http://www.putchildrenfirst.org/flu.html
If a tobacco company sourced, funded, guided, and wrote scientific
studies to prove cigarettes don't cause lung cancer, not a single
American would give the studies any credibility.
Yet, our own Centers for Disease Control (CDC), a government agency
responsible for administering our National Immunization Program, has
done the very same thing by sourcing, funding, guiding, and writing
research to try and prove that vaccines, and a mercury preservative
used in vaccines, have not fueled an epidemic of autism and other
neurodevelopmental disorders in our nation's children.
Why would the CDC do this? See for yourself, from more than two dozen
secret documents and emails in the words of those responsible.
The longer the CDC denies the true cause of the autism epidemic, the
less resources we can dedicate to treating our children today. It's
time to put our children first.
PutChildrenFirst.org was founded by parents to let the world know that
the Centers For Disease Control (CDC), a division of the Department of
Health and Human Services, is covering-up the relationship between a
near-tripling of vaccinations for our children in the 1990s and the
epidemic of autism and other neurodevelopmental disorders that began
at exactly the same time.
In 1999, the world was made aware through a joint statement by the AAP
and Federal health authorities that our children were receiving
dangerous levels of mercury through vaccines as part of the Childhood
Immunization Schedule. Soon thereafter, the CDC's own internal
analysis showed a startling correlation between autism and injected
mercury.
For the next 7 years, the CDC has manipulated data, hidden results,
purchased studies, and deceived parents, pediatricians, and
politicians in a blatant act of self-preservation and pharmaceutical
industry protectionism. When the mercury-autism connection could not
be disproven using our own American data, the CDC shopped the world
for studies to try and refute any correlation, finally finding support
from a Danish vaccine manufacturer.
We don't expect everyone who reads this website to believe us. Our
proof comes through the very words of the people responsible for this
cover-up. The Freedom of Information Act, which many of the
perpetrators did not realize applied to them, has allowed us to
unearth dozens of documents never before seen by the public. We invite
you to see for yourself. It's time to put our children first.
Introduction
"He tells me that he's got twins, and one of the twins got sick. The
doctor says, well, we've got to give him a vaccination. They give him
the vaccination while the kid is sick, and within days, this kid
starts changing and showing symptoms. Low and behold, these are
identical twins, same DNA, same, the whole deal, same egg. And that
child who was vaccinated has autism today. And this family is
struggling with it. And they believe, they believe as deeply as they
can, it's the thimerosal that caused this reaction. This is -- you
find this all over the country. You and Deidre have been terrific on
this issue. And yet, we still have mercury in vaccinations around the
country. It's absurd. I don't get it." - Senator John Kerry (D-MA),
Imus in the Morning, March 7, 2006
The vaccine-autism debate is hotter than ever and shows no signs of
abatement. We should know, we are parents of autistic children and the
ultimate determination of autism's cause is more important to us than
anyone. The more we know about cause, the more we know about how to
treat our children and reverse the symptoms of autism.
You will often see references in the press to the "proof" that there
is no correlation between vaccines and autism and between a vaccine
preservative made of mercury called Thimerosal and autism. Doctors
will often recite this "proof" to their patients and health
authorities are quick to reference this "proof" whenever pressed. For
all those people who are certain there is "proof," please read this
website and read the words of the people who created this "proof" and
decide for yourself.
This website is ultimately about how science is administered, how
peer-reviewed studies are organized, and how our federal health system
really works. Without the details, it's hard to appreciate the outrage
many parents have for how the Centers for Disease Control (CDC) has
engineered a process to produce an outcome.
Also, it's critical to understand the distinction between
epidemiological science and biological science. Epidemiology is a
backward-looking statistical science that measures relationships
between events, like the relationship between the number of
mercury-containing vaccines received and the number of autism
diagnoses. Any epidemiological study requires hundreds of assumptions,
and it's therefore notoriously susceptible to manipulation. Biological
science is different, and tends to produce more concrete evidence.
Monkeys are injected with Thimerosal, and mercury brain levels are
measured. Autistic children are compared to neurotypical children for
the amount of mercury in their bodies and brains. Cells are injected
with Thimerosal, and the impact on immune system modulators is
analyzed.
The CDC has relied exclusively on epidemiology to create their "proof"
that vaccines don't cause autism. And, they have not allowed anyone
else to look at their data, despite their obligation to do just that.
In the meantime, parents have dug deep into their pockets to sponsor
biological science, and the results, as you will read, are stunning.
It's hard to put into words what's at stake here. We believe a
generation of children have been unnecessarily poisoned. Million of
lives and families have been ruined, and we continue to poison
children with mercury all over the world, including here in the U.S.
There are billions at stake. The liability is enormous to vaccine
manufacturers. If we're right, there is jail time for the people
involved.
To make matters more absurd, despite recommending the removal of
Thimerosal (mercury) from vaccines in 1999, the CDC today has added
the flu shot to the recommended vaccine schedule for infants, pregnant
women, and young children annually. The majority of flu shots are
loaded with mercury, and this poison is creeping back into our kids at
disturbing levels. The CDC and American Academy of Pediatrics are
actually fighting state bans of Thimerosal, how can this be happening?
The CDC is in charge of administering our vaccine program. They are
also responsible for vaccine safety. To expect the CDC to stand up and
say, "this was our fault, this should have never happened" is asking a
lot, it would probably represent the greatest case of
self-incrimination in the history of mankind. They won't come clean
without a fight.
The longer the CDC stalls, denies, and obfuscates, the longer it will
take to focus the scientific community on treatment for our children.
By denying the actual cause, government funds are not available to
optimize treatment. This is the ultimate tragedy - these children
could be getting so much better if treated properly, if the truth were
to prevail. Our health authorities are spending all their time and
energy defending vaccines and the poor decisions they made when we
should all be asking and trying to solve the much more important
question, "Why are so many of our children sick?"
In the meantime, many parents have stopped looking to our health
authorities to help their children. Working with more than 400
courageous Doctors all over the country, they are following the Defeat
Autism Now! Protocol to treat their children biomedically and seeing
great results, with thousands of children fully recovered. The #1
treatment according to a parent survey? Chelation therapy to remove
heavy metals, particularly mercury, from their children's bodies.
Learn more at www.generationrescue.org.
We need objective journalists and our elected representatives to lend
a hand now. Autism is a national emergency and a national shame.
Chapter I: pre-1999
There's Mercury in Vaccines?
"The recognition that some children could be exposed to a cumulative
level of mercury over the first six months of life that exceeds one of
the federal guidelines on methyl mercury now requires a weighing of
two different types of risks when vaccinating infants. On the one
hand, there is the known serious risk of diseases and deaths caused by
failure to immunize our infants against vaccine-preventable infectious
diseases; on the other, there is the unknown and probably much smaller
risk, if any, of neuro-developmental effects posed by exposure to
thimerosal. The large risks of not vaccinating children far outweigh
the unknown and probably much smaller risk, if any, of cumulative
exposure to thimerosal-containing vaccines over the first six months
of life.
Nevertheless, because any potential risk is of concern, the Public
Health Service, the American Academy of Pediatrics, and vaccine
manufacturers agree that thimerosal-containing vaccines should be
removed as soon as possible. Similar conclusions were reached this
year in a meeting attended by European regulatory agencies, the
European vaccine manufacturers, and the US FDA which examined the use
of thimerosal-containing vaccines produced or sold in European
countries."
- Joint Statement of The American Academy of Pediatrics and the
Public Health Service (FDA & CDC), July 7, 1999, 4:15pm
At 4:15 pm Eastern time on a Friday afternoon in July 1999, a joint
statement by the AAP and Public Health Service was released to the
press advising Americans that the amount of mercury in vaccines
administered to children, through a preservative called Thimerosal,
exceeded Federal Health guidelines. This statement did not reveal the
amount of panic, backdoor negotiating, and concern federal health
officials had been engaged in for the past few weeks, after the levels
of mercury had been calculated by dumbfounded federal officials
reviewing submissions from vaccine manufacturers responding to a broad
FDA inquiry regarding mercury in consumer products. While this article
from Pediatrics ultimately looks at the policy makers favorably, it
does help explain how frenetic the process was.
How could July 1999 be the first time Federal Officials realized there
was mercury in vaccines exceeding our own safety standards? There are
many answers to this question. For some officials, this was the first
time they had learned mercury was even in vaccines. Others clearly
knew and had been concerned for some time, and at least one vaccine
manufacturer realized the levels were high eight years earlier, in
1991.
Thimerosal was first used as a preservative in vaccines in the late
1930s, long before we understood the extreme neurotoxicity of mercury.
As the FDA ratcheted up safety standards, Thimerosal was grandfathered
through due to its history without ever having to undergo any safety
testing. We may not be reading so much about Thimerosal today if the
CDC hadn't embarked upon an aggressive plan to add vaccines to the
Recommended Childhood and Adolescent Immunization Schedule in the late
1980's. In 1988, the Haemophilus Influenzae type B (Hib) vaccine was
added to the schedule, followed by the Hepatitis B (HepB) vaccine in
1991. Together, these two vaccines added six shots to the schedule,
and tripled the amount of mercury children born after 1991 received
compared to the previous generation.
The joint statement above downplayed the risk of mercury injected in
newborns, and it downplayed the degree to which mercury exceeded
federal safety standards. Doing the simple math, a child following the
recommend schedule and receiving vaccines at birth, 2 months, 4
months, and 6 months was receiving mercury in excess of the EPA safe
standards by a factor of 36x, 120x, 77x, and 66x, respectively. That's
120 times the safe Federal standard!! (See chart).
The start of the sharp increase in autism and other neurodevelopmental
disorders matches the change in the vaccine schedule. In the 1980s the
incidence of autism was somewhere between 1 in 10,000 and 1 in 5,000,
today it is 1 in 150. (See chart).
"The Food and Drug Administration (FDA) Modernization Act of 1997
called for the FDA to review and assess the risk of all mercury
containing food and drugs. In line with this review, U.S. vaccine
manufacturers responded to a December 1998 and April 1999 FDA request
to provide more detailed information about the thimerosal content of
their preparations which include this compound as a preservative,"
said the statement.
The Federal Health authorities were well aware of the potential damage
their public announcement could cause to the National Immunization
Program, and they did their best to downplay risks, slow down change,
and avoid blame or liability. Perhaps most astonishing of all, there
is still Thimerosal, at high levels, being injected in our children
before their first birthday, 7 years after this joint statement was
released.
What's Egregious About This Time Period?
1. The FDA missed (or tolerated) mercury being injected in babies
at levels well in excess of Federal safety standards and despite
thousands of studies documenting Thimerosal's extreme toxicity. The
job of the FDA is to protect our children from, amongst other things,
unsafe drugs.
2. When the FDA realized its mistake, they did not choose to
recall vaccines.
3. Merck, a vaccine manufacturer, was aware of the mercury issue
in vaccines in 1991, yet failed to do anything to protect children.
4. When adding vaccines to the schedule in the late 80s and early
90s, the FDA only required vaccines to be tested independently. No
testing was ever done to determine the risk of cumulative exposure of
multiple vaccines, often received on the same day.
5. When faced with the information regarding high mercury levels
in vaccines, the federal health authorities seemed more concerned with
the risk of undermining the National Immunizations Program and
creating liability for pharmaceutical companies than the health of our
children.
6. In 2006, Thimerosal remains in vaccines, despite statements
like this that are on the FDA's own website today: "During the past
ten years, the FDA has provided informal and formal advice to
manufacturers recommending that new vaccines under development be
formulated without thimerosal as a preservative."
7. In 2006, despite the 1999 announcement, both CDC and AAP are
actively fighting laws at the state level intended to ban mercury once
and for all from children's vaccines.
Where is the Evidence?
