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THE ANTHRAX VACCINE: READ THIS BEFORE YOU TAKE IT. by Kevin Hoffman |
The fourth death from Anthrax ÷ and the first infections of people not affiliated with the media, government or postal service ÷ has ratcheted up the fear factor for an already jittery public. Wouldnāt it be great if there were an anthrax vaccine? Turns out there is. The military has known about it for years and has inoculated some half-million troops. Now thereās talk of vaccinating police officers, firefighters, postal employees and others on the front line. But before you or someone you love takes the anthrax vaccine, you may want to listen to some of those who already have. Tom Colosimo, 29, lives in Pittsfield, Pennsylvania, about 100 miles east of Erie. A nine-year veteran of the Air Force, he received four anthrax inoculations between February 1998 and September 1999. Before the shots, he was strong enough to work as a bouncer and handsome enough to pursue a modeling career. Now, his face and head have been scarred by numerous falls, and heās so disabled that his wife, Tracy, must take care of him full-time. Colosimoās problems began soon after his first shot, when he felt a burning sensation in his arm. Within a few days, he started experiencing fatigue, dizziness and headaches. He submitted to a second shot and cysts swelled on his scalp and face. A doctor told him the cysts might be caused by sweat because Colosimo was working out so much. Colosimo was inclined to agree. "Maybe it is just a coincidence," he wrote in an e-mail. He reported he was in relatively good health on a form he filled out shortly before being deployed to Kuwait on December 7, 1999, several months after taking a fourth shot. Soon after arriving overseas, however, he began to suffer from a cough, chest pains and nausea. In eight weeks, he shed 40 pounds from his well-muscled physique. He began to suffer frequent dizziness and fainting spells, which he described in an e-mail to his sister, Anne Rodgers, now a Cleveland middle-school teacher: "Itās like my whole world tunnels down to a narrow slit. It happens every day." "Something is wrong with me and I am scared." It seemed obvious that something was seriously wrong with Colosimo, but not everyone believed he was sick. He developed a reputation as a malingerer ÷ one who fakes sickness to avoid work ÷ a slur apparently so widespread that it was known to a sheriffās sergeant who responded to an April 6 emergency call. According to Colosimo, the sergeant asked Tracy if this was the same guy emergency personnel had responded to a few days earlier at the base. When she said yes, he grabbed Colosimo by the nipples and twisted them, causing extreme pain. The sergeant said he was sick of playing games, Colosimo says, and accused him of faking his illness. (The sheriff later investigated the incident and said that pinching someoneās nipples is a rarely used but legitimate technique to assess a patientās level of consciousness, but calling a patient a "faker" is "not acceptable.") Since then, Colosimoās condition has declined precipitously. He has suffered numerous "drop attacks" during which he has badly cut his head and face. They got so bad that his mother padded all the sharp corners in her house and bought him a sparring helmet to protect his head. He also developed chemical sensitivities, a condition shared by 13 percent of Gulf War veterans, according to one study. After cleaning the oven last July, he became delirious and wandered off, turning up eight hours later awash in blood, vomit and urine, remembering nothing save waking up in a mini-mall parking lot. In September of last year, Colosimoās mother picked up her phone and heard a voice so slow and slurred that she thought it was a prank call. It took several moments to realize it was her son, stammering "Something is wrong with me and I am scared." Just what is wrong with Colosimo remains a subject of dispute. He and his family have become convinced that his illness stems from the anthrax vaccine, but those in the military have been less inclined to speak with one voice. Colosimoās medical records from the Walter Reed Army Medical Center in Washington, D.C., where he was hospitalized for treatment of his mysterious ailments, list "anthrax intoxification" as his admission diagnosis. Marine Major General Randall West, special advisor to defense secretary Donald Rumsfeld for anthrax and biological defense, said in testimony before a House subcommittee that "of all the people that were here today, there was only one person that has a medical diagnosis that directly links it to the anthrax vaccine · unfortunately, the doctors do believe that · Colosimoās problems were caused by the anthrax vaccine." But just days later, Colosimo received an e-mail from one of his former military doctors, saying, "I · wanted to clarify, since another inquiry was made to us, that we never told you that you had Īanthrax intoxification.ā" Regardless, Colosimo is not alone in his struggle to have his illness recognized as being caused by the anthrax vaccine. His activism has made him something of a living martyr for others who claim they, too, have been sickened. Kathy Hubbell, a 52-year-old Montana mother who works in public relations, first heard about the anthrax vaccine in the summer of 2000. Her son, a staff sergeant in the Air Force who has asked that his name not be used, was about to receive his first, mandatory shot of the vaccine. His wife sent Hubbell a frantic e-mail telling her the news. Hubbellās initial reaction: "What do they think he is, a cow?" Her flippancy can be forgiven because, at the time, anthrax was known primarily as a disease that afflicted livestock. America hadnāt seen a human case of inhaled anthrax ÷ the deadliest form of the disease ÷ since 1978, and had documented only 18 such cases in all of the 20th century. A vaccine to protect humans against infection had existed for more than 30 years, but for most of that time it was used almost exclusively by woolworkers and veterinarians. That changed when the Department of Defense started vaccinating soldiers against the threat of anthrax