The Anthrax Vaccine> Mandatory inoculations fuel a growing fear and mistrust in the U.S. military

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A Maine Air National Guard member in Bangor once considered the warnings about the military’s anthrax vaccine program just so much hype.

Not anymore.

Plagued by unremitting fever, fatigue, headache, loss of appetite, dizziness and nausea since beginning the six-shot series last month, the Guard member from Bangor’s 101st Refueling Wing now believes the Defense Department is using people in the military as guinea pigs for an untested vaccine.

“I joined the military to die for my country, not to have my country kill me,” said the Guard member, who has lost weight and struggles just to get out of bed each morning.

One of several people from the local Wing who told the Bangor Daily News recently that they had serious reservations about the vaccine’s safety, the Guard member asked not to be identified because of disciplinary action that could result from criticizing Defense Department policy.

“I want to help others make a better decision,” said the soldier, ruefully recalling that a family doctor had advised against the vaccination. The soldier said the doctor had warned, “I wouldn’t take it even if someone put a gun to my head.”

Part of a three-phase program implemented by the U.S. military in 1998, the vaccination is now mandatory only for those who are deploying to South Korea and the Persian Gulf. Of the nearly 1,000 members of the 101st Wing, 170 have received shots to date.

Early-deploying troops will be immunized during the second phase, which is expected to begin within a year, pending relicensing of the Michigan plant where the vaccine is manufactured. The final phase will kick in three years later when nondeploying troops and new recruits will be vaccinated.

Across the country, more than 400,000 service members have been inoculated, with hundreds complaining of health problems after the shot, according to a medical expert. Approximately 200-300 others have refused the vaccine, choosing to be discharged or face a military court.

The program could spawn a mass exodus by forcing people to choose between their military careers and a vaccination they believe is inherently unsafe, according to 101st Wing Chief of Staff Lt. Col. William Beutel. The military’s efforts to retain and recruit people by offering pay hikes, promotions and increased benefits would be sabotaged, he said.

The groundswell of protest erupted almost immediately after Secretary of Defense William Cohen ordered the program two years ago.

Critics say the vaccine hasn’t been tested enough and that it has too many side effects. They point out that the plant where the vaccine is manufactured has been cited for quality control and reporting violations and that the Defense Department hasn’t always been upfront about other potentially dangerous substances faced by the military.

The Defense Department insists that the vaccine is safe and effective, that members of the military are being frightened by inaccurate information, and that the incidence of adverse reactions is similar to that for other vaccines. The armed forces must be prepared to protect the country from biological warfare, the government warns.

A controversial vaccine

At the heart of the issue is a vaccine designed to protect the armed forces from a highly lethal biological agent. Pentagon officials have said that at least 10 countries have anthrax in their arsenals or are in the process of acquiring it.

A naturally occurring bacterium found in domesticated animals, anthrax can be produced as dry spores that, when inhaled, bring coma and death within a few days. Skin contact with live, infected animals or with their hide, hair or bones may lead to anthrax infection.

Developed in the United States during the 1950s and 1960s for humans, the vaccine was licensed by the National Institutes of Health’s Division of Biologics Standards for at-risk veterinarians, lab employees and livestock handlers in 1970. Responsibility for vaccine regulation later was transferred from NIH to the Food and Drug Administration.

First given in large numbers to Gulf War troops in 1990, the vaccine was manufactured at the state-owned Michigan Biologics Product Institute in Lansing, which was cited numerous times in the 1990s for violating FDA standards.

The plant was purchased in September 1998, by BioPort Corp., 11 percent of which is owned by William Crowe, a former admiral and past head of the joint chiefs of staff. Prior to the purchase, the plant had stopped manufacturing the vaccine to begin renovations of the anthrax production facilities. No new vaccine has been produced while the facility undergoes renovations and seeks recertification. Troops are receiving stockpiled vaccine.

Recipients are warned the anthrax vaccine may cause temporary soreness, redness, itching, swelling and lumps at the injection site, as well as muscle or joint aches, headaches, rash, chills, fever, nausea and loss of appetite. Some people said they have experienced a burning sensation where the shot is administered.

Lost faith

For Beutel, the military’s anthrax program is as much a symbol of lost faith as it is flawed policy. “It’s the first time I’ve felt that the Department of Defense really doesn’t have people’s best interests at heart,” said the officer, who decided months ago that he would refuse to be vaccinated once the shot became mandatory.

“If all the facts and testing were there and anthrax was something I felt we need to protect ourselves from, I’d be a staunch supporter,” said Beutel who plans to retire in April. “But when I look at the whole picture, I’m not comfortable with what I see.”

