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FDA reviews HPV vaccine for older women

GARDASIL.jpg The FDA has promised a speedy review of Gardasil, the HPV vaccine, for women over 26 years old.

The designation means that the U.S. Food and Drug Administration is expected to make its decision on the marketing application within 6 months, rather than within the agency's typical 10-month review period.

Nice. Because let's not forget that 25% of women in the U.S. (yes, grown-ups too) have HPV. Now we just have to see if the FDA sticks to their schedule. Hopefully the "controversy" factor will be a bit less since this about adult women.

Posted by Jessica - March 20, 2008, at 08:12AM | in Health , Sex

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22 Comments

[0+] Author Profile Page TexasMomma said:

I think that's great! I'm 26 and right at the cut-off age, and I'm really interested in getting it.

I'm married and have been in a monogamous relationship since I was 18, so my risk factors are not high, but goodness forbid I'm ever exposed to HPV through sexual assault or through sexual contact if the hubby and I ever divorce. I think it's just common sense to protect yourself if you've got the option, and this is definitely something I'll be discussing with my doctor.

[0+] Author Profile Page katie.virginia said:

I'm right before the cut off age for the vaccine. Fortunately, my top of the line insurance will pay for one shot a year. I paid for my second shot last year and this year my shot was free. It is about $300 all together. Unfortunately, I did have the cervical problems a couple of years ago and my Dr. said the vaccine would prevent any more of that. I wish they had the vaccine before I went to college.

[0+] Author Profile Page katie.virginia said:

I'm right before the cut off age for the vaccine. Fortunately, my top of the line insurance will pay for one shot a year. I paid for my second shot last year and this year my shot was free. It is about $300 all together. Unfortunately, I did have the cervical problems a couple of years ago and my Dr. said the vaccine would prevent any more of that. I wish they had the vaccine before I went to college.

[0+] Author Profile Page katie.virginia said:

I'm right before the cut off age for the vaccine. Fortunately, my top of the line insurance will pay for one shot a year. I paid for my second shot last year and this year my shot was free. It is about $300 all together. Unfortunately, I did have the cervical problems a couple of years ago and my Dr. said the vaccine would prevent any more of that. I wish they had the vaccine before I went to college.

Is there anyone else out there who ISN'T getting the vaccine? I'm well below the cut-off age, but the speed with which the FDA approved the vaccine, and especially the pushy, fear-mongering ad campaigns made me think twice about shelling out for three shots that made most of my friends pass out and feel like shit for days.

[0+] Author Profile Page spatiallydiffusedbudgie said:

As my brother says, maybe men should be vaccinated too. He is worried by reports that men who 'give oral pleasure' might develop mouth cancer.

He's a dear.


[0+] Author Profile Page spatiallydiffusedbudgie said:

As my brother says, maybe men should be vaccinated too. He is worried by reports that men who 'give oral pleasure' might develop mouth cancer.

He's a dear.


[0+] Author Profile Page EG said:

I want this to go through quickly. My doctor has no problem giving me the shots, but my insurance may not cover it because I'm not in the right age group, and I don't have 450 bucks to throw around.

$450? Here somewhere in Europe it costs almost twice as much and it's not covered by any insurance at all. And the median monthly wage would be around $1100. (The average is like $2500 but I haven't seen a living employee who gets as much.)
Now tell me about expensive.
Actually my parents were pushing me into getting this vaccine when it came to the market. I sent them to hell with such idea. When they offered to pay it for me, I told them to give me the cash, that I'll find a better way how to spend it. Luckily, they found some other hobby after few weeks :D
I hear, however, that in Germany it's covered from the public health insurance and that they even invite people to go and get the vaccine.

[0+] Author Profile Page EG said:

Sure, I'll tell you about expensive when it comes to healthcare. I'm on medications for asthma and depression, and with my insurance, I spend 200 bucks a month on the meds I need. If I did not have insurance, those meds would be...let me see...fourteen hundred dollars a month. Median yearly wage for women is 23,500, which, monthly, is...2000, less taxes, take-home would be around...oh, 1500. And nobody's even visited a doctor yet.

Seriously, Europeans should not get into a health-care-costs argument with Americans.

IncredibleKates: From what I understand, the speed with which the vaccine was approved had everything to do with the bureaucracy and nothing to do with the safety of the drug.

