U.S. GOVERNMENT PRINTING OFFICE

WASHINGTON : 

1

79–006 CC 2000

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
(II)

COMMITTEE ON GOVERNMENT REFORM

DAN BURTON, Indiana, Chairman

BENJAMIN A. GILMAN, New York

CONSTANCE A. MORELLA, Maryland

CHRISTOPHER SHAYS, Connecticut

ILEANA ROS-LEHTINEN, Florida

JOHN M. MCHUGH, New York

STEPHEN HORN, California

JOHN L. MICA, Florida

THOMAS M. DAVIS, Virginia

DAVID M. MCINTOSH, Indiana

MARK E. SOUDER, Indiana

JOE SCARBOROUGH, Florida

STEVEN C. LATOURETTE, Ohio

MARSHALL ‘‘MARK’’ SANFORD, South

Carolina

BOB BARR, Georgia

DAN MILLER, Florida

ASA HUTCHINSON, Arkansas

LEE TERRY, Nebraska

JUDY BIGGERT, Illinois

GREG WALDEN, Oregon

DOUG OSE, California

PAUL RYAN, Wisconsin

HELEN CHENOWETH-HAGE, Idaho

DAVID VITTER, Louisiana

HENRY A. WAXMAN, California

TOM LANTOS, California

ROBERT E. WISE, JR., West Virginia

MAJOR R. OWENS, New York

EDOLPHUS TOWNS, New York

PAUL E. KANJORSKI, Pennsylvania

PATSY T. MINK, Hawaii

CAROLYN B. MALONEY, New York

ELEANOR HOLMES NORTON, Washington,

DC

CHAKA FATTAH, Pennsylvania

ELIJAH E. CUMMINGS, Maryland

DENNIS J. KUCINICH, Ohio

ROD R. BLAGOJEVICH, Illinois

DANNY K. DAVIS, Illinois

JOHN F. TIERNEY, Massachusetts

JIM TURNER, Texas

THOMAS H. ALLEN, Maine

HAROLD E. FORD, JR., Tennessee

JANICE D. SCHAKOWSKY, Illinois

———

BERNARD SANDERS, Vermont

(Independent)

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

ILEANA ROS-LEHTINEN, Florida

JOHN M. MCHUGH, New York

JOHN L. MICA, Florida

DAVID M. MCINTOSH, Indiana

MARSHALL ‘‘MARK’’ SANFORD, South

Carolina

LEE TERRY, Nebraska

JUDY BIGGERT, Illinois

HELEN CHENOWETH-HAGE, Idaho

ROD R. BLAGOJEVICH, Illinois

TOM LANTOS, California

ROBERT E. WISE, JR., West Virginia

JOHN F. TIERNEY, Massachusetts

THOMAS H. ALLEN, Maine

EDOLPHUS TOWNS, New York

BERNARD SANDERS, Vermont

(Independent)

JANICE D. SCHAKOWSKY, Illinois

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
(3)

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)

(V)

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)

1Public Law 105–277, title XVI, sec. 1603(d).

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.

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.
2

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.

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.

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
3

3 10 U.S.C. 1107(f); 21 CFR Part 50; Executive Order No. 13139 of Sept. 30, 1999.

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
4

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).

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 secondgeneration, 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
5

5DOD media release, ‘‘Defense Department to Start Immunizing Troops Against Anthrax,’’

No. 679–97, Dec. 15, 1997. 6 AVIP briefing slides (in subcommittee files).

7DOD 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. 8See supra note 5, p. 1.

9 Ibid.

10 Ibid. 11Letter 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). 12Major William Terry, ‘‘Tracking Troops’ Anthrax Shots,’’ (with charts), ArmyLINK News,

March 1999. 13 Ibid.

spore form can be used as a biological weapon. The effort is called

the Anthrax Vaccine Immunization Program [AVIP].5

The program was designed to be implemented in three phases:6

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

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

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

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
6

14Department of Defense, AVIP tri-fold brochure, ‘‘What Every Service Member Should Know

About Anthrax’’ (undated) (in subcommittee files). 15Department of Defense website on Anthrax Vaccination Immunization Program, http://

www.anthrax.osd.mil. 16Letter 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). 17Steve Bowman, Department of Defense Anthrax Vaccination Program (98–873F), Congressional Research Service report (updated), Oct. 28, 1998, p. 2. 18Prepared statement of Dr. Sue Bailey, Assistant Secretary for Health Affairs, DOD,