The program is undercutting the military’s esprit de corps, according to another local Guard member who also prefers to remain anonymous.

“It’s tearing at the moral fiber of the entire organization,” said the soldier, who hasn’t been vaccinated. “Before, we all worked side by side. Now it’s created two camps – the people who don’t have a problem with the vaccine and the people who are worried about the serious physical ramifications.”

The officers in charge are pushing for it, according to the Guard member who understands that they’re “following orders and doing what they’re told to do [regardless of] whether they think it’s right or wrong.”

“But somewhere along the line somebody should be saying this isn’t safe, this isn’t right,” said the Guard member.

Testifying before a congressional hearing on anthrax vaccine safety, anthrax expert Dr. Meryl Nass of Freeport said troops have reason for concern.

The vaccination program constitutes a public health crisis, according to Nass, who said “a statistically significant relationship” exists between the anthrax vaccine and Gulf War syndrome, a disorder characterized by sleep disturbances, muscle and joint pain, headaches, fatigue, memory loss, rashes, confusion and other problems.

When the vaccine was first approved by the NIH, the data accompanying the license application were from a different anthrax vaccine, according to Nass. No information on effectveness or long-term safety was ever provided. The Defense Department still hasn’t supplied long-term safety information to the FDA, she said.

Studies on whether the vaccine actually works are inconclusive, according to the physician. Since exposing humans to inhaled anthrax would be unethical, indirect tests have been done in which antibody levels are measured.

“But those don’t give us a good idea if humans can survive when exposed to anthrax,” she said.

Tests involving animals don’t settle the question either, said Nass. Many guinea pigs injected with the human vaccine died after being exposed to anthrax, and monkeys were tested against only two different strains of anthrax, Nass said. While scientists know of more than 100 strains, an infinite number could be developed, she said.

And while Secretary of Defense Cohen ordered supplemental testing for the vaccine, those tests “weren’t as extensive as FDA requires for initial approval [of a vaccine],” Nass said.

Some lots of vaccine never received the supplemental tests, according to Nass.

Education lacking

Controversy over the vaccne could have been averted if the Defense Department had been more proactive from the beginning, according to Undersecretary of Defense Charles Cragin, admitting that the outcry was unexpected.

“We weren’t out there with a robust education and information program, particularly with the Guard and the Reserve,” he said. “Unlike our active-duty colleagues, [Guard and Reserve] commanders only have a limited amount of time to communicate everything they have to. And while we were informing those who were immediately [in line to get inoculated], others were taking the initiative to inform themselves and not getting the right information.”

More than 1,500 lab workers at the research and development center at Fort Detrick in Maryland who received the vaccine have been followed for the last 20 years and none has developed unexplained symptoms, Cragin said.

When Cohen ordered supplemental testing he wanted “to assure himself that any lots were totally up to all standards and that the vaccine was safe and pure and potent,” said Cragin. Only lots that passed the supplemental testing have been approved for use, he said.

Acknowledging that historically the Defense Department “hasn’t always been totally candid and aboveboard” when informing troops of dangers such as nuclear fallout and Agent Orange, a defoliant believed to cause illness used during the Vietnam War, Cragin said officials are trying to do better.

“We’re tracking every vaccination so we know who received what lot and when and we can follow up, educating all our troops on the potential adverse health effects and encouraging them to report problems,” he said.

Reports of debilitating side effects are evaluated by an Anthrax Vaccine Expert Committee, an independent group operated by the Department of Health and Human Services, which reviews complaints and determines whether symptoms are related to the vaccination, the deputy secretary said.

Meanwhile, Cragin said he has received five shots and that he feels fine. Secretary Cohen has completed the series, Cragin said.

Not everyone affected

Several Maine Guard members who did not want to be identified said their vaccinations had left them feeling fine and that they were not worried about any resultant health problems.

“It’s good to feel protected,” said one, while another called it “no big deal – just part of being in the military and serving your country.”

Someone else didn’t believe “the government would disable their total force by forcing somebody to take something they know is bad for them.”

A third soldier questioned the horror stories disseminated on the Internet. “I haven’t seen any real evidence that there’s a problem. The authenticity of the Internet information is highly questionable – anybody can post anything on the Internet.”

The vaccine’s benefits outweigh the risks, according to Chaplain Richard Dickinson who took the third shot last weekend in Bangor and said his arm was more tender than it had been with the previous two.

