```

[House Report 106-556]
[From the U.S. Government Publishing Office]

                                                 Union Calendar No. 304

106th Congress, 2d Session -  -  -  -  -  -  -  -  House Report 106-556

 
   THE DEPARTMENT OF DEFENSE ANTHRAX VACCINE IMMUNIZATION PROGRAM: 
                       UNPROVEN FORCE PROTECTION

                               __________

                             FOURTH REPORT

                                 by the

                     COMMITTEE ON GOVERNMENT REFORM

                             together with

                   DISSENTING AND SUPPLEMENTAL VIEWS

                                     

                                     

     Available via the World Wide Web: http://www.house.gov/reform
            http://www.access.gpo.gov/congress/cong005.html

 April 3, 2000.--Committed to the Committee of the Whole House on the 
              State of the Union and ordered to be printed

                               __________

                    U.S. GOVERNMENT PRINTING OFFICE
79-006                     WASHINGTON : 2000

                     COMMITTEE ON GOVERNMENT REFORM

                     DAN BURTON, Indiana, Chairman
BENJAMIN A. GILMAN, New York         HENRY A. WAXMAN, California
CONSTANCE A. MORELLA, Maryland       TOM LANTOS, California
CHRISTOPHER SHAYS, Connecticut       ROBERT E. WISE, Jr., West Virginia
ILEANA ROS-LEHTINEN, Florida         MAJOR R. OWENS, New York
JOHN M. McHUGH, New York             EDOLPHUS TOWNS, New York
STEPHEN HORN, California             PAUL E. KANJORSKI, Pennsylvania
JOHN L. MICA, Florida                PATSY T. MINK, Hawaii
THOMAS M. DAVIS, Virginia            CAROLYN B. MALONEY, New York
DAVID M. McINTOSH, Indiana           ELEANOR HOLMES NORTON, Washington, 
MARK E. SOUDER, Indiana                  DC
JOE SCARBOROUGH, Florida             CHAKA FATTAH, Pennsylvania
STEVEN C. LaTOURETTE, Ohio           ELIJAH E. CUMMINGS, Maryland
MARSHALL ``MARK'' SANFORD, South     DENNIS J. KUCINICH, Ohio
    Carolina                         ROD R. BLAGOJEVICH, Illinois
BOB BARR, Georgia                    DANNY K. DAVIS, Illinois
DAN MILLER, Florida                  JOHN F. TIERNEY, Massachusetts
ASA HUTCHINSON, Arkansas             JIM TURNER, Texas
LEE TERRY, Nebraska                  THOMAS H. ALLEN, Maine
JUDY BIGGERT, Illinois               HAROLD E. FORD, Jr., Tennessee
GREG WALDEN, Oregon                  JANICE D. SCHAKOWSKY, Illinois
DOUG OSE, California                             ------
PAUL RYAN, Wisconsin                 BERNARD SANDERS, Vermont 
HELEN CHENOWETH-HAGE, Idaho              (Independent)
DAVID VITTER, Louisiana

                      Kevin Binger, Staff Director
                 Daniel R. Moll, Deputy Staff Director
           David A. Kass, Deputy Counsel and Parliamentarian
                    Lisa Smith Arafune, Chief Clerk
                 Phil Schiliro, Minority Staff Director

Subcommittee on National Security, Veterans Affairs, and International 
                               Relations

                CHRISTOPHER SHAYS, Connecticut, Chairman
MARK E. SOUDER, Indiana              ROD R. BLAGOJEVICH, Illinois
ILEANA ROS-LEHTINEN, Florida         TOM LANTOS, California
JOHN M. McHUGH, New York             ROBERT E. WISE, Jr., West Virginia
JOHN L. MICA, Florida                JOHN F. TIERNEY, Massachusetts
DAVID M. McINTOSH, Indiana           THOMAS H. ALLEN, Maine
MARSHALL ``MARK'' SANFORD, South     EDOLPHUS TOWNS, New York
    Carolina                         BERNARD SANDERS, Vermont 
LEE TERRY, Nebraska                      (Independent)
JUDY BIGGERT, Illinois               JANICE D. SCHAKOWSKY, Illinois
HELEN CHENOWETH-HAGE, Idaho

                               Ex Officio

DAN BURTON, Indiana                  HENRY A. WAXMAN, California
            Lawrence J. Halloran, Staff Director and Counsel
                           Jason Chung, Clerk
           David Rapallo, Minority Professional Staff Member
                         LETTER OF TRANSMITTAL

                              ----------                              

                                  House of Representatives,
                                     Washington, DC, April 3, 2000.
Hon. J. Dennis Hastert,
Speaker of the House of Representatives,
Washington, DC.
    Dear Mr. Speaker: By direction of the Committee on 
Government Reform, I submit herewith the committee's fourth 
report to the 106th Congress. The committee's report is based 
on a study conducted by its Subcommittee on National Security, 
Veterans Affairs, and International Relations.
                                                Dan Burton,
                                                          Chairman.

                                 (iii)

                                     
                            C O N T E N T S

                              ----------                              
                                                                   Page
  I. Summary..........................................................1
        Findings in brief........................................     4
        Recommendations in brief.................................     4
 II. Background.......................................................4
III. Discussion......................................................17
        Findings.................................................    17
        Recommendations..........................................    45

                                 Views

Dissenting views of Hon. Henry A. Waxman, Hon. Rod R. 
  Blagojevich, Hon. Tom Lantos, Hon. Major R. Owens, Hon. Eleanor 
  Holmes Norton, Hon. Elijah E. Cummings, Hon. Danny K. Davis, 
  Hon. John F. Tierney, Hon. Harold E. Ford, Jr., and Hon. Janice 
  D. Schakowsky..................................................    59
Supplemental views of Hon. Bernard Sanders.......................    66

                                  (v)

  
                                                 Union Calendar No. 304
106th Congress                                                   Report
                        HOUSE OF REPRESENTATIVES
 2d Session                                                     106-556

======================================================================

    THE DEPARTMENT OF DEFENSE ANTHRAX VACCINE IMMUNIZATION PROGRAM: 
                       UNPROVEN FORCE PROTECTION

                                _______
                                

 April 3, 2000.--Committed to the Committee of the Whole House on the 
              State of the Union and ordered to be printed

                                _______
                                

   Mr. Burton, from the Committee on Government Reform submitted the 
                               following

                             FOURTH REPORT

    On March 9, 2000, the Committee on Government Reform 
approved and adopted a report entitled, ``The Department of 
Defense Anthrax Vaccine Immunization Program: Unproven Force 
Protection.'' The chairman was directed to transmit a copy to 
the Speaker of the House.

                               I. Summary

    Responding to service members' complaints of program 
insensitivity to adverse health effects, inadequate medical 
recordkeeping, and heavy-handed program operation, the 
Subcommittee on National Security, Veterans Affairs, and 
International Relations initiated an oversight investigation 
into the design and implementation of the Department of Defense 
[DOD] force-wide, mandatory Anthrax Vaccine Immunization 
Program [AVIP]. Because the anthrax vaccine is still being 
studied as a potential causative or contributing factor in Gulf 
war veterans' illnesses,\1\ the subcommittee measured the 
program against this standard: Any expanded use of the same 
vaccine should be undertaken only with the greatest care and 
only to the extent necessary.
---------------------------------------------------------------------------
    \1\ Public Law 105-277, title XVI, sec. 1603(d).
---------------------------------------------------------------------------
    As currently designed and implemented, the anthrax vaccine 
program fails on both counts. The AVIP lacks a consistent 
standard of care and is designed to reach far beyond those at 
risk.
    Based on the testimonial and documentary record,\2\ the 
subcommittee finds the AVIP a well-intentioned but overwrought 
response to the threat of anthrax as a biological weapon. 
Against the so-called ``asymmetric'' threats to U.S. 
conventional military superiority posed by a growing range of 
chemical and biological weapons, the anthrax vaccine program 
represents a medical maginot line, a fixed fortification 
protecting against attack from only one direction.
---------------------------------------------------------------------------
    \2\ In response to the subcommittee's investigative requests, DOD 
provided more than 100,000 pages of documentary and electronic records 
on the anthrax vaccine program from 1991 to the present. Five 
subcommittee hearings were held in 1999, encompassing 20 hours of 
testimony from 46 witnesses. The full Committee on Government Reform 
also heard testimony on the subject of vaccines for military defense on 
Oct. 12, 1999.
---------------------------------------------------------------------------

                          Unrealistic Program

    As a mandatory, force-wide countermeasure to the real 
threat of weaponized anthrax on the battlefield, the vaccine 
effort is unrealistic. It expands and distorts the use of 
invasive, dated medical technology to address perceived 
weaknesses in detection technology and external physical 
protection against biological attack. Born of a post-Gulf war 
panic over apparent weaknesses in chemical and biological [CB] 
warfare defenses, the AVIP is an unmanageably broad military 
undertaking built on a dangerously narrow scientific and 
medical foundation.
    At best, the vaccine provides some measure of protection to 
most who receive it. Just how much protection is acquired, by 
whom, for how long, and against what level of challenge are 
questions DOD answers with an excess of faith but a paucity of 
science.
    Many members of the armed forces do not share that faith. 
They do not believe merely suggestive evidence of vaccine 
efficacy outweighs their concerns over the lack of evidence of 
long term vaccine safety. Nor do they trust DOD has learned the 
lessons of past military medical mistakes: atomic testing, 
Agent Orange, Persian Gulf war drugs, and vaccines. Heavy 
handed, one-sided informational materials only fuel suspicions 
the program understates adverse reaction risks in order to 
magnify the relative, admittedly marginal, benefits of the 
vaccine.
    As a military operation, the AVIP rests on weak conceptual 
and logistical footing. It suffers from poor planning, 
inflexible execution, and over-extended supply lines. As a 
health care effort, the AVIP compromises the practice of 
medicine to achieve military objectives.
    The decision to use the 1950's era vaccine, which requires 
an elaborate inoculation regime of six shots over 18 months, 
presents daunting, perhaps insurmountable, logistical 
challenges to reach a force of 2.4 million active duty and 
reserve component members. Research to support a shorter, more 
manageable inoculation regimen was not completed before the 
AVIP was launched. Development of a purer, potentially less 
reactogenic anthrax vaccine using recombinant technologies was 
not pursued aggressively.

                            Unstable Supply

    The sole-source procurement strategy leaves the program 
vulnerable to supply shortages and price increases. Because 
Food and Drug Administration [FDA] regulations require a 
dedicated production facility for spore-based biologics, other 
pharmaceutical firms will not commit the time and capital 
needed to manufacture an old vaccine for a very limited market. 
As a result, DOD and the sole vaccine maker are locked in a 
mutually dependent relationship.
    The manufacturer, struggling to reopen a plant with a 
checkered regulatory history, clings to a captive customer. 
Threats to stop production render DOD unable to resist demands 
for extraordinary financial relief and pressure to permit the 
use of publicly funded improvements to monopolize the private 
domestic and foreign markets as well.

                            Uncertain Safety

    Incurious reliance on FDA approval of the vaccine as 
``safe'' for occupational exposure blinds the program to 
potential adverse reaction trends in a vastly expanded, 
demographically diverse population of vaccine recipients. 
Adverse events following vaccination are reported by women at 
twice the rate among men. The vaccine may be as safe as many 
other approved products, but valid data to support, or refute, 
that proposition will not come from the AVIP. Preposterously 
low adverse report rates generated by DOD point to a program 
far more concerned with public relations than effective force 
protection or the practice of medicine.
    The AVIP raises an ominous question: Who protects the force 
from ill-conceived force protection? The anthrax vaccine effort 
is designated a ``commander's program,'' not a medical program, 
so DOD doctors appear unable to act as advocates for individual 
patients in the face of command pressure to meet force-wide 
inoculation levels. FDA regulations reach only the vaccine 
producer, the BioPort Corp., not the activities of the vaccine 
purveyor, the Pentagon, although for purposes of the AVIP the 
distinction is meaningless.

                           Untested Efficacy

    Administration of the anthrax vaccine for mass prophylaxis 
against biological warfare should be considered an off-label 
use of the product to treat an indication for which it is not 
explicitly licensed. DOD's operational use of a standard of 
``functional protection'' after three inoculations constitutes 
a de facto alteration of the approved six shot regimen. Both 
the new indication and the new schedule should be undertaken 
only pursuant to FDA regulations governing clinical trials of 
investigational new drugs [IND].
    Under supervision of the FDA and an Institutional Review 
Board [IRB], DOD would be required to inform vaccine recipients 
adequately, obtain informed consent, and gather data on vaccine 
safety consistently. If necessary, DOD could request the 
President waive the informed consent requirement for certain 
deployed personnel under the statute, regulation, and Executive 
order that provide far greater protections to service members 
than the process used for similar waivers during the Gulf 
war.\3\
---------------------------------------------------------------------------
    \3\ 10 U.S.C. 1107(f); 21 CFR Part 50; Executive Order No. 13139 of 
Sept. 30, 1999.
---------------------------------------------------------------------------

Findings in Brief

    1. The AVIP is a well-intentioned but over-broad response 
to the anthrax threat. It represents a doctrinal departure 
overemphasizing the role of medical intervention in force 
protection.
    2. The AVIP is vulnerable to supply shortages and price 
increases. The sole-source procurement of a vaccine that 
requires a dedicated production facility leaves DOD captive to 
old technology and a single, untested company. Research and 
development on a second-generation, recombinant vaccine would 
allow others to compete.
    3. The AVIP is logistically too complex to succeed. 
Adherence to the rigid schedule of six inoculations over 18 
months for 2.4 million members of a mobile force is unlikely, 
particularly in reserve components. Using an artificial 
standard that counts only shots more than 30 days overdue, DOD 
tolerates serious deviations from the Food and Drug 
Administration [FDA] approved schedule.
    4. Safety of the vaccine is not being monitored adequately. 
The program is predisposed to ignore or understate potential 
safety problems due to reliance on a passive adverse event 
surveillance system and DOD institutional resistance to 
associating health effects with the vaccine.
    5. Efficacy of the vaccine against biological warfare is 
uncertain. The vaccine was approved for protection against 
cutaneous (under the skin) infection in an occupational 
setting, not for use as mass protection against weaponized, 
aerosolized anthrax.

Recommendations in Brief

    1. The force-wide, mandatory AVIP should be suspended until 
DOD obtains approval for use of an improved vaccine. To 
accomplish this:
          2. DOD should accelerate research and testing on a 
        second-generation, recombinant anthrax vaccine; and,
          3. DOD should pursue testing of the safety and 
        efficacy of a shorter anthrax inoculation regimen; and,
          4. DOD should enroll all anthrax vaccine recipients 
        in a comprehensive clinical evaluation and treatment 
        program for long term study.
    5. While an improved vaccine is being developed, use of the 
current anthrax vaccine for force protection against biological 
warfare should be considered experimental and undertaken only 
pursuant to FDA regulations governing investigational testing 
for a new indication.

                             II. Background

                              The Program

    On December 15, 1997, after what DOD described as ``a 
detailed, deliberative process'' spanning almost 4 years,\4\ 
Secretary of Defense William S. Cohen announced a program to 
immunize all active duty personnel against anthrax, a bacterial 
disease that in spore form can be used as a biological weapon. 
The effort is called the Anthrax Vaccine Immunization Program 
[AVIP].\5\
---------------------------------------------------------------------------
    \4\ Anthrax Immunization Program, 106th Cong., 1st sess., p. 8 
(1999) (Subcommittee on National Security, Veterans Affairs, and 
International Relations hearing of Mar. 24, 1999, No. 106-17) 
[hereinafter ``NSVAIR anthrax hearing (I)''] (prepared statement of Dr. 
Sue Bailey).
    \5\ DOD media release, ``Defense Department to Start Immunizing 
Troops Against Anthrax,'' No. 679-97, Dec. 15, 1997.
---------------------------------------------------------------------------
    The program was designed to be implemented in three 
phases:\6\
---------------------------------------------------------------------------
    \6\ AVIP briefing slides (in subcommittee files).
---------------------------------------------------------------------------
          Phase I (3/98-1/00) forces assigned or rotating to 
        high threat areas 400,000
          Phase II (1/00-1/04) early deploying forces into high 
        threat areas 1,000,000
          Phase III (10/02-9/06) remainder of the total force, 
        boosters, et cetera 1,000,000
    The AVIP is a medical force protection effort undertaken by 
DOD pursuant to a 1993 policy calling for immunizations 
``against validated biological warfare threat agents, for which 
suitable vaccines are available, in sufficient time to develop 
immunity before deployment to high-threat areas . . .'' \7\
---------------------------------------------------------------------------
    \7\ DOD Directive 6205.3, ``DOD Immunization Program for Biological 
Warfare Defense.'' Nov. 26, 1993. Other elements of force protection 
include intelligence about threats, detection capability, physical 
protection (suits, masks, et cetera), post-exposure treatment with 
antisera and antibiotics, and strategic deterrence. In the Gulf war, up 
to 150,000 U.S. service personnel received one or two doses of the 
anthrax vaccine along with other immunizations and medications. Due to 
poor or non-existent recordkeeping, however, DOD is unable to conduct a 
systematic follow-up on the health effects, if any, of the Gulf war 
vaccines.
---------------------------------------------------------------------------
    According to the DOD news release announcing the vaccine 
program, ``After a three year study, Secretary of Defense 
William S. Cohen concluded that the vaccination is the safest 
way to protect highly mobile U.S. military forces against a 
potential threat that is 99 percent lethal to unprotected 
individuals.'' \8\ Cohen added, ``To be effective, medical 
force protection must be comprehensive, well documented, and 
consistent. I have instructed the military to put such a 
program in place.'' \9\
---------------------------------------------------------------------------
    \8\ See supra note 5, p. 1.
    \9\ Ibid.
---------------------------------------------------------------------------
    Accordingly, Secretary Cohen set four conditions on the 
start of vaccinations:
          1) supplemental testing to assure sterility, safety, 
        potency, and purity of the vaccine stockpile;
          2) implementation of a system for fully tracking 
        anthrax immunizations;
          3) approval of operational plans to administer the 
        vaccine and communications plans to inform military 
        personnel; and
          4) review of medical aspects of the program by an 
        independent expert.\10\
---------------------------------------------------------------------------
    \10\ Ibid.
---------------------------------------------------------------------------
    In 1998, supplemental testing of the anthrax vaccine 
stockpile began.\11\ An elaborate interim recordkeeping and 
tracking system was designed to combine vaccination data from 
the three military services into an existing central data base, 
the Defense Enrollment Eligibility Reporting System 
[DEERS].\12\ A more efficient, centralized immunization records 
system is under development.\13\ Communication plans were 
approved centered around a ``tri-fold'' brochure to be given to 
service personnel.\14\ An anthrax vaccine website was also 
created.\15\ A physician reviewed the AVIP program plans.\16\
---------------------------------------------------------------------------
    \11\ Letter from Anthony M. Lutrell, vice president, Quality 
Assurance, BioPort Corp., to Dr. Michael Gilbreath, Joint Program 
Office for Biological Defense, DOD, Jan. 8, 1999 (in subcommittee 
files).
    \12\ Major William Terry, ``Tracking Troops' Anthrax Shots,'' (with 
charts), ArmyLINK News, March 1999.
    \13\ Ibid.
    \14\ Department of Defense, AVIP tri-fold brochure, ``What Every 
Service Member Should Know About Anthrax'' (undated) (in subcommittee 
files).
    \15\ Department of Defense website on Anthrax Vaccination 
Immunization Program, http://www.anthrax.osd.mil.
    \16\ Letter from Dr. Gerard N. Burrow, Special Advisor to the 
President for Health Affairs, David Page Smith Professor of Medicine, 
Professor of Obstetrics and Gynecology, Yale University School of 
Medicine, to DOD Undersecretary Rudy de Leon, Feb. 19, 1998 (in 
subcommittee files).
---------------------------------------------------------------------------
    In March 1998, at the request of the regional commander, 
48,000 troops assigned to the Persian Gulf area began the 
vaccination series. On May 18, 1998, Secretary Cohen pronounced 
the four conditions fulfilled and approved the total force 
program, which began in September with troops in Korea.\17\
---------------------------------------------------------------------------
    \17\ Steve Bowman, Department of Defense Anthrax Vaccination 
Program (98-873F), Congressional Research Service report (updated), 
Oct. 28, 1998, p. 2.
---------------------------------------------------------------------------
    DOD cited several factors to support the conclusion the 
anthrax vaccine is both safe for widespread use and effective 
against the most likely anthrax threat:
          1) FDA approval and monitoring of the vaccine;
          2) vaccine usage since approval;
          3) assured production capacity;
          4) independent medical review;
          5) supplemental vaccine testing; and,
          6) vaccine tests in animals.\18\
---------------------------------------------------------------------------
    \18\ Prepared statement of Dr. Sue Bailey, Assistant Secretary for 
Health Affairs, DOD, NSVAIR anthrax hearing (I), p. 9 .
---------------------------------------------------------------------------

                      FDA Approval of the Vaccine

    The AVIP uses the only anthrax vaccine licensed for 
manufacture in the United States. Anthrax Vaccine Absorbed 
[AVA] was approved as safe in 1970 based on animal studies and 
one study of wool workers exposed to indeterminate levels of 
cutaneous (through skin) and airborne anthrax spores. The 
disease primarily infects grazing animals and the vaccine has 
been used since 1970 by some veterinarians, livestock workers, 
and researchers at risk from exposure. The approved 
immunization process requires a fixed schedule of six 
injections over 18 months and an annual booster. The vaccine 
does not contain live anthrax bacteria, but challenges the 
immune system to mount a response to filtered elements of the 
killed bacteria absorbed into an adjuvant.\19\
---------------------------------------------------------------------------
    \19\ The FDA-approved immunization schedule: Day 1, 2 weeks, 4 
weeks, 6 weeks, 6 months, 12 months, and 18 months. An adjuvant is an 
ingredient that modifies or enhances the effectiveness of the drug or 
treatment.
---------------------------------------------------------------------------
    Subsequent FDA review of the studies in 1985 concluded the 
vaccine was safe, ``fairly well tolerated,'' and effective 
against cutaneous anthrax, but that data from both human and 
animal tests was insufficient to support a finding of efficacy 
with regard to airborne exposure.\20\ In analyzing the benefit/
risk ratio of classifying the old vaccine as compliant under 
new FDA standards, the expert panel concluded, ``This vaccine 
is recommended for a limited, high-risk of exposure population 
along with other industrial safety measures designed to 
minimize contact with potentially contaminated material. The 
benefit-to-risk assessment is satisfactory under the prevailing 
circumstances of use.'' \21\ (Emphasis added).
---------------------------------------------------------------------------
    \20\ Federal Register, 21 CFR Part 610, Dec. 13, 1985, p. 51058.
    \21\ Ibid.
---------------------------------------------------------------------------
    The sole producer of the vaccine is the Michigan Biologics 
Products Institute [MBPI], formerly the Michigan Public Health 
Department. Since licensure in 1970, FDA monitoring of the 
vaccine consisted of collecting adverse reaction data and 
conducting intermittent manufacturing plant inspections.
    While detailed information on inspection activities prior 
to 1990 is not readily available, FDA regulatory scrutiny of 
the manufacturer has been increasing since then. The Lansing, 
MI, facility has been cited repeatedly by the FDA for quality 
control deficiencies and ``numerous significant deviations from 
the Federal Food, Drug, and Cosmetic Act, FDA's regulations and 
the standards in MBPI's license.'' \22\ In March 1997, the FDA 
warned MBPI that steps would be taken to revoke production 
licenses, including anthrax vaccine, unless immediate actions 
were taken to correct longstanding deficiencies.\23\ In March 
1998, the plant was closed for $1.8 million in renovations and 
a $15 million expansion funded by DOD.\24\ Vaccine production 
resumed in May 1999, but neither the renovated facility nor any 
newly produced vaccine lots have been approved by the FDA.\25\
---------------------------------------------------------------------------
    \22\ DOD's Mandatory Anthrax Vaccine Immunization Program for 
Military Personnel, 106th Cong., 1st sess., p. 58 (1999) (Subcommittee 
on National Security, Veterans Affairs, and International Relations 
hearing of Apr. 29, 1999, No. 106-26) [hereinafter ``NSVAIR anthrax 
hearing (II)''] (testimony of Dr. Kathryn Zoon, Director, FDA Center 
for Biologics Evaluation and Research).
    \23\ Center for Biologics Evaluation and Research, FDA, ``FDA Warns 
Michigan Biological Products Institute of Intention to Revoke 
Licenses,'' No. D0382, Mar. 11, 1997.
    \24\ Department of Defense's Sole-Source Anthrax Vaccine 
Procurement, 106th Cong., 1st sess., p. 8 (1999) (National Security, 
Veterans Affairs, and International Relations Subcommittee hearing of 
June 30, 1999) [hereinafter ``NSVAIR anthrax hearing (III)''] 
(testimony of Louis J. Rodrigues, Director, Defense Acquisitions 
Issues, National Security and International Affairs Division, U.S. 
General Accounting Office).
    \25\ DOD news briefing, Monday, Dec. 13, 1999 (available at http://
www.defenselink.mil and in subcommittee files).
---------------------------------------------------------------------------
    Deviations from good manufacturing practices can affect 
vaccine safety and effectiveness. FDA will not permit the 
release of vaccines not documented to meet approved potency, 
sterility, and stability levels. Based on concerns over the 
impact of production process errors on vaccine quality, BioPort 
quarantined 11 lots of anthrax vaccine. Additional lots are 
being held pending resolution of questions about potency 
testing that arose during the supplemental review.\26\
---------------------------------------------------------------------------
    \26\ ``Medical Readiness: DOD Faces Challenges in Implementing Its 
Anthrax Vaccine Immunization Program,'' (GAO/NSIAD-00-36) U.S. General 
Accounting Office, Oct. 22, 1999, p. 13. See also, Department of 
Defense Joint Program Office--Biological Defense, ``Investigation of 
Supplemental Potency Testing'' JPO-0855 (undated) (in subcommittee 
files). See also, prepared statement of BG Eddie Cain, Joint Program 
Manager, Joint Program Office for Biological Defense, NSVAIR anthrax 
hearing (II), p. 68.
---------------------------------------------------------------------------
    Under FDA regulations, stockpiled lots must be tested for 
potency at predetermined intervals. Potency tests are done 
using guinea pigs by comparing the survival rates of animals 
vaccinated with the test lot(s) against those vaccinated with a 
previously manufactured control or ``reference'' lot. Potency 
test failures during the DOD supplemental testing program have 
raised questions regarding the validity of test procedures and 
the selection of reference lots.\27\
---------------------------------------------------------------------------
    \27\ Letter from Joseph S. Little, Contracting Officer, Department 
of the Army to Fuad El-Hibri, BioPort Corp., Sept. 23, 19989 (in 
subcommittee files).
