GLOBALIZATION, BIOSECURITY, AND THE FUTURE OF THE LIFE SCIENCES

Committee on Advances in Technology and the Prevention of Their Application to Next Generation Biowarfare Threats

Development, Security, and Cooperation Policy and Global Affairs Division

Board on Global Health

Institute of Medicine

INSTITUTE OF MEDICINE AND NATIONAL RESEARCH COUNCIL OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS
Washington, D.C.
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Globalization, Biosecurity, and The Future of the Life Sciences GLOBALIZATION, BIOSECURITY, AND THE FUTURE OF THE LIFE SCIENCES Committee on Advances in Technology and the Prevention of Their Application to Next Generation Biowarfare Threats Development, Security, and Cooperation Policy and Global Affairs Division Board on Global Health Institute of Medicine INSTITUTE OF MEDICINE AND NATIONAL RESEARCH COUNCIL OF THE NATIONAL ACADEMIES THE NATIONAL ACADEMIES PRESS Washington, D.C. www.nap.edu

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Globalization, Biosecurity, and The Future of the Life Sciences THE NATIONAL ACADEMIES PRESS 500 Fifth Street, N.W. Washington, DC 20001 NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance. This study was supported by contracts between the National Academies and the Department of Homeland Security, the Centers for Disease Control and Prevention, the Food and Drug Administration, the National Institute of Allergy and Infectious Diseases, the National Science Foundation, and the Intelligence Technology Innovation Center. The views presented in this report are those of the National Research Council and Institute of Medicine Committee on Advances in Technology and the Prevention of Their Application to Next Generation Biowarfare Threats and are not necessarily those of the funding agencies. International Standard Book Number 0-309-10032-1 (BOOK) International Standard Book Number 0-309-65418-1 (PDF) Library of Congress Control Number 2006925454 Additional copies of this report are available from the National Academies Press, 500 Fifth Street, N.W., Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www.nap.edu. Copyright 2006 by the National Academy of Sciences. All rights reserved. Printed in the United States of America.

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Globalization, Biosecurity, and The Future of the Life Sciences THE NATIONAL ACADEMIES Advisers to the Nation on Science, Engineering, and Medicine The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Ralph J. Cicerone is president of the National Academy of Sciences. The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Wm. A. Wulf is president of the National Academy of Engineering. The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J. Cicerone and Dr. Wm. A. Wulf are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

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Globalization, Biosecurity, and The Future of the Life Sciences COMMITTEE ON ADVANCES IN TECHNOLOGY AND THE PREVENTION OF THEIR APPLICATION TO NEXT GENERATION BIOWARFARE THREATS Stanley M. Lemon, Co-chair, University of Texas Medical Branch at Galveston David A. Relman, Co-chair, Stanford University Roy Anderson, Imperial College, London Steven M. Block, Stanford University Christopher F. Chyba,* Stanford University and SETI Institute Nancy Connell, University of Medicine and Dentistry of New Jersey Freeman Dyson, Princeton University Joshua M. Epstein, Brookings Institution and Santa Fe Institute Stanley Falkow, Stanford University Stephen S. Morse, Columbia University Randall S. Murch, Virginia Polytechnic Institute and State University Paula Olsiewski, Alfred P. Sloan Foundation C. Kumar N. Patel, Pranalytica, Inc. Clarence J. (CJ) Peters, University of Texas Medical Branch at Galveston George Poste, Arizona State University C. Kameswara Rao, Foundation for Biotechnology Awareness and Education, Bangalore Julian Perry Robinson, University of Sussex Peter A. Singer, University of Toronto Christopher L. Waller, Pfizer Global Research and Development Staff Eileen Choffnes, Senior Program Officer Stacey Knobler,† Senior Program Officer Leslie A. Pray, Science Writer Kate Skoczdopole, Senior Program Assistant *   Princeton University after July 1, 2005. †   Until April 2005.

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Globalization, Biosecurity, and The Future of the Life Sciences Preface The most significant recognized biological attack launched in the United States in recent times came shortly after the devastating events of 9/11 in late 2001. Combined, these events propelled the nation into what many perceived to be a new era, fraught with the real hazards of global terrorism abetted by the exploitation of common everyday technologies—in the one case, an efficient and highly automated national postal service, and in the other, the enormous latent energy carried by a commercial airliner set for a transcontinental flight. That the biological agent used in the postal attacks was anthrax, a “classic” choice of those intent on waging biological warfare, undoubtedly contributed to the nature of the government’s response and the biodefense research priorities that evolved subsequently with a nearly exclusive focus on well-recognized, “traditional” biowarfare agents. Such a focus is dangerously narrow, although past successes in weaponizing anthrax and the potentially devastating consequences of a smallpox release within an immunologically naïve population cannot be ignored. Conventional threats must be addressed by any successful biodefense plan. However, it would be dangerous to ignore the ingenuity displayed in the past by those who are intent on disrupting and perhaps destroying our society. Smart and well-informed terrorists who seek to use against us the technologies we have developed and upon which we have come to rely so heavily at the beginning of the 21st century have unparalleled opportunities to do harm. We also need to be concerned about the unintended consequences from those who use technologies in an irresponsible or ill-informed manner. These dangers are nowhere more evident than in the life sciences, where bio-