More than 30 Wing members have confided to him that they are ambivalent about the vaccine. “If taking the vaccine is such a struggle that you can’t come to terms with it, the military will probably prove to be too threatening a place for you – there’s stuff a whole lot scarier than this,” he has told them.

Even military personnel have a moral obligation to question directives, according to Dickinson. Still, in the end, being a team player means following orders, he said.

101st experience

No one with the 101st has been coerced into taking the vaccine, Operations Group commander Col. Doug Damon said last week during the third series of vaccinations.

Wing members have access to a notebook filled with information on both sides of the issue, including Internet articles, newspaper clippings and a Department of Defense videotape narrated by a scientist from the Centers for Disease Control and Prevention, said Damon.

“We need people to educate themselves and make an informed decision,” Damon said. “We don’t want someone to give up his or her career and look back and say, +Gee, I thought the vaccine was something else.”‘ The officer had no qualms about rolling up his sleeve. “Nothing has been scrutinized more closely than this product,” said Damon who has had “zero reaction” to the shots.

One hundred five Wing members volunteered in January to begin receiving the inoculations and boosters which are to be given over 18 months, according to medical staff.

While several failed to return for their second shot two eeks later, they all came back last weekend for the third series.

One Guard member reported redness at the injection site and another complained of flulike symptoms and subsequently was diagnosed as having the flu by a Bangor doctor, according to clinic commander Dr. Henry Litz. Both were offered a Vaccine Adverse Event Reporting System form, but declined to fill it out, he said.

A third person who was experiencing abdominal pain turned out to have suffered a gall bladder attack, said Litz.

But Beutel said Wing members have told him that they know of others who felt ill after receiving the vaccine and never reported their symptoms.

Since the immunization program began in 1998, another 65 Wing members have been vaccinated because they were being deployed. Litz said he wasn’t aware that any had suffered side effects.

Meanwhile, Litz himself has received three shots and “feels great,” he said.

A matter of mistrust

Mistrust of the program has proved a barrier for Beutel. “I have to be able to do my job, and part of that is believing the orders and rules and regulations set out for us,” he said.

Last spring, after deciding to learn more about the issue, Beutel reviewed more than 1,600 pages of Senate reports, House hearings, and presentations before the National Subcommittee for Security, Veterans Affairs and International Relations, created to look at the anthrax issue.

“All the testimony out there was pretty hard to ignore,” he recalled. “More often than not, a new program comes out and military members do what they have to do and that’s it.

“But there had to be something these people were upset about. The more I read, the more convinced I became that something was drastically wrong.”

Deciding that he had a moral obligation to speak out as a private citizen, Beutel sent three “point papers” to members of Maine’s congressional delegation, urging them to vote for a bill that would impose a moratorium on the vaccination program pending more review. U.S. Rep. John Baldacci is a co-sponsor of that legislation.

The military is now short 750 pilots and is projected to be over 2,000 short in three years – even before any impact from the anthrax program is taken into account, according to Beutel, who for years has been researching retention and recruitment rates and demographics. Ninety-three percent of the enlisted force will make a re-enlistment decision between 1999 and 2002, he said.

“The potential exists for a large number to decide to leave the force,” said Beutel.

Beutel argues that the loss of 100 experienced pilots, factoring in the cost of replacing them, will be more expensive for the military than inoculating every soldier.

“Does it make sense to continue to pour money into a program that hasn’t been proven effective when the cost of the program pales in comparison to the cost of the loss of military personnel?” he asked.

Declaring opposition

His time in the military may be limited, but Beutel still is putting himself on the line by declaring his opposition to the vaccine.

“I’ve taken a different point of view and I’m going to get some flak from senior leadership,” he said. “They can think I’m a rabble-rouser, that I’m influencing others. But I haven’t done that. I just tell people they need to get the facts and that they have to make up their own minds.”

Beutel already has been criticized for putting his rank on the cover letter of the first paper. While he included a disclaimer stating that the opinions and comments didn’t necessarily represent those of the United States Air Force or of the Air National Guard, his superiors were not pleased.

“If he had sent it as Bill Beutel, he’s got every right in the world and I’ll defend and respect that right,” said Maj. Gen. Earl Adams, adjutant general of the Maine National Guard. “But as Lieutenant Colonel William Beutel it takes on the semblance of an official position and it is not the official position of that military unit or of the National Guard or of Secretary Cohen.”

Beutel is concerned that adverse reactions to the vaccine aren’t being documented. “I hear about people saying they haven’t felt well and that they didn’t fill out the [VAERS] form,” said Beutel. “But I advise people who tell me they’re not feeling well to go back to the clinic and fill it out. I tell them that if they don’t have a form I’ll get one off the Department of Defense’s anthrax Web site.”

