| georgia 2005-03-29, 6:52 pm |
| ".......Lilly is the original manufacturer of thimerosal, a mercury
derivative used
in childhood vaccines as a preservative. The result of a discovery
process
by law firm Waters and Kraus showed that Lilly knew of mercury's
toxicity as
early as 1930 but nonetheless "secretly sponsored a human toxicity
study on
patients already known to be dying of meningococcal meningitis."
"Lilly then cited this study repeatedly for decades as proof that
thimerosal
was of low toxicity and harmless to humans," states a press release
from the
law firm.........."
part 2
When byronchild asked CDC spokesperson Curtis Allen for a copy of the
contract that would detail the agreement between the IOM and the CDC,
Allen
stated that the contract would be available only in a heavily
"redacted" or
blacked-out format.
The IOM stated "no comment" to byronchild about the leaked transcript
or its
use in the pending civil court case.
The Transcript of the First Organizational Meeting of the IOM Committee
On January 11, 2001, the IOM's Immunization and Safety Review committee
members gathered for its first organizational meeting in Washington,
DC. It
is this meeting's transcript that has been submitted as an exhibit by
Waters
and Kraus, a Dallas, Texas law firm.
During the IOM's open meeting, Walter Orenstein, MD, the Director of
the
National Immunization Program at the CDC, charged the committee to
specifically address: "the causal relationship between the vaccine and
adverse effect; the biologic mechanisms that could account for the
adverse
effect; and the significance of the safety concern in the context of
society
at large." ( Orenstein presided over another leaked CDC transcript from
June
2000, see sidebar 1. )
However, according to Gordon Douglas, MD, Director of Strategic
Planning for
the Vaccine Research Center at the National Institutes of Health (NIH)
the
IOM committee was hired by the CDC to "rule out the proposed links".
The NIH
serves as America's medical research agency.
Douglas stated in a Princeton university lecture summary that, "Four
current
studies are taking place at the CDC in collaboration with the NIH to
rule
out the proposed links between immunizations and autism, immunizations
and
possible developmental regression, inflammatory bowel disease and the
MMR
vaccine, and thimerosal and the risk of autism. In order to undo the
harmful
effects of research claiming to link the MMR vaccine to an elevated
risk of
autism, we need to conduct and publicize additional studies, strengthen
the
program to assure parents of MMR's safety, and further educate
pediatricians
and primary care physicians."
Formerly Douglas served as the president of vaccine manufacturer and
federal
lawsuit defendant Merck Vaccines from 1991 to 1999. According to an LA
Times
story on February 8, 2005, while serving as president of Merck, Douglas
received a memo from Maurice R. Hilleman, MD, an internationally
renowned
vaccinologist, who told Douglas that six-month-old babies who received
their
vaccines on schedule would receive a mercury dose 87 times higher than
the
Environmental Protection Agency deemed safe. (The NIH announced a
"sweeping
ethics reform" on February 1, 2005, see side bar 2. To view the Merck
memo:
http://www.nomercury.org/science/do...Memo_2-8-05.pdf
)
>From the beginning of the IOM committee's meeting behind the closed
doors of
the National Academies of Science building on January 12, 2001,
committee
members repeatedly expressed their "need for reassurance" and concern
over
their charge, evidence, methodology, and public communication goals,
especially to parents.
"We've got a dragon by the tail here," states a committee member in the
transcript. "At the end of the line, what we know is - and I agree -
that
the more negative that presentation [the report] is, the less likely
people
are to use vaccination, immunization, and we know what the results of
that
will be. We are kind of caught in a trap. How we work our way out of
the
trap, I think, is the charge."
Instead of focusing on scientific data which could possibly tarnish the
current routine childhood vaccine policy, "The transcript sets forth in
significant detail stated biases, preferences and/or predetermination
of
various committee members in January, 2001, i.e. before any medical or
scientific evidence had been presented to the committee (emphasis
added),"
states t he court document.