---------------------------------------------------------------------------

                      Assured Production Capacity

    MPBI was purchased in September 1998 by the BioPort Corp., 
a new company formed by private investors, including former 
Joint Chiefs Chairman Adm. William J. Crowe. The next month 
BioPort was awarded a DOD contract valued at $29 million to 
produce anthrax vaccine for the AVIP.\28\ The contract (DAMD17-
98-C 8052) provides for a 1 year base period and 2 option 
years. The contract provides for a full-term, fixed price, 
fixed annual quantity because ``the Government currently 
requires all the AVA [anthrax vaccine absorbed] that BioPort 
can produce.'' Under the agreement, BioPort will receive 
progress payments at various stages of the anthrax vaccine 
production process.
---------------------------------------------------------------------------
    \28\ Department of Defense (1998) Award/Contract: U.S. Army Medical 
Research ACQ Activity--BioPort Corp., DAMD17-98-C-8052, Sept. 17, 1998.
---------------------------------------------------------------------------
    On August 5, 1999, DOD announced the contract had been 
``restructured'' to increase the price by $24.1 million, 
including $18.7 million of advance payments.\29\
---------------------------------------------------------------------------
    \29\ Department of Defense media release, ``DOD Announces Contract 
Restructuring,'' Aug. 5, 1999 (in subcommittee files).
---------------------------------------------------------------------------
    This contract, and earlier contracts with MPBI and MDPH, 
were accompanied by a justification and authorization for other 
than full and open competition (sole source). The sole source 
procurement was authorized because ``Michigan Biologics 
Products Institute [MBPI] is the only organization in the U.S. 
with a Food and Drug Administration [FDA] license to 
manufacture AVA'' and ``[d]ue to the time and expense required 
to produce a licenced product, investing in alternate 
manufacturers is not considered to be an effective way of 
meeting the Government's requirements.'' \30\ DOD also 
indemnified MBPI/BioPort against liability arising from ``the 
risks of adverse reactions, or the failure to confer immunity 
against anthrax . . .'' \31\
---------------------------------------------------------------------------
    \30\ Joseph S. Little ``Justification and Approval for Other than 
Full and Open Competition,'' Anthrax Vaccine Absorbed, DAMD17-97-0014 
(JPO 0836) May 20, 1997 (in subcommittee files).
    \31\ Memorandum of decision, Secretary of the Army Louis Caldera, 
Authority Under Public Law 85-804 to include an indemnification clause 
in contract DAMD 17-91-C-1139 with Michigan Biologic Products 
Institute, Sept. 3, 1998 (in subcommittee files).
---------------------------------------------------------------------------
    Potential liability resulting from adverse events was a 
major issue for the anthrax vaccine manufacturer even when the 
vaccine was used by only a few hundred people each year. In 
1986, Secretary of the Army John Marsh, Jr., authorized 
indemnification of the State of Michigan Department of Public 
Health, which would not provide the vaccine without 
indemnification due to ``the possibility that persons 
vaccinated may develop anaphylaxis or some unforeseen reaction 
of serious consequences, including death.'' \32\
---------------------------------------------------------------------------
    \32\ Memorandum of decision, Secretary of the Army John O. Marsh, 
authority under 50 U.S.C. 1431-1435 (Public Law 85-804) to include an 
indemnification clause in contracts or purchase orders with the State 
of Michigan, Feb. 27, 1986 (in subcommittee files).
---------------------------------------------------------------------------
    In 1992, Secretary of the Army Togo West, Jr., approved a 
request to indemnify the anthrax vaccine manufacturer, the 
Michigan Biologics Product Institute [MBPI], against all 
liability arising from:

        the unusually hazardous risks associated with 
        potentially severe adverse reactions and the potential 
        lack of efficacy of the AVA. These concerns stem from: 
        a) the limited use of the vaccine to date, i.e., tests 
        prior to approval of the vaccine by the Food and Drug 
        Administration are on too small a scale to permit 
        accurate assessment of types and severity of adverse 
        reactions (only widespread use can provide this 
        assessment); and b) insufficient experience in mass 
        immunization programs to truly evaluate the efficacy of 
        the vaccine. Moreover, there is no way to predict 
        whether the pathogen against which the vaccine may be 
        used will be sufficiently similar to the pathogen used 
        in tests to ensure vaccine efficacy.\33\ (Emphasis 
        added).
---------------------------------------------------------------------------
    \33\ Memorandum of decision, Secretary of the Army Togo West, Jr., 
authority under Public Law 85-804 to include an indemnification clause 
in contract DAMD17-91-C-1139 with the Michigan Biologic Products 
Institute [undated] (in subcommittee files).

    In 1998, Secretary of the Army Louis Caldera again 
authorized indemnification of MBPI because ``the size of the 
proposed vaccination program may reveal unforwarned 
idiosyncratic adverse reactions.'' \34\ The contracting officer 
justified the later indemnification request, in part, because, 
``Since 1990, approximately 600,000 doses have been issued from 
MBPI's stockpile. The limited use of AVA to date versus the 
large number of doses that are being stockpiled and subject to 
use may expand the data base to a point where the statistical 
significance of a predicted adverse reaction may become a 
reality.'' \35\
---------------------------------------------------------------------------
    \34\ See supra note 31.
    \35\ Joseph S. Little, Contracting Officer, ``Contracting Officer's 
Request for Authorization for Indemnification Under Authority of Public 
Law 85-804,'' Oct. 8, 1997, p. 3 (in subcommittee files).
---------------------------------------------------------------------------
    Following the Gulf war, and prior to adoption of the DOD 
immunization policy in 1993, and the mandated AVIP in 1998, 
Pentagon officials considered and rejected alternative anthrax 
vaccine production sites.\36\ Instead, an acquisition strategy 
was adopted focusing solely on the MBPI/BioPort vaccine.\37\
---------------------------------------------------------------------------
    \36\ BG Eddie Cain, ``Procurement of the Anthrax Vaccine-Single 
Source Versus Additional Site,'' DOD information paper, JPO 0920, Oct. 
19, 1998 (in subcommittee files).
    \37\ BG John C. Doesberg, ``Acquisition Strategy for the 
Procurement of Anthrax Vaccine Adsorbed,'' Joint Program Office for 
Biological Defense, JPO 0120, Feb. 1, 1997 (in subcommittee files).
---------------------------------------------------------------------------

                        Vaccine Usage and Safety

    DOD literature says the anthrax vaccine ``has been safely 
and routinely administered in the United States to 
veterinarians, laboratory workers, and livestock handlers for 
more than 25 years.'' \38\ Testimony at the March 24 hearing 
indicated between 100 and 300 civilians may receive the vaccine 
each year. Since approval, and prior to the AVIP, fewer than 
68,000 doses had been distributed apart from stocks used in 
Operation Desert Storm.\39\
---------------------------------------------------------------------------
    \38\ See supra note 14.
    \39\ Prepared statement of Dr. Kathryn Zoon, Director, FDA Center 
for Biologics Evaluation and Research, NSVAIR anthrax hearing (II), pp. 
52-53.
---------------------------------------------------------------------------
    As with any vaccine, anthrax inoculation can cause adverse 
health events in some individuals, ranging from soreness or 
swelling at the injection site (local reactions) to fevers, 
chills, muscle aches, and anaphylaxis \40\ (systemic 
reactions). Local reaction may be mild, moderate, or severe 
enough to require medical attention. Systemic reactions are 
generally considered clinically more significant. Reactions may 
increase in severity after successive injections.\41\
---------------------------------------------------------------------------
    \40\ Anaphylaxis is one form of hypersensitivity to a drug or 
antigen. Anaphylactic shock is an often severe, sometimes fatal, 
physical reaction characterized by respiratory symptoms, fainting, 
swelling, and itching.
    \41\ Michigan Biologic Products Institute, ``Anthrax Vaccine 
Absorbed: How Supplied, References, Description, Clinical Pharmacology, 
Indications and Usage, Contraindications, Warnings, Precautions, 
Adverse Reactions, Dosage and Administration,'' FDA License No. 99, 
Rev. February 1998 (in subcommittee files).
---------------------------------------------------------------------------
    The AVA has been described as a relatively crude, 
imprecisely characterized vaccine, and estimates of reaction 
rates vary widely.\42\ According to the FDA-approved AVA 
product labeling, 30 percent of vaccine recipients can be 
expected to suffer mild local reactions, 4 percent will incur 
moderate local reactions and less than 0.2 percent will 
experience systemic reactions.\43\ In 1994 and 1995, DOD 
considered the need for a new anthrax vaccine ``based on the 
reactogenicity of the current vaccine.'' \44\
---------------------------------------------------------------------------
    \42\ Phillip Brachman and Arthur Friedlander, Vaccines, 2d ed., pp. 
729-739, Philadelphia, WB Saunders (1994).
    \43\ See supra note 41.
    \44\ LTC George W. Anderson, Jr., memorandum ``Minutes of the FDA 
meeting of May 5, 1994 Concerning Production and Purification of PA 
from Delta Stern-1 (pPa102) CR4,'' U.S. Army Medical Research Institute 
on Infectious Diseases, May 19, 1994 (in subcommittee files).
---------------------------------------------------------------------------
    To avoid adverse reactions, the vaccine should not be given 
to those who experienced a severe reaction to a previous dose 
or to those with acute respiratory disease or an active 
infection. Immune compromised persons (i.e., HIV infected) may 
not respond to the vaccine. It is not recommended for pregnant 
women or for those under 18 or over 65 years of age.\45\
---------------------------------------------------------------------------
    \45\ See supra note 41.
---------------------------------------------------------------------------
    The Army Anthrax Vaccine Immunization Plan directs medical 
personnel to report severe adverse reactions (resulting in 
hospitalization or more than 24 hours lost from duty) through 
the Vaccine Adverse Events Reporting System [VAERS] 
administered by the Department of Health and Human Services 
[HHS].\46\ Within HHS, VAERS is a joint project of the Centers 
for Disease Control [CDC] and the Food and Drug Administration 
[FDA].\47\ VAERS guidance recommends recording any clinically 
significant symptoms occurring subsequent to vaccine 
administration, whether or not a causal relationship has been 
established between the vaccine and the adverse reaction.\48\
---------------------------------------------------------------------------
    \46\ Gen. William W. Crouch, U.S. Army Vice Chief of Staff, 
memorandum ``Army Anthrax Vaccine Immunization Program Plan,'' Apr. 29, 
1998, p. 3 and annex C (in subcommittee files).
    \47\ FDA Center for Biologics Evaluation and Research, ``Vaccine 
Adverse Events Reporting System [VAERS]'' available at http://
www.fda.gov.cber/vaers/faq.htm.
    \48\ Ibid.
---------------------------------------------------------------------------
    The Army Medical Surveillance Activity also receives copies 
of VAERS forms from all the uniformed services and produces a 
quarterly report for the U.S. Army Medical Command.\49\ The 
Army Surgeon General has requested the assistance of the HHS 
Vaccine Injury Compensation Program in evaluating all anthrax-
related VAERS data.\50\
---------------------------------------------------------------------------
    \49\ See supra note 46, p. C-7.
    \50\ Anthrax Vaccine Adverse Reactions, 106th Cong., 1st sess. 
(1999) (subcommittee on National Security, Veterans Affairs, and 
International Relations hearing of July 21, 1999) [hereinafter ``NSVAIR 
anthrax hearing (IV)''] [The subcommittee hearing has not yet been 
printed. Page numbers in this and subsequent references to statements 
at this hearing refer to individual prepared written statements or the 
unofficial transcript, held in subcommittee files.] (prepared statement 
of Gen. Robert Claypool, pp. 13-14).
---------------------------------------------------------------------------
    The AVIP convened a clinical conference in May 1999 to 
discuss anthrax issues, including adverse events. Col. Renata 
Engler, M.D., chief, Allergy-Immunology Department, Walter Reed 
Army Medical Center, presented data from ongoing research and 
case studies showing higher adverse reaction rates in 
women.\51\ Also discussed at the conference was the Army 
Surgeon General's proposed longitudinal cohort study to assess 
near-term and long-term health effects of the anthrax 
vaccine.\52\
---------------------------------------------------------------------------
    \51\ Col. Renata Engler, M.D., USA, Chief, Allergy and Immunology 
Department, Walter Reed Army Medical Center, ``Presentation-Anthrax 
Immunization: Challenges for the Future,'' Department of Defense 
Conference for Biological Warfare Defense Immunizations, Fort Detrick, 
MD, May 25-27, 1999 (in subcommittee files).
    \52\ Department of the Army, Office of the Surgeon General, 
``Memorandum for Conference Participants,'' Apr. 16, 1999, p. 2 (in 
subcommittee files).
---------------------------------------------------------------------------
    To convey important information about medical exemptions 
and adverse reactions, the Army implementation plan directs 
commanders and medical staff to provide recipients ``adequate 
information on the vaccine, its safety, its benefits, and the 
need for adherence to the immunization schedule prior to the 
first anthrax vaccination.'' \53\ The other service 
implementation plans contain identical or similar requirements.
---------------------------------------------------------------------------
    \53\ See supra note 46 p. C-5.
---------------------------------------------------------------------------
    On April 1, 1999, VAERS data (1990 to 1999) contained 101 
reports of adverse events associated with anthrax inoculation, 
14 of which were considered serious.\54\ In May 1999, DOD 
reported a total of 123 VAERS filings with FDA, but included 
only 65 of those in the caculation of an adverse reaction rate 
of 0.007 percent of 890,888 vaccinations given to date. 
According to DOD, only 11 VAERS reports ``met strict reporting 
requirements.'' \55\
---------------------------------------------------------------------------
    \54\ Testimony of Dr. Kathryn Zoon, Director, FDA Center for 
Biologics Evaluation and Research, NSVAIR anthrax hearing (II), p. 55.
    \55\ Department of Defense, briefing slide, ``Anthrax Vaccine 
Adverse Events-Vaccine Adverse Event Reporting System [VAERS] 
Military--Week Ending May 21, 1999'' May 28, 1999 (in subcommittee 
files).
---------------------------------------------------------------------------

                       Independent Medical Review

    A review of the AVIP plans, and of basic literature on the 
anthrax vaccine, was conducted by Dr. Gerard N. Burrow, of the 
Yale University School of Medicine.\56\ According to Dr. 
Burrow,\57\ he conducted his review over 3 months, read 
materials provided by DOD, and interviewed Pentagon officials 
responsible for designing and implementing the program. On 
February 19, 1998, in a four page letter, he concluded, ``The 
anthrax vaccine appears to be safe and offers the best 
available protection against wild-type anthrax as a biological 
warfare agent.'' The letter contains two paragraphs on safety 
and efficacy. Regarding the safety of the vaccine stockpile, 
all of which was manufactured under conditions cited by FDA as 
deficient, Dr. Burrow pointed to the DOD supplemental testing 
program, and the fact that ``FDA directed MBPI to do a 
comprehensive review to demonstrate that deviations in biologic 
product lines did not impact anthrax vaccine quality and 
integrity. The results of this review should be available in 
the near future.'' \58\ Regarding efficacy of the vaccine, the 
letter recites usage figures since approval in 1970 and cites 
the conclusion of an unpublished DOD study that ``unit 
effectiveness could best be preserved through the use of pre-
deployment vaccination.'' \59\
---------------------------------------------------------------------------
    \56\ See supra note 16.
    \57\ In an Apr. 16, 1999 telephone conversation with subcommittee 
staff, Dr. Burrow said his charge was a general review of the program, 
and that as an internist, he has little experience with vaccines. His 
primary recommendation was the use of focus groups of military 
personnel to determine appropriate communication strategies.
    \58\ See supra note 16.
    \59\ Ibid.
---------------------------------------------------------------------------
    In a letter to the subcommittee in response to a request to 
testify on his review of the program, Dr. Burrow wrote:

          Unfortunately, I do not believe I can make a 
        significant contribution to the work of your Committee. 
        I chaired the Institute of Medicine Committee that 
        reviewed the Defense Department program for clinical 
        care of Gulf War veterans in active service and 
        interacted with personnel in the Office of Health 
        Affairs. The Defense Department was looking for someone 
        to review the program in general and make suggestions, 
        and I accepted out of patriotism. I was very clear that 
        I had no expertise in Anthrax and they were clear that 
        they were looking for a general oversight of the 
        vaccination program.
          I visited the Pentagon on a number of occasions, 
        talked with a variety of people in and out of 
        government and presented my report which you have to 
        the Secretary on March 2, 1998. I had no access to 
        classified information. . . .\60\ (Emphasis added).
---------------------------------------------------------------------------
    \60\ Letter from Dr. Gerard N. Burrow, Yale University School of 
Medicine, to Representative Christopher Shays, Apr. 26, 1999 (in 
subcommittee files).
---------------------------------------------------------------------------

                          Supplemental Testing

    To address concerns over the age and quality of stockpiled 
vaccine, DOD undertook an effort to re-test the product before 
use. A contractor was retained to conduct supplemental testing 
of vaccine lots, all of which had been manufactured in an aging 
production facility, and some of which had been approved by the 
FDA for use beyond the initial expiration date.
    Mitretek Systems Inc., reviewed vaccine production records 
and observed additional testing conducted by BioPort 
personnel.\61\ Of the 31 vaccine lots \62\ subjected by DOD to 
supplemental testing, 18 remained unavailable as of July 1999 
due to unresolved purity, potency, or sterility issues.\63\
---------------------------------------------------------------------------
    \61\ See supra note 17, p. 3.
    \62\ Each lot contains approximately 200,000 doses of vaccine.
    \63\ See supra note 26, p. 13.
---------------------------------------------------------------------------
    Some involved in the program opposed supplemental testing 
as redundant and likely to cause more problems than it solved 
by establishing a self-imposed vaccine safety standard in 
addition to FDA lot-release criteria.\64\ Their concerns were 
validated when the supplemental testing program appears to have 
overwhelmed the MBPI/BioPort testing capabilities, producing 
anomalous results and delaying the program.\65\ Once the 
testing problems became apparent, vaccine lots not technically 
in the stockpile when the AVIP was announced were not subjected 
to the supplemental assays under the rationale the FDA was 
requiring the same tests for lot release.\66\ All the lots 
submitted for supplemental testing had also undergone the same 
FDA lot release protocols.
---------------------------------------------------------------------------
    \64\ Dr. Michael Gilbreath, information paper, JPO 0364, Feb. 4, 
1998 (in subcommittee files); prepared statement of Dr. Robert C. 
Myers, Chief Operating Officer, BioPort Corp., NSVAIR anthrax hearing 
(II), pp. 83-84.
    \65\ Ibid. (Gilbreath information paper).
    \66\ Letter from Secretary of Defense William Cohen to 
Representatives Shays (CT), Gilman (NY), Kelly (NY), Souder (IN), Ose 
(CA), and Talent (MO), Sept. 30, 1999, attachment p. 1 (in subcommittee 
files).
---------------------------------------------------------------------------

                        Animal Data on Efficacy

    DOD's determination the vaccine affords protection against 
virtually all strains of airborne anthrax spores rests 
primarily on studies of vaccinated animals (guinea pigs, 
rabbits, and monkeys) challenged with various strains of the 
disease.\67\ But widely varied results within and between 
animal species suggest variable modes of protection not 
necessarily correlated to antibody levels stimulated by the 
vaccine.\68\ Without a proven model in animals that is known to 
correlate to protection in humans, animal data remains only 
suggestive.
---------------------------------------------------------------------------
    \67\ Testimony of Dr. Sue Bailey, DOD Assistant Secretary for 
Health Affairs, NSVAIR anthrax hearing (I), p. 11.
    \68\ Prepared statement of Dr. Meryl Nass, NSVAIR anthrax hearing 
(II) pp. 108-111.
---------------------------------------------------------------------------
    Vaccine-acquired anthrax immunity may also be limited or 
overwhelmed when the subject is challenged with variant anthrax 
strains.\69\ A report by the Senate Committee on Veterans' 
Affairs concluded that:
---------------------------------------------------------------------------
    \69\ Ibid.

        data suggests that the vaccine can protect humans 
        against inhaled anthrax but to date there is inadequate 
        information to judge how well it works, particularly 
        against weaponized anthrax, which could cause exposure 
        to greater concentrations of anthrax than has occurred 
        among workers exposed on the job.\70\
---------------------------------------------------------------------------
    \70\ Report of the Special Investigation Unit on Gulf War 
Illnesses, Senate Committee on Veterans' Affairs, 105th Cong., 2d 
sess., Sept. 1998, S. Rpt. 105-39, p. 122. See aslo, ``Is Military 
Research Hazardous to Veteran's Health?-Lessons Spanning Half a 
Century,'' staff report prepared for the Committee on Veterans Affairs, 
U.S. Senate, p. 11, 103rd Cong., 2d sess., S. Rpt. 103-97, Dec. 8, 
1994.

    In response to questions regarding the efficacy of the 
vaccine against antibiotic resistant or genetically altered 
---------------------------------------------------------------------------
anthrax strains, DOD said

        The current US-licensed anthrax vaccine is considered 
        to be highly effective against naturally occurring 
        strains of anthrax, including antibiotic resistant 
        strains. The development of genetically engineered 
        organisms using anthrax or any other biological warfare 
        agent is a potential threat that must be evaluated 
        carefully. We are not aware, however, of any 
        information to suggest that these modified strains have 
        been used in any context other than the research 
        laboratory.\71\
---------------------------------------------------------------------------
    \71\ See supra note 66.

    When one U.S. laboratory studying the release of anthrax at 
Sverdlovsk implied the Russian mixtures of anthrax strains 
might overcome the protection afforded by the anthrax vaccine, 
DOD persuaded the author ``to correct the press release to make 
it more accurate.'' The modification stated, in part, ``there 
is no experimental data or evidence to suggest that such a 
mixture is resistant to the FDA-licensed anthrax vaccine used 
by the US military.'' \72\
---------------------------------------------------------------------------
    \72\ Ibid. Nor is there data demonstrating the vaccine is effective 
against altered or mixed anthrax strains.
---------------------------------------------------------------------------

                         Opposition to the AVIP

    Some have refused the vaccine. Active duty personnel have 
been disciplined under service-specific policies for refusing a 
lawful order. Reservists and National Guard members have 
resigned or transferred to units or ``non-mobility'' positions 
which do not require the vaccine. The DOD does not collect 
uniform records on refusals, but media reports indicate more 
than 300 service men and women have refused to take the 
shot.\73\
---------------------------------------------------------------------------
    \73\ ``Vaccine Refused by 23 Aircraft Carrier Sailors,'' Associated 
Press, Mar. 11, 1999 (in subcommittee files). The reported number of 
vaccine refusers has remained fairly stable in public reports, between 
200 and 300, for some months.
---------------------------------------------------------------------------
    Hearing testimony and correspondence from Reservists and 
National Guard members suggests up to 30 percent of some units 
would resign or seek to transfer due to the anthrax 
program.\74\ Their concerns focus on the lack of systematic, 
long-term studies on anthrax vaccine health effects.\75\
---------------------------------------------------------------------------
    \74\ Impact of the Anthrax Vaccine Program on Reserve and National 
Guard Units, 106th Cong., 1st sess., p. 57 (Subcommittee on National 
Security, Veterans Affairs and International Relations hearing, Sept. 
29, 1999) [hereinafter ``NSVAIR anthrax hearing (V)''] [The 
subcommittee hearing has not yet been printed. Page numbers in this and 
subsequent references to statements at this hearing refer to individual 
prepared written statements or the unofficial transcript, held in 
subcommittee files.] Testimony of Capt. David Panzera; testimony of 
Tech. Sgt. William Mangieri, NSVAIR anthrax hearing (V), p. 58) see 
also, testimony of Capt. Thomas Rempfer, NSVAIR anthrax hearing (I), p. 
110; testimony of Maj. Redmond Handy, NSVAIR anthrax hearing (I), pp. 
102-102. DOD does not collect data on refusals or resignations 
attributable to the vaccine. An informal survey of Reserve and Guard 
units shows more than 700 current or likely departures due to the AVIP. 
The survey can be found at: http://www.dallasnw.quik.com/cyberella/
Anthrax/Chron--Info.html, pp. 12-13.
    \75\ Testimony of Col. Redmond Handy, NSVAIR anthrax hearing (I), 
p. 91; prepared statement of Ms. Randi Martin-Allaire, NSVAIR anthrax 
hearing (II), p. 171; prepared statement of Sgt. Michael Shepard, 
NSVAIR anthrax hearing (II), p. 193; testimony of Major Cheryl Hansen, 
NSVAIR anthrax hearing (V), p. 31.
---------------------------------------------------------------------------
    Safety is also an issue for some because the anthrax 
vaccine is one of the exposures under study by the National 
Academy of Sciences' Institute of Medicine [IOM] pursuant to 
the Persian Gulf War Veterans Act of 1998, enacted as Title XVI 
of the 1998 Omnibus Appropriations Act, Public Law 105-277. The 
law directs IOM to review associations between illnesses and 
wartime exposures that warrant a presumption of service-
connection for sick Gulf war veterans.\76\ That study is 
ongoing.
---------------------------------------------------------------------------
    \76\ Public Law 105-277, title XVI.
---------------------------------------------------------------------------
    Efforts to meet Secretary Cohen's four preconditions to 
AVIP implementation, intended to address likely reservations 
about the program, have only served to intensify concerns: \77\
---------------------------------------------------------------------------
    \77\ Letter from Representativess Benjamin Gilman (NY), et. al. to 
Defense Secretary William Cohen, July 20, 1999, p. 1 (in subcommittee 
files).
---------------------------------------------------------------------------
          1. Problems with supplemental testing underscore 
        vaccine safety and production issues. The failure to 
        test all lots produced before the plant closed suggests 
        to some the promise of supplemental testing was not 
        fulfilled.
          2. The prerequisite communication effort engenders 
        resentment and mistrust as simplistic DOD attempts at 
        education and risk communication portray very limited 
        vaccine use as ``routine'' \78\ and attack those with 
        legitimate questions as ``paranoics'' \79\ and simple-
        minded victims of Internet propaganda.\80\
---------------------------------------------------------------------------
    \78\ See supra note 14.
    \79\ Lt. Gen. Ronald Blanck, ``Ignore the Paranoics: The Vaccine is 
Safe,'' Army Times, Feb. 2, 1999, p. 12.
    \80\ Douglas J. Gilbert, American Forces Press Service, ``Anthrax 
Vaccine Called Effective Force Protection,'' DefenseLink, Nov. 5, 1998 
(in subcommittee files); Washington Times, ``Anthrax Shots Drive Air 
Force Veteran From Service,'' Oct. 13, 1999, p. 18; PBS New Hour, 
``Anthrax Vaccine,'' Oct. 21, 1999 (comments of Gen. Blanck) 
(transcript in subcommittee files); Col. Guy Strawder, ``AVIP 
Director's Newsletter'' (in subcommittee files).
---------------------------------------------------------------------------
          3. Delays in posting data to the tracking system 
        reduce its value as a real time indicator of medical 
        readiness and increases tolerance of deviations in the 
        FDA approved inoculation regimen.\81\
---------------------------------------------------------------------------
    \81\ Bradley Graham, ``Anthrax Shots Missing Targets?'' Washington 
Post, Sept. 29, 1999, p. A27.