Beutel said he knows of at least 40 people in the Wing who are worried about what they’re going to do when the vaccine becomes mandatory. “Some are having physical exams to establish a baseline in case something happens,” he said. “Others are vowing to leave the Guard.”

The vaccine already may have caused several Wing members to abandon their military careers, according to Beutel, who said he couldn’t be sure since clearance forms don’t necessarily list specific reasons for resignation.

It’s wrong that military people are facing such a dilemma, Beutel lamented. “People who put their lives on the line shouldn’t have to make career decisions over a questionable vaccine program,” he said.

More than anything he wishes he weren’t going it alone. “Something is wrong here, and we ought to stand up and say so,” he said. “Everyone knows that the emperor has no clothes, but they’re too concerned about losing their jobs to point it out.”

Doctor blames FDA

Meanwhile, Nass takes issue with the FDA’s handling of the vaccine. She said the department failed to regularly inspect the anthrax-producing part of the plant; allowed the facility to redate the vaccine after a majority of lots had expired using an unreliable potency test; and never verified the manufacturer’s data.

The FDA could have chosen independently to test the vaccine before releasing lots for use, but didn’t do so for many years, according to Nass.

After the Gulf War, when so many questions were raised, the FDA should have reviewed its treatment of the vaccine and realized there was a lack of data and “loose ends everywhere,” she said.

The FDA disagrees. John Taylor, the FDA’s senior adviser for regulatory policy, said the vaccine went through all the usual testing procedures as well as some not routinely required.

Ordinarily, before a vaccine is released the FDA looks at the safety, potency and sterility data provided by the manufacturer for each lot, Taylor said. But because of a 1996 anthrax plant inspection in which investigators found significant deviations, the FDA actually sampled and tested the vaccine.

After assigning an investigator to “take a deeper look at how the vaccine was being manufactured,” the FDA issued a warning that it would revoke the plant’s license unless improvements were made, said Taylor. The department has ontinued to inspect the plant “at least on an annual basis,” he said.

The FDA allowed the facility to redate the vaccine because “according to our evaluation it was still safe and effective,” said Taylor.

The potency test needed revamping, according to Taylor, who said the FDA is working with BioPort to develop a new one. “We recognized a weakness, but the quality of the vaccine wasn’t affected in any way,” he said.

The FDA has looked extensively at a possible link between Gulf War syndrome and the anthrax vaccine by monitoring adverse effects reported by troops during the war, according to Taylor. No correlation has ever been established, he said.

Side effects delayed

So far, more than 600 complaints have been reported to the FDA, according to Nass. Side effects from the shots could take as long as a year to surface, she said, predicting that at least 20,000 people could suffer chronic ill effects.

Some complaints haven’t been reported since many people don’t know whom to complain to and others may not be relating their symptoms to the vaccine, according to the physician.

The numbers are further skewed since medical professionals were instructed during the first 15-18 months of the program not to report complaints to the FDA unless someone was hospitalized or missed more than 24 hours of work, she said.

Vaccines aren’t a vigorous defense against biological weapons, according to Nass. “There are so many biological weapons out there that you can’t vaccinate everyone for everything,” she said, pointing out that multiple vaccinations cause adverse reactions in people by overly stimulating the immune system.

Even if a successful vaccine were manufactured, terrorists would “just take another weapon off the shelf,” she said. “And if [a vaccine] isn’t effective, you give everyone a false sense of security and you march troops into a contaminated area and they get sick. The whole thing is totally foolish from a military strategy position.”

Anthrax is difficult to use to attack large numbers of people, according to Nass. “People have been able to make it and deploy it for the last 60 years and there haven’t been any major epidemics,” she said.

The spores must be sized just right to enter the lungs, and 50,00 to 1 million of them must be inhaled to become sick, said the doctor.

“Since it only goes where the wind sends it, it has a limited traveling area,” she said. “Once it hits the ground it doesn’t easily get back into the air.

“There are so many other things we could be doing instead of making people chronically ill with the vaccine,” said Nass, calling for better masks, sensors that can detect biological agents, and strengthening of the Biological Weapons Treaty.

Nass speculated that one of the reasons the Defense Department gave BioPort millions of dollars to purchase and renovate the plant could have been that the former head of the joint chiefs of staff was at the company’s helm.

But an associate of Adm. Crowe’s said Thursday that Crowe’s group was awarded the bid for the plant because the state of Michigan decided it had made the best offer. The decision to renovate the facility began when the company was still owned by the state and it simply continued, he said.

