Current News |
Public Tells
Government Panel: Vaccine Safety Must
Come First
by Barbara Loe Fisher
It has been 22 years since the U.S.
Congress acknowledged vaccine injuries
and deaths by passing the National
Childhood Vaccine Injury Act and 17
years since the Institute of Medicine
first confirmed that vaccines can cause
brain and immune system dysfunction
while admitting there were significant
"gaps" in scientific knowledge about
vaccine risks. After nearly three
decades of resisting public calls from
parents of vaccine injured children for
a formal investigation into vaccine
safety, the U.S. Department of Health
and Human Services (DHHS) has
established the National Vaccine
Advisory Committee Working Group on
Vaccine Safety to review a scientific
research agenda proposed by DHHS.
On April 11, government health officials
invited a few parents to Capitol Hill in
Washington, D.C. to participate on a
public engagement panel followed by a
one hour public comment period. It was
both business as usual and a departure
of business as usual that left this
participant wondering if it was really a
new day and hoping is was not just an
old day dressed up in new clothes.
There were physicians, scientists and
policymakers on the Committee and in the
audience who have been in charge of
operating the mass vaccination system
since the early 1980s: Dixie Snider, MD,
Louis Cooper, MD and Neal Halsey, MD;
and the 1990's: Bruce Gellin, Robert
Ball, MD, Geoff Evans, MD; and since
2000: Marie McCormick, MD, Dan Salmon,
PhD, Ben Schwartz, MD, John Iskander,
MD, Karen Midthun, MD, Larry Pickering,
MD and others. They admitted they had
come together not only to create a
scientific agenda to investigate vaccine
risks but to also address the growing
public
"crisis of trust"
in the mass vaccination system
The draft recommendations of the
Scientific Agenda created by the
Immunization Safety Office (ISO) was not
released to the public until 9 a.m. on
April 11 so parents attending the
meeting did not have time to critique
and tailor remarks made during the
afternoon public engagement panel and
public comment session. However, the
informed public critical of vaccine
safety did make a number of important
suggestions.
As the first panel participant from the
public to speak, I gave a
presentation on
vaccine safety research priorities
summarizing past and current public
calls to investigate vaccine risks and
proposed a "20-year study that
prospectively enrolls and compares the
health outcomes of two groups of
children, one group who will be
vaccinated with the CDC recommended 48
doses of 14 vaccines by age six and 60
doses of 16 vaccines by age 12 versus
another group, who will remain
unvaccinated."
Another panel participant, Peter Bell,
of Autism Speaks, described his son's
regression into autism. While making it
clear he is strongly pro-vaccine, Peter
gave an eloquent plea for credible
scientific research into vaccine safety
issues and asked Committee members and
government officials to "not demonize
parents who are asking questions and
searching for answers" to outstanding
questions about vaccine risks.
Another presentation from panel members
who were supposed to be representing the
public was given by attorney Lisa
Randall of Voices for Vaccines. She
criticized the inclusion of "activists"
critical of vaccine safety who "do not
represent the mainstream" public opinion
and said that she does not want her
children to be in the same room with
unvaccinated children whose parents have
not "stepped up to the plate" and
vaccinated them. At public comment time
vaccine safety advocate Kelli Ann Davis,
who had worked to press government
officials to increase public
participation in the meeting, questioned
where the funding for
Vaccines for
Children came from and called
for SafeMinds board member Mark Blaxill,
who was co-author with me of the 2004
White Paper "From Safety Last to
Children First" (www.ageofautism
.com and
www.nvic.org)
to be appointed to the NVAC Working
Group.
Former pediatric ICU nurse and attorney
Terry Poling, whose daughter Hannah was
recently awarded
uncontested
federal compensation under
the National Childhood Vaccine Injury
Act of 1986 after receiving nine
vaccines on one day and regressing into
autism, asked the Committee to conduct
research to identify biological high
risk markers for vaccine-related
regression. Terry said that Hannah's
development of mitochondrial dysfunction
following vaccination could be a clue as
to why some children are more vulnerable
to vaccination than other children.
