1. Policy Update on the HPV Vaccine in South Carolina
Heather M. Brandt, PhD, CHES
University of South Carolina
Cancer Prevention and Control Program
Arnold School of Public Health
Department of Health Promotion, Education, and Behavior
Sarah R. Bryant, MPH
University of South Carolina
Arnold School of Public Health
Department of Health Promotion, Education, and Behavior
Annual Meeting of the South Carolina Cancer Alliance • May 11, 2007

2. Session Overview
This session will provide general information about human papillomavirus (HPV) and cervical cancer as well as the impact in SC. Public health policies related to prevention and control of cervical cancer will be discussed, including a look at the proposed HPV vaccine requirement - pros and cons.
Objectives:
By the end of the session, participants will:
Understand what HPV is and its impact on South Carolina.
Understand what can be done to prevent cervical cancer.
Understand how a policy study can be used to determine South Carolina's readiness for mandatory HPV vaccination.
Understand that South Carolina may not ready for mandatory HPV vaccination.

3. Epidemiologic Overview of Cervical Cancer and HPV
The main risk factor for cervical cancer is persistent, oncogenic (or high risk), genital HPV infection. Oncogenic types of HPV are necessary, but not sufficient, causes of cervical cancer (and other types of cancer). Epidemiologists have yet to identify what other factors must be present or under what circumstances one woman with oncogenic HPV develops cervical cancer. Some factors known to have a strong relationship are cigarette smoking and immunosuppression. However, no one has conclusively identified any other necessary causes of cervical cancer.
This is important from a policy perspective

4. Cervical Cancer Worldwide
7th most frequently occurring cancer overall (2002)
2nd most common cancer among women worldwide (2002)
493,000 new cases
3rd most common cause of cancer-related deaths among women worldwide (2002)
274,000 deaths
Much more common in developing world
83% of new cases
Cervical cancer is a tremendous burden to women living in the developing world, which is the driving force behind these staggering statistics demonstrating the distribution of cervical cancer.
The 2002 data are the most currently available. In the next year or so, we anticipate updated statistics for 2003 and possibly 2004.
Source: Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, CA Cancer J Clin Mar-Apr;55(2):

5. Cervical Cancer Worldwide
Estimated Number of New Cancer Cases and Cancer Deaths in 2002
Clear difference between developed and developing world
This bar chart may be a little hard to reach, but it shows an important difference in the number of new cases and deaths of cervical cancer in the developed and developing world. There is a dramatic difference in the number of cervical cancer cases and deaths. It is the most marked difference. For other types of cancer, such as breast, you see a more even picture. For colorectal, there are more new cases and deaths in the developed world.
Source: Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, CA Cancer J Clin Mar-Apr;55(2):

6. Cervical Cancer Worldwide
Age-standardized Incidence and Mortality Rates for Cervical Cancer
Eastern Africa
This chart presents a more specific picture of the problem by specific continental regions. Eastern Africa has the highest rates of incidence and mortality with Western Asia having the lowest. Northern America is also near the bottom. This picture reinforces the burden of disease in developing nations with none or less developed cervical cancer screening programs. These are also potentially the areas in which vaccines for some types of HPV would have the greatest public health impact through reductions in cervical cancer incidence and mortality.
Northern America
Source: Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, CA Cancer J Clin Mar-Apr;55(2):

