nih. gov/oba/biosecurity/PDF/United_States_Government_Policy_ for_Oversight_of_DURC_FINAL_version_032812.pdf. Accessed August 20, 2012. 147. Epstein GL. Preventing biological weapon development through the governance of life science research. Biosecur Bioterror. 2012;10(1):17 37. 148. Gronvall GK, Waldhorn RE, Henderson DA. The scientific response to a pandemic. PLoS Pathog. 2006;2(2):e9. 149. Preston R. The Hot Zone. New York, NY: Random House; 1994. 150. Naughton JM. Nixon renounces germ weapons, orders destruction of stocks; restricts use of chemical arms. New York Times. November 25, 1969. 151. Jo L. Husbands, interview by Madeline Drexler, June 9, 2011. 152. Ron Atlas, interview by Madeline Drexler, June 9, 2011. 153. Check E. US officials urge biologists to vet publications for bioterror risk. Nature. 2003;211:197. 154. Kennedy D. Better never than late. Science. 2005;310(5746):195. 155. Keim PS. The NSABB recommendations: rationale, impact, and implications. mBio. 2012;3(1):pii:e00021 12. 156. Webster RG. Mammalian transmissible H5N1 influenza: the dilemma of dual use research. mBio. 2012 Jan 31;3(1):pii:e00005 12.

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157. Keim PS. Q&A: Reasons for proposed redaction of flu paper. Nature. 2012;482(7384):156 157. 158. Tucker JB, Okutani SM. Global Governance of “Contentious” Science: The Case of the World Health Organization’s Oversight of Small Pox Virus Research. Stockholm: Weapons of Mass Destruction Commission; October 2004. http://www.un.org/ disarmament/education/wmdcommission/files/No18.pdf. Accessed August 20, 2012. 159. Smallpox. Global Alert and Response (GAR). World Health Organzation website. http://www.who.int/csr/disease/smallpox/en/ index.html. Accessed March 27, 2012. 160. Tucker JB. Preventing the misuse of biology: lessons from the oversight of smallpox virus research. Int Secur. 2006;31(2):116 150. 161. The Controlling Dangerous Pathogens Project. Center for International Security Studies at Maryland. School of Public Policy, University of Maryland website http://www.cissm.umd.edu/ projects/pathogens.php. Accessed August 16, 2011. 162. Steinbruner J, Harris ED, Gallagher N, Okutani SM. Controlling Dangerous Pathogens: A Prototype Protective Oversight System. College Park, MD: Center for International and Security Studies at Maryland, Advanced Methods of Cooperative Security Program; 2007. 163. Containing the biological threat. Rethinking Global Security. Spring 2004. International Peace and Security Program. MacArthur Foundation website. http://www.macfound.org/press/publications/ rethinking global security/#containing. Accessed May 1, 2012. 164. Okutani S, Steinbruner J. The protective oversight of biotechnology. Biosecur Bioterror. 2004;2(4):273 280.

200 Notes

165. Gulden T, Siegel J. The development of prototype data management systems for the Biological Research Security System (BRSS). Biosecurity Workshop; College Park, Maryland; October 2010. 166. Brickley P. Science police needed? Genome Biol. April 8, 2003. http://genomebiology.com/2003/4/4/spotlight 20030408 01. Accessed August 20, 2012. 167. Gerald LE. Better rules for biotech research. Issues Sci Technol. 2003;20(1):6. 168. Paula Olsiewski, interview by Gigi Kwik Gronvall and Madeline Drexler, January 28 2011. 169. Towards better biosecurity. Nature. 2006;440(7085):715. 170. John Steinbruner, interview by Gigi Kwik Gronvall, July 8, 2011. 171. Fouchier R, Osterhaus AB, Steinbruner J, et al. Preventing pandemics: the fight over flu. Nature. 2012;481(7381):257 259. 172. Pollack A. Scientists create a live polio virus. New York Times. July 12, 2002:A1. 173. Wimmer E. The test tube synthesis of a chemical called poliovirus. The simple synthesis of a virus has far reaching social implications. EMBO Rep. 2006;7 Spec No.:S3 S9. 174. Smith HO, Hutchison CA 3rd, Pfannkoch C, Venter JC. Generating a synthetic genome by whole genome assembly: phiX174 bacteriophage from synthetic oligonucleotides. Proc Natl Acad Sci U S A. 2003;100(26):15440 15445. 175. Gibson DG, Glass JI, Lartigue C, et al. Creation of a bacterial cell controlled by a chemically synthesized genome. Science. 2010;329(5987):52 56. 176. Wade N. Synthetic bacterial genome takes over a cell, researchers report. New York Times. May 20, 2010:A17(L).

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177. Isaacs FJ, Carr PA, Wang HH, et al. Precise manipulation of chromosomes in vivo enables genome wide codon replacement. Science. 2011;333(6040):348 353. 178. Wade N. With mammoth genes, scientists ask: what if? New York Times. November 20, 2008:A1. 179. Wade N. Genetic code of E. coli is hijacked by biologists. New York Times. July 14, 2011:A14. 180. Carlson R. The changing economics of DNA synthesis: how are the economics of synthetic biology likely to develop in the coming years? Nat Biotechnol. 2009;27(12):1091 1094. 181. Carlson R. The pace and proliferation of biological technologies. Biosecur Bioterror. 2003;1(3):203 214. 182. Garfinkel MS, Endy D, Epstein GL, Friedman RM. Synthetic Genomics: Options for Governance. October 7, 2007. http://www. www.jcvi.org/cms/research/projects/syngen options/. Accessed October 18, 2012. 183. Garfinkel MS, Endy D, Epstein GL, Friedman RM. Synthetic genomics | options for governance. Biosecur Bioterror. Dec 2007;5(4):359 362. 184. Robert Friedman and Michele Garfinkel, interview by Gigi Kwik Gronvall, August 2, 2011. 185. National Science Advisory Board for Biosecurity. Addressing Biosecurity Concerns Related to the Synthesis of Select Agents. December 2006. http://oba.od.nih.gov/biosecurity/pdf/Final_ NSABB_Report_on_Synthetic_Genomics.pdf. Accessed August 20, 2012.

202 Notes

186. Code of Conduct for Best Practices in Gene Synthesis. International Association Synthetic Biology (IASB) website. http:// www.ia sb.eu/go/synthetic biology/synthetic biology/code of conduct for best practices in gene synthesis/. Accessed August 20, 2012. 187. International Gene Synthesis Consortium (ICSC). Harmonized Screening Protocol: Gene Sequence & Customer Screening to Promote Biosecurity. Undated. http://www. genesynthesisconsortium.org/wp content/uploads/2012/02/IGSC Harmonized Screening Protocol1.pdf. Accessed August 20, 2012. 188. Church GM. A Synthetic Biohazard Non proliferation Proposal. Boston, MA: Harvard Medical School; August 6, 2004. 189. Committee on Scientific Milestones for the Development of a Gene Sequence Based Classification System for the Oversight of Select Agents; National Research Council. Sequence Based Classification of Select Agents: A Brighter Line. Washington, DC: National Academies Press; 2010. 190. Gronvall GK. HHS guidance on synthetic DNA is the right step. Biosecur Bioterror. 2010;8(4):373 376. 191. Pollack A. Presidential bioethics panel gives a green light to research in synthetic biology. New York Times. December 16, 2010:A28. 192. Presidential Commission for the Study of Bioethical Issues. New Directions: The Ethics of Synthetic Biology and Emerging Technologies. Washington, DC; 2010. http://bioethics.gov/cms/ synthetic biology report. Accessed August 20, 2012. 193. Brian Rappert, interview by Gigi Kwik Gronvall and Crystal Franco, May 2, 2011. 194. Malcolm Dando, interview by Gigi Kwik Gronvall, August 2, 2011.

203 Preparing for Bioterrorism

195. Rappert B. A teachable moment for biological weapons: the seventh BWC Review Conference and the need for international cooperation in education. Bull At Sci. 2011;67(3):44 50. 196. National Security Council. National Strategy for Countering Biological Threats. November 2009. http://www.whitehouse.gov/ sites/default/files/National_Strategy_for_Countering_BioThreats. pdf. Accessed August 20, 2012. 197. Australia, Japan, Switzerland on behalf of the “JACKSNNZ,” and Sweden. Possible Approaches to Education and Awareness Raising Among Life Scientists. Geneva: Preparatory Committee for the Seventh Review Conference of the States Parties to the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on Their Destruction; April 13 15, 2011. 198. Final Document of the Seventh Review Conference. Seventh Review Conference of the States Parties to the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on Their Destruction. Geneva; 2011. http://www.unog. ch/80256EDD006B8954/(httpAssets)/570C9E76CAAB510AC12579 72005A6725/$file/ADVACNCE BWC+7RC+Final_Document.pdf. Accessed August 21, 2012. 199. Taylor T. Opening remarks made at: The International Council for the Life Sciences Biosafety and Biosecurity International Conference 2007. Abu Dhabi; November 12, 2007. http://www. iclscharter.org/editor/userfiles/image/Biosafety_and_Biosecurity_ International_Conference_2007.pdf. Accessed April 25, 2012.

204 Notes

200. Taylor T. Awareness Raising through Direct Action. Paper presented at: National Science Advisory Board for Biosecurity (NSABB); Bethesda, Maryland; November 6 7, 2008. http://oba. od.nih.gov/biosecurity/NSABB_3rd_Roundtable_Presentation/ NSABB%20Taylor%206%20Nov%2008.pdf. Accessed March 30, 2012. 201. Terence Taylor, interview by Gigi Kwik Gronvall, March 29, 2012. 202. Our Work: Biosafety and Biosecurity International Conference (BBIC). International Council for the Life Sciences (ICLS) website. http://www.iclscharter.org/eng/our_work_bbic.asp. Accessed April 3, 2012. 203. Third Biosafety and Biosecurity International Conference (BBIC) website. 2011. http://www.rss.jo/ar/node/523. Accessed May 1, 2012. 204. Fifty fifth World Health Assembly. WHA55.16. Agenda item 13.15: Global public health response to natural occurrence, accidental release or deliberate use of biological and chemical agents or radionuclear material that affect health. Geneva; May 18, 2002. http://apps.who.int/gb/archive/pdf_files/WHA55/ewha5516.pdf. Accessed September 10, 2012. 205. World Health Organization. Responsible Life Sciences Research for Global Health Security: A Guidance Document. Geneva; 2010. http:// whqlibdoc.who.int/hq/2010/WHO_HSE_GAR_BDP_2010.2_eng. pdf. Accessed September 10, 2012. 206. World Health Organization. Life Science Research: Opportunities and Risks for Public Health. Mapping the Issues. Geneva; 2005. http://www.who.int/ethics/Life%20Science%20Research.pdf. Accessed September 10, 2012.

