Up in the Air About Anthrax

Oct. 1, 1999

Air Force Capt. Jonathan E. Richter is a third-generation military officer. A C-5 pilot in the Air Force Reserve at Dover AFB, Del., he flew missions in both Operations Desert Storm and Northern Watch and is not, in his own estimate, the sort of person who normally goes around looking for ways to disobey his superiors.

However, on Feb. 3, 1999, Richter was injected with anthrax vaccine from lot #FAV 030. The same lot was used for his second shot on Feb. 19. Five days later, his problems began. His right shoulder began to ache, as if he’d thrown a baseball hard without warming up. Then his left shoulder began to feel the same way. Soon, his spine hurt so badly that he could hardly get out of bed in the morning.

Since then, his arthritis-like symptoms have stabilized mostly in his feet and left hand. He has no way of proving that the vaccine is the cause, but he’s not taking any chances. He told a Congressional panel on July 21 that “taking another shot is not part of the Jon Richter health care program” and that he will resign his commission before taking another anthrax injection.

“Those in command seem to have shrugged their shoulders at the numbers of people leaving military service, with the attitude that an order was given and it should be carried out,” he said in an appearance before a House subcommittee. “We are growing tired of the denials-that everything is OK-when in fact it isn’t.”

Two years after Secretary of Defense William S. Cohen first announced that all US military personnel would be vaccinated against the deadly biological agent anthrax, the Pentagon is facing a growing revolt against the program. Around 200 active, Guard, and Reserve members of the armed services have refused to take part in the six-shot vaccination program, according to DoD’s own records. However, the Pentagon admits it doesn’t have a formal tracking system. The numbers refusing to take the shots in the Guard and Reserve may be greater than DoD reports, based on Congressional testimony from reservists and news articles around the country.

Some of the active duty holdouts have been court-martialed. Reservists face not courts-martial but a sudden end to their military careers.

Morale at “All-Time Low”

For instance, Richter claims that many pilots-by his count, about 60 percent of those in the unit-plan to resign rather than face the anthrax vaccine needle. He said, “I can only assume that the people in the other specialties required to execute the mission of an airlift airplane such as the C-5 are leaving as well. Word travels fast. Morale is at an all-time low.”

US military health officials find this development frustrating. They claim that the vaccine is safe and effective and that many reluctant members of the military are being frightened by outdated and inaccurate information.

Furthermore, anthrax is a deadly threat that terrorists could well employ against US forces in the years ahead. It is, in the words of the Pentagon, “a clear and present danger to US service personnel.” Declining anthrax vaccinations is akin to refusing to wear a helmet in combat, top officials argue.

“If you get anthrax, … you are effectively dead,” Secretary of the Air Force F. Whitten Peters told the Senate Armed Services Committee during his July 21 confirmation hearing.

Moreover, virtually every senior uniformed and civilian military leader has either begun or completed the full series of six anthrax shots required for complete protection. Inoculees include Cohen, Peters, Deputy Secretary of Defense John J. Hamre, Army Gen. Henry H. Shelton (Chairman of the Joint Chiefs of Staff), USAF Gen. Joseph W. Ralston (JCS vice chairman), and all four chiefs of the uniformed services, including USAF’s Gen. Michael E. Ryan.

Pentagon health officials acknowledge that they have been somewhat taken aback by the sudden squall of resistance to anthrax vaccinations. They felt that the rise of unconventional means of warfare and regional conflicts would make only too obvious the need for such a program of protection.

The program’s foundation was laid in 1993. In that year, Defense Department officials issued a directive on immunizations for biological warfare defense, which established government policy, responsibilities, and procedures for the stockpiling of biological agent vaccines. Military planners are studying the virtues of a dozen or more different kinds of shots to safeguard US troops from attacks by the Saddam Husseins of the future.

From the outset, say planners, it was clear that anthrax would be the biggest near-term biowar danger. It is cheap, easy to produce, and easy to load into a long-range weapon. The Iraqi military knows all about it.

Anthrax is a disease that occurs naturally in herd animals, such as cows. Humans can catch it by eating contaminated meat, handling contaminated animals or animal products, or directly inhaling anthrax germs.

