Robert F. Kennedy Jr. investigates the government cover-up of a mercury/autism scandal
2005 11 18
By Robert F. Kennedy Jr. | rollingstone.com
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
bioterrorism. 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 eleven 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. Under the expanded schedule of vaccinations, multiple shots
were often administered on a single day: At two months, when the infant brain is
still at a critical stage of development, children routinely received three
innoculations that delivered 99 times the approved limit of mercury.
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 a
total of 187 micrograms of ethylmercury - a level forty percent 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 "had financial ties to the pharmaceutical companies that were developing
different versions of the vaccine."
Offit, who shares a patent on one of the vaccines, acknowledged to me that he
"would make money" if his vote 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.
NOTE: This story has been updated to correct several inaccuracies in the
original, published version. As originally reported, American preschoolers
received only three vaccinations before 1989, but the article failed to note
that they were innoculated a total of eleven times with those vaccines,
including boosters. The article also misstated the level of ethylmercury
received by infants injected with all their shots by the age of six months. It
was 187 micrograms - an amount forty percent, not 187 times, greater than the
EPA's limit for daily exposure to methylmercury. Finally, because of an editing
error, the article misstated the contents of the rotavirus vaccine approved by
the CDC. It did not contain thimerosal. Salon and Rolling Stone regret the
errors.
Article from: http://www.whale.to/vaccine/kennedy.html
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