The Pentagon on Monday suspended compulsory vaccination of U.S. troops against anthrax after a federal judge here ordered the military to stop treating its personnel like "guinea pigs."
U.S. District Judge Emmet G. Sullivan ruled that the mandatory inoculations, administered to hundreds of thousands of troops since 1998, were violating a law passed that same year prohibiting the use of certain experimental drugs on troops.
A spokesman for the Justice Department, which represented the military in the case, said the Pentagon "will have to follow the judge's order" and instruct medical personnel at U.S. military facilities to temporarily halt the vaccinations while it reviews the ruling. The order was effective immediately.
Anthrax is a naturally occurring bacterium that most commonly causes illness in cattle and sheep. When dried and inhaled, anthrax spores can be deadly to humans, and anthrax is a known biological warfare agent.
More than 900,000 service members have been vaccinated in recent years against a variety of diseases and bioterrorism threats, including anthrax. As concerns have grown about the safety of the anthrax vaccine, though, hundreds of military personnel have been court-martialed or given other punishments for refusing it, the Pentagon said.
The federal government approved the vaccine in the 1970s. But in his ruling Monday, Sullivan agreed with the plaintiffs' argument that the vaccine was licensed only for use as protection against cutaneous anthrax, an easily treatable skin infection that occurs when anthrax spores enter a cut or sore. The Food and Drug Administration still classifies the vaccine as experimental for use against inhalational anthrax, a far more serious form of the disease that results from breathing in the spores.
To date, evidence that the vaccine is linked to possible health risks ranging from sterility to cardiac arrest to immune disorders has been scanty. But lawyers representing soldiers who are refusing the inoculations say the shots have sickened hundreds and caused a handful of deaths. And the FDA has acknowledged that at least five service members have become ill after taking the vaccine.
In his 33-page opinion, Sullivan ruled that the anthrax vaccinations violate a law passed by Congress following fears that similar inoculations may have led to illnesses among veterans of the 1991 Persian Gulf War that have come to be known as Gulf War Syndrome.
The law prohibits the administration of new drugs or those unapproved for their intended use to service members without their informed consent. The consent requirement may be waived only by the president.
"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," Sullivan wrote.
"Absent an informed consent or presidential waiver, the United States cannot demand that members of the armed forces also serve as guinea pigs for experimental drugs."
The judge rejected the Defense Department's argument that the refusal of military personnel to be vaccinated undermined U.S. military readiness and hampered its ability to protect troops if biological weapons were used in battle.
The judge said he was "not convinced that requiring the [Defense Department] to obtain informed consent will interfere with the smooth functioning of the military."
Sullivan ordered the government to file its responses to the injunction by Jan. 30.
The lawsuit was filed in March against the secretary of Defense, the secretary of Health and Human Services and the commissioner of the FDA by six unidentified service members and civilian contractors.
Three of the plaintiffs have been ordered to get the vaccine. Three more have begun the series of inoculations. The vaccination program requires six shots over 18 months, plus annual booster shots.
"All plaintiffs," the judge wrote, "have established that they will imminently suffer a harm that is actual, concrete, and inflicted at the hands of defendants."
Mark Zaid, one of two lead attorneys representing the plaintiffs in the lawsuit, said he was "ecstatic" at the ruling.
"It is a fantastic holiday present to all the service members who were facing this illegal vaccine," Zaid said. "It's a culmination of almost six years of work, so we're definitely pleased."
Zaid had represented two plaintiffs in a similar lawsuit filed in 2001. But the case was dismissed after the plaintiffs, both Air Force officers, left military service. One of them, Capt. John Buck, had been sentenced to 60 days of base restriction and was fined $21,000 for refusing the anthrax vaccine. The other, Maj. Sonnie Bates, was forced to end his 14-year military career.
"There is a long history that individuals cannot be experimented on without their consent, and that is exactly what is going on with the anthrax vaccine," Zaid said.
The vaccine has been used since the 1970s to protect veterinarians and scientists working with anthrax.
In 1997, believing that Iraq and other nations had produced biological weapons containing anthrax, then-Secretary of Defense William S. Cohen ordered all 2.4 million members of the armed forces immunized, though that program was scaled back after the vaccine's sole U.S. producer experienced manufacturing problems.
The government contends that the vaccine is safe, with only rare serious side effects. A report last year by the General Accounting Office, the investigative arm of Congress, showed that a significant percentage of troops who had received anthrax shots reported inflammation in the area of the vaccination. Some reported extreme fatigue, joint pain and chronic memory loss.