,’ --a United States General Accounting Office Report to the Chairman, Committee on GAO Governmental Affairs, U.S. Senate December 1990 BIOLOGICAL WARFARE Better Controls in DOD’s Research Could Prevent Unneeded Expenditures . . GAO,‘NSIAD-91-68 National Security and International Affairs Division B-241869 December 27,199O The Honorable John Glenn Chairman, Committee on Governmental Affairs United States Senate Dear Mr. Chairman: This report responds to your request that we review the medical component of the Department of Defense’s Biological Defense Research Program. It discusses, among other things, the need for the Department to implement better program controls to ensure that all medical research and development efforts are directed toward validated biological warfare threat agents. It contains recommendations to the Secretary of the Army aimed at improving the management of the program. Unless you publicly announce its contents earlier, we plan no further distribution of this report for 30 days. At that time, we will send copies to the Secretaries of Defense and the Army, the Director of the Office of Management and Budget, and other interested parties. This report was prepared under the direction of Richard Davis, Director, Army Issues, who may be reached on (202) 275-4141. Other major contributors are listed in appendix III. Sincerely yours, Frank C. Conahan Assistant Comptroller General Ekecutive Summq In 1972, over 100 countries signed the Biological and Toxin Weapons Purpose Convention, which prohibits the development, production, and stock- piling of biological and toxin weapons. Since 1972, however, the number of nations having or suspected of having offensive biological warfare programs has increased from 4 to 10, with some of these countries being located in the Middle East, according to the Army’s senior biological warfare analyst. 1T.S.military forces facing the threat of biological war- fare must have medical countermeasures to defend against a biological weapons attack. The Department of Defense, through its Biological Defense Research Program, is responsible for developing these counter- measures, and the Congress has appropriated about $370 million since fiscal year 1984 for this purpose. The Chairman of the Senate Committee on Governmental Affairs requested that GAO determine whether the program’s medical research and development projects were (1) directed at validated biological war- fare threat agents, (2) used to develop medical products for the defense of IJ.S. forces, and (3) coordinated with other federal research organiza- tions to avoid unnecessary duplication. The mission of the medical component of the research program is to Background develop medical defenses, such as vaccines and drugs, to defend against biological warfare. The Department of Defense defines a “biological warfare threat” as a biological agent that the intelligence community has assessed as being developed or produced as a weapon. The Armed Forces Medical Intelligence Center, in conjunction with other intelligence agencies, validates the biological agents that present a bonafide threat to U.S. forces. The Academy of Health Sciences, a component of the Army’s Health Services Command, determines the requirements for drugs and vaccines needed to counter these validated threats. The Army’s Medical Research and Development Command, at Fort Detrick, Maryland, executes the medical component of the research program through research and development projects. The Command reports to the Army Surgeon General. The Army, because it did not have adequate internal controls in its med- Results in Brief ical research program, unnecessarily expended funds on research and development efforts that did not address validated threats and may have duplicated research efforts of other federal agencies. GAO’S review showed that Page 2 GAO/NSIADSlBB Biological DefenseResearch . 49 research projects, valued at about $47 million, were directed at bio- logical agents that the Armed Forces Medical Intelligence Center had not assessed as warfare threat agents; . an additional 57 projects, valued at about $48 million, were questionable because neither GAO nor the Army could readily determine whether these projects addressed validated biological threat agents; l research projects were not independently reviewed by the Academy or the Intelligence Center to ensure that the research addressed validated threat agents; . 