In their natural state, anthrax germs live in spores, which can survive for decades if buried. To turn the disease into a weapon, these spores are milled into a fine-ground dust that can be sprayed over a wide area through the use of any number of delivery methods.

How It Kills

Once inhaled, anthrax reproduces and releases toxins that attack the lungs. The victim’s first indication that he or she has been poisoned is the onset of vague flu-like symptoms, notably high fever and chest pain. Death comes abruptly, through oxygen depletion, shock, and respiratory and cardiac failure.

Absent vaccination, anthrax is virtually always fatal.

At least 10 potential US adversaries have worked on anthrax weapons, according to US intelligence data. The reaction of law enforcement authorities to anthrax hoaxes has been extraordinary. In one recent incident, the presence of a suspicious envelope caused a virtual shutdown of downtown Washington, D.C., for hours and sent office workers into the streets to be cleaned by paramedics. These reactions show how seriously the US government takes the threat.

“[Anthrax] has been weaponized and we know it is deployed in about 10 countries around the world,” Peters told the Senate panel. “Our view is that it is unconscionable to allow our pilots and aircrews to fly into those countries, which are high-threat countries, without being inoculated against anthrax, just as we would inoculate people against smallpox.”

In May 1998, Cohen ordered that everyone who wears a US military uniform-active, Guard, or Reserve-eventually receive anti-anthrax shots. Under Cohen’s order, the Total Force will be covered by a three-phase program. Phase 1 involves inoculating all forces that are now assigned to or will be rotating through high-threat areas in Southwest Asia and Korea. Phase 2 will involve forces designated for early deployment into those areas. Phase 3 is everyone else.

DoD envisions finishing this huge inoculation project by 2006.

Inoculation involves more than rolling up a sleeve for a single shot. The present Anthrax Vaccination Immunization Program entails a series of six shots administered over a period of 18 months. The first three inoculations are delivered at zero, two, and four weeks. Boosters are then administered at six, 12, and 18 months.

The Pentagon insists that the vaccine is safe. Army Maj. Gen. Robert G. Claypool, deputy assistant secretary of defense, health operations policy, said that several studies have shown that the incidence of adverse reactions to anthrax vaccination is comparable to that for other commonly used vaccines.

Studies done at the time of FDA licensure of the vaccine showed that in 16,000 doses the anthrax vaccine causes a mild reaction in 3 to 20 percent of those who take it. Fewer than 1 percent exhibited a severe reaction, Claypool reported to Congress on July 21.

By way of comparison, the pneumonia vaccine has a 71 percent rate of localized soreness. The typhoid vaccine causes localized tenderness in 98 percent of recipients, pain by 56 percent, a feeling of malaise in 24 percent, and headaches in 11 percent.

As of midsummer, the Pentagon reported only 103 adverse reactions to the anthrax vaccine, out of more than 977,000 doses administered. Of these 103 events, only 14 reactions resulted in more than 24 hours of lost duty.

Pentagon health officials say they are aware of isolated, inexplicable systemic health problems that have developed in some military personnel around the time they received an anthrax shot. But they say they are not aware of any pattern of long-term side effects from the anthrax vaccine.

“Some Degree of Risk”

“Any vaccine carries with it some degree of risk with its use,” said Claypool. “In the case of the anthrax vaccine, the scales of balance are clearly tipped in favor of its use to protect our military forces.”

These explanations do not satisfy those who believe that their anthrax shot made them sick. The Pentagon’s tracking system is underreporting adverse events for a number of reasons, these critics claim.

In some units, fear of possible side effects has proved as contagious as any flu virus. An ANG member testifying before Congress stated that the Connecticut Air National Guard lost eight pilots who refused the shots. At Travis AFB, Calif., the guardsman said that 17 KC-10 crew members resigned rather than face the anthrax needle.

Many of those who are worried about the vaccine’s effects cite the military’s long history of underplaying the threat posed to its members by certain substances and practices, from Agent Orange to radiation testing.

“The missing element of the mandatory anthrax vaccine program is trust,” said Rep. Christopher Shays (R-Conn.) during a series of Congressional hearings on the issue.

Dover is one of the Air Force bases where suspicion about the vaccine has been strong and widespread, due to a large number of personnel with unexplained health problems that began to crop up around the time of vaccination.