NSVAIR anthrax hearing (I), p. 9 . 19The 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. 20Federal Register, 21 CFR Part 610, Dec. 13, 1985, p. 51058. 21 Ibid.

to be given to service personnel.14 An anthrax vaccine website was

also created.15 A physician reviewed the AVIP program plans.16

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

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

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

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, highrisk 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).
7

22DOD’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. 24Department 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). 25DOD news briefing, Monday, Dec. 13, 1999 (available at http://www.defenselink.mil and in

subcommittee files). 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. 27Letter from Joseph S. Little, Contracting Officer, Department of the Army to Fuad El-Hibri,

BioPort Corp., Sept. 23, 19989 (in subcommittee files).

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

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

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
8

28Department of Defense (1998) Award/Contract: U.S. Army Medical Research ACQ Activity—

BioPort Corp., DAMD17–98–C–8052, Sept. 17, 1998. 29Department of Defense media release, ‘‘DOD Announces Contract Restructuring,’’ Aug. 5,

1999 (in subcommittee files). 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). 31Memorandum 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). 32Memorandum 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).

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.

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

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

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

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
9

33Memorandum 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). 34See 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). 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). 38See supra note 14. 39Prepared statement of Dr. Kathryn Zoon, Director, FDA Center for Biologics Evaluation and

Research, NSVAIR anthrax hearing (II), pp. 52–53. 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.

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).

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

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

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

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 signifi-
10

41Michigan 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). 42Phillip Brachman and Arthur Friedlander, Vaccines, 2d ed., pp. 729–739, Philadelphia, WB

Saunders (1994). 43See supra note 41. 44LTC 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). 45See supra note 41. 46Gen. 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). 47FDA Center for Biologics Evaluation and Research, ‘‘Vaccine Adverse Events Reporting System [VAERS]’’ available at http://www.fda.gov.cber/vaers/faq.htm. 48 Ibid. 49See 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).

cant. Reactions may increase in severity after successive injections.41

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

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

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

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

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
11

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). 52Department of the Army, Office of the Surgeon General, ‘‘Memorandum for Conference Participants,’’ Apr. 16, 1999, p. 2 (in subcommittee files). 53See supra note 46 p. C–5. 54Testimony of Dr. Kathryn Zoon, Director, FDA Center for Biologics Evaluation and Research, NSVAIR anthrax hearing (II), p. 55. 55Department 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). 56See 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. 58See supra note 16.

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

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.

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

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
12

59 Ibid. 60Letter from Dr. Gerard N. Burrow, Yale University School of Medicine, to Representative

Christopher Shays, Apr. 26, 1999 (in subcommittee files). 61See supra note 17, p. 3. 62 Each lot contains approximately 200,000 doses of vaccine. 63See supra note 26, p. 13. 64Dr. 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).

‘‘unit effectiveness could best be preserved through the use of predeployment vaccination.’’ 59

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).

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

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
13

66Letter 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). 67Testimony of Dr. Sue Bailey, DOD Assistant Secretary for Health Affairs, NSVAIR anthrax

hearing (I), p. 11. 68Prepared statement of Dr. Meryl Nass, NSVAIR anthrax hearing (II) pp. 108–111. 69 Ibid. 70Report 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. 71See supra note 66.

release.66 All the lots submitted for supplemental testing had also

undergone the same FDA lot release protocols.

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.

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:

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

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

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
14

72 Ibid. Nor is there data demonstrating the vaccine is effective against altered or mixed anthrax strains. 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. 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. 75Testimony 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. 76Public Law 105–277, title XVI. 77Letter from Representativess Benjamin Gilman (NY), et. al. to Defense Secretary William

Cohen, July 20, 1999, p. 1 (in subcommittee files). 78See supra note 14.

data or evidence to suggest that such a mixture is resistant to the

FDA-licensed anthrax vaccine used by the US military.’’ 72

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

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

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.

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

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
15

79Lt. Gen. Ronald Blanck, ‘‘Ignore the Paranoics: The Vaccine is Safe,’’ Army Times, Feb. 2,

1999, p. 12. 80Douglas 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). 81 Bradley Graham, ‘‘Anthrax Shots Missing Targets?’’ Washington Post, Sept. 29, 1999, p.