1. Merck Internal Memo Citing Dangerous Levels of Mercury In
Vaccines
March 1991
Written By Dr. Maurice Hilleman and sent to Dr. Gordon Douglas,
President of Merck Vaccine Division
This memo was written 8 years before the FDA "discovered"
there was mercury in vaccines well in excess of Federal safety
standards. Among the many unsettling comments, Dr. Hilleman notes
that, "Sweden is requiring Thimerosal-free single-dose packaging of
all products...The U.S. Food & Drug Administration (CBER) does not
have this concern." He writes:
"If 8 doses of Thimerosal-containing vaccine were given in the
first 6 months of life (3 DPT, 2 HIB, and 3 Hepatitis B) the 200 ug of
mercury given, say to an average size of 12 lbs., would be about 87X
the Swedish daily allowance of 2.3 ug of mercury for a baby of that
size. When viewed in this way, the mercury load appears rather large."
What happened to this memo? Did FDA ever see it? Did CDC ever
see it? What did Merck do with this information?
Source: Leaked transcript from sealed court filings.
2. Patriarca FDA/CBER Internal Email: "Asleep at the Switch"
July 2 1999
Written by Dr. Peter Patriarca, CBER/FDA, and sent to Dr. Lawrence
Bachorik, FDA.
This memo was written by Dr. Peter Patriarca, who at the time
was the Director of the Office of Vaccines Research and Review, within
the FDA Division of the Center for Biologics Evaluation and Research.
This is the division of the FDA with responsibility for vaccine
safety. The email was written to Dr. Lawrence Bachorik, Ph.D, the
FDA's Senior Adviser for communication. It was written in the frenzy
leading up to the public announcement on July 7. It highlights the
concern on vaccination policy over the safety of our children and the
genuine concern FDA had for how this announcement would cause their
inaction to be perceived. He writes:
"You should also be aware that if the U.S. (and perhaps the
EU) adopts a position that the theoretical risk of ethyl mercury
exposure outweigh its potential benefits to the point where no
vaccines used in the US or Europe will contain thimerosal [which is
where things appear to be headed}, this could also have a severe
impact on global ('third world') vaccination programs, particularly
for hepatitis B and whole-cell DTP vaccines. which for various
reasons, will almost certainly have to have thimerosal as an
ingredient for potentially many years to come. WHO has already made a
plea to the American Academy of Pediatrics to "tread lightly" and
"consider the global ramifications" of their evolving policy. Finally,
in my own personal opinion - and as a heads-up because I believe it
could come up -- the greatest point of vulnerability on this issue is
that the systematic review of thimerosal in vaccines by the FDA could
have been done years ago and on an ongoing basis as the childhood
immunization schedule became more complex. The calculations done by
FDA are not complex. I'm not sure if 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."
Source: FOIA filing by parents.
3. Patriarca FDA/CBER to CDC Email: "A Plan is In Place"
June 29 1999
Written by Dr. Peter Patriarca and sent to Dr. Roger Bernier and Dr.
Jose Cordero, CDC
This memo was also written by Dr. Peter Patriarca, a few days
before the memo above, and sent to two of the leaders of the National
Immunization Program at CDC, Dr. Roger Bernier and Dr. Jose Cordero.
In it, Dr. Patriarca shows even more fully how concerned FDA was about
their image after the pending announcement, and Dr. Patriarca stresses
that a plan to deal with Thimerosal has "already been in place for
many years." He writes:
"The fact of the matter is that an 'interim plan' (for
potential removal of thimerosal) has already been in place for many
years we just need to 'speed up' the existing plan not create a 'new'
interim plan."
Patriarca noted that hastening the removal of thimerosal
would, "...raise questions about FDA being 'asleep at the switch' for
decades by allowing a potentially hazardous compound to remain in many
childhood vaccines, and not forcing manufacturers to exclude it from
new products. It will also raise questions about various advisory
bodies regarding aggressive recommendations for use. We must keep in
mind that the dose of ethylmercury was not generated by 'rocket
science'. Conversion of the percentage thimerosal to actual micrograms
of mercury involves ninth grade algebra. What took the FDA so long to
do the calculations? Why didn't CDC and the advisory bodies do these
calculations when they rapidly expanded the childhood immunization
schedule?"
Source: FOIA filing by parents.
4. Dr. Maurer to Congressman Burton Email: "Risks which can be
avoided"
December 4 2002
Written by Dr. Wolfgang Maurer to Congressman Dan Burton (R-IN),
Committee on Government Reform
Dr. Maurer is an international expert on mercury in medicine
from Vienna University (Austria). His email helps highlight how much
was known about Thimerosal's toxicity and how far ahead of the FDA
Europe appeared to be on the issue of mercury in vaccines. This email
highlights FDA's inexplicable complacency in dealing with Thimerosal
in vaccines. He writes:
"... more organic mercury was given with vaccines in the 1st
yr of live (sic) compared to food. During all this time I addressed my
concerns also to representatives of the pharmaceutical industry at
meetings in Austria and abroad, also to representatives of
US-manufacturers of vaccines...In a letter to the European
Pharmacopoiea (addressed to Jean-Marc Spiesser) dated 21.May 1996 I
again formulated my concerns and proposed a ban on
organomercurials...To my opinion it was very clear in the [1980s],
that [thimerosal] is an unappropiate preservative in medicines. Major
toxicity concerns regarding its use in preparations with a high volume
per injection and/or low body weight and major concerns due to
potential mass sensitization so jeopardizing every vaccination
programm (sic)...In medicine risks which can be avoided must be
avoided. I urge you to ban organomercurials in medicinal products and
also in medical devices."
Source: Committee on Government Reform, U.S. House of
Representatives.
5. Dr. Ruth Etzel to AAP Email: "Be Open and Honest Now"
July 2 1999
Written by Dr. Ruth Etzel, USDA Division of Epidemiology and Risk
Assessment, to the American Academy of Pediatrics team involved with
the announcement
This email was written soon after Dr. Etzel learned of the
strategy regarding the July 9, 1999 announcement. In it, she expresses
her concern with the approach being recommended and the risk of loss
of trust. Perhaps no better email exists that predicts what has taken
place over the last seven years. We only wish Dr. Etzel's advice had
been followed. She writes:
"The AAP should be dedicated to promptly providing truthful
information about this situation to pediatricians. We must follow the
three basic rules: (1) Act quickly to inform pediatricians that the
products have more mercury than we realized (2) Be open with consumers
about why we didn't catch this earlier (3) Show contrition...To keep
faith, we must be open and honest now and move forward quickly to
replace these products...This is what American parents want to hear
from their pediatricians. Anything less may cause them to lose faith
in our recommendations."
Source: FOIA filing by parents.
6. Dr. Fred Varrichio FDA/CBER Email: "7,000 Reports on
Thimerosal"
January 19, 1999
Written by Dr. Fred Varrichio to Dr. Leslie Ball, internal FDA email
within the FDA Division of the Center for Biologics Evaluation and
Research.
This email was from Dr. Varrichio to Dr. Ball. Dr Varrichio
was charged with doing research on Thimerosal's toxicity, and this
email highlights how much information was already present in the
scientific literature on the dangers of Thimerosal. He writes:
"I have some results for you. Problem is that there are 7000
reports that mention Thimerasol. What to do now. Obviously looking at
all 7000 is a brute force approach."
Source: FOIA filing by parents.
7. Dr. Ben Schwartz CDC/NIP Email: "Cumulative Exposure"
July 3, 1999
Written by Dr. Ben Schwartz to all the leaders of the National
Immunizations Program at CDC.
This email was from Dr. Ben Schwartz to all the key decision
makers at CDC, written just six days before the July 9, 1999
announcement, and it highlights the intense focus of the participants
on CYA and moderation, rather than the safety of children. Dr.
Schwartz recommends a form of trickery that many members of CDC and
FDA have used since: focusing on "cumulative exposure" rather than
daily exposure of mercury. This is analogous to a Doctor saying, "Take
one aspirin a day for 90 days", the patient instead takes 90 aspirin
on one day, and viewing those two events as having equivalent
outcomes. Dr. Scwartz is recommending adding up the safe daily dose of
mercury, looking at that dosing over a six month period, and comparing
it to the amount of mercury children receive, without bothering to
note that all the mercury is received in 2 visits to the doctor.
"As a parent of a 3-month old, I was very uncomfortable with
the good vaccine/bad vaccine dichotomy and would have been reluctant
to accept a Thimerosal containing product for my baby. Given the
approach presented below, I would be very comfortable knowing that my
child would receive a Thimerosal containing product as long as the
defined safe cutoff for mercury is not exceeded [PCF note: it was
exceeded, by any standard]...When the focus of the communication was
on the vaccine product rather than the child, there was an inherent
contradiction: why are we moving to Thimerosal free vaccines if
vaccines containing this product are safe? Parents inevitably would
want vaccines that dont contain thimerosal, leading to shortages,
deferral of vaccination, and receipt of mercury concentrations that
exceed the cutoff by some children. The communication problem is
avoided by presenting child focused messages."
Source: FOIA filing by parents.
8. Thimerosal MSDS from Eli Lilly
Update December 22, 1999
Official Material Safety Data Sheet
This is a copy of the actual MSDS for Thimerosal from its
manufacturer, Eli Lilly. Any scientist at CDC or FDA would have had
access to this MSDS. Excerpts:
"Exposure Guidelines: Thimerosal - no known occupational
limits established...Exposure to mercury in utero and in children can
cause mild to severe mental retardation and mild to severe motor
coordination impairment...Use of chelating agents such as BAL may be
needed to treat ingestion of mercury...Target Organ Effects: Mercury -
Nervous system effects (insomnia, tremor, anorexia, weakness,
headache), liver effects (jaundice, digestive effects (hypermotility,
diarrhea)."
9. Quiet Scientist No More: Dr. David Graham
November 19, 2004
USA Today
This article from USA Today from famed whistleblower Dr. David
Graham of the FDA highlights the internal climate of the FDA as it
relates to people who come forward with safety concerns:
"Graham says he has heard concerns similar to his from
counterparts who monitor medical devices and biologics, such as
vaccines, but they're reluctant to come forward. "They are absolutely
afraid for their jobs," Graham says. "We've got families to support."
He's married to his college sweetheart, and they have six children
ages 9 to 23."
10. Jon Ryter: Warning to Be Downplayed
July 1, 1999
Freerepublic.com
This was written 8 days before the announcement and represent
one of the few journalists who accurately predicted the strategy and
approach of the Public Health Service in "warning" about Thimerosal.
"The CDC, like all other bureaus of government recognizes that
when you need to release negative information, release it on Friday
since most Americans ignore the news on the weekends. The concern of
the IAG staffer who turned this document over to me was that the CDC
was engaging in a coverup that was deliberately attempting to play
down the danger of the chemical THIMEROSAL, an organomecurial
preservative used to stabilize many of the vaccines, immoglobins and
some food products simply because the government cannot afford to
dispose of its entire inventory of vaccines containing this
substance."
Chapter II: 1999-2000
Simpsonwood
"the number of dose related relationships [between mercury and autism]
are linear and statistically significant. You can play with this all
you want. They are linear. They are statistically significant." - Dr.
