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Letter to the Senate |
Letter to the House
Letter to
Senate Health, Education, Labor and Pensions Committee
February 23, 2010
Senator Tom Harkin, Chairman
Senator Michael Enzi, Ranking Member
Senate Health, Education, Labor and Pensions Committee
428 Dirksen Senate Office Building
Washington, DC 20510
Dear Senators Harkin and Enzi,
In light of the growing number of questions and concerns
regarding vaccine safety, it is imperative that the U.S.
government rely on the best, most thorough and rigorous
science possible. The Department of Health and Human
Services is legally and ethically bound to do everything
reasonably possible to ensure the safety of vaccines.
The undersigned organizations request congressional
hearings to investigate and review the role and
performance of HHS and its constituent agencies to
ensure vaccine safety. We call on Congress to fulfill
its proper oversight function to ensure full compliance
with law.
Congress should review the claims of HHS and the Centers
for Disease Control (CDC) that vaccines are safe with a
jaundiced eye. The existing evidence on vaccine safety
is grossly insufficient and fails to meet the
requirements of public confidence. In fact, significant
evidence points to suppression of science that could
prove or disprove vaccine safety. This suppression may
be due to potential liability and financial conflicts of
interest involving individuals and organizations
responsible for scientific studies and vaccine safety
policies. Furthermore, HHS has blatantly disregarded
laws that Congress passed requiring it to thoroughly
study vaccine safety.
HHS non-compliance with the congressional Mandate for
Safer Vaccines in the 1986 National Childhood Vaccine
Injury Compensation Act clearly calls for congressional
intervention and investigation. HHS’
congressionally-mandated research to reduce vaccine
injuries has been flawed and inadequate. The Mandate
specifically states, “[M]ake or assure improvements in,
and otherwise use the authorities of the Secretary with
respect to, the licensing, manufacturing, processing,
testing, labeling, warning, use instructions,
distribution, storage, administration, field
surveillance, adverse reaction reporting, and recall of
reactogenic lots or batches, of vaccines, and research
on vaccines, in order to reduce the risks of adverse
reactions to vaccines." The only way HHS can be in
compliance with the mandate is by conducting proper
tests using both vaccinated and unvaccinated children,
which to date, has not been done.
The Court of Federal Claims, which determines
compensation for vaccine injuries, must rely on the best
available vaccine safety science for its decisions. The
consequences of government agencies willfully providing
insufficient or flawed science for determinations of
this magnitude are astounding from the standpoints of
public health and justice. Surely ignorance is no
substitute for science.
HHS adherence to the spirit and intent of the Combating
Autism Act of 2006 is in serious question, resulting in
inadequate vaccine safety science and research. An
important additional reason for Congress to act now is
that the Court of Federal Claims is likely to soon
release its Omnibus Autism Proceeding “test cases” on
the possible link between the mercury-containing
preservative thimerosal and autism. If there has been
any suppression of evidence and science or significant
conflicts of interest contaminating the research that
undergirds the Court’s determinations, there is an
urgent need for Congress to act. HHS’ and CDC’s failures
to provide adequate science on vaccine safety contribute
to judicial decisions being made in a vacuum. Many
officials claim there is no link between vaccines and
autism when in fact many reputable experts, including
the former Chairman of the National Institutes of Health
Dr. Bernadine Healy and HHS’ own scientific advisory
panel, the National Vaccine Advisory Committee (NVAC),
argue that the evidence is insufficient.
Below are just a few examples of suppression of science
and conflicts of interest Congress should review; the
full texts are available at our website
www.coalitionforvaccinesafety.org:
- Former Chairman of
the National Institute of Health (NIH) Dr. Bernadine
Healy, said, about a link between vaccines
containing thimerosal and autism, "What we’re seeing
in the bulk of the population: vaccines are safe.
But there may be this susceptible group. The fact
that there is concern, that you don’t want to know
that susceptible group is a real disappointment to
me. If you know that susceptible group, you can save
those children. If you turn your back on the notion
that there is a susceptible group… what can I say?"