A27. 82See supra note 60 and accompanying text. 83Testimony of Capt. Thomas Rempfer, NSVAIR anthrax hearing (I), pp. 40–41; testimony of

Maj. Russell Dingle, NSVAIR anthrax hearing (I), p. 49.

‘‘paranoics’’ 79 and simple-minded victims of Internet propaganda.80

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

4. Contrary to subsequent DOD characterizations, the promised outside, expert, scientific review of the program was only

very general in nature.82

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

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
16

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 ElHibri, 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:
17

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.

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

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
18

85Dr. Stephen C. Joseph, Assistant Secretary of Defense for Health Affairs, ‘‘Biological Warfare—Information Memorandum’’ (undated) p. 2 (in subcommittee files). 86DOD information paper,‘‘DOD Biological Warfare Threat Analysis,’’ Dec. 15, 1997, p. 1. See

also, Proliferation: Threat and Response, Department of Defense, November 1997. 87Office 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. 88See supra note 66, attachment p. 13. 89 Ibid. 90See 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. 91See supra note 66. 92Prepared 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.

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.

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

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

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

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
19

93Prepared statement of Dr. Sue Bailey, DOD Assistant Secretary for Health Affairs, NSVAIR

anthrax hearing (I), p. 8. 94See supra note 14. 95Prepared statement of Dr. Sue Bailey, DOD Assistant Secretary for Health Affairs, NSVAIR

anthrax hearing (I), p. 13. 96Prepared 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. 97DOD, briefing slide entitled, ‘‘Anthrax Threat,’’ Apr. 20, 1998 (in subcommittee files). 98DOD, briefing slide entitled, ‘‘Assessment,’’ Apr. 20, 1998 (in subcommittee files).

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

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

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

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

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

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
20

99 Ibid. 100Prepared statement of Dr. Sue Bailey, Assistant Secretary of Defense for Health Affairs,

NSVAIR anthrax hearing (I), p. 8. 101Letter from Sandra K. Stuart, Assistant Secretary of Defense (Legislative Affairs) to the

Honorable Christopher Shays (CT), p. 1, Dec. 15, 1997. 102Letter 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). 103Department of Defense, information paper, ‘‘DOD Biological Warfare Force Protection,’’

Dec. 15, 1997, p. 2 (in subcommittee files). 104See supra note 7, p. 2. 105Department of Defense, ‘‘Operational Requirements Document [ORD] for Improved Anthrax Vaccine,’’ Oct. 2, 1995, p. 1 (in subcommittee files).

So Saddam would be ‘‘unlikely to use WMD unless he perceives regime’s survival at stake.’’ 99

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

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

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

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

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 im-
21

106 Ibid., p. B–1. 107 Ibid., p. 2. 108 U.S. Army Medical Research Institute of Infectious Diseases [USAMRIID], briefing slide,

‘‘Problems with Current MDPH Vaccine,’’ (undated) (in subcommittee files). 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. 110See supra note 44, p. 1. 111See supra note 85, p. 5. 112 Ibid.

munization program will be conducted under certain alert or mobilization conditions.’’ 106

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.

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

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

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.

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)
22

113 Ibid., p. 7. 114DOD, Medical Defense Against Biological Material, (undated) p. 1. 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). 116Testimony of Lt. Gen. Charles H. Roadman, Surgeon General, USAF, NSVAIR anthrax

hearing (I), p. 17. 117Testimony of R.Adm. Todd Fisher, Deputy Surgeon General, USN, NSVAIR anthrax hearing (I), p. 17.

• medical (vaccines) countermeasures to prevent disease

• contamination avoidance

• decontamination 113

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:

. . . 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

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:

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

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
23

118Testimony of Lt. Gen. Charles H. Roadman, II, Surgeon General, USAF, NSVAIR anthrax

hearing (I), p. 18. 119Testimony of Captain Thomas Rempfer, NSVAIR anthrax hearing (I), p. 40. 120 Ibid. 121 Ibid. 122See supra note 85, p. 11. 123 Ibid. 124See supra note 103. 125Dr. 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.

and weapons. So we should also provide the best armor against biological dangers that we can. That armor is immunization.’’ 118

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

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:

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

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

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

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
24

127Prepared statement of Dr. Sue Bailey, Assistant Secretary of Defense for Health Affairs,

NSVAIR anthrax hearing (I), p. 10. 128DOD, Public Affairs Talking Points, p. 1, Dec. 15, 1997. 129Prepared statement of Dr. Sue Bailey, Assistant Secretary of Defense for Health Affairs,

NSVAIR anthrax hearing (I), p. 10. 130Department of Defense, Medical Services—Immunizations and Chemoprophylaxis, Army

Regulation 40–562, NAVMEDCOMINST 6230.3, AFR 161–13, CG COMDTINST M6230.4D, Oct.

