Mandating a human papillomavirus vaccine: An investigation into whether such legislation is constitutional and prudent

American Journal of Law and Medicine

Volumn 34, Issue 1, 2008, Pages 65-84

  Dowling, Tracy Solomon ^a  

^a BOSTON UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

HUMAN PAPILLOMAVIRUS VACCINE L1, TYPE 6,11,16,18; WART VIRUS VACCINE;

ADOLESCENT; ADULT; ARTICLE; CHILD; FEMALE; HUMAN; IMMUNOLOGY; LEGAL ASPECT; MALE; MANDATORY PROGRAM; SCHOOL; UNITED STATES; UTERINE CERVIX TUMOR; VIROLOGY;

ADOLESCENT; ADULT; CHILD; FEMALE; HUMANS; MALE; MANDATORY PROGRAMS; MICHIGAN; PAPILLOMAVIRUS VACCINES; SCHOOLS; UNITED STATES; UTERINE CERVICAL NEOPLASMS;

EID: 52049099889     PISSN: 00988588     EISSN: None     Source Type: Journal    
DOI: 10.1177/009885880803400103     Document Type: Article

References (209)

1. Jennifer Corbett Dooren, Merck Cervical-Cancer Vaccine is Approved for Use in Women - Gardasil Could Sharply Cut Key Viruses Behind Disease; CDC to Set Forth Guidelines, WALL ST. J., Jun. 9, 2006, at A16;
2. GlaxoSmithKIine submitted its HPV vaccine, Cervarix, for FDA approval. Press Release, Glaxo Smith Kline, GSK Submits Biologics License Application to U.S. Food and Drug Administration for Cervarix, (Mar. 29, 2007), available at http://www.gsk.com/ ControllerServlet?appId=4&pageId=402&newsid=1000. GSK's vaccine has a different formulation than Gardasil which creates a stronger, longer lasting response against certain strands of HPV.
3. Id. This Note will focus on Gardasil because the FDA has approved it.
4. World Health Organization, Global Cancer Rates Could Increase by 50% to 15 million by 2020, http://www.who.int/mediacentre/news/releases/2003/ pr27/en/ (last visited Feb. 22, 2008).
5. Jessica A. Kahn & David I. Bernstein, Human Papillomavirus Vaccines and Adolescents, 17 CURRENT OPINION OBSTETRICS GYNECOLOGY 476, 476 (2005).
6. Press Release, Food and Drug Administration, FDA Licenses New Vaccine for Prevention of Cervical Cancer and Other Diseases in Females Caused by the Human Papillomavirus (June 8, 2006), available at http://www.fda.gov/bbs/topics/NEWS/2006/NEW01385.html.
7. Id.
8. Debbie Saslow et al., American Cancer Society Guideline for Human Papillomavirus (HPV) Vaccine Use to Prevent Cervical Cancer and its Precursors, 57 Cal. Cancer J. Clinicians 7, 16 (2007). According to a national survey, 24% of fifteen year old, 40% of sixteen year old, and 70% of eighteen year old females reported having already engaged in sexual activity.
9. Id.
10. S.B. 1417 (Mich. 2007); CA A.B. 16 (Cal. 2007); H.B. 1914 (Va. 2007); S.B. 10 (Ill. 2007); S.B. 155 (Ga. 2008); H.B. 81 (Ohio 2007); H.B. 561 (Fla. 2007); S.B. 327 (Ind. 2007); A.B. 5810 (N.Y. 2007); S.B. 139 (Vt. 2007); H.B. 29 (Miss. 2008).
11. Jacobson v. Mass., 197 U.S. 11, 24-25 (1905)(upholding mandatory vaccination law for smallpox).
12. See Sue J. Goldie et al., Projected Clinical Benefits and Cost-Effectiveness of a Human Papillomavirus 16/18 Vaccine, 96 J. NAT'L CANCER INST. 604, 604 (2004).
13. Dooren, supra note 1.
14. James G. Hodge, Jr. & Lawrence O. Gostin, School Vaccination Requirements: Historical, Social, and Legal Perspectives. 90 KY. L.J. 831, 834 (2001-2002).
15. U.S. CONST. AMEND. X.
16. Lochner v. New York, 198 U.S. 45, 53 (1905).
17. James G. Hodge, Jr. The Role of New Federalism and Public Health Law, 12 J.L. & HEALTH 309, 318 (1998).
18. Id. at 319
19. (citing Berman v. Parker, 348 U.S. 26, 31 (1954)).
20. Id.
21. Ross D. Silverman, No More Kidding Around: Restructuring Non-Medical Childhood Immunization Exemptions to Ensure Public Health Protection, 12 ANNALS HEALTH L. 277, 278 (2003).
22. LAWRENCE O. GOSTIN, PUBLIC HEALTH LAW: POWER, DUTY, RESTRAINT 21 (2000). Public health regulations inevitably "entail [] potential trade-offs between public goods and private interests. "
