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– Overcoming Negative Commentary HPV and Cervical Prevention through Health Literacy and

Tag Words: Gardasil, HPV, , Ceravix, human papillomavirus, genital warts, STD

Authors: Roxana M. Demel, Alanna Murday, Agnieszka Rucki with Julie M. Fagan, Ph.D.

Summary

This Classipedia has been written and illustrated not only to educate youth about HPV, but to also spread awareness about the prevention against HPV related through the use of Gardasil.Part I of the Classipedia discusses the overall research and is subsequently broken down into three parts. We begin by introducing HPV; what HPV is, how it is replicated, how it is transmitted, and symptoms of . We then follow through by going into detail about cancer; the common types associated with HPV, general stages from precancerous conditions to cancerous ones, associated symptoms, and various treatments. We then finally discuss Gardasil by discussing the general importance of health literacy, mechanisms affecting overall health ill prevention, and finally comparing and contrasting Gardasil with . Part II of the Classipedia illustrates our community service project. We each wrote letters to school nurses for twelve schools throughout New Jersey and requested that they incorporate our strategically designed lesson plans into their curriculum. We broke down the objectives of the lesson plan, included an outline of the lesson plan (a 30-40 minute presentation), an educational video, handouts (consisting of a coupon, brochure, and a patient information printout), and an optional worksheet/quiz.Part III and the final part of our Classipedia was our video project. Our general goal was to raise awareness about general statistics associated with HPV and by illustrating how easy can be through the attainment of Gardasil. Questions associated with the interviews are listed. We interviewed students on campus to find out what their general knowledge about Gardasil was. We also interviewed a Doctor of Pharmacy to get a professional opinion and facts associated with Gardasil.

Video Link

Gardasil:Overcoming Negative Commentary:http://www.youtube.com/watch?v=wI4K5W_Pe4Y The Issue: Gardasil

General information about HPV (AR) Many students, no matter what their education level is, have not heard of one of the most common viruses- the human papillomavirus (HPV). The purpose of this Classipedia is to not only educate youth about HPV, but also spread awareness about the prevention against HPV related cancers. We would like to explain what HPV is, how it causes cancer and other , what to do when infection with HPV is suspected, what steps one should take in order to avoid infection and lastly we will discuss the resources available for prevention of cancer development from HPV- namely Gardasil .

A human papillomavirus (HPV) belongs to a bigger group of viruses recognized as . So what are oncoviruses? The prefix onco- originated from ancient greek word “onkos”, meaning tumor. Thus oncoviruses are group of viruses, which are capable of causing cancer. Moreover, HPV is also a retrovirus, which means that the genetic material of this particular virus is present as RNA, in contrast to other viruses, which use DNA as their genetic material. (Walboomers et al., 1999). It is important to mention that preponderance of both human and animal viruses identified to this day do not cause cancer. The ability of certain strains of HPV to cause cancer is still being research by many laboratories world-wide and even though the precise mechanism of action is not yet understood, we will describe in some detail what is believed to happen within a human cell infected with HPV.

Once a person is infected with HPV, the virus uses its “molecular arsenal” of proteins to get inside a cell. If the virus succeeds the into a cell, it than is capable of inserting its RNA into human DNA, which then is a subject for replication. The copies of viral RNA (in form of DNA) are used as a template for translation into proteins and other molecules needed for viral assembly. Once the virus replicates itself, it is able to affect neighboring cells, causing infection, weakening human and setting everything in overdrive. Researchers believe that HPV stops either completely or partially the action of tumor suppressor protein –p53. This inactivation of p53 is supposed to be the reason behind the oncogenisity of HPV, because it switches off the normal pathways in a cell and turns on the “fight” pathways, causing changes that lead to uncontrollable cell growth (Schiffman, 2003).

So far more than 200 different types (strains) of HPV have been identified and studied. However, only about 15 to 20 strains have been classified as oncoviruses. The other types of HPV are known for their ability to cause warts, both genital and on other parts of the body like hands and feet. The table below shows some examples of oncoviruses and the cancers associated with their infection (CDC, 2011).

Virus Associated cancer types Hepatitis viruses, including Liver cancer hepatitis B (HBV) and hepatitis C (HCV) Human T-lymphotropic virus Various types of , including T-cell lukemia (HTLV) Human papillomaviruses (HPV) Cervical, anal, penal cancers are some of the examples. Some HPV viruses have also been associated with cancers of the head, neck and throat. Kaposi’s -associated Kaposi’s sarcoma, and certain herpesvirus Merkel cell polyomavirus Merkel cell Epstein–Barr virus (EBV) Lymphomas

Table 1. Summary of cancer-causing viruses. This data was obtained from the CDC (Center for control and prevention) on February 25th, 2011. NA indicates that no data is available.

Figure 1. Graphical representation of HPV cycle in human host. This figure is not drawn to scale. This life cycle of HPV is simplified, while some details are omitted. This figure can be accessed at pathmicro.med.sc.edu.

If anyone is interested in seeing HPV infected (symptomatic) patients, please access the following links http://www.pathguy.com/fem/f321.jpg , http://w-cancer.com/wp- content/uploads/2010/02/hpv-and-cervical-cancer.jpg

So far we explained what HPV is, how it replicates, and the proposed mechanism associated with cancer. In the next paragraph, we will describe how HPV is transmitted. In most cases HPVs are sexually transmitted. This can happen during sexual intercourse both anal and vaginal. A person can be infected by HPV even when their partner (male or female) shows no symptoms or signs of disease. What is more, HPV has very long latency period, meaning that it can stay inactive for long period of time, resulting in signs of years after being exposed to the virus. Mentioned above are the ways by which HPV associated with cancer can be spread (infection doesn’t necessarily mean cancer). There are other strains of HPV, which can cause warts. Those are the most common ones and they can also be considered STDs. However, in some cases, HPV associated warts can be spread by sharing towels, utensils, even though hand shake (when the virus is active). Most importantly one can contract more than one kind of HPV, in which case the infection can lead to very serious health problems (Sinal, 2005).

