Merck's Marketing of Gardasil to Older Women QuestionedOct 20, 2008 | Parker Waichman LLP In an effort to boost sales of Gardasil, Merck & Co. has been marketing the controversial cervical cancer vaccine to women who may not benefit from it, according to a report on Bloomberg.com. Merck's Gardasil marketing effort now focuses on women aged 19-26, the vast majority of whom are already sexually active, the Bloomberg article said. But most experts agree that Gardasil offers the most protection - and is most cost-effective - when administered to younger girls.
Gardasil was approved by the Food & Drug Administration (FDA) in June 2006. At the time of its approval, Merck said that clinical trials had proven the vaccine to be between 90-100% effective in preventing the transmission of some strains of the Human Papillomavirus (HPV) that cause cervical cancer. Shortly after its approval, the Centers for Disease Control (CDC) issued a recommendation that all young girls between the ages of 11 and 12 receive the Gardasil vaccine.
Not everyone has been so enthusiastic about Gardasil, mainly over safety concerns. There have been 9,749 adverse reactions following Gardasil and 21 reported deaths since 2006. Those side effects, which were reported to the Vaccine Adverse Event Reporting System (VAERS) included 10 miscarriages, 78 severe outbreaks of genital warts and six cases of Guillain-Barré syndrome, an autoimmune disorder that can result in paralysis.
Gardasil may also cause more allergic reactions than other vaccines. Last month, Australian researchers at the Children’s Hospital at Westmead are reported that young women in that country who received Gardasil to prevent cervical cancer were five to 20 times more likely to suffer a rare and severe allergic reaction - anaphylaxis - versus other girls who received other vaccines in comparable school-based vaccination programs.
Side-effect concerns are taking their toll, and many parents don't want their young daughters exposed to such a questionable vaccine. According to Bloomberg.com, US sales of Gardasil dropped by 33 percent this past summer. Since then, Merck shifted its marketing efforts to older women. To reach the older age group, Bloomberg.com reports that Merck is advertising on the networking Web site Facebook.com and in college bookstores and coffee shops. The company has also been selling $32 cervical-cancer awareness charm bracelets on the Internet. And, Merck is seeking FDA approval to market Gardasil to women through age 45.
But Merck's latest Gardasil marketing efforts are being questioned on some fronts, as it is unclear how much older women would benefit from the vaccine. In August, a study in the New England Journal of Medicine questioned the cost effectiveness of such an approach. A treatment is typically considered cost effective if it costs health systems less than $50,000 or $100,000 for one additional year of life. The analysis, conducted by Harvard researchers, predicted that it would cost $43,600 to extend life expectancy by one year when girls are vaccinated at 12. But when girls up to age 18 are included in the analysis, that ratio rises to $97,300 and to $153,000 through age 26.
The American Cancer Society is on record as recommending that Gardasil vaccination efforts focus on younger girls. ``The push needs to be with the 11- to 12-year-olds,'' Debbie Saslow, director of breast and cervical cancer for the American Cancer Society, told Bloomberg.com. ``It is not going to be as effective in the older women.''
But Merck is not really interested in how effective Gardasil might be for women in the older age group. Faced with declining sales of other drugs in its product line - specifically Vytorin and Zetia - and questions about the safety of the asthma drug Singulair, its top-selling product, Merck desperately needs to prop up Gardasil sales.