UCSF

In 2006, Gardasil, the first human papillomavirus (HPV) vaccine was approved by the Food and Drug Administration to protect women age 9-26 against four strains of HPV, 16, 18, 6, and 11 that cause 70 percent of cervical cancer cases and 90 percent of genital warts cases respectively. The objective of this dissertation was to understand the process of the development, approval, and marketing of the Gardasil vaccine. This project used a qualitative, exploratory, single case study research method using data collected from articles, press releases, government, and industry documents, as well as interviews from key informants in 2008 and 2009. After the technology was acquired by Merck in 1995, the clinical trials were conducted from 1997 to 2005, and Gardasil was approved with five years of data to support claims of safety and efficacy. Promotional campaigns began in 2005 prior to Gardasil's release through awareness efforts that linked HPV and cervical cancer. The primary marketing campaign for Gardasil began after its approval and release to encourage females to visit their physicians to discuss vaccination and to encourage physicians to give the vaccine. The campaign has been a success, resulting in about 25 percent of eligible females receiving the vaccine and making Gardasil a profitable venture. Gardasil is sold at high prices largely in the United States where cervical cancer has been largely mitigated by pap smears and preventive health care. Merck facilitated the social construction of the human papillomavirus as a problem needing treatment and successfully positioned Gardasil to be the solution to that problem.