April 30, 2015
S.2712 (Krueger) / A.1528 (Paulin)
With nearly all sexually active men and women contracting Human Papillomavirus (HPV) at some point in their lives, HPV is the most common sexually transmitted infection (STI)1 in the United States.2 And its consequences can be dire. In fact, some forms of HPV cause cancer, including vaginal cancer, cervical cancer, penile cancer, and anal cancer.3
However, prevention is within reach. Approved by the Food and Drug Administration (FDA) in 2006, the HPV vaccine is now recommended for all young people 9-26.4 While more and more parents are getting their children vaccinated, young people who seek out confidential healthcare are not able to access the vaccine because providers have been told that New York law requires parental consent. This means that many teens remain vulnerable.
S.2712/A.1528 would remedy this problem by clarifying that qualified health care professionals are legally authorized to provide medical care, including vaccines that prevent sexually transmitted diseases to minors who are capable of giving informed consent, without obtaining the consent of a parent or guardian. This critical clarification will increase the rates of young people who are protected against HPV and the risk of cancer. The NYCLU strongly urges lawmakers to pass this legislation.
The Risk of Harm is Grave; but Prevention is Possible and Safe
HPV is the most common sexually transmitted infection: in 2013, the Centers for Disease Control and Prevention (CDC) estimated that 79 million Americans are infected with HPV, 14 million people become newly infected each year and virtually all sexually active people are infected with HPV at some point in their lifetime.5 And some strains of HPV are deadly.
HPV causes almost all cases of cervical cancer worldwide, 85% of all anal cancer cases, and close to half of vaginal, vulvar, and penile cancers.6 In the United States, about 12,900 new cases of invasive cervical cancer will be diagnosed this year and 4,100 women will die from cervical cancer.7 Two HPV strains (16 and 18) in particular are linked to 70% of all cervical cancer cases, and two other strains (6 and 11) are linked to 90% of cases of genital warts.8
Fortunately, HPV can be prevented. There are currently two available HPV vaccines: Merck’s Gardasil and GlaxoSmithKline’s Cervarix. Gardasil protects against four strains of the virus.9 Approved for use in women and men ages 9-26, Gardasil has been proven 100% effective in preventing the strains that cause cervical cancer, and 99% effective in preventing the strains that cause genital warts.10 Cervarix prevents two strains of HPV, 16 and 18.11
And the vaccines have not only proved to be effective, but safe as well. As of 2012, more than 46 million doses of the HPV vaccine have been distributed in the United States.12 The FDA and CDC closely monitor the safety of all vaccines through the Vaccine Adverse Event Reporting System (VAERS).13 Through this system, the FDA and CDC have continually found that the benefits of the HPV vaccine far exceed any risk.14
Indeed, studies of HPV vaccines involving thousands of people in many countries around the world, including the United States, have found that HPV vaccines are safe.15 The mild adverse effects reported in these studies involved fever, dizziness, and nausea, and pain at the site of the vaccination.16
Legislation is Needed to Lift Barriers to Preventive Care
The New York Civil Liberties Union believes that New York State law and policy already provide authority for minors to consent on their own to the provision of medical treatment, such as vaccines, that prevents sexually transmitted infections.17 However, in the past the New York State Department of Health (DOH) has interpreted the law that allows minors to consent to STD medical treatment as excluding preventive treatment, and has advised providers that they lack the authority to administer the HPV vaccine to young people without parental consent.
Because health care providers rely heavily on DOH guidance to inform their practice, we believe that a change in the law is necessary to clarify health care providers’ authority to administer a vaccine without parental consent. Such a change is justified and critical for the following reasons: (1) clarifying the law will facilitate an increase in minors who receive potentially lifesaving treatment; (2) ensuring confidentiality encourages minors to get the treatment they need; and (3) prohibiting providers from administering the vaccine confidentially creates a perverse paradigm where once infected, minors are able to access treatment without parental consent, but they are unable to access care to prevent infection.
