Who's Guarding What? A Poststructural Feminist Analysis of Gardasil Discourses

Abstract

In May 2006 the Gardasil vaccine was approved for implementation in the United States to prohibit the spread of four strains of the human papillomavirus (HPV) that can lead to cervical cancer. Through a poststructural feminist reading, I critique ideologies at play throughout the Food and Drug Administration (FDA) approval hearing for this vaccine. I explore the conditions that gave rise to the adoption of the Gardasil vaccine as evidenced in the hearing transcript, and probe contradictions between choices the FDA enacted for the feminine body with those recommendations from lead scientists of Merck that urged the inclusion of males in the vaccination process. Along the way, I respond to appeals from scholars to address matters of health policy formation and implementation as critical and underexplored dimensions of health communication. I offer a vision that makes way for proactive engagement of males in reproductive and sexual health, particularly as the FDA delayed vaccine approval for males until 2009.

Notes

1“There are 35,000 cancers in the United States that are caused by HPV every year. Twenty-five thousand are caused by 16 and 18.” A million cases of genital warts, 900,000 caused by vaccine types. Six-thousand cases of RRP (Recurrent Respiratory Papillomatosis), 5,400 are caused by vaccine types in both men and women and boys and girls” (FDA, 2006, p. 70).

²The composition of the committee included six FDA staff members, four of whom were MDs, one of whom is an RN, and two whom have their MPH. Fifteen participants were acting as temporary voting members. Of these members, 13 were MDs, one RN, and one MSN. These members represented agencies including Wyeth Research Industry, National Institutes of Health, Center for Bioethics and Culture, National Vaccine Office, Department of Health and Human Service, Baylor College of Medicine, Texas Children's Hospital, Centers for Disease Control and Prevention, and Columbia University, College of Physicians and Surgeons.

³Explaining how the research was conducted for prophylactic efficacy, Dr. Bar described to the committee the four protocols—5, 7, 13 and 15. Protocol 5 was specifically an HPV 16 study with the “longest term follow up in the data base” (FDA, 2006, p. 35). Protocol 7 was a dose ranging study, and 13 was “designed to look at the impact of the vaccine of CIN of any grade [and] external genital lesions” (p. 35). Protocol 15 “was designed to be a real world study to look at the impact of the vaccine on cancer” (p. 36). “And for the most important end point the study, which is HPV 16 and 18, all four types together, we combined all the studies of Gardasil” (FDA, 2006, p. 36).

⁴Though not immediately available with the transcript, I have since been able to acquire and identify them as equally supportive in their requests for vaccinating women and girls.

⁵The National Women's Health Network, American Society Health Association, Society of Gynecologic Oncologists, Women in Government, Coalition of Labor Union Women, Medical Director, Association of Reproductive Health Professionals, Reproductive Health Technologies Project, Society for Women's Health Research, National Coalition for Cancer survivorship, and American Society for Reproductive Medicine.

6“The concept of ‘immuno-bridging’ is used to ‘bridge’ or to extend efficacy data from the age groups studied in clinical trials of the quadravalent HPV vaccine to either age categories. The rationale is that participants in the HPV vaccine clinical trials demonstrated measurable increases in type-specific HPV antibody levels, as well as reductions in HPV clinical-related disease. Thus, if the ‘extended’ age groups show a comparable immunologic response, the similar clinical efficacy would be expected” (Mahoney, 2006, p. 14).