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207. World Health Organization. Scientific Working Group on Life Science Research and Global Health Security: Report of the First Meeting. Geneva; October 16 18, 2006. http://www.who.int/csr/ resources/publications/deliberate/WHO_CDS_EPR_2007_4/en/ index.html. Accessed September 10, 2012. 208. World Health Organization. Research Policy and Management of Risks in Life Scienes Research for Global Health Security: Report of the Meeting. Bangkok, Thailand; December 10 12, 2007. http:// www.who.int/csr/resources/publications/deliberate/WHO_HSE_ EPR_2008_4/en/index.html. Accessed September 10, 2012. 209. World Health Organization; US Government; National Science Advisory Board for Biosecurity. International Roundtable on Dual Use Life Sciences Research. http://oba.od.nih.gov/biosecurity/ pdf/1st%20International%20Roundtable%20FINALWeb.pdf. Accessed March 27, 2012. 210. Oshinsky DM. Polio: An American Story. New York, NY: Oxford University Press; 2005. 211. Smithsonian National Museum of American History, Behring Center. Whatever Happened to Polio? http://americanhistory.si.edu/ polio/americanepi/communities.htm. Accessed April 12, 2012. 212. Meldrum M. “A calculated risk”: the Salk polio vaccine field trials of 1954. BMJ. 1998;317(7167):1233 1236. 213. Vaccines and Preventable Diseases: Polio Disease Questions and Answers. Department of Health and Human Services Centers for Disease Control and Prevention website. http://www.cdc.gov/ vaccines/vpd vac/polio/dis faqs.htm. Accessed April 12, 2012. 214. Gene Matthews, interview by Gigi Kwik Gronvall, February 1, 2012. 215. Swendiman KS, Elsea JK. Federal and State Quarantine and Isolation Authority. Washington, DC: Congressional Research

206 Notes

Service; August 16, 2006; updated January 23, 2007. http://www. fas.org/sgp/crs/misc/RL33201.pdf. Accessed August 20, 2012. 216. Knox R. Arizona TB patient jailed as a public health menace. National Public Radio. June 11, 2007. http://www.npr.org/templates/ story/story.php?storyId 10874970. Accessed April 12, 2012. 217. Proposal to the Alfred P. Sloan Foundation for Support for the Consensus Forum. State Emergency Public Health Powers and the Bioterrorism Threat. Centers for Disease Control and Prevention, Public Health Law Program. February 1, 2001. 218. Goldberg DS. Against the very idea of the politicization of public health policy. Am J Public Health. 2012;102(1):44. 219. Gostin LO. Public health law reform. Am J Public Health. 2001 September;91(9):1365 1368. 220. Misrahi JJ, Foley M. Cantigny Conference on State Emergency Health Powers and the Bioterrorism Threat. Centers for Disease Control and Prevention, American Bar Association Standing Committee on Law and National Security, The National Strategy Forum; 2001. 221. Public Health Statute Modernization National Excellence Collaborative. Turning Point: Collaborating for a New Century in Public Health. Turning Point National Program Office at the University of Washington; 2003. 222. Gene Matthews, e mail correspondence with Gigi Kwik Gronvall, January 31, 2012. 223. The Center for Law and the Public’s Health at Georgetown and Johns Hopkins Universities. The Model State Emergency Health Powers Act As of December 21, 2001: A Draft for Discussion Prepared for the Centers for Disease Control and Prevention (CDC). http:// www.publichealthlaw.net/MSEHPA/MSEHPA.pdf. Accessed April 12, 2012.

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224. Hodge JG. The evolution of law in biopreparedness. Biosecur Bioterror. 2012;10(1):38 48. 225. Gostin LO. Public health law in an age of terrorism: rethinking individual rights and common goods. Health Aff (Millwood). 2002;21(6):79 93. 226. Public Health Security and Bioterrorism Preparedness and Response Act of 2002. June 12, 2002. Pub. L. No. 107 188;116 Stat 594. 227. Committee on Public Health Strategies to Improve Health; Institute of Medicine. For the Public’s Health: Revitalizing Law and Policy to Meet New Challenges. Washington, DC: National Academies Press; 2011. 228. Gostin LO. The Model State Emergency Health Powers Act: public health and civil liberties in a time of terrorism. Health Matrix Clevel. 2003;13(1):3 32. 229. Larry Gostin, interview by Madeline Drexler, July 29, 2011. 230. Matthews GW, Markiewicz M. Update on emergency liability protection for volunteer entities. Biosecur Bioterror. 2009;7(1):51 54. 231. American Red Cross. Pandemic Influenza Planning Guidance: Update on Worker Safety, Additional Mass Care Planning Tools. Washington, DC: American Red Cross; 2007. 232. Public/Private Legal Preparedness Initiative, UNC Gillings School of Global Public Health. Good Samaritan Entity Liability Protection Initiative. January 12, 2009. http://nciph.sph.unc.edu/law/good_ sam.htm. Accessed August 20, 2012. 233. Trust for America’s Health. Ready or Not? Protecting the Public’s Health from Diseases, Disasters, and Bioterrorism. December 2007. http://healthyamericans.org/reports/bioterror07/. Accessed April 12, 2012.

208 Notes

234. Trust for America’s Health. Ready or Not? Protecting the Public’s Health from Diseases, Disasters, and Bioterrorism. December 2009. http://healthyamericans.org/reports/bioterror09/. Accessed August 20, 2012. 235. Leslie Jacobs, phone interview by Madeline Drexler, November 16, 2011. 236. Parker ER. University of the Pacific McGeorge School of Law. Final report to Sloan Foundation, January 16, 2004. 237. Jacobs LG. A message from Professor Jacobs. Bioterrorism & National Security. University of the Pacific McGeorge School of Law website. http://www.mcgeorge.edu/Faculty_and_Scholarship/ Centers_and_Institutes/Capital_Center_for_Public_Law_and_ Policy/Reports_Studies_and_Policy_Projects/Bioterrorism_and_ National_Security.htm. Accessed September 10, 2012. 238. Journal of National Security Law & Policy. http://www.jnslp.com/. Accessed April 12, 2012. 239. Overview. Critical Infrastructure Sector Partnerships. Department of Homeland Security website. http://www.dhs.gov/files/ partnerships/editorial_0206.shtm. Accessed June 15, 2012. 240. US Department of Homeland Security. Homeland Security Presidential Directive 7: Critical Infrastructure Identification, Prioritization, and Protection. December 17, 2003. http://www. dhs.gov/xabout/laws/gc_1214597989952.shtm. Accessed January 25, 2012. 241. US Department of Homeland Security. Federal Emergency Management Agency. Chapter 8: Business Crisis and Continuity Management and Planning Emergency and Risk Management Case Studies Textbook. All of the chapters can be found here: http:// training.fema.gov/EMIWeb/edu/emoutline.asp. Accessed June 15, 2012.

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242. International Center for Enterprise Preparedness. Proceedings of the International Public Private Preparedness Summit; Florence, Italy; April 27 28, 2006. http://www.nyu.edu/intercep/proceedings summary.pdf. Accessed January 25, 2012. 243. Implementing Recommendations of the 9/11 Commission Act of 2007. P.L. 110 53. August 3, 2007. http://intelligence.senate.gov/ laws/pl11053.pdf. Accessed January 25, 2012. 244. Caudle S. National preparedness requirements: harnessing management system standards. Homeland Security Affairs. 2011;7(14). http://www.hsaj.org/?fullarticle 7.1.14. Accessed January 25, 2012. 245. Bruce Blythe, interview by Gigi Kwik Gronvall, June 7, 2011. 246. Representatives of ASIS International (ASIS); Disaster Recovery Institute International (DRII); National Fire Protection Association (NFPA); Risk and Insurance Management Society IR. Framework for Voluntary Preparedness: Briefing Regarding Private Sector Approaches to Title IX of H.R. 1 and Public Law 110 53, “Implementing Recommendations of the 9/11 Commission Act of 2007.” January 18, 2008. 247. Al Berman, interview by Gigi Kwik Gronvall, June 13, 2011. 248. US Department of Homeland Security. Secretary Napolitano announces new standards for private sector preparedness [press release]. Washington, DC: June 15, 2010. http://www.dhs.gov/ ynews/releases/pr_1276616888003.shtm. Accessed January 25, 2012. 249. US Department of Homeland Security. Federal Emergency Management Agency. Voluntary private sector accreditation and certification preparedness program. Fed Register. 2010 Oct 1;75(190):60773. http://edocket.access.gpo.gov/2010/pdf/2010 24673. pdf. Accessed January 25, 2012. 250. Don Schmidt, interview by Gigi Kwik Gronvall, June 3, 2011.

210 Notes

251. Moscaritolo A. AT&T certified by DHS in disaster preparedness. PC Mag.com. March 14, 2012. http://www.pcmag.com/ article2/0,2817,2401591,00.asp. Accessed June 15, 2012. 252. National summit to address business readiness for flu pandemic. CIDRAP News. February 1, 2006. http://www.cidrap.umn.edu/ cidrap/content/influenza/panflu/news/feb0106summit.html. Accessed January 25, 2012. 253. Osterholm MT, Schwartz J. Living Terrors: What America Needs to Know to Survive the Coming Bio terrorist Catastrophe. New York, NY: Delacorte Press; 2000. 254. Bird flu: the untold story. The Oprah Show. http://www.oprah. com/oprahshow/The Next Pandemic/1. Accessed August 21, 2012. 255. Avian Flu: Addressing the Global Threat: Hearings Before the House Committee on International Relations. 109th Cong, 1st Sess (2005) (statement of Michael T. Osterholm, PhD, MPH). http://commdocs.house.gov/committees/intlrel/hfa24906.000/ hfa24906_0f.htm. Accessed January 25, 2012. 256. Previous Summit and Seminar Registrants. Keeping the World Working During the H1N1 Pandemic: Protecting the Employee Health, Critical Operations, and Customer Relations; Minneapolis, MN; September 22 23, 2009. CIDRAP website. http:// attendesource.com/profile/web/index.cfm?PKwebID 0x65757d46 &varPage hotel. Accessed January 25, 2012. 257. 2006 summit coverage: conference poll: 18% of businessess have pandemic plan. CIDRAP News. February 15, 2006. http:// www.cidrap.umn.edu/cidrap/content/influenza/biz plan/news/ feb1506survey.html. Accessed January 25, 2012.

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258. CIDRAP and International SOS join forces to provide corporations with crucial information on pandemic preparedness. Medical News Today. April 21, 2007. http://www.medicalnewstoday.com/ releases/68440.php. Accessed January 25, 2012. 259. CIDRAP Business Source. 10 Point Framework for Pandemic Influenza Business Preparedness. 2006. http://www.cidrap.umn.edu/ cidrap/files/34/10 point%20framework.pdf. Accessed August 21, 2012. 260. Osterholm MT. Final column: pandemic preparedness after H1N1: remember if you’ve seen one pandemic, you’ve seen one pandemic. CIDRAP Business Source. June 2, 2011. http://www. cidrapsource.com/source/briefing/osterbrief/060211_10_mto.html. Accessed January 25, 2012. 261. William Raisch, interview by Madeline Drexler, May 19, 2011. 262. Fifth Public Hearing of the National Commission on Terrorist Attacks Upon the United States (2003) (statement of William G. Raisch). http://govinfo.library.unt.edu/911/hearings/hearing5/witness_ raisch.htm. Accessed January 25, 2012. 263. Dreyer SJ, Ingram D. Enterprise risk management: Standard & Poor’s to apply enterprise risk analysis to corporate ratings. Standard and Poor’s. May 7, 2008. http://www.standardandpoors. com/prot/ratings/articles/en/us/?articleType HTML&asset ID 1245321771617. Accessed January 25, 2012. 264. S&P Capital IQ. http://www.standardandpoors.com/products services/CapitalIQ/en/us. Accessed January 25, 2012. 265. Ursano R. Workplace preparedness for terrorism: report of findings to Alfred P. Sloan Foundation. Center for the Study of Traumatic Stress, Uniformed Services University School of Medicine; 2011. http://www.usuhs.mil/psy/SloanReport.html. Accessed January 25, 2012.

212 Notes

266. Vineburgh N, Fullerton C, Ursano R. Chapter 9: Disaster Consequence Management. J Workplace Behav Health. 2005;20(1):159 181. 267. Alfred P. Sloan Foundation. 2006 Annual Report. http://www.sloan. org/fileadmin/media/files/annual_reports/2006_annual_report.pdf. Accessed September 13, 2012. 268. Garwin RL, Gomory RE, Meselson MS. How to fight bioterrorism. Washington Post. May 14, 2002:A21. 269. Fisk WJ. Review of Health and Productivity Gains from Better IEQ. Berkeley, CA: Environmental Energy Technologies Division, Indoor Environment Department, Lawrence Berkeley National Laboratory; 2000. 270. US Environmental Protection Agency. Indoor Air Facts No. 4 (revised) Sick Building Syndrome. 2010. http://www.epa.gov/iaq/ pdfs/sick_building_factsheet.pdf. Accessed May 27, 2011. 271. Humphries C. Indoor ecosystems. Science. 2012;335(6069):648 650. 272. Harvey Brickman, interview by Madeline Drexler, March 30, 2011. 273. American Society of Heating, Refrigerating Air Conditioning Engineers, Inc. Guideline for the Risk Management of Public Health and Safety in Buildings. 2009. 274. ASHRAE to host building security broadcast. Air Conditioning, Heating & Refrigeration News. 2004;221(14):27. 275. Hitchcock PJ, Mair M, Inglesby TV, et al. Improving performance of HVAC systems to reduce exposure to aerosolized infectious agents in buildings; recommendations to reduce risks posed by biological attacks. Biosecur Bioterror. 2006;4(1):41 54.