7. Public Health Problem: Excess Cervical Cancer Mortality
In the United States, in comparison to the rest of the world, our rates of cervical cancer incidence and mortality are relatively low. However, problems persist that challenge us in our efforts to
If a picture can say a 1,000 words, then this map can sum up the problem of cervical cancer. This is the problem in one single map. You may notice the dark pink areas the cover much of the state of South Carolina and many states in the southeastern United States. There are also pockets of dark pink areas in Appalachia, the Lower Rio Grande Valley, and in Native communities in the southwest. The dark pink areas indicate excess cervical cancer mortality – places in the US where deaths of cervical cancer are much higher than they should be as compared to the rest of the nation. In South Carolina, we rank 3rd in the US in new cases and 8th in deaths of cervical cancer.
The introduction of the Pap test in the mid-1900s was a tremendous breakthrough in cervical cancer prevention. Since that time, in the US, we have seen a 75% reduction in deaths due to cervical cancer. The decline in deaths from cervical cancer in the US, as well as the improved survival of women with advanced disease have resulted, according to experts (Dr. Rubin), from widespread application of routine screening with the Pap test, the emergence of gynecologic oncology as a distinct medical subspecialty, and the completion of important clinical trials. This is an amazing improvement. However, not all women have benefited equally. Women of color, women living in rural regions, women with low income levels have seen fewer benefits in the US and around the world. These women continue to die of cervical cancer at much higher rates. This is a problem for which we have some idea of the solution. First, we need to encourage and support women having regular Pap tests. Second, if a woman has an abnormal Pap test, we need to encourage and support her seeking of follow-up care in a timely manner to make sure that the abnormal cells do not become cancerous. In the past year, as you may have heard, a vaccine for some types of HPV has been introduced. This presents another opportunity to prevent cervical cancer. Right now, the vaccine is recommended for females aged These seem like fairly straightforward solutions. However, the problem is more complex when you consider all the other factors that relate to getting a Pap test, getting follow-up care, getting the vaccine… transportation, health care costs, time off work, finding someone to care for children… But, we need to do something about this problem, which is why all of us are here today.
Source: Freeman HP, Wingrove BK. Excess cervical cancer mortality: A marker for low access to health care in poor communities. Rockville, MD: National Cancer Institute, Center to Reduce Cancer Health Disparities; Report: NIH Pub. No

8. Cervical Cancer Disparities in SC
African American women are 1.5 times more likely to be diagnosed with cervical cancer than European American women in SC.
African American women are almost 2.5 times more likely to die from cervical cancer than European American women in SC.
African American women are more likely to report having a Pap test in past three years compared to European American women yet are less likely to obtain timely follow-up care in SC.
Source: Brandt HM, Modayil MV, Hurley D, Pirisi-Creek LA, Johnson MG, Davis J, Mathur SP, Hebert JR. Cervical cancer disparities in South Carolina: An update of early detection, special programs, descriptive epidemiology, and emerging directions. J S C Med Assoc Aug;102(7):

9. HPV: The Basics
Very common and usually harmless sexually transmitted infection
Transmission is skin-to-skin (not through bodily fluids)
~75% of sexually active people will acquire in lifetime
Most common among year olds
Over 100 types of HPV
40 types can infect anogenital region of males and females
HPV is VERY common. In fact, it is estimated that 6 million people in the US will acquire a new genital HPV infection each year and at least 70% of sexually active people will acquire a genital HPV infection during their lives. HPV is the most common virally transmitted infection; however, we do not have good surveillance data because HPV is not a reportable sexually transmitted infection.
HPV infects all different parts of the body. There are many types – over 100 – of HPV. About 40 types can infect the anogenital region of males and females.
Age is also a risk factor; as women get older, more cases of cervical cancer are diagnosed. Additionally, more cases of cervical cancer are found among women of color and women of lower SES.
In the past 20 years, HPV has been identified as the main, etiological risk factor. Other sexually transmitted infections have been implicated, such as herpes and chlamydia. The sexual link has long been suspected since the time that it was discovered that virgins and nuns rarely, if ever, developed cervical cancer. As early as the 16th century, HPV has been identified on mummified remains. Currently, up to 15 types of HPV are classified as oncogenic, or high-risk: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68, 73, 82 (13 HCII)… prevalence of HPV infection detected by circulating antibodies is higher in women than men
And, a key question in the field is.. “What are the other risk factors that contribute to the development of cervical cancer?”
Suspected co-factors include diet, cigarette smoking, and immunosuppression (pregnancy, HIV, other infections or chronic illnesses). I have purposely excluded oral contraceptive use as a co-factor because a recent review by Miller et al (2004) determined that a causal relationship between OC use and cervical cancer was premature. Most research in this area has resulted in the belief that women who use OCs are less likely to use barrier methods, such as condoms, resulting in more HPV infections among OC users. Miller et al’s findings contradict Smith et al’s (2003) findings published in The Lancet, which indicated the relative risk of cervical cancer increases with increasing duration of oral contraceptive use.

