That's why we need more school clinics to dispense contraceptives and family planning advice.
After all, the kids are going to mess around anyway, right?
Posted on 01/31/2007 4:01:47 AM PST by XR7
A bill concerning the mandatory vaccination of US middle-aged schoolgirls against cervical cancer is considered controversial and some states even try to pull it back.
The vaccine is only produced by Merck Sharp & Dohme (Merck & Co) and is called Gardasil. This is the world’s first vaccine against cervical cancer and other diseases caused by certain types of the human papillomavirus (HPV).
The US Food and Drug Administration (FDA) approved Gardasil for mass-prescription on June 8, 2006, after a lot of clinical tests. The tests also indicated that Gardasil’s administratin to girls should occur before they become sexually active.
According to statistics, 270,000 women died of cervical cancer worldwide in 2002, making this form of cancer one of the deadliest. In the US, cervical cancer killed around 3,700 women in 2002.
Some states (through their Senate representatives) are not convinced yet of the efficacy of the vaccine. Sen. Delores G. Kelley, a Baltimore County Democrat, said yesterday that she plans to pull a bill she herself sponsored that calls for all sixth-grade girls to be vaccinated by September 2008. She voiced the concern of some parents and educators that addressed her, after chickenpox and hepatitis B vaccinations failed to immunize students from grades six to nine.
The success of the vaccine in clinical tests and FDA’s approval has determined more than a dozen states to consider introducing the mandatory vaccination with Gardasil. Some medical experts and watchdog groups have questioned though Merck’s active lobbying, although the company’s involvement is not a surprise, since it is for the moment the only producer of the substance. The groups and the medical experts also imply that state mandates are premature.
Sen. Kelley said she was not aware of "those external politics."
"The timing is just not right," she said, adding that she will likely introduce the bill again next year. "I decided to do this at a time when things have settled down and we can approach this in a more deliberative manner."
Gardasil is given in 3 injections over 6 months, namely at enrollment, and 2 and 6 months later. Gardasil protects against four subtypes that together account for 70 per cent of all cervical cancers and 90 per cent of genital warts. It has been shown to be more than 95-per-cent effective.
Some conservatives and parental-rights groups say such a requirement would encourage premarital sex and interfere with the way they raise their children. Some fear the HPV vaccine’s protection would boost young girls’ appetite for an early sexual life.
For other critics, it is the notion that their youthful innocence could be violated, during the course of three shots over six months, by a medical practitioner's potential sex-education lecture.
But Merck said its lobbying efforts have been aboveboard.
Merck has funneled money through Women in Government, an advocacy group of female state legislators.
An official from Merck’s vaccine division sits on Women in Government's business council, and many of the bills around the country have been introduced by members of Women in Government.
"Cervical cancer is of particular interest to our members because it represents the first opportunity that we have to actually eliminate a cancer," said Susan Crosby, president of Women in Government.
Merck spokeswoman Janet Skidmore would not say how much the company is spending on lobbyists or how much it has donated to Women in Government. Crosby also declined to specify how much the drug company gave.
But Skidmore said: "We disclosed the fact that we provide funding to this organization. We're not in any way trying to obscure that."
The New Jersey drug company, which is building a vaccine plant in Durham, could generate billions in sales if Gardasil -- at $360 for the three-shot regimen -- were made mandatory across the country. Most insurance companies now cover the vaccine, which has been shown to have no serious side effects.
The National Advisory Committee on Immunization says girls and women aged 14 to 26 should also be vaccinated against human papillomavirus (HPV) even if they are already sexually active, because they may not yet have been infected.
Rep. Debbie Clary, a Cleveland County Republican, has no doubt that a North Carolina legislator eventually will introduce a bill requiring HPV vaccination. "I don't know if it will be this year or the next, but I'm certain it will be discussed," she said. "It's obvious that Merck is pushing for mandates."
"I think it will be a tremendous debate, because you're treading on territory that is a parent's decision," Clary said.
On June 29, Advisory Committee on Immunization Practices (ACIP) recommended that Gardasil be placed on the childhood immunization schedule at the 11 to 12 year old visit. They also recommended that the vaccine be included in the federal Vaccines for Children Program, which would provide the vaccines free of charge to children under the age of 18 who are uninsured. Merck & Co., Inc. is a global research-driven pharmaceutical company. Established in 1891, Merck discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs.
