oversight

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)

                                                                     ,’       --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
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