There’s no getting around it: Craig Mosely (not his real name), a 43-year-old HIV positive graphic artist from Atlanta, isn’t a young woman between the ages of nine and 26. So Gardasil, the vaccine that protects against four strains of human papillomavirus (HPV), isn’t FDA-approved for him—yet. (HPV, which is sexually transmitted, can lead to cervical cancer in women and genital warts and anal cancer in both sexes.) Insurance won’t cover treatments unless they’re FDA-approved, so if Mosely wants the vax, he has to pay for it himself. Having paid $200 a shot, he’s already had two of the three that comprise an effective Gardasil safeguard. The vax may offer protection to anyone who hasn’t yet been exposed to the full quad of dangerous HPV strains, and Mosely wants Gardasil just in case. “I probably already have some HPV strains,” he says, “but the vax can keep me from getting others.”
Mark Feinberg, MD, of Merck & Co., which manufactures Gardasil, says the vax is now being tested in men (and could be ready for FDA review in 2008). He warns that Gardasil can protect only against HPV strains you haven’t already contracted; it won’t affect any strains you may already have. What’s more, tests to screen for HPV strains aren’t available outside of clinical trials.
That hasn’t stopped positive men like Mosely from getting their docs to approve the shots. While these HIV doctors agree that positive people may benefit, others, like Joel Palefsky, MD, of University of California, San Francisco, caution that studies are needed to establish the safety and effectiveness of the drug for use by positive people. Feinberg says Merck will undertake those studies—and that Gardasil’s FDA-approval doesn’t require pre-screening for HIV. (Translation: Scientists don’t foresee safety problems for positive people who get the vax). Hit the inject button.