A federal judge's ruling on Wednesday ordering the Pentagon to stop forcing its troops to take the anthrax vaccine represents the latest setback for the Pentagon and its controversy-plagued inoculation program. Proclaiming that the "involuntary anthrax vaccination program is rendered illegal," Judge Emmet Sullivan of the U.S. District Court for the District of Columbia sided with six military personnel who had opposed the shots. The judge ruled the vaccine had never "been tested by the greatest scrutiny of all -- public scrutiny." The Pentagon is expected to appeal the decision.
The ruling comes just months after the Pentagon, labeling the vaccination program "a success," announced it was expanding the pool of personnel who would receive the shots, including soldiers serving within the U.S. Pacific Command, as well as some civilians.
Critics argue the program is anything but a success. Meryl Nass, a civilian physician in Maine and an expert on anthrax and biological weapons, estimates that 10 percent of the vaccine's recipients experience serious side effects, such as arthritis, neurological impairment, memory loss and migraine attacks. (The Pentagon says the bad-reaction rate is 1 in 100,000.) United Press International reported that at least 10 people have died after receiving the vaccination. Last summer there was an outbreak of more than 100 potentially life-threatening pneumonia cases among G.I.'s, and some medical experts said the illnesses were related to anthrax shots. To date, hundreds of servicemen and women have faced court-martial or administrative discharge for refusing to take the shots, while thousands more have left the military to avoid being vaccinated under the program. "I am elated about the news" of the court ruling, said Anne Spaith, a former Department of Defense civilian employee who retired on medical disability after receiving what she called the "extremely dangerous, forced" vaccination and becoming ill.
The federal government first approved an anthrax vaccine three decades ago, and it has since been used regularly to protect veterinarians and scientists susceptible to cutaneous exposure who work with anthrax. But the six unidentified plaintiffs in the class-action suit insist the anthrax vaccine's FDA license does not include approval for use against anthrax that is inhaled, as any weaponized or terrorist use of anthrax would be. In 2001, five Americans were killed when they inhaled or absorbed anthrax sent through contaminated letters.
The Pentagon maintains that the vaccine is licensed for protection against anthrax whether it is inhaled or absorbed through the skin. Attorney Mark Zaid, who argued the plaintiffs' case, counters, "This vaccine was never licensed for its current intended use, which is to combat inhalation anthrax. That may seem like a technical point, but it's very serious. We're not anti-vaccine. But there is clearly a problem with this vaccine. Our goal is to make sure the DoD follows the law."
Despite a Pentagon spokeswoman's comment Thursday that the ruling "hit us very suddenly and very unexpectedly," the judge's decision should not have come as a complete surprise, because on Dec. 22, 2003, the same judge ordered the Pentagon to halt the vaccination program. Sullivan concluded the drug was experimental -- and therefore illegal -- because the FDA had never given its approval for the vaccine's use against inhalation anthrax. Then, just eight days later, after 18 years of inaction, the FDA announced the vaccine was safe and effective in battling inhalation anthrax. The FDA insisted its decision was completely unrelated to the lawsuit, but Sullivan found the FDA's Dec. 30 maneuver to be "highly suspicious." He lifted the temporary injunction on the use of the vaccine, and the lawsuit continued.
In a memorandum in response to Wednesday's ruling, Secretary of Defense Donald Rumsfeld downplayed the decision, saying that the vaccine program has simply been put on "pause," and that the legal setback was similar to that suffered on Dec. 22. However, that ruling was a preliminary injunction, designed to stop vaccinations while the case was argued. By contrast, Wednesday's ruling was a permanent injunction that will remain in effect "unless and until the FDA" obeys the law, Sullivan wrote.
Rumsfeld's memo ordered the Department of Defense to "stop giving anthrax immunizations until further notice." John Richardson, a retired lieutenant colonel in the U.S. Air Force Reserve and a critic of the anthrax vaccination program, thinks that order represents a tacit admission that the shots, deemed mandatory by the Pentagon, were not being given in response to a valid threat. If members of the military truly faced an imminent anthrax danger, Rumsfeld could announce that the shots would be given to those who wanted them, or he could ask the president for an executive waiver, which would trump Sullivan's ruling. The fact that Rumsfeld did neither, says Richardson, suggests the vaccinations were being used as a political prop, particularly on the eve of the Iraq war, to heighten general fear about Saddam Hussein's alleged stockpile of weapons of mass destruction.