At least 30 Dover personnel have filed reports with the Anthrax Vaccine Adverse Event Reporting System in recent months, according to Lt. Richard J. Rovet, a health care integrator for the flight medicine clinic at the base. These included six reports of dizziness, six reports of ringing in the ears, 10 reports of joint pain, two reports of chronic fatigue, and one report of a painfully swollen testicle.

Capt. Michelle Piel is a 13-year Air Force veteran and a C-5 Galaxy pilot stationed at Dover. She says that her arm went numb for about 20 minutes after she received her first anthrax shot on Oct. 21, 1998, from lot #030. Weeks later, while flying a return leg from humanitarian relief operations in Honduras, the right side of her head filled up with fluid.

“It was as if a faucet were turned on inside my head,” she told Congress in written testimony.

A flight surgeon grounded her for a head cold and middle ear infection. Thus began a long struggle with fatigue, nausea, and other flu-like symptoms. Six months later, 12 doctors had yet to reach a firm diagnosis of her condition. Her wing commander sent her to the immunology clinic at Walter Reed Army Medical Center, where researchers did tests that revealed some indications of an immune system disorder.

“The last few months I have felt some improvement in my condition,” she said. “The dizziness has become less frequent. … There is no way that I know of to prove that the anthrax vaccine caused any of this. All I can tell you is that I became uncharacteristically ill after I started taking the anthrax shots. It has taken 12 doctors and eight months for me to finally find any reason for my symptoms.”

Dover Calls a Halt

In May, Col. Felix M. Grieder, commander of the 436th Airlift Wing at Dover, suspended anthrax vaccinations for a week for those under his command until he could obtain more information about the vaccine’s safety. He is not the only field commander who ordered such a pause. In July, the commander of the Air National Guard’s 122nd Fighter Wing, Fort Wayne IAP, Ind., suspended shots for his 950-member unit, in part to allow more time for vaccine education efforts. Vaccinations will resume this fall or winter, said Guard officials.

The rebellion has reached the point where some House Republicans want the vaccinations stopped altogether. A number of GOP members are backing legislation that would either make the vaccinations voluntary or suspend the program until the National Institutes of Health conducts a safety study.

The idea of going to a voluntary anthrax immunization program does not sit well with senior Pentagon leaders. In a joint statement this summer on this subject, Cohen and Shelton had this to say: “Our commanders must know that all, not simply some fraction, of their forces are protected from this biological threat. Soldiers, sailors, airmen, and Marines fight in teams, and they need to know that all team members are protected from anthrax. … Allowing a voluntary vaccination program is inadequate in the face of this deadly threat.”

Still, Rep. Dan Burton (R­Ind.) decried a situation “when five Marines are court-martialed because they are concerned they may not be fit for duty if they take a vaccine, and when 30 percent of the pilots in a Reserve unit resign rather than take this vaccine.” These kinds of events, said Burton, constitute “clear signals that something is wrong.”

For the critics, one major and specific concern is that the anthrax vaccine is in fact untested. Studies of its effects, they say, all carry the label “short-term.”

Small Sample

Though the Food and Drug Administration has approved use among veterinarians, laboratory workers, and livestock handlers for 30 years, very few such workers have actually taken it, charged Mark S. Zaid, a lawyer who has represented military personnel who refuse the vaccine. He said that only about 20,000 to 30,000 people received anthrax shots in the last half-century, prior to the Pentagon’s first widespread use.

“The Defense Department’s inoculation of 150,000 servicemen during the Gulf War … was the first major use of the vaccine in any significant quantity,” he said.

Others question whether the vaccine would be effective against inhaled anthrax germs-the most likely method of ingestion. They point out that the only US producer of the vaccine has had FDA-documented quality control problems in the past. And Zaid, among others, claims that the Pentagon’s own studies show a systemic reaction rate to the vaccine that is two to seven times higher than the manufacturer’s predictions.

Even a systemic reaction rate of 1 percent or so will incapacitate from 17,000 to 32,000 service members, said Zaid, considering the large numbers of service personnel receiving the vaccine.

The Pentagon strongly defends its decision to opt for servicewide anthrax protection. The effort is not primarily a medical program, officials say.

