Safety of Merck's HPV vaccine Gardasil 'lost' in debate

The effectiveness and safety of Merck's human papillomavirus vaccine Gardasil has "been lost" because of Merck's lobbying campaign for mandating vaccination for school attendance, and the "real losers" might be "girls and women who need access" to the vaccine, Boston Globe columnist Ellen Goodman writes in an opinion piece (Goodman, Boston Globe, 3/2).

Gardasil and GlaxoSmithKline's experimental 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.

However, the company last month decided to suspend its lobbying campaign in light of opposition from some parents, patient advocacy groups and public health officials (Kaiser Daily Women's Health Policy Report, 2/21).

According to Goodman, the "rush for school mandates has slowed to a crawl" because of opposition from an "odd collection" of opponents backed by the "legions who have come to regard Big Pharm with big suspicions."

Merck "earned" the opposition from its lobbying campaign, and it is "wise to keep one eye on the costs and another on alternative vaccines," Goodman writes.

However, she adds that parents who are "queasy" about HPV vaccination mandates should remember that opponents of mandates are "not necessarily your friend."

It is "not easy for any parent to accept that their middle-schooler get protection" against a sexually transmitted infection, but Gardasil is "extraordinarily safe and effective against a lethal disease," Goodman writes, concluding, "Too much suspicion can be bad for your daughter's health" (Boston Globe, 3/2).