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Assessing Mandatory HPV Vaccination: Who Should Call the Shots?

Published online by Cambridge University Press:  01 January 2021

Gail Javitt ,
Deena Berkowitz  and
Lawrence O. Gostin
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Extract

The human papillomavirus (HPV) is the most common sexually transmitted infection worldwide. In the United States, more than six million people are infected each year. Although most HPV infections are benign, two strains of HPV cause 70 percent of cervical cancer cases. Two other strains of HPV are associated with 90 percent of genital warts cases.

In June 2006, the Food and Drug Administration (FDA) approved the first vaccine against HPV. Sold as Gardasil, the quadrivalent vaccine is intended to prevent four strains of HPV associated with cervical cancer, precancerous genital lesions, and genital warts. Following FDA approval, the national Advisory Committee on Immunization Practices (ACIP) recommended routine vaccination for girls ages 11-12 with three doses of quadrivalent HPV vaccine. Thereafter, state legislatures around the country engaged in an intense effort to pass laws mandating vaccination of young girls against HPV. This activity was spurred in part by an intense lobbying campaign by Merck, the manufacturer of the vaccine.

Type
Independent
Information
Journal of Law, Medicine & Ethics , Volume 36 , Issue 2 , Summer 2008 , pp. 384 - 395
Copyright
Copyright © American Society of Law, Medicine and Ethics 2008

