Judge Reverses Anthrax Ruling -- 8 Jan 2003

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http://www.washingtonpost.com/wp-dyn/articles/A63161-2004Jan7.html

Judge Reverses Anthrax Ruling

Pentagon May Resume Vaccinating Members of Military

By Vernon Loeb

Washington Post Staff Writer

Thursday, January 8, 2004; Page A21

A federal judge in Washington lifted a preliminary injunction yesterday and told

the Pentagon that it may resume a program of mandatory anthrax inoculations for

all U.S. service members except six plaintiffs in a lawsuit challenging the

legality of the government's anthrax vaccine.

U.S. District Judge Emmet G. Sullivan ruled after the Food and Drug

Administration issued a formal determination last week that the vaccine provides

effective protection against deadly anthrax bacteria, whether they are inhaled

or absorbed through the skin.

In issuing his injunction on Dec. 22 blocking mandatory anthrax inoculations,

Sullivan ruled that the vaccine is an experimental drug " being used for an

unapproved purpose " because the FDA has formally authorized its effectiveness

only against anthrax spores absorbed through the skin.

With a court date in the case set for next week, neither the Justice Department

nor the Pentagon had any immediate comment on Sullivan's latest ruling or the

status of the vaccine program, which the Defense Department suspended pending

further action by Sullivan.

Mark S. Zaid, a Washington lawyer who filed the suit challenging the program,

called Sullivan's decision lifting the preliminary injunction a temporary

setback and said his clients would prevail at trial in challenging the anthrax

vaccine.

Zaid said he will soon ask Sullivan to reissue an order blocking mandatory

anthrax inoculations because the FDA's approval of the vaccine was itself

flawed, based only on animal research. Another government investigation of the

vaccine, being carried out by the Centers for Disease Control and Prevention and

based on human research, will not be completed until 2007, he said.

Zaid said he will also soon introduce evidence in court to bolster his argument

that, even with the new FDA approval, the anthrax vaccine should still be

considered illegal because it is being improperly administered by the military.

While the FDA maintains that the vaccine is safe and effective if service

members receive a total of six injections over an 18-month period, the military

does not follow the proper injection schedule and often administers two or three

shots, instead of the required six, Zaid said.

In defending the program and asking Sullivan to lift his preliminary injunction,

senior defense officials said the anthrax vaccine is safe and effective for

military personnel. Before the FDA's determination last week, they cited a March

2002 study by the National Academy of Sciences' Institute of Medicine concluding

that the vaccine is effective " for the protection of humans against anthrax,

including inhalation anthrax, caused by all known or plausible engineered

strains of Bacillus anthracis. "

At the time, defense officials bristled at Sullivan's conclusion that service

members receiving the anthrax vaccine were serving as " guinea pigs for

experimental drugs. "

A million service members have received the vaccine since the Pentagon began a

program for mandatory inoculations in 1998, including 600,000 to 700,000 who

received the vaccine since June 2002 as the military prepared for war in Iraq.

Hundreds of other service members have refused to take the vaccine out of

concerns about its safety, and many have been court-martialed for refusing the

vaccine, forced out of the military and, in some cases, imprisoned.