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By Richard Currey
As this issue of The VVA Veteran went to press, the military
reinstated its anthrax vaccination program.
The Anthrax
Vaccine Immunization Program (www.anthrax.osd.mil) is emerging
from a three-year hiatus after Federal Judge Emmet G. Sullivan
ordered the Department of Defense to suspend anthrax vaccinations
in May 2004. Judge Sullivan ruled the anthrax vaccine was
an experimental drug that had not been subjected to appropriate
testing or cleared for human use by the U. S. Food and
Drug Administration. Notably, Judge Sullivan found that
hundreds of service members received the inoculations without
informed consent, a direct violation of the regulatory
statutes conferring protection to human subjects involved
in medical research—and a clear breach
of medical ethics.
In imposing the injunction, Judge Sullivan
said that “the
women and men of our armed forces put their lives on the
line every day to preserve and safeguard the freedoms that
all Americans cherish and enjoy. Absent an informed consent…the
United States cannot demand that members of the armed forces
also serve as guinea pigs for experimental drugs.”
Judge Sullivan’s use of the phrase “guinea pigs” is
no exaggeration, according to retired Air National Guardsman
Steve Fisher. “Judge Sullivan was right on the money.
The military has been experimenting with the anthrax vaccine,
and hundreds of us have gotten sick. Or died.”
Fisher received four anthrax inoculations over a six-month
period in 1999 and 2000, and went on to suffer a progressive
series of worsening medical symptoms that ultimately forced
his discharge from the Air National Guard on medical grounds,
retirement from a career as a civilian aircraft maintenance
technician with the Guard, the loss of a flourishing sideline
business as an electrician, the collapse of his marriage,
a protracted battle with the VA for disability benefits,
and thousands of out-of-pocket dollars spent for medical
care that continues to this day.
Fisher is president of Protecting
Our Guardians (POG), a veterans’ advocacy group organized
to defend service members from the perils of the anthrax
vaccine. “At
the very least,” Fisher said, “we’d like
to make the vaccine optional.” And, he added “I
mean truly optional, where an individual is not punished
or ostracized if he or she elects to forego the vaccine.
The best scenario, though, is that the anthrax program be
shut down until such time that the vaccine is proven safe,
effective, and truly necessary.”
Complexities, Confusion
Navigating the universe of military vaccines is fraught with
complexities and confusions. The federal government voices
its vaccine policies variously–and sometimes in contradiction—through
DoD, FDA, VA, as well as the Centers for Disease Control
and Prevention, Congress, and all branches of the military.
Since the matters at hand are medical, scientific, and legal,
lay people are often at a disadvantage in ferreting out information
and understanding it once they have.
“This is a key
area where POG can help,” Fisher
said. “The research alone can tie you up in knots.” Waving
a hand across a table in his office to indicate the hundreds
of pages of reports, letters, and files that document his
own case, Fisher underscored the persistence any vaccine-injured
service member or veteran will need to “work their
case.”
On the anthrax front alone, debate swirls around four intersecting
points: ethics, safety, efficacy, and need. The Sullivan
decision found that the anthrax vaccine was unlicensed for
human use, yet was administered to hundreds of thousands
of service members without their informed consent. This matter
also was tested in the 2001 case of an Air Force physician,
Capt. John Buck, who refused to take or administer the vaccine
on similar grounds. In a military hearing Buck was prohibited
from mounting a defense on the medical, scientific, and ethical
merits of his position. He was barred from introducing documentary
proof, nor was he allowed friendly witnesses or expert testimony.
After
advising the hearing officer that he had come to an “ethical
crossroads” as an individual and a medical doctor who
had taken the Hippocratic Oath, Buck was summarily convicted
of disobeying a direct order, confined to base for sixty
days, had an official reprimand placed in his service record,
and fined $1,500 a month for fourteen months.
Buck and another
Air Force officer, a pilot who had also “conscientiously
objected” to the anthrax vaccine, later filed a civil
suit against DoD. Meanwhile, however, the government used
legal technicalities that established the anthrax vaccine
was not experimental (through a narrow doorway of interpretation).
With the anthrax program back in action, DoD has revised
and updated their Web sites, apparently believing all responsibilities
to inform and educate have been met.
