COUNTERING BIOTERRORISM

THE ROLE OF SCIENCE AND TECHNOLOGY

Panel on Biological Issues

Committee on Science and Technology for Countering Terrorism

INSTITUTE OF MEDICINE

NATIONAL RESEARCH COUNCIL
OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS
Washington, D.C.
www.nap.edu



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Countering Bioterrorism: The Role of Science and Technology COUNTERING BIOTERRORISM THE ROLE OF SCIENCE AND TECHNOLOGY Panel on Biological Issues Committee on Science and Technology for Countering Terrorism INSTITUTE OF MEDICINE NATIONAL RESEARCH COUNCIL OF THE NATIONAL ACADEMIES THE NATIONAL ACADEMIES PRESS Washington, D.C. www.nap.edu

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Countering Bioterrorism: The Role of Science and Technology 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. Support for this project was provided by institutional funds. International Standard Book Number 0-309-08607-8 Additional copies of this report are available from the National Academies Press, 500 Fifth Street, N.W., Lockbox 285, Washington, DC 20055; call (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www.nap.edu. Copyright 2002 by the National Academy of Sciences. All rights reserved. Printed in the United States of America.

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Countering Bioterrorism: The Role of Science and Technology 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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Countering Bioterrorism: The Role of Science and Technology PANEL ON BIOLOGICAL ISSUES BARRY R. BLOOM, Co-chair, Harvard School of Public Health JOSHUA LEDERBERG, Co-chair, Sackler Foundation at the Rockefeller University RONALD ATLAS, University of Louisville RUTH BERKELMAN, Emory University GAIL CASSELL, Lilly Research Laboratories, Eli Lilly and Company THOMAS R. CECH, Howard Hughes Medical Institute DAVID FRANZ, Southern Research Institute CLAIRE FRASER, Institute for Genomic Research DAVID GALAS, Keck Graduate Institute of Applied Life Sciences CDR SHAUN JONES, U.S. Navy ROBERT A. LAMB, Howard Hughes Medical Institute/Northwestern University SIMON LEVIN, Princeton University JOHN MEKALANOS, Harvard Medical School TOM MONATH, Acambis, Inc. RANDALL MURCH, Federal Bureau of Investigation EDWARD D. PENHOET, University of California, Berkeley DAVID RELMAN, Stanford University PETER ROSEN, University of California, San Diego LUIS SEQUEIRA, University of Wisconsin JEFFERY TAUBENBERGER, Armed Forces Institute of Pathology DEAN WILKENING, Stanford University CATHERINE WOTEKI, Iowa State University Liaisons from the Parent Committee to the Panel MARGARET A. HAMBURG, Nuclear Threat Initiative P. ROY VAGELOS, Merck & Co., Inc. (retired)

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Countering Bioterrorism: The Role of Science and Technology Staff ANDREW M. POPE, Director, Board on Health Sciences Policy CATHY T. LIVERMAN, Senior Program Officer, Board on Health Promotion and Disease Prevention JENNIFER KUZMA, Senior Program Officer, Board on Life Sciences ALDEN B. CHANG, Administrative Assistant, Board on Health Sciences Policy JUDY ESTEP, Senior Program Assistant, Board on Health Promotion and Disease Prevention Consultant KATHI E. HANNA, Writer

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Countering Bioterrorism: The Role of Science and Technology COMMITTEE ON SCIENCE AND TECHNOLOGY FOR COUNTERING TERRORISM LEWIS M. BRANSCOMB, Harvard University, Co-chair RICHARD D. KLAUSNER, Bill and Melinda Gates Foundation, Co-chair JOHN D. BALDESCHWIELER, California Institute of Technology BARRY R. BLOOM, Harvard School of Public Health L. PAUL BREMER III, Marsh Crisis Consulting WILLIAM F. BRINKMAN, Lucent Technologies (retired) ASHTON B. CARTER, Harvard University CHARLES B. CURTIS, Nuclear Threat Initiative MORTIMER L. DOWNEY III, PB-Consult RICHARD L. GARWIN, Council on Foreign Relations PAUL H. GILBERT, Parsons Brinckerhoff Quade & Douglas, Inc. M.R.C. GREENWOOD, University of California, Santa Cruz MARGARET A. HAMBURG, Nuclear Threat Initiative WILLIAM HAPPER, Princeton University JOHN L. HENNESSY, Stanford University JOSHUA LEDERBERG, Sackler Foundation at the Rockefeller University THOMAS C. SCHELLING, University of Maryland MAXINE F. SINGER, Carnegie Institution of Washington NEIL J. SMELSER, University of California, Berkeley (retired) PHILIP M SMITH, McGeary & Smith P. ROY VAGELOS, Merck & Co., Inc. (retired) VINCENT VITTO, Charles S. Draper Laboratory, Inc. GEORGE M. WHITESIDES, Harvard University R. JAMES WOOLSEY, Shea & Gardner Staff RONALD D. TAYLOR, Study Director ELIZABETH L. GROSSMAN, Program Officer MARY G. GORDON, Information Officer SUSAN G. CAMPBELL, Administrative Assistant IAN M. CAMERON, Project Assistant

