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Air Force Capt. Jonathan
E. Richter is a third-generation military officer.
A C-5 pilot in the Air Force Reserve at Dover AFB,
Del., he flew missions in both Operations Desert Storm
and Northern Watch and is not, in his own estimate,
the sort of person who normally goes around looking
for ways to disobey his superiors.
However, on Feb. 3, 1999, Richter was injected with
anthrax vaccine from lot #FAV 030. The same lot was
used for his second shot on Feb. 19. Five days later,
his problems began. His right shoulder began to ache,
as if he'd thrown a baseball hard without warming up.
Then his left shoulder began to feel the same way.
Soon, his spine hurt so badly that he could hardly
get out of bed in the morning.
Since then, his arthritis-like symptoms have stabilized
mostly in his feet and left hand. He has no way of
proving that the vaccine is the cause, but he's not
taking any chances. He told a Congressional panel on
July 21 that "taking another shot is not part
of the Jon Richter health care program" and that
he will resign his commission before taking another
anthrax injection.
"Those in command seem to have shrugged their
shoulders at the numbers of people leaving military
service, with the attitude that an order was given
and it should be carried out," he said in an appearance
before a House subcommittee. "We are growing tired
of the denials-that everything is OK-when in fact it
isn't."
Two years after Secretary of Defense William S. Cohen
first announced that all US military personnel would
be vaccinated against the deadly biological agent anthrax,
the Pentagon is facing a growing revolt against the
program. Around 200 active, Guard, and Reserve members
of the armed services have refused to take part in
the six-shot vaccination program, according to DoD's
own records. However, the Pentagon admits it doesn't
have a formal tracking system. The numbers refusing
to take the shots in the Guard and Reserve may be greater
than DoD reports, based on Congressional testimony
from reservists and news articles around the country.
Some of the active duty holdouts have been court-martialed.
Reservists face not courts-martial but a sudden end
to their military careers.
Morale at "All-Time Low"
For instance, Richter claims that many pilots-by his
count, about 60 percent of those in the unit-plan to
resign rather than face the anthrax vaccine needle.
He said, "I can only assume that the people in
the other specialties required to execute the mission
of an airlift airplane such as the C-5 are leaving
as well. Word travels fast. Morale is at an all-time
low."
US military health officials find this development
frustrating. They claim that the vaccine is safe and
effective and that many reluctant members of the military
are being frightened by outdated and inaccurate information.
Furthermore, anthrax is a deadly threat that terrorists
could well employ against US forces in the years ahead.
It is, in the words of the Pentagon, "a clear
and present danger to US service personnel." Declining
anthrax vaccinations is akin to refusing to wear a
helmet in combat, top officials argue.
"If you get anthrax, ... you are effectively
dead," Secretary of the Air Force F. Whitten Peters
told the Senate Armed Services Committee during his
July 21 confirmation hearing.
Moreover, virtually every senior uniformed and civilian
military leader has either begun or completed the full
series of six anthrax shots required for complete protection.
Inoculees include Cohen, Peters, Deputy Secretary of
Defense John J. Hamre, Army Gen. Henry H. Shelton (Chairman
of the Joint Chiefs of Staff), USAF Gen. Joseph W.
Ralston (JCS vice chairman), and all four chiefs of
the uniformed services, including USAF's Gen. Michael
E. Ryan.
Pentagon health officials acknowledge that they have
been somewhat taken aback by the sudden squall of resistance
to anthrax vaccinations. They felt that the rise of
unconventional means of warfare and regional conflicts
would make only too obvious the need for such a program
of protection.
The program's foundation was laid in 1993. In that
year, Defense Department officials issued a directive
on immunizations for biological warfare defense, which
established government policy, responsibilities, and
procedures for the stockpiling of biological agent
vaccines. Military planners are studying the virtues
of a dozen or more different kinds of shots to safeguard
US troops from attacks by the Saddam Husseins of the
future.
From the outset, say planners, it was clear that anthrax
would be the biggest near-term biowar danger. It is
cheap, easy to produce, and easy to load into a long-range
weapon. The Iraqi military knows all about it.
Anthrax is a disease that occurs naturally in herd
animals, such as cows. Humans can catch it by eating
contaminated meat, handling contaminated animals or
animal products, or directly inhaling anthrax germs.
