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Wednesday, May 16, 2007

HPV Vaccine, Right of Girls To Health

By Tracee Sioux

I have been a little surprised at the reaction to a vaccine for HPV (human papillomavirus virus), which causes cervical cancer.

I suppose I thought most of the planet, like me, have spent some time hoping that mad-scientists will eventually eradicate cancer. So, when I heard they had an actual vaccine, Center for Disease Control , Approximately 20 million people are currently infected with HPV. At least 50 percent of sexually active men and women acquire genital HPV infection at some point in their lives. By age 50, at least 80 percent of women will have acquired genital HPV infection. About 6.2 million Americans get a new genital HPV infection each year.

My brain is trying to wrap itself around the fact that 80 percent of ALL women will acquire a form of HPV.

Hypothetically, this means out of my grandmother, mother, self, daughter and sister only one of us will NOT be infected. I’m going guess my 83-year-old grandmother might be the safe one.

You know what the whole argument feels like to me? It feels like the same hypocritical puritanical judgment we have always inflicted on our girls and their sexuality.

If you weren’t a slut you wouldn’t get cervical cancer. Serves you right!

However, in this case, it is patently unjustifiable. A girl’s virtue will not keep her from contracting HPV. There is a large population of girls at risk of contracting HPV through cheating or abuse.

A woman is at risk for dying of cervical cancer if she has the bad luck of being married to an adulterer.

* Though they vary from study to study, the most widely accepted figures indicate that between 50 and 70 percent of married men (between 38 and 53 million men) have cheated or will cheat on their wives, according to Ruth Houston, the author of “Is He Cheating on You?-829 Telltale Signs.”

Sexual abuse victims are also at risk of contracting HPV, which can develop into cancer.

* During FFY 2005, an estimated 899,000 children in the 50 States, the District of Columbia, and Puerto Rico were determined to be victims of abuse or neglect. Approximately 9.3% of them were victims of sexual abuse, according to the U.S. Department of Health and Human Services, Children’s Department, 2005 Child Maltreatment report.

* Twenty percent of teenage girls and young women have experienced some form of dating violence, according to the United States Department of Justice Office on Violence Against Women.

Not requiring the vaccine is unfairly denying basic healthcare to ALL girls period. According to the intercourse is not required to contract the HPV virus. One should assume that many young girls participate in foreplay or sexual experimentation for years prior to having actual sex.

Condoms or other contraceptives do not prevent the spread of HPV because an exchange of fluids is not required to pass the virus from person to person. HPV can be spread from skin to skin and condoms do not cover all contagious areas.

The only thing to protect girls from cervical cancer is the Gardasil HPV vaccine. The vaccine prevents 70% of cervical cancer. Other drug companies are developing similar vaccines which may be more or less effective.

What breaks my heart is the inevitable image of a woman in her early 20s finding out that she may die or never be able to conceive because she contracted this virus. Maybe she had sex with her steady boyfriend in high school and they broke up and she married her college boyfriend and they became a typical young married couple who goes to church every Sunday. Oh, but instead of wearing a scarlet letter “A” she gets to fight cancer. With chemotherapy, hair loss, infertility and possible death.

This cancer kills around 26% of women who are diagnosed with it.

Maybe her parents are people with conservative family values, or maybe her insurance company won’t cover it because the state doesn’t require it to enter school, or her parents are just ignorant and irresponsible.

Either way, no girl deserves to die of cancer because she had sex, not even a promiscuous girl. The punishment, and really lets just admit it’s punitive to deny someone basic healthcare in an attempt to prevent sex, is not equal to the crime.

This scare-tactic method of encouraging abstinence has been ineffective in the face of AIDS, pregnancy and every other sexually transmitted disease. Why, would we think that it would be effective just because cancer is in the forbidding sentence? Adolescents have no sense of mortality. They have no sense of future long-term consequences. It’s the curse and blessing of the teenager that they are blissfully unaware that they will ever be 30.

Nor is cervical cancer or HPV a natural consequence or an unforeseeable circumstance from having sex anymore. No more than having babies is a natural consequence of sex. I have sex all the time, but we have chosen to have only two children and have used information and scientific advancement to prevent the natural consequence of children. Now that we know what causes cervical cancer and we know we can vaccinate girls against it, then there is deliberate harm in withholding the vaccine. Now that we have the knowledge and access to a vaccine, cervical cancer is now a natural consequence of neglecting the health of our girls.

I don’t agree with the argument that it’s the parents’ right to choose whether or not their daughter should be vaccinated. I believe it is every girl’s absolute right to be protected from cervical cancer. The only way to ensure that a girl has access to her right to basic health is for the government to require the vaccination.

The reason all vaccinations are required to enter school is to prevent the spread of communicable diseases that pose a significant health threat to society. HPV and cervical cancer represent a significant health threat to ALL girls, promiscuous or not, and HPV is a very wide-spread communicable disease.

