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Sunday, Nov 8, 2009
"I think at least 10 percent of recipients have continued problems afterwards. Other vaccines with continuing reactions are usually 1 in every 1,000," says Nass, who believes the military greatly underreports cases of adverse reactions. "I think everybody in the U.S. military knows somebody who is sick from the anthrax vaccine."
In the British military, which administers essentially the same anthrax vaccine, the shots are voluntary. (Only about half the soldiers take the shots.) According a report by the British National Gulf Veterans and Families' Association, they anticipate adverse reactions among 30 percent of the 22,000 troops who took the inoculation.
The anthrax 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, as part of a multibillion-dollar biowarfare defense program. Officials insisted the shots were necessary to protect the U.S. military from the threat of anthrax, which had been developed for biological warfare.
"It would be unconscionable for us not to provide this kind of protection to our troops," says Turner at the Pentagon.
For a time, much of the controversy concerned whether the vaccine itself met acceptable manufacturing standards. For years, BioPort's facility in Lansing, Mich., struggled to win FDA approval, as inspectors found equipment being used without approval, labeling errors, and changes being made to the vaccine formula without proper consultation. In 1998 the FDA announced, "The manufacturing process for anthrax vaccine is not validated." The move effectively quarantined BioPort's vast supply of vaccine.
"They had just an horrendous track record at the facility in Michigan," says Russell Dingle, a retired lieutenant colonel with the Air National Guard in Connecticut who has researched the vaccine for years. "If you go back and read the previous FDA reports, it's like the Three Stooges of vaccine production."
(Waytes at BioPort says the FDA's ruling on the facility was not surprising since the company had purchased it from the state of Michigan in 1998 and was in the process of a multi-year renovation.)
By 2000, with the release of a critical General Accounting Office report on the vaccination program, as well as the embarrassing admission that BioPort was simply unable to manufacture the vaccine in accordance with FDA requirements, the Pentagon was on the defensive. "We have been behind the ball," said Deputy Defense Secretary Rudy deLeon, testifying before Congress. Politicians on both sides of the aisle dressed down the military for misjudging the cost and popularity of the program as well as the availability of the vaccine.
As a 2000 presidential candidate, Republican Sen. John McCain, R-Ariz., called for a moratorium on the vaccination program. By the fall of 2000, then-candidate George 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."
By the summer of 2001, with the BioPort facility still not allowed to produce the vaccine and the Bush administration taking a close look at the whole process, "the program, for all intents and purposes, had ended," notes Dingle.
Also in 2001, Connecticut's attorney general, concerned the state might bear responsibility if its guardsmen got sick from the vaccine, wrote the Department of Defense and the FDA urging them to abandon the program. "In effect, the military is forcing its personnel to serve as human guinea pigs for an unlicensed drug that has not been proven to be safe or effective," wrote Richard Blumenthal. He also noted, "Since the vaccine has not been tested on humans, there is no basis for concluding that it is safe and effective."
The 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."
Waytes insists, "Every bit of scientific evidence indicates [troops] would be protected" from inhalational anthrax.
Most of that second-guessing vanished with the still-unsolved release of the deadly post-Sept. 11 anthrax letters, which produced unprecedented fear about the mysterious killer. The letters set off a chain reaction, with the FDA quickly changing course and reapproving the BioPort facility, giving the company permission to produce massive amounts of vaccinations. This ultimately made it possible for the Pentagon to vaccinate mass numbers of troops.
"If the anthrax letters were never sent, then the FDA wouldn't have re-licensed the BioPort plant; then there would be no vaccination," notes Nass.
Still, as part of the 2002 deal, the FDA required the insert package for the vaccine to be revised; it now includes 40 possible serious adverse effects. BioPort also upped the percentage of recipients who suffer systemic reaction from just 0.2 percent to between 5 and 35 percent. That's different from the severe reaction rate, which the Pentagon insists is much, much lower.
Waytes explains that the percentage increase from 0.2 did not reflect a change in the vaccine itself, but rather improved monitoring techniques used in more recent studies. Rather than depending on people to call back to report reactions, newer studies kept much closer tabs on recipients, and therefore documented a potentially higher reaction rate.
"I had my fingers crossed that BioPort had improved its oversight and it wouldn't be as dangerous as it used to be," says Nass, one of the only doctors in America who treats anthrax vaccine victims. "During the [springtime portion of the] war I got no calls. But now the troops are coming back and they're sick and I'm getting calls, about one a day."
The surest way to avoid getting sick is not to take the shots. But soldiers who do -- and hundreds have -- face court-martial proceedings, which critics say are uncalled for.
"It would be like if you worked for Firestone when the exploding tire scandal broke and the management says to its employees, 'For benefit of the company, we want you to keep using the tires to demonstrate we have faith in Firestone.' That's what the military is asking soldiers to do," says Stephen Robinson, executive director of the National Gulf War Resource Center. "They're forced to take this absurd loyalty test and there's no safety net in the event you become ill."
In a 2000 court-martial case, Canada's top military judge ruled a soldier could refuse the anthrax vaccination, saying that the batch of vaccine was dangerous.
The U.S. Department of Defense, however, is taking a hard line. "If somebody disobeys a direct legal order they have to deal with the consequences," says Pentagon spokesman Turner. "We'd hope after people heard the facts, not the rumors, they'd take the vaccination."
But a steady stream of soldiers are refusing:
"When you start to dig a hole and find yourself in it, the first thing you should do is stop digging," says Buck, who was court-martialed in 2001 and now works in an emergency room at a Houston hospital. "I can't tell you how much I wish [the Pentagon] would stop digging. But I don't think they will. What I think will happen is a new vaccine will be created and they'll switch over, and the problems associated with this vaccine will not be disclosed for 10 or 15 years until all the major players have moved on. And years from now we'll watch about it on the History Channel, alongside programs about the Gulf War syndrome."
Looking back, former Marine Hawkins says, "Yes, I wish I had refused the vaccine. But if you asked me if I'd serve my country I would, no questions asked."
Hawkins knows his health, his ability to function day-to-day, will never be same. "I have to deal with the consequences for the rest of my life," he says. "But I've been trained as a Marine to survive, so that's what I'm going to do."
