Posted on Mon, Jul. 25, 2005
http://www.kansascity.com/mld/kansascity/12214696.htm? (must register to view original article)

Anthrax vaccine under fire
Refusal rate concerns military; troops speak out

By DAVID GOLDSTEIN
The Star's Washington Correspondent

WASHINGTON Shonya McBride remembers very clearly the night she
rolled over in her sleep and her hand fell across her husband's
chest. She awoke with a start.

"His heart was just pounding out of his chest," she said. That was
in 1999, after Travis McBride, a 22-year-old Marine Corps sergeant,
had received the second of six mandatory inoculations of the anthrax
vaccine.

By the fourth shot, he had developed serious heart problems, chronic
fatigue and severe joint pain. McBride never made it to the fifth.
Within a year, he was medically discharged.

He had been ordered to take the shots, like probably hundreds of
military men and women who believe the vaccine boomeranged and made
them seriously ill.

"If I had had the option, I wouldn't have taken it," said McBride,
now 28 and an Atchison County sheriff's deputy.

For the past two months, however, incoming military personnel have
had the option of not taking the anthrax vaccine, as a result of a
federal lawsuit won last year by some military personnel who
objected.

For now, instead of being threatened with courts-martial and
dishonorable discharges, soldiers are told the shots are voluntary.

As a result, half of the military and civilian Defense personnel
asked since May to take the shots have declined, according to the
Pentagon.

The refusal rate worries the military, which many believe would like
to reinstate the mandatory rule for all active duty personnel and
reserves.

"That means that half of our (newest) troops could be harmed in an
enemy attack and possibly die," said Marianne Coats, a spokeswoman
for the Military Vaccine Agency. "This concerns us very much indeed."

Vaccine critics said the situation is an improvement.

Mark Zaid, an attorney involved in the lawsuit, said that much
progress has been made since the days of military courts-martial,
but added that it remains subjective whether the vaccine being
voluntary is a good thing.

What concerns Zaid and other critics is that the anthrax information
brochure that the military hands out contains none of the
information that comes packaged with the vaccine about risks and
medical reactions possibly linked to it.

Beyond the more common nausea, fever and chills, other medical
problems possibly linked to the vaccine, according to the
manufacturer's insert, include multiple sclerosis, encephalitis,
leukemia, blood clots, nervous system disorders, lymphoma and immune
deficiencies.

"The Defense Department does not wish for troops to even know the
dangers explained on the vaccine's own label," Zaid said.

Col. John Grabenstein, director of the Military Vaccine Agency, said
in an e-mail response to a series of questions that since 1998, the
military has provided "detailed educational programs" to explain the
anthrax vaccine.

The Pentagon and the Food and Drug Administration insist that the
vaccine, which has been given to about 1.3 million military and some
civilian personnel since 1998, is safe and effective.

Citing a 2002 National Academy of Sciences study, Grabenstein said
that the anthrax vaccine posed no greater risk of serious health
problems than any other vaccine.

But some former soldiers, outside experts, military activists and
other supporters do not think that is accurate.

Former Master Sgt. Dennis Brewster of Augusta, Kan., was diagnosed
with an array of medical ailments after the shots, including
chronic, widespread joint pain, chronic headaches, chronic fatigue
and irritable bowel syndrome.

"I knew how I was before the shot, and I got the shot and I know
what happened to me," he said.

No informed consent

The anthrax vaccine has been controversial almost from the beginning.

The FDA licensed it in 1970, but only for anthrax exposure through
the skin because the disease was largely confined to the livestock
industry.

No human testing of its effectiveness had been done. The testing
that was performed, in 1962, was on a different version of the
vaccine. The manufacturing process had changed by 1970 when it was
licensed.

The vaccine was never approved to protect against anthrax
inhalation, which is how troops would encounter the toxin on the
battlefield and why the military forced soldiers to be vaccinated.

Still, the Pentagon used it to vaccinate certain units against
anthrax before the 1991 Gulf War because of fears that Iraq had
biological weapons. Since then, researchers at Kansas State
University have found a possible link between the vaccine and the
series of mysterious maladies known as Gulf War Syndrome experienced
by many veterans of that conflict.

In 1997, as concern heightened about troops deployed to the Persian
Gulf and Korean peninsula, the Pentagon made the vaccine mandatory.
The regimen was a series of six doses over 18 months, with annual
boosters.

The threat of anthrax as a battlefield weapon is probably greater in
North Korea than anywhere else, according to Jonathan Tucker, a
chemical and biological weapons expert at the Center for
Nonproliferation Studies at the Monterey Institute for International
Studies.

"I'm not familiar with any evidence that the (Iraq) insurgency or
the Taliban has access to anthrax," he said. "North Korea is
assessed to have a biological weapons program, and anthrax would
probably be an agent in its arsenal."

Meanwhile, the sole manufacturer of the vaccine, the BioPort Corp.
of Lansing, Mich., has been cited several times by the FDA for
quality control problems.

The military shut down the vaccine program last fall when a federal
judge ruled in favor of six anonymous former and current Defense
Department employees who alleged that the vaccine was being used in
a way for which it had not been licensed and should not be forced on
anyone.

The government has appealed the ruling. In the meantime, the
Pentagon began the voluntary inoculations in May under an emergency-
use authority, citing a high bioterrorist threat.

`Blind eye' alleged

Six years after taking the vaccine, McBride's heart problems shadow
his family's every move. When he takes his 5-year-old son fishing,
he and his wife make sure the child remembers how to dial 911 in
case his father has a problem.