By now, you know what HPV is, how it replicates and how it is transmitted. Next, you need to learn what the symptoms of infection with HPV are. What makes this particular virus dangerous is the fact that in majority of cases the infected individual does not demonstrate any signs or symptoms of illness, which can add to the rise of HPV related infections. Moreover, 90% of HPV infections do not require medical attention, because human’s immune system is capable of fighting the viral intruder and the virus is vacant from human body within two years. However, situations when medical attention should be searched for include the presence of abnormal growth in the form of cauliflower (wart), abdominal pain, bleeding from vagina, constant tiredness, weight loss and any other out of the ordinary symptoms. In addition, the strains of HPV responsible for genital and other warts do not cause cancer. The oncogenic HPV strains (high- risk) include: type 31, 16, 45 and 18 (CDC, 2011).

What is important to understand is the fact that if the possibility of HPV infection, especially with the high risk strains is minimized the likelihood of developing HPV associated cancer is close to zero. Moreover, all cervical cancers are HPV related, thus regular screening is highly recommended. The next part of the classipidia will explain in a greater detail the connection of HPV with cancer.

Cancer Prevention (RD) Certain types of genital warts are notorious for increasing a woman’s chance towards acquiring cancer of the cervix and the vulva. These types of warts occur due to certain types of HPV, which are the main causes of cervical cancer. These particular forms of HPV are different from those that are known to cause penile or . However, cervical cancer is not as common in the United States due to the common utilization of Pap smears. Nevertheless, cervical cancer is still the third leading form of cancer afflicting women worldwide.

Cervical cancer is a form of cancer that develops in the cervix. It typically begins gradually as , a precancerous condition. This is easily detected through a Pap smear and is just as easily treatable. This simple fact only serves to augment the importance of why women should receive regular Pap smears. By seeking regular checkups and detecting the early stages of this cancer, women increase their chance of being alive in five years by ninety-two percent. This is only if the cancer has not spread outside the area of the cervix, or if it has only been found to have spread on the inside of the cervix walls. However, by not seeking regular checkups and detecting this crucial early stage, that five-year survival rate steadily declines as the cancer gradually and inevitably spreads to other areas. Most women that are unfortunate enough to get diagnosed with cervical cancer have either not had regular Pap smears in their lives or have not had follow-ups regarding abnormal results.

If precancerous changes are left undetected, they can later potentially develop into cervical cancer and eventually spread to the bladder, intestines, lungs, and even liver. This of course could take years. However, the sooner the stages are discovered, the easier they are to treat. Patients with cervical cancer will be unable to detect the occurrence themselves since problems will not usually arise until the cancer has advanced and spread. In most cases, cervical cancer has no symptoms in its early stages. To check for these conditions, there are unique tests that are needed. However, when symptoms do arise, there are quite a few that could possibly arise. The less advanced forms of cervical cancer may have the following symptoms: · Vaginal discharge that is constant: indications for this can vary from being pale, watery, pink, brown, bloody, or even foul-smelling. · Vaginal bleeding could abnormally arise between periods, after intercourse, or after menopause (a time when women begin to cease receiving their period entirely). · Periods could grow to be heavier and last for a longer time than their natural cycle. Furthermore, more advanced cervical cancer symptoms may include the following; · A depleting desire for food · Loss in weight · An increase in loss of energy · Pain of the pelvic, back, and leg regions · Heavy vaginal bleeding · Leaking of urine or feces from the vagina · Bone fractures

Due to the fact that both precancerous changes of the cervix and cervical cancer cannot be detected with the naked eye, tests and examinations are highly recommended. A Pap smear is one useful tool in screening for both precancer and cancer. If abnormal changes are indeed found, a colposcopy should be conducted. This procedure includes a close examination of the cervix, one that is under close magnification. Pieces of tissue are then removed surgically and then sent to a laboratory for further examination. Other tests may also include Endocervical curettage, ECC for short, in which the opening of the cervix is examined, or Conr biops.

If diagnosed with cervical cancer, the woman’s health care provider will then order more tests to be done in order to determine the progression of the cancer and to see exactly how far it has spread. This process is known as staging. Tests for these could comprise of a CT scan, a Cystooscopy, an MRI, a chest x-ray, or an intravenous pyelogram – IVP.

Honestly, the specific treatment for cervical cancer really depends on quite a few factors; they include which stage the cancer is in, the specific size and shape of the tumor, the age and overall general health of the woman, and level of which she wishes to have children in the future.

In order to cure the early stages of cervical cancer, removing or destroying the targeted precancerous or cancerous tissues is the most effective course of action. Of course, there are various ways in which this can be done without removing the uterus or damaging the cervix. All forms also make sure to enable the woman to still have the ability to have children in the future. The following are four of the available forms of surgery. LEEP, also known as loop electrosurgical excision procedure, uses electricity to remove the abnormal tissue. Cryotherapy freezes the targeted abnormal cells. Laser therapy uses light to burn the targeted abnormal tissue. Finally, hysterectomy removes the uterus only and not the ovaries. However, this final particular procedure is not performed often for cervical cancer that has not spread. It could though be done in women who have experienced repeated LEEP procedures. Two further treatments for the more advanced forms of cervical cancers are also available, however they most likely do not provide the same benefits that less invasive procedures do. The first is radical hysterectomy. This more invasive procedure actually removes the uterus and much of the surrounding tissues which include the internal lymph nodes and the upper part of the vagina. A pelvic exenteration is an even more extreme type of surgery in which all of the organs of the pelvis, including the bladder and rectum, are removed.

