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Misty L. Trepke

http://www..com

 

Federal Judge Halts Forced Military Anthrax Shots

By PAULINE JELINEK

12-22-3

 

WASHINGTON (AP) - Saying American soldiers should not be used

as " guinea pigs for experimental drugs, " a federal judge Monday

ordered the Pentagon 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.

 

Officials at the Defense Department and Food and Drug Administration

said they had not seen the ruling and had no immediate comment. 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.

 

" 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, " Sullivan said in Monday's 34-page ruling.

 

" 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, " Sullivan said.

 

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 William 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 over 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 of 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.

 

Officials declined to identify those areas. Nor would they say how

many troops would be given the vaccine. It is likely that these

areas include the Persian Gulf and the Korean peninsula.

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