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PEDIATRICS Vol. 109 No. 6 June 2002, pp. 1153-1159

SPECIAL ARTICLE

The Process of Public Policy Formulation: The Case of Thimerosal in Vaccines

Gary L. Freed, MD, MPH*, Margie C. Andreae, MD*, Anne E. Cowan, MPH* and Samuel L. Katz, MD{ddagger}

* Child Health Evaluation and Research Unit, Division of General Pediatrics, University of Michigan Medical Center, Ann Arbor, Michigan
Dagger; Department of Pediatrics, Duke University Medical Center, Durham, North Carolina

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Abbreviations: FDA, Food and Drug Administration • AAP, American Academy of Pediatrics • PHS, Public Health Service • EPA, Environmental Protection Agency • CDC, Centers for Disease Control and Prevention • NVPO, National Vaccine Program Office • AAFP, American Academy of Family Physicians • CBER, Center for Biologics Evaluation and Research • WHO, World Health Organization • ATSDR, Agency for Toxic Substances and Disease Registry • COID, Committee on Infectious Diseases • ACIP, Advisory Committee on Immunization Practices • IAG, Interagency Vaccine Group • NVAC, National Vaccine Advisory Committee


   INTRODUCTION
 
Effective immunization programs have markedly diminished the incidence of vaccine-preventable diseases. As a result, there now exists in society a lower awareness of the actual risks associated with the diseases themselves and a greater prominence of the potential risks of adverse effects associated with vaccines.

Concern regarding public reactions to new vaccine safety issues may place pressure on policymakers and/or health care providers to act quickly in response to new information. However, this concern must be tempered by the necessary caution required to assess the intended and unintended risks and benefits of any action undertaken. The interplay of these potentially competing demands is well illustrated by the recent safety concern involving the use of thimerosal in vaccines.


   EMERGENCE OF THIMEROSAL AS A CONCERN
 
Thimerosal is a mercury-containing compound that has been widely used as an antimicrobial agent in vaccines for over 60 years. Human exposure to mercury may have potentially significant health consequences. By mid-1999, the Food and Drug Administration (FDA) had discovered that children could be exposed to an amount of mercury from vaccines that exceeded 1 of 3 existing federal safety thresholds. After this realization, the organized medical and public health communities in the United States became involved in a series of urgent and intense discussions to determine an appropriate response to the issue. This manuscript describes and analyzes the process that led to the July 7, 1999, joint American Academy of Pediatrics (AAP)/US Public Health Service (PHS) statement on thimerosal,1 with the goal of suggesting improvements for managing similar vaccine safety concerns in the future.


   METHODS
 
We conducted structured interviews with over 15 individuals involved in the discussions and negotiations leading to the joint AAP/PHS statement on thimerosal. The individuals represented both the governmental agencies and nongovernmental organizations involved, including the FDA, the Environmental Protection Agency (EPA), the Centers for Disease Control and Prevention . . . [Full Text of this Article]

Reprint requests to (G.L.F.) Division of General Pediatrics, University of Michigan, Ann Arbor, MI 48109-0456. E-mail: gfreed@med.umich.edu




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