In their natural state, anthrax germs live in spores,
which can survive for decades if buried. To turn the
disease into a weapon, these spores are milled into
a fine-ground dust that can be sprayed over a wide
area through the use of any number of delivery methods.
How It Kills
Once inhaled, anthrax reproduces and releases toxins
that attack the lungs. The victim's first indication
that he or she has been poisoned is the onset of vague
flu-like symptoms, notably high fever and chest pain.
Death comes abruptly, through oxygen depletion, shock,
and respiratory and cardiac failure.
Absent vaccination, anthrax is virtually always fatal.
At least 10 potential US adversaries have worked on
anthrax weapons, according to US intelligence data.
The reaction of law enforcement authorities to anthrax
hoaxes has been extraordinary. In one recent incident,
the presence of a suspicious envelope caused a virtual
shutdown of downtown Washington, D.C., for hours and
sent office workers into the streets to be cleaned
by paramedics. These reactions show how seriously the
US government takes the threat.
"[Anthrax] has been weaponized and we know it
is deployed in about 10 countries around the world," Peters
told the Senate panel. "Our view is that it is
unconscionable to allow our pilots and aircrews to
fly into those countries, which are high-threat countries,
without being inoculated against anthrax, just as we
would inoculate people against smallpox."
In May 1998, Cohen ordered that everyone who wears
a US military uniform-active, Guard, or Reserve-eventually
receive anti-anthrax shots. Under Cohen's order, the
Total Force will be covered by a three-phase program.
Phase 1 involves inoculating all forces that are now
assigned to or will be rotating through high-threat
areas in Southwest Asia and Korea. Phase 2 will involve
forces designated for early deployment into those areas.
Phase 3 is everyone else.
DoD envisions finishing this huge inoculation project
by 2006.
Inoculation involves more than rolling up a sleeve
for a single shot. The present Anthrax Vaccination
Immunization Program entails a series of six shots
administered over a period of 18 months. The first
three inoculations are delivered at zero, two, and
four weeks. Boosters are then administered at six,
12, and 18 months.
The Pentagon insists that the vaccine is safe. Army
Maj. Gen. Robert G. Claypool, deputy assistant secretary
of defense, health operations policy, said that several
studies have shown that the incidence of adverse reactions
to anthrax vaccination is comparable to that for other
commonly used vaccines.
Studies done at the time of FDA licensure of the vaccine
showed that in 16,000 doses the anthrax vaccine causes
a mild reaction in 3 to 20 percent of those who take
it. Fewer than 1 percent exhibited a severe reaction,
Claypool reported to Congress on July 21.
By way of comparison, the pneumonia vaccine has a
71 percent rate of localized soreness. The typhoid
vaccine causes localized tenderness in 98 percent of
recipients, pain by 56 percent, a feeling of malaise
in 24 percent, and headaches in 11 percent.
As of midsummer, the Pentagon reported only 103 adverse
reactions to the anthrax vaccine, out of more than
977,000 doses administered. Of these 103 events, only
14 reactions resulted in more than 24 hours of lost
duty.
Pentagon health officials say they are aware of isolated,
inexplicable systemic health problems that have developed
in some military personnel around the time they received
an anthrax shot. But they say they are not aware of
any pattern of long-term side effects from the anthrax
vaccine.
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Is It Mythology?
These examples
were drawn from a statement published on the
Defense Department's official anthrax vaccination
Web site (www.anthrax.osd.mil).
Myth:
There is no defense against anthrax.
Fact:
Vaccination is the best defense against biological
warfare involving anthrax. Nuclear, biological,
and chemical gear and protective masks should
also be used.
Myth: Antibiotics
are just as effective against anthrax as the
vaccine.
Fact:
Antibiotics can be effective in cases of cutaneous
anthrax [caused by contact with infected animals
or contaminated animal products], ... [but]
antibiotics have not been proven effective
against the more deadly forms of anthrax: inhaled
and ingested.
Myth:
The anthrax vaccine can cause me to catch anthrax.
It works by actually injecting live cells into
my body to build immunity.
Fact:
The anthrax vaccine does not use live bacteria.
It is a sterile product made from a strain
of anthrax that does not cause disease.
Myth:
Service members will have ample warning of
an anthrax attack due to effective detection
devices.
Fact:
Until reliable detectors are available in sufficient
numbers, usually the first indication of a
biological attack in unprotected soldiers will
be ill soldiers.
Myth:
Anthrax must be hand-delivered; it cannot survive
any other means of deployment.