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References

Saslow, D. et al., “American Cancer Society Guideline for Human Papillomavirus (HPV) Vaccine Use to Prevent Cervical Cancer and its Precursors,” CA: A Cancer Journal for Clinicians 57, no. 1 (2007): 7–28.Google Scholar
Editorial, “Should HPV Vaccination Be Mandatory for All Adolescents?” The Lancet 368, no. 9543 (2006): 1212.CrossRefGoogle Scholar
U.S. 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, Press Release, June 8, 2006, available at <http://www.fda.gov/bbs/topics/NEWS/2006/NEW01385.html> (last visited March 5, 2008).+(last+visited+March+5,+2008).>Google Scholar
Centers for Disease Control and Prevention, CDC's Advisory Committee Recommends Human Papillomavirus Virus Vaccination, Press Release, June 29, 2006, available at <http://www.cdc.gov/od/oc/media/pressrel/r060629.htm> (last visited March 5, 2008).+(last+visited+March+5,+2008).>Google Scholar
Pollack, A. and Saul, S., “Lobbying for Vaccine to Be Halted,” New York Times, February 21, 2007, availiable at <http://query.nytimes.com/gst/fullpage.html?sec=health&res=9403E6D6123EF932A15751C0A9619C8B63&n=Top%2FReference%2FTimes%20Topics%2FPeople%2FS%2FSaul%2C%20Stephanie> (last visited March 14, 2008).+(last+visited+March+14,+2008).>Google Scholar
Centers for Disease Control and Prevention, Childcare and School Immunization Requirements, 2005–2006, August 2006, available at <http://www.immunize.org/laws/2005–06_izrequirements.pdf> (last visited March 5, 2008).+(last+visited+March+5,+2008).>Google Scholar
Centers for Disease Control and Prevention, “A Closer Look at Human Papillomavirus (HPV),” 2000, available at <http://www.cdc.gov/std/Trends2000/HPV-close.htm> (last visited March 5, 2008); Centers for Disease Control and Prevention, “Genital HPV Infection — CDC Fact Sheet,” May 2004, available at <http://www.cdc.gov/std/HPV/STDFact-HPV.htm> (last visited March 5, 2008).+(last+visited+March+5,+2008);+Centers+for+Disease+Control+and+Prevention,+“Genital+HPV+Infection+—+CDC+Fact+Sheet,”+May+2004,+available+at++(last+visited+March+5,+2008).>Google Scholar
See Saslow, et al., supra note 1.Google Scholar
Datta, S. D. et al., “Sentinel Surveillance for Human Papillomavirus among Women in the United States, 2003–2004,” in Program and Abstracts of the 16th Biennial Meeting of the International Society for Sexually Transmitted Diseases Research, Amsterdam, The Netherlands, July 10–13, 2005.Google Scholar
Centers for Disease Control and Prevention, “Human Papillomavirus (HPV) Infection,” July 2, 2007, available at <http://www.cdc.gov/std/hpv/default.htm> (last visited March 5, 2008).+(last+visited+March+5,+2008).>Google Scholar
Nichols, J. R., “Human Papillomavirus Infection: The Role of Vaccination in Pediatric Patients,” Clinical Pharmacology and Therapeutics 81, no. 4 (2007): 607–610.Google Scholar
See Saslow, et al., supra note 1.Google Scholar
Walboomers, J. M. et al., “Human Papillomavirus is a Necessary Cause of Invasive Cervical Cancer Worldwide,” Journal of Pathology 189, no. 1 (1999): 12–19.3.0.CO;2-F>CrossRefGoogle Scholar
Chan, J. K. and Berek, J. S., “Impact of the Human Papilloma Vaccine on Cervical Cancer,” Journal of Clinical Oncology 25, no. 20 (2007): 2975–2982.CrossRefGoogle Scholar
See Saslow, et al., supra note 1.Google Scholar
Simma, B. et al., “Squamous-Cell Carcinoma Arising in a NonIrradiated Child with Recurrent Respiratory Papillomatosis,” European Journal of Pediatrics 152, no. 9 (1993): 776–778.CrossRefGoogle Scholar
Dunne, E. F. et al., “Prevalence of HPV Infection among Females in the United States,” JAMA 297, no. 8 (2007): 813–819.CrossRefGoogle Scholar
Markowitz, L. E. et al., “Quadrivalent Human Papillomavirus Vaccine: Recommendations of the Advisory Committee on Immunization Practices (ACIP),” Morbidity and Mortality Weekly Report 55, no. RR-2 (2007): 1–24.Google Scholar
