Military's Sole Supplier of Anthrax Vaccine Still Can't Make It

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October 6, 2001- http://anthraxvaccine.org/kinzer.html -

October 6, 2001

 

 

Military's Sole Supplier of Anthrax Vaccine Still Can't Make It

By STEPHEN KINZER

LANSING, Mich., Oct. 5 — With concern growing over the possibility of

biological weapons being used against Americans, anthrax vaccine should be

pouring out the door of the only laboratory in the United States licensed to

make it.

But although the laboratory is working frantically to meet government

standards so it can begin producing the vaccine, it has failed to do so. As

a result, the government program aimed at vaccinating all American soldiers

against anthrax is at a standstill.

On Monday, National Guard sentries arrived to guard the plant, which is

owned by BioPort Corporation, but the sole supplier of anthrax vaccine to

the military has not produced a single dose since 1998, when it bought the

plant from the state.

Problems have plagued BioPort from the beginning. It failed Food and Drug

Administration inspections in 1999 and 2000; inspectors cited problems

including poor documentation and improper procedures in the room where the

vaccine was packaged. Corporate managers hope to begin producing anthrax

this year, but that depends on the outcome of a third F.D.A. inspection,

which has not yet been scheduled.

At a hearing of the Senate Armed Services Committee last year, Senator Tim

Hutchinson, Republican of Arkansas, called BioPort's record " an unmitigated

disaster. " Mr. Hutchinson said its failures were " costing the American

taxpayer millions and millions of dollars and jeopardizing the safety of our

troops who we're not able to provide that anthrax vaccination. "

Others say that problems are not all the fault of the laboratory, which

started life as the Michigan Biologic Products Institute before it was

bought by BioPort.

" There's a lot of criticism of BioPort, " said Tara O'Toole, deputy director

of the Center for Civilian Biodefense Studies at Johns Hopkins University,

" but to be fair, there's also a lot of talk that the Defense Department

significantly underfunded the whole effort and didn't give it the priority

it deserved. "

" In retrospect, " Ms. O'Toole said, " the whole notion of turning this over to

a new contractor instead of an established pharmaceutical company looks

questionable. "

Plant officials say that since the terror attacks last month on the World

Trade Center and the Pentagon, their 220 employees have been working with

new fervor.

" Our commitment has deepened measurably, " said Kim Brennen Root, a BioPort

spokeswoman. " People are getting up every morning thinking: `I know what my

job is. I know what I have to do and I have a very clear purpose.' "

The only other plant that produces anthrax vaccine, Ms. Root said, is in

Britain.

Many experts believe that if terrorists were to launch an attack using

biological agents, anthrax would be among their most likely choices.

Although anthrax is said to be difficult to produce and spread in large

doses, an enemy that managed to do so could inflict considerable damage. A

1993 government study found that spraying just 220 pounds of aerosol anthrax

over Washington could kill up to three million people.

The Soviet Union was known to have experimented with military uses of

anthrax, as have about 10 other countries, including North Korea and Iraq.

Some reports say that Osama bin Laden, whom Bush administration officials

describe as head of the world's principal terror network, has also taken an

interest in chemical and biological warfare.

" It's a good bio-terror weapon and even better for biological warfare, and

it's lying on the ground in places like Afghanistan " said William Dietrich,

an assistant professor at Harvard Medical School who is researching the

anthrax bacterium. " If you have a collection of soldiers you want to kill

without infecting your own population or soldiers, " Professor Dietrich said,

" anthrax has good properties with regard to that. If you can produce it and

disperse it on a battlefield, you can kill a lot of people very quickly.

It's a very terrible, high-fatality kind of illness that we don't have

enough tools in our arsenal to stop. "

In the Persian Gulf war, when what is now the BioPort plant was still run by

the State of Michigan, thousands of American soldiers were given an anthrax

vaccine made here. Some later charged that it contributed to the mysterious

illnesses, sometimes referred to as gulf war syndrome, that afflicted some

veterans of the conflict. In recent years, more than 400 soldiers have been

disciplined for refusing to take the anthrax vaccine, and others have

complained of adverse reactions. Supporters of the vaccination program,

however, say no credible evidence has been produced to show that it causes

serious side effects.

The vaccine BioPort wants to produce involves six shots over 18 months.

Critics have called this approach impractical and unreliable, urging BioPort

researchers to concentrate on developing a new one.

" They've got a pretty profound problem, " said Lawrence Halloran, staff

director of the House Subcommittee on National Security, which investigated

BioPort after it fell behind in its efforts to provide the vaccine to the

military. " They can't demonstrate within any range of certainty that their

vaccine is scientifically valuable. "

Even if the company passes its next Food and Drug Administration inspection

and is allowed to resume production, the first several million doses will be

assigned for military use.

In recent days more than 1,200 people, including many doctors, have called

BioPort asking to buy anthrax vaccine. They are transferred to a recording

that says, " All the stockpile that currently exists is owned by the

Department of Defense. At this time there is no opportunity for any

commercial sales. " The government has said it has no plans to vaccinate

civilians.

The Defense Department is BioPort's only customer, and it has invested $126

million in the Lansing plant over the last decade. Military commanders say

they want to immunize all 2.4 million active and reserve troops against

anthrax but have so far managed to begin immunizing only about 500,000,

mostly those in the Persian Gulf. There is no figure on the number who have

received the full course of vaccination.

Michigan began producing anthrax vaccine in 1970, selling it to small

numbers of animal handlers, mill workers and others who might be exposed to

the disease. After the gulf war, demand grew.

In 1998, the state sold the plant to BioPort, a newly formed company whose

most prominent board member is Adm. William J. Crowe Jr., a former chairman

of the Joint Chiefs of Staff and former ambassador to Britain.

Some Lansing residents opposed the plant's privatization in 1998 and have

been sharply critical of it since.

" They have never met their responsibilities, " said Lingg Brewer, a former

state legislator from Lansing. " They bought the company at a fire-sale price

with the help of political connections, and since then they have not been

able to make any vaccine that meets F.D.A. standards. They're doing a lot of

chest-thumping about protecting the nation's interest, but they're actually

unwitting allies of our enemies because of their incompetence and their

greed. "

Robert Kramer, president of BioPort, who has been at odds with Mr. Brewer

for years, rejected his charges.

" Mr. Brewer has made the same claims over and over again, and they have all

been discounted by courts, by Congress and by appropriate state and federal

agencies, " Mr. Kramer said. " I find it unconscionable that at a time when

our country is uniting around our military and the national assets that

serve it, he will continue to make his irresponsible and unsubstantiated

allegations. He is doing a disservice to the 220 employees of BioPort and,

more importantly, to his country. "

Concerns about BioPort are especially acute as officials in Washington begin

reassessing the country's readiness to fend off biological attacks. One

group of senators has introduced a bill calling for $1.4 billion to improve

defenses against this form of terrorism.

The National Guard soldiers took up positions at BioPort on Monday and

quickly installed a series of low concrete barriers near the front gate and

began unrolling barbed-wire fencing. But until then the plant was separated

from public streets by no more than a chain-link fence that a child could

climb over.

" It's a joke, " said a woman working at a state office building across the

street. " We're nervous. Anything could happen. "