Regarding whether or not there is a link between
vaccines and autism, “The question has not been
answered.” (http://www.cbsnews.com/stories/2008/05/12/cbsnews_investigates/main4086809.shtml)
- NIMH Director Dr.
Thomas Insel at a January 2009 Interagency Autism
Coordinating Committee (IACC) meeting: “I'm
concerned about the optics … of having HRSA vote on
issues related to autism and vaccines when they have
a large court case, the optics of having people who
have, could be perceived to have, um, or to
represent those with a financial investment in this
issue. It takes it out of the
realm of a scientific question, a research question,
and it raises the possibility that some could see
whatever comments we make as being biased by
nonscientific issues, and I understand that's a risk
in lots of things that we do, this one really feels,
since this is a court case that is soon going to
become public, and I think it's fairly close to a
large omnibus effort, um, I think that this one
really does represent some jeopardy for this
process, for this committee, almost any way in which
it comes out. If we say, yes we think it's important
to look at this, and to provide additional
information, it implies that we believe that there
is a relationship between autism and vaccines, and
it suggests, um, that, um, in some way this runs
opposite to what HHS may define through the HRSA
process.” (from the minutes of the meeting)
- Former Congressman
David Weldon (R-FL) “I recently received documents
from the Centers for Disease Control confirming that
one of the studies upon which they rely heavily, was
twice rejected by respectable journals. Both the
Journal of the American Medical Association (JAMA)
and The Lancet rejected the Madsen study examining
rates of autism among children before and after the
removal of thimerosal in Denmark in 1992. A top CDC
official wrote to Pediatrics urging them to give
“expedited” consideration to what he characterized
as a “powerful epidemiology study.” Yet the study
had significant weaknesses and they knew it. (April
19, 2007 statement from the Congressional Record)
- HHS conceded in a
settlement agreement that vaccines led to autism in
a child due to mitochondrial disfunction, Poling ex.
rel. Poling v. Sec'y of HHS, 2008 WL 1883059. The
Court of Federal Claims decided in 2007 that child’s
autism was due to vaccine-induced acute
disseminating encephalomyelitis (ADEM), Banks v.
Sec'y of HHS, 2007 WL 2296047. Despite these
determinations of vaccine-induced autism, HHS
asserted throughout the Omnibus Autism Proceeding
that an autism-vaccine link is “junk science.”
http://www.uscfc.uscourts.gov/omnibus-autism-proceeding.
- Former CDC Director
Dr. Julie Gerberding (now president of Merck
Vaccines) reluctantly admitted on CNN on March 19,
2008 that “vaccines can occasionally cause fever in
kids” and, if a child is predisposed to
mitochondrial disorder (which may be 20% or more of
autistic children), the fever can result in damage
where “some of the symptoms can have the
characteristics of autism.”
http://www.youtube.com/watch?v=Dh-nkD5LSIg.
- The Institute of
Medicine’s (IOM) 2004 report on vaccine safety,
often cited as exonerating the role of vaccines in
autism, specifically left open the potential for
environmental triggers, including vaccines, by
stating "[a]bsent biomarkers, well defined risk
factors, or large effect sizes, the committee cannot
rule out, based on the epidemiological evidence, the
possibility that vaccines contribute to autism in
some small subset or very unusual circumstances."
http://www.iom.edu/Reports/2004/Immunization-Safety-Review-Vaccines-and-Autism.aspx.
Despite this IOM statement, HHS has made no effort
since to study or screen out possible subsets of
vulnerable children.
- Dr. Louis Cooper,
former head of the American Academy of Pediatrics,
recently stated: “What has been missing in order to
give parents confidence that immunization is one of
the best ways to protect the health of their
children? Our national failure falls into two
categories. First, we've had inadequate ongoing,
credible education of the public and health
professions from trusted public-health officials
concerning the known and unknown benefits and risks
of vaccines. Today's parents have little fear of
diseases they mistakenly think have been eliminated
by vaccines. Second, there's been grossly
insufficient investment in research on the safety of
immunization. Together, these failures contributed
to undermining of public confidence.” (“The
Confidence Gap: Why the Obama Administration Needs
to Restore Public Faith in the Safety of Childhood
Vaccines,” Newsweek Feb. 23, 2009)
http://www.newsweek.com/id/185986.
