Part 2 - thimerosal's dangers - vaccinations
- From: "georgia" <jwissmille@xxxxxxx>
- Date: 17 Jul 2005 13:55:04 -0700
Internal documents reveal that Eli Lilly, which first developed
thimerosal,
knew from the start that its product could cause damage -- and even
death --
in both animals and humans. In 1930, the company tested thimerosal by
administering it to twenty-two patients with terminal meningitis, all
of
whom died within weeks of being injected -- a fact Lilly didn't bother
to
report in its study declaring thimerosal safe. In 1935, researchers at
another vaccine manufacturer, Pittman-Moore, warned Lilly that its
claims
about thimerosal's safety "did not check with ours." Half the dogs
Pittman
injected with thimerosal-based vaccines became sick, leading
researchers
there to declare the preservative "unsatisfactory as a serum intended
for
use on dogs."
In the decades that followed, the evidence against thimerosal continued
to
mount. During the Second World War, when the Department of Defense used
the
preservative in vaccines on soldiers, it required Lilly to label it
"poison." In 1967, a study in Applied Microbiology found that
thimerosal
killed mice when added to injected vaccines. Four years later, Lilly's
own
studies discerned that thimerosal was "toxic to tissue cells" in
concentrations as low as one part per million -- 100 times weaker than
the
concentration in a typical vaccine. Even so, the company continued to
promote thimerosal as "nontoxic" and also incorporated it into topical
disinfectants. In 1977, ten babies at a Toronto hospital died when an
antiseptic preserved with thimerosal was dabbed onto their umbilical
cords.
In 1982, the FDA proposed a ban on over-the-counter products that
contained
thimerosal, and in 1991 the agency considered banning it from animal
vaccines. But tragically, that same year, the CDC recommended that
infants
be injected with a series of mercury-laced vaccines. Newborns would be
vaccinated for hepatitis B within twenty-four hours of birth, and
two-month-old infants would be immunized for haemophilus influenzae B
and
diphtheria-tetanus-pertussis.
The drug industry knew the additional vaccines posed a danger. The same
year
that the CDC approved the new vaccines, Dr. Maurice Hilleman, one of
the
fathers of Merck's vaccine programs, warned the company that
six-month-olds
who were administered the shots would suffer dangerous exposure to
mercury.
He recommended that thimerosal be discontinued, "especially when used
on
infants and children," noting that the industry knew of nontoxic
alternatives. "The best way to go," he added, "is to switch to
dispensing
the actual vaccines without adding preservatives."
For Merck and other drug companies, however, the obstacle was money.
Thimerosal enables the pharmaceutical industry to package vaccines in
vials
that contain multiple doses, which require additional protection
because
they are more easily contaminated by multiple needle entries. The
larger
vials cost half as much to produce as smaller, single-dose vials,
making it
cheaper for international agencies to distribute them to impoverished
regions at risk of epidemics. Faced with this "cost consideration,"
Merck
ignored Hilleman's warnings, and government officials continued to push
more
and more thimerosal-based vaccines for children. Before 1989, American
preschoolers received only three vaccinations -- for polio,
diphtheria-tetanus-pertussis and measles-mumps-rubella. A decade later,
thanks to federal recommendations, children were receiving a total of
twenty-two immunizations by the time they reached first grade.
As the number of vaccines increased, the rate of autism among children
exploded. During the 1990s, 40 million children were injected with
thimerosal-based vaccines, receiving unprecedented levels of mercury
during
a period critical for brain development. Despite the well-documented
dangers
of thimerosal, it appears that no one bothered to add up the cumulative
dose
of mercury that children would receive from the mandated vaccines.
"What
took the FDA so long to do the calculations?" Peter Patriarca, director
of
viral products for the agency, asked in an e-mail to the CDC in 1999.
"Why
didn't CDC and the advisory bodies do these calculations when they
rapidly
expanded the childhood immunization schedule?"
But by that time, the damage was done. Infants who received all their
vaccines, plus boosters, by the age of six months were being injected
with
levels of ethylmercury 187 times greater than the EPA's limit for daily
exposure to methylmercury, a related neurotoxin. Although the vaccine
industry insists that ethylmercury poses little danger because it
breaks
down rapidly and is removed by the body, several studies -- including
one
published in April by the National Institutes of Health -- suggest that
ethylmercury is actually more toxic to developing brains and stays in
the
brain longer than methylmercury.
Officials responsible for childhood immunizations insist that the
additional
vaccines were necessary to protect infants from disease and that
thimerosal
is still essential in developing nations, which, they often claim,
cannot
afford the single-dose vials that don't require a preservative. Dr.
Paul
Offit, one of CDC's top vaccine advisers, told me, "I think if we
really
have an influenza pandemic -- and certainly we will in the next twenty
years, because we always do -- there's no way on God's earth that we
immunize 280 million people with single-dose vials. There has to be
multidose vials."
But while public-health officials may have been well-intentioned, many
of
those on the CDC advisory committee who backed the additional vaccines
had
close ties to the industry. Dr. Sam Katz, the committee's chair, was a
paid
consultant for most of the major vaccine makers and shares a patent on
a
measles vaccine with Merck, which also manufactures the hepatitis B
vaccine.
