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Anthrax - Is it a shot in the dark?
John Ruddy, Soundings Staff
May 1999

"Wanna see an admiral faint?" Vice Adm. Hank Giffin said just as the hospital corpsman was about to stick a needle in his arm. A boyish grin fixed on his face, the giantesque, hearty, middle-aged flag officer sat calmly as he addressed a small cadre of public affairs officers, photographers, reporters and various attendees. Normally admirals, or anybody for that matter, aren't dogged by such an entourage for a mere shot in the arm.

But this was different. Everybody in the military gets this shot, and Giffin, who commands Naval Surface Force U.S. Atlantic Fleet, was no special case. It was his turn to get his anthrax vaccination. With cameras clicking and a bevy of onlookers shuffling around, Giffin kept a smile frozen on his face. Not an easy feat. Nobody really likes to get a shot. The idea of an invasive piece of metal piercing a vein to inject tiny organisms into the bloodstream seems the stuff of a hair-raising sci-fi yarn, or a good episode of "The X-Files." But Giffin felt OK about the shot.

"I've looked at it carefully," he said about the vaccine while waiting for the injection. "I've researched it personally. "I think it's unfortunate that there's a lot of misinformation going around. I'm absolutely confident that this is a safe shot and that it's the smart thing to do."

Anthrax - Is it a shot in the dark?
Many people in the military agree with Giffin, but a growing number of people inside and outside of the military are beginning to wonder if it is the smart thing to do. Since Secretary of Defense William Cohen's announcement Dec. 15, 1997 that all 2.4 million U.S. forces would be inoculated against the deadly anthrax bacterium, descent among the ranks has risen. According to the Department of Defense, the program, known as the Anthrax Vaccine Immunization Program (AVIP), is a prudent way to protect US forces from a biological weapons attack of anthrax.

As of May 12, 283,369 men and women in the armed forces have gotten 864,515 shots. The number of those reporting ill side effects is small, perhaps less than 100; the number or service people refusing the shot is also small, maybe around 200, depending on who you talk to. But grass-roots resistance to the vaccination program, reports of side effects and illnesses, a study from the Government Accounting Office that raises the specter of a possible link between the anthrax vaccine and the mysterious menu of maladies known as Gulf War Syndrome and two recent congressional hearings have caused many to rethink the wisdom of the anthrax vaccination program.

Lori Greenleaf questions the wisdom of the program. Her son, Erik Julius, was one of the first servicemen to take the shot in early 1998 as the program was getting under way. Then he took another. Then he got sick. Shortly after that, Greenleaf became the springboard for a small, but growing, grass-roots opposition to AVIP. "I'm very concerned for my son's long-term health," Greenleaf said on the phone from her home in Colorado. "He still suffers from tightness in the chest, he has chronic stomach aches. He's able to attend school and work, he's not bed-ridden, but we don't know what the future will bring. "It's very difficult."

Reports of others becoming ill from the shot are starting to surface. And a small but increasing number of service people are starting to refuse the shot under penalty of a less-than-honorable discharge or even court-martial. Joining these refusers and Greenleaf are a number of military members, their families and spouses, civilian physicians and lawyers, and politicians who are also questioning the shot. Still, the majority of military members are following orders and getting their anthrax shots. And many feel confident that it's the right thing to do.

"It's like a flak jacket or helmet," said Capt. Konrad Hyashi, force medical officer for SURFLANT. "I think as people get more information, they'll be more comfortable with it." At Tulane University School of Medicine in New Orleans, Hyashi, like any other students of tropical medicine, became very familiar with the anthrax bacterium, known in more scientific circles as Bacillus anthracis. As a naval officer serving in Haiti in 1994 during Operation Uphold Democracy, Hyashi came a little closer to the B. anthracis bug than he probably wanted. "Anthrax is a real issue down there," Hyashi said. Three years before the current vaccination program, the SURFLANT doctor underwent the now-familiar anthrax shot regimen of six injections: The first three shots are given two weeks apart, three more follow at the six-, 12- and 18-month mark, and the whole series is followed by a yearly booster. "It's a disease that's been around for thousands of years."

Long-term germ
Indeed anthrax has been with us a very long time. The most infamous outbreak, one of the plagues visited upon the Pharaohs of ancient Egypt, was recorded in the Old Testament in Exodus 9: "Behold, the hand of the Lord is upon thy cattle which is in the field." B. anthracis is a bacterium that causes the disease anthrax, which primarily afflicts animals, especially grazing livestock such as sheep and cattle. The most common anthrax infection occurs when the bacteria enter a cut or wound, causing lumpy, black ulcers. The deadliest aspect of the bacterium is that it can "hibernate" in the soil for years in spore form. And it's precisely the longevity that makes anthrax especially dangerous and virulent.