7, 1988. 131See supra note 105, p. 1. 132See supra note 66, p. 14. 133 Ibid.

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

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.

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

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
25

134Defense Threat Reduction Agency, Policy Memorandum 99–22, July 23, 1999, p. 2 (in subcommittee files). 135Prepared statement of Kwai-Cheung Chan, NSVAIR anthrax hearing (II), p. 17. 136Testimony of Col. Renata Engler, Chief, Allergy-Immunology Service, Walter Reed Army

Medical Center, NSVAIR anthrax hearing (IV), p. 173. 137See supra note 46, p. 1. 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).

a part of the individual’s permanent Occupational Health

Record.134

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

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

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.
26

139See supra note 26, p. 12 140 Ibid., p. 5. 141 Ibid. 142 Ibid., p. 13. 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. 144FDA 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). 146Production 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.

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

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:

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

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.
27

147Dr. Sue Bailey, Department of Defense news briefing, Dec. 13, 1999, p. 2 (available at:

http://www.defenselink.mil) (in subcommittee files). 148Letter 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. 150Testimony 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. 151Defense Contract Audit Agency, report No. 2261–97G21000018, Department of Defense,

Sept. 24, 1997 (in subcommittee files). 152Prepared statement of Louis J. Rodrigues, Director, Defense Acquisition Issues, National

Security and International Relations Division, GAO, NSVAIR anthrax hearing (III), p. 7. 153DOD 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). 154Testimony of David R. Oliver, Jr., Principal Deputy Under Secretary of Defense for Acquisition and Technology, NSVAIR anthrax hearing (III), p. 65. 155Testimony 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).’’

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

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

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

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

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
28

156Testimony of Louis J. Rodrigues, Director, Defense Acquisition Issues, National Security

and International Relations Division, GAO, NSVAIR anthrax hearing (III), p. 28. 157 Ibid., p. 16. 158 Ibid., p. 15. 159See supra note 36, p. 1. 160See supra note 37.

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.

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

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

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

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
29

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). 162See supra note 108. 163Letter 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). 164Testimony of David R. Oliver, Jr., Principal Deputy Under Secretary of Defense for Acquisition and Technology, NSVAIR anthrax hearing (III), p. 69. 165See supra note 130.

vaccine. The suggestion was not incorporated in the final document.161

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

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

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
30

166See supra note 41. 167 E-mail from Col. Fred Gerber dated Sept. 1, 1998 (in subcommittee files). 168Form #PHS–731, Department of Defense (in subcommittee files). 169Service-specific subsystems: the Army MEDPROS, Navy SAMS and R–STARS, Air Force

MITS. 170See supra note 26, p. 10. 171 Ibid., p. 20. 172 Ibid., p. 21. 173 Ibid., p. 22.

FDA approved inoculation regime is six shots over 18 months, with

a subcutaneous injection of AVA to be given as follows:

#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

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

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

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:

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

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 up-
31

174 Ibid. 175 E-mails from Maj. Guy Strawder dated Feb. 17, 1999 (in subcommittee files). 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. 177See supra note 108. 178Prepared 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. 179Memorandum on ‘‘Policy Deviation from Anthrax Vaccine Immunization Schedule’’ from

the Department of Defense dated Sept. 11, 1998, p. 1 (in subcommittee files). 180See 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. 181Department of Defense, ‘‘Anthrax Vaccine Immunization Program Quarterly Review,’’ Jan.

22, 1999, p. 9 (in subcommittee files). 182Letter and accompanying computer diskette from Charles L. Cragin to Representative

Christopher Shays dated Aug. 23, 1999 (in subcommittee files).

dated 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

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

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

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
32

183 E-mails from James Dougherty dated Sept. 1, 1999. (in subcommittee files) 184Testimony of Charles L. Cragin, Acting Assistant Secretary for Reserve Affairs, NSVAIR

anthrax hearing (V), p. 104 (in subcommittee files). 185See supra note 175. 186See supra note 182. 187See 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. 188See supra note 134, p. 2.

