I don't believe in compulsory vaccination, but are you aware of how many young women are raped every year? I hate to say it, but an awful lot of them are below the legal age. Seems like if I were a parent, the choice to get my daughter vaccinated would be obvious.

Also, Eric, why aren't you worried about the vaccine for Hepatitis B? This vaccine prevents what is essentially a sexually transmitted disease, too -- and, far worse than Gardasil, it's administered even to infants. If we want sex to be dangerous, so that people will refrain from casual indulgence, then why don't we prohibit this vaccine too?

If I may speculate, I think what scares people about Gardasil is that it gives women more sexual freedom than it gives men. The Hepatitis B vaccine protects against a disease that strikes men as well as women, which makes it ok.

Jason,

You are incorrect to assume that I'm opposed to Gardasil in general. I do oppose making it compulsory (though I have no problem with mandating vaccination for contagious diseases). Otherwise, I am simply making a prediction about the controversy that will arise from it.

I do think you are correct that the possibility of rape will be the reason that many parents who expect their children not to become sexually active while in high school will justify vaccinating them against HPV.

As for Hepatitis B, it is much more easily spread by non-sexual contact than is HPV. For instance, in countries with a moderate prevalence of Hep B, it is predominantly spread among children.

Consider a different case. In South Africa frequently the husband goes to the city to work for a year, gets infected with AIDS, and brings the infection home to his wife.
Likewise HPV is not "an entirely avoidable disease." A woman can reduce her risk by staying chaste and trying to select a trustworthy husband, but the risk won't be zero.

Note that Merck plans to market this vaccine as cancer prevention not STD prevention. Long version of my thoughts are here.Short version is I think the case can be made for voluntary vaccination.I do not think they have made the case for mandatory vaccination for any reason other than vaccinating a large segment of the population produces "herd immunity" and increases the effectiveness of the vaccine.

What are the side effects?

Has anyone seen the "non-ads" for this product that have been airing long before FDA approval?
It speaks volumes about the drug manufacturing and marketing process that, even before FDA approval was obtained, Merck has been heavily pushing their black-and-white, public-service-announcement-style ad campaign to whip up a frenzy of worry over HPV's link to cervical cancer.

These ads don't explicitly push a particular product, which makes them look like Merck is actually doing some sort of public-service campaign -- except that they just happen to address the exact issue this not-yet-approved drug attempts to treat and urges women to "tell somone" about the terrifying problem.

The whole "tell someone" campaign looks like a campaign for public awareness -- except for the little Merck logo that appears at the end. Certainly makes one cynical . . .

What are the side effects?

According to the Merck press release, they are the following:

Vaccine-related adverse experiences that were observed in clinical trials at a frequency of at least 1.0 percent among recipients of GARDASIL and also greater than those observed among recipients of placebo, respectively, were pain (83.9 percent vs. 75.4 percent), swelling (25.4 percent vs. 15.8 percent), erythema (24.6 percent vs. 18.4 percent), fever (10.3 percent vs. 8.6 percent), and pruritis (3.1 percent vs. 2.8 percent).

Pretty typical for a vaccine. By the way, pruritis and erythema are medical terms for itching and redness. Difficulty breathing has also been reported "very rarely" according to the patient information sheet (http://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_ppi.pdf). As with any vaccine, there is a risk of an unexpected allergic reaction to one of the vaccine components.

Cervical cancer is the second-leading cause of death for women, and 80 percent of women will have acquired genital HPV infection by age 50. As Gardasil is "most effective when administered before the onset of sexual activity," I'd call this one a no brainer.

Correction, JohnS: Cervical cancer is the second-leading cause of cancer death for women (worldwide). Heart disease is the #1 killer in the US.

Correction, JohnS: Cervical cancer is the second-leading cause of cancer death for women...

Which still makes it a no brainer in favor of mass vaccinations.

But what about the studies linking vaccinations to the onset of other problems like autism and autism-cluster syndromes? I mean, cervical cancer is certainly a tremendous problem, but mandatory vaccination would be a problem as well.

