Deadly
Immunity
By Robert F. Kennedy Jr.
Salon.com
Thursday 16 June 2005
A
Salon/Rolling Stone joint investigation.
When
a study revealed that mercury in childhood vaccines may
have caused autism in thousands of kids, the government
rushed to conceal the data - and to prevent parents from
suing drug companies for their role in the epidemic.
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.