Specifically sited are statements by the IOM's study director Kathleen
Stratton, PhD, and committee chair Marie McCormick, MD. These
statements,
the law firm says, strongly suggest Stratton and McCormick deliberately
railroaded their committee into specific outcomes (all in italics
directly
from court document):
Dr. McCormick, for example, in speaking of the CDC, noted that the
agency
"wants us to declare, well, these things are pretty safe on a
population
basis." (See Exhibit 1 at page 33).
"The committee's bias and predetermination of the causality issues
presented
are found at page 74 in a comment from Dr. Stratton:
Dr. Stratton: "We said this before you got here, and I think we said
this
yesterday, the point of no return, the line we will not cross in public
policy is to pull the vaccine, change the schedule. We could say it is
time
to revisit this but we will 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."
Similarly, Dr. McCormick, at page 97 in discussing whether autism could
be
associated with vaccines, stated that "we are not ever going to come
down
that it is a true side effect," despite the fact that the committee had
not
yet considered any evidence on this issue.
At page 123, Dr. Stratton indicated that, despite not having heard any
of
the evidence, the probable conclusion was going to be that the evidence
was
"inadequate to accept or reject a causal relation." "Chances are, when
all
is said and done, we are still going to be in this category. It is just
a
general feeling that we probably still are not going to be able to make
a
statement."
Stratton joined the IOM in 1990 and was later awarded the IOM's Cecil
Research Award for her contributions to vaccine safety. McCormick is
the
Sumner and Esther Feldberg Professor of Maternal and Child Health at
the
Harvard School of Public Health.
Congressmen, researchers and parents petitioned the IOM Committee to
delay
their final meeting and report last year until an animal study
demonstrating
a link between mercury and autism by Mady Hornig, MD, an associate
professor
at Columbia University, could be completed.
The IOM refused to delay their final meeting and issued their "no link"
report on May 2004. The Columbia university study confirming the link
between mercury and autism was completed and presented to the public in
June
2004.
"This is a perfect example of the scientific findings that the IOM
ignored
when creating their recent report on the potential of the
vaccine-autism
link," stated Lyn Redwood, RN, MSN, NP, president of Safeminds, an
independent nonprofit organization. "The IOM was well aware that
studies
like these were due for release, but chose to ignore them.The findings
in
this study make clear that the IOM was more interested in regurgitating
CDC
spin than incorporating hard science like Dr. Hornig's report. Such
information would force the government to face the reality of the
mercury
threat and take definitive action to protect countless children from
potential neurological damage."
The US Office of Special Counsel (OSC) - an independent investigative
and
prosecutorial agency that serves as a channel for whistleblowers --
forwarded hundreds of disclosures "alleging public health and safety
concerns about childhood vaccines that include a mercury-based
preservative
known as thimerosal, and its possible link to neurological disorders,
including autism" to the US Congress on May 20, 2004, the day after the
IOM
issued its "no link" report.
The OSC letter requesting congressional action was addressed to US
Senator
Judd Gregg (R-NH) - who introduced Senate Bill 3 and its provisions for
liability protection for vaccine manufacturers on January 24, 2005.
The OSC's letter to Gregg stated, "it appears there may be sufficient
evidence to find a substantial likelihood of a substantial and specific
danger to public health caused by the use of thimerosal/mercury in
vaccines
because of its inherent toxicity."
"Due to the gravity of the allegations, I am forwarding a copy of the
information disclosed to you in your capacity as Chairmen of the Senate
Committee and House Committee with oversight authority for HHS. I hope
that
you will review these important issues and press HHS for a response to
this
very serious public health danger," states the OSC letter to Gregg. (To
view
the OSC letter:
http://www.nomercury.org/science/do...ase_5-20-04.pdf
)
Conflict of Interest in IOM Governing Council
Currently, members of the IOM's governing Council include, among 19
others ,
Gail H. Cassell, PhD, of Eli Lilly and Company and Helene D. Gayle, MD,
from
the Bill and Melinda Gates Foundation - the same foundation that
donated the
world's sixth largest charitable gift of $1.5 billion to create and
sustain
GAVI.
Lilly is the original manufacturer of thimerosal, a mercury derivative
used
in childhood vaccines as a preservative. The result of a discovery
process
by law firm Waters and Kraus showed that Lilly knew of mercury's
toxicity as
early as 1930 but nonetheless "secretly sponsored a human toxicity
study on
patients already known to be dying of meningococcal meningitis."
