495820,000 Military anthrax vaccine deaths
- Dec 31, 2005Pentagon withheld 20,000 Military death from anthrax vaccinations
An Incomplete Picture
Despite promises that hospitalizations after anthrax vaccinations
would be reported, the Pentagon withheld data on more than 20,000 cases.
BY BOB EVANS
December 4 2005
bevans @ dailypress.com 247-4758
The Pentagon never told Congress about more than 20,000
hospitalizations involving troops who'd taken the anthrax vaccine,
despite repeated promises that such cases would be publicly disclosed.
Instead, a parade of generals and Defense Department officials told
Congress and the public that fewer than 100 people were hospitalized
or became seriously ill after receiving the shot from 1998 through 2000.
They also showed Congress written policies that required public
reports to be filed for hospitalizations, serious illnesses and cases
where someone missed 24 hours or more of duty.
But only a sliver of those cases were reported, while the rest were
withheld from Congress and the public, records obtained by the Daily
Critics of the vaccine, veterans' advocates and congressional staffers
say the Pentagon's deliberate low-balling of hospitalizations helped
persuade Congress and the public that the vaccine was safe.
Keeping the actual number of illnesses secret contributed to a shorter
list of government-recognized side effects for the drug, giving
patients and physicians a false idea of what might constitute a
vaccine-related illness or problem. Doctors are expected to know the
full list of side effects and alert federal drug safety officials
whenever they see a repeat of those symptoms.
Repeated evidence of the same adverse side effect after a vaccination
is one of the most telling signs of a systematic problem with a drug
or vaccine, as opposed to a coincidental relationship, vaccine safety
During the Daily Press' investigation of the vaccine and its effects,
the newspaper found three cases of amyotrophic lateral sclerosis -
ALS, or Lou Gehrig's disease - that the military hadn't reported. The
disease destroys muscles and nerves, is always fatal and rarely hits
people younger than 45.
One of the three cases involves Navy Capt. Denis Army of Virginia
Beach. Army died in 2000, after developing symptoms less than a week
after his first anthrax vaccination - and a few days before his 45th
birthday. His widow filed the first public acknowledgement of his
death and its temporal connection to the vaccine this year. That
occurred after she talked to a Daily Press reporter and learned that
she could file a report with the federal Vaccine Adverse Event
Reporting System, or VAERS.
SAILOR'S DEATH NOT REPORTED BY MILITARY
Navy Petty Officer 2nd Class Kristin Shemeley died of ALS in 2001, at
29. Her symptoms began about two months after her third shot, a sworn
legal document detailing her illness says.
Before Shemeley died, she spent 14 months in Walter Reed Army Medical
Center in Washington, where she was regularly visited by high-ranking
military officers, said her mother, Ginger Shemeley of Quakertown, Pa.
She says her daughter repeatedly told those generals and admirals that
she was suffering because of the vaccine and even pleaded with one of
them to stop giving it to troops. Several of those generals and
admirals had promised Congress that such cases would be publicly
reported to VAERS.
The military never filed a VAERS report on Kristin Shemeley. Ginger
Shemeley filed one after her daughter died.
Col. John Grabenstein, director of the military's vaccine agency, said
no one from the military intentionally misled Congress or the public.
He said the 20,765 hospitalizations merely followed vaccinations in
time, without documented proof of a cause-and-effect relationship.
He said a statistical analysis showed that those who'd been vaccinated
weren't more likely to be hospitalized or likely to seek medical
treatment than those in the military who hadn't been vaccinated from
1998 through 2000.
Some medical experts say this approach doesn't adequately address the
problems of many people who report illnesses after anthrax
vaccination. That's because the approach is limited to comparing rates
of illness involving one symptom or disease - instead of the complex
combination of symptoms and illnesses that many veterans report after
getting their shots.
The data that the Daily Press used to document the underreporting of
hospitalizations came from a report that Grabenstein supplied in
response to the newspaper's request. It's never been made public until
It covers 1998 through 2000, when the Pentagon did detailed
evaluations every three months to compare hospitalizations, clinic
visits and medical treatment data for those who'd been vaccinated,
compared with troops who hadn't. This quarterly analysis stopped and
hasn't been done since, Grabenstein said.