NVIC Director of Patient Safety, Vicky
Debold, PhD, RN, who recently founded
Children's Health & Safety Research,
LLC, described her son's regression into
autism after receiving seven vaccines on
one day. Among the patient safety areas
she defined were the "failure to rescue"
which, in the case of vaccines policy
"would be the pervasive failure on the
part of nurses and physicians to
recognize the importance of challenge-rechallenge
phenomena and to modify the vaccination
schedule accordingly. This is how my son
was injured and is crucial to minimizing
future risk."
SafeMinds board member Jim Moody, JD,
commented that a lack of credible
scientific studies demonstrating vaccine
safety makes the application of
one-size-fits-all vaccine policies on
the entire child population an
uncontrolled "scientific experiment."
Journalist David Kirby, author of
"Evidence of Harm" warned the Committee
members that "history will judge each
and every one of you. A year from now,
five years from now, ten years from now
people like me will look back on the
history of vaccine safety in this
country and look at you folks and say:
"What did they do?"
Attorney Patty Healy, who was a former
biotech scientist and is NVIC's Director
of Counseling, told the Committee that
when she became a new Mom eight years
ago, she looked at the science for
vaccine proof of safety and found it so
lacking in substance that she made the
difficult decision not to vaccinate her
daughter. Patty challenged the Committee
to be dedicated to investigating and
embracing the truth about vaccine safety
no matter what it may be. "Show me the
science" she said and "let the chips
fall where they may."
Committee Chair Andy Pavia, MD, and the
Committee members listened attentively
to the public panel members
presentations and to the parents who
spoke during the public comment time.
Several Committee members, including
consumer member Tawny Buck, who has a
DPT vaccine injured daughter, asked
questions of government health officials
and made comments indicating that there
is a heightened interest in conducting
well designed scientific studies
examining vaccine injuries and deaths.
Only time will tell if the meeting on
Capitol Hill last Friday was for real or
for show. Three decades is long enough
to wait for government to listen to the
people and take action to find out the
truth about vaccine risks so every child
in America has the opportunity to grow
up healthy.
***********************************************************
"A government-appointed working group is
charged with picking the most important
safety questions for the Centers for
Disease Control and Prevention to
research over the next five years.
What's unique is that the group also is
supposed to get significant public input
in setting those priorities, an effort
to ease skepticism that authorities hide
or discount important information about
vaccines. "A crisis of trust is going to
be a crisis of public health," said Dr.
Bruce Gellin, head of the National
Vaccine Program Office. "There's been a
lot of anger and a lot of distrust over
issues of vaccine safety," Dr. Andrew
Pavia, a University of Utah pediatric
infectious disease specialist who is
chairing the group, told the meeting
Friday. "There's a need to engage as
many voices as possible," he added.
"It's a chance to make sure the right
questions are going to be asked." -
Lauren Neergard, Associated Press (April
12, 2008)
http://ap.google.com/article/ALeqM5gQkR4fS0l1M7ouxFGOr6WtrJpkPQD8VVVRTO0
"What doctors in positions of power in
the Department of Health and Human
Services need to know at this critical
point in time is this: Young parents
today, who trusted doctors to give them
good advice about how to keep their
children well, do not understand why
their children are never well when they
have been given twice as many vaccines
as children in previous generations
received. They want a full-scale,
transparent scientific investigation
into all potential environmental causes
of autism and other chronic immune and
brain disorders conducted by extra-mural
researchers who are not connected to
vaccine makers and policymakers with a
bias toward existing policy......Just as
we did a quarter century ago, they are
asking you to listen to what happened to
their children after vaccination and
take immediate steps to modify current
vaccine policies to demonstrate a
respect for preventing vaccine
reactions, biodiversity and the right to
informed consent." - Barbara Loe Fisher,
Co-founder & President, NVIC (April 11,
2008)
http://www.nvic.org/Issues/vaccine_safety_priorities_2008.htm
" History will judge each and every one
of you. A year from now, five years from
now, ten years from now, people like me
will look back on the history of vaccine
safety in this country, and look at you
folks, and say, "What did they do?" Now,
I am going to guess from your body
language that you know that there is an
issue here. We have a problem with the
vaccine schedule. We don't know what it
