Baltimore Examiner Sickening Results - disabled after the anthrax vaccine

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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.

" 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 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. "

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. "

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. "

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 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. , 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. "

" 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. "

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 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. "

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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Reader Comments:

POSTED Nov 20, 2008

Capt (Ret) Kelli Donley: " Thank you for bringing much-needed

attention to a huge problem. Just a correction, though - I only had 3

of the series of 6 shots - 1 (Lot FAV008) in the states and 2 (Lot

FAV048B) in Korea, then the supply ran out, so I didn't get any more.

However, of the 3 shots I received, the vaccination schedule was not

followed due to short supply. The Walter Vaccine HealthCare

Center filed a VAERs Report on me when I requested a medical records

review in May 2005 (5 years after my first symptoms). "