The reason the immunization should be given upon enter the sixth-grade is because a lot of sexual experimentation occurs in junior high school. By high school, for a lot of our girls, it’s already too late. By the time a girl reaches 26, coincidentally around the same time she’s considering marriage, so many girls have already contracted the virus the CDC doesn’t even recommend the vaccine.

The reason parents, in general, are not a good option to guard their daughters’ health in the case of HPV and cervical cancer is that parents usually aren’t the first to know about their daughters’ sexual activity. If seven out of 10 girls have sex by the time they are 17, it’s reasonable to assume that six of those girls’ parents don’t know about it.

Texas was the first state to confront the issue. They confronted it with puritanical judgment and a complete denial of reality.

I encourage you to write your legislature, governor and health department and request that the vaccination be required for girls in your state.

If you’re a parent, please be pro-active and responsible for your daughter’s future health by getting her immunized against the HPV virus. This is a prime teachable moment to talk to young girls about the potential consequences of sexual experimentation in an honest and open way. I really believe if we are open and honest with girls about sex, instead of punitive, forbidding and secretive then we will be much more effective in encouraging them to make better decisions about their sexuality.

8 comments:

JayMonster said...

I have twice written on this subject already here and here. In short I am simply astounded by the way people are so wiling allow cancer to go unchecked in this case, just for political points or some strangely odd religious view that just because someone receives this vaccination it is somehow a "license" for a woman to have sex.

To me, it is at best, simply another example of treating women as second class citizens. If this was an inoculation for men, it would already be covered and done with. (Since we all know boys are "unable to control their urges" and hence need to be protected).

There is no valid reason I have seen given yet that justifies not making this a mandatory inoculation for all girls (and for it to be covered 100% by insurance as well).

mhatrw said...

Despite the idiotic rhetoric of conservative nuts, there are a lot of good medical reasons to wait before mandating a vaccine that was approved less than a year ago based on only two years of clinical results.

For example, the most recently release clinical results are very disappointing.

To summarize this published medical journal article:

1. In the FUTURE I trial, GARDASIL demonstrated no clinical efficacy among the general subject population for overall reduction in the rates of grade 2 and grade 3 cervical intraepithelial neoplasia and adenocarcinoma -- the only recognized precursors to cervical cancer.

2. In the larger FUTURE II trial, GARDASIL demonstrated no clinical efficacy among the general subject population for overall reduction in the rates of grade 3 cervical intraepithelial neoplasia and adenocarcinoma -- the strongest (and many would argue only valid) precursors to cervical cancer.

3. Extrapolating from GARDASIL's very limited clinical "success" (in the FUTURE II study only) against grade 2 cervical dysplasias (40% of which regress spontaneously), 129 women would be have to be vaccinated (at a cost of about $60,000) to prevent a single grade 2 cervical dysplasia.

4. GARDASIL's protection against cancer associated HPV strains 16 and 18 appears to cause a disproportionate increase in of pre-cancerous dysplasias associated with other HPV strains associated with cervical cancer "raising the possibility that other oncogenic HPV types eventually filled the biologic niche left behind after the elimination of HPV types 16 and 18."

5. Even if look only at the FUTURE II results (in which for some reason GARDASIL performed better among the general female population), we are talking about just a 17% decrease in all high grade dysplasias -- many of which would spontaneously regress without treatment. So we would have vaccinate 129 women (at about $500 for the three shot regimen) to avoid a single, eminently treatable dysplasia. That's about $60,000 per dysplasia prevented.

This is all directly from the article linked above.

I myself would add that we currently have only 3 years of follow up to go on in terms of both GARDASIL's safety and efficacy among the 16 to 26 year female population, no data concerning its efficacy among 9 to 12 year old girls and only 18 months of follow up on less than 600 total preteen girls in terms of safety data about GARDASIL within its targeted population.

Also see : The Journal of the American Medical Association and The Wall Street Journal

It appears that the vaccinated cohort sees a 20%+ increase in high grade cervical dysplasias caused by cancer-associated HPV strains other than HPV 16 and 18. One possible explanation is that HPV 6 or HPV 11 infections are antagonistic to more dangerous HPV infections.

So Sioux Me said...

The stdies I've read indicate that they have followed 11,000 girls for 5 years. How many more years should girls be exposed to a cirus that causes cancer?

I'm no Doctor. But, neither are most parents of girls. Is there a risk? Absolutely.

However, the vaccine has been approved by the FDA, which is not infallible, but is definately a lot more equipped than the majority of parents to determine the safety vs. risk factors of this vaccine.

mhatrw said...

Your information is wrong. The best efficacy data that exists for GARDASIL (by far) was just released, and includes just three years of follow up. Furthermore, parents who leave these decisions up to the FDA instead of informing themselves about the actual clinical data are letting FDA politics determine their childrens' health.