Dr. Neal Halsey, another committee member, worked as a researcher for
the
vaccine companies and received honoraria from Abbott Labs for his
research
on the hepatitis B vaccine.
Indeed, in the tight circle of scientists who work on vaccines, such
conflicts of interest are common. Rep. Burton says that the CDC
"routinely
allows scientists with blatant conflicts of interest to serve on
intellectual advisory committees that make recommendations on new
vaccines,"
even though they have "interests in the products and companies for
which
they are supposed to be providing unbiased oversight." The House
Government
Reform Committee discovered that four of the eight CDC advisers who
approved
guidelines for a rotavirus vaccine laced with thimerosal "had financial
ties
to the pharmaceutical companies that were developing different versions
of
the vaccine."
Offit, who shares a patent on the vaccine, acknowledged to me that he
"would
make money" if his vote to approve it eventually leads to a marketable
product. But he dismissed my suggestion that a scientist's direct
financial
stake in CDC approval might bias his judgment. "It provides no conflict
for
me," he insists. "I have simply been informed by the process, not
corrupted
by it. When I sat around that table, my sole intent was trying to make
recommendations that best benefited the children in this country. It's
offensive to say that physicians and public-health people are in the
of industry and thus are making decisions that they know are unsafe for
children. It's just not the way it works."
Other vaccine scientists and regulators gave me similar assurances.
Like
Offit, they view themselves as enlightened guardians of children's
health,
proud of their "partnerships" with pharmaceutical companies, immune to
the
seductions of personal profit, besieged by irrational activists whose
anti-vaccine campaigns are endangering children's health. They are
often
resentful of questioning. "Science," says Offit, "is best left to
scientists."
Still, some government officials were alarmed by the apparent conflicts
of
interest. In his e-mail to CDC administrators in 1999, Paul Patriarca
of the
FDA blasted federal regulators for failing to adequately scrutinize the
danger posed by the added baby vaccines. "I'm not sure there will be an
easy
way out of the potential perception that the FDA, CDC and
immunization-policy bodies may have been asleep at the switch re:
thimerosal
until now," Patriarca wrote. The close ties between regulatory
officials and
the pharmaceutical industry, he added, "will also raise questions about
various advisory bodies regarding aggressive recommendations for use"
of
thimerosal in child vaccines.
If federal regulators and government scientists failed to grasp the
potential risks of thimerosal over the years, no one could claim
ignorance
after the secret meeting at Simpsonwood. But rather than conduct more
studies to test the link to autism and other forms of brain damage, the
CDC
placed politics over science. The agency turned its database on
childhood
vaccines -- which had been developed largely at taxpayer expense --
over to
a private agency, America's Health Insurance Plans, ensuring that it
could
not be used for additional research. It also instructed the Institute
of
Medicine, an advisory organization that is part of the National Academy
of
Sciences, to produce a study debunking the link between thimerosal and
brain
disorders. The CDC "wants us to declare, well, that these things are
pretty
safe," Dr. Marie McCormick, who chaired the IOM's Immunization Safety
Review
Committee, told her fellow researchers when they first met in January
2001.
"We are not ever going to come down that [autism] is a true side
effect" of
thimerosal exposure. According to transcripts of the meeting, the
committee's chief staffer, Kathleen Stratton, predicted that the IOM
would
conclude that the evidence was "inadequate to accept or reject a causal
relation" between thimerosal and autism. That, she added, was the
result
"Walt wants" -- a reference to Dr. Walter Orenstein, director of the
National Immunization Program for the CDC.
For those who had devoted their lives to promoting vaccination, the
revelations about thimerosal threatened to undermine everything they
had
worked for. "We've got a dragon by the tail here," said Dr. Michael
Kaback,
another committee member. "The more negative that [our] presentation
is, the
less likely people are to use vaccination, immunization -- and we know
what
the results of that will be. We are kind of caught in a trap. How we
work
our way out of the trap, I think is the charge."
Even in public, federal officials made it clear that their primary goal
in
studying thimerosal was to dispel doubts about vaccines. "Four current
studies are taking place to rule out the proposed link between autism
and
thimerosal," Dr. Gordon Douglas, then-director of strategic planning
for
vaccine research at the National Institutes of Health, assured a
Princeton
University gathering in May 2001. "In order to undo the harmful effects
of
research claiming to link the [measles] vaccine to an elevated risk of
autism, we need to conduct and publicize additional studies to assure
parents of safety." Douglas formerly served as president of
vaccinations for
Merck, where he ignored warnings about thimerosal's risks.
In May of last year, the Institute of Medicine issued its final report.
Its
conclusion: There is no proven link between autism and thimerosal in
vaccines. Rather than reviewing the large body of literature describing
the
toxicity of thimerosal, the report relied on four disastrously flawed
epidemiological studies examining European countries, where children
received much smaller doses of thimerosal than American kids. It also
cited
a new version of the Verstraeten study, published in the journal
Pediatrics,
that had been reworked to reduce the link between thimerosal and
autism. The
new study included children too young to have been diagnosed with
autism and
overlooked others who showed signs of the disease. The IOM declared the
case
closed and -- in a startling position for a scientific body --
recommended
that no further research be conducted.