William Weil, American Academy of Pediatrics. Simpsonwood, GA, June 7,
2000
"the issue is that it is impossible, unethical to leave kids
unimmunized, so you will never, ever resolve that issue [regarding the
impact of mercury]." - Dr. Robert Chen, Chief of Vaccine Safety and
Development, Centers For Disease Control, Simpsonwood, GA, June 7,
2000
"Forgive this personal comment, but I got called out at eight o'clock
for an emergency call and my daughter-in-law delivered a son by
c-section. Our first male in the line of the next generation and I do
not want that grandson to get a Thimerosal containing vaccine until we
know better what is going on. It will probably take a long time. In
the meantime, and I know there are probably implications for this
internationally, but in the meanwhile I think I want that grandson to
only be given Thimerosal-free vaccines." - Dr. Robert Johnson,
Immunologist, University of Colorado, Simpsonwood, GA, June 7, 2000
"But there is now the point at which the research results have to be
handled, and even if this committee decides that there is no
association and that information gets out, the work has been done and
through the freedom of information that will be taken by others and
will be used in other ways beyond the control of this group. And I am
very concerned about that as I suspect that it is already too late to
do anything regardless of any professional body and what they say
My
mandate as I sit here in this group is to make sure at the end of the
day that 100,000,000 are immunized with DTP, Hepatitis B and if
possible Hib, this year, next year and for many years to come, and
that will have to be with thimerosal containing vaccines unless a
miracle occurs and an alternative is found quickly and is tried and
found to be safe." - Dr. John Clements, World Health Organization,
Simpsonwood, GA, June 7, 2000
Soon after the joint statement by the AAP and Public Health Service
was released, all hell broke loose, and the CDC moved into damage
control mode, where they remain today, seven years later. (Here's a
great article from the Hepatitis Control Report on the panic.) Parents
of autistic children began to compare the symptoms of autism to the
symptoms of mercury poisoning, and a feisty Congressman from Indiana
with an autistic grandson, Dan Burton, started using his pulpit as
head of the Committee on Government Reform to ask very tough
questions. By August, two months after the joint statement, his
committee was in a full-scale investigation of conflict in vaccine
policy, which the CDC knew.
Shockingly, CDC received letters in July and September 1999 from Merck
and SmithKline Beecham, respectively, letting CDC know that full
production of Thimerosal-free vaccines for Hepatitis B and DTaP could
be made available almost immediately. To SmithKline, CDC responded
with a tepid letter thanking them for the offer, but not taking them
up on it. Thimerosal would remain in the vaccines on the Childhood
Immunization Schedule for three more years, into late 2002, before
Thimerosal-free vaccines were finally available for all vaccines, as
this letter from FDA to Congressman Dave Weldon demonstrates. CDC's
inexplicable complacency in the face of the July 1999 statement to
switch over to Thimerosal-free vaccines was highlighted in this March
2006 article by Robert F. Kennedy, Jr in the Huffington Post.
As part of the FDA Modernization act that spurred the joint statement,
FDA was required to commission the Institute of Medicine to review the
impact of mercury in vaccines. The IOM's study began in late 1999 with
an expected publication date in 2001. For the CDC, the walls were
starting to close in, particularly for the man responsible for both
vaccine development and vaccine safety, Dr. Robert Chen. The knowledge
of a looming IOM review spurred CDC to take matter into their own
hands.
Soon after the AAP statement a young CDC epidemiologist, Dr. Thomas
Verstraeten, was given the task of comparing neurodevelopmental
outcomes of children exposed to Thimerosal using the CDC's internal
database, the Vaccine Safety Datalink (VSD). CDC hoped to run their
own analysis, establish no relationship between Thimerosal and autism,
give the analysis to the IOM, and close this chapter for good. By
November of 1999, just 5 months after the joint statement, Dr.
Verstraeten was in a near panic as the data he was analyzing was
showing a clear, unassailable, ugly truth: there was a statistically
significant relationship between the amount of mercury children were
receiving through their vaccines and autism. No matter how he tried to
run the numbers, he wrote, the association "just won't go away."
In June of 2000, six months after Dr. Verstraeten's analysis revealed
a clear correlation, the CDC commissioned a private meeting at the
Simpsonwood Conference Center in Atlanta, GA, with representatives
from the CDC, other health organization (WHO, FDA) and representatives
of vaccine manufacturers to share some startling news: despite six
full months of trying to dumb down the data, CDC's analysis was still
showing a statistically significant relationship between
neurodevlopmental disorders, especially autism, and Thimerosal
children received through their vaccines.
The Simpsonwood meeting set that stage for the way the CDC has
conducted themselves ever since: control the damage, bury the data,
and ensure that the National Immunization Program never misses a beat.
The candor and incriminating statements of the Simpsonwood attendees
is at times breathtaking, as some of the above quotes demonstrate, and
a whole website could be devoted to analyzing the words of the
participants. A great summary of the Simpsonwood meeting is available
through this excellent article written by Dr. Russell Blaylock. The
transcript from the meeting was stamped with the words "Do Not Copy or
Release" and "Confidential", but was obtained by parents through FOIA.
What's Egregious About This Time Period?
1. Dr. Verstaeten's analysis of the CDC's VSD showed a clear and
unassailable relationship between Thimerosal received and
neurodevelopmental disorders. Recent emails now show how Dr.
Verstraeten began the complex task of managing the relationship down
and the advice he received in doing so. By the time his work was
actually published in Pediatrics, almost 3 years later, the data had
been manipulated to the point of showing no association between
Thimerosal and autism. For an explanation of how the CDC removed the
association, click here.
2. In the midst of the controversy surrounding Thimerosal, CDC
was given the opportunity to switch to Thimerosal-free versions of
Hepatitis B and DTaP immediately following the joint statement by two
vaccine manufacturers in the Fall of 1999 and chose not to.
3. The Simpsonwood meeting was unprecedented: a secret meeting
convened by a public government agency (CDC) that also included
vaccine manufacturers. Why were vaccine manufacturers involved in
policy decision and reviewing data that could potentially make them
liable for billions in damages? No document more clearly demonstrates
the inability of public health officials to put our children first
than the Simpsonwood transcript.
Where is the Evidence?
1. Simpsonwood Transcript
June 7-8, 2000
Simpsonwood Conference Center, Atlanta, GA
This transcript, at 238 pages, is a challenging read, and Dr.
Blaylock's article is a great place to start. The scope of the
transcript is breathtaking, as it shows the wide range of concerns,
very few of which have anything to do with the safety of children,
that the individuals responsible for US vaccine policy wrestled with
as they were confronted with data unassailably linking thimerosal from
vaccines and damaged children. Perhaps Dr. Robert Chen of CDC summed
it up best towards the end of the meeting, setting the stage for a
cover-up now in its seventh year:
"We have been privileged so far that given the sensitivity of
information, we have been able to manage to keep it out of, let's say,
less responsible hands..."
Source: FOIA filing by parents.
2. Verstraeten CDC Internal Email: "It Just Won't Go Away"
December 17, 1999
Written by Dr. Thomas Verstraeten, CDC, and sent to Dr. Robert Davis
and Dr. Frank Destefano, title, CDC.
Dr. Verstraeten was responsible for the preliminary analysis
of the CDC's Vaccine Safety Datalink to determine if a relationship
existed between Thimerosal and autism. The "It" in Dr. Verstraeten's
subject line of "It just won't go away" is the correlation between
Thimerosal and autism. Dr. Verstraten also notes that "all the harm is
done in the first month."
Dr. Verstraeten's email is a working email describing the
analysis he is doing with references to spreadsheets that contain
specific data. Not until a recent FOIA was that data available which
you can now see here. This new information, through the data known as
"Generation Zero", highlights just how extreme the correlations were
between Thimerosal and neurodevelopmental disorders.
As one example, on the first page of the spreadsheet, if you
look under the "2990" category for autism, it shows a 7.62 incidence
for children who receive the largest mercury dose in month 1, called
"HgCat1 (3)", a highly statistically-significant correlation.
Source: FOIA filing by parents.
3. Verstraeten CDC Internal Email: "Disprove an Unpleasant
Theory"
July 14, 2000
Written by Dr. Thomas Verstraeten, CDC, and sent to Dr. Phillipe
Grandjean
This email was written one month after the Simpsonwood secret
meeting. Dr. Verstraeten, as the lead CDC epidemiologist analyzing the
Generation Zero data showing a high correlation between mercury and
autism, was very frustrated by the focus of participants in the
Simpsonwood meeting on managing information, liability, and
reputations, rather than the science and data at hand. He complains:
"Unfortunately, I have witnessed how many experts, looking at
this thimerosal issue, do not seem bothered to compare apples to pears
at the best and insist that if nothing is happening in these studies
[referring to some old science on other types of mercury exposure]
then nothing should be feared of thimerosal.
I do not wish to be the advocate of the anti-vaccine lobby and
sound like being convinced that thimerosal is or was harmful, but at
least I feel we should use sound scientific argumentation and not let
our standards be dictated by our desire to disprove an unpleasant
theory."
Source: SafeMinds
4. Merck and Smithkline letters, 1999: We can be thimerosal-free
today
July 7, 1999 and July 31, 1999
Letters sent from vaccine manufacturers to the CDC.
These letters were only recently acquired through parent
filings of FOIA. Merck wrote:
"Beginning in early September 1999
the Company believes it
could provide sufficient thimerosal-free vaccine."
SmithKline wrote:
"SB is in a position to to supply...the only DTPa vaccine that
does not use Thimerosal as a preservative in enough quantities to
supply the estimated U.S. market needs for the remainder of 1999."
CDC responded to SmithKline:
"[The CDC NIP staff] has communicated this updated information
regarding your supply to the 64 immunization projects. CDC also plans
to monitor DTaP ordering patterns and continue to provide the States
with a choice among currently licensed brands of DTaP vaccines."
Translation: Although we just said mercury should be removed
from vaccines quickly, we are not going to take you up on your offer
to do just that. Robert F. Kennedy's recent article on this letter
exchange helps capture the outrage many feel.
Source: FOIA filing by parents.
5. Boyle CDC Internal Email: "What happens if you do this?"
April 25, 2000
Written by Dr. Coleen Boyle, Acting Assistant Director for Science to
Dr. Frank Destefano, title, CDC.
Dr. Boyle wrote this email after reviewing the Verstraeten
analysis in an internal CDC meeting. By this time, CDC had begun to
manipulate the data in order to reduce the correlation between mercury
and childhood disorders, although the correlation was still strong
enough for the Simpsonwood meeting to take place two months later.
Dr. Boyle's questions reveal much about the nature of the
manipulation. She writes:
"Since most of the dx's [diagnosis] are generally not picked
up until the 2nd or 3rd year of life had you considered eligibility
criteria of at least 18 months or 2 years?? What happens if you do
this?"
What Dr. Boyle is noting is that the current analysis CDC is
doing includes children as young as six months of age in their
analysis, who have no chance of being diagnosed with autism yet, which
allows the relative incidence level to decline. The average age of
autism diagnosis is estimated to be 4. So, a reasonable cutoff for any
analysis trying to find autism incidence would be 2 1/2 or 3 (rather
than the 18 months Dr. Boyle mentions), not 6 months old. The only
reason to include 6 month-olds in the analysis of the incidence of an
autism diagnosis is to lower the incidence and exonerate Thimerosal.
She continues:
"For me the big issue is the missed cases - and how this
relates to exposure. Clearly there is a gross underreporting."
Dr. Boyle is pointing out the limitations of the CDC's
analysis. The CDC relied on two large West Coast HMOs to get data on
the number of patients with an autism diagnosis. CDC maintained the
internal data on the vaccines these children received and put the two
sets of information together to establish if those receiving more
mercury had higher rates of autism. The problem is that HMOs
materially underreport the number of cases of autism relative to
national averages because many parents go outside of their HMO to get
the diagnosis and to seek treatment for their children.
CDC had considerably lower incidence levels to start with
based on their data source. They lowered the age they were looking at,
before children can receive an autism diagnosis, to lower the
incidence even further, and they still had a material correlation
strong enough to warrant an emergency meeting in Simpsonwood.
Source: FOIA filing by parents.
6. Letter From FDA to Congressman Dave Weldon, M.D. (R-FL)
June 18, 2003
Letter from the FDA confirming the actual expiration dates of
Thimerosal-containing vaccines for children to Congressman Dave
Weldon, M.D. (R-FL)
This letter refutes the often-reported fallacy that Thimerosal
was removed from children's vaccines in 1999. In fact,
Thimerosal-containing vaccines were in the market with expiration
dates as late as September 2002, as this letter explicitly states.
