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HPV Vaccine Approved For Women In Developing Countries

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sciencerules
07/09/09

In reply to HPV Vaccine Approved For Women In Developing Countries
Cervarix has been available for a while in the UK, just not in the states.

And this? IS AWESOME. 80% of cervical cancer deaths are in developing countries. This is going to be a huge boon to these women.
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anibundel
07/09/09

In reply to HPV Vaccine Approved For Women In Developing Countries
Ok, I want to state RIGHT NOW that the "Related Stories" feature on the side bar is an awesome idea. Unforch, it looks like it's searching for key words, and not content, which, like Google ads in your gmail, produces unintended hilarious results.
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Her Grace
07/09/09

@anibundel: I both like it and find it very cluttered-looking. It's a lot of stuff. I wonder if I can adblock the frame?
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Karkadann
07/09/09

In reply to HPV Vaccine Approved For Women In Developing Countries
The HPV vaccine is a bunch of crap. What they dont mention is the terrible side effects it produces, as well as the fact that HPV generally goes away on its own within two years at the most.

There is also no way in hell I would even consider trusting something such as this from a corporation that is hell bent on getting as much money from me as it possibly can, for the sole reason of keeping me just sick enough to keep comin back for more.
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sciencerules
07/09/09

@Karkadann: The side effects are pretty rare. Although you're right that 90% of HPV infections clear themselves in two years, it's the ones that linger that cause the cancer. And it's hard to tell if you're going to be the woman it lingers in.
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linnyt is a walking cliché
07/09/09

@sciencerules: I just got the first HPV vaccine shot last week. A few of my friends have had precancerous cells in their Paps and I feel like the benefits outweigh the risks.
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justfudgey
07/09/09

In reply to HPV Vaccine Approved For Women In Developing Countries
Can these really be called cervical cancer vaccines? After all, they don't work against cancer directly, but against cancers caused by HPV. Gardasil bills itself as a vaccine against HPV - not a cancer vaccine.
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Edited by justfudgey at 07/09/09 12:52 PM justfudgey was starred justfudgey was unstarred

hungryhungrycaterpillar
07/09/09

In reply to HPV Vaccine Approved For Women In Developing Countries
...but are the women in these countries asking for these vaccines, or do they have more pressing concerns? Unfortunately, pumping money into these (very well intentioned) programs often pulls it out of others. Unless Gates or some other foundation funds it, this might not be an entirely good news story...
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sciencerules
07/09/09

@hungryhungrycaterpillar: I think it's fantastic, mostly because 80% of cervical cancer deaths are in countries like this, mostly due to inadequate health care/screening. It's a pretty sweet way to save a lot of lives.
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Aleckto
07/09/09

@sciencerules: For real. The graphs showing the rate of cervical cancer after Pap smears were widely implemented in the US are just awesome -- it's clear when they started, since the rate just plummets afterward, where it was a pretty steady plateau before.
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hungryhungrycaterpillar
07/09/09

@sciencerules: Yes, but my point is that if women are dying from malaria, or TB, or unsafe water supplies, then an HPV vaccine's likely to be pretty far down the list of things that they want for themselves and their families. The cost of one of these vaccines may currently be saving many more lives than one, and it woudl be a great shame if the funds were diverted towards something that isn't supported by community perceptions of need.
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musicpup
07/09/09

In reply to HPV Vaccine Approved For Women In Developing Countries
I wonder if it was possible for GAVI to apply for funds with the Bill Gates Foundation? It was founded for such situations, no?
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Ipomoea
07/09/09

@musicpup: homeward bound: Gates Foundation hasn't really focused on STIs, from what I understand. World-wide, they're very much focused on wiping out malaria (I'm not sure if there's a reasoning behind that beyond malaria being something you are genetically more susceptible to, etc).
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vwbugirl
07/09/09

