One Less Risk, Or One Less Girl? Situating Gardasil and Cervical Cancer Risk in the Context of Risk-Reduction Medicine

Abstract

How does a drug with a limited safety and efficacy record become an international blockbuster? In June 2006 the FDA approved and recommended a new vaccine directed against 4 types of sexually transmitted human papillomavirus, associated with 70% of cervical cancer cases and 90% of genital wart cases. Branded as a "cervical cancer vaccine" Gardasil has been met with as much fanfare as controversy, and retains blockbuster status in Merck's portfolio. Sold as a cancer risk-reduction method, Gardasil carries its own risks, with startlingly low efficacy and elevated likelihood of serious adverse events (side effects). Through the lens of risk, this dissertation examines Gardasil's popularity in the face of evidence that it is neither as safe nor as effective as advertised. Through three distinct research projects, I identify (a) five sociological factors responsible for Gardasil's success on the heels of Vioxx, one of the biggest drug scandals in history; (b) how amongst healthy vaccinated girls, cervical cancer is experienced as a "risk object," yet when a young woman experiences a serious adverse event that "object of risk" and her "experience of risk" shift toward Gardasil; and (c) that Gardasil is so trusted among young women, that warnings about potential side effects from others made some girls more likely to get vaccinated and have a positive opinion on the vaccine, suggesting that Gardasil benefits from a broader cultural assumption that vaccines are inherently safe and effective. Physicians and pharmaceutical marketing also play an important role. Gardasil is a risk-reduction drug and vaccine purported to treat risk while it simultaneously creates new risk for further health problems in some consumers. This dissertation contributes to sociological literatures on pharmaceuticalization, pharmaceutical pseudoscience, the social construction of risk, research on regulatory agencies, and the sociology of medicine more broadly.