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Pentagon weighs options in anthrax vaccine suit - Latest hearing pushed back at government’s request

By Gayle S. Putrich
Air Force Times staff writer

The question of whether the Defense Department will be allowed to resume ordering service members to take the controversial anthrax vaccine continues to drag on in court.

A status hearing, in which the judge would ask questions and hear arguments from both sides without rendering a decision, was scheduled for June 27. But that was pushed back indefinitely, sources say, at the request of the government for reasons that are unclear.

“We’re just waiting,” said Mark Zaid, an attorney for the six anonymous military and federal civilian plaintiffs in the suit, Doe v. Rumsfeld. “DoD needs to decide what they’re going to do.”

The vaccine program became voluntary in early 2004 after a federal judge halted mandatory shots because he said the vaccine was being used in an unapproved way.

After nearly two years of further study, the Food and Drug Administration issued a “final rule” in December 2005 that the anthrax vaccine is “safe and effective” as protection against both the skin and inhalation forms of the disease.

Defense officials hoped the FDA’s decision would force a reversal of the earlier court order that made the shots voluntary. The Defense Department also wanted an appellate court to rule that the government was within its rights all along to order troops to take the vaccine. That request, however, was turned down.

The injunction that made the shots voluntary ended with the FDA’s Dec. 19 licensing of the drug against inhalation anthrax. A three-judge panel of the D.C. District Court of Appeals agreed in a Feb. 9 decision that “the injunction is dissolved and this case no longer presents a live controversy on which we may pass judgment.”

However, instead of saying that forcing troops to take the vaccine was legal all along, the panel kicked the case back to the original judge, U.S. District Judge Emmet G. Sullivan, “with instructions to the district court to consider that request.”

Sullivan’s decision could have an impact on hundreds, perhaps thousands, of service members who were punished for refusing an order to take the vaccine when the shots were mandatory.

If Sullivan rules that the Pentagon was within its rights to order people to take the anthrax vaccine even though it had not yet been properly licensed by the FDA, then the punishments meted out to those who refused the inoculations will stand.

If, however, it is ultimately determined that the Pentagon was wrong to have forced the shots on troops, those punished for refusing the drugs will be able to petition for the correction of their service records.

Service members are responsible for their own records; the Defense Department will not offer to update them, even if they are inaccurate. And there is a six-year statute of limitations on changing records in situations involving disciplinary action.

The Pentagon’s top health affairs official, Dr. William Winkenwerder Jr., had his own take on the situation when he spoke with Air Force Times editors and reporters June 12.

He indicated the Defense Department got what it wanted from the appellate court, though he said the program will remain voluntary for now.

“The DoD appeal was not rejected,” Winkenwerder insisted. “The FDA made a final decision after the federal judge had placed an injunction on the program. And the final decision from the FDA, the final rule, allows the department to use the vaccine as we would see fit. And we are reviewing our program.”

He said the Pentagon has made no decision whether to continue the existing voluntary approach indefinitely or “return to a mandatory approach or … change the target population that we would seek to protect.”

Zaid said the plaintiffs will file a challenge if the Pentagon moves to reinstate a mandatory program, but “we have no complaints with a voluntary program — we never have.”

The issue, he said, has been that up until the FDA properly approved the drug in 2005, it was illegal to administer it, which means the order to take it was unlawful and troops should not have been punished for refusing to obey.

At that time, “the vaccine was unlawful,” he said. “We have very strict rules, and if you are not in compliance with the FDA, it is unlawful to administer a drug, whether it’s a DoD drug or a Merck drug. And that is what this case has always been about.”

When the status hearing finally takes place, it will be the latest step in a long legal journey that began in 1998, when the Pentagon required shots to protect troops against the possible use of anthrax as a biological weapon.

The case, which has become a tangled web of arguments about scientific research methods, complex statistics and drug safety, boils down to two questions: Is the anthrax vaccine safe, and does it work?

Government officials contend that scientific data show the series of six shots to be safe, and that they protect against all forms of anthrax, including airborne spores — the most probable form of anthrax that terrorists would use.

But opponents say the vaccine, made by a Michigan company that over the years has endured numerous financial problems and health code issues at its plant, risks making service members ill.

Hundreds of troops have complained of health problems they believe are linked to the vaccine. Despite congressional requirements that the Pentagon track the potential health risks of anthrax shots, the Daily Press of Newport News, Va., reported in December that defense officials had kept from public view reports of the hospitalization of more than 20,000 service members following anthrax vaccinations.

Defense officials contend there is no evidence that any of those hospitalizations are linked to the vaccine.