(It's also worth noting that the FDA has no mechanism for tracking
vaccines on the shelf, so its plausible that vaccines were in the
supply chain well past their expiration dates.)
Today, the timing of the removal of Thimerosal is becoming
even more murky, as CDC has recently placed Influenza vaccine on the
recommended schedule, the vast majority of which are loaded with
mercury, as this UPI article, "Mercury Creeps Back In", notes.
Merck appears to have contributed to this misunderstanding,
with this press release in 1999, which was extremely misleading. As
this Los Angeles Times article in 2005 noted:
"Drug maker Merck & Co. continued to supply infant vaccine containing
a mercury-based preservative for two years after declaring that it had
eliminated the chemical.
In September 1999, amid rising concern about the risks of mercury in
childhood vaccines, Merck announced that the Food and Drug
Administration had approved a preservative-free version of its
hepatitis B vaccine.
"Now, Merck's infant vaccine line," the company's press release said,
"is free of all preservatives."
But Merck continued to distribute vaccine containing the chemical
known as thimerosal, along with the new product, until October 2001,
according to an FDA letter sent in response to a congressional
inquiry.
The thimerosal-containing supplies had expiration dates in 2002."
Chapter III:2001
IOM: Biologically Plausible
"When members of an advisory committee have financial relationships
with different companies whose products are being reviewed, subtle
pressures can be brought to bear to respect the parochial interests of
other committee members. This sort of clubby relationship can lead to
an overall decline in vigilance in matters under review. Such a lack
of vigilance was noted in the deliberations over the Rotavirus
vaccine." - Conflicts of Interest in Vaccine Policy Making, Committee
on Government Reform, U.S. House of Representatives, August 21, 2000
"Mr. Speaker, I will say tonight that mercury should be taken out of
every vaccine in the country, and it should be taken out today. There
should be an instant recall on any vaccine that is going into our
children that has mercury in it." - Congressman Dan Burton, Speech
before the US House of Representatives, May 15, 2001
"The Committee concludes that although the hypothesis that exposure to
thimerosal-containing vaccines could be associated with
neurodevelopmental disorders is not established and rests on indirect
and incomplete information, primarily from analogies with
methylmercury and levels of maximum mercury exposure from vaccines
given in children, the hypothesis is biologically plausible." -
October 2001, Immunization Safety Review: Thimerosal - Containing
Vaccines and Neurodevelopmental Disorders, Institute of Medicine
Late 2000 and 2001 was a rough time for the CDC. Simpsonwood had
already highlighted the challenges CDC faced with the data they were
sitting on. In August of 2000, two months after Simpsonwood, Dan
Burton's Government Reform Committee released a highly critical
document on the conflicts of interest at CDC and FDA for decision made
on the Rotavirus vaccine, recently recalled due to intussusception in
children (a severe bowel disorder), and critical of vaccine policy
making in general.
In January 2001, parents associated with the nonprofit group SafeMinds
published an article in a peer-reviewed journal titled Autism: A Novel
Form of Mercury Poisoning. Chairman Burton continued to hold hearings,
browbeating public health officials over the lapse on thimerosal and
what was being done about it. This was followed up that May by a
speech by Chairman Burton demanding FDA recall any vaccine containing
thimerosal at once (they didn't).
Once it was clear that unsafe levels of mercury were in the vaccine
supply, FDA was required to hire the Institute of Medicine to review
thimerosal and any role it may play in damaging children. With the
weight IOM carried with the scientific community, IOM's conclusions,
expected to be published in late 2001, were of grave concern to CDC.
By the summer of 2001, CDC was aware of IOM's likely conclusion, which
was not particularly favorable to CDC: they were going to say that the
notion that thimerosal created neurological disorders was
"biologically plausible" and merited further study. CDC had already
given IOM their data from the VSD, which had been manipulated enough
to neither prove nor disprove an association.
Perhaps most frustrating about the recommendations of the IOM in
October 2001 is that CDC did not pursue any of them. Where IOM
recommended further work to assess biologically plausibility (like
measuring mercury levels in autistic children), CDC would focus
exclusively on epidemiology, a statistical science easily manipulated.
Where IOM encouraged CDC to explore the growing reports of autistic
children recovering after chelation therapy, a treatment to remove
mercury and other metals from the body, CDC never did anything to
explore the reports further. Where IOM encouraged CDC to replace any
thimerosal containing vaccines immediately, CDC still has vaccines
with thimerosal targeted at infants today, five years later.
Luckily for the children, what CDC did not realize was that parents
would dig into their own pockets to fund biological research to prove
what had been done to their children, as we will discuss in Chapter 5.
CDC was in a bind. They knew what the Generation Zero data had shown
and how explosive that information, if released, would be to the
National Immunization Program, their jobs, and vaccine manufacturer
liability. They also knew IOM was not going to let them off the hook,
and that more work and analysis would be recommended. It left only two
alternatives for CDC, both of which they continue to follow today:
1. Never, ever let anyone else see the Generation Zero data nor
any of CDC's other internal data. Given all the shortcuts and
assumptions CDC made to manage down the risks, independent researchers
would most assuredly come to a different conclusion. Even though laws
required CDC to share this data publicly, they would become experts at
buying time and "losing" data when pressured.
2. Since the U.S. data shows a high correlation, go to other
countries and find willing participants to manufacture data that will
"prove" thimerosal and autism are unrelated.
With that strategy in place, a few months prior to the release of the
IOM study, CDC employees, under the guidance of their bosses, Dr.
Walter Orenstein, Director of the NIP and Dr. Roger Bernier, Associate
Director of Science for the NIP, began a world-wide inquiry to find
data from other countries that would be used bail them out. Not only
would CDC initiate, fund, and structure these studies, but their own
employees would also end up as published authors in the studies
exonerating thimerosal's role in autism.
What's Egregious About This Time Period?
1. In 2000-2001, after Simpsonwood, CDC slowed down the timing of
the release of their own analysis on thimerosal and autism (the
analysis, begun in mid-1999, and discussed at Simpsonwood in 2000,
would not get published until late-2003), with CDC leaders aware that
the data implicated Thimerosal.
2. Almost all of the 2001 recommendations of the IOM were ignored
by CDC.
3. A Congressman on the floor of the House or Representatives
made an impassioned plea to recall vaccines with thimerosal and
nothing was done about it.
4. 2001 was the beginning of a pattern that continues to this day
of CDC stalling and not allowing independent researchers access to the
data behind their VSD analysis of autism and thimerosal.
Where is the Evidence?
1. 2001 IOM: Immunization Safety Review: TCVs and
Neurodevelopmental Disorders
October 2001
Institute of Medicine
This document from the Institute of Medicine noted the
"biological plausibility" of thimeorsal causing neurological damage in
children and directed more research to be done. What's most alarming
about the 2001 IOM study is how few of their recommendations CDC
actually followed, which highlights the clear path CDC was already on:
find epidemiology studies that can be manipulated, hire IOM once the
studies have been created (which they did in 2004), and close the door
on the debate. IOM makes many recommendations in here that were never
pursued including:
IOM Recommendation: "The committee recommends the use of
thimerosal-free DTaP, Hib, and hepatitis B vaccines in the United
States, despite the fact that there might be remaining supplies of
thimerosal-containing vaccines available [effectively echoing
Congressman Burton's call for a recall]."
CDC response: Nothing, and thimerosal remains in vaccines
today given to infants.
IOM Recommendation: "The committee recommends case-control
studies examining the potential link between neurodevelopmental
disorders and thimerosal-containing vaccines."
CDC Response: No case-control studies ever done.
IOM Recommendation: "The committee recommends further analysis
of neurodevelopmental outcomes in these populations [children who
received no thimerosal in their vaccines]"
CDC Response: No analysis ever done.
IOM Recommendation: "The committee recommends research on how
children, including those diagnosed with neurodevelopmental disorders,
metabolize and excrete metals, particularly mercury."
CDC Response: No research ever done.
IOM Recommendation: "The committee recommends continued
research on theoretical modeling of ethylmercury exposures, including
the incremental burden of thimerosal on background mercury from other
sources."
CDC Response: No research ever done.
IOM Recommendation: "The committee recommends careful,
rigorous, and scientific investigations of chelation when used in
children with neurodevelopmental disorders, especially autism."
CDC response: Nothing. We know of no case where CDC
investigated claims of a fully recovered autistic child or explored in
any way biomedical treatment of autistic children.
IOM Recommendation: "The committee recommends research to
identify a safe, effective, and inexpensive alternative to thimerosal
for countries that decide they need to switch."
CDC response: No research done. Thimerosal was developed in
the 1930s, no safety testing has ever been done on it, and yet the
vaccine industry cannot develop a safer preservative that doesn't
include mercury, the second most toxic substance on earth?
Source: IOM
2. Letter from Dave Weldon to Julie Gerberding: "Absurd results"
October 31, 2003
From Congressman Dave Weldon, M.D. to the Director of the CDC, Julie
Gerberding.
This letter was written in 2003, but highlights the conduct of
CDC in the previous few years, including the management of data and
the unwillingness to share data with outside researchers.
"A review of these documents leaves me very concerned that
rather than seeking to understand whether or not some children were
exposed to harmful levels of mercury in childhood vaccines in the
1990s, there may have been a selective use of the data to make the
associations in the earliest study [Generation Zero] disappear...This
demonstrates to me how excessive manipulation of data can lead to
absurd results."
Source: FOIA filing by parents.
3. Instant Recall Speech, Dan Burton
May 15, 2001
Speech by Congressman Dan Burton before the U.S. House of
Representatives
We only wish Congressman Burton's request had been honored. In
2006, Thimerosal remains in vaccines given to infants and pregnant
women.
Source: Committee on Government Reform.
Chapter IV: 2001-2002
CDC World Travel
"Thus these data [referring to some anecdotal information in his
email] do not support and in fact argue strongly against the
allegation that the thimerosal in vaccines (or variation on this
theme, increase in the number of antigens) is responsible for the
increase in autism. Research into better understanding autism and its
possible increase is needed, but following red herrings do (sic) not
help anyone." - Private email from Dr. Robert Chen, Chief of Vaccine
Safety, National Immunization Program, CDC, June 13, 2001
Dr. Chen was Chief of Vaccine Safety for the CDC's National
Immunization Program (NIP) and the man ultimately responsible for
monitoring the safety of vaccines (Dr. Chen was quietly removed from
this position in early 2005, largely due to his conduct during this
time. Most of the emails from Dr. Chen received through FOIA look like
this, with all correspondence deleted by CDC lawyers). Dr. Chen's
comments above, and the time he made them, are very revealing:
- Dr. Chen's comments are twelve months after Simpsonwood, where
he and Dr. Verstraeten shared information regarding the troubling
correlation between thimerosal and autism from their own data. Dr.
Chen also had access to the "Generation Zero" data, which had shown an
even higher correlation between thimerosal and autism. He knew there
was a problem!
- In the twelve months since Simpsonwood, no new scientific
studies had been published, and Dr. Verstraeten was working to
dumb-down the CDC's internal data.
- Dr. Chen was actively working to keep the CDC's data from
being reviewed by outside researchers, which CDC has successfully done
through today.
- Dr. Chen was involved in a worldwide search for data on autism
and thimerosal, the brainchild of Dr. Roger Bernier, Associate
Director for Science of the NIP and headed by Dr. Diane Simpson, the
Deputy Director of the NIP.
CDC's effort, beginning in the summer of 2001, was in anticipation of
the IOM's report coming out in the October 2001. They knew what it was
going to say and they knew it was going to be trouble. The CDC's
subsequent worldwide effort was an attempt to find corroborative data
showing no link between autism and thimerosal and get it to the IOM or
release it at the same time as the IOM report was released. As Dr.