"It's really the spores that are the major problem with the spread of anthrax," said Dr. Timothy Boss, lecturer and associate professor of microbiology at Eastern Virginia Medical School in Norfolk. "Spores can survive for decades in the soil so once an area is contaminated with anthrax spores, it becomes basically uninhabitable." When Hyashi and others went into Haiti 1994 as part of a civil assistance team the Navy provided to help farmers, they were potentially exposed to anthrax spores that lay dormant in the Haitian topsoil for decades, perhaps even before World War II, when Japanese scientists were turning Chinese civilians and American POWs into human guinea pigs as part of their inhumane biological weapons experiments. "I'm grateful we've got a vaccine," Hyashi said.

Long-term germ 2
The vaccine Hyashi took has also been around for a few decades. It was developed in the 1950s and 60s and finally approved in 1970 by the FDA. Though the actual mechanics of how the vaccine works may belong to the realm of microbiologists and immunologists, the basic principle is accessible to the layman. When an anthrax spore enters the body, it releases a protein-based toxin composed of three parts: edema factor (EF), lethal factor (LF) and protective antigen (PA). In order for the toxin to invade the body's cells, either EF, LF or both have to form a complex with PA. This complex binds with and enter the cells, killing them. As Boss explained, the anthrax vaccine helps the body create protective antigen antibodies, thus rendering EF and LF harmless.

From the date of the approval of the vaccine known as Anthrax Vaccine Adsorbed, also referred to as MDPH after Michigan Department of Public Health, the laboratory now known as BioPort that developed it up until around 1990, anywhere from a few thousand to tens of thousands received the shots. The exact number isn't known, but the vaccine was administered during this time to those who would be at risk to coming into contact with the virulent spores. This list included anyone from veterinarians, workers who came into contact with animals or animal products, and military personnel involved in the development of B. anthracis itself.

It wasn't until the Gulf War, when the threat of biological attack with weaponized anthrax was deemed a real threat to coalition forces in the Persian Gulf, that the vaccine was administered en masse. Of the nearly 700,000 American forces in theater during the war, as many as 150,000 received vaccinations for anthrax, among other protective drugs. Again, the exact number of those who received the vaccine, how many vaccines were administered, and in combination with what other drugs, seems to be as mysterious as the illnesses that Gulf War vets now suffer from. Now, after a seven-year hiatus, the anthrax vaccine is once again being administered en masse. However, now the layman is beginning to question the science behind the vaccine.

Trials and tribulations
Dr. Meryl Nass isn't a layman. She's a physician with Parkview Hospital in Brunswick, Maine, and a member of Physicians for Social Responsibility, a nonprofit group that advocates a variety of issues such as environmental protection and arms control. For the past 10 years she has been studying anthrax and the FDA-approved vaccine. In her mind there is no question about the DoD's decision to administer the anthrax vaccine to all 2.4 million of it's uniformed personnel: AVIP is a bad idea. "There are no trials for efficacy or safety in the current licensed vaccine," Nass said during a phone interview from Parkview. "The important thing to note is that the Brachman trial used a different vaccine."

The Brachman trial was a study conducted in the 1950s for the military by Philip Brachman. During this study, wool mill workers in New England at risk for contracting anthrax were vaccinated against the disease. Of the 26 workers who were diagnosed with anthrax, four died. Some of the workers had received vaccinations, some a placebo, while others were only observed. Brachman compared the vaccinees with non-vaccinees and concluded that the vaccine had an efficacy level of 92.5 percent. Trials and tribulations 2. This is the only clinical trial of such a vaccine on humans infected with anthrax. As the Department of Defense readily points out, since the occurrence of anthrax in humans is so rare today there is less than one case per year in the U.S. on average it would be unethical to conduct tudies with humans. The rarity of human anthrax precludes further testing.

According to Virginia Stephanakis, a spokesperson for the Army Surgeon General, the office in charge of AVIP, the Brachman study is "not conclusive, but very suggestive." And many scientists concur with that. Others scientists, like Nass, also think the study is inconclusive. But they disagree on what the study suggests. The problem that opponents of AVIP have with the Brachman study is that the vaccine that was tested was not the one that was approved by the FDA in 1970. The FDA has by no means tried to conceal this discrepancy and contends that both vaccines, which "are similar, but not identical," are based on immunity to protective antigen. Still, Nass is not convinced that either vaccine can protect troops against the type of
anthrax that they would most likely face on the biological warfare battlefield inhalational anthrax.

Anthrax can attack the body in three ways: cutaneous, ingestional and inhalational. The first type is the most common and is the kind that causes black ulcers on the skin. It is treatable with antibiotics, though fatal in about 20 percent of cases if left untreated, according to the CDC. Ingestional, or gastrointestinal, anthrax, usually caused by eating meat from an infected animal, is rarer and has an untreated mortality rate of anywhere from 25 percent to 60 percent.