Another treatment that could be used to treat cancer that has spread beyond the pelvis or to treat cancer that has returned is , which can either be external or internal. Internal radiation therapy uses a device filled with radioactive material that is placed next to the cancerous cells, inside of the woman’s vagina. When the woman goes home, the device is removed. External radiation therapy employs beams of radiation that are directed from a large machine that is aimed onto the body exactly where the cancer is located. This particular form is similar to an x-ray. Furthermore, another test known as uses drugs to strategically kill off the cancer. Some of these drugs include 5-FU, cisplatin, carboplatin, ifosfamide, paclitaxel, and cyclophosphamide. Many times, radiation and chemotherapy will be employed before and/or after surgery.

There are multiple aspects that may determine the results of cervical cancer. They all depend on the particular forms of cancer, the stage in which it is in, and even the specific age and general physical state that the woman is in.

When complications do arise, they may be due to a number of reasons. First, there are few forms of cervical cancers that do not react well to treatments. Some could possibly reoccur after treatment. Women who aim at having treatments that will save their uterus have a higher risk of having the cancer return. This particular phenomenon is referred to as recurrence. Lastly, surgery and radiation can cause problems with sexual, bowel, and bladder functions (A.D.A.M, Cervical Cancer).

Aside from cervical cancer, there are some forms of HPV that may cause cancer of the anus. There are two types of these cancers which are found in the anus; cancers of the anal canal, which are found above the anal verge, and cancers of the anal margin, which are below the anal verge. Both forms of cancers are treated very differently (A.D.A.M., Genital Warts).

There are many forms of tumors that can form in the anus. Not all of these tumors develop into cancer – some remain benign, or non-cancerous. However, there may also be some growths that begin as benign but eventually develop into cancer over time. This is what has been previously been referred to as pre-cancerous conditions.

In order to get a better understanding for all the varying types of benign or cancerous tumors related to anal cancer, each will be listed from here on.

The first to be discussed are polyps. These are small, bumpy, or mushroom-like growths which develop in the mucosa or just under it. There are several kinds, all of which are benign and all of which vary depending on their cause and location. Inflammatory polyps arise due to inflammation from injury or infection. Lymphoid polyps are caused by an overgrowth of lymph tissue. This is part of the immune system. Small nodules of lymph tissue are normally present under the anal inner lining. Hypertrophied anal papillae, also called fibroepithelial polyps, are growths of connective tissue that are covered by squamous cells. They are simply an enlargement of the normal papillae, which are small folds of mucosa found at the dentate line.

Another form of benign growths is skin tags. These are growths of connective tissue that are covered by squamous cells. Skin tags are often mistaken for hemorrhoids. However, they are not truly hemorrhoids.

Condylomas, more commonly known as warts, are caused by specific strands of HPV. They are growths occurring just outside the anus and in the lower anal canal below the dentate line. People who have previously acquired warts have a higher risk of developing anal cancer in the future.

In rare cases, benign tumors can grow in other tissues of the anus. They include the following: · Adnexal tumors – these growths are usually benign and start in the hair follicles or sweat glands of the skin just outside of the anus. These tumors stay in the perianal skin area and do not grow into the anal region. · Leiomyomas – these develop from smooth muscle cells. · Granular cell tumors – these develop from nerve cells and are composed of cells that contain lots of tiny spots, or granules. · Hemangiomas – they start in the lining of the cells of vessels. · Lipomas – they start from fat cells. · Schwannomas – these develop from cells that cover nerves.

Even though some precancerous changes in the anal mucosa are harmless in their early stages, others are known to later develop into cancer. As previously mentioned, this is known as dysplasia. Dysplasia occurring in the anus is known as both anal intraepithelial neoplasia, or AIN, and as anal squamous intraepithelial lesions, SILs. In relation to how these cells look under the microscope they can be divided into 2 groups, either low-grade or high-grade. The cells in low- grade AIN resemble those of normal cells while the cells in high-grade AIN look much more abnormal. Low-grade AIN often goes away without treatment; it has a low chance of turning into cancer. However, high-grade AIN is less likely to go away without treatment. If left untreated, high-grade AIN may eventually become cancer. It therefore needs to be closely watched. Some cases of high-grade AIN will ultimately need to be treated.

Even though they have not grown into any of the deeper layers of the tissue, some abnormal cells on the surface of the anus could possibly look like cancer cells. This particular phenomenon is known as , CIS, or Bowen's disease. Some doctors view this as the earliest form of anal cancer. On the other hand, others consider it the most advanced type of AIN, which is considered a pre-cancer rather than a true cancer.

As mentioned before, most anal cancers in the United States are squamous cell . These tumors come from the squamous cells that line the anal margin and most of the anal canal. This is one invasive form of anal cancer. Cells of invasive squamous cell carcinomas are distinguished by having already spread beyond the surface to the deeper layers of the lining. Squamous cell carcinomas of the anal margin, or perianal skin, are treated similarly to those of the skin found elsewhere in the body.

Cloacogenic carcinomas, or basaloid or transitional cell carcinomas, are sometimes listed as a subclass of squamous cell cancers. However, they develop in the transitional zone, or the cloaca. These cancers look slightly different under the microscope but behave and are treated the same as other squamous cell carcinomas of the anal canal.

There are a small number of anal cancers known as adenocarcinomas. Most often though, they arise from the rectum and are treated as rectal carcinomas. However, these can also develop in glands located under the anal mucosa that release their secretions into the anal canal, or in the apocrine glands, a form of sweat gland of the perianal skin.

Paget's disease is a type of apocrine gland carcinoma that spreads through the surface layer of the skin. It can affect the skin in any location of the body. However, most often than not it affects the skin around the perianal area, vulva, or breast. Paget’s disease of the bone is a highly different disease and should not be confused with the latter.

