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http://www.trivalleyherald.com/Stories/0,1413,86~10669~1848187,00.html

12/23/2003

Decision puts limits on vaccine

Former Livermore man

By STAFF AND WIRE REPORTS

WASHINGTON -- Saying American soldiers should not be used as " guinea pigs

for experimental drugs, " a federal judge ordered the Pentagon on Mon-day to stop

mandatory anthrax vaccinations started in 1998.

U.S. District Judge Emmet G. Sullivan said he was persuaded by plaintiffs

in a class action suit that the vaccine is experimental and being " used for an

unapproved purpose " -- that is, for exposure to airborne anthrax as well as

exposure through the skin.

The news made at least one local man smile.

" I really feel like what we did was worthwhile now, " former Marine Pfc.

Lundbom remarked. " For a while it was starting to feel like it was all

for nothing. "

In 1999, Lundbom, then 21, received a less-than-honorable military

discharge for refusing to take the anthrax vaccine -- but not before he suffered

months of intimidation and harassment from his supervisors for disobeying

orders, he said.

Lundbom -- a former Livermore resident who now lives in Gilroy and works

for Intel -- testified about his experiences before Congress four years ago.

He said he hopes Monday's ruling will strengthen his legal battle to

upgrade his less-than-honorable discharge.

Officials at the Defense Department and the Food and Drug Administration

did not immediately comment on the court's decision.

But the federal government has long maintained that the licensed vaccine

is safe, is not experimental and can be used for protection against anthrax

inhaled or absorbed through the skin.

More than 900,000 servicemen and women have received the shots, among the

millions of doses of various vaccines administered annually to protect troops

against disease and bioterror threats.

Hundreds of service members have been punished or discharged for refusing

them, according to the Pentagon.

In 1999 -- two years after immunizations had begun in the armed forces --

Lundbom was stationed in Okinawa.

When officials started inocculating his unit, Lundbom said a " fishy " vibe

prompted him to research the vaccine on the Internet. There he discovered a

number of " unanswered questions. "

Scientists were debating whether the drug actually warded off the inhaled

form of anthrax and would protect soldiers from bioterrorism on the battlefield.

Lundbom said he also became concerned about the dearth of research on

potential cancer and sterility causing effects.

" It seemed like there wasn't really much going on to find out what was

going on in these vaccines. I wasn't about to put that stuff in my body. "

Initially, Lundbom was among 26 serviceman who refused the shot.

Eventually, all but five " gave in " and accepted the vaccine, he said.

" We refused three times, and we were punished three times over. Basically

it was like slave labor for six months until I was able to get some sort of

outside representation. ... I couldn't mail letters. I couldn't make calls. "

In Monday's 34-page ruling, Judge Sullivan stated, " The women and men of

our armed forces put their lives on the line every day to preserve and safeguard

the freedoms that all Americans cherish and enjoy.

" Absent an informed consent or presidential waiver, the United States

cannot demand that members of the armed forces also serve as guinea pigs for

experimental drugs. "

In granting the preliminary injunction, Sullivan ordered the government to

file responses by Jan. 30.

Anthrax is a naturally occurring virus that typically affects sheep and

cattle. When inhaled, dry anthrax spores can be deadly to humans.

The federal government approved the vaccine three decades ago. But

plaintiffs -- unidentified active duty, National Guard and civilian defense

employees -- say the license was only for exposure through the skin, and that it

may not be safe.

Sullivan's ruling said the label on the vaccine does not specify which

method of anthrax exposure it protects against.

He cited a 1998 law prohibiting the use of new drugs or those unapproved

for their intended use unless people being given the drug consent to its use or

the president waives the consent requirement.

Congress passed the law amid fears that the use of such drugs may have led

to unexplained illnesses -- which have come to be known as Gulf War Syndrome --

among veterans of the 1991 Persian Gulf War.

The anthrax vaccine itself has been approved since the 1970s and used

regularly to protect veterinarians and scientists working with anthrax.

Believing Iraq and other nations had produced anthrax weapons, former

Secretary of Defense Cohen in 1997 ordered the armed forces immunized.

While the government does not recommend vaccinating the general public, it

says the vaccine overall is very safe, with rare severe side effects such as

dangerous allergic reactions.

But hundreds of military personnel have refused the shots, worried they

could be connected to complaints of chronic fatigue, memory loss and other

problems.

A leaflet inserted with the product, which originally stated that adverse

reaction occurred in 0.2 percent of cases, was recently revised to reflect a

rate between 5 percent and 35 percent, the ruling said. It said there have been

at least six deaths linked to the vaccine.

The 0.2 percent rate came from an earlier government report that there

were only 105 serious reactions in more than 830,000 recipients, the ruling said

without giving details.

The program was started to vaccinate all 2.4 million members of the active

and reserve military, but was radically reduced after factory violations by the

nation's sole vaccine manufacturer resulted in dwindling supplies.

The FDA cleared Lansing, Mich.-based BioPort's manufacturing plant in

January 2002 to produce the vaccine and to resume shipments.

After a three-month study considering the new domestic need, previous

supply problems and other issues, the Pentagon decided to give the shots only to

troops, essential civilians and contractors who are assigned for more than 15

days to " higher threat " areas of the world -- the Persian Gulf and the Korean

Peninsula.

Rep. Ellen Tauscher, D-Alamo, long has been an advocate for servicemen

refusing the vaccine. The congresswoman could not be reached for comment on the

ruling.

But Lundbom says four years ago she helped persuade the Marines to drop

its court-martial against him.

In 1999, he told the Congressional Committee on Government Reform that he

was punished in " immoral, unethical and illegal " ways for refusing the vaccine.

" I've been waiting for something definite like this (ruling) to come down

so I can have a solid case for my appeal for my upgrade, " Lundbom said Monday.

" I didn't leave the military -- I was forced out. "

Staff writer Jeanine Benca contributed to this story

Meryl Nass, MD

H 207 276-5092

W 207 288-5082 ext 220 or pager 441

C 207 522-5229

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