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276. Committee on Protecting Occupants of DOD Buildings from Chemical and Biological Release, National Research Council. Protecting Building Occupants and Operations from Biological and Chemical Airborne Threats: A Framework for Decision Making. Washington, DC: National Academies Press; 2007. 277. US Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health. Guidance for Filtration and Air Cleaning Systems to Protect Building Environments from Airborne Chemical, Biological, or Radiological Attacks. Cincinnati, OH: NIOSH; 2003. http://www.cdc.gov/niosh/docs/2003 136/ pdfs/2003 136.pdf. Accessed August 21, 2012. 278. The Real Estate Roundtable website. http://www.rer.org/. Accessed May 27, 2011. 279. Mills E. Commissioning: capturing the potential. ASHRAE Journal. February 2011:1 2. 280. Mills E. Building Commissioning: A Golden Opportunity for Reducing Energy Costs and Greenhouse Gas Emissions. Berkeley, CA: Lawrence Berkeley National Laboratory; July 21, 2009. 281. Proctor ME, Blair KA, Davis JP. Surveillance data for waterborne illness detection: an assessment following a massive waterborne outbreak of Cryptosporidium infection. Epidemiol Infect. 1998;120(1):43 54. 282. Public Health Security and Bioterrorism Preparedness and Response Act of 2002, H.R. 3448 (2002). 283. Syndromic surveillance for bioterrorism following the attacks on the World Trade Center New York City, 2001. MMWR Morb Mortal Wkly Rep. 2002;51 Spec No:13 15. 284. Buehler JW, Sonricker A, Paladini M, Soper P, Mostashari F. Syndromic surveillance practice in the United States: findings

214 Notes

from a survey of state, territorial, and selected local health departments. Adv Dis Surveill. 2008;6(3). http://www.isdsjournal. org/articles/2618.pdf. Accessed August 21, 2012. 285. Das D, Weiss D, Mostashari F, et al. Enhanced drop in syndromic surveillance in New York City following September 11, 2001. J Urban Health. 2003;80(2 Suppl 1):i76 88. 286. Reingold A. If syndromic surveillance is the answer, what is the question? Biosecur Bioterror. 2003;1(2):77 81. 287. About ISDS. International Society for Disease Surveillance website. http://www.syndromic.org/about isds. Accessed May 20, 2011. 288. Nuzzo JB. The biological threat to U.S. water supplies: toward a national water security policy. Biosecur Bioterror. 2006;4(2):147 159. 289. Rosalie Philips, Executive Director Tufts Health Care Institute (THCI); Joanne Kelly, Finance (THCI); Rosemarie Curran, Manager of Marketing and Development (THCI); Dr. David Buckeridge, ISDS Board President and Board Member; Dr. Laura Streichert, ISDS Executive Director, Tufts Health Care Institute leadership; interview by Crystal Franco, May 3, 2011. 290. Farzad Mostashari, interview by Madeline Drexler, May 2, 2011. 291. Toner ES, Nuzzo JB, Watson M, et al. Biosurveillance where it happens: state and local capabilities and needs. Biosecur Bioterror. 2011;9(4):321 330. 292. Distribute. International Society for Disease Surveillance website. http://isdsdistribute.org/. Accessed January 25, 2012. 293. Greenko J, Mostashari F, Fine A, Layton M. Clinical evaluation of the Emergency Medical Services (EMS) ambulance dispatch based syndromic surveillance system, New York City. J Urban Health. 2003;80(2 Suppl 1):i50 56.

215 Preparing for Bioterrorism

294. Das D, Metzger K, Heffernan R, Balter S, Weiss D, Mostashari F. Monitoring over the counter medication sales for early detection of disease outbreaks New York City. MMWR Morb Mortal Wkly Rep. 2005;54 Suppl:41 46. 295. SaTScan Version History.pdf. SaTScan™ website. http://www. satscan.org/cgi bin/satscan/register.pl/SaTScan%20User%20 Guide?todo process_version_history_download. Accessed January 26, 2012. 296. GIS Center of Excellence. New York City Department of Health and Mental Hygiene website. http://home2.nyc.gov/html/doh/ html/epi/giscenter.shtml. Accessed January 26, 2012. 297. Lombardo JS, Burkom H, Pavlin J. ESSENCE II and the framework for evaluating syndromic surveillance systems. MMWR Morb Mortal Wkly Rep. 2004;53 Suppl:159 165. 298. Greenblatt S. Rutgers University forum offers glimpse of anti terrorism’s future. Knight Ridder/Tribune Business News. October 30, 2003:1. 299. Director Fred Roberts recalls DIMACS’s successes, prepares to lead new consortium [news release]. New Brunswick, NJ: Rutgers, The State University of New Jersey, Media Relations; November 13, 2009. http://news.rutgers.edu/medrel/research/renowned mathematica 20091113/director fred robert 20091113/. Accessed September 10, 2012. 300. Rutgers gets $3M to hunt for clues to terrorism. Record (Hackensack, NJ). July 28, 2006:A03. 301. DIMACS's International Conference on Computational and Mathematical Epidemiology 2002. DIMACS's website. http:// dimacs.rutgers.edu/Workshops/Opening/. Accessed September 10, 2012.

216 Notes

302. Fred S. Roberts, e mail communication to Gigi Kwik Gronvall, April 28, 2011. 303. About the RODS Laboratory. University of Pittsburgh RODS Laboratory website. http://www.rods.pitt.edu/site/content/ view/14/77/. Accessed June 27, 2011. 304. History of the RODS Laboratory. University of Pittsburgh RODS Laboratory Web site. https://www.rods.pitt.edu/site/content/ view/13/78. Accessed January 26, 2012. 305. Greenman C. Tracking an outbreak minute by minute. New York Times. July 4, 2002. 306. Connolly C. Bush promotes plans to fight bioterrorism. Washington Post. February 6, 2002. 307. Snowbeck C. Olympics bioterror security starts here. Pittsburgh Post Gazette. February 9, 2002. 308. Uscher Pines L, Farrell CL, Cattani J, et al. A survey of usage protocols of syndromic surveillance systems by state public health departments in the United States. J Public Health Manag Pract. 2009;15(5):432 438. 309. Hearings Before the Subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce, 107th Cong, 1st Sess (2001) (statement of Michael Wagner). 310. US Centers for Disease Control and Prevention. Outbreaks of avian influenza A (H5N1) in Asia and interim recommendations for evaluation and reporting of suspected cases United States, 2004. MMWR Morb Mortal Wkly Rep. 2004;53(5):97 100. 311. Taubenberger JK, Morens DM. 1918 influenza: the mother of all pandemics. Emerg Infect Dis. 2006;12(1):15 22.

217 Preparing for Bioterrorism

312. World Health Organization. Cumulative number of confirmed human cases for avian influenza A(H5N1) reported to WHO 2003 2012. http://www.who.int/influenza/human_animal_interface/ EN_GIP_20120706CumulativeNumberH5N1cases.pdf. Accessed July 27, 2012. 313. World Health Organization, Department of Communicable Disease Surveillance and Response. Vaccines for Pandemic Influenza: Informal Meeting of WHO, Influenza Vaccine Manufacturers, National Licensing Agencies, and Government Representatives on Influenza Pandemic Vaccines. Geneva, Switzerland; November 11 12, 2004. http://www.who.int/influenza/ meeting2004_11_08/en/. Accessed March 2, 2012. 314. H5N1 avian influenza: first steps towards development of a human vaccine. Wkly Epidemiol Rec. 2005;80(33):277 278. 315. US Government Accountability Organization. Influenza Vaccine: Shortages in 2004 05 Season Underscore Need for Better Preparation. GAO 05 984. September 2005. http://www.gao.gov/new.items/ d05984.pdf. Accessed August 21, 2012. 316. Grady D. With few suppliers of flu shots, shortage was long in making. New York Times. October 17, 2004. 317. Morse SS, Garwin RL, Olsiewski PJ. Public health. Next flu pandemic: what to do until the vaccine arrives? Science. 2006;314(5801):929. 318. Barry JM. The Great Influenza: The Epic Story of the Deadliest Plague in History. New York, NY: Viking; 2004. 319. Morens DM, Fauci AS. The 1918 influenza pandemic: insights for the 21st century. J Infect Dis. 2007;195(7):1018 1028.

218 Notes

320. Barry JM, Viboud C, Simonsen L. Cross protection between successive waves of the 1918 1919 influenza pandemic: epidemiological evidence from US Army camps and from Britain. J Infect Dis. 2008;198(10):1427 1434. 321. John M. Barry, interview by Tara Kirk Sell, March 19, 2011. 322. Inglesby TV, Nuzzo JB, O’Toole T, Henderson DA. Disease mitigation measures in the control of pandemic influenza. Biosecur Bioterror. 2006;4(4):366 375. 323. Barry JM. Pandemics: avoiding the mistakes of 1918. Nature. 2009;459(7245):324 325. 324. Fiers W, De Filette M, El Bakkouri K, et al. M2e based universal influenza A vaccine. Vaccine. 2009;27(45):6280 6283. 325. Barry JM. Pandemic reality check; what can be done and what can’t to protect against H1N1. Washington Post. June 23, 2009:A19. 326. Models of Infectious Disease Agent Study (MIDAS). National Institutes of Health, National Institute of General Medical Sciences website. http://www.nigms.nih.gov/Research/FeaturedPrograms/ MIDAS/. Accessed May 9, 2011. 327. Larson RC, Nigmatulina KR. Engineering responses to pandemics. Stud Health Technol Inform. 2009;8(1 4):311 339. 328. Nigmatulina KR, Larson RC. Living with influenza: impacts of government imposed and voluntarily selected interventions. Eur J Oper Res. 2009;195(2):613 627. 329. MIT BLOSSOMS. Blended Learning Open Source Science or Math Studies website. http://blossoms.mit.edu/. Accessed May 9, 2011. 330. Finkelstein S, Prakash S, Nigmatulina K, Klaiman T, Larson R. Pandemic influenza: non pharmaceutical interventions and behavioral changes that may save lives. International Journal of Health Management and Information. 2010;1(1):1 18.

219 Preparing for Bioterrorism

331. Cauchemez S, Donnelly CA, Reed C, et al. Household transmission of 2009 pandemic influenza A (H1N1) virus in the United States. N Engl J Med. 2009;361(27):2619 2627. 332. Hayden FG, Belshe R, Villanueva C, et al. Management of influenza in households: a prospective, randomized comparison of oseltamivir treatment with or without postexposure prophylaxis. J Infect Dis. 2004;189(3):440 449. 333. Jennings LC, Miles JA. A study of acute respiratory disease in the community of Port Chalmers. II. Influenza A/Port Chalmers/1/73: intrafamilial spread and the effect of antibodies to the surface antigens. J Hyg (Lond). 1978;81(1):67 75. 334. Green MS, Bromberg M, Libling A. A randomized, controlled, unblinded, clinical trial of the acceptability and efficacy of non pharmaceutical methods in preventing spread of influenza within the family: results of the 2006 2008 study. Project report for the Sloan Foundation; 2008. 335. Centers for Disease Control and Prevention. Interim Recommendations for Facemask and Respirator Use to Reduce 2009 Influenza A (H1N1) Virus Transmission. September 24, 2009. http://www.cdc.gov/h1n1flu/masks.htm. Accessed May 9, 2011. 336. US Department of Health and Human Services. HHS Pandemic Influenza Plan. Washington, DC: US Dept. of Health and Human Services; 2005. http://www.Flu.gov/planning preparedness/federal/ hhspandemicinfluenzaplan.pdf. Accessed September 10, 2012. 337. First U.S. cell based flu vaccine plant set for dedication [news release]. Washington, DC: US Department of Health and Human Services; December 12, 2011. http://www.hhs.gov/news/ press/2011pres/12/20111212a.html. Accessed August 21, 2012. 338. Paddock C. America steps up readiness for flu pandemic. Medical News Today. February 2, 2007.

