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A Simple Question - FDA Advised Not to Answer
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By SafeMinds President, Theresa Wrangham
Late last year I became interested in the
emails between parent Twyla Ramos and the FDA
regarding testing of thimerosal levels in
vaccines that were posted on the Age of
Autism website. After surfing the FDA's
website, I started my own inquiries the
beginning of February and based them on the
FDA's
published policy on the principal
protections of vaccine safety that requires
the firm to test samples from each lot for
safety, potency and purity, and carries out
spot-testing of its own.
My question was simple, did FDA spot testing
encompass post licensure verification of the
manufacturer's purification process in the
production of vaccines and how often did they
perform spot testing post licensure.
After several emails and a phone
conversation, the FDA stated they can
conduct spot checks but would not confirm
that spot checks have ever been conducted
post licensure and stated that current
litigation prevented further comment. Emails
also confirmed that the FDA relies heavily on
data furnished by the manufacturer in any
review of vaccines with specific test results
available via the Freedom of Information Act
(FoIA), which is currently experiencing a
backlog of requests.
Fortunately for the public, the media appears
to get their FoIA requests fulfilled in short
order and reported on Merck's recent troubles
with the FDA, which coincidentally relied
upon Merck reporting most violations on their
own. (FDA report shows problems at Merck
vaccine plant - Karl Stark, Philadelphia
Inquirer, Apr. 24, 2008)
That requests for clarification of published
policy regarding vaccine safety are denied
and all communications with FDA officials on
the matter ended with a disclaimer stating
that the communication does not constitute a
formal opinion or position, doesn't inspire
trust or portray any real effort to be
transparent. The attitude was noted in the
FDA Science and Mission at Risk Report from
the Subcommittee on Science and Technology
issued late last year that stated the "FDA is
engaged in reactive regulatory priority
setting or a fire-fighting regulatory posture
instead of pursuing a culture of proactive
regulatory science," and so the status quo
remains in being unable to get the answers to
which we, the consumer/People, are entitled.
When the FDA, and other government agencies
involved with vaccine safety, can't answer a
simple yes or no question and continue to
hide behind FoIA and their attorneys, other
remedy must be pursued. Until vaccine safety
can be assured with modern testing standards
and independent data, the passage of
legislation requiring removal of mercury from
our vaccines, examination of other toxins
present in vaccines and testing of our
vaccine schedule is necessary.
The next opportunity to raise our voice on
the matter is the Green
the Vaccine Rally in
DC on June 4, 2008.
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Cement-Manufacturing Plants - One of the Largest Sources of Mercury Pollution
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From SafeMinds Environmental Committee Chair Scott Laster
Did you know that cement-manufacturing plants
are one of the largest sources of mercury
pollution? The SafeMinds Environmental
Committee is raising awareness on major
sources of mercury pollution and on the
efforts by environmental groups to push for
more-stringent mercury emissions requirements.
Following is an article on efforts by
environmental organizations to reduce
emissions from cement kilns in New York.
Three NY cement kilns account for nearly one
third of all mercury pollution in the state
-- groups urge the governor to limit mercury
pollution
October 25, 2007
Albany, NY -- Environmental groups took
action today to push for reductions of
dangerous mercury pollution from New York
cement kilns. The groups are urging the New
York State Department of Environmental
Conservation and Governor Eliot Spitzer to
include mandatory mercury reductions in an
air pollution permit for the Lafarge North
America plant, the state's largest cement kiln.
New York's three cement kilns, in Ravena,
Glens Falls, and Catskill, account for
approximately 600 pounds of mercury emissions
each year, or about half of the total amount
of mercury coming from the state's 26
coal-fired power plant boilers. As actual
mercury emissions testing from two of the
three kilns have not been measured, it is
possible that the real numbers for mercury
from cement kilns could be much higher.
"The cement industry in New York has for
years been given a free ride when it comes to
reducing their mercury pollution," said
Sierra Club Atlantic Chapter Conservation
Chair Susan Lawrence. "It's time Lafarge and
other cement kilns start drastically reducing
this dangerous pollution and protecting our
air and water from mercury contamination."