Diane Simpson says in this August 7, 2001 email:
"I don't have any new data at the moment and am frantically trying to
see what is available and how best to get it in time for the expected
IOM report release (we have given up trying to submit it in time for
the report as they are in the process of writing it)."
Dr. Simpson's actions beginning in June of 2001, the same month when
Dr. Chen made the above comment, require some context. The Deputy
Director of the NIP, Dr. Simpson, was given the task of finding data
on autism and thimerosal in other countries. And not just any data,
she was looking for data that would support the statement of her
colleague up above, Dr. Robert Chen, that there was no relationship,
despite the fact that they had both seen the Generation Zero data and
both attended Simpsonwood. Further, you have the division of the CDC
that is responsible for keeping vaccination rates high, the division
that would be held most responsible for creating the autism epidemic,
and one of the leaders of that division, Dr. Robert Chen, who had the
most to lose, directly involved in a process to find data about the
relationship between thimerosal and autism.
Would CDC be "frantic" to find data that would corroborate the
conclusion coming from IOM, that the thimerosal-autism relationship
was "biologically plausible"? No, she was frantic to find data to
disprove it. In the same month, she tells a Swedish researcher in this
email that they could fly to Sweden immediately to look at data,
"because our IOM committee's work is in process and we expect them to
issue their report in the next several weeks, we expect increased
public concern and questions in the near future." In an email with
another CDC employee, referring to data she may have unearthed in
Denmark, she writes, "it is also possible that the data won't help us
at all, but we won't know until we see it." How won't it help? It
won't help unless it can be used to exonerate Thimerosal and the CDC.
As an example, Dr. Simpson's communication with the State of
California (where autism data is the best in the country) produced a
stunning data set, and one quickly buried. In this email, we see data
provided by Dr. Loring Dales from the California Dept of Health
showing the relationship between the vaccination rates of DTP by
second birthdays, and the number of autism cases in California. One of
Dr. Simpson's colleagues mentions "this looks like material for a
graph." The graph is created, page 3 of the email, and there is a
clear, linear relationship between the increase in vaccination rates
(from 50.9% to 75.7%) and the number of autism cases per year (from
176 to 1182, a 6.7x increase) between 1980-1994. Needless to say,
California was not the source of additional follow-up.
Dr. Simpson was an interesting choice to lead this initiative. She was
oblivious to the full-blown epidemic of autism, as this email, on June
8, 2001 shows:
"I have seen statements claiming huge increases in the incidence rate
of autism in the US over the past 10-15 years. The only data I have
seen from California. Are there national estimates for autism in the
US or is everything extrapolated from the California data?"
Nonetheless, Dr. Simpson began her search, as introductory emails to
California, Sweden, Belgium, and Denmark show. Dr. Simpson's goal,
through her emails, was very clear: exonerate thimerosal. Not all of
Dr. Simpson's correspondence was well received, and in fact some of it
was quite comical. A Swedish Doctor, Dr. Marta Granstrom, responded in
this email to Dr. Simpson with a clear point of view on thimerosal:
"I am very well aware of the recent concerns in the US over thiomersal
(an alternative name for thimerosal). On the expert committee of the
European Pharmacopoeae I represent Sweden and had in vain tried to get
Europe to ban its use in single dose vials until the US interest in
the issue...I thanked Neal Halsey [AAP member who spearheaded the
joint statement in 1999] in the name of European infants for the help
when I met him again last year."
By August, Dr. Simpson was getting desperate as she lamented in an
email that, "events have slightly accelerated with Walt's return
[Walter Orenstein, Director of the NIP] and anxiety over trying to get
these data. Consequently, we are TENTATIVELY planning for you and I to
go to Denmark and Sweden on August 22...if a trip is to occur in time
for the IOM it has to be in this time frame." In many ways, the trip
to Sweden and Denmark was Dr. Simpson's last shot at finding data, as
her August 6 email shows:
"Should we find that any other country has good data on both autism
and vaccines, we will work to get that data on a case by case basis.
i.e., I don't know what we are going to do and don't want to think
about it right now- but we will do something."
The "something" Dr. Simpson did was find a Danish vaccine company,
Status Serum Institute, willing to work with CDC. A company who sold
thimerosal-containing vaccines and a company who would soon see an
enormous rise in the number of vaccines sold to the United States.
Along with her colleague, Dr. Paul Stehr-Green, Dr. Simpson was
heading to Denmark. Two years later, Dr. Simpson and Dr. Stehr-Green
would be published authors, along with employees of SSI, letting the
world know that the Danish data proved that thimerosal does not cause
autism. These Danish studies would then form the basis for a NEW IOM,
initiated by CDC, that in 2004 would declare that the
thimerosal-autism hypothesis was without merit, and has since been
referenced as "proof" that thimerosal is safe. It all started with Dr.
Diane Simpson's trip to Denmark. We even found a copy of her travel
voucher.
Separately, in 2002, the CDC outsourced the maintenance and analysis
of the Vaccine Safety Datalink database to a private lobbying
organization that represents health insurance companies, America's
Health Insurance Plans, in a contract valued at more than $190
million. This private outsourcing of government data, contracted in
the midst of the furor over the CDC's mishandling of Thimerosal-autism
data, has served to insulate VSD data from the Freedom of Information
Act ever since. As of today, no outside scientists have been able to
review the American data CDC used to exonerate Thimerosal.
In contrast, the VAERS (Vaccine Adverse Events Reporting System)
database, a reporting system on vaccine adverse events available to
the public, is maintained with $21 million (over a comparable time
period) by the Constella Group. At a very large expense to taxpayers,
the most meaningful vaccine injury data, the VSD Data, are hidden from
the American public.
What's Egregious About This Time Period?
1. CDC actively shopped for studies in other countries that would
exonerate thimerosal, and wielded influence with international
researchers through their ability to make grants and purchase large
quantities of vaccines. Rather than relying on independent
researchers, they orchestrated the studies within CDC's headquarters,
often from the same division responsible for advocating for
administering vaccines. CDC employees would actually co-author a
number of these international studies. This email show the leaders of
CDC debating which studies from Denmark to provide funding for.
2. The Chief of Vaccine Safety, Dr. Robert Chen, was on the
record in 2001 referring to the thimerosal-autism hypothesis as a "red
herring" and a waste of time.
3. Through their correspondence, it is clear that CDC employees
were only looking for one kind of data, data to exonerate thimerosal.
When they came across data that showed the opposite, they moved on.
4. CDC outsourced all of the VSD data to a private lobbying
organization for more $190 million to insulate the data from the
Freedom of Information Act.
Where is the Evidence?
1. Email from Chen to Unknown recipient: "Red Herrings"
June 13, 2001
Email between Dr. Robert Chen, Chief of Vaccine Safety, NIP, and
unknown recipient.
"Thus these data [referring to some anecdotal information in
his email] do not support and in fact argue strongly against the
allegation that the thimerosal in vaccines (or variation on this
theme, increase in the number of antigens) is responsible for the
increase in autism. Research into better understanding autism and its
possible increase is needed, but following red herrings do (sic) not
help anyone."
Dr. Chen's comments and the time he made it are revealing
because: they are twelve months after Simpsonwood, when he and Dr.
Verstraeten shared information regarding the troubling correlation
between thimerosal and autism from their own data. Dr. Chen also had
access to the "Generation Zero" data, which had shown an even higher
correlation between thimerosal and autism. He knew there was a
problem! In the twelve months since Simpsonwood, no new scientific
studies had been published, and Dr. Verstraeten was working to
dumb-down the CDC's internal data. Dr. Chen was actively working to
keep the CDC's data from being reviewed by outside researchers, which
CDC has successfully done through today. Dr. Chen was involved in a
worldwide search for data on autism and thimerosal, the brainchild of
Dr. Roger Bernier, Associate Director for Science of the NIP and
headed by Dr. Diane Simpson, the Deputy Director of the NIP.
Source: FOIA filing by parents.
2. Email from Simpson to Stehr-Green: "Data Won't Help Us"
August 2, 2001
Email between Dr. Diane Simpson, Deputy Director of NIP, CDC, and Dr.
Paul Stehr-Green, CDC employee
Dr. Simpson was charged with spearheading a worldwide effort
for CDC to find data in other countries with a clear goal: exonerate
thimerosal. In this email, referring to data she may have unearthed in
Denmark, she writes:
"It is also possible that the data won't help us at all, but
we won't know until we see it."
How won't it help? It won't help unless it can be used to
exonerate thimerosal and the CDC. If it doesn't help, like the data in
#3 below, CDC would not pursue it.
Source: FOIA filing by parents.
3. Email from Dales to Simpson: "Looks like a graph"
June 8, 2001
Email from Dr. Loring Dales, California Dept. of Health, to Dr. Diane
Simpson, Deputy Director of NIP, CDC
Dr. Simpson's communication with the State of California
(where autism data is the best in the country) produced a stunning
data set, and one quickly buried. The data provided here by Dr. Loring
Dales from the California Dept of Health shows the relationship
between the vaccination rates of DTP by second birthdays, and the
number of autism cases in California. One of Dr. Simpson's colleagues
mentions "this looks like material for a graph." The graph is created,
page 3 of the email, and there is a clear, linear relationship between
the increase in vaccination rates (from 50.9% to 75.7%) and the number
of autism cases per year (from 176 to 1182, a 6.7x increase) between
1980-1994. Needless to say, California was not the source of
additional follow-up.
Source: FOIA filing by parents.
4. Email from Granstrom to Simpson: "In the name of infants"
June 22, 2001
Email from Dr. Marta Granstrom of Sweden to Dr. Diane Simpson, Deputy
Director of NIP, CDC
In CDC's effort to find data to exonerate thimerosal, they
reached out to many different scientists. In Dr. Granstrom, CDC
received a stern reply on the dangers of Thimerosal in vaccines:
"I am very well aware of the recent concerns in the US over
thiomersal. On the expert committee of the European Pharmacopoeae I
represent Sweden and had in vain tried to get Europe to ban its use in
single dose vials until the US interest in the issue...I thanked Neal
Halsey [AAP member who spearheaded the joint statement in 1999] in the
name of European infants for the help when I met him again last year."
Source: FOIA filing by parents.
5. Email from Simpson to Gilberg: "Increased public concern"
August 7, 2001
Email from Dr. Diane Simpson, Deputy Director of NIP, CDC, to Dr.
Christopher Gillberg, Sweden
This email highlights the concern CDC had regarding the
release of the 2001 IOM report and the publicity around the conclusion
that the thimerosal-autism hypothesis is "biologically plausible" In
this email, she tells a Swedish researcher that she and Dr.
Stehr-Green could fly to Sweden immediately to look at data:
"because our IOM committee's work is in process and we expect
them to issue their report in the next several weeks, we expect
increased public concern and questions in the near future."
Source: FOIA filing by parents.
6. VSD Contract to America's Health Plan Excerpt
September 20, 2002
Contract signed by CDC to outsource analysis of the VSD data
The CDC outsourced the maintenance and analysis of the Vaccine
Safety Datalink database to a private lobbying organization that
represents health insurance companies, America's Health Insurance
Plans, in a contract valued at more than $190 million. This private
outsourcing of government data, contracted in the midst of the furor
over the CDC's mishandling of Thimerosal-autism data, has served to
insulate VSD data from the Freedom of Information Act ever since. As
of today, no outside scientists have been able to review the American
data CDC used to exonerate Thimerosal. Here is a copy of AHIP's 2003
Annual Report on the VSD.