But do these actions truly satisfy the government’s
ethical obligations to those serving in uniform and their
families? Particularly if, as many maintain, the anthrax
vaccine is still a very risky proposition?
The anthrax vaccine, known as “anthrax vaccine adsorbed”or “AVA,” is
the same formulation used in earlier programs that came under
fire for safety concerns and led to a significant number
of military resignations. Some, like retired Air Force Lt.
Col. Redmond Handy, vice president of POG, chose retirement
rather than be placed in the position of receiving a questionable
vaccine or ordering subordinates to receive it.
For others, like Steve Fisher, the vaccine’s disastrous
side effects curtailed successful military careers. The reality
of these side effects, which can include chronic immune deficiencies,
brain and nervous system disorders, chronic fatigue syndrome,
and conditions mimicking multiple sclerosis and rheumatoid
arthritis, are documented in scientific papers spanning more
than a decade, echoed by expert panels, and demonstrated
in the struggles of vaccine-disabled veterans.
As it happens, both DoD and FDA agree that anthrax and other
vaccines carry potentially severe risks. But both agencies
also have long contended that the event rate of serious side
effects is low and the vaccines used by the military are
therefore safe for large-scale use.
Indeed, the reported side-effect rate of 1-2 percent suggests
that AVA is as safe as any other vaccine. But the accuracy
of those figures has long been questioned, with some vaccine
critics claiming the actual side-effect rate might run to
10 percent or higher. Steve Fisher said that it is widely
understood that under-reporting (or non-reporting) of adverse
events has skewed the statistics downward to create a false
sense of safety.
Fisher’s personal experience with VAERS (Vaccine Adverse
Event Reporting System) forms points to a dysfunctional process.
He once filed his own form, only to be told that the VAERS
process was a command function and not the responsibility
of the individual. Yet the same individual who offered that
guidance later admitted to not filing VAERS forms ever, directly
flouting DoD directives to do so.
The VAERS forms would appear to represent a classic military
conundrum: The official directive is to file the forms, while
at the local command level, filers might be reprimanded or
punished. “I’ve been told by people in a position
to know that VAERS reporting [throughout the military] is
discouraged or just not done,” Fisher said. “So
how can we say with any certainty what the AVA side-effect
rate really is?”
An accurate sense of what is meant by “side effect” is
further complicated by the fact that a reportable adverse
reaction can range from a slight redness at the injection
site to a life-threatening disability. Efforts to screen
out individuals who might be predisposed to more severe vaccine
effects is haphazard at best.
And what about the vaccine’s actual effectiveness—its
ability to create sustained immunity to anthrax infection?
The AVA protocol demands an initial series of six shots over
eighteen months followed by an annual booster shot to maintain
immunity. “That’s just absurd,” said Redmond
Handy. “It means a service member could receive some
twenty-four anthrax shots over a twenty-year career. What
other vaccine needs a protocol that extreme?” Handy
maintained that such a dosing schedule implied a vaccine
of minimal effectiveness, another reason he believes AVA
needs more rigorous evaluation.
A final controversy centers on the likelihood of an anthrax
attack against our troops in the field. “The only two
countries on earth that have the capacity to produce and
deploy weaponized anthrax are the United Sates and the former
Soviet Union,” Handy said. “And even if that
reality changes anytime soon, it is well known that anthrax
is difficult to deploy and of questionable effectiveness
in the field or in combat. It’s just not much of a
weapon among the choices that are out there.” So why,
Handy wondered, is this vaccine so urgently needed by our
troops? If the actual threat of an anthrax attack is remote,
why risk the health of able-bodied service members?
More Than Anthrax
POG has recently expanded the scope of its mission to include
other vaccines in addition to anthrax, reflecting the fact
that AVA is not the only specter in the military’s
vaccine closet. POG’s membership now includes Michael
Berger, a former National Guardsman with disabilities officially
linked to smallpox vaccine.
Berger’s story was first
covered in these pages (The Needle and the Damage Done: Vaccinating
America’s Soldiers, January/February 2005) after he
suffered vaccine-related heart disease and, more recently,
nervous system disorders also attributed to vaccines.
A medic with more than twenty years of service at the time
he was assigned to the 452nd Combat Support Hospital at Ft.
McCoy, Wisconsin, in early 2003, Berger received a routine
battery of inoculations, including anthrax and smallpox vaccines.
