One thing neither the Pentagon nor Big Pharm is willing to do for U.S troops "Bear Any Burden"

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Anthrax vaccine damage The American Prospect

Bear Any Burden
That's one thing neither the Pentagon nor Big Pharm is willing to do for our troops.

By Mark Leon Goldberg
Web Exclusive: 02.28.05

As a general rule, 26-year-old National Guard members ought to be some of most physically fit people on the planet. For eight out of the nine years that Randi Airola served as a technician in the Army and Air National Guard, she met that description. Then, in March 1999, in a moment that would the mark beginning of the end of her honorable military service (and the start of a lifelong struggle), Airola received her fourth dose of a compulsory vaccine to prevent service members from contracting anthrax.

The anthrax vaccine given to service members requires six doses plus an annual booster shot. Airola had taken the shot before, so the slight lightheadedness she felt after leaving the doctor's office was nothing for her to get worked up over. The next day, though, while serving as honor guard at a funeral, she nearly passed out. She spent the rest of the week in bed, suffering from an immobilizing combination of muscle weakness, abdominal cramping, sore joints, and vertigo.

Over the coming months, her pain increased, growing so intense that even a daily dose of 16,000 milligrams of Motrin wouldn't offer enough relief to get her through the day. Civilian doctors were baffled by her condition, and though she missed 140 hours of work in a two-month span, she was denied any referral to see a military physician.

Officials in Airola's chain of command shrugged off the possibility that the anthrax vaccine may have been responsible for her condition, and in October 1999, she was ordered to take her fifth shot. She refused, and was honorably discharged in 2000. Not long after, she was diagnosed with Fibromyalgia.

"Today I only suffer from memory loss and occasional headaches," Airola wrote me in a recent e-mail. "I'm better off than I was." That, of course, is an understatement. But with her improved condition, Airola has channeled her pain, anger, and frustration into advocacy on behalf of veterans injured from the anthrax vaccine. Now, Airola serves as the executive director of the Military Vaccine Education Network, a group of veterans and assorted allies that advocate on behalf of service members who have been seriously injured from their mandatory inoculations.

Given Airola's devotion to the cause, I was not surprised to see her written testimony on a table reserved for press at a February 8 hearing of the Senate Subcommittee on Bioterrorism Preparedness and Public Heath. The subcommittee had met that day to discuss the future of the nation's biodefense strategies. As was expected, panelists from the Bush administration teamed with pharmaceutical-company representatives to admonish Congress to try hard to entice those companies into developing new bioterrorism vaccines.

At issue was a collection of industry-friendly measures, known as BioShield II, that would expand upon the incentives already available to pharmaceutical companies that develop bioterrorism vaccines. Last June, President Bush signed into law a $6 billion program intended to broaden the nation's stockpiles of vaccines for biological nasties like smallpox, anthrax, and botulism. Project BioShield, as the program is known, passed nearly unanimously through Congress.

But to those testifying before the subcommittee, it was not an entirely sufficient catalyst. What is urgently needed, they insisted, is a set of extensive product-liability protections that would shield companies that manufacturer bioterrorism countermeasures -- specifically, vaccines -- from punitive lawsuits.

Under a provision of "The Protecting America in the War on Terror Act 2005" (the likely legislative vehicle of BioShield II), introduced by Senator Judd Gregg in January, manufacturers of bioterrorism vaccines would be granted just that. Even if they make a faulty product, those manufacturers would be indemnified from punitive lawsuits. Except in extreme cases of fraud, someone injured by a poorly manufactured bioterrorism vaccine would not be able to collect anything more than $250,000 in compensatory damages.

Bioterrorism-vaccine manufacturers insist that liability protection is a crucial incentive. After all, every vaccine contains potentially dangerous organisms, and some recipients of any vaccine will experience adverse side effects, which can sometimes be quite severe. As it is now, the federal government often grants such protections on a case-by-case basis when it negotiates individual procurement contracts.

But enshrining into law such blanket liability protection begs the question: If the manufacturer is not liable for the safety of its product, who is?

