Volunteers for study to be questioned for
resumed its controversial mandatory anthrax vaccinations
program for selected troops last week despite the fact that
its own doctors are quietly conducting research into adverse
effects of the vaccine, a RAW
STORY investigation has found.
While the Defense Department maintains that the anthrax vaccine
is safe and poses no long-term risks to recipients, a little-known
program at Walter Reed – the National Vaccine Healthcare Center
– seems to contradict the military’s assertions.
Documents obtained by RAW
STORY, including a participant’s agreement, case
history and government documents, show that military medical
personnel have known since at least 1998 that there are genetic
triggers between illnesses and some required immunizations,
including the anthrax vaccine. They also reveal the military
knew and did not implement routine pre-screening which could
help reduce vaccine-related illnesses.
A flyer posted by the Vaccine Healthcare Center shows that
Walter Reed is soliciting servicemembers who have suffered as
a result of the vaccine. The flyer asserts that “adverse effects
may include redness or swelling where the shot was given (larger
than the bottom of a soda can) and/or more than 24 hours of
headaches, muscle/joint pains, and/or fatigue (tiredness) that
interfered with your daily activities.”
“Only one visit and only one blood draw is required,” the flyer
says. “You will also receive annual e-mail or telephone follow-up
surveys for eight years.”
(Click on the image to enlarge.)
US Army Medical Command Media Relations Officer Margaret Tippy
made several efforts to put RAW
STORY in touch with Vaccine Healthcare Center officials
over the past several weeks. Defense medical officials, however,
did not returned repeated request for information about the
In 2004, a federal judge ruled that the military’s mandatory
administration of the vaccine was
illegal because the Food and Drug Administration had not
approved its use for inhalation anthrax, only for anthrax contracted
through the skin. After FDA approval, the judge allowed voluntary
injections. The Defense Department resumed mandatory shots this
month. The Pentagon continues to defend the efficacy and safety
of the vaccine.
“I'll say once again, the vaccine is safe and effective,” Assistant
Secretary of Defense for Health Affairs William Winkenwerder
Doctors have raised questions about the vaccine for years.
According to a transcript
of an Apr. 16, 1998 meeting of the Armed Forces Epidemiological
Board, military experts concluded that pre-vaccination screenings
could be conducted because the military has "the technological
and data capture capability" to do so, and that they should
be done because "we're dealing with this problem with anthrax
now and many other immunizations."
"There is going to be more in the future," the transcript added.
The existence of the Vaccine Healthcare Center complicates
the mystery surrounding vaccine-related illnesses, suggesting
either that pre-screening is not part of the vaccination process
or that genetic triggers are not the only cause of vaccine related
Created in 2001 as a joint effort of the Centers for Disease
Control and the Department of Defense, the VHC program and its
network of treatment and research facilities are largely unknown
even among the military community. Walter Reed Medical Center
serves as the headquarters of the program, which also includes
clinics at Fort Bragg, Lackland Air Force Base and Portsmouth
Naval Medical Center.
Since its inception, the treatment component of the program
has helped hundreds of soldiers suffering serious and sometimes
debilitating side-effects from anthrax and other vaccinations
to get the proper military medical treatment, vaccine exemptions
and case management that they would not have access to otherwise.
Many anti-vaccination advocates question why the VHC treatment
program is not more widely publicized and why the VHC's research
is not available to medical professionals and the public.
Dr. Meryl Nass, an anthrax expert and physician who has treated
soldiers suffering from adverse reactions to the anthrax vaccine,
believes the VHC's research findings should be released.
"I knew they were doing this kind of research, but they just
wouldn't admit it," Dr. Nass said in a phone interview last
week. "VHC has been conducting this type of research, but they
haven't been publishing any of it. This could save more people
from becoming ill."
Luis Hernandez's mystery lesion
Luis Hernandez, a recently-retired Navy reservist, is a current
participant in the VHC study. Hernandez says he was approached
last September by VHC researchers to take part during a routine
visit to Walter Reed relating to his disability claim. (His
affidavit for the program is available
here. The sections of his file describing his symptoms and
their impact on his quality of life are here.)
An Iraq War veteran who served in the US military for 25 years,
the 51-year-old New Yorker received his first series of anthrax
vaccinations when he was mobilizing for deployment in February
2003, a month before Operation Iraqi Freedom began.
A few days after receiving his third anthrax vaccination, Hernandez
says, he developed a lesion on his leg that he was told was
most likely a spider bite. He was put on a course of antibiotics
and continued preparing for deployment.
"I had never had health problems," he said.
The lesion grew and other autoimmune problems developed. In
May 2006, Hernandez was forced to return home to receive medical
"When I got back, I had 13 lesions," he said. "It was just
too much for my immune system," he said of the vaccine. "They
didn't know what the hell I had."
