House Government Reform Committee (Shays') Report -
Full report available:
The Department of Defense Anthrax Vaccine Immunization Program:
UNPROVEN FORCE PROTECTION
17 Feb 2000
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.
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.
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.
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.
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.
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