In reply to HPV Vaccine Approved For Women In Developing Countries
AH F. Every time I hear about HPV vaccines I get terribly angry. I got it right before Gardasil came out. Thank goodness others wont feel the same way soon.
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philoclea
07/09/09

@vwbugirl: Well.... I got it too, though a few years before the vaccine. Still, cervical cancer is *so* totally preventable with regular check-ups (I say this having had a scare) that it's not a tragedy to have HPV. But it does mean we have to be really good at taking care of ourselves.
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shorty63136
07/09/09

@vwbugirl: Gardasil has also been known to help women shed the virus. Sometimes you do shed it on your own but the vaccine does help, depending on which strains you were positive for in the beginning.
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lilredpanda
07/09/09

@philoclea: Exactly. Women in these countries don't have widespread access to quality healthcare, so we need tools to prevent HPV and other infections (in addition to figuring out ways to improve access to care).
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ngoandy
07/09/09

@shorty63136: Do you have any references you can supply for Gardasil helping shed the virus?

I've never heard that before.
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shewar
07/09/09

@vwbugirl: So did I, though clinicians still insist it would be helpful to get the vaccine since it's not possible to determine which strains of HPV were contracted, and it could still protect against the ones that I haven't. However, the $360 isn't only prohibitive to women in developing countries.
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shewar
07/09/09

@ngoandy: I'm curious about this too. My understanding is that if you've got a healthy immune system, you'll eventually suppress the virus and have normal paps. However, like any virus, you never get rid of it.
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BlondeGoddess
07/09/09

@philoclea: And your body often clears up an HPV infection by itself.
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shorty63136
07/09/09

@ngoandy: Studies and such? No. It's probably too early for that. But in the conversation I had with my gyno, she let me know that she has been re-testing her HPV-positive patients who received Gardasil and many are testing negative for any strains. I was also one of those patients. But in my case, she isn't sure if I shed it on my own or as a result of the Gardasil. I hadn't asked her for a re-test between the initial one and the time I completed the Gardasil and was re-tested. It was probably 2 or so years between.
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Edited by shorty63136 at 07/09/09 1:31 PM shorty63136 was starred shorty63136 was unstarred

TheGintheCity
07/09/09

@shewar: Exactly. My insurance doesn't cover any "adult immunizations" and I was at the top of the age range, so I said forget it.
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MissMoneypenny
07/09/09

@shewar: Paps don't test for HPV, they test for abnormal cervical cells that are signs of early cancer. Most women don't get tested for HPV routinely. Your body does clear the infection, but lasting damage to the cells of your cervix can cause cancer.
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Blueberry26
07/09/09

@ngoandy: My gyno said the same thing ... I also know that when I volunteered with Planned Parenthood they I was told that it was recently discovered that the virus can go away by itself after awhile. Or rather, the cells it has infected die off without leaving behind more virus to infect other cells. I haven't seen any research on it, but this is what I heard from PPAZ
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sciencerules
07/09/09

@Blueberry26: That's true. Your immune system can also take care of the infection. 90% of HPV infections clear within two years.
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shewar
07/09/09

@MissMoneypenny: I'm aware they don't test for HPV. I've gone through the whole process, unfortunately. But a pap coming back abnormal pretty much indicates that you've contracted HPV. Then comes the colposcopy, biopsy, etc. And you don't "clear" a virus. It is not possible. Your symptoms (if any) disappear. You develop antibodies, thus suppressing the virus. It becomes latent in your body, and should stay that way unless something seriously compromises your immune system.

Doctors have been so confused about cancer-causing strains of HPV since they surfaced within the last decade. I've been told so many conflicting opinions by respectable MDs over the past 6 years that I feel like my head will explode.
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Aleckto
07/09/09

@shewar: No, you get rid of viruses all the time. You might be thinking of herpes viruses, some of which (like the herpes or chicken pox viruses) hang out in your nerves for the rest of your life. And you retain antibodies against the viruses you've been exposed to for most, if not all, of your life. But you can get rid of HPV, completely, on your own -- the vaccine just might speed up the process.