“It is a line commanders’ program to keep our deployed military personnel safe and prevent combat casualties,” said Dr. Sue Bailey, assistant secretary of defense for health affairs.

The anthrax vaccine was first licensed by the FDA in 1970. “There have been no long-term side effects reported,” according to Bailey.

Furthermore, the vaccine is indeed effective against inhaled anthrax, DoD says. Or at least, the prevention of inhalation anthrax “is not inconsistent with the current product label,” said Bailey, reading from an FDA memo.

According to the Pentagon’s top doctor, it is not possible to directly determine the efficacy of the vaccine in humans against aerosol exposure to anthrax spores. Conducting such a study would be highly unethical.

Numerous studies using animals have indeed been carried out, the Pentagon said. Military researchers have relied in particular on rhesus monkeys for these studies.

“These animal studies showed that the FDA-approved anthrax vaccine provided greater than 95 percent protection against high-dose aerosol challenge with anthrax in the monkey model,” said Bailey.

A February 1998 FDA investigation of state-run Michigan Biologics Product Institute found “significant deviations” from FDA regulations, according to FDA officials. As a result of this probe, BioPort Corp., which bought MBPI in September 1998 and is now the DoD contractor for anthrax vaccine, is holding 11 lots of the vaccine in quarantine storage.

Kathryn C. Zoon, director of the FDA Center for Biologics Evaluation and Research, told Congress, “These lots are still in quarantine and will remain in quarantine until the company submits required information to [the FDA].”

DoD officials say they will continue to be vigilant as they look for unexpected reactions to the vaccine. They insist that they are committed to fully investigating all questions about the shots’ value.

Said the Pentagon’s Claypool: “We know anthrax kills and immunization protects. … Immunizing men and women we place in harm’s way to prevent death or a serious injury is our moral and ethical duty. … It would be unconscionable for us not to do so.”

Is It Mythology

These examples were drawn from a statement published on the Defense Department’s official anthrax vaccination Web site (www.anthrax.osd.mil).

Myth: There is no defense against anthrax.

Fact: Vaccination is the best defense against biological warfare involving anthrax. Nuclear, biological, and chemical gear and protective masks should also be used.

Myth: Antibiotics are just as effective against anthrax as the vaccine.

Fact: Antibiotics can be effective in cases of cutaneous anthrax [caused by contact with infected animals or contaminated animal products], … [but] antibiotics have not been proven effective against the more deadly forms of anthrax: inhaled and ingested.

Myth: The anthrax vaccine can cause me to catch anthrax. It works by actually injecting live cells into my body to build immunity.

Fact: The anthrax vaccine does not use live bacteria. It is a sterile product made from a strain of anthrax that does not cause disease.

Myth: Service members will have ample warning of an anthrax attack due to effective detection devices.

Fact: Until reliable detectors are available in sufficient numbers, usually the first indication of a biological attack in unprotected soldiers will be ill soldiers.

Myth: Anthrax must be hand-delivered; it cannot survive any other means of deployment.

Fact: Anthrax bacteria can be deployed by missiles and artillery shells.

Myth: The anthrax vaccine is experimental and under investigation.

Fact: The anthrax vaccine is not experimental or investigational. It has been used safely to protect at-risk industrial and laboratory workers for almost 30 years.

Myth: The reliability of the anthrax vaccine is based on only one human efficacy group-wool mill workers.

Fact: Clinical studies with approximately 1,200 wool mill workers have demonstrated protection against cutaneous anthrax. Since conducting lethal challenge studies in humans is considered unethical, determining the actual efficacy of the vaccine is not possible. However, there have been numerous tests of the anthrax vaccine involving animal models (i.e., rhesus monkey model) upon which the FDA determined its safety and efficacy.

Myth: The anthrax vaccine may cause sterility.

Fact: The vaccination has been routinely used for the past 28 years and has not been associated with sterility.

Myth: Anthrax kills only farm animals.

Fact: Anthrax kills both animals and humans.

Peter Grier, the Washington editor of the Christian Science Monitor, is a longtime defense correspondent and regular contributor to Air Force Magazine. His most recent article, “The China Problem,” appeared in the August 1999 issue.