Basal cell carcinomas are particular types of that can develop in the perianal skin. These tumors are much more common in areas surrounding the skin that are most exposed to the sun, such as the face and hands, and account for only a small number of anal cancers. They are often treated with surgery to remove the cancer.

Malignant melanoma is a cancer that develops from cells in the skin or anal lining comprised of melanin, the brown pigment. Only a very small percentage, about 1-2%, of anal cancers are melanomas. They are far more common on parts of the body that are exposed to the sun. If melanomas are found at an early stage, that is before they have grown deeply into the skin or spread to the lymph nodes, they can be removed with surgery and the chance that the patient is given a prognosis for long-term survival is very good. However, because they are hard to see, most anal melanomas are found at a later stage. If possible, the entire tumor is removed with surgery. If all of the tumor can be removed, a cure is possible. Even when the melanoma has spread too far to be removed completely, other treatments may be given.

Gastrointestinal stromal tumors are rare anal cancers that are much more commonly found in the stomach or small intestine. When these are found at an early stage, they are removed with surgery. When they have spread beyond the anus, they can be treated with drug therapy.

HPV and Cervical Cancer Prevention (AM) Cancer is the second leading cause of mortality in the United States, with approximately one and a half million cases diagnosed in 2008. Over 500,000 were expected to die in 2008, which makes cancer responsible for about twenty-five percent of deaths in the United States. The American Cancer Society estimated that over sixty percent of those cancer deaths were preventable through improved health education. Recently, cancer has been a large concern with economic implications. Each year, medical bills and loss in productivity from cancer cost over $200 billion in the US alone (Siegel, 2009). Despite the high rates of cancer deaths, cancer is largely preventable through frequent screening, early detection, and treatment. Cervical cancer in particular is almost completely preventable due to screening and early treatment, along with the HPV on the market, like Gardasil and Cervarix. This implies that, although this cancer is preventable, we are not utilizing the proper preventative procedures.

Health literacy is the foundation on which health education and prevention efforts are built. Without health literacy, individuals would not be able to understand information that would be required to make informed health choices. The Health Belief Model has recently been used to help understand the factors behind why individuals choose not to access available preventative healthcare. The Health Belief Model explains the six main factors behind the failure to access preventative healthcare. The first factor is perceived susceptibility, which describes one’s perceived chances of acquiring a specific medical condition. The next factor is perceived severity, which describes one’s perception of how grim a specific medical condition and/or its end results might be. The third factor is perceived benefit, which describes one’s perceived advantage to addressing the medical condition or reducing their risk. The next factor is perceived barriers, which describes one’s opinion of the mental and physical costs it requires to take action against a medical condition. The last two factors of the HBM are self efficacy and cues to action. Cues to action describe the approaches used by lay health workers to help individuals take action against their medical condition. Ultimately, the individuals should eventually have self efficacy, which is the self-assurance one has to perform preventative health measures (Turner, 2004).

Figure 2: Health Belief Model Flowchart http://www.ohprs.ca/hp101/mod4/module4c3.htm Adapted from Nutbeam and Harris, 1998

Each factor of the HBM needs to be specifically targeted for advancement if effective health prevention is to be improved. The first factor could be improved by portraying increased susceptibility by targeting the specific population. Individuals will only make better decisions if they believe the risk is high. The second factor can be affected by elucidating the risks and outcomes associated with common medical conditions. These first two factors should be addressed collectively in order to augment the perceived danger that individuals feel and respond to when seeking preventative healthcare or treatment. Similarly, the next two factors perceived barriers and benefits should be addressed together in order to educate individuals on the overall outcome expectations. Perceived benefits are targeted by identifying the long- and short-term positive outcomes from treatment. Examples of short-term positive outcomes include early detection and increased effectiveness of treatment. Examples of long-term positive outcomes include living and sustaining a manageable, healthful life. However, perceived barriers are much more difficult to change and ultimately affect individuals’ healthcare decisions the most. Individuals will only change their healthcare decisions if the perceived benefits greatly outnumber both the old consequences and new barriers. In order to address these barriers, they must be pinpointed first and then addressed by encouragement, support, and monetary motivation. However, there are many important barriers that deal with anxiety, apprehension, and emotional or physical discomfort. Self-efficacy and cues to action are the last steps in improving health education and preventative healthcare. Increasing information, awareness, and constant reminders will help improve cues to action and ultimately improve how individuals obtain healthcare (Austin, 2002).

There are two types of Human Papillomavirus vaccines produced today, Gardasil and Cervarix. Both of these vaccines are licensed by the FDA and are recommended by the CDC. Gardasil is a four-part vaccine that is produced by Merck. It confers resistance against four strains of Human Papillomaviruses. The vaccine contains HPV viral protein subunits, parts of the virus’s Two strains of HPV, 16 and 18, cause 75% of cervical cancer and two strains, 6 and 11, cause approximately 90% of genital warts. These HPV strains can also cause vulvar, vaginal, anal, and penile cancers. Gardasil is recommended for 9 to 26 year olds, both males and females. Gardasil is also known by its alternative name, Silgard.

Cervarix is the second HPV available. Like Gardasil, it contains HPV viral protein subunits, parts of the virus’s two types of HPV, 16 and 18. However, it is produced and distributed by GlaxoSmithKline and it does not protect against the two Human Papillomavirus strains that cause genital warts. In its clinical trials, Cervarix did have cross-reactivity and protect against HPV strains 31 and 45. Additionally, Cervarix contains AS04, which is a combination of adjuvant additives that boost the immune system. This vaccine is advised for 9 to 26 year old females only.

Both Cervarix and Gardasil require three separate doses via injection, each dose spaced a few months apart. Any doctor’s office, clinic, or hospital should be able to schedule and deliver these vaccine doses. Without any insurance, each dose will cost $125.00. However, New Jersey state health insurances cover most of the costs and require only a $10.00 co-pay for each dose, for a total of $30.00 for cancer prevention.

