Public Health Feature - November 2009
Tex Med. 2009;105(11):47-52.
By Crystal Conde
Cervical cancer can devastate the lives of women afflicted with the disease. Early detection and prevention are vital in the fight against cervical cancer, yet many women don't receive necessary screenings or fail to receive a Pap test on a regular basis. Now, physicians have an additional preventive tool in the fight against cervical cancer: the quadrivalent human papillomavirus (HPV) vaccine Gardasil.
A Texas Medical Association Web-based survey of Texas physicians who provide direct patient care in family medicine, pediatrics, obstetrics and gynecology, and internal medicine indicates that, despite the preventive benefits of the HPV vaccine, physicians in the state are slow to recommend it consistently to their 11- and 12-year-old female patients.
In 2005, 11,999 women in the United States were diagnosed with cervical cancer, and 3,924 died from the disease, according to the U.S. Centers for Disease Control and Prevention (CDC).
To reduce the incidence of HPV-associated disease, the U.S. Food and Drug Administration (FDA) in 2006 approved Gardasil for girls and women aged 9 to 26 years. The vaccine protects against four strains of HPV most commonly associated with causing many, but not all, cases of cervical cancer and genital warts. CDC added the HPV vaccine to its routine childhood vaccination schedule in 2007.
In 2008, TMA's Physician Oncology Education Program (POEP) conducted a survey, in part, to examine physicians' recommendations of the HPV vaccine for 11- and 12-year-old girls. Of the 7,815 physicians who received the e-mail survey invitation, 1,122 completed the survey.
Findings published in the August issue [ PDF ] of Cancer Epidemiology, Biomarkers & Prevention , the journal of the American Association for Cancer Research, reveal that fewer than half of survey respondents follow recommendations for universal HPV vaccination of 11- and 12-year-old girls. Specifically, 48.5 percent of respondents indicated they always recommend the HPV vaccine to girls in that age group. CDC's Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination of girls in this age group with three doses of HPV vaccine. According to ACIP, the vaccination series can begin in girls as young as 9 years.
The study also explored physicians' intentions to recommend the HPV vaccine to 11- and 12-year-old boys and physicians' attitudes about mandated HPV vaccination for 11- and 12-year-old girls.
POEP Chair Lewis Foxhall, MD, associate professor of clinical cancer prevention at The University of Texas M.D. Anderson Cancer Center, says physicians should take advantage of every opportunity to screen women for cervical cancer and talk to their young female patients about the value of the HPV vaccine.
"The thing to remember is that no one should die in this country from cervical cancer. We have wonderful screening and early detection tools. Now we have an opportunity for primary prevention through the vaccine," Dr. Foxhall said.
Dr. Foxhall also stresses the importance of continuing to perform Pap tests and necessary screenings. According to CDC, six of 10 cervical cancers occur in women who've either never received a Pap test or haven't been tested in the past five years.
The results of the POEP survey send a message to physicians that they should do their HPV vaccine homework before deciding to recommend vaccination, according to Salvatore J. LoCoco, MD, a coauthor of the study and chair of TMA's Committee on Cancer. Dr. LoCoco practiced gynecologic oncology in Texas but now works in the Department of Obstetrics and Gynecology at the University of Illinois College of Medicine at Peoria.
"The benefit of having done the survey is it pointed out a big knowledge deficit in the practicing medical community. POEP has remedied that knowledge gap and has propelled a lot of physicians to ensure patients get the vaccine," he said.
POEP is educating Texas physicians about the HPV vaccine through the Guidelines on HPV Vaccination pocket guide and the program's Speakers' Bureau. (See " POEP Resources Help Physicians Prevent Cancer .")
Possible factors affecting physicians' recommendations for the HPV vaccine may include a physician's experience of witnessing the consequences of cervical cancer in patients and his or her commitment to using vaccines, according to Jane C. Rider, MD, a San Angelo pediatrician and member of TMA's Committee on Child and Adolescent Health.
