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Mandating a Human Papillomavirus Vaccine: An Investigation into Whether Such Legislation is Constitutional and Prudent

Published online by Cambridge University Press:  06 January 2021

Tracy Solomon Dowling
Tracy Solomon Dowling*
Affiliation:
Boston University School of Law; Princeton University
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Extract

Merck’s recently released vaccine, Gardasil, may revolutionize cervical cancer prevention. With the rate of detected cervical cancer cases and associated deaths rising rapidly, cervical cancer is a major public health concern. Infection with the human papillomavirus, a sexually transmitted disease, is a necessary cause of cervical cancer. Gardasil protects against two specific “high risk” strains of HPV, associated with about 70% of cervical cancer cases, and blocks infection by two other strains of HPV, responsible for 90% of genital warts cases. Proponents of Gardasil believe that vaccination of women between the ages of 12 and 26 can slow the spread of cervical cancer by eradicating the two major HPV strands associated with the cancer’s development.

Type
Article
Information
American Journal of Law & Medicine , Volume 34 , Issue 1 , March 2008 , pp. 65 - 84
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 2008

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References

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; GlaxoSmithKline submitted its HPV vaccine, Cervarix, for FDA approval. Press Release, GlaxoSmithKline, 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. Id. This Note will focus on Gardasil because the FDA has approved it.

2 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).

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4 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.

5 Id.

6 Saslow, Debbie 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)CrossRefGoogle ScholarPubMed. 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. Id.

7 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).

8 Jacobson v. Mass., 197 U.S. 11, 24-25 (1905)(upholding mandatory vaccination law for smallpox).

9 See Goldie, Sue J. et al., Projected Clinical Benefits and Cost-Effectiveness of a Human Papillomavirus 16/18 Vaccine, 96 J. Nat’l Cancer Inst. 604, 604 (2004)CrossRefGoogle ScholarPubMed.

10 Dooren, supra note 1.

11 Hodge, James G. Jr. & Gostin, Lawrence O., School Vaccination Requirements: Historical, Social, and Legal Perspectives. 90 Ky. L.J. 831, 834 (2001-2002)Google Scholar.

12 U.S. Const. amend. x.

13 Lochner v. New York, 198 U.S. 45, 53 (1905).

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15 Id. at 319 (citing Berman v. Parker, 348 U.S. 26, 31 (1954)).

16 Id.

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18 Gostin, Lawrence O., Public Health Law: Power, Duty, Restraint 21 (2000)Google Scholar. Public health regulations inevitably “entail [] potential trade-offs between public goods and private interests.” Id. at 4.

19 Jacobson v. Mass., 197 U.S. 11, 11 (1905).

20 Id.

21 Id. at 26.

22 Id. at 26-27.

23 See Hodge & Gostin, supra note 11, at 834.

24 Jacobson, 197 U.S. at 28.

25 Id.

26 Id. at 31.

27 Hodge & Gostin, supra note 11, at 856.

28 Jacobson, 197 U.S. at 39.

29 Id. at 39-40.

30 Hodge & Gostin, supra note 11, at 857.

31 260 U.S. 174 (1922).

32 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).

33 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).

34 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. Id.at 713-14.

35 Id.

36 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).

37 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.

38 Hodge & Gostin, supra note 11, at 833.

39 Id.; 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)Google Scholar; “Smallpox has been eradicated; polio is on the verge of eradication; and measles has been controlled or eliminated in numerous countries around the world.” Orenstein, Walter A., 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)CrossRefGoogle Scholar.

40 See Hodge & Gostin, supra note 11, at 834.

41 Id. These childhood diseases include measles, pertussis, mumps, rubella, diphtheria, tetanus and polio. Id.

42 Id. at 875 (citing U.S. Gen. Acct. Office, Preventative Health Care for Children: Experience From Selected Foreign Countries (1993)).

43 Edwards, Kathryn M., State Mandates and Childhood Immunization, 284 JAMA 3171, 3171 (2000)CrossRefGoogle ScholarPubMed.

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45 Id.

46 Id. at 19.

47 For a discussion on non-mendical exemptions to school immunization requirements see Saad Omer, B. et. al., Nonmedical Exemptions to School Immunization Requirements: Secular Trends and Association of State Policies with Pertussis Incidence, 296 JAMA 1757 (2006)CrossRefGoogle ScholarPubMed.