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 callup.184 Nevertheless, according to an internal DOD document, readiness estimates based on AVIP tracking data are ‘‘still suspect.’’ 185

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.

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 An-
33

189Letter from Dr. Katherine C. Zoon to Dr. Sue Bailey dated Sept. 29, 1999 (in subcommittee

files). 190See supra note 46, p. C–5. 191See supra note 41. 192Department of Defense, ‘‘Clinical Practice Guidelines for Managing Adverse Events After

Anthrax and Other Vaccinations,’’ Nov. 15, 1999 pp. 1–2. (in subcommittee files). 193See supra note 26, pp. 24–26. 194Prepared statement of Randi J. Martin-Allaire, NSVAIR anthrax hearing (II), p. 170. 195Prepared statement of Roberta Groll, NSVAIR anthrax hearing (II), pp. 176–179; and prepared statement of David Churchill, NSVAIR anthrax hearing (II), pp. 183–188. 196Debra Funk, ‘‘Air Guard Unit Delays Anthrax Inoculations,’’ Air Force Times, July 5, 1999,

p. 29. 197 E-mails and meeting notes (in subcommittee files). 198See supra note 74. 199Testimony of Maj. Gen. Paul Weaver, Director, Air National Guard, DOD, NSVAIR anthrax hearing (V), p. 118. 200 E-mails (in subcommittee files).

thrax Vaccine Immunization Program follow the FDA approved schedule.189

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

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.

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

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

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

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
34

201 Command Anthrax Policy, U.S. Air Force Reserve, June 22, 1999 (in subcommittee files). 202See supra note 26, p. 35. 203 Ibid. 204See supra note 108. 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. 206See supra note 41. 207Prepared statement of Kathryn C. Zoon, Ph.D., NSVAIR anthrax hearing (II), pp. 52–53. 208See supra note 1. 209Prepared statement of Kwai-Cheung Chan, Director, Special Studies and Evaluation Section, National Security and International Relations Division, GAO, NSVAIR anthrax hearing

(II), p. 11.

made by anyone scheduled or directed to begin the anthrax immunizations.201

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)

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.

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

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
35

210 Ibid., p. 16. 211See 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. 213Prepared statement of Kwai-Cheung Chan, Director, Special Studies and Evaluation Section, National Security and International Relations Division, GAO, NSVAIR anthrax hearing

(II), p. 16. 214Prepared 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).

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

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).

Table I: Reactions to Licensed Anthrax Vaccine Reported in Various Studies

Study Type of Reporting

Number Vaccinated (or

doses)

Local reactions (percent) Systemic reactions (percent)

Mild Moderate/Severe Mild Moderate/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

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
36

215Prepared statement of Capt. Michelle L. Piel, NSVAIR anthrax hearing (IV), p. 3 (in subcommittee files). 216 Ibid. 217 Ibid. 218 Ibid. 219 Ibid., p. 4. 220See supra note 108. 221Letter from Lt. Gen. Ronald R. Blanck to Mark Zaid dated Dec. 10, 1999, p. 1 (in subcommittee files). 222See supra chart at note 213. 223See supra note 33. 224 Ibid. 225 Ibid.

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

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

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

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

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 con-
37

226Deborah Funk, ‘‘Military Officials Order Study to Determine Vaccine’s Safety, Long-term

Side effects,’’ Army Times, July 12, 1999, p. 12. 227Prepared statement of Maj. Gen. G. Robert Claypool, Deputy Assistant Secretary for

Health Operations Policy, DOD, NSVAIR anthrax hearing (IV), p. 12 (in subcommittee files). 228Testimony 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). 229Testimony of Dr. Shushil K. Sharma, Special Studies and Evaluations Section, National

Security and International Relations Division, GAO, NSVAIR anthrax hearing (II), p. 25. 230See supra note 26, p. 32.

trolled, cohort studies only now being discussed to learn more

about reaction rate differences by age and gender.226

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

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

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

GAO found, ‘‘This is misleading because of potential underreporting of events to VAERS, and the potential for overstating the reac-
38

231 Ibid. 232 Ibid. 233Prepared statement of Dr. Meryl Nass, NSVAIR anthrax hearing (II), p. 107. 234Prepared 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). 235See supra note 26, p. 32. 236See supra note 30. 237Prepared statement of Lt. Richard Rovet, NSVAIR anthrax hearing (IV), p. 2 (in subcommittee files). 238Testimony of Lt. Richard Rovet, NSVIAR anthrax hearing (IV), p. 25 (in subcommittee

files). 239 Ibid. 240Prepared statement of Capt. Michelle L. Piel, NSVAIR anthrax hearing (IV) p.3 (in subcommittee files).

tion 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

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

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.