"Physicians, such as pediatricians, who immunize frequently, are going to be more likely to give a vaccine, including one for HPV prevention," Dr. Rider said. "Obstetrician-gynecologists and other practitioners who deal with cancer of the cervix and see what it does to the lives of women would be likely to give the vaccine, too."
Susan L. Rosenthal, PhD, vice-chair of pediatrics at Columbia University and a study coauthor, says that overall "physicians are very positive about recommending this vaccine to adolescent girls. In general, with all new vaccines … there's a slow uptake of physicians and parents as doctors integrate the vaccine into practice and as parents become more knowledgeable about it. This vaccine is no different than previous vaccines in that it takes physicians a while to get it into the routine of clinical practice," said Dr. Rosenthal, a former professor of pediatrics at The University of Texas Medical Branch at Galveston.
In her pediatric practice, Dr. Rider says, parents' primary concern about the HPV vaccine is that it will encourage girls to become sexually active. The second-most-common concern she hears has to do with the vaccine's side effects.
The POEP survey asked physicians to report the most common barriers to HPV vaccination. The No. 1 barrier reported by 69.2 percent of respondents was parental refusal to vaccinate because of vaccine safety concerns.
Safety concerns had been heightened among patients and health care professionals when an Aug. 19 article coauthored by the FDA and CDC and published in the Journal of the American Medical Association ( JAMA ) reviewed safety data for Gardasil for select adverse events reported to the Vaccine Adverse Event Reporting System from June 2006 to December 2008.
A joint statement by the FDA and CDC said adverse events included local injection site reactions, syncope, dizziness and nausea, headaches, hypersensitivity reactions, pancreatitis, autoimmune disorders, pregnancy, and deaths.
Among the study findings published in JAMA , researchers stated that the vaccine didn't appear to be the cause of unusual side effects. The article noted that 32 deaths had been reported following vaccination with Gardasil. The FDA and CDC stated: "In the majority of cases with available autopsy, death certificate and medical records, the cause of death was explained by factors other than the vaccine." The organizations also concluded that "Gardasil continues to be safe and effective, and its benefits continue to outweigh its risks."
Nevertheless, parents have questions about the HPV vaccine's safety. Dr. Rosenthal realizes physicians who vaccinate devote a lot of time to educating parents and patients about vaccine safety.
"Physicians need to listen to patients' safety concerns, provide accurate information, and respond in a respectful manner. They have a responsibility as community leaders not to let the media misrepresent vaccine safety information. The data show that the HPV vaccine is safe," she said.
Dr. LoCoco agrees the vaccine is safe and adds the most common side effects of the HPV vaccine are skin reactions and allergic reactions.
If parents are open to considering the HPV vaccine for their children, Dr. Rider says she takes time to discuss side effects with them and to inform them of the vaccine's benefits.
While the report shows 48.5 percent of respondents always recommend the HPV vaccine to 11- and 12-year-old girls, survey results brought to light that physicians reported the highest HPV vaccine recommendation rate - 64.4 percent - among 13- to 17-year-old girls. (See " Physician HPV Vaccine Recommendations to Girls by Age Group .")
Dr. Foxhall attributes this difference in recommendation rates to parents' attitudes regarding their young children's initiation of sexual activity. He says parents need to realize the longer they wait to immunize their daughters against HPV, the greater the risk of exposure to the disease.
"It's a more difficult discussion physicians have to have with parents of younger children. When children get older, concerns about sexual activity are heightened. At that point, I think parents are more open to talking about the HPV vaccine," Dr. Foxhall said.
Among her patients, Dr. Rider says parents of older girls are more amenable to considering the vaccine.
"Parents realize that as girls age they're going to be sexually active eventually," she said.
Dr. Rosenthal notes that while it's difficult for physicians to determine when an individual child will begin having sex, physicians must strive to vaccinate young female patients before the onset of sexual activity.
"While few 13-year-olds have initiated having sex, a small minority have. They're your high-risk children," she said. "If you're going to protect every child, physicians have to give the vaccine before the population starts having sex."
The survey questioned physicians about their intentions to recommend the HPV vaccine to boys. HPV infection in men can cause anal, penal, and oropharyngeal cancers, and the virus in men contributes largely to infection and subsequent cervical cancer in women.