10. HPV: The Basics Two categories of genital HPV infection
High-risk or oncogenic (cancer causing)
Cervical dysplasia (“abnormal cells”) and cervical cancer
Other types of cancer: penile, anal, vaginal, vulvar, oral, head and neck…
Low-risk or non-oncogenic (not cancer causing)
Genital warts
The 40 types of HPV that can infect the anogenital region of males and females are broken into two main categories: high-risk and low-risk. High-risk refers to those types that are oncogenic or capable of causing cancerous changes; thus meaning an individual is at higher risk of cancer. Low-risk refers to those types that are non-oncogenic but can cause genital warts and possibly mild changes that mimic pre-cancerous changes but will not lead to cancer; thus meaning an individual is at lower risk of cancer.
The major clinical outcomes of HPV are linked or connected to the types of HPV:
High-risk types cause pre-cancerous changes (e.g., cervical intraepithelial neoplasia) and cervical cancer
Low-risk types cause genital warts

11. HPV: The Basics Prevention: How to STOP getting and/or passing on HPV
Use condoms
Avoid sexual contact
Limit number of sexual partners
Wait until older to have sexual contact
Vaccines (for females)

12. HPV: The Basics Detection: How to find out if you have or had HPV
High-risk HPV types
Females: having a Pap test and then an HPV DNA test
Males: No approved ways to know for sure
Low-risk HPV types
Looking at the genital area of males and females for genital warts that can be seen
No approved methods of detecting high-risk HPV in males… males in US are asymptomatic and there is NO WAY to tell if a man has high-risk HPV
Abrasion of anogenital area and then collect exfoliated cells with moistened swab for review under microscope has shown most promise as a detection method
Visual inspection can be done by an individual and/or by health care provider
“At home” testing – using washcloth soaked in vinegar on genitals to look for presence of HPV

13. Gardasil®: First HPV Vaccine
New vaccine, called Gardasil® (Merck & Co.), for some types of genital HPV infection is available
Females age 9-26
Four types of genital HPV infection
High-risk (oncogenic) types 16, 18
Present in ~70% of cervical cancer cases
Low-risk (non-oncogenic) types 6, 11
Cause ~90% of genital warts cases

14. Gardasil®: First HPV Vaccine
Preventive vaccine
Ideally given before sexually active
No evidence of harm if given to female who already has HPV
Vaccines will not replace cervical cancer screening (but will likely change it in the future)

15. Gardasil®: First HPV Vaccine
Virus-like particles – “copycat” or “look like” HPV types
Three doses (0, 2, 6 months)
How long the vaccine lasts is unknown
Studies will continue
Cost is about $120 per dose (~$360 total for three doses)
Public assistance programs
Private insurance

16. Gardasil®: First HPV Vaccine
100% effective in short term, cervical cancer and genital warts outcomes caused by four HPV types (6, 11, 16, 18) included in the vaccine
Very safe as demonstrated in studies thus far
Most common side effect is pain and soreness at injection site and mild fever in some women
Protects against:
Cervical cancer
Precancerous cervical lesions
Precancerous vaginal lesions
Precancerous vulvar lesions
Genital warts

17. Analyzing Policy Opportunities for Mandatory HPV Vaccination in South Carolina
Sarah R. Bryant, MPH
USC Arnold School of Public Health
Practicum for degree in Health Promotion, Education, and Behavior