(Basically, the HPV hangs out in skin cells, where there are fewer white blood cells around to see them and kill the skin cells. Having the boost of a vaccine, which primes the white blood cells to kill infected skin cells, may help them get rid of the infected cells faster, before they can be damaged by the virus. The virus affects the DNA of the skin cells they infect, which is what can cause the abnormalities or dysplasia that can later become cancer.)

Sigh. I wish I were better at not sounding like a science textbook.
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Edited by Aleckto at 07/09/09 5:02 PM Aleckto was starred Aleckto was unstarred

shewar
07/09/09

@Aleckto: Every medical text I've read on this subject claims that a virus is always in your system. Why would HPV be different? (I'm not arguing here, I'm genuinely interested!) In the case of HPV, it "clears" when you no longer find it in a test. However it still resides in your body, in very small amounts. I've also read that most of us contain very small amounts of the Herpes virus, and a negative test just means you fall below a certain number.

This actually has me wondering... is contracting the virus and "clearing it" somewhat similar to getting the vaccine itself? You've created the antibodies and sufficiently suppressed it. Are you more or less safe from developing cervical cancer (assuming you contracted all of the strains that cause cancer)? Of course the vaccine is still helpful in preventing warts, or whatever cancer causing strains you may have not contracted.
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margareita metermaid
07/09/09

In reply to HPV Vaccine Approved For Women In Developing Countries
This is great news...though I wish the vaccine could work for more than just teenaged/early twenties women. Correct me if I'm wrong, but isn't it only recommended for those who haven't been sexually active?
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musicpup
07/09/09

@margareita metermaid: The reason it's recommended for women and girls who haven't been sexually active is because you'd be immunizing them before they can be exposed to the virus.
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alouette
07/09/09

@margareita metermaid: I think initially, but now more and more young women (late teens, early 20s) who have had sex are getting it. So maybe the guidelines changed, I'm not sure.
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colormeroutine
07/09/09

@margareita metermaid: Because it's only preventative, and almost everyone who's been sexually active for a while already has HPV exposure
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Madlenka
07/09/09

@margareita metermaid: It's my understanding that it's equally as effective for everyone who hasn't been exposed to the virus, and not effective (or as effective) if you have been exposed. Because of the high cost, it's only recommended for women that aren't sexually active because they have definitely not already been exposed to the virus. So, women who are sexually active may have already been exposed, thus reducing its overall efficacy. Essentially vaccinating someone who has already been exposed to the virus is waste of money, and insurance providers/those paying for the vaccine don't want to absorb that waste. Corrections to that understanding of it are more than welcome.
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Edited by Madlenka at 07/09/09 12:53 PM Madlenka was starred Madlenka was unstarred

shorty63136
07/09/09

@margareita metermaid: No, they recommend it based on age, not virginity status. I got Gardasil at age 22 (maybe I was 23) and had already been sexually active and had 3 strains of HPV (not the ones outlined in the Gardasil vaccine though).
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margareita metermaid
07/09/09

@musicpup: homeward bound: yeah, I figured that part of it, but i was hoping perhaps that had changed (maybe the vaccine had been found to also work for sexually active women), especially since a lot of women in developing countries don't have as much of a say in when they become sexually active or visit the health care clinics.
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schweppes
07/09/09

@margareita metermaid: I'm pretty sure it's b/c the clinical trials were only done for women in their 20s - so the FDA can't approve it for men or women older than that. It's less a matter of it being less effective and more a matter of government regulations - my OBGYN has vaccinated men, and vaccinated women in their 30s (I asked about it last time I went, apparently I'm chatty). So, yes, everyone should get it ! Even if you already tested positive for HPV, there are a bunch of strains in the vaccine!
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FrabjousDay
07/09/09