---------------------------------------------------------------------------
          4. Contrary to subsequent DOD characterizations, the 
        promised outside, expert, scientific review of the 
        program was only very general in nature.\82\
---------------------------------------------------------------------------
    \82\ See supra note 60 and accompanying text.
---------------------------------------------------------------------------
    Others question the necessity of the program, asking 
whether it betrays a lack of confidence in deterrence and other 
force protection elements, and suggesting a vaccine program 
makes anthrax attack more, not less, likely.\83\
---------------------------------------------------------------------------
    \83\ Testimony of Capt. Thomas Rempfer, NSVAIR anthrax hearing (I), 
pp. 40-41; testimony of Maj. Russell Dingle, NSVAIR anthrax hearing 
(I), p. 49.
---------------------------------------------------------------------------

                   Hearings and Legislative Proposals

    On March 24, 1999, the Subcommittee on National Security, 
Veterans Affairs, and International Relations held the first of 
five hearings on the Department of Defense [DOD] Anthrax 
Vaccination Immunization Program [AVIP] entitled, ``The Anthrax 
Immunization Program,'' the hearing examined the effectiveness 
and efficiency of the AVIP as a medical force protection 
measure, a recordkeeping initiative and long term procurement. 
The subcommittee heard testimony from Dr. Sue Bailey, Assistant 
Secretary for Health Affairs, U.S. Department of Defense, 
accompanied by, Lt. Gen. Ronald R. Blanck, U.S. Army; Rear 
Admiral Todd Fisher, Deputy Surgeon General U.S. Navy; Lt. Gen. 
Charles H. Roadman II, U.S. Air Force; Capt. Thomas Rempfer, 
Connecticut Air National Guard; Maj. Russell Dingle, 
Connecticut Air National Guard; Pfc. Stephen M. Lundbom, U.S. 
Marine Corps; Attorney Mark Zaid; Col. Redmond Handy, Member 
Reserve Officer Association; and Lorene K. Greenleaf.
    On April 29, 1999, the subcommittee held a hearing on the 
AVIP entitled, ``DOD's Mandatory Anthrax Vaccine Immunization 
Program for Military Personnel.'' The purpose of this hearing 
was to examine the vaccine's safety and effectiveness against 
an aerosolized biological weapons attack. Individuals who 
testified disputed the Department of Defense claim the vaccine 
is unquestionably safe for force wide use. Some who testified 
are experiencing serious illnesses they associate with the 
anthrax vaccine. Testimony was received from Kwai-Cheung Chan, 
Director, Special Studies and Evaluations Section, National 
Security and International Affairs Division, General Accounting 
Office; Dr. Katherine Zoon, Director, Center for Biologics 
Evaluation and Research, Food and Drug Administration; Dr. 
Michael Gilbreath, Medical Project Manager, Joint Program 
Office for Biological Defense; Dr. Robert Myers, Chief 
Operating Officer, BioPort Corp.; Dr. Meryl Nass; David 
Churchill; Randi Martin-Allaire; Roberta Groll; and Michael 
Shepard.
    On June 30, 1999 the subcommittee held a hearing entitled, 
``Department of Defense's Sole Source Anthrax Vaccine 
Procurement.'' The primary focus was to examine AVIP 
acquisition strategies and procurement activities pursued by 
the Department of Defense to purchase the vaccine. Issues 
examined included the technical and financial ability of 
BioPort to supply the vaccine at the contracted price, and the 
effect of management problems on the safety and the quality of 
the vaccine produced. Testimony was given by Louis J. 
Rodrigues, Director, Defense Acquisition Issues, National 
Security and International Affairs Division, General Accounting 
Office; David Oliver, Jr., Principal Deputy Under Secretary of 
Defense for Acquisition and Technology, Department of Defense; 
and Fuad El-Hibri, chief executive officer, BioPort Corp.
    On July 21, 1999, the National Security Subcommittee held 
its fourth hearing on the AVIP. Entitled, ``Anthrax Vaccine 
Adverse Reactions,'' the hearing focused on the program's 
willingness to recognize and ability to treat adverse reactions 
to the vaccine in military personnel. Issues discussed included 
the extent the main adverse event surveillance system used by 
DOD, the joint FDA/CDC Vaccine Adverse Event Reporting System 
[VAERS], under-reports adverse events and adverse vaccine 
reactions. Testifying at this hearing were CPT Michelle Piel, 
USAF; LT Richard Rovet, USAF; SGT Robert Soska, USA; CPT Jon 
Richter, USAR; Kwai-Cheung Chan, Director, Special Studies and 
Evaluations Section, National Security and International 
Affairs Division, General Accounting Office; MG Robert 
Claypool, Deputy Assistant Secretary for Health Operations 
Policy, Department of Defense accompanied by, RADM Michael 
Cowen, Deputy Director for Medical Readiness, Joint Staff, 
Department of Defense; COL Renata Engler, Chief, Allergy-
Immunology Department, Walter Reed Army Medical Center; and Dr. 
Susan Ellenberg, Director, Division of Biostatistics and 
Epidemiology, Center for Biologics Evaluation and Research, 
Food and Drug Administration.
    The subcommittee held its fifth hearing on the AVIP on 
September 29, 1999 entitled, ``Impact of the Anthrax Vaccine 
Program on Reserve and National Guard Units.'' The hearing 
examined the implementation of the AVIP in reserve component 
units and the impact of the program on retention, readiness, 
and morale. Testifying at the hearing were Lt. Col. Thomas 
Heemstra, Indiana Air National Guard; Maj. Cheryl Hansen, Air 
Force Reserves; Capt. David Panzera, New York Air National 
Guard; Tech. Sgt. William Mangiere, New York Air National 
Guard; Charles Cragin, Acting Assistant Secretary for Reserve 
Affairs, Department of Defense, accompanied by, Maj. Gen. Paul 
Weaver, Jr., Director, Air National Guard, Department of 
Defense; Col. Frederick Gerber, Director, Health Care 
Operations, Office of the Army Surgeon General, Department of 
Defense; and Col. James Dougherty, Air Surgeon, National Guard 
Bureau, Department of Defense.
    In the first session of the 106 Congress, two bills were 
introduced regarding the anthrax vaccine program:
          Representative Walter Jones (NC) introduced H.R. 2543 
        on July 16, 1999. Entitled, ``The American Military 
        Health Protection Act,'' the bill would instruct the 
        Department of Defense to make the anthrax vaccination 
        immunization program voluntary for all members of the 
        Armed Forces until the FDA has approved a new anthrax 
        vaccine for humans or the FDA has approved a new, 
        reduced course of shots for the current anthrax 
        vaccine. This bill was referred to the Committee on 
        Armed Services.
          Representative Benjamin Gilman (NY), introduced H.R. 
        2548 on July 19, 1999, cosponsored by Representatives 
        Sue Kelly (NY) and Bob Filner (CA). H.R. 2548 would 
        suspend further implementation of the Department of 
        Defense anthrax vaccination program until the vaccine 
        is determined to be safe and effective through a study 
        by the National Institutes of Health. The Department of 
        Defense Anthrax Vaccination Moratorium Act was referred 
        to the Committee on Armed Services and to the Committee 
        on Commerce.
          The fiscal year 2000 Defense Appropriations Act (H.R. 
        2561) contained a provision directing the Comptroller 
        General to report on: effects on morale, retention and 
        recruiting; the civilian costs and burdens associated 
        with adverse reactions for members of the reserve 
        components; adequacy of long and short term health 
        monitoring; assessment of the anthrax threat, including 
        but not limited to foreign doctrine, weaponization, 
        quality of intelligence, and other biological threats. 
        DOD was directed to contract with the National Research 
        Council to conduct studies on: vaccine adverse events 
        and adverse reactions, particularly among women; 
        vaccine efficacy against inhalation anthrax; 
        correlation of animal models to safety and efficacy in 
        humans; research gaps; and other matters.

                            III. Discussion

                                Findings

1. The AVIP is well-intentioned but over-broad response to the anthrax 
        threat. It represents a doctrinal departure overemphasizing the 
        role of pre-exposure medical intervention in force protection

    DOD bases the scope of AVIP on the scope of the threat, and 
the perceived need for additional, individual force protection 
to meet that threat. Threat assessment requires objective and 
subjective analyses of U.S. vulnerability, enemy capacity, and 
enemy intentions. ``A threat analysis, the first step in 
determining risk, identifies and evaluates each threat on the 
basis of various factors, such as its capability and intent to 
attack an asset, the likelihood of a successful attack, and its 
lethality.'' \84\
---------------------------------------------------------------------------
    \84\ Combating Terrorism--Threat and Risk Assessments Can Help 
Prioritize and Target Program Investments, U.S. General Accounting 
Office, GAO/NSIAD-98-74, April 1998 p. 3.
---------------------------------------------------------------------------
    Since the King of Athens poisoned his enemy's wells in 600 
BC and Alexander the Great hurled diseased animal corpses over 
the walls of a besieged city, ground forces have been 
vulnerable to casualties caused by natural or pernicious 
exposure to chemical and biological pathogens.\85\ But in the 
absence of proven capability and intent to use biological 
weapons, vulnerability alone does not constitute a validated 
threat for purposes of determining appropriate and effective 
countermeasures.
---------------------------------------------------------------------------
    \85\ Dr. Stephen C. Joseph, Assistant Secretary of Defense for 
Health Affairs, ``Biological Warfare--Information Memorandum'' 
(undated) p. 2 (in subcommittee files).
---------------------------------------------------------------------------
    Appropriately, much of the information regarding the BW 
capabilities and intentions of potential adversaries, and even 
allies, is classified. As a result, most public descriptions of 
the anthrax threat focus on the general vulnerability of 
unprotected forces to anthrax attack, the general ease and 
availability of anthrax production and the likely lethality of 
a successful anthrax attack.
    According to various unclassified DOD statements, more than 
10 countries ``have, or are developing, a biological warfare 
capability.'' \86\ Those nations are: China, Iran, Iraq, 
Israel, Libya, North Korea, South Korea, Syria, Taiwan, and 
Russia. Other public lists also include Egypt, Cuba, Japan, and 
the former Soviet states in Eastern Europe that may have 
inherited bio-warfare capabilities.\87\ For purposes of the 
AVIP, ``The high threat areas validated by our intelligence 
community for the potential use of anthrax as a biological 
weapon of mass destruction includes [sic] Korea, Israel, 
Jordan, Kuwait, Saudi Arabia, Bahrain, Qatar, Oman, UAE, and 
Yemen.'' \88\ Anthrax is not seen as a threat in the 
Balkans.\89\
---------------------------------------------------------------------------
    \86\ DOD information paper,``DOD Biological Warfare Threat 
Analysis,'' Dec. 15, 1997, p. 1. See also, Proliferation: Threat and 
Response, Department of Defense, November 1997.
    \87\ Office of Technology Assessment, U.S. Congress, 
``Proliferation of Weapons of Mass Destruction: Assessing the Risks,'' 
p. 65, OTA-15C-559, August 1993 (in subcommittee files). Notably 
included among those nations are United States allies who, it must be 
presumed, pose less danger to U.S. forces than nations currently 
opposing U.S. policy goals.
    \88\ See supra note 66, attachment p. 13.
    \89\ Ibid.
---------------------------------------------------------------------------
    Other descriptions of the anthrax threat focus on the 
relative ease of acquisition, mass production, and 
weaponization of the stable, long-lasting anthrax microbe. 
According to DOD, production of biological warfare agents does 
not require specialized equipment or advanced technology. 
Biological agents are more potent and efficient than chemical 
weapons, and can be delivered through a variety of means. 
Legitimate uses (i.e., vaccine manufacture) for ``dual use'' 
production technologies make counter-proliferation strategies 
difficult to implement successfully.\90\
---------------------------------------------------------------------------
    \90\ See supra note 86. The release of deadly chemical sarin gas in 
Tokyo by the Aum Shinrikyo cult highlighted the terrorist, and by 
implication, the military threat posed by chemical and biological 
weapons. But subsequently acquired information regarding the cult's 
unsuccessful attempts to use biological agents is seen by some as a 
counter to the argument those agents are not technically challenging to 
produce and deploy.
---------------------------------------------------------------------------
    Secretary Cohen told Members, ``Anthrax poses a clear and 
present danger to our armed forces. It is the weapon of choice 
for germ warfare because it is easy to weaponize and is as 
lethal as the Ebola virus. At least seven potential adversaries 
have worked to develop the offensive use of anthrax.'' \91\
---------------------------------------------------------------------------
    \91\ See supra note 66.
---------------------------------------------------------------------------
    In testimony before a subcommittee of the House Armed 
Services Committee, Deputy Secretary of Defense John Hamre 
said, ``Currently, at least 10 nation states and 2 terrorist 
groups are known to possess, or have in development, a 
biological warfare capability.'' \92\
---------------------------------------------------------------------------
    \92\ Prepared statement of John J. Hamre, Deputy Secretary of 
Defense, submitted to the Subcommittee on Military Personnel, House 
Committee on Armed Services, p. 2, Sept. 30, 1999.
---------------------------------------------------------------------------
    DOD testimony to the subcommittee portrayed the threat 
similarly: ``As identified by the chairman of the Joint Chiefs 
of Staff, anthrax is a major threat to our troops. Anthrax is 
the primary biological warfare threat faced by U.S. forces. 
More than 10 countries, including Iraq, have or are suspected 
of developing this biological warfare capability. Anthrax is 
the biological weapon most likely to be encountered because it 
is highly lethal, easy to produce in large quantities, and 
relatively easy to develop as a weapon.'' \93\
---------------------------------------------------------------------------
    \93\ Prepared statement of Dr. Sue Bailey, DOD Assistant Secretary 
for Health Affairs, NSVAIR anthrax hearing (I), p. 8.
---------------------------------------------------------------------------
    The AVIP tri-fold brochure describes the threat as follows:

        Biological weapons are maintained by several countries 
        around the world. Use of these weapons could cause 
        widespread illness among unprotected military forces.
        Anthrax is the biological weapon most likely to be 
        encountered because it is:
           Highly lethal
           Easy to produce in large quantities
           Relatively easy to develop as a weapon
           Easily spread over a large area
           Easily stored and dangerous for a long time 
        \94\
---------------------------------------------------------------------------
    \94\ See supra note 14.

    Clearly, DOD has determined the threat is real and 
imminent, and has concluded it would be irresponsible not to 
deploy an available countermeasure to protect the lives and 
fighting capability of U.S. forces.\95\
---------------------------------------------------------------------------
    \95\ Prepared statement of Dr. Sue Bailey, DOD Assistant Secretary 
for Health Affairs, NSVAIR anthrax hearing (I), p. 13.
---------------------------------------------------------------------------
    But similar statements on the threat have been made by DOD 
for many years. According to GAO testimony, ``The nature and 
magnitude of the military threat of biological warfare [BW] has 
not changed since 1990, both in terms of the number of 
countries suspected of developing BW capability, the types of 
BW agents they possess, and their ability to weaponize and 
deliver those BW agents. Inhalation anthrax is considered by 
DOD to be the primary BW threat because of its lethality, ease 
of production, and weaponization.'' \96\
---------------------------------------------------------------------------
    \96\ Prepared statement of Kwai-Cheung Chan, Director, Special 
Studies and Evaluation Section, National Security and International 
Affairs Division, U.S. General Accounting Office, NSVAIR anthrax 
hearing (II), p. 12.
---------------------------------------------------------------------------
    According to unclassified briefing materials assessing the 
anthrax threat, anthrax stocks and weaponized anthrax have been 
confirmed only in Southwest Asia. A stock of anthrax has been 
confirmed in Northeast Asia. Capacity to produce and weaponize 
anthrax elsewhere (South Asia or transnational) is suspected 
but unconfirmed.\97\
---------------------------------------------------------------------------
    \97\ DOD, briefing slide entitled, ``Anthrax Threat,'' Apr. 20, 
1998 (in subcommittee files).
---------------------------------------------------------------------------
    Assessment of the Iraqi threat concludes that substantial 
anthrax production capacity exists but exceeds the ability to 
weaponize. While Iraq appears likely to be able to launch a BW 
attack using AL HUSSEIN ballistic missiles, aircraft delivery 
is seen as less likely due to United States and Coalition air 
superiority.\98\ So Saddam would be ``unlikely to use WMD 
unless he perceives regime's survival at stake.'' \99\
---------------------------------------------------------------------------
    \98\ DOD, briefing slide entitled, ``Assessment,'' Apr. 20, 1998 
(in subcommittee files).
    \99\ Ibid.
---------------------------------------------------------------------------
    So the threat remains tactically limited and regional. The 
AVIP is universal.
    Several factors appear to have fueled the 1997 decision to 
launch a mandatory, force-wide program to address a long 
acknowledged, regionally-based threat.
    After the Gulf war, the Department of Defense undertook 
what is now characterized as ``a detailed, deliberative 
process'' \100\ over more than 3 years that culminated in the 
conditional decision to implement a mandatory, force-wide 
anthrax immunization program. ``After a three year study, the 
Department has concluded that the vaccination is the only safe 
way to protect highly mobile U.S. military forces against a 
potential threat that is 99 percent lethal to unprotected 
individuals.'' \101\
---------------------------------------------------------------------------
    \100\ Prepared statement of Dr. Sue Bailey, Assistant Secretary of 
Defense for Health Affairs, NSVAIR anthrax hearing (I), p. 8.
    \101\ Letter from Sandra K. Stuart, Assistant Secretary of Defense 
(Legislative Affairs) to the Honorable Christopher Shays (CT), p. 1, 
Dec. 15, 1997.
---------------------------------------------------------------------------
    That study was conducted, for the most part, behind closed 
doors. However, the documentation provided to the subcommittee 
by DOD \102\ describes a process more predetermined than 
deliberative, as the obvious operational benefits of passive, 
pre-exposure protection (versus cumbersome protective masks and 
suits), and the Iraqi threat, drove the decision to use the 
only vaccine currently available.\103\
---------------------------------------------------------------------------
    \102\ Letter from Representative Christopher Shays, chairman, 
Subcommittee on National Security, Veterans Affairs, and International 
Relations, House Committee on Government Reform to Secretary of Defense 
William Cohen, May 12, 1999 (in subcommittee files).
    \103\ Department of Defense, information paper, ``DOD Biological 
Warfare Force Protection,'' Dec. 15, 1997, p. 2 (in subcommittee 
files).
---------------------------------------------------------------------------
    In November 1993, DOD Directive 6205.3 set out a broad 
policy supporting immunization research, development, testing, 
acquisition and stockpiling of vaccines against current and 
emerging biological warfare threats. The directive required 
immunization only of ``designated'' or ``programmed'' personnel 
against agents ``for which suitable vaccines are available, in 
sufficient time to develop immunity before deployment to high 
threat areas. . . .'' \104\
---------------------------------------------------------------------------
    \104\ See supra note 7, p. 2.
---------------------------------------------------------------------------
    With regard to anthrax, DOD conducted research and program 
planning to develop an ``improved anthrax vaccine'' [IAV] that 
would generate immunity against the known threat in a 
reasonable time. According to a DOD Operational Requirements 
Document [ORD], the need for an improved vaccine was identified 
in the Mission Needs Statement [MNS] for medical defense 
against chemical and biological warfare agents in August 1994 
and in the MNS for Department of Defense biological defense in 
August 1992.\105\
---------------------------------------------------------------------------
    \105\ Department of Defense, ``Operational Requirements Document 
[ORD] for Improved Anthrax Vaccine,'' Oct. 2, 1995, p. 1 (in 
subcommittee files).
---------------------------------------------------------------------------
    The mission profile for the improved vaccine called only 
for inoculation of deployed and rapid deployment units ``based 
on intelligence estimates of the potential for use of specific 
BW agents against U.S. forces. . . . Other military personnel 
will be vaccinated prior to departure to BW threat areas. An 
accelerated immunization program will be conducted under 
certain alert or mobilization conditions.'' \106\
---------------------------------------------------------------------------
    \106\ Ibid., p. B-1.
---------------------------------------------------------------------------
    Shortcomings of the currently licensed vaccine were seen as 
the ``serious logistical obstacles, especially for reserve 
forces'' posed by the approved six-shot schedule and reports 
that suggest ``this vaccine may not provide universal 
protection against all anthrax strains.'' \107\ Minimum 
standards for the improved vaccine included generation of a 
protective immune response within 14 days of administering 
three inoculations.
---------------------------------------------------------------------------
    \107\ Ibid., p. 2.
---------------------------------------------------------------------------
    Briefing materials produced by the U.S. Army Medical 
Research Institute of Infectious Disease [USAMRIID] in 1994 
listed the following problems with the current vaccine:
          Prolonged immunization schedule
          Reactogenicity:
                Systemic reactions: 0.7-1.3%
                Significant local reactions: 2.4-3.9% (5.9%)
          Vaccine components completely undefined in terms of 
        characterization and quantitation of the PA, and other 
        bacterial products and constituents present
          Significant lot-to-lot variation in the PA immunogen 
        content
          Human trials with similar but not identical vaccine 
        showed protection against cutaneous anthrax but 
        insufficient data to show efficacy against inhalation 
        anthrax
          Made from spore-forming strain requiring dedicated 
        production facility \108\
---------------------------------------------------------------------------
    \108\ U.S. Army Medical Research Institute of Infectious Diseases 
[USAMRIID], briefing slide, ``Problems with Current MDPH Vaccine,'' 
(undated) (in subcommittee files).
---------------------------------------------------------------------------
    Minutes of a May 1994 USAMRIID meeting addressed ``the 
Army's need for a new Anthrax vaccine. This need is based on 
reactogenicity of the current vaccine, the desire to make a 
vaccine with defined and well characterized components, and the 
need to produce a vaccine which does not require a BL-3 \109\ 
containment for production or a dedicated production facility, 
since B. anthracis is a spore former.'' \110\
---------------------------------------------------------------------------
    \109\ Bio-Safety Level 3, the second most stringent of the four 
levels of controls to protect persons handling infectious agents. For a 
description of current bio-safety standards see: http://www.cdc.gov/od/
ohs/biosfty/bmbl4/bmbl4s3t.htm.
    \110\ See supra note 44, p. 1.
---------------------------------------------------------------------------
    Iraq's 1995 declarations to the United Nations Special 
Commission [UNSCOM] described ``a substantial BW program'' 
\111\ including 8,000 liters of anthrax, 6,000 of which Iraq 
claimed to have weaponized in missile warheads, aerial bombs, 
rockets, remote-control aircraft and agricultural sprayers 
mounted on planes and helicopters.\112\ At the same time, DOD 
interest in an improved anthrax vaccine diminished sharply. 
Reservations about the suitability of the old vaccine were put 
aside once it was made the centerpiece of the proposed 
immunization effort.
---------------------------------------------------------------------------
    \111\ See supra note 85, p. 5.
    \112\ Ibid.
---------------------------------------------------------------------------
    The vaccine program is just one element of the Joint 
Biological Warfare Defense concept encompassing:
         detection and warning
         individual (masks, suits) and collective 
        protection (sealed command and control facilities)
         medical (vaccines) countermeasures to prevent 
        disease
         contamination avoidance
         decontamination \113\
---------------------------------------------------------------------------
    \113\ Ibid., p. 7.
---------------------------------------------------------------------------
Treaties, anti-proliferation regimes, as well as the prospect 
of tactical and nuclear retaliation, are also meant to deter 
use of chemical and biological weapons.
    These are meant to be parts of an ``integrated and 
overlapping systems approach to BW defense ''\114\ in which 
both military and medical considerations dictate a hierarchy of 
force protection measures emphasizing contamination avoidance 
and physical protection over medical intervention and 
decontamination. One statement of chem/bio defense doctrine 
ranks force protection strategies as follows:
---------------------------------------------------------------------------
    \114\ DOD, Medical Defense Against Biological Material, (undated) 
p. 1.

        . . . The most effective and singularly most important 
        prophylaxis in defense against biological warfare 
        agents is physical protection. Preventing exposure of 
        the respiratory tract and mucous membranes . . . to 
        infectious and/or toxic aerosols through use of a full-
        face respirator will prevent exposure, and should, 
        theoretically, obviate the need for additional 
        measures. Chemical protective masks effectively filter 
        biological hazards.
        . . . All medical prophylactic modalities described 
        should be viewed only as secondary (i.e., backup), and 
        are not be relied upon as primary protective measures. 
        Agent exposures near the source of dissemination will 
        be high, and likely to overwhelm any medical protective 
        measure.\115\
---------------------------------------------------------------------------
    \115\ Ibid. The section on Prophylaxis and Therapy continues: ``The 
precise efficacy of available medical countermeasures has, of course, 
never been evaluated in actual field circumstances, but is largely 
inferred from laboratory studies on nonhuman primates. While these 
extrapolations may be inexact, they strongly support the efficacy of 
vaccines and drugs at some agent dose.'' (Emphasis in original).

    The AVIP makes medical prophylaxis a primary aspect of 
force protection and CBW deterrence. In testimony, the DOD 
Assistant Secretary for Health Affairs put the proposition 
quite directly: ``Our greatest and prime biological enemy today 
is anthrax. And our strongest weapon against anthrax is 
vaccination.'' \116\ The Navy's Deputy Surgeon General added:
---------------------------------------------------------------------------
    \116\ Testimony of Lt. Gen. Charles H. Roadman, Surgeon General, 
USAF, NSVAIR anthrax hearing (I), p. 17.

        We are fortunate to have a time tested, safe and 
        effective vaccine to provide an important element of 
        the body armor needed to defend our personnel against 
        weaponized anthrax. Anthrax has now joined other 
        immunizations received by our Service men and women to 
        protect against disease threats just as important as 
        wearing a gas mask or carrying a rifle when on the 
        battlefield.\117\
---------------------------------------------------------------------------
    \117\ Testimony of R.Adm. Todd Fisher, Deputy Surgeon General, USN, 
NSVAIR anthrax hearing (I), p. 17.

    The Air Force Surgeon General expressed a similar 
rationale: ``In addition to the potential human cost, mass 
casualties would degrade our military mission, military 
capability and mission accomplishment. We would not send people 
into battle without helmets and weapons. So we should also 
provide the best armor against biological dangers that we can. 
That armor is immunization.'' \118\
---------------------------------------------------------------------------
    \118\ Testimony of Lt. Gen. Charles H. Roadman, II, Surgeon 
General, USAF, NSVAIR anthrax hearing (I), p. 18.
---------------------------------------------------------------------------
    But some service members see an important difference 
between the physical body armor worn in battle, which can be 
removed, and medical prophylaxis, which cannot. ``The body 
armor that our Department of Defense refers to is perceived by 
many service members as `tin foil armor.' '' \119\
---------------------------------------------------------------------------
    \119\ Testimony of Captain Thomas Rempfer, NSVAIR anthrax hearing 
(I), p. 40.
---------------------------------------------------------------------------
    Primary reliance on medical intervention may also undermine 
confidence in other elements of the force protection hierarchy. 
