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SafeMinds Review of Miles & Takahashi Study on Rh Immune Globulin, Thimerosal, and Autism
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SafeMinds has released a review of the May
2007 study on thimerosal and autism by Judith
H. Miles and T. Nicole Takahashi appearing in
the May issue of the American Journal of
Medical Genetics. The review challenges the
study conclusion that the mercury
preservative thimerosal administered to
pregnant women through Rh immune globulin
injections (RhIg) does not increase the risk
for autism.
The SafeMinds review, available here, uncovered an earlier version of the study data, presented by Drs. Miles and Takahashi at a conference in 2005. Earlier data showed an increased rate of RhIg administration during pregnancy of children later diagnosed with an autism spectrum disorder (ASD) compared to their non-ASD siblings, as shown in the graph at right. This positive finding of an increased risk of autism from RhIg is consistent with other published studies reporting an association and is in contradiction to the later journal version of Miles and Takahashi.
The SafeMinds review found multiple reasons
for why the journal version may have differed
from the earlier 2005 version. The sample was
altered so that the majority of multiplex
families and nearly half the minority
families were removed, representing
approximately 1/3 of the original sample. The
final sample may reflect selection bias
related to the exposure variable, RhIg with
thimerosal, as 59% of the eligible families
were lost to follow up or declined to
participate, and those excluded are likely to
have had greater RhIg exposure. The authors
failed to adequately identify the amount of
mercury in the RhIg given, invalidating
exposure risk calculations. They reported
that all RhIg given was the Johnson & Johnson
brand RhoGAM®, even though this brand had
only half the market share during the period
of most study pregnancies. The RhIg
comparison control group in the journal
version consisted of just 27 families, too
small for statistical power.
The study deficiencies may be linked to
conflicts of interest. Johnson & Johnson was
a study sponsor, Dr. Miles has served as an
expert witness in RhIg/autism litigation, and
the authors' clinic is oriented strictly to
genetic causality in autism, with no room for
environmental contributions like mercury. The
SafeMinds review concludes that higher
quality, unbiased studies are needed to
adequately address autism-mercury concerns.
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Maloney Bill Reintroduced
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NAA Action Alert
Congresswoman Carolyn Maloney (D-NY) has
reintroduced the "Comprehensive Comparative
Study of Vaccinated and Unvaccinated
Populations Act of 2007". Please call or fax
your representative in the House and ask them
to sign on to H.R.2832 today!
For contact information for your reps visit
www.congress.org and type in your zip code.
When you call your congressman's office, ask
for their health staffer, let them know that
you are a constituent and you are calling to
ask that your congressman co-sponsor H.R.2832.
Legislation Aims to Resolve Thimerosal
Controversy
Maloney Introduces Bill to Require
Comprehensive Study to Resolve the Question
of a Possible Link between Mercury and Autism
WASHINGTON, DC - Congresswoman Carolyn
Maloney (D-NY) introduced the "Comprehensive
Comparative Study of Vaccinated and
Unvaccinated Populations Act of 2007" (H.R.
2832), legislation that would require the
National Institutes of Health (NIH) to
conduct a comprehensive comparative study of
vaccinated and unvaccinated populations,
which may resolve the controversy about the
possible link between autism and mercury or
other vaccine components (click here for text
of the legislation).
Many parents have raised concerns about the
effect that thimerosal, which was widely used
as a preservative in vaccines and is made of
mercury - a known neurotoxin, may have had on
a child's chances of developing autism and
other neurological disorders. The study
mandated by this new legislation would try to
help resolve this controversy once and for all.
"Vaccines have been instrumental in reducing
the incidence of many once-common diseases,
but we owe it to parents and children to
study and resolve the question of the
possible link between thimerosal in vaccines
and autism," said Maloney. "What is
ultimately needed to resolve this issue one
way or the other is a comprehensive national
study comparing outcomes between vaccinated
and unvaccinated children. As the most
scientifically advanced country in the world,
we should be jumping at the chance to conduct
a comprehensive national study to resolve the
questions that have been raised. Parents
deserve answers, and children deserve no less
than absolutely certainty and safety."
"The time has come to put the questions about
thimerosal behind us and get some concrete
answers about possible dangers associated
with this vaccine preservative. Vaccines are
critical to protecting public health, but we
must know for certain that at the same time
doctors are providing children with
life-saving medicine that they are not also
exposing them to a substance that could make
them more prone to developing autism. As the
world leader in medical research, it is
incumbent upon the United States to take the
lead on this matter and launch a
comprehensive study on thimerosal so we can
make smarter decisions about vaccines in the
future," said Congressman Maurice Hinchey
(D-NY), an original co-sponsor of the bill.
Congressman Ron Paul (R-TX) is the bill's
other original co-sponsor.