3 of the 10 medical products already developed for the defense of . U.S. forces and 2 of the 6 products under development do not address validated warfare threat agents; and l the Army and at least two other federal agencies were conducting med- ical research on many of the same agents. Principal Findings Millions Allocated for The Army’s medical research program included research on biological Researchon Agents N‘ot agents that had not been assessed by the Armed Forces Medical Intelli- gence Center as warfare threats. In April 1990, GAO reviewed Validated as Threats 218 ongoing or recently completed medical research projects, valued at about $239 million. GAO determined, with the assistance of the Academy and the Intelligence Center, that 49 projects were not directed at vali- dated threat agents. Neither GAO nor the Army could readily determine whether an additional 57 projects addressed validated threat agents because the Army project summaries did not contain sufficient informa- tion The combined cost of the 106 projects was about $95.3 million of the $239 million, or about 40 percent. The U.S. Army Medical Research and Development Command officials acknowledged that some research projects did not address validated threat agents. These officials believed that the Intelligence Center’s interpretation of threat agents was too narrow because it did not include agents that were (1) highly infectious by aerosol or other means, (2) stable in the environment, and (3) of low to moderate communica- bility. Using this broad criteria, the Medical Command could conduct research on virtually all biological agents. All proposed research projects are reviewed by Medical Command per- sonnel for methodology, scientific merit, and military need. However, page3 GAO/NSIADo1sBBLologicalDefense Besemh Executive summluy neither the Command nor independent organizations such as the Academy or the Intelligence Center assessedprojects to ensure that they were directed at validated biological warfare threat agents. Some Medical Products Do Since 1965, nearly one third of the medical products that the Army has Not Address Validated developed or is developing address agents not validated as warfare threats. Three of 10 products already developed and 2 of 6 products Threat Agents under development fall into this category. Of the $45 million the Army spent on all 16 products by the end of fiscal year 1990, $19 million, or 43 percent, was spent on the 5 products not addressing validated threat agents. In addition, the Army plans to continue to spend funds for the 2 products under development that do not address validated threats. Some Medical Command The Medical Command may unnecessarily duplicate medical research, ResearchMay Duplicate either in whole or in part, that is being performed by federal civilian agencies. Army regulations require a search of the Department of Researchof Other Defense’s technical data base before a research project is initiated to Agencies prevent unnecessary duplication of effort but do not require Command personnel to search other federal research data bases. Command per- sonnel responsible for conducting these searches told GAO that they did not access other federal data bases. GAO'S search of the Federal Research in Progress data bases disclosed that both the Army and the National Institutes of Health or the Centers for Disease Control were conducting medical research on about 23 of the same agents. For example, both the Army and the National Institutes of Health were conducting research to develop an improved anthrax vac- cine. In addition, the Army, the National Institutes of Health, and the Centers for Disease Control were researching dengue fever. While GAO recognizes that duplication of research is not always inappropriate, the Army, to get the most from its research, needs to coordinate its research projects with those of other federal agencies. GAO recommends that the Secretary of the Army direct the Medical Recommendations Research and Development Command to . review all ongoing medical research projects to determine whether they address validated warfare threat agents, and discontinue all projects that do not: page4 Executive Summary l arrange for independent reviews of all proposed research projects by officials from the Armed Forces Medical Intelligence Center and the Academy of Health Sciences to ensure that all future projects address validated warfare agents, and report the results of each review to the Army Surgeon General; and l discontinue development of all products that do not address a validated threat. To avoid unnecessary duplication of effort and improve coordination, GAO also recommends that the Army amend its regulations to require the systematic coordination of its medical biological research projects with those of other federal research agencies. As requested, GAO did not obtain official agency comments on this Agency Comments report. However, it discussed information obtained during the review with agency officials and included their views where appropriate. Page 6 GAO/NSIAlb9189 Biologlcnl Lkfeme Reeeareh Contents Executive Summary 2 Chapter 1 8 Introduction Program Funding History