One hearing witness asked if the vaccine might not ``create a 
facade of force protection'' provoking an adversary to even 
more lethal chem/bio or conventional attack.\120\ He noted:
---------------------------------------------------------------------------
    \120\ Ibid.

        These foundations of force protection rely on a 
        credible willingness to use force. This resolve won the 
        Cold War and it won the Gulf war. Abandoning this time 
        tested doctrine and emphasizing the inevitability of 
        biological attack to advocate a defensive anthrax 
        vaccination policy may inadvertently result in 
        legitimizing biological warfare.\121\
---------------------------------------------------------------------------
    \121\ Ibid.

    The vaccine policy also reflects a lack of confidence in 
current force protection equipment. Physical barriers, 
effective against all toxins and microbes if used properly and 
in time, are now viewed as ``likely to remain only partially 
effective for the foreseeable future.'' \122\ Protective suits 
and masks ``degrade individual operating capabilities and force 
effectiveness . . .'' \123\ The purpose of the current doctrine 
on bio/chemical defense ``is to maintain combat operations 
unencumbered by contamination and the wearing of the protective 
gear.'' \124\
---------------------------------------------------------------------------
    \122\ See supra note 85, p. 11.
    \123\ Ibid.
    \124\ See supra note 103.
---------------------------------------------------------------------------
    Even this doctrinal reliance on the primacy of medical 
protection does not necessarily demand the universal, pre-
deployment inoculation that characterizes the AVIP. Throughout 
the policy deliberation process, the option was considered to 
hold vaccines in stockpiles and defer actual immunization until 
mobilization to a threat area.\125\ As late as September 1997, 
decision memoranda to the Under Secretary of Defense contained 
a recommendation to: ``Maintain the planning guidance for total 
force immunization as a contingency plan, ready for finalizing, 
coordination, and approval at the appropriate time based on: 
(a) resolution, in conjunction with the FDA, of facility 
production issues; and/or (b) changes in the validated anthrax 
biological warfare threat.'' \126\
---------------------------------------------------------------------------
    \125\ Dr. Edward D. Martin, et. al., Acting Assistant Secretary of 
Defense (Health Affairs), Department of Defense, ``Memorandum for 
Deputy Secretary of Defense--Anthrax Vaccination Implementation Plan--
ACTION MEMORANDUM,'' p. 1, Sept. 19, 1997 (in subcommittee files).
    \126\ Ibid., p. 2.
---------------------------------------------------------------------------
    The decision to launch the force-wide, mandatory 
immunization program, despite well documented misgivings about 
the vaccine and the capacity of the vaccine manufacturer, seems 
to have been driven by a genuine concern to avoid casualties, a 
military requirement for theoretically uniform protection 
within deployed units, an expansive view of demands on U.S. 
troop mobility, and the daunting logistics of the chosen 
vaccine.
    ``Why is it essential that the anthrax immunization be 
mandatory? Military commanders have the responsibility to 
ensure the health and safety of their troops and to carry out 
their mission responsibilities. Anthrax is a serious threat. We 
have a safe and efficacious vaccine. To not use the vaccine 
constitutes a failure to protect our troops and a risk to 
carrying out military missions.'' \127\ According to DOD, ``We 
are morally obligated to provide the best protection we are 
capable of providing to our troops--in the case of protection 
against anthrax, there is a vaccine to provide individual 
immunity to this biological warfare agent.'' \128\ According to 
Dr Bailey, ``Like other vaccines that are required to prepare 
military personnel for deployment, the anthrax vaccine is 
mandatory.'' \129\
---------------------------------------------------------------------------
    \127\ Prepared statement of Dr. Sue Bailey, Assistant Secretary of 
Defense for Health Affairs, NSVAIR anthrax hearing (I), p. 10.
    \128\ DOD, Public Affairs Talking Points, p. 1, Dec. 15, 1997.
    \129\ Prepared statement of Dr. Sue Bailey, Assistant Secretary of 
Defense for Health Affairs, NSVAIR anthrax hearing (I), p. 10.
---------------------------------------------------------------------------
    But the anthrax vaccine requirement differs from general 
military immunization and chemoprophylaxis policy in two 
significant respects. Other inoculations are required pursuant 
to medical, not military command authority,\130\ and they are 
required primarily to maintain and protect the health of 
personnel from naturally occurring diseases or pathogens 
endemic to specific duty or deployment areas. Although the 
threat of natural anthrax ``remains a significant problem in 
numerous countries throughout Africa, the Middle East, Europe 
and Asia,'' \131\ the general military immunization policy 
contains no reference to the anthrax vaccine.
---------------------------------------------------------------------------
    \130\ Department of Defense, Medical Services--Immunizations and 
Chemoprophylaxis, Army Regulation 40-562, NAVMEDCOMINST 6230.3, AFR 
161-13, CG COMDTINST M6230.4D, Oct. 7, 1988.
    \131\ See supra note 105, p. 1.
---------------------------------------------------------------------------
    When asked how the United States program compared to the 
approach of allied forces, such as Great Britain which began a 
voluntary program, or Israel which appears to rely primarily on 
antibiotic treatments, the Pentagon responded, ``DOD does not 
base its policies on those of our allies or coalition 
partners.'' \132\ Because ``our Armed Forces must be prepared 
to conduct successful military operations worldwide at a 
moments [sic] notice,'' DOD believes the ``mandatory AVIP is 
clearly in our best interests and strongly supports our 
national security and military strategies.'' \133\
---------------------------------------------------------------------------
    \132\ See supra note 66, p. 14.
    \133\ Ibid.
---------------------------------------------------------------------------
    But there will be exceptions. A July 1999 Defense Threat 
Reduction Agency policy on anthrax immunization says:

        Deploying civilian employees who decline to participate 
        in the DTRA-AVIP will be required to execute a 
        ``Statement of Informed Declination'' attesting to the 
        Agency's offer of anthrax immunization and the 
        individual's decision to decline. By signing this 
        statement, the employee acknowledges and willingly 
        assumes the enhanced medical risk associated with 
        travel to affected regions without receiving the 
        recommended vaccinations. Hence, his/her deployment to 
        these regions in support or mission requirements will 
        not necessarily be precluded. This statement will 
        become a part of the individual's permanent 
        Occupational Health Record.\134\
---------------------------------------------------------------------------
    \134\ Defense Threat Reduction Agency, Policy Memorandum 99-22, 
July 23, 1999, p. 2 (in subcommittee files).

    One of the primary reasons for the mandatory AVIP is the 
perceived need for consistent levels of force protection within 
and between deployed units to guarantee military effectiveness. 
Field commanders need to know the capabilities of their 
members. But even the force-wide, mandatory anthrax vaccine 
program is unlikely to meet that need. DOD concluded, but 
cannot prove, that individual antibody response to the vaccine 
equals protection from anthrax attack. That is, DOD believes 
the more anthrax-fighting antibodies produced, the more medical 
``body armor'' has been acquired. Animal studies suggest this 
may be the case for some species, but no correlate has been 
developed to permit extrapolation of this conclusion to 
humans.\135\
---------------------------------------------------------------------------
    \135\ Prepared statement of Kwai-Cheung Chan, NSVAIR anthrax 
hearing (II), p. 17.
---------------------------------------------------------------------------
    In any event, DOD does not test military personnel for 
antibody levels to determine the extent to which members of a 
unit may have acquired protection against anthrax. Uniform 
protection is also unlikely because individual immunological 
response to the vaccine can vary substantially due to a variety 
of factors, including gender, and contemporaneous 
administration of other vaccines or medicines.\136\ 
Nevertheless, DOD concludes enrollment in the AVIP equals 
protection for purposes of satisfying the need for uniform 
force protection.\137\
---------------------------------------------------------------------------
    \136\ Testimony of Col. Renata Engler, Chief, Allergy-Immunology 
Service, Walter Reed Army Medical Center, NSVAIR anthrax hearing (IV), 
p. 173.
    \137\ See supra note 46, p. 1.
---------------------------------------------------------------------------
    And, the very factors cited by DOD as necessitating 
universal AVIP coverage may actually work against that goal. 
Rapid mobility and the mixture of active and reserve forces 
mean individuals bring variable levels of protection to their 
assignments, depending on the number of shots taken to date and 
their individual immune system response. Some people don't 
respond to the vaccine at all.\138\ So, beyond the general 
proposition that vaccinated individuals are likely to have some 
protection against some level of attack, the AVIP will not 
assure a commander that a unit is uniformly or even 
substantially protected. In tactical terms, the protection 
afforded by vaccination would be needed only during the time 
between detection and the order to deploy individual and 
collective physical protective measures (suits, masks, tents, 
et cetera). Better detection capability, improved masks and a 
battlefield doctrine to deploy protective measures earlier 
could limit or eliminate the need even for that small window of 
protection provided by the vaccine.
---------------------------------------------------------------------------
    \138\ Investigational New Drug [IND] application for anthrax 
vaccine adsorbed [AVA] submitted by Michigan Biologic Products 
Institute, Lansing, MI, Sept. 20, 1996, pp. 28-29 (in subcommittee 
files).
---------------------------------------------------------------------------

2. The AVIP is vulnerable to supply shortages and price increases. The 
        sole-source procurement of a vaccine that requires a dedicated 
        production facility leaves DOD captive to old technology and a 
        single, untested company. Research and development on a second-
        generation, recombinant vaccine would allow others to compete

    DOD has built a force-wide program on the narrowest 
possible industrial base.
    According to GAO, ``The most critical component of the 
program, an adequate supply of vaccine, is threatened by 
testing delays and possible loss of production capability.'' 
\139\ Moreover, GAO found ``DOD's plans for maintaining an 
adequate supply of vaccine are optimistic . . . and assume that 
FDA will grant approval of tested lots in less time than in the 
past.'' \140\ Despite the possibility of further delays or a 
recurrence of financial problems at BioPort, ``DOD does not 
have a formal contingency plan to deal with such 
possibilities.'' \141\
---------------------------------------------------------------------------
    \139\ See supra note 26, p. 12
    \140\ Ibid., p. 5.
    \141\ Ibid.
---------------------------------------------------------------------------
    When DOD launched the AVIP, subject to the Secretary's four 
conditions including supplemental testing, MBPI/BioPort held 40 
lots of vaccine, roughly the equivalent of 8 million doses, or 
enough vaccine to provide 1.3 million people the full six-shot 
regimen (assuming all lots were used before the expiration of 
original or extended label dating). But problems in the 
supplemental testing program delayed or precluded release of 18 
lots.\142\ GAO found:
---------------------------------------------------------------------------
    \142\ Ibid., p. 13.

          In summary, as of June 23, 1999, only 713,000 doses 
        in the stockpile were available for use, and more than 
        half of them--about 416,000 doses--will expire in 
        February and April 2000. On the basis of DOD's 
        estimates of doses required per month, the 713,000 
        doses would sustain phase 1 of the program through 
        December 1999.\143\
---------------------------------------------------------------------------
    \143\ Ibid., p. 15; including an estimated 3-month supply already 
delivered to the field at the time of this estimate, GAO concluded the 
program could be sustained at best through March 2000.

    But even that delayed schedule may be optimistic. FDA 
inspectional findings on the renovated facility contain a 
number of observations repeated from the February 1998 
inspection.\144\ FDA considered those earlier findings 
``significant'' and took issue with DOD officials 
characterizing cGMP matters as mere ``bookkeeping 
difficulties'' in public statements.\145\ If problems with the 
renovated facility are determined to be significant enough to 
bar release of vaccine lots produced since May 1999,\146\ DOD 
could face severe shortages.
---------------------------------------------------------------------------
    \144\ FDA Form 483, Nov. 15-23, 1999 (in subcommittee files). See 
also, Stars and Stripes, ``Cohen Defends Mandatory Anthrax Shots After 
Ordering FDA-Related Suspension,'' p. 1, Dec. 20, 1999.
    \145\ E-mails between Food and Drug Administration and Department 
of Defense dated Aug. 31-Sept. 1, 1999 (in subcommittee files).
    \146\ Production of consistency lots began in the renovated and 
expanded BioPort facility in May 1999. Data on consistency lots is 
submitted to FDA to validate the production process. Other lots have 
also been produced by BioPort in the expanded facility, but use of 
those at risk lots depends on FDA approval of the facility license 
supplement, an amendment to the license regarding the potency test and 
approval of test data on each lot.
---------------------------------------------------------------------------
    Because resumption of vaccine production has been delayed 
longer than anticipated by plant renovations and efforts to 
meet FDA compliance requirements, implementation of phase II of 
the AVIP, scheduled to begin in early 2000, has been delayed 
``in the range of 6 to 12 months.'' \147\
---------------------------------------------------------------------------
    \147\ Dr. Sue Bailey, Department of Defense news briefing, Dec. 13, 
1999, p. 2 (available at: http://www.defenselink.mil) (in subcommittee 
files).
---------------------------------------------------------------------------
    In addition to production problems and delays, BioPort may 
not be a reliable financial partner in the vaccine enterprise. 
At the subcommittee's request, the General Accounting Office 
[GAO] examined the structure and status of the financial 
relationship between DOD and BioPort.\148\ They reviewed the 
contract documents, proposals and analyses done in connection 
with DOD procurement of the anthrax vaccine.\149\
---------------------------------------------------------------------------
    \148\ Letter to David Walker, Comptroller General, U.S. General 
Accounting Office from Representative Christopher Shays, chairman, 
Subcommittee on National Security, Veterans Affairs, and International 
Relations, House Committee on Government Reform, May 13, 1999 (in 
subcommittee files).
    \149\ Contract Management--Observations on DOD's Financial 
Relationship with the Anthrax Vaccine Manufacturer, prepared statement 
of Louis J. Rodrigues, Director, Defense Acquisition Issues, National 
Security and International Relations Division, GAO, GAO/T-NSIAD-99-24, 
June 30, 1999.
---------------------------------------------------------------------------
    Only 9 months after entering into the agreement, BioPort's 
ability to perform under the contract was in doubt.\150\ In 
June 1999, the Defense Contract Audit Agency [DCAA] completed 
an audit of BioPort's financial condition and reached a similar 
conclusion.\151\ According to GAO, estimates contained in 
BioPort's business plan and contract proposal have proven 
highly optimistic.\152\
---------------------------------------------------------------------------
    \150\ Testimony of Louis J. Rodrigues, Director, Defense 
Acquisition Issues, National Security and International Affairs 
Division, U.S. General Accounting Office, NSVAIR anthrax hearing (III), 
p. 4.
    \151\ Defense Contract Audit Agency, report No. 2261-97G21000018, 
Department of Defense, Sept. 24, 1997 (in subcommittee files).
    \152\ Prepared statement of Louis J. Rodrigues, Director, Defense 
Acquisition Issues, National Security and International Relations 
Division, GAO, NSVAIR anthrax hearing (III), p. 7.
---------------------------------------------------------------------------
    As a result, BioPort had to request emergency assistance 
from DOD and major modifications to the contract.\153\ In order 
to remain able to produce vaccine for the AVIP, BioPort sought 
and received an advance payment of $10 million, a significant 
per-dose price increase and DOD permission to sell up to 
300,000 doses each year on the open market, despite the fact 
those doses would be produced using government furnished 
equipment under the DOD contract.\154\ DOD also authorized 
BioPort's sale of up to 70,000 doses from the vaccine produced 
under the prior contract but either released or deemed never 
part of the stockpile.\155\
---------------------------------------------------------------------------
    \153\ DOD briefing slides, ``BioPort Contract--Anthrax Vaccine,'' 
June 2, 1999 (in subcommittee files). See also, BioPort Corp. media 
release, ``Anthrax Vaccine Manufacturer Calls for Fair and Reasonable 
Cotract,'' June 30, 1999 (in subcommitee files).
    \154\ Testimony of David R. Oliver, Jr., Principal Deputy Under 
Secretary of Defense for Acquisition and Technology, NSVAIR anthrax 
hearing (III), p. 65.
    \155\ Testimony of David R. Oliver, Jr., Principal Deputy Under 
Secretary of Defense for Acquisition and Technology, NSVAIR anthrax 
hearing (III), pp. 64-65. See also, DOD briefing slides, ``Anthrax 
Vaccine Absorbed Information Brief,'' June 4, 1999 (in subcommittee 
files). The briefing contained the following points: ``Ms. Spector 
advised that doses in the inventory that have been paid for cannot be 
used by BioPort for Private/Foreign Sales'' and ``Release doses from 
stockpile for private sales--JPO/OSD action (very political).''
---------------------------------------------------------------------------
    This early, extraordinary relief was necessary because 
production delays reduced estimated income. And, the 
procurement had to be done by means of a fixed price contract 
because neither side to the contract knew what it actually cost 
to produce the vaccine.\156\ In its transition from a state-
owned facility to a private enterprise, MBPI/BioPort has not 
fully implemented promised cost control and cost accounting 
systems to support a more appropriate cost-reimbursement 
procurement.
---------------------------------------------------------------------------
    \156\ Testimony of Louis J. Rodrigues, Director, Defense 
Acquisition Issues, National Security and International Relations 
Division, GAO, NSVAIR anthrax hearing (III), p. 28.
---------------------------------------------------------------------------
    GAO also found the dependent relationship between DOD and 
BioPort unusual and risky. While sole-source procurements for 
vaccines may be common, those producers usually have other 
product lines generating income from other customers. In this 
case, problems with the production and delivery of the one 
vaccine put the corporation in an extemely bad financial 
position.\157\
---------------------------------------------------------------------------
    \157\ Ibid., p. 16.
---------------------------------------------------------------------------
    One vaccine producer operating a single production site 
also points to security risks. GAO observed, ``But if we are 
relying upon this vaccine as part of the backbone of our 
defensive biological program, the question of vulnerability to 
a single site becomes an issue. If you made a decision with 
respect to that vulnerability that led you to want to have an 
alternative site, then we probably should be looking at 
establishing a second source.'' \158\
---------------------------------------------------------------------------
    \158\ Ibid., p. 15.
---------------------------------------------------------------------------
    Following the Gulf war, and prior to adoption of the DOD 
immunization policy (1993) and the mandated AVIP (1998), 
Pentagon officials considered and rejected alternative anthrax 
vaccine production sites.\159\ Instead, an acquisition strategy 
was adopted focusing solely on the MBPI/BioPort vaccine.\160\
---------------------------------------------------------------------------
    \159\ See supra note 36, p. 1.
    \160\ See supra note 37.
---------------------------------------------------------------------------
    Since 1993, DOD has focused almost exclusively on the 
older, FDA approved vaccine, to the exclusion of development 
work on newer, recombinant vaccine formulations. Not 
surprisingly, DOD market surveys detected little interest by 
other pharmaceutical or biologics companies in producing the 
older anthrax vaccine under a licence from MBPI. So it appears 
DOD's sole source justification may be self-validating, in that 
there is only one AVA producer because the single largest 
vaccine customer has decided to deal with only one producer.
    Other manufacturers would be more likely to express an 
interest in recombinant vaccine production because it can be 
done more safely and efficiently than older vaccine formulation 
methods involving live bacteria. But DOD decided not to 
emphasize recombinant anthrax vaccine development due to the 
lengthy (6 to 8 years) development and approval time, and 
potential high costs.
    Yet, had DOD officials elected to pursue second-generation 
anthrax vaccine development aggressively 6 years ago, they 
would be nearing completion on a newer, purer anthrax vaccine. 
BioPort's current financial demands, and the company's power to 
hold the AVIP hostage in the future, appear to undermine DOD's 
determination the MBPI/BioPort acquisition strategy would prove 
more affordable than new vaccine development.
    One legal review of the BioPort contract sole source 
justification suggested DOD add a reference to ways competition 
might be increased by utilizing alternative technologies to 
produce the anthrax vaccine. The suggestion was not 
incorporated in the final document.\161\
---------------------------------------------------------------------------
    \161\ Elizabeth Arwine, Legal Advisor, ``Legal Review of 
Justification and Approval [J&A];'' Michigan Biologic Products 
Institute [MBPI], Jun. 3, 1997, p. 1 (in subcommittee files). See also, 
Joseph S. Little, ``Response to JAG Comments,'' Department of Defense 
memorandum for record, June 4, 1997 (in subcommittee files).
---------------------------------------------------------------------------
    It appears the choice of the MBPI vaccine for use in the 
AVIP may also have been premised on DOD and the manufacturer 
obtaining FDA approval to reduce the lengthy shot course from 
six shots over 18 months, to just two or three inoculations 
over 6 weeks. DOD developed a detailed program to gain approval 
for a shortened AVA shot course due to problematic levels of 
systemic (0.7 to 1.3 percent) and significant local reactions 
(2.4 to 3.9 percent) associated with the prolonged immunization 
schedule.\162\ An Investigational New Drug [IND] application 
was filed on September 20, 1996 at the FDA to study a reduced 
anthrax vaccine shot course, but design of a definitive 
comparison study has never been submitted.\163\
---------------------------------------------------------------------------
    \162\ See supra note 108.
    \163\ Letter from Melinda K. Plaisier, Interim Associate 
Commissioner for Legislative Affairs, Food and Drug Administration to 
Representative Christopher Shays, chairman, Subcommittee on National 
Security, Veterans Affairs, and International Relations, House 
Committee on Government Reform, Mar. 15, 1999 (in subcommittee files).
---------------------------------------------------------------------------
    So now, having foregone opportunities to improve or 
diversify anthrax vaccine production capacity, both DOD and 
BioPort are in a fiscal squeeze. Having made a substantial 
investment in MBPI and BioPort, DOD now faces hard, costly 
choices between sustaining the sole FDA licensed manufacturer 
of the anthrax vaccine, which may prove inadequate, and/or 
embarking on the establishment and licensure of another. In 
future budgets, DOD must consider to fund ``developing a second 
source to BioPort or developing a different approach to solve 
the anthrax problem and don't take that money and put it 
against solving another bio-threat. . . .'' \164\
---------------------------------------------------------------------------
    \164\ Testimony of David R. Oliver, Jr., Principal Deputy Under 
Secretary of Defense for Acquisition and Technology, NSVAIR anthrax 
hearing (III), p. 69.
---------------------------------------------------------------------------
    While these alternatives are being reviewed, the mandatory 
force-wide program to provide protection against what DOD 
characterizes as the pre-eminent biological warfare threat is 
on a very uncertain procurement footing. Without more 
extraordinary DOD assistance, BioPort appears financially 
incapable of capitalizing and sustaining a highly technical, 
heavily regulated manufacturing process. The same financial 
pressures that hindered MBPI's ability to comply with FDA good 
manufacturing practices could also continue to affect BioPort's 
capacity to produce a safe and effective product on schedule.

3. The AVIP is logistically too complex to succeed. Adherence to the 
        rigid schedule of six inoculations over 18 months for 2.4 
        million members of a mobile force is unlikely, particularly in 
        reserve components. Using an artificial standard that counts 
        only shots more than 30 days overdue, DOD tolerates serious 
        deviations from the Food and Drug Administration [FDA] approved 
        schedule

    No other vaccine required by DOD for force health or combat 
protection demands so complex an administration schedule.\165\ 
The FDA approved inoculation regime is six shots over 18 
months, with a subcutaneous injection of AVA to be given as 
follows:
---------------------------------------------------------------------------
    \165\ See supra note 130.
---------------------------------------------------------------------------
        #1--start of series
        #2--2 weeks later
        #3--1 month after start of series
        #4--6 months after start of series
        #5--1 year after start of series
        #6--18 months after start of series.
        Booster--annually after completion of initial 
        series.\166\
---------------------------------------------------------------------------
    \166\ See supra note 41.
---------------------------------------------------------------------------
    The ability to track immunizations and meet this schedule 
was one of Secretary Cohen's four preconditions to the AVIP. 
But even the Secretary of Defense received his fourth 
inoculation 3 weeks before it was due.\167\
---------------------------------------------------------------------------
    \167\ E-mail from Col. Fred Gerber dated Sept. 1, 1998 (in 
subcommittee files).
---------------------------------------------------------------------------
    In an effort to comply with the elaborate timetable, DOD 
administers a three-tiered recordkeeping system. Each 
inoculation should be recorded on the individual service 
member's shot record.\168\ Data recorded should include the 
date and AVA lot number. The same data is also entered into one 
of the service branch medical systems.\169\ Finally, the 
service branch systems periodically forward inoculation data to 
the Defense Enrollment Eligibility Reporting System [DEERS], a 
pre-existing facility modified to serve as an interim access 
point for centralized AVIP data. In the future, DOD plans to 
centralize AVIP data using an upgrade of the Composite Health 
Care System now under development.\170\
---------------------------------------------------------------------------
    \168\ Form #PHS-731, Department of Defense (in subcommittee files).
    \169\ Service-specific subsystems: the Army MEDPROS, Navy SAMS and 
R-STARS, Air Force MITS.
    \170\ See supra note 26, p. 10.
---------------------------------------------------------------------------
    This system was designed to address problems with medical 
recordkeeping encountered during Operation Desert Shield, 
Desert Storm, and in Bosnia.\171\ However, while GAO found some 
improvements in vaccination records, a sampling of AVIP 
tracking at four locations discovered varying levels of 
discrepancies between paper and electronic data. According to 
GAO:
---------------------------------------------------------------------------
    \171\ Ibid., p. 20.

        Inconsistency in dates could lead to vaccinations being 
        given off-schedule and to inaccurate readiness reports. 
        Inconsistent or missing lot information could hinder 
        investigations, should concerns arise over a specific 
        lot. Also, information that is not recorded in paper 
        records makes it difficult to address adverse reactions 
        needing immediate care or determine the validity of 
        subsequent claims for disability compensation.\172\
---------------------------------------------------------------------------
    \172\ Ibid., p. 21.

    GAO also found use of DEERS data more limited than 
anticipated. ``DEERS was envisioned as a major source of 
reports on program implementation. However, concerns about the 
timeliness and accuracy of data in DEERS have cause service 
representatives to rely on interim, service-specific tracking 
systems, and other systems to track and report vaccination 
information.'' \173\ Specific concerns centered on duty station 
data, found in some cases to be updated only 6 to 9 months 
late.\174\ This severely limits the utility of DEERS as a tool 
to generate unit compliance or readiness reports, since the 
database often does not reflect current unit membership. 
Readiness estimates based on AVIP tracking data are ``still 
suspect,'' according to an internal DOD document.\175\
---------------------------------------------------------------------------
    \173\ Ibid., p. 22.
    \174\ Ibid.
    \175\ E-mails from Maj. Guy Strawder dated Feb. 17, 1999 (in 
subcommittee files).
---------------------------------------------------------------------------
    The difficulties of tracking anthrax vaccinations in the 
active force are compounded in reserve component units,\176\ 
given changing unit memberships and monthly training schedules 
unlikely to match the inoculation regime. This difficulty was 
anticipated,\177\ but DOD acknowledged in testimony that 
compliance with the FDA inoculation schedule in reserve 
component units was lower than in the active force due to less 
frequent drill schedules and timing of access to military 
medical facilities for purposes of receiving the vaccine.\178\
---------------------------------------------------------------------------
    \176\ Reserve components consist of Army, Navy, Air Force, and 
Marine reserve units as well as Army and Air National Guard units. 