220 Notes

339. FDA chief defends H1N1 vaccine supply. Reuters. November 12, 2009. 340. National Center for Immunization and Respiratory Diseases; US Centers for Disease Control and Prevention. Use of influenza A (H1N1) 2009 monovalent vaccine: recommendations of the Advisory Committee on Immunization Practices (ACIP), 2009. MMWR Recomm Rep. 2009;58(RR 10):1 8. 341. Grady D. Review shows safety of H1N1 vaccine, officials say. New York Times. December 4, 2009. 342. SteelFisher GK, Blendon RJ, Bekheit MM, Lubell K. The public’s response to the 2009 H1N1 influenza pandemic. N Engl J Med. 2010;362(22):e65. 343. Siston AM, Rasmussen SA, Honein MA, et al. Pandemic 2009 influenza A(H1N1) virus illness among pregnant women in the United States. JAMA. 2010;303(15):1517 1525. 344. Centers for Disease Control and Prevention. Updated CDC Estimates of 2009 H1N1 Influenza Cases, Hospitalizations and Deaths in the United States, April 2009 April 10, 2010. May 14, 2010. http://www.cdc.gov/h1n1flu/estimates_2009_h1n1.htm. Accessed February 6, 2012. 345. Roos R. Study: in life years lost, H1N1 pandemic had sizable impact. CIDRAP News. March 23, 2010. 346. Viboud C, Miller M, Olson D, Osterholm M, Simonsen L. Preliminary estimates of mortality and years of life lost associated with the 2009 A/H1N1 pandemic in the US and comparison with past influenza seasons. PLoS Curr. 2010;RRN1153. 347. Osterholm MT. Preparing for the next pandemic. Foreign Aff. 2005;84(4):24 37.

221 Preparing for Bioterrorism

348. Osterholm MT. Unprepared for a pandemic. Foreign Aff. 2007;86(2):47 57. 349. Osterholm MT. Pandemic influenza vaccine: the US government is not doing enough. Clin Pharmacol Ther. 2007;82(6):635 637. 350. Griffin MR, Monto AS, Belongia EA, et al. Effectiveness of non adjuvanted pandemic influenza A vaccines for preventing pandemic influenza acute respiratory illness visits in 4 U.S. communities. PLoS One. 2011;6(8):e23085. 351. Fiore AE, Uyeki TM, Broder K, et al. Prevention and control of influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP), 2010. MMWR Recomm Rep. 2010;59(RR 8):1 62. 352. Mike Osterholm, interview by Gigi Kwik Gronvall, March 4, 2012. 353. Osterholm MT, Kelley NS, Sommer A, Belongia EA. Efficacy and effectiveness of influenza vaccines: a systematic review and meta analysis. Lancet Infect Dis. 2012;12(1):36 44. 354. Kelly H, Valenciano M. Estimating the effect of influenza vaccines. Lancet Infect Dis. 2012;12(1):5 6. 355. Mike Osterholm, interview by Madeline Drexler, September 20, 2011. 356. ACIP recommends universal annual influenza vaccination. Infection Control Today. February 24, 2010. 357. Alfred P. Sloan Jr. dead at 90; G.M. leader and philanthropist. New York Times. February 18, 1966. http://www.nytimes.com/learning/ general/onthisday/bday/0523.html. Accessed August 13, 2012. 358. Glass TA, Schoch Spana M. Bioterrorism and the people: how to vaccinate a city against panic. Clin Infect Dis. 2002;34(2):217 223.

222 Notes

359. Schwartz J. The truth hurts; efforts to calm the nation’s fears spin out of control. New York Times. October 28, 2001. http://www. nytimes.com/2001/10/28/weekinreview/the truth hurts efforts to calm the nation s fears spin out of control.html?pagewanted all. Accessed August 13, 2012. 360. Public advocate introduces safety preparedness project for New York City [news release]. Bronx, NY: Office of the Public Advocate for the City of New York; August 21, 2002. http:// publicadvocategotbaum.com/new_news/releases_8_21_02.html. Accessed August 28, 2012. 361. Public Advocate of the City of New York. Being Prepared: In an Emergency, What to Know, What to Do. August 2002. 362. The New York City Office of Emergency Management and the New York Mets announce Ready New York at Shea Stadium [news release]. New York, NY: New York City Office of Emergency Management; August 14, 2003. http://www.nyc.gov/html/oem/ html/news/03_08_14_mets.shtml. Accessed June 11, 2012. 363. Saul M. Gilbert makes emergency tips a li’l less grim. NY Daily News. July 11, 2003. 364. New York Times Editorial Board. Preparing for an emergency. New York Times. June 4, 2006. 365. Get Prepared. Get Involved. New York City Office of Emergency Management website. http://www.nyc.gov/html/oem/html/get_ prepared/ready.shtml. Accessed April 6, 2012. 366. Badkhen A. N.Y. on high alert for GOP conclave: only minor changes to security plans after new warning. San Francisco Chronicle. August 6, 2004. 367. Lisa Orloff, interview by Gigi Kwik Gronvall, February 13, 2012.

223 Preparing for Bioterrorism

368. World Cares Center website. http://www.worldcares.org. Accessed February 14, 2012. 369. Who We Are. History. World Cares Center website. http://www. worldcares.org/content/who we are/history. Accessed June 11, 2012. 370. September Space. Free Disaster Preparedness: What are you thinking about New York? [pamphlet]. August 13, 2004. 371. Letter from Dennis P. McNulty, Major Commanding Officer, Emergency Management Section, Office of the Attorney General, State of New Jersey, to commend World Care Center’s actions during Hurricane Irene. February 1, 2012. 372. Biosurveillance: Hearings Before the Subcommittee on Homeland Security of the House Committee on Appropriations, 111th Cong, 2nd Sess (2010) (statement of Tara O’Toole, MD, MPH). http://www. dhs.gov/ynews/testimony/testimony_1271436311919.shtm. Accessed June 11, 2012. 373. Falkenrath RA, Zavasky D M. Grant proposal to the Alfred P. Sloan Foundation. Sloan Foundation records. 374. Maher D. Homeland security. New York Magazine. June 24, 2002. 375. Doormen receive anti terror training. USA Today. May 28, 2004. 376. Thomas Shortman Training. Instructor’s Guide: NY Safe and Secure: Restoring a Sense of Well being to the Citizens of New York City. 2004.

224 Selected Bibliography

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Barbera, Joseph A., and Anthony G. Macintyre. Medical and Health Incident Management (MaHIM) System: A Comprehensive Functional System Description for Mass Casualty and Health Incident Management. Washington, DC: Institute for Crisis, Disaster, and Risk Management, George Washington University, October 2002.

Barry, John M. The Great Influenza: The Epic Story of the Deadliest Plague in History. New York: Viking, 2004.

Bipartisan WMD Terrorism Research Center. Bio Response Report Card. Washington, DC, October 2011.

Buehler, James W., Amy Sonricker, Marc Paladini, Paula Soper, and Farzad Mostashari. “Syndromic Surveillance Practice in the United States: Findings from a Survey of State, Territorial, and Selected Local Health Departments,” Advances in Disease Surveillance 6, no. 3 (2008). http:// www.isdsjournal.org/articles/2618.pdf.

225 Preparing for Bioterrorism

CIDRAP Business Source, Center for Infectious Disease Research and Policy, University of Minnesota. 10 Point Framework for Pandemic Influenza Business Preparedness. 2006. http://www.cidrap.umn.edu/cidrap/ files/34/10 point%20framework.pdf.

Committee on Advances in Technology and the Prevention of Their Application to Next Generation Biowarfare Threats. National Research Council. Globalization, Biosecurity, and the Future of the Life Sciences. Washington, DC: National Academies Press, 2006.

Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism. Prevention of WMD Proliferation and Terrorism Report Card: An Assessment of the U.S. Government’s Progress in Protecting the United States from Weapons of Mass Destruction Proliferation and Terrorism. Washington, DC: January 26, 2010.

Committee on Public Health Strategies to Improve Health, Institute of Medicine. For the Public’s Health: Revitalizing Law and Policy to Meet New Challenges. Washington, DC: National Academies Press, 2011.

Committee on Research Standards and Practices to Prevent the Destructive Application of Biotechnology, National Research Council. Biotechnology Research in an Age of Terrorism. Washington, DC: National Academies Press, 2004.

Committee on Standards and Policies for Decontaminating Public Facilities Affected by Exposure to Harmful Biological Agents: How Clean Is Safe? National Research Council. Reopening Public Facilities After a Biological Attack: A Decision Making Framework. Washington, DC: National Academies Press, 2005.

226 Selected Bibliography

Committee on Strengthening and Expanding the Department of Defense Cooperative Threat Program. Global Security Engagement: A New Model for Cooperative Threat Reduction. Washington, DC: National Academies Press, 2009.

Danzig, Richard. Catastrophic Bioterrorism What Is To Be Done? Washington, DC: Center for Technology and National Security Policy, National Defense University, August 2003. http://www.brad.ac.uk/acad/sbtwc/ dube/lectures/lecture6/Slide_20.pdf.

Danzig, Richard, Marc Sageman, Terrance Leighton, et al. Aum Shinrikyo: Insights into How Terrorists Develop Biological and Chemical Weapons. Washington, DC: Center for a New American Security, July 2011. http:// www.cnas.org/files/documents/publications/CNAS_AumShinrikyo_ Danzig_1.pdf.

Epstein, Gerald L. “Preventing Biological Weapon Development Through the Governance of Life Science Research,” Biosecurity and Bioterrorism 10, no. 1 (2012): 17 37. doi:10.1089/bsp.2011.0091.

Franco, Crystal, and Tara Kirk Sell. “Federal Agency Biodefense Funding, FY2012 FY2013,” Biosecurity and Bioterrorism 10, no. 2 ( 2012): 162 181. doi:10.1089/bsp.2012.0025.

Garfinkel, Michelle S., Drew Endy, Gerald L. Epstein, and Robert M. Friedman. Synthetic Genom,ics: Options for Governance. October 7, 2007. http://www.jcvi.org/cms/research/projects/syngen options/.

Garwin, Richard L., Ralph E. Gomory, and Matthew S. Meselson. “How to Fight Bioterrorism,” Washington Post, May 14, 2002:A21.

227 Preparing for Bioterrorism

Gottron, Frank, and Dana A. Shea. Federal Efforts to Address the Threat of Bioterrorism: Selected Issues and Options for Congress. Washington, DC: Congressional Research Service, February 8, 2011.

Gursky, Elin, Thomas V. Inglesby, and Tara O’Toole. “Anthrax 2001: Observations on the Medical and Public Health Response,” Biosecurity and Bioterrorism 1, no. 2 (2003): 97 110. doi:10.1089/153871303766275763.

Henderson, D. A. Smallpox: The Death of a Disease: The Inside Story of Eradicating a Worldwide Killer. Amherst, NY: Prometheus Books, 2009.

Henderson, D. A. “The Looming Threat of Bioterrorism,” Science 283, no. 5406 (1999): 1279 1282. doi: 10.1126/science.283.5406.1279.

Hitchcock, Penny J., Michael Mair, Thomas V. Inglesby, et al. “Improving Performance of HVAC Systems to Reduce Exposure to Aerosolized Infectious Agents in Buildings; Recommendations to Reduce Risks Posed by Biological Attacks,” Biosecurity and Bioterrorism 4, no. 1 (2006): 41 54. doi:10.1089/bsp.2006.4.41.

Hodge, James G. “The Evolution of Law in Biopreparedness,” Biosecurity and Bioterrorism 10, no. 1 (2012): 38 48. doi:10.1089/bsp.2011.0094.

Hylton, Wil S. “Warning: There’s Not Nearly Enough of this Vaccine to Go Around,” New York Times Magazine October 26, 2011:26.

Inglesby, Thomas V., Tara O’Toole, D. A. Henderson, et al. “Anthrax as a Biological Weapon, 2002: Updated Recommendations for Management,” Journal of the American Medical Association 287, no. 17 (2002): 2236 2252. http://jama.jamanetwork.com/article.aspx?articleid 195404.

228 Selected Bibliography

Kellman, Barry. “An International Criminal Law Approach to Bioterrorism,” Harvard Journal of Law and Public Policy 25, no. 2 (2002): 721. http://law journals books.vlex.com/vid/international approach bioterrorism 54431271.

Larson, Richard C, and Karima R. Nigmatulina. “Engineering Responses to Pandemics,” Studies in Health Technology and Informatics 8, no. 1 4 (2009): 311 339.