Interestingly, on AHIP's website, they state their priorities
for 2005-06, which includes "Thimerosal and Autism", despite the
recommendation of the 2004 IOM to no longer pursue the link between
Thimerosal and autism:
"2005-06 Priority Studies Include:
Risk of Alopecia following Hepatitis B Vaccination
Influenza Vaccine and Bell's palsy
Thimerosal and Autism
Yellow Fever in Children and Adults
The Safety of the Pediatric Influenza Vaccine: A Population-based
Study 1993 - 2003"
Chapter V: 2003
It's Rotten in Denmark
"Mercury is hazardous to humans. Its use in medicinal products is
undesirable, unnecessary and should be minimized or eliminated
entirely. Manufacturers of vaccines and thimerosal, (an ethlymercury
compound used in vaccines), have never conducted adequate testing on
the safety of thimerosal. The FDA has never required manufacturers to
conduct adequate safety testing on thimerosal and ethlymercury
compounds...Thimerosal used as a preservative in vaccines is likely
related to the autism epidemic. This epidemic in all probability may
have been prevented or curtailed had the FDA not been asleep at the
switch regarding injected thimerosal and the sharp rise of infant
exposure to this known neurotoxin. Our public health agencies' failure
to act is indicative of institutional malfeasance for self-protection
and misplaced protectionism of the pharmaceutical industry" - Mercury
In Medicine: Taking Unnecessary Risks, Committee On Government Reform,
U.S. House of Representatives, May 21, 2003
The Mercury In Medicine report, from Chairman Burton's Committee on
Government Reform, was released in May 2003, and provided a scathing
indictment of the Federal Health bureaucracy and their inexplicable
complacency regarding mercury and vaccines. Despite the entire report
being publicly available in the Congressional Record, it has gotten
little publicity.
While the Mercury In Medicine report was certainly not welcome by CDC,
they knew that by the Fall of 2003 the pendulum would swing back
towards exonerating Thimerosal with the near simultaneous release of
four separate studies between September and November in four separate
medical journals that would provide the basis for "proof" that
vaccines and autism are unrelated as cited by the IOM six months later
in their 2004 report. Three of those studies, in Pediatrics, The
Journal of the American Medical Association, and The American Journal
of Preventative Medicine, would be based on the Danish data, and one
study, also in Pediatrics, would be the data finally released by CDC
of their analysis of the VSD.
For practicing Doctors, medical journals are their primary source of
information from the outside world. For pediatricians, tasked with
administering the lengthy U.S. Immunization Schedule, Pediatrics, the
Journal of the American Academy of Pediatrics, is their trusted source
of information. We believe few pediatricians are remotely aware of the
conflicts, limitations, and manipulation that the published studies
were subjected to, and that few realize many of the published authors
were CDC employees or SSI employees, a Danish vaccine manufacturer.
Because Pediatrics is the trusted source of information for Doctors,
and because the two Pediatrics studies are most often cited regarding
"proof", we will focus our time analyzing these two.
In September 2003, Pediatrics published Thimerosal and the Occurrence
of Autism: Negative Ecological Evidence From Danish Population-Based
Data. Thimerosal was removed from Danish vaccines in 1992, and the
study showed that not only did autism rates not go down after its
removal, they actually went up. The study's lead other, Kristeen
Madsen, had been one of the Danish researchers Dr. Diane Simpson
reached out to early on in her world travel of 2001. This study was
highly flawed for the following reasons (read SafeMinds' critique
here):
- The data as it was captured was blatantly obscured. The study
looked at data between 1970-2000. In 1995, the Danish registry added
"Outpatient Clinics" to their count of autism cases. It turns out that
Outpatient Clinics are where 93% of Danish children are diagnosed with
autism, so the number of autism cases before 1995 did not include the
clinics. More surprising, the authors even note this in the study:
"since 1995 outpatient activities were registered as well...the
proportion of outpatient to inpatient activities was about 4 to 6
times as many outpatients as inpatients...this may exaggerate the
incidence rates."
Exaggerate the incidence rates? It is the equivalent of doing
a study on "Divorce Rates in North America" and counting Mexico and
Canada only for the first few years, then adding in the United States,
and noting that divorce rates went up. As a SafeMinds critique of the
study noted, "Therefore, their purported increase after 1994 can be
explained entirely by the registration of an existing autism
population that did not require hospitalization." To compound the
problem, Denmark also changed the diagnostic code they used, to the
more universal ICD10 code, beginning in 1993, which would have further
raised the rates.
Dr. Madsen, in his communications with Dr. Diane Simpson two
years earlier, actually noted this discrepancy in Danish data in an
email exchange:
Dr. Simpson: "Did they [autism rates] increase after 1993??"
Dr. Madsen: "Yes but not very dramatically and there could be
more reasons for that. First of all we had a change from ICD8 to ICD10
in 1994 and furthermore our outpatient clinics were registered in our
surveillance from 1995."
- The rates of autism in Denmark and the number of vaccines and
amount of mercury received in children are markedly lower than the
U.S. Danish children receive 75% less Thimerosal than American
children, they receive immunizations when they are older, and the U.S.
autism rate is TEN TIMES the rate of Denmark (Denmark is 1 in 1,600,
U.S. is 1 in 166). As an example, here is an email exchange back in
2001 discussing data from Great Britain between Dr. Verstraeten, the
author of the CDC's internal analysis, and Robert Chen. Dr.
Verstraeten notes that the British numbers will probably not be
helpful because the Thimerosal received by British children is too low
relative to American children: "The maximum exposure is indeed
relatively low...it may not be worth doing this after all." Denmark's
Thimerosal was as low or lower than Britain, but they proceeded with
the study anyway.
- The study authors were conflicted, and the conflicts were not
reported in the study, as they should have been. Of the seven
co-authors of the study, three had received direct funding from the
CDC on vaccine-safety related projects. One of the authors, Poul
Thorsen, was a CDC employee. And, two of the authors were employees of
Statens Serum Institute, a Danish vaccine manufacturer. Here's SSI's
Annual Report. Interestingly, page 28 shows that sales of vaccine
products to the U.S. were particularly high in 2002. None of these
conflicts are mentioned anywhere in the study.
- CDC actual wrote a letter to Pediatrics recommending
publication of the study. This letter, written prior to the official
date of submission, reveals how involved in the study CDC was
(remember, one of their employees was a co-author). Jose Cordero,
Director of the Division of the CDC responsible for developmental
disabilities, oversees the CDC's efforts to fight autism. He notes,
"its findings provide one strong piece of evidence that thimerosal is
not causally linked to autism." Dr. Cordero, too, had seen the
Generation Zero data and attended the meeting in Simpsonwood.
Two months later, Dr. Vestraeten's data, which began with a panic in
late 1999 ('It just won't go away"), was published in Pediatrics
titled Safety of Thimerosal-Containing Vaccines: A Two-Phased Study of
Computerized Health Maintenance Organizations. Perhaps most
frustrating about this study is that it is often referenced as "proof"
that vaccines do not cause autism when it was actually a
neutral-outcome study, as Dr. Verstraeten himself noted, in a letter
to Pediatrics:
"Surprisingly, however, the study is being interpreted now as negative
[where 'negative' implies no association was shown between Thimerosal
and autism] by many...The article does not state that we found
evidence against an association, as a negative study would. It does
state, on the contrary, that additional study is recommended, which is
the conclusion to which a neutral study must come...A neutral study
carries a very distinct message: the investigators could neither
confirm nor exclude an association, and therefore more study is
required."
This study was highly flawed for the following reasons (read
SafeMinds' critique here):
- The data was manipulated to remove the strong correlation
between mercury and autism. As Chapter II discussed, the initial
analysis using Vaccine Safety Datalink data (VSD) showed a high
correlation between Thimerosal and autism, called "Generation Zero."
The CDC used many techniques to dumb-down the numbers including
removing comparisons to children who had received no Thimerosal,
lowering the age of children available for the analysis, and including
a bankrupt HMO, with notoriously faulty data systems, in their final
round of analysis. This HMO helped neutralize the findings reviewed at
Simpsonwood. As SafeMinds reported:
"The general drift of their design changes was clear, to
reduce the statistical power through conscious manipulation of
statistical methods, data classifications, and samples."
- Dr. Verstraeten, the study's author, had been an employee of
Glaxo SmithKline for more than 2 years by the time the study was
published. This blatant conflict, with a study author employed by a
company being sued by parents for Thimerosal in vaccines, was never
noted in the Pediatrics study.
- Even with all the manipulation, the study was still a neutral
outcome study.Many people would be surprised to know that the study
itself cites a correlation between Thimerosal-containing vaccines and
both "tics" and "language delay." Beyond that, the study neither
proves nor disproves an association between Thimerosal and autism and
recommends that more work needs to be done.
What's Egregious About This Time Period?
1. CDC and SSI employees were the primary study authors of
studies that would exonerate their own policies (CDC) and products
(SSI).
2. Conflicts of the study authors were never cited in any of the
studies published.
3. CDC knew about the limitations of the Danish data, but moved
towards publication any way, with a senior official actually lobbying
Pediatrics for publication.
4. CDC manipulated evidence of a correlation between Thimerosal
and autism from their own VSD data, despite the overwhelming evidence
of "Generation Zero" and the data presented at Simpsonwood.
5. We have never proven, using American data, that Thimerosal
didn't cause the autism epidemic, yet "proof" is often cited of
exactly that.
Where is the Evidence?
1. Email from Simpson to Madsen: "It would mean a great deal to
us"
June 12-13, 2001
Communication between Dr. Diane Simpson, Deputy Director of the
National Immunization Program for CDC, and Kreesten Madsen, a Danish
scientist.
This email is important for a number of reasons. Firstly, it
is the first communication between CDC and the Danish Dr. Madsen, who
would later co-author the Pediatrics study in September 2003
exonerating Thimerosal. It shows that CDC is looking anywhere to try
and find data and that the heads of the National Immunizations
Program, like Dr. Simpson, are leading the charge.
Dr. Simpson: "Our primary question is: did the rates increase
dramatically from the late 1980's into the 1990s as they did here in
the United States. A quick answer to that question would mean a great
deal to us here!!!"
Secondly, Dr. Madsen highlights an issue that would be
manipulated to form the basis for the 2003 Pediatrics study:
outpatient clinics, where the majority of Danish children are
diagnosed with autism, were not included in the Danish registry until
1995. This administrative change forms the basis for the studies put
forth by CDC regarding the "proof" in Denmark that Thimerosal does not
cause autism.
Dr. Madsen: "To the best of my knowledge - no, the rates did
not increase dramatically in the late 1980's..."
Dr. Simpson: "Did they increase after 1993??"
Dr. Madsen: "Yes, but not very dramatically and there could be
more reasons for that...and furthermore our outpatient clinics were
registered in our surveillance from 1995."
Source: FOIA filing by parents.
2. Email from Verstraeten to Chen: "Not worth doing"
June 26, 2001
Communication between Dr. Thomas Verstraeten, head of internal
analysis of CDC Vaccine Safety Data and Dr. Robert Chen, Director of
Vaccine Safety, CDC.
This email is important for two reasons:
- It shows that CDC rejected British data because the amount of
Thimerosal British children received through vaccines was too low
relative to American children to generate a fair comparison. Yet, the
same issue existed in Denmark, and the studies were done anyway, as
CDC was more "frantic" to find data to exonerate Thimerosal.
- It shows that CDC was using grant money to influence where
studies were done. After expressing disappointment over the British
numbers, Dr. Verstraeten notes that maybe the money can be given to
"Harald in Sweden." CDC controlled the funds for the research that was
done.
As Dr. Verstraeten writes:
"The maximum exposure [in Britain] is indeed relatively low...my
estimate is that you need at least >50 [mcg of mercury] by 3 months or
>100 by 6 months to see an effect if there is one which you barely
make...I hate to say this, but given these concerns, it may not be
worth doing this after all. On the other hand, maybe the grant can be
given to Harald in Sweden..."
Source: FOIA filing by parents.