This week, Generation Rescue is releasing a
phone survey that offers a preliminary look
at vaccinated versus unvaccinated groups.
According to Generation Rescue co-founder
J.B. Handley, "Our study was meant to
highlight the critical importance of the
research required by H.R. 2832. A sound
study like the one proposed in the bill is
needed to help resolve the issue of whether
there is a link between vaccines and autism."
In the past, those who claim the preservative
thimerosal has no effect on children have
also claimed that a comprehensive study
comparing vaccinated and unvaccinated
populations could not be done in the United
States because there was not a big enough
unvaccinated population with which to compare
the general vaccinated population. However,
Dan Olmsted of UPI wrote a series of articles
about the autism epidemic that identified a
number of populations suitable for study,
including: the Amish; children whose parents
don't vaccinate for religious reasons;
patients of Homefirst, an alternative medical
practice in Chicago that does not vaccinate;
and others. The Maloney legislation proposes
comparing vaccinated populations with
unvaccinated populations such as these.
A broad spectrum of vaccines containing
thimerosal was manufactured for domestic use
until 1999, and the nation's inventory of
vaccines included some containing thimerosal
for several years afterwards. Thimerosal is
still used in most flu vaccines, and it
remains in most vaccines administered to
children in the developing world.
Background:
Maloney introduced similar legislation in the
109th Congress. Maloney also introduced a
bill with Congressman Dave Weldon, M.D.
(R-FL) last year that would give
responsibility for the nation's vaccine
safety to an independent agency within the
Department of Health and Human Services,
removing most vaccine safety research from
the Centers for Disease Control (CDC).
Currently, the CDC has responsibility for
both vaccine safety and vaccine promotion,
which is an inherent conflict of interest
that is increasingly garnering public
criticism.
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Vaccinated Children Two and a Half Times More Likely to Have Neurological Disorders Like ADHD and Autism
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New Survey in California and Oregon Finds
New Findings Emerge as Debate Rages in
Court
Portland, OR - June 26, 2007 - As the first
trial in Vaccine Court explores the
relationship between vaccines and autism, a
new survey released today indicates a strong
correlation between rates of neurological
disorders, such as ADHD and autism, and
childhood vaccinations.
The survey, commissioned by Generation
Rescue, compared vaccinated and unvaccinated
children in nine counties in Oregon and
California. Among more than 9,000 boys age
4-17, the survey found vaccinated boys were
two and a half times (155%) more likely to
have neurological disorders compared to their
unvaccinated peers. Vaccinated boys were 224%
more likely to have Attention Deficit
Hyperactivity Disorder (ADHD), and 61% more
likely to have autism.
For older vaccinated boys in the 11-17 age
bracket, the results were even more
pronounced. Vaccinated boys were 158% more
likely to have a neurological disorder, 317%
more likely to have ADHD, and 112% more
likely to have autism. Complete survey
results are available at
www.GenerationRescue.org.
Generation Rescue commissioned the phone
survey. Data was gathered by SurveyUSA, a
national market research firm, which surveyed
parents by phone on more than 17,000
children, ages 4-17, in five counties in
California (San Diego, Sonoma, Orange,
Sacramento, and Marin) and four counties in
Oregon (Multnomah, Marion, Jackson, and Lane).
The survey asked parents whether their child
had been vaccinated, and whether that child
had one or more of the following diagnoses:
Attention Deficit Disorder (ADD), ADHD,
Asperger's Syndrome, Pervasive Development
Disorder-Not Otherwise Specified (PDD-NOS),
or Autism. The phone survey was chosen to
mirror the methodology the Centers for
Disease Control (CDC) uses to establish
national prevalence for neurological
disorders in their national phone survey.
Timed to the release of the survey results,
Generation Rescue also ran full-page
advertisements in Washington's Roll Call, The
Oregonian, and The Orange County Register
today. The ad compares the 36 pediatric
vaccines the CDC recommends today to the 10
recommended in 1983, and asks, "Are We
Over-Vaccinating Our Kids?"
"No one has ever compared prevalence rates of
these neurological disorders between
vaccinated and unvaccinated children," said
J.B. Handley, co-founder of Generation
Rescue, whose son was diagnosed with autism.
"The phone survey isn't perfect, but these
numbers point to the need for a comprehensive
national study to gather this critical
information."
In Washington, Congresswoman Carolyn Maloney
(D-NY) has been advocating for such a survey.
Co-sponsored by Rep. Maurice Hinchey (D-NY)
and Rep. Ron Paul (R-TX), the "Comprehensive
Comparative Study of Vaccinated and
Unvaccinated Population Act of 2006," or H.R.
2832, was introduced on June 22, and would
require the National Institutes of Health to
complete this research.
