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SMALLPOX: IS THE DEPARTMENT OF DEFENSE PREPARED? A thesis presented to the Faculty of the U.S. Army Command and General Staff College in partial fulfillment of the requirements for the degree MASTER OF MILITARY ART AND SCIENCE General Studies by STEPHEN M. FORD, MAJ, USA PharmD., Philadelphia College of Pharmacy and Science, Philadelphia, Pennsylvania, 1990 Fort Leavenworth, Kansas 2003 Approved for public release; distribution is unlimited. REPORT DOCUMENTATION PAGE FormApprovedOMBNo. 0704-0188 Publicreportingburderforthiscollectionofinformationisestibatedtoaverage1hourperresponse,includingthetimeforreviewinginstructions,searchingexistingdatasources,gatheringandmaintainingthedataneeded,andcompleting andreviewingthiscollectionofinformation.Sendcommentsregardingthisburdenestimateoranyotheraspectofthiscollectionofinformation,includingsuggestionsforreducingthisburdertoDepartmentofDefense,Washington HeadquartersServices,DirectorateforInformationOperationsandReports(0704-0188),1215JeffersonDavisHighway,Suite1204,Arlington,VA22202-4302.Respondentsshouldbeawarethatnotwithstandinganyotherprovisionof law,nopersonshallbesubjecttoanypenaltyforfailingtocomplywithacollectionofinformationifitdoesnotdisplayacurrentlyvalidOMBcontrolnumber.PLEASEDONOTRETURNYOURFORMTOTHEABOVEADDRESS. 1.REPORTDATE(DD-MM-YYYY) 2.REPORTTYPE 3.DATESCOVERED(FROM-TO) 06-06-2003 thesis 05-08-2002to06-06-2003 4.TITLEANDSUBTITLE 5a.CONTRACTNUMBER SMALLPOX: 5b.GRANTNUMBER ISTHEDEPARTMENTOFDEFENSEPREPARED? 5c.PROGRAMELEMENTNUMBER Unclassified 6.AUTHOR(S) 5d.PROJECTNUMBER Ford,Stephen,M 5e.TASKNUMBER 5f.WORKUNITNUMBER 7.PERFORMINGORGANIZATIONNAMEANDADDRESS 8.PERFORMINGORGANIZATIONREPORT USArmyCommandandGeneralStaffCollege NUMBER 1ReynoldsAve ATZL-SWD-GD FortLeavenworth,KS66027-1352 9.SPONSORING/MONITORINGAGENCYNAMEANDADDRESS 10.SPONSOR/MONITOR'SACRONYM(S) , 11.SPONSOR/MONITOR'SREPORT NUMBER(S) 12.DISTRIBUTION/AVAILABILITYSTATEMENT A1,AdministrativeorOperationalUse 06-06-2003 USArmyCommandandGeneralStaffCollege 1ReynoldsAve Ft.Leavenworth,KS66027-1352 13.SUPPLEMENTARYNOTES 14.ABSTRACT BiologicalweaponsposeaclearandpresentdangertoU.S.nationalsecurity,U.S.forces,andkeyalliesandfriends.Theirlowcost,low visibility,highpotency,accessibility,andeasydeliverymakeBWattractivetoadversariesseekingnewmethodsofviolencewhencurrentones nolongerachievetheirintendedeffect.Withacasefatalityrateof30percentandnoeffectivetreatmentsmallpoxisoneofthemostfearedof allbiologicalweapons.Thus,thecentralresearchquestionis:Giventheasymmetricthreatposedbybiologicalweaponsandrecentadvancesin biotechnology,istheDepartmentofDefense(DoD)preparedtocounterthecurrentsmallpoxthreat?Acomparativeanalysiswascompleted evaluatingdifferencesbetweensmallpoxandinfluenzapreparedness.Theanalysisincludedevaluationofdetectionandsurveillance(the componentsofrecognition),aswellasappliedresearch,specializedinfrastructure,anddiseasepreventionandcontrol(theelementsof intervention).TheanalysisdeterminedDoDislargelyunprepared.Recommendationstoimproveresponseinclude:researchanddevelopment ofnewvaccinesandantivirals,enhancedvaccineproductioncapacity,additionalresearchfocusedatbolsteringnonspecificimmunity, improvedclinicaldiagnosticsandadditionalspecializedlaboratoryinfrastructure. 15.SUBJECTTERMS Smallpox;Biologicalweapons;Asymmetricwarfare;DepartmentofDefense;Planning;Diseaseprevention;Detection;Vaccines;Antivirals 16.SECURITYCLASSIFICATIONOF: 17.LIMITATION 18. 19.NAMEOFRESPONSIBLEPERSON OFABSTRACT NUMBER Buker,Kathy SameasReport [email protected] (SAR) 78 a.REPORT b.ABSTRACT c.THISPAGE 19b.TELEPHONENUMBER Unclassified Unclassified Unclassified InternationalAreaCode AreaCodeTelephoneNumber 9137583138 DSN 5853138 StandardForm298(Rev.8-98) PrescribedbyANSIStdZ39.18 MASTER OF MILITARY ART AND SCIENCE THESIS APPROVAL PAGE Name of Candidate: MAJ Stephen M. Ford Title of Thesis: Smallpox: Is the Department of Defense Prepared? Approved by: ________________________________________, Thesis Committee Chair LTC Randall A. Espinosa, M.D. ________________________________________, Member LTC Eric P. Katz, B.S. ________________________________________, Member LTC Daniel J. Jones, M.B.A. Accepted this 6th day of June 2003 by: _________________________________________, Director, Graduate Degree Programs Philip J. Brookes, Ph.D. The opinions and conclusions expressed herein are those of the student author and do not necessarily represent the views of the U.S. Army Command and General Staff College or any other governmental agency. (References to this study should include the foregoing statement.) ii ABSTRACT SMALLPOX: IS THE DEPARTMENT OF DEFENSE PREPARED? by MAJ Stephen M. Ford, 79 pages. Biological weapons pose a clear and present danger to U.S. national security, U.S. forces, and key allies and friends. Their low cost, low visibility, high potency, accessibility, and easy delivery make BW attractive to adversaries seeking new methods of violence when current ones no longer achieve their intended effect. With a case fatality rate of 30 percent and no effective treatment smallpox is one of