being used as a weapon of biological warfare during the Gulf War. On Dec. 15, 1997, the department began a program to vaccinate all 2.4 million active and reserve members of the military. Dr. Meryl Nass suspects the anthrax vaccine might play a role in Gulf War Syndrome. After arriving at the Air Force base, Hubbell began to hear stories that sounded "like something out of a very dark science fiction novel." The "kids" ÷ her name for the fresh-faced military personnel like her son ÷ told her that the anthrax vaccine was making everyone sick, that they were being used as guinea pigs in a military experiment. "They wouldnāt do this to our troops," she remembers thinking at the time. That night, she went online and began researching the vaccine. For the first hour or so, her search was confined to Department of Defense sites, and the information they contained, watered down as it was, reassured her. But before long, she strayed from the official sites and began to get the first inkling that something was very wrong. She stumbled across majorbates.com, a site run by Sonnie Bates, a major who had been court-martialed by the Air Force after refusing to submit to the vaccine. In a letter to his brigadier general posted on the website, Bates ticks off a list of 15 members of his squadron, the 9th Airlift Squadron at the Dover, Delaware, Air Force Base, who became sick after taking the vaccine. There was Bill, who had developed cysts all over his body, including on his heart. Mike, who suffered eight seizures and crippling bone and joint pain. Cindy, who experienced episodes of vertigo and had obtained a waiver to stop receiving the vaccine until her health improved. Worst of all was Michael: paralyzed and hooked up to a ventilator, he could only communicate with his eyes. "Oh my God," Hubbell recalls thinking after reading the site. "This is what theyāre doing to my son." Hubbellās son only took three out of the regimen of six anthrax vaccine shots before the vaccine program stalled due to dwindling supply. Today, he suffers from mysterious bumps and blisters that his family attributes to the vaccine. He is one of the lucky ones. Dr. Meryl Nass, a nationally renowned anthrax expert, was one of the first to sound alarms about the militaryās mass inoculation program. She had researched anthrax in 1989, so when people began to suggest that the anthrax vaccine might play a role in Gulf War Syndrome, she decided to check it out. She found that a number of studies had looked at a variety of potential causes, but none looked at the anthrax vaccine. "Thatās very curious," she remembers thinking. In a few hours, Nass wrote the short piece that would eventually vault her to prominence among those who feel that the anthrax vaccine makes people sick. When the military began its program to inoculate all 2.4 million troops, Nass was deluged with calls asking her advice. "Lots of people starting asking me, ĪShould I take it?ā" Nass says. "And I said I donāt have any evidence that itās dangerous and Iām not going to advise you not to take it. The point Iām trying to make is that we donāt know one way or the other and it would be very valuable to gather some data before you do a mass inoculation program." Of course, the Department of Defense went ahead with the program anyway. Nass says she has heard from thousands of people given the vaccine who claim that it made them sick. The official figures used by the Department of Defense list only 836 adverse reactions deemed to "certainly or probably" have been caused by the anthrax vaccine. Of those, 88 reactions are classified as being so severe that the soldier had to be removed from duty for a full day or more. A scant 10 more required hospitalization. To hear the defense department tell it, the anthrax vaccine is perfectly safe. The military has taken a blame-the-victim approach: Troops who said the vaccine made them ill, like Colosimo, found themselves labeled as malingerers. Fifty-one people who refused to take the inoculations were court-martialed. The website for BioPort, the Lansing, Michigan, corporation that is the worldās sole licensed manufacturer of the anthrax vaccine, tells a similar story about the vaccineās safety. The site repeatedly assures visitors that the vaccine is "safe and effective." The companyās anger at those who would suggest otherwise is readily apparent. In a section titled "Myths and Facts," BioPort launches into a lengthy defense at the hypothetical suggestion that the vaccine is "experimental and under investigation." "I was too sick to fly. I was too sick to get another shot. But my illness wasnāt reportable," says Captain Michelle Piel. Despite BioPortās braggadocio about licensing, the safety record of its manufacturing plant could be described as spotty at best. Prior to 1993, the FDA didnāt even try to inspect the facility, because the inspectors had not been vaccinated against anthrax. When the FDA did get around to inspecting the plant, then owned by the Michigan Department of Public Health, it found a clutch of problems that compromised the sterility of the manufacturing process. The problems persisted, and in March 1997, the FDA sent a letter threatening to revoke the facilityās license. BioPort bought the plant and renovated it, but it, too, failed FDA safety inspections. It remains closed today, which accounts for the drought of vaccine during this critical time. Then there is the question of whether the vaccine is even effective. A study of an earlier anthrax vaccine, manufactured by Merck Pharmaceutical Corp., found that it protected humans against anthrax absorbed through the skin, but could not determine its efficacy against inhaled anthrax, which is what killed the tabloid photographer in Florida, the two postal employees in Washington and the hospital worker in New York. To date, and for obvious reasons, no human studies have been done on the vaccineās efficacy against inhaled anthrax. In studies that have been done on animals, results vary for different species and cannot be extrapolated for humans. The defense department says it is planning further research in this area. One might argue that some protection is