Anthrax vaccine refuser avoids jail time

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Anthrax vaccine refuser avoids jail time
Air Force doctor is restricted to base, must forfeit $21,000


By Deborah Funk
Times staff writer

An Air Force doctor who refused to take the mandatory anthrax vaccine will be
restricted to his base for 60 days and must forfeit $1,500 of pay for 14
months, a total of $21,000.
Capt. John Buck, 32, an emergency room physician at Keesler Air Force Base,
Miss., said he disobeyed the order to take the shot last fall because of
concerns over the safety and efficacy of the vaccine and the legality of the
program.

“I think if I would have been able to present the documents to support my
case, I easily could have gotten a lighter sentence,” Buck said. “I think
$21,000 is pretty stiff.”

It could have been much worse, however, and Buck was prepared — he had a
toothbrush and his uniform stashed in a duffel bag at the courthouse in the
event he was sent to jail.

Never saw documents

A panel of 11 officers convicted Buck of willful disobedience of a lawful
order, an offense that carries a maximum penalty of five years in prison.

As was the case at his trial, in the May 22 sentencing phase the jury again
was not allowed to see documents that the defense believed supported Buck’s
case and explained his refusal to be vaccinated.

Officials at Keesler called the sentence fair.

“He had nothing but stellar performance reports,” said Belinda Bazinet, a
Keesler spokeswoman. “He’s a good doctor, and the panel gave him the
sentence they thought was appropriate. All along, we thought nonjudicial
punishment was the appropriate means to deal with disobeying the order.”

The prosecutor, Capt. Jeffrey Harr, told the panel he was not seeking jail
time for Buck, the first military doctor to refuse the vaccine that the
Pentagon says will protect against aerosolized anthrax on the battlefield.

During two days of pretrial motions, Buck’s attorneys submitted about 50
documents that questioned the safety and efficacy of the vaccine and the
legality of its use.

But after the judge, Air Force Lt. Col. Mark Allred, ruled the panel would
not be allowed to see the documents, Buck submitted a conditional request to
resign from the Air Force with no less than a general discharge rather than
stand trial.

Brig. Gen. Roosevelt Mercer Jr., commander of the 81st Training Wing at
Keesler, rejected that request.

At his sentencing, Buck told jurors his interest in the vaccine was sparked
by a fellow doctor who complained of some problems after taking the shots.

Concerned about the vaccine

Several emergency room patients also complained of problems, Buck said
without being specific.

His subsequent reading turned up inspection reports from the Food and Drug
Administration that said the manufacturing pro-cess for the vaccine hadn’t
been validated.

Buck said he also read of questions raised in Congress about the safety and
efficacy of the vaccine and whether its use to protect against aerosolized
anthrax was legal under its FDA license without informed consent.

“I’m not saying the anthrax vaccine can’t or should not be used,” Buck said
in a statement to the panel. “But if it is, it must comply with federal law”
requiring informed consent for off-label or investigational uses of the
vaccine.

“Only the president can determine in the name of national security [that] the
right of informed consent will be waived by signing an executive order,” he
said. “The law is designed to protect the rights of our servicemen.”

“Many other physicians” were concerned over the vaccine “but were afraid to
speak out for fear of retaliation,” he said.

While Buck also was concerned about the vaccine’s safety and efficacy, his
objections stem more from questions about the legality of the inoculation
program, “which I believe compromised my profession,” he said.

Buck told jurors that he gambled at court-martial “for the rights of our
servicemen at my own peril.”

Whether Buck will again be required to take the shots depends on his
deployment status. Currently, only troops deploying to Southwest Asia must
take them.

It is unlikely Buck will be put on deployment status for that region, Bazinet
said, but added that decision ultimately depends on the needs of the Air
Force. 

BioPort contracts with another company to fill vials

By Deborah Funk
Times staff writer

BioPort Corp., the nation’s only anthrax-vaccine manufacturer, is turning to
another company to help gain regulatory approval and get back into operation.
BioPort hired Hollister-Stier Laboratories LLC of Spokane, Wash., a maker of
products for allergy tests, to fill vials of anthrax vaccine. The company
plans to fill two lots of vaccine per month when BioPort returns to full
production.

Based on the volume of past anthrax-vaccine lots, Hollister-Stier would
handle roughly 360,000 doses a month.

The filling and packaging portion of BioPort’s production line at its
Lansing, Mich., plant came under fire from Food and Drug Administration
inspectors who pointed out the company did not guarantee that the vaccine’s
sterility would be maintained during the filling process.

But that isn’t the only hurdle BioPort must overcome to win FDA approval
before its plant, which closed for an overhaul in 1998, can resume operation.
BioPort must meet other requirements, such as showing that each vaccine batch
produced at the plant is identical in composition.

Both Hollister-Stier’s filling operation and BioPort’s renovated
manufacturing plant need FDA approval before they can activate the supply
line that eventually leads to the Pentagon. BioPort officials say they expect
to gain FDA approval for the manufacturing line and for Hollister-Stier’s
filling operation in early 2002.

“We couldn’t be more pleased with this alliance,” BioPort president and
chief operating officer Bob Kramer said in a statement. “Hollister-Stier is a
great company with a proven track record of sound manufacturing practices and
FDA compliance.”

The Pentagon is using the vaccine as a defense against what it calls the
greatest germ-warfare threat to U.S. troops, aerosolized anthrax.

The military’s mandatory vaccine program began just a month before the
manufacturing plant, then owned by the state of Michigan, shut down for
repairs and expansion. It was subsequently sold to BioPort, a private company.

Throughout the process, both defense and company officials have been overly
optimistic about how quickly they could clear the FDA’s checklist and get
back in business.

As supplies of vaccine produced before the plant closed dwindled, Pentagon
officials have been forced to scale back the program significantly so that
now only a relative handful of people — those going to Southwest Asia for
more than 30 days — are getting the mandatory shots.

Enough doses are left only to carry the program into autumn. How Pentagon
officials plan to stretch the supply beyond that is unclear.

80 years in business

Founded in 1921, Hollister-Stier makes at least half of its income
manufacturing and distributing sterile allergy extracts used in scratch skin
tests. The company had been part of Bayer Corp. until Bayer sold its allergy
line in 1999. Since then, Hollister-Stier has continued to make and
distribute its own products and also has worked under contract with other
companies to manufacture and fill various products.

The company is the only facility in the state of Washington that manufactures
both drugs and biologic products.

“As a contract manufacturer, we must be in [FDA] compliance all the time,”
said Hollister-Stier president and chief executive officer Tony Bonanzino.
“We cannot miss a beat.”

Bonanzino is aware of the controversy surrounding the vaccine and the
Pentagon’s mandatory vaccination program, he said.

“Obviously, we wouldn’t have gone down this road if we didn’t believe in the
product and the program,” he said.

“Of all the vaccines I have researched, I have never seen one scrutinized as
extensively as this one.”

 

 

 

"When the way comes to an end, then change - having changed, you pass through."

      I. Ching

 

 Bruce "Doc". Melson

http://www.docmelson.com/

http://www.docmelson.com/MedicsPlace/index.htm