Lauritzen, Andrea, and Francesco Quattrini. Black ICE: Bioterrorism International Coordination Exercise, After Action Report. http://merln.ndu. edu/archivepdf/wmd/State/79521.pdf.

Martin, James W., George W. Christopher, and Edward M. Eitzen. “History of Biological Weapons: From Poisoned Darts to Intentional Epidemics,” in Medical Aspects of Biological Warfare (Textbooks of Military Medicine series), ed. Zygmunt F. Dembek. Washington, DC: Office of the Surgeon General, US Army, The Borden Institute, 2007, 5.

Matthews, Gene W., and Millissa Markiewicz. “Update on Emergency Liability Protection for Volunteer Entities,” Biosecurity and Bioterrorism 7, no. 1 (2009): 51 54. doi:10.1089/bsp.2009.0008.

Middleton, Grace. “Medical Reserve Corps: Engaging Volunteers in Public Health Preparedness and Response, Biosecurity and Bioterrorism 6, no. 4 (2008): 359 360. doi: 10.1089/bsp.2008.1113.

Morse, Stephen S., Richard L. Garwin, and Paula J. Olsiewski. “Public Health. Next Flu Pandemic: What to Do Until the Vaccine Arrives?” Science 314, no. 5801 (2006): 929. doi: 10.1126/science.1135823.

229 Preparing for Bioterrorism

National Commission on Children and Disasters. 2010 Report to the President and Congress. AHRQ Publication No. 10 M037. Rockville, MD: Agency for Healthcare Research and Quality, October 2010. http:// cybercemetery.unt.edu/archive/nccd/20110427002908/http:/www. childrenanddisasters.acf.hhs.gov/index.html.

National Science Advisory Board for Biosecurity, National Institutes of Health. Addressing Biosecurity Concerns Related to the Synthesis of Select Agents. December 2006. http://oba.od.nih.gov/biosecurity/pdf/Final_ NSABB_Report_on_Synthetic_Genomics.pdf.

National Security Council. The White House. National Strategy for Countering Biological Threats. November 2009. http://www.whitehouse.gov/ sites/default/files/National_Strategy_for_Countering_BioThreats.pdf. Accessed August 20, 2012.

Noble, Ronald K. Remarks at 1st INTERPOL Global Conference on Preventing Bioterrorism. Lyon, France: March 1 2, 2005. https://www.interpol.int/ Public/ICPO/speeches/NobleBioTerrorism20050301.asp. Accessed August 20, 2012.

Steinbruner, John, and Stacy Okutani. “The Protective Oversight of Biotechnology,” Biosecurity and Bioterrorism 2, no. 4 (2004): 273 280. doi:10.1089/bsp.2004.2.273.

Osterholm, Michael T., Nicholas S. Kelley, Alfred Sommer, and Edward A. Belongia. “Efficacy and Effectiveness of Influenza Vaccines: A Systematic Review and Meta analysis,” The Lancet Infectious Diseases 12, no. 1 (2012): 36 44. doi:10.1016/S1473 3099(11)70295 X.

O’Toole, Tara, Michael Mair, and Thomas V. Inglesby. “Shining Light on ‘Dark Winter,’” Clinical Infectious Diseases 34, no. 7 (2002): 972 983. doi: 10.1086/339909.

230 Selected Bibliography

Presidential Commission for the Study of Bioethical Issues. New Directions: The Ethics of Synthetic Biology and Emerging Technologies. Washington, DC: 2010. Presidential Commission for the Study of Bioethical Issues. http://bioethics.gov/cms/synthetic biology report. Accessed August 20, 2012.

Rappert, Brian. “A Teachable Moment for Biological Weapons: The Seventh BWC Review Conference and the Need for International Cooperation in Education,” Bulletin of the Atomic Scientists 76, no. 3 (2011): 44 50. doi: 10.1177/0096340211406875.

Russell, Philip K., and Gigi Kwik Gronvall. “U.S. Medical Countermeasure Development Since 2001: A Long Way Yet to Go,” Biosecurity and Bioterrorism 10, no. 1 (2012): 66 76. doi:10.1089/bsp.2012.0305.

Schoch Spana, Monica. “The People’s Role in U.S. National Health Security: Past, Present, and Future,” Biosecurity and Bioterrorism 10, no. 1 (2012): 77 88. doi:10.1089/bsp.2011.0108.

Smith, Bradley T., Thomas V. Inglesby, Esther Brimmer, et al. “Navigating the Storm: Report and Recommendations from the Atlantic Storm Exercise,” Biosecurity and Bioterrorism 3, no. 3 (2005): 256 267. doi:10.1089/ bsp.2005.3.256.

The White House. National Security Strategy. Washington, DC: May 2010. http://www.whitehouse.gov/sites/default/files/rss_viewer/national_ security_strategy.pdf.

Trust for America’s Health. Ready or Not? Protecting the Public’s Health from Diseases, Disasters, and Bioterrorism. December 2009. http:// healthyamericans.org/reports/bioterror09/.

231 Preparing for Bioterrorism

Tucker, Jonathan B., and Stacy M. Okutani. Global Governance of “Contentious” Science: The Case of the World Health Organization’s Oversight of Small Pox Virus Research. Stockholm: Weapons of Mass Destruction Commission, October 2004. http://www.un.org/ disarmament/education/wmdcommission/files/No18.pdf.

Ursano, Robert. Workplace Preparedness for Terrorism: Report of Findings to Alfred P. Sloan Foundation. Bethesda, MD: Center for the Study of Traumatic Stress, Uniformed Services University of the Health Sciences, 2011. http://www.usuhs.mil/psy/SloanReport.html.

US Department of Health and Human Services. National Health Security Strategy of the United States of America. December 2009. http://www.phe. gov/Preparedness/planning/authority/nhss/strategy/Documents/nhss final.pdf.

US Office of Technology Assessment. Proliferation of Weapons of Mass Destruction: Assessing the Risks. OTA ISC 559. Washington, DC: Office of Technology Assessment, 1993. http://www.au.af.mil/au/awc/awcgate/ ota/9341.pdf. Accessed August 10, 2012.

World Health Organization. Responsible Life Sciences Research for Global Health Security: A Guidance Document. Geneva 2010. http://whqlibdoc. who.int/hq/2010/WHO_HSE_GAR_BDP_2010.2_eng.pdf.

232 Appendix

∂

Sloan Foundation Biosecurity Grants, 2000-2010

(Arranged alphabetically by name of principal investigators)

2000

D. A. Henderson, University Distinguished Professor and Director, and Tara O’Toole, Deputy Director, Johns Hopkins Center for Civilian Biodefense Studies, Baltimore, Maryland

2001

Lawrence O. Gostin, Professor, Georgetown University Law Center, Georgetown University, Washington, DC

Jo L. Husbands, Director, Committee on International Security and Arms Control, National Academy of Sciences, Washington, DC

233 Preparing for Bioterrorism

Harold M. Koenig, Chairman and President, Annapolis Center for Science Based Public Policy, Annapolis, Maryland

Anthony D. Moulton, Director, Public Health Practice Program Office, Centers for Disease Control and Prevention; National Strategy Forum, Inc., Chicago, Illinois

Richard Rotanz, Deputy Director, Office of Emergency Management, City of New York, New York

Ira S. Rubenstein, Chair, Center for Economic and Environmental Partnership, New York, New York

John D. Steinbruner, Director, Center for International and Security Studies, School of Public Policy, University of Maryland Foundation, Inc., Adelphi, Maryland

2002

Joseph A. Barbera, Co director, Institute for Crisis, Disaster and Risk Management, George Washington University, Washington, DC

H. E. Barney Burroughs, President and CEO, Building Wellness Consultancy, Inc., Alpharetta, Georgia

Kathleen Crosby, Senior Vice President, The Advertising Council, Inc., New York, New York

Lynn E. Davis, Senior Political Scientist, RAND Corporation, Arlington, Virginia

234 Appendix

Stewart Desmond, Deputy Public Advocate for Communications, Fund for the City of New York, New York

Joshua M. Epstein, Senior Fellow, Brookings Institution, Washington, DC

Richard E. Friedman, President/Chair, National Strategy Forum, Inc., Chicago, Illinois

Richard J. Hatchett, Project Director, New York Biotechnology Association, Inc., Stony Brook, New York

Claret M. Heider, Vice President, Multihazard Mitigation Council/ Building Seismic Safety Council, National Institute of Building Sciences, Washington, DC

William D. Hunt, Professor, School of Electrical and Computer Engineering, Georgia Tech Research Corporation, Atlanta, Georgia

Barry Kellman, Professor, College of Law, DePaul University, Chicago, Illinois

Hal Levin, President, Indoor Air 2002, Inc., Santa Cruz, California

Pamela Lippe, Executive Director, Earth Day New York, Inc., New York, New York

Kenneth D. Mandl, Division of Emergency Medicine, Children’s Hospital, Boston, Massachusetts

Donald K. Milton, Department of Environmental Health, Harvard School of Public Health, Harvard University, Cambridge, Massachusetts

Michael Moodie, President, Chemical and Biological Arms Control Institute, Washington, DC

235 Preparing for Bioterrorism

Farzad Mostashari, President, OutbreakDetect, Inc., New York Academy of Medicine, New York, New York

Roger A. Pielke, Jr., Professor, Department of Environmental Studies, University of Colorado Foundation, Inc., Boulder, Colorado

Fred S. Roberts, Director, Center for Discrete Mathematics and Theoretical Computer Science, Rutgers University, New Brunswick, New Jersey

2003

Michael Berkowitz, Deputy Commissioner of Special Projects, Office of Emergency Management, City of New York, New York

Steven Brill, President, America Prepared Campaign, Inc., New York, New York

Kathleen Crosby, Senior Vice President, The Advertising Council, Inc., New York, New York

Jonah J. Czerwinski, Senior Research Associate, Center for the Study of the Presidency, Washington, DC

Elizabeth A. Davis, Director, Emergency Preparedness Initiative, National Organization on Disability, Washington, DC

Amanda J. Dory, International Affairs Fellow, Center for Strategic and International Studies, Washington, DC

Alan R. Fleischman, Senior Vice President, New York Academy of Medicine, New York, New York

236 Appendix

David R. Franz, President, Spectrum BD Consulting, Frederick, Maryland

Richard E. Friedman, President/Chair, National Strategy Forum, Inc., Chicago, Illinois

Daniel Hastings, Director, MIT Technology and Policy Program, Massachusetts Institute of Technology, Cambridge, Massachusetts

Farzad Mostashari, President, OutbreakDetect, Inc., New York Academy of Medicine, New York, New York

Benjamin W. Moulton, Executive Director, American Society of Law, Medicine and Ethics, Inc., Boston, Massachusetts

Elizabeth Rindskopf Parker, Dean, McGeorge School of Law, University of the Pacific, Sacramento, California

John D. Steinbruner, Director, Center for International and Security Studies, School of Public Policy, University of Maryland Foundation, Inc., Adelphi, Maryland

Michael M. Wagner, Director, RODS Laboratory, Center for Biomedical Informatics, University of Pittsburgh, Pittsburgh, Pennsylvania

Martin J. Weiland, Manager, Government Outreach, American Society of Heating, Refrigerating, and Air Conditioning Engineers, Inc., Atlanta, Georgia

Patricia S. Wrightson, Senior Program Officer, National Academy of Sciences, Washington, DC

237 Preparing for Bioterrorism

2004

Michael E. Clark, President, Citizens Committee for New York City, Inc., New York, New York

Patricia K. Coomber, Senior Research Fellow, Center for Technology and National Security Policy, National Defense University Foundation, Inc., Washington, DC

Ottorino Cosivi, Project Leader, Department of Communicable Disease, Surveillance and Response, World Health Organization, Geneva, Switzerland

R. P. Eddy, Senior Fellow for Counter Terrorism, Manhattan Institute for Policy Research, Inc., New York, New York

Jo L. Husbands, Director, Committee on International Security and Arms Control, National Academy of Sciences, Washington, DC

Gwang-Pyo Ko, Professor, Division of Environmental and Occupational Health, University of Texas Health Science Center at Houston, Texas

Kate D. Levin, Commissioner, City of New York Department of Cultural Affairs, Mayor’s Fund to Advance New York City, New York

