The new HPV vaccine— Be sure you know the facts
Sarah Zarbock, PA-C
n June of this year, the FDA approved the quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine (Gardasil).1 The important fact about this vaccine is that it is intended to prevent diseases caused by HPV types 6, 11, 16, and 18—including cervical cancer, condyloma acuminata, and precancerous lesions associated with cervical adenocarcinoma in situ. The approval was based on a priority review of results from four randomized, placebo-controlled phase 2 and 3 clinical studies in 20,541 HPV-naïve women aged 16 to 26 years.2 Results showed that the vaccine was 100% effective at preventing HPV 6-, 11-, 16- and 18related cervical precancerous lesions and noninvasive cervical cancers. Furthermore, it prevented 99% of genital warts. The vaccination regimen consists of three 0.5-mL doses, the first given at baseline and the second and third given 2 and 6 months later. The vaccine will cost about $120 per dose.3 The CDC’s Advisory Committee on Immunization Practices (ACIP) has recommended that all 11- to 12-year-old girls receive the series of three injections.4 The vaccine is FDAapproved for girls and women aged 9 to 26 years.
embarrassed myself when I researched this editorial and learned that the vaccine is effective against the four types of HPV that cause 70%—not 100%—of cervical cancers. Protection against 70% of cervical cancers is a pretty incredible level of success. But what about the other 30% of cervical cancers? It’s this pesky statistic that seemed to have been swept under the publicity carpet, as it were. So what are the facts? Cervical cancer has gone from being one of the top killers of American women to not even being on the list of the top 10. This year, cervical cancer represents just 1% of the 679,510 new cancer cases and 1% of
One potential consequence of the vaccine is that women may assume they need not get Pap smears.
anticipated cancer deaths.6 (To put these numbers in perspective, consider that approximately 41,000 women will die of breast cancer this year and 72,000 will die of lung cancer.6) Between 1955 and 1992, the number of deaths due to cervical cancer dropped by an amazing 74%.7 From 1997 to 2003, the number of cervical cancer cases in the United States dropped by 4.5% each year, while the number of deaths dropped by 3.8% each year, according to a government Web site that tracks cancer trends.8 Yet approximately 10,000 cases of cervical cancer are diagnosed each year in the United States, and some 3,700 American women die annually from this disease.3
What are the facts?
Because of its ability to protect against four types of HPV that cause 70% of all cervical cancers and 90% of genital warts, this vaccine is an incredibly important addition to preventive health care for women. But misconceptions and controversy have surrounded it, beginning with the headlines that appeared after the vaccine’s approval. I certainly agree with officials who called the vaccine a major public health breakthrough, but the headlines bordered on the unbelievable. For instance, more than one news report stated that the “cervical cancer vaccine [was] 100% effective.”5 It’s hard to ignore headlines that talk about a 100% cancer cure rate. Could that really be true? The sources for the story certainly were legitimate; after all, the FDA approved the vaccine1 and a CDC advisory panel “unanimously” recommended it.4 Frankly, I was somewhat
The author is the editor in chief of JAAPA. 14 JAAPA VOL.19, NO. 9 SEPTEMBER 2006
The role of the Pap smear
According to the American Cancer Society, most invasive cervical cancers are found in women who have not had regular Pap tests or have failed to abide by the guidelines for follow-up testing.9 Perhaps one potentially tragic consequence of the development of the HPV vaccine—and of the advertising hoopla surrounding it—
is that some women may assume that if they get the vaccine, they no longer need to get Pap smears. After all, that conclusion makes sense if these women believe that the HPV vaccine is 100% effective and “will virtually eliminate cervical cancer.”10 What they really need to know is the fact that the vaccine is 100% effective against only four types of HPV. The Pap smear is a simple, quick, relatively noninvasive test. We women go to our gynecologist, family physician, or clinic, lie quietly on the examining table, and count the dots in the ceiling tile until the procedure is over. Most of us receive good news with our test result that enables us to heave a sigh of relief for another year or so. But good news will continue to elude a number of women. A survey conducted on behalf of the Vagisil Women’s Health Center found that 17% of respondents are not visiting their doctors annually and 28% do not have Pap tests each year.11 Of those women who are not visiting their physicians annually, 41% do not think that annual physicals and Pap tests are necessary, as they do not have any current health problems; 30% dislike the exam so much that they put it off until they have a problem; 26% say they don’t have insurance and can’t afford to go; 19% “forget to do it”; 17% are not aware that an annual exam is recommended; 13% are “afraid of what the doctor might find”; and 9% don’t go because they don’t like their doctor. The women who answered this survey—and women like them—are part of a vulnerable population that is now joined by the newest set of women who believe, by virtue of receiving the HPV vaccine, that a Pap smear is no longer necessary.
and providers will have to carefully consider which types of discussions they feel are appropriate and which they are comfortable having. Other questions still to be answered include what to do for other types of HPV that can cause cervical cancer, how long the vaccine’s protection will last, how to ensure that women will get the recommended booster every 5 years, how to treat HPV infections that are already present at the time of the vaccination, and how this series of vaccinations will be paid for.
