[NVIC] Public Tells Government Panel: Vaccine Safety Must Come First

[Guest guest]

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 , MD and Neal

Halsey, MD; and the 1990's: Bruce Gellin, Ball, MD, Geoff ,

MD; and since 2000: Marie McCormick, MD, Dan Salmon, PhD, Ben Schwartz,

MD, Iskander, MD, 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, Bell, of Autism Speaks, described his

son's regression into autism. While making it clear he is strongly

pro-vaccine, 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 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 , 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 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.

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. " -

Neergard, Associated Press (April 12, 2008)

http://ap.google.c om/article/ALeqM5gQkR4fS0l1M7ouxFGOr6WtrJpkPQ

D8VVVRTO0

" 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_saf ety_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? " - 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_saf

ety_priorities_2008.htm

Gov't Seeks Help With

Vaccine Questions

Associated Press

April 13, 2008

by 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. 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. 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

www.nvic.org

email:

news@...

phone: 703-938-dpt3

web:

http://www.nvic.org

--------------------------------------------------------

Sheri Nakken, former R.N., MA, Hahnemannian

Homeopath

Vaccination Information & Choice Network, Nevada City CA & Wales

UK

Vaccines -

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