To the chagrin of U.S. troops, the likely answer is the Department of Defense. Our troops are certain to be the first recipients of any new bioterrorism vaccine; under the doctrine of Force Health Protection, the Pentagon seeks to immunize as many service members as possible from potential biological threats. Despite the fact that no soldier has yet to suffer a bioterrorism attack in Iraq or Afghanistan, the Pentagon insists our soldiers face that constant threat. Further, under a provision of the original BioShield legislation, the Defense Department reserves the right to administer to soldiers experimental new vaccines (in the event of a vaguely defined "emergency") before they are fully approved by the Food and Drug Administration (FDA).

Once the Defense Department purchases mass quantities of a vaccine, there is little incentive to discontinue its use, even if it becomes clear that the vaccine is not as safe or effective as first promised. For our soldiers, the combination of product-liability protection and the Defense Department's oversight can be a double misfortune. "A historical lesson that industry may not want to acknowledge is that when the removal of manufacturers' liability is sought and obtained, the resulting products have usually been associated with serious safety issues," wrote Dr. Meryl Nass, one of the world's foremost experts on bioterrorism vaccines, in submitted testimony to the subcommittee. (She submitted her written testimony in absentia.)

The troubled history of the anthrax vaccine underscores this phenomenon well. In 1998, the Army procured the vaccine with a contract that guaranteed product-liability protections for the manufacturer. Since then, more than a million troops have taken the vaccine -- most after the post-September 11 anthrax scare and in the run-up to the Iraq War. In September 2002, a General Accounting Office report found that systemic reactions to the anthrax shot (that is, the worst category of adverse reactions) occurred at more than 100 times the estimated 0.2-percent rate that the manufacturer had printed on the product insert.

To make matters worse, Nass says, federal agencies have effectively shifted the real costs of liability protection onto other federal agencies. As she pointed out in her testimony, although it was the Army's decision to indemnify the vaccine's manufacturer, the Defense Department has not felt much of a pinch in its pockets from soldiers who have become disabled as a consequence of the anthrax vaccine. Under a 1950 Supreme Court decision that has come to be known as the Feres Doctrine, the federal government is not liable under the Federal Tort Claims Act for injuries to members of the armed forces sustained while on active duty. Further, disabled veterans are paid primarily by the Department of Veterans Affairs and/or Social Security disability.

These structural barriers to accountability may help to explain the Pentagon 's cavalier attitude toward soldiers who question the anthrax vaccine's safety. As word of the adverse reactions to the vaccine spread through the ranks, soldiers began to refuse the order to take it; some of those refuseniks have since been discharged, and at least 100 have been court-martialed for their insubordination.

In March 2003, six service members who refused to take the vaccine filed suit against the Defense Department. The plaintiffs did not claim any tort, but alleged that the vaccine that soldiers were routinely ordered to take was never legally approved as a countermeasure against the inhalation form of anthrax. Last October, District Judge Emmet Sullivan decided in their favor. Sullivan ruled that the FDA had failed to follow its own licensing procedure for the vaccine and ordered the program halted until the FDA relicenses the vaccine, soldiers are granted the right to refuse to take the vaccine, or the president waives the right of informed consent. "Absent an informed consent or presidential waiver," Sullivan wrote in his October 27 opinion, "the United States cannot demand that members of the armed forces also serve as guinea pigs for experimental drugs."

Despite his ruling, the Defense Department continued to administer the vaccine, and on February 14, the judge warned Donald Rumsfeld that he may be held in contempt for violating the court's order. For its part, the Defense Department claims that only 250 people were "mistakenly" given the vaccine after the ruling; other estimates put the number of those illegally vaccinated at upward of 900.

The numbers of those vaccinated in violation of the court order, however, is beside the point. As the Defense Department's flagship vaccination program, the saga of the anthrax treatment shows what could happen if sweeping product-liability protections, as envisioned in BioShield II, are not paired with an overhaul of the Pentagon's own accountability structure. Soldiers deserve safe and effective vaccines, but the system is not set up to maximize a product's safety. If product liability is neither the responsibility of the manufacturer nor any burden to the Defense Department (which purchases and administers the vaccine), the risks of a poorly made product are disproportionately born by the service member.

Given the potential danger of any vaccine, liability protection may, in fact, be a prerequisite for shareholders to back a company that manufacturers bioterrorism vaccines. But as service members like Randi Airola know, it can be hard to trust the Pentagon.

Mark Leon Goldberg is a Prospect writing fellow

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