Information is power
The HPV vaccine is a major medical achievement that the FDA has found to be safe and effective. It has the potential to protect the health of millions of women. I’m a great believer that information is power and that we, as health care providers, are obliged to take this opportunity to learn the facts about the HPV vaccine and to help our patients understand these facts. Hopefully, we all have been adhering to the Pap screening recommendations and will continue to do so. But now, with the new HPV vaccine, we can play a key role in educating our patients, especially in being clear in communicating what the vaccine does and does not prevent. Discussion of the vaccine can also be a catalyst for having appropriate and timely discussions with young patients about sex, sexually transmitted diseases, and sexual safety. Why not get started right away by asking your patients this simple question: “Did you know that cervical cancer ■ is caused by certain types of a common virus?”
1. US Food and Drug Administration. FDA licenses new vaccine for prevention of cervical cancer and other diseases in females caused by human papillomavirus. FDA News. August 10, 2006. Available at: http://www.fda.gov/bbs/topics/NEWS/2006/ NEW01385.html. Accessed August 8, 2006. 2. FDA approves cervical cancer vaccine. American Journal of Clinical Pathology AJCP News. August 10, 2006. Available at: http://www.ajcp.com/headlines/news/ 200606082.html. Accessed August 8, 2006. 3. FDA approves Merck’s GARDASIL®, the world’s first and only cervical cancer vaccine. Available at: http://www.merck.com/newsroom/press_releases/product/2006_ 0608.html. Accessed August 10, 2006. 4. CDC’s advisory committee recommends human papillomavirus virus vaccination. Press release. June 29, 2006. Available at: http://www.cdc.gov/OD/OC/MEDIA/ pressrel/r060629.htm. Accessed August 10, 2006. 5. Young E. Cervical cancer vaccine 100 percent effective. NewScientist.com. Available at: http://www.newscientist.com/article.ns?id=dn3089. Accessed August 10, 2006. 6. American Cancer Society. Cancer Facts and Figures, 2006. Available at: http://www. cancer.org/downloads/STT/CAFF2006PWSecured.pdf. Accessed August 10, 2006. 7. American Cancer Society. Detailed guide: Cervical cancer. What are the key statistics about cervical cancer? Available at: http://www.cancer.org/docroot/CRI/content/ CRI_2_4_1X_What_are_the_key_statistics_for_cervical_cancer_8.asp?sitearea. Accessed August 10, 2006. 8. National Cancer Institute. SEER Surveillance Epidemiology and End Results. Cancer stat fact sheets. Cancer of the cervix uteri. Available at: http://seer.cancer.gov/ statfacts/html/cervix.html. Accessed August 10, 2006. 9. American Cancer Society. Detailed guide: cervical cancer. Can cervical cancer be prevented? Available at: http://www.cancer.org/docroot/CRI/content/CRI_2_4_2X_ Can_cervical_cancer_be_prevented_8.asp. Accessed August 10, 2006. 10. American Council on Science and Health. Whelan EM. Cancer triumph and travail (from the Washington Times). June 15, 2006. Available at: http://www.acsh.org/ healthissues/newsID.1352/healthissue_detail.asp. Accessed August 10, 2006. 11. New survey shows women not informed on the latest feminine health information. PR Newswire. Available at: http://www.prnewswire.com/cgi-bin/stories.pl?ACCT= 104&STORY=/www/story/08-25-2003/0002005685&EDATE. Accessed August 8, 2006.
Other unanswered questions
Other issues surrounding the HPV vaccine are not related to public misconceptions about it. For instance, the vaccine will not protect women who have been infected with HPV types 6, 11, 16, or 18 prior to vaccination, indicating the importance of immunization before exposure. Presumably for that reason, the ACIP specified that girls 11 to 12 years old should receive the vaccine series. But this would seem to require discussing sexually transmitted diseases with girls at an early age—the FDA’s approved labeling includes children as young as 9 years. Granted, parents generally don’t talk about polio with their 2-yearolds or about diphtheria, tetanus, and pertussis with their 5-year-olds before the children are vaccinated against these diseases. They might, however, tell the children that these vaccines will keep them from getting sick from some bad diseases, and the same approach can be used for the HPV vaccine. Parents
VOL.19, NO. 9 SEPTEMBER 2006 JAAPA