Pharmaceutical Companies' Role in State Vaccination Policymaking

The Case of Human Papillomavirus Vaccination

Michelle M. Mello, JD, PhD; Sara Abiola, JD, PhD; James Colgrove, PhD

Disclosures

Am J Public Health. 2012;102(5):893-898. 

In This Article

Abstract and Introduction

Abstract

Objectives. We sought to investigate roles that Merck & Co Inc played in state human papillomavirus (HPV) immunization policymaking, to elicit key stakeholders' perceptions of the appropriateness of these activities, and to explore implications for relationships between health policymakers and industry.
Methods. We used a series of state case studies combining data from key informant interviews with analysis of media reports and archival materials. We interviewed 73 key informants in 6 states that were actively engaged in HPV vaccine policy deliberations.
Results. Merck promoted school-entry mandate legislation by serving as an information resource, lobbying legislators, drafting legislation, mobilizing female legislators and physician organizations, conducting consumer marketing campaigns, and filling gaps in access to the vaccine. Legislators relied heavily on Merck for scientific information. Most stakeholders found lobbying by vaccine manufacturers acceptable in principle, but perceived that Merck had acted too aggressively and nontransparently in this case.
Conclusions. Although policymakers acknowledge the utility of manufacturers' involvement in vaccination policymaking, industry lobbying that is overly aggressive, not fully transparent, or not divorced from financial contributions to lawmakers risks undermining the prospects for legislation to foster uptake of new vaccines.

Introduction

In June 2006, the Food and Drug Administration approved the first vaccine against human papillomavirus (HPV), the sexually transmitted virus implicated in three quarters of all cases of cervical cancer. Gardasil, produced by Merck & Co Inc, was licensed for vaccination of females aged 9 to 26 years for the prevention of cervical cancer and genital warts.[1] The same month, the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention recommended routine vaccination of girls aged 11 to 12 years, with catch-up vaccination of females aged 13 to 26 years.[2] A remarkable burst of legislative activity followed. Within a year, legislation relating to the vaccine was introduced in 41 states and the District of Columbia, including bills in 24 states that would mandate HPV vaccination for 6th-grade girls.[3]

Interest in the political forces behind HPV legislation remains high.[4] Following media reports that Merck was heavily involved in promoting school-entry mandates, questions arose about the extent and appropriateness of industry involvement in vaccine policy. The presidential candidacy of Texas Governor Rick Perry recently prompted a new round of public and media scrutiny of the issue after opponent Representative Michele Bachmann accused the governor of ordering girls to receive the HPV vaccination because of his financial and political ties to Merck.[5] We aimed to investigate these industry roles and elicit key stakeholders' perceptions of their appropriateness and effects on policy outcomes.

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