is. You have the power to listen to
these community people, and make some
decisions. And you are maybe going to
make the decision that you are going to
look into this situation, and change
things. Or, are you going to decide to
protect the status quo?" - David Kirby,
Journalist (April 11, 2008)
"As a nurse who used to work in the
pediatric ICU unit, studied public
health and became a lawyer, I am caring
for a daughter who suffered regressive
autism after receiving nine vaccines on
one day. I now find myself in the middle
of a contentious debate about vaccines
and autism. What happened to Hannah, who
has mitochondrial dysfunction associated
with her autism and was awarded
uncontested compensation in the federal
Vaccine Injury Compensation Program,
should stimulate immediate research into
identifying biological markers for
screening for vulnerable children." -
Terry Poling, JD, RN (April 11, 2008)
"I have a 10-year old boy named Sam. At
his 15-month well-baby visit, he
experienced a number of serious adverse
reactions after receiving seven
vaccines. He hasn't fully recovered and
it is unlikely that he will.
Unfortunately, despite my having
doctorates in nursing and public health,
neither I, not our pediatrician, knew
that the earlier and milder vaccine
reactions were warning signs that he was
potentially at risk for future and more
serious vaccine reactions....The damage
is done and, for Sam, it's too late to
go back. But it's not too late for other
children.... At its' core, the tendency
to rigidly stress the need for
compliance with a single clinical
practice guideline - the national
vaccination schedule - for all infants
and a reluctance to instruct physicians
to meaningfully engage parents in shared
decision making or to personalize
vaccination health care create
conditions that precipitate medical
errors and result in unnecessary harm."
- Vicky Debold, PhD, RN, Director,
Children's Health & Safety Research, LLC
and NVIC Director of Patient Safety
(April 11, 2008)
"I am a lawyer and I used to work in the
biotech industry as a scientist. Eight
years ago when I became a new Mom I
looked to medicine and science for
answers about vaccination. What I found
was an absence of scientific studies on
the long-term effects of vaccination and
the health of vaccinated vs.
unvaccinated children. I asked my
pediatrician to show me the science.
Because of the lack of valid scientific
studies in these areas, I chose not to
vaccinate my child..... Public health
officials are supposed to investigate
vaccine risks and only care about
finding the truth, regardless of the
outcome. They should look for the truth
and let the chips fall where they may."
- Patty Healy, JD, Director of
Counseling, NVIC (April 11, 2008)
==========================================
Vaccine Safety
Research Priorities: Engaging the Public
Barbara Loe Fisher
Co-founder & President
National Vaccine Information Center
National Vaccine Advisory Committee
Vaccine Safety Working Group
Washington, D.C.
April 11, 2008
The National Vaccine Information Center
is a non- profit educational
organization founded in 1982 to prevent
vaccine injuries and deaths through
public education (www.nvic.org). We
represent the vaccine injured as well as
families with healthy children and
health care professionals united in
support of the ethical principle of
voluntary, informed consent to
vaccination.
I am the mother of three children,
including a son who suffered a brain
inflammation within hours of his fourth
DPT shot in 1980 and was left with
multiple learning disabilities. I worked
with parents and Congress on the
National Childhood Vaccine Injury Act of
1986, which created the federal Vaccine
Injury Compensation Program and vaccine
safety provisions, including mandatory
adverse event reporting and recording,
as well as the Vaccine Adverse Events
Reporting System and also mandated the
Institute of Medicine's 1991 and 1994
reviews of the scientific literature for
evidence that vaccines can cause injury
and death. [1] [2] [3] [4]
During the past three decades that I
have served on committees or forums at
the FDA, Institute of Medicine, and CDC,
including acting as chair of the
subcommittee on vaccine adverse events
for the National Vaccine Advisory
Committee between 1988 and 1991, the
greatest challenge has been to convince
public health officials and
pediatricians to take seriously the
concerns parents have about the quality
and quantity of scientific information
available to them when making informed
vaccination decisions for their
children. From the parent's perspective,
as Mark Blaxill, of Safe Minds, and I
pointed out in the White Paper [5] we
co-authored after the Blue Ribbon Panel
on Vaccine Safety in 2004, a
comprehensive and transparent scientific
examination of vaccine risks is long
overdue [6] [7] because, today, the
Number One question for many parents
raising young children is:
Why are so many of our highly
vaccinated children so sick?