Also, your friends feeling like shit has nothing to do with the vaccine. It is impossible for the virus present in the injection to reproduce and the volume is such that soreness of the injection sight is the greatest short-term effect. Besides, wouldn’t you rather feel like shit for a few days for the sake of GREATLY reducing your risk for cervical cancer? If you’re sexually active, it’s near to certain you will get at least one type of HPV at some point in your life. Further more, getting this vaccine isn't just about you. It has no known negative side effects, so why not suck it up and get the shot to benefit yourself as well as those countless folks effected by your sexual decisions.

spatiallydiffusedbudgie: It would be wonderful if insurers covered it for men. Too bad most don't.

It is very telling that this vaccine was approved for girls and younger women first. It shows what the HPV vaccine is really about: keeping sexy, young (sometimes VERY young)women sexually available, and and able to bear children. Why wasn't this money spent on, say, breast cancer research? Because breast cancer is a disease that usually affects older women. Who cares if our mothers, grandmothers, parters, and role models die. If they can no longer reproduce, then they have outlived their usefulness. (Not to mention that men can't get breast cancer through sexual contact.) The fact that this drug was approved for 12 YEAR OLDS before it was approved for women over 26, just shows that the this vaccine is really about keeping women sexually available, rather than women's health. HPV can be prevented through abstinence; maybe HPV could be prevented in 12, 13, and 14 year olds by NOT HAVING SEX WITH THEM!

Heller, are you joking? you have to be, right?

Initial research showed Gardisil as ineffective in older women. Besides, with the very high prevalence of HPV in women age 14-59, it makes plenty of sense for emphasis to be put on the vaccination of younger women.

With the huge mess this vaccine has faced, we should frankly be thankful it's even out on the market. With plenty of people thinking "HPV can be prevented through abstinence," it's remarkable that Gardasil even jumped its hurdles.

i work in HPV/cervical cancer research, and our research group was just talking about this the other day.

long story short, there is no proven benefit to giving the vaccine to older women. the reason the FDA has sped this one through is so Merck can make more money [they're still trying to recover from the vioxx debacle a few years ago].

giving the vaccine to young women has nothing to do with preserving "young sexy women" and everything to do with biology - the vaccine is most effective when given before women become sexually active.

and that 25% figure is over a woman's entire lifespan, not at any given time [e.g. 25% of you will have an HPV infection at some point in your life]. most HPV infections resolve on their own; there is only cause for concern when the infection becomes persistent. for older women, getting tested [and keeping a close eye on things if positive] is more effective than getting vaccinated.

Cuddlebot3000: I usually see the 25% figure representing "at any given time."

"According to a 1997 American Journal of Medicine article, nearly three in four Americans between the ages of 15 and 49 have been infected with genital HPV at some point in their life."

I have no intention of getting this vaccine anytime soon, either, IncredibleKates. I don't trust the FDA for a second. I'll wait a year or so until some class actions hit the courts or some buried PMA studies surface.

Also, I did NOT understand all the fervor over mandatory vaccination last year. Since when should the government be allowed to pump its likely oblivious, legally unchoosing children full of drugs it shoddily regulates? Or, hell, full of ANY drugs, for that matter? How is legislating eleven-year-old girls' bodies any more forgiveable than legislating adult women's bodies? (At least the adult women had some role in voting those legislators into office, after all.)

Funding for lower-income people to get the shots if they want, sure. Government mandates that anyone, adults or schoolkids, get a particular Big Pharma player's shots, no.

However, re: Cuddlebot3000: Huh? Merck escaped its Vioxx headache easily, paying just $5.85 billion to settle it all when hasing it out (or settling later) could have cost upward of $20 billion. I really doubt that was a huge concern of the FDA in approving Gardasil, especially since Vioxx didn't exactly polish the agency's reputation, either.