better than none at all, but that contention fails to account for the health problems some claim are caused by the vaccine. Several studies have linked the anthrax vaccine to Gulf War Syndrome. One study of Kansas Gulf War veterans found that 34 percent of those who were vaccinated and deployed met the definition for Gulf War Syndrome, compared to 4 percent of Gulf War-era veterans who were not deployed and did not receive the vaccination. Interestingly, 12 percent of Gulf War-era veterans who received the vaccination but were not deployed also met the definition for Gulf War Syndrome, which suggests that vaccines used during the war "may be a contributing factor." What about those official figures that say the incidence of adverse reactions to the vaccine are very low? To date, more than a half-million troops have been inoculated with the vaccine, and a mere 10 have reported reactions severe enough to require hospitalization. Surely, if this vaccine were as bad as opponents say, more people would be reporting serious side effects. Not necessarily, critics say. The system used to collect the data, the FDAās Vaccine Adverse Event Reporting System (VAERS) relies on voluntary reporting of bad reactions, meaning thereās no way to know whether one in 10 or one in 100 of the people who suffer adverse events actually go out of their way to report them. Furthermore, the defense department seems to have sent a clear signal to troops that it doesnāt want to hear anything that might contradict its conclusions. Take, for example, the case of Captain Michelle Piel, one of the 15 members of Sonnie Batesā squadron who claim to have been sickened by the vaccine. In written testimony to the House Government Reform and Oversight Committeeās Subcommittee on National Security, Veterans Affairs and International Relations, Piel recounts that her arm went numb for 20 minutes after she received her first anthrax vaccine shot in October 1998. Weeks later, while she was flying a plane home from Honduras, the right side of her head filled with fluid. "It was as if a faucet were turned on inside my head," she says. After landing in North Carolina, a flight surgeon grounded her on sight for a head cold and a middle ear infection. In November, she received her second dose of the six-shot vaccine regimen, and again suffered soreness in her arm. Over the course of the rest of that day and the next, she felt excessive fatigue. She was referred to a doctor, who diagnosed her with an inflammation of the inner ear. Her shot regimen was discontinued. Pielās symptoms worsened in December and she says she became so dizzy that she couldnāt drive, read or concentrate. She was fatigued and nauseated, had to be taken care of by her husband and her mother, and couldnāt work. Months later, her condition improved, but she says "the fatigue is like living at midnight and remains a major factor in how I live." In May 1999, Piel became aware of VAERS. She knew she could file a report herself, she says, but thought that she and her doctor should file one together. She says her request was met with reluctance, however, and that the chief flight surgeon said her particular reaction didnāt fall within the criteria of reportable events, which he defined as difficulty breathing, rashes, sweating, fever, nodules and anaphylactic shock. "It didnāt make sense to me," she recounts. "I was too sick to fly. I was too sick to get another shot. But my illness wasnāt reportable on a VAERS form?" Itās no wonder that the House subcommittee that the VAERS numbers are not an accurate reflection of reactions troops are suffering. The subcommitteeās report, titled "Unproven Force Protection," states, "Preposterously low adverse report rates generated by [the Department of Defense] point to a program far more concerned with public relations than effective force protection or the practice of medicine." Since the tragedy of September 11, Kathy Hubbellās anti-vaccine website ÷ anthraxvaccine.net ÷ has seen a spike in traffic. "I think until now, people didnāt feel connected to the military," Hubbell says. "Itās really sad, but it had to come home to people. And I would have wished for any other way but this one to have brought it home." But many of the new visitors seem to have the wrong impression about the purpose of her website. Theyāve been asking where they can get the vaccine, to vaccinate themselves and their families. BioPort, too, has been receiving civilian requests for vaccines, so much so that it now routes callers to an automatic message that says, "All the stockpile that currently exists is owned by the Department of Defense. At this time there is no opportunity for any commercial sales." The company has promised to be back online soon to replenish the militaryās depleted vaccine supply. Barring a policy change, it probably wonāt be long after that that the mandatory vaccination program will kick back into high gear. To those civilians clamoring for the vaccine, Hubbell says, "Even if you could get it, you donāt want it." In response to the first post-September 11 request for the vaccine, Hubbell says she wrote: "The bottom line is, our troops are not protected and our civilians are not protected and we just have to pray for a saner world."
The spells became much worse in March 2000 after he returned to the Air Force base in Utah, where he was stationed. He would go into trances, during which he seemed to stare right through Tracy. At work one afternoon, while pouring water in the breakroom, he collapsed, and a co-worker had to call 911 to revive him. He passed out twice more during the first week of April and stopped breathing several times in the following weeks.
Hubbellās son was one of them. She had already planned to visit and say goodbye to him because he was due to ship out to Saudi Arabia. The visit would also give her a chance to check into the anthrax shot.
"The anthrax vaccine is not experimental or investigational," says the website. "It is a licensed product. It was licensed by the Food and Drug Administration in 1970 and re-certified in 1986. It has been used to protect at-risk industrial and laboratory workers for almost 30 years."