23. Id. at 4.
24. Jacobson v. Mass., 197 U.S. 11, 11 (1905).
25. Id.
26. Id. at 26.
27. Id. at 26-27.
28. See Hodge & Gostin, supra note 11, at 834.
29. Jacobson, 197 U.S. at 28.
30. Id.
31. Id. at 31.
32. Hodge & Gostin, supra note 11, at 856.
33. Jacobson, 197 U.S. at 39.
34. Id. at 39-40.
35. Hodge & Gostin, supra note 11, at 857.
36. U.S. 174 (1922).
37. Id. at 176-77 (finding that mandatory vaccinations for school attendance and giving broad power to local boards to determine such mandates does not violate the 14th Amendment).
38. Seubold v. Fort Smith Special Sch. Dist., 237 S.W.2d 884, 888 (Ark. 1951)(upholding state police powers to mandate smallpox vaccination for school attendance).
39. See Viemeister v. White, 84 N.Y.S. 712 (N.Y. App. Div. 1904), aff'd, 72 N.E. 97 (N.Y. 1904)(upholding mandatory vaccinations for New York school attendance). The Appellate Court also finds that education is not a constitutional right, but rather an extension of a privilege. Viemeister, 84 N.Y.S. at 713. The legislature can impose any reasonable regulations on this privilege.
40. Id. at 713-14.
41. Id.
42. Maricopa County Health Dept. v. Harmon, 750 P.2d 1364,1365 (Ariz. 1987) (holding that the state can prohibit children from entering school until the children provide proof they have had the measles vaccination).
43. This fourth criterion may never be guaranteed and refers mostly to patients who know their health will be adversely affected by having the vaccine, but are forced to have it anyway.
44. Hodge & Gostin, supra note 11, at 833.
45. Id.;
46. Cts. For Disease Control & Prevention, U.S. Dep't of Health and Hum. Servs., Ten Great Public Health Achievements - United States, 1900-1999, 48 MORBIDITY & MORTALITY WKLY. REP. 241, 241 (1999)
47. "Smallpox has been eradicated; polio is on the verge of eradication; and measles has been controlled or eliminated in numerous countries around the world." Walter A. Orenstein, et. al. Immunizations in the United States: Success, Structure, and Stress: A complex Collaboration Involving Government, Industry, Providers, Academe, Professional Societies, and Third-Party Buyers, 24 HEALTH AFFAIRS 599, 599 (2005).
48. See Hodge & Gostin, supra note 11, at 834.
49. Id. These childhood diseases include measles, pertussis, mumps, rubella, diphtheria, tetanus and polio.
50. Id.
51. Id. at 875 (citing U.S. GEN. ACCT. OFFICE, PREVENTATIVE HEALTH CARE FOR CHILDREN: EXPERIENCE FROM SELECTED FOREIGN COUNTRIES (1993)).
52. Kathryn M. Edwards, State Mandates and Childhood Immunization, 284 JAMA 3171, 3171 (2000).
53. Walter A. Orenstein & Alan R. Hinman, The Immunization System in the United States - the Role of School Immunization Laws, 17 VACCINE S19, S23 (1999).
54. Id.
55. Id. at 19.
56. For a discussion on non-mendical exemptions to school immunization requirements see Saad B. Omer et. al., Nonmedical Exemptions to School Immunization Requirements: Secular Trends and Association of State Policies with Pertussis Incidence, 296 JAMA 1757 (2006).
57. Orenstein & Hinman, supra note 44, at S19.
58. However, in most states, less than one perfect of students are exempt. Id.
59. Silverman, supra note 17, at 277.
60. American Cancer Society, Overview: Cervical Cancer, http://www.cancer.org/docroot/CRI/CRI_2_1x.asp?dt=8 (last visited Feb. 22, 2008)
61. see Press Release, Food and Drug Administration, FDA Licenses New Vaccine for the Prevention of Cervical Cancer and Other Diseases in Females Caused by the Human Papillomavirus (June 8, 2006), available at http://www.fda.goc/cder/offices/OODP/whatsnew/gardisil.htm
62. see also Lisa E. Manhart, et al. Human Papillomavirus Infection Among Sexually Active Young Women in the United States: Implications for Developing a Vaccination Strategy, 33 SEX. TRANSM. DIS. 502 (2006).
