briefs


Ethics and the HPV Vaccine

1. Objectives
Teachers' Objectives

After completing this module, you should be able to teach
1.) The fundamentals of cervical cancer screening, epidemiology, progression, and treatment
2.) The ethical principles underlying pediatric reproductive decision-making
3.) The public health model that informs mandatory childhood vaccination

Curriculum Integration Ideas

This brief may be used in life science classes during units for topics including:
1.) Human reproduction and sexually transmitted diseases
2.) Human physiology including cancer screening and prevention
3.) Public policy discussions on pediatric vaccinations

2. Cervical Cancer


The cervix is the termination of the uterus that joins the uterus with the vagina. While cervical cancer is the most common gynecologic cancer in women in the world, it is relatively unique in cancer terms in that most cases stem from an infectious cause. Human papillomavirus has many different sub-types, but types 16 and 18 are responsible for 65% of cases of invasive cervical cancer. In the United States, 1 in 135 women have a lifetime risk of developing this cancer. Risk factors include cigarette smoking, lower socioeconomic class, older age, obesity, high risk sexual activity, high number of full-term pregnancies, and African-American race. The greatest risk factor for cervical cancer, however, is the lack of regular screening.

Routine screening for cervical cancer is of paramount importance as most early cancers are asymptomatic. The main screening too is the Papanicolaou (Pap) smear which is usually performed yearly and involves a simple outpatient test. If abnormal Pap smear findings are noted, colposcopy which includes visualizing the cervix under a microscope may be performed as an outpatient. Biopsies can be taken during colposcopy to make a diagnosis.

As in most cancers, accurate staging of the invasiveness of diseases is important to guide prognosis and treatment. Staging requires both imaging (CT and MRI scans) and surgical evaluation of the extent of the cancer and whether it has metastasized to lymph nodes. Treatment involves a combination of surgery, radiation, and chemotherapy depending on the severity of the disease. If cervical cancer is found and treated early, the 5-year survival rate is an impressive 100%. This is why routine Pap smears are so important. If the disease is allowed to progress, the 5-year survival rate drops to 18%.

3. A Closer Look - Childhood Vaccinations

There are many vaccinations recommended in childhood and adolescence by the Centers for Disease Control and Prevention. Most of these vaccinations require series of several injections to achieve sufficient levels of immunity. Some of the vaccinations prevent against infections spread by airborne droplets while others are spread by direct contact. Examples include vaccines against pertussis (whooping cough), chicken pox, and poliovirus.

Many of the CDC-recommended vaccinations are required for school-age children. People with personal beliefs against vaccinations, medical contraindications to vaccine administration, or allergy to a component of the vaccination are exempt from these requirements. A unique class of required childhood vaccination is that against the hepatitis B virus (HBV). HBV is unique in that it is either sexually-transmitted or transferred via blood; therefore, it is not spread by casual contact such as the viruses and bacteria protected against by the other recommended vaccines.

HPV vaccines that protect against types 16 and 18 which cause the majority of cervical cancer were recently released. In fact, vaccination against these two types has shown to decrease the cervical cancer incidence in those vaccinated by 95%. There are two types of vaccines available currently, one that protects against only types 16 and 18 and another that also protects against types 6 and 11 (which cause genital warts). Unlike HBV, HPV can only be spread by sexual contact not through blood transfer. Here is a video clip with more information.




4. What Are Some Of The Ethical Issues?

There is a wide variety of ethical issues that have been raised by the cervical cancer vaccine.

Pediatric Decision-Making

One of the main controversies surrounding the cervical cancer vaccine is the issue of pediatric decision-making. Parents must consent to their daughters receiving the vaccination; often times, the daughters are old enough to assent and may disagree with their parents. As children age, the balance changes from surrogate decision-making by their parents on their behalf to their own ability to make informed decisions. In many states, reproductive care is considered confidential for adolescents and does not require parental consent. Since HPV is sexually-transmitted, questions arise as to whether this may cause children to engage in high-risk sexual activity since there is a perceived protection from some of the ramifications. However, high-risk behavior can lead to a number of other sexually-transmitted diseases, pregnancy, and emotional complications. What do you think? Should the cervical cancer vaccine by mandatory? For what, if any, conditions should parents be allowed to refuse the vaccine for their daughters?

Inequality & Sexually Transmitted Diseases

The first cervical cancer vaccine was released in 2006 and was only FDA approved for girls aged 16-26. Critics, especially the gay/lesbian/bisexual/transsexual populations, were vocal about the fact that the vaccine was not approved for use in males. Males, like females, are susceptible to genital warts from HPV. Anal and oral cancer are also caused by HPV types 16 and 18. In September 2009, the FDA approved the sale of the cervical cancer vaccine to males aged 9-26. The delay in FDA approval was primarily due to insufficient data from clinical trials for the young male population. Should clinical trials be designed to equally treat or protect men and women? Can you think of other examples where men and women are treated unfairly by the design of clinical trials?

Due to the oftentimes personally, politically, and culturally sensitive nature of reproductive diseases, research and treatment is often lacking compared to diseases that are not sexually-transmitted or do not affect the reproductive organs. For example, women are often embarrassed to discuss menopausal symptoms or males, testicular pain. We do not currently have a vaccine to prevent any other cancer, yet the cervical cancer vaccine remains cloaked in debate among politicians, parents, and health policy advisors. If HPV was transmitted to airborne particles and not through sexual activity, do you think the controversy surrounding its mandatory administration would be as pronounced?

5. Review Questions

1. Detail the risk factors for cervical cancer. Which ones are preventable?
2. Discuss the importance of routine screening for cervical cancer.
3. Identify the key ethical issues surrounding the cervical cancer vaccine. Would you recommend the vaccine for yourself (if you are a girl)? How about, in the future, for your daughter? What problems for informed consent are raised by each case?
4. What is the difference between consent and assent?
5. Discuss some other scenarios in which parents make medical decisions for their children. What potential conflicts can you think of when surrogates make decisions?

References

1. Williams Gynecology, 1st ed
2. CDC Child and Adolescent Immunization Schedules
3. University of Pennsylvania, Center for Bioethics, Ethics of Vaccines Project
4. American Academy of Pediatrics, Informed Consent, Parental Permission, and Assent in Pediatric Practice


Multimedia

CalTV's Christina Berke takes a look at Gardasil, the new vaccine said to be an almost perfect solution for HPV, the leading cause of cervical cancer and genital warts.