Issue:  Vol. 48 / No. 7 / 15 February 2018

FDA OKs cancer vaccine


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Some forms of cancer are caused by a virus that can be transmitted through sexually related activity. On June 8, the Food and Drug Administration approved the first vaccine to prevent vaginal, cervical, and anal cancer.

The FDA approval is sex-specific, for females ages 9-26. Merck, the company that makes the vaccine, is conducting trials for gay men.

The vaccine, Gardasil, is 100 percent effective against two strains of human papillomavirus (HPV) that are responsible for about 70 percent of those cancers and two others that cause more than half of all genital warts.

HPV can be transmitted through contact with skin, fingers, and sex toys and need not involve penetration. It takes years for the slow-acting virus to produce warts and abnormal skin lesions that can develop into cancer, so recent sexual history is no indication of risk for developing those cancers.

Gardasil has no therapeutic effect once someone becomes infected with HPV, so it is important that people be vaccinated before or soon after they become sexually active.

Lesbians are no exception. Regular use of a Pap smear to monitor for development of lesions, and their removal before they become cancerous, is recommended for all women.

HPV is extremely common among gay men; University of California San Francisco researcher Joel Palefsky has found rates of infection as high as 85 percent.

Trial seeks gay men

"Rates of anal cancer among men who have sex with men are the same as rates of cervical cancer among women before Pap smears became routine, yet most men are unaware of this disease," said Andrea Krick, who coordinates recruitment for the gay men's trial of Gardasil that is under way in six U.S. cities. They are: San Francisco, New York, Boston, Philadelphia, Washington, D.C., and Chicago.

The trial has had greater difficulty recruiting participants than the company had anticipated. Krick said that part of the problem is that "girls go to the doctor regularly and guys just don't." But it goes beyond that to "just the lack of disease knowledge" of HPV and the risk of cancer.

The study is looking for healthy, sexually active men who self-identify as gay; with a low number of sexual partners; ages 16-26; and who do not have any symptoms of HPV infection. The men must be willing to commit to the three-shot vaccination program over six months, and follow up out to three years.

Krick said the gay men who are most likely to be aware of HPV are those who already are infected and have had problems with warts – they are not eligible for the trial.

HPV also is known to cause cancer in the penis and mouth, though it is not a leading cause of cancer in those parts of the body. A recent study in Spain found HPV present in the anus of 83 percent, in the penis of 38 percent, and in the mouth of 33 percent of HIV-positive gay men. Persons who are HIV-positive are several times more likely than average to develop HPV-related cancers.

Palefsky recommends regularly monitoring the bottoms of gay men with a variant of the Pap smear that he adapted for use in the anus. Abnormal growths should be removed before they can develop into cancer.

More information on HPV and how to participate in the Gardasil trial is available at

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