William J. Long, Professor and Chair, Sam Nunn School of International Affairs, Georgia Institute of Technology, Georgia Tech Research Corporation, Atlanta, Georgia

Gene W. Matthews, Director, Institute of Public Health Law, National Foundation for the Centers for Disease Control and Prevention, Inc., Atlanta, Georgia

238 Appendix

Patricia McGinnis, President and CEO, Council for Excellence in Government, Washington, DC

Linda G. Nelson, Director, Thomas Shortman Training School and Safety Fund Local 32B J, New York, New York

Dava J. Newman, Professor, Department of Aeronautics and Astronautics, Massachusetts Institute of Technology, Cambridge, Massachusetts

Ronald K. Noble, Secretary General, International Criminal Police Organization INTERPOL, Lyon, France

Lisa Orloff, Founder and Executive Director, World Cares Center, Inc., New York, New York

Tara O’Toole, CEO and Director, Center for Biosecurity of UPMC, Baltimore, Maryland

Elizabeth Rindskopf Parker, Dean, McGeorge School of Law, University of the Pacific, Sacramento, California

Jonathan B. Tucker, Senior Researcher, Monterey Institute of International Studies, Monterey, California

Robert J. Ursano, Chairman, Department of Psychiatry, Uniformed Services University of the Health Sciences, Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., Rockville, Maryland

239 Preparing for Bioterrorism

2005

Emily Bentley, Executive Director, Environmental Monitoring and Assessment Program, Council of State Governments, Lexington, Kentucky

Ottorino Cosivi, Project Leader, Preparedness for Deliberate Epidemics, Division of Communicable Diseases, World Health Organization, Geneva, Switzerland

Eva Cramer, Vice President for Biotechnology and Scientific Affairs, SUNY Downstate Medical Center, Brooklyn, New York

Richard Danzig, Sam Nunn Prize Fellow, International Security Program, Center for Strategic and International Studies, Washington, DC

Robert M. Friedman, Vice President for Environmental and Energy Policy, J. Craig Venter Institute, Rockville, Maryland

David Gershon, CEO, Global Action Plan for the Earth, Inc., Woodstock, New York

Lawrence O. Gostin, Professor, Georgetown University Law Center, Georgetown University, Washington, DC

Lynn A. Jennings, Counselor to the CEO, Council for Excellence in Government, Washington, DC

Matthew S. Meselson, Professor, Department of Molecular and Cellular Biology, President and Fellows of Harvard College, Cambridge, Massachusetts

240 Appendix

Len Pagano, President and CEO, Safe America Foundation, Inc., Marietta, Georgia

Elizabeth Rindskopf Parker, Dean, McGeorge School of Law, University of the Pacific, Sacramento, California

Carmen Lúcia Pessoa-Silva, Medical Officer, Department of Epidemic and Pandemic Alert and Response, World Health Organization, Geneva, Switzerland

Rosalie Phillips, Executive Director, Tufts Health Care Institute, Boston, Massachusetts

William G. Raisch, Director, International Center for Enterprise Preparedness (InterCEP), New York University, New York, New York

Brian Rappert, Professor, Department of Sociology, School of Historical, Political and Sociological Studies, University of Exeter, Exeter, United Kingdom

Irwin Redlener, Director, National Center for Disaster Preparedness, Columbia University, New York, New York

Lynne M. Ross, Executive Director, National Association of Attorneys General, Washington, DC

Reid L. Sawyer, Executive Director, Combating Terrorism Center, United States Military Academy, West Point; Association of Graduates of the United States Military Academy, West Point, New York

Mark R. Shulman, Director of Graduate Programs, Pace University School of Law, White Plains, New York

241 Preparing for Bioterrorism

Peter A. Singer, Director, Joint Centre for Bioethics, University of Toronto, Toronto, Ontario, Canada

Mark S. Smolinski, Vice President for Biological Programs, Nuclear Threat Initiative, Washington, DC

Lawrence G. Spielvogel, Consulting Engineer, ASHRAE Fellow, American Society of Heating, Refrigerating, and Air Conditioning Engineers, Inc., Atlanta, Georgia

John D. Steinbruner, Director, Center for International and Security Studies, School of Public Policy, University of Maryland Foundation, Inc., Adelphi, Maryland

Terence Taylor, President and Executive Director, International Institute for Strategic Studies, Washington, DC

David A. Wilkinson, Principal, Bellwether Group, Inc., Boston, Massachusetts

2006

Edward L. Baker, Jr., Director, North Carolina Institute for Public Health, University of North Carolina, Chapel Hill, North Carolina

James W. Buehler, Research Professor, Department of Epidemiology, School of Public Health, Emory University, Atlanta, Georgia

H. E. Barney Burroughs, President and CEO, Building Wellness Consultancy, Inc., Alpharetta, Georgia

242 Appendix

Nick Green, Science Policy Manager (International Security), American Friends of the Royal Society, Inc., London, United Kingdom

Robert Jones, Founder, Craic Computing, LLC, Seattle, Washington

Jay D. Keasling, Professor of Chemical Engineering and Bioengineering, and Director, Berkeley Center for Synthetic Biology, Regents of the University of California Berkeley, Berkeley, California

Douglas J. Meffert, Professor, Tulane/Xavier Center for Bioenvironmental Research, Tulane University, New Orleans, Louisiana

Stephen S. Morse, Director, Center for Public Health Preparedness, Mailman School of Public Health, Columbia University, New York, New York

Ronald K. Noble, Secretary General, International Criminal Police Organization Interpol, Lyon, France

Michael T. Osterholm, Director, Center for Infectious Disease Research and Policy (CIDRAP), University of Minnesota, Minneapolis, Minnesota

Alan Pearson, Director, Biological and Chemical Weapons Control Program, Center for Arms Control and Nonproliferation, Washington, DC

Robert J. Ursano, Chairman, Department of Psychiatry, Uniformed Services University of the Health Sciences; Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., Rockville, Maryland

243 Preparing for Bioterrorism

David A. Wilkinson, Principal, Bellwether Group, Inc., Boston, Massachusetts

2007

Joseph A. Barbera, Co director, Institute for Crisis, Disaster, and Risk Management, George Washington University, Washington, DC

Bruce T. Blythe, CEO, Crisis Management International, Inc., Atlanta, Georgia

Ottorino Cosivi, Project Leader, Preparedness for Deliberate Epidemics, Department of Communicable Diseases, World Health Organization, Geneva, Switzerland

Richard Danzig, Chairman of the Board, Center for a New American Security, Inc., Washington, DC

Eric Eisenstadt, Vice President for Research, J. Craig Venter Institute, Rockville, Maryland

Richard A. Falkenrath, Deputy Commissioner for Counter terrorism, New York Police Department, New York, New York

Michele S. Garfinkel, Policy Analyst, J. Craig Venter Institute, Rockville, Maryland

Manfred S. Green, Director, Israel Center for Disease Control, and Professor of Epidemiology and Preventive Medicine, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel

244 Appendix

Jo L. Husbands, Senior Project Director, Office of International Affairs, National Academy of Sciences, Washington, DC

Richard C. Larson, Professor, Department of Civil and Environmental Engineering and in the Engineering Systems Division, Massachusetts Institute of Technology, Cambridge, Massachusetts

Patricia McGinnis, President and CEO, Council for Excellence in Government, Washington, DC

Paul Nampala, Executive Secretary, Uganda National Academy of Sciences, Kampala, Uganda

Tara O’Toole, CEO and Director, Center for Biosecurity of UPMC, Baltimore, Maryland

Sven Panke, Professor, Institute for Process Engineering, Swiss Federal Institute of Technology, Zurich, Switzerland

William G. Raisch, Director, International Center for Enterprise Preparedness (InterCEP), New York University, New York, New York

Brian Rappert, Professor, Department of Sociology, School of Historical, Political and Sociological Studies, University of Exeter, Exeter, United Kingdom

John D. Steinbruner, Director, Center for International and Security Studies, School of Public Policy, University of Maryland Foundation, Inc., Adelphi, Maryland

245 Preparing for Bioterrorism

2008

Edward L. Baker, Jr., Director, North Carolina Institute for Public Health, University of North Carolina, Chapel Hill, North Carolina

Michele S. Garfinkel, Policy Analyst, J. Craig Venter Institute, Rockville, Maryland

Lauren Bic Ha, Managing Director, BioBricks Foundation, Inc., Cambridge, Massachusetts

Kendall L. Hoyt, Assistant Professor of Medicine, Dartmouth Medical School; Lecturer, Thayer School of Engineering, Dartmouth College, Hanover, New Hampshire

Anne-Marie Mazza, Director, Committee on Science, Technology, and Law, National Academy of Sciences, Washington, DC

Thomas H. Murray, President and CEO, The Hastings Center, Garrison, New York

Ronald K. Noble, Secretary General, International Criminal Police Organization Interpol, Lyon, France

Brian Rappert, Professor, Department of Sociological Studies, University of Exeter, Exeter, United Kingdom

David Rejeski, Director, Foresight and Governance Project, Woodrow Wilson International Center for Scholars, Washington, DC

Terence Taylor, Director and Chairman of the Board, International Council for the Life Sciences, Washington, DC

246 Appendix

2009

John M. Barry, Distinguished Visiting Scholar, Center for Bioenvironmental Research, Tulane University, New Orleans, Louisiana

Kavita M. Berger, Project Director, American Association for the Advancement of Science, Washington, DC

Amanda Bowman, New York Director/Conference Director, Center for Security Policy, Inc., Washington, DC

Richard Danzig, Chairman of the Board, Center for a New American Security, Inc., Washington, DC

Michele S. Garfinkel, Policy Analyst, J. Craig Venter Institute, Rockville, Maryland

James William Jones, Senior Fellow, American Society of Mechanical Engineers, New York, New York

Andrea Loettgers, Division of Humanities and Social Sciences, California Institute of Technology, Pasadena, California

Kenneth N. Luongo, President, Partnership for Global Security, Washington, DC

Anne-Marie Mazza, Director, Committee on Science, Technology, and the Law, National Academy of Sciences, Washington, DC

Thomas H. Murray, President and CEO, The Hastings Center, Garrison, New York

247 Preparing for Bioterrorism

Michael T. Osterholm, Director, Center for Infectious Disease Research and Policy (CIDRAP), University of Minnesota, Minneapolis, Minnesota

William G. Raisch, Director, International Center for Enterprise Preparedness (InterCEP), New York University, New York, New York

David Rejeski, Director, Foresight and Governance Project, Woodrow Wilson International Center for Scholars, Washington, DC

2010

Clark Kent Ervin, Director, The Aspen Institute, Washington, DC

Jo L. Husbands, Scholar/Senior Project Officer, National Academy of Sciences, Washington, DC

Thomas V. Inglesby, CEO and Director, Center for Biosecurity of UPMC, Baltimore, Maryland

Michael J. Osterholm, Director, Center for Infectious Disease Research and Policy (CIDRAP), University of Minnesota, Minneapolis, Minnesota

248 Index

9 Andrews Air Force Base, 17 9/11, xi, xv, 5, 7, 12, 22, 26, 35, 38–39, 79, anthrax, xiii, 2, 11, 15, 16, 30, 43, 46, 47, 84, 103, 105, 115, 118, 125, 165, 166, 169, 48, 55, 57, 106, 135 170, 176. See also World Trade Center letter attacks, xi–xii, xv, 1, 5, 12, 15, 29, attacks 30, 31, 43, 45, 60, 61, 62, 79, 103, 105, 9/11 Commission, 58, 61, 122 108, 125, 128, 139, 146, 147, 165, 166 Implementing Recommendations of antibiotic resistance, 74, 80 the 9/11 Commission Act, 116 antiviral agents, 80, 155 Applied Marine Technology, Inc., 52 A Armed Forces Institute of Pathology, 152 Advertising Council, 23–26, 168 arms control, 65, 66, 67, 84, 91 Air Filtration. See HVAC systems ASIS International, 117–118 Airlie House Workshop, 65–68 Association of State and Territorial Al Qaeda, 173 Health Officials (ASTHO), 110 Albright, Madeleine, 50 Atlantic Storm, 44, 48, 49–52, 53, 54 Albright, Parney, 80 Atlas, Ronald, xix, 79, 85 American Bar Association, 102, 113 Aum Shinrikyo attacks, xii, 10, 44, 55–58 American Civil Liberties Union, 108 American National Standards Institute, B 117 Bacillus anthracis. See anthrax American Public Health Association, 19, bacteriophage, 87 110 Baker, Edward, xix, 110 American Society for Microbiology, 85 Barbera, Joseph, xix, 29–32 American Society of Heating, Refrigerating and Air-Conditioning Biomedical Advanced Research and Engineers (ASHRAE), 131–133, 135 Development Authority (BARDA), 40 Analytic Services, Inc., 18 Barry, John, xix, 120, 151–154 Bartlett, John G., xiii

