Deadly Immunity
By Robert F. Kennedy Jr.
Salon.com
Thursday 16 June 2005
A Salon/Rolling Stone joint investigation.
Original
Article Here
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In June 2000,
a group of top government scientists and health officials
gathered for a meeting at the isolated Simpsonwood
conference center in Norcross, Ga. Convened by the
Centers for Disease Control and Prevention, the meeting
was held at this Methodist retreat center, nestled
in wooded farmland next to the Chattahoochee River,
to ensure complete secrecy. The agency had issued
no public announcement of the session - only private
invitations to 52 attendees. There were high-level
officials from the CDC and the Food and Drug Administration,
the top vaccine specialist from the World Health Organization
in Geneva, and representatives of every major vaccine
manufacturer, including GlaxoSmithKline, Merck, Wyeth
and Aventis Pasteur. All of the scientific data under
discussion, CDC officials repeatedly reminded the
participants, was strictly "embargoed."
There would be no making photocopies of documents,
no taking papers with them when they left.
|
The federal officials and industry representatives had assembled
to discuss a disturbing new study that raised alarming questions
about the safety of a host of common childhood vaccines administered
to infants and young children. According to a CDC epidemiologist
named Tom Verstraeten, who had analyzed the agency's massive
database containing the medical records of 100,000 children,
a mercury-based preservative in the vaccines - thimerosal
- appeared to be responsible for a dramatic increase in autism
and a host of other neurological disorders among children.
"I was actually stunned by what I saw," Verstraeten
told those assembled at Simpsonwood, citing the staggering
number of earlier studies that indicate a link between thimerosal
and speech delays, attention-deficit disorder, hyperactivity
and autism. Since 1991, when the CDC and the FDA had recommended
that three additional vaccines laced with the preservative
be given to extremely young infants - in one case, within
hours of birth - the estimated number of cases of autism had
increased fifteenfold, from one in every 2,500 children to
one in 166 children.
Even for scientists and doctors accustomed to confronting
issues of life and death, the findings were frightening. "You
can play with this all you want," Dr. Bill Weil, a consultant
for the American Academy of Pediatrics, told the group. The
results "are statistically significant." Dr. Richard
Johnston, an immunologist and pediatrician from the University
of Colorado whose grandson had been born early on the morning
of the meeting's first day, was even more alarmed. "My
gut feeling?" he said. "Forgive this personal comment
- I do not want my grandson to get a thimerosal-containing
vaccine until we know better what is going on."
But instead of taking immediate steps to alert the public
and rid the vaccine supply of thimerosal, the officials and
executives at Simpsonwood spent most of the next two days
discussing how to cover up the damaging data. According to
transcripts obtained under the Freedom of Information Act,
many at the meeting were concerned about how the damaging
revelations about thimerosal would affect the vaccine industry's
bottom line.
"We are in a bad position from the standpoint of defending
any lawsuits," said Dr. Robert Brent, a pediatrician
at the Alfred I. duPont Hospital for Children in Delaware.
"This will be a resource to our very busy plaintiff attorneys
in this country." Dr. Bob Chen, head of vaccine safety
for the CDC, expressed relief that "given the sensitivity
of the information, we have been able to keep it out of the
hands of, let's say, less responsible hands." Dr. John
Clements, vaccines advisor at the World Health Organization,
declared flatly that the study "should not have been
done at all" and warned that the results "will be
taken by others and will be used in ways beyond the control
of this group. The research results have to be handled."
In fact, the government has proved to be far more adept
at handling the damage than at protecting children's health.
The CDC paid the Institute of Medicine to conduct a new study
to whitewash the risks of thimerosal, ordering researchers
to "rule out" the chemical's link to autism. It
withheld Verstraeten's findings, even though they had been
slated for immediate publication, and told other scientists
that his original data had been "lost" and could
not be replicated. And to thwart the Freedom of Information
Act, it handed its giant database of vaccine records over
to a private company, declaring it off-limits to researchers.
By the time Verstraeten finally published his study in 2003,
he had gone to work for GlaxoSmithKline and reworked his data
to bury the link between thimerosal and autism.
Vaccine manufacturers had already begun to phase thimerosal
out of injections given to American infants - but they continued
to sell off their mercury-based supplies of vaccines until
last year. The CDC and FDA gave them a hand, buying up the
tainted vaccines for export to developing countries and allowing
drug companies to continue using the preservative in some
American vaccines - including several pediatric flu shots
as well as tetanus boosters routinely given to 11-year-olds.
The drug companies are also getting help from powerful lawmakers
in Washington. Senate Majority Leader Bill Frist, who has
received $873,000 in contributions from the pharmaceutical
industry, has been working to immunize vaccine makers from
liability in 4,200 lawsuits that have been filed by the parents
of injured children. On five separate occasions, Frist has
tried to seal all of the government's vaccine-related documents
- including the Simpsonwood transcripts - and shield Eli Lilly,
the developer of thimerosal, from subpoenas. In 2002, the
day after Frist quietly slipped a rider known as the "Eli
Lilly Protection Act" into a homeland security bill,
the company contributed $10,000 to his campaign and bought
5,000 copies of his book on bioterrorism. Congress repealed
the measure in 2003 - but earlier this year, Frist slipped
another provision into an anti-terrorism bill that would deny
compensation to children suffering from vaccine-related brain
disorders. "The lawsuits are of such magnitude that they
could put vaccine producers out of business and limit our
capacity to deal with a biological attack by terrorists,"
says Andy Olsen, a legislative assistant to Frist.