Vaccination rates with multiple vaccines
in America are at an all-time high [8]
and, with 1 in 6 vaccinated child in
America now learning disabled [9]; 1 in
9 suffering with asthma [10] [11] [12];
1 in 150 developing autism [13] [14],
and 1 in 450 becoming diabetic [15] ,
this is a legitimate question. America
spends more than 75 percent of the $2
trillion price tag for health care to
treat the chronically ill and disabled
[16] and it is estimated that, by 2025,
1 in 2 Americans will be chronically ill
or disabled. [17]
The scientific, economic, political and
moral imperative for addressing the new
epidemic of chronic disease and
disability, which has developed in the
last quarter century and is compromising
more children than were ever harmed by
any infectious disease epidemic,
including polio, makes the vaccine
safety research agenda you are
developing the most important federal
health research funding priority today.
It is a funding priority that must not
take money from the vaccine injury trust
fund created in 1986 to compensate
vaccine injured children, [18] but
urgently requires independent
appropriations by Congress to support a
national research program created in
collaboration with those most concerned
about vaccine safety to generate
evidence-based information the people
will trust. With more than 2,000
clinical trials worldwide [19] that will
bring dozens of new vaccines to market
soon, the first step in securing public
trust is to add at least two more well
informed consumer representatives
critical of vaccine safety to this NVAC
Working Group and the general National
Vaccine Advisory Committee.
In 1995, the Institute of Medicine
convened a Vaccine Safety Forum of
stakeholders to examine and publish
reports on vaccine safety issues. [20]
[21] [22] During that four year public
engagement initiative, a time when
autism was affecting 1 in 1,000
children, [23] I provided statements on
behalf of concerned parents outlining
vaccine research priorities and methods
for detecting and responding to vaccine
adverse event reports [24] [25] - which
I will make available to the Committee
for your consideration - and yet again
to the 2001 IOM Immunization Review
Committee [26] which generated the
following statement in their 2002 report
on Multiple Immunizations and Immune
Dysfunction:
"The Committee was unable to address the
concern that repeated exposure of a
susceptible child to multiple
immunizations over the developmental
period may also produce atypical or
non-specific immune or nervous system
injury that could lead to severe
disability or death (Fisher, 2001).
There are no epidemiological studies
that address this. Thus, the committee
recognizes with some discomfort that
this report addresses only part of the
overall set of concerns of some of those
most wary about the safety of childhood
immunizations." [27]
Whether you believe vaccines rarely, if
ever, cause injury or death and that
government should force everyone to take
vaccines without exception, or you
believe that vaccines are pharmaceutical
products that carry risks which are
greater for some than others and that
government should allow voluntary,
informed consent to taking a vaccine
risk that is not equal for all, most
reasonable people do agree that
individuals genetically or otherwise
biologically at high risk should be
identified so their lives can be spared.
Parents today are using mass
communication and new technology to
educate themselves about vaccines. When
they evaluate the components of vaccines
- from mercury, aluminum and
formaldehyde [28] - to animal and human
cell substrates that can be contaminated
with adventitious agents [29] - they are
finding no credible scientific studies
proving safety; when they question
pediatricians about the safety of giving
their babies 8 vaccines on one day, they
are being denied medical care instead of
being given proof of safety; when they
tell their doctor their child regressed
after vaccination into autism, they are
often told it is all a "coincidence" and
so no report is ever made to the Vaccine
Adverse Event Reporting System; when
their children suffer vaccine reactions
and are re-vaccinated again and again,
despite deterioration into chronic poor
health, they are losing faith in a mass
vaccination system that dismisses
individual health as unimportant
compared to public health when
implementing a one-size-fits-all, no
exceptions policy.
