April 2008 - Vaccine Safety Research Priorities: Engaging the Public

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 Paper⁵   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:

Vaccination rates with multiple vaccines in America are at an all-time high⁸   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 diabetic¹⁵, 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 disabled¹⁶   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 children¹⁸,   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 worldwide¹⁹   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 Committee²⁶    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 formaldehyde²⁸ – to animal and human cell substrates that can be contaminated with adventitious agents²⁹ – 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 America³⁰,  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 extramural 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.

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