18. Background Availability of an innovation, i.e. HPV vaccine
Mandatory HPV Vaccination Policy
South Carolina’s House Bill 3136
7th grade girls; school year
Stay tuned for update!
Michigan’s Senate Bill 132
6th grade girls; school year
not passed
Texas’s Governor’s Executive Order
still stands
I’m very interested in reproductive health policy, so I wanted to do something in that area for my Practicum. It just so happened that last Fall, when I was trying to finalize what I would do, I learned that a Bill had been prefiled in the South Carolina House of Representatives. The Bill would be introduced to the House in the next Session, which happened to be this January. House Bill 3136 said that all incoming 7th grader girls would have to be vaccinated for hpv before they could start school in the school year.
So, I quickly met with my professors to figure out a way to learn about what Bill 3136 would mean for South Carolinians, as controversy over mandating hpv vaccination was spreading across the country like wildfire, as other states were considering similar legislation, such as Michigan.
Michigan was the first state to try to mandate hpv vaccination. Senate Bill 132 stated that incoming 6th grade girls have the HPV vaccine before the 2008 school year. But, the Bill did not pass, so no mandate occurred.
Texas’s Governor bypassed the State’s legislature altogether by issuing an Executive Order that would have a similar mandate to that of Michigan’s, in that 6th grade girls would have to be vaccinated by the 2008 school year. The Order still stands, as it hasn’t been revoked yet.

19. Purpose
This study was conducted to determine South Carolina’s readiness for a mandatory HPV vaccination policy.
So, as part of my practicum, I conducted this study was done to try to determine if South Carolina is ready for such a policy to mandate the HPV vaccine.

20. Research Questions
How much do policymakers and stakeholders know about HPV, cervical cancer, and HPV vaccines?
What do policymakers and stakeholders think about mandating the HPV vaccine?
What are the perceptions of South Carolinians’ opinions about the possible mandate according to policymakers and stakeholders?
Since I would be using formative research methods rather than conducting a quantitative study, I did not have hypotheses, but I had research questions to guide my work.
The specific research questions for the study were:
How much do policymakers and stakeholders know about HPV, cervical cancer, and HPV vaccines?
What do policymakers and stakeholders think about mandating the HPV vaccine?
What are the perceptions of South Carolinians’ opinions about the possible mandate according to policymakers and stakeholders?

21. Methods Study population South Carolina Legislators (Representatives)
Physicians
Researchers
DHEC Officials
Lobbyist
To answer the research questions and achieve the purpose of the study, I decided that I needed to talk to 4 kinds of people: legislators, doctors, and researchers. I picked these 4 groups of people because they’re the ones who would made such a big decision as mandating that people get the hpv vaccine- they’re the policy-makers and stakeholders. I was also able to interview a lobbyist, too.
Because the Bill that I wanted to look at, 3136, was a House Bill, I only interviewed Representatives. I didn’t feel like I had enough time to interview enough Senators also. I also wanted to focus on Representatives because they would be the ones to have to deal with most of the issues related to the HPV vaccine.
I wanted to talk to physicians and researchers also, because they’re the ones who administer the vaccine, and have done research on its safety and effectiveness. Some of the researchers included have conducted HPV and cervical cancer research in South Carolina and had a good understanding of the social and behavioral aspects of the issue.
I also wanted to talk with some Department of Health and Environmental Control, or State Health Department, officials because they also have the power to make vaccinations mandatory.

22. Methods Data Collection semi-structured interview guide
knowledge of HPV, cervical cancer, and an HPV vaccine
opinions about mandatory HPV vaccination
perceived barriers to getting an HPV vaccine
the public’s perception of an HPV vaccine
To answer my questions, I decided that I needed to talk to the policymakers one-on-one to get their opinions.
The semi-structured interview guide addressed knowledge of HPV, cervical cancer, and an HPV vaccine; opinions about mandatory HPV vaccination; perceived barriers to getting an HPV vaccine; and the public’s perception of an HPV vaccine.

23. Methods Data Collection Data Analysis and Interpretation
in-person, telephone, , or fax interviews at about 20 minutes each
recorded field notes and paraphrased responses
Data Analysis and Interpretation
Constant Comparison Method
responses grouped by theme
Also analyzed by another person
I conducted in-person or telephone interviews based on the preference of the interviewee. Two of the interviews were done by , and one by fax, as no specific meeting time could be set with three of the interviewees. Each interview lasted about 20 minutes, and I took notes from each interview, paraphrasing the interviewees’ responses to the questions.

