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Has anthrax vaccine's effect become a military secret?
By: Maryanne Kocis MacLeod, Macomb Daily Staff Writer November 06, 2001

BioPort in Lansing is the only U.S. laboratory to make the anthrax vaccine. Until the facility meets Food and Drug Administration guidelines, it is barred from releasing the vaccine.

Before he was transferred to Dover Air Force Base in Delaware, Maj. Sonnie Bates casually requested his immunization schedule, which included the anthrax vaccine, be put up-to-date.

Administrative difficulties, however, prevented that from taking place.

Shortly after arriving at Dover in May 1999, Bates found out that was a good thing.

The 38-year-old career military man was told 14 base personnel had developed debilitating side effects after taking the vaccine. The former base commander responded to their reports by discontinuing the vaccine program -- and was promptly transferred to a desk job inside the Pentagon.

A new commander was assigned and the anthrax vaccine program at Dover, intended to protect troops from exposure to the bacteria, was reinstated. That didn't stop Bates from calling each of the 14 affected personnel and listening to their stories. Additional research through military and medical channels convinced him the vaccine was not an acceptable risk.

In December 1999, Bates, of Dover, Del., became the highest ranking military officer to refuse the anthrax vaccine.

As a result, he was forced to resign after 14 years in the Air Force, $5,000 in bonuses and paychecks were withheld and Bates was fined $4,200. In addition to losing his medical benefits and retirement package, he was threatened with a court martial. In February 2000, Bates, who now works as a pilot for a private corporation, shared his story with TV's "60 Minutes."

"My military career was not more important than my integrity," Bates said. "I couldn't look these people in the face, people who thought they had finally found somebody to give them a voice, and turn my back on them.

"I did it for my own health as well," Bates continued. "I have three children and my youngest son is autistic. If I lose my health, there's no one to care for him or the rest of my family."

Air Force Surgeon General spokesperson Betty Ann Mauger said Bates knew the consequences and still refused to follow orders.

"He choose dismissal in lieu of a court martial," Mauger said.

On Nov. 11, Bates' wife Roxanne will further detail her family's experience at the Rolling Resistance Rally from noon to 3 p.m. in Lansing, home to BioPort, the nation's only anthrax vaccine manufacturer. The rally, which will be held on the steps of the state capitol, was organized by opponents of the anthrax immunization program including Roxanne Bates and Battle Creek resident Robin Hawes, a former member of the Air National Guard, who became sick after taking the vaccine.

The rally's goal is to gain government recognition for those who have become ill, educate military personnel about possible adverse reactions and provide those scheduled for the vaccine with information that may reduce side effects. Organizers also hope to raise public awareness and build support for a vaccine program that would give military personnel a choice. One study indicates that between 30 and 40 percent of those immunized experienced varying degrees of side effects.

So far the federal government denies any link between the vaccine and adverse effects ranging from chronic fatigue, to migraine headache, severe diarrhea, blood blisters, muscle tremors, reduced concentration, memory loss, lesions in the coronary arteries, loss of consciousness, coma, and in a handful of cases, death.

"The vaccine we use is FDA-released, and is safe and effective," said James Turner, Department of Defense spokesman. "There are no known long-term side effects to anthrax vaccine."

In its last Food and Drug Administration inspection in October 2000, BioPort received 17 pages of violations, many of which dealt with cleanliness and sterility issues, as well as failure to bring past violations up to code.

According to FDA spokeswoman Lenore Gelb, the facility is barred from releasing any vaccine until it can meet FDA guidelines. Gelb would not say when that inspection would take place. However, Bates said the inspection was scheduled for this fall, and new vaccine is expected to be released in January.

Although the plant is licensed to produce the vaccine, the vaccine itself does not meet current FDA standards, in large part because it cannot be tested on humans.

BioPort representatives did not return phone calls as of press time.

To date, 511,000 servicemen and women have received at least one unit in the six-shot schedule since March 1998, Turner said.

In June, the DoD announced that it would begin limiting the vaccine to special mission units, researchers and congressionally mandated study participants because of a shortage of FDA-released vaccine, Turner said.

But Dr. Meryl Nass, an internist from Freeport, Maine, and national expert on anthrax, Gulf War and Chronic Fatigue syndromes, said the DoD's June announcement did not reflect a change in policy; researchers, study participants and special mission units were always the target of the vaccine program.

In fact, the DoD stepped up administration of the vaccine following the Sept. 11 attack -- without making a formal announcement -- said Nass, who will speak at the Rolling Resistance Rally in Lansing.

"When I first heard about this, I didn't think it was possible the vaccine was responsible," Nass admitted. "But after talking to over 1,000 people who became ill, all of whom said the same thing, you know something has to be going on."

So far, the government has not allowed any independent testing of the vaccine, Nass said.

"It might just be we don't know how to make a vaccine that isn't virulent," Nass said.

For one thing, current manufacturing procedures are unable to produce a consistent version. It is not uncommon for one lot to contain 40 times the active ingredient as the last. Distribution of expired lots and contamination of the vaccine itself further complicate the problem, Nass said.

Interestingly, symptoms of Gulf War Syndrome are identical to the adverse reactions associated with the anthrax vaccine. This is especially relevant given that many of those suffering from GWS never made it to the Gulf, but were in fact immunized against anthrax in preparation for potential deployment, Nass said.

With all of this in mind, Nass believes the vaccine should be administered with informed consent. In other words, those who choose not to be vaccinated after learning of potential side effects can do so without being forced to leave the military.

Meanwhile, the vast majority of those who became so sick they could not continue working must now face life with a chronic illness -- born of their military service -- without medical benefits or disability compensation.

"There are no cures," Nass said. "In a few cases, there are some Band-Aids, but the vast majority of those affected are still sick."

In addition to providing background on the issue, Nass' Web site, www.anthraxvaccine.net, includes vitamin regiments that have in some cases reduced side effects.

Rolling Resistance organizers Robin Hawes and Tom Starkweather, both former members of the Air National Guard's 110th Fighter Wing in Battle Creek, are among those who lost their health, their medical benefits and their civilian and military jobs at the air base.

"I'm not going to tell people not to take the shot," Starkweather said. "In the military, you don't have a choice. I just want to give people information so they can go to their doctor, get on a schedule and hopefully minimize their symptoms."

The Air National Guard alone has lost 25 percent of its membership over the issue, according to rally organizers -- an allegation Air Force representatives deny.

For Hawes, educating her female peers is especially important.

"Women have an 80-percent higher reaction rate than men," said Hawes, whose story was featured in the October issue of Self magazine. "I don't want to see anyone else hurt by this vaccine. There are so many people who are sick, so many still working and afraid to come forward and say they are sick."

Edna Frazier of Harrison Township is among those who does not want to see anyone else hurt. Her son, Air Force Spc. John Carroll, 22, a paratrooper with the 82nd Airborne Division at Fort Bragg, N.C., did not want to take the vaccine -- but wanted even less to give up his career in the military.

"He's happy, he's living his dream and I just have to be thankful that he wasn't one of the unlucky ones that got sick," said Frazier, who opposes mandatory immunization. "Every day I just keep saying those extra little prayers that everything will be OK."