"Lilly then cited this study repeatedly for decades as proof that
thimerosal
was of low toxicity and harmless to humans," states a press release
from the
law firm.
While Lilly ceased the sale of thimerosal in 1991, their licensing
agreements demonstrate continued profits from the product until at
least
2010.
Lilly is the single biggest contributor to the Republican Party from
the
pharmaceutical industry donating $1.6 million in the last US election.
Senate Majority Leader Bill Frist (R-TN), co-sponsor of Senate Bill 3,
was
the author of a controversial bill that contained a provision that
would
protect Eli Lilly and other vaccine manufacturers from lawsuits over
mercury
in the 2002 Homeland Security Act.
Frist's other notable tie to Lilly is the fact that the vaccine
manufacturer
bought 5,000 copies of the senator's book on bioterrorism and
distributed
them to physicians after September 11, 2001.
The basis of the Frist family fortune is the Hospital Corporation of
America
(HCA), the largest for-profit hospital chain in the country, which was
founded by Frist's father and brother. (For more on Senator Frist see
sidebar 3).
GAVI - Using Corrupt Research to Vaccinate the World?
GAVI's public and private sector partners include governments in
industrialized and developing countries, UNICEF, the World Health
Organization, WHO, the World Bank, non-governmental organizations,
foundations, vaccine manufacturers, and public health and research
institutions. WHO and GAVI's headquarters are both in Geneva,
Switzerland.
To date a total of almost $1.3 billion, in addition to the Gates
endowment,
has been raised from international governments and private sources as
well
as an additional $1.19 billion in pledges toward GAVI's goal of a 90%
routine immunization rate by 2010 for all of its 70 underdeveloped
countries/grantees.
For vaccine manufacturers, the Gates' billions for GAVI represent a
guaranteed pipeline of money. For governments of undeveloped countries,
the
funds may be used for any aspect of health as long as their country's
vaccine rate increases. If the rates drop, so do the funds.
According to GAVI figures, 4 million children have been vaccinated for
diphtheria, tetanus, and whooping cough; 42 million more children have
been
vaccinated with hepatitis B; and 991 million single-use disposable
syringes
have been produced for the program.
" GAVI relies on technical and scientific information and advice from
the
Global Advisory Committee on Vaccine Safety. Based on the committee's
findings, GAVI and its partners will continue to support the use of
vaccines
that contain thimerosal," responded Gates Foundation spokesperson Jenny
Sorensen to byronchild's inquiry.
If the accusation that the IOM "predetermined" the outcome of their
reports
is true, what does this bode for a worldwide vaccine policy that is now
being routinely employed through GAVI's partners and the governments of
undeveloped countries who rely on the IOM's vaccine safety information
to be
accurate?
World Economic Forum questions GAVI's Global Vaccine Campaign
Is the solution for creating a healthy world a global vaccine campaign?
During the World Economic Forum's 2003 Annual Meeting in Davos,
Switzerland,
GAVI's global vaccine campaign was intensely debated by panelists.
WEF panelists were not convinced that GAVI's goals were realistic or a
panacea for the complex needs of underdeveloped countries.
"There is a strong tendency to see vaccines as a cure-all that can work
in
isolation," said Geoffrey Foster, Founder and Consultant, International
Child Welfare and Health, Family AIDS Caring Trust, FACT, Zimbabwe, and
Social Entrepreneur. "Instead, vaccines must be set firmly within a
realistic and holistic context. In the past, in Europe, death and
disease
dropped because of nutrition and education. Vaccines must accompany
poverty
alleviation or children will be stunted both physically and
intellectually."
The World Economic Forum is a global community of business, political,
intellectual and other leaders of society. The forum is an independent
international organization incorporated as a Swiss not-for-profit
foundation
and has NGO consultative status with the Economic and Social Council of
the
United Nations.
