SEEKING SECURITY

Pathogens, Open Access, and Genome Databases

Committee on Genomics Databases for Bioterrorism Threat Agents

Board on Life Sciences

Division on Earth and Life Studies

Policy and Global Affairs Division

NATIONAL RESEARCH COUNCIL OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS
Washington, D.C.
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Seeking Security: Pathogens, Open Access, and Genome Databases SEEKING SECURITY Pathogens, Open Access, and Genome Databases Committee on Genomics Databases for Bioterrorism Threat Agents Board on Life Sciences Division on Earth and Life Studies Policy and Global Affairs Division NATIONAL RESEARCH COUNCIL OF THE NATIONAL ACADEMIES THE NATIONAL ACADEMIES PRESS Washington, D.C. www.nap.edu

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Seeking Security: Pathogens, Open Access, and Genome Databases THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW 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 Contract No. DBI-0314614 between the National Academy of Sciences and the National Science Foundation. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the authors and do not necessarily reflect the views of the organizations or agencies that provided support for the project. International Standard Book Number 0-309-09305-8 (Book) International Standard Book Number 0-309-54544-7 (PDF) Additional copies of this report are available from the National Academies Press, 500 Fifth Street, NW, Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www.nap.edu. Copyright 2004 by the National Academy of Sciences. All rights reserved. Printed in the United States of America

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Seeking Security: Pathogens, Open Access, and Genome Databases 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. Bruce M. Alberts 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. Bruce M. Alberts and Dr. Wm. A. Wulf are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

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Seeking Security: Pathogens, Open Access, and Genome Databases COMMITTEE ON GENOMICS DATABASES FOR BIOTERRORISM THREAT AGENTS STANLEY FALKOW (Chair), Stanford University, Palo Alto, California CORRIE BROWN, University of Georgia, Athens, Georgia DAVID R. FRANZ, Midwest Research Institute, Frederick, Maryland CLAIRE M. FRASER, The Institute for Genomic Research, Rockville, Maryland PAUL KEIM, Northern Arizona University, Flagstaff, Arizona TERENCE TAYLOR, International Institute for Strategic Studies, Washington, DC Staff KERRY BRENNER, Study Director EILEEN CHOFFNES, Senior Program Officer SETH STRONGIN, Senior Program Assistant ROBERT TAYLOR, Writer NORMAN GROSSBLATT, Senior Editor

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Seeking Security: Pathogens, Open Access, and Genome Databases BOARD ON LIFE SCIENCES COREY S. GOODMAN (Chair), Renovis Inc., South San Francisco, California RUTH BERKELMAN, Emory University, Atlanta, Georgia R. ALTA CHARO, University of Wisconsin, Madison. Wisconsin DENNIS CHOI, Merck Research Laboratories, West Point, Pennsylvania JOANNE CHORY, The Salk Institute for Biological Studies, La Jolla, California JEFFREY L. DANGL, University of North Carolina, Chapel Hill, North Carolina PAUL R. EHRLICH, Stanford University, Palo Alto, California JAMES M. GENTILE, Hope College, Holland, Michigan LINDA GREER, Natural Resources Defense Council, Washington, DC ED HARLOW, Harvard Medical School, Cambridge, Massachusetts DAVID HILLIS, University of Texas, Austin, Texas KENNETH F. KELLER, University of Minnesota, Minneapolis, Minnesota RANDALL MURCH, Institute for Defense Analyses, Alexandria, Virginia GREGORY A. PETSKO, Brandeis University, Waltham, Massachusetts STUART L. PIMM, Duke University, Durham, North Carolina BARBARA A. SCHAAL, Washington University, St. Louis, Missouri JAMES TIEDJE, Michigan State University, East Lansing, Michigan KEITH YAMAMOTO, University of California, San Francisco, California Staff FRANCES E. SHARPLES, Director KERRY A. BRENNER, Senior Program Officer ROBIN A. SCHOEN, Senior Program Officer MARILEE K. SHELTON-DAVENPORT, Senior Program Officer ROBERT T. YUAN, Senior Program Officer ADAM P. FAGEN, Program Officer EVONNE P. Y. TANG, Program Officer BRENDAN BRADLEY, Program Assistant/Research Intern SETH STRONGIN, Senior Program Assistant DENISE GROSSHANS, Financial Associate

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Seeking Security: Pathogens, Open Access, and Genome Databases Preface This committee was empaneled by the National Research Council to analyze the scientific issues that might accompany the release into the public domain of genome sequences for infectious agents with potential national security implications. Specifically, the committee was asked to consider the following: What are the categories of genome data that should be of greatest concern? What are the pros and cons of unlimited vs. restricted access to the scientific information? What are some options for making decisions about the release of this information into the public domain? In an ideal world, it would be easy to advocate for a free and ready distribution of all genome information into the public domain. That would be in the spirit of free scientific inquiry as it would lead to the most scholarly and creative use of the information that is inherent (although not always obvious) in deciphering the genomic blueprint of any living thing. However, we live in a world where a small minority of individuals and, sadly, perhaps even some world governments might use pathogenic microbes as weapons. We have to ask to what extent genome information, particularly of microorganisms and their hosts, might help these misguided individuals. Biologists, unlike physicists, haven’t yet formulated many natural laws, and I am sorry to report that there is no sure pathway to making an effective vaccine, isolating new effective anti-infective compounds, or indeed understanding what makes a pathogen a pathogen. I have tried for 50 years and can attest to the fact that, even when the microbial genes