The practice of not reporting all hospitalizations continues.
Quarterly analysis of the vaccine's effects ended just as the nation's
only manufacturing site for the drug regained its license. That was in
2002, after federal inspections found many safety and other problems
that prompted a shutdown and renovation that began in early 1998.
The company's current manufacturing techniques provide greater potency
compared with earlier versions of the drug, said the Government
Accountability Office, Congress' investigative arm. The manufacturer,
BioPort Inc., says there's no difference in the drug made since 2002
that might cause health problems.
TOP GENERAL NOT TOLD MONITORING TO END
The decision to discontinue the quarterly health monitoring program
means that the biggest gap in research about the vaccine remains:
There are no systematic long-term studies of the health of those
who've taken the drug. Most studies that the Pentagon cites as support
for the vaccine's safety involve monitoring that lasted days to a few
None lasted as long as five years, the minimum length of time
recommended by a nationally recognized panel of scientists assembled
by the Institute of Medicine in 2002. The institute is a nonprofit
organization that provides expert advice to Congress and other
After the quarterly reviews of the vaccine's effects stopped, more
than a million troops were forced to take the vaccine - until a
federal judge ruled last year that the drug had never been adequately
licensed for protection against anthrax use in warfare.
He ordered the military to make vaccination voluntary. The Pentagon is
appealing that ruling. Lawyers argued the case Thursday, and a
decision is expected by February.
VACCINE MONITORING STILL IMPORTANT
Grabenstein said he decided to halt the quarterly studies after
consulting the chairman of the Institute of Medicine panel and its
staff, and with doctors affiliated with the military. He acknowledged
that he didn't consult the general who ultimately was responsible for
the anthrax program.
The chairman of the institute panel, Brian Strom, said he didn't
recall what was discussed at the time about the quarterly reports. But
he said, "I think they should continue to be using it," in case
there's a problem.
Another panel member, Linda Cowan, said she's sure the committee
expected quarterly reviews to continue and pointed to a number of the
panel's recommendations and findings that she said clearly
contradicted Grabenstein's interpretation of its report.
Strom and Cowan emphasized that they thought the vaccine was still safe.
Beth Clay isn't so sure. She directed the staff of Congress' House
Government Reform Committee investigation into the anthrax vaccine
from 1998 to 2001. She continued working on the subject as a
congressional staff member through 2003, after her Republican boss was
no longer chairman of the committee.
Clay said the military's decision not to report all the
hospitalizations gave the public and Congress a rosier picture of the
vaccine than it deserved.
"We were never given this data," she said. "Had we seen this, the
committee would have had significant questions" and would have
demanded more information about the program.
After reviewing the report obtained by the Daily Press, Clay said it
raised several questions about the vaccine's safety. She said Congress
was never told about the detailed level of data in the report but was
assured regular monitoring of the vaccine and its health effects would
Terminating the quarterly reviews would seem to break those promises,
she said. "It's just appalling that they didn't keep up with this,"
LINK BETWEEN VACCINE, HOSPITALIZATIONS?
Steve Robinson is executive director of the National Gulf War Resource
Center, a lobbying and advocacy group for veterans. He said he was
stunned when he learned that the reviews had stopped: "They track the
flu vaccine and not the anthrax vaccine, which is totally crazy to me."
He said discovery of the hospitalization data showed that the Pentagon
couldn't be trusted to monitor the vaccine's safety.
"You can't let Enron investigate Enron, and you can't let DOD (the
Department of Defense) investigate DOD," he said. "We work with the
people who have been hurt by this vaccine every day."
No one knows how many, or how few, of the 20,765 hospitalizations are
directly attributable to the vaccine. Ruling out certain illnesses,
such as broken bones or injuries from falls or other accidents, might
appear a safe bet. But military doctors have documented cases where
broken bones and other injuries from falling were the result of
vaccine-induced loss of consciousness affecting the nervous system -
sometimes beginning months after vaccination.
The difficulty of figuring out what's related and what isn't is why
safety officials encourage people to file reports even if they're not
WHY PENTAGON DIDN'T FILE HOSPITAL REPORTS
Still, medical experts consulted by the Daily Press said it's unlikely
that the vast majority of the 20,765 hospitalizations resulted from
the vaccine. They said that if all hospitalizations had been filed
with VAERS, it would have overloaded the system and caused problems
for experts trying to analyze the data.