249 Preparing for Bioterrorism

Berman, Al, xx, 117, 118 BioSense system, 139 Beslan massacre, 32 biotechnology, xviii, 78, 79, 83, 84, 88, 91, 92, 97 Big City Emergency Managers, Inc., 27–29 stewardship of, 73–98 bio-criminalization, 67, 68 Biotechnology Research in an Age of Terrorism. See Fink Report biodefense, 2, 7, 9, 14, 17, 21, 54, 61, 75, 145 civilian biodefense, xiii, 2, 5, 12, 13, 15, bioterrorism, xii, xiv, xviii, 1–5, 8, 11, 13, 16, 22, 46 14–17, 40, 79, 82, 101, 102–4, 105, 111, 119, 126, 127, 129, 130, 133, 139, 145, 147, biofuels, 88 165, 167, 171, 172 biological agents, 4, 15, 43, 63, 66, 81, 97, building safety, 128–137 128, 134 countering, 42–62, 141–143 Biological Research Security System, laws, 63–72, 112–114 83–86 prevention and response, 69–72 biological warfare, xii, xvii, 2, 6, 13, 44, Bioterrorism Incident Response Guide, 70 45, 48, 49, 53, 62, 128, 129–131, 136 BioWatch, 142, 171–172 biological weapons, xii–xv, xvii–xix, 3, 4, 6, 9–11, 14, 16, 24, 42, 46, 48, 55–58, 59, Bipartisan WMD Terrorism Research 63–65, 66, 67, 73, 74, 78, 96, 130, 136 Center. See WMD Center disarmament, 9 bird flu. See H5N1 influenza Iraq, 10, 14 Black ICE, 44, 48, 52–54 reconstruction of viruses, 81, 86, 87 Black ICE II, 54 Soviet Union, xii, 10, 14, 79 BLOSSOMS Initiative, 156 Biological Weapons Convention (BWC), xviii, 9, 10, 60, 63, 67, 93, 94 Blythe, Bruce, xx, 117 Bio-Response Report Card, 58–62 bombings, xii, 10, 14, 125, 165 biosafety, 20, 67, 77, 78, 93, 94–96, 97 botulinum toxin, 15 Biosafety and Biosecurity International botulism, 55, 57 Conference, 95, 96 Brickman, Harvey, xx, 131–133 biosecurity, xv–xvi, xviii–xix, xxi, 11, British Standards Institution, 118 12, 16, 17, 21–22, 55, 67, 89, 93, 94–96, 97, 98, 101, 102, 105, 112, 113, 134, 137, Bromberg, Michal, 158 144–146, 164–174, 176-177 Brundtland, Gro Harlem, 52 sustainable approaches, 1–8

250 Index

Bruno, Joe, 29 Center for Discrete Mathematics and Theoretical Computer Science, Buckeridge, David, xx, 140 144–146 Building Owners and Managers Center for Infectious Disease Research Association (BOMA), 133 and Policy (CIDRAP), 119–121, 159–163 buildings Center for International Security Studies owners, 4, 130–133, 135, 136, 137, 165 at Maryland, 83–86 safety, 20, 128–137 Center for Strategic and International sick building syndrome, 129, 130, 137 Studies, 18, 88 Bush, George W., 34, 40, 171 Center for the Study of Traumatic Stress, 125, 126 Business Executives for National Security (BENS), 61 Centers for Disease Control and Prevention, US (CDC), xiii, xv, 6, 20, Business Source (CIDRAP), 119, 121 30, 45, 100, 102, 105, 110, 134, 139, 155, businesses 158 business leaders, 4, 119, 121 chemical weapons, 24, 42, 55–58, 59, 64 business owners, 3 Cheney, Dick, 40 enterprise risk management, 124 children, 25, 160, 167 preparing for emergencies, xix, 17, 115–127 threat to, 12, 32–34 Chiron, 150 C Church, George, 87, 90 Cantigny Conference on State civil liberties, 100, 112, 113 Emergency Public Health Powers and individual rights, 108, 112 the Bioterrorism Threat, 102–104 Clinton, Bill, xii, 11, 15 Capital Center for Public Law and Policy, 112 Columbia University, 33, 150 Cello, Jeronimo, 86 Commission on the Prevention of Weapons of Mass Destruction Center for a New American Security, 56 Proliferation and Terrorism (WMD Center for Biosecurity (UPMC), xvi, xxi, Commission), 59 13–22, 49, 134, 136 Congress, xv, 14, 18, 20, 21, 34, 45, 59, 60, Center for Civilian Biodefense Studies 125, 128. See also policymakers ( JHU), xiii, xxi, 12, 13 House Committee on International Relations, 120

251 Preparing for Bioterrorism

Council for Excellence in Government, Department of State, US, 45, 53, 54, 72 27–29 DePaul University, 65, 66 counterterrorism, 42–62, 165, 172 dirty bombs, 24, 42 Crisis Management International, 117 disabled persons, 12, 35–37 Crosby, Kathy, xx, 24, 26 Disaster Recovery Institute International, customs operations, 66, 71 117 diseases, xiii, 18, 44, 50, 51, 54, 73, 96, 109, D 127, 156, 157. See also individual disease names Dando, Malcolm, xx, 91–94 epidemics, xiii, xix, 7, 11, 12, 18, 20, 50, Danzig, Richard, xx, 46–47, 55–58 51, 54, 62, 99, 100, 140, 151, 152, 156, Dark Winter, xv, 17–18 168 Davis, Elizabeth, xx, 35–37 infectious, xiii, xvii, 2, 4, 11, 13, 16, 20, 46, 48, 62, 74, 86, 100, 106, 113, 127, de novo synthesis, 87, 89 138, 139, 145, 156 Defense Advanced Research Projects naturally occurring, xvii, 1, 2, 46, 95, Agency (DARPA), 136 139 Defense Threat Reduction Agency pandemic modeling, 155–157 (DTRA), 136 surveillance of, 17, 60, 138–147 Department of Agriculture, US, 45 Distribute Project, 140 Department of Commerce, US, 45 DNA, 86, 88, 89, 90, 130 Department of Defense, US, 6, 22, 45, dual-use research, 74, 76, 77, 91–94, 98, 47, 136 112 Department of Education, US, 33 of concern, 77, 81, 82, 92, 98 Department of Energy, US, 136 oversight of, 82, 83–86 Department of Health and Human E Services, US, xv, 6, 14, 15, 22, 31, 37, 45, 47, 81, 89, 107, 120, 136, 141, 159 Eliasson, Jan, 51 Department of Homeland Security, US, emergency management and response 6, 12, 19, 22, 24, 25, 26, 28, 43, 45, 47, agencies, 32 60, 88, 117, 118, 119, 122, 124, 136, 145, 168, 169 emergency managers, 12, 27–29 Department of Justice, US, 45 Emergency Preparedness Initiative, 35–37

252 Index

Endo, Seiichi, 57 ramifications of bioterrorism on, 48–54 Endy, Drew, 88 Forum for Big City Emergency Environmental Protection Agency, US, Managers, 27–29 45, 134, 136 foundations, role of, 178 EPI Global, 37 Fox, Carol, 117 epidemiology, xv, 18, 51, 144–146 Franz, David, xx, 46, 47 Epstein, Gerald, 88 Friedman, Robert, xx, 88–89 Espino, Jeremy, 146 European Commission, 49 G European Molecular Biology Garfinkel, Michele, xx, 88 Organization, 88 Garwin, Richard, 129, 150 F GenBank, 89 Falkenrath, Richard, xx, 172 genes, 74, 76, 88 families genetic engineering, xviii, 10, 57 emergency plans, 25, 170 genetic sequences, 76, 87, 89 preventing flu transmission, 157–159 of extinct animals, 87 Federal Bureau of Investigation, US, 6, synthesis of, 76, 86–90 43, 60, 72, 169 synthetic genomics, 96 Federal Emergency Management Agency, George Washington University, 29–32 US, 18, 19, 27, 29 Georgetown University, 101, 104, 105 Fink Report, 75, 78–82, 92 German Marshall Fund, 49 Fink, Gerald R., 79 Global Conference on Preventing first responders, xii, xiv, 13, 24, 31, 34, 35 Bioterrorism, 69 Fishman, Mike, 174 Global Security Institute, 66 Food and Drug Administration, US, 6, Gomory, Ralph E., xiv, xviii, xix, 2–5, 8, 22, 24, 45 16–17, 39, 129, 130–131, 137, 165, 175 food security, 24, 95 Good Samaritan organizations, 109–111 foreign policy Gostin, Larry, xx, 101, 104, 105, 107, 108 Gotbaum, Betsy, 167

253 Preparing for Bioterrorism

Graham, Bob, 59, 61 I grants, xix, 4, 7, 12, 16, 17, 20, 33, 36, 39, Immune Building Program, 136 78, 94, 101, 102, 109, 122, 139, 141–143, 164, 165, 172 Infectious Diseases Society of America, xiii–xiv, 14 Green, Manfred S., 158 influenza, xv, xvii, 5, 87, 106, 119–121, 140, Ground Zero, 38 141, 147, 148–163. See also pandemic flu prevention in families, 157–159 H Information Management Services, Inc., H1N1, 20, 121, 151 141 2009 pandemic, 159–163 infrastructure, 28, 68, 115 H5N1 influenza, 20, 76–77, 81, 82, 86, 121, Inglesby, Tom, xx, 14, 136, 175-178 148–150, 155 Institute for Crisis, Disaster, and Risk Harvard University, 87, 90 Management, 18, 29 Hatchett, Richard, xx, 38–41 Institute of Medicine, 107 health care, xiii–xiv, 4, 6, 10, 12–15, 17, 18, insurance, 122, 123 20, 21, 29–32, 34, 37–41, 43, 44, 48, 50, 52, 59, 61, 62, 70, 75, 100, 104, 109, 120, intelligence, 14, 34, 59, 60, 145 127, 130, 134, 139, 143, 145 Intelligence Advanced Research Projects Healthcare Reform Act, 140 Agency (IARPA), 22 Henderson, D. A., xi–xvi, xx, 13, 14, 16, International Center for Enterprise 17, 22, 51, 175 Preparedness, 117, 118, 122–125, 166 HIV, 106 International Council for the Life Sciences, 78, 94–96 Hospital Preparedness Program, US, 31, 32 International Human Rights Law Institute, 66 hospitals, xv, 6, 11, 12, 18, 29–32, 39, 43, 99, 104, 129, 131, 137, 146, 147, 172 International Institute for Strategic Sciences, 94 Human Genome Project, 10 International Maritime Organizations, 53 Husbands, Jo L., xx, 79, 80, 81 International Society for Disease HVAC systems, 4, 5, 128–133, 135, 137, 165 Surveillance, 139, 140 INTERPOL, 53, 65, 66, 68, 69–72 Iraq, 10, 32