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

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,
39

241Testimony of Capt. Michelle L. Piel, NSVAIR anthrax hearing (IV), p. 59 (in subcommittee

files). 242Testimony of Capt. Jon Richter, NSVAIR anthax hearing (IV), p. 38 (in subcommittee

files). 243 Ibid, p. 41. 244Prepared 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. 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. 248See supra note 51, pp. 3–7.

‘‘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

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

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

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).

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 es-
40

249 Ibid., p. 12. 250 Ibid. 251See supra note 245.

tablishment’’ 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

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

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).

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
41

252 E-mails from Col. Fred Gerber dated November 17, 1998 (in subcommittee files). 253 ‘‘Anthrax Vaccine: Safety and Efficacy Issues,’’ (GAO/NSAID–00–48) U.S. General Accounting Office, Oct. 12, 1999, pp. 1–7. 254 Ibid., p. 3. 255 Ibid., p. 4. 256Prepared statement of Kwai-Cheung Chan, Director, Special Studies and Evaluation Section, National Security and International Affairs Division, GAO, NSVAIR anthrax hearing (II),

p. 13. 257 Ibid., p. 11. 258See supra note 138, pp. 87–88.

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

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

Since the AVIP began, DOD has undertaken two active followup 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

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.

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
42

259Only research and testing facilities now present an occupational setting posing a danger

of anthrax exposure. 260Prepared 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.

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.

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

All the DOD animal studies support the view that the licensed

vaccine can protect some animals against exposure to some strains
43

261See supra note 253, p. 8. 262Prepared statement of Dr. Meryl Nass, NSVAIR anthrax hearing (II), p. 108. 263 Ibid., p. 110. 264Prepared statement of Dr. Sue Bailey, Assistant Secretary for Health Affairs, DOD,

NSVAIR anthrax hearing (I), p. 11. 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. 266See supra note 138, p. 90. 267Stephen 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. 268Protective antigen [PA] is one of three proteins involved in the mechanism of anthrax toxicity.

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

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

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

One study comparing the efficacy of a live spore vaccine to a PAbased vaccine, like the AVA, concluded, ‘‘Immunization with cellfree 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

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.

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:
44

269The current potency test uses guinea pigs. 270See 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). 271Memorandum from Gregory B. Knudson to Representative Christopher Shays dated May

8, 1999, (in subcommittee files). 272William J. Broad, ‘‘Gene-Engineered Anthrax: Is It a Weapon?’’ New York Times, Feb. 14,

1998 (in subcommittee files). 273 Ibid.

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).

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

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

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

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
45

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.
46

274See supra note 79. 275See supra note 80. 276Testimony of MG Paul Weaver, Director, Air National Guard, NSVAIR anthrax hearing

(V), p. 119. 277Prepared statement of Charles Cragin, Acting Assitant Secretary for Reserve Affairs,

NSVAIR anthrax hearing (IV), p. 3. 278Letter (with attachments) from Charles Cragin to Representative Christopher Shays, attachment p. 1, Oct. 21, 1999. (in subcommittee files). 279Prepared statement of Charles Cragin, Acting Assitant Secretary for Reserve Affairs,

NSVAIR anthrax hearing (IV), p. 4.

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.

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.

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

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
47

280See supra note 134. 281See supra note 66, p. 1. 282Testimony of Kwai-Cheung Chan, Director, Special Studies and Evaluation Section, National Security and International Affairs Division, GAO, NSVAIR anthrax hearing (IV), p. 100. 283Testimony of Col. Renata Engler, Chief, Allergy and Immunology Department, Walter Reed

Army Medical Center, NSVAIR anthrax hearing (IV), p. 155. 284Prepared statement of Kwai-Cheung Chan, Director, Special Studies and Evaluation Section, National Security and International Relations Division, GAO, NSVAIR anthrax hearing

(IV), p. 13.

made available to essential civilian employees of the Defense

Threat Reduction Agency.280

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.

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.

