Blue_ribbon By Mark Blaxill and Barbara Loe Fisher

Editor's Note: Today's third installment in our serialization of this important White Paper on children's health and vaccine safety is titled  "FROM EXPANSION OF VACCINE INTERVENTIONS TO A COMMITMENT TO A TOTAL HEALTH PERSPECTIVE." Mark Blaxill,  Age of Autism's Editor at Large, and Barbara Loe Fisher of the National Vaccine Information Center were invited to be on a CDC Blue Ribbon Panel in 2004 to consider the issue. Dissatisfied with the official report's conclusions, they wrote their own detailed response, which has never before been published. Age of Autism is running the entire document in eight parts through the end of the year; earlier installments can be found under Mark's name on our Home Page. Given the debate over the ever-increasing number of mandatory vaccinations and their possible link to autism and other health problems, the series is especially timely today.
The Blue Ribbon Panel was convened to consider a proposal to separate vaccine risk management from risk assessment [at the CDC]. We concur with the spirit of this proposal and believe that independence in vaccine safety assessment is overdue. The National Immunization Program has long confused vaccine safety with vaccine promotion. But we also see a deeper force driving the problems with vaccine safety, a force that goes beyond simple questions of organization and governance. The longstanding commitment of our public health leadership to expansion of the mandatory vaccination programs places pressure on the watchdogs of safety to make vaccine risk assessment friendly not just for current programs, but also for new vaccines. Dr. Robert Chen, the official most responsible for vaccine safety over the last decade has openly confessed to this bias in print.

"Given the current increasingly "anti-vaccine" milieu, it is hard to imagine that the full potential of new vaccines will be harnessed. To avoid this impending tragedy, we need to critically examine the factors influencing this change in public sentiments."

- Dr. Robert Chen, Vaccine Safety and Development Branch, National Immunization   Program, CDC, "Vaccine Risks: real, perceived and unknown", Vaccine, 1999.

Dr. Chen sets forth here the central fallacy of modern vaccine policy: if some vaccine interventions have done some good, then more interventions will do more good. His conclusion that the failure to expand the vaccine program would be a "tragedy" reflects this a priori assumption, shared by so many, that we have only just begun to harness the potential for strategies of increased intervention. Numerous careers, major research programs and large-scale commercial investments have been bet on the promise of public acceptance of unlimited vaccine interventions. Much is at stake.

In just a few short years, we have seen the effects of this strategy. Through the 1970s, the childhood immunization schedule consisted of interventions against a short list of diseases: smallpox, polio, diphtheria, pertussis and tetanus. Today, the CDC's "universal use" list for children has expanded to include vaccines against measles, mumps, rubella, hepatitis B, haemophilus influenza B, varicella, pneumococcal and influenza. Before they reach their second birthday, a child born today will receive 32 separate vaccine doses when following the CDC's recommended schedule. With these additions, we have embarked on a public health strategy that constitutes a radical shift in the way our species experiences its environment and a radical shift in the way the human immune and neurological systems develop during the first critical months of life. In a quite literal sense, we have entered unexplored territory.

As the childhood vaccine program has expanded, it has also changed character. The earliest vaccines—polio, diphtheria, smallpox—protected against highly infectious and frequently fatal diseases, diseases to which infants were also highly vulnerable. The new additions to the vaccine program have not targeted similar attributes or shared the same benefits. These new targets are often less dangerous to children (chickenpox or rubella), less infectious (haemophilus influenza B or pneumococcal) or otherwise less prevalent among children (hepatitis B).   

Although the original vaccines had demonstrable preventive benefits, their risks were also meaningful. Dramatic, sometimes fatal, adverse events associated with neurological damage have been documented, most notably with whole cell pertussis vaccine, but also with oral polio vaccines. The re-introduction of smallpox vaccine after September 11, 2001 was curtailed due to unacceptable rates of adverse events, including cardiac events that led to death. One distinguishing feature of these events, however, was their clear cause-and-effect relationship with single vaccine exposures.

As the vaccine program has expanded, we face new safety concerns. In addition to the ongoing risk of single vaccine adverse events, we need to recognize new exposure risks, either from the cumulative effect of vaccine ingredients or from the unintended consequence of interactions between vaccine and other environmental antigens and the potential for accidents in a complex, closely-coupled system like the developing immune system.

Vaccine mercury exposure provides a dramatic example of the cumulative effect risk. Exposing the developing brain to mercury was never a good idea, but the introduction of two new vaccines in the early 1990s (not to mention the increasing practice of antenatal Rho D immunization) tripled the earliest exposure rates. These additions effectively compounded acknowledged mercury risks to pregnant mothers from seafood consumption and dental amalgams. In the case of mercury, we see the dark side of the "more is better", expansionist bias: if some mercury exposure is bad, then more is unquestionably worse. Yet now the CDC has recommended new childhood mercury exposures via influenza vaccines, when evidence continues to accumulate underscoring the danger of these exposures.

More complex, but no less concerning, is the issue of interactive effects. We simply do not know what the risks of these 39 doses of 12 vaccines might be for human health when combined together in developing infants. In the face of this recent escalation in intervention, common sense would suggest a testing discipline involving more than assessments of each new vaccine, or even combination vaccine, on its own, but rather involving comprehensive assessments of the old strategy vs. the new strategy in their entirety. Such comprehensive testing has been dismissed as too expensive, or even absurd. But it has never been attempted.

So as parents, we are faced with a puzzling paradox.  We want our children to be healthy, but they are not, even though we have done what we have been told to do by public health officials and pediatricians. We see families around us in similar distress, with asthma inhalers and epi pens as common in schools today as peanut butter and jelly sandwiches were in our day. We are concerned about a radical strategy of intervention that has never been tested for safety and yet we watch as responsible government officials behave defensively and with more regard for their beliefs and careers than for the future of our children. We want to believe in the integrity of our public health system, yet we cannot, because we fear that excessive specialization and bureaucratic inertia has led us away from the only focus that matters: the overall health and well-being of our children. We believe it is time to call a halt to the expansionist momentum and revisit basic strategic premises. We strongly encourage the CDC to move away from strategies focused on the parts to a strategy focused on a total health perspective. This may be difficult, but it is necessary if we are going to answer the question: why are so many children chronically ill today?
Next: Part 4



Thanks for this informative series. It's interesting to me to read how hard the public health complex is working to frame the issues with inflammatory language and talking points. Anyone who questions the schedule, even those who believe that vaccines are an important tool for public health, are categorized as part of an "anti-vaccination" rabble. Unfortunately, this can be an effective strategy to keep the necessary study from getting done in the short term but I remain hopeful that reason will ultimately pervail and good science will give us answers.

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