March 3, 2007

American Cancer Society Releases Guidelines On Merck's HPV Vaccine Gardasil

The American Cancer Society in the Jan. 19 issue of its journal CA: A Cancer Journal for Clinicians recommended that girls ages 11 and 12 receive Merck's human papillomavirus vaccine Gardasil, the Washington Times reports (Altamirano, Washington Times, 1/20). Gardasil in clinical trials has been shown to be 100% effective in preventing infection with HPV strains 16 and 18, which together cause about 70% of cervical cancer cases. FDA in July 2006 approved Gardasil for sale and marketing to girls and women ages nine to 26, and CDC's Advisory Committee on Immunization Practices later that month voted unanimously to recommend that girls ages 11 and 12 receive the vaccine (Kaiser Daily Women's Health Policy Report, 1/12). The ACS guidelines state that girls as young as age nine can receive the vaccine and recommend the vaccine for girls and women ages 13 to 18 to complete the three-shot series or to catch up on missed shots (Washington Times, 1/20). The guidelines also say that there is not enough data to recommend whether women ages 19 to 26 should be vaccinated. Harmon Eyre, lead author of the guidelines and chief medical officer of ACS, in a statement said, "The vaccine holds remarkable potential, but unless the same population of women who right now do not have access to or do not seek regular Pap tests gets this vaccine, it will have limited impact." Eyre added that it is "critical" that women continue to be screened regularly even if they have received the vaccine (HealthDay News/CBC News, 1/19). Several states recently have introduced legislation that would require girls as young as age 11 to receive Gardasil unless parents and guardians choose to opt out of the requirement, the Times reports. According to the National Conference of State Legislatures, all 50 states and the District of Columbia allow parents and guardians to opt out of vaccines for medical reasons, and all states except Mississippi and West Virginia allow religious opt-outs, while 20 states allow opt-outs for philosophical or personal reasons. ACS estimates that 11,150 cervical cancer cases will be diagnosed this year in the U.S. and that 3,670 women will die from the disease (Washington Times, 1/20).

Related Opinion Piece
Legislation that would require girls entering the sixth grade in Washington, D.C., Public Schools to receive Gardasil is a "small but critical component" of a larger strategy to fight cervical cancer, City Council members and legislation sponsors David Catania and Mary Cheh, write in a Washington Post opinion piece (Catania/Cheh, Washington Post, 1/21). According to the legislation, female students would be required to show proof of vaccination before enrolling in the sixth grade unless their parent or legal guardian chose to "opt out." The bill does not specify the circumstances under which girls would be allowed an exemption (Kaiser Daily Women's Health Policy Report, 1/10). "While we strongly endorse the use of the vaccine, this decision rests ultimately with parents and guardians," Catania and Cheh write. According to Catania and Cheh, the district has the highest cervical cancer rate in the U.S., and the D.C. Cancer Coalition estimates that 92% of the district's cases occurring among minority women. Gardasil is the "first major breakthrough in preventing cervical cancer since the introduction of the Pap test in the 1940s," Catania and Cheh write, concluding, "Our city has the resources, talent and leadership to prolong the lives of our residents. However, complacency will not bring this about" (Washington Post, 1/21).

"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

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