Reserve units are elements of the national military. National Guard 
units are state militias unless federalized.
    \177\ See supra note 108.
    \178\ Prepared statement of Charles L. Cragin, Acting Assistant 
Secretary for Reserve Affairs, DOD, NSVAIR anthrax hearing (V), pp. 5-
7; testimony of Charles L. Cragin, NSVAIR anthrax hearing (V), p. 150.
---------------------------------------------------------------------------
    As the logistical challenges of vaccine compliance 
increase, so do the risks of deviations from the approved 
schedule. While the effect of schedule deviations is another 
unknown element of the AVIP, DOD concludes ``the greater the 
deviation the less certain the protective effect in humans.'' 
\179\ Nevertheless, ``DOD set a timeliness goal of vaccinating 
90 percent of all service members no more than 30 days after 
their vaccinations are due. . . .'' \180\ DOD reports meeting 
that goal.\181\
---------------------------------------------------------------------------
    \179\ Memorandum on ``Policy Deviation from Anthrax Vaccine 
Immunization Schedule'' from the Department of Defense dated Sept. 11, 
1998, p. 1 (in subcommittee files).
    \180\ See supra note 26, p. 24. See also, testimony of Charles L. 
Cragin, Acting Assistant Secretary for Reserve Affairs, DOD, NSVAIR 
anthrax hearing (V), p. 150.
    \181\ Department of Defense, ``Anthrax Vaccine Immunization Program 
Quarterly Review,'' Jan. 22, 1999, p. 9 (in subcommittee files).
---------------------------------------------------------------------------
    On August 4, 1999, the subcommittee requested data on 
vaccine regimen compliance in all reserve component units then 
enrolled in the vaccine program. The DEERS reports provided to 
the subcommittee contained shot records on 32,681 individuals 
who had received one or more inoculations prior to July 31, 
1999. Almost half (15,625) the individuals listed were overdue 
to receive an inoculation. In some cases, entire units had 
missed the schedule by a month or more. A summary of the data 
follows:

------------------------------------------------------------------------
         Branch/Res. Comp           # Enrolled   # Overdue    % Overdue
------------------------------------------------------------------------
AFReserves.......................         8931         2954           33
AIRNG............................         9246         2482           27
ArmyNG...........................         2441         1443           59
ArmyReserves.....................         5802         3661           63
MCReserves.......................         2730         1967           72
USNReserves......................         3531         3118     88 \182\
------------------------------------------------------------------------

    The Air Surgeon, Col. James Dougherty, disputed the 
accuracy of the DEERS data. In an e-mail reacting to a media 
report of poor compliance in a Connecticut Air National Guard 
unit, he said ``all the data are inaccurate'' because the DEERS 
system is updated weeks after shots are actually 
administered.\183\ DOD also said the data showing overdue 
inoculations was inflated due to the inadvertent inclusion of 
Individual Ready Reserve forces, service members who are 
separated from military service but available for call-up.\184\ 
Nevertheless, according to an internal DOD document, readiness 
estimates based on AVIP tracking data are ``still suspect.'' 
\185\
---------------------------------------------------------------------------
    \182\ Letter and accompanying computer diskette from Charles L. 
Cragin to Representative Christopher Shays dated Aug. 23, 1999 (in 
subcommittee files).
    \183\ E-mails from James Dougherty dated Sept. 1, 1999. (in 
subcommittee files)
    \184\ Testimony of Charles L. Cragin, Acting Assistant Secretary 
for Reserve Affairs, NSVAIR anthrax hearing (V), p. 104 (in 
subcommittee files).
    \185\ See supra note 175.
---------------------------------------------------------------------------
    If the centralized tracking system cannot provide a real-
time picture of the inoculation status of the entire force, or 
individual units, it fails to meet the operational standard set 
by the Secretary as a condition of AVIP implementation.
    The data provided to the subcommittee by DOD also showed 
most reserve component members receive the first three 
inoculations on schedule, with compliance deviations occurring 
with regard to subsequent shots.\186\ That may not be entirely 
inadvertent. DOD documents contain the statement ``Soldiers 
with 3 or more vaccinations are Protected.'' \187\ The DOD 
position that ``functional protection'' \188\ is provided after 
only three of the six required inoculations sets a 
deployability standard against which reserve component 
commanders are measured. Once members of a unit have received 
three shots, there appears to be little incentive to press for 
further compliance with an increasingly unpopular program.
---------------------------------------------------------------------------
    \186\ See supra note 182.
    \187\ See supra note 134, p. 2, and e-mails from Department of 
Defense personnel dated Feb. 17-Apr. 14, 1999 (in subcommittee files); 
If the manufacturer of a pharmaceutical or biologic product advised 
patients or physicians that half the FDA approved dosage or 
administration regimen was as effective against the labeled indication, 
it would be a serious violation of FDA regulations.
    \188\ See supra note 134, p. 2.
---------------------------------------------------------------------------
    There is little scientific evidence to support the theory 
that three shots protect as well as six. DOD expended 
significant time and resources in 1994 and 1995 on plans and 
programs to demonstrate the safety and efficacy of a shorter 
anthrax inoculation regime, and a different route of 
administration. An Investigational New Drug [IND] application 
was filed to guide further animal studies and clinical trials 
in humans. But the effort appears to have all but abandoned 
when planning for the AVIP began. Support for the FDA 
application to reduce the shot course seems to have been 
redirected to vaccine acquisition and AVIP logistics.
    In September 1999, the Director of the FDA Center for 
Biologics Evaluation and Research, Dr. Katherine Zoon, wrote to 
Dr. Sue Bailey, Assistant Secretary of Defense for Health 
Affairs regarding data showing significant deviations from the 
AVA administration routine:

        . . . Because we are unaware of any data demonstrating 
        that any deviation from the approval intervals of doses 
        found in the approved labeling will provide protection 
        from anthrax infection, we strongly recommend that the 
        Anthrax Vaccine Immunization Program follow the FDA 
        approved schedule.\189\
---------------------------------------------------------------------------
    \189\ Letter from Dr. Katherine C. Zoon to Dr. Sue Bailey dated 
Sept. 29, 1999 (in subcommittee files).

    Prior to the administration of each shot, medical personnel 
are directed to provide information on the vaccine and the 
program, and to inform each recipient regarding the health 
factors that should exclude a person.\190\ Exclusionary factors 
include severe reaction to a previous shot, active infection, 
pregnancy, current immuno-suppression.\191\ Service members 
should also be informed regarding the identification and 
reporting of adverse health events suffered subsequent to 
inoculation.\192\
---------------------------------------------------------------------------
    \190\ See supra note 46, p. C-5.
    \191\ See supra note 41.
    \192\ Department of Defense, ``Clinical Practice Guidelines for 
Managing Adverse Events After Anthrax and Other Vaccinations,'' Nov. 
15, 1999 pp. 1-2. (in subcommittee files).
---------------------------------------------------------------------------
    But GAO found medical staff and service members were not 
well informed about reporting adverse events and found more 
than 40 percent of those sampled had not received information 
on how to report vaccine related adverse events.\193\ Testimony 
by service members reflected the GAO findings.
---------------------------------------------------------------------------
    \193\ See supra note 26, pp. 24-26.
---------------------------------------------------------------------------
    Ms. Randi Martin-Allaire, a civilian employee of the 
Michigan Air National Guard told the Subcommittee, ``I was on 
antibiotics at the time I received my fourth injection, and was 
never asked if I was on any type of medication or 
antibiotics.'' \194\ Her colleagues described similar miscues 
and confusion over the standards for identifying and treating 
vaccine adverse reactions.\195\
---------------------------------------------------------------------------
    \194\ Prepared statement of Randi J. Martin-Allaire, NSVAIR anthrax 
hearing (II), p. 170.
    \195\ Prepared statement of Roberta Groll, NSVAIR anthrax hearing 
(II), pp. 176-179; and prepared statement of David Churchill, NSVAIR 
anthrax hearing (II), pp. 183-188.
---------------------------------------------------------------------------
    Service members report AVIP information and briefings seem 
designed to persuade, not educate. The inability of Air Force 
briefers to answer service members' questions led one commander 
to suspend the vaccination program until the Air Force Surgeon 
General personally intervened.\196\ Vaccine recipients also 
report mass inoculations during which no questions regarding 
current health status are asked and no VAERS forms made 
available.\197\
---------------------------------------------------------------------------
    \196\ Debra Funk, ``Air Guard Unit Delays Anthrax Inoculations,'' 
Air Force Times, July 5, 1999, p. 29.
    \197\ E-mails and meeting notes (in subcommittee files).
---------------------------------------------------------------------------
    The AVIP is made more complex by the need to address 
growing resistance to the vaccine, specifically in reserve 
component units. The impact of the AVIP on retention in reserve 
component units could be significant. Informal surveys by 
service members suggest the Air National Guard may suffer air 
crew attrition of 30 percent or more.\198\ To date, the Defense 
Department has not acknowledged any unusual pattern of 
resignations attributable to the AVIP.\199\
---------------------------------------------------------------------------
    \198\ See supra note 74.
    \199\ Testimony of Maj. Gen. Paul Weaver, Director, Air National 
Guard, DOD, NSVAIR anthrax hearing (V), p. 118.
---------------------------------------------------------------------------
    It is not clear where the Department might look to discern 
such a pattern. DOD collects no centralized data on refusals or 
resignations attributable to the vaccine program. Some service 
members also said unit commanders openly discouraged 
attribution of resignations or transfers to the AVIP.\200\ An 
Air Force Reserve Interim Anthrax Policy forbids the approval 
of transfer requests made by anyone scheduled or directed to 
begin the anthrax immunizations.\201\
---------------------------------------------------------------------------
    \200\ E-mails (in subcommittee files).
    \201\ Command Anthrax Policy, U.S. Air Force Reserve, June 22, 1999 
(in subcommittee files).
---------------------------------------------------------------------------
    GAO was critical of this lack of monitoring to determine 
the effectiveness of the AVIP communications effort.\202\ 
Without data on refusals, ``it is difficult to better target 
educational efforts and address emerging concerns. These 
problems need to be resolved if the program is to succeed in 
vaccinating the entire force against anthrax.'' \203\ (emphasis 
added)
---------------------------------------------------------------------------
    \202\ See supra note 26, p. 35.
    \203\ Ibid.
---------------------------------------------------------------------------
    To address the logistical challenges of the current 
immunization schedule, and to reduce the number of exposures to 
a ``reactogenic'' \204\ vaccine, DOD developed a detailed 
program to gain approval for a shortened AVA shot course, but 
FDA approval has not been pursued.
---------------------------------------------------------------------------
    \204\ See supra note 108.
---------------------------------------------------------------------------

4. Safety of the vaccine is not being monitored adequately. The program 
        is predisposed to ignore or understate potential safety 
        problems due to reliance on a passive adverse event 
        surveillance system and DOD institutional resistance to 
        associating health effects with the vaccine

    Based on data gathered during limited occupational use 
since licensure, the AVA can be considered nominally safe. But 
the vastly expanded use of the vaccine for a new purpose 
requires a proactive approach to emerging safety issues. That 
approach is not now a part of the AVIP.
    As with any vaccine, anthrax inoculation can cause adverse 
health events in some individuals, ranging from soreness or 
swelling at the injection site (local reactions) to fevers, 
chills, muscle aches, and anaphylaxis \205\ (systemic 
reactions). Local reaction may be mild, moderate, or severe 
enough to require medical attention. Systemic reactions are 
generally considered clinically more significant. Reactions may 
increase in severity after successive injections.\206\
---------------------------------------------------------------------------
    \205\ Hypersensitivity to a drug or antigen. Anaphylactic shock is 
an often severe, sometimes fatal, physical reaction characterized by 
respiratory symptoms, fainting, swelling, and itching.
    \206\ See supra note 41.
---------------------------------------------------------------------------
    More inoculations mean more reactions. An immunization 
program using a vaccine requiring six shots and annual boosters 
should be prepared to deal with some number and variety of 
adverse health effects. Despite having been licensed for almost 
30 years, the vaccine had not been widely used prior to the 
Gulf war.\207\ As noted previously, lack of adequate medical 
recordkeeping prevents systematic study of that cohort for 
health effects possibly associated with the anthrax vaccine and 
other medicines and toxins. The vaccine is being studied as a 
potential factor in Gulf war veterans' illnesses.\208\ As GAO 
noted, ``The long term safety of the vaccine has not yet been 
studied.'' \209\
---------------------------------------------------------------------------
    \207\ Prepared statement of Kathryn C. Zoon, Ph.D., NSVAIR anthrax 
hearing (II), pp. 52-53.
    \208\ See supra note 1.
    \209\ Prepared statement of Kwai-Cheung Chan, Director, Special 
Studies and Evaluation Section, National Security and International 
Relations Division, GAO, NSVAIR anthrax hearing (II), p. 11.
---------------------------------------------------------------------------
    The AVA has been described as a relatively crude, 
imprecisely characterized vaccine, and estimates of reaction 
rates vary widely.\210\ According to the FDA-approved AVA 
product labeling, 30 percent of vaccine recipients can be 
expected to suffer mild local reactions, 4 percent will incur 
moderate local reactions, and less than 0.2 percent will 
experience systemic reactions.\211\ In 1994 and 1995, DOD 
considered the need for a new anthrax vaccine ``based on the 
reactogenicity of the current vaccine.'' \212\
---------------------------------------------------------------------------
    \210\ Ibid., p. 16.
    \211\ See supra note 41.
    \212\ ``Minutes of FDA Meeting of 5 May 94 Concerning Production 
and Purification of PA from Delta Sterne,'' Department of the Army, May 
19, 1994, p. 1.
---------------------------------------------------------------------------
    In April 29, 1999 testimony \213\ before the subcommittee, 
the General Accounting Office [GAO] summarized studies of 
anthrax vaccine reactions, finding rates of systemic reactions 
ranging from 0.05 percent to 48 percent. (Table 1, below).
---------------------------------------------------------------------------
    \213\ Prepared statement of Kwai-Cheung Chan, Director, Special 
Studies and Evaluation Section, National Security and International 
Relations Division, GAO, NSVAIR anthrax hearing (II), p. 16.

                                       Table I: Reactions to Licensed Anthrax Vaccine Reported in Various Studies
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                             Local reactions (percent)     Systemic reactions (percent)
                                                              Type of         Number     ---------------------------------------------------------------
                          Study                              Reporting    Vaccinated (or                     Moderate/                       Moderate/
                                                                              doses)           Mild           Severe           Mild           Severe
--------------------------------------------------------------------------------------------------------------------------------------------------------
IND.....................................................  Active/Passive         3,984 a          6-20 b          1-10 b          None b          0.05 b
Pittman (1997)..........................................          Active             508              16               5            29 c              14
TAMC (1998).............................................          Active             536   Not Addressed   Not Addressed            43 d               5
DOD (Current monitoring)................................         Passive       223,000 eeeee
--------------------------------------------------------------------------------------------------------------------------------------------------------
a This number represents the number of study participants who received the first dose of the licensed vaccine.
b These figures represent the percentage of people who experienced this type of reaction during the study, even if they had previously been inoculated
  with the Merck vaccine.
c This figure also includes persons who had reactions of ``unknown'' severity.
d This figure represents the frequency of the most common side effect, myalgia.
e DOD testified that as of Mar. 16, 1999, more than 223,000 service members have been immunized. There had been 42 reports on adverse effects submitted
  to the FDA and CDC. Only seven service members required hospitalization or experienced loss of duty for more than 24 hours.

    In later testimony, GAO also observed:

        In addition to reporting to VAERS, DOD has conducted 
        three efforts to actively collect data on adverse 
        reactions after service members received the anthrax 
        vaccine. Data from these efforts show that women 
        reported twice the rate of adverse reactions than men 
        for both local (e.g. swelling) and systemic (e.g. 
        malaise and chills) reactions. In addition, a higher 
        proportion of women than men reported making an 
        outpatient medical visit after a vaccination, and more 
        than twice the percentage of women reported that they 
        missed one or more duty shifts after their vaccinations 
        than did men.\214\
---------------------------------------------------------------------------
    \214\ Prepared statement of Kwai-Cheung Chan, Director, Special 
Studies and Evaluation Section, National Security and International 
Relations Division, GAO, NSVAIR anthrax hearing (IV), p. 3 (in 
subcommittee files).

    Captain Michelle L. Piel believes she suffered an adverse 
reaction to the anthrax vaccine. Fatigue, dizziness, joint pain 
and severe cold-like symptoms following her first two 
inoculations resulted in the loss of flight status. When she 
suggested submitting a report to VAERS, she testified, ``My 
request met reluctance.'' \215\ Because her symptoms did not 
fall within the range of expected vaccine reactions, doctors as 
Dover Air Force Base did not associate her illness to the AVA. 
She concluded, ``This is a major reason why adverse events from 
the anthrax vaccine are underreported.'' \216\ She added,``It 
didn't make sense to me. I was too sick to fly. I was too sick 
to get another shot. But my illness wasn't reportable on a 
VAERS form?'' \217\
---------------------------------------------------------------------------
    \215\ Prepared statement of Capt. Michelle L. Piel, NSVAIR anthrax 
hearing (IV), p. 3 (in subcommittee files).
    \216\ Ibid.
    \217\ Ibid.
---------------------------------------------------------------------------
    When others at Dover suspected health effects might be 
linked to the vaccine, efforts to report a trend ``were met 
with resistance and discouragement from within Dover's medical 
community.'' \218\ According to Capt. Piel, ``It took 6 months 
to reach the right, highly specialized doctors to begin to 
diagnose my immune system problems.'' \219\
---------------------------------------------------------------------------
    \218\ Ibid.
    \219\ Ibid., p. 4.
---------------------------------------------------------------------------
    At the reaction rates cited by the U.S. Army Medical 
Research Institute of Infectious Diseases [USAMRIID],\220\ the 
anthrax vaccine program, when implemented across the entire 2.4 
million member force, could produce 31,200 systemic reactions 
and up to 93,600 severe local reactions. Recently, the Army 
Surgeon General conceded that, ``Systemic events occur in 5 to 
35 percent of anthrax-vaccine recipients.'' \221\ At the range 
of systemic reactions found by DOD in the Tripler Army Medical 
Center active surveillance study, the AVIP could generate over 
1 million systemic reactions, many thousands of which will 
require medical management and treatment.\222\
---------------------------------------------------------------------------
    \220\ See supra note 108.
    \221\ Letter from Lt. Gen. Ronald R. Blanck to Mark Zaid dated Dec. 
10, 1999, p. 1 (in subcommittee files).
    \222\ See supra chart at note 213.
---------------------------------------------------------------------------
    Given that prospect, it might have been expected by service 
members that an integral part of the AVIP would be highly 
sensitive active and passive surveillance systems to ``permit 
accurate assessments of types and severity of adverse 
reactions'' \223\ because ``only widespread use can provide 
this assessment.'' \224\ That was one factor which lead DOD to 
indemnify the vaccine manufacturer against the ``unusually 
hazardous risks'' of vaccine production.\225\
---------------------------------------------------------------------------
    \223\ See supra note 33.
    \224\ Ibid.
    \225\ Ibid.
---------------------------------------------------------------------------
    To better quantify those risks, and to detect adverse 
reaction trends early, the program design could have included 
detailed medical protocols on screening, vaccine 
administration, and adverse events. The AVIP could have 
assembled and trained a multi-disciplinary network of health 
professionals to manage the anticipated adverse event caseload. 
It could have provided each recipient with a simple, one page 
vaccine information sheet on adverse events and drug inter-
actions of the type routinely provided with childhood vaccines. 
The AVIP could have designed and initiated the controlled, 
cohort studies only now being discussed to learn more about 
reaction rate differences by age and gender.\226\
---------------------------------------------------------------------------
    \226\ Deborah Funk, ``Military Officials Order Study to Determine 
Vaccine's Safety, Long-term Side effects,'' Army Times, July 12, 1999, 
p. 12.
---------------------------------------------------------------------------
    The AVIP does not include those safety elements.
    Instead, the program now relies primarily on an adverse 
event surveillance and reporting system known to understate the 
nature and extent of health effects associated with vaccine 
administration. Access to immunologists and allergists is 
limited geographically. Not until 1 year after the program 
began did DOD update briefing materials to include information 
on reporting adverse events and revise program regulations to 
make reporting requirements more inclusive, clarify patient and 
provider responsibilities, and explain how to process a Vaccine 
Adverse Event Reporting System [VAERS] form. Only in July 1999 
did DOD distribute draft clinical guidelines that outline 
clinical protocols, pre-treatments, specialty referral 
processes, contraindications, categorizations of local and 
systemic reactions, and associated treatment algorithms.\227\
---------------------------------------------------------------------------
    \227\ Prepared statement of Maj. Gen. G. Robert Claypool, Deputy 
Assistant Secretary for Health Operations Policy, DOD, NSVAIR anthrax 
hearing (IV), p. 12 (in subcommittee files).
---------------------------------------------------------------------------
    According to GAO testimony, studies have shown passive 
systems sometimes capture only 1 percent of adverse events 
temporally or causally related to use of a medical device or 
vaccine. Reports also vary in quality and utility due to 
inconsistencies in identifying and interpreting health effects 
as vaccine related. A passive system is useful as a 
``sentinel'' to alert clinicians to unexpected events.\228\ 
``It does not tell you how often, with what severity, or does 
not establish causality. The limitations are very well 
accepted.'' \229\
---------------------------------------------------------------------------
    \228\ Testimony of Kwai-Cheung Chan, Director, Special Studies and 
Evaluation Section, National Security and International Relations 
Division, GAO, NSVAIR anthrax hearing (IV), p. 125 (in subcommittee 
files).
    \229\ Testimony of Dr. Shushil K. Sharma, Special Studies and 
Evaluations Section, National Security and International Relations 
Division, GAO, NSVAIR anthrax hearing (II), p. 25.
---------------------------------------------------------------------------
    Because passive systems are voluntary, the data generated 
are subject to a self-selection bias, in that trends in 
volunteered data cannot be extrapolated as if representative of 
an entire cohort or population. As a result, information from a 
passive reporting system, like VAERS, is not an appropriate 
source of data for use in generating adverse reaction rates.
    Nevertheless, AVIP reports and DOD public statements 
portray the ratio of VAERS reports to inoculations given as an 
adverse reaction rate.

        In presenting reaction rate data, program and DOD 
        officials have shown reactions reported to VAERS as a 
        percentage of all vaccinations. They did so in several 
        briefings to GAO and congressional staff, in prepared 
        testimony, and on the program's Internet site. However, 
        according to FDA guidance, incidents in the VAERS 
        database reflect a temporal, not necessarily a causal, 
        relationship with vaccination and thus should not be 
        used to calculate the incidence of reactions.\230\
---------------------------------------------------------------------------
    \230\ See supra note 26, p. 32.

    GAO found, ``This is misleading because of potential 
underreporting of events to VAERS, and the potential for 
overstating the reaction rate because reports sent to VAERS are 
not confirmed to be causally linked to the vaccination.'' \231\ 
The potential for overreporting is limited, however, by DOD 
screening of VAERS reports before inclusion in quarterly AVIP 
figures. In this regard, GAO concluded, ``Thus, DOD does not 
have reliable information on the extent of adverse reactions.'' 
\232\
---------------------------------------------------------------------------
    \231\ Ibid.
    \232\ Ibid.
---------------------------------------------------------------------------
    Even if useful to gauge short term reactions, passive 
reporting systems are also unlikely to capture long term or 
chronic health effects or syndromes, since providers and 
vaccine recipients do not generally associate an illness with 
an event far removed in time.\233\ But many service members are 
concerned over possible long term health effects of the anthrax 
vaccine, alone or in combination with other treatments and 
exposures.\234\ According to GAO, ``A primary reason for 
dissatisfaction with information about long-term side effects 
appears to be that research has not been done to address the 
topic. According to program officials, such studies have 
recently been discussed but are not yet funded or underway.'' 
\235\
---------------------------------------------------------------------------
    \233\ Prepared statement of Dr. Meryl Nass, NSVAIR anthrax hearing 
(II), p. 107.
    \234\ Prepared statement of Capt. Michelle L. Piel, NSVAIR anthrax 
hearing (IV) (in subcommittee files); prepared statement of Capt. Jon 
Richter, NSVAIR anthrax hearing (IV) (in subcommittee files); and e-
mails sent to the subcommittee (in subcommittee files).
    \235\ See supra note 26, p. 32.
---------------------------------------------------------------------------
    The AVIP's strict VAERS reporting requirements of 
hospitalization or more than 24 hours absence from duty limit 
the scope of any safety surveillance to severe, short term 
reactions. This overly narrow interpretation of adverse event 
data could result in DOD missing the types and severity of 
adverse reactions only widespread use would otherwise reveal. 
The ``statistical significance of a predicted adverse 
reaction'' \236\ will only become apparent if the statistics 
are permitted to capture the full range of available data.
---------------------------------------------------------------------------
    \236\ See supra note 30.
---------------------------------------------------------------------------
    A system already known for underreporting can be made even 
less reliable in the hands of an institutional culture 
resistant, even hostile, to reports attributing ill health to 
the anthrax vaccine. Air Force Lieutenant Richard Rovet, while 
serving as Health Care Integrator for the Flight Medicine 
Clinic at Dover AFB, noted a number of individuals reporting 
potentially vaccine-related symptoms: dizziness, ringing in the 
ears, joint pain, muscle aches, memory impairment, fatigue, 
numbness, prolonged fever and chills, localized and persistent 
rashes.\237\ He said there was significant confusion in the 
field regarding reportable reactions ``especially in regard to 
what constitutes systemic reaction.'' \238\ Lt. Rovet testified 
medical providers saw the issue of identifying vaccine 
reactions ``politically sensitive and like to avoid it.'' \239\
---------------------------------------------------------------------------
    \237\ Prepared statement of Lt. Richard Rovet, NSVAIR anthrax 
hearing (IV), p. 2 (in subcommittee files).
    \238\ Testimony of Lt. Richard Rovet, NSVIAR anthrax hearing (IV), 
p. 25 (in subcommittee files).
    \239\ Ibid.
---------------------------------------------------------------------------
    That resistance reduces what few incentives already 
motivate military personnel to report sick. Particularly when 
complaining of symptoms of unknown origin, a service member 
risks the label ``malingerer'' or ``depressed.'' \240\ If 
seeking care seems a dead end, ``why risk your flying status if 
you are just suffering some of the mild symptoms of joint pain 
or you feel a little bit tired? Why should you go to the doctor 
if you feel you can continue to operate an airplane? And that 
is why people don't come forward.'' \241\
---------------------------------------------------------------------------
    \240\ Prepared statement of Capt. Michelle L. Piel, NSVAIR anthrax 
hearing (IV) p.3 (in subcommittee files).