3. Letter From Cordero to Pediatrics
December 10, 2002
Dr. Cordero, Director of the CDC's National Center on Birth Defects
and Developmental Disabilities, to Pediatrics in support of
publication of the Danish study exonerating Thimerosal.
Dr. Cordero, who had been privy to the Generation Zero data
and was present at the Simpsonwood meeting, encouraged Pediatrics to
publish the Danish study, despite its fatal flaws, and noted "its
findings provide one strong piece of evidence that thimerosal is not
causally linked to autism."
Source: FOIA filing by parents.
4. Criticisms of Danish Studies
2002-2003
Soon after their publication, many helpful criticisms of the
Danish studies were released, including:
SafeMinds analysis of the network of Danish researchers and
the CDC available here
SafeMinds analysis of the Pediatrics study available here
SafeMinds analysis of the Journal of American Medical
Association study available here
5. Criticisms of CDC's Study in Pediatrics
2002-2003
Soon after their publication, many helpful criticisms of the
CDC's Study in Pediatrics were released including:
SafeMinds detailed analysis of the manipulation of data by the
CDC available here
SafeMinds analysis of "Generation Zero" VSD data available
here
Dr. Mark Geier's letter to Pediatrics available here
Chapter VI: 2004
IOM Slams the Door (Quickly)
"The body of epidemiological evidence favors the rejection of a causal
relationship between thimerosal-containing vaccines and autism." -
March 2004, Immunization Safety Review, Institute of Medicine
The Institute of Medicine (IOM) is a private institution. According to
their website, "the IOM's mission is to serve as adviser to the nation
to improve health. The Institute provides unbiased, evidence-based,
and authoritative information and advice concerning health and science
policy to policy-makers, professionals, leaders in every sector of
society, and the public at large." The IOM is often requested by
government institutions to weigh in on matters of public concern or
issues that are controversial.
In the medical community, the IOM is viewed as having a pristine
reputation and the highest ethical standards, and therefore their word
is considered final on many different matters. That's why the 2004
report, dismissing the link between vaccines and autism, is so
devastating for our kids. It is the "proof" so often cited by
journalists that autism is not caused by vaccines, and their
conclusion in 2004 inhibits Federal funding from exploring the
vaccine-autism connection. And, it renders exploration of treatment
for autism, like the removal of mercury from our children's bodies,
moot.
Many were concerned about the likely conclusions of the IOM, including
Congressman Dave Weldon (R-FL), who in this speech to the IOM prior to
the release of the study, noted:
"This atmosphere of intimidation even surrounds today's hearing. I
received numerous complaints that this event is not a further attempt
to get at the facts but rather a desire to sweep these issues under
the rug."
The 2004 IOM was a kangaroo court with a pre-ordained outcome. Unlike
the CDC, the Institute of Medicine is a private institution and not
subject to the Freedom of Information Act. The IOM Committee Members,
particularly Dr. Kathleen Stratton, was apparently livid when they
learned these transcripts had been leaked. She should have been
profoundly embarrassed.
The Committee Members own words betray them: the fix was in. The 2004
IOM Report, so roundly cited as "proof" that vaccines don't cause
autism, was tainted because:
1. The CDC was the client and paying for the study. Here's a copy
of the study parameters.
2. The committee members made the CDC's expectations clear from
the beginning. Here's a discussion between Dr. Marie McCormick,
Chairman of the Committee, and Dr. Kathleen Stratton, Study Director
of the Committee, BEFORE they had reviewed any of the evidence on
either side of the debate:
Dr. McCormick: ...[CDC] wants us to declare, well, these
things are pretty safe on a population basis (p. 33).
Dr. Stratton: ...The point of no return, the line we will not
cross in public policy is pull the vaccine, change the schedule. We
could say it is time to revisit this, but we would never recommend
that level. Even recommending research is recommendations for policy.
We wouldn't say compensate, we wouldn't say pull the vaccine, we
wouldn't say stop the program. (p. 74)
Dr. McCormick: ...we are not ever going to come down that
[autism] is a true side effect...(p. 97)
- IOM Committee Meeting, 1/12/2001 Closed-Door Meeting
Transcript
3. The committee was largely made up of health policy advocates,
who were concerned with vaccination rates, not the health of our
children. There were no toxicologists or doctors of autistic children
on the committee, and time was dedicated to discussing issues of
vaccination policy, rather than whether or not there was evidence that
vaccines caused harm. Here Dr. Stratton discusses the benefits of
putting the debate to rest "no matter what" in order to allay parents
concerns "to vaccinate or not vaccinate."
"I think that as Alicia just point (sic) out is I think when
CDC was thinking about significance and we were thinking about, it's
more is this such a concern, and the risk of putting it rest (sic), or
not putting it to rest does not relate to a recommendation to change
the schedule, but parent decisions and actions to vaccinate or not
vaccinate. So I think it is not would there be a policy recommendation
about it, but do we have reason to believe, or is even a theoretical
concern that this is not put to rest. And more and more parents are
going to follow this, and get involved, and stop getting immunized,
therefore the risk of disease will go up. So it's not a policy
recommendation that would lead to measles going up, but the true on
the street worry about this. And is there a benefit to putting to rest
no matter what."
- Kathleen Stratton, IOM Committee Meeting, 3/9/2001
Closed-Door Meeting Transcript, pp. 120-1 (emphases added)
4. The committee refused to look at hundreds of case reports
showing the relationship between vaccinations and autism.
Dr. Johnston: Barbara Loe Fisher [NVIC] could give you names.
Mrs. Fisher said she had cases. I think she came up to say if you
needed any cases to demonstrate the points, you could have them.
Dr. McCormick: She was demonstrating causality. She was taken
by your case series that you did-the Guillaume Barre (sic) and
whatever, the tetanus. She was all ready to get you cases to prove
causality.
Dr. Wilson: Well, let's see them.
Dr. McCormick: Let's not do that. Do you have a free weekend
that you want to plod through them?
- IOM Committee Meeting, 1/12/2001 Closed-Door Meeting
Transcript, pp. 149 & 150 (emphasis added)
5. The committee based their conclusions SOLELY on epidemiology:
the Danish studies and the CDC's own analysis of the VSD. As Chapter 5
showed, the Danish studies were highly flawed, originated by the CDC,
authored by CDC and a Danish vaccine manufacturer employees, and based
on a change to the Danish database that any Ninth grade math student
could understand. And, by the admission of the author of the CDC's
study using their VSD data, a neutral outcome was produced, meaning it
should not have contributed in any way to the IOM's conclusion.
Denmark was all they had.
6. The IOM was informed that a number of biological studies were
awaiting publication, and the IOM rushed their report in ADVANCE of
those studies.
The IOM refused to review any drafts of biological studies
linking vaccines and autism, and rushed their report, relying solely
on epidemiology, in advance of biological studies in the next twelve
months from scientists at Columbia University, University of Arkansas,
Northeastern University, Johns Hopkins University, Harvard University,
and the University of Washington.
Dr. Thomas Burbacher, a professor from the University of
Washington, produced compelling research demonstrating how injected
Thimerosal ended up as high levels of inorganic mercury in the brains
of chimps. In his study, he noted:
"A recently published IOM review (IOM 2004) appears to have abandoned
the earlier recommendation [of studying mercury and autism] as well as
back away from the American Academy of Pediatrics goal [of removing
mercury from vaccines]. This approach is difficult to understand,
given our current limited knowledge of the toxicokinetics and
developmental neurotoxicity of thimerosal, a compound that has been
(and will continue to be) injected in millions of newborns and
infants."
The 2004 IOM Report did the opposite of its goal of putting
the vaccines-autism debate to rest, it reignited parents and increased
activism. In fact, it sparked the courageous FOIA requests filed by
parents, completed despite some personal retaliation by the CDC and
IOM, that have led to the paper trail of evidence highlighted on this
site, and it sickened certain employees of the IOM enough to cause
them to leak the transcripts of Committee deliberations. As
Congressman Dave Weldon said in remarks to Congress soon after the
report's release:
"In my 10 years of service in U.S. Congress, I have never seen a
report so badly miss the mark. I have heard some weak arguments here
in Washington, D.C., and I can tell my colleagues that the arguments
put forward in this IOM report are indeed very weak...
Now, I had a follow-up conversation on February 3 of this year [2004]
with Dr. Gerberding [head of the CDC], and she assured me that the
Institute of Medicine's February meeting was not an attempt to "draw
conclusions," but merely to "update the science," of where we are,
basically. However, it is clear that this report draws conclusions;
and what is perhaps the greatest outrage, it goes further to call for
the halt of further research...
The Institute of Medicine bases their decision almost entirely on five
epidemiological studies. Epidemiology is essentially the statistical
analysis of disease in populations. All of these studies were
conducted by researchers with an interest in not finding an
association. All of the studies had significant shortcomings, all of
which the IOM itself declares would miss the association with autism
in a genetically susceptible subset of children...
The latest IOM report is simply part of a PR campaign, in my view."
IOM President Harvey Fineberg defended the committee in this
statement, explaining that, "the members of the committee underwent a
stringent review process that ensured all were free of financial
conflicts of interest and were not biased for or against any vaccine
safety hypothesis." Yet, these secretly obtained handwritten meeting
notes reveal that many Committee members had conflicts of interest and
they were openly discussed, like the notes stating "Pharma company"
and "$5000 Merck" and "vaccines should be continued" and "Smith-Kline
Beecham" and "American Home Products" and "financial push to approve
vaccines."
The fix was in, our kids couldn't win. This is the "proof" so often
written about that vaccines, and a preservative in vaccines made of
mercury, do not cause autism. If you were a parent, would it feel like
proof to you?
What's Egregious About This Time Period?
1. From the beginning, the outcome of the 2004 IOM study, often
cited as "proof" that vaccines do not cause autism, was pre-ordained
by the CDC, as the words of the IOM Committee members demonstrate. Not
only was the CDC paying for the study, but their needs were clearly
stated by the Chairman of the Committee: protect the National
Immunization Program.
2. IOM Committee members rushed the report to the public, despite
knowing that peer-reviewed biological studies were being published
soon.
3. The IOM Committee looked solely at epidemiological studies,
notorious for their ease of manipulation. Further, the studies they
based their decision on were from Denmark, where fatal flaws in the
data pool used in Denmark made the results meaningless. This, despite
compelling biological evidence presented to the committee by leading
scientists.
4. In an extraordinary step, the IOM recommended no further
research dollars be dedicated to the vaccine-autism hypothesis.
Where is the Evidence?
1. Conflicts of Interest: Presentation for Senatorial Inquiry
November 15, 2005
Presentation compiled for Senate Committees spelling out how the CDC
constructed the IOM Committee to reach a pre-determined outcome.
This 55 page document provides a complete summary of the
methodology employed by the CDC to influence the outcome of the 2004
IOM. It has been shared with key members of both the Senate and the
House as of November 2005 and has never been publicly released. It
summarizes:
"All the epidemiological research on links to autism and
thimerosal exposure that the IOM ISR Committee cites as the basis for
its final report conclusion, rejecting a causal link between
thimerosal exposure and autism, was undertaken with CDC money or by
researchers with close ties to the CDC."
And, this second presentation spells out in detail for the IOM
Committee proceedings were managed to produce the outcome CDC was
looking for including changing their charter, avoiding case reports,
and disregarding biological evidence.
Source: Private Source.
2. IOM Closed Door Committee Meeting
January 12, 2001
Leaked transcript of IOM Committee Deliberations. As a private
institution, the IOM is not subject to the Freedom of Information Act.
This transcript, in a meeting held long before ANY evidence
was reviewed; show how the conclusion had already been pre-determined
by CDC:
Dr. McCormick: ...[CDC] wants us to declare, well, these
things are pretty safe on a population basis (p. 33).
Dr. Stratton: ...The point of no return, the line we will not
cross in public policy is pull the vaccine, change the schedule. We
could say it is time to revisit this, but we would never recommend
that level. Even recommending research is recommendations for policy.