24. Results 17 Interviews Conducted Format Sample Description 4 in-person
10 telephone 2
1 fax
Sample Description
7 Legislators
3 Physicians
4 Researchers
2 DHEC Officials
1 Lobbyist
I ended up doing 17 interviews, which is different from what I submitted for this competition. At the time I submitted my Abstract, I was planning on getting more interviews completed, but the people I was interviewing are very busy, and extremely hard to track down, even for a 20 minute interview. I have copies of a revised Abstract here, for anyone who would like a copy.
I did 4 of the interviews in-person, and 10 over the phone, 2 were completed through , and 1 was done by fax.
Of the 17 people I interviewed, 7 were legislators,3 were physicians,4 were researchers,2 were from the health department, and 1 was a lobbyist.

25. Results Major Themes Limited knowledge Variable attitudes
mixed knowledge about HPV, cervical cancer, and an HPV vaccine among participants
Variable attitudes
mixed attitudes about an HPV vaccination mandate
After I went through the interview responses many times, the overarching themes that became apparent were:
Mixed levels of knowledge about hpv, cervical cancer, and an HPV vaccine;
Mixed attitudes about a legislative hpv vaccination mandate,

26. Results Barriers to HPV vaccination Perception of the onus of cost
the vaccine’s cost
lack of information about the vaccine
parental acceptance of the vaccine
Perception of the onus of cost
both private insurance and the government should pay for an HPV vaccine, regardless of mandatory status
Both private insurance and government dollars should pay for the vaccine, regardless of whether or not it’s mandatory; and
A general agreement that the vaccine’s cost,
a lack of information about the vaccine,
and parental acceptance of it are some individual-level and community-level barriers to getting vaccinated.

27. Results Public perceptions
public has mixed views about HPV, cervical cancer, and an HPV vaccine, if they know about it
if mandated, most of the public will get vaccinated, regardless of how much they know about the vaccine
I also noticed that the interviewees agreed that the public has mixed views about hpv, cervical cancer, or a vaccine, if they know about it at all;
and that they think most of the public will just go get vaccinated, regardless of how much they know about it, if a mandate was put into effect.
I know this sounds somewhat confusing, but in the interviews, respondents would say that the public doesn’t know much about HPV. Then later in the interview, when asked what the public would do if a mandate was put into effect, some participants said that most people would go get vaccinated just because they had too. The public may not be perceived as knowing much about it, but that they’ll just go get it anyway.

28. Results Facilitating factors of mandatory HPV vaccination policy
high level of vaccination if required
95% vaccination rate
increased availability of funding
could reduce gaps in who has access to the vaccine
could result in greater public health impact by reducing numbers of cases and deaths from cervical cancer
I also noticed that HPV vaccination policy, in South Carolina anyway, could be driven by four main factors: the high level of vaccination a community gets if it’s required,
how the vaccine would be funded,
how safe and how well the vaccine works,
and what the public thinks about it.

29. Public Views of HB 3136
Ancillary examination of public opinion throughout project period exuded some study results
WLTX.com Posts
In general, demonstrated a lack of education about HPV, cervical cancer, and HPV vaccine
“I've been doing my own research and there are 21 different strains of HPV, this shot only protects against 5.”
“This is just another way to make money for the drug manufacturing companies.”

30. Public Views of HB 3136 Published public comments
“If it is sexually transmitted, then what about the boys?”
“Why would we want our children to be the drug companies guinna [sic] pigs?”
“Boys are getting this HPV from girls who do not know that they are affected and passing it on to another girl. (Engaging in SEX)”

31. Public Views of HB 3136 Published public comments
“The lawmakers, politicians, and lobbyists who support this bill should have a vasectomy and/or their tubes tied.”
“Parents should have to apply for a license to have kids.”

32. Public Views of HB 3136 Published public comments
“The state and gov't needs to look into the families that just keep having babies and living off the welfare system, why not mandate that they get their tubes tied or a vasecotomy [sic] after the 4th or 5th kid?”
“Sign my child up and let me not worry about talking to her about sex and STD’s.”

33. Public Views of HB 3136 Published public comments
“Nanny state politics.”
“Stop the madness!!! Stay out of my life.”
“Do we live in a communist country?”
“So by 2009 it will be mandatory, I guess I will be home schooling my children.”