the most feared of all biological weapons. Thus, the central research question is: Given the asymmetric threat posed by biological weapons and recent advances in biotechnology, is the Department of Defense (DoD) prepared to counter the current smallpox threat? A comparative analysis was completed evaluating differences between smallpox and influenza preparedness. The analysis included evaluation of detection and surveillance (the components of recognition), as well as applied research, specialized infrastructure, and disease prevention and control (the elements of intervention). The analysis determined DoD is largely unprepared. Recommendations to improve response include: research and development of new vaccines and antivirals, enhanced vaccine production capacity, additional research focused at bolstering nonspecific immunity, improved clinical diagnostics and additional specialized laboratory infrastructure. iii ACKNOWLEDGMENTS I would like to thank the members of my research committee for their support and encouragement this past year. Dr. Randall Espinosa, LTC Eric Katz, and LTC Dan Jones. In light of your many competing responsibilities, I appreciate your willingness to assist me with this project and recognize the many contributions each made to its success. I would also like to thank my sister, Annette Stoner, for her editing expertise. Her assistance was invaluable and improved this work. Thank you as well for your support and encouragement. Lastly, I would like to thank my wife, Shirley, and my children, Freddy, Anna, Gregory, John, Deven, and Robert. Thank you for supporting me and for the many sacrifices you each made in allowing me to complete this research. I love you all very much! iv TABLE OF CONTENTS Page THESIS APPROVAL PAGE.....................................................................................................................ii ABSTRACT.................................................................................................................................................iii ACKNOWLEDGMENTS..........................................................................................................................iv ACRONYMS..............................................................................................................................................vii LIST OF TABLE.........................................................................................................................................ix CHAPTER I. INTRODUCTION...............................................................................................................1 Background and Context of the Problem............................................................................................2 The Biological Weapons Threat...................................................................................................2 Biotechnology.................................................................................................................................3 History and Potential as a Biological Weapon...........................................................................4 Epidemiology and Virology..........................................................................................................7 Smallpox Disease...........................................................................................................................7 The Research Question.........................................................................................................................9 Assumptions.........................................................................................................................................10 Key Terms.............................................................................................................................................11 Limitations............................................................................................................................................11 Delimitations........................................................................................................................................12 Significance of the Study....................................................................................................................12 CHAPTER II. LITERATURE REVIEW...............................................................................................14 The Biological Weapons and Smallpox Threat...............................................................................15 Biotechnology......................................................................................................................................23 Biological Agent Detection and Warning........................................................................................27 Surveillance..........................................................................................................................................29 Treatment..............................................................................................................................................30 