Koutsky, L. A. et al., “A Controlled Trial of a Human Papillomavirus Type 16 Vaccine,” New England Journal of Medicine 347, no. 21 (2002): 1645–1651; Brown, D. R. et al., “Early Assessment of the Efficacy of a Human Papillomavirus Type 16L1 Virus-Like Particle Vaccine,” Vaccine 22, nos. 21–22 (2004): 2936–2942; Wheeler, C. M., “Advances in Primary and Secondary Interventions for Cervical Cancer: Human Papillomavirus Prophylactic Vaccines and Testing,” Nature Clinical Practice Oncology 4, no. 4 (2007): 224–235; Villa, L. L. et al., “Prophylactic Quadrivalent Human Papillomavirus (Types 6, 11, 16, and 18) L1 Virus-Like Particle Vaccine in Young Women: A Randomized Double-Blind Placebo-Controlled Multicentre Phase II Efficacy Trial,” The Lancet Oncology 6, no. 5 (2005): 271–278; see Saslow, , supra note 1.Google Scholar
Id. (Villa).Google Scholar
See Wheeler, , supra note 19.Google Scholar
Miller, N. B., Clinical Review of Biologics License Application for Human Papillomavirus 6, 11, 16, 18 L1 Virus Like Particle Vaccine (S. cerevisiae) (STN 125126 GARDASIL), manufactured by Merck, Inc.,” Food and Drug Administration, June 8, 2006, available at <http://www.fda.gov/cber/review/hpvmer060806r.pdf> (last visited March 5, 2008).+(last+visited+March+5,+2008).>Google Scholar
Centers for Disease Control and Prevention, HPV Vaccine — Questions and Answers for the Public, June 28, 2007, available at <http://www.cdc.gov/vaccines/vpd-vac/hpv/downloads/hpv-gardasil-gbs.pdf> (last visited April 2, 2008).+(last+visited+April+2,+2008).>Google Scholar
National Conference of State Legislatures, “HPV Vaccine,” July 11, 2007, available at <http://www.ncsl.org/programs/health/HPVvaccine.htm> (last visited March 5, 2008).+(last+visited+March+5,+2008).>Google Scholar
Id.Google Scholar
S.B. 1230, 2006 Session, Virginia (2007); H.B. 2035, 2006 Session, Virginia (2007).Google Scholar
HPV Vaccination and Reporting Act of 2007, B.17–0030, 18th Council, District of Columbia (2007).Google Scholar
Governor of the State of Texas, Executive Order RP65, February 2, 2007, available at <http://www.governor.state.tx.us/divisions/press/exorders/rp65> (last visited March 5, 2008).+(last+visited+March+5,+2008).>Google Scholar
S.B. 438, 80th Legislature, Texas (2007); H.B. 1098, 80th Legislature, Texas (2007).Google Scholar
The states are Colorado, Maine, Nevada, New Mexico, New York, North Dakota, Rhode Island, and South Carolina. See National Conference of State Legislatures, supra note 24.Google Scholar
The states are Colorado, Indiana, Iowa, North Carolina, North Dakota, Texas, Utah, and Washington. Id. (National Conference of State Legislatures).Google Scholar
The states are Maryland, Minnesota, and New Mexico. Id. (National Conference of State Legislatures).Google Scholar
Centers for Disease Control and Prevention, RotaShield (Rotavirus) Vaccine and Intussusception, 2004, available at <http://www.cdc.gov/vaccines/vpd-vac/rotavirus/vacrotashield-historical.htm> (last visited March 14, 2008); Rennels, M. B., “The Rotavirus Vaccine Story: A Clinical Investigator's View,” Pediatrics 106, no. 1 (2000): 123–125.CrossRefGoogle Scholar
Mao, C. et al., “Efficacy of Human Papilomavirus-16 Vaccine to Prevent Cervical Intraepithelial Neoplasia: A Randomized Controlled Trial,” Obstetrics and Gynecology 107, no. 1 (2006): 18–27.CrossRefGoogle Scholar
Villa, L. L. et al., “Immunologic Responses Following Administration of a Vaccine Targeting Human Papillomavirus Types 6, 11, 16 and 18,” Vaccine 24, no. 27–28 (2006): 5571–5583; Harper, D. M. et al., “Sustained Efficacy Up to 4.5 Years of a Bivalent L1 Virus-Like Particle Vaccine against Human Papillomavirus Types 16 and 18: Follow Up from a Randomized Controlled Trial,” The Lancet 367, no. 9518 (2006): 1247–1255.Google Scholar
Hodge, J. G. and Gostin, L. O., “School Vaccination Requirements: Historical, Social, and Legal Perspectives,” Kentucky Law Journal 90, no. 4 (2001–2002): 831–890.Google Scholar
Duffy, J., “School Vaccination: The Precursor to School Medical Inspection,” Journal of the History of Medicine and Allied Sciences 33, no. 3 (1978): 344–355.CrossRefGoogle Scholar
See Hodge, and Gostin, , supra note 36.Google Scholar
Id.Google Scholar
Jacobson v. Commonwealth of Massachusetts, 197 U.S. 11 (1905).Google Scholar
Gostin, L. O. and Hodge, J. G., “The Public Health Improvement Process in Alaska: Toward a Model Public Health Law,” Alaska Law Review 17, no. 1 (2000): 77–125.Google Scholar
Zucht v. King, 260 U.S. 174 (1922).Google Scholar