Even many conservatives are shocked by the government's
effort to cover up the dangers of thimerosal. Rep. Dan Burton,
a Republican from Indiana, oversaw a three-year investigation
of thimerosal after his grandson was diagnosed with autism.
"Thimerosal used as a preservative in vaccines is directly
related to the autism epidemic," his House Government
Reform Committee concluded in its final report. "This
epidemic in all probability may have been prevented or curtailed
had the FDA not been asleep at the switch regarding a lack
of safety data regarding injected thimerosal, a known neurotoxin."
The FDA and other public-health agencies failed to act, the
committee added, out of "institutional malfeasance for
self protection" and "misplaced protectionism of
the pharmaceutical industry."
The story of how government health agencies colluded with
Big Pharma to hide the risks of thimerosal from the public
is a chilling case study of institutional arrogance, power
and greed. I was drawn into the controversy only reluctantly.
As an attorney and environmentalist who has spent years working
on issues of mercury toxicity, I frequently met mothers of
autistic children who were absolutely convinced that their
kids had been injured by vaccines. Privately, I was skeptical.
I doubted that autism could be blamed on a single source,
and I certainly understood the government's need to reassure
parents that vaccinations are safe; the eradication of deadly
childhood diseases depends on it. I tended to agree with skeptics
like Rep. Henry Waxman, a Democrat from California, who criticized
his colleagues on the House Government Reform Committee for
leaping to conclusions about autism and vaccinations. "Why
should we scare people about immunization," Waxman pointed
out at one hearing, "until we know the facts?"
It was only after reading the Simpsonwood transcripts, studying
the leading scientific research and talking with many of the
nation's preeminent authorities on mercury that I became convinced
that the link between thimerosal and the epidemic of childhood
neurological disorders is real. Five of my own children are
members of the Thimerosal Generation - those born between
1989 and 2003 - who received heavy doses of mercury from vaccines.
"The elementary grades are overwhelmed with children
who have symptoms of neurological or immune-system damage,"
Patti White, a school nurse, told the House Government Reform
Committee in 1999. "Vaccines are supposed to be making
us healthier; however, in 25 years of nursing I have never
seen so many damaged, sick kids. Something very, very wrong
is happening to our children." More than 500,000 kids
currently suffer from autism, and pediatricians diagnose more
than 40,000 new cases every year. The disease was unknown
until 1943, when it was identified and diagnosed among 11
children born in the months after thimerosal was first added
to baby vaccines in 1931.
Some skeptics dispute that the rise in autism is caused
by thimerosal-tainted vaccinations. They argue that the increase
is a result of better diagnosis - a theory that seems questionable
at best, given that most of the new cases of autism are clustered
within a single generation of children. "If the epidemic
is truly an artifact of poor diagnosis," scoffs Dr. Boyd
Haley, one of the world's authorities on mercury toxicity,
"then where are all the 20-year-old autistics?"
Other researchers point out that Americans are exposed to
a greater cumulative "load" of mercury than ever
before, from contaminated fish to dental fillings, and suggest
that thimerosal in vaccines may be only part of a much larger
problem. It's a concern that certainly deserves far more attention
than it has received - but it overlooks the fact that the
mercury concentrations in vaccines dwarf other sources of
exposure to our children.
What is most striking is the lengths to which many of the
leading detectives have gone to ignore - and cover up - the
evidence against thimerosal. From the very beginning, the
scientific case against the mercury additive has been overwhelming.
The preservative, which is used to stem fungi and bacterial
growth in vaccines, contains ethylmercury, a potent neurotoxin.
Truckloads of studies have shown that mercury tends to accumulate
in the brains of primates and other animals after they are
injected with vaccines - and that the developing brains of
infants are particularly susceptible. In 1977, a Russian study
found that adults exposed to much lower concentrations of
ethylmercury than those given to American children still suffered
brain damage years later. Russia banned thimerosal from children's
vaccines 20 years ago, and Denmark, Austria, Japan, Great
Britain and all the Scandinavian countries have since followed
suit.
"You couldn't even construct a study that shows thimerosal
is safe," says Haley, who heads the chemistry department
at the University of Kentucky. "It's just too darn toxic.
If you inject thimerosal into an animal, its brain will sicken.
If you apply it to living tissue, the cells die. If you put
it in a petri dish, the culture dies. Knowing these things,
it would be shocking if one could inject it into an infant
without causing damage."
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 22 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, 10 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 24 hours of birth, and 2-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 6-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 22 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 6 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 advisors, told me, "I think if we
really have an influenza pandemic - and certainly we will
in the next 20 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 advisors 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
pocket 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, Penn., 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 32 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.
--------------------------------------------------------------------------------
Robert F. Kennedy Jr. is senior attorney for the Natural Resources
Defense Council, chief prosecuting attorney for Riverkeeper
and president of Waterkeeper Alliance. He is the co-author
of The Riverkeepers.