The Service Project: Letter to School Nurse

To whom it may concern,

We are Rutgers University undergraduate students working on a community service project for our Ethics in Science and Society class. The main goal of the class is to make a difference in our surroundings with science. We as a group chose to increase awareness of the rise in HPV and its linkage to various forms of cancer. We would like to stress the fact that as many may not be aware, some forms of HPV related cancers are 100% preventable. We are writing to you today to request permission to personally (or through the school nurse) educate Junior and/or seniors in your high school by spreading awareness through the use of an easily accessible vaccine – Gardasil.

We would love to give a short 30 minute presentation which would cover general information about HPV, its associated cancers, and most importantly Gardasil; in which we would cover its accessibility, cost, and overall effectiveness.

Thank you for your time and consideration.

Sincerely, Roxana M. Demel Aggie Rucki Alanna Murday

Lesson Plan Instructional Objectives: 1. Cognitive - After participating in this lesson on Gardasil, the students should be able to demonstrate knowledge of the material covered by participating in the HPV activity. 2. Affective - After participating in this Gardasil lesson, the students should be able to understand what HPV virus is, how it’s transmitted, treated and prevented. Moreover, students should have a perceptive of what is cancer and the types of cancers caused by HPV as well as the general information about Gardasil as a type of prevention against cervical cancer. Materials: 1. Lesson Plan a. HPV-description, transmission, how it causes cancer, symptoms, treatment, prevention b. Cancer- description, types, symptoms, treatment, prevention, survival c. Gardasil- description, HPV types, Ceravix, FDA approved pros/benefits, cons/side effects, insurance, coupon/brochure, patient info sheet 2. HPV/Gardasil video ( http://www.youtube.com/watch?v=jHOOnl5tjW0) 3. Gardasil coupon, brochure, and patient information printout (to be handed out at the end of class) 4. Worksheet/Quiz (to be handed out at the end of class)

Procedure: 1. Introduction: o Good morning class. We will begin the class with a quick 5-minute video. This will set up the stage for what we are going to cover in the next 30 to 40 minutes. 2. Content: a. HPV- an overview: - HPV stands for Human Papillomavirus, it is a common virus and about 90% of sexually active people are infected with this virus at some point in their lives, however in most cases the infection is transient and goes away on its own within two years - HPV can infect the skin and mucous membranes, moreover there are more than 100 different types of HPV virus (only about 30 types of HPV are considered to be sexually transmitted) - Different types of HPV infect different parts of the human body, most common are the feet, hands, genitals, throat and eyes b. HPV- transmission: - The types of HPV that cause common warts can be spread through skin to skin contact as well as by sharing infected towels or other objects - The types of HPV that cause genital warts are spread through genital contact as well as other bodily fluids such as sperm, vaginal discharge, saliva - Genital HPV cannot be transmitted through by breathing the same air, touching inanimate objects or hand-shake. - HPV can be transmitted from infected mother to her child during labor, however it is very rare c. HPV – symptoms: - In most cases there people infected with the virus show no symptoms or signs of infection and in 75% of cases the virus goes away on its own within 2 years - Genital warts caused by HPV usually appear as small bumps. Warts can become visible months after contracting the virus. Genital warts do not turn into cancer - It is unknown when and why HPV causes cancer, however only the high-risk types of HPV like type 31, 16, 45 and 18 when remaining active for prolonged period of time can start turning normal cells into cancerous ones d. HPV- treatment and prevention: - Variety of drugs in the form of creams of pills are available for treatment - Warts can be removed surgically - HPV caused cancer can be treated by surgical excision or chemo - HPV can be prevented by practicing safe sex (condoms) and the high risk types of HPV are targeted by Gardasil vaccine e. Cancer- description: - Cancer is a class of diseases in which a group of cells divides and grows uncontrollably. In some cases cancer cells can gain mobility and metastasize or spread to other locations in a body. Only a small percentage of HPV infections turn into cancer. f. Types of cancers caused by HPV: - Most prevalent types of cancers caused by HPV are the cancers of: vulva, cervix, vagina, anus, and penis. Those cancers are caused by the genital- high-risk HPV types - In some cases HPV can lead to throat, head and neck cancers. The HPV types associated with those cancers are 6, 16, and 11. g. Cervical Cancer – symptoms: - Almost all of cervical cancers are caused by HPV and in the early stages of cancer there are no symptoms present - Check with your doctor if you notice any of the symptoms listed below: · Vaginal discharge that is constant: indications for this can vary from being pale, watery, pink, brown, bloody, or even foul- smelling. · Vaginal bleeding could abnormally arise between periods, after intercourse, or after menopause (a time when women begin to cease receiving their period entirely). · Periods could grow to be heavier and last for a longer time than their natural cycle. - If you experience any of the symptoms below, they may be associated with advanced cervical cancer: · A depleting desire for food · Loss in weight · An increase in loss of energy · Pain of the pelvic, back, and leg regions · Heavy vaginal bleeding · Leaking of urine or feces from the vagina · Bone fractures h. Cervical cancer - treatments and mechanisms towards prevention: - Treatment of cervical cancer depend on the stage of cancer, the size and shape of the tumor - Early stage cancer can be removed by surgical excision without damaging the cervix or uterus - Treatment for more advanced cervical cancer may include: · Radical hysterectomy, this more invasive procedure actually removes the uterus and much of the surrounding tissues which include the internal lymph nodes and the upper part of the vagina · Pelvic exenteration is an even furthermore extreme type of surgery in which all of the organs of the pelvis, including the bladder and rectum, are removed. ·Radiation may be used to treat cancer that has spread beyond the pelvis, or cancer that has returned. Radiation therapy can either be external or internal and be applied before or after surgery. · Internal radiation therapy uses a device filled with radioactive material that is placed next to the cancerous cells, inside of the woman’s vagina. When the woman goes home, the device is removed. · External radiation therapy employs beams of radiation that are directed from a large machine that is aimed onto the body exactly where the cancer is located. This particular form is similar to an x-ray. · Chemotherapy, uses drugs to kill strategically kill off the cancer. - Cervical cancer can be prevented by practicing safe sex, getting yearly pap smears (this clearly does not prevent cancer but can help with the detection of early stages), and through the acquisition of Gardasil. i. Gardasil description – Gardasil is a vaccine that protects against four types of Human Papillomavirus. It is also known as Silgard. The vaccine contains HPV viral proteins, which are part of the viral capsid (exterior). It induces an immune response to HPV that allows the body to fight off the virus (if exposed) in order prevent infection. Gardasil HPV strains - It contains proteins from HPV strains 6 and 11 that cause 90% of genital warts and HPV strains 16 and 18 that cause 75% of cervical cancer. These HPV strains can also cause vulvar, vaginal, anal, and penile cancers. j. Ceravix – Ceravix is the second HPV vaccine available. It contains proteins that protect against HPV strains 16 and 18. It does not contain proteins that protect against HPV strains 6 and 11. For this reason, it only protects against cervical cancer and is only recommended for females. k. FDA approved – Both Gardasil and Ceravix have undergone extensive clinical trials and are FDA approved. They both require three separate injections over a period of six months. They are both recommended by the Centers for Disease Control & Prevention for females 9 to 26 years old. Gardasil is also recommended for males 9 to 26 years old. There is a patient information sheet attached at the end. l. Gardasil cost – With no insurance, Gardasil costs $125 per injection, for a total of $375. However, there are coupons available, the one attached is a coupon for $150 off the total price. With New Jersey state insurance (Blue Cross Blue Shield), the co-pay is $10 per injection, for a total of $30. With other insurance companies, the co-pay will vary. m. Cons/Side effects - Side effects include injection site soreness, redness, mild fever (from immune response), and mild fatigue. Another negative of vaccination is the cost without insurance. n. Pros/Benefits – Prevention against HPV caused cervical cancer and genital warts. Possible prevention against HPV caused vaginal, anal, and penile cancers. 3. Closure: o Great job today class. I hope you enjoyed our lesson on HPV and Gardasil. Before you leave for today I would like to ask if you have any questions or comments. (Answer questions). Have a good day ladies and gentlemen.

