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" (http://www.ageofautism.com/ .com and http://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)