Hinman, A. R. et al., “Childhood Immunization: Laws that Work,” Journal of Law, Medicine & Ethics 30, no. 3 (2002): 122–127; Malone, K. M. and Hinman, A. R., “Vaccination Mandates: The Public Health Imperative and Individual Rights,” in Goodman, R. A. et al., Law in Public Health Practice (New York: Oxford University Press, 2006).Google Scholar
See Centers for Disease Control and Prevention, supra note 6.Google Scholar
Lo, B., “HPV Vaccine and Adolescents’ Sexual Activity: It Would Be a Shame If Unresolved Ethical Dilemmas Hampered This Breakthrough,” BMJ 332, no. 7550 (2006): 1106–1107.Google Scholar
Zimmerman, R. K., “Ethical Analysis of HPV Vaccine Policy Options,” Vaccine 24, no. 22 (2006): 4812–4820.Google Scholar
Stanwyck, C. et al., “Vaccination Coverage Among Children Entering School — United States, 2005–06 School Year,” JAMA 296, no. 21 (2006): 2544–2547.Google Scholar
See Hodge, and Gostin, , supra note 36.Google Scholar
Calandrillo, S. P., “Vanishing Vaccinations: Why Are So Many Americans Opting Out of Vaccinating Their Children?” University of Michigan Journal of Legal Reform 37 (2004): 353–440.Google Scholar
Id.Google Scholar
Hart, B., “My Daughter Won’t Get HPV Vaccine,” Chicago Sun Times, February 25, 2007, at B6.Google Scholar
Cummings, J., “Seventy Percent of U.S. Adults Support Use of the Human Papillomavirus (HPV) Vaccine: Majority of Parents of Girls under 18 Would Want Daughters to Receive It,” Wall Street Journal Online 5, no. 13 (2006), available at <http://www.harrisinteractive.com/news/newsletters/wsjhealthnews/WSJ0nline_HI_Health-CarePoll2006vol5_iss13.pdf> (last visited March 5, 2008).Google Scholar
Marbella, J., “Sense of Rush Infects Plan to Require HPV Shots,” Baltimore Sun, January 30, 2007, available at <http://www.redorbit.com/news/science/819751/the_baltimore_sun_jean_marbella_column_sense_of_rush_infects/index.html> (last visited March 14, 2008).+(last+visited+March+14,+2008).>Google Scholar
Reimer, S., “Readers Worry About HPV Vaccine: Doctors Say It's Safe,” Baltimore Sun, April 3, 2007.Google Scholar
Pollack, A. and Saul, S., “Lobbying for Vaccine to Be Halted,” New York Times, February 21, 2007, available at <http://query.nytimes.com/gst/fullpage.html?sec=health&res=9403E6D6123EF932A15751C0A9619C8B63&n=Top%2FReference%2FTimes%20Topics%2FPeople%2FS%2FSaul%2C%20Stephanie> (last visited March 14, 2008).+(last+visited+March+14,+2008).>Google Scholar
Partridge, J. and Koutsky, L., “Genital Human Papillomavirus in Men,” The Lancet Infectious Diseases 6, no. 1 (2006): 21–31.CrossRefGoogle Scholar
See Markowitz, et al., supra note 18.Google Scholar
Id.Google Scholar
See Partridge, and Koutsky, , supra note 56.Google Scholar
Partridge, J., “Genital Human Papillomavirus Infection in Men: Incidence and Risk Factors in a Cohort of University Students,” Journal of Infectious Diseases 196, no. 15 (2007): 1128–1136. It should be noted that the higher incidence might be due to the increased sensitivity of the HPV-PCR-based testing procedure used in this recent study.CrossRefGoogle Scholar
Id.Google Scholar
Kim, J., “Vaccine Policy Analysis Can Benefit from Natural History Studies of Human Papillomavirus in Men,” Journal of Infectious Diseases 196, no. 8 (2007): 1117–1119.CrossRefGoogle Scholar
See Partridge, and Koutsky, , supra note 56.Google Scholar
Id.Google Scholar
Barnabas, R. V., Laukkanen, P., and Koskela, P., “Epidemiology of HPV 16 and Cervical Cancer in Finland and the Potential Impact of Vaccination: Mathematical Modeling Analysis,” PLoS Medicine 3, no. 5 (2006): 624–632.CrossRefGoogle Scholar
Id.Google Scholar
Hughess, J. P., Garnett, G. P., and Koutsky, L., “The Theoretical Population Level Impace of a Prophylactic Human Papillomavirus Vaccine,” Epidemiology 13, no. 6 (2002): 631–639.CrossRefGoogle Scholar
Elbasha, D., “Model for Assessing Human Papillomavirus Vaccination Strategies,” Emerging Infectious Diseases 13, no. 1 (January 2007): 28–41. Please note that these researchers are employed by Merck, the producer of Gardasil vaccine.CrossRefGoogle Scholar
Wong Wai v. Williamson, 103 F. 1 (N.D. Cal. 1900).Google Scholar
Vacco v. Quill, 521 U.S. 793 (1997); Washington v. Glucksberg, 521 U.S. 702 (1997).Google Scholar
Pollack, A., “Rising Costs Make Doctors Balk at Giving Vaccines,” New York Times, March 24, 2007.Google Scholar
Id.Google Scholar