254 Index

Ivins, Bruce, 60 laws, 8, 84, 93, 122 “affirmative defense,” 123 J bioterrorism, 63–72, 112–114 J. Craig Venter Institute, 87, 88 criminal, 65–68 Jacobs, Leslie Gielow, xx, 112–114 liability protection for Good Samari- tans, 109–111 Jennings, Lynn, xx, 28, 29 public health, 99–114 Johns Hopkins University, xiii, xvi, xxi, Leavitt, Michael, 120 12, 13, 21, 49, 105, 142 Levin, Simon, 145 Journal of National Security Law and Policy, 113 Libling, Adi, 158 Journal of the American Medical Association, 15 M MacArthur Foundation, 67 K Macintyre, Anthony G., 31 Kellman, Barry, xx, 65–68 Madrid train attack, 125 Kelly, Raymond, xx, 173 MaHIM system, 29–32 Kelso, J. Clark, 112 Mary Ann Liebert, Inc., 21 Khan, Abdul Qadeer, 64 mass casualties, 11, 47, 60, 129 Kidder, Lynne, xx, 61–62 response, 29–32 Kids in Disasters Wellbeing, Safety, and mass warning systems, 28 Health Act, 34 Massachusetts Institute of Technology Koppel, Ted, 51, 120 (MIT), 79, 88, 155 Kulldorff, Martin, 141 mathematics, 39, 144–146, 155, 156 L Matsumoto, Chizuo, 55 Matthews, Gene, xx, 100–104, 110 Larsen, Randy, xx, 61–62 McGeorge School of Law, 112–114 Larson, Richard, xx, 155–157 Medical Reserve Corps, 12, 37–41, 166 law enforcement, xii, 3, 4, 5, 39, 43, 44, 57, 63–72, 132, 155, 165, 169, 170, 173, medical volunteers, 12, 37–41 174. See also INTERPOL Meselson, Matthew, 129 Lawlor, Major General Bruce, 26

255 Preparing for Bioterrorism

Middle East and North Africa (MENA), National Library of Medicine, 146 94, 95 National Organization on Disability, military, 2, 9, 10, 14, 53, 153 35–37 Model State Emergency Health Powers National Public Radio, 51 Act, 104–108 National Research Council, xxi, 80 Models of Infectious Disease Agent National Science Advisory Board for Study, 155 Biosecurity (NSABB), 76, 81, 85, 89, 98 monkeypox, 71 National Security Council, 92 Morse, Stephen, 150 National Strategy Forum, 102 Mostashari, Farzad, xx, 140–143 National Symposium on Medical mousepox virus, 74–75, 76 and Public Health Response to Bioterrorism, 14 N National War College, 61 Napolitano, Janet, 119 natural disasters, xv, 26, 27, 37, 115, 116, 127, 168, 171 National Academy of Sciences, 47, 75, 78, 79, 90 New York Academy of Medicine, 139, 141–143 National Association of County and City Health Officials, 110 New York City, 27, 28, 29, 38–40, 48, 125, 131, 132, 139, 164–174 National Cancer Institute, 141 Department of Health and Mental National Center for Disaster Hygiene, 139, 140, 141, 142, 166, 170 Preparedness, 32–34 Office of Emergency Management, 39, National Commission on Children and 168, 170, 173 Disasters, 34 Ready New York campaign, 166–168 National Commission on Terrorist New York Fire Department, 39, 173 Attacks Upon the United States, 58 New York Police Department, 33, 39, 132, National Fire Protection Association, 117, 165, 171–172, 173 118 New York Safe and Secure training National Health Security Strategy, 20 program, 173–174 National Institute of Standards and New York University, 122–125, 166 Technology, 134 Nixon, Richard, xviii National Institutes of Health, xiii, 6, 45, 89, 155 Noble, Ron, xx, 68, 69–71, 72

256 Index

North Atlantic Treaty Organization Parker, Elizabeth Rindskopf, 112 (NATO), 53 pathogens, xvii, 5, 59, 62, 64, 66, 67, North Carolina Institute for Public 73, 74, 76, 78, 80, 83, 85, 87, 89, 112, Health, 109, 110 129–131, 144, 171, 172 Nuclear Threat Initiative, 49, 52 mail-order, 86–90 nuclear threats and security, 10, 20, 24, Paul, Aniko V., 86 42, 46, 59, 60, 64, 71, 74, 90 Pennsylvania State University, 87 Nunn, Sam, xv, 18 Pentagon, xi attacks, 125 O PERCS program, 170 O’Toole, Tara, 14, 22 pharmacies, 139, 142, 147 Obama, Barack, 12 plague, 15, 54, 71 Office of Public Health Preparedness, US, 22 police. See law enforcement Office of Technology Assessment, 10 policymakers, 5, 17, 19–21, 33, 74, 78, 87, 91–93, 95, 103–104, 106, 113, 116. See Office of the Surgeon General, 37 also Congress Oklahoma City bombing, 10, 14, 125 polio, 76, 86, 87, 88, 99, 100, 101, 157 Oklahoma National Memorial Institute post-traumatic stress disorder, 34 for the Prevention of Terrorism, 18 preparedness, xv, xvi, xviii–xix, xx, Olsiewski, Paula, xviii, 3–4, 5, 39–40, 85, 1–8, 58–62, 97, 98, 102, 104, 106, 108, 101–102, 117, 132, 150, 165 109–111, 130, 148–163 Organization for Security and businesses, 115–127 Cooperation in Europe, 53 children, 32–34 Orloff, Lisa, xx, 169, 170 civilians, 9–41 Osterholm, Michael, xx, 119–121, 161–163 disabled persons, 35–37 Ostfield, Marc, 54 human continuity, 125–127 medical volunteers, 12, 37–41 P New York City, 164–174 pandemic flu, 4, 17, 20, 76, 112, 119–121, Princeton University, 145 168. See also influenza PS-Prep program, 118, 122, 124 1918 outbreak, 76, 81, 149, 150–154, 160

257 Preparing for Bioterrorism public health, xi–xvi, xix, 3, 4, 5, 7, 11–15, ricin, 72 17–22, 29–32, 33, 34, 40, 43, 44, 52, Ridge, Tom, 24, 26 54, 59, 71, 77, 86, 96, 97, 100, 133, 134, 138–140, 142–143, 144, 145, 148, 151, 155, Risk and Insurance Management Society, 157, 160, 161, 163, 172 Inc., 117 emergencies, 31, 106–108, 109 Roberts, Fred S., xx, 144, 145 law, 99–114 Rutgers University, 144 state emergency powers, 102–108 Public Health Security and Bioterrorism S Preparedness and Response Act, 107, 139 salmonella salad bar attack, 43 public panic, 11, 19 Sarbanes-Oxley disclosures, 121 fear of, 6, 41, 166, 167 public policy, 8, 96, 134 sarin gas, 55, 56 SARS, xv, 20, 112 Q SaTScan program, 141–143, 166 quarantines, 100, 102, 104, 106, 107, 113, Schengen Agreement, 50 150, 152, 153 Schmidt, Don, xx, 117, 118 R Schoch-Spana, Monica, 14, 19 radiation, 24, 42, 71, 168 science biosecurity and, 144–146 Raisch, Bill, xx, 117, 122, 124 dual-use research, 83–86, 91–94 Rappert, Brian, xx, 91–94 genetics. See genes READY campaign, 12, 23–26 indoor ecology, 130 Real Estate Roundtable, 136 life sciences, 94–96, 96–98 Real-Time Outbreak and Disease preventing misuse of, 71, 78–82 Surveillance Laboratory, 142, 146–147 scientists, xvii, xviii, 3, 4, 5, 10, 14, 17, 21, Red Crescent Societies (IFRC), 53 22, 70, 71, 76, 77–82, 83–86, 90, 95, 98, 144–146 Red Cross, 36, 66, 109, 110, 170 deliberative seminars for, 91–94 International Federation of, 53 Service Employees International Union, Redlener, Irwin, xx, 33, 34 173, 174 reload, 46

258 Index

Shalala, Donna, 14 Tishman, John L., 131 shigella, 95 toxins, 81, 106 Siegel, Marc H., 117 Transatlantic Biosecurity Network, 49 Sloan, Alfred P., Jr., 164 Trust for America’s Health (TFAH), 110, 111 smallpox, xii, xiii, xv, xvii, 2, 11, 15, 17, 18, 49–51, 53, 74–76, 83, 87, 106, 112 Tsui, “Rich” Fu-Chiang, 146 eradication program, 13, 51 tuberculosis, 100 Soviet Union, xii, xvii, 10 Tufts Health Care Institute, 139 Stafford Act, 111 Tulane University, 152 Standard & Poor’s, 124 tularemia, 15 Steinbruner, John, xx, 83–86 Turning Point Model State Public Health stem cells, 10 Act, 105, 107

Stern, Mitchell, xx, 71–72 U Stevens, Robert, 29 UN Department for Disarmament subway systems, xii, 9, 125, 142 Affairs, 53 attacks, 10, 55 UN General Assembly, 51 syndromic surveillance, 138–143, 146, 147, UN Security Council, 64, 67 166 UNSCR 1540, 64, 65, 67 software, 141–43 University of Bradford, 91, 92 T University of Connecticut, 141 Talent, Jim, 59, 61 University of Maryland, 75 Taylor, Terry, xx, 95 University of Minnesota, 161 Tel Aviv University, 158 University of Pittsburgh, xvi, 17, 142 terrorism, xv, xviii, xix, 2, 10, 12, 14, 27, UPMC, 13, 17 44, 46, 59, 74, 77, 132, 134 Ursano, Robert J., xx, 125–27 children as targets, 32–34 US Advisory Committee on preparing for, 23–26, 115–127, 164–174 Immunization Practices, 162 Thompson, Tommy, 120

259 Preparing for Bioterrorism

US Army Medical Research Institute of White House Office of Homeland Infectious Diseases (USAMRIID), xxi, Security, 23 46 White House Office of Science and US Conference of Mayors, 19 Technology Policy, 80 US General Services Administration, 134 Wimmer, Eckard, 86, 87 US government, xii, xv, xviii, xx, 1, 2, Winfrey, Oprah, 120 7–8, 11–12, 13, 14, 16, 18, 31, 76, 77, 81, workers, building and service, 173–174 82, 89, 90, 108, 111, 155, 159, 166, 167 countering bioterrorism, 42–54, 58–62 Working Group on Civilian Biodefense, 15 US Postal Service, 125, 134 Working Group on Community US Secret Service, 169 Engagement in Public Health Emergency Planning, 19 V World at Risk, 59, 60 vaccines, xvii–xviii, 3, 4, 16, 18, 40, 50, 51, World Cares Center, 169–171 55–57, 74, 75, 80, 88, 99, 100, 106, 113, 144, 145, 154, 155, 148–158, 159–163 World Health Assembly, 96 Venter, J. Craig, 87 WHA55.16, 96–97 World Health Organization (WHO), 13, viral hemorrhagic fevers, 15 20, 49, 51, 52, 53, 77, 83, 96–98, 107, 149, 160 W World Trade Center attacks, xii, 10, 14, Wagner, Michael, xx, 146, 147 38, 125, 165. See also 9/11 Washington, DC, xi, 20, 27, 28, 29, 40, Wye River Workshop, 45–47 66, 107, 110, 125 water security, 24, 52, 95 X weapons of mass destruction, 42, 58–62 Xavier University, 152 Senate Caucus on WMD Terrorism, 20 WMD Center, 45, 58–62 WMD Commission, 59, 61 West Nile virus, 141 White House National Security Council, 17

260 D. A. Henderson

Dr. D. A. Henderson, distinguished scholar at the Center for Biosecurity of UPMC, professor of public health and medicine at the University of Pittsburgh, and dean emeritus and professor of health policy and management at the Johns Hopkins Bloomberg School of Public Health, was the founding director of the Johns Hopkins Center for Civilian Biodefense Strategies in 1998. From November 2001 through April 2003, he served as director of the US Office of Public Health Emergency Preparedness and, later, as a principal science advisor in the Office of the Secretary of HHS. Dr. Henderson is world-renowned for leading the 1966-1977 global campaign to eradicate smallpox, for which he was awarded the Presidential Medal of Freedom. His acclaimed 2009 book, Smallpox: Death of a Disease (Prometheus), is a personal account of that campaign. Dr. Henderson has also been awarded the National Medal of Science, the Japan Prize, and the National Institute of Social Sciences Gold Medal.

Madeline Drexler

Contributing author Madeline Drexler is an award-winning journalist specializing in public health, medicine, and science. Her book Emerging Epidemics: The Menace of New Infections (Penguin, 2010) is an update of her 2003 book Secret Agents: The Menace of Emerging Infections (Penguin), both of which have received wide critical praise. Drexler’s work has appeared in numerous prestigious news outlets, among them, the New York Times, the Wall Street Journal, and many other national publications. Since 2003, she has been a contributing writer for the peer-reviewed journal Biosecurity and Bioterrorism, publishing provocative long-form interviews with leading scientists and policymakers.