"Generation Rescue's study is impressive and
forcefully raises some serious questions
about the relationship between vaccines and
autism. What is ultimately needed to resolve
this issue one way or the other is a
comprehensive national study of vaccinated
and unvaccinated children," said
Congresswoman Maloney. "The parents behind
Generation Rescue only want information.
These parents deserve more than road blocks,
they deserve answers. We can and should move
forward in search of those answers. That's
why I've introduced a common sense bill that
would require the National Institutes of
Health (NIH) to conduct a comprehensive,
comparative study on the possible link
between autism and thimerosal."
From 1983 to 2007, autism rates have climbed
from 1 in 10,000 children to 1 in 150
children, a growth rate of 6,000% (boys are
significantly more affected by neurological
disorders, accounting for approximately 80%
of all cases). ADHD currently affects 1 in 13
children. In the same period, the CDC's
recommended vaccine schedule more than
tripled. The simmering debate over the cause
of childhood neurological disorders shows no
sign of cooling, but no study had ever been
done to look at unvaccinated children.
Lisa Handley, co-founder of Generation
Rescue, adds, "Everyone working with autism
wants to identify the cause so we can focus
on treatment and prevention. A national study
like HR 5940 could help end this debate and
focus all of our resources on helping our
kids. Its time has come, and we hope Congress
will choose to put our children first."
Click
here to read complete survery results.
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Parents and Physicians Outraged over Comments from NBC's Dr. Snyderman
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on Autism Omnibus Hearings
NAA Press Release
Physician's ties to drug companies prompt
letter to NBC asking for Snyderman's
dismissal and network retraction
Washington, DC - NBC's coverage of the Autism
Omnibus Proceedings in the U.S. Federal
Claims Court that began last week has sparked
a firestorm of criticism among parents of
vaccine-injured children from around the
country. A letter protesting on-air
statements made last week by NBC chief
medical editor Dr. Nancy Snyderman has been
sent to top NBC officials.
The letter, signed by over 50 advocacy
organizations and physicians, objects to Dr.
Snyderman's assertion on last Tuesday's Today
show that the mercury-based preservative
thimerosal no longer exists in vaccines.
Thimerosal is still contained in most flu
shots and several other vaccines as well.
Before coming to NBC, Dr. Snyderman served as
ABC's medical correspondent for 17 years
where she was briefly suspended for being
paid to promote J & J's product Tylenol. She
later spent four years with Johnson & Johnson
as Vice President of Consumer Education. J &
J's company Ortho Clinical Diagnostics is
responsible for producing the
thimerosal-containing RhoGAM shot
administered to RH-negative women during and
after pregnancy. Ortho is currently the
respondent in litigation for fetal injuries
associated with the shot, including autism.
"Tolerating such a blatant conflict of
interest is bad enough, but the fact that NBC
did not disclose Dr. Snyderman's Johnson &
Johnson ties to viewers is completely
unacceptable," according to National Autism
Association Vice President and grandparent
Ann Brasher. "It appears that Dr. Snyderman
is speaking on behalf of J & J and not as an
unbiased physician looking out for the best
interests of children.
Also raising concern is Dr. Snyderman's
unequivocal statement in an earlier NBC
broadcast that there is "no science" to
support a link between thimerosal and the
development of autism. Advocacy
organizations are quick to point out a
plethora of peer-reviewed published science
supporting the extreme neurotoxicity of
thimerosal and the relationship between
mercury exposure and neurological injuries
with symptoms nearly identical to those of
autism.
NBC has not responded to the letter sent last
week from the advocacy organizations. To read
the letter to NBC, click
here.
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Autism: Why the Debate Rages
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(CBS) Sharyl Attkisson is the Capitol Hill Correspondent for CBS News.
With the first autism case now being heard in
federal vaccine court in Washington D.C., it
makes sense to ask: Why is anyone even still
debating the possibility of a link between
vaccines and autism?
After all, for years, many government health
officials, advisors and vaccine manufacturers
have said there's no association.
Here are a number of reasons why the question
remains open:
While government scientists, advisors and
pharmaceutical companies have been
responsible for infinite lifesaving and life
improving medical advances, they are not
infallible.
It's the same group that originally thought
it was safe to use x-ray machines in shoe
stores, gave pregnant women Thalidomide for
morning sickness and once allowed mercury in
medicines. They assured us Vioxx and Duract
were safe painkillers, prescribed Rezulin for
diabetics and then denied any of them were
responsible for patient deaths. If we never
questioned that group, we might not have
discovered that Fen-phen and the dietary
supplement Ephedra are not safe weight loss
products, that antidepressants in kids can
lead to suicidality and Viagra can cause
blindness. The list goes on.
