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COMMENTARY |
a Departments of Bioethics and Obstetrics and Gynecology
b Section of Adolescent Medicine, Department of General Pediatrics, Cleveland Clinic, Cleveland, Ohio
Abbreviations: HPV; human papillomavirus • STI; sexually transmitted infection
The human papillomavirus (HPV) vaccine has the potential to significantly decrease the incidence of diseases caused by HPV, specifically cervical cancer. Approved by the US Food and Drug Administration since late June 2006, this vaccine is currently being marketed for clinical use in girls and women aged 9 to 26 years.1 Effective policies and guidelines about immunization should include consideration of the unique health care needs of adolescents, who represent the majority of this target population. Issues that pertain to adolescents' ability to consent for reproductive health care in an independent fashion and confidential manner already provoke challenging ethical and legal dilemmas. The HPV vaccine is likely to raise similar questions about informed consent and confidentiality, particularly when adolescents request it in addition to other sexually transmitted infection (STI) services that they can access without the consent or knowledge of their parents. The fact that the adolescent who is under 18 years of age can consent for treatment of STIs but not for prevention via this vaccine at the current time remains a subtlety that is lost on many teens, parents, and even health care providers. The answers to questions of adolescents' access to the vaccine will play a significant role in the clinical application of the HPV vaccine and a successful immunization strategy.
Health care providers and policy makers must now address important issues about the integration of the HPV vaccine into clinical practice in a way that maximizes its efficacy through timely patient access and administration. Because HPV is an STI, the goal of a primary immunization strategy is to administer the vaccine before viral exposure at the onset of sexual activity. For this reason, childhood and early adolescence is a prime time to target this type of intervention. Moreover, the best antibody response to this vaccine occurs by 14 years of age. Early administration, before or at the beginning of puberty, may be used by parents and clinicians optimally to help initiate dialogue about prevention of cancer, unwanted physical/sexual contact, and other difficult topics with parents of children and early adolescents. Unfortunately, many currently unvaccinated young people are still within the age range for which the vaccine is Food and Drug Administration approved but well past early adolescence. Current data demonstrate that these adolescents represent a significant and growing segment of the population infected with the HPV virus. Of the 6.2 million men and women infected with the HPV virus in this decade, 4.6 million were adolescents and young adults during the ages of 15 to 24 years.2 Before 18 years of age, parental consent remains mandatory; after 18 years, adolescents and young adults are already entitled to autonomy and privacy with this vaccine. The only barrier to confidentiality potentially lies in nonconfidential billing for this fairly expensive vaccination, which costs $120 per shot for the series of 3.
Adolescence ranges from 10 years of age as the lower limit to 25 years of age as the upper limit.3,4 The teenage years are a unique developmental time during which children transition into adults in terms of their physical bodies, psychological capacities, and social responsibilities.5 This period of development poses a challenge to parents, physicians, and policy makers. The physical changes that take place allow adolescents to take on adult activities, such as intercourse and pregnancy. At the same time, they are still considered to be minors and, as such, are not privy to the same rights and privileges as adults, specifically when it comes to decisions about their own medical care.6
These considerations raise an important question about the practical integration of the vaccine into adolescent health care. Will the HPV vaccine be viewed as a mechanism to preserve reproductive health or as an immunization to prevent a common communicable disease? The distinction has critical implications for adolescents in terms of their ability to access the vaccine while they are underaged. In the first scenario, the HPV vaccine might be viewed as one part of a reproductive health care package to prevent or treat an STI, not dissimilar from the use of a condom or antibiotic. By the current legal system, minors are permitted to consent for their own medical care when it pertains to the treatment of STI.7 Following this logic, adolescents may be permitted seek the vaccine as they would for other reproductive health care needs. In the second scenario, administration of the HPV vaccine would be part of routine medical care in which other standard vaccines are provided. In this case, adolescents would not be able to access the vaccine on their own because, by law, minors are not permitted to consent for their own general medical care.7 Instead, parental authorization would be required, as it is currently for other routine vaccines.
Data demonstrate that adolescents are educated about and interested in vaccines to protect against sexually transmitted diseases.8 It should be anticipated that adolescents will present to physicians for administration of the HPV vaccine, understanding it to be an integral part of preventive reproductive health care. Furthermore, a subset of adolescents may request the vaccine without the direct involvement of their parents, just as many already do for STI treatment or contraceptive management.
