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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.

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"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)


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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
 


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