Fact:
Anthrax bacteria can be deployed by missiles
and artillery shells.
Myth:
The anthrax vaccine is experimental and under
investigation.
Fact:
The anthrax vaccine is not experimental or
investigational. It has been used safely to
protect at-risk industrial and laboratory workers
for almost 30 years.
Myth:
The reliability of the anthrax vaccine is based
on only one human efficacy group-wool mill
workers.
Fact: Clinical studies with approximately 1,200 wool
mill workers have demonstrated protection against
cutaneous anthrax. Since conducting lethal
challenge studies in humans is considered unethical,
determining the actual efficacy of the vaccine
is not possible. However, there have been numerous
tests of the anthrax vaccine involving animal
models (i.e., rhesus monkey model) upon which
the FDA determined its safety and efficacy.
Myth: The anthrax vaccine may cause sterility.
Fact: The vaccination has been routinely used for
the past 28 years and has not been associated
with sterility.
Myth: Anthrax kills only farm animals.
Fact: Anthrax
kills both animals and humans.
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"Some Degree of Risk"
"Any vaccine carries with it some degree of risk
with its use," said Claypool. "In the case
of the anthrax vaccine, the scales of balance are clearly
tipped in favor of its use to protect our military
forces."
These explanations do not satisfy those who believe
that their anthrax shot made them sick. The Pentagon's
tracking system is underreporting adverse events for
a number of reasons, these critics claim.
In some units, fear of possible side effects has proved
as contagious as any flu virus. An ANG member testifying
before Congress stated that the Connecticut Air National
Guard lost eight pilots who refused the shots. At Travis
AFB, Calif., the guardsman said that 17 KC-10 crew
members resigned rather than face the anthrax needle.
Many of those who are worried about the vaccine's
effects cite the military's long history of underplaying
the threat posed to its members by certain substances
and practices, from Agent Orange to radiation testing.
"The missing element of the mandatory anthrax
vaccine program is trust," said Rep. Christopher
Shays (R-Conn.) during a series of Congressional hearings
on the issue.
Dover is one of the Air Force bases where suspicion
about the vaccine has been strong and widespread, due
to a large number of personnel with unexplained health
problems that began to crop up around the time of vaccination.
At least 30 Dover personnel have filed reports with
the Anthrax Vaccine Adverse Event Reporting System
in recent months, according to Lt. Richard J. Rovet,
a health care integrator for the flight medicine clinic
at the base. These included six reports of dizziness,
six reports of ringing in the ears, 10 reports of joint
pain, two reports of chronic fatigue, and one report
of a painfully swollen testicle.
Capt. Michelle Piel is a 13-year Air Force veteran
and a C-5 Galaxy pilot stationed at Dover. She says
that her arm went numb for about 20 minutes after she
received her first anthrax shot on Oct. 21, 1998, from
lot #030. Weeks later, while flying a return leg from
humanitarian relief operations in Honduras, the right
side of her head filled up with fluid.
"It was as if a faucet were turned on inside
my head," she told Congress in written testimony.
A flight surgeon grounded her for a head cold and
middle ear infection. Thus began a long struggle with
fatigue, nausea, and other flu-like symptoms. Six months
later, 12 doctors had yet to reach a firm diagnosis
of her condition. Her wing commander sent her to the
immunology clinic at Walter Reed Army Medical Center,
where researchers did tests that revealed some indications
of an immune system disorder.
"The last few months I have felt some improvement
in my condition," she said. "The dizziness
has become less frequent. ... There is no way that
I know of to prove that the anthrax vaccine caused
any of this. All I can tell you is that I became uncharacteristically
ill after I started taking the anthrax shots. It has
taken 12 doctors and eight months for me to finally
find any reason for my symptoms."
Dover Calls a Halt
In May, Col. Felix M. Grieder, commander of the 436th
Airlift Wing at Dover, suspended anthrax vaccinations
for a week for those under his command until he could
obtain more information about the vaccine's safety.
He is not the only field commander who ordered such
a pause. In July, the commander of the Air National
Guard's 122nd Fighter Wing, Fort Wayne IAP, Ind., suspended
shots for his 950-member unit, in part to allow more
time for vaccine education efforts. Vaccinations will
resume this fall or winter, said Guard officials.
The rebellion has reached the point where some House
Republicans want the vaccinations stopped altogether.
A number of GOP members are backing legislation that
would either make the vaccinations voluntary or suspend
the program until the National Institutes of Health
conducts a safety study.
The idea of going to a voluntary anthrax immunization
program does not sit well with senior Pentagon leaders.
In a joint statement this summer on this subject, Cohen
and Shelton had this to say: "Our commanders must
know that all, not simply some fraction, of their forces
are protected from this biological threat. Soldiers,
sailors, airmen, and Marines fight in teams, and they
need to know that all team members are protected from
anthrax. ... Allowing a voluntary vaccination program
is inadequate in the face of this deadly threat."
Still, Rep. Dan Burton (RInd.) decried a situation "when
five Marines are court-martialed because they are concerned
they may not be fit for duty if they take a vaccine,
and when 30 percent of the pilots in a Reserve unit
resign rather than take this vaccine." These kinds
of events, said Burton, constitute "clear signals
that something is wrong."
For the critics, one major and specific concern is
that the anthrax vaccine is in fact untested. Studies
of its effects, they say, all carry the label "short-term."
Small Sample?
Though the Food and Drug Administration has approved
use among veterinarians, laboratory workers, and livestock
handlers for 30 years, very few such workers have actually
taken it, charged Mark S. Zaid, a lawyer who has represented
military personnel who refuse the vaccine. He said
that only about 20,000 to 30,000 people received anthrax
shots in the last half-century, prior to the Pentagon's
first widespread use.
"The Defense Department's inoculation of 150,000
servicemen during the Gulf War ... was the first major
use of the vaccine in any significant quantity," he
said.
Others question whether the vaccine would be effective
against inhaled anthrax germs-the most likely method
of ingestion. They point out that the only US producer
of the vaccine has had FDA-documented quality control
problems in the past. And Zaid, among others, claims
that the Pentagon's own studies show a systemic reaction
rate to the vaccine that is two to seven times higher
than the manufacturer's predictions.
Even a systemic reaction rate of 1 percent or so will
incapacitate from 17,000 to 32,000 service members,
said Zaid, considering the large numbers of service
personnel receiving the vaccine.
The Pentagon strongly defends its decision to opt
for servicewide anthrax protection. The effort is not
primarily a medical program, officials say.
"It is a line commanders' program to keep our
deployed military personnel safe and prevent combat
casualties," said Dr. Sue Bailey, assistant secretary
of defense for health affairs.
The anthrax vaccine was first licensed by the FDA
in 1970. "There have been no long-term side effects
reported," according to Bailey.
Furthermore, the vaccine is indeed effective against
inhaled anthrax, DoD says. Or at least, the prevention
of inhalation anthrax "is not inconsistent with
the current product label," said Bailey, reading
from an FDA memo.
According to the Pentagon's top doctor, it is not
possible to directly determine the efficacy of the
vaccine in humans against aerosol exposure to anthrax
spores. Conducting such a study would be highly unethical.
Numerous studies using animals have indeed been carried
out, the Pentagon said. Military researchers have relied
in particular on rhesus monkeys for these studies.
"These animal studies showed that the FDA-approved
anthrax vaccine provided greater than 95 percent protection
against high-dose aerosol challenge with anthrax in
the monkey model," said Bailey.
A February 1998 FDA investigation of state-run Michigan
Biologics Product Institute found "significant
deviations" from FDA regulations, according to
FDA officials. As a result of this probe, BioPort Corp.,
which bought MBPI in September 1998 and is now the
DoD contractor for anthrax vaccine, is holding 11 lots
of the vaccine in quarantine storage.
Kathryn C. Zoon, director of the FDA Center for Biologics
Evaluation and Research, told Congress, "These
lots are still in quarantine and will remain in quarantine
until the company submits required information to [the
FDA]."
DoD officials say they will continue to be vigilant
as they look for unexpected reactions to the vaccine.
They insist that they are committed to fully investigating
all questions about the shots' value.
Said the Pentagon's Claypool: "We know anthrax
kills and immunization protects. ... Immunizing men
and women we place in harm's way to prevent death or
a serious injury is our moral and ethical duty. ...
It would be unconscionable for us not to do so."
Peter Grier, the Washington editor of the Christian Science
Monitor, is a longtime defense correspondent and regular
contributor to Air Force Magazine. His most recent article,
"The
China Problem," appeared in the August 1999
issue.
Copyright Air Force Association. All rightsreserved.
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