We have the technology today to
investigate and define the pathology
involved in vaccine induced brain and
immune system dysfunction at the
cellular and molecular level. A 20-year
study that prospectively enrolls and
compares the health outcomes of two
groups of children, one group who will
be vaccinated with the CDC recommended
48 doses of 14 vaccines by age six and
60 doses of 16 vaccines by age 12 versus
another group, who will remain
unvaccinated, will give us preliminary
answers in six years about measured
pathological changes in immune and brain
function in both groups, including
information about genetic variability
and the development of learning
disabilities, ADHD, autism, severe
allergies, asthma, juvenile diabetes and
other chronic disease and disability.
In considering the question posed to
this panel "How Do We Effectively Engage
the Public," I am reminded of a
statement drafted a half century ago by
a young group of dissidents who founded
a participatory democracy movement in
America, [30] a progressive concept that
I learned about first-hand during a
participatory democracy experiment
initiated by the CDC between 2002 and
2005 called the Vaccine Policy Analysis
Collaborative. [31]
In calling for a reform of government
institutions to be more inclusive and
transparent in their operation, the
students referred to the great chasm
that has developed between those who
govern and those who are governed in
America. They described the "felt
powerlessness of ordinary people, the
resignation before the enormity of
events" saying,
"The subjective apathy is encouraged by
the objective American situation - the
actual structural separation of people
from power, from relevant knowledge,
from pinnacles of
decision-making.....the very isolation
of the individual - from power and
community and the ability to aspire -
means the rise of democracy without
publics." [32]
It is the duty of a government of, by
and for the people to listen to the
people and act when they are suffering,
whether they are in a minority or the
majority. Respect for the people and a
willingness to share decision-making
power with them is an approach that will
foster trust in government officials and
public policy. Threats and coercion will
destroy it. [33]
What doctors in positions of power in
the Department of Health and Human
Services need to know at this critical
point in time is this:
Young parents today, who trusted doctors
to give them good advice about how to
keep their children well, do not
understand why their children are never
well when they have been given twice as
many vaccines as children in previous
generations received. They want a
full-scale, transparent scientific
investigation into all potential
environmental causes of autism and other
chronic immune and brain disorders
conducted by extra-mural researchers who
are not connected to vaccine makers and
policymakers with a bias toward existing
policy. They want a greater separation
of the vaccine risk assessment and
safety oversight responsibilities from
the vaccine policymaking and promotion
activities more in the model of the
National Transportation Safety Board.
Just as we did a quarter century ago,
they are asking you to listen to what
happened to their children after
vaccination and take immediate steps to
modify current vaccine policies to
demonstrate a respect for preventing
vaccine reactions, biodiversity and the
right to informed consent.
If we can agree that individual health
and life is to be valued and that the
most vulnerable among us should be
protected; if we can agree that when one
of us is sick or suffering, we are all
diminished if we do nothing; if we can
agree that the individual biological
differences among us must be
acknowledged when making vaccine
policies because biodiversity is what
strengthens the human race and
distinguishes our humanity, then there
is no reason we cannot find answers to
outstanding questions about vaccine
risks and develop public health policies
that truly protect the biological
integrity, the health and well being, of
our individual children, our
communities, our nation and the world.
To access the 33 references with live
links for the above statement by Barbara
Loe Fisher, go to
http://www.nvic.org/Issues/vaccine_safety_priorities_2008.htm
ARTICLE:
Gov't Seeks Help With
Vaccine Questions
Associated Press
April 13, 2008
by Lauren Neergaard
Click here for the
URL:
WASHINGTON (AP) - The government began
an unprecedented effort Friday to give
vaccine critics a say in shaping how the
nation researches safety questions
surrounding immunizations.
