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An Interdisciplinary Argument to Lower the Age of Consent for the Human Papillomavirus Vaccine

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An Interdisciplinary Argument to Lower the Age of Consent for the Human Papillomavirus Vaccine AN INTERDISCIPLINARY ARGUMENT TO LOWER THE AGE OF CONSENT FOR THE HUMAN PAPILLOMAVIRUS VACCINE A Thesis Submitted to the Faculty Of the Graduate School of the University of Minnesota Allison M. Whelan In Partial Fulfillment of the Requirements For the Degree of Master of Arts in Bioethics Dr. Steven Miles, Advisor May 2015 © Allison M. Whelan, 2015 Acknowledgements I would like to thank Dr. Steven Miles, my thesis advisor and mentor for his tremendous guidance and involvement in the development and completion of this thesis. From the very beginning of this project, he devoted much time and energy into providing some of the most prompt and helpful feedback I have ever received on any paper during my long academic career. Without his detailed, thoughtful, and critical feedback, this thesis would not have been possible. Knowing Dr. Miles and working with him during my time at the University of Minnesota was a true honor and privilege. I would also like to thank Professor June Carbone and Dr. Jennifer Needle for their insightful and helpful feedback on my thesis drafts and their willingness to serve on my committee. I could not have completed this thesis without the time and dedication of these three professionals. I want to extend my gratitude to the entire Center for Bioethics faculty and staff. I felt welcome and comfortable at the Center from the very first day I spoke with Margie O’Neill about my interest in the University’s law and bioethics joint degree program. In one way or another, everyone at the Center played a critical role in my completion of both my law and master’s degrees. My sincere thanks to Professor Michele Goodwin, whom I consider a mentor, friend and colleague, for all her support and advice throughout my graduate career. I cannot adequately express how grateful and fortunate I am to have met you. I would also like to thank my parents, Dan and Karen, and my sisters, Kaitlin and Molly, for their love and support. I would not be where I am without you. I owe all of you the world and more. i Dedication This thesis is dedicated to my parents, Dan and Karen, and my sisters, Kaitlin and Molly. ii Table of Contents I. HUMAN PAPILLOMAVIRUS, CANCER, AND THE VACCINE’S DEVELOPMENT ......... 7 A. HUMAN PAPILLOMAVIRUS : PREVALENCE , RISK , AND CONSEQUENCES ............................. 7 B. THE VACCINE ’S DEVELOPMENT , SAFETY , EFFICACY , AND CURRENT USE ...................... 18 1. Development and Licensure of Gardasil and Cervarix ................................................. 18 2. Monitoring Vaccine Safety ........................................................................................... 23 3. Vaccine Efficacy .......................................................................................................... 26 4. HPV Vaccination Rates ................................................................................................ 31 C. THE LEGAL LANDSCAPE OF PARENTAL RIGHTS AND MINOR CONSENT ........................... 33 1. Parental Rights and Parental Consent to Minors’ Health Care ..................................... 34 a. History and Background Law .............................................................................................. 34 b. Vaccinations and Parental Consent ..................................................................................... 41 2. Minor’s Consent to Health Care ................................................................................... 44 II. OPPOSITION TO THE HPV VACCINE AND LOWERING THE AGE OF CONSENT .... 53 A. BRIEF HISTORY OF THE ANTI -VACCINATION MOVEMENT ............................................... 53 B. HPV VACCINE -SPECIFIC CONCERNS AND REASONS FOR OPPOSING A LOWER AGE OF CONSENT ........................................................................................................................... 60 1. Safety Concerns ............................................................................................................ 61 2. Concerns about Sexual Mores and Promotion of Sexual Activity ................................ 67 3. Cost Concerns ............................................................................................................... 76 4. Payment and Confidentiality if Age of Consent is Lowered ........................................ 80 5. Adolescent Inability to Understand Potential Safety Risks .......................................... 84 6. Role of Parent and Family: The Importance of “Parent-Child Unity” .......................... 89 7. Effect on Use of Cancer Screening and Other Preventive Care .................................... 