Merck (MRK) clearly wants to seek any and all possible FDA approvals, no matter how unusual, for its Gardasil human papillomavirus vaccine. Which, of course, explains why it told Medscape Oncology it will present information that purports to show Gardasil's success at preventing anal cancer in gay men.
It is not clear exactly what indication Merck will seek from the FDA. The question will be whether Merck can execute this approval without offending the gay community, or getting drawn into a debate about why it wants such a specific indication for a disease so rare that it can't possibly be profitable for Merck.
The backdrop here is that both Merck and GlaxoSmithKline (GSK) -- which markets Gardasil's only rival, Cervarix -- have been dreaming up new populations for their vaccines ever since they were first approved. Such as, for instance, penile cancer and head and neck cancers, which both companies have explored.
The data as described by Medscape string together several separate facts that Merck seems to be hoping will add up to an FDA nod to market Gardasil as an STD vaccine for gays. Those separate facts are:
- Merck claims that Gardasil reduced the incidence of anal lesions caused by HPV among gay patients in the test, even though a majority of the study participants were straight.
- Genital warts and anal lesions are caused by HPV, not by being gay, although Joel M. Palefsky, a professor of medicine at the University of California at San Francisco, told Medscape, "Men who have sex with men have a 17-times higher rate of anal cancer than the general population."
- Merck admits there is no proof that HPV causes anal cancer (but this is a reasonable assumption given HPV's general association with cancers).
- Only about 2,000 male Americans per year get anal cancer -- so this a rare condition (although 73 percent of those cancers are associated with the HPV strain that Gardasil protects against).
And finally: Don't you just love Palefsky's quote about how women get a "two-fer" with Gardasil:
The new study results suggest that women who are vaccinated with Gardasil will get a "two-fer," said Dr. Palefsky, referring to protection against both cervical and anal lesions. He also noted that the subject of anal cancer in women is "coming more to light" since the related death of 1970s cultural icon Farrah Fawcett.Related: