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_http://www.baltimoreexaminer.com/local/112008anthraxpart2.html_

(http://www.baltimoreexaminer.com/local/112008anthraxpart2.html)

Sickening results

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.

Eddie Norman (center)

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

really

destroyed me.â€

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 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 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 Wolfowitz that the anthrax vaccination program

was “a political problem for us.â€

Four months later, Sen. Tom Daschle, D-S.D., wrote to Secretary of Defense

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.â€

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 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.â€

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.â€

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.â€

He was flown to the Walter 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.â€

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.â€

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?â€

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.â€

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.â€

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.â€

Passive surveillance

Was the Pentagon aware of the serious health risks that came with the

anthrax vaccine?

“No question,†says D.A. , former dean of the s Hopkins School

of Public Health and former chief of public health emergency preparedness. “

There were a series of reports of very severe problems.â€

“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 , 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.â€

Serious reactions to any type of vaccination are supposed to be monitored

through the Vaccine Adverse Events Reporting System, a “passive

surveillanceâ€

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.’ â€

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.â€

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 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 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.â€

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.â€

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