At the time, refusing the order to take the vaccine wasn't an
option. He loved being a Marine and hoped to make a career out of it.

"I was an enlisted serviceman," he said. "I was told to jump; you
asked, `How high?' I was just doing what I was ordered."

So was Army Sgt. Sandra Larson of Spokane, Wash. In 2000, three
months after receiving her final shot while assigned to Fort Riley,
Kan., she died of a rare blood disorder at the age of 32.

"It was as if there was something in her that was killing her immune
system, shutting her down," her sister, Nancy Rugo, told a
congressional committee after her death.

Between 1990 and 2004, 16 people died after taking the vaccine,
according to the government's Vaccine Adverse Event Reporting
System. Most suffered heart, lung and immune system problems, and
cancer.

All but five were dead within three months of their last
vaccination. In addition, the reporting system shows that nearly
4,500 other recipients have had medical reactions, with nearly 8
percent listed as "serious," meaning the problems were life-
threatening, required hospitalization or resulted in a major
disability.The reports are submitted by vaccine recipients and
providers, relatives, health-care givers and others, but are not
necessarily inclusive of everyone who has had a reaction.

The Institute of Medicine, a division of the National Academy of
Sciences, called the vaccine reporting data "useful as a sentinel
for adverse events." But it cautioned that the reports might
be "underreported, incomplete, or duplicative," and that the claims
are not always verified by medical officials.

Grabenstein said that anyone who becomes sick after a
vaccination "deserves the best care we can give them, whether a
vaccine is the cause of their health problem or not."

But Meryl Nass, a Maine internist and leading critic of the vaccine,
said the military had turned "a blind eye" to the risks. She has
examined numerous vaccine recipients with serious illnesses,
including several who served in the Kansas Air National Guard.

"The people who become disabled more often than not have multiple
diagnoses," Nass said. "They also, more often than not, have
syndromes that are rare or nonexistent in the patients that doctors
normally see. Their bodies are not doing what they're supposed to be
doing."

Leaving the big B-1 behind

Worries began to seep through the military ranks within two years of
the start of the vaccine inoculations.

Pentagon reports show that between 2000 and 2004, 149 service
members refused the vaccine.

Some were court-martialed for refusing an order and given bad
conduct discharges. About a dozen cases are in stages of appeal.

In a 2002 study, the General Accounting Office surveyed Air National
Guard and Air Force Reserve aircrews and found that 16 percent of
more than 800 airmen who responded had either transferred, become
inactive or left the service between 1998 and 2000 to avoid the
shots. An additional 18 percent said they planned to leave soon.

The GAO, now known as the Government Accountability Office, also
found that about 84 percent of the pilots and crew members who took
the vaccine during that period experienced side effects or adverse
reactions, a rate more than double what the manufacturer claimed at
the time.

In addition, the study found that about 24 percent of those
reactions were systemic meaning that they affected their entire
bodies. That was "more than 100 times higher" than what the
manufacturer estimated, the GAO said.

The military ordered former Maj. David Towne, who flew for the 128th
Bomb Squadron of the Kansas Air National Guard, to take the shot in
1999. Towne was torn because he loved flying the big B-1 bombers,
but worried about developing health problems and jeopardizing his
civilian career as a commercial pilot.

"I wear a bicycle helmet, I wear my seat belt. I just decided it was
not worth it for me to take it," he said. "They told me I was
unpatriotic and would regret this for the rest of my life. They
questioned my integrity."

Towne, who is 39 and now lives in Ohio, offered to resign but
received a general discharge instead. He has appealed.

"These are people who volunteer their lives and livelihood to
protect America," said Peter Martuscello of Wichita, a 57-year old
former Kansas Air National Guard technical sergeant who was
medically discharged after taking the vaccine. He developed Guillain-
Barre Syndrome, an immune disorder, and other problems.

"To dump on people like that is crazy," Martuscello said. "That's
the sad part. They gave you no option."

And no information on possible risks, according to several former
soldiers who took the vaccine and became ill.

Brewster said that when his unit in the 184th Bomb Wing of the
Kansas Air National Guard got a briefing about the vaccine in June
1999, "They didn't tell us about any risk. They gave us the basic
standard speech," he said. "They said there was some talk out there,
but it was all Internet hype."

A week after receiving the first shot, Brewster started feeling like
he had the flu. Then a powerful fatigue came over him. His ankles,
knees, shoulders, elbows and hands all began to hurt. He also got
severe headaches. By the fourth shot, his health had further
deteriorated. He was in and out of the hospital for intestinal
surgery and heart problems. He also became hyperallergic.

Brewster retired in 2001 under honorable conditions after 23 years
of service. He has a one-man home remodeling business that allows
him to take time off when he's feeling badly and runs out of energy.
He sleeps a lot.

"A lot of the guys hid the illness and still are," said Brewster,
who had been a full-time civilian employee of the Guard, in addition
to his military service. "Had I not ended up in the hospital, I
probably would have tried to hide mine."

The anthrax vaccine, he said, "cost me my career."
Anthrax timeline

1970: FDA approves vaccine for skin exposure

1991: Military gives vaccine to some troops in the first Gulf War

1997: Pentagon orders vaccine mandatory for all military personnel
1998: Congress passes law requiring informed consent if troops are
given drugs unapproved for their intended use

1998-99: FDA finds quality-control problems at vaccine plant

2000: Sgt. Sandra Larson takes final anthrax shot at Fort Riley,
Kan. Larson dies three months later.

2000: Institute of Medicine concludes vaccine is safe

2000: Federal judge stops mandatory shots.

2005: Voluntary vaccine program begins