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Early letter may affect anthrax ruling

WASHINGTON, March 30 (UPI) -- The Defense Department has sent a letter, possibly to hundreds of service personnel, apologizing for wrongly inoculating them with a controversial anthrax vaccine after a federal judge ordered the program stopped.

The timing of the letter, however, appears to forestall additional requirements directed by that judge, Emmet Sullivan of the U.S. District Court in the District of Columbia, and could create even more friction between him and the Pentagon.

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Sullivan is expected to rule in the next couple of days on whether Defense Secretary Donald Rumsfeld is in contempt of court for failing to promptly halt inoculations of defense personnel with the controversial medication, called Anthrax Vaccine Absorbed or AVA.

The Pentagon vaccinated about 500 people after Sullivan issued his order last Oct. 27, with some of the shots being given as late as March 7 of this year.

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Sullivan also is supposed to rule on a Defense Department request to modify the injunction, a decision that could lead to a formal resumption of the vaccination program. He has expressed displeasure with the Pentagon's handling of the injunction, however, even suggesting "systemic ineptitude" at one point.

Attorneys representing the department have returned the favor, telling Sullivan on March 21 they were preparing to go over his head and appeal the case if he refused to modify the injunction.

During the March 21 hearing, the Defense Department's attorneys said military readiness is being damaged by the halt in the program. In January, the department obtained from the Food and Drug Administration -- in another highly controversial move -- an Emergency Use Authorization, allowing the inoculations to proceed. The lawyers asserted Sullivan should recognize the emergency authorization as a legal way for the department to continue giving the shots despite the injunction.

The letter of apology appears to stem from a discussion during a hearing on Feb. 14. Opponents to AVA suggested those given the shots after the court issued the injunction should be notified of their rights.

"I think they should be given some notice," Sullivan said. "Notice of whether they have rights or not? I'm not so sure. Maybe at the end of the day the court will direct the government to at least tell them that at the time they were inoculated there was an outstanding court order."

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Sullivan said he felt "very strongly about (notification)," and added those inoculated incorrectly perhaps should be sent a copy of the court order and "let the chips fall where they may."

On March 21, Sullivan and Defense Department counsel Brian Boyle engaged in a protracted discussion over the letter and to whom it should be sent. He said the Pentagon did not want to send it to personnel who were inoculated incorrectly the first two days after the injunction because it was unreasonable to expect the order to be carried out instantaneously.

The vast majority of those inappropriately inoculated received the shots in the first two days after the injunction. Leaving out those vaccinated during the first 48 hours would greatly reduce the number of people notified.

Boyle admitted, however, some inoculations were given as late as March 7, when nine marine reservists were vaccinated in Cincinnati. Other vaccinations have taken place as well.

"The inoculations were not an attempt to keep the program alive," Boyle said.

Sullivan again indicated he thought the Defense Department was not taking the injunction seriously.

"This is not a small claims court." he said. "This is a federal court."

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Sullivan then directed that a letter be sent over Rumsfeld's signature.

Unknown to Sullivan at the time, however, the letter already had been sent and signed by Col. Steven Jones, director of the Military Vaccine Agency.

"This letter is not any sort of a health warning," Jones wrote. "You received the same vaccine that was given to other military personnel prior to Oct. 28, 2004."

The letter did apologize, however, and offered further information via a Web site.

Defense Department lawyers later filed a clarification with the court, saying the letter, dated March 8, already had been mailed to approximately 90 percent of the affected service personnel.

It is not clear how Sullivan will react to both the timing of the letter and the fact the court was not promptly informed. Given that he directed Rumsfeld to send the letter, only to be told later that the letter already had gone out -- and given his unhappiness with the Pentagon's handling of other aspects of the controversy over the past two years -- Sullivan may take a harder line.

The next hearing on the injunction, the letter and the contempt order is scheduled for April 1.

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