Management Structure of the BDRP Medical Component 8 9 Objectives, Scope, and Methodology 9 Chapter 2 12 Army Management of Funds Allocated for Research of Agents Not Validated as Warfare Threats 12 the Medical BDRP Can Medical Command Does Not Search Other Federal 13 Be Improved Research Data Bases to Prevent Duplication Conclusions 14 Recommendations 15 Chapter 3 16 Some of the Army’s Medical Products Developed Since 1965 16 Medical Products Under Development 17 Medical Products Do Conclusions 17 Not Address Validated Recommendation 17 Threat Agents Appendixes Appendix I: Medical Research and Development Program 18 Categories Appendix II: Research Conducted by the Army and Other 19 Agencies Involving the Same Biological Agents Appendix III: Major Contributors to This Report 20 Tables Table 1.1: Program Funding for the BDRP Medical 8 Component Table 2.1: BDRP Funding by Threat and Non-Validated 12 Threat Projects Table 3.1: BDRP Products Developed Since 1965 16 Table 3.2: BDRP Products Under Development 17 Page 6 GAO/NSIAD-91438Biological DefenseResearch contents Abbreviations BDRP Biological Defense Research Program DOD Department of Defense GAO General Accounting Office page 7 GAO/NSLALS9188Biological DefenseResearch Chapter 1 Introduction The Biological Defense Research Program (BDRP) is aimed at ensuring the sustained effectiveness of U.S. military forces in biological warfare by providing medical countermeasures that deter, constrain, or defeat biological warfare threats. The Department of Defense (DOD) defines a “biological warfare threat” as a biological agent that is assessed by the intelligence community as being developed or produced as a weapon. Medical defenses against these threats include preventive vaccines, drugs, therapeutic measures, and patient treatment and management procedures. The Department of the Army, serving as DOD’s executive agent, executes the medical component of the BDRP through research and development projects. In response to DOD’S information about the growing number of countries Program Funding having or suspected of having offensive biological warfare capability, History the Congress steadily increased funding for medical biological defense research from $29.2 million in fiscal year 1984 to a high of $69.9 million in fiscal year 1989. The fiscal year 1990 appropriation declined slightly to $66.4 million. This appropriation included $55.4 million for tech- nology base funding categories-basic, exploratory, and advanced (non- systems) research projects-and $11 million for product development and testing.’ (Appendix I describes the research program categories.) Total program funding allocated to medical research for fiscal years 1984 through 1990 was $369.7 million, as shown in table 1.1. Medical Component Dollars in millions Fiscal year Funding appropriated 1984 529206 1985 36.463 1986 52031 1987 56976 1988 - 58798 1989 69857 1990 66398 Total $369.729 The Army’s fiscal year 1991 budget request totaled $66.3 million. ‘Advancednonsystemsdevelopmentincludespreparationfor full-scaleproductionand advanced testingof a medicalproduct Page 8 GAO/NSIAD9188 Biological DefenseResearch Chapter1 Introduction The U.S. Army Medical Research and Development Command, at Fort ManagementStructure Detrick in Frederick, Maryland, manages the medical component of the of the BDRP Medical BDRP, directing the research and development of drugs and vaccines Component needed to defend against biological warfare agents. The Commander of the Medical Command reports to the Army Surgeon General. Within the Command, the U.S. Army Medical Research Institute of Infectious Dis- eases, also at Fort Detrick, serves as the lead medical laboratory for the BDRP. Other organizations play a vital role in the BDRP. The Academy of Health Sciences, a subordinate command of the US. Army Health Services Com- mand, has responsibility for preparing requirements documents for medical research against biological warfare threat agents for the U.S. Army Training and Doctrine Command. Under a memorandum of understanding with the Training and Doctrine Command, the Academy establishes the requirements for medical products (drugs and vaccines) that are needed to counter biological warfare threats. The Armed Forces Medical Intelligence Center, a tri-service organization at Fort Detrick, is responsible, in conjunction with other intelligence agencies, for analyzing and validating information on biological agents that present a warfare threat to U.S. forces. This intelligence informa- tion is intended for use by the Academy of Health Sciences in setting requirements needed to counter the threats. The Chairman of the Senate Committee on Governmental Affairs asked Objectives, Scope,and us to evaluate WD'S Biological Defense Research Program. As arranged Methodology with the