Mandatory anthrax inoculations should resume, court told
By Gordon Trowbridge
Times staff writer
A government agency’s ruling that the controversial anthrax vaccine is safe should clear the way for resumption of mandatory shots for military personnel, government attorneys argue in a new court filing.
A Dec. 19 ruling by the Food and Drug Administration that the vaccine is “safe and effective” against all forms of anthrax should lead to either reversing a federal judge’s ruling halting the vaccinations, or tossing the case out as moot, Justice Department lawyers argue in a request to the U.S. Court of Appeals for the District of Columbia Circuit.
That court is considering the government’s appeal of a lower-court ruling that halted the Pentagon’s mandatory anthrax vaccinations. The case involves six anonymous plaintiffs who argued the government was violating the law by requiring military personnel to take the shots or face legal punishment.
But the FDA ruling, the government argues, destroys the reasoning for the lower court’s decision. And though the court could simply vacate that ruling and end the case, the government says it should instead reverse the lower court and rule that the government was within its rights all along to order the vaccine.
That is a crucial issue for military members, said Steve Robinson of the National Gulf War Resource Center, which opposes mandatory vaccinations.
Even if the new FDA ruling allows vaccinations to go forward, “we still have the question of all these people who have been court-martialed in the interim,” Robinson said.
Those service members, he said, were justified in refusing the vaccine before the FDA’s formal approval of its use.
Robinson views as suspicious the timing of the FDA ruling, which came less than three weeks after the appeals court heard oral arguments in the case.
“They’ve had plenty of opportunity to show any scientific evidence,” he said. “They did this strictly on the basis of the lawsuit.”
The government’s latest filing in the case specifically denies that FDA has been “holding back” its new order. “FDA has simply worked diligently to complete its longstanding regulatory responsibilities,” the motion contends.
The new filings are just the latest twist in a complicated legal process that dates back to 1998, when the Pentagon began requiring vaccinations to protect troops against anthrax used as a biological weapon.
The case, which involves arguments about scientific research methods, disputes over complex statistics and debates over federal laws and agency rules governing drug safety, is at heart a debate over one question: Is the anthrax vaccine safe?
Government officials contend that reams of scientific data show the shots are safe, and that they protect against all forms of anthrax, including airborne spores likely to be the form used as a weapon.
But opponents say the vaccine, manufactured by a Michigan company that has had numerous financial and technical problems, risks making service members ill.
Hundreds of troops have complained of health problems they believe are linked to the vaccine. And despite congressional requirements that the Pentagon track the potential health risks of anthrax shots, the Daily Press of Newport News, Va., reported this month that defense officials had kept from public view reports of more than 20,000 hospitalizations of service members following vaccinations.
The government contends there is no evidence that any of those hospitalizations are connected to the vaccine.