GARDASIL is a new vaccine from Merck that has now been clinically shown to strongly protect against two dangerous, cancer associated HPV strains -- HPV 16 and HPV 18 -- for at least three years among women previously unexposed to these strains. HPV 16 and HPV 18 are currently associated with 70% of all cervical cancer cases. Medical experts hope that this means that GARDASIL could potentially end up reducing cervical cancer contraction rates by as much as 70%. So far, the limited clinical evidence available tells a very different story.

Because so few women contract cervical cancer and because cervical cancer's average latency period after initial HPV infection is over 20 years, it would take hundreds of thousands of subjects and/or decades to conclusively demonstrate that GARDASIL actually reduces cervical cancer in any population. Therefore, the end points used to demonstrate GARDASIL's effectiveness against cervical cancer in GARDASIL's two biggest studies (FUTURE I & II) were chosen to be the number of high grade cervical lesions -- or alternatively, the number of patients with high grade cervical lesions -- prevented over a 3 year period. High grade cervical lesions consist of grade 2 and grade 3 cervical intraepithelial neoplasias and all adenocarcinomas in situ. Among women in the USA, the vast majority of high grade cervical lesions either regress spontaneously or are successfully treated. However, the FDA currently considers high grade lesions to be acceptable surrogate outcomes for cervical cancer.

Here are the most recent and by far most comprehensive clinical results for GARDASIL in terms of reduction of high grade cervical lesions over a three year period.


For the general 16 to 26 year old population

FUTURE I

For the unvaccinated group, there were 194 total high grade lesions diagnosed -- 101 associated with HPV 16 & 18 and 93 associated with other dangerous, cancer causing HPV strains. For the vaccinated group, there were 182 total high grade lesions diagnosed -- 76 associated with HPV 16 & 18 and 106 associated with other dangerous HPV strains. That's a 6% overall decrease high grade HPV lesions but a 14% increase in other dangerous unprotected HPV strains for the vaccinated group.

FUTURE II

For the unvaccinated group, there were 361 total high grade lesions diagnosed -- 207 associated with HPV 16 & 18 and 154 associated with other dangerous, cancer causing HPV strains. For the vaccinated group, there were 281 total high grade lesions diagnosed -- 103 associated with HPV 16 & 18 and 178 associated with other dangerous HPV strains. That's a 22% overall decrease high grade lesions but a 16% increase in high grade lesions associated with dangerous unprotected HPV strains for the vaccinated group.

In terms of individual subjects rather than lesions (some subjects had multiple high grade lesions), vaccinated patients were 17% less likely to develop high grade cervical lesions overall but 15% more likely to develop high grade cervical lesions associated with dangerous unprotected HPV strains.

Combined FUTURE I & II

For the unvaccinated groups, there were 555 total high grade lesions diagnosed -- 308 associated with HPV 16 & 18 and 247 associated with other dangerous, cancer causing HPV strains. For the vaccinated groups, there were 463 total high grade lesions diagnosed -- 179 associated with HPV 16 & 18 and 284 associated with other dangerous HPV strains. That's a 16.6% decrease in overall high grade lesions but a 15.0% increase in high grade lesions associated with dangerous unprotected HPV strains for the vaccinated group.


For the sub-population of subjects who tested negative for both HPV 16 and 18

FUTURE I: Merck did not publish these results.
FUTURE II: Vaccinated patients were 27% less likely to develop high grade cervical lesions overall and at most 8% more likely to develop high grade cervical lesions associated with dangerous HPV strains other than HPV 16 & 18.


For the sub-population of subjects who tested positive for either HPV 16 and 18 or both

FUTURE I: Merck did not publish these results.
FUTURE II: Vaccinated patients were 9% less likely to develop high grade cervical lesions overall and at least 105% more likely to develop high grade cervical lesions associated with dangerous HPV strains other than HPV 16 & 18.


This is not an opinion. These are Merck's very own published clinical results for FUTURE I and FUTURE II.

So Sioux Me said...

Obviously, you are well versed medically. I'll avoid discussing the clinical studies and address my main concern.

You said,
"parents who leave these decisions up to the FDA instead of informing themselves about the actual clinical data are letting FDA politics determine their childrens' health."

My response to that would be that the vast majority of parents do not look up any drug company's clinical data to determine whether or not they get their children vaccinated against any virus. In fact, the majority of parents based ALL of their children's healthcare decisions on what the FDA approves and what their pediatrician recommends and what shots are required for their kids to go to school. We kind of have to as we have no medical foundation to dispute or prove any of it - we, mere mortals which hold no medical or science degrees.

If, in fact, the FDA judges the vaccine to be safe - which they have. If my pediatrician recommends it for my daughter - which she does. If it prevents girls from contracting certain virus' that cause cervical cancer - which you know, I have to trust the FDA, drug company and pediatrician since I'm unqualified as a medical professional.

