The rise and fall of the lyme disease vaccines: a cautionary tale for risk interventions in American medicine and public health.
BACKGROUND
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evidence of their safety and efficacy in clinical trials and initial postmarketing surveillance, one vaccine was withdrawn before the regulatory review and the other after only three years on the market.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 investigation 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 vaccines, analyzed the regulatory hearings, and conducted interviews with key participants.


RESULTS
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 vaccines 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.


CONCLUSIONS
The social and psychological efficacy of many risk-reducing practices and products, such as new "personalized vaccines," is to provide insurance and reduce fear. Yet the actions of self-interested actors can easily undermine this appeal. In addition to evaluating the scientific efficacy and safety of these practices and products, policymakers and others need to understand, anticipate, and perhaps shape the potential social and psychological work they might do.
University of Pennsylvania, Philadelphia, PA 19104, USA. aronowit@wharton.upenn.edu
Robert A
RA
Aronowitz
D017277:Drug Approval / Q000331:legislation & jurisprudence; D006291:Health Policy; D006801:Humans; D016365:Liability, Legal; D008193:Lyme Disease / Q000517:prevention & control*; D022123:Lyme Disease Vaccines / Q000009:adverse effects*; D018570:Risk Assessment; D056737:Safety-Based Drug Withdrawals; D014481:United States
D022123:Lyme Disease Vaccines