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Countering Bioterrorism: The Role of Science and Technology Preface The September 11, 2001, attacks galvanized the nation to strengthen its counterterrorism defenses. Immediately following the attacks, the presidents of the National Academy of Sciences, National Academy of Engineering, and Institute of Medicine wrote to President Bush offering the advice of the National Academies on how best to harness the country’s science and technology capacity to meet critical security and antiterrorism needs. In December 2001, the National Academies appointed a committee of 24 of the country’s leading scientific, engineering, medical, and public policy experts to offer counsel on an integrated science and technology plan for combating terrorism. To supplement the knowledge of its members, the committee convened eight panels with expertise in specific topic areas, from the chemical and biological disciplines to the domains of energy, information technology, and transportation. Barry Bloom and Joshua Lederberg, both members of the main committee, co-chaired the Panel on Biological Issues, which comprised 22 experts in medicine, public health, microbiology, cellular biology, virology, drug and vaccine development, health policy, laboratory analysis, plant pathology, zoonotic disease, food-borne disease, molecular biology, genomics, emergency medical response systems, infectious disease, bioterrorism, bioforensics, statistics, and epidemiological modeling. The main committee’s report, Making the Nation Safer: The Role of Science and Technology in Countering Terrorism, was released on June 25, 2002. The committee recommends a strategy whereby the nation’s scientific and engineering capacity can be strengthened and brought to bear in the fight against terrorism. Making the Nation Safer synthesizes the contributions of the eight expert

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Countering Bioterrorism: The Role of Science and Technology panels into chapters, each containing specific research and policy recommendations. The contribution of the Panel on Biological Issues (Chapter 3 of Making the Nation Safer) is reprinted in this report to provide a focused report on the scientific and technological measures needed to counter bioterrorism. The executive summary of the main committee’s report is reprinted in Appendix A of this report. The Panel on Biological Issues met three times over a 5-month period with extensive interactions by email and conference calls. The panel wishes to thank the following individuals who provided briefings to the panel: William Winkenwerder, Department of Defense; Kevin Tonat, Department of Health and Human Services; D.A. Henderson, Department of Health and Human Services; Anthony Fauci, National Institute of Allergy and Infectious Diseases; Kathryn Zoon, Food and Drug Administration; David Lipman, National Center for Biotechnology Information; Chuck Ludlum, Office of Senator Joseph Lieberman; and William Dallas Jones, California Office of Emergency Services. The panel’s contribution was reviewed as part of the main committee’s report by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the National Research Council’s 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 charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. The full listing of the reviewers of the main committee’s report is provided in that report. Several of those reviewers were selected because of their expertise relevant to the biological sciences and bioterrorism. Special appreciation is expressed to the following reviewers: Steven M. Block, Stanford University; Floyd E. Bloom, The Scripps Research Institute; Stanley Falkow, Stanford University; Thomas J. Kelly, Sloan-Kettering Institute; Harley W. Moon, Iowa State University; Lucy Shapiro, Stanford University; Harold E. Varmus, Memorial Sloan-Kettering Cancer Center. Although these individuals provided many constructive comments and suggestions, they were not asked to endorse findings and conclusions, nor did they see the final document before its release. The review was overseen by R. Stephen Berry, James Franck Distinguished Service Professor Emeritus, University of Chicago, and Gerald P. Dinneen, Retired Vice President of Science and Technology, Honeywell Inc. Appointed by the National Research Council, they were responsible for making certain that an independent examination of the report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for content rests entirely with the authors and the institution.

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Countering Bioterrorism: The Role of Science and Technology Andrew Pope, Jennifer Kuzma, and Cathy Liverman managed the panel’s work. Kathi Hanna, a consultant to the committee, summarized the panel’s deliberations into a draft of the report. Judy Estep worked on the details of this publication. Special thanks go to Alden Chang for his work in support of the main report.

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Countering Bioterrorism: The Role of Science and Technology Contents     EXECUTIVE SUMMARY   1 1   INTRODUCTION   9     The Need for Approaches with Multiple Benefits,   11     Changing Research Paradigm,   12     Organization of This Report,   12 2   INTELLIGENCE, DETECTION, SURVEILLANCE, AND DIAGNOSIS   15     Intelligence and Information Management,   15     Identification of Biological Agents in the Environment,   16     Surveillance and Diagnosis of Infection and Disease,   19 3   PREVENTION, RESPONSE, AND RECOVERY   27     Uncertain Understanding of the Effects of Biological Weapons,   28     Microbial Forensics and Analysis of Trace Evidence,   30     An Approach to Defining Bioterrorist Threats,   31     Developing Antimicrobials and Antivirals,   33     Rapid Vaccine Development,   35     Improvement and Testing of Environmental and Personal Protective Equipment,   36     Approaches to Preparing the Health Care System for Response and Recovery: The Need for Surge Capacity,   37

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Countering Bioterrorism: The Role of Science and Technology     Approaches to Preparing the Food and Agriculture System for Response and Recovery,   40     Communicating Risks and Responses to the Public,   41     Development of Treatment Protocols,   42     Develoment of Decontamination Protocols,   42 4   POLICY AND IMPLEMENTATION   45     Develop Scientific and Technological Human Resources,   45     Need for Standards and Standardization,   46     Facilitate Development of Therapeutics and Vaccines: Engagement of Industry,   47     Regulatory Reform,   49 5   CONCLUDING REMARKS   53     REFERENCES   57     APPENDIXES     A   EXECUTIVE SUMMARY FROM FULL REPORT   59 B   PANEL AND STAFF BIOGRAPHIES   83