Hundreds in military reject vaccine for anthrax
Published Tuesday, Oct. 30, 2001, in the San Jose Mercury News
BY LISA M. KRIEGER
[SJ]Mercury News
The threat of anthrax would motivate anyone, it would seem, to seek a protective vaccine -- particularly members of the armed forces, who could be exposed to mass spraying of lethal bacterial spores while on the battlefield.
But in the military, where anthrax shots are required, hundreds of active-duty troops, reservists and National Guard members have been rejecting the vaccine. They say it is dangerous and can cause a variety of ailments.
Even as the U.S. Centers for Disease Control prepares to give the military's anthrax vaccine to civilians at most risk in the current anthrax scare, these servicemen and women are continuing their fight against the military's vaccine rule.
Russell Dingle, a former major and flight commander with the Connecticut Air National Guard who wouldn't take the shot, says: ``If anything, current events have strengthened our commitment.''
``I believe the servicemen of this country deserve a vaccine that is safe and effective. The current vaccine is not,'' said Dingle, who resigned from his job because he believes the vaccine is illegal -- and said he could not obey an illegal order.
The military inoculated some Gulf War troops against anthrax, and made the shots a requirement for all servicemen and women in 1997. The program has been slowed by production problems with the vaccine, but the Pentagon is placing renewed importance on it as more troops head to the Middle East.
A vaccine against anthrax is critical, doctors say, because exposure to the invisible microbe may not be recognized in time to start treatment. Even if treatment is started promptly, doctors worry about long-term regimens of antibiotics for people who are frequently exposed to the microbe.
``It's time we initiate a large-scale anthrax vaccine program. We don't know what's coming and we can't control it,'' said Dr. Thomas Inglesby of the Johns Hopkins Center for Civilian Biodefense Studies, speaking to the Infectious Diseases Society of America in San Francisco on Sunday.
At the conference, Dr. James Hughes of the CDC said, ``We are recommending increased access to the pre-exposure vaccine for the higher-risk groups, such as lab scientists and members of emergency response teams, or workers who rotate through multiple decontamination procedures.''
Vaccines work by triggering the production of antibodies in the blood, which fend off the deadly bacteria and thus prevent infection. The anthrax vaccine may also work as a treatment and shorten the time needed to stay on antibiotics.
Vaccine debate
While many vaccines have been controversial due to fears of side effects, this particular vaccine has prompted more than its share of debate.
One problem is that the vaccine is ancient by medical standards -- essentially unimproved since its reformulation in the 1960s.
To make matters worse, the nation's sole supplier of the vaccine stopped producing it in 1998 after the FDA found manufacturing problems such as poor sanitation and sterility.
The company, called BioPort, of Lansing, Mich., has since renovated its facility -- thanks to a $24.1 million boost from the Defense Department -- and is hoping to get the FDA go-ahead to resume production in mid-November.
BioPort's vaccine stockpile will be released for use by civilians once the FDA gives it the green light. The FDA says the anti-anthrax agent is a safe, approved vaccine.
The Pentagon also believes that the vaccine is a safe and effective tool to protect soldiers from the lethal consequences of anthrax used as a weapon.
It warns that servicemen and women should not be allowed to decide on their own which orders to obey and which to disregard. The Pentagon has dealt firmly with anyone refusing to take the shots -- disciplining, jailing or forcing resignations from 441 servicemen and women.
According to Pentagon statistics, more than 2 million doses of the vaccine have been administered to 519,847 military personnel. Of these, 1,592 complained of adverse health effects and 54 -- about one in 10,000 -- required hospitalization.
Pentagon officials reject complaints that the vaccine, which was among injections administered to U.S. troops who fought in Iraq in 1991, causes ailments such as chronic fatigue syndrome, autoimmune diseases and severe joint pain. And officials are not convinced that the vaccine is the cause of the mysterious ``Gulf War syndrome'' that has afflicted thousands of soldiers, as some troops allege.
Organized opposition
In response, families of such troops have joined a group called the Anthrax Vaccine Network, based in Missoula, Mont. The group is demanding that the vaccine be withdrawn until it can be replaced with a safer version.
The group includes the family of 32-year-old Sgt. Sandra Larson, who died of a rare blood disease called aplastic anemia. Her family blames her death on an 18-month anthrax vaccination program at Camp Stanley in Korea. Clarence McNamer, a master sergeant who is a flying crew chief on C-5 aircraft at Travis Air Force Base, says the shots caused his hair to fall out and pustules to form on his scalp.
Thomas J. Colosimo, a senior airman in the United States Air Force who is stationed at Andrews Air Force Base in Maryland, says, ``When I was vaccinated, I was not informed of any potential adverse side effects. There were no handouts, product inserts, literature or health questionnaires to read or fill out.'' Now suffering episodes of vertigo, memory loss, shortness of breath and fatigue, Colosimo has been denied disability benefits and faces discharge in November.
The Anthrax Vaccine Network contends that the current vaccine, licensed in the 1970s, has failed to meet federal requirements of vaccine efficacy in humans. Only one study proved efficacy -- and this involved a different vaccine and studied cutaneous, or skin-contact, not inhalation anthrax.
And while representatives of the group say the Department of Defense is correct to submit to the Food and Drug Administration an Investigational New Drug application requesting permission to use the vaccine for aerosolized anthrax, an investigational drug requires informed consent -- so troops should not be forced to take it.
``Civilians will be getting an experimental vaccine, an expired vaccine. They're getting the same stuff that made the troops sick,'' said Network president Kathy Hubbard of Missoula, who began researching the vaccine after her son was given two shots.
Several troops and their families have gone so far as to sue the government in federal court, calling the vaccine an ``unapproved drug'' and contending that the U.S. Defense Department and the FDA have illegally authorized its mandatory use.
Safety concerns caused the American Public Health Association to urge a delay in mandatory vaccination in the military, or make immunization voluntary.
Rep. Christopher Shays, R-Conn., chairman of the Subcommittee on National Security for the House Committee on Government Reform, in congressional testimony called the immunization effort ``a very misguided program . . . It may be that the military is going to use this even though it's not FDA-approved, and that's very unsettling. Pull the plug.''
For a while, it seemed that the controversy would cool.
That's because the production problems with the vaccine shortage have slowed the military's anthrax program to a near-standstill. Only members of high-risk special forces have been vaccinated.
But in the current war against terrorism, inoculating U.S. troops and high-risk civilians against anthrax is once again a top national priority. Earlier this month, Secretary of Defense Donald Rumsfeld said the Pentagon continues to support the vaccination program.
Capt. John Buck, an emergency room physician at Keesler Air Force Base in Mississippi, was court-martialed in May and sentenced to $21,000 in fines and confinement to the base for his refusal to take the vaccine.
He calls the vaccination effort ``a well-intended program developed to protect our troops from the threat of anthrax.''
``However, it was built on a very narrow scientific foundation,'' he added. ``The military objectives are being achieved -- while compromising the practice of medicine.''
Contact Lisa M. Krieger at lkrieger@sjmercury.com or (408) 920-5565.
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