Jacksonville Daily News
http://www.jdnews.com
Judge clears anthrax shots in
the military
January 08, 2004
ERIC STEINKOPFF
DAILY NEWS STAFF
A federal judge Wednesday reversed his previous decision and cleared the way for the military to resume the anthrax vaccination program.
U.S. District Court Judge Emmet G. Sullivan in Washington, D.C., overturned his December ruling that stated the military could no longer inoculate service members with the anthrax vaccination unless troops volunteered or under a presidential order. The two-page order ended the injunction he imposed Dec. 22 to halt the vaccinations.
The Pentagon has not said whether it will resume the vaccinations.
At the center of Sullivan's previous ruling was a lack of approval by the U.S. Food and Drug Administration. Sullivan had stated that the "United States cannot demand that members of the armed forces also serve as guinea pigs for experimental drugs."
The FDA status changed on Dec. 30 when it gave final approval to the 18-year-old vaccination and called it safe and effective for use against inhaled anthrax. In his order Wednesday, Sullivan questioned the timing of the FDA's action.
"Although the timing of the issuance of the rule is arguably highly suspicious, nevertheless, the rule has been issued and the principal reason for the issuance of the injunction has been addressed by the government," the judge's written order said.
According to an FDA press release, a number of different biological products that included various forms of the anthrax vaccination were considered in 1970, 1972. Recommendations were published in 1985 but never approved.
"In 1985 we were told to look at a number of different vaccines," said FDA spokeswoman Lenore Geld. "All that was required of the FDA was, for the record, to answer that the vaccine was safe and effective."
Sullivan's order still banned forced vaccination for six military personnel who filed a class-action lawsuit to stop the mandatory vaccinations that started in 1998.
Department of Defense officials also contend that the vaccination is safe, as do military doctors at Camp Lejeune Naval Hospital. But a September 2002 U.S. General Accounting Office report to Congress says that the rate of adverse reactions to the vaccine are considerably greater than advertised.
At least one Camp Lejeune Marine and another aboard New River Air Station say they are suffering from Gulf War Syndrome-like symptoms due to the vaccine. Neither has set foot in Iraq or Kuwait, but both received a series of anthrax shots before they came down with symptoms that they say the military medical system would not diagnose. Both were given medical discharges.
U.S. Rep. Walter Jones, R-N.C., said prior to Sullivan's Wednesday action that he became concerned about the anthrax vaccine three or four years ago. Had Sullivan's original ruling stood, Jones said he was prepared to ask Congress to review anthrax cases.
A spokesman for U.S. Sen. Elizabeth Dole, R-N.C., said she was looking into the recent FDA approval.
Geld said the matter has been under review by the FDA for more than two decades.
"These deliberations have been going on for years," Geld said. "The timing is not related to the ruling. It just so happened that it came out now."
Sullivan's original ruling, however, could have opened the door to legal action for those in the military punished because they refused the vaccination. That could have been devastating to the Department of Defense, said Vaughn Taylor, an attorney in Jacksonville who specializes in military law.
"Assuming that the judge's ruling (would have been) upheld, there could be a very good case in the U.S. District Court for having rank restored. All could be given honorable discharges, they could pursue being reinstated in the military (and) ask for all back pay, allowances and damages offset by the earnings they had since (punishment)."
Washington-area attorney Mark S. Zaid, a Washington, D.C., attorney who handles anthrax cases, said the FDA's action was illegal and that the Center for Disease Control is researching the subject as part of a study to be completed in 2007.
""The government's victory (Wednesday) may only be fleeting. We plan to revive the program-wide injunction (and) challenge the FDA final rule."
For more information visit the FDA Web site at www.fda.gov. To obtain more information from those opposed to the anthrax case, email contact@anthraxvaccine.net.
Contact Eric Steinkopff at esteinkopff@jdnews.com or 353-1171,
Ext. 236.
Last revised: February 2004