Click here: Lawsuit on Anthrax Vaccinations Targets
FDA Role (washingtonpost.com)
http://www.washingtonpost.com/wp-dyn/articles/A36273-2001May2.html
Lawsuit on Anthrax Vaccinations Targets FDA Role
By Bill Miller
Washington Post Staff Writer
Thursday, May 3, 2001; Page A22
A former Air Force major and an Air Force physician who refused to take a mandatory vaccine for anthrax filed a federal lawsuit yesterday that challenges the legality of the Pentagon's controversial program to immunize 2.4 million military employees. The suit was filed by Sonnie Bates, a major who was given an honorable discharge last year after refusing the vaccine, and John Buck, a physician who faces court-martial proceedings. Lawyers said Bates is the highest-ranking active-duty military officer to turn down the vaccine and that Buck was the first physician to refuse to take it. Bates and Buck are among more than 450 military personnel who have refused to undergo a six-shot anthrax vaccination program as protection against biological warfare. More than 500,000 active-duty and reserve troops have been fully vaccinated since the program began in 1998. Those who refuse face disciplinary proceedings for insubordination, and plaintiffs' lawyers said that more than 60 service members have faced charges.
The vaccine was developed in the United States in the 1950s and 1960s and
licensed by the federal government in 1970. The lawsuit, filed in U.S. District
Court in Washington, maintains that the Food and Drug Administration
never authorized the vaccine for use as protection against biological warfare
and cites health and safety concerns. The suit seeks a court order that would
require the FDA to treat the vaccine as an experimental drug. Such a ruling
would mean the military could no longer administer it without informed consent.
"The ultimate purpose of this lawsuit is to open the eyes of the Pentagon
and the new administration and have them say, 'Enough is enough, this has to
end,' " said Mark S. Zaid, who is representing Bates and Buck along with
co-counsel John J. Michels Jr. Although some service members have challenged the
military's policy on constitutional grounds, Zaid said that yesterday's lawsuit
was the first targeting the FDA's role in the matter. In March, the Supreme
Court turned down a Marine's claim that his military prosecution for refusing
the vaccine violated his constitutional rights.
Pentagon officials had hoped to vaccinate all personnel by 2003 but have been
slowed by a continuing shortage of the vaccine. They have temporarily scaled
back the program, focusing primarily on service members being sent into the
Persian Gulf. "This is an FDA-approved vaccine, and it's safe and
effective," said Jim Turner, a Defense Department spokesman. "There is
a very real threat . . . and we want to have our people ready."
Turner said the FDA has determined that the vaccine should not be treated as an
experimental drug. He cited a November 1999 letter from the FDA that said there
was "no basis" for concluding that the vaccine should be restricted in
that way. The letter was written to Rep. Dan Burton (R-Ind.), who has voiced
concerns about the vaccine. Turner declined to comment on the lawsuit.
An FDA spokeswoman did not return a call seeking comment.
Bates, of Ellendale, Del., refused to take the vaccine in November
1999, leading to the end of his 14-year military career. He now is a corporate
pilot. Buck is scheduled to face court-martial charges in September at Keesler
Air Force Base in Mississippi.
© 2001 The Washington Post Company
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