@margareita metermaid: It *can* be given to older women, but it's not as effective. Plus there's a huge concern that it actually makes HPV that's already present in your system worse. The FDA reported that if you've already been exposed to HPV (and what, 80% of people have, I think?) that the efficacy rate is negative 47%. That's why they're trying to give it to girls before they become sexually active.
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shewar
07/09/09

@margareita metermaid: Capping the age limit at 26 always seemed incredibly arbitrary, as if that is the oldest one could possibly still be a virgin. It's assumed that you've been slutting it up for years and have already contracted everything you possibly could.
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CherriSpryte
07/09/09

@schweppes: This is true. And my OBGYN will vaccinate women regardless of age as well - not sure if they'll provide it to men, though.
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thesciencegirl wields the truth like a mighty axe.
07/09/09

@schweppes: I think you're absolutely right. The FDA will only endorse its use for the demographics tested, thus the age specification. It doesn't necessarily mean that the vaccine is ineffective for older people (though if it is less effective in previously exposed people, that does obvs. correlate with age).
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Edited by thesciencegirl wields the truth like a mighty axe. at 07/09/09 1:19 PM

Ipomoea
07/09/09

@schweppes: My OBGYN at Planned Parenthood told me that even though I was outside the age range (and thus insurance wouldn't cover it), they were doing a lot of vaccinations on men and older women who were willing to pay out-of-pocket for it. I'm thinking that's what I'm going to give myself for my 29th birthday.
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Her Grace
07/09/09

@FrabjousDay: Cite, plz.
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FrabjousDay
07/09/09

@Her Grace: Sure. Can't find out how to hyperlink it, I'm afraid you'll have to copy and paste the link : http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4222B3.pdf.

There's a chart on page 13 that tracks observed efficacy for women who were HPV-positive when vaccinated, -44.6%!!!

[EDIT] Oops, I noticed that earlier I accidentally said -47%, I messed up the number a little.
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Edited by FrabjousDay at 07/09/09 4:42 PM FrabjousDay was starred FrabjousDay was unstarred

Madlenka
07/09/09

In reply to HPV Vaccine Approved For Women In Developing Countries
This is great news. I can't even express how insane it seems to me that there exists a vaccine for cancer and it's not widely available.

Yes, yes, yes, I know why it hasn't been; my statement was unabashedly normative.
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sequined
07/09/09

In reply to HPV Vaccine Approved For Women In Developing Countries
Is this vaccine, like Gardasil, also a 3-shot regimen? I ask A. because I didn't see it in the blurb and am curious and 2. because I think the six-month window is/could be a deterrent for people (like those of us who are under-insured, for instance). Just wonderin'.
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BlondeGoddess
07/09/09

@sequined: Plus, they might have to travel far for a clinic. So my guess is, it's a one-shot deal.
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musicpup
07/09/09

@sequined: I believe they're all three-shot regimens. My concern is also whether the long time window would discourage women and girls from getting immunized, not to mention that the rate of sexual assault and rape are so high in developing countries that it would seem unlikely for the women and girls to have NOT been exposed to HPV.
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anonanimal
07/09/09

@sequined: Definitely could pose some difficulty. I didn't get my last shot because I don't have health insurance anymore. Hopefully it is just a one-shot.
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Callipegian
07/09/09

@anonanimal: This happened to me too - I changed jobs (and insurance carriers) after my second shot two years ago, and never got around to getting the third shot. I got dx'ed with HPV last month. :/ And I had insurance and a car the whole time!