In the few days that followed he thought he was experiencing
a case of flu until he had a major heart attack while on
field exercises.
Another soldier vaccinated at the same time, Rachel Lacy,
died a few weeks later. Under public and political pressure,
DoD convened two independent scientific review panels to
look into her death. Both panels concurred that Lacy’s
death was almost certainly related to vaccines, although
since she received several inoculations in a single day it
was impossible to tease out which one was the culprit.
Mike Berger was only beginning to put the picture together
as he worked his way through the Army’s medical system
after his heart attack. Just as he thought he was about to
be medically discharged, he was brought to Walter Reed Army
Medical Center by the Army’s National Vaccine Health
Center, which advised Berger that he would be at the hospital
for about two weeks. By the time Berger brought his case
to VVA, he had been at Walter Reed for nearly a year and
was in deteriorating health, trapped in the military’s
bureaucratic maze, and deeply frustrated. “I felt like
a hamster on a wheel—no matter how long or far I thought
I’d run, I was always in the same place,” he
said. “Paperwork was lost, or it was wrong, or it was
sent to the wrong offices. And all the while my health was
getting worse.”
Immunization Nightmare
As of 1999, Steve Fisher knew he was experiencing reactions
to the anthrax vaccine. He had seen an Air Force doctor,
Capt. John Dice, who agreed and annotated Fisher’s
military shot record with a hand-written note indicating
Fisher was an anthrax-reactor and further immunizations should
be deferred. Despite this, Fisher received a fourth shot
the same day he saw Dr. Dice because of a miscommunication
with a medical technician. Dr. Dice was apologetic, the medic
chastened, but further damage was almost certainly done,
since Fisher subsequently saw a worsening of his symptoms
along with the emergence of new symptoms.
Fisher returned to his home installation, McConnell AFB
in Wichita, Kansas, where he worked with the 184th Bomber
Wing. “The
command decided it was going to take action against me for
trying to get my VAERS forms filed,” Fisher said. “The
CO called me in and said, ‘I don’t want you talking
anymore about the anthrax shots.’” A command
directive was subsequently issued stating that “no
one in the unit could speak about the anthrax vaccine with
anyone at any time,” according to Fisher. The directive
required that unit members sign to indicate understanding
and agreement; Steve Fisher hand-wrote on his form that he
reserved the right to speak about his anthrax issues with
his personal physicians.
Meanwhile, Fisher said, the 184th was losing pilots who
were concerned about anthrax vaccine. Rather than challenge
the issue and struggle with tainted records or bad discharges,
they were quietly resigning their commissions.
During this period, Fisher was struggling with a panoply
of vaccine side effects, from ringing in his ears (a known
AVA side effect) to a case of vertigo (dizziness) that was
incapacitating. “Sometimes I’d be walking and
just fall down,” Fisher said. “I fell in the
shower. I’d even keel over when I was just sitting
down.” Fisher also developed muscle and joint pain.
He couldn’t kneel, couldn’t hold tools, couldn’t
stand on a ladder. Then there was the overwhelming fatigue. “My
work suffered and my supervisor started leaning on me about
job performance,” he said.
Despite a convoluted administrative process with many starts
and stops, Fisher was finally honorably discharged from the
Guard and retired from his job as a civilian technician with
the Guard in August 2001. Along the way, he was diagnosed
with chronic fatigue syndrome, non-specific musculoskeletal
illness, asthma, sleep apnea, heart valve damage, and an
inflamed esophagus.
“I never had any of these problems or anything remotely
like them before I received the anthrax shots,” Fisher
said.
Fisher sought assistance from veterans’ service organizations
in settling a disability benefit dispute with the VA. Although
he received some help, including an increase in his rating,
he found the VSOs he approached to be as challenged as he
was in knowing how to manage vaccine-related injuries. When
Fisher heard about POG (founded by Marguerite Armistead,
whose husband was an Air National Guard pilot who endured
anthrax vaccine effects) he knew the need existed for an
advocacy organization focused exclusively on vaccine health —and
that he needed to be a member.
“POG, as much as anything, is about public scrutiny,” Fisher
said. “We want to see accountability, and we want to
see care for our vaccine-injured vets. The way DoD is currently
playing it, it’s a closed case. FDA has cleared AVA
and the program is up and running. But too many questions
are unanswered. Too many vets are sick and fighting for care.