Committee, our work included only the medical component of the program because the Army has allocated the majority of BDRP funds to this component since 1984. Our objectives were to determine whether the program’s medical research and development projects were (1) directed at validated biological warfare threat agents, (2) coordi- nated with other federal research organizations to avoid unnecessary duplication, and (3) used to develop medical vaccines, drugs, and other products for the defense of U.S. forces. We reviewed 2 18 ongoing or recently completed BDRP projects, as of April 1990, to determine whether the Army’s policies and procedures, including internal controls, were adequate to ensure that research and development was directed at only biological warfare threats. Because of the technical nature of the projects, the Academy of Health Sciences, with the help of the Armed Forces Medical Intelligence Center, assisted page9 GAO/NSIADSlSBBiologicalDefenseRese~h Chapter 1 Introduction us in determining which projects involved research on agents identified by the Intelligence Center as warfare threats. We did not, nor did the Academy, attempt to assess the scientific merit or value of the research. To evaluate the adequacy of the Army’s coordination with civilian agen- cies, we obtained information on the program’s use of data bases for federal civilian research on the same biological agents. Through a lim- ited literature search, we determined whether other federal agencies, such as the National Institutes of Health and the Centers for Disease Control, were conducting research on the same biological agents being researched by the Army. In addition, we obtained and analyzed docu- mentation and interviewed officials from the Centers for Disease Con- trol in Atlanta, Georgia, and from the National Cancer Institute, the National Institute of Allergy and Infectious Diseases, and the National Institute of Neurological Disorders and Stroke, all in Bethesda, Mary- land, to determine whether these agencies had an interest in the same biological agents as did the BDRP. Further, we examined the Army’s use of independent reviews for research proposals, discussed the use of independent reviews with pro- gram officials, and reviewed applicable Army regulations. To determine the number of medical products produced for the defense of U.S. forces against biological warfare, we obtained and reviewed Army documentation from 1965 to the present. We discussed this infor- mation with officials from the Army and the Department of Health and Human Services’ Food and Drug Administration, in Rockville, Maryland, which approves the Army’s use of new drugs and vaccines. Given the expense and sometimes long-term nature of medical research, we did not attempt to assess the adequacy of the number of medical products developed by the Army relative to the resources invested. To accomplish our objectives, we interviewed officials from the Depart- ment of the Army and the Army’s Training and Doctrine Command, Fort Monroe, Norfolk, Virginia, and the Army’s Academy of Health Sciences, Fort Sam Houston, San Antonio, Texas. We also obtained and analyzed documentation and interviewed officials from the following military activities at Fort Detrick, in Frederick, Maryland: . U.S. Army Medical Research and Development Command, l U.S. Army Medical Research Institute of Infectious Diseases, l U.S. Army Medical Material Development Activity, and . DOD’s Armed Forces Medical Intelligence Center. Page 10 GAO/NSlAD9188 Biological DefenseResearch Chapter 1 lnboduetlon We reviewed Financial Integrity Act reports submitted by the Army to the Secretary of Defense for fiscal years 1987 through 1989 to deter- mine whether any management control weaknesses were identified con- cerning the Army’s implementation of the program. We conducted our review from September 1989 to October 1990 in accordance with generally accepted government auditing standards. Because of the technical nature of the program, our Chief Medical Adviser assisted us in this review. As requested, we did not obtain offi- cial agency comments, but we discussed the information in this report with agency officials. Their views are included in the report where appropriate. Page 11 GAO/NSlAD9ls8 Biological DefenseResearch Chapter 2 Army Managementof the Medical BDRP Can Be Improved The Army, because it did not have adequate internal controls in the BDRP’S medical component, allocated at least $47 million to research and development that did not address validated biological warfare threat agents. Further, the Army’s review of proposed research did not include an assessment of whether the research was directed at validated war- fare threats. Moreover, some of the Army’s research may duplicate research of federal civilian agencies because Medical