    \241\ Testimony of Capt. Michelle L. Piel, NSVAIR anthrax hearing 
(IV), p. 59 (in subcommittee files).
---------------------------------------------------------------------------
    An Air Force Reservist, Capt. Jon Richter, also suffered 
chronic symptoms he attributed to the vaccine. While he came 
forward, he testified there is little incentive for others do 
so. ``I was encountering more of my squadron mates who were 
vaccinated that said they too had experienced various 
reactions, including tinnitus, dizziness, muscle and joint 
pain, and, in one case, gray-outs. However, most were 
attempting to keep it low profile and did not readily discuss 
these matters for fear of reprisal.'' \242\ ``Word travels 
fast. Morale is at an all time low. People are trigger shy 
about coming forward with their symptoms. There is an air of 
fear and distrust prevalent throughout.'' \243\
---------------------------------------------------------------------------
    \242\ Testimony of Capt. Jon Richter, NSVAIR anthax hearing (IV), 
p. 38 (in subcommittee files).
    \243\ Ibid, p. 41.
---------------------------------------------------------------------------
    A reluctance to acknowledge vaccine related health effects 
could also block access to the immunologists and allergists 
experienced in the diagnosis and treatment of adverse 
reactions. This can be a more acute problem for National Guard 
and Reserve members whose level of access to military medicine, 
particularly specialists, for vaccine matters is uncertain. 
Witnesses at the subcommittee's April 29 hearing from the 
Michigan Air National Guard described a difficult and time 
consuming process to gain access to medical personnel with 
relevant expertise.\244\
---------------------------------------------------------------------------
    \244\ Prepared statement of Roberta Groll, NSVAIR anthrax hearing 
(II), pp. 176-179; prepared statement of Randi Martin-Allaire, NSVAIR 
anthrax hearing (II), pp. 167-171; and prepared statement of David 
Churchill, NSVAIR anthrax hearing (II), pp. 183-188.
---------------------------------------------------------------------------
    According to the Dr. Renata Engler, Chief Immunologist at 
the Water Reed Army Medical Center, and a consultant to the 
AVIP, ``Vaccine administration is serious business and deserves 
more care and training of those who deliver the service.'' 
\245\ One critical issue, she said, ``is that stakeholders who 
understand the clinical issues have NOT been represented in the 
organizational policy development.'' \246\ ``There is a problem 
that the organization does NOT have a forum for experienced, 
ongoing clinical input into the many problems that surround 
immunization delivery and adverse reaction management.'' \247\ 
(Emphasis in original).
---------------------------------------------------------------------------
    \245\ E-mails from Col. Renata Engler dated Dec. 4, 1998 (in 
subcommittee files).
    \246\ E-mail from Col. Renata Engler dated Dec. 15, 1998 (in 
subcommittee files).
    \247\ Ibid.
---------------------------------------------------------------------------
    Those problems include recognition of potentially life-
threatening hypersensitive reactions, use of pre-treatments to 
mitigate vaccine reactions and the criteria to be applied to 
determine temporary or permanent medical exemption, or waiver, 
from the AVIP. At the first DOD conference on biological 
warfare immunizations, held in May 1999, Dr. Engler made a 
presentation on the clinical challenges posed by the AVIP. She 
summarized several case studies of those who had suffered 
adverse reactions to the anthrax vaccine, with data from Walter 
Reed Army Medical Center, data from Dr. Hoffman's study in 
Korea, and patient profiles from Dover AFB.\248\ In her slide 
presentation, she noted a ``fear of military medical 
establishment'' and concluded the AVIP message should be, 
``Every service member deserves the same quality of care as ANY 
OTHER PATIENT: investigate problems proactively & objectively, 
validate suffering, knowledge base and unknowns. Vaccines are 
drugs & NOT 100% safe.'' \249\
---------------------------------------------------------------------------
    \248\ See supra note 51, pp. 3-7.
    \249\ Ibid., p. 12.
---------------------------------------------------------------------------
    Regarding the availability of medical deferrals and 
waivers, Dr. Engler asked, ``Should medical waivers become a 
punitive event? . . . Do we want rigid administrative 
guidelines that polarize and antagonize service members with 
problems? Can we acknowledge risk & include choice of affected 
AD in final disposition? Does every service member have to be 
immunized or is there room for a benefit risk ratio 
discussion?'' \250\
---------------------------------------------------------------------------
    \250\ Ibid.
---------------------------------------------------------------------------
    Room for that discussion may be limited. The risk/benefit 
decision underlying the AVIP can conflict with the clinician's 
duty to weigh the risks and benefits to the individual patient. 
In an e-mail exchange with Col. Fred Gerber, operational head 
of the AVIP, Dr. Engler posed the following example:

        A rash within 2 hours of the vaccine could represent an 
        increased risk for life threatening anaphylaxis with 
        next dose--if you ignore this and do not handle it 
        appropriately and a subsequent dose results in 
        significant harm, you are outside the standard of care 
        and would NOT be excused by the ``active duty'' 
        blanket. Our specialty has worked with this type of 
        patient and achieved successful and safe subsequent 
        vaccination but this requires expertise and very 
        carefully prepared informed consent. ETHICALLY, you 
        cannot expose a soldier to a medical treatment if he/
        she is at increased risk for harm from it and yes we do 
        waiver people for serious vaccine reactions from future 
        reactions and they continue on active duty for the most 
        part. Anthrax brings unique urgency to the scenario and 
        a group discussion on these issues with an ethicist is 
        crucial.\251\ (Emphasis in original).
---------------------------------------------------------------------------
    \251\ See supra note 245.

    Col. Gerber, while disclaiming any purview over clinical 
issues, was unwilling to acknowledge that safety considerations 
might need to overcome the AVIP imperative in some number of 
---------------------------------------------------------------------------
cases:

        Not sure I agree with what you've presented Renata. If 
        . . . she had a rash within 2 hrs of shot #1 . . . 
        [w]hy would that exempt her from getting rest of series 
        and going to Korea? Who should go in her place? Those 
        become the issues. Korea is one of the two AVIP Phase I 
        High Threat Areas . . . everyone is at increased risk 
        for exposure to anthrax there. By your algorithm, when 
        we get to Phase II of the AVIP, new soldiers coming 
        into service would be put out of service because of an 
        adverse reaction to anthrax . . . what about an adverse 
        to any of the other 17 immunizations? . . . Call it 
        like you see it, but I wouldn't quickly exempt soldiers 
        from worldwide assignments who have rashes, pain, 
        swelling, etc. Let's face it, AVA is one of many 
        soldiers have to take. The more exotic vaccines are yet 
        to come. . . . Does a rash in 2 hours mean you can't 
        get any more immunizations without additional clinical 
        follow-up/eval? I'm not sure it does.\252\
---------------------------------------------------------------------------
    \252\ E-mails from Col. Fred Gerber dated November 17, 1998 (in 
subcommittee files).

    Concerns about the short and long term safety of the 
anthrax vaccine are legitimate. It is disingenuous for DOD to 
say 30 years of use have seen no serious short-term or chronic 
adverse health effects associated with the vaccine. For most of 
that time, no one was looking.
    The short-term adverse reaction rates contained in the FDA-
approved labeling were derived from data gathered during 
testing of an earlier, less reactogenic anthrax vaccine. FDA 
only established the Vaccine Adverse Event Reporting System in 
1990. That passive surveillance system, while useful to detect 
sentinel events or clusters for further study, understates the 
extent of reactions. Limited use of the vaccine since licensure 
has yielded limited information that suggests higher reaction 
rates, particularly in women.\253\
---------------------------------------------------------------------------
    \253\ ``Anthrax Vaccine: Safety and Efficacy Issues,'' (GAO/NSAID-
00-48) U.S. General Accounting Office, Oct. 12, 1999, pp. 1-7.
---------------------------------------------------------------------------
    Since the AVIP began, DOD has undertaken two active follow-
up surveys of vaccine recipients, one in Korea and another at 
Tripler Army Medical Center, Hawaii. The results of both 
studies indicates both local and systemic reactions at 
generally higher rates than described in the product labeling. 
According to GAO, ``The data gathered in Korea also show that 
after the first two shots, more than twice the proportion of 
women than men reported systemic reactions of fever, malaise, 
or chills than did men.'' \254\ The Tripler survey also 
demonstrates gender differences in reported reactions.\255\
---------------------------------------------------------------------------
    \254\ Ibid., p. 3.
    \255\ Ibid., p. 4.
---------------------------------------------------------------------------
    Service members' concerns about the impact of manufacturing 
process lapses on vaccine quality and safety are well placed. 
For biological products, the process is the product. 
``[Q]uality cannot be guarantees from final tests on random 
samples but only from a combination of in-process tests, end-
product tests, and strict controls of the entire manufacturing 
process.'' \256\ At BioPort, and its predecessor the Michigan 
Biologics Products Institute, those controls were found to be 
less than strict.
---------------------------------------------------------------------------
    \256\ Prepared statement of Kwai-Cheung Chan, Director, Special 
Studies and Evaluation Section, National Security and International 
Affairs Division, GAO, NSVAIR anthrax hearing (II), p. 13.
---------------------------------------------------------------------------
    The long-term safety of the licensed vaccine has not been 
studied.\257\ It is of little comfort to service members that 
no other vaccines have been subject to any post-licensure 
longitudinal study. Unlike more modern vaccines, the AVA was 
approved before animal toxicity studies were even required. As 
a result, ``studies have not been performed to evaluate the 
effect of AVA on carcinogenesis, mutagenesis or impairment of 
fertility. Animal reproduction studies have not been conducted 
with AVA. Neither is it known whether AVA can cause fetal harm 
when administered to a pregnant woman or whether it can affect 
reproductive capacity.'' \258\
---------------------------------------------------------------------------
    \257\ Ibid., p. 11.
    \258\ See supra note 138, pp. 87-88.
---------------------------------------------------------------------------
    It is unlikely the current anthrax would be approvable 
under modern regulatory standards for the safety and efficacy 
of biological products. It seems unlikely BioPort will be able 
to achieve and sustain modern manufacturing standards for safe 
vaccines.

5. Efficacy of the vaccine against biological warfare is uncertain. The 
        vaccine was approved for protection against cutaneous (under 
        the skin) infection in an occupational setting, not for use as 
        mass protection against weaponized, aerosolized anthrax

    Uncertainties about safety might be more readily accepted 
if there were no questions about the effectiveness of the 
anthrax vaccine. Safety risks would be tolerable if the 
benefits were unquestioned. But there are questions. The 
proposition that the AVA will provide effective protection 
against the most likely form of weaponized anthrax, aerosolized 
spores in significant quantities, is unproven.
    And, until there is an anthrax attack, the proposition must 
remain unproven. The industrial settings in which anthrax was a 
threat have all but disappeared.\259\ It would be unethical to 
expose human test subjects to a lethal agent. So, based on 
proven efficacy against indeterminate levels of cutaneous 
exposure in an industrial setting, it can only be assumed the 
vaccine provides equivalent protection against high levels of 
inhalation exposure.
---------------------------------------------------------------------------
    \259\ Only research and testing facilities now present an 
occupational setting posing a danger of anthrax exposure.
---------------------------------------------------------------------------
    That assumption is supported by data from tests on 
vaccinated animals who survive aerosol challenge. But different 
survival rates between animal species, and between anthrax 
strains, raise more questions than the vaccine answers about 
the actual physiological mechanism of protection. Without a way 
to correlate animal data to human protection (i.e., PA antibody 
titers), efficacy of the vaccine may never be more than 
suggested or inferred.
    According to GAO:

        Studies on the efficacy of anthrax vaccine have been 
        limited to a study of the efficacy of the earilier 
        version for humans and studies of the efficacy of the 
        licensed vaccine for animals. The only study of the 
        efficacy of the vaccine for humans was performed by 
        Brachman, using the original vaccine. The Brachman 
        study claimed that the vaccine gave 93 percent (and a 
        lower confidence limit of 65 percent) protection 
        against anthrax penetrating the skin. It found that the 
        number of individuals who contracted anthrax by 
        inhalation was too low to assess the efficacy of the 
        vaccine against this form. There has been no specific 
        study of the efficacy of the licensed vaccine in 
        humans. Rather, its efficacy in humans has been 
        inferred from other data, including a reduction in the 
        incidence of anthrax following immunization of at-risk 
        individuals and from animal experiments.\260\
---------------------------------------------------------------------------
    \260\ Prepared statement of Kwai-Cheung Chan, Director, Special 
Studies and Evaluation Section, National Security and International 
Affairs Division, GAO, NSVAIR anthrax hearing (II), pp. 16-17.

    All the DOD animal studies support the view that the 
licensed vaccine can protect some animals against exposure to 
some strains of anthrax either by inoculation or inhalation. 
But animal species differ in susceptibility.\261\ In testimony 
submitted to the subcommittee, Dr. Meryl Nass summarized the 
available data from animal studies of anthrax vaccine efficacy. 
``One can see varying survival rates from 0-100% depending upon 
the strain of anthrax used and possibly other parameters of the 
experiment. Survival rates in guinea pigs varied from 23% to 
71% when they were exposed to inhaled anthrax.'' \262\ Studies 
in mice showed survival rates between no higher than 10 
percent.\263\
---------------------------------------------------------------------------
    \261\ See supra note 253, p. 8.
    \262\ Prepared statement of Dr. Meryl Nass, NSVAIR anthrax hearing 
(II), p. 108.
    \263\ Ibid., p. 110.
---------------------------------------------------------------------------
    In concluding the current vaccine is effective against 
aerosol challenge, DOD relies primarily on studies using rhesus 
monkeys. ``These animal studies showed that the FDA-approved 
anthrax vaccine provided greater than 95% protection against 
high-dose aerosol challenge with anthrax in the monkey model. 
Human antibody response to the FDA-licensed vaccine provides 
further suggestive evidence that the FDA-licensed anthrax 
vaccine will protect against inhalation anthrax.'' \264\
---------------------------------------------------------------------------
    \264\ Prepared statement of Dr. Sue Bailey, Assistant Secretary for 
Health Affairs, DOD, NSVAIR anthrax hearing (I), p. 11.
---------------------------------------------------------------------------
    But, according to GAO, ``several studies have shown no 
direct comparison of immunity in humans to that in monkeys.'' 
\265\ In fact, the one immunized monkey that died in the DOD 
studies ``had a low antibody titer similar to other monkeys 
that lived following a lethal aerosol challenge.'' \266\
---------------------------------------------------------------------------
    \265\ U.S. General Accounting Office, Correspondence to 
Representative Steve Buyer from Kwai Cheung-Chan, ``Summary of GAO's 
Findings on the Safety and Efficacy of the Anthrax Vaccine,'' (GAO-
NSIAD-00-54R), Nov. 4, 1999, p. 3.
    \266\ See supra note 138, p. 90.
---------------------------------------------------------------------------
    One study comparing the efficacy of a live spore vaccine to 
a PA-based vaccine, like the AVA, concluded, ``Immunization 
with cell-free preparations which contained components of that 
anthrax toxin did not provide adequate protective response 
against some challenge isolates of B. anthracis. The fact that 
the spore vaccine provided protection against all isolates 
tested suggests that other antigens may play a role in active 
immunity.'' \267\
---------------------------------------------------------------------------
    \267\ Stephen F. Little and Gregory B. Knudson, ``Comparative 
Efficacy of Bacillus anthracis Live Spore Vaccine and Protective 
Antigen Vaccine against Anthrax in the Guinea Pig,'' Infection and 
Immunity, May 1986, vol. 52, No. 2, p. 511.
---------------------------------------------------------------------------
    DOD resists that suggestion because confidence in the 
efficacy of the current anthrax vaccine in humans, against all 
known strains, depends heavily on the conclusions 1) that the 
antibody response to the one antigen, PA,\268\ protects against 
the toxic mechanism of all natural anthrax, and 2) that the 
antibody response in animals correlates to a similar protective 
response in humans.
---------------------------------------------------------------------------
    \268\ Protective antigen [PA] is one of three proteins involved in 
the mechanism of anthrax toxicity.
---------------------------------------------------------------------------
    The lack of an immunological correlate of protection 
against anthrax limits the extent of efficacy claims that can 
be made about the current vaccine, and it poses a profound 
challenge to the studies needed to approve an improved vaccine 
or a shorter AVA shot course. In describing the challenges to 
demonstration of efficacy for proposed changes in the dose and 
use of the current anthrax vaccine, DOD noted:

        Presently there are no precise serological or other 
        immunological correlates of protection to enable 
        conclusions to be drawn from immunization studies in 
        man. The extrapolation from animal studies to humans 
        likewise is seriously complicated by this fact. . . .
        The demonstration in some animal models that protection 
        with the present vaccine varies across challenge 
        strains further complicates studies and limits the 
        breadth of efficacy claims that can be made.
        To date, no animal or other potency test has been 
        demonstrated to be well correlated with protection of 
        humans. The potency test required for the present 
        vaccine \269\ has not been well correlated to efficacy 
        in humans and it is doubtful that it can be. (Emphasis 
        added).
---------------------------------------------------------------------------
    \269\ The current potency test uses guinea pigs.
---------------------------------------------------------------------------
        It has recently been stated that the antigenic 
        components of the licensed vaccine are not well defined 
        and that there is lot to lot variation in the level of 
        protective antigen. Because of these points, efficacy 
        studies will likely have to include multiple lots to 
        demonstrate consistency of protection.\270\
---------------------------------------------------------------------------
    \270\ See supra note 138, p. 45 (presentation slide entitled, 
``Challenges to Demonstration of Efficacy for the Proposed Changes in 
Dose and Use of Anthrax Vaccine,'' included in supporting documentation 
to MBPI IND application) (in subcommittee files).

    Regarding efficacy, one author of an anthrax vaccine study 
wrote, ``My concern is not the long-term health effects of this 
vaccine, but rather that it is not efficacious against all 
strains of B. anthracis. If I were the scientific director of 
an offensive BW program for a government hostile to the U.S., I 
would direct my investigators to repeat this experiment, 
screening a larger number of B. anthracis isolates until a 
strain was isolated that would kill immunized animals, and then 
use that vaccine resistant strain as the stock for producing 
spores to be used in filling BW submunitions.'' \271\
---------------------------------------------------------------------------
    \271\ Memorandum from Gregory B. Knudson to Representative 
Christopher Shays dated May 8, 1999, (in subcommittee files).
---------------------------------------------------------------------------
    Genetically engineered anthrax strains could also defeat 
the current vaccine if the resulting organism caused disease in 
new ways. Reports that Russian scientists successfully inserted 
genes into a virulent anthrax strain were received by DOD with 
some skepticism. Col. Gerald Parker, then-commander of 
USAMRIID, was quoted as saying the claims needed to be 
evaluated ``to learn whether the advance is theoretical or 
practical, and whether it could sidestep the American anthrax 
vaccine.'' \272\ Taking a more skeptical approach to threat 
assessment than DOD uses with regard to natural anthrax, Col. 
Parker added, ``It's one thing to do this in the lab. But its a 
whole different thing to produce it in large quantities to be 
used as a weapon. That would be very difficult.'' \273\
---------------------------------------------------------------------------
    \272\ William J. Broad, ``Gene-Engineered Anthrax: Is It a 
Weapon?'' New York Times, Feb. 14, 1998 (in subcommittee files).
    \273\ Ibid.
---------------------------------------------------------------------------
    Concerns about the efficacy, and by implication the 
necessity, of the vaccine are legitimate given the extent of 
unproven, unknown, and perhaps unknowable, aspects of the 
protection afforded. The vaccine almost certainly could be 
overwhelmed by a high-dose aerosol exposure. Immunized troops 
near an initial release point could still suffer significant 
casualties. The vaccine may have diminished effect against 
highly virulent strains, or combinations of strains. The 
vaccine may provide no protection against genetically 
engineered anthrax.

                            Recommendations

1. The force-wide, mandatory AVIP should be suspended until DOD obtains 
        approval for use of an improved vaccine

    The anthrax vaccine program is not sustainable in its 
present form. Due to the lack of assured production, AVIP phase 
II has already been delayed. Confidence in the quality of the 
vaccine stockpile is low and the capacity to procure sufficient 
new production remains highly doubtful. The program should be 
suspended while contingency plans for allocation of available 
vaccine are formalized and research is conducted to obtain a 
safer, more effective vaccine.
    Signaling an awareness the anthrax immunization effort was 
on weak conceptual and logistical footing from the start, 
Secretary Cohen announced four preconditions to the start of 
the program: supplemental vaccine testing, an adequate tracking 
system, completed implementation and communication plans and an 
independent scientific review. Those were appropriate. Had they 
been more scrupulously addressed, the AVIP might be a very 
different, much better program.
    The military anthrax immunization program should have been 
conditioned on completion of the same level of research and 
testing required of other battlefield systems. We would not ask 
U.S. forces to fight using rifles designed in the 1950's. We 
should not ask them to rely on 1950's era medical technology, 
when modern science has the capacity to produce an improved 
vaccine. Much has changed in the biologics industry since the 
AVA was first approved in 1970. As evidenced by FDA 
inspectional findings in 1998 and 1999, not enough has changed 
at the vaccine production facility to bring it into full 
compliance with modern manufacturing standards. It is doubtful 
the AVA would be approved by the FDA today.
    As additional assurance the anthrax immunization program is 
as safe as possible, DOD should test the vaccine for toxicity, 
mutagenicity, carcinogenicity and reproductive effects in 
animals. The current AVIP should be suspended while those 
studies, and other steps recommended by the subcommittee, are 
undertaken.
    The AVIP should be suspended because it lacks an essential 
element in a medical program: trust. However well-intentioned, 
the anthrax vaccine effort is viewed by many with suspicion. It 
is seen as another chapter in a long, unhappy history of 
military medical malfeasance in which the healing arts are 
corrupted to serve a lethal purpose.
    The fundamental rationale for the AVIP--that something, 
even an old, questionably effective vaccine, is better than 
nothing--gives little comfort to those who daily see their 
forebears and colleagues grow sicker from radiation testing, 
Agent Orange, and Gulf war illnesses. If the noble experiment 
fails, if the vaccine ultimately causes more casualties than 
weaponized anthrax, many men and women in uniform do not 
believe their Government will acknowledge their sacrifice or 
treat their wounds.
    Trust must be earned. It can be earned only with a degree 
of candor and openness that has not been the hallmark of the 
AVIP to date. While claiming a new awareness of the need for 
effective risk communication, the Pentagon still reverts to 
absolutist declarations, heavy handed propaganda, and ad 
hominem attacks whenever the risks of the anthrax vaccine are 
communicated too effectively or persistently. In a culture 
based on a chain of command and the power to compel, attempts 
at persuasion and education often devolve into intimidation. 
Labeling opponents ``paranoics'' \274\ and ridiculing the 
intelligence or courage of those with legitimate questions 
\275\ are not the methods of modern risk communication.
---------------------------------------------------------------------------
    \274\ See supra note 79.
    \275\ See supra note 80.
---------------------------------------------------------------------------
    Nowhere is DOD's failure to communicate the relative risks 
and benefits of the AVIP more obvious than in reserve component 
units. The bulk of vocal resistance to the AVIP has arisen in 
the few Reserve and National Guard units included in phase I. 
Those service members have more options than active duty 
personnel. If they conclude the anthrax vaccine poses more risk 
than benefit to their civilian and military careers, they can 
resign, or seek a transfer to a non-mobility position. Many 
have done so.
    DOD appears to be in denial on this issue, ignoring clear 
signs the anthrax program is having, and will certainly have, a 
substantial impact on retention and morale in reserve component 
units. At the subcommittee's September 29, 1999 hearing on the 
subject, Maj. Gen. Paul Weaver, Director, Air National Guard, 
testified there had been ``one known refusal documented.'' 
\276\ Previously, the subcommittee had received testimony and 
correspondence from several members of Air Guard units who had 
refused the vaccine, more than one of whom were in the hearing 
room when Gen. Weaver made that statement.
---------------------------------------------------------------------------
    \276\ Testimony of MG Paul Weaver, Director, Air National Guard, 
NSVAIR anthrax hearing (V), p. 119.
---------------------------------------------------------------------------
    Principal Deputy Assistant Secretary of Defense (Reserve 
Affairs) Charles Cragin testified the impact of the AVIP on 
retention was ``negligible'' \277\ despite having been given 
information just days before that more than half the air crew 
in one unit has submitted resignations attributable directly to 
the anthrax program.\278\ At the same hearing, Mr. Cragin 
conceded ``the Department's efforts to inform and educate 
reserve personnel about the anthrax protection program were not 
initially as robust as they should have been.'' \279\
---------------------------------------------------------------------------
    \277\ Prepared statement of Charles Cragin, Acting Assitant 
Secretary for Reserve Affairs, NSVAIR anthrax hearing (IV), p. 3.
    \278\ Letter (with attachments) from Charles Cragin to 
Representative Christopher Shays, attachment p. 1, Oct. 21, 1999. (in 
subcommittee files).
    \279\ Prepared statement of Charles Cragin, Acting Assitant 
Secretary for Reserve Affairs, NSVAIR anthrax hearing (IV), p. 4.
---------------------------------------------------------------------------
    Until much more is known about the true impact of a 
mandatory vaccine program on retention, readiness, and morale 
in the most voluntary sector of the all-volunteer U.S. armed 
forces, the AVIP should be suspended.
    Rather than risk long term health impairment, some service 
members would be willing to consider the vaccine-preventable 
risk of anthrax among the inherent, unavoidable risks of 
military service. They do not have that option, an opportunity 
to assume risk made available to essential civilian employees 
of the Defense Threat Reduction Agency.\280\
---------------------------------------------------------------------------
    \280\ See supra note 134.
---------------------------------------------------------------------------
    Others view this force protection effort as an untested 
medical solution to a purely mechanical problem--contamination 
prevention and avoidance--better solved by physical rather than 
pharmacological technology. With regard to the anthrax vaccine, 
DOD appears to accept more unknowns and greater technological 
risks than would be tolerated in any combat weapon system. As a 
result, some service members are not convinced this 
``commander's program'' is for their long-term protection as 
much as for battlefield convenience and the preservation of 
short-term mission capability while under anthrax attack. 
Suspension of the AVIP would allow DOD to focus more attention 
and resources on development and deployment of chemical defense 
doctrine, tactics, detection capability as well as individual 
and collective protection equipment effective against all 
threats.
    The subcommittee makes no recommendations regarding the 
status of those service members who left the armed forces 
voluntarily, or as the result of disciplinary actions, due to 
the anthrax vaccine program. Just as each service branch, 
operating under the Uniform Code of Military Justice, 
determined its own approach to vaccine refusals, each should 
determine through its own processes what appeals, if any, might 
be available in the event the AVIP is restructured or 
suspended.

2. DOD should accelerate research and testing on a second-generation, 
        recombinant anthrax vaccine

    Despite the ``clear and present danger'' \281\ posed to 
U.S. troops by anthrax as a biological weapon, DOD considers 
development of an improved anthrax vaccine ``an unfunded 
requirement.'' \282\ Had that requirement been addressed more 
aggressively after the Persian Gulf war, the 8 to 10 year 
development, testing and FDA approval process now posited by 
DOD as an potential barrier to a new vaccine could have already 
been breached.
