Monday February 12, 1:52 am Eastern Time

Lawsuit on Anthrax Vaccinations Targets FDA Role

By Bill Miller

Washington Post

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.