Some Common Sense About the HPV Vaccine

Stickdog is, of course referring to the actual effectiveness of Gardasil, not claiming that No One dies of cervical cancer. Approx. 4000 women will die of it this year. Gardasil is going to be given to girls age 11-12. It's effective duration is supposed/hypothesized to be five years. It protects against only two strains of HPV, which make up 10% of HPV cases. Sure, it may be beneficial. But only if you haven't had sex yet. And then just until your daughter is 16 or 17? This Is A Perry/Merck scam on Texans. It should be able to purchased by any Texan parent who wants it for their daughter, and will be.

But it is not some wonder drug that needs to be mandated to be given to every young girl in Texas to prevent an epidemic. This drug has only been tested for 7 years upon approx. 27,000 test subjects. I don't believe that my daughters should be used here in Texas as the first mass test subjects for millions of vaccinations and their possible side effects.

There's a lot of Texas parents out there with no religious considerations on this one, who think this is a very, very bad idea.

@Ben
Respectfully, it seems as though you're arguing for much improving sex ed, too. Boys certainly do contract HPV.

As for them being "much more into their own health"--I can't fathom what you mean, but if it means they're less likely to seek treatment then that argues even more for immunization, and early.

@ Stickdog
As to cervical cancer not being deadly--well I guess it's just fine to condemn a proportion of the population to cervical scrapings, painful and somewhat risky surgeries, and costly cancer treatments then?

Ever had a blister agent applied to your genitals?

I dated a woman who had contracted both HPV and cervical cancer. I watched her endure three surguries while doctors carved eight inches off the end of her cervix over a four-year period. I sat while she twisted kleenex after kleenex to shreds as we waited to find out whether she would have to go again. I held her hand while doctors used lasers and electrical arcs to excise warts.

I am deeply suspicious of Merck, but Gardasil is cheap at the price if it works as advertised. Hell, it's worth it even if it only stops genital warts, which your summation says it does 97.5% of the time.

And if being vaccinated might possibly encourage a few young women or men to get laid a year earlier, big whoop. It's still at least as effective as some alternatives.

A few extra orgasms over the course of a lifetime have not been proven to have any deleterious effect. HPV on the other hand ...

In medical cost vs. benefit modeling (which strongly informs national medical public policy making and far too strongly informs the medical policies of HMOs), the most critical component is a value called "cost per life year gained."

If the cost per life year gained is under $50,000, that is generally considered a decent investment by US medical policy makers. If "cost per life year" gained is over $100,000, that is generally considered a wasteful medical policy because that money could surely be put to much better use elsewhere. Yes, this is cruel and heartless to some degree, but wide scale medical cost allocations do need to be made and, more relevantly, are continually made using these cost plus risk vs. benefit analyses. Think HMOs. Now consider why pap smears, blood tests and urine tests aren't recommended every month for everyone. Testing monthly could definitely save more than a few lives, and there is no measurable associated medical risk. But the cost would be astronomical versus the benefit over the entire US population when comparing these monthly tests to other therapies, procedures and medicines.

Now on to GARDASIL. By the time you pay doctors a small fee to inventory and deliver GARDASIL in three doses, you are talking about paying about $500 for this vaccine. And because even in the best case scenario GARDASIL can confer protection against only 70% of cervical cancer cases, GARDASIL cannot ever obsolete the HPV screening test that today is a major component of most US women's annually recommended pap smears. These tests screen for 36 nasty strains of HPV, while GARDASIL confers protection against just four strains of HPV.

Now let's consider GARDASIL's best case scenario at the moment -- about $500 per vaccine, 100% lifetime protection against all four HPV strains (we currently have no evidence for any protection over five years), and no risk of any medical complications for any subset of the population (Merck's GARADSIL studies were too small and short to make this determination for adults, these studies used potentially dangerous alum injections as their "placebo control" and GARDASIL was hardly even tested on little kids). Now, using these best case scenario assumptions for GARDASIL, let's compare the projected situation of a woman who gets a yearly HPV screening test starting at age 18 to a woman who gets a yearly HPV screening test starting at age 18 plus the three GARDASIL injections at age 11 to 12. Even if you include all of the potential medical cost savings from the projected reduction in genital wart and HPV dysplasia removal procedures and expensive cervical cancer procedures, medicines and therapies plus all of the indirect medical costs associated with all these ailments and net all of these savings against GARDASIL's costs, the best case numbers for these analyses come out to well over $200,000 per life year gained -- no matter how far the hopeful pro-GARDASIL assumptions that underpin these projections are tweaked in GARDASIL's favor.