Nass now wonders whether a connection exists between the vaccine and the many cases of multiple sclerosis and lupus with which Gulf War veterans were diagnosed soon after they received the shots.

Both are autoimmune diseases, said Nass, pointing out that the vaccine has led to other autoimmune problems such as hypothyroidism, pernicious anemia and rheumatoid arthritis.

From where Nass sits, it’s time for the Defense Department to accept defeat. “They had a vaccine they thought would be safe and effective, and it turned out to be neither,” she said. “But instead of admitting they made a mistake, they’re doing everything they can to cover it up and continue.

“I’ve thought to myself – historically what mistakes have they admitted to in the past? I can’t come up with any time they’ve ever said they’ve made a mistake. And if you have an organization that can’t admit to making a mistake, you have a serious problem.”

Delegation reacts

Additional studies and hearings on the vaccination program are warranted, Maine’s congressional delegation agrees. Spokespersons for U.S. Sens. Olympia Snowe and Susan Collins and U.S. Rep. John Baldacci said they have received a significant number of calls and letters from concerned members of the military and their families.

Fustration is a common theme among constituents, according to Dave Lackey, spokesman for Snowe.

“There is a real feeling that they’re yelling into the wind,” he said, “that the Pentagon hasn’t taken their concerns as seriously as they’d like.”

Anthrax: What is it?

Anthrax is produced by the bacteria bacillus anthracis. A tough protective coat allows the bacteria to survive for decades as spores. Anthrax is dangerous because it is:

Highly lethal.

One of the easiest biological agents to manufacture. Spores can be produced in large quantities using basic knowledge of biology.

Spores can be easily spread in the air by missiles, rockets, artillery, aerial bombs and sprayers.

Spores can be stored for decades without losing viability.

Easily spread in the air over a large area.

Anthrax is almost always deadly if not treated early.

There is no indication of exposure.

There is no cloud or color.

There is no smell.

There is no taste.

There is no indication of an attack when dispersed by aerosol spray.

Three types of anthrax diseases:

Cutaneous anthrax – caused by contact with infected animals or contaminated animal products.

Gastrointestianl anthrax – caused by ingestion of contaminated meat.

Inhalation anthrax – caused by inhalation of anthrax spores

Incubation period: 1 to 6 days.

Symptoms of inhalation anthrax:

Flulike aches and pains.

Fever, malaise, fatigue, cough and mild chest discomfort followed by severe difficulty breathing.

Diagnosed by:

Isolating the bacteria from blood, other body fluids or skin lesions.

Blood culture, measuring specific antibodies late in the course of the disease.

Treatment:

Treatment is usually not effective after symptoms are present. High dose antibiotic treatment administered early after exposure can lower the death rate slightly. By the time symptoms develop, it is highly likely death will occur despite the best efforts of modern medical science. Ninety-nine percent lethal to unprotected individuals.

What it does:

The disease occurs when spores enter lungs, migrate to the lymph nodes, change to the bacterial forms, multiply, and produce toxins. These toxins cause bleeding and destruction of structures in the middle of the chest (medical term: hemorrhagic necrotizing mediastinitis). Shock and death occur within 24-36 hours.

Anthrax: Through the ages

1500 B.C.

The fifth Egyptian plague, around 1500 B.C., is believed to have been a result of anthrax.

During the Middle Ages, anthrax became known as the Black Bane. It was responsible for nearly destroying the cattle herds of Europe.

1800s Louis Pasteur studied this disease and developed the first man-made vaccine for animals.

1897 Robert Koch grew the anthrax bacillus in pure culture, demonstrated its ability to form endospores, and produced experimental anthrax disease by injecting it into animals.

1970 The anthrax vaccine has been routinely administered to professionals who may come in contact with anthrax spores occupationally.

1979 An outbreak of human anthrax occurred in Sverdlovsk, U.S.S.R. (now Ekaterinburg, Russia). Although it was officially blamed on consumption of contaminated meat, Russian scientists have acknowledged that it resulted from the inhalation of spores accidentally released from a nearby military research facility.

Early 1990s Inspection teams discovered that Iraq produced 8,000 liters of anthrax spores — an amount believed capable of killing every man, woman and child on Earth.

1990 and 1991 More than 150,000 U.S. troops were given anthrax vaccinations.

May 18, 1998 Secretary of Defense William Cohen approved the plan to vaccinate all U.S. service members for anthrax. The vaccination will serve as one of the primary defenses against the use of biological warfare by rogue nations.