Merck Co., makers of Gardasil vaccine, just released a study claiming the success for Gardasil to treat genital warts in males. Gardasil is currently only approved for women ages 9 to 26 to prevent the human papillomavirus (HPV) that is thought to lead to 70% of cervical cancer cases. The study was funded by Merck, who plans to submit an application to the FDA by the end of 2008 for approval to treat HPV in males with Gardasil.
The study included 4,065 men between 16 and 26 who had not been infected with at least one of the four HPV types before the start of the study. This means that they may have already been infected with up to three of the four HPV strains (6, 11, 16 and 18). At the beginning of the study there were no signs of genital wart outbreaks on any participants. The results showed that Gardasil helped to prevent external genital lesions or wart outbreaks compared to the placebo group. Gardasil was 90.4 percent effective with the placebo group experiencing 31 cases of external genital lesions and the Gardasil group only having 3.
It is important to note that Gardasil can not cure the HPV virus. The Center for Disease Control and Prevention (CDC) has approved Gardasil for young women to prevent cervical cancer, but it only works if you don’t already have HPV (the most common STI). The CDC states on their website that “Most HPV types cause no symptoms and go away on their own.” In fact, most people don’t even know they have HPV because they have never experienced any symptoms.
Giving the Gardasil vaccine to young boys may not make sense because they aren’t at risk for developing cervical cancer. Using the vaccination to solely prevent HPV may not outweigh the risk and potential side effects for young men. Gardasil is a relatively new drug, only approved a couple years ago, and all the side effects may still be unknown. Already there have been over 10,000 reported adverse effects from females taking the drug. Of those side effects, 27 deaths were reported as well as other serious events like Guillain-Barré Syndrome and blood clots in the heart, lungs, and legs. So far, these have not been directly linked to Gardasil.
What do you think? Should Gardasil be approved for boys and young men? Please share your experiences and thoughts about the HPV vaccine!