A federal judge's decision on Monday, demanding that the Department of Defense stop forcing servicemen and women to take anthrax vaccinations, may compel President Bush to sign a special order and take responsibility for the medical policy that critics say is harmful and unnecessary.
Responding to a request for a preliminary injunction made in court last May by a group of soldiers who opposed the shots, Judge Emmet G. Sullivan of the U.S. District Court in Washington ruled the anthrax vaccine must be considered experimental, since it has never been approved by the Federal Drug Administration for the purposes the Pentagon uses it -- to protect members of the U.S. military from a weaponized anthrax attack.
"Until the vaccine has proven tested in that area, the United States cannot demand that members of the armed forces serve as guinea pigs for experimental drugs," wrote the judge. "The women and men of our armed forces put their lives on the line every day to preserve and safeguard the freedoms that all Americans cherish and enjoy."
The Pentagon had no immediate comment.
In order to reinstate the vaccine program, the Pentagon, according to Sullivan, must get Bush to sign a waiver of informed consent. That's because in the wake of the Gulf War Syndrome, Congress passed a law forbidding the use of experimental drugs unless people being given the drug consent to take it. If the Pentagon insists the anthrax vaccine be mandatory, it will be up to Bush to sign off on it, effectively robbing soldiers of a choice. To date, hundreds of servicemen and women facing courts-martial have refused to take the shots, while thousands more have left the military because of the vaccination program.
"The Pentagon will literally have to ask President Bush to tell the troops, 'You must take this vaccine,'" says attorney Mark Zaid, who argued the case before Judge Sullivan. "That's never been done before at the presidential level."
The irony would be rich, since as a candidate in 2000, Bush criticized then-President Clinton's anthrax vaccination policy. But as president, Bush has continued and even accelerated the same vaccination regime. With the massive troop deployment in Iraq this year, and another troop rotation scheduled for 2004, nearly 1 million have been vaccinated. Before Monday's ruling, every soldier heading for Iraq was forced to take the anthrax shot.
"It is clearly time for the Pentagon to reassess the mandatory nature of the anthrax vaccine program," said Sen. Jeff Bingaman, D-N.M., in the wake of the judge's ruling. Bingaman has been a vocal opponent of the vaccination policy and last month introduced a resolution in the Senate urging the Pentagon to change it. "A growing number of armed forces personnel are convinced their health problems are related to their anthrax vaccine," Bingaman said. "The Pentagon and the president should not take their concerns lightly."
The vaccination program has been marked by controversy since its inception in 1998, when the Clinton-run Pentagon announced it would inoculate its 2.4 million service members, both active and reserve. Officials insisted the shots were necessary to protect the U.S. military from the threat of anthrax that had been developed for biological warfare.
"The anthrax vaccine is probably one of the safest and most studied vaccines there is right now," James Turner, a Department of Defense spokesman, recently told Salon.
Yet for years, critics inside and outside the government have argued the vaccine is dangerous. They say it causes far too many adverse reactions -- cases in which, instead of boosting the immune system, the vaccine triggers a violent and sometimes deadly physical reaction. They charge that the military is forcing troops to take the shots to prove their loyalty, or for political reasons, even though, the critics say, that the shots have not been proved to be safe enough. Earlier this month, several servicemen detailed to Salon how their health went into dramatic and unexplained declines after they received anthrax shots.
Last month, the Pentagon conceded the vaccine might have killed a soldier who died of pneumonia-like symptoms in April. Over the summer, there was an outbreak of more than 100 potentially life-threatening pneumonia cases among GIs serving in Operation Iraqi Freedom, illnesses that some experts claim were related to the anthrax shots.
The controversy has not been confined to the United States. In February, on the eve of the war with Iraq, the president of the Australian Medical Association announced that in her opinion no definitive scientific evidence showed that the anthrax vaccine was safe. And in a 2000 court-martial case, Canada's top military judge ruled a soldier could refuse the anthrax vaccination, on the grounds that the shots amounted to unsafe medical treatment. (In the British military, the anthrax shots are voluntary and roughly half the troops take them.)
A major concern about the vaccine's effectiveness is that it hasn't been tested against inhalational anthrax. When anthrax is used as a weapon it will likely be aerosolized and therefore inhaled. A 1994 report by the Senate Veterans Affairs Committee concluded that the vaccine "should be considered investigational when used as a protection against biological warfare."
But Zaid, the attorney, notes that when the FDA approved the anthrax vaccine in the early '70s, it was to protect against cutaneous anthrax, which enters the body through the skin.
"The DOD was saying the vaccine applies to weaponized vaccine exposure as well as cutaneous," says Zaid. "We said there's no evidence that demonstrates it's safe or effective against weaponized anthrax. And we used all government documents, internal FDA and DOD documents, to contradict every statement the government made in court."