Hpv Vaccine, Not Immune To Controversy

International Journal of Gynecology and Obstetrics (2008) 101, 123–124

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SPECIAL EDITORIAL

HPV vaccine: Not immune to controversy recipient of many teaching awards including the APGO Excellence in Teaching Award. In addition, she developed and directed the Middle Eastern Women's Health Program at the Center of Excellence for Women's Health at the University of Michigan. In recognition of her contributions, in 2005 Dr Hammoud was awarded the Arab American and Chaldean Council's Excellence in Health Care Award.

Maya Hammoud, M.D. Weill Cornell Medical College, Qatar

Maya Hammoud is Associate Professor of Obstetrics and Gynecology and Senior Associate Dean for Education at Weill Cornell Medical College in Qatar. She is a fellow of the American College of Obstetrics and Gynecology and current Chair of the Undergraduate Medical Education Committee of the Association of Professors of Gynecology and Obstetrics (APGO). Dr Hammoud is a United States citizen of Lebanese origin. She completed her medical degree and residency training at the University of Michigan, where she joined the faculty and became Director of the Obstetrics and Gynecology clerkship. She was the Interim Associate Dean for Student Programs before relocating to Qatar. Dr Hammoud introduced many innovations to the third year medical student curriculum including technology and simulations. She has run many teaching workshops for faculty development and in training residents how to teach. She is the

The introduction of Gardasil (Merck & Co, Whitehouse Station, NJ, USA) as a vaccine to the human papillomavirus (HPV) has received much media attention worldwide since its approval by the US Food and Drug Administration in 2006. From the United States to the United Kingdom, New Zealand, and Malaysia, news headlines have highlighted various issues and controversies surrounding the HPV vaccine. ʻʻOuch! Cervical cancer shots painful” [1] released by the Associated Press in January 2008 outlines the most recent complaint about the vaccine; the shot seems to cause more pain than other vaccines. In the United Kingdom, more controversial discussion appeared in The Times in ʻʻIs it time for a cancer jab?” [2], where two opposing answers to the question: ʻʻMy daughter is 12 and not yet sexually active. Should I arrange for her to have the cervical cancer jab?” posed by a British parent were presented. On the supporting side, the parent is encouraged to obtain the vaccine for protection; while on the opposing side, testing of the vaccine mainly on adult women, nonprotection against other sexually transmitted diseases, and side effects—including some serious ones such as blood clots—were presented as reasons for not obtaining the vaccine. From New Zealand, the article ʻʻHPV vaccine—why are we waiting?” [3] criticizes the government for not funding or prioritizing the HPV vaccine, despite the prime minister calling it an ʻʻinternational breakthrough.” The article highlights public misconceptions about fears that vaccination might promote sexual promiscuity and erode family values. In Malaysia, similar issues were raised in the article ʻʻTo vaccinate or not?” [4] following concerns that ʻʻgiving the vaccination to young girls is like giving these girls permission to have sex.” Are these controversies misperceptions underscored by the media or are they evidence-based? A review of the recent literature on the issues surrounding the HPV vaccine has shown similar controversies and additional concerns that do not seem to draw as much media attention.