The meeting, the first of more to be
set, came amid new controversy about
vaccines and autism - and a fledgling
theory that vaccinations might worsen a
rare condition called mitochondrial
dysfunction that in turn triggers
certain forms of autism.
Federal health officials said the work,
being planned for two years, wasn't in
response to that controversy, and
encompasses many more questions than
autism - from rare side effects of the
new shingles vaccine to how to predict
who's at risk for encephalopathy
sometimes triggered by other
inoculations.
A government-appointed working group is
charged with picking the most important
safety questions for the Centers for
Disease Control and Prevention to
research over the next five years.
What's unique is that the group also is
supposed to get significant public input
in setting those priorities, an effort
to ease skepticism that authorities hide
or discount important information about
vaccines.
"A crisis of trust is going to be a
crisis of public health," said Dr. Bruce
Gellin, head of the National Vaccine
Program Office.
"There's been a lot of anger and a lot
of distrust over issues of vaccine
safety," Dr. Andrew Pavia, a University
of Utah pediatric infectious disease
specialist who is chairing the group,
told the meeting Friday.
"There's a need to engage as many voices
as possible," he added. "It's a chance
to make sure the right questions are
going to be asked."
Numerous studies have addressed vaccines
and autism and found no link, including
with a once- common mercury-based
preservative.
The newest question surfaced last month,
with news that the government had agreed
to pay the family of 9-year-old Hannah
Poling for injuries linked to vaccines.
Her family said Hannah was a healthy 19-
month-old when she received five shots,
encompassing nine vaccines. She became
feverish, her behavior gradually
changed, and she was eventually
diagnosed with autism. Her parents filed
a claim under the vaccine compensation
act that the government granted on the
presumption that the vaccines could have
exacerbated an underlying condition -
although federal health officials have
insisted that doesn't mean vaccines
cause autism.
But the mitochondria question is on the
list of top research questions the CDC
made public Friday.
And Hannah's mother joined other
anti-autism advocates Friday in making a
plea for that research to speed forward.
"We have a lead, a very strong lead. We
need to look at the mitochondria," Terry
Poling told the government panel. "We
need to identify children at risk, and
we need to learn how to immunize them
safely. We need to develop methods and
criteria to screen for susceptible
children. Maybe we need to wait to
vaccinate until critical developmental
milestones have been met."
Mitochondria are energy factories for
cells, and mitochondrial disease -
estimated to affect about 1 in 5,000
births - can thus attack any organ,
including the brain, by depriving it of
energy. Scientists believe that stress
such as an infection can set off that
cascade of damage in people with
underlying mitochondrial dysfunction,
but whether a vaccine alone causes
enough stress to do so isn't known.
A bigger question for some of the
government's advisers Friday was what
the CDC's proposed research agenda
didn't include - the question of how
many vaccines should be given in one
visit, and if they're all really needed
by age 2.
"We all have to have our kids vaccinated
by the time they go into daycare or
kindergarten, but ..... does it all have
to happen in the first two years?" asked
panelist Dr. Christopher Carlson of the
Fred Hutchinson Cancer Research Center,
himself the father of a 9-year-old with
a mild type of autism called Asperger's.
"I'm not saying there's proof one way or
the other. But the lack of options is a
concern I think we should think about."
National Vaccine Information Center
NVIC E-News is a free service of the
National Vaccine Information Center and
is supported through donations.
NVIC is funded through the financial
support of its members and does not
receive any government subsidies.
Barbara Loe Fisher, President and Co-
founder.
Learn more about vaccines, diseases
and how to protect your informed consent
rights at:
http://www.nvic.org
Quick Links...
VACCINE AWAKENING BLOG
ARE WE OVER VACCINATING OUR CHILDREN?
Vaccine Safety Bulletin
STATE LAWS AND EXEMPTIONS
International Memorial For Vaccine
Victims
Military Biodefence Vaccine Project
HPV VACCINE FACTS
The Doctor's Corner
Join our mailing list!
email:
news@nvic.org
phone: 703-938-dpt3
web: http://www.nvic.org |
|
|
|