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
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 Press show.
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
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 experts say.
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
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 today.
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,
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 months.
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 government agencies.
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
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
"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 continue.
Terminating the quarterly reviews would seem to break those promises, she
said. "It's just appalling that they didn't keep up with this," she said.
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
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 sure.
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
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
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 anthrax.
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 detected.
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 agencies.
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
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
Clay and other congressional aides say these assurances came in private,
too. "We had lengthy conversations that they were supposed to report," she
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
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
He said, "The simple answer is it's so obvious, it's never appeared in the
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 vaccine lot."
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
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
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
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 technological solutions."
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
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."