---------------------------------------------------------------------------
    \281\ See supra note 66, p. 1.
    \282\ Testimony of Kwai-Cheung Chan, Director, Special Studies and 
Evaluation Section, National Security and International Affairs 
Division, GAO, NSVAIR anthrax hearing (IV), p. 100.
---------------------------------------------------------------------------
    Although an improved vaccine based on recombinant 
technology may not necessarily have better safety 
characteristics than the current vaccine,\283\ it would address 
two other problems plaguing the AVIP. Production of a second 
vaccine, at a second site, would diversify the industrial 
capacity to support so critical a program, making vaccine 
supplies more abundant and more secure from attack. And, 
because recombinant techniques do not require extensive 
dedicated facilities, capital costs can be allocated across 
more than one product, increasing the likelihood other 
manufacturers would compete for DOD contracts.
---------------------------------------------------------------------------
    \283\ Testimony of Col. Renata Engler, Chief, Allergy and 
Immunology Department, Walter Reed Army Medical Center, NSVAIR anthrax 
hearing (IV), p. 155.
---------------------------------------------------------------------------
    The second generation vaccine studied by DOD was also more 
consistently characterized in terms of PA content than the 
AVA.\284\ Lot-to-lot consistency would address one challenge 
noted by DOD to demonstrating efficacy of a vaccine that cannot 
be tested in humans.\285\ It would also give commanders greater 
confidence that vaccinated troops, to the greatest extent 
possible, have achieved a more uniform level of protection.
---------------------------------------------------------------------------
    \284\ Prepared statement of Kwai-Cheung Chan, Director, Special 
Studies and Evaluation Section, National Security and International 
Relations Division, GAO, NSVAIR anthrax hearing (IV), p. 13.
    \285\ See supra note 108.
---------------------------------------------------------------------------
    David Oliver, Principal Deputy Under Secretary of Defense 
for Acquisition and Technology, said in testimony that DOD 
would be reviewing procurement options with regard to a second 
AVA production site versus a new vaccine. He suggested, 
however, that funds spent on an improved anthrax vaccine would 
limit funds available to address other bio-threats.\286\ That 
trade-off puts anthrax on a par with other biological agents in 
terms of threat, when in fact DOD considers anthrax the pre-
eminent bio-threat. Budgets estimates for the Joint Vaccine 
Acquisition Program [JVAP] indicate DOD anticipates procurement 
of limited, deployment-contingent stocks of vaccines against 
other biological weapons, making anthrax the only agent 
targeted for universal immunization. Improving the medical 
prophylaxis against the primary threat should be a DOD funding 
priority.
---------------------------------------------------------------------------
    \286\ Testimony of David R. Oliver, Jr., NSVAIR anthrax hearing 
(III), pp. 68-69.
---------------------------------------------------------------------------
    DOD concedes, ``In the case of anthrax vaccine, the current 
FDA-licensed vaccine is not ideal. The vaccine was developed in 
the 1950's and 1960's by the state-of-the-art procedures at 
that time, and licensed in 1970. Advances in biotechnology and 
genetic engineering may enable improvements in the vaccine that 
allow fewer doses or use of highly purified protective antigen. 
The DOD scientists are pursuing both of these objectives. A 
highly-purified recombinant protective antigen vaccine has 
shown efficacy in animal models.'' \287\
---------------------------------------------------------------------------
    \287\ Department of Defense, ``Information About the Anthrax 
Vaccine and the Anthrax Vaccine Immunization Program,'' prepared by the 
AVIP Agency, Jan. 25, 2000, pp. 12-13 (available at: http://
www.anthrax.osd.mil) (in subcommittee files).
---------------------------------------------------------------------------
    But DOD is unwilling to wait for the research, development, 
and FDA approval processes,\288\ even though DOD believes 
``within a year we will get FDA approval for reduced dose based 
on the science.'' \289\
---------------------------------------------------------------------------
    \288\ Ibid.
    \289\ Testimony of Col. Fred Gerber, Director, Health Care 
Operations, Office of the Army Surgeon General, NSVAIR anthrax hearing 
(V), p. 153.
---------------------------------------------------------------------------
    To address the domestic bioterrorism threat, the Department 
of Health and Human Services' National Institute of Allergy and 
Infectious Diseases formed a working group to develop and test 
a second generation anthrax vaccine, and the Institute has 
funded some research. DOD should support those efforts.
    With regard to an improved anthrax vaccine, the American 
Public Health Association adopted a policy statement in 
November 1999 urging DOD to ``delay any further immunization 
against anthrax using the current vaccine or at least to make 
immunization voluntary'' \290\ and to convene a commission of 
military and non-military public health experts to review 
safety and efficacy evidence for the current vaccine, attempt 
to determine when an improved vaccine might be available, and 
make recommendations about continuation of the current 
program.\291\ Their recommendations were based on the concern 
``that mandatory immunization with a vaccine of unproved 
efficacy when an improved vaccine may soon be available, is 
contrary to public health principles and may adversely effect 
the acceptance of voluntary or mandatory immunization programs 
in which there is good evidence of efficacy and safety. . . .'' 
\292\
---------------------------------------------------------------------------
    \290\ ``Anthrax Immunization,'' American Public Health Association, 
policy statement No. 9930, Nov. 10, 1999.
    \291\ Ibid.
    \292\ Ibid.
---------------------------------------------------------------------------

3. DOD should pursue testing of the safety and efficacy of a shorter 
        anthrax inoculation regimen

    A shorter shot course could reduce the cost of the 
immunization program, simplify delivery logistics, and lower 
the incidence of adverse reactions.
    According to GAO testimony, ``No studies have been done to 
determine the optimum number of doses of the anthrax vaccine.'' 
\293\ The original inoculation schedule of three doses was 
based on a regimen developed using animals in the early 1950's. 
However, three people who received three doses of a weaker 
formulation of the vaccine became infected after exposure to 
anthrax. The number of doses was then arbitrarily increased to 
six, the number used in the only human efficacy study published 
in 1962, and thus the number approved by FDA.\294\
---------------------------------------------------------------------------
    \293\ Testimony of Kwai-Cheung Chan, Director, Special Studies and 
Evaluation Section, National Security and International Affairs 
Division, GAO, NSVAIR anthrax hearing (IV), p. 97.
    \294\ Prepared statement of Kwai-Cheung Chan, Director, Special 
Studies and Evaluation Section, National Security and International 
Affairs Division, GAO, NSVAIR anthrax hearing (IV), p. 5.
---------------------------------------------------------------------------
    Even if a prolonged, multi-shot regimen is necessary to 
generate an initial immune response, the annual booster may be 
unnecessary. GAO noted:

        In November 1971, the Division of Biologics Standards, 
        NIH, noted an apparent increase in reports of adverse 
        reactions after individuals received booster shots. The 
        Division considered it advisable to reevaluate the need 
        for annual boosters and possibly the amount of the 
        booster dose. Although the record is unclear as to 
        whether or not NIH requested a reevaluation, to date, 
        no such reevaluation has been done.\295\
---------------------------------------------------------------------------
    \295\ Ibid., p. 6.

    The 1993 DOD Directive on biological warfare defense 
mandates immunization ``against validated biological warfare 
threat agents, for which suitable vaccines are available, in 
sufficient time to develop immunity before deployment to high 
threat areas. . . .'' \296\ (Emphasis added). For this purpose, 
``suitable'' should not just mean FDA approved, but 
demonstrably as safe and effective as possible for the intended 
military use. A vaccine that takes 18 months, and annual 
boosters, to confer immunity should not be considered suitable 
under the policy.
---------------------------------------------------------------------------
    \296\ See supra note 7.
---------------------------------------------------------------------------
    In 1995, the Joint Program Manager for Biological Defense 
reported, ``The immunization schedule of 6 shots over 18 months 
has stopped the approval process for an annual immunization 
program against this high threat biological warfare agent. 
Moreover, it has been used by critics to question the relevance 
of the biological defense [BD] vaccine program to the DOD.'' 
\297\
---------------------------------------------------------------------------
    \297\ Col. John C. Doesburg, Joint Program Manager for Biological 
Defense, memorandum on ``Urgent Requirement for Integrated Command 
Support to Revise the Immunization Schedule for Anthrax Vaccine'' (JPO 
0045) from the Department of the Army, Nov. 17, 1995 (in subcommittee 
files).
---------------------------------------------------------------------------
    If the time to develop immunity could be reduced 
substantially, use of the anthrax vaccine would be safer and 
could be targeted far more effectively to forces deploying to 
high threat areas.
    Based on animal studies and research into the immunological 
response to the vaccine in humans, DOD concludes most persons 
acquire the bulk of whatever protection is achieved after two 
or three shots.\298\ DOD documents assert that three 
inoculations provide functional protection, and the services' 
AVIP implementation plans set as ``desirable'' the goal that 
``all personnel assigned to high threat areas receive their 
first three shots prior to deployment.'' \299\ In the interest 
of reducing adverse reactions, particularly in persons whose 
immune systems have already mounted a complete response to the 
vaccine, DOD should put its belief in the efficacy of a reduced 
shot course to the test of rigorous scientific trials.
---------------------------------------------------------------------------
    \298\ Testimony of Maj. Gen. Robert Claypool, Deputy Assistant 
Secretary for Health Operations Policy, NSVAIR anthrax hearing (IV), p. 
179; Arthur M. Friedlander, Philip R. Pittman, and Gerald W. Parker, 
``Anthrax Vaccine: Evidence for Safety and Efficacy Against 
Inhalational Anthrax,'' the Journal of the American Medical 
Association, Dec. 8, 1999, vol. 282, No. 22, pp. 2104-2106.
    \299\ See supra note 46, p. 1, sec. 1(a)(8).
---------------------------------------------------------------------------
    To the extent those efficacy studies were put aside due to 
the lack of a correlates of human immunity, that challenge will 
have to be overcome in any event as DOD attempts to develop and 
deploy other vaccines against other bio-threats. That work 
might as well be done in support of a safer vaccine against the 
primary biological warfare threat, anthrax.
    In terms of increased safety, there is also some evidence 
an intramuscular injection would produce fewer side effects and 
adverse reactions than subcutaneous administration. DOD 
expended significant time and resources in 1994 and 1995 on 
plans and programs to demonstrate the safety and efficacy of a 
shorter anthrax inoculation regime, and a different route of 
administration, but appears to have all but abandoned those 
efforts when planning for the AVIP began. Support for the FDA 
application to reduce the shot course seems to have been 
redirected to vaccine acquisition and AVIP logistics.

4. DOD should enroll all anthrax vaccine recipients in a comprehensive 
        clinical evaluation and treatment program for long term study

    DOD only recently began ``to design a set of studies to 
better evaluate the long term safety of the anthrax vaccine . . 
. to conform with present-day, post-marketing practices.'' 
\300\ While employing active surveillance techniques, these 
will be cohort studies because ``[i]t would be labor-intensive, 
cost-prohibitive, and would not conform to civilian 
expectations for us to use this in all 2.4 million service 
personnel whom we will administer the vaccine to.'' \301\ 
According to Gen. Claypool, DOD will also use linked databases 
to conduct active surveillance of vaccine recipients, using 
DEERS and ``the large medical database residing at a tri-
service defense medical surveillance system here in the 
National Capital region of the Walter Reed installation.'' 
\302\
---------------------------------------------------------------------------
    \300\ Testimony of Maj. Gen. Robert Claypool, Deputy Assistant 
Secretary for Health Operations Policy, NSVAIR anthrax hearing (IV), p. 
108.
    \301\ Ibid.
    \302\ Ibid., p. 109.
---------------------------------------------------------------------------
    But these steps, coming more than 1 year after AVIP 
implementation, are not enough to monitor the impact of the 
vaccine program on military health. Having missed the 
opportunity to study the large cohort of service members who 
received the AVA during Operations Desert Shield and Desert 
Storm, DOD has an obligation to reach beyond ``civilian 
expectations'' to evaluate the safety of this vaccine.
    Particularly for members of reserve component units, access 
to primary care and specialists at military facilities can be 
limited. According to DOD, adverse events after the anthrax 
vaccine are ``line of duty illnesses.'' \303\ Therefore,
---------------------------------------------------------------------------
    \303\ Dr. Sue Bailey, ``What Everyone Needs to Know about the 
Anthrax Vaccine'' quarterfold brochure, Department of Defense, Nov. 1, 
1999, p. 3 (in subcommittee files).

        a member of the Reserve Component may present 
        themselves for initial treatment and evaluation at any 
        military treatment facility, after vaccination during a 
        period of duty. The member will be examined and 
        provided necessary medical care. Once treatment is 
        rendered or the individual's emergent condition is 
        stabilized, a Line of Duty and/or Notice of Eligibility 
        status will be determined by the member's unit, as 
        required. No treatment beyond that justified to 
        stabilize the condition or emergency is authorized 
---------------------------------------------------------------------------
        until Service connection is validated.

But requiring an immediate determination of service-connection 
for vaccine related health effects means many short term, and 
most long term, adverse reactions will not be monitored by DOD 
physicians. The causal attribution of health effects to 
inoculations is difficult, becomes more difficult over time, 
and remains unlikely in a military program institutionally 
resistant to any suggestion the vaccine is not safe. Service 
members should not bear the burden of proof the vaccine caused 
their ill-health subsequent to inoculation. The process of 
proving service-connection has frustrated Gulf war veterans' 
efforts to obtain accurate diagnoses, effective treatments, and 
fair compensation for their unexplained illnesses. It should 
not be repeated in the AVIP.
    Enrollment of every vaccine recipient in a clinical 
evaluation and treatment protocol would allow DOD to capture a 
unique and valuable data set for use in their longitudinal 
studies, avoiding disputes over cohort selection bias and other 
methodological issues. The evaluation and treatment program 
could also be the vehicle for assembly of the multidisciplinary 
teams envisioned by Dr. Engler \304\ to develop and implement 
clinical protocols and maintain a consistent standard of care 
in the AVIP. It would also help assure service members the 
vaccine program, as a medical force protection effort, has as 
its primary purpose the protection of the health of the force.
---------------------------------------------------------------------------
    \304\ E-mails from Col. Renata Engler dated Dec. 4-8, 1998 (in 
subcommittee files).
---------------------------------------------------------------------------

5. While an improved vaccine is being developed, use of the current 
        anthrax vaccine for force protection against biological warfare 
        should be considered experimental and undertaken only pursuant 
        to FDA regulations governing investigational testing for a new 
        indication

    Under FDA regulations, use of an FDA-approved product in an 
unapproved way, or for an unapproved purpose, can only be 
undertaken pursuant to clinical trial protocols contained in 
Investigational New Drug [IND] applications.\305\ IND protocols 
must be approved by an Institutional Review Board charged to 
monitor the scientific credibility and ethical soundness (i.e., 
patient protections) of the trial. FDA must agree the trial 
proves the product is safe and effective for the proposed use. 
Informed consent must be obtained from persons enrolled in IND 
drug or vaccine trials.
---------------------------------------------------------------------------
    \305\ 21 CFR Part 312.
---------------------------------------------------------------------------
    If DOD proposed to use the anthrax vaccine against a 
disease or indication not currently described in the FDA-
approved product labeling (i.e., high blood pressure), an IND 
application would be required. If DOD proposed to alter the 
FDA-approved AVA inoculation regimen (i.e., by eliminating one 
or more of the six shots), and IND would be required.
    Despite the fact the vaccine was approved as safe and 
subsequently deemed effective only against cutaneous anthrax 
infection, DOD asserts use of the FDA-approved AVA as 
prophylaxis against weaponized, inhalation anthrax does not 
constitute an off-label use against a new indication because 
``[w]hile the package insert for this vaccine is nonspecific as 
to the route of exposure, DOD has long interpreted the scope of 
the license to include inhalation exposure, including that 
which would occur in a biological warfare context.'' \306\
---------------------------------------------------------------------------
    \306\ Letter from Dr. Stephen C. Joseph to Dr. Michael A. Friedman 
dated Mar. 4, 1997 (in subcommittee files).
---------------------------------------------------------------------------
    While some in DOD may have interpreted the scope of MBPI's 
FDA license to include inhalation anthrax by implication, 
others proceeded as if explicit labeling for the indication 
would be necessary. Throughout development of the anthrax 
policy that eventually became the AVIP, some in DOD interpreted 
FDA regulations as requiring approval of both a reduced number 
of inoculations and the new indication. A 1995 memo states:

        The use of a reduced schedule to protect service 
        members from aerosol exposure to anthrax can only 
        legally be done if the FDA licenses the vaccine for 
        that specific schedule and indication. . . . Obtaining 
        FDA license approval for a specific immunization 
        schedule change and for a labeled indication change 
        (aerosol challenge) must provide data that establish 
        safety of two doses of the vaccine given at 0 to 4 
        weeks since this schedule does not mimic the current 
        schedule of 0, 2 and 4 weeks. More extensive problems 
        exist in demonstrating vaccine efficacy against an 
        aerosol challenge.\307\
---------------------------------------------------------------------------
    \307\ Micheal J. Gilbreath, Ph.D., ``Is the current Anthrax 
vaccination regimen necessary?'' Department of Defense information 
paper (JPO 0044), Nov. 10, 1995, pp. 1-2.

    In September 1996, the vaccine manufacturer, MBPI, 
submitted an IND application which said, ``The ultimate purpose 
of this IND is to obtain a specific indication for inhalation 
anthrax and a reduced vaccination schedule.'' \308\ (Emphasis 
added). Briefing slides produced by USAMRIID in October 1997 
reference two separate objectives to be met in a supplement to 
the AVA license:
---------------------------------------------------------------------------
    \308\ See supra note 138, p. 1.
---------------------------------------------------------------------------
         Supplement to AVA license to reduce the number 
        of immunizations and change the route of immunization.
         Supplement AVA license to explicitly include 
        inhalational anthrax as an indication.\309\
---------------------------------------------------------------------------
    \309\ Department of Defense, ``Supplemental to AVA License'' 
USAMRIID presentation slides, Oct. 28, 1997 (in subcommittee files).
---------------------------------------------------------------------------
Since 1997, the Department of Defense Nuclear/Biological/
Chemical [NBC] Defense--Annual Report to Congress has referred 
to medical CBW countermeasures proven safe because they have 
``been widely used to treat other medical conditions.'' \310\ 
The report cites pyridostigmine bromide, the botulinum toxoid 
vaccine, both used for CB prophylaxis only pursuant to INDs, 
and the anthrax vaccine. But DOD's interpretation of the 
current AVA labeling rests on the conclusion there is but one 
indication--anthrax infection acquired by any means. Against 
what ``other medical condition'' was the anthrax vaccine used 
to prove its safety?
---------------------------------------------------------------------------
    \310\ Department of Defense Nuclear/Biological/Chemical [NBC] 
Defense--Annual Report to Congress, March 1999, pp. 3-3 to 3-4; 
Department of Defense Nuclear/Biological/Chemical [NBC] Defense--Annual 
Report to Congress, February 1998, pp. 3-4 to 3-5; Department of 
Defense Nuclear/Biological/Chemical [NBC] Defense--Annual Report to 
Congress, March 1997, pp. 3-4 to 3-5.
---------------------------------------------------------------------------
    When DOD asked the FDA to concur with the implicit 
inclusion of inhalation anthrax in the current product 
labeling, the response was affirmative but tepid. FDA Lead 
Deputy Commissioner Michael Friedman wrote:

         While there is a paucity of data regarding the 
        effectiveness of Anthrax Vaccine for prevention of 
        inhalation anthrax, the current package insert does not 
        preclude this use. The original efficacy trail clearly 
        showed that the vaccine conferred a high level of 
        protection against cutaneous exposure. None of the 5 
        inhalation cases in this trial occurred in Anthrax 
        Vaccine recipients, but these data alone are 
        insufficient to allow definitive statistical 
        conclusions. Results from animal challenge studies have 
        also indicated that pre-exposure administration of 
        Anthrax Vaccine protects against inhalation anthrax.
          Therefore, I believe your interpretation is not 
        inconsistent with the current label.\311\
---------------------------------------------------------------------------
    \311\ Letter from Dr. Michael A. Friedman to Dr. Stephen C. Joseph 
dated Mar. 13, 1997 (in subcommittee files).

    It was on this basis DOD proceeded to design the AVIP 
without informed consent procedures, or an informed consent 
waiver, and without other elements of a clinical trial such as 
consistent data gathering and detailed health outcome 
monitoring.
    DOD was aware of the extensive problems confronting the 
effort to prove vaccine efficacy for the new indication, most 
notably that ``. . . no animal or other potency tests has [sic] 
been demonstrated to be well correlated with protection of 
humans.'' \312\ DOD conducted, and plans to continue, studies 
attempting to validate an animal model so findings can be 
extrapolated to humans.
---------------------------------------------------------------------------
    \312\ See supra note 307, p. 2. The memo continues, ``The potency 
test required for the present vaccine has not been well correlated to 
efficacy in humans.'' The current potency test uses guinea pigs. Tests 
challenging different animal species with a range of anthrax strains 
showed the vaccine provides varied levels of protection. Against some 
strains, vaccinated guinea pigs and mice suffered 100 mortality. In DOD 
studies using nonhuman primates (rhesus monkeys) between 88 and 100 
percent of the vaccinated animals survived.
---------------------------------------------------------------------------
    In launching the AVIP, DOD did not confront those problems 
but sidestepped them by concluding use of the vaccine to 
prevent anthrax infection, however acquired, would not require 
an IND as long as the approved inoculation schedule was 
followed. So the AVIP's cumbersome logistics, additional costs, 
and increased risk of adverse reactions all flow directly from 
an unwillingness to do the research and testing to develop a 
better vaccine or improve the safety and efficacy of the 
current AVA.
    That research and testing will have to be done in any 
event. In 1997 DOD told Congress:

          DOD complies with all Food, Drug and Cosmetic Act 
        requirements. The Food and Drug Administration [FDA] 
        requires large-scale field trials in human subjects to 
        demonstrate efficacy of drug and biologicals prior to 
        licensure. There are, however, legal and ethical 
        constraints that preclude such efficacy studies for NBC 
        countermeasures. Field studies of efficacy cannot be 
        performed, since exposure to most NBC agents does not 
        usually occur naturally. Moreover, the high lethality 
        and/or toxicity of NBC agents also makes it unethical 
        to expose human subjects in controlled efficacy studies 
        usually required by the FDA for product licensure 
        (e.g., test of effectiveness of the product against the 
        threat in humans). For these reasons, many NBC 
        countermeasures are likely to remain in an 
        Investigational New Drug [IND] status, requiring their 
        administration under provisions of an approved protocol 
        and with written informed consent from their service 
        members. In contingency situations, DOD may request a 
        waiver of informed consent from the FDA. DOD continues 
        to work with the FDA to seek alternative methods for 
        demonstrating safety and efficacy of NBC medical 
        countermeasures and to obtain their licensure.\313\ 
        (emphasis added)
---------------------------------------------------------------------------
    \313\ See supra, note 310, 1998 report, p. 3-4.

    Given the predicted likelihood NBC vaccines will be 
available only in IND status for some years to come, DOD will 
need to develop the capacity to conduct broad-based clinical 
trials and effectively communicate risk/benefit assessments 
through informed consent processes. In the interests of 
deploying a safer, presumably more effective vaccine against 
the pre-eminent biological warfare threat, DOD should be 
willing to develop that capacity now. Instead, DOD has chosen 
to address the primary threat with a dated, secondary 
countermeasure with substantial unknowns regarding quality, 
safety, and efficacy.
    In prescribing the vaccine, DOD is engaging in the practice 
of medicine. ``It is true doctors can use drugs off label. It 
is never true they can do so without informed consent of the 
patient . . . You are not immunized from getting informed 
consent.'' \314\ If DOD were to concede administration of AVA 
against inhalational battlefield exposure is an off label use, 
informed consent would be required. The AVIP could be 
transformed, for most, into a voluntary program, with limited 
mandatory usage of the vaccine possible only pursuant to a 
carefully monitored informed consent waiver.
---------------------------------------------------------------------------
    \314\ Testimony of Arthur Caplan, Ph.D., Force Protection: 
Improving Safeguards for Administration of Investigational New Drugs to 
Members of the Armed Forces, 106th Cong., 1st sess. (1999), unofficial 
transcript, p. 77 (subcommittee on National Security, Veterans Affairs 
and International Relations hearing of Nov. 9, 1999) (in subcommittee 
files).
---------------------------------------------------------------------------
    In a statement submitted to the subcommittee, the 
Association of American Physicians and Surgeons asserted:

          A distinction must be made between treatment and 
        experimentation. It may be asserted that anthrax 
        vaccine (unlike pyridostigmine bromide as used in the 
        Gulf War or anti-botulinum vaccine) constitutes 
        ``treatment,'' or that it is not experimental because 
        of being declared safe and effective by FDA. . . . In 
        fact, the anthrax vaccine was licensed by the FDA 
        before efficacy studies were required. Its efficacy 
        against inhalational anthrax has been questioned. . . . 
        British epidemiologist suggested that troops be 
        publicly randomized to receive active vaccine or 
        placebo, clearly implying that many consider the 
        vaccine to be experimental.\315\
---------------------------------------------------------------------------
    \315\ Submitted statement of Dr. Jane M Orient, executive director, 
Association of American Physicians and Surgeons, NSVAIR anthrax hearing 
(I), p. 119, citing the European Journal of Epidemiology 4:12-19, 1998 
and Ness AR, Harvey I, Gunnell D, Smigh GD: ``All troops sent to Gulf 
should be randomized to receive anthrax vaccination or placebo.'' 
British Medical Journal 316:1322, 1998.

    The AAPS recommended a careful examination of the medical 
ethics involved in military, and civilian, vaccination efforts, 
noting the entire point of informed consent in combat is ``not 
to prevent soldiers from obtaining whatever protection may be 
afforded them by an investigational agent that has not been 
adequately tested, but rather, it is to give them the choice of 
whether they think the `protection is worth the risks of 
adverse effects.' '' \316\
---------------------------------------------------------------------------
    \316\ Ibid. (quoting Grodin MA, Annas GJ: Journal of the American 
Medical Association 277:712-713, 1997).
---------------------------------------------------------------------------
    Although DOD's track record administering INDs or informed 
consent waivers is not exemplary,\317\ current procedural 
safeguards, adopted since the Gulf war, provide far more 
protection to service members receiving investigational 
products than the AVIP now provides.