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Seeking Security: Pathogens, Open Access, and Genome Databases that are essential for pathogenicity are known, we more often than not don’t understand their function, nor do we yet understand the underpinnings of susceptibility to or risk of infection of humans or other hosts. And we don’t know why we so often fail to develop sterilizing immunity to infections such as HIV/AIDS or to all the other persistent infections that plague (no pun intended) humans. Thus, with or without the availability of sophisticated biological research tools like genome sequences, we continue to face the potential for catastrophic epidemics due to naturally occurring organisms; and these, like the intentional release of infectious agents of bioterrorism, are probably not predictable or preventable. We need to push ahead to conquer global infectious diseases because they remain the greatest cause of worldwide death and suffering. Yet, unquestionably we face a dilemma that there will be a future time, and it is coming closer and closer, when in the wrong hands biotechnology making use of genome information could create a novel pathogen with unique properties. It is useful to consider that on the day of our committee’s workshop a parallel National Academies meeting was held dealing with the coronavirus that is the agent of SARS. SARS must be close to the perfect example of the dilemma that faces our committee, the scientific community, and anyone else concerned with policy and national security. The virus has a potential to cause a greater morbidity and mortality than the pandemic influenza A strain of the World War I era. The virus has been isolated. Its sequence was promptly published in the public domain, and dozens of companies and laboratories throughout the world are in the process of developing diagnostic reagents and proposed vaccines and are seeking to uncover the pathogenic mechanism with sophisticated contemporary research methods. It is not clear that a vaccine will work. It is not clear whether SARS will return. Sequence availability or not, we don’t understand why the influenza A strain of the 1918 era was so virulent in young people, nor do we understand why the SARS virus caused such severe disease in people compared with the virus that supposedly came from a civet-like host in China. How do we apply criteria to determine what is legitimate research or what is sensitive information or what can and cannot be published? It could be argued that the availability of the complete genome sequence of human isolates of SARS could be used by a very sophisticated bioterrorist as a pathway to synthesize a new version of the SARS virus. Which do we fear more, nature or bioterrorism? Would we gain anything by restricting access to the SARS viral sequence? Would there be any gain or loss in restricting release of later sequences? Should we restrict the sharing of information on the genes or motifs associated with host range or the induction of immunity? Is this information likely to be used by fanatics

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Seeking Security: Pathogens, Open Access, and Genome Databases who would employ the tactic of bioterrorism? Which answers best serve the global good? That example is an encapsulation of the problem that confronted us as we began our study. There is no hiding the fact that ours is an immensely difficult task, and I suspect that some of the participants in our workshop took the challenge of speaking to us because it is an immensely difficult task. With this report, the committee has attempted to provide answers as well as we could. Stanley Falkow, Chair

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Seeking Security: Pathogens, Open Access, and Genome Databases Acknowledgments This study was sponsored by the National Science Foundation, the National Institutes of Health, the Central Intelligence Agency, and the Department of Homeland Security. The input of workshop speakers and participants was of particular value to the committee in its deliberations. The committee thanks them for taking the time to share their expertise. A list of those who attended the workshop can be found in Appendix C. This report has been reviewed in draft form by persons chosen for their diverse perspectives and technical expertise in accordance with procedures approved by the National Research Council 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 of objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following for their review of this report: Michael A. Apicella, University of Iowa, College of Medicine Enriqueta C. Bond, Burroughs Wellcome Fund Joe DeRisi, University of California, San Francisco Gerald Epstein, Center for Strategic and International Studies David Galas, Keck Graduate Institute Gerald Mandell, University of Virginia

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Seeking Security: Pathogens, Open Access, and Genome Databases Randall S. Murch, Institute for Defense Analyses Eugene W. Myers, University of California, Berkeley David Relman, Stanford University James Tiedje, Michigan State University Although the reviewers listed above have provided 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 Harold J. Fallon, University of Alabama School of Medicine (emeritus) and May Berenbaum, University of Illinois. Appointed by the National Research Council, they were 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 author committee and the institution.

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Seeking Security: Pathogens, Open Access, and Genome Databases Contents     Executive Summary   1 1   Introduction   15      The Life-Science Revolution,   15      Related National Academies Projects,   17      Charge to the Committee,   18 2   Genome Databases Today   21      Genome Databases,   21      Genome Sequencing,   21      Genome Data and Analysis,   23      Database-Access Policy,   25      Use of Genomics in Modern Life-Science Research,   27      Meningococcus B Vaccine,   30      SARS Coronavirus,   31      Vaccines,   32      Drug Therapies,   32      Diagnostics,   33      Genomics and Bioterrorism,   33      Modern Technology,   33      Potential Malefactors,   35      How Genome Data Might Be Misused,   36

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Seeking Security: Pathogens, Open Access, and Genome Databases 3   Issues in the Control of Genome Information: From Discussions at the Committee’s Workshop   39      Stakeholders in the Debate over Release of Genome Data,   40      Domestic Interest Groups and Perspectives,   41      International Issues,   43      Categories of Genome Data,   44      Data from Bioterror Agents vs. Other Pathogens,   45      Data from Naturally Occurring vs. Genetically Engineered Pathogens,   45      Primary Genome Sequences vs. Annotations,   46      Microarray and Other Functional Genome Data,   46      Tools for Analyzing Genome Data,   47      Potential Data-Control Mechanisms,   47      Classify Some Data,   48      Withhold Some Data from Widespread Public Release,   48      Allow Unlimited Data Access but Require Registration,   49      Summary of Issues Related to Restricting Access to Genome Data,   50 4   Conclusions and Recommendations   52      Recommendation 1,   52      Current Polices Are Effective,   53      Effective Restriction of Genome Data Is Not Practical,   54      Pathogen Genome Sequences Are Not Uniquely Dangerous,   55      Recommendation 2,   57      Recommendation 3,   58      Recommendation 4,   62      Recommendation 5,   64     References   65     Appendixes     A   Statement of Task   69 B   Agenda   71 C   Participants   73