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DEADLY
IMMUNITY
Robert
F. Kennedy Jr. investigates the government cover-up of a mercury/autism scandal
By
ROBERT F. KENNEDY JR.
In June 2000, a group of top
government scientists and health officials gathered for a meeting at the
isolated Simpsonwood conference center in
Norcross
,
Georgia
. 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 fifty-two 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 adviser 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 eleven-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 bio-terrorism. The measure was repealed
by Congress 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 pre-eminent 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 twenty-five 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 eleven 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 twenty-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 twenty 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 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 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, 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.
WORD
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