This is far from over.”
Help from VVA
By late July 2004, the military vaccine program had scored
an ominous series of questionable deaths and chronic illnesses,
along with the outrage of those who found themselves targeted
in disciplinary proceedings, even courts-martial, for refusing
smallpox or anthrax vaccines. As military personnel and their
families began to alert members of Congress, Assistant Secretary
of Defense William Winkenwerder, Jr., reported that the Army
had identified 37 cases of heart inflammation in the wake
of smallpox vaccination—but the vaccine was still considered
safe.
Winkenwerder later was fired from his post after the nation
learned of the systematic poor care for soldiers at Walter
Reed Army Medical Center. But before those disturbing revelations,
smallpox-reactor Mike Berger ended up barred from his own
disability evaluation hearing at Walter Reed. Berger was
told by his lawyer that the disability board “was sticking
at ten percent, and if I argued about it they would rescind
the offer entirely.”
Berger’s first few months at home were tough. “It
was as much my medical issues as the uncertainty about what
would happen to me and my family.” Berger kept in touch
with friends and contacts at VVA and took his health needs
to the local VA. Both helped. “I got moral support
and ongoing encouragement from VVA, big doses of that ‘don’t
give up’ attitude. And my doctors at the VA here have
been absolutely outstanding.”
His disability rating has been raised, and Berger is encouraged
by news that the VA likely will revisit his rating another
time in light of his continuing symptoms.
“What has become very clear to me in these past few
years,” Berger said, “is that when a veteran
needs help the most—when you’re at your weakest —is
exactly when you have to be your own strongest advocate.
So many of the steps I’ve taken with the Army and the
VA have been uphill battles, despite the fact that both the
Army and the VA are supposed to be looking out for me.”
Berger is particularly grateful for assistance he received
from VVA. “A source of friendship,” Berger said, “and
an advocate when I was feeling powerless, comfort when I
was hurting physically and emotionally, always there when
I needed someone to say, ‘We’ve been there, too,
so don’t give up. It does get better.’” And
while Berger expressed gratitude for “giving voice
to my issue,” he said that many individuals at VVA
made it clear there were “hearts out there who cared
about me as well as my issue.”
Getting Congress To Act
Steve Fisher, during a conversation with VVA at his office
in northern Virginia, recalled a lesson from his years of
service. “If the chain of command fails you, take your
problem to your Member of Congress. POG is doing exactly
that. We’re focused on bringing attention to the anthrax
vaccine before Congress, preparing positions for Congress
to consider, and lobbying on behalf of desired legislation.”
POG
has drafted language for a bill that would suspend further
appropriations for the anthrax program “until such
time as a vaccine is developed that is demonstrably effective
and safe” for recipients and the military community
at large.
“The burden of proof in this matter has yet to be satisfied
by the U.S. government,” Redmond Handy said. “We,
as service members, veterans, and citizens are owed at least
that much.” Handy compared the anthrax program to friendly
fire. “This is an abusive situation,” he said. “There
is a striking lack of evidence of effect in these shots.
There is a lack of evidence of safety. And there is a lack
of military legitimacy.”
The participation of Mike Berger in POG now expands those
concerns to the smallpox vaccine as well. Berger’s
condition is somewhat improved, although he still needs regular
medical care for his smallpox-related disabilities. He’s
back to work in Michigan but also contributing time to POG. “I’m
not completely recovered,” he said, “and may
never be. But now’s the time to try and help others
caught up in the same problems I’ve faced.”
Steve Fisher welcomes the assistance. “I’ve
met, read about, or heard about so many others who got sick
after getting shots,” he said. “If we can bring
all those voices together, I think DoD will finally have
to take notice.”
Fisher said that helping lawmakers gain awareness and make
an informed decision is paramount. For now, he believes the
best route to that end is to suspend the anthrax program
until the vaccine is proven safe. “If there’s
any one-line slogan I can think of that sums up POG’s
objectives at this point,” he said, “it’s ‘Stop
The Shots.’
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2011, Vietnam Veterans of America. All Rights Reserved. 8719 Colesville Road, Suite 100, Silver Spring, MD 20910