Six months after the FDA rejected Merck and Co.'s request to approve the distribution of Gardasil - the HPV vaccine - to women aged 27 to 45, they've sent a response letter to Merck requesting that they resubmit their request after a full 48-month study. Merck's original application included research from a 24-month period.
As Shark Fu noted, January is Cervical Cancer Awareness Month, so I'm not too surprised that this update is being released now. The good news is that the end of the 48-month study will be by the fourth quarter of 2009. Let's just hope this will be enough.
In the meantime, Merck also requested FDA approval for its use in males last month. I'm definitely curious how that's going to play out.
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hmm, I recently asked my dr about guardasil. I'm 31. She told me that women my age are no longer at high risk for hpv viruses that cause cervical cancer . . . something about the cervix aging/changing/becoming harder or more wrinkly. Any chance that Merck just wants to sell more of this vaccine when it isn't actually needed?
I don't know, my obgyn said that the only reason it's only given to people up to 26 right now is because that's the age that the first studies stopped at, not because there's any medical reason for it.
It's all terribly new and difficult to sort through, isn't it?
I definitely believe that Merck is more concerned with making lots of moolah than they are with spreading awareness about HPV, but oh well. I still think this vaccine is a good thing nonetheless.
Approval for males would be excellent, because it has actually been found that HPV in males is linked to throat cancer. HPV doesn't just affect women, contrary to popular belief.
Agreed on the males thing. Men are at risk for penile, throat and anal cancer from HPV. HPV is very common, and condoms don't fully protect against it.
Gardasil protects against the 4 most common form of genital HPV. Do we think that the less common forms will "move in" and become more prevalant now?
Coming from Australia, where the HPV vaccine was distributed free to women under the age of 26, I find it incredible that it hasn't even been approved there yet. Even if it's not relevant for you, comet, that doesn't mean that it's not of benefit to whole generations of girls and women.
It HAS been approved in the U.S. for females ages 26 and under. It has not been approved for females ages 27-45 or for men.
"I definitely believe that Merck is more concerned with making lots of moolah than they are with spreading awareness about HPV, but oh well. I still think this vaccine is a good thing nonetheless."
To be fair, Merck gives away tons and tons of Gardisil for free. Hardly any of our patients pay for it.
While I think vaccinating against HPV is a wonderful, and much needed thing, I really feel that the vaccine needs to be re-formulated and re-tested. I've read conflicting things about the vaccine, and quite a few mention how one not-so-rare (still somewhat rare, but not rare enough to be ignored) side-effect is death, and some other ones are paralysis, etc.
I myself received the vaccine and had an allergic reaction to it (not nearly as bad as paralysis or death) but I had rashes on my face for about 9 months after the vaccine. Definitely not fun.
To be fair, I'm sure cervical cancer is much less fun than having rashes, but the vaccine doesn't necessarily prevent cervical cancer anyway--only preventing certain HPV strains that can lead to cervical cancer.
I would really love to see Merck or Gardisil address the issue of the safety of the vaccine and do something about it, but I am sure they won't. It seems really clear that they only trying to make money off of the legitimate fears of HPV and cervical cancer.
/rant.
I did find it kind of strange that women were jumping up & down when this came out, even though so much research was...missing. And given the sketchy track record of vaccines in general. Yet I found very little criticism of it.
I agree, Danyell. In fact, when it was made mandatory for junior high age girls in some states (coincidentally following Merck donations to the governors' reelection funds), there was a lot of hostility expressed toward parents who did not want their children to get the vaccine. It was very prevalent on this blog. All I can think is that Merck did a very nice job of passive marketing to quiet down the lack of research and work the masses behind the idea that you would have to be nutty not to get the vaccine.
Anyone who brought up the lack of research, the fact that a more comprehensive vaccine was in the works (at the time, it has since been released. Wonder if all those girls who got the first batch think they are protected or were told that they would need the new one just months later), or the immunological concerns was immediately accused of having a political or religious agenda -- because we can trust big pharmaceuticals!
It is interesting to see how people can be influenced so easily.