Allowing Providers to Administer the Vaccine will Protect More Young People from a Cancer-Causing Virus
Although young people (ages 15-24) represent just 25 percent of the sexually experienced population, they account for almost half (49 percent) of all new HPV cases.18 This means that intervention is particularly important for young people before they are exposed to HPV. Indeed, best medical practice suggests that the vaccine should be offered in the course of regular pediatric visits, or when a provider learns that a young person is about to become or has been sexually active.19
However, because many adolescent health care professionals are deterred from providing the HPV vaccine to adolescents, they miss a critical opportunity to prevent HPV. In an open letter written to the legislature in 2014, health care professionals from across the state urged the legislature to take action by clarifying their legal ability to provide the vaccine.20
These providers see countless adolescents in their practice, and yet, they feel their hands are tied to prevent the spread of HPV and the various forms of cancer it can lead to. Making clear that providers of adolescent health care have the legal authority to provide confidential, preventive STI treatment will increase the incidence of HPV vaccination, which will prevent the spread of a potentially deadly virus among New York’s young people.
Ensuring Confidentiality Encourages Young People to Seek Care
In general, parents are required to be involved in decisions about their child’s health care. However, not all teens have healthy, safe family relationships, and some teens are unable or unwilling to involve their parents, especially when it comes to reproductive and sexual health care.21 Studies show that teens will simply not seek sexual health care services if their confidentiality is compromised or they are required to involve a parent.22
Thus, to encourage young people to get the health care they need, the law allows minors in New York to consent on their own to confidential reproductive and sexual health care, specifically testing and treatment for sexually transmitted diseases.23 Public health experts and professional medical associations strongly support this approach, including the Society for Adolescent Medicine, the American Medical Association, the American Academy of Pediatrics, the American Academy of Family Physicians, and the American Public Health Association.24
Allowing access to preventive STI care without unwarranted constraints is simply good medicine. This legislation appropriately safeguards the confidentiality of information related to preventive care for sexually transmitted infections; this will encourage young people to seek medical care that may save their lives.
Maintaining a False Distinction Between Treatment and Prevention Leads to Perverse Results
DOH has taken the position that the HPV vaccine is not “treatment” for purposes of the statute that allows minors to consent to confidential treatment of STIs. The distinction the Department has made between preventive medical care and medical treatment is a false one that is contrary to the weight of legal authority in this area.25 Although minors may currently access confidential treatment for STIs once infected, the state’s public health policy prevents minors from accessing potentially life-saving preventive care to avoid infection in the first place.
Drawing a distinction between treatment and prevention unnecessarily ties providers’ hands, and contravenes the important public health principles behind our state laws protecting minors’ rights to access reproductive and sexual health care. When a young person seeks confidential reproductive or sexual health care, this presents an opportunity for a health care professional to also provide important preventive sexual health care, including the HPV vaccine.
However, if providers are required to obtain parental consent for vaccines in all cases, they may be forced to decide between breaching confidentiality and missing a critical opportunity for providing preventive care. This legislation will make clear in the law that medical treatment includes preventive treatment related to STIs. This clarification will ensure that minors can receive, as part of routine medical care, preventive care that protects against STIs.
The Legislature Should Not Delay: Pass S.2712/A.1528
S.2712/A.1528 would clarify New York law to ensure that young people can access confidential preventive STI treatment that could save their lives. The bill would make clear that qualified health care practitioners may lawfully provide preventive treatment, including vaccines that prevent STIs, to minors who have the capacity to provide informed consent. HPV is the single leading cause of cervical cancer; young people in New York State deserve access to critical prevention without undue barriers. The NYCLU therefore urges swift passage of the bill.
1 New York Public Health Law uses the term “sexually transmitted disease.” To reflect current medical terminology this memorandum uses the term “sexually transmitted infection (STI)” except where referring specifically to language found in a statute or bill. For purposes of this memorandum, these terms mean the same thing.