State law authorizes the NYSDEC Commissioner
to require the state's cement kilns to reduce
their mercury cement kiln emissions by as
much as 99%. The U.S. Environmental
Protection Agency has been foot-dragging for
nearly a decade on producing a national rule
limiting mercury pollution from cement kilns.
"EPA has been sitting idly by while cement
kilns spew toxic pollution into our air and
water. The State of New York should step in
and address this public health hazard," said
Earthjustice attorney Keri Powell. "New York
has often been a leader in environmental
protection. Now is the time for the governor
and the DEC to lead us toward better
protection from mercury pollution."
Earthjustice, on behalf of Sierra Club and
other local environmental and public health
groups, has challenged the EPA's federal
cement kiln rule, claiming that it violates
the Clean Air Act by failing to require
cement kilns to reduce their mercury
emissions. New York State Attorney General
Andrew Cuomo joined in that litigation, and
while he was attorney general, Governor
Spitzer joined in a separate lawsuit
challenging a weak Bush administration plan
that did little to limit mercury pollution
from coal-fired power plants.
"As attorney general, Governor Spitzer worked
to protect New York by fighting for a
stringent limit on mercury pollution from
power plants," said Jason K. Babbie, Senior
Environmental Policy Analyst with NYPIRG, the
New York Public Interest Research Group. "We
hope the Spitzer administration will build on
his track record of leadership on this issue
by including strict mercury limits for the
Lafarge kiln and all other New York cement
kilns."
In addition to limiting mercury pollution
from the Lafarge kiln, the groups are urging
the DEC to test mercury emissions from the
kilns in Glens Falls and Catskill. In 2002,
the Lafarge kiln reported annual mercury
emissions of only 40 pounds; it was not until
actual stack emissions testing in 2004 that
it was discovered the kiln actually emits
approximately 400 pounds of mercury each
year. Currently, the Lehigh Northeast Cement
Co. in Glens Falls reports annual mercury
emissions of only 14 pounds, while the St.
Lawrence Cement Co. plant in Catskill reports
annual mercury emissions of only 49 pounds.
It is likely that mercury emissions from
these facilities are much higher.
"Without definitive stack emissions testing,
there's no way to know for sure what these
kilns are emitting," Powell added.
"Especially because of its egregious
under-reporting of mercury emissions,
Lafarge's Title V air permit should not be
renewed by the DEC without specific controls
on mercury emissions," said Susan Falzon,
member of the Board of Directors with Friends
of Hudson. "Given the public health impacts
of mercury it is unconscionable that three
cement kilns operating within about 50 miles
of one another -- Lafarge in Ravena, SLC
(Holcim) Catskill and Glens Fall Lehigh --
emit massive amounts of mercury that would
not be permissible if they were power plants.
New York must immediately implement
enforceable limits on mercury emissions in
the cement industry to protect the health of
pregnant and nursing mothers and their
children."
Mercury pollution is a major problem for New
York and the northeastern United States. To
date, the New York State Department of Health
has issued fish consumption advisories for at
least 85 specific waterbodies or sections of
water bodies, warning women of childbearing
age not to eat fish because of dangerously
high mercury levels. The EPA estimates that 1
in every 6 women has mercury levels in their
blood high enough to harm development in
unborn children.
"Forest ecosystems with wetlands, rivers and
lakes that have been impacted by acid rain,
such as those in New York, are highly
sensitive to mercury pollution," said Dr.
Charles T. Driscoll, university Professor of
Environmental Systems Engineering and
Director of the Center for Environmental
Systems Engineering at Syracuse University.
"In particular a biological mercury hotspot
in the Adirondacks and the Catskill region
has been identified as an area of concern due
to mercury pollution. Studies have shown that
lakes in New York and elsewhere in the
Northeast have received substantial inputs of
mercury from local and regional sources, so
any controls on these sources will help
decrease this mercury contamination."