Gardasil Worksheet NAME: DATE:

Use your books (handout, notes, internet, dictionary) to answer the true/false questions below: 1. Genital warts can turn into cancer 2. Gardasil prevents against all types of HPV infections 3. One can be infected with HPV by breathing the air of an infected person 4. Cervical cancer is caused by HPV in most cases 5. Most HPV infections present no symptoms 6. Receiving only one dose of Gardasil is sufficient for prevention against HPV

Terms Linked to HPV Use your books (handout, notes, internet, dictionary) to define the terms listed below. 1. Cancer 2. Genital warts 3. Cervical cancer 4. Vaccine 5. HPV

Lesson Plan was sent to the following schools:

(RD) Verona High School – Shirley Bush [email protected] Glen Ridge High School – Donna Doria [email protected] Montclair High School – Laura Schwartz [email protected] Belleville High School – Nicole Rusignuolo [email protected]

(AR) Brick Township High School - S. Panini [email protected] (Grades 9 and 10) E. Robinson [email protected] (Grades 11 and 12) Toms River North High School - Lisa Rizzo [email protected] Wall High School- Madonna Clayton - [email protected] Jackson High School - Marites Delfin [email protected]

(AM) Red Bank Regional High School - Gail Canning [email protected] Rumson Fair Haven Regional High School - Linda Nill [email protected] Manasquan High School - C. Bontales [email protected] Shore Regional High School - Trish Smith [email protected]

Appendices

Video Project: Interview Questions Video - interview Pharm.D., questions to ask  What is your medical/training background?  Have you heard of Gardasil or Ceravix?  Do you know how they work to prevent cervical cancer?  What is your personal opinion of them?  Do you think the benefits outweigh the risks?  Would you recommend it to your younger patients?  Would you recommend it to your family members?  Are you aware of any significant benefits or risks associated with either vaccine that you would want the public to know about?  Do you think there are any benefits towards administering the vaccine to anyone outside the targeted age group?  Why is a particular age group targeted? Interview questions for female/male students  Have you heard of Gardasil?  What do you know about it?  What is your personal opinion about it?  Have you gotten it? We believe that we achieved our general goal through completing this Classipedia. We overcame the negative commentary associated with Gardasil by educating the public on the general information linked with this product. We showed that cancer prevention can be as easy as 1, 2, 3 (shots)!