93 8. Additional Doses and Follow-Up Care ......................................................................... 99 III. MEDICAL, ETHICAL, AND POLICY ARGUMENTS FOR LOWERING THE AGE OF CONSENT FOR THE HPV VACCINE ............................................................................... 103 A. MEDICAL REASONS FOR LOWERING THE AGE OF CONSENT ........................................... 104 B. ETHICAL REASONS FOR LOWERING THE AGE OF CONSENT ............................................ 110 iii 1. Autonomy .................................................................................................................. 110 2. Nonmaleficence .......................................................................................................... 118 3. Beneficence ................................................................................................................ 120 4. Justice.......................................................................................................................... 125 C. POLICY REASONS FOR LOWERING THE AGE OF CONSENT .............................................. 136 1. Cost-Effectiveness ..................................................................................................... 136 2. Emotional and Psychological Costs of HPV-Related Outcomes ................................ 147 a. Emotional Impact of Abnormal Test Results, Cancer Diagnosis, and Treatment .............. 147 b. Emotional and Psychosocial Impact and Stigma of Sexually Transmitted Infections ........ 153 IV. LOWERING THE AGE OF CONSENT IS APPROPRIATE AND IMPORTANT FOR INDIVIDUAL AND PUBLIC HEALTH REASONS ......................................................... 160 V. CONCLUSION ....................................................................................................................... 162 iv INTRODUCTION “Our children are basically guinea pigs in this grotesque experiment because so much is not yet know [sic] about the effects of this new vaccine.” 1 “[W]e just don’t trust it. Knowing that Merck, you know, the makers of Vioxx, developed it doesn’t help.” 2 “There is no history for Gardasil. It hasn’t been around long enough for that. Are doctors and Big Pharma infallible? I don’t think so, and I don’t think my doctor’s word is gospel.” 3 “If you have a daughter . DO NOT allow yor [sic] child to have this vaccine, it is dangerous and could cause death, paralysis, suffocation, seizures, lupis [sic], and Gillian Barre syndrom [sic] which mimicks [sic] MS!!!” 4 “While an HPV vaccine may be a smart health choice for some, my choice to vaccinate my hypothetical child or not does not have the same impact on YOUR hypothetical child's safety as it does with illnesses like polio, measles [sic], diphtheria [sic], and other mandatory vaccinating diseases.” 5 1 cags2606, Comment to Why Aren’t More Girls Getting the HPV Vaccine? , RH REALITY CHECK (May 9, 2012, 4:00 AM), http://rhrealitycheck.org/article/2012/05/09/why-arent-more-girls- getting-hpv-vaccine/#comment-794749645. 2 anonymous99, Comment to Why Aren’t More Girls Getting the HPV Vaccine? , RH REALITY CHECK (May 9, 2012, 4:00 AM), http://rhrealitycheck.org/article/2012/05/09/why-arent-more- girls-getting-hpv-vaccine/#comment-794749650. Vioxx was a painkiller manufactured by Merck and initially approved by the FDA. Vioxx was later withdrawn from the market after it was found to greatly increase the risk of heart problems and even death. Estimates suggest Vioxx use was linked to thousands of heart attacks and deaths. See Snigdha Prakash & Vikki Valentine, Timeline: The Rise and Fall of Vioxx , NAT ’L PUB . RADIO (Nov. 10, 2007, 2:40 PM), http://www.npr.org/templates/story/story.php?storyId=5470430. 3 bess, Comment to Why Aren’t More Girls Getting the HPV Vaccine? , RH REALITY CHECK (May 9, 2012, 4:00 AM), http://rhrealitycheck.org/article/2012/05/09/why-arent-more-girls- getting-hpv-vaccine/#comment-794749666. 4 Nancy Jones, Comment to Amanda Froelich, It’s Official: 139 Girls Have Died from HPV Vaccinations , TRUE ACTIVIST (Oct. 13, 2013, 3:13 PM), http://www.trueactivist.com/its-official- 139-girls-have-died-from-hpv-vaccinations/. 5 maiac, Comment to Why Aren’t More Girls Getting the HPV Vaccine? , RH REALITY CHECK (May 9, 2012, 4:00 AM), http://rhrealitycheck.org/article/2012/05/09/why-arent-more-girls- getting-hpv-vaccine/#comment-794749670. This statement is somewhat misguided. Although HPV is not transmitted through casual contact like other diseases frequently vaccinated against such as the flu, measles, mumps, and rubella, an individual’s decision whether or not to get the 1 “[A] vaccine that has been around since 2006 has NOT stood the test of time in terms of long term effects. There is no damn way I am letting a pharmaceutical company tell me that THEIR studies show that it is ‘safe’ when they stand to make $600 off of me . Ever heard of the fox and the chicken house? They think
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