(Disclaimer:  This blog entry contains sexually explicit information.)

How in the world is Merck gonna rebrand a product it has spent so much time, effort and money gearing toward females so that males will use it, too?

I'm not sure, but it'll be interesting to watch if or when MRK wins Food and Drug Administration approval of Gardasil for boys/young men.

This morning the company announced positive results from a big test of the vaccine on males. Gardasil is a $300-$400 set of three shots given over six months to prevent HPV, the most common sexually transmitted disease, which is the leading cause of cervical cancer.

But males carry and spread the virus, which can also cause other types of cancer (i.e. anal, penile and oral) that are less common than cervical cancer, but can be every bit as serious. Merck

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[MRK  Loading...      ()   ] says it plans to file for FDA approval of Gardasil for males by the end of this year. If all goes smoothly, the company could get the agency's go ahead around the middle or second half of 2009. Many analysts think it could reinvigorate sales growth of Gardasil which is, nonetheless, a blockbuster. But, again, I come back to the question of how Madison Avenue will sell it.

Gardasil for females has sparked a significant amount of social debate and controversy—i.e. critics say it promotes promiscuity, that vaccination should be up to the parents of underage children and not mandated by schools or governments and others have tried to stir up worries about the vaccine's safety. Recently, the Centers for Disease Control said there's no evidence the shots are harmful.

Here, Merck will face the challenge of convincing parents of minor males that Gardasil's worth the expense to prevent their kid(s) from getting genital warts, a very rare form of cancer and from spreading a virus to others (a chivalrous/common-good reason?). And I can just hear the schoolyard comments like, "Gardasil's for girls!", or "Gardasil's for gay guys!" HPV is a big issue for sexually active gay and bisexual men. But Dr. Howard Grossman at the Fenway Community Health Clinic in Boston told me that HPV is also a significant concern for straight men who he said are using (according to a recent study, in surprising numbers) anal sex toys.

In the third quarter Merck sold more than $400 million worth of Gardasil. But the company acknowledges it's been having trouble convincing young women between the ages of 19 and 26 to get the shots. Earlier this week, during lunch at a Cleveland Clinic conference, I was sitting at a table with an OB GYN who is an outspoken proponent of Gardasil. She mentioned a startling anecdote to a few of us sitting within earshot that she has encountered female patients around 20 years old who said their pediatricians had told them there was no need to get the vaccine because they'd be virgins when they got married.

Merck has its work cut out for it.

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