We wouldn't say compensate, we wouldn't say pull the vaccine, we
wouldn't say stop the program. (p. 74).
Dr. McCormick: ...we are not ever going to come down that
[autism] is a true side effect...(p. 97)
On pages 149 & 150, you see the following exchange, showing
how the IOM Committee avoided looking at case studies demonstrating
how vaccines caused autism in children:
Dr. Johnston: Barbara Loe Fisher [NVIC] could give you names.
Mrs. Fisher said she had cases. I think she came up to say if you
needed any cases to demonstrate the points, you could have them.
Dr. McCormick: She was demonstrating causality. She was taken
by your case series that you did -- the Guillaume Barre (sic) and
whatever, the tetanus. She was all ready to get you cases to prove
causality.
Dr. Wilson: Well, let's see them.
Dr. McCormick: Let's not do that. Do you have a free weekend
that you want to plod through them?
Source: Private source provided leaked transcript.
3. IOM Committee Meeting
February 9, 2004
Transcript of IOM Committee Meeting, including multiple presentations
from biological scientists.
This transcript, a lengthy 355 pages, includes presentations
by six scientists showing a clear correlation between mercury and
autism, including 2 scientists who were on the cusp of publishing
their research. None of the information provided by these scientists
was considered in the IOM's conclusion. As two examples, here is a
statement provided by David Baskin, M.D., Professor of Neurosurgery,
Baylor College of Medicine (p.228):
"...it is an example of a quantitative assessment of live
cells from autistic individuals using molecular biological tools, and
it suggests
that a subset of autistic children appear to be more
sensitive than their unaffected siblings to thimerosal."
And, Boyd Haley, Ph.D., the Chair of the Chemistry Department
of the University of Kentucky (p. 270):
"...there appears to be a subset of the population that cannot
effectively excrete mercury, and they are at a greater risk for
exposure in the general population...But the rate of autism in Denmark
is somewhere -- I looked at the chart in the paper, and the highest
level was around five [5 cases of autism per 10,000 children], and
younger age groups it was even lower, down to less than two. In this
country, I see numbers where it is 67 per 10,000. So I don't think
that comparison of that piece of research is really very relevant."
Source: Institute of Medicine.
4. Special Order by Congressman Dave Weldon, M.D.
June 18, 2004
Speech before the House of Representatives
This speech was delivered on the House floor after the IOM
report was released:
"In my 10 years of service in U.S. Congress, I have never seen
a report so badly miss the mark. I have heard some weak arguments here
in Washington, D.C., and I can tell my colleagues that the arguments
put forward in this IOM report are indeed very weak...
Now, I had a follow-up conversation on February 3 of this year
[2004] with Dr. Gerberding [head of the CDC], and she assured me that
the Institute of Medicine's February meeting was not an attempt to
"draw conclusions," but merely to "update the science," of where we
are, basically. However, it is clear that this report draws
conclusions; and what is perhaps the greatest outrage, it goes further
to call for the halt of further research...
The Institute of Medicine bases their decision almost entirely
on five epidemiological studies. Epidemiology is essentially the
statistical analysis of disease in populations. All of these studies
were conducted by researchers with an interest in not finding an
association. All of the studies had significant shortcomings, all of
which the IOM itself declares would miss the association with autism
in a genetically susceptible subset of children...
The latest IOM report is simply part of a PR campaign, in my
view."
Source: Congressional Record.
5. Email from Marie McCormick, "Injure the Nervous System"
June 9, 2004
Private email to a parent
This private email was written by Marie McCormick, Chairperson
of the 2004 IOM Committee. It highlights how misused and misquoted the
2004 IOM report is, often referred to as proof that thimerosal is
"safe", which the report never concluded. In it, she quotes a portion
of the IOM report:
"The committee accepts that under certain conditions, infections and
heavy metals, including thimerosal, can injure the nervous system."
Something that can "injure the nervous system" is not safe.
Thimerosal has never been tested for safety and no proof exists that
it is safe. On the contrary, there are thousands of documents in the
literature that discuss its extreme toxicity, starting with
thimerosal's own Material Safety Data Sheet that, amongst other
things, states:
"Exposure Guidelines: Thimerosal - no known occupational limits
established... Exposure to mercury in utero and in children can cause
mild to severe mental retardation and mild to severe motor
coordination impairment... Target Organ Effects: Mercury - Nervous
system effects (insomnia, tremor, anorexia, weakness, headache), liver
effects (jaundice, digestive effects (hypermotility, diarrhea)."
Thimerosal is made of mercury. Mercury is 1000x more toxic
than lead. If lead were in vaccines, the world would be in an uproar
because lead's toxicity is well known, and thimerosal is ONE THOUSAND
TIMES WORSE. Some of the many studies documenting himerosal's extreme
toxicity, at levels well below what our children receive through
vaccines, include:
Comparison of Blood and Brain Mercury Levels in Infant Monkeys
Exposed to Methylmercury or Vaccines Containing Thimerosal
Uncoupling of ATP-mediated Calcium Signaling and Dysregulated
IL-6 Secretion in Dendritic Cells by Nanomolar Thimerosal
Thimerosal induces neuronal cell apoptosis by causing
cytochrome c and apoptosis-inducing factor release from mitochondria
Thimerosal Neurotoxicity is Associated With Glutathione
Depletion: Protection with Glutathione Precursors
Activation of Methionine Synthase by Insulin-like Growth
Factor-1 and Dopamine: a Target for Neurodevelopmental Toxins and
Thimerosal
Thimerosal Induces DNA Breaks, Caspase-3 Activation, Membrane
Damage, and Cell Death in Cultured Human Neurons and Fibroblasts
Epilogue: Present day
Better science, better kids, and a DJ
Don Imus: Well the studies that have been done, Senator, they didn't
exactly say that. What they said was they couldn't find any evidence
of harm [from Thimerosal in vaccines], which is 180 degrees from the
CDC, the IOM, or anybody else or any of these people who are
ridiculing these parents all over the country. It's a lot different
than saying that it's safe. And, as you know and everybody else on the
planet knows, that thimerosal is a neurotoxin. Injecting it at the
levels they do and used to do - and still do, by the way - into the
bloodstreams of infants, must do something.
Senator Joseph Lieberman (D-CT): Absolutely. Absolutely, and that's
exactly why I wrote the letter and why I put the requirement in the
legislation we adopted last year. Here's the point - a lot of the
experts have reached the conclusion that the vaccines had nothing to
do with the incredible increase in autism after the decade of the
`90s, but I don't think the question has been answered. Deirdre's
right to take on this fight and what we're asking for in one of the
appropriations bills that passed is that the National Institute of
Environmental Health Sciences convene a totally independent, big, new
study of the possible links between thimerosal and autism...
Don Imus: I mean, I would say to all these scientists and all of these
various physicians and all of these other people who claim there's no
link between thimerosal and autism, "Prove to me that it's safe." You
don't have to be a doctor to know that a neurotoxin has to do
something. If it doesn't cause autism, which I personally think it
does, but if it doesn't, it must do something. It's mercury. You know,
when women get pregnant, they tell them to reduce their fish intake to
one serving a week and that's even a different, less toxic, kind of
mercury...
- Imus in the Morning Transcript, Interview with Senator Joseph
Lieberman (D-CT), March 23, 2006
In 2005 and 2006, Don Imus and his courageous wife, Deirdre, have
raised the national consciousness on the issue of autism and
Thimerosal and have provided political cover for Senators to begin to
speak out publicly in a way that would have been unimaginable only a
year ago, as recent transcripts with Senator Joe Lieberman (D-CT) and
Senator John Kerry (D-MA) demonstrate. Don and Deirdre have truly
chosen to put our children first!
The emergence of Don and Deirdre was an unexpected blessing for our
children. They are the icing on the cake for momentum that began to
build ever since the release of the IOM's 2004 report. Other
journalists who have also stepped up include David Kirby, author of
Evidence of Harm, published in 2005; Dan Olmsted, a writer for UPI,
with frequent investigative pieces in his "Age of Autism" series, and
Robert F. Kennedy Jr., author of a scathing indictment of the CDC and
IOM published simultaneously in Rolling Stone and on Salon.com in the
Summer of 2005.
Better Science
As mentioned in Chapter VI, the biological science keeps coming,
building up a stronger and stronger case for Thimerosal's role in
causing autism:
From the University of Kentucky, a study of first baby haircuts study
showed autistic children have abnormally low levels of mercury in hair
samples demonstrating an impaired ability to excrete heavy metals
(see)
From Columbia University, a subset of mice injected with Thimerosal,
equivalent to the frequency and dosing of the pediatric vaccine
schedule, developed "autistic" symptoms (see)
From Northeastern University, Thimerosal was proven to disrupt
cell-to-cell communication, known as methylation, which could produce
many of the symptoms of autism (see)
From the University of Arkansas, autistic children were shown to have
a decreased ability to manufacture glutathione, the body's most
important detoxifying agent (see)
From Arizona State University, autistic children were shown to excrete
higher levels of mercury when given a chelating agent versus their
neurotypical peers (see)
From the University of Washington, monkeys injected with ethylmercury
(mercury in Thimerosal) had twice the amount of inorganic mercury in
their brains compared to methylmercury (environmental mercury) (see)
From U.C. Davis, Thimerosal was shown to create immune system
dysfunction in mice cells. Immune system dysfunction is common amongst
autistic children (see)
From the journal American Physicians and Surgeons, a study shows the
rates of autism have begun to decline as mercury has been removed from
vaccines (see)
Better Kids
The issue that we hear the least about today is actually the most
important: our children are recovering from autism and going on to
lead normal lives. With a movement known as "biomedical" treatment for
autism, more than 400 doctors across the country are working with more
than 20,000 parents to treat autistic children by removing the metals
and viruses from their bodies.
These 400 Doctors are part of a coalition of Doctors, known as Defeat
Autism Now! Doctors or DAN!, courageously treating autistic children
for what actually ails them: mercury poisoning and all the devastating
symptoms that mercury creates including gastrointestinal distress,
immune system dysregulation, vitamin and mineral deficiencies, sleep
impairment, and food allergies, to name a few.
Twice a year, Defeat Autism Now! holds a national conference where
recovered autistic children are featured on stage and videotaped.
Stories are appearing more frequently in the press about recovered
children. Thousands of children are fully recovered, and thousands
more are well on their way. To learn more about biomedical treatment
for Autism, visit the DAN! website and Generation Rescue.
Mysteriously, we know of no examples where the CDC has followed up
publicized claims by parents of recovered children to investigate. Why
not? Why wouldn't the CDC want to know how these children were
recovered to put an end to an epidemic? The CDC's website notes, "It
is important that we treat common DDs [developmental disabilities],
and especially the ASDs [Autism Spectrum Disorders], as conditions of
urgent public health concern..."
2006 and Beyond
Our children are running out of time. Every lost day is one day less
to treat them properly and give them the best chance to lead a happy,
normal life.
Mystifyingly, because of the addition of the flu shot to the
recommended schedule for childhood vaccinations, the level of mercury
our children are receiving is actually on the rise again, as this
recent article from UPI "Mercury Creeps Back In", points out. You can
also look at this chart - children by the age of 5 will receive 53% of
the mercury received by children at the peak of mercury exposure in
the mid-1990s.
The CDC and American Academy of Pediatrics are also actively opposing
state bans of Thimerosal. So far, seven states have passed laws
banning mercury from vaccines: California, New York, Illinois,
Missouri, Iowa, Delaware, and Washington with many more considering
legislation. And yet, CDC and AAP, two of the authors of the 1999
joint statement, are opposing these laws. In 2001, the AAP stated:
"Mercury in all of its forms is toxic to the fetus and children and
efforts should be made to reduce exposure to the extent possible to
preg