Autism - An Epidemic Too Big To Ignore
During the years that the IOM reports were drafted, 2001 to 2004, more
than
4,500 petitions for "vaccine injuries resulting in autism spectrum
disorder"
, piled up in an Omnibus Autism Proceeding with the US Court of Federal
Claims.
Currently, autism is the fastest growing developmental disability in
the
United States, with one in 166 US children diagnosed with Autism
Spectrum
Disorder, up from 1 in 2500 a decade ago, and over 1.77 million
affected.
In the last four years alone, the number of cases of autism has nearly
doubled in California. "It is growing much faster than the growth of
the
population and other forms of childhood disabilities," states Cliff
Allenby,
director of the State Department of Development Services.
A report by the independent Environmental Working Group issued in
December
2004 found that autistic children had less glutathione, an antioxidant
that
helps rid the body of toxic metals, when compared to a sample of
healthy
children. The study, led by Jill James, PhD, a professor of
biochemistry and
pediatrics at the university of Arkansas for Medical Sciences, found
that a
glutathione deficit "may contribute to the development and clinical
manifestation of autism."
Autism is not a disease but a 'condition' often characterized by a
failure
to bond, lack of social interaction, avoidance of eye-to-eye contact,
difficulties in language development, and repetitive behaviors known as
stimming (self-stimulation). Milder forms of autism are Asperger's
Syndrome
, Pervasive Developmental Disorder and Attention Deficit/Hyperactivity
Disorder . Collectively they are known as Autism Spectrum Disorder,
ASD.
States Take Matters Into Their Own Hands
After multiple congressional hearings on conflicts of interest within
the
vaccine industry and government, repeated IOM reports stating no link
between vaccines and autism, and with no official FDA recall for
mercury
containing vaccines, US citizens and state legislators took matters
into
their own hands and in May 2004, Iowa became the first state to ban
mercury
in vaccines.
During the same three-year period the IOM committee reviewed its data
on the
vaccines and autism link, the Iowa Human Resources Committee reviewed
scientific and biological data from independent researchers.
'After three years of review, I became convinced there was sufficient
credible research to show a link between mercury and the increased
incidents
in autism,' said Iowa Senator Ken Veenstra. 'The fact that Iowa's 700
percent increase in autism began in the 90s, right after more and more
vaccines were added to the children's vaccine schedules, is solid
evidence
alone.The IOM has not convinced me this action is not needed. I feel
strongly we need to pursue a use of alternative vaccines."
US Congressional Representative Dave Weldon, MD, (R-FL), called the IOM
reports "heavily biased and unrepresentative of all the available
scientific
and medical research." Weldon said the reports discounted the
biological
evidence presented by US Congressional investigative reports and
university
studies. It also discounted thousands of parent activists who pointed
to the
parallel increase in vaccination requirements and the rise in autism
rates
starting in the early 1990s.
California Governor Arnold Schwarzenegger signed his state's mercury
ban
last year and more than a dozen other states are currently considering
their
own bans.
Senate Bill 3 would seek to repeal the current states bans and to
prohibit
more states from enacting their own bans on mercury, a violation of the
US
Constitution's Tenth Amendment . (See side bar 4 for a complete list of
the
bill's proposals.)
Senate Bill 3 - Dissolution of Civil Rights?
Sighting the IOM reports' green light to justify the act's proposed
sweeping
protections for the vaccine industry, the bill states that, " After
considering recent changes in the litigation environment with respect
to
vaccines as well as recent scientific evidence and reports by the
Institute
of Medicine (italics added) and others with respect to the safety of
vaccines and their components and ingredients, the Secretary of Health
and
Human Services and the Attorney General shall, not later than 6 months
after
the date of enactment of this Act, jointly submit recommendations to
the
appropriate committees of Congress concerning necessary modifications
to the
Vaccine Injury Compensation Program and Federal rules regarding
litigation
involving vaccines."
"The war on terror is a different kind of war and requires a different
kind
of preparedness," US Senator Judd Gregg (R-NH) said in a press release
about
the bill. "Specifically, this bill encourages development of products
needed
to protect the nation against biological, radiological or nuclear
agents as
well as infectious diseases. It expands the availability and
accessibility
of vaccines. Finally, it strengthens capacity and coordination, so we
can
respond effectively during public health emergencies."