---------------------------------------------------------------------------
    \317\ In 1990, DOD requested authority to administer IND products, 
pyridostigmine bromide and botulinum toxoid vaccine, to certain 
military personnel. DOD also requested a waiver of informed consent 
requirements in connection with the use of those products by the armed 
forces. The FDA granted the DOD requests under the terms of an interim 
rule establishing the procedures and conditions under which informed 
consent waivers could be obtained by DOD. But DOD did not meet the 
conditions FDA placed on the waivers, failing to provide information to 
individual service members about the IND products and failing to keep 
the medical records necessary to fulfill the protocols and capture data 
about the safety of the drugs. Despite some improvements in medical 
recordkeeping, DOD's next use of an IND vaccine showed similar 
problems. In 1997, the General Accounting Office observed ``nearly one 
fourth of the soldiers who received an investigational tick-borne 
encephalitis vaccine before deploying to Bosnia did not have this 
information noted in their files.'' (``Defense Health Care: Medical 
Surveillance Improved Since Gulf War, but Mixed Results in Bosnia,'' 
[GAO/NSIAD-97-136] U.S. General Accounting Office, May 13, 1997, p. 
33.)
---------------------------------------------------------------------------
    In November 1997 the subcommittee proposed, and the full 
Government Reform and Oversight Committee approved, an 
oversight report on Gulf war veterans' illnesses containing 18 
findings and 18 recommendations.\318\ Among them was the 
finding that ``[t]he FDA was passive in granting and failing to 
enforce the conditions of a waiver to permit use of PB by DOD'' 
and the recommendation that ``FDA should grant a waiver of 
informed consent requirements for the use of experimental or 
investigational drugs by DOD only upon receipt of a 
Presidential finding of efficacy and need.'' \319\
---------------------------------------------------------------------------
    \318\ Gulf War Veterans' Illnesses: VA, DOD Continue to Resist 
Strong Evidence Linking Toxic Causes to Chronic Health Effects, 2d 
report by the Committee on Government Reform and Oversight, House 
Report 105-388, Nov. 7, 1997, pp. 3-6.
    \319\ Ibid.
---------------------------------------------------------------------------
    Legislation reflecting that recommendation was introduced 
in both chambers of Congress.\320\ The 1999 Defense 
Authorization Act contained provisions, codified at 10 U.S.C. 
1107(f), implementing the recommendation by strengthening 
notice requirements and by requiring a Presidential 
authorization for any waiver of informed consent.
---------------------------------------------------------------------------
    \320\ H.R. 4035, 105th Cong., 2d sess.; S. 2057, 105th Cong., 2d 
sess.
---------------------------------------------------------------------------
    In view of the new statutory provision, FDA on October 5, 
1999 revoked the 1990 interim final rule and issued a new 
regulation to govern DOD compliance with IND conditions and 
informed consent waivers.\321\
---------------------------------------------------------------------------
    \321\ Federal Register, 21 CFR Parts 50 and 312, Oct. 5, 1999, p. 
54180.
---------------------------------------------------------------------------
    On September 30, 1999 the White House issued Executive 
Order 13139 establishing the procedures by which the President 
would comply with the new law.\322\ The Executive order says 
``[w]aivers of informed consent will be granted only when 
absolutely necessary'' and only upon a written determination by 
the President that obtaining consent is not feasible, is 
contrary to the best interest of the service member or is not 
in the interest of national security. In the event a waiver is 
granted, the DOD Secretary must notify Congress and publish a 
notice in the Federal Register. No waiver may last more than 
one year. Waivers may be renewed based on a new, fully 
documented request.'' \323\
---------------------------------------------------------------------------
    \322\ Executive order of Sept. 30, 1999, ``Improving Health 
Protection of Military Personnel Participating in Particular Military 
Operations'' No. 13139, the White House, Washington, DC.
    \323\ Ibid.
---------------------------------------------------------------------------
    The statute establishes clear U.S. policy that waiver of 
informed consent in military operations is deemed appropriate 
and necessary under certain circumstances. The statute, the FDA 
interim rule and Executive Order 13139 describe, and limit, 
those circumstances and attempt to ensure any decision to use 
IND drugs or vaccines without informed consent is as open as 
possible, supported by sufficient information and authorized at 
the highest level.
    The new regime for waiving informed consent requirements 
appears far more rigorous and transparent than the system 
employed under the original interim rule. The statute is very 
explicit in describing the information that must be provided to 
each individual service member being given an IND drug or 
vaccine. The written information must include a clear statement 
the substance is investigational, the reason the drug or 
vaccine is considered necessary, information regarding possible 
side effects and drug interactions, and any other information 
FDA may require as part of the IND protocol.
    That is more clinically useful information than the AVIP 
now routinely conveys. Consistently providing balanced risk/
benefit assessments in an IND setting would also move DOD 
closer to its stated goal of more effective risk communication. 
According to an article linked to the DOD AVIP website:

          People are different. One size does not fit all when 
        it comes to explaining risk. Some prefer short, simple 
        messages about a vaccine's benefits and risks.8,12,68 
        These people, presumably a majority of the population, 
        will be satisfied with the summary information 
        comprising the Vaccine Information Sheets [VISs] 
        published by the Centers for Disease Control and 
        Prevention. Others want more detailed information. Some 
        will scour the literature to explore every fact they 
        can find. The goal of risk communication involving 
        vaccines should be informed consent.68 True consent to 
        vaccination is only possible if the individual has 
        received all the information he or she wants and 
        understands that information. Then an informed vaccine 
        decision can be made. Providing this information 
        demonstrates respect for the individual. From the 
        clinician's perspective, the consent process can be 
        part of the efforts to identify contraindications to 
        vaccination (e.g., severe hypersensitivity, 
        immunodeficiency).\324\
---------------------------------------------------------------------------
    \324\ Department of Defense, ``Anthrax Vaccine Immunization 
Program'' at Internet page http://www.anthrax.osd.mil/ citing John D. 
Grabenstein and James P. Wilson, ``Are Vaccines Safe? Risk 
Communication Applied to Vaccination,'' Hospital Pharmacy, Vol. 34, No. 
6, pp 713-729 (available at http://www.anthrax.osd.mil/SCANNED/
ARTICLES/grabedocs/vaccines.htm).

    The FDA ``believes that exceptions from the informed 
consent requirement should apply rarely and only when 
sufficient additional protections are provided to the military 
personnel affected.'' \325\ The agency also expresses the view 
that DOD should pursue drug development through normal 
regulatory procedures, despite the obvious difficulty of 
acquiring efficacy data regarding chemical and biological 
warfare exposures. In the future, requests for informed consent 
waivers must be accompanied by a history and projected time 
line for full scale development of the drug or vaccine in 
question.\326\ No more waiting until the eve of war to shortcut 
a process that could have been underway for months or years.
---------------------------------------------------------------------------
    \325\ See supra note 321 p. 51484.
    \326\ Ibid.
---------------------------------------------------------------------------
    Under the new law, only the President may waive prior 
consent requirements, and only after certifying in writing that 
obtaining consent is not feasible, is contrary to the best 
interest of the service member, or is not in the interest of 
national security. With regard to the first two justifications, 
the President must apply the standards and criteria used by the 
FDA for waivers. Those standards and criteria are detailed in 
the new FDA interim rule. To meet them, the Secretary of 
Defense must document for the President all the scientific 
data, threat assessment, lack of alternatives, and conditions 
under which the IND product will be used.
    The FDA regulation strengthens the role of the 
Institutional Review Board [IRB] in approving and monitoring 
the IND protocols for which waivers are granted. IRBs are 
panels charged with assuring that clinical trials have 
legitimate scientific goals and that protocols protect human 
subjects. Under the regulation, an IRB must review all aspects 
of the proposed IND and waiver. Significantly, the IRB must 
include at least three members who are not employees of the 
Federal Government. This should add some element of independent 
review to DOD waiver requests. The rule also requires detailed 
certifications from DOD regarding recordkeeping systems, 
medical staff training, and communication of benefits and 
risks.
    The Executive order of September 30, 1999 mirrors the FDA 
regulation in many respects, requiring the DOD Secretary to 
support a waiver request with written justification, rationale, 
and proof of IRB review. The Assistant to the President for 
National Security Affairs and the Assistant to the President 
for Science and Technology must also review the request. After 
approval of a waiver, the Eexecutive order requires monitoring 
and periodic reports on compliance with IND protocols and 
waiver conditions.
    These more explicit and elaborate procedures address many 
of the problems noted in the execution of the Gulf war waivers. 
If applied rigorously, those safeguards could also form the 
basis for a mandatory anthrax vaccine program for certain 
deployed forces, Special Forces, or other elements determined 
by the President to warrant vaccination in the interests of 
national security. The remainder of the force could choose to 
enroll in an IND protocol \327\ or assume the risks of 
biological warfare not addressed by individual and collective 
protection, detection, battle tactics and deterrence.
---------------------------------------------------------------------------
    \327\ Open protocols could be established for the on-going trial of 
a reduced vaccine regimen or a trial of a purer vaccine.
---------------------------------------------------------------------------
    In July 1999, the Air Force Times editorialized it was time 
to ``Stop Mandatory Anthrax Inoculations'' because the 
manufacturer appeared unreliable, and because:

          More research is needed to understand the long-term 
        risk of using the anthrax vaccine. And now, long after 
        initiating the vaccination program, the Pentagon is 
        finally planning such a long-term study of the 
        vaccine's health effects. That's good, but until those 
        risks are understood, the Pentagon should proceed with 
        caution--not reckless abandon.\328\
---------------------------------------------------------------------------
    \328\ ``Stop Mandatory Anthrax Inoculations,'' Air Force Times, 
Army Times Publishing Co., Jul. 12, 1999, p. 44.

The editorial concluded ``the risks of the vaccine are 
outweighed by the risk of contracting anthrax'' \329\ and 
advised service members to take the shots. ``But in the absence 
of empirical evidence proving the vaccine's long-term safety, 
the troops should be given the chance to decline. Give them the 
information they need to make wise, informed decisions for 
themselves. Let those who decline live with what they consider 
a reasonable risk.'' \330\
---------------------------------------------------------------------------
    \329\ Ibid.
    \330\ Ibid.

DISSENTING VIEWS OF HON. HENRY A. WAXMAN, HON. ROD R. BLAGOJEVICH, HON. 
   TOM LANTOS, HON. MAJOR R. OWENS, HON. ELEANOR HOLMES NORTON, HON. 
  ELIJAH E. CUMMINGS, HON. DANNY K. DAVIS, HON. JOHN F. TIERNEY, HON. 
           HAROLD E. FORD, JR., AND HON. JANICE D. SCHAKOWSKY

    We agree with many points set forth in the report. We 
submit dissenting views, however, because we disagree with the 
report's primary recommendations regarding whether to suspend 
the Department of Defense [DOD] program and reclassify the 
anthrax vaccine as ``experimental.''

                   i. assured production and capacity

    We agree that the anthrax program is vulnerable to supply 
shortages. Because the producer has been unable to obtain the 
Food and Drug Administration [FDA] approval to reopen its 
renovated production facility, no source of anthrax vaccine 
currently exists. Without a guaranteed supply, DOD will 
continue to experience difficulty meeting the demand it has 
created through its program to vaccinate all 2.4 million 
service members.
    We also agree that the program is vulnerable to price 
increases. Within a year of agreeing to produce anthrax vaccine 
for DOD, the producer and DOD renegotiated the terms of the 
contract. The producer obtained advance payments, a price 
increase, and permission to sell on the open market, despite 
DOD's need for the vaccine. Explanations about the 
foreseeability and need for this renegotiation were 
unsatisfactory.
    Although we acknowledge that DOD enters into exclusive 
contracts as a regular course of business, we agree that 
accelerating research and testing on a second-generation, 
recombinant anthrax vaccine may encourage competition and 
enhance production stability. One potential benefit of such a 
vaccine is that it could be produced in various facilities 
rather than a single, dedicated facility. In addition to 
enhancing competition, diversifying the source of anthrax 
vaccine could reduce security risks at production sites.

                       ii. complexity of program

    The anthrax vaccination program is logistically complex. 
The FDA-licensed shot regimen requires six shots over a period 
of 18 months and a booster shot annually thereafter. The report 
correctly raises serious concerns about DOD's ability to 
perform successfully this regimen for certain members of its 
force. For example, it is difficult for DOD to deliver timely 
shots to Reserve and Guard service members who report for duty 
less frequently than active duty members.
    We also agree that DOD's ``timeliness goal'' of vaccinating 
90 percent of service members within 30 days after vaccinations 
are due is insufficient. Under this standard, the first three 
vaccine inoculations--which FDA requires in 2-week intervals--
instead could be delivered on the same day and still be 
considered ``timely.'' We note that FDA wrote to DOD in 
September 1999 expressing concern with potential deviations 
from the approved schedule.\1\
---------------------------------------------------------------------------
    \1\ Letter from Dr. Katherine C. Zoon to Dr. Sue Bailey (Sept. 29, 
1999).
---------------------------------------------------------------------------
    If DOD continues the vaccination program, we recommend that 
DOD take measures to improve the administration of its program. 
We note that DOD has accomplished significant improvements, 
such as the utilization of the Defense Enrollment Eligibility 
Reporting System to combine service-based record systems into 
one central repository. In addition to upgrading these 
recordkeeping systems through the Composite Health Care System, 
we recommend that DOD revise its timeliness standard from 1 
month to a window of days.

                         iii. safety monitoring

    We agree that vaccine safety could be monitored more 
thoroughly and comprehensively. The report acknowledges that, 
``[a]s with any vaccine, anthrax inoculation can cause adverse 
health events in some individuals . . ..'' The report also 
points out that, at the rates of adverse reactions cited by 
DOD, implementation across the entire force could produce 
thousands of systemic and local reactions. Although only a 
small percentage of these would require extended treatment or 
hospitalization, we agree that aggressively managing this 
anticipated caseload must be a priority for DOD.
    The report suggests that the program may not be capable of 
performing adequate monitoring because of DOD's ``institutional 
resistance to associating health effects with the vaccine.'' 
The subcommittee heard from several service members who relayed 
accounts of inappropriate behavior by DOD personnel. Although 
the subcommittee did not verify the prevalence or accuracy of 
these accounts, we do not doubt that such actions inevitably 
occur, whether or not officially sanctioned. While we disagree 
that DOD is incapable of performing adequate safety monitoring, 
we believe DOD should meet a higher standard. We recommend 
several measures to raise DOD's performance.
    As part of its safety monitoring program, DOD relies on the 
Vaccine Adverse Event Reporting System [VAERS]. Under this 
system, FDA collects reports of symptoms temporally related to 
the receipt of the anthrax vaccine. DOD requires its physicians 
to file VAERS reports only if such reactions result in 
hospitalization or the loss of 24 hours of work. Although DOD 
physicians are permitted to file VAERS reports in cases below 
this threshold, it appears this is seldom done. We recommend 
that DOD require its physicians to file VAERS reports for all 
adverse events that result in hospitalization, any amount of 
missed duty, or any other negative health effects considered 
relevant by service members or their physicians.
    The subcommittee also heard from several service members 
who claimed they were never told about VAERS forms or were 
unable to access them. DOD has been proactive in this regard 
by, in addition to taking other steps, placing on its website a 
direct link to the on-line FDA VAERS form. To augment this 
effort, we suggest that DOD consider distributing paper copies 
of VAERS forms with each dose of anthrax vaccine administered.

                           iv. vaccine safety

    The report does not conclude that the anthrax vaccine is 
unsafe. The report states that the vaccine ``may be as safe as 
many other approved products'' and ``can be considered 
nominally safe.'' In their appearances before the subcommittee 
and committee, officials from the General Accounting Office 
[GAO] never stated that they believed the vaccine is unsafe. 
Instead, both the committee report and GAO argue that the 
vaccine's safety has not been demonstrated sufficiently to 
date.
    FDA testified on several occasions before the subcommittee 
and the full committee that the agency believes the vaccine is 
safe. On April 29, 1999, FDA stated, ``[w]e believe anthrax 
vaccine is a safe and effective vaccine for the prevention of 
anthrax disease.'' \2\ At a later hearing, FDA officials 
reported that ``FDA continues to view the anthrax vaccine as 
safe and effective for individuals at high risk of exposure to 
anthrax, when used in accordance with the approved labeling.'' 
\3\ At another hearing, FDA officials explained why they 
believe the vaccine is safe:
---------------------------------------------------------------------------
    \2\ Anthrax (II): Safety and Efficacy of the Mandatory Vaccine, 
Hearing before the Subcommittee on National Security, Veterans Affairs, 
and International Relations, House Committee on Government Reform, 
106th Cong., 1st sess. (Apr. 29, 1999) (testimony of Dr. Katherine 
Zoon, Director, Center for Biologics Evaluation and Research).
    \3\ Anthrax Vaccine Adverse Reactions, Hearing before the 
Subcommittee on National Security, Veterans Affairs, and International 
Relations, House Committee on Government Reform, 106th Cong., 1st sess. 
(July 21, 1999) (testimony of Susan S. Ellenberg, Ph.D., Director, 
Division of Biostatistics and Epidemiology, Center for Biologics 
Evaluation and Research).

        Our confidence in this vaccine, like all vaccines, is 
        based upon four components: first--the review of 
        manufacturing and clinical trials and subsequent 
        clinical laboratory experience with the vaccine; 
        second--ongoing inspections of the manufacturing 
        facility; third--our lot release requirements; and 
        fourth--our ongoing collection and analysis of adverse 
        event reports. So far, the data gathered from VAERS 
        reports on anthrax vaccine do not signal concerns about 
        the safety of the vaccine.\4\
---------------------------------------------------------------------------
    \4\ Defense Vaccines: Force Protection of False Security? Hearing 
before the House Committee on Government Reform, 106th Cong., 1st sess. 
(Oct. 12, 1999) (testimony of Dr. Katherine Zoon, Director, Center for 
Biologics Evaluation and Research).

    Without additional information to the contrary, we are not 
in a position to overturn FDA's judgment. Unlike FDA officials, 
we have little or no medical expertise. In our opinion, the 
report's criticism of a lack of studies demonstrating safety is 
insufficient to overturn FDA's findings based on the vaccine's 
30-year history.
    In addition, we fear the report's expectations for the 
safety of a new generation vaccine may be overly optimistic. 
The report recommends that DOD suspend its program only until 
it obtains ``approval for use of an improved vaccine.'' Yet the 
recombinant vaccine envisioned by the report may be no safer 
than the existing version. The report concedes that ``an 
improved vaccine based on recombinant technology may not 
necessarily have better safety characteristics than the current 
vaccine,'' but it offers no further explanation.
    We would encourage further safety research on a new anthrax 
vaccine. In addition, we agree with the report's recommendation 
to pursue testing of the safety and efficacy of a shorter 
anthrax inoculation regimen. We also agree with the report's 
emphasis on continued testing for intramuscular injections, 
which may reduce reaction rates generally and address 
proportionally higher reaction rates among women.

          v. classification of the vaccine as ``experimental''

    With respect to reclassification of the vaccine, we also 
defer to FDA's opinion that DOD's current use of the anthrax 
vaccine should not be considered ``experimental.'' On November 
3, 1999, Representatives Burton, Shays, Gilman, and Jones wrote 
to FDA essentially proposing the report's recommendation to 
reclassify the vaccine as ``experimental'' and conduct 
investigational new drug [IND] testing.\5\ The rationale for 
this argument was that FDA had approved the vaccine for use 
against ``cutaneous'' infection (through the skin) during 
occupational use, but not against ``inhalation'' infection 
(through the lungs) during wartime.
---------------------------------------------------------------------------
    \5\ Letter from Representatives Burton, Shays, Gilman, and Jones to 
Dr. Jane E. Henney (Nov. 3, 1999).
---------------------------------------------------------------------------
    In a November 26, 1999, response, FDA found no basis for 
this proposal.\6\ FDA corrected a misconception that the 
vaccine is licensed only for use ``by a limited population of 
individuals at risk for cutaneous exposure to anthrax.'' \7\ 
FDA also stated that ``use of the vaccine for protection 
against both cutaneous and inhalation anthrax exposure is not 
inconsistent with the labeling.'' \8\ Addressing the proposal 
directly, FDA stated:
---------------------------------------------------------------------------
    \6\ Letter from Melinda K. Plaisier to Representative Walter B. 
Jones (Nov. 26, 1999).
    \7\ Id. at 2.
    \8\ Id.

        There is presently no basis for concluding that the 
        anthrax vaccine, a licensed product, when used in 
        accordance with current labeling, should be used 
        pursuant to an IND application or, as requested in your 
        letter, that FDA ``place the anthrax vaccine back under 
        IND status.'' \9\
---------------------------------------------------------------------------
    \9\ Id. at 3.
---------------------------------------------------------------------------

               vi. recommendation to suspend the program

    Whether to suspend the vaccination program is a decision 
that must be made by security experts based on the most 
complete information relevant to all risks and benefits. These 
factors are sometimes unquantifiable; indeed, some are 
unknowable and will remain so until ultimately tested in 
combat. Because the report is not based on classified 
information regarding the likelihood of an anthrax attack, it 
provides insufficient information to overturn DOD's decision to 
pursue the vaccination program.
    The report recognizes that ``[t]hreat assessment requires 
objective and subjective analyses of U.S. vulnerabilities, 
enemy capacity, and enemy intentions.'' The report also 
acknowledges that ``much of the information regarding the BW 
[biological weapons] capabilities and intentions of potential 
adversaries, and even allies, is classified.'' Yet the report 
bases its conclusions only on unclassified information. Members 
received no classified information at the full committee level, 
and the subcommittee had no closed hearings in which it could 
consider such information.
    As a result, the report's conclusions--that ``the threat 
remains tactically limited and regional'' and that the program 
``is designed to reach far beyond those at risk''--do not 
reflect DOD's full judgment about the actual extent of the 
threats involved. The report states that ``DOD has determined 
the threat is real and imminent, and has concluded it would be 
irresponsible not to deploy an available countermeasure to 
protect the lives and fighting capability of U.S. forces.'' 
Without additional information to the contrary, we defer to 
DOD's conclusion.

                           vii. kevin edwards

    At the committee meeting to consider this report, 
Representative Dan Burton, chairman of the Committee on 
Government Reform, raised the case of Kevin Edwards. He began 
his statement by displaying photographs of Mr. Edwards's 
bruised body. He then said:

        We have spoken to many individuals who have been ill 
        for a very, very long time. One example is Mr. Edwards 
        of North Carolina. I want you to look at these 
        pictures. I think these pictures will show what can 
        happen when there really is a bad reaction or an 
        adverse event. Mr. Edwards has what appears to be third 
        degree burns on much of his body but in fact, it is a 
        condition that developed after receiving the anthrax 
        vaccine.

    Subsequent investigation by the minority does not 
substantiate Mr. Burton's allegations. While Chairman Burton 
attributed Mr. Edwards's illness to the anthrax vaccine, he 
failed to disclose that Mr. Edwards's case had been considered 
by the Anthrax Vaccine Expert Committee. Although the Privacy 
Act protects Mr. Edwards's medical records, the findings of the 
Expert Committee were fundamentally different from Chairman 
Burton's conclusions.
    Exhibit 1 to these views is a letter from Representative 
Henry A. Waxman, ranking minority member, that sets forth 
additional details related to Mr. Edwards's case.\10\
---------------------------------------------------------------------------
    \10\ Letter from Representative Henry A. Waxman, ranking minority 
member, to Representative Dan Burton, chairman (Mar. 17, 2000) (exhibit 
1).
---------------------------------------------------------------------------
                                   Hon. Henry A. Waxman.
                                   Hon. Rod R. Blagojevich.
                                   Hon. Tom Lantos.
                                   Hon. Major R. Owens.
                                   Hon. Eleanor Holmes Norton.
                                   Hon. Elijah E. Cummings.
                                   Hon. Danny K. Davis.
                                   Hon. John F. Tierney.
                                   Hon. Harold E. Ford, Jr.
                                   Hon. Janice D. Schakowsky.

                                   
                                   

               SUPPLEMENTAL VIEWS OF HON. BERNARD SANDERS

    The chairman of the Subcommittee on National Security, 
Veterans Affairs, and International Relations is to be 
commended for the extremely thorough hearings he has held 
leading up to this report. He is also to be commended for the 
extremely well documented report, itself, and the decisive 
recommendations contained therein. All of these recommendations 
are fully supported by the testimony presented to the 
subcommittee--testimony which raised serious questions about 
the anthrax vaccine, its manufacturer, and the Department of 
Defense's [DOD] vaccination program.
    As the report documents, the anthrax vaccine is of 
questionable efficacy and safety. DOD's mishandling of the 
vaccination program has exacerbated these concerns. Questions 
about efficacy have been compounded by the failure of DOD to 
administer the six shot regimen in accordance with the FDA-
approved vaccination schedule. Safety concerns have been 
heightened by DOD's failure to track and record adverse 
reactions. Moreover, DOD's refusal to even acknowledge the 
concerns raised by members of the armed services has created 
significant morale problems among active service members, as 
well as National Guard and Reserve forces.
    DOD also must shoulder the blame for failing to pursue a 
more effective and safe vaccine against anthrax. Had DOD acted 
immediately after the Persian Gulf war to find an alternative; 
a safer, more effective vaccine would be available now.
    Against this backdrop of DOD mismanagement and 
stonewalling, some service members have refused to be 
vaccinated against anthrax. As a result, service members have 
been disciplined, including being discharged from the armed 
services. While I fully understand the need for the military to 
insist on compliance with lawful orders, DOD cannot escape its 
own responsibility for the refusal of its members to take the 
vaccine.
    The subcommittee's report expressly ``makes no 
recommendation regarding the status of those service members 
who left the armed forces voluntarily, or as the result of 
disciplinary action, due to the anthrax vaccine.'' Some have 
questioned whether the order to take the vaccine itself is 
lawful. The subcommittee did not set out to answer that 
question and the testimony it received was not adequate to 
resolve it.
    DOD's position is buttressed by the Food and Drug 
Administration's [FDA] view that DOD's anthrax program does not 
represent an off-label use. However, given the documented 
failure of DOD to administer the vaccine in accordance with the 
FDA's approved schedule, DOD's insistence on deploying service 
members before the six shot regimen is complete, and the 
insufficiency of scientific evidence to support claims of 
efficacy against weaponized anthrax, it is not clear that the 
FDA's position would pass muster under the Administrative 
Procedures Act's ``arbitrary, capricious or contrary to law'' 
standard.
    This ambiguity and the well documented DOD mishandling of 
its anthrax vaccine program argues strongly that, at a minimum, 
DOD should exercise extreme leniency in its treatment of 
service members who have refused to take the anthrax vaccine, 
including removing derogatory findings and comments in service 
records, reversing reductions in rank and pay, and permitting 
the re-enlistment of members who have been discharged.
    If DOD accepts the subcommittee's recommendation--as it 
should--to recategorize its anthrax program as being in 
Investigational New Drug status then future disciplinary 
proceedings will be unnecessary because service members will 
only receive the vaccine after providing their informed 
consent.
    If there is one thing that the subcommittee learned from 
its review of DOD's anthrax vaccination program it is that the 
trust of many service members has been severely shaken. 
Acceptance of the recommendations in the subcommittee's report 
and reversal of prior disciplinary actions will go a long way 
toward rebuilding the trust of service members in the DOD and 
would be in the best interest of our Nation's armed forces.
                                   Hon. Bernard Sanders.

                                  
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