THE MILBA NK QUARTER LY A MULTIDISCIPLINARY JOURNAL OF POPULATION HEALTH AND HEALTH POLICY The Rise and Fall of the Lyme Disease Vaccines: A Cautionary Tale for Risk Interventions in American Medicine and Public Health R O B E RT A . A R O N O W I T Z University of Pennsylvania Context: Two vaccines to prevent Lyme disease (LD) were developed and tested in the 1990s. Despite evidence of their safety and efficacy in clinical trials and initial postmarketing surveillance, one vaccine was withdrawn before the regulatory review and the other after only three years on the market. An inves- tigation of their history can illuminate (1) the challenges faced by many new risk-reducing products and practices and (2) the important role played by their social and psychological, as distinct from their biomedical or scientific, efficacy in how they are used, and their ultimate market success or failure. Methods: This article reviewed medical and popular literature on LD vac- cines, analyzed the regulatory hearings, and conducted interviews with key participants. Findings: Even if proved safe and effective, LD vaccines faced regulatory and market challenges because the disease was geographically limited, treatable, and preventable by other means. Pharmaceutical companies nevertheless hoped to appeal to consumers’ desire for protection and control and to their widespread fear of the disease. The LD advocacy community initially supported the vac- cines but soon became critical opponents. The vaccines’ success was seen as threatening their central position that LD was chronic, protean, and difficult to treat. The activists’ opposition flipped the vaccines’ social and psychological efficacy. Instead of the vaccines restoring control and reducing fear, demand was undermined by beliefs that the vaccines caused an LD-like syndrome. Address correspondence to: Robert A. Aronowitz, University of Pennsylvania, Cohen Hall, Rm. 325, 249, S. 36th Street, Philadelphia, PA 19104 (email: aronowit@wharton.upenn.edu). The Milbank Quarterly, Vol. 90, No. 2, 2012 (pp. 250–277) c 2012 Milbank Memorial Fund. Published by Wiley Periodicals Inc. 250