Merck pledges to stop lobbying States on Gardasil

Merck has decided to suspend its campaign to lobby for state proposals that would mandate girls receive its human papillomavirus vaccine Gardasil in light of opposition from some parents, patient advocacy groups and public health officials, the Wall Street Journal reports (Carreyrou/Rubenstein, Wall Street Journal, 2/21).

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. Merck last year began lobbying state legislatures to pass laws mandating that middle school age girls receive Gardasil. 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 (Kaiser Daily Women's Health Policy Report, 2/8). Texas Gov. Rick Perry (R) on Feb. 2 signed an executive order mandating HPV vaccination for girls entering the sixth grade beginning in September 2008, and at least 20 states are considering proposals that would mandate HPV vaccination for young girls. Some public health experts recently have expressed concern that proponents of HPV vaccination proposals, including Merck, have acted far too fast and are potentially undermining eventual prospects for the broadest possible immunization (Kaiser Daily Women's Health Policy Report, 2/20). According to the Journal, opposition to proposals has grown in recent weeks among parents who are concerned about the mandates and the potential side effects of vaccination (Wall Street Journal, 2/21).

Merck Comments, Reaction
"Our goal is preventing women from getting HPV and cervical cancer," Richard Haupt, executive director of medical affairs for Merck's vaccines division, said, adding, "What's unfortunate is that our role appears to be a distraction to that goal" (Gardner, Washington Post, 2/21). Haupt said the company would continue distributing information about the Gardasil if requested by government officials, the AP/Long Island Newsday reports. Anne Francis, chair of an American Academy of Pediatrics committee that advocates for better insurer reimbursement for vaccines, said Merck's decision to stop lobbying is "a good move for the public," adding that the initiation of the campaign was "a little bit premature ... so soon after (Gardasil's) release, before we have a picture of whether there are going to be any untoward side effects" (Johnson, AP/Long Island Newsday, 2/21). Joseph Bocchini, chair of the American Academy of Pediatrics' Committee on Infectious Diseases, lauded Merck's move. "At this point, we really don't know whether we even need to consider a mandate," Bocchini said, adding, "We need to get some data over time" (Rubin, USA Today, 2/21). After Merck's announcement, Perry spokesperson Krista Moody said, "Gov. Perry's executive order was not about a company. It's about saving lives and preventing women from contracting cancer" (Hoppe, Dallas Morning News, 2/20).

Washington Times Examines Age Group Targeted for Gardasil
The Washington Times on Wednesday examined whether lawmakers are targeting the "wrong age group" in their efforts to require girls ages 11 to 13 to receive Gardasil. According to the Times, Gardasil has proven effectiveness for only five years (Lopes/Dolan, Washington Times, 2/21).