When it comes to vaccines, the same group
failed to predict that the 1990's rotavirus
(diarrhea) vaccine would have to be pulled
from the market after infant deaths. They
encouraged use of the oral polio vaccine
(eventually discontinued after it gave too
many children polio). And they allowed the
use of a mercury neurotoxin preservative in
childhood vaccines, only to admit later that they
hadn't thought to calculate the cumulative
amount kids were getting as more and more
vaccines were added to the childhood
immunization schedule.
Recent history demonstrates that too often,
government health officials, mainstream
doctors and pharmaceutical companies aren't
on the leading edge of alerting us to health
risks; they're bringing up the rear. Patients
feel left to fend for themselves, seeking
independent research and opinions on their
own. They and their dogged, relentless
determination have often been the catalyst that
eventually brings medical dangers to the
forefront.
Click
here to read the full article.
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FDA Abandons Pro-Mercury Fillings Policy
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From Consumers for Dental Choice
An intense set of interactions with FDA since
the Court of Appeals opinion on April 13 has
borne fruit. On April 19, we advised FDA of
liability exposure of key staff, then on May
2 notified FDA lawyers that we had the papers
prepared to file another lawsuit unless FDA
wanted to meet. On May 10, top FDA officials
met with food and drug law expert Jim Turner
and me; we gave FDA a month to change course
-- else we would return to court.
FDA responded -- favorably. Hemmed in by its
own scientific panel, facing another lawsuit
from us, challenged by an increasingly
aroused public, and unable to justify a
policy that this mercury is somehow different
from the mercury in medicines for dogs or
fish for humans, FDA changed course. On June
14, FDA's lawyer notified me, by phone and in
writing (e-mail is below) that FDA will write
an entirely new regulation on mercury
fillings. It is the harbinger of hope we may
have been seeking from this powerful agency.
Here's what it means:
- The great news: FDA abandons its policy
(expressed in its proposed regulation of
2002) to write into law a sleazy
special-interest rule prohibiting warnings,
covering up the existence of mercury, and
maintaining mercury exposure's side effect is
"allergies." After a five-year battle, we
broke the A.D.A.'s stranglehold over FDA
policy.
- The bad news: Today, and tomorrow, the
ugly status quo remains. Dentists deceive
parents by calling the fillings silver.
Toxic mercury fillings are still the choice
of the assembly-line dentists working on our
soldiers, our youth, our minorities, and our
working poor. FDA gives no timetable to
propose its new regulation.
- The mystery: With an in-house fight
apparently going on between FDA reformers and
FDA's mercury protectors, the result is not
predictable. But at last, top officials are
listening to our side -- Professor Boyd
Haley, Dr. Rich Fischer, and Dr. Mike Fleming
met June 22 with FDA's Associate Commissioner
for Science. I have written FDA six
questions about legally required steps.
We haven't won - far from it. But truly, the
A.D.A. has lost. FDA is no longer dancing to
its tune. The issue of mercury toxicity from
amalgam will be the subject of a great
national debate -- the news the A.D.A. and
the pro-mercury dentists have long dreaded.
Let me not sugar-coat it: a major battle lies
ahead as FDA determines its policy, and
perhaps at FDA's typical glacial speed. We
must vigilantly advocate our cause -- inside
the agency, before the public, and if
necessary back to the courts. I welcome your
views about our next step. Grassroots
activism by consumers, and speaking out by
dentists and other health professionals, is
more important than ever.
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New Book Benefits Autism Research
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Wall & Mean: A Novel by Tom Bernard
Tom Bernard, the father of a child with
autism, is
publishing his first book, Wall and Mean.
Proceeds
from the sale of the book will benefit
SafeMinds and
Autism Speaks.
Book Description
"Captures the tone and feel of Wall Street
better than
anything I've ever read. A snapshot of the
trader's
soul."-Michael Lewis
Wholesome Pennsylvania kid and Wall Street
phenom George Wilhelm is poised to become one of
the most successful young bond traders in the
business. A gambler at heart, George has
turned his
old poker skills into big profits on the
Emerging
Markets desk. Now those same skills have got him
trying to out-trade the sports bookies in
Vegas, and
George's hard-won security is in jeopardy as
he racks
up a ruinous gambling debt.
When the Brooklyn mafia sends two hitmen to
collect,
things turn ugly in a hurry: these boys have
clearly
never heard of a fair fight. George must
scramble to
keep his pursuers away from the bank and his
family,
while risking everthing on an all-or-nothing
trade. Set
in the glitter and grime of New York City
during the
bond-market boom of 1993, Wall and Mean is a
fast-
paced and surprising debut from a veteran of The
Street.
Click
here to order your copy now.
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Join MIA_MercuryIndcedAutism Action List
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Please join a new Yahoo group called MIA-Mercury
Induced Autism. The goal in the formation of
this list
was to create a resource where parents,
grandparents, and anyone whose life has been
impacted by mercury induced autism could go to
seek information or find support.
To join the discussion please click here.
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