And genital warts in young men, looks like an issue they can nail
According to Merck, their HPV vaccine, Gardasil has proved 90% effective in preventing the uncomfortable affliction known as genital warts in men. They plan to present the results of a recent study at a European medical conference later today. It is their hope that the results of this study will support their case with the FDA. They have requested approval to market Gardasil to boys as a way to prevent genital warts, but as of yet the FDA has not moved on a reply.
On June 8th, 2008, the HPV-vaccine, Gardasil was approved for use in girls and women between ages 9 and 26 years old. Men can spread the virus and, although the HPV-vaccine, Gardasil has been approved for men to prevent genital warts in 40 countries, it has not been approve for that use in the U.S. Critics of the HPV-Vaccine state that there still is no medical proof that Gardasil prevents penile cancer or other HPV-associated cancers in men. There also is no evidence the vaccine prevents the spread of HPV from men to women.
The new Merck study involved about 4,065 men ages 16 to 26 from nearly 20 countries, and included more than 1,000 men in the US. The results showed Gardasil was 90 percent effective in preventing genital warts, with only 15 cases of persistent infection in a vaccinated group of males as compared to 101 cases in a group that was given a placebo. And it was about 45 percent effective in preventing infection with the four strains of HPV that the vaccine targets.
Anna Giuliano, H. Lee Moffitt Cancer Center & Research Institute in Tampa, Florida, is on record for stating, “This opens up some really important questions for further research. The cancers in men which are HPV related are really only now being understood.” Although some researchers find the results of the test “very exciting,” it’s not clear if “promising results” will be enough convince American’s to get their teenage boys vaccinated.
Maura Gillison, an HPV researcher at Johns Hopkins University, who was not involved in the Merck study, notes that, to date, only 1 in 4 girls in the targeted demographic, have been vaccinated. “When parents are sitting in a room discussing with a pediatrician whether to vaccinate their child against anything, they’d like to know what the potential benefit is. A parent might say ‘I’m not inclined to vaccinate my child to prevent a benign genital wart.”
FDA and CDC officials will be reviewing Merck’s interim analysis from, and want to see additional data concerning Gardasil’s effect on precancerous lesions.
Lauri Markowitz, an HPV expert at the U.S. Centers for Disease Control and Prevention, said “It’s obviously encouraging data but the policy makers will be looking at variety of different issues,” including how cost effective the shot would be if used in males.
Sources: Merck Press Releases, Associated Press Articles