This is from the Fred Hutchinson Cancer Research Center:

An important risk factor for cervical cancer is infection with certain types of human papillomavirus (HPV), the virus family that causes warts. Researchers have found a higher risk of cervical cancer among women who become sexually active at an early age and among those who have had many sexual partners. These behaviors likely increase risk because they contribute to a greater probability of infection by sexually transmitted microorganisms, including HPV. The risk of cervical cancer is also higher among smokers and women with weakened immune systems. Women who do not have regular Pap tests also face increased risk. It is currently believed that, in many cases, cervical cancer develops when two or more risk factors act together.

http://www.fhcrc.org/research/diseases/cervical_cancer/

There was another good article on the risk factors for cervical cancer that was just too long to copy, but this is the link: http://www.oncolink.org/types/article.cfm?c=6&s=17&ss=129&id=8226

The point is that this particular type of cancer seems to follow specific behaviors that are controllable: becoming sexually active at an early age, having many sexual partners, smoking, compromised immune systems, contraction of other STDs, organ transplants, Hodgkin's disease, etc. According to one site I checked, while only a very small percentage of women who have HPV will develop cervical cancer, almost all cervical cancers have evidence of HPV virus in them.

The recommendations are simple: get regular PAP smear tests and modify the risk factors you can control. Why introduce something new into your system, when so much can be accomplished without it?

But what about the studies linking vaccinations to the onset of other problems like autism and autism-cluster syndromes?

There are no peer reviewed studies that link autism to vaccinations. And least not on this planet.

Why introduce something new into your system, when so much can be accomplished without it?

Because the "new thing" is also something under your control and it stops the virus far more cleanly, safely and effectively than anything else.

Again, a no brainer.

"There are no peer reviewed studies that link autism to vaccinations. And least not on this planet."

Yet the anectodotal evidence persists. My parents know a couple in Michigan who had a child born with autism. The mother got a vaccine during her pregnancy (before she found out she was pregnant), and they later discovered that her getting the vaccine at that time was the most likely reason her child was born with autism.

"Because the "new thing" is also something under your control and it stops the virus far more cleanly, safely and effectively than anything else."

Under your control only if getting it is not made mandatory, which is one of the questions with the Gardisil vaccine - what if it's made mandatory before children are admitted to school?

And just because something has benefits in killing viruses "cleanly, safely and effectively" doesn't make it a good thing to introduce into your body. Antibiotics kill bacteria "cleanly, safely and effectively", yet we now have strains of antibiotic-resistant bacteria that we have few if any medications to treat. Where did the bacteria develop resistance to these "clean, safe and effective" antibiotics?

Yet the anectodotal evidence persists.

As do anecdotes about leprechauns, fairies and honest politicians. Doesn't make them real. Anecdotal evidence doesn't mean anything. Every time the claims for a casual link between vaccines and autism has been investigated, it's come up as bunk.

Vaccines don't cause autism.

...what if it's made mandatory before children are admitted to school?

Then it's effectiveness will increase dramatically, more people will be immune to HPV, and an unprecedented number of women and men will be saved from HPV related cancer and other illnesses across the lifespan. That's a good thing.

And just because something has benefits in killing viruses "cleanly, safely and effectively" doesn't make it a good thing to introduce into your body.

This vaccine stops viruses, stops pain, stops suffering, stops death without itself causing pain, suffering or death. I'm missing the bad here.

Where did the bacteria develop resistance to these "clean, safe and effective" antibiotics?

In our bodies, because we over proscribed their use. Instead of using them to kill off serious, harmful and deadly agents, we used them to treat things the body fights off well enough by itself. We've learned and are making serious changes, here and abroad.

The difference here is that vaccines prevent major illnesses, illnesses that cause lasting, permanent and often fatal damage to human beings.

Their use is a very, very good thing.

