Michigan Anthrax Vaccine Isn't the Answer to Attacks
Dec 28, 2001
There are problems with effectiveness and adverse reactions
of the vaccine, little proof that it would work against airborne anthrax and no
proof that it would work against genetically altered anthrax. There are also
questions about the competence of the managers of Bioport Corp. that remain
unanswered.
A 1985 Food and Drug Administration review panel on
bacteriological vaccines came to some revealing conclusions. The panel defined
efficacy as having a useful degree of clinical protection, and safety as not
causing the disease that's being protected against. It said field trials must
provide the final critical assessment, noted the lack of controlled field
trials in the new drug application but relied on textile mill studies using
imported goat hair and accepted the vaccine as 93 percent effective against
cutaneous anthrax and said "efficacy against inhalation anthrax is not
well documented ... due to its extremely low incidence."
The panel did not anticipate use for mass immunization, and
said "safety is not a concern given its very limited distribution, and the
benefit to risk aspects of occupational exposure for its intended users (hide
handlers, veterinarians, etc.) ... recommended for a LIMITED high risk exposure
population." The Department of Defense's intended use goes far beyond the
scope of the Food and Drug Administration's review, with poor proofs of
efficaciousness.
General Accounting Office researcher Nancy Kingsbury
testified recently before Congress about changes in the manufacturing process,
filter changes, which affected the purity and potency of the vaccine. Bioport
did not document the changes to the FDA, even though the onus is on the
manufacturer to insure quality. The Defense Department found hundred-fold
increases in protective-antigen levels that year that led to much higher
adverse reaction rates than Bioport claimed. The company claimed a 0.2 percent
severe reaction rate, defined as systemic with "malaise and lassitude
combined with chills and fever." The GAO's research showed 9-11 percent.
This is something veterans groups have been saying all along, especially women,
who have significantly higher adverse reaction rates.
The April 2000 inspection citations by the FDA refer to
mysteriously altered documents relating to the production process. Moreover,
as agents of the state, Robert Meyer and Robert VanRavensway sold the lab to
themselves in a virtually 100 percent leveraged deal, paid for by the Pentagon,
minimizing its value because the anthrax contracts were for $3 per dose. Before
the ink was dry on the contract, they went to the Pentagon and said we need $10
a dose and $10 million. The Pentagon gave them $10 a dose and $18 million.
They've received $125 million, and $5 million a month since, and the company
can't deliver it because they can't get FDA approval.
The
Defense Department's auditor general is on record as saying he "doubts
Bioport's ability to ever meet the terms of its contract." Setting aside
its conflict of interest, the very least the Defense Department should do is to
foreclose its liens on Bioport and remove current management.
The Centers for Disease Control and the National Institutes
of Health, in cooperation with the FDA, should have an enlarged and clearly
defined role in the production of an improved and proven vaccine that maintains
the same standard for the military as it does for the public, one that does not
take six shots and eighteen months to administer, and that protects against
airborne and genetically altered anthrax. We need a second source for it with
both conforming to current good manufacturing practices. This would promote
competition. Our country deserves no less.
Lingg Brewer is a former Democratic state representative from Holt.