Most respondents indicated they would recommend the vaccine to boys in the future, should it be approved for use in that population. Specifically, 68 percent of respondents reported they were extremely or somewhat likely to recommend the HPV vaccine to 11- and 12-year-old boys. Eighty-two percent would recommend the vaccine to 13- to 17-year-old boys.
Researchers are currently looking at use of the HPV vaccine in boys. Colleagues with the Male Quadrivalent HPV Vaccine Efficacy Trial Study Group, sponsored by Merck, presented findings at the 25th International Papillomavirus Congress in May.
At seven months, researchers reported 97 percent to 99 percent of vaccine recipients had developed antibodies to HPV types 6, 11, 16, and/or 18. Researchers also noted that the vaccine's efficacy against any external genital lesions due to the four types was 90.4 percent; against anal-genital warts, 89.4 percent; and against intraepithelial neoplasia, 100 percent.
In September, an FDA advisory committee voted to recommend approval of the vaccine Gardasil for males aged 9 to 26 to prevent genital warts. The FDA must consider the committee's recommendation in determining whether to approve Gardasil to prevent genital warts in boys and young men. If approved, the vaccine would be recommended to thwart genital warts in boys, not to prevent anal, penal, and oropharyngeal cancers in men or to curtail HPV transmission from men to women.
Research findings and the FDA's vote are promising for future use of the HPV vaccine in boys in the United States. Dr. LoCoco says, however, women should be the priority group to receive the HPV vaccine.
"In terms of cost-effectiveness, with a finite amount of resources available, because we don't see penile cancers and HPV-related lesions in men at the rate we do in women, it's more cost-effective to concentrate efforts on women now. We need to put efforts into vaccinating women first," he said.
In addition to examining physicians' attitudes about vaccinating boys against HPV, the POEP study asked survey participants about their views on mandating the HPV vaccine for school enrollment for 11- and 12-year-old girls in Texas.
In 2007, Gov. Rick Perry issued an executive order to mandate the HPV vaccine for all girls entering sixth grade in 2008. TMA's position was that it strongly supported physicians' ability to immunize young girls with the HPV vaccine but didn't endorse Governor Perry's mandate.
House Bill 1098 by Rep. Dennis Bonnen (R-Angleton) and Sen. Glenn Hagar Jr. (R-Katy) preempted the governor's executive order and allowed students to be admitted to elementary and/or secondary school without having had the HPV vaccine.
The bill called for the Health and Human Services Commission (HHSC) to provide educational material about HPV that is unbiased, medically and scientifically accurate, and peer reviewed. The bill also required HHSC to make it available to parents or legal guardians at the appropriate time within the immunization schedule. HB 1098 expires Jan. 11, 2011, so the legislature can revisit the HPV mandate.
About 42 percent of physician survey respondents agreed or strongly agreed that HPV vaccination should be mandated for 11- and 12-year-old girls in the state. Reasons for supporting a mandate included ensuring widespread vaccine uptake (81.3 percent), ensuring that those with poor access to care receive the vaccine (76 percent), and the ability of parents to opt out of vaccination for their children because of religious or other beliefs (42.4 percent).
According to Dr. LoCoco, mandating the HPV vaccine in girls communicates the importance of this type of vaccine in the overall health of women and aids in more widespread protection against the virus.
"Everyone realizes, especially those working in public health, that mandate means we get funding for those who can't afford it. If you don't mandate it, those who can't afford it won't get it. You won't have as big a societal impact on preventing cancer without a mandate," Dr. LoCoco said.
The most common objections to an HPV vaccine mandate for 11- and 12-year-old girls from the survey included concern that patients not covered by Medicaid or the Vaccines for Children program wouldn't be able to pay for the vaccine (73 percent), poor public understanding of HPV and the HPV vaccine (48.2 percent), and insufficient long-term safety data (45 percent).
Dr. Rosenthal says she thinks many physicians would be in favor of an eventual HPV vaccine mandate, once the vaccine has been on the market longer and physicians have become more familiar with it.
