PEDIATRICS Vol. 105 No. 3 March 2000, pp. 638-640

COMMENTARY:
Child Health Policymaking

The American Academy of Pediatrics (AAP) seeks to improve the health and well-being of America's children, in part, by formulating well-designed child health policy statements. The development of child health policy statements should always consider 4 key principles: integrity, credibility, fairness, and responsibility. A recent example of the child health policymaking process of the AAP was the joint statement of the AAP and US Public Health Service on the use of a mercury-containing preservative called thimerosal in vaccines and recommendations for hepatitis B vaccine administration. The perceived need to address the thimerosal issue quickly to provide pediatricians with timely recommendations precluded an extensive inclusive policymaking process. The process used demonstrates that the AAP, the US Public Health Service and other public agencies, and experts from academia can respond quickly and work together in the best interests of our children. This commentary will reflect on how the child health policymaking process of the AAP tried to consider these 4 key principles in its deliberations and understand the possible implications of alternative policy options.

The principle of integrity involves the need to gain as complete an understanding of the issue as possible and communicate an unbiased assessment, acknowledging both what is known and not known. The AAP sought to maintain the integrity of the process by presenting the available information to pediatricians in as impartial and intellectually honest way as possible. The AAP became aware of information that children who received all the recommended immunizations could be exposed to amounts of mercury in thimerosal-containing vaccines during the first 6 months of life in excess of the Environmental Protection Agency-recommended limits. However, the exposure was within the safe levels established by the Food and Drug Administration (FDA) and Agency for Toxic Substances and Disease Registry (ATSDR) federal agencies. The AAP policymakers believed that disregarding the Environmental Protection Agency guidelines in favor of the ATSDR and FDA levels might compromise the perceived integrity of the policymaking process. All 3 of these federal agency guidelines were based on data obtained from pregnant women after inadvertent exposures to high concentrations of methyl mercury after the ingestion of contaminated grain or fish. Unfortunately, the information on thimerosal was insufficient to provide answers to all the relevant policy questions. First, human toxicity data were not available on ethyl mercury, the type of mercury contained in thimerosal, which is considered to be less toxic than methyl mercury. Second, insufficient data were available to quantify the risk of low-level mercury exposures. The basis for determining safe amounts of mercury was unclear especially with respect to the age of the child and the difference between intermittent and prolonged exposures. AAP policymakers dealt with the issue of insufficient information and nonquantifiable risk by using the words "small, if any risk, of thimerosal-containing vaccines."

The principle of credibility involves issues of conflict of interest and the belief that AAP policymakers are serving the best interests of children rather than the special interests of pediatricians, governmental agencies, or the vaccine industry. The AAP wanted to be proactive and to provide pediatricians and the public with well reasoned recommendations about thimerosal in a timely manner. Concern was raised that delaying the release of the information and our analysis of its implications until after the information came out in the media could be viewed by the public as a cover up. Public confidence in the safety of vaccines could be eroded and parents might think that pediatricians were unaware of the hazards of thimerosal or chose to ignore FDA concerns about vaccine safety. Early release of information would maintain confidence in the vaccine program.

The principle of fairness addresses the need to develop policy recommendations that result in 1 uniform standard of care for all children, rather than multiple standards that may be influenced by family income, insurance status, or other sociodemographic factors. Formulating policy that would result in immunizing low-income children eligible for VFC-free vaccines with thimerosal-containing vaccines while offering other children the option of receiving the limited supplies of vaccines without thimerosal would not be fair.

The principle of responsibility involves recognizing how the consequences of the policy might have unintended effects detrimental to the public good. The AAP tried to balance the need to address the small but nonquantifiable risk of thimerosal with the importance of maintaining confidence in the safety of vaccines and their role in protecting our children from preventable disease. There were 2 extreme policy options. One was to advocate a ban on all thimerosal-containing vaccines to eliminate any possible mercury risk associated with a preventive intervention. The other was to take no immediate action because vaccine manufacturers, at the urging of the FDA, were developing thimerosal-free vaccines and federal guidelines for mercury exposure were imprecise and may not indicate toxic exposure levels. The AAP believed that a ban on all thimerisal-containing vaccines was irresponsible and unwarranted. Such a policy recommendation misrepresented the level of risk and could create widespread panic about the safety of vaccines. Such a policymaking decision would be the public health equivalent of inappropriately shouting fire in a crowded theater. However, doing nothing until thimerosal vaccine supplies became available would fail to take action to increase the margin of safety associated with the existing vaccines. Therefore, the AAP recommended that thimerosal-containing hepatitis B vaccine be postponed for 6 months in infants whose mothers were documented to be serologically hepatitis B uninfected until sufficient supplies of hepatitis B vaccine without thimerosal become available. The AAP hoped that temporarily altering the schedule slightly for hepatitis B vaccine would not place infants of serologically negative mothers at increased risk of becoming infected during this time period. The policy would extend the margin of safety for continuing to use other thimerosal-containing vaccines for all children until vaccine manufactures could produce adequate supplies of thimerosal-free vaccines to resume routine hepatitis B immunizations at birth. However, the AAP also recognized the difficulties in assessing how the recommendations might impact the prevention of hepatitis B. To what extent would delaying the first doses of hepatitis B result in newborns at risk not being immunized and older infants not receiving hepatitis B vaccinations? To what extent would these recommendations alter the public perception of the hepatitis B vaccine safety? Would physicians restart newborn immunizations once sufficient thimerosal-free hepatitis B vaccine becomes available? We are still uncertain about the answers to these questions. Therefore, in addition to dealing with a nonquantifiable risk of thimerosal, the AAP had to consider the nonquantifiable consequences of its recommendations on both hepatitis B and the entire vaccine delivery system.

The AAP tried to respond to the thimerosal issue with integrity, credibility, fairness, and a sense of responsibility in a very timely manner. It appears that sufficient supplies of thimerosal-free hepatitis B vaccine are or soon will be available to resume routine newborn hepatitis B immunization practices. Once this occurs, pediatricians must take the lead to assure that children receive maximum protection against hepatitis B and rapidly resume routine newborn immunization.

Stephen Berman, MD, FAAP
Department of Pediatrics
University of Colorado School of Medicine
Denver, CO 80218

FOOTNOTES

Received for publication Nov 23, 1999; accepted Dec 1, 1999.

Address correspondence to Stephen Berman, MD, FAAP, The Children's Hospital, 1056 E 19th Ave, B032, Denver, CO 80218. E-mail: berman.stephen{at}tchden.org

ABBREVIATIONS

AAP, American Academy of Pediatrics; FDA, Food and Drug Administration; ATSDR, Agency for Toxic Substances and Disease Registry.