Some Parents Concerned Bills Mandating HPV Vaccination Would Expose Daughters To Unexpected Side Effects, Wall Street Journal Reports

Main Category: Pediatrics / Children's Health
Also Included In: Women's Health / Gynecology;  Immune System / Vaccines;  Cancer / Oncology
Article Date: 12 Feb 2007 - 6:00 PST

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An increasing number of parents are concerned that pending state bills that would require girls ages 11 and 12 to receive a human papillomavirus vaccine before entering school would expose their children to the "unforeseen side effects of a new vaccine," the Wall Street Journal reports (Carreyrou, Wall Street Journal, 2/7). Merck's HPV vaccine Gardasil and GlaxoSmithKline's HPV vaccine Cervarix in clinical trials have 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. GSK in April plans to file for FDA approval of Cervarix, and it expects approval by the end of this year (Kaiser Daily Women's Health Policy Report, 1/19). Lawmakers in 23 states and the District of Columbia have introduced bills that would mandate HPV vaccination, according to Women in Government, a nonpartisan organization of female legislators, USA Today reports (Rubin, USA Today, 2/8). According to the Journal, some religious conservatives have "long voiced opposition" mandating to the HPV vaccines because "it would, in effect, condone premarital sex." Some parents are concerned because 82 adverse events have been reported since Gardasil was approved, including nausea, fever, rashes and fainting spells. Many of the state bills contain clauses allowing parents to opt out of an HPV vaccine requirement, but some do not, the Journal reports. Texas Gov. Rick Perry (R) last week issued an executive order mandating that all girls in the state entering the sixth grade receive an HPV vaccine as of September 2008. The executive order includes an opt-out clause for religious or other "reasons of conscience" (Wall Street Journal, 2/7). State Sen. Jane Nelson (R) on Wednesday asked Texas Attorney General Greg Abbott (R) to issue an opinion on the legality of Perry's order, and state Rep. Dennis Bonnen (R) has introduced a bill that would overturn the order (Austin Peterson, AP/CBS News, 2/8). Perry on Tuesday in his State of the State address said, "I refuse to look a young woman in the eye who suffers from this form of cancer and tell her that we could have stopped it but we didn't" (Austin Peterson, AP/Fort Worth Star-Telegram, 2/6). In a statement he added, "Providing the HPV vaccine doesn't promote sexual promiscuity any more than providing the hepatitis B vaccine promotes drug use" (Aynesworth, Washington Times, 2/7).

Merck Lobbying Campaign
Merck last year began an "aggressive lobbying campaign" in state legislatures to pass laws mandating that middle-school age girls receive Gardasil, the Journal reports (Wall Street Journal, 2/7). Merck also supports requiring private insurers to cover Gardasil, which costs $360 and is administered in three injections given over six months, as well as funding for programs that help defray vaccine costs for low-income and uninsured children. Women in Government, a nonpartisan organization of female legislators across the U.S. that receives corporate donations from Merck, has been lobbying lawmakers on the issue (Kaiser Daily Women's Health Policy Report, 1/29). Merck did not disclose how much money it has funneled into its lobbying campaign or donated to Women in Government, the Journal reports. Tracy Morris, spokesperson for Women in Government, also declined to say how much the group had received from Merck. Margaret McGlynn, president of Merck's vaccine division, on Tuesday at a Merrill Lynch conference in New York City acknowledged the company's lobbying campaign for Gardasil but said, "States decide what works for them" (Wall Street Journal, 2/7).

Gardasil Might Protect Against More HPV Strains, Merck Official Says
Gardasil in recent trials has shown that it might be effective in offering broader protection against additional strains of HPV that are not directly targeted by the vaccine, Bev Lybrand, a Merck vice president who heads the Gardasil commercialization effort, said at the Merrill Lynch conference, the AP/Business Week reports. Merck is now testing whether Gardasil can prevent precancerous lesions that are caused by additional HPV strains, and early data from the study have been promising, the company said. "We're encouraged by the interim analysis of the endpoints," Lybrand said, adding that the company hopes to present trial data on potential protection against additional HPV strains "as soon as possible at an appropriate medical meeting" (Loftus, AP/Business Week, 2/6).

Broadcast Coverage
NPR's "News & Notes" on Tuesday included a discussion about Perry's executive order and HPV in the black community. Guests on the program include Michael Myers, executive director of the New York Civil Rights Coalition; Jeff Obafemi Carr, host of the radio program "Freestyle"; and Laura Washington, a columnist for the Chicago Sun-Times (Cox, "News & Notes," NPR, 2/6). Audio of the segment is available online.

NPR's "Talk of the Nation" on Wednesday included a discussion on the efficacy of the vaccine and whether immunization should be required by states. Guests on the program include Robert Rose, an associate professor at the University of Rochester Medical Center who helped develop the vaccine; Gregory Zimet, a professor in the Department of Pediatrics at the at the Indiana University School of Medicine and the Indiana University Cancer Center who has researched attitudes toward vaccination mandates; and Dawn Richardson, who is president of Parents Requesting Open Vaccine Education and opposes mandatory vaccination against HPV (Conan, "Talk of the Nation," NPR, 2/7). Audio of the segment is available online.

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