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House Government Reform Committee (Shays') Report -

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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