Command per- sonnel were not required to conduct searches of those agencies’data bases. The Army was conducting research on biological agents that were not Funds Allocated for assessed by the Intelligence Center as warfare threats. In April 1990, Researchof Agents the Army had 2 18 ongoing or recently completed BDRP research projects Not Validated as valued at about $239 million. We determined that 49 projects, valued at $47.4 million, or about 20 percent of the total funds, were not directed Warfare Threats at validated biological threats. For another 57 projects, valued at about $48 million (another 20 percent of the total funds), we could not deter- mine whether the projects were directed at validated biological threats because the Army project summaries did not contain sufficient informa- tion Table 2.1 shows the results of this analysis. Table 2.1: BDRP Funding by Threat and Non-Validated Threat Projects Perc;;m~ Percentage Number of of total Type of projects projects ___-.____-__. projects Dollar value dollars Non-threat ~- 49 22.5 $47,390.468 198 ___.. __ Unknown 57 26 1 47,966.716 ___-_ 20 1 Threat-related 112 51 4 143,633.474 60 1 __.___--~ Total 218 100.0 $236,990,666 100.0 The U.S. Army Medical Research and Development Command acknowl- edged that it was conducting research on biological agents that have not been validated by the Intelligence Center as warfare threats. Medical Command officials told us that they believed that the Intelligence Center’s interpretation of threat agents was too narrow because the Intelligence Center identifies only those biological threat agents that are being developed or produced as weapons. In addition to the biological agents assessed by the Intelligence Center as potential warfare agents, the Medical Command believed that other agents must be researched if they were (1) highly infectious by aerosol or other means, (2) stable in the environment, and (3) of low to moderate communicability. Using this Page 12 GAO/‘NSIALb9149Biologicd Defense Research Chapter 2 Army Man@ement of the Mdcal BDRPCan Be Improved broad criteria, the Medical Command could conduct research on virtu- ally all biological agents. The Medical Command’s interpretation of what constitutes a threat agent contradicts DOD’s definition-that is, an agent assessedby the intelligence community as being developed or produced as a weapon.’ Technical Review Did Not The Medical Command’s in-house review of proposed projects did not require that research be directed at validated warfare threats. All Ensure That Proposed projects are subject to an in-house technical review by Medical Com- ResearchAddressed - mand personnel for methodology, scientific merit, and military need. Validated Threat Agents However, neither the Command nor independent organizations such as the Academy or the Intelligence Center assessedprojects to ensure that they were directed at validated threat agents. Army regulations require a search of the Defense Technical Information Medical Command Center’s data bank prior to initiating a research project in order to pre- Does Not Search Other vent unnecessary duplication of effort. However, there is no similar Federal ResearchData requirement for the Medical Command to search other federal research data bases, and we found that it did not perform such searches. Accord- Basesto Prevent ingly, the Medical Command was unaware of research being done that Duplication could benefit the BDRP. Army regulation 70-9, “Research Information Systems and Reports,” dated May 1981, requires a thorough search of the Defense Technical Information Center data base before new research is started to prevent unnecessary duplication among DOD components. We found that these searches were generally conducted. The personnel responsible for con- ducting the search of the Defense Technical Information Center’s data base told us that they do not access other data bases. Medical Command officials told us that BDRP scientists are experts in the field, who keep abreast of the latest scientific developments by attending seminars and reading professional publications pertaining to their areas of expertise. Our literature search of the Federal Research in Progress data bases dis- closed that both the Army and the National Institutes of Health or the Centers for Disease Control were conducting research or had an interest ‘The Assistantto the Secretaryof Defensefor Atomic EnergyprovidedDOD’sdefinition tu the Senate Committeeon GovernmentalAffairs ma written responseto questmnsraisedduring a Ilay 17. 