Several studies have been done, and they have been published in several prestigious medical journals:

http://dx.doi.org/10.1001/jama.290.6.781
http://tinyurl.com/2ovy95
http://tinyurl.com/2tbuma

None of these studies even so much as consider a strategy of GARDASIL plus a regimen of annual HPV screenings starting at age 18 to be worth mentioning (except to note how ridiculously expensive this would be compared to other currently recommended life extending procedures, medicines and therapies) because the cost per life year gained is simply far too high. What these studies instead show is that a regimen of GARDASIL plus delayed (to age 21, 22, 23, 25 or 27) biennial or triennial HPV screening tests may -- depending on what hopeful assumptions about GARDASIL's long term efficacy and risks are used -- hopefully result in a modest cost per life year savings compared to annual HPV screening tests starting at age 18.

If you don't believe me about this, just ask any responsible OB-GYN or medical model expert. Now, why do I think all of this is problematic?

1) Nobody is coming clean (except to the small segment of the US population that understands medical modeling) that the push for widespread mandatory HPV vaccination is based on assuming that we can use the partial protection against cervical cancer that these vaccines hopefully confer for hopefully a long, long time period to back off from recommending annual HPV screening tests starting at age 18 -- in order to save money, not lives.

2) Even in the best case scenario, the net effect is to give billions in tax dollars to Merck so HMOs and PPOs can save billions on HPV screening tests in the future.

3) These studies don't consider any potential costs associated with any potential GARDASIL risks. Even the slightest direct or indirect medical costs associated with any potential GARDASIL risks increase the cost per life year gained TREMENDOUSLY and can even easily change the entire analysis to cost per life year lost. Remember that unlike most medicines and therapies, vaccines are administered to a huge number of otherwise healthy people -- and, at least in this case, 99.99% of whom would never contract cervical cancer even without its protection.

4) These studies don't take in account the fact that better and more regular HPV screening tests have reduced the US cervical cancer rate by about 25% a decade over the last three decades and that there is no reason to believe that this trend would not continue in the future, especially if we used a small portion of the money we are planning on spending on GARDASIL to promote free annual HPV screening tests for all low income uninsured US women.

5) The studies assume that any constant cervical cancer death rate (rather than the downward trending cervical cancer death rate we have today) that results in a reduced cost per life year gained equates to sound medical public policy.

As I said before, if any of you don't believe me about this, please simply ask your OB-GYN how the $500 cost of GARDASIL can be justified on a cost per life year gained basis if we don't delay the onset of HPV screening tests and back off from annual HPV screening tests to biennial or triennial HPV screening tests.

The recommendations are already in: http://tinyurl.com/33p9q6

The USPSTF strongly recommends ... beginning screening within 3 years of onset of sexual activity or age 21 (whichever comes first) and screening at least every 3 years ...

Even if they don't agree with having consensual sex before marriage or whatever, they should think about their daughter getting raped. Well then she would worry about getting cancer the least, but heck why risk it?
Or are we in Iran where the woman is guilty for being raped?

My goodness, it's just protection... Those people freak me out.

Or what about a married woman whose husband cheats, gets the virus, then gives it to his wife? Or perhaps the wife is guilty of making her husband cheat and therefore deserves to get a virus that could give her cancer? Sheesh, the vaccine makes perfect sense to me, it's disgusting that anyone opposes it.

A thought on the opt-out clause: They don't like it because if you deliberately refuse to get your daughter vaccinated and then she gets cervical cancer down the road, she will remember that you took steps to prevent her from preventing the disease. And blame you.

So she is supposed to blame the government for not forcing her parents to vaccine her...

This is very good news, but this is a sexually transmitted disease, and women are only half of the story. To get a strong 'herd immunity' effect, the boys need to be vaccinated too.

