The authors represented our respective organizations -- National Vaccine Information Center and Safe Minds -- as invited participants to the Blue Ribbon Panel on Vaccine Safety on June 3-4, 2004, in Atlanta. We appreciated receiving our invitations to attend. We also respect and acknowledge the efforts of the chair, Dr. Louis Cooper, to summarize the discussion in his Summary Report. Given the mix of the participants, many of whom have close ties to the past CDC leadership and/or personal involvement in setting the recent course of U.S. public health policy and practice, we did not expect that the Summary Report would convey our sense of urgency and concern. Although the Summary Report represented a good faith effort to report on the Blue Ribbon Panel's proceedings, it did not provide a coherent reporting of the case for comprehensive change. Accordingly, our two organizations have joined together to author this White Paper on Vaccine Safety, entitled, "From Safety Last to Children First."

We should note at the outset that our most fundamental dissent from the larger group is the framing of the agenda itself.   We are far less concerned with focusing on vaccination than we are concerned with focusing on better health outcomes for America's children. Although our organizations have frequently (and unfairly) been described as "anti-vaccine," we share the view that vaccine programs to manage infectious diseases can be a valuable part of strategies to advance the mission of childhood health. These diseases, however, reflect only a fraction of the adverse health outcomes facing children today and a decreasing fraction of these. So although the focus of the agenda for the Blue Ribbon Panel reflects the misplaced emphasis on infectious diseases, we choose not to restrict our Response to the Summary Report to the agenda as defined. Instead we will address the case for change based on some core principles and a hopeful vision of the future.

We share a sense of hope that America's public health focus can be reformed to serve the health needs of children and families in the 21st century. A forward-looking focus for public health practice would embrace:

1) A mission of securing positive health outcomes for children and families;

2) A commitment to a total health perspective, including chronic as well as infectious disease, developmental disability as well as episodic illness, and quality of life as well as the absence of disease;

3) A recognition of the crisis of the chronic disease epidemics among children, including autism, learning disabilities, attention deficits and other neuro-developmental disorders as well as asthma, allergy, juvenile-onset diabetes and other autoimmune disorders;

4) A vaccine policy that treats all citizens, including parents, as intelligent participants in the health choices they make for themselves, their children and their communities and requires true informed consent for participation in vaccine programs;

5) An operating philosophy that sets a goal of zero vaccine adverse reactions and treats each reaction respectfully, indeed as a resource for diagnosis and prevention of future vaccine adverse reactions, especially those that lead to chronic adverse health outcomes;

6) A governance model for vaccine policy-making based on true public accountability, characterized by public inclusion, openness to scientific criticism and a willingness to accept past shortfalls as an opportunity for learning, growth and change.

We believe that this positive focus is notably absent in public health policy and practice today. Consequently, we share a grave concern that the past approach of public health authorities requires comprehensive and fundamental reform. In contrast to our vision of hope, we see a current approach that is fixated on:

1) A mission of fighting a war on disease that disregards the secondary and tertiary consequences of war and views innocent children as inevitable casualties;

2) A commitment to an unprecedented expansion in the childhood vaccine program , with inadequate, if any, consideration given to the cumulative and interactive effects of this strategy;

3) A consistent posture of hyping the risk of infectious disease, a communication model that relies on fear, hyperbole and incomplete information;

4) A vaccine program concerned largely with herding "the public" into a state of compliance, reflecting a view of citizens as a monolithic entity in need of instruction rather than engagement;

5)  An operating ethos in vaccine safety management of utilitarianism, one that allows for "acceptable losses", based on an approach that places "safety last" in funding priorities;

6) A pattern of governance in which many decision-makers have direct financial and/or career conflicts of interest that produce biases to program expansion and the defense of past policy decisions.

The continued pursuit of the current approach has created an adversarial environment that jeopardizes the health of America's children and the long-term well-being of our nation. Within the CDC, a defensive bureaucracy finds it increasingly difficult to reconcile past ideological and policy commitments with the emerging realities. Parent organizations, faced by institutional complacency (with respect to epidemic childhood illnesses like autism) and defensiveness (with respect to the examination of plausible environmental and biological hypotheses), are forced into confrontations they do not enjoy, consuming time they do not have. Pediatric organizations, long resigned to becoming instruments of state policy by allowing their members to become a toll gate for vaccine administration in well child visits, have come adrift from the service mission that motivates most pediatricians, securing positive health outcomes for children, not maximizing their office visits. Vaccine manufacturers, prisoners of their extraordinary corporate profit rates, pursue short term profit enhancement with too little regard for the adverse effects to which inappropriate usage of their products may contribute. In the meantime, as a nation we have too many sick children and no shared view about how they got that way.   

This all must change.
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Next: Part 2 of 8.