[links.health, links.sexuality]

[wispfox]

From fourgates, Merck's cervical cancer vaccine wins US approval. Unfortunately, it's currently only for women between 9-26, so I'm a little over their cutoff age.

Comments

[catya.livejournal.com]

i'm going to ask my dr for it anyway, we'll see!

[wispfox.livejournal.com]

Mmm! Point. Can't hurt to mention interest in it, in case it _does_ eventually become available to people outside that current group.

[brynndragon.livejournal.com]

Why the cutoff age, and why isn't it available to men (who can get and spread HPV, although it obviously won't give them cervical cancer)? Any ideas?

[wispfox.livejournal.com]

Based on a comment in joedecker's post about the same thing (but a different page), probably about what they've done trials on at this point.

He said (http://joedecker.livejournal.com/830356.html) "(Merck continues to do tests to prove safety and efficacy in other age groups, men, and so forth, so the range of indicated patients will quite possibly increase with time.)"

[joedecker.livejournal.com]

My understanding is that Merck did segregated tests on the vaccine based on age. They did find what I'm told is an unusually large differential in antibody response with respect to age between the kids and and the adults just within the 9-26 group, but I haven't read the study.

I believe that Merck attempted in their approval to pull in a higher cutoff age but the FDA sent them back for more work to demonstrate efficiacy there.

I did find the signups for the studies in SF for men, I'm too old for that particular study, but I suspect there's some combination of feeling like they have to check it's efficicacy/safety differentially, and starting with groups that they can get the most bang per buck (or most bucks) from... but I don't really know, I'm just speculating.

Also, there's some good data that Cerivax (GSK's still-to-be-approved entry into the HPV vaccine market) will have a broader age range. ref. Sorry I don't have more references still at hand, I have to run out for a hair appt.

[fourgates.livejournal.com]

I think they simply limit it to the populations where they can show efficacy, and it's a lot more work to show efficacy in the older groups. The dependent variable in these studies is not incidence of HPV but incidence of conversion from HPV- to HPV+ (well, there are several dependent variables, but they're essentially evidence for the same thing). Conversions are most frequent in the younger, more sexually active (more partners) years. So while 80% of all women may have contracted HPV by age 50, they're more likely to catch it while younger. Back to the base rates for conversions: if the conversion rate for people age 21-30 is 2% per year and the conversion rate for people age 31-40 is 1%, it'll take at least twice as many study participants to demonstrate positive effect from the vaccine with the same degree of certainty. It's not that the drug companies don't care about the older market; they just want to go at it in the most sensible order.

[joedecker.livejournal.com]

I think that's right, I believe it may also be possible that they started the different age-ranged trials at different times.

[szasz.livejournal.com]

We feel your pain. My girlfriend's out of that age range by less than one year. Hoping for some expanded approvals as they do more studies.

[phaedra-lari.livejournal.com]

In most cases, those sorts of approvals are recommendations - once the FDA approves something, doctors can usually do what they think best with it as I understand it.

[ayalanya.livejournal.com]

from my perspective: eeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeee!!!! *bounce*

from my perspective on your behalf: gah! what? why?

[wispfox.livejournal.com]

(the probable reason for why): http://wispfox.livejournal.com/638878.html?thread=4154526#t4154526

[kar0na.livejournal.com]

I hope this means they're close to finding a cure for HPV.

[wispfox.livejournal.com]

I don't _think_ vaccine means much in terms of actual cure, unfortunately...