- Members of the CDC's
Advisory Committee on Immunization Practices get
money from vaccine manufacturers. Relationships have
included: sharing a vaccine patent; owning stock in
a vaccine company; payments for research; getting
money to monitor manufacturer vaccine tests; and
funding academic departments. The conflict of
interest by key decision-makers poses a threat to
the health of our nation’s children. A recent report
of the HHS Office of Inspector General found that
97% of outside advisers at the CDC in 2007,
including those on the Advisory Committee on
Immunization Practices, had at least one omission in
their financial disclosure forms. (CDC’s Ethics
Program for Special Government Employees on Federal
Advisory Committees,
http://oig.hhs.gov/oei/reports/oei-04-07-00260.pdf)
- While the U.S.
government has compensated more than 1,300 brain
injury claims in the Court of Federal Claims since
1988, it refuses to study those cases or track how
many of them result in autism. The Vaccine Injury
Compensation Program fund has $3.1 billion, but if
the 4,900 families with claims of autism were to
receive awards, the compensation fund would fall
short by $15 billion to $25 billion, providing a
possible incentive for ignoring or suppressing
proper research on vaccine safety and autism.
ftp://ftp.publicdebt.treas.gov/dfi/tfmb/dfivi0110.pdf.
These examples highlight
conflicts of interest and inadequacies in the science
that we would like the Congress to explore. We would be
happy to provide more examples. We offer our full
support, assistance and cooperation with a hearing or
series of hearings, and look forward to your response.
Sincerely,
Mary Holland, Esq.
Coalition for Vaccine Safety, Steering Committee
Co-founder of the Elizabeth Birt Center for Autism Law
and Advocacy
Cc’d
Senator Patrick Leahy, Chairman
Senator Jeff Session, Ranking Member
Senate Judiciary Committee
224 Dirksen Senate Office Building
Washington, DC 20510
Letter to the
Subcommittee on Health, House Energy and Commerce
Committee
February 23, 2010
Congressman Frank Palone, Chairman
Congressman Nathan Deal, Ranking Member
Subcommittee on Health, House Energy and Commerce
Committee
2125 Rayburn House Office Building
Washington, DC 20515
Dear Representatives Palone and Deal,
In light of the growing
number of questions and concerns regarding vaccine
safety, it is imperative that the U.S. government rely
on the best, most thorough and rigorous science
possible. The Department of Health and Human Services is
legally and ethically bound to do everything reasonably
possible to ensure the safety of vaccines. The
undersigned organizations request congressional hearings
to investigate and review the role and performance of
HHS and its constituent agencies to ensure vaccine
safety. We call on Congress to fulfill its proper
oversight function to ensure full compliance with law.
Congress should review the claims of HHS and the Centers
for Disease Control (CDC) that vaccines are safe with a
jaundiced eye. The existing evidence on vaccine safety
is grossly insufficient and fails to meet the
requirements of public confidence. In fact, significant
evidence points to suppression of science that could
prove or disprove vaccine safety. This suppression may
be due to potential liability and financial conflicts of
interest involving individuals and organizations
responsible for scientific studies and vaccine safety
policies. Furthermore, HHS has blatantly disregarded
laws that Congress passed requiring it to thoroughly
study vaccine safety.
HHS non-compliance with the congressional Mandate for
Safer Vaccines in the 1986 National Childhood Vaccine
Injury Compensation Act clearly calls for congressional
intervention and investigation. HHS’
congressionally-mandated research to reduce vaccine
injuries has been flawed and inadequate. The Mandate
specifically states, “[M]ake or assure improvements in,
and otherwise use the authorities of the Secretary with
respect to, the licensing, manufacturing, processing,
testing, labeling, warning, use instructions,
distribution, storage, administration, field
surveillance, adverse reaction reporting, and recall of
reactogenic lots or batches, of vaccines, and research
on vaccines, in order to reduce the risks of adverse
reactions to vaccines." The only way HHS can be in
compliance with the mandate is by conducting proper
tests using both vaccinated and unvaccinated children,
which to date, has not been done.