48 Orenstein & Hinman, supra note 44, at S19. However, in most states, less than one perfect of students are exempt. Id.

49 Silverman, supra note 17, at 277.

50 American Cancer Society, Overview: Cervical Cancer, http://www.cancer.org/docroot/CRI/CRI_2_1x.asp?dt=8 (last visited Feb. 22, 2008); 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; see also Manhart, Lisa E., 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)CrossRefGoogle ScholarPubMed.

51 Press Release, Food and Drug Administration, supra note 4. About 92% of cervical cancer cases worldwide occur in low and middle income countries. Outterson, Kevin, Patent Buy-Outs for Global Disease Innovations for Low- and Middle-Income Countries, 32 Am. J. L. Med. 159, 164 (2006)CrossRefGoogle ScholarPubMed.

52 Brisson, J. et. al, Risk Factors for Cervical Intraepithelial Neoplasia: Differences Between Low – and High-Grade Lesions, 140 Am. J. Epidemiol. 700 (1994)CrossRefGoogle ScholarPubMed, available at http://www.ncbi.nlm.nih.gov/pubmed/7942772?dopt=Abstract.

53 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).

54 Id.

55 See Dunne, Eileen F et. al., Prevalence of HPV Infection Among Females in the United States, 297 JAMA 813 (2007)CrossRefGoogle ScholarPubMed; Manhart, supra note 50.

56 Manhart, supra note 50.

57 Dunne, supra note 55, at 813.

58 Manhart, supra note 50, at 505.

59 Id.

60 Id. at 502.

61 Id.

62 Id. at 517. This study also concluded that vaccinating boys should also be seriously considered. Id.. For more information on prevalence of HPV in men, see Dunne, Eileen F. et. al., Prevalence of HPV Infection Among Men: A Systematic Review of the Literature, 194 J. Infectious Dis. 1044 (2006)CrossRefGoogle ScholarPubMed.

63 Dunne, supra note 55, at 813.

64 Id.

65 Id. at 816. 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.

66 Id.

67 Id.

68 Id.

69 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).

70 See Dunne, supra note 55, at 816.

71 Dooren, supra note 1.

72 Centers for Disease Control and Prevention, supra note 70.

73 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/topics/NEWS/2006/NEW01385.html. The priority approval process is used for products with the potential to provide significant health benefits. Id.

74 Id.

75 Centers for Disease Control and Prevention, supra note 70.

76 Id. Is this even any better?

77 Press Release, Food and Drug Administration, supra note 4.

78 Kahn & Bernstein, supra note 3, at 476.

79 Id.

80 Centers for Disease Control and Prevention, HPV Vaccine Questions and Answers, supra note 70.

81 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/09vaccine.html.

82 Id.

83 Centers for Disease Control and Prevention, CDC Vaccine Price List, http://www.cdc.gov/nip/vfc/cdc_vac_price_list.htm.

84 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) 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”]

85 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.

86 Id.

87 Id.

88 Bauer, Heidi & Ault, Kevin, Human Papillomavirus: Current Prevalence and Future Protection. 33 Sex. Trans. Dis. 509, 509 (2006)CrossRefGoogle ScholarPubMed. Unnecessary procedures could also adversely affect a woman's reproductive health or create complications related to the procedure. Id.

89 Insinga, Ralph P. et al., The Health Care Costs of Cervical Human Papillomavirus- Related Disease, 191 Am. J. Obstetrics &Gynecology 114, 114 (2004)CrossRefGoogle ScholarPubMed. 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.

90 Id.

91 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.” Id. at 118.

92 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. Id. at 118.

93 Id. at 119.

94 Id.

95 Insinga, Ralph P., Annual Productivity Costs Due to Cervical Cancer Mortality in the United States, 16 Women's Health Issues 236, 240 (2006)CrossRefGoogle ScholarPubMed.

96 Insinga, supra note 89, at 119. These costs do not include indirect and non-medical costs including lost work, pain and suffering, etc. Id.

97 Insinga, supra note95, 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.

98 Id. at 236.

99 Id.

100 Id.

101 Goldie, Sue J. et al., Projected Clinical Benefits and Cost-effectiveness of a Human Papillomavirus 16/18 Vaccine, 96 J. Nat’l Cancer Inst. 604, 604 (2004)CrossRefGoogle ScholarPubMed.

