OP ED by Lingg Brewer

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This appeared on the op ed page of today's (12-28-01) Detroit News.

Michigan anthrax vaccine isn't the answer to attacks

By Lingg Brewer / Special to The Detroit News

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Anthrax terrorists and hoaxers are making the cry for an anthrax vaccine

louder, especially when we have a vaccine sitting on the shelf in Lansing --

sort of. Distributing the troubled vaccine made by its troubled manufacturer

will be no cure-all. Improved detection and antibiotics would better serve

the nation than the vaccine made by the Michigan company Bioport.

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 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, Meyer and 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.