Then I believe it's morally wrong to withhold a girl's health to prevent her from having premarital sex. And I believe it's a method that is ineffective and may cost some girls their lives.

Obviously, even if the state does require the vaccine upon entry to school parents, like yourself, who have the background to disect the clinical research can "opt out" of having your daughter vaccinated.

Threat Assessment & Response Canada said...

Hi, Tracee.

Thanks for your carnival submission. I'll post the link to your post on Monday.

I like your blog and have linked you to my blog.

Just so you know, I don't bite (unless bitten first) and if, while you are visiting my blog, you see something that you have questions about, or if there's something you wish we'd write about and haven't, your comments, questions and suggestions are most helpful.

I think we are both interested in accomplishing some similar things.

Laurie

Janet said...

Hey Tracee,
It's good to see you so fired up about this subject. Having worked for a company that creates the tests that screens for cervical cancer I have an opinion on this subject. Mind you it is my own opinion and not necessarily one that my former employer shares.

My opinion is this, we should be doing all we can to stop cervical cancer. The annual pap test is a wonderful way to ensure this. In fact it is a rather excessive screening test if you ask the UK. Their National Health Service (NHS) only requires testing once every three year. Why? Because cervical cancer is one of the slowest forming cancers out there. Meaning, it could take anywhere from 6 to 10 years to develop and therefore if the cancer or pre-cancerous cells are missed on a pap test, 3-6 years later there’s a likely chance those cells are still in their pre-malignant stage.
HPV is the lead cause of cervical cancer, fact. But, just because one has HPV doesn't mean they'll get cancer. So this is the debate, do we make it a mandatory vaccination, and screen for HPV with every pap test? I don't think so and this is why. I am morally apposed to companies making money off of this, and deceiving the average person into think they need it. They’ve got you so fired up about this, that you become their advocate and force the medical industry to adopt their product and line their pockets. Can a person get cervical cancer having tested positive for HPV? Yes, but rarely. Does testing positive for HPV mean you have cervical cancer? Absolutely not. All testing positive for HPV means, is that the doctor will then perform an unnecessary colposcopy, a very painful and invasive procedure I might add for the young 12 year old girl, when it's not necessary. It just costs more and the insurance prices go up. Very, very few women develop cervical cancer before the age of 20, and still not many develop it before they're 30. It's a slow growing cancer.

The medical and pharmaceutical companies will argue that with the slight chance of testing positive for HPV and then having it develop into cancer is reason enough to screen and vaccinate every woman. So, the drug companies are taking advantage of this fact and setting their prices high. Testing positive for HPV is a way for medical companies to make a buck. And that my friend is the real reason they are pushing so hard to 1- get the FDA backing and 2- motivate the public. Their ploy is to get the individual to go and ask their provider for the screening, who in tern turns to their laboratory, medical and insurance companies and demand the service. Which, in the end, is how they make their money. Just because a product is FDA approved doesn’t mean everyone needs to have it. All the FDA is saying is that the product is not harmful and in fact has some beneficial value to it.
The HPV vaccine is a wonderful medical breakthrough, but it is not an end all cure all for cervical cancer, nor will it keep women free from developing cervical cancer. There are many strands of HPV and this test/vaccine only picks up just a few of those strands. That all gets complicated, but the fact is that it is not the final answer we’ve all been looking for.
Am I apposed to vaccination? No. But do I think it should be mandatory, absolutely not, because right now all I think it is doing is lining the pockets of the pharmaceutical company. I agree with the person who quoted the research, and say give it some time. In the mean time lives will still be saved they same way they have been for the past 50 years, and that is by screening for pre-cancerous cells at the cervix on a regular basis.
Janet

So Sioux Me said...

Janet,

I knew you would add something valuable to the conversation. For those of you who don't know Janet, she sold something to do with Pap Smear tests to doctors for a pharmacuedical company. Hense, the knowledge of pharmacudical greed.

I suppose I just wonder how complicated these decisions for our girls get. I mean, whether I must or not I go get my pap smear every year - just in case. But, Janet is saying the fear of "just in case" is instilled by the drug company which is making money off my fear.

Yet, I have personally known two women - young women in their 20s -who have fought cervical cancer, one who was unable to ever have children. So I know that there is an actual threat of this cancer.

I also personally know a young teenager who has HPV in her throat, having gone through many surgeries including a tracheostomy (hole in her throat to breath). Imagine walking around Junior High with that. Her mother passed it to her during birth.

Ainsley is 5 and when she is 9 I will have her vaccinated. It will protect her from some cervical cancer causing strains of HPV.

This does not take the place of sexual education to inform her of the risks. Nor does it condone any sexual activity, as sex isn't necessary to contract this virus.

My concern for girls is that the sexual implications are being irrationally and unjustly used to withhold the vaccine.