"This bill is labeled as an 'anti-terror' bill, but it is power grab by
the
federal government and an assault on self-governance and the informed
consent ethic. It takes away the freedom of the people to make their
voices
heard through their elected state representatives and protect
themselves
from unsafe drugs, such as Celebrex and Vioxx, and unsafe vaccines,
such as
those that contain high levels of mercury. It gives unprecedented
liability
protection to the drug industry and broad powers to federal officials
to
hide the truth from the people about vaccine and prescription drug
risks,"
said Barbara Loe Fisher, president of America's largest and oldest
vaccine
safety and consumer watchdog organization the National Vaccine
Information
Center.
"Protecting the public health was not delegated to the federal
government
and public health laws, including laws governing use of vaccines, have
always been under the control of citizens residing in each state," said
Fisher. "The irony of this bill is that it is using the families of
citizens
who have given their lives to defend our nation's freedom in order to
take
rights and freedoms away from other families. Military veterans should
not
be used to protect the drug industry and take away the freedom for all
Americans to have their voices heard through their elected state
representatives. This bill does not serve justice or freedom."
An internationally renowned bio-ethicist who has previously spoken on
vaccine policy issues at the National Vaccine Information Center
conference,
told byronchild magazine that people should not be surprised by the
contents
of the IOM transcript or Senate Bill 3. 'Old paradigms do not die
easily,'
he said. 'This is just the nature of the beast.'
Side Bar 1: Not The First Leaked Transcript
The 2001 IOM transcript is not the first to be leaked to the public.
Another
closed meeting transcript from June of 2000 recorded 53 scientists from
the
CDC, FDA, and the vaccine industry at the Simpsonwood Retreat Center in
Georgia to review the findings of a statistically significant
correlation
between mercury-containing vaccines and neurological conditions.
The discovery was made by CDC employee Thomas Verstraeten, MD, using
the
CDC's own data. The meeting was not open to the public or announced in
the
Federal Register, and the CDC has still not made their findings public.
Verstraeten has since left the CDC to work for a vaccine manufacturer
in
Belgium. He has also not responded to a US Congressional subpoena.
However the meeting transcript was included in the "Mercury in
Medicine:
Taking Unnecessary Risks?" report that was the result of a three year
investigation by the US Congress' Subcommittee on Human Rights and
Wellness,
Committee on Government Reform's Report published in April 2003.
The Simpsonwood meeting was presided over by Walter Orenstein, MD, the
Director of the National Immunization Program at the CDC. Orenstein
presented the public charge to the IOM committee on January 11, 2001,
the
day before the closed organizational meeting.
(To read the Simpsonwood transcript go to:
http://www.nomercury.org/science/do..._Transcript.pdf
To read the Verstraeten study:
http://www.nomercury.org/science/do...VSDstudy001.pdf )
Side Bar 2: Sweeping Ethics Reform to End Culture of Corruption?
Drug industry influence on medical research and practice and on the
prescribing of drugs is pervasive. After a yearlong investigation into
the
"culture" of conflicts of interest between its scientists and
manufacturers,
on February 1, 2005, the National Institutes of Health, the US leading
agency for medical research, announced a "sweeping ethics reform".
Under the new rules which reversed a 1995 decision that allowed
"moonlighting" between the scientists and industry, all NIH employees
have
been prohibited from engaging in employment with pharmaceutical and
biotechnology companies, supported research institutions, including NIH
grantees, health care providers and insurers. NIH employees were also
required to sell their stock in any of the above.
In a "town hall" meeting for employees on February 3, 2005, NIH
director
Elias A. Zerhouni, MD, announced the need for a summit of government
and
academic leaders to address conflicts of interest throughout American
medical research as part of the ethics reform.
The NIH announcement came after a year-long investigation in to
conflicts of
interest and the "discovery, made by congressional investigators, that
more
than 100 NIH employees had not disclosed various relationships they had
with
pharmaceutical and biotech companies, in violation of government ethics
rules" according to a Washington Post article on February 3, 2005.
