Why Anthrax Vaccine Is Sparse

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Why Anthrax Vaccine Is Sparse

by Philipkoski

Wednesday, October 10, 2001 5:00 a.m. EDT

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The vaccine against anthrax is in the hands of a single company that is running

out of money, hasn't gained FDA approval for the vaccine or its manufacturing

facilities and hasn't produced a single dose of the vaccine since it took over

production in 1998.

The entire United States is relying on BioPort, of Lansing, Michigan, to produce

the anthrax vaccine, for which demand has spiked since Sept. 11. The company has

supplied the military with only half a million doses out of 14 million promised,

leaving even front-line military personnel unprotected in the event of a

bio-terrorism attack.

The company, which would not return phone calls, has a spotty past, and possibly

not much of a future if Congress passes the Defense Authorization bill, which

includes an amendment that would bring the production of the anthrax vaccine

under government control.

" We've had 10 years of experience with the private sector tying to produce it

with little to show for it, " said D.J. O'Brien, a spokesman from the office of

Senator Tim Hutchinson (R-Arkansas).

The amendment would give BioPort until April 2002 to clean up its act, after

which it recommends that the military stop paying BioPort and find an

alternative source for the vaccine.

The amendment allocates $3.8 million for the planning and design of a new

facility owned by the government. O'Brien said Hutchinson thinks a new facility

would cost about $380 million.

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The BioPort contract is being carefully re-examined by the Department of Defense

in light of the Sept. 11 attacks, a spokesman said.

" The Department is close to finishing the review, and will make the best

decision to protect its service members against the threat of biological

weapons, " said , a spokesman for the Department of Defense.

Many believe it's time to dissolve BioPort's military contract, in light of its

performance since it took over production of the anthrax vaccine in 1998.

" As a general principle, this is something that really belongs in the private

sector, " said Block, a professor of biological sciences and applied

physics at Stanford University. " But in this particular instance, and especially

in light of recent events, it may be better done within the military. "

BioPort bought out the state-owned Michigan Biologic Products Institute in 1998,

and the Department of Defense became its only customer.

The takeover itself is considered suspicious by some.

" The company acquired the Michigan Biologic Products Institute for the express

purpose of taking over and acquiring a lucrative military contract, " said a

bio-warfare expert who asked not to be named and accused company officials of

" war profiteering. "

BioPort's most visible board member is Admiral J. Crowe, former chairman

of the Joint Chiefs of Staff.

The FDA repeatedly flunked BioPort in inspections in 1999 and 2000 because of

contamination and suspicious changes made to expiration dates. The agency has

barred the company from releasing any of the vaccine as a result.

A third FDA inspection has not yet been scheduled. If it passes, the company has

told reporters it hopes to begin producing more anthrax vaccine this year.

The problems don't end with the FDA inspections. BioPort has also been

questioned about where it has spent advance payments made by the military.

The military gave BioPort an $18 million advance in 1999. Still, the company

told the Pentagon in early 2000 it faced a possible cash shortfall of up to $18

million. The Department of Defense paid the company an additional $20 million to

stay afloat.

An audit by the Pentagon's inspector general in April 2000 reported that BioPort

had spent more than $2 million inappropriately, according to Defense Week. About

$1 million went to renovate a plasma production operation, a commercial venture

unrelated to the anthrax program. Another $1.1 million was spent on office

remodeling, furniture, parking lot and road paving. Furniture for the company's

CEO, Fuad El-Hibri, cost $23,000, the audit said.

The report also said the company was incurring " excessive travel costs,

excessive severance pay and unsubstantiated consulting costs. " The investigation

found that $1.28 million had been set aside for senior management bonuses in

2000, or " 109 percent greater than the managers' base salary, " which inspectors

deemed " unreasonable in light of its current financial condition. "

The anthrax vaccine was the subject of controversy even before it was in such

high demand. Approximately 400 soldiers faced reprimands rather than take the

vaccine because of side effects that some said were severe.

The FDA has found the vaccine to be effective, but approved it only for anthrax

absorbed through the skin. In the event of a bio-warfare attack, anthrax would

most likely be released into the air and inhaled, which causes a different

version of the disease for which the vaccine has not been tested. The FDA could

be in violation of federal law for allowing military personnel to take it.

BioPort apparently lost one of its own employees to the vaccine in July 2000:

Dunn, who monitored test animals for BioPort and its state-owned

predecessor. He had received 11 doses of the anthrax vaccine.

A county medical examiner said Dunn experienced an inflammatory response to the

vaccine that contributed to his death. BioPort hired its own pathologist and put

out a press release saying, " His autopsy report does not reveal that the anthrax

vaccine led to the death of BioPort Corp. employee Dunn. " Rather, the

pathologist said his death was caused by " ventricular arrhythmia " that may or

may not have been caused by the vaccine.

A man in Florida died of the first case of anthrax in 25 years on Friday. A

second case has been confirmed, and still another was reported by the New York

Post on Tuesday. All three people worked in a Boca Raton building housing

several supermarket tabloids, including The National Enquirer.

Officials said " human intervention " is likely, but terrorism has not been

confirmed. The 300 people who work in the building and anyone who spent more

than an hour inside since Aug. 1 were advised to be examined for exposure.

About 1,200 people so far have called BioPort asking how they can get

vaccinated. The company responds with a recording that says no vaccine is

commercially available because any that will be produced is reserved for the

military.

National Guard sentries began guarding the company's facilities last week.

Some experts say anthrax is the most likely agent to be used by terrorists

because it's tasteless, odorless and difficult to detect in the air or water.

" It's the easiest to work with, " said Mark Wheelis, a professor of microbiology

and a bioweapons historian at the University of California at . " It's not

particularly hazardous to grow and it has a long shelf life. "

The problem is, Wheelis said, it has to be broken into extremely small airborne

particles. Also, for a person to become infected he must inhale 10,000 spores of

anthrax bacteria.

" The first cases would appear within three days, but there could be new cases

appearing for a month, " Wheelis said. " Sometimes spores are inhaled and can sit

(dormant) for three weeks. "

The vaccine business is not attractive to biotech and pharmaceutical

entrepreneurs. It's unpredictable and rarely profitable, which is why only four

biotech businesses are based on developing vaccines. Seldom do big

pharmaceuticals take on vaccines.

The government needs to find a way to give companies incentives to contract with

a federal facility, but a mechanism for that is still not clear.

" The problem is right now there's no market, and hopefully there never will be a

market for these sorts of pharmaceuticals, " said Cilluffo, senior policy

analyst and deputy director of the Center for Strategic and International

Studies in Washington.