Actually that's not true. Boys wont get it, so they wont be vaccinated.

Simple is it? Treat people who need to be treated. It is like pregnancy. I cant get that, so I wont take the Pill.

Hepatitis is something I can get, so I use a cute little rubber hat. Btw: There are more people dying from Hep than from AIDS.

Ben - that's false. Males can indeed get HPV. While it obvioulsy doesn't cause cervical cancer, it can cause rectal cancer in men who have anal sex, and it has been associated with other cancers, which men can also get.

Besides which, in being vaccinated you are protecting your partner/s.

Actually that's not true. Boys wont get it, so they wont be vaccinated.

It has been shown time and time again that males are carriers. as is clearly implied by the phrase 'sexually transmitted disease'.

The Facts About GARDASIL

1. GARDASIL is a vaccine for 4 strains of the human papillomavirus (HPV), two strains that are strongly associated (and probably cause) genital warts and two strains that are typically associated (and may cause) cervical cancer. About 90% of people with genital warts show exposure to one of the two HPV strains strongly suspected to cause genital warts. About 70% of women with cervical cancer show exposure to one of the other two HPV strains that the vaccine is designed to confer resistance to.

2. HPV is a sexually communicable (not an infectious) virus. When you consider all strains of HPV, over 70% of sexually active males and females have been exposed. A condom helps a lot (70% less likely to get it), but has not been shown to stop transmission in all cases (only one study of 82 college girls who self-reported about condom use has been done). For the vast majority of women, exposure to HPV strains (even the four "bad ones" protected for in GARDASIL) results in no known health complications of any kind.

3. Cervical cancer is not a deadly nor prevalent cancer in the US or any other first world nation. Cervical cancer rates have declined sharply over the last 30 years and are still declining. Cervical cancer accounts for less than 1% of of all female cancer cases and deaths in the US. Cervical cancer is typically very treatable and the prognosis for a healthy outcome is good. The typical exceptions to this case are old women, women who are already unhealthy and women who don't get pap smears until after the cancer has existed for many years.

4. Merck's clinical studies for GARDASIL were problematic in several ways. Only 20,541 women were used (half got the "placebo") and their health was followed up for only four years at maximum and typically 1-3 years only. More critically, only 1,121 of these subjects were less than 16. The younger subjects were only followed up for a maximum of 18 months. Furthermore, less than 10% of these subjects received true placebo injections. The others were given injections containing an aluminum salt adjuvant (vaccine enhancer) that is also a component of GARDASIL. This is scientifically preposterous, especially when you consider that similar alum adjuvants are suspected to be responsible for Gulf War disease and other possible vaccination related complications.

5. Both the "placebo" groups and the vaccination groups reported a myriad of short term and medium term health problems over the course of their evaluations. The majority of both groups reported minor health complications near the injection site or near the time of the injection. Among the vaccination group, reports of such complications were slightly higher. The small sample that was given a real placebo reported far fewer complications -- as in less than half. Furthermore, most if not all longer term complications were written off as not being potentially vaccine caused for all subjects.

6. Because the pool of test subjects was so small and the rates of cervical cancer are so low, NOT A SINGLE CONTROL SUBJECT ACTUALLY CONTRACTED CERVICAL CANCER IN ANY WAY, SHAPE OR FORM -- MUCH LESS DIED OF IT. Instead, this vaccine's supposed efficacy is based on the fact that the vaccinated group ended up with far fewer cases (5 vs. about 200) of genital warts and "precancerous lesions" (dysplasias) than the alum injected "control" subjects.

7. Because the tests included just four years of follow up at most, the long term effects and efficacy of this vaccine are completely unknown for anyone. All but the shortest term effects are completely unknown for little girls. Considering the tiny size of youngster study, the data about the shortest terms side effects for girls are also dubious.

8. GARDASIL is the most expensive vaccine ever marketed. It requires three vaccinations at $120 a pop for a total price tag of $360. It is expected to be Merck's biggest cash cow of this and the next decade.

These are simply the facts of the situation as presented by Merck and the FDA.

For a more complete discussion on GARDASIL with sources, click on my name.

I actually never think about people having anal sex. Well I seem to have a limited view on that on.

Still it is easier to vaccine women, as they will get cancer.