All of the snide rhetoric aside, you still haven't answered the question about why a vaccine for what is overwhelmingly a sexually transmitted disease, which can and should be controllable by behavior change first, should be mandated for administration to school-age children.

On the subject of the vaccination/autism debate, for further research, I've provided these links:

http://www.garynull.com/Documents/autism99b2.htm

http://www.jpands.org/vol11no2/ayoub.pdf

http://www.scoop.co.nz/stories/HL0503/S00089.htm

http://www.webmd.com/content/Article/81/97024.htm

http://www.ei-resource.org/Articles/autism-art06.asp

http://www.icpa4kids.org/research/children/autism.htm

Please note, too, that most of the information I've found denying a link between autism and vaccination focused on the vaccination of children; those studies finding a link evaluated the effects of the vaccination on pregnant women whose children developed autism.

Further, after the first studies came out with questions on a purported link between autism and vaccinations, manufacturers began eliminating thimerosal from the live virus vaccines.

The “no brainer” solution is actually a solution of the logical mind. The problem is that the human mind is not all knowing, and will never have all the information. Have you ever noticed that medical solutions provided by profit-driven Big Pharma usually lead to the need for yet more of their products?

I know this is probably too late to be of much benefit to the discussion, but I wrote more about this subject after the discussions here, because it's important. I'm certainly not the all-knowing fountain of wisdome for the universe, but it bothers me that so many people may be hurt - physically, psychologically - in the names of convenience and marketing.

Has anyone read this article as an additional argument within this discussion? Namely, how to ensure a 9-year-old doesn't already have HPV and how Gardasil can CAUSE cancer in those who have it already...
http://www.metaball.ca/ball_Dec-06/1206_04.html

Dear "no brainer" Eric Seymore,

Just curious about the concern of the high amount of aluminum that is part of the ingredients? Aluminum which is associated with Alzheimer's disease and seizures also cancer producing in laboratory mice (it is used as an additive to promote antibody response) The antibody response would, a no brainer, occur due to the need for the body to purge/neutralize a poison, not good. So common sense would dictate, would it not, that injecting something that 'could' cause alzheimers, and/or seizures, well, Not doing so would be a 'No Brainer' wouldn't it?

So I've been watching all these ads on TV telling people to find out about GARDASIL. And then I read that Merck was lobbying for this vaccine to become mandatory. Then I saw that the Texas governor is making this vaccine mandatory in Texas for preteens. So I finally decided to look into it.

Here's the scoop:

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 subjects were 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. This vaccine was just approved in June, 2006. It was never tested on pre-teens except in a tiny trial run with at most 18 months of follow up. Even if we subscribe to the theory that HPV causes cervical cancer, there is ZERO hard data showing that this vaccine reduces cervical cancer rates or cervical cancer mortality rates, which are both already very low in the US and getting lower every year. Now Texas has already made this vaccine mandatory for middle school with all sorts of useful idiots and Big Pharma operatives clamoring for more states to make this vaccine COMPULSORY immediately.

Has everyone gotten the picture or should I continue?

I came across your blog. Personally, I am livid that this decision came from Texas.

We're talking about a drug just approved less than a year ago!

UGH!

I have thoughts posted as well...
For Your Own Good

Perhaps we should trackback?

I have HPV and for those of you who think I contracted it because I was unprotected...your wrong. I could be your daughter, your neighbor, your sister--because apparently as my GYN as tried to comfort me with this is a VERY common STD and i've heard number that about 70 percent of the population has this. It is no comfort, especially when only a few years later, i was being told that i have cancerous cells on my cervix at only 23.

NO I DON'T BELIEVE IN MANDATING THE VACCINATION-we should have the choice of what is put into our bodies.

But I would have rather put up with a few simple side effect over crying in bed at night thinking that for the rest of my life I am going to be suffering from the unknown, and from something that no one ever told me you could catch while being protected.

MULL over that for a few minutes...because more people have HPV than are willing to discuss it, and when it is viewed at as a Cancer it is more socially exceptable to speak about than an STD.
Respectfully, Kathryn

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