Tracee

Wednesday, May 16, 2007

HPV Vaccine, Right of Girls To Health

By Tracee Sioux

I have been a little surprised at the reaction to a vaccine for HPV (human papillomavirus virus), which causes cervical cancer.

I suppose I thought most of the planet, like me, have spent some time hoping that mad-scientists will eventually eradicate cancer. So, when I heard they had an actual vaccine, Center for Disease Control , Approximately 20 million people are currently infected with HPV. At least 50 percent of sexually active men and women acquire genital HPV infection at some point in their lives. By age 50, at least 80 percent of women will have acquired genital HPV infection. About 6.2 million Americans get a new genital HPV infection each year.

My brain is trying to wrap itself around the fact that 80 percent of ALL women will acquire a form of HPV.

Hypothetically, this means out of my grandmother, mother, self, daughter and sister only one of us will NOT be infected. I’m going guess my 83-year-old grandmother might be the safe one.

You know what the whole argument feels like to me? It feels like the same hypocritical puritanical judgment we have always inflicted on our girls and their sexuality.

If you weren’t a slut you wouldn’t get cervical cancer. Serves you right!

However, in this case, it is patently unjustifiable. A girl’s virtue will not keep her from contracting HPV. There is a large population of girls at risk of contracting HPV through cheating or abuse.

A woman is at risk for dying of cervical cancer if she has the bad luck of being married to an adulterer.

* Though they vary from study to study, the most widely accepted figures indicate that between 50 and 70 percent of married men (between 38 and 53 million men) have cheated or will cheat on their wives, according to Ruth Houston, the author of “Is He Cheating on You?-829 Telltale Signs.”

Sexual abuse victims are also at risk of contracting HPV, which can develop into cancer.

* During FFY 2005, an estimated 899,000 children in the 50 States, the District of Columbia, and Puerto Rico were determined to be victims of abuse or neglect. Approximately 9.3% of them were victims of sexual abuse, according to the U.S. Department of Health and Human Services, Children’s Department, 2005 Child Maltreatment report.

* Twenty percent of teenage girls and young women have experienced some form of dating violence, according to the United States Department of Justice Office on Violence Against Women.

Not requiring the vaccine is unfairly denying basic healthcare to ALL girls period. According to the intercourse is not required to contract the HPV virus. One should assume that many young girls participate in foreplay or sexual experimentation for years prior to having actual sex.

Condoms or other contraceptives do not prevent the spread of HPV because an exchange of fluids is not required to pass the virus from person to person. HPV can be spread from skin to skin and condoms do not cover all contagious areas.

The only thing to protect girls from cervical cancer is the Gardasil HPV vaccine. The vaccine prevents 70% of cervical cancer. Other drug companies are developing similar vaccines which may be more or less effective.

What breaks my heart is the inevitable image of a woman in her early 20s finding out that she may die or never be able to conceive because she contracted this virus. Maybe she had sex with her steady boyfriend in high school and they broke up and she married her college boyfriend and they became a typical young married couple who goes to church every Sunday. Oh, but instead of wearing a scarlet letter “A” she gets to fight cancer. With chemotherapy, hair loss, infertility and possible death.

This cancer kills around 26% of women who are diagnosed with it.

Maybe her parents are people with conservative family values, or maybe her insurance company won’t cover it because the state doesn’t require it to enter school, or her parents are just ignorant and irresponsible.

Either way, no girl deserves to die of cancer because she had sex, not even a promiscuous girl. The punishment, and really lets just admit it’s punitive to deny someone basic healthcare in an attempt to prevent sex, is not equal to the crime.

This scare-tactic method of encouraging abstinence has been ineffective in the face of AIDS, pregnancy and every other sexually transmitted disease. Why, would we think that it would be effective just because cancer is in the forbidding sentence? Adolescents have no sense of mortality. They have no sense of future long-term consequences. It’s the curse and blessing of the teenager that they are blissfully unaware that they will ever be 30.

Nor is cervical cancer or HPV a natural consequence or an unforeseeable circumstance from having sex anymore. No more than having babies is a natural consequence of sex. I have sex all the time, but we have chosen to have only two children and have used information and scientific advancement to prevent the natural consequence of children. Now that we know what causes cervical cancer and we know we can vaccinate girls against it, then there is deliberate harm in withholding the vaccine. Now that we have the knowledge and access to a vaccine, cervical cancer is now a natural consequence of neglecting the health of our girls.

I don’t agree with the argument that it’s the parents’ right to choose whether or not their daughter should be vaccinated. I believe it is every girl’s absolute right to be protected from cervical cancer. The only way to ensure that a girl has access to her right to basic health is for the government to require the vaccination.

The reason all vaccinations are required to enter school is to prevent the spread of communicable diseases that pose a significant health threat to society. HPV and cervical cancer represent a significant health threat to ALL girls, promiscuous or not, and HPV is a very wide-spread communicable disease.

