By Mark Blaxill and Barbara Loe Fisher
Editor's Note: This is the fifth of eight installments of a "white paper" on vaccine safety written by Mark Blaxill, Age of Autism's Editor at Large, and Barbara Loe Fisher of the National Vaccine Information Center. Titled "From Herding the Public to Informed Consent," it charts a path from the current coercive immunization mandates to a more balanced and rational approach. Given new efforts to compel vaccination in a Maryland school district, and to add four more required vaccines to the schedule in New Jersey, their alternative vision is especially timely.
The rising complexity of vaccine risks and benefits makes the assessment of risk far more sensitive to the assessment of such complex trade-offs. But when the guardians of vaccine safety [at the CDC] play a dual role as advocates of program expansion, the potential for bias, conflict of interest and bureaucratic error in these assessments rise when there are no mechanisms in place for self-correction. When advocates of vaccine programs can also exercise the coercive power of the state to enforce their decisions through vaccine mandates, the risks of catastrophic failure multiply.
In an open society, we typically rely on the free choices of informed citizens as the corrective mechanism for dealing with complex trade-offs. We express our freedom in two ways, through the free market (for economic trade-offs) or free elections (for policy making). In either domain, we know from long experience that assigning decision rights to centralized state authorities can produce lasting inefficiencies and/or inappropriate concentrations of power. Checks and balances on such power are essential to prevent the abuse of power by the state and secure improved outcomes for society.
Vaccine programs introduce special problems in an open society. Mass vaccination programs for infectious disease prevention are based on the premise that herd immunity is the only way to manage infectious diseases. Achieving herd immunity requires widespread compliance, indeed significantly greater compliance than either free markets or free elections require for success. Vaccination coverage rates sufficient to provide herd immunity have been estimated to be in the 80-95% range depending on the disease. Achieving such high compliance rates in large populations demands extraordinary efforts. Compounding this difficulty, public health officials have increasingly defined success as compliance rates approaching 100%, a shift from a goal of herd immunity to a goal of local elimination, even global eradication, of most diseases for which vaccines have been developed. With such aggressive targets the exercise of economic choice ("I don't want to receive that service") or the declaration of dissent ("I don't support that policy") runs in direct opposition to the interests of the bureaucracy in meeting its performance goals.
In order to reach these rising compliance targets, vaccine program sponsors ask for and typically receive exemptions from normal checks and balances on state power. These exemptions are justified because the prevention of disease is seen as an area in which the interests of the collective override the rights of the individual. Consequently, manufacturers receive exemptions from product liability laws. Citizens face powerful sanctions if they fail to comply with state recommendations -- children can be denied entry to school, parents can be declared negligent, and pediatricians can deny service to families when they choose not to vaccinate. Program managers are protected from accountability to external parties in numerous ways.
These exemptions can end up producing an unhealthy relationship between citizens and central authorities. In the eyes of the officials, a diverse and autonomous citizenry becomes a monolithic and (ideally) submissive "public." The public must be convinced of the virtues of compliance so that the herd can maintain its immunity and remain safe from disease. The more submissive the herd, the greater the opportunity for heroic achievements in disease elimination and the less the need to apply coercive measures to dissenting citizens.
Yet the childhood immunization program is the only medical intervention capable of producing injury or death that the state imposes on healthy children. Vaccines are also the only privately manufactured product whose universal consumption is made a prerequisite for participation in public services. These extraordinary exemptions from our normal democratic system of checks and balances and free markets demand extraordinary, and constant, scrutiny. Vaccine program management must not only work when safety is secured, it must also be robust in the face of safety failures.
But how robust can our system of vaccine safety management ever be? If one assumes that program managers are always diligent, competent and correct in their assessments and that the programs themselves unambiguously and universally safe, then these exemptions from our standards of openness are a small price to pay for results. But when there is a possibility of negligence, incompetence, or even well-intentioned error, these protections run the risk of perpetuating and exacerbating truly catastrophic failures. In their book, The Virus and the Vaccine, Deborah Bookchin and Jim Schumacher elaborated the dangers:
"The decisions of our health policy makers, even when well intentioned are not always well informed. And sometimes those decisions are not even well intentioned. Sometimes they are based on bias or inadequate scientific evidence. Sometimes they are biased by the close relationship between the pharmaceutical industry and the government health officials who are charged with regulating that industry. Moreover, sometimes even the best scientists can make mistakes. The safest medical products can have unforeseen side effects. Things do occasionally go wrong, sometimes dreadfully wrong, during even the most noble of scientific endeavors ."
And when things do go wrong, the inevitably defensive reactions can creep down a slippery slope from the prevention of unnecessary panic to the dissemination of propaganda and the suppression of dissent. The resources available to health officials to mount defenses in the face of failure are extensive. Prestigious journals can relax their standards in support of questionable research; at-risk constituencies can mobilize resources to attack discomforting facts; funding agencies can deny resources for investigations into possible failures; and conscientious scientists can face disincentives (even sanctions) when they pursue unpopular investigations.
One powerful bulwark against such breakdowns is the right of informed consent. Informed consent requires and empowers each citizen to make choices for themselves and their families based on their independent assessment of risks and benefits. Informed consent thereby provides a counterbalancing force against overreaching activities of the state and provides incentives for manufacturers to improve the safety and effectiveness of their products:
• In the absence of an ability to choose between vaccine formulations, combinations and producers, citizens can at least exercise choice with respect to timing and receipt of specific vaccinations;
• In the absence of meaningful product guarantees or warranties, citizens can request and expect the provision of scientific information regarding attributed risks and benefits of vaccines;
• In the absence of clear scientific knowledge regarding the immunological mechanisms, failure modes and adverse exposure consequences, citizens can seek, consider and act on information from multiple sources, reserving the right to critically review official interpretations of vaccine benefits and risks and freely act upon the information they have obtained.
Today, parents who wish to make a different choice with respect to their children's vaccinations face numerous obstacles. They can claim a medical exemption if their child has suffered a "severe vaccine reaction" that must meet restrictive CDC standards as a contraindication to further vaccination and are able to find a doctor willing to write a medical exemption to vaccination. They can, in most states, claim exemption based on sincerely held religious beliefs. In eighteen states, they can exercise their right to a philosophical or conscientious belief exemption to vaccination. But everywhere these rights might be exercised, they are, practically speaking, nearly impossible to obtain (in the case of medical exemptions), under challenge (religious exemptions) or available only to a small number of parents who are aware of their rights.
In real life, when parents resist their pediatrician's advice, they risk sanctions of varying severity, up to and including loss of medical care, health insurance and even custody. Pediatricians or nurses can and do notify Child Welfare authorities when parents resist vaccination and the parents can be charged with child medical neglect. Parents can postpone the age at vaccination, but in doing so they forego access to most child-care and educational services. Indeed, with respect to the universal hepatitis B birth dose, they often find that vaccination takes place in hospital nurseries without their knowledge, preceding consent. The provision of true informed consent, which has defined the ethical practice of modern medicine and is so essential as a counterweight to state power, remains a distant promise for most American parents.
Next week: Part 6