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Globalization, Biosecurity, and The Future of the Life Sciences technology and our understanding of the biological processes that define our very being are advancing at extraordinary rates. Concerns about how new developments in the life sciences, including their convergence with other rapidly advancing fields such as nanotechnology and materials science, may enable the creation and production of wholly new threats of biological origin led to the formation of the Committee on Advances in Technology and the Prevention of Their Application to Next Generation Biowarfare Threats, an ad hoc committee of the National Research Council and the Institute of Medicine. The committee’s charge has been to examine current trends and future objectives of research in the life sciences that may enable the development of a new generation of future biological threats. In taking on the charge to define a horizon of 5 to 10 years, the committee has sought to identify ways to anticipate, identify, and mitigate these dangers to society. While this has been far from easy, and while the committee may worry about how successful it has been in fulfilling its charge as this report goes to press, several conclusions stand out with startling clarity. First, the future is now. Even in the short time since the creation of the committee, we have seen the phenomenon of RNA interference capture the collective consciousness of the life sciences community, providing entirely new insights into how human genes are normally regulated and how this regulation might be disrupted for malevolent purposes by those intent on doing harm. Similarly, “synthetic biology,” an approach embraced and discussed by few at the time the committee was formed, has now been redefined and promoted on the cover of one of the most widely read scientific journals. Neither of these developments could have been foretold even a few years back, pointing to the futility of trying to predict with accuracy what will come in the next few years. This leads to the second conclusion, that the task of surveying current technology trends in order to anticipate what new threats may face us down the road will be never ending. This report, published in early 2006, will in some respects be out of date by 2007. These considerations led to two of the major recommendations adopted by the committee: the need to survey the threat horizon continually for what we may face in the future and, in order to do this effectively, the need to enhance in a significant manner the scientific expertise of those charged with this task. Thus, rather than laying forth a list of threats as perceived at the end of 2005, the committee has endeavored to describe a process and set of organizing principles, a method by which technological advances might be assessed and future risks for their malevolent use considered. Such a contribution is likely to be more lasting than any specific list, although the process itself must be continuously reassessed in light of advancing knowledge.

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Globalization, Biosecurity, and The Future of the Life Sciences In addressing our charge, committee members have been blessed by a large committee, well endowed with expertise in a number of diverse scientific fields and with several international members consistent with the imperative that these issues be addressed in a global context. Our discussions highlighted many different perspectives held by members of the committee—differences that stem from past experiences in the very different fields represented by the members, which include biological discovery, global emerging infections, nuclear physics, bioethics, law enforcement, and international arms control, to list a few. However, every member was challenged by the committee’s charge. Paradigms for threat reduction that may have worked reasonably well for controlling nuclear arms proliferation, information control, materials inventory, and so forth, may have limited relevance to the control of biological weapons proliferation. This is especially true given the wide dispersion of biological information and the mechanisms in place that support this globally, the capacity of the relevant materials to replicate, and the lack of any readily apparent “global bargain” resembling the “Atoms for Peace” initiative of the past. Yet it is increasingly important that life scientists, and the funding agencies and editors who support their activities, take every possible step to ensure that the fruits of their work are not exploited in a malevolent fashion, to the detriment of society. This will require that those working in the life sciences achieve a much greater appreciation of the dangers than that now held by most and a greater willingness to shoulder this responsibility. A new ethos is required, and it must be achieved on a global scale. This was apparent to all committee members, although a clear path toward achieving this goal was apparent to none of us—our recommendations are but first steps in this direction. In many ways, this committee has worked in the shadows of the groundbreaking National Research Council report Biotechnology Research in an Age of Terrorism (2004), commonly known as the Fink report. However, there is a clear difference between that report and the present one. Our focus has been on advances in the life sciences and related and convergent technologies that are likely to alter the biological threat spectrum over the next 5 to 10 years. To a greater extent than was the case with the previous effort, we have attempted to take a global perspective and consider how future threats might be anticipated. In contrast, the Fink report focused primarily on the regulatory oversight of research employing biotechnology and the flow of scientific knowledge derived from the use of biotechnology, mostly within the United States. It is an unfortunate reality that almost all advances in life sciences technology pose potential “dual-use” risks. But better science is the best protection against potential threats. This is not to advocate the creation of a biological arms race, but to recognize the simple fact that better vac-

