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Sickening results

http://www.baltimoreexaminer.com/local/112008anthraxpart2.html#comments
By Deborah Rudacille
Examiner Correspondent 11/20/08

Editor’s note: This is the second of two parts.
Eddie Norman is only 43 years old, but he gets confused when he tries to remember important dates. The Fort Meade veteran walks with an old man’s shuffle and has twice experienced kidney failure. To combat this misery, he takes 13 pills a day.

“What anthrax has done to me, I can’t put a number on,” he says. “It really destroyed me.”

Norman is not a victim of the anthrax letter attacks of 2001. He is a casualty of the Army’s Anthrax Vaccine Immunization Program, instituted in 1998 to protect American troops from the threat of biological warfare. About 2.1 million troops have received the vaccine.

The number of troops who have died, been disabled or suffered chronic health problems after receiving the vaccine easily eclipses the five dead and 17 sickened by the bio-terror attack that began just a week after the Sept. 11 attacks.

Between 1998 and 2000, the first two years of the mandatory vaccination program, approximately 20,765 troops were hospitalized, according to vaccination data that the Pentagon long withheld from lawmakers. The illnesses ranged from systemic reactions such as numbness, joint pain and extreme fatigue to autoimmune diseases such as lupus, musculo-skeletal disorders and other chronic conditions.

It is impossible to say with certainty how many have fallen ill after getting the shots because no one is keeping exact count.

The Food and Drug Administration, however, has confirmed 21 deaths following anthrax vaccination, including Richard Dunn, an employee of the anthrax manufacturer — 16 more than the number of people killed in the letter attacks.

The FDA does not say the troops died because of the vaccine, only that they died after taking the shots.

A troubled program

In the summer of 2001, the Department of Defense’s Anthrax Vaccine Immunization Program was on life support, with veterans, members of Congress and even high-level staff in the newly installed Bush administration all itching to pull the plug.

Active duty military personnel risked court-martial and reservists resigned en masse rather than take the vaccine. According to a 2002 General Accounting Office study that interviewed about 1,200 troops, the reserves were bleeding air crews, as more than half of the 301st Air Squadron at Travis Air Force Base in California had quit or planned to resign rather than take the shots. An Air Guard unit in Connecticut lost a third of its pilots.

Two-thirds of the Guard and Reserve pilots in that study told the GAO they did not support the vaccination program, and as many as 85 percent of those who received the shots said they had experienced side effects. Most admitted they had not reported their symptoms to medical personnel or supervisors for fear of being grounded.

The Pentagon told the GAO that “several hundred” active duty personnel also had refused the vaccine.

In April 2001, White House Deputy Chief of Staff Karl Rove sent a memo to Deputy Secretary of Defense Paul Wolfowitz that the anthrax vaccination program was “a political problem for us.”

Four months later, Sen. Tom Daschle, D-S.D., wrote to Secretary of Defense Donald Rumsfeld challenging the program. A House of Representatives committee report already had recommended suspending the program because of its “experimental” status.

In the midst of the turmoil, the FDA shut down the vaccine’s manufacturer, BioPort Corp. of Lansing, Mich., after citing the company with 84 violations in the manufacturing process. The touted Pentagon program was on the ropes.

But by the fall of 2001, the anthrax attacks breathed new life into BioPort, as the vaccine was in demand not only by the military, but also by consumers, who suddenly were willing to roll up their sleeves. Eight years later, BioPort — now Rockville-based Emergent BioSolutions Inc. — has netted nearly $1 billion in government contracts to produce a vaccine that some biosafety experts call “antiquated.”

Emergent Biosolutions spokeswoman Tracey Schmitt rebutted the allegations made by sick veterans who took the vaccine.

“Biothrax, which is the only FDA-approved vaccine to prevent the infection of anthrax, has been studied more than just about any vaccine in the United States and has been deemed safe and effective,” said Schmitt, who noted that the Institute of Medicine of the National Academies found the vaccine safe and effective in its 2002 report.

Last month, Secretary of Health and Human Services Michael Leavitt declared a seven-year “anthrax emergency,” contracting for another 14.5 million doses of the controversial vaccine for the civilian stockpile at a cost of about $404 million. Leavitt also extended blanket immunity from legal liability for anthrax vaccine-related injuries and deaths to Emergent as well as to government officials and agencies recommending use of its vaccine.

“In the summer of 2001 we were on the verge of getting the entire program canceled,” says an Air Guard pilot whose commander forbids him from speaking publicly about the vaccine. “After the anthrax letter attacks, everyone looked the other way.”

Shot down

In 1988, Norman joined the Army and served in Operations Desert Shield and Desert Storm. He received numerous vaccinations while deployed overseas. Shortly after returning home, he got so sick that he had to be treated at the Gulf War clinic in El Paso, Texas.

Nonetheless, he advanced from private first class to staff sergeant over the next decade. “I have a folder this thick, full of awards,” he says proudly. “That’s the kind of person I was.”

After the implementation of AVIP in 1998, he underwent his second round of anthrax vaccinations and immediately experienced muscle pain and stiffness and ringing in his ears, which grew progressively worse with each shot.

After the fourth shot, Norman says, he started suffering from tremors and involuntary muscle jerks. Following the fifth shot, “I couldn’t get myself out of the bathtub. I couldn’t get in and out of a car.”