Grabenstein said those were among the reasons that the full number of
hospitalizations was not reported. Another reason, he said, was that
examinations of the data showed that if there were adverse effects
from the vaccine, they were so infrequent, they weren't detectable by
statistical analysis. Doing this type of analysis - instead of simply
reporting the incidents to VAERS - provided a more definitive look at
the health effects of the vaccine, he said. As a result, "we decided
not to file" public reports about all hospitalizations, he said.
Those considerations weren't relayed to Congress or the public.
During the years covered by the hospitalization report obtained by the
Daily Press, dozens of sick veterans who'd received the shot went to
Capitol Hill, complaining of various health problems. Some got the
shot for the 1991 Persian Gulf War, in which the vaccine had its first
widespread use. Others were members of the military forced to take the
shots under a mandatory program that began in 1998.
Their complaints had common themes: Fatigue. Chronic pain in joints
and other symptoms of arthritis. Tingling in their feet, arms and
hands. Mental lapses. Often, more than one of the symptoms were
present, making diagnoses difficult.
Sympathetic doctors testified that these complaints were indicative of
autoimmune problems, in which the body's natural protective mechanisms
go haywire and start attacking healthy cells and tissue. The doctors
said that could result if the vaccine overstimulated the vets' immune
systems. The vaccine primes the system to develop protection against
Bewildered and sometimes-angry members of Congress asked how many vets
were affected. Pentagon doctors and generals used the cases reported
to VAERS - fewer than 100 hospitalizations or other "serious events"
from 1998 to 2000 - or said the number was so small, it couldn't be
VACCINE REPORTS ARE FIRST LINE OF DEFENSE
The two sets of numbers for how many hospitalizations followed the
shot come from a comparison of two sets of data kept by three federal
The Food and Drug Administration and the Centers for Disease Control
and Prevention maintain the only database open to public inspection,
VAERS. VAERS is the nation's first line of defense in identifying
possible problems with vaccines after they've been licensed, said
Susan Ellenberg, who led the FDA's efforts to monitor vaccine safety
from 1993 to 2004.
During congressional testimony before the House Government Reform
Committee's Subcommittee on National Security, Veterans Affairs and
International Relations in July 1999, Ellenberg explained how and why
the system worked.
VAERS was established to help identify and head off problems once a
vaccine is licensed and more people are taking it, she said. The few
hundred people typically involved in vaccine or drug testing and
licensing trials can't mimic the diversity of age, race, gender and
other biologic variables encountered once the vaccine gets widespread
public use, she explained.
Reports to VAERS by civilian doctors and hospitals are mostly
voluntary, based on suspicion of a connection between an illness or
injury and a vaccination, Ellenberg told Congress.
Doctors and others are encouraged to file a report, known as a
VAERS-1, even when they aren't sure there's a cause and effect, she
said. That's because VAERS requires as many reports of problems as
possible, so experts can identify possible patterns and investigate
further, she said.
GENERALS' TESTIMONY PROMISED REPORTS
During the same congressional hearing, Lt. Gen. G. Robert Claypool -
then the deputy assistant secretary of defense for health operations
policy - assured Congress that military doctors, hospitals and medical
officials were filing VAERS-1 forms, too.
And, he said, they were expected to report even more cases than
civilians - including all hospitalizations.
"The duty to report adverse medication events has been codified for
many years," Claypool testified. "The joint regulation requires
submission of a form VAERS-1 for all adverse events resulting in more
than 24 hours of lost duty time or any period of hospitalization.
These requirements represent a higher standard than in comparable
civilian community health care settings."
There was no mention that the word "all" didn't mean all hospitalizations.
Two months later, Lt. Gen. Ronald R. Blanck, then the Army's surgeon
general and the top Pentagon official responsible for the anthrax
vaccine program from 1998 to 2000, gave similar assurances to Congress.