The HPV vaccine is still quite new in the marketplace. Physicians can implement office interventions to increase the immunization rate among their young female patients and to avoid missed vaccination opportunities.
Having an expressed, well-communicated office policy regarding the vaccine is a good idea, Dr. Foxhall says. Office staff members can develop reminder lists and flow charts and help clinicians make recommendations to patients when they're eligible for the vaccine.
Dr. Rider says her nurse reviews each patient chart at the time of an office visit to make sure all immunizations are current. If they're not, she offers vaccinations, including that for HPV, at that time.
For guidance on effective office interventions, Dr. Foxhall recommends that physicians visit the Agency for Healthcare Research and Quality's Put Prevention Into Practice Web site . ( MedBytes , on page 64 of the June 2008 issue of Texas Medicine , features performance improvement Web sites with a focus on putting preventive measures into the medical practice.)
Ensuring adolescent patients receive the required and recommended vaccines is key to preventing disease, Dr. Foxhall says. TMA's Be Wise - Immunize SM Physician Toolkit for Adolescents includes a physician manual that details HPV vaccine safety, efficacy, and recommendations.
The toolkit also contains a brochure with HPV questions and answers provided by the Texas Department of State Health Services, along with best practice guidelines, vaccine safety information, complete details about ImmTrac (Texas' immunization registry), and more. All materials are available in English and Spanish.
Physicians may download a PDF version of the adolescent toolkit free of charge on the Be Wise - Immunize Web site . It's also available by contacting Tammy Wishard, TMA's outreach coordinator, at (800) 880-1300, ext. 1470, or (512) 370-1470, or by e-mailing Tammy Wishard .
Recommending the HPV vaccine as part of routine clinical practice could save many lives in the next generation of young women, Dr. LoCoco says. He adds that the vaccine has long-term implications for decreasing incidences of precancerous lesions of the cervix and costly sexually transmitted diseases.
"The report was eye-opening. It has reinvigorated the discussion to make sure physicians push for efforts to get women vaccinated universally," he said. "I'd like to repeat the survey in the next year to see how physicians' attitudes toward the HPV vaccine have changed."
Crystal Conde can be reached by telephone at (800) 880-1300, ext. 1385, or (512) 370-1385; by fax at (512) 370-1629; or by e-mail at Crystal Conde .
Be Wise - Immunize is a service mark of the Texas Medical Association.
POEP Resources Help Physicians Prevent Cancer
Founded in 1987, the Texas Medical Association's Physician Oncology Education Program (POEP) provides Texas medical professionals with resources to aid in the reduction of cancer morbidity and mortality. One such tool to educate physicians about the human papillomavirus (HPV) vaccine is the Guidelines on HPV Vaccination pocket guide.
Lewis Foxhall, MD, a Houston family physician and chair of POEP, says the pocket guide is valuable in providing physicians with a summary of the recommended patient populations who should receive the vaccine, answers to commonly asked questions, and HPV talking points to discuss with patients. To request a pocket guide, call Cassandra Sanchez at (800) 880-1300, ext. 1672, or (512) 370-1672; or e-mail email@example.com.
POEP also conducts statewide lectures that incorporate information about the HPV vaccine. The POEP Speakers' Bureau includes more than 100 cancer experts throughout Texas who volunteer to speak to physicians and other health care professionals on cancer prevention, screening, early detection, and control. Many lectures provide continuing medical education credit.
To request a speaker, call Leslie Jones at (800) 880-1300, ext. 1671, or (512) 370-1671, or e-mail Leslie Jones . More information on POEP physician resources and programs is available online .
Dr. Foxhall says POEP will continue to educate practicing physicians about the HPV vaccination recommendations of the U.S. Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices in an effort to improve immunization rates among girls in the target age groups.
"We need to look at what else we can do to improve the uptake rate. With any new intervention, it takes a while to get physicians engaged," Dr. Foxhall said. "We'll try to help make physicians aware of the vaccination guidelines and to inform them of vaccine-related concerns from parents. That way, physicians will be armed with information they can communicate with parents about the need for the vaccine."
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