34. Mandatory HPV Vaccination now?
March 21, 2007
Passed Subcommittee
Health and Environmental Affairs (3)
April 12, 2007
Passed full Committee
3M: Medical, Military, Public and Municipal Affairs Committee (18)
April 18, 2007
Bill tabled (by Rep. Brady)

35. Mandatory HPV Vaccination in the future?
2 ways vaccine could be funded
Unfunded mandate (Medicaid)
Funded mandate (DHEC)
2008 fiscal year
Not in DHEC budget
2009 fiscal year
Wait and see
DHEC will mandate in 2009

36. Conclusions Mandate Premature Vaccine perceived as too new
not enough data to show safety and efficacy
Parental right interference
should be parents’ choice
Lack of public knowledge
So based on this study, I found that it’s too early for a mandate in South Carolina, according to the people who would make an hpv vaccine mandate happen.
The main reasons given were that the vaccine’s too new,
A mandate interferes with parental rights, and that
The public doesn’t know enough about HPV, cervical cancer, or an HPV vaccine yet.

37. Conclusions
Variation in knowledge levels of HPV, cervical cancer, and an HPV vaccine
Legislators as compared to Physicians, Researchers, and DHEC Officials
Generally, legislators knew much less about hpv, cervical cancer, and Gardasil than the physicians, researchers, and Health Department folks, which I expected. The legislators only have enough time while they’re in session to know a little about everything, while the others can spend most of their time on a few things.
Also, the public is perceived to have a low level of knowledge about HPV, cervical cancer, and Gardasil.

38. Conclusions Variation in opinions about mandatory HPV vaccination
government’s right versus for the greater good
Consensus that young females should be vaccinated, regardless of mandate
Also, I noticed that there were large variations in opinions about mandating the vaccine; whether the government has the right to do so, or if it’s for the greater good.
However, there was a basic consensus that young females should be vaccinated, regardless of whether a mandate is put into effect or not.

39. Recommendations Public health education
HPV, cervical cancer, HPV vaccine
SC Cancer Disparities Community Network
efforts to provide educational materials and programs to address gaps in knowledge
Connect public health researchers with policy efforts
Based on what I found in doing this study, there are two things that need to happen:
The public needs health education about HPV, and how the vaccine can reduce cases and deaths of cervical cancer.
The South Carolina Cancer Disparities Community Network is currently working on HPV-related education in African-American women.
Also, Public Health researchers need to be connected with policy efforts, so that policymakers can make the best health decisions for our state.

40. Lessons Learned Legislative process has many layers
Few legislators make decisions for many people
Timing of policy is key
Opportunities for coordinated public health education and advocacy
Public health education must come before legislation
Physicians and researchers may lack knowledge about the legislative process

41. Cervical Cancer Prevention and Control Policy Success & Opportunities in South Carolina

42. Policy Across the U.S.

43. Policy Success in SC Best Chance Network
National Breast and Cervical Cancer Early Detection Program
Breast and Cervical Cancer Treatment Act
Expand Medicaid coverage to provide treatment to all uninsured/underinsured women in South Carolina

44. Policy Opportunities in SC
HPV vaccines
Mandate?
Funding for DHEC?
Follow-up care of abnormal Pap tests (i.e. cervical dysplasia)
HPV DNA testing?
Colposcopy?
Repeat Pap testing?
Treatment of cervical dysplasia?

45. Next steps… For what policy change can we (SCCA) advocate to eradicate cervical cancer among women in South Carolina?

46. Educational Resources
HPV educational materials and messages for women (partially informed by results of SC study)
Go to:
HPV educational materials and messages for health care providers (partially informed by results of SC study)
Go to:
Dr. Sharpe and I were asked by the CDC to provide feedback on the educational materials.

47. Educational Resources
American Cancer Society
1-800-ACS-2345 ( )
National Cancer Institute (NCI) Cancer Information Service
CANCER ( )
NCI Understanding Cancer Series: HPV Vaccine
Go to:

48. Contact Information
Heather M. Brandt, PhD, CHES
University of South Carolina
Cancer Prevention & Control Program
2221 Devine Street, Suite 200
Columbia, South Carolina 29208
Tel:
Complete list of scientific references are available upon request.