2 Centers for Disease Control and Prevention, “Genital HPV Infection - Fact Sheet,” Feb. 23, 2015, available at http://www.cdc.gov/std/hpv/stdfact-hpv.htm.
4 U.S. Food and Drug Administration, “Gardasil,” (last seen March 18, 2015), available at http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm0....
5 Centers for Disease Control and Prevention, “Fact Sheet: Incidence, Prevalence, and Cost of Sexually Transmitted Infections in the United States,” Feb. 2013, available at http://www.cdc.gov/std/stats/sti-estimates-fact-sheet-feb-2013.pdf.
6 National Cancer Institute at the National Institutes of Health, “HPV and Cancer,” March 2012, available at http://www.cancer.gov/cancertopics/factsheet/Risk/HPV.
7 American Cancer Society, “Detailed Guide: Cervical Cancer: What Are the Key Statistics About Cervical Cancer?,” Feb. 2015, available at http://www.cancer.org/cancer/cervicalcancer/detailedguide/cervical-cance....
8 “HPV and Cancer,” supra note 6.
9 United States Food and Drug Administration, “Gardasil Questions and Answers,” March 2014, available at http://www.fda.gov/BiologicsBloodVaccines/Vaccines/QuestionsaboutVaccine... Centers for Disease Control and Prevention, “Vaccine Information Statement for Gardasil,” May 2013, available at www.cdc.gov/vaccines/hcp/vis/vis-statements/hpv-gardasil.pdf; United States Food and Drug Administration, “FDA approves Gardasil 9 for prevention of certain cancers caused by five additional types of HPV,” Dec. 2014, available at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm426485.htm (The FDA has also recently approved Merck’s Gardasil 9 for females ages 9 through 26 and males ages 9 through 15. Gardasil 9 protects against 5 additional HPV types in addition to those covered by the original Gardasil.).
10 Id., “Gardasil Questions and Answers.”
11 Centers for Disease Control and Prevention, “Vaccine Information Statement for Cervarix,” May 2011, available at www.cdc.gov/vaccines/hcp/vis/vis-statements/hpv-cervarix.pdf .
12 Centers for Disease Control and Prevention, “HPV Vaccine Information for Clinicians - Fact Sheet,” July 2012, available at http://www.cdc.gov/std/hpv/stdfact-hpv-vaccine-hcp.htm.
13 See generally, The Vaccine Adverse Event Reporting System, available at http://vaers.hhs.gov/index.
14 Id.; Centers for Disease Control and Prevention, “Information from FDA and CDC on Gardasil and its Safety,” July 2008, available at http://www.cdc.gov/vaccinesafety/Vaccines/HPV/HPVArchived.html; Jay Gee et al., Division of Healthcare Quality and Promotion, Centers for Disease Control and Prevention, “Monitoring the safety of quadrivalent human papillomavirus vaccine: findings from the Vaccine Safety Datalink,” Oct. 2011, available at http://www.ncbi.nlm.nih.gov/pubmed/21907257 (a 38-month Vaccine Safety Datalink study of over 600,000 Gardasil vaccinations found no statistically significant difference in adverse effects from the Gardasil vaccine when compared to other vaccines).
17 See N.Y. Pub. Health Law § 2305(2) (providing that “[a] licensed physician, or in a hospital, a staff physician, may diagnose, treat or prescribe for a person under the age of twenty-one years without the consent or knowledge of the parents or guardian of said person, where such person is infected with a sexually transmissible disease, or has been exposed to infection with a sexually transmissible disease.” Because HPV is a “sexually transmitted disease,” because sexually active minors have been exposed, and because the HPV vaccine is a treatment, physicians should be able to provide it without parental consent under the statute.)
18 “Fact Sheet: Incidence, Prevalence, and Cost of Sexually Transmitted Infections in the United States,” supra note 5.