The reason the immunization should be given upon enter the sixth-grade is because a lot of sexual experimentation occurs in junior high school. By high school, for a lot of our girls, it’s already too late. By the time a girl reaches 26, coincidentally around the same time she’s considering marriage, so many girls have already contracted the virus the CDC doesn’t even recommend the vaccine.

The reason parents, in general, are not a good option to guard their daughters’ health in the case of HPV and cervical cancer is that parents usually aren’t the first to know about their daughters’ sexual activity. If seven out of 10 girls have sex by the time they are 17, it’s reasonable to assume that six of those girls’ parents don’t know about it.

Texas was the first state to confront the issue. They confronted it with puritanical judgment and a complete denial of reality.

I encourage you to write your legislature, governor and health department and request that the vaccination be required for girls in your state.

If you’re a parent, please be pro-active and responsible for your daughter’s future health by getting her immunized against the HPV virus. This is a prime teachable moment to talk to young girls about the potential consequences of sexual experimentation in an honest and open way. I really believe if we are open and honest with girls about sex, instead of punitive, forbidding and secretive then we will be much more effective in encouraging them to make better decisions about their sexuality.

8 comments:

JayMonster said...

I have twice written on this subject already here and here. In short I am simply astounded by the way people are so wiling allow cancer to go unchecked in this case, just for political points or some strangely odd religious view that just because someone receives this vaccination it is somehow a "license" for a woman to have sex.

To me, it is at best, simply another example of treating women as second class citizens. If this was an inoculation for men, it would already be covered and done with. (Since we all know boys are "unable to control their urges" and hence need to be protected).

There is no valid reason I have seen given yet that justifies not making this a mandatory inoculation for all girls (and for it to be covered 100% by insurance as well).

mhatrw said...

Despite the idiotic rhetoric of conservative nuts, there are a lot of good medical reasons to wait before mandating a vaccine that was approved less than a year ago based on only two years of clinical results.

For example, the most recently release clinical results are very disappointing.

To summarize this published medical journal article:

1. In the FUTURE I trial, GARDASIL demonstrated no clinical efficacy among the general subject population for overall reduction in the rates of grade 2 and grade 3 cervical intraepithelial neoplasia and adenocarcinoma -- the only recognized precursors to cervical cancer.

2. In the larger FUTURE II trial, GARDASIL demonstrated no clinical efficacy among the general subject population for overall reduction in the rates of grade 3 cervical intraepithelial neoplasia and adenocarcinoma -- the strongest (and many would argue only valid) precursors to cervical cancer.

3. Extrapolating from GARDASIL's very limited clinical "success" (in the FUTURE II study only) against grade 2 cervical dysplasias (40% of which regress spontaneously), 129 women would be have to be vaccinated (at a cost of about $60,000) to prevent a single grade 2 cervical dysplasia.

4. GARDASIL's protection against cancer associated HPV strains 16 and 18 appears to cause a disproportionate increase in of pre-cancerous dysplasias associated with other HPV strains associated with cervical cancer "raising the possibility that other oncogenic HPV types eventually filled the biologic niche left behind after the elimination of HPV types 16 and 18."

5. Even if look only at the FUTURE II results (in which for some reason GARDASIL performed better among the general female population), we are talking about just a 17% decrease in all high grade dysplasias -- many of which would spontaneously regress without treatment. So we would have vaccinate 129 women (at about $500 for the three shot regimen) to avoid a single, eminently treatable dysplasia. That's about $60,000 per dysplasia prevented.

This is all directly from the article linked above.

I myself would add that we currently have only 3 years of follow up to go on in terms of both GARDASIL's safety and efficacy among the 16 to 26 year female population, no data concerning its efficacy among 9 to 12 year old girls and only 18 months of follow up on less than 600 total preteen girls in terms of safety data about GARDASIL within its targeted population.

Also see : The Journal of the American Medical Association and The Wall Street Journal

It appears that the vaccinated cohort sees a 20%+ increase in high grade cervical dysplasias caused by cancer-associated HPV strains other than HPV 16 and 18. One possible explanation is that HPV 6 or HPV 11 infections are antagonistic to more dangerous HPV infections.

So Sioux Me said...

The stdies I've read indicate that they have followed 11,000 girls for 5 years. How many more years should girls be exposed to a cirus that causes cancer?

I'm no Doctor. But, neither are most parents of girls. Is there a risk? Absolutely.

However, the vaccine has been approved by the FDA, which is not infallible, but is definately a lot more equipped than the majority of parents to determine the safety vs. risk factors of this vaccine.

mhatrw said...

Your information is wrong. The best efficacy data that exists for GARDASIL (by far) was just released, and includes just three years of follow up. Furthermore, parents who leave these decisions up to the FDA instead of informing themselves about the actual clinical data are letting FDA politics determine their childrens' health.