On Wednesday, ruling on strictly procedural grounds, the judge said that when the FDA gave its OK on Dec. 30 for use of the vaccine to protect against inhalation anthrax, it did not follow its own procedures allowing for public comment. Federal agencies, when instituting new rules, sometimes issue calls for public comments. During a period that can last several months, concerned parties (citizens as well as lobbyists) can express support for or raise concerns about the new rule. The agency takes those comments into consideration before issuing a final rule.
"While the policy of submitting comments on an agency's proposed order may be unusual, it is the course the agency chose to take and this Court shall ensure that the agency follows through its commitment to the public," Sullivan wrote. "By refusing to give the American public an opportunity to submit meaningful comments on the anthrax vaccine's classification, the agency violated the Administrative Procedure Act."
That's the administrative argument. But lurking beneath the surface of the case is the larger suspicion by critics that the vaccine is simply unsafe and is causing members of the military to become seriously ill -- that instead of boosting the immune system, the vaccine in some cases is triggering a violent and sometimes deadly physical reaction.
The anthrax program has been marked by controversy since its inception in 1998, when the Pentagon during the Clinton administration announced it would inoculate its 2.4 million service members, both active and reserve, as part of a multibillion-dollar biowarfare defense program. Citing health concerns, some members of the military objected. To date, approximately 1.2 million members of the military have been given the anthrax vaccine.
In 1999, when Air Force Reserve pilots were required to take the vaccine at Dover Air Force Base in Delaware, 55 pilots out of 120 in the Reserve wing stationed there refused and then resigned. Many were full-time commercial pilots who feared that the vaccine's side effects would end their aviating careers.
In the fall of 2000, then candidate George W. Bush announced, "I don't feel the current administration's anthrax immunization program has taken into account the effect of this program on the soldiers in our military and their families. Under my administration, soldiers and their families will be taken into consideration." There are indications that, urged by strategist Karl Rove, who was concerned about the political ramifications, the Bush administration early on tried to address the problems surrounding the vaccinations and do away with the mandatory program. But then came the terrorist attacks of Sept. 11 and the subsequent anthrax deaths, followed by the run-up to war with Iraq, which was framed as a battle over WMD. Suddenly, instead of trying to eliminate the vaccination program, the Bush administration accelerated its implementation.
But the controversy has continued to grow. In 2001, Connecticut's attorney general, concerned the state might bear responsibility if its National Guardsmen got sick from the vaccine, wrote the Department of Defense and the FDA urging them to abandon the program. That same year, John Buck, an Air Force captain, became the first military physician court-martialed for refusing to take the anthrax shot. Soon after he refused, he met with an Air Force superior and talked about how he couldn't, in good conscience, take the vaccine if he didn't believe in the quality of the science behind it. "At one point the commander said, 'Son, sometimes you have to check your integrity at the front door.' I about fell out of my chair," Buck told Salon last year.
Also in 2001, during the anthrax scare on Capitol Hill, Senate Majority Leader Bill Frist, R-Tenn., a physician, urged Senate staffers not to take the vaccine because "there are too many side effects." (Some doctors think it's safer to take antibiotics after being exposed to anthrax than to be vaccinated in advance.)
This month, the Delaware News Journal has published an exhaustive investigation into the anthrax vaccine controversy, centering its attention on Dover, Del. The paper reported that "troops received anthrax vaccine starting in 1999 that may have contained squalene, a substance that can be used to increase the potency of vaccine. Some researchers believe that even trace amounts of squalene can suppress the immune system, causing arthritis, neurological problems, memory loss and incapacitating migraine headaches."
Squalene is a fatlike substance that occurs naturally in the body, but some scientists argue that injecting even trace amounts can cause serious illness. According to the News Journal, testing by the FDA in 2000 detected squalene in varying amounts in the vaccine used at Dover. The paper reported, "The military has secretly experimented with squalene to test its ability to boost the effectiveness of some vaccines. The Department of Defense has admitted conducting tests on humans using squalene in vaccines in Thailand. But the military said any contamination in the vaccine in Dover must have occurred accidentally."
On Oct. 10, the paper quoted a former Dover commander who halted the vaccine program after the rash of baffling illnesses as saying, "In my opinion, there was illegal medical experimentation going on."
The anthrax vaccine controversy has not been confined to the United States. In Britain, where the shot is voluntary for troops, roughly half of those deployed in Iraq have refused the vaccine. 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 vaccination on the grounds that it amounted to unsafe medical treatment.