63. Press Release, Food and Drug Administration, supra note 4.
64. About 92% of cervical cancer cases worldwide occur in low and middle income countries. Kevin Outterson, Patent Buy-Outs for Global Disease Innovations for Low- and Middle-Income Countries, 32 AM. J. L. MED. 159, 164 (2006).
65. J. Brisson et. al, Risk Factors for Cervical Intraepithelial Neoplasia: Differences Between Low - and High-Grade Lesions, 140 AM. J. EPIDEMIOL. 700 (1994), available at http://www.ncbi.nlm.nih.gov/pubmed/7942772?dopt=Abstract.
66. Center for Disease Control, Human Papillomavirus Information for Clinicians, http://www.cdc.gov/std/hpv/common-infection/CDC/ HPV_Clinicianbro_HR.pdf (last visited Feb. 22, 2008).
67. Id.
68. See Eileen F Dunne et. al., Prevalence of HPV Infection Among Females in the United States, 297 JAMA 813 (2007)
69. Manbart, supra note 50.
70. Manhart, supra note 50.
71. Dunne, supra note 55, at 813.
72. Manhart, supra note 50, at 505.
73. Id.
74. Id. at 502.
75. Id.
76. Id. at 517.
77. This study also concluded that vaccinating boys should also be seriously considered. Id..
78. For more information on prevalence of HPV in men, see Eileen F. Dunne et. al., Prevalence of HPV Infection Among Men: A Systematic Review of the Literature, 194 J. INFECTIOUS DIS. 1044 (2006).
79. Dunne, supra note 55, at 813.
80. Id.
81. Id. at 816.
82. These results should be questioned because two of the tested women who reported never having had sex also tested positive for herpes simplex type 2 and Chlamydia. Id.
83. Id.
84. Id.
85. Id.
86. Centers for Disease Control and Prevention, HPV Vaccine Questions and Answers, http://www.cdc.gov/std/hpv/STDFact-HPV-vaccine.htm#hpvvac3 (last visited Feb. 22, 2008).
87. See Dunne, supra note 55, at 816.
88. Dooren, supra note 1.
89. Centers for Disease Control and Prevention, supra note 70.
90. Press Release, Food and Drug Administration, FDA Licenses New Vaccine for Prevention of Cervical Cancer and Other Diseases in Females Caused by Human Papillomavirus: Rapid Approval Marks Major Advancement in Public Health, (June 8, 2006), available at http://www.fda.gov/ bbs/topies/NEWS/2006/NEW01385.html. The priority approval process is used for products with the potential to provide significant health benefits.
91. Id.
92. Id.
93. Centers for Disease Control and Prevention, supra note 70.
94. Id. Is this even any better?
95. Press Release, Food and Drug Administration, supra note 4.
96. Kahn & Bernstein, supra note 3, at 476.
97. Id.
98. Centers for Disease Control and Prevention, HPV Vaccine Questions and Answers, supra note 70.
99. Gardiner Harris, U.S. Approves Use of Vaccine for Cervical Cancer, N.Y. TIMES, June 8, 2006, available at http://www.nytimes.com/2006/06/09/health/ogvaccine.html.
100. Id.
101. Centers for Disease Control and Prevention, CDC Vaccine Price List, http://www.cdc.gov/nip/vfc/cdc_vac_price_list.htm.
102. See Michigan Vaccines for Children, Shots for Your Child, http://www.michigan.gov/documents/after_9_VFC_brochure_128629_7.pdf (last visited Feb. 22, 2008)
103. and Michigan Department of Community Health, Human Papillomavirus (HPV) Vaccine Costs and Financing, http://www.michigan.gov/documents/mdch/ 2HPVFactsCosts010507final_182595_7.pdf (last visited Feb. 22, 2008) [hereinafter "Michigan's VFC Program"]
104. Id. There will be a more in depth look at the qualifications and coverage under VFC when this paper discusses mandatory vaccination of students in Michigan.
105. Id.
106. Id.
107. Heidi Bauer & Kevin Ault, Human Papillomavirus: Current Prevalence and Future Protection. 33 SEX. TRANS. DIS. 509, 509 (2006).
108. Unnecessary procedures could also adversely affect a woman's reproductive health or create complications related to the procedure. Id.