"I came to the conclusion that we have a systemic problem," Zerhouni
said in
an LA Times interview on February 12, 2005. "They were not just
isolated
events. They reflected the complete set of rules that had been adopted
over
the years, which had transformed the culture. I said, if that's the
case,
let's bring back the culture to where it needs to be: That is, public
first.
"That's the hardest part," he said. "It's easy to come up with
regulations.
It's not easy to change a culture."
To read the NIH report: http://www.nih.gov/news/pr/feb2005/od-01.htm
Sidebar 3: Who is Senate Majority Leader Bill Frist (R-TN), co-sponsor
of
Senate Bill 3?
According to the Center for Justice and Democracy, these are some facts
about Senator Bill Frist, MD:
.. The basis of the Frist family fortune is the Hospital Corporation of
America (HCA), the largest for-profit hospital chain in the country,
which
was founded by Frist's father and brother.
.. Frist and his wife have $26 million in HCA stock in a so-called
"blind
trust."
.. HCA has agreed to pay the federal government more than $1.7 billion
in
civil and criminal penalties, the largest health care settlement in
history,
for massive Medicare, Medicaid and Tricare billing fraud.
.. Frist has gotten more than $2.3 million from doctors, health
insurers,
drug companies and others in the health care industry, roughly 20
percent of
all the contributions to his two Senate races, raising more cash from
health-care interests than 98 percent of his colleagues.
.. Frist has voted against patients' rights to sue their HMOs for
failure to
provide adequate treatment while supporting tax subsidies to HMOs and
insurance companies to offer prescription drugs to seniors, rather than
providing them through Medicare. Frist has received $123,750 in
campaign
cash from HMOS.
.. To date, Frist has received $265,023 from the pharmaceutical
industry.
The
pharmaceutical industry was also the largest single contributor to the
National
Republican Senatorial Campaign Committee that Frist chaired, giving
about $4
million - and Lilly was the single biggest contributor to the GOP from
that
industry, having given $1.6 million in the last election cycle.
.. In 2002, Frist engineered the insertion of a provision into the
Homeland
Security bill that would protect Eli Lilly and other pharmaceutical
giants
from lawsuits over mercury in vaccines. Not long after Frist introduced
the
legislation, the Pharmaceutical Research and Manufacturers of America,
the
drug industry's trade group, gave $10,000 to his political action
committee.
This report from:
http://www.centerjd.org/free/mythbusters-free/Frist.pdf
Side Bar 4: Senate Bill 3 - What It Could Do
Of major concern to vaccine safety and civil rights advocates are the
following provisions in Senate Bill 3:
* Eliminates a state's right to more strictly regulate vaccines and
drugs
and more fully inform their citizens about vaccine and drug risks than
does
the federal government. Laws already passed in California and Iowa
limiting
mercury content in vaccines would be repealed.
* Gives comprehensive liability protections to drug companies.
Eliminates a
citizen's right to seek justice in state courts for drug and vaccine
injuries and deaths and limits awards in federal courts. Gives tax
credits,
grants and patent extensions to the drug industry.
*Allows the Department of Health and Department of Justice, the
defendants
in the federal Vaccine Injury Compensation Program, to write the terms
of
their own defense in order to further limit awards to vaccine injured
children.
* Creates and funds a mandatory, national electronic tracking system
operated by the Centers for Disease Control (CDC) to monitor vital
records
of citizens relating to both notifiable and non-notifiable diseases and
"new
trends" and "patterns in public health." Creates penalties for states
and
health care providers not reporting in a "timely manner" to the
national
tracking system. There are no provisions for mandatory reporting of
serious
health problems following vaccine and prescription drug use or
punishments
for not reporting serious side effects.
S. 3 is being promoted by sponsors as a military veteran benefit bill
because it raises the death benefits and other financial support for
the
families of soldiers who lost their lives in the war in Iraq.
>From the National Vaccine Information Center's website. For a point by
point
examination of the bill, visit the site at
http://www.nvic.org/ActionAlerts/S3Article.htm .
For the actual bill: Senate Bill 3:
http://www.nomercury.org/science/do...or_Act_2005.pdf
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