1989. congressionalhearing. Page 13 GAO/NSlAD-9183Biological DefenseResearch chapter2 Army Management of the Medical BDRPCan Be lmptwed in the detection, treatment, or prevention of about 23 of the same dis- eases.2For instance, both the Army and the National Institutes of Health were conducting research to develop an improved anthrax vaccine. Also, the Army, the National Institutes of Health, and the Centers for Disease Control were researching dengue fever. Appendix II contains a list of the agents we identified for which both the Army and the National Insti- tutes of Health or the Centers for Disease Control had one or more research projects underway involving the same biological agents. While the research methods and goals may differ, the list shows that civilian health agencies are concerned about many of the same biological agents as the Army. Further, our literature search disclosed that other federal agencies, such as the U.S. Department of Agriculture and the National Science Founda- tion, also had ongoing research on some of the same agents as the Army. For instance, both the Army and the Department of Agriculture were conducting research on botulism and Venezuelan equine encephalitis. We recognize that duplication of research is not always inappropriate. How- ever, the Army, because it does not coordinate its research with federal civilian agencies, cannot ensure that its research is not unnecessarily duplicating other agencies’research on the same agents. The Army’s medical BDRP program unnecessarily expended millions of Conclusions dollars on research projects that did not address validated biological warfare threat agents. The Medical Command was aware of the Armed Forces Medical Intelligence Center’s validated list of warfare threat agents, but believed that this information was interpreted too narrowly. Therefore, the Medical Command researched biological agents that it assessed as threats, in addition to those validated by the Intelligence Center. Further, the Command did not determine whether proposed research projects addressed validated threat agents. Moreover, the Com- mand did not systematically query the data bases of federal civilian agencies involved in similar research to avoid duplication. The Army and at least two other agencies were conducting medical research on as many as 23 agents. We recommend that the Secretary of the Army direct the Medical Recommendations Research and Development Command to (1) review all ongoing medical ‘Federal Researchin Progressdata basesprovide accessto information aboutongoingfederally fundedresearchprojectsin the fields of physcal sciences,engineering,and life sciences. Page 14 GAO/NSlAD-9189Biologkai Defense Research Chapter 2 Army Managementof the Medical BDRPCan Be Improved research projects to determine whether they address validated warfare threat agents, and discontinue all projects that do not; and (2) arrange for independent reviews of all proposed research projects by officials from the Armed Forces Medical Intelligence Center and the Academy of Health Sciences to ensure that all future projects address validated war- fare agents, and report the results of each review to the Army Surgeon General. We also recommend that the Army amend its regulations to require the systematic coordination of its medical biological research projects with those of other federal research data bases. Page 16 GAO/NSIAD9189 Biolo@cd DefenseResearch Chapter 3 Someof the Army’s Medical Products Do Not Address Validated Threat Agents The Army has developed and is developing several biological vaccines and drugs for U.S. military forces who might encounter biological war- fare. However, nearly one third of these products did not address vali- dated biological warfare threat agents. Since 1965, the Army invested about $45 million in development and initial production costs for about 16 medical products. Of the $45 million, over $19 million, or 43 percent, was spent for 5 medical products that did not address validated threats. Moreover, the Army continues to develop medical products that do not address validated threats. Over the past 25 years, the Army completed the development of 10 med- Medical Products * ical products, costing about $24.6 million. However, 3 of the 10 products Developed Since 1965 did not address validated biological warfare threats. Of the $24.6 mil- lion, about $17.1 million, or 70 percent, was spent to develop the 3 prod- ucts that did not address validated threats. Table 3.1 shows the 10 products developed since 1965. Table 3.1: BDRP Products Developed Since 1965 Dollars in mtlllons Development and initial Directed at Fiscal production validated Product year costs threat Vaccine, Venezuelan equine encephalltrs 1965 - $0.234 Yes Vaccine, tularemla - ~~- 1966 0.242 Yes Vaccine, eastern equke encephalltls 1968 0.437 Yes Vaccine, raft valley fevera 1969 12.351 No Vaccme, Venezuelan equine encephalltrs 1975 1 138 Yes Drug. rlbavrrin 1979 2.702 Yes Vaccme western equrne encephak 1984 0.243 Yes Vaccine, Argentine hemorraqhlc fever” 1986 4 086 No Vaccme, chrkungunya 1986 0 722 No Vaccine, Q fever 1989 2 479 Yes Total 524.634 aThe Army used BDRP funds to develop this product, even though thusdisease is not a bologlcal threat agent but a naturally-occurrlng. or “lnfectlous,” disease that affects large numbers of people in various parts of the world Page 16 GAO/NSlAB9148 Biological DefenseResearch The Army’s six additional medical products under development are for Medical Products- either the identification of, protection against, or treatment for various Under Development biological agents.’ These include four products for use against validated warfare agents and two products for agents that are not validated by the intelligence community as threats. The two products not directed at validated threats accounted for $2.1 million of the total developmental costs, or about 10 percent. The products under development are shown in table 3.2. Table 3.2: BDRP Products Under Development Dollars In mtlllons Directed at Development validated Product cost0 threat Toxoid, botulinal polyvalent $3 006 Yes Immune olobulln lassa fever 1915 NO Vaccine, anthrax recombinant DNA 0015 Yes Vaccine, vacclnta vectored Venezuelan equine Yes encephalltls 0 737 Vaccme, vacclnla vectored Korean hemo&ghx fever 0 190 No System, rapld identlftcatlon 14492 Yes Total $20.355 aThese costs are as of !he end of fiscal year 1990 The Army has developed several medical countermeasures against bio- Conclusions logical warfare since 1965. However, of the $45 million invested in the development of 16 products, about 43 percent of this amount has been spent on products that do not address valid biological threat agents. So far, the Army has spent about $2 million on products still being devel- oped that do not address valid threats. We recommend that the Secretary of the Army direct the Medical Recommendation Research and Development Command to discontinue development of the two products that do not address validated threats. lProductsselectedfor development.but not funded,wereexcludedfrom this analysis Page I7 GAO/NSlAD914XJBiological Defense Research Appendix I Medical Researchand Development Program Categories I Basic research (funding category 6.1): Technology Base Research . identification and isolation of infecting agents and . characterization of agents. Exploratory development (funding category 6.2): definition of animal models, preparation of vaccine and drug candidates, improvement of disease diagnosis and agent identification, and epidemiological studies. Advanced nonsystems development (funding category 6.3A): . scale-up production and . advanced testing. Advanced systems development (funding category 6.3B): Product Development 9 safety and efficacy testing. Engineering development (funding category 6.4): . large-scale field trials and . initial purchase of product. Page 18 GAO/NSL4D9148 Biological Defense Research Agencies involved National Centers for ;$uhtes 0f Disease Biological agent Control Anthrax X Venezuelan ec~uine enceohalltls X Lassa fever Ebola virus Hemorraghlc fever with renal syndrome Congo Crimean hemorraghlc fever Dengue fever X Yellow fever X Alphawruses X Eastern equine encephalllls x Arbovnuses X X 0 fever X Tetanus x Plaaue x Tetrodotoxln x Saxltoxin X RlClll -x BrevetoxIns x Enterotoxlns -X Hantaan wus X ArenavIruses X vacclnia wus X Botulism X Page 19 GAO, NSIAD9188 Biological DefenseResearch Appendix III Major Contributors to This Report Henry L. Hinton, Associate Director National Security and *John R. Henderson, Assistant Director International Affairs Derek B. Stewart, Assignment Manager Division, Washington, D.C. Murray Grant, M.D., Chief Medical Adviser Human Resources Division, Washington, D.C. Frederick P. German, Regional Management Representative Philadelphia Regional Leo J. Shilling, Jr.. Evaluator-In-Charge Office Alonzo M. Echols, Evaluator Frank W. Imbrogno, Evaluator Page 20 GAO/NSIAD914!3 Biological Defense Research Requests for copies of GAO reports should be sent to: U.S. General Accounting Office Post Office Box 6015 Gaithersburg, Maryland 20877 Telephone 202-275-6241 The first five copies of each report are free. Additiona copies are $2.00 each. There is a 25% discount on orders for 100 or more copies mailed to a single address. Orders must be prepaid by cash or by check or money order made out to the Superintendent of Documents. United States Firs t-Class Mail General Accounting Office Postage & Fees Paid Washington, D.C. 20548 GAO Permit No. GlOO I Official Business Pe@ty for:. Private Use $300 .. .:. ’ :’ ,* ‘? 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Biological Warfare: Better Controls in DOD's Research Could Prevent Unneeded Expenditures
Published by the Government Accountability Office on 1990-12-27.
Below is a raw (and likely hideous) rendition of the original report. (PDF)