109. Ralph P. Insinga et al., The Health Care Costs of Cervical Human Papillomavirus-Related Disease, 191 AM. J. OBSTETRICS & GYNECOLOGY 114, 114 (2004). It is important to note that the research center behind this research is the Kaiser Permanente Center for Health Research and that this research was supported by an unrestricted gift to the University of Wisconsin-Madison from Merck Research Laboratories. This research may represent a conflict of interest, where Merck, the creator of Gardasil, was paying for its creation and could substantially gain from a beneficial report.
110. Id.
111. Id. The results also displayed a trend towards increasing costs with a major concern being false positives. Treating false positives includes "discomfort, inconvenience, psychological distress, lost production, and resources."
112. Id. at 118.
113. Id. at 119. Estimates suggest that 55% to 60% of women with cervical cancer did not receive a Papanicolaou test within the previous three years.
114. Id. at 118.
115. Id. at 119.
116. Id.
117. Ralph P. Insinga, Annual Productivity Costs Due to Cervical Cancer Mortality in the United States, 16 WOMEN'S HEALTH ISSUES 236, 240 (2006).
118. Insinga, supra note 89, at 119. These costs do not include indirect and non-medical costs including lost work, pain and suffering, etc.
119. Id.
120. Insinga, supra note 95, at 236. This report was created by the Department of Health Economic Statistics at Merck Research Laboratories in North Wales, Pa. The reader should realize Merck funded the research for this article and the author is a Merck employee. Thus, the results must be scrutinized.
121. Id. at 236.
122. Id.
123. Id.
124. Sue J. Goldie et al., Projected Clinical Benefits and Cost-effectiveness of a Human Papillomavirus 16/18 Vaccine, 96 J. NAT'L CANCER INST. 604, 604 (2004).
125. Id. at 612.
126. Id. at 609.
127. Id.
128. Id. at 612.
129. Id.
130. Jo Waller et al., Mothers' Attitudes Towards Preventing Cervical Cancer Through Human Papillomavirus Vaccination: A Qualitative Study, 15 CANCER EPIDEMIOL. BIOMARKERS PREV. 1257, 1260 (2006).
131. Laura J. Grimshaw-Mulcahy, HPV Vaccination Fights Cervical Cancer, Nursing Spectrum, July 30, 2007, available at http://nursingspectrum.netstation.us/ce447.pdf.
132. Waller, supra note 107, at 1259.
133. Amanda F. Dempsey et al., Factors that are Associated with Parental Acceptance of Human Papillomavirus Vaccines: A Randomized Intervention Study of Written Information About HPV, 117 VACCINE 1486, 1493 (2006).
134. Id. Researchers tested their hypothesis that the receipt of HPV information by parents would increase knowledge and acceptability, but instead found that such information did not substantially alter parental acceptability. This could be caused by the relatively homogeneous sample taken.
135. Id.
136. Waller, supra note 107, at 1259.
137. Id.
138. Dempsey, supra note 110, at 1489.
139. Waller, supra note 107, at 1259.
140. Id at 1257.
141. Id. at 1259.
142. Id.
143. H.B. 1061 (S.D. 2007).
144. See legislation cited supra note 7.
145. Exec. Order No. RP65, 32 Tex. Reg. 595 (Tex. 2007).
146. Id.
147. Id. In 2007, a bill was signed into law that overrides the Governor's executive order and prohibits any elementary or secondary school requirement for the HPV vaccine. H.R. 1098, 2007 80th Leg. (Tex. 2007).
148. S.B. 1417 (Mich. 2005).
149. Michigan Care Improvement Registry, School/Childcare Manual, 43 (2007), http://www.mcir.org/SCCcontent.html (follow the "MCIR School/ Childcare Manual" hyperlink).
150. Id. at 3. Vaccines must be up to date for each year of school, however, the HPV vaccine will not be required until children are in sixth grade because the vaccine is recommended for children aged 12-26. Michigan Care Improvement Registry, School Packet, http://www.mcir.org/ SCCcontent.html (follow "School Packet" hyperlink).