Presumably, a law mandating the vaccine would not carry a a provision requiring parents to change pediatricians. So any "sex education lectures" that might violate these parents' innocent little darlings' "youthful innocence" wouldn't be changing due to the vaccine mandate. No one is completely safe from rape, and even the most hard-core fundamentalist versions of Christianity allow for forgiveness of sexual "sins", so a young woman who has perfectly virtuous in her religious parents' eyes may still marry a man who has been sexually active before marriage (or for that matter, who is a widower and whose late wife was not a practitioner of lifelong monogamy), and be exposed to HPV. Parents who want to reduce their children's risk of cancer will want them to have this vaccine (and it is presumed to also be preventive of penile cancer, which, though much rarer than cervical cancer, is nearly always caused by the same strains of HPV). Whether this vaccine should be mandatory or not is an issue of political philosophy (i.e. should the government be able to mandate anything?).
As for the money thing, no state or federal government should be mandating anything that is provided by only one seller. I'm not sure how to get around this while still protecting the intellectual property rights of the seller, but there must be a way. If some private company develops a highly effective vaccine for a disease which is a critical public health/national security issue, mandating the vaccine would probably be an appropriate role for government (especially if it carried an informed opt-out provision), but neither mandating huge profits for a single company, nor mandating confiscating that company's valuable intellectual property rights would be appropriate. We'd better figure this one out before al-Qaeda starts deliberatly spreading something like Ebola or SARS or some new bug they've cooked up.
As I understand it, the tests have demonstrated that the vaccine results in antibodies for the virus. I can't imagine why that wouldn't work in boys as well as girls.
Most HPV infections are acquired by age 25 or so. The best time to vaccinate is before women or girls become sexually active.
Clinical trials in males are currently ongoing. I would expect the vaccine to be approved for males in the next year or two.
"According to statistics, 270,000 women died of cervical cancer worldwide in 2002, making this form of cancer one of the deadliest. In the US, cervical cancer killed around 3,700 women in 2002.
That is in no way the deadliest form of cancer in the USA.
Breast cancer caused by the pill dwarfs that number, as do many other cancers, such as colon and pancreatic cancers, lung cancer.
I think this should be carefully studied before mass inocculation occurs, and even then it should be offered only as a CHOICE, not a mass, taxpayer funded, innoculation. It would be foolish to rush into mass inocculation, only to discover a few years down the road that the cure caused more cancers than it was supposed to prevent.
Uhm, I think that description probably applies to 97% of adults in the U.S...
Yes, I'd want to see a source on that, too. With a link to the actually study so we can determine the sample size and any selection bias.
I would administer this vaccine to my children in a heartbeat. I want them to avoid sex until marriage but I can in no way influence the men they will marry and what they will do before marriage (I have known many men who slept arround only to then get religious and become moral, but spiritual repentence does not get rid of microbes).
I believe it is child abuse not to give your children this vaccine.
And I believe if you truly believe that you have no business procreating.
While I question the first part of your statement, I agree with the second. The number of people who refuse to have sex because of the fear of HPV has to be so statistically close to zero as to make no difference. Aids, yes. HPV, no way.
That's why we need more school clinics to dispense contraceptives and family planning advice.
After all, the kids are going to mess around anyway, right?
"Lots of clinical tests" How many of those were on prepubescent girls? Lots of other drugs have lower age cutoffs because trials were not conducted on children. How much do we know about the vaccine's impact on their sexual development?
"administratin [sic]... before they become sexually active" That says to me that the drug doesn't work after the fact and the trials showed if you're already having sex, there is no effect. OK, I can understand why you look to the lower ages to get ahead of the curve statistically, but back to my first point, what age groups were used to establish the drug's safety?
Plenty of products have been pulled after years on the market when the long-term effects became known. Are we rushing this to market with a forced program simply due to sexual politics? Has anyone done the environmental impact statement on the potential sterilization of a generation of girls? DES was supposed to do wonderful things, too!
Tell me where the trial lawyers stand on this and then we'll really see.
Really? And your statistic comes from where?
My daughters were both insulted when our doctor suggested the vaccine.
An STD gives one the cancer
You should see the movie Children of Men. It is set 18 years after the world's last live child was born in 2009. No one has been born after that year, because for some reason all the world's women are infertile.
THe Varicella vaccine has been on the market for over 10 years and is not a state mandated requirement in my state. I chose to have my child vaccinated AFTER the vaccine had been in use for two years.
The push for Gardasil to be mandated so soon after FDA approval is being rushed, in my opinion. Clinical trials are still limited to a fixed number of participants. I want to see it in use more before I have my daughter considered.
I am from the swine flu generation...and am glad that I refused the 'free' shot.
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