Smallpox Vaccination.........................................................................................................................30 Response to a Smallpox Attack.........................................................................................................32 CHAPTER III. RESEARCH METHODOLOGY..................................................................................34 CHAPTER IV. ANALYSIS.....................................................................................................................37 A Threat Assessment...........................................................................................................................37 Biotechnology......................................................................................................................................38 An Assessment of Preparedness........................................................................................................40 Detection and Surveillance..........................................................................................................40 Smallpox..................................................................................................................................41 Analysis: Criteria Partially Met..........................................................41 Influenza..................................................................................................................................43 Analysis: Criteria Met.......................................................................43 Applied Research..........................................................................................................................44 Smallpox..................................................................................................................................44 Analysis: Criteria Not Met.................................................................44 Influenza..................................................................................................................................46 Analysis: Criteria Met.......................................................................46 Specialized Infrastructure............................................................................................................46 Smallpox..................................................................................................................................46 Analysis: Criteria Partially Met..........................................................46 Influenza..................................................................................................................................48 v Analysis: Criteria Met.......................................................................48 Prevention and Control................................................................................................................49 Smallpox..................................................................................................................................49 Analysis: Criteria Not Met.................................................................49 Influenza..................................................................................................................................52 Analysis: Criteria Partially Met..........................................................52 Analysis Summary........................................................................................................................54 CHAPTER V. CONCLUSIONS AND RECOMMENDATIONS......................................................55 REFERENCE LIST....................................................................................................................................64 INITIAL DISTRIBUTION LIST.............................................................................................................67 CERTIFICATION FOR MMAS DISTRIBUTION STATEMENT...................................................68 vi ACRONYMS ADRs Adverse reactions BSL-4 Biosafety level-4 BWC Biological and Toxin Weapons Convention BWs Biological weapons CDC Centers for Disease Control and Prevention DNA Deoxyribonucleic acid DoD Department of Defense ECTV Ectromelia virus ESSENCE Electronic Surveillance System for Early Notification of Community-Based Epidemics EV Eczema vaccinatum FDA Food and Drug Administration GV Generalized vaccinia HDV Hepatitis D HBV Hepatitis B IL-4 Interleukin-4 HIV Immunodeficiency virus IND Investigational new drug MMWR Morbidity and Mortality Weekly Report MIRV Multiple independent reentry vehicle PCR Polymerase chain reaction PV Progressive vaccinia RFLP Restriction fragment length polymorphism TK Thymidine kinase vii USAMRIID U.S. Army Medical Research Institute of Infectious Diseases VIG Vaccinia immunoglobulin WMD Weapons of mass destruction WHO World Health Organization viii LIST OF TABLE Table Page 1. Analysis Summary........................................................................................ 54 ix