And actually doubt men are as eager to get a vaccination as women are. Just because they are much more into their own health.

Hey I agree, it'd be best to vaccine em all, but then you may want to see, that it wont work out, as the vaccine has not yet been approved everywhere. So maybe it'd be better to tackle the problems where we can, not where we cant or rather not as well.

Hey Stickdog, I'll be sure and tell my friend who is dying of cervical cancer right here in the US because it was diagnosed late that you said cervical cancer isn't deadly. I'm sure she'll feel much better after that.

stickdog,

Cervical cancer has decreased in incidence and mortality because of vigilant diagnosis (with pap smears) and aggressive treatment, not becaus anything about the underlying rate of infection has changed. One point of vaccination is to eliminate the need for such surveillance, and for invasive procedures (cone biopsies etc) to treat pre-cancerous lesions.

The other, and more important point, is that surveillance does occasionally fail, as Kristin's story can attest. And no, it isn't always the woman's fault that she didn't get a pap smear. Sometimes the rate of spread would have been too quick for regular surveillance anyway. CDC's 2002 stats: 12085 cases, 3952 deaths.

The study design you apparently think ideal would be unethical, since precancerous changes in the control group have to be treated according to the standard of care. That's why no one died.

In the interest of more rational argument, you also might want to compare the rates and costs of paps, colposcopies, biopsies, hysterectomies, etc to the cost of the vaccine.

Merck has a history of fudging facts on research. They are being invetigated by the justice department for fraud regarding VIOXX.

The research regarding Guardasil is scanty. None of the research was done in the United States. Merck only began testing this vaccine last Decemember in Japan. That study only involves a hundred girls.

I don't have a problem with making this vaccine available to all who feel that the gains associated with Guardasils ability to protect against two of the twelve forms of HPV far outweigh the risks associated with the fact that not much is known about the long term effects of Guardasil.

Opt out is a cop out. Everyone who objects to their kid being used as test subject will be forced to check the box called religious objection. If the school does not have the parents opt out the girl may recieve the shot anyways.

Scientists should be ethical. It is not ethical to compell girls ,using a heavy handed mandate, to participate in a pharmaceutical experiment.

Also Guardasil only theoretically might stop cervical cancer. Guardasil only stops two forms HPV. This does not make Guardasil a cervical cancer vaccine. Cervical cancer is terrible but it is not a plague. It not contracted in a school classroom or during casual contact. Very few women contract cervical cancer. So basic human rights should not be thrown out the window over a vaccine for HPV.

Thankyou Mandy, I couldn't have said it better myself,I have a daughter that will turn 11 this year and I have no intention of using her as a test subject.But for these reasons you get called every name in the book and accused of not caring about your child. I love my child deeply and I'm not going to follow the trendy and vaccinate now and ask questions later. Ive seen alot of propaganda supporting this vaccine but nothing about the vaccine itself. Alot about cervial cancer but nothing about how the vaccine works, the tests involved in determining IF it works, or anything about long term effects.I mean how would they know if their subjects came in contact with hpv. Did they expose these women to it? not to mention the way pharmacuetical companies get their many drugs
"approved" is questionable at best. The panel that makes these recomendations have been shown to have a vested interest in the said drug doing well on the market, which should be illegal but the FDA claims they need people associated with the products to give informed opinions.It all sounds really shady to me I don't trust these companies as far as I can throw them because make no mistake about it their # 1 concern is for their shareholders profits. It wouldn't be the first time they threw out negative test results cause they didn't turn out the way they hoped. These jerk aren't going to be happy til' everyone in the world is taking some kind of pill they make.By the way I'm not a conservative christian, I am a believer in God and I'm perfectly aware that my child will have sex sooner or later probably before marraige but lets hope all the money we're pouring into safe sex education will pay off just a little.

been shown to have a vested interest in the said drug doing well on the market, which should be illegal but the FDA claims they need people associated with the products to give informed opinions.It all sounds really shady to me I don't trust these companies as far as I can throw them because make no mistake about it their # 1 concern is for their shareholders profits. It wouldn't be the first time they threw out negative test results cause they didn't turn out the way they hoped. These jerk aren't going to be happy