102 Id. at 612.

103 Id. at 609.

104 Id.

105 Id. at 612.

106 Id.

107 Waller, Jo et al., Mothers’ Attitudes Towards Preventing Cervical Cancer Through Human Papillomavirus Vaccination: A Qualitative Study, 15 Cancer Epidemiol. Biomarkers Prev. 1257, 1260 (2006)CrossRefGoogle ScholarPubMed.

108 Laura J. Grimshaw-Mulcahy, HPV Vaccination Fights Cervical Cancer, Nursing Spectrum, July 30, 2007, available at http://nursingspectrum.netstation.us/ce447.pdf.

109 Waller, supra note 107, at 1259.

110 Dempsey, Amanda F. 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).Google ScholarPubMed

111 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. Id.

112 Waller, supra note 107, at 1259.

113 Id.

114 Dempsey, supra note 110, at 1489.

115 Waller, supra note 107, at 1259.

116 Id at 1257.

117 Id. at 1259.

118 Id.

119 H.B. 1061 (S.D. 2007).

120 See legislation cited supra note 7.

121 Exec. Order No. RP65, 32 Tex. Reg. 595 (Tex. 2007).

122 Id.

123 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).

124 S.B. 1417 (Mich. 2005).

125 Michigan Care Improvement Registry, School/Childcare Manual, 43 (2007), http://www.mcir.org/SCCcontent.html (follow the “MCIR School/Childcare Manual” hyperlink).

126 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).

127 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).

128 Mich. Comp. Laws § 333.9215 (2007).

129 Id.

130 Id.

131 Id.

132 Id.

133 Mich. Comp. Laws 333.9208 (2007).

134 Centers for Disease Control and Prevention, supra note75.

135 Michigan's VFC Program, supra note 84 (indicating that a VFC-enrolled provider is automatically enrolled in both components of Michigan's VFC program).

136 Id. (commenting that underinsured “have insurance coverage that does not cover vaccination”).

137 Id.

138 Id.

139 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).

140 Michigan's VFC Program, supra note 84.

141 Id.

142 Lochner v. New York,198 U.S. 45, 53 (1905).

143 Jacobson v. Mass., 197 U.S. 11, 25 (1905).

144 Id. at 27.

145 Id. at 38.

146 Press Release, Food and Drug Administration, supra note 4.

147 Id.

148 Jacobson, 197 U.S. at 28.

149 Id.

150 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. Id.

151 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.

152 Jacobson, 197 U.S. at 32.

153 Id. at 26-27.

154 Id. at 31.

155 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).

156 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.

157 Zimmerman, Richard K, Ethical Analysis of HPV Vaccine Policy Options, 24 Vaccine 4812, 4814 (2006)CrossRefGoogle ScholarPubMed.

158 Id. at 4813. Hepatitis B can also be spread through the exchange of blood products. Id. at 4815.

159 Id. at 4815.

160 Seward, Jane F. & Orenstein, Walter A., Commentary: The Case for Universal Varicella Immunization, 25 Pediatric Infectious Disease J. 45, 45 (2006)Google ScholarPubMed.

161 Id.

162 Id.

163 Edwards, supra note 43, at 3172.

164 Zimmerman, supra note 157, at 4813.

165 Id. at 4814.

166 Id.

167 Peter Sprigg, Pro-Family, Pro-Vaccine – But Keep it Voluntary, Wash. Post, July 15, 2006, at A21.

168 Id.

169 Id.

170 Id.

171 Id.

172 Id.

173 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.

174 Andrew Pollack & Stephanie Saul, Lobbying for Vaccine to be Halted, N.Y. Times, Feb. 1, 2007, C1.

175 Sigrid Fry-Revere, The Rush to Vaccinate, N.Y. Times, Mar. 25, 2007, at 9.

176 Edwards, supra note 43, at 3171.

177 Daley, Matthew F. et al., A National Survey of Pediatrician Knowledge and Attitudes Regarding Human Papillomavirus Vaccination, 118 Pediatrics 2280, 2280 (2006)CrossRefGoogle ScholarPubMed.

178 Id.

179 Id.

180 Id. at 2281.

181 A Vaccine's Promise, supra note 150.

182 Jeanne Whalen, Armed with New Vaccines, Drug Makers Target Teenagers, Wall St. J., Aug. 23, 2006, at B1.

183 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.