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124 The 2007 Advisory Committee on Immunization Practices' recommendation report on the quadrivalent HPV vaccine [5] summarized the studies evaluating its efficacy and concluded that the vaccine has high efficacy in preventing persistent HPV infection, cervical cancer precursor lesions, vaginal and vulvar cancer precursor lesions, and genital warts caused by HPV types 6, 11, 16, or 18 among females who have not already been infected with the respective HPV type. The report recommended vaccination of females aged 11–12 years based on several considerations, including studies showing high antibody titers achieved after vaccination at that age, and data on HPV epidemiology and age of sexual debut in the United States. The vaccine has been demonstrated to provide protection for at least 5 years with no evidence of waning protection. Long-term follow-up studies are underway to determine duration of protection. The recommendation also considered cost-effectiveness evaluations and the established young adolescent healthcare visit at age 11–12 years recommended by several professional organizations. Therefore, concerns regarding the study population are not totally unfounded, as most of the studies were indeed done on adult women, and the age recommendation was based mostly on assumptions and convenience. In addition, basing the age recommendation on the girls' age of sexual debut in the United States is not necessarily applicable to other countries and cultures. As for the safety of the vaccine, which some have questioned, information is available on the Centers for Disease Control and Prevention website [6]. Since May 8, 2007, the site has received a total of 1763 reports of potential side effects following HPV vaccination, of which 94 (5%) are defined as serious. They include 13 unconfirmed reports of Guillain–Barré syndrome and 4 deaths: 1 involving a pulmonary embolism, 1 involving deep venous thrombosis (both in women on birth control pills), and 2 reportedly caused by influenza unrelated to vaccination. Therefore, none of the 4 deaths appears to be caused by the vaccination. Such reports of serious adverse reactions cause fear among parents who are trying to make the decision of whether to administer a vaccine to their daughter or not. Obviously, as with any other drug or vaccine, years of postmarketing surveillance are required to confirm initial efficacy and safety estimates based on premarketing trials. Additional issues that have received just as much media attention include defining the optimal age for vaccination, vaccination of males, the need for boosters, introduction of the vaccine in low-income countries, and the impact of vaccination on screening programs [7]. Furthermore, the cost-effectiveness of the HPV vaccine has not been clearly outlined. Although the studies suggest that the introduction of the HPV vaccine could be cost-effective in certain countries [8,9], the key variables regarding its introduction worldwide have not been well addressed. The vaccine is expensive, and it will be challenging to get it to where it is needed most to have the most significant impact. However, the facts remain that cervical cancer is the leading cause of death in women in low-income countries and that HPV vaccines are very effective in preventing the infection of the

SPECIAL EDITORIAL two most common high-risk HPV genotypes, which cause 70% of all cervical cancer. FIGO's President, Professor Dorothy Shaw, has highlighted the major programs and priorities endorsed by FIGO's Executive Board [10]. Saving women's lives through fighting cervical cancer was identified as one of the high priority action areas for FIGO. With the introduction of the HPV vaccine it is important to develop effective plans that integrate immunization with appropriate cervical screening programs. Continuing data collection about the efficacy and safety of the vaccine, educating healthcare providers and the public, documenting cost-effectiveness, and improving vaccine delivery—especially in low-income countries—are all important elements for effective strategies toward implementing appropriate programs and reducing cervical cancer worldwide.

References [1] Stobbe M. Ouch! Cervical cancer shots painful. Associated Press; January 3 2008. http://ap.google.com/article/ALeqM5h huO4x2Hjvo2Y-NJXxMPQpfpGYRwD8TULMF80. Accessed January 5, 2008. [2] Stuttaford T, Godson S. Is it time for a cancer jab? The Times; December 29 2000. http://www.timesonline.co.uk/tol/life_and_ style/health/our_experts/article3103543.ece. Accessed January 5, 2008. [3] Azariah S. HPV vaccine — why are we waiting? New Zealand Doctor Online; December 19 2007. http://www.nzdoctor.co.nz/ news?article=6d18bff6-fabf-4bff-91b2-b23d32ca087b. Accessed January 5, 2008. [4] Mokhtar NA. To vaccinate or not? The Star; December 16 2007. http://thestar.com.my/health/story.asp?file=/2007/12/16/ health/19746501&sec=health. Accessed January 5, 2008. [5] Markowitz LE, Dunne EF, Saraiya M, Lawson H, Chesson H, Unger ER. Quadrivalent human papillomavirus vaccine: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2007;56:1–24. http://www.cdc. gov/mmwr/preview/mmwrhtml/rr5602a1.htm. Accessed January 5, 2008. [6] HPV vaccine — questions and answers for the public. Centers for Disease Control and Prevention; June 28 2007. http://www.cdc. gov/vaccines/vpd-vac/hpv/hpv-vacsafe-effic.htm. Accessed January 5, 2008. [7] Wright TC, Bosch FX, Franco EL, Cuzick J, Schiller JT, Garnett GP, et al. HPV vaccines and screening in the prevention of cervical cancer. Vaccine 2006;24(Suppl 3):S251—61. [8] Newall AT, Beutels P, Wood JG, Edmunds WJ, MacIntyre CR. Cost-effectiveness analyses of human papillomavirus vaccination. Lancet Infect Dis 2007;7:289—96. [9] Kulasingam S, Connelly L, Conway E, Hocking JS, Myers E, Regan DG, et al. A cost-effectiveness analysis of adding a human papillomavirus vaccine to the Australian National Cervical Cancer Screening Program. Sex Health 2007;4:165—75. [10] Shaw D. A vision for FIGO. Int J Gynecol Obstet 2007;97:82—5.

Maya Hammoud Weill Cornell Medical College, Qatar E-mail address: [email protected].