Dio -

for the study i'm working on, we collect all the HPV+ specimens that are tested here at the lab [i work in a lab at a large HMO, where all HPV clinical specimens are tested]. our positivity rate is 5-7%.

bear in mind, there are something like 70 strains of genital HPV, but only 15 that are considered "high-risk" [the HPV test only captures the high-risk strains], so the waters get kind of muddy when speaking of "genital HPV." the 3/4 figure probably 1) includes all genital HPV strains, not just the high risk ones, and 2) is not limited to women.

so i guess with that in mind, that 25% figure originally cited could also include all genital HPV strains, even though most of them are asymptomatic infections and not cause for concern.

have i sufficiently confused everyone yet?

everybodyever -

all i know is the running joke is that HPV stands for "help pay for vioxx."

the fact of the matter is that the HPV vaccine is of no benefit to older women. at the same time, there is no harm in giving it to them either [save your wallet. $450 is nothing to sneeze at] - the vaccine has demonstrated minimal side effects. it has already been validated in study after study, so there is essentially nothing left for the FDA to do other than sign off on the different demographics to recommend [read: market] it to.

cuddlebot3000: thanks for the clarification. Makes perfect sense.

everybodyever: I work for a NYC law firm on Vioxx litigation. 4 years ago, most expected the Vioxx debacle to be the end of Merck altogether. 4.8 billion seems small compared to $20 billion, you're right, but Merck invested HUGE amounts of money into Vioxx. R&D, marketing, distribution, etc. plus the massive amount of money they paid and are still paying defense attornies. The settlement alone nearly eqauls Merck's annual operating budget. The settlement and the loss of Vioxx is no small hit on the company.

You have reason not to trust the FDA, and with current Tort reform, you'll soon have more, but please go out and educate yourself on Gardasil and Gardasil research before you mak a final decision not to get the vaccine.

[0+] Author Profile Page angelicdemon said:

I'm amazed at the low understanding practically everyone has about HPV and what it actually is and how many people actually have it!

The HPV shot isn't a bad idea, but why aren't we promoting cervical health and pap smears? We all know that because you have the shot doesn't mean you are going to not get cancer as 30% of cervical cancers are thought to be caused by other factors than HPV.

not only that, if we actually tested for high risk HPV DNA in abnormal pap smears we could detect cancer earlier as well. A study showed that performing such tests would result in 55% more cases being detected earlier.

In Canada, however, there are not many labs which have the instrumentation to test for retroviral DNA.....

This issue is not so much a big deal in northern rich countries where pap tests are (generally) readily available. however, there are a lot of myths regarding pap tests. There are people who believe you should only get pap tests after you start having sex. Uh, what? Pap tests should be performed on every woman no matter her sexuality or status.

Unfortunately for us, we live in a society where pharmaceutical companies have a lot of power. It's ridiculous knowing that these people will go at any length to protect people who should be getting regular pap tests but will completely ignore women in the poorer states where cervical cancer is one of the main killing cancers in women!

"HPV can be prevented through abstinence; maybe HPV could be prevented in 12, 13, and 14 year olds by NOT HAVING SEX WITH THEM!"

Sorry heller, although it is absolutely true that we can prevent the spread of HPV (and, for that matter, many other types of STIs) with abstinence, this is complete bullshit. Abstinence-only practices are poor and only cause fear, dramatisation and keep everyone uneducated about their reproductive rights as well as their own health. We should educated our children instead of risk, healthy relationship practices, how to say no to sex, what types of sex exist and why respecting your partner is important. We should also show them what types of birth control exist, empower them to talk about sexuality and sex with their partners and with others in a positive way.

Oh as for the percentage of people who have HPV.. I've heard that's highly debatable. I've been told as many as 75% of the population who is sexually active will get HPV at least once in their lives, and if you have sex with a partner who has had other partner(s).

All in all, HPV vaccines can be useful, but I'm appalled to hear that doctors are telling their patients that it will more than likely rid of a chance of getting cervical cancer.

angelicdemon:Pap tests should be performed on every woman no matter her sexuality or status.

The medical recommendations in my country suggest that women have their first pap smear 2 years after their first sexual experience. Doctors here refuse to do routine pap smears on virgins.

Thank you to Dio and ? for setting me straight. You are right, I did not know that gardisil doesn't work in older women. And yes, I realize abstinence is not the complete answer. (And yes, abstinence only policy etc. is RIDICULOUS!) I should have said something more like, we, as a society, need to stop sexualizing young girls. (Yes, I was trying to be a little disgusting and incendiary by saying "We should stop having sex with them.") And I still believe that our patriarchal society tends to focus on women's health issues that affect men's ability to have safer sex with us. But, overall, I stand corrected.

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