I'm sure this is going to be a challenge for women in developing countries to get access to / prioritize, but hopefully the local WHO / health NGO outfits will help publicize it properly.
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lilredpanda
07/09/09

@sequined: The six-month window would definitely be a deterrent for women who have to travel a long distance to a clinic (and thus spend time away from work or family obligations). At least in my public health experience, it's a lot easier to figure out how to pay for something than it is to encourage a community to accept a new prevention tool, especially if it's inconvenient.
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shorty63136
07/09/09

@anonanimal: Did they make you pay for the shots individually? Usually, insurance companies pay either after the first shot or pony it all up after the last shot. But if you are covered from the first shot, I am almost positive that your insurer is REQUIRED to let you finish the series. I would definitely check into that.
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BlondeGoddess
07/09/09

In reply to HPV Vaccine Approved For Women In Developing Countries
It's approved for developing countries, but not for America?
Does this say more about the vaccine or the FDA?
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PinkSoxHat
07/09/09

@BlondeGoddess: The FDA isn't exactly a model of efficiency.
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Spaceman Bill Leah
07/09/09

@BlondeGoddess: I'd say it's politics/FDA. Things can take much longer to be approved in the US vs. Europe even, not just the developing world.
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anonanimal
07/09/09

@BlondeGoddess: I'm not even sure. That statement made me feel a bit uneasy. Does this mean that there may be something defective with the vaccine, or that it just takes the FDA a long time to approve it?
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margareita metermaid
07/09/09

@BlondeGoddess: maybe because the pharm companies think americans should pony up for the cost of gardasil-- make the money where they think they can? And also, more chances of getting sued in the USA over faulty testing if the drug causes some kind of side effect?
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philoclea
07/09/09

@BlondeGoddess: Yikes. Good point.

Still, it seems the gains to be made are greater in developing countries... so I'm ok with that being prioritized.
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thegogglesdonothing
07/09/09

@BlondeGoddess: That's pretty common. There are quite a few drugs commonly used in Europe that aren't approved for sale in America - 'not approved' doesn't necessarily mean 'dangerous or bad'. I'd imagine that they're working to get FDA approval.
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VioletBeauregarde: Party Pooper Extraordinaire
07/09/09

@BlondeGoddess: I was wondering that myself. I wonder how extensive the testing process was before the drug began being offered, and whether this has anything to do with it not being offered in the US. Or perhaps it has more to do with drug company competition.
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justfudgey
07/09/09

@anonanimal:
The FDA is very, very slow. There is a huge amount ton of paperwork, studies, audits, etcetera involved with any new product, especially pharmaceuticals or invasive devices/products.
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FrabjousDay
07/09/09

@BlondeGoddess: Cervarix hasn't been approved in the U.S. yet because Gardasil has a patent that disables anyone else from marketing an HPV vaccine for another three or four years, I think. Which is ridiculous because so far, Cervarix seems to be a safer option.
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Edited at 07/09/09 1:02 PM FrabjousDay was starred FrabjousDay was unstarred

BlondeGoddess
07/09/09

@anonanimal: That's what I was wondering. I'm saying this, because the US and Europe have dumped so many meds in Africa with serious side-effects, meds that couldn't get approved, that were over the sell-by date, etc.
Although this sounds like a genuine effort. If they can solve the logistic part of it.
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BlondeGoddess
07/09/09

@FrabjousDay: That just makes me so mad!
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BinderClip
07/09/09

@BlondeGoddess: A lot of big-pharma companies have been testing products on the 'developing' world for years, now. My mother ran an NGO in Sri Lanka and a number of the women with whom she worked were part of a Depoprevera (sp?) trial in the late '70s and '80s. They have to test it on SOMEONE in order to tinker with it, and the human subjects regulations are much less strict in non-Western countries. So I wouldn't be surprised if that were the case here.
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shorty63136
07/09/09

@FrabjousDay: Pharmaceutical companies are granted patents for 11 years from the time that the FDA approves them. They can also file appeals (stating that they haven't recouped R&D and marketing monies) AFTER those 11 years, granting them another 1 to 3 years of exclusivity. This actually makes sense b/c it prevents companies from coming in and creating a generic (basically making a clinically equivalent copy) after letting the big pharma company spend all the money and do all the leg work in getting it approved, marketing it, and distributing it. That stuff costs millions upon millions of dollars to do initially. I do think that 11 years is a bit excessive. I would've gone with 7, depending on the drug. I believe Valtrex is up for generic status in 2009 though.
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