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
48

285See supra note 108. 286Testimony of David R. Oliver, Jr., NSVAIR anthrax hearing (III), pp. 68–69. 287Department 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). 288 Ibid. 289Testimony of Col. Fred Gerber, Director, Health Care Operations, Office of the Army Surgeon General, NSVAIR anthrax hearing (V), p. 153. 290 ‘‘Anthrax Immunization,’’ American Public Health Association, policy statement No. 9930,

Nov. 10, 1999. 291 Ibid.

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.

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.

DOD concedes, ‘‘In the case of anthrax vaccine, the current FDAlicensed 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

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

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 nonmilitary 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 recommenda-
49

292 Ibid. 293Testimony of Kwai-Cheung Chan, Director, Special Studies and Evaluation Section, National Security and International Affairs Division, GAO, NSVAIR anthrax hearing (IV), p. 97. 294Prepared statement of Kwai-Cheung Chan, Director, Special Studies and Evaluation Section, National Security and International Affairs Division, GAO, NSVAIR anthrax hearing (IV),

p. 5. 295 Ibid., p. 6. 296See supra note 7.

tions 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

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

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

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.

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
50

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). 298Testimony 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. 299See supra note 46, p. 1, sec. 1(a)(8). 300Testimony of Maj. Gen. Robert Claypool, Deputy Assistant Secretary for Health Operations

Policy, NSVAIR anthrax hearing (IV), p. 108. 301 Ibid.

been used by critics to question the relevance of the biological defense [BD] vaccine program to the DOD.’’ 297

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.

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
51

302 Ibid., p. 109. 303Dr. Sue Bailey, ‘‘What Everyone Needs to Know about the Anthrax Vaccine’’ quarterfold

brochure, Department of Defense, Nov. 1, 1999, p. 3 (in subcommittee files). 304 E-mails from Col. Renata Engler dated Dec. 4–8, 1998 (in subcommittee files).

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

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,

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.
52

305 21 CFR Part 312. 306Letter from Dr. Stephen C. Joseph to Dr. Michael A. Friedman dated Mar. 4, 1997 (in subcommittee files). 307Micheal J. Gilbreath, Ph.D., ‘‘Is the current Anthrax vaccination regimen necessary?’’ Department of Defense information paper (JPO 0044), Nov. 10, 1995, pp. 1–2.

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.

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

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
53

308See supra note 138, p. 1. 309Department of Defense, ‘‘Supplemental to AVA License’’ USAMRIID presentation slides,

Oct. 28, 1997 (in subcommittee files). 310Department 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. 311Letter from Dr. Michael A. Friedman to Dr. Stephen C. Joseph dated Mar. 13, 1997 (in

subcommittee files).

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:

• 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

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?

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

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
54

312See 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. 313See supra, note 310, 1998 report, p. 3–4.

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.

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)

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
55

314Testimony 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). 315Submitted 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. 316 Ibid. (quoting Grodin MA, Annas GJ: Journal of the American Medical Association

277:712–713, 1997). 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.)

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.

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

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

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.

In November 1997 the subcommittee proposed, and the full Government Reform and Oversight Committee approved, an oversight
56

318Gulf 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. 320 H.R. 4035, 105th Cong., 2d sess.; S. 2057, 105th Cong., 2d sess. 321Federal Register, 21 CFR Parts 50 and 312, Oct. 5, 1999, p. 54180. 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.

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

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.

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

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

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.
57

324Department 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). 325See supra note 321 p. 51484. 326 Ibid.

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

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.

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 pro-
58

327Open protocols could be established for the on-going trial of a reduced vaccine regimen or

a trial of a purer vaccine. 328 ‘‘Stop Mandatory Anthrax Inoculations,’’ Air Force Times, Army Times Publishing Co., Jul.

12, 1999, p. 44. 329 Ibid. 330 Ibid.

tocols 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.

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

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
(59)

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
60

1Letter from Dr. Katherine C. Zoon to Dr. Sue Bailey (Sept. 29, 1999).

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

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
61

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). 4Defense 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).

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:

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

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.
62

5Letter from Representatives Burton, Shays, Gilman, and Jones to Dr. Jane E. Henney (Nov.

3, 1999). 6Letter from Melinda K. Plaisier to Representative Walter B. Jones (Nov. 26, 1999).

7 Id. at 2.

8 Id.

9 Id. at 3.

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.

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:

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

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
63

10Letter from Representative Henry A. Waxman, ranking minority member, to Representative

Dan Burton, chairman (Mar. 17, 2000) (exhibit 1).

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

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.
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(66)

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
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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.

Æ