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

April 16, 2008

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

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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

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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

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s

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 "

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utism

..com and

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to be appointed to the NVAC Working Group.

Former pediatric ICU nurse and attorney Terry Poling, whose daughter

Hannah was recently awarded

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sted

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)

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" 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)

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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