The Court of Federal Claims, which determines
compensation for vaccine injuries, must rely on the best
available vaccine safety science for its decisions. The
consequences of government agencies willfully providing
insufficient or flawed science for determinations of
this magnitude are astounding from the standpoints of
public health and justice. Surely ignorance is no
substitute for science.
HHS adherence to the spirit and intent of the Combating
Autism Act of 2006 is in serious question, resulting in
inadequate vaccine safety science and research. An
important additional reason for Congress to act now is
that the Court of Federal Claims is likely to soon
release its Omnibus Autism Proceeding “test cases” on
the possible link between the mercury-containing
preservative thimerosal and autism. If there has been
any suppression of evidence and science or significant
conflicts of interest contaminating the research that
undergirds the Court’s determinations, there is an
urgent need for Congress to act. HHS’ and CDC’s failures
to provide adequate science on vaccine safety contribute
to judicial decisions being made in a vacuum. Many
officials claim there is no link between vaccines and
autism when in fact many reputable experts, including
the former Chairman of the National Institutes of Health
Dr. Bernadine Healy and HHS’ own scientific advisory
panel, the National Vaccine Advisory Committee (NVAC),
argue that the evidence is insufficient.
Below are just a few examples of suppression of science
and conflicts of interest Congress should review; the
full texts are available at our website
www.coalitionforvaccinesafety.org:
- Former Chairman of
the National Institute of Health (NIH) Dr. Bernadine
Healy, said, about a link between vaccines
containing thimerosal and autism, "What we’re seeing
in the bulk of the population: vaccines are safe.
But there may be this susceptible group. The fact
that there is concern, that you don’t want to know
that susceptible group is a real disappointment to
me. If you know that susceptible group, you can save
those children. If you turn your back on the notion
that there is a susceptible group… what can I say?"
Regarding whether or not there is a link between
vaccines and autism, “The question has not been
answered.” (http://www.cbsnews.com/stories/2008/05/12/cbsnews_investigates/main4086809.shtml)
- NIMH Director Dr.
Thomas Insel at a January 2009 Interagency Autism
Coordinating Committee (IACC) meeting: “I'm
concerned about the optics … of having HRSA vote on
issues related to autism and vaccines when they have
a large court case, the optics of having people who
have, could be perceived to have, um, or to
represent those with a financial investment in this
issue. It takes it out of the
realm of a scientific question, a research question,
and it raises the possibility that some could see
whatever comments we make as being biased by
nonscientific issues, and I understand that's a risk
in lots of things that we do, this one really feels,
since this is a court case that is soon going to
become public, and I think it's fairly close to a
large omnibus effort, um, I think that this one
really does represent some jeopardy for this
process, for this committee, almost any way in which
it comes out. If we say, yes we think it's important
to look at this, and to provide additional
information, it implies that we believe that there
is a relationship between autism and vaccines, and
it suggests, um, that, um, in some way this runs
opposite to what HHS may define through the HRSA
process.” (from the minutes of the meeting)
- Former Congressman
David Weldon (R-FL) “I recently received documents
from the Centers for Disease Control confirming that
one of the studies upon which they rely heavily, was
twice rejected by respectable journals. Both the
Journal of the American Medical Association (JAMA)
and The Lancet rejected the Madsen study examining
rates of autism among children before and after the
removal of thimerosal in Denmark in 1992. A top CDC
official wrote to Pediatrics urging them to give
“expedited” consideration to what he characterized
as a “powerful epidemiology study.” Yet the study
had significant weaknesses and they knew it. (April
19, 2007 statement from the Congressional Record)
- HHS conceded in a
settlement agreement that vaccines led to autism in
a child due to mitochondrial disfunction, Poling ex.
rel. Poling v. Sec'y of HHS, 2008 WL 1883059. The
Court of Federal Claims decided in 2007 that child’s
autism was due to vaccine-induced acute
disseminating encephalomyelitis (ADEM), Banks v.