He was flown to the Walter Reed Vaccine Health Center and discharged from the Army three years later without ever returning to work. His request for a disability retirement was recently denied. “When I went into the military my goal was to retire from the military,” he says. “Anthrax stopped me. I want that on my record.”

Capt. Kelli Donley’s military career also crash landed after she received the vaccine. Donley, of Beloit, Kan., joined the Air Force in October 1998 and received the first of three anthrax shots before being deployed to South Korea in 2000. Because the vaccine supply was low in the States, due to BioPort’s difficulties with the FDA, she received the other shots overseas from stockpiled supplies.

Like many troops, Donley, a former military lawyer, had a localized reaction to the shots. “My entire right arm went numb,” she says.

“They told me that was normal and that it would go away, and it did. But soon afterward, I started getting clumsy.”

A few months after her last shot, she was gripped by an attack of vertigo and began slurring words. She sought help from a military doctor, but a thyroid test produced normal results, and no further tests were ordered.

It was only after she returned to the States in 2003 that another military doctor ordered an MRI. “It confirmed that I wasn’t making it up.

My cerebellum [that part of the brain that’s critical to coordination and motor control] had shrunk,” Donley says. A civilian neurologist diagnosed her disease as sporadic spinocerebellar ataxia, which occurs when various parts of the nervous system that control movement are damaged.

Donley won a 100 percent disability retirement in 2006, after showing up with 238 pages of evidence. “My records were tight,” she says. “How many can say that?”

Woodbridge, Va., resident Steve Fisher received shots before being deployed to the Persian Gulf in 1999. The former aircraft mechanic spent 26 years in the military and was stationed at McConnell Air Force Base in Wichita, Kan., when he was vaccinated.

“After the first [shot], I got a big lump on my arm,” Fisher said. “After the second one, it swelled again, and I started having flu symptoms. After the third one, my arm swelled up like a peach, and I started having muscular problems, ringing in my ears, vertigo. I’d be walking, and I’d just fall over.”

A base physician diagnosed chronic fatigue syndrome and fibromyalgia and sent him to be tested for allergenicity to the vaccine, he says. Without his consent, the technician, who was administering the test, gave him a fourth shot.

“Then I got really sick,” he says. “I got lesions, lost my hair, couldn’t shake hands, couldn’t walk. For a while, I was worried that I would never walk again.”

Nearly a decade after receiving his last dose of anthrax vaccine, Fisher still suffers from chronic fatigue syndrome, fibromyalgia, an eroded esophagus, asthma, tinnitus and other chronic conditions associated with the vaccine.

“I wish I was an isolated case,” he says, “but I’m not.” Of the 150 men in his unit who got the shots, he says, “seven of us were completely disabled.”

Passive surveillance

Was the Pentagon aware of the serious health risks that came with the anthrax vaccine?

“No question,” says D.A. Henderson, former dean of the Johns Hopkins School of Public Health and former chief of public health emergency preparedness. “There were a series of reports of very severe problems.”

“We used to say that if we gave 10,000 people a glass of water, some number would get a rash and a headache,” says Henderson, who headed the World Health Organization’s campaign to eradicate smallpox through a mass vaccination in the 1970s. “The problem is, how do you sort this out and figure out what is attributable to the vaccine.”

Serious reactions to any type of vaccination are supposed to be monitored through the Vaccine Adverse Events Reporting System, a “passive surveillance” system set up in 1990 to alert the Centers for Disease Control and Prevention and the FDA to potential health problems. Slightly fewer than 6,000 reports of adverse events following anthrax vaccination had been filed through July 2008, according to the FDA.

However, servicemen and women treated in military clinics say clinic staff failed to file VAERS reports. Fisher filled out his own report and faxed it to the FDA, only to be reprimanded by a clerk at the clinic where he was being treated. “She said, ‘You shouldn’t have filled out that form. We’re supposed to do that.’ ”

The same woman later admitted that she had not been sending in the forms. Fisher says she told him directly, “I was directed not to.”

For years, the Pentagon limited the recording of vaccine events to reactions leading to either hospitalization or loss of 48 hours or more of duty time. The Pentagon also rejected a GAO recommendation in 2002 that it institute an active surveillance program to identify and monitor adverse events associated with the vaccine.

Physicians at the Walter Reed Vaccine Health Center preparing letters for sick soldiers filing for disability will say only that their symptoms are “temporally related” to anthrax vaccination. Fisher, Donley and Norman all have copies.

Scientists are fond of pointing out that correlation does not prove causality, and no study has yet proven a causal relationship between the vaccine and the more than 40 side effects reported on the product’s label. That may be because none of the agencies tasked with monitoring the vaccine’s safety has conducted a large epidemiological study of vaccine recipients.

At this late date, even the mechanism by which the vaccine creates immunity is not well understood, says George Mason University professor Serguei Popov. “The vaccine is a very crude precipitate,” he says, “a kind of complex biological soup that contains some protective antigen,” together with proteins and “a certain amount of toxins.”

Popov says that he is suspicious of the vaccine not just because of the health problems reported by veterans, but because it requires so many shots to build and maintain immunity. “Six shots in a year,” he points out. “It’s ridiculous.”

Go to "Scientific impossibility: Did FBI get their man in Bruce Ivins?" for Part I of this series

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