New Research Could Change Marketing of Gardasil to Boys

THE LINKS ARE NOT LIVE. COPY AND PASTE INTO BROWSER FOR FURTHER READING

July 20, 2011 — New research suggests that Merck's human papillomavirus vaccine, Gardasil, is effective in both boys and girls to prevent various types of cancers, but many parents are wondering whether it is an important vaccine for their sons, the New York Times <http://www.nytimes.com/2011/07/19/health/19garda.html>  reports (Rabin, New York Times, 7/18). In December 2010, FDA approved Gardasil for the prevention of anal cancer in both girls and boys ages nine through 26. The vaccine already was approved to prevent cervical, vulvar and vaginal cancers associated with HPV for the same age group (Women's Health Policy Report <http://www.nationalpartnership.org/site/News2?news_iv_ctrl=-1&abbr=daily2_&page=NewsArticle&id=27247%20> , 12/23/10). Initially, research only indicated that vaccinating boys was effective for reducing the risk of genital warts, which are diagnosed in two in 1,000 men annually. According to the Times, this modest benefit left parents skeptical of giving the vaccine to their sons. Additionally, pediatricians have not aggressively promoted the vaccine's use in boys, and not all health plans cover the three-shot series, which can cost $400. "It seems like a lot of effort for little return," Glen Stream, president-elect of the American Association of Family Physicians <http://www.aafp.org/online/en/home.html> , said.

However, a growing number of studies has linked HPV to a range of cancers in both genders, the Times reports. Two strains of HPV have been linked to anal cancer, penile cancer and common cancers found in the throat and tonsils, where the virus may be spread through oral sex. Merck is trying to use the new data to garner enthusiasm for the vaccine and encourage its use as a shield against many forms of cancers.

A new clinical trial of several hundred men who have sex with men found that three years after being vaccinated, those who received Gardasil were significantly less likely to have developed high-grade precancerous anal lesions than a comparison group. Three of the 194 men who were vaccinated developed the abnormalities, compared with 13 of 208 men who received placebo injections. Merck recently presented the data to a CDC advisory panel. The Times suggests that there will soon be enough research to "tip the scales in favor of a national recommendation" to include Gardasil on the male vaccination routine.

The vaccine's protection from anal cancer would mostly benefit gay men, who have a higher risk than heterosexual men. Debbie Saslow, director for breast and gynecological cancers at the American Cancer Society <http://www.cancer.org/> , said the data are strong but that conducting a vaccination campaign targeted at gay men is "very stigmatizing." The vaccine should be given to young people before they become sexually active, and "[m]ost young men don't realize they're in that category or tell their health care provider they're in that category until after they've been sexually active, usually with multiple partners," she said (New York Times, 7/18).