References

A.D.A.M. "Cervical Cancer." PubMed Health. National Center for Biotechnology Information, 28 Dec. 2010. Web. 23 Feb. 2011. . A.D.A.M. "Genital Warts." PubMed Health. National Center for Biotechnology Information, 22 Dec. 2010. Web. 23 Feb. 2011. . Austin, L. T., Ahmad, F., McNally, M.-J., & Stewart, D. E. (2002, May/June). Breast and Cervical Cancer Screening in Hispanic Women: A Literature Review Using the Health Belief Model. Women's Health Issues, 12(3), 122-128. Engelstad, L. P., Stewart, S., Otero-Sabogal, R., Leung, M. S., Davis, P. I., & Pasick, R. J. (2005). The Effectiveness of a Community Outreach Intervention to Improve Follow-up Among Underserved Women at Highest Risk for Cervical Cancer. Preventive , 41, 741-748. "Genital HPV Infection - CDC Fact Sheet". Centers for Disease Control and Prevention (CDC). February 25, 2011. http://www.cdc.gov/std/HPV/STDFact-HPV.htm. Retrieved February 25, 2011. Howe, S. L., Vargas, D. E., Granada, D., & Smith, J. K. (2005). Cervical Cancer Prevention In Remote Rural Nicaragua: A Program Evaluation. Gynecologic , 99, 232-235. Schiffman M, Castle PE (2003). "Human papillomavirus: and public health". Archives of Pathology & Laboratory Medicine 127 (8): 930–4 Sinal SH, Woods CR (2005). "Human papillomavirus infections of the genital and respiratory tracts in young children". Seminars in pediatric infectious diseases 16 (4): 306–16 Stöppler, MD, Melissa Conrad. "Genital Warts (HPV Infection)." EMedicineHealth. Web 23 Feb. 2011. . Turner, L.W., Hunt, S.B., DiBrezzo, R., & Jones, C. (2004). Design and implementation of An osteoporosis prevention program using the health belief model. American Journal of Health Studies, 19(2), 115-121. Reprinted with permission. Walboomers JM, Jacobs MV, Manos MM (1999). "Human papillomavirus is a necessary cause of invasive cervical cancer worldwide". J. Pathol. 189 (1): 12–9. doi:10.1002/(SICI)1096- 9896(199909)189:1<12::AID-PATH431>3.0.CO;2-F "What Is Anal Cancer?" American Cancer Society. 20 Aug. 2010. Web. 23 Feb. 2011. . Editorials

(R. Demel)

Hello! My name is Roxana Demel and I am an undergraduate student at Rutgers University working on a community service project for our Ethics in Science and Society class. The main goal of the class is to make a difference in our surroundings through the use of science. Along with my group, we chose to increase awareness on the rise in HPV and its linkage to various forms of cancer. We strive to stress the fact that as many may not be aware, some forms of HPV related cancers are 100% preventable.

I am writing to you today to request permission to personally educate the public through the publication of my letter. My ultimate goal is to spread awareness through the use of this easily accessible vaccine – Gardasil.

My publication covers general information about HPV, its associated cancers, and most importantly Gardasil; in which I discuss its accessibility, cost, and overall effectiveness. Thank you for your time and consideration. Sincerely, Roxana M. Demel ______

Editorial Written to Women’s Health Magazine The Simple Facts, Often Left Forgotten What would you say if you found out that in 2002, the WHO International Agency for Research on Cancer estimated that 17.8% of human cancers were caused by infection, 11.9% of which are caused by seven different viruses? What would you say if you learned that according to another recent study conducted by the American Cancer Society, 87% of Toronto High School students have never heard of the Human Virus, known as HPV (CDC, 2011)? The truth is, HPV happens to be one of the aforementioned cancer-causing viruses. It functions by altering cells. More specifically, it functions by interfering with the proteins that suppress tumors. This interference causes the infected cells to proceed into a different stage of the cell cycle which ultimately replicates the virus gene.

In most cases, HPV does not cause symptoms to arise. However, some types are known to cause genital warts. Certain types of genital warts are notorious for increasing a woman’s chance towards acquiring cancer of the cervix and the vulva. These types of warts occur due to certain types of HPV, which are the main causes of cervical cancer. These particular forms of HPV are different from those that are known to cause penile or anal cancer. However, cervical cancer is not as common in the United States due to the common utilization of Pap smears. Nevertheless, cervical cancer is still the third leading form of cancer afflicting women worldwide.

Cervical cancer is a form of cancer that develops in the cervix. It typically begins gradually as dysplasia, a precancerous condition. This is easily detected through a Pap smear and is just as easily treatable. This simple fact only serves to augment the importance of why women should receive regular Pap smears. By seeking regular checkups and detecting the early stages of this cancer, women increase their chance of being alive in five years by ninety-two percent. This is only if the cancer has not spread outside the area of the cervix, or if it has only been found to have spread on the inside of the cervix walls. However, by not seeking regular checkups and detecting this crucial early stage, that five-year survival rate steadily declines as the cancer gradually and inevitably spreads to other areas. Most women that are unfortunate enough to get diagnosed with cervical cancer have either not had regular Pap smears in their lives or have not had follow-ups regarding abnormal results.

HPV is also known to cause two other forms of cancers that are commonly found in the anus: cancers of the anal canal, which are found above the anal verge, and cancers of the anal margin, which are below the anal verge. Both forms of cancer are treated very differently. There are many forms of tumors that can develop in the anus. Not all of these will develop into cancer. Some are benign, non-cancerous. However, the same growths that start off as benign may later develop into cancer over time.

If you are considering a step to take in preventing some of these cancer causing infections, there are two vaccines on the market to take into consideration. One is Gardasil, also known as Silgard, and the other is Cervarix. Both of these are licensed by the Food & Drug Administration and recommended by the Centers for Disease Control & Prevention.

Gardasil is a quadrivalent vaccine produced by Merck that specifically helps protect against four types of Human Papilloma viruses. The vaccine contains HPV viral protein subunits, parts of the virus’s. There are two types of HPV, 16 and 18, that cause 75% of cervical cancer and two types, 6 and 11, cause 90% of genital warts. These HPV strains can also cause vulvar, vaginal, anal, and penile cancers. Gardasil is recommended for both males and females between the ages of nine and twenty six. Cervarix is the second infection preventing vaccine available. Like Gardasil, it contains HPV viral protein subunits: 16 and 18. However, it is manufactured by GlaxoSmithKline and does not protect against the two HPV strains that cause genital warts. In its clinical trials, Cervarix did have cross-reactivity and it did not protect against HPV strains 31 and 45. Additionally, Cervarix contains AS04, which is a combination of adjuvant additives that boost the immune system. Unlike Gardasil, this vaccine is only recommended for females between the ages of nine and twenty six.