GARDASIL is a new vaccine from Merck that has now been clinically shown to strongly protect against two dangerous, cancer associated HPV strains -- HPV 16 and HPV 18 -- for at least three years among women previously unexposed to these strains. HPV 16 and HPV 18 are currently associated with 70% of all cervical cancer cases. Medical experts hope that this means that GARDASIL could potentially end up reducing cervical cancer contraction rates by as much as 70%. So far, the limited clinical evidence available tells a very different story.

Because so few women contract cervical cancer and because cervical cancer's average latency period after initial HPV infection is over 20 years, it would take hundreds of thousands of subjects and/or decades to conclusively demonstrate that GARDASIL actually reduces cervical cancer in any population. Therefore, the end points used to demonstrate GARDASIL's effectiveness against cervical cancer in GARDASIL's two biggest studies (FUTURE I & II) were chosen to be the number of high grade cervical lesions -- or alternatively, the number of patients with high grade cervical lesions -- prevented over a 3 year period. High grade cervical lesions consist of grade 2 and grade 3 cervical intraepithelial neoplasias and all adenocarcinomas in situ. Among women in the USA, the vast majority of high grade cervical lesions either regress spontaneously or are successfully treated. However, the FDA currently considers high grade lesions to be acceptable surrogate outcomes for cervical cancer.

Here are the most recent and by far most comprehensive clinical results for GARDASIL in terms of reduction of high grade cervical lesions over a three year period.


For the general 16 to 26 year old population

FUTURE I

For the unvaccinated group, there were 194 total high grade lesions diagnosed -- 101 associated with HPV 16 & 18 and 93 associated with other dangerous, cancer causing HPV strains. For the vaccinated group, there were 182 total high grade lesions diagnosed -- 76 associated with HPV 16 & 18 and 106 associated with other dangerous HPV strains. That's a 6% overall decrease high grade HPV lesions but a 14% increase in other dangerous unprotected HPV strains for the vaccinated group.

FUTURE II

For the unvaccinated group, there were 361 total high grade lesions diagnosed -- 207 associated with HPV 16 & 18 and 154 associated with other dangerous, cancer causing HPV strains. For the vaccinated group, there were 281 total high grade lesions diagnosed -- 103 associated with HPV 16 & 18 and 178 associated with other dangerous HPV strains. That's a 22% overall decrease high grade lesions but a 16% increase in high grade lesions associated with dangerous unprotected HPV strains for the vaccinated group.

In terms of individual subjects rather than lesions (some subjects had multiple high grade lesions), vaccinated patients were 17% less likely to develop high grade cervical lesions overall but 15% more likely to develop high grade cervical lesions associated with dangerous unprotected HPV strains.

Combined FUTURE I & II

For the unvaccinated groups, there were 555 total high grade lesions diagnosed -- 308 associated with HPV 16 & 18 and 247 associated with other dangerous, cancer causing HPV strains. For the vaccinated groups, there were 463 total high grade lesions diagnosed -- 179 associated with HPV 16 & 18 and 284 associated with other dangerous HPV strains. That's a 16.6% decrease in overall high grade lesions but a 15.0% increase in high grade lesions associated with dangerous unprotected HPV strains for the vaccinated group.


For the sub-population of subjects who tested negative for both HPV 16 and 18

FUTURE I: Merck did not publish these results.
FUTURE II: Vaccinated patients were 27% less likely to develop high grade cervical lesions overall and at most 8% more likely to develop high grade cervical lesions associated with dangerous HPV strains other than HPV 16 & 18.


For the sub-population of subjects who tested positive for either HPV 16 and 18 or both

FUTURE I: Merck did not publish these results.
FUTURE II: Vaccinated patients were 9% less likely to develop high grade cervical lesions overall and at least 105% more likely to develop high grade cervical lesions associated with dangerous HPV strains other than HPV 16 & 18.


This is not an opinion. These are Merck's very own published clinical results for FUTURE I and FUTURE II.

So Sioux Me said...

Obviously, you are well versed medically. I'll avoid discussing the clinical studies and address my main concern.

You said,
"parents who leave these decisions up to the FDA instead of informing themselves about the actual clinical data are letting FDA politics determine their childrens' health."

My response to that would be that the vast majority of parents do not look up any drug company's clinical data to determine whether or not they get their children vaccinated against any virus. In fact, the majority of parents based ALL of their children's healthcare decisions on what the FDA approves and what their pediatrician recommends and what shots are required for their kids to go to school. We kind of have to as we have no medical foundation to dispute or prove any of it - we, mere mortals which hold no medical or science degrees.

If, in fact, the FDA judges the vaccine to be safe - which they have. If my pediatrician recommends it for my daughter - which she does. If it prevents girls from contracting certain virus' that cause cervical cancer - which you know, I have to trust the FDA, drug company and pediatrician since I'm unqualified as a medical professional.

