Sunday, October 5, 2008

Three Shots and You're Vaccinated

I had my final injection last Friday, I noticed only the slightest tenderness at the injection site (not having noticed any the first two times.) This completes my vaccination process.

At this point, Merck's ongoing Phase III study of Gardasil in men continues, I'll report when and if results are published, or as other related news comes out.

Wednesday, May 14, 2008

HPV and oral cancers in men

HPV linked to more than half of throat/tonsil cancers in men. When will the Gardasil men's studies reach their endpoints? How much longer do we have to wait?

Monday, April 21, 2008

Second Shot

Had my second injection today. It got delayed a couple days after a minor dental thing, the next injection is four months from now.

I didn't follow up after the first injection, I should say that I didn't notice any side-effects at all, I suspect the second one will go the same way.

I had a lovely discussion with the nurse who did the injections, she's involved with writing protocols for the clinic, and said I was to give her a ring if I got any trouble about the injection. I said that I expected some confusion but that everyone had been cool and reasonable about it.

I guess I should say more about this. Off-label use of any sort of procedure or medication is going to raise eyebrows, particularly if a medication someone has only ever seen given to (say) women is being given to men. Given the serious danger of error in any sort of medical prescription, it's only right that unusual applications of medications, particularly off-labels ones, should raise enough attention for people to at least double-check that the prescription was, say, written correctly. This isn't bias or discrimination, it's just good "systems engineering" to make sure that the chances of medical error are reduced. I don't sweat it, if you find yourself in my position, you shouldn't either.

Monday, February 18, 2008

First shot

Last Friday I dropped by the medical foundation for the first of my three Gardasil shots.

I noticed no side-effects, it's possible that there was slight swelling that was hard to see from my point-of-view of the injection site on my left shoulder.

The nurse injecting me, as well as the paperwork, made a point of referring to the shot as "the HPV vaccine" rather than by its product name. I wondered about this for a while, but surmise that a generic name like that is more likely to trigger a "wait a minute" response in case of error, so I can see at least one possible point.

Next injection is two months from now, the one after is four months later.

Wednesday, February 13, 2008

Apppointment

First injection at 10:15 Friday. Making the appointment was a little strange, I ended up having to call to make the appt. with the injection clinic, and I could, early in the call, hear what I imagine was confusion on the part of the person I was talking to, eventually she said this might be the first injection of a guy done at their facility. Interesting!

Saturday, February 9, 2008

HPV and oral cancer

This article discusses HPV being the cause of an increasing proportion of cases of oral cancer in men, likely both because of an increase in oral sex, as well as a decline in smoking, reducing the number of smoking-related oral cancer cases.


That same article notes that Merck intends to ask for FDA approval to use Gardasil on men sometime in 2008, other reports I've seen say the studies they have might still not apply to my age group.

Friday, February 8, 2008

Going for It!

My doctor has agreed to give me an off-label Gardasil vaccination, and I have just indicated to her that I'd like to proceed with it.

Okay, now, some important disclaimers:

I am absolutely not recommending that you follow my lead, or do not follow my lead in this. I am by necessity working with limited information. I will share with you my thinking, but only for completeness sake. I am not a doctor. My doctor did not recommend that I have this vaccination. The FDA has not approved it for use in patients like myself.

Those disclaimers aside, do I think this is a good idea for me?

Let's break it down. I think there are two basic concerns. Safety and efficacy. On top of that, there's are just costs (time and money, it won't be covered by insurance), and meta-concerns.

First, safety. Published tests only cover Gardasil safety in women. Two things give me additional comfort here, but they should not necessarily be something *you* take for granted. First, Merck has been running for several years a test on men. These tests have not been released to the public, but Merck has announced it intends to ask for approval for men this year in any case. While I have no illusions that Merck would not push for approval of a borderline safety case, the completion of the study, combined with the rarity of gender-specific safety issues in similar vaccines, make my comfort in the general safety of this choice strong.

Second, efficacy. I am far from convinced that this will be effective. The number I keep pulling out of my ass is about 30%, reflecting that the vaccine is effective in younger unexposed women, but lacking additional data on older people and men, and without any actual evidence that I have or have not taken on various HPV strains. I'd almost be surprised if I'd never taken on HPV in some strain or another at this point in my life. Moreover, Herpevac, IIRC, a HSV vaccine, was shown to be effective in women and not men, there's some precedent for gender-specific activity, although that may or may not reflect the differences in the anatomy. Very little is known (or at least published) about effectiveness with respect to anal, penile, throat and mouth cancers. So, I pull "30%" out of my ass. That's enough that it might make a difference to me, or a partner, or a partner's partner someday, but far from anything certain. If I'd come up with 10%, I wouldn't be doing this. If I'd come up with 70%, I would have pushed for this sooner.

Price: I'm paying for this out of pocket. *shrug*. The three injections are going to run me about $360, as I understand it. But that's why I have money, to make my life better. I'm not particularly cost-sensitive, of course that's an issue for most folks.

Other terms: One concern my doctor expressed, not so much as an accusation as a "I would be concerned if X, but I don't imagine that's your way.", was that I'd presume efficacy and change my behavior based on the thought that the vaccine was effective when it might not be. This both has implications for my own health and my partners, and this leaves me, I feel, with an ethical duty to not only explain to potential partners why they should not feel particularly "safer" because I've done this. And I think that's probably right.

Anyway, I weighed it all, and there, the decision is made, the die is cast. Wish me luck. Wish us all luck, a successful vaccine that prevented oral, throat, penile anal and cervical cancer in large swaths of the population would be a very great thing indeed.

Welcome!

Gardasil, Merck's HPV vaccine, currently has approval for use in the US "on-label" for younger women. This vaccine has the potential to make a difference not only in the landscape of cervical cancer, but also, possibly, other cancers that both men and women might be at risk for--oral, throat, penile and anal cancers all seem to have some correlation with HPV infection.

For this reason, I explored being vaccinated with Gardasil "off-label" with my doctor. This blog will talk about the vaccination process and some of the issues surrounding Gardasil as well as off-label uses of Gardasil, particularly in men.

Now, the issues here are complex, and I'm using this blog to explore them and share them, but you should take everything here with a great deal of skepticism, for reasons that I will be elaborating on in future posts.

Until then, welcome.