When he told the military he thought that his illness was related
to the vaccine, he said, staff told him he was "delusional"
and the relation between his mystery autoimmune illness and
the shots "were in his head."
"For a while," he said, "I thought I was going crazy."
A private physician who had been attending to Hernandez's case
referred him to Walter Reed's Vaccine Healthcare Center to seek
additional tests in hopes of diagnosing the "mystery illness."
Hernandez said no one in the military had ever told him of the
According to Hernandez's medical documents, the reservist was
suffering from muscle spasms, headaches, recurring skin lesions,
chronic fatigue and depression when he first visited Walter
Reed in January 2004.
"Hernandez' life has been profoundly effected [sic] by his
clinical symptoms," VHC staff wrote. "He is in constant pain,
has difficulty functioning at his civilian job and has used
400 hours of civilian sick leave."
will post excerpts from Hernandez's documents later today.
"We have noted in a number of service members who now exhibit
chronic, refractory headaches as well as persistent musculoskeletal
pain in temporal association with the receipt of the anthrax
vaccine," VHC staff added. "Based on these observations, we
are attempting to establish case definitions as well as diagnostic,
treatment and vaccination options."
"When I got down there, they told me, 'we know what you got,
but we can't fix you,'" Hernandez said of VHC staff. "They said
they had seen other service members with the same symptoms."
Hernandez is now asking the same question many vaccinated soldiers
already have: Is the vaccine safe? Did the military know the
vaccine could cause health problems?
"The D.O.D. is telling us that the vaccine is safe, and yet
they are conducting this multi-million dollar research project,"
he said. "It is too late for me, but the military is just going
to pump these kids' bodies full of this stuff."
Dr. Nass, who practices medicine in Maine, believes the vaccine
is unsafe and is responsible for a host of illnesses in U.S.
"There are so many people who are damaged by this vaccine,"
she remarked. "Its use makes no sense."
The numbers of soldiers who have become ill as a result of
the anthrax vaccine is largely unknown, primarily because conditions
may not be not either properly diagnosed or recorded, and because
many military studies are not available to health care professionals
or the public.
In 2003, 22-year-old Army Reservist Specialist Rachel Lacy
died shortly after receiving her first batch of vaccines. According
to a military
medical panel, the evidence surrounding Lacy's death "favored
a causal relationship," but the panel decided that the "evidence
was not conclusive." The cause of death was described as "a
severe inflammatory process affecting her lungs, findings consistent
with a diagnosis of systemic lupus erythematosus (SLE) or lupus."
Manufacturer says studies show product is safe
Created by Emergent BioSolutions (formerly Bioport), the anthrax
vaccine is known as BioThrax or Anthrax Vaccine Absorbed and
was first licensed by the Food and Drug Administration in 1970.
It remains the only FDA-approved anthrax vaccine for use in
In an interview with RAW
STORY, Emergent Biosolutions spokesperson Dr. Tom
Waytes said the anthrax vaccine has been studied more than just
about any vaccine in the US and has been deemed safe and effective.
He said the vaccine has no higher adverse reaction rate than
most other vaccines. A recent
report issued by the military reviewing the vaccine's safety,
as well as a 2002 report issued by the Institute of Medicine,
he added, have also backed the vaccine.
In the Institute of Medicine's report – which reviewed existing
studies on the vaccine's safety and effectiveness – the committee
found that "the available evidence shows that the currently
licensed anthrax vaccine, Anthrax Vaccine Adsorbed (AVA), is
reasonably safe and effective, with the caveat that the studies
reviewed were carried out in populations of healthy adults only."
The IOM report also pointed out that "although the committee
found no data indicating that vaccination with AVA is associated
with later-onset adverse events or with any serious or lasting
adverse events," few, if any, studies had been done regarding
the vaccine's long term safety.
"DoD should carefully evaluate options for longer-term follow-up
of the possible health effects of vaccination against anthrax
(and other service-related exposures)," committee members urged
in their report.
Last May, the Government Accountability Office (GAO) issued
a report that called for "a better, alternative vaccine."
In the May 2006 report, the GAO said the "vaccine has not been
adequately tested on humans; no studies have been done to determine
the optimum number of doses; the long-term safety has not been
studied and data on short-term reactions are limited."
Dr. Waytes asserted that the majority of soldiers' claims that
the vaccine causes autoimmune disorders and serious illnesses
are "in people's minds."
Dr. Nass disagrees.
"We really don't know about long-term safety," Nass said, noting
that the majority of studies are focused on short-term effects.
"The data just doesn't exist."
Late last year, another group of anonymous soldiers and civilians
filed a new lawsuit to stop the resumption of the mandatory
program. The Pentagon has filed a motion to dismiss the case,
according to one of the lead lawyers for the plaintiffs, retired
Air Force Lt. Col. John Michels.
"This whole thing just has this bureaucratic momentum," Michels
Larisa Alexandrovna and Muriel Kane contributed research
to this report.