House Government Reform Committee (Shays') Report -
Full report available:
http://www.house.gov/reform/ns/reports/anthrax1.pdf
The Department of Defense Anthrax Vaccine Immunization Program:
UNPROVEN FORCE PROTECTION
17 Feb 2000
Summary
Responding to service members complaints of program insensitivity to adverse health
effects, inadequate medical record keeping and heavy-handed program operation, the
Subcommittee 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, 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.
Based on the testimonial and documentary record, 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 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 Corporation, 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.
Findings in Brief
1.The AVIP is a well-intentioned but over-broad response to the anthrax threat. It
represents a doctrinal departure overemphasizing the role of medical intervention in force
protection.
2.The AVIP is vulnerable to supply shortages and price increases. The sole-source
procurement of a vaccine that requires a dedicated production facility leaves DOD captive
to old technology and a single, untested company. Research and development on a
second-generation, recombinant vaccine would allow others to compete.
3.The AVIP is logistically too complex to succeed. Adherence to the rigid schedule of six
inoculations over 18 months for 2.4 million members of a mobile force is unlikely,
particularly in reserve components. Using an artificial standard that counts only shots
more than 30 days overdue, DOD tolerates serious deviations from the Food and Drug
Administration (FDA) approved schedule.
4.Safety of the vaccine is not being monitored adequately. The program is predisposed to
ignore or understate potential safety problems due to reliance on a passive adverse event
surveillance system and DOD institutional resistance to associating health effects with
the vaccine.
5.Efficacy of the vaccine against biological warfare is uncertain. The vaccine was
approved for protection against cutaneous (under the skin) infection in an occupational
setting, not for use as mass protection against weaponized, aerosolized anthrax.
Recommendations in Brief
1.The force-wide, mandatory AVIP should be suspended until DOD obtains approval for use of
an improved vaccine. To accomplish this:
2.DOD should accelerate research and testing on a second-generation, recombinant anthrax
vaccine; and,
3.DOD should pursue testing of the safety and efficacy of a shorter anthrax inoculation
regimen; and,
4.DOD should enroll all anthrax vaccine recipients in a comprehensive clinical evaluation
and treatment program for long term study.
5.While an improved vaccine is being developed, use of the current anthrax vaccine for
force protection against biological warfare should be considered experimental and
undertaken only pursuant to FDA regulations governing investigational testing for a new
indication.
Please call your Congressional Reps., and the Government Reform Committee:
Congressional switch number (202) 224-3121