Military may not change anthrax shot rules
The FDA's OK of the vaccine opens the door for mandatory shots, but it's unlikely to happen soon.
BY BOB EVANS
The U.S. Food and Drug Administration has once again decided that the anthrax vaccine used by the military meets safety and effectiveness standards, paving the way for the return of the controversial mandatory shot program.
But that doesn't mean the "take the shot or take a court-martial approach" will resume soon - or for very long.
The FDA ruling, announced late Thursday, means the military could bypass a court injunction and resume putting needles into troops' arms without their consent, says Mark Zaid. He's one of the lawyers who has helped six unnamed members of the military and Department of Defense employees win a series of rulings in federal court that stopped the mandatory vaccination program in October 2004.
For the time being, the Department of Defense will continue the voluntary program put in place in May while it mulls its options, defense spokeswoman Cynthia Smith said Friday. She declined comment on the legal issues involved.
Since the voluntary program began, about half the troops eligible to receive the vaccine have accepted it, the Pentagon has said. At Fort Eustis, only 27 percent have been willing to get the shots, medical officials said last month.
Zaid said he and his colleagues anticipated the FDA decision and have prepared a lawsuit that would attempt to block any mandatory vaccination program on other grounds.
The anthrax vaccine has been controversial since the early 1990s, when some doctors and veterans of the 1991 Gulf War began questioning whether widespread health problems among veterans of that war were attributable to the vaccine.
Even though the vaccine has been licensed by the government since 1970, it hadn't been given to more than a few hundred people a year until the 1991 war, when military officials fearful of Saddam Hussein's use of chemical and biological weapons began inoculating troops.
When many troops came home from that war and began complaining about joint pain, memory loss, intestinal problems and other maladies that doctors couldn't explain, some researchers began to link those who were sick with those who'd taken the shots. That research was inconclusive and the military decided in 1998 to make the shots mandatory for everyone in uniform and for civilians who might enter areas where anthrax could be used as a weapon.
They said Iraq and other countries might figure out how to turn anthrax into a weapon and that the consequences of not vaccinating troops could be catastrophic.
Anthrax is a biological weapon that produces toxins once inside the body, whether it is ingested, inhaled or comes in contact with open sores in the skin.
Anthrax as a weapon would take the form of an aerosol - something that would be dispersed in the air and inhaled.
When the vaccine was first licensed for use by the government, there was no distinction made about whether it was considered effective against anthrax that came in contact with the skin or anthrax that was inhaled. The scientific trials with humans that led to licensing primarily involved situations where anthrax came in contact with the skin.
In the mid-1970s, a panel of scientists asked to review licensing of anthrax vaccine and other drugs said there was insufficient evidence that it was effective against inhaled anthrax but recommended it be allowed for protection against anthrax in contact with skin. The license didn't distinguish between the two exposures, however.
As troops began complaining about the effects of the vaccine in recent years, they began examining the licensing process and found that the FDA had never properly held an effective, meaningful public comment period before approving the drug.
They went to court and argued that because of this failure, the Department of Defense couldn't force troops to take the vaccine without their consent - that the drug was, in effect, experimental.
A federal judged ruled repeatedly that the troops were right. He stopped the vaccination program last year, then in May allowed it to continue as long as troops signed statements that they'd taken the vaccine voluntarily after being given information about its potentially harmful effects.