He said, "We have a reporting system that when either of those two
criteria are met, that is, either a patient is hospitalized following
an anthrax immunization or misses duty because of it for greater than
24 hours, we have an active reporting system. That must be reported to
us. We, in turn, report it to the Food and Drug Administration, and
they have a group that reviews those reactions."
Clay and other congressional aides say these assurances came in
private, too. "We had lengthy conversations that they were supposed to
report," she said.
But the numbers reported were very low. And the Pentagon stuck with
them for years to persuade the public that the shot was safe.
In December 2003, Pentagon officials conducted a news conference to
rebut a judge's ruling that the shots had been given illegally and
that troops had been used as "guinea pigs." Grabenstein was asked
whether he had "any data on the numbers of people who have had bad
adverse reactions to the vaccine and would have required hospitalization."
He said that only 69 hospitalizations had been reported to VAERS for
the anthrax vaccine from 1998 through 2000. A panel of civilian
experts had analyzed each, he said, and decided that 11 were results
of the shot. The 69 cases were "a complete, exhaustive list of what
was reported," Grabenstein said.
Grabenstein told the Daily Press that his statement wasn't misleading.
He said no one should expect all hospitalizations after vaccination to
be reported to VAERS - despite the Pentagon's written policies -
because the number included cases unrelated to the vaccine, sometimes
years after vaccination.
He said, "The simple answer is it's so obvious, it's never appeared in
NO EXCEPTIONS NOTED IN POLICY MEMOS
The memo, "Policy for Reporting Adverse Events Associated With the
Anthrax Vaccine," serves as the standing order for all military
personnel. It reads: "For the purposes of reporting anthrax vaccine
adverse events, a Form VAERS-1 must be completed and submitted using
service reporting procedures for those events resulting in a hospital
admission or time lost from duty for greater than 24 hours or for
those events suspected to have resulted from contamination of a
The memo lists additional circumstances requiring a report, but
nothing that would permit excluding hospitalizations after
vaccination. It refers to the Pentagon's formal regulations, which
don't include the exclusions that Grabenstein cited.
The data on all hospitalizations after anthrax vaccination comes from
the Pentagon's Defense Medical Surveillance System, or DMSS. This
computerized tracking system pulls medical records for every shot,
clinic visit, hospitalization or other instance of medical treatment
for active-duty military personnel.
Experts in health care and statistics say it's one of the most
important medical databases in the world. That's because of its
precision, its millions of patients, and the diversity of drugs and
vaccines used by the armed forces. By design, it's more complete and
accurate than VAERS. Unlike VAERS, its data isn't open to the public.
EXPERTS: NO EXCUSE FOR SECRET DATA
The Institute of Medicine report that Grabenstein cited as supporting
the vaccine's safety and his decision to end the quarterly monitoring
program also says the DMSS database should be open to researchers
outside the government, with precautions to protect the privacy of
individuals' health records.
This hasn't been done. Grabenstein said the military had not been able
to figure out how to protect individuals' health records and make it work.
Strom of the institute panel and other experts say it should not be
that difficult. "There's no excuse," he said. "We use these kinds of
data sets in Medicaid and Medicare data all the time. There are
Cowan, another member of the panel, said the institute's
recommendation was based, in part, on the military saying it couldn't
afford all the analysis that the data was good for: "That way, you get
the most of what the American people have invested in."
Strom said keeping the data from the public only bolstered the
perception that the military was hiding the truth about the vaccine.
Walter Schumm is a professor of family studies and an expert on
statistical methods at Kansas State University. He said he and other
researchers would love to get the DMSS data. He's a retired Army
colonel who's spent more than a decade using statistical analysis to
examine the vaccine's safety - after friends and others in uniform
began complaining about health problems after the shots.
Schumm has used other data made public on the anthrax vaccine to
publish several scientific papers that poke holes in the safety
assertions made by Pentagon doctors and researchers.
Good science involves people with different approaches to the same
problem having a chance to test their theories, Schumm and others say.
Their findings might cement the safety assertions, he said, but no one
knows for sure until the military loosens its hold on the facts and data.
He said, "If you let independent people have the data, you risk losing
control. In combat, letting things get out of control gets people
killed, so loss of control is a very sensitive issue. I'm just sure
they're trying to protect their program." Copyright © 2005, Daily Press
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