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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."
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