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The Center for Science in Public Interest's Fourth National Integrity in Science Conference
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July 11 in Washington D.C.
The Center for Science in the Public Interest's
Fourth National INTEGRITY IN SCIENCE
CONFERENCE, REJUVENATING PUBLIC SECTOR
SCIENCE will be held on July 11, 2008 in
Washington D.C.
This day long event will forge an agenda for
independent, regulatory science and
protecting public sector scientists from
political meddling and corporate influence.
Click
here for agenda and registration information.
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Fever, Vaccines and "Mitochondrial Autism"
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By David Kirby - Reprinted from Age of Autism
When the US Government conceded that vaccines
had contributed to the development of autism
in nine-year-old Hannah Poling, there was
much speculation about what could trigger
autistic regression in children with low
cellular energy from mitochondrial dysfunction.
Many experts who oppose the idea that
vaccines could be linked to autism -
including those at the CDC - first suggested
that a single-point mutation in Hannah's
mitochondrial DNA, inherited from her mother,
was the actual underlying cause of her
neurological problems.
The vaccines, they said, only made a bad
situation worse. Many went so far as to
insist that Hannah's precarious genetic
situation would have deteriorated into
"features of autism" anyway - with or without
the vaccines.
But that explanation fell apart: Hannah's
mother has the exact same mitochondrial
mutation, and yet she never developed any
neuro-psychological disorders. Moreover,
Hannah does not have "classic" mitochondrial
disease - a rare, inherited, and usually very
serious disorder.
Instead, Hannah had a moderate dysfunction of
her mitochondria, one that was so mild and
asymptomatic that it went undetected - and
apparently undisturbed - until July 19, 2000,
when she received nine vaccinations at once.
The rest is medical history.
The government stated in its second
concession statement in February, (in which
her epilepsy was also determined to be
vaccine-related), that the "cause" of
Hannah's "autistic encephalopathy" was:
"Underlying mitochondrial dysfunction,
exacerbated by vaccine-induced
fever and immune stimulation that exceeded
metabolic reserves."
Many people jumped on the "vaccine induced
fever" part of that sentence, and they are
still running with it. Some have inferred
that it is a well known fact that children
with disorders of their mitochondria can
readily regress into autistic encephalopathy
- if they encounter any number of infant
febrile infections.
This idea was supported by one of the experts
on mitochondrial dysfunction and autism that
I interviewed, who has studied 30 children
with regressive ASD at the same clinic. He
discovered that all 30 patients have the same
markers for mild mitochondrial dysfunction:
in this case, slightly abnormal levels or
ratios of the same amino acids and liver enzymes.
One of the 30 children was Hannah Poling.
Click
here to read the remainder of this article.
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SafeMinds 2008 Flu Vaccine Brochures Now Available
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SafeMinds printed 2007-2008 flu vaccine brochures are now here. You can download the brochure here or contact us to order printed copies.
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Looking for an easy way to support SafeMinds?
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Go Shopping!
That's right, go ahead and buy something for
yourself -- a new CD, the latest bestseller,
everyday essentials like pet food or
vitamins, even a computer. But first join
www.iGive.com/SafeMinds.
Every time you shop at one
of the over 680 name-brand stores in the
iGive.com Mall, we'll receive a donation of
up to 26% of each purchase you make, at no
cost to you.
Remember, donating to SafeMinds won't cost
you a thing. But we'll miss out on a lot of
extra dough, if you don't join. So visit
www.iGive.com/SafeMinds
now. Membership is
free and your privacy is guaranteed.
Click
here to join.
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Visit The Age of Autism
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The Age
of Autism is the nation's first daily Web
newspaper for the environmental-biomedical
community - those who believe autism is an
environmentally induced illness, that it is
treatable, and that children can recover. For
the most part, the major media in the United
States aren't interested in that point of
view, they won't investigate the causes and
possible biomedical treatments of autism
independently, and they don't listen to the
most important voices - those of the parents.
Visit the website at www.ageofautism.com.
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