The report may have satisfied the CDC, but it convinced no one. Rep.
David
Weldon, a Republican physician from Florida who serves on the House
Government Reform Committee, attacked the Institute of Medicine, saying
it
relied on a handful of studies that were "fatally flawed" by "poor
design"
and failed to represent "all the available scientific and medical
research."
CDC officials are not interested in an honest search for the truth,
Weldon
told me, because "an association between vaccines and autism would
force
them to admit that their policies irreparably damaged thousands of
children.
Who would want to make that conclusion about themselves?"
Under pressure from congress, parents and a few of its own panel
members,
the Institute of Medicine reluctantly convened a second panel to review
the
findings of the first. In February, the new panel, composed of
different
scientists, criticized the earlier panel for its lack of transparency
and
urged the CDC to make its vaccine database available to the public.
So far, though, only two scientists have managed to gain access. Dr.
Mark
Geier, president of the Genetics Center of America, and his son, David,
spent a year battling to obtain the medical records from the CDC. Since
August 2002, when members of Congress pressured the agency to turn over
the
data, the Geiers have completed six studies that demonstrate a powerful
correlation between thimerosal and neurological damage in children. One
study, which compares the cumulative dose of mercury received by
children
born between 1981 and 1985 with those born between 1990 and 1996, found
a
"very significant relationship" between autism and vaccines. Another
study
of educational performance found that kids who received higher doses of
thimerosal in vaccines were nearly three times as likely to be
diagnosed
with autism and more than three times as likely to suffer from speech
disorders and mental retardation. Another soon-to-be published study
shows
that autism rates are in decline following the recent elimination of
thimerosal from most vaccines.
As the federal government worked to prevent scientists from studying
vaccines, others have stepped in to study the link to autism. In April,
reporter Dan Olmsted of UPI undertook one of the more interesting
studies
himself. Searching for children who had not been exposed to mercury in
vaccines -- the kind of population that scientists typically use as a
"control" in experiments -- Olmsted scoured the Amish of Lancaster
County,
Pennsylvania, who refuse to immunize their infants. Given the national
rate
of autism, Olmsted calculated that there should be 130 autistics among
the
Amish. He found only four. One had been exposed to high levels of
mercury
from a power plant. The other three -- including one child adopted from
outside the Amish community -- had received their vaccines.
At the state level, many officials have also conducted in-depth reviews
of
thimerosal. While the Institute of Medicine was busy whitewashing the
risks,
the Iowa legislature was carefully combing through all of the available
scientific and biological data. "After three years of review, I became
convinced there was sufficient credible research to show a link between
mercury and the increased incidences in autism," says state Sen. Ken
Veenstra, a Republican who oversaw the investigation. "The fact that
Iowa's
700 percent increase in autism began in the 1990s, right after more and
more
vaccines were added to the children's vaccine schedules, is solid
evidence
alone." Last year, Iowa became the first state to ban mercury in
vaccines,
followed by California. Similar bans are now under consideration in
thirty-two other states.
But instead of following suit, the FDA continues to allow manufacturers
to
include thimerosal in scores of over-the-counter medications as well as
steroids and injected collagen. Even more alarming, the government
continues
to ship vaccines preserved with thimerosal to developing countries --
some
of which are now experiencing a sudden explosion in autism rates. In
China,
where the disease was virtually unknown prior to the introduction of
thimerosal by U.S. drug manufacturers in 1999, news reports indicate
that
there are now more than 1.8 million autistics. Although reliable
numbers are
hard to come by, autistic disorders also appear to be soaring in India,
Argentina, Nicaragua and other developing countries that are now using
thimerosal-laced vaccines. The World Health Organization continues to
insist
thimerosal is safe, but it promises to keep the possibility that it is
linked to neurological disorders "under review."
I devoted time to study this issue because I believe that this is a
moral
crisis that must be addressed. If, as the evidence suggests, our
public-health authorities knowingly allowed the pharmaceutical industry
to
poison an entire generation of American children, their actions
arguably
constitute one of the biggest scandals in the annals of American
medicine.
"The CDC is guilty of incompetence and gross negligence," says Mark
Blaxill,
vice president of Safe Minds, a nonprofit organization concerned about
the
role of mercury in medicines. "The damage caused by vaccine exposure is
massive. It's bigger than asbestos, bigger than tobacco, bigger than
anything you've ever seen."
It's hard to calculate the damage to our country -- and to the
international
efforts to eradicate epidemic diseases -- if Third World nations come
to
believe that America's most heralded foreign-aid initiative is
poisoning
their children. It's not difficult to predict how this scenario will be
interpreted by America's enemies abroad. The scientists and researchers
--
many of them sincere, even idealistic -- who are participating in
efforts to
hide the science on thimerosal claim that they are trying to advance
the
lofty goal of protecting children in developing nations from disease
pandemics. They are badly misguided. Their failure to come clean on
thimerosal will come back horribly to haunt our country and the world's
poorest populations.
.
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