Then I believe it's morally wrong to withhold a girl's health to prevent her from having premarital sex. And I believe it's a method that is ineffective and may cost some girls their lives.

Obviously, even if the state does require the vaccine upon entry to school parents, like yourself, who have the background to disect the clinical research can "opt out" of having your daughter vaccinated.

Threat Assessment & Response Canada said...

Hi, Tracee.

Thanks for your carnival submission. I'll post the link to your post on Monday.

I like your blog and have linked you to my blog.

Just so you know, I don't bite (unless bitten first) and if, while you are visiting my blog, you see something that you have questions about, or if there's something you wish we'd write about and haven't, your comments, questions and suggestions are most helpful.

I think we are both interested in accomplishing some similar things.

Laurie

Janet said...

Hey Tracee,
It's good to see you so fired up about this subject. Having worked for a company that creates the tests that screens for cervical cancer I have an opinion on this subject. Mind you it is my own opinion and not necessarily one that my former employer shares.

My opinion is this, we should be doing all we can to stop cervical cancer. The annual pap test is a wonderful way to ensure this. In fact it is a rather excessive screening test if you ask the UK. Their National Health Service (NHS) only requires testing once every three year. Why? Because cervical cancer is one of the slowest forming cancers out there. Meaning, it could take anywhere from 6 to 10 years to develop and therefore if the cancer or pre-cancerous cells are missed on a pap test, 3-6 years later there’s a likely chance those cells are still in their pre-malignant stage.
HPV is the lead cause of cervical cancer, fact. But, just because one has HPV doesn't mean they'll get cancer. So this is the debate, do we make it a mandatory vaccination, and screen for HPV with every pap test? I don't think so and this is why. I am morally apposed to companies making money off of this, and deceiving the average person into think they need it. They’ve got you so fired up about this, that you become their advocate and force the medical industry to adopt their product and line their pockets. Can a person get cervical cancer having tested positive for HPV? Yes, but rarely. Does testing positive for HPV mean you have cervical cancer? Absolutely not. All testing positive for HPV means, is that the doctor will then perform an unnecessary colposcopy, a very painful and invasive procedure I might add for the young 12 year old girl, when it's not necessary. It just costs more and the insurance prices go up. Very, very few women develop cervical cancer before the age of 20, and still not many develop it before they're 30. It's a slow growing cancer.

The medical and pharmaceutical companies will argue that with the slight chance of testing positive for HPV and then having it develop into cancer is reason enough to screen and vaccinate every woman. So, the drug companies are taking advantage of this fact and setting their prices high. Testing positive for HPV is a way for medical companies to make a buck. And that my friend is the real reason they are pushing so hard to 1- get the FDA backing and 2- motivate the public. Their ploy is to get the individual to go and ask their provider for the screening, who in tern turns to their laboratory, medical and insurance companies and demand the service. Which, in the end, is how they make their money. Just because a product is FDA approved doesn’t mean everyone needs to have it. All the FDA is saying is that the product is not harmful and in fact has some beneficial value to it.
The HPV vaccine is a wonderful medical breakthrough, but it is not an end all cure all for cervical cancer, nor will it keep women free from developing cervical cancer. There are many strands of HPV and this test/vaccine only picks up just a few of those strands. That all gets complicated, but the fact is that it is not the final answer we’ve all been looking for.
Am I apposed to vaccination? No. But do I think it should be mandatory, absolutely not, because right now all I think it is doing is lining the pockets of the pharmaceutical company. I agree with the person who quoted the research, and say give it some time. In the mean time lives will still be saved they same way they have been for the past 50 years, and that is by screening for pre-cancerous cells at the cervix on a regular basis.
Janet

So Sioux Me said...

Janet,

I knew you would add something valuable to the conversation. For those of you who don't know Janet, she sold something to do with Pap Smear tests to doctors for a pharmacuedical company. Hense, the knowledge of pharmacudical greed.

I suppose I just wonder how complicated these decisions for our girls get. I mean, whether I must or not I go get my pap smear every year - just in case. But, Janet is saying the fear of "just in case" is instilled by the drug company which is making money off my fear.

Yet, I have personally known two women - young women in their 20s -who have fought cervical cancer, one who was unable to ever have children. So I know that there is an actual threat of this cancer.

I also personally know a young teenager who has HPV in her throat, having gone through many surgeries including a tracheostomy (hole in her throat to breath). Imagine walking around Junior High with that. Her mother passed it to her during birth.

Ainsley is 5 and when she is 9 I will have her vaccinated. It will protect her from some cervical cancer causing strains of HPV.

This does not take the place of sexual education to inform her of the risks. Nor does it condone any sexual activity, as sex isn't necessary to contract this virus.

My concern for girls is that the sexual implications are being irrationally and unjustly used to withhold the vaccine.

Tracee