19 “HPV Vaccine Information for Clinicians - Fact Sheet,” supra note 12.
20 Letter from Adolescent Health Care Providers, to the New York State Legislature, New York Civil Liberties Union (March 1, 2014) (on file with NYCLU).
21 See Stanley Henshaw and Kathryn Kost, “Parental Involvement in Minors’ Abortion Decisions,” 24 Fam. Plan. Persp. 196, 207 (1992).
22 Jonathan Klein et al., “Access to medical care for adolescents: Results from the 1997 Commonwealth Fund Survey of the Health of Adolescent Girls,” 25 J. of Adolescent Health 120 (1999).
23 See N.Y. Pub. Health Law § 2305.
24 See, e.g., American Public Health Association, “Confidentiality Standards Folder: Adolescent Access to Comprehensive, Confidential Reproductive Health Care” (1990); American Academy of Family Physicians, “Policies: Adolescent Health Care: Confidentiality” (2006), available at http://www.aafp.org/about/policies/all/adolescent-confidentiality.html; American Medical Association, “Policy: Confidential Health Services for Adolescents,” available at https://www.ama-assn.org/ssl3/ecomm/PolicyFinderForm.pl?site=www.ama-ass... Council on Ethical and Judicial Affairs, American Medical Association, “Council Report: Mandatory Parental Consent to Abortion,” 269 JAMA 82, 83 (1993); Carol Ford et al., Society for Adolescent Medicine, “Confidential Health Care for Adolescents,” 35 J. Adolescent Health 1 (2007), available at https://www.adolescenthealth.org/SAHM_Main/media/Advocacy/Positions/Aug-... .
25 As courts around the country, including New York, have recognized, when the term has been left undefined by the legislature, the plain meaning of treatment encompasses comprehensive preventive treatment, including vaccine treatments. See, e.g., Kemp by Wright v. State, 687 A.2d 715, 718 (N.J. 1997) (holding that the examination received prior to a rubella vaccine was an examination “for the purpose of treatment”); People, on Complaint of Burke, v. Steinberg, 73 N.Y.S.2d 475, 477 (N.Y. Mag. Ct. 1947) (holding that “vaccination is a treatment given to a human being, even though no disease is present” and the administration of a vaccine is “treatment as well as preventive medicine”). In areas as different as medical malpractice law and family law, vaccines have been recognized as medical treatments for the purposes of actions and court orders in a number of state and federal courts. Titchnell v. U.S., 681 F.2d 165, 170-1 (3d Cir. 1982) (holding that the administration of a flu shot to the plaintiffs fell below the standard of care required for “the treatment of a patient”); Calabrese v. Trenton State College, 392 A.2d 600, 606 (N.J. Super. Ct. App. Div. 1978), aff’d, 413 A.2d 315 (N.J. 1980) (holding that the “administration of a given drug”, here, an anti-rabies vaccine, is a treatment for the purpose of medical malpractice actions); Boyd v. Louisiana Medical Mut. Ins. Co., 593 So. 2d 427, 428-29 (La. Ct. App. 1991) (finding that while Louisiana law requires “physicians…to provide patients with information sufficient to permit the patient to make an informed and intelligent decision on whether to submit to a proposed course of treatment,” the risks associated with receiving a polio vaccine were not adequately material to prevent a reasonable person from consenting to the treatment); Jolynn W. v. Vincent X., 924 N.Y.S.2d 608 (N.Y. App. Div. 2011) (finding that it was in the best interests of child to reside with father who, among other things, “obtained medical treatment” for his daughter, including “bringing her up to date on her vaccinations”); In re Christine M., 595 N.Y.S.2d 606, 613 (N.Y. Fam. Ct. 1992) (considering, among other factors, “the possibility of a cure (or prevention)” and “the risk associated with the recommended treatment” to conclude that the parents’ failure to inoculate their children against measles was deprivation of treatment constituting medical neglect).