Inhalational anthrax is by far the most fatal of the three. It starts with a few days of flu-like symptoms including fever, fatigue and chest discomfort. The disease progresses until respiratory distress caused by bleeding in the lungs induces shock. In 95 percent of all cases, death occurs within 24 to 48 hours. As military experts know, troops would most likely face this type of anthrax threat, which would decimate even the most heavily armed and technologically advanced army. However, as Nass pointed out, the Brachman study primarily dealt with the most innocuous form of the disease: cutaneous anthrax. The workers in the wool mill were exposed to anthrax spores in the wool they were processing. Of the 21 cases of cutaneous anthrax, 15 had received the placebo, three were part of the observational group and three had received vaccinations. The remaining five cases were inhalational, of which four died.

No one in this group received vaccinations. To Nass, these numbers suggest that while the vaccine shows some efficacy against cutaneous anthrax, there is no evidence to suggest that it would be effective against inhalational anthrax. Despite the belief of Nass and others that the Brachman study is inconclusive, military officials reaffirm their belief that in the face of a potential biological warfare threat, the current vaccine, while not fail-safe, is the best available protection against one of the most nefarious types of warfare created by man.

"There is a documented, recognized, valid threat out there and we have an FDA-approved vaccine that's been proven safe and effective over several decades," said Jim Turner, a DoD spokesman. Stephanakis agreed: "I think it would be unethical not to protect people when we have the protection."

Congress catches the bug
Nass doesn't see it that way. Studies with guinea pigs, mice, rabbits and rhesus monkeys have yielded a variety of results and depending on who you talk to, the studies can either be seen as conclusive or inconclusive. One thing that's easy to conclude is that Nass is not persuaded by the DoD's argument for the vaccine and she made Rep. Christopher Shays, R-Conn., well aware of her position April 29 when she testified before a hearing by the Subcommittee on National Security, Veterans Affairs and International Relations, which Shays chairs. A few congressmen from the subcommittee have publicly called for AVIP to be made voluntary or to be temporarily
halted until further investigation.

In the second of four hearings, which have been called to look into AVIP and the vaccine itself, Nass not only expressed her concerns about the vaccine's efficacy based on the scientific literature she has researched, but her suspicions about its necessity and safety. "We have short-term studies that fly in the face of DoD assertions, we have no good long-term data, we have people getting sick and we have people getting sick immediately after they get vaccinated," Nass said in a phone interview with Soundings.

Congress catches the bug 2
Lori Greenleaf's son Erik was one of those who became ill after getting his shot. At the time, Erik was a sailor aboard the aircraft carrier USS Independence stationed in the Persian Gulf. On March 30 he called his mother to see if she could find out anything about the shot he was about to get. He'd heard some scuttlebutt around the ship and was a little apprehensive. Greenleaf started making phone calls and got on the Internet. At the GulfWar Veterans home page she found a 1994 Senate report by the Committee on Veterans' Affairs, chaired at the time by John D. Rockefeller, D-West Va., that raised her concerns. When she tried to get back with Erik, the couldn't get through by phone or e-mail as she usually could. It was too late, though. Erik had already taken his first shot.

When she finally got a hold of Erik, he told her of his plan to refuse the second shot. "And then they started threatening him with prison time, brig time, bad misconduct discharge," she said in a faint voice. "Oh, you name it, he got the threats. He eventually gave in and took the second shot. "After the second one, Erik began feeling terrible tightness in his chest, headaches. When he came home on leave, he had a rash all over his trunk and back." As time wore on, Erik's condition improved and things seemed to be looking up. But when he left the Navy as scheduled in October 1998, Greenleaf became concerned again. She noticed that his rash had left spots and white discoloration on his skin. And Erik still suffered from tightness in the chest and chronic stomach aches. But soon they would have cause for even greater concern.

Before Erik got his first shot, the Government Accounting Office, the congressional watchdog committee, made public a report that raised concerns among Shays' subcommittee members, Gulf War vets and current service members. The report raises serious questions about the mystery enshrouding GulfWar Syndrome and about its possible connection to the dilemma facing those now in line to get the anthrax shot. Whether the allegations the report brings forth are sound remains to be seen. One thing is certain, a new word has reluctantly entered the military vocabulary: squalene.

In part two of "Anthrax: A shot in the dark?" read about the GAO's report on squalene, an additive that is sometimes used in vaccines, and how it could possibly affect people, like Erik Julius, who've gotten the anthrax vaccine. Also in next week's issue find out more about: Lori Greenleaf's fight against AVIP, why people are refusing the anthrax shot, who's becoming ill and their congressional testimony, what the military is saying, how the Internet has played a role, the 1994 Rockefeller report, the Nuremberg Code, why some believe the number of refusers and those getting ill is greater than is being reported and why everybody in the military is reading Vanity Fair.