Sec'y of HHS, 2007 WL 2296047. Despite these
determinations of vaccine-induced autism, HHS
asserted throughout the Omnibus Autism Proceeding
that an autism-vaccine link is “junk science.”
http://www.uscfc.uscourts.gov/omnibus-autism-proceeding.
- Former CDC Director
Dr. Julie Gerberding (now president of Merck
Vaccines) reluctantly admitted on CNN on March 19,
2008 that “vaccines can occasionally cause fever in
kids” and, if a child is predisposed to
mitochondrial disorder (which may be 20% or more of
autistic children), the fever can result in damage
where “some of the symptoms can have the
characteristics of autism.”
http://www.youtube.com/watch?v=Dh-nkD5LSIg.
- The Institute of
Medicine’s (IOM) 2004 report on vaccine safety,
often cited as exonerating the role of vaccines in
autism, specifically left open the potential for
environmental triggers, including vaccines, by
stating "[a]bsent biomarkers, well defined risk
factors, or large effect sizes, the committee cannot
rule out, based on the epidemiological evidence, the
possibility that vaccines contribute to autism in
some small subset or very unusual circumstances."
http://www.iom.edu/Reports/2004/Immunization-Safety-Review-Vaccines-and-Autism.aspx.
Despite this IOM statement, HHS has made no effort
since to study or screen out possible subsets of
vulnerable children.
- Dr. Louis Cooper,
former head of the American Academy of Pediatrics,
recently stated: “What has been missing in order to
give parents confidence that immunization is one of
the best ways to protect the health of their
children? Our national failure falls into two
categories. First, we've had inadequate ongoing,
credible education of the public and health
professions from trusted public-health officials
concerning the known and unknown benefits and risks
of vaccines. Today's parents have little fear of
diseases they mistakenly think have been eliminated
by vaccines. Second, there's been grossly
insufficient investment in research on the safety of
immunization. Together, these failures contributed
to undermining of public confidence.” (“The
Confidence Gap: Why the Obama Administration Needs
to Restore Public Faith in the Safety of Childhood
Vaccines,” Newsweek Feb. 23, 2009)
http://www.newsweek.com/id/185986.
- Members of the CDC's
Advisory Committee on Immunization Practices get
money from vaccine manufacturers. Relationships have
included: sharing a vaccine patent; owning stock in
a vaccine company; payments for research; getting
money to monitor manufacturer vaccine tests; and
funding academic departments. The conflict of
interest by key decision-makers poses a threat to
the health of our nation’s children. A recent report
of the HHS Office of Inspector General found that
97% of outside advisers at the CDC in 2007,
including those on the Advisory Committee on
Immunization Practices, had at least one omission in
their financial disclosure forms. (CDC’s Ethics
Program for Special Government Employees on Federal
Advisory Committees,
http://oig.hhs.gov/oei/reports/oei-04-07-00260.pdf)
- While the U.S.
government has compensated more than 1,300 brain
injury claims in the Court of Federal Claims since
1988, it refuses to study those cases or track how
many of them result in autism. The Vaccine Injury
Compensation Program fund has $3.1 billion, but if
the 4,900 families with claims of autism were to
receive awards, the compensation fund would fall
short by $15 billion to $25 billion, providing a
possible incentive for ignoring or suppressing
proper research on vaccine safety and autism.
ftp://ftp.publicdebt.treas.gov/dfi/tfmb/dfivi0110.pdf.
These examples highlight
conflicts of interest and inadequacies in the science
that we would like the Congress to explore. We would be
happy to provide more examples. We offer our full
support, assistance and cooperation with a hearing or
series of hearings, and look forward to your response.
Sincerely,
Mary Holland, Esq.
Coalition for Vaccine Safety, Steering Committee
Co-founder of the Elizabeth Birt Center for Autism Law
and Advocacy
Cc’d
Congressman John Conyers, Chairman
Congressman Lamar Smith, Ranking Member
House Judiciary Committee
|