There may be several reasons why teenagers may seek the vaccine on their own. First, adolescents may not be vaccinated even when they involve their parents in their health care. Some parents may be conscientious objectors to all vaccines,9 a view not always held by their adolescent children. Others may object to the idea of a vaccine to prevent an STI. Although many parents expect that they would approve of the vaccine for their children, there are some who would decline the vaccine out of concerns that administration will condone and encourage early sexual activity.8,10,11 The data clearly do not support this claim, but myths and misperceptions abound, just as they do for other sexually related topics.12,13 In addition, parents may not perceive that their child is at risk for an STI and recognize the need for protection from HPV.14 In general, the opportunity to vaccinate adolescents remains less consistent and predictable than for younger children, because health care encounters during this time are more sporadic, with not all health plans currently covering routine preventive visits and immunization.15,16 Providers who tend to adopt evidence-based recommendations later may delay advocating for this vaccine until anecdotal evidence from their "early-adopter" peers accrues. Such a delay also contributes to missed opportunities for older adolescents.
Adolescents may take the initiative to be immunized independent from any type of parental involvement. Although adolescents often include their parents in decision-making when it comes to heath care concerns, particularly reproductive issues, this open line of communication is not true of all adolescents and families.17 A subset of this population elects to seek reproductive health care services without the active and direct involvement of their parents.7,18 This reticence displayed by some teens to involve parents in their reproductive health choices can occur for a variety of reasons, including a growing need to take ownership of their own reproductive health.19 Others seek confidential care because of fear of parental disclosure, with the expectation of embarrassment and/or disapproval.19 Data have demonstrated that adolescents are less likely to present for appropriate and timely reproductive preventive care when they are required to formally involve their parents either through mandatory parental notification or consent.20 Furthermore, many adolescents are aware of and concerned about the degree of confidentiality that will be afforded to them by a health care professional when they request STI or contraceptive services.21 Even if adolescents continued to present for care under parental reporting or consent mandates, it has been suggested that they may be disinclined to disclose their sexual habits truthfully or request the necessary reproductive testing, treatment, or prophylactics for fear of the real or perceived repercussions from their parents acquiring this information.22
Regardless of the adolescents' motivation, their requests for vaccination may arise in a variety of clinical settings, including visits to their pediatrician, family physician, or a family-planning clinic, where they may present with a sibling, friend, or partner or by themselves. Such visits present health care providers with an unparalleled window of opportunity to initiate and continue HPV vaccine administration. Lack of parental authorization, whether because the adolescent's mother or father may not be reachable or the adolescent truly seeks confidentiality in immunization, should not overshadow the chance to initiate or continue immunization administration. By the time the adolescent returns for health care (with or without a parent), she may have initiated sexual activity, with the vaccine losing its maximum potential efficacy. By the current model of adolescent health care, physicians would have to forfeit this opportunity to initiate administration of the HPV vaccine until a later time.
The answer to this clinical dilemma may be in extending the existing minor treatment statutes for adolescent reproductive health care to apply to HPV vaccination. Minor treatment statutes give adolescents the ability to consent for testing and treatment of sexually transmitted diseases without the knowledge or involvement of their parents despite the fact that they are still considered minors.23 However, these statutes do not currently allow teens to provide independent authorization for other aspects of their health care such as immunizations and routine medical visits.24 Extending these exceptions to apply to prevention as well as to treatment of STIs would give adolescents the authority to be vaccinated against HPV viral subtypes.
The minor treatment statues were not intended to undermine the importance of parental involvement in adolescents' decision-making or ignore the fact that adolescents look to their parents for guidance and approval.25 Furthermore, they were not intended to dissuade physicians from encouraging their adolescent patients to open a dialogue about reproductive health. Instead, the statutes were developed in response to evidence about adolescents' health-seeking and risk-taking behavior, acknowledging that adolescents' independent access to reproductive health care services currently plays a vital role in maintaining personal and public health.26 These statutes were established in response to the fact that untreated STIs have serious health sequelae for the individual adolescent, such as acute and chronic pelvic pain and infertility.27 Untreated STIs affect public health both in terms of transmission to other members of the population and the impact on national health care resources. The estimated cost for management of pelvic inflammatory disease is $1.06 billion, and cost for its sequelae such as chronic pelvic pain, ectopic pregnancy, and infertility total up to $821 million.28 Precedent has been set by the minor treatment statutes that were established out of concern of untreated STIs on the health of individual adolescent patients and the public. Following this logic, it should not be ethically problematic to extend these minor treatment statutes to adolescents who seek administration of the HPV vaccine without the involvement of their parents. Clinicians, parents, and adolescents can be reminded that this vaccine provides 100% protection against HPV types 16 and 18, which account for 70% of cervical cancer. Thus, this vaccine is not 100% effective but is part of a comprehensive prevention strategy for cervical cancer.