151. Michigan Department of Community Health, Required Childhood Immunizations for Michigan School Settings (2007), http://www.michigan.gov/documents/SchoolRules_170324_7.pdf (last visited May 11, 2007).
152. MICH. COMP. LAWS § 333.9215 (2007).
153. Id.
154. Id.
155. Id.
156. Id.
157. MICH. COMP. LAWS 333.9208 (2007).
158. CENTERS FOR DISEASE CONTROL AND PREVENTION, supra note 75.
159. Michigan's VFC Program, supra note 84 (indicating that a VFC-enrolled provider is automatically enrolled in both components of Michigan's VFC program).
160. Id. (commenting that underinsured "have insurance coverage that does not cover vaccination").
161. Id.
162. Id.
163. Centers for Disease Control and Prevention, VFC Eligibility FAQs: FAQS about State Immunization Projects, http://www.cdc.gov/NIP/vfc/ st_immz_proj/faqs_eligibility.htm#8 (last visited Feb 22, 2008).
164. Michigan's VFC Program, supra note 84.
165. Id.
166. Lochner v. New York, 198 U.S. 45, 53 (1905).
167. Jacobson v. Mass., 197 U.S. 11, 25 (1905).
168. Id. at 27.
169. Id. at 38.
170. Press Release, Food and Drug Administration, supra note 4.
171. Id.
172. Jacobson, 197 U.S. at 28.
173. Id.
174. A Vaccine's Promise, WALL ST. J., Jul. 21, 2006, at W11. In some circumstances, children born to mothers with HPV may face up to a hundred operations to remove wart-like growths in their throats.
175. Id.
176. Leslie Goldman, The Birds, the Bees and HPV: Vaccine for Preteen Girls Combats Sexually Passed, Cancer-Causing Infection, CHI. TRIB., Sept. 19, 2006, at CN6.
177. Jacobson, 197 U.S. at 32.
178. Id. at 26-27.
179. Id. at 31.
180. Currently 303 million people. U.S. Census Bureau, U.S. Population Clock, http://www.census.gov/main/www/popclock.html (last visited Mar. 6, 2008).
181. It is also worth noting that this would be the sole mandatory childhood vaccine that targets a single gender, an issue that this paper recognizes, but does not address.
182. Richard K Zimmerman, Ethical Analysis of HPV Vaccine Policy Options, 24 VACCINE 4812, 4814 (2006).
183. Id. at 4813.
184. Hepatitis B can also be spread through the exchange of blood products. Id. at 4815.
185. Id. at 4815.
186. Jane F. Seward & Walter A. Orenstein, Commentary: The Case for Universal Varicella Immunization, 25 PEDIATRIC INFECTIOUS DISEASE J. 45, 45 (2006).
187. Id.
188. Id.
189. Edwards, supra note 43, at 3172.
190. Zimmerman, supra note 157, at 4813.
191. Id. at 4814.
192. Id.
193. Peter Sprigg, Pro-Family, Pro-Vaccine - But Keep it Voluntary, WASH. POST, July 15, 2006, at A21.
194. Id.
195. Id.
196. Id.
197. Id.
198. Id.
199. American Academy of Pediatrics, Prevention of Human Papillomavirus Infection: Provisional Recommendations for Immunization of Females With Quadrivalent Human Papillomavirus Vaccine, May 23, 2007, available at http://www.cispimmunize.org/ill/pdf/HPVprovisional.pdf.
200. Andrew Pollack & Stephanie Saul, Lobbying for Vaccine to be Halted, N.Y. TIMES, Feb. 1, 2007, C1.
201. Sigrid Fry-Revere, The Rush to Vaccinate, N.Y. TIMES, Mar. 25, 2007, at 9.
202. Edwards, supra note 43, at 3171.
203. Matthew F. Daley et al., A National Survey of Pediatrician Knowledge and Attitudes Regarding Human Papillomavirus Vaccination, 118 PEDIATRICS 2280, 2280 (2006).
204. Id.
205. Id.
206. Id. at 2281.
207. A Vaccine's Promise, supra note 150.
208. Jeanne Whalen, Armed with New Vaccines, Drug Makers Target Teenagers, WALL ST. J., Aug. 23, 2006, at B1.
209. Press Release, Kaiser Daily Women's Health Policy, CDC Panel Recommends HPV Vaccine Gardasil for All Girls Ages 11, 12, Recommends Coverage by Federal Program (June 30, 2006), available at http://www.kaisernetwork.org/Daily_reports/rep_index.cfm?DR_ID=38231.