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Globalization, Biosecurity, and The Future of the Life Sciences cines, better drugs, and better countermeasures in general, not to mention anticipation of potential threats, will stem from such a flow of information. The committee has broadly considered ways to prevent or mitigate the consequences of malevolent exploitation (either by state actors, nonstate groups, or individuals) or naïve misuse of these technologies. To the extent that we do cover some ground trod earlier by the Fink report, for example, in considering how regulations and policies may have utility in addressing these risks—the conclusions here are much the same: The committee recognizes and emphasizes the counterproductive nature of efforts to control the flow of biological information. Given the widening threat spectrum, the best means of future protection comes from the exploitation of science, paradoxically the very advances in technology about which there is so much concern. It is imperative that we (defined broadly as free societies) keep ahead scientifically and remain technologically advantaged over potential opponents. Such protection can only come from a robust scientific enterprise, which in turn depends on the free exchange of biological data among scientists. Committee members have been struck by the often “self-centered” and limited perspective taken by some in the United States charged with addressing these critically important issues. Although we cannot pretend to understand completely the forces that govern advances in science and technology and the need for regulating these activities in diverse regions of the globe, it is clear that different societies may have vastly different perspectives on these issues and may adopt divergent paths while aiming to achieve similar goals. To succeed in reducing the threats posed by these advancing technologies will require an appreciation of these differences and an understanding that science does not stop at our borders. The futile nature of attempting to predict the future accurately and which of the myriad scenarios a set of terrorists or malevolent state actors might choose leads to the committee’s final conclusion—which is perhaps the most obvious, the most important, but the least novel and therefore, unfortunately, the least likely to be heeded. The best anticipatory practices, thoughtful predictions, and preventive actions are unlikely to be completely successful in preventing a future significant biological attack, whether with a conventional “classic” biological weapons agent or a newly engineered weapon of biological origin. Thus, we must be prepared; the best preparation will be to strengthen the nation’s fractured public health infrastructure and the lack of coordination that exists among the myriad federal and state agencies that will be called on in such an event. Unfortunately, many of the same considerations likely apply to all nations of the world. Ironically, substantial returns from these investments are guaranteed. Even in the absence of a deliberate attack, a robust and

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Globalization, Biosecurity, and The Future of the Life Sciences agile public health system and a biodefense strategy informed by advancing science and technology greatly enhances our ability to address the ever-present and constantly evolving threats to health from nature, as should be clear from the avian flu threat and other emerging infectious diseases. Although short on sizzle, such efforts are imperative. The costs will be high if we fail to make such investments. The committee is indebted to the many individuals who provided their unique perspectives on the issues it faced and who through formal presentations and discussions ensured that the committee possessed the information it needed to inform its findings and recommendations. These individuals include Robert Carlson, James B. Petro, Pim Stemmer, Charles Rice, Drew Endy, Herb Lin, Sonia Miller, John Steinbruner, Barry Kellman, Michael Moodie, Terence Taylor, David Lipman, Charles Jennings, Phillip Campbell, Jonathan Tucker, Gerald Epstein, Jerrold Post, David Banta, Decio Ripandelli, Charles Arntzen, Miguel Gomez Lin, Luis Herrera-Estrella, Rosiceli Barreto Goncalves Baetas, Jacques Ravel, Patrick Tan Boon Ooi, Abdallah Daar, Gerardo Jimenez-Sanchez, Tibor Toth, Amy Sands, Robert Mathews, Jerome Amir Singh, Peter Herby, Nadrian Seeman, Michael Morgan, Kathryn Nixdorff, and Elliott Kagan. The committee also greatly appreciates the role played by the Instituto Nacional de Salud Pública (National Institute of Public Health) in Cuernavaca, Mexico, in hosting a workshop convened by the committee in September 2004 and recognizes in particular the head of the Institute, Mauricio Hernandez, and his staff. This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the National Academies’ Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the process. We wish to thank the following individuals for their review of this report: Ronald Atlas, University of Louisville; Edouard Brezin, French Academy of Science; Robert Carlson, University of Washington; Malcolm Dando, Bradford University; Drew Endy, Massachusetts Institute of Technology; Gerald Epstein, Center for Strategic and International Studies; David Franz, Midwest Research Institute; Gerald Fink, Whitehead Institute for Biomedical Research; Alistair Hay, Leeds University; James Hughes, Emory University; Stephen Johnston, University of Texas; Gigi Kwik Grönvall, Johns Hopkins University; Frederick Murphy, University of California, Davis; and Mark Wheelis, University of California, Davis.