Integration of the hepatitis B vaccination into clinical practice provides insight into some of the practical challenges associated with introducing immunizations for STIs into health care, particularly when it comes to adolescent health. At the current time, minor treatment statutes do not make exceptions for the administration of most vaccines. Written informed consent from the parents is required for the administration of vaccinations administered in childhood years, such as the measles-mumps-rubella and diphtheria-tetanus-acellular pertussis vaccines. Studies have indicated that since the introduction of this vaccine, adolescent patients request the administration of the hepatitis B vaccine without the direct participation of their parents as part of their sexual health care.29 With time, this issue is less prominent, now that the vaccine has become part of the immunization schedule for infants routinely. Although most states require parental consent for the hepatitis B vaccine, a few have extended minor treatment statutes for this vaccine under the condition that it must be provided within the context of a family-planning care setting to underaged adolescents who have missed the primary series.29 This decision was in response, in part, to research that indicated that these young men and women are most likely reflecting their parents' concerns about their health by their decision to be vaccinated against hepatitis B but chose to make reproductive decisions in private.
Experiences with the hepatitis B vaccine are particularly relevant to forming clinical guidelines and health policy about the HPV vaccine. Both of these vaccines represent the transition of health care from treatment to prevention. Currently, there is no long-acting preventive vaccine for common STIs such as chlamydia and gonorrhea. Instead, prevention is vulnerable to the access, use, and compliance with barrier methods for each sexual encounter. Health maintenance strategies for these types of infections are focused on early detection and treatment. In contrast, STI vaccination places emphasis on infection prevention while providing superior protection by removing dependency on user compliance from the equation. The introduction of an HPV vaccine represents one of many innovative ways to prevent disease that will be introduced into the clinical arena in the coming years. As translational clinical research continues to develop innovative therapeutics that preserve reproductive health through prevention strategies, health care providers and policy makers must be prepared to address the challenges associated with adolescent health care.
Effective health policy should identify and prepare for potential barriers that may arise during the integration of innovative medical interventions into clinical care. In the case of the HPV vaccine, health care providers and policy makers should anticipate the challenges associated with addressing the needs of a diverse population of girls and women aged 9 to 26 years. Adolescents under 18 years of age present a specific set of challenges, because they represent a group that can be targeted before the initiation of sexual activity but do not have the authority to vaccinate themselves against the virus. Health policies and guidelines should optimally incorporate knowledge of adolescents' specific health care needs and utilization behaviors, allowing for adolescents' independent access to the HPV vaccine. Given that 99.7% of cervical cancer is HPV related and can occur years after the original infection, often acquired in adolescence or young adulthood, such a policy change would represent an effective public health intervention that could reduce the morbidity and mortality of women of all ages.
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FOOTNOTES |
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Address correspondence to Ellen S. Rome, MD, MPH, Section of Adolescent Medicine, Cleveland Clinic, Lerner College of Medicine at Case, 9500 Euclid Ave, A120, Cleveland, OH 44195. E-mail: romee{at}ccf.org
Financial Disclosure: Dr Rome participates on the Merck Speakers' Bureau. Dr Farrell has indicated she has no financial relationships relevant to this article to disclose.
Opinions expressed in these commentaries are those of the authors and not necessarily those of the American Academy of Pediatrics or its Committees.
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This article has been cited by other articles:
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  S. J. Schaffer, J. Fontanesi, D. Rickert, J. D. Grabenstein, M. C. Rothholz, S. A. Wang, D. Fishbein, and for the Working Group on Complementary Settings How Effectively Can Health Care Settings Beyond the Traditional Medical Home Provide Vaccines to Adolescents? Pediatrics, January 1, 2008; 121(Supplement_1): S35 - S45. [Abstract] [Full Text] [PDF]
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