Both Cervarix and Gardasil require three separate doses via injection; each dose is spaced a few months apart. Any doctor’s office, clinic, or hospital should be able to schedule and deliver these vaccine doses. Without any insurance, each dose will cost $125. However, New Jersey state health insurances covers most of the costs and requires a $10 co-pay for each dose, making for a total of $30 spent towards cancer prevention. It cannot get any easier than 1, 2, 3. ______

(A. Rucki)

To whom it may concern, My name is Agnieszka Rucki and I am a student in Rutgers University. I am writing to you, because I believe that with your help I will be able to educate the public about the potentials of Gardasil vaccine. As you may know this vaccine was approved by FDA for Human Papillomavirus (HPV) infection prevention in young women. However, the world-wide fear and skepticism against any vaccination due to the hypothetical link to autism, added to the lower than expected rate of Gardasil administration. My goal is to explain to the public that cervical cancer is highly (98%) preventable with the vaccine when proper guidelines are followed. Moreover, I believe that educating the public about Gardasil will be the beginning of eradication of cervical cancer. Additionally, I am acting in the best interest of women, and I am in no way connected to the pharmaceutical company manufacturing Gardasil. Sincerely, Agnieszka Rucki

______

Editorial Written to Home News & Tribune (East Brunswick) Why are we still questioning it? Human papillomavirus (HPV) infection is one of the most common sexually transmitted disease all over the world. According to CDC studies all of cervical cancers are associated with HPV exposure. Moreover, certain strains of the virus have also been linked to anal, penis and vaginal cancers. What is more, in majority of cases an individual exposed to HPV develops no symptoms of infection, which adds to the rise of HPV associated diseases world- wide. The risk of developing HPV-associated cancer led to growing interest in cancer prevention and the development of a vaccine against HPV, namely Gardasil. Because the vaccine is fairly new, and people nowadays are very suspicious of using new, “not tested enough” vaccines or other drugs, the number of teenage girls being vaccinated with Gardasil is low. My goal is to convince the public that the fear of getting vaccinated has no basis and that the statistics and science behind the vaccine should change the mind of anyone in doubt.

One of the main reasons teenage girls do not receive Gardasil vaccine is due to lack of perceptive of the implications of HPV infection and its link to cancer. It is important to stress that 100% of cervical cancer is caused by HPV virus, and even though Gardasil works only against four types of the virus (out of 20 known types), those four types are the cause of 70 to 90 % of cervical cancer. Moreover, Gardasil should be administered during early teenage hood (13 years of age or so), because the vaccine itself is not therapeutic and it does not treat cancer, therefore administration of this vaccination during an age when the child is not sexually active (not exposed to HPV), increases protection against cervical cancer by 99% according to CDC.

Another major anxiety against in general, is the hypothetical link of the measles, mumps and rubella (MMR) vaccine to autism. This suspicion led some parents to question whether to vaccinate their children at all. According to CDC and other sources there is not a scientific, nor statistical proof that there in fact is correlation between the two. Moreover, there is enough evidence that because the decline in MMR and other vaccinations, the rate of occurrence of those, vaccine-preventable diseases is on a rise.

To sum up, I just wanted to say that we all tend to be skeptic when it comes to trying out new things, especially new medications or vaccination in this case; however we need to remember that Gardasil vaccination underwent numerous clinical trials. The results of those trials show that cervical cancer can be prevented. And that just as was eradicated years ago due to the development of vaccine against it, we now can try to eradicate or at least diminish the incidence of cervical cancer if we give Gardasil a chance.

(A. Murday)

To whom it may concern, My name is Alanna Murday and I am a student at Rutgers University. I am writing to you because I believe that with your help I will be able to educate the public about the positives of vaccination. My goal is to explain to the public that deadly infectious diseases are a major concern and are completely preventable with vaccination. I believe I am acting in the best interests of parents and children. Sincerely, Alanna Murday ______

Editorial Written to Asbury Park Press You better believe in modern medicine, otherwise you wouldn’t be here I am writing because I still cannot believe that so many people live in our modern society but refuse modern medicine. It should not be considered a modern “perk,” like cell phones and laptops, but a necessity that keeps our society functioning effectively. The very first vaccine was invented over two hundred years ago for one of history’s most vicious diseases, smallpox. This terrible disease was completely wiped off the planet in the mid-1970s thanks to one practice, mass vaccination. I’m sure that there were a few adverse side effects after vaccinating the whole world, but that is bound to happen when millions of people are given a dose of the same thing, even if it is something as innocuous as a glass of milk. If people freaked out every time there was an adverse reaction to the and refused to get vaccinated, we would absolutely have smallpox circulating today. People don’t realize that vaccines were once considered miracle workers; you would get one little shot and be saved from terrible diseases that were often fatal or at least debilitating (like smallpox, polio, and measles). These diseases used to be COMMON, as common as getting the chickenpox when you were a kid (but there’s a vaccine for that now too). Parents used to be worried sick about these diseases their children could catch. Now it seems like parents are worried sick about the vaccines that prevent them! It is only because of vaccines that these diseases are either eradicated or a rarity in industrialized countries. Unlike smallpox, measles and polio were not eradicated, there are very low levels still circulating in the human population, even in the United States. This is why small populations of unvaccinated children in the US and UK have contracted measles and actually died. This is the first time in history in the US where infant/child mortality has increased over time. We are going backwards in public health, and we need to go forward, if not for the sake of society, at least for the sake of our own children. I know that all parents want is to do what is best for their children, but with all the misinformation on the internet it is easy to find what you want to find or simply get confused. The Centers for Disease Control and Prevention (CDC) is largely made up of scientists and has hundreds of vaccine specialists, particularly in pediatrics. They do not make any money from recommending vaccines; they have one goal, to control and prevent disease. They wouldn’t recommend vaccines if they didn’t want their own children vaccinated. Please, trust the experts and not the overreaction stories on the internet.