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Globalization, Biosecurity, and The Future of the Life Sciences Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations, nor did they see the final draft of the report before its release. The review of this report was overseen by Gilbert Omenn, of the University of Michigan. Appointed by the National Academies, he was responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution. Most important, this study and this report benefited greatly from the efforts of Eileen Choffnes, study director, who played a critical role in the committee’s work and deliberations. Among her many contributions, she provided invaluable insight into previous efforts by the National Academies that related to many of the issues the committee was charged to address, helpful feedback on the committee’s progress toward its goals, an effective organizational structure, constant encouragement (and occasional prodding), and great dedication to the project. For all of this the committee is most grateful. Other members of the National Research Council/Institute of Medicine staff also contributed substantially to the committee’s work, including Stacey Knobler, who made important and thoughtful contributions during the early phases of the study, and Kate Skoczdopole and Katherine McClure, who provided extensive assistance in orchestrating committee meetings, organizing the international workshop, and keeping information flowing between committee members. Additional assistance with the writing of this report was provided by Leslie A. Pray. The committee expresses its profound gratitude to all of these highly talented individuals, with whom it has been a pleasure and a privilege to work during the past two years. Stanley M. Lemon, Co-chair David A. Relman, Co-chair

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Globalization, Biosecurity, and The Future of the Life Sciences Contents     Executive Summary   1 1   Framing the Issue   15      Committee Charge and Process,   16      Emerging Technologies in the Life Sciences,   19      Notable Features of Technological Growth in the Life Sciences,   24      Definitions,   27      20th Century Germ-Based Biowarfare,   32      Beating Nature: Is It Possible to Engineer a “Better Pathogen,”   35      Natural Threats,   35      The Evolution of Pathogenicity: What Does It Take to Cause Disease?,   40      The Importance of the Host Response,   45      Advancing Technologies Will Alter the Future Threat Spectrum,   46      The Development and Use of Biological Weapons,   49      Biological Weapons are Fundamentally Different from Other “Weapons of Mass Destruction,”   52      The “Arms Race” Metaphor and the Difficult Issue of Secrecy,   59      The Need to Strike a Balance: Benefits of Technological Growth,   60      The Dual-Use Dilemma,   62      Committee Process,   65      Report Road Map,   65

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Globalization, Biosecurity, and The Future of the Life Sciences 2   Global Drivers and Trajectories of Advanced Life Sciences Technologies   79      The Global Marketplace,   82      The Pharmaceutical Industry,   84      Global Growth of the Biotechnology Industry,   85      The Fledgling Nanobiotechnology Industry,   87      Agricultural Biotechnology,   90      Industrial Biotechnology,   96      Biodefense,   97      Global Dispersion of Knowledge,   98      Global Scientific Productivity,   98      Global Growth in Biotech Patent Activity,   102      Information Technology,   104      Global Dispersion of People,   106      Trends in Higher Education,   107      A Snapshot of the Global Technology Landscape,   112      East Asia and the Pacific,   113      Eastern Europe and Central Asia,   118      Latin America and the Caribbean,   120      Middle East and North Africa,   123      South Asia,   125      Sub-Saharan Africa,   127      Summary,   129 3   Advances in Technologies with Relevance to Biology: The Future Landscape   139      A Classification Scheme for Biological Technologies,   140      Acquisition of Novel Biological or Molecular Diversity,   142      DNA Synthesis,   143      DNA Shuffling,   146      Bioprospecting,   148      Combinatorial Chemistry: Generating Chemical Diversity,   150      High-Throughput Screening,   154      Directed Design,   156      Rational Drug Design,   156      Synthetic Biology,   159      Genetic Engineering of Viruses,   161      Understanding and Manipulating Biological Systems,   165      RNA interference,   165      High-Affinity Binding Reagents (Aptamers and Tadpoles),   169      Computational Biology and Bioinformatics,   170      Systems Biology,   173

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Globalization, Biosecurity, and The Future of the Life Sciences      Genomic Medicine,   175      Modulators of Homeostatic Systems,   178      Production, Delivery and “Packaging,”   181      Plants as Production Platforms—“Biopharming”,   181      Microfluidics and Microfabrication,   183      Nanotechnology,   184      Aerosol Technology,   186      Microencapsulation Technology,   189      Gene Therapy Technologies,   191      Targeting Biologically Active Materials to Specific Locations in the Body,   192      The Complementarity and Synergy of Technologies,   195      Conclusion,   197 4   Conclusions and Recommendations   213      Conclusion 1,   218      Recommendation 1,   219      Conclusion 2,   231      Recommendation 2,   232      Conclusion 3,   236      Recommendation 3,   236      Conclusion 4,   243      Recommendation 4,   244      Conclusion 5,   256      Recommendation 5,   257      Summary,   262      Annex 4-1,   264      Annex 4-2,   268     Appendixes     A   Acronyms and Abbreviations   283 B   Committee Meetings   287 C   Biographical Sketches of Committee Members   289

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