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.
You miss the point, Doc. I don't have a problem with them making money, or a lot of money, or even a lot of government money. I'm a free market guy. What I have a problem with is that this is all going very fast. It looks to me like Merck is desperate to brng in as many dollars as possible before a competitor gets a vaccine to market. Given the tendency to rush approval of drugs that make promiscuity easier (such as RU-486) I am suspicious and I don't think the science is there yet.
Are you saying we shouldn't vaccinate against the childhood diseases we immunize for now?
Not quite.
...Human papillomavirus infection at the United States-Mexico border: implications for cervical cancer prevention and control.
A cross-sectional study of 2319 women, ages 15-79 years, self-referring for gynecological care was conducted between 1997 and 1998. HPV was detected by PCR using the PYGMY 09/11 L1 consensus primer, and HPV genotyping was conducted using the reverse line blot method. Overall, the HPV prevalence was 14.4% with no significant differences observed by country after adjustment for age. ...
In both countries, HPV prevalence declined linearly with age from 25% among women ages 15-19 years to 5.3% among women 56-65 years. Factors significantly independently associated with HPV infection were older age [adjusted odds ratio (AOR) = 0.15 for ages 56-65 years compared with those 15-19 years], ...
If you like increasing your risk, go for it. putting young girls on the pill for "protection" of embarrasing mommy by coming home pregnant, are at 72% increased risk of breast cancer. DepoProvera will increase her risk310%. Smoking doesn't cause cancer either, it just increases your risk.
Glaxo Smith Kline is in the late stages of clinical trials of their vaccine (the trials may already be complete) so there will be competition soon. As for the science, I have read all the relevant papers and spoken to some of the scientists involved and the science is strong. And teenagers and people in their 20's have been misbehaving since the beginning of time. The vaccine won't affect that one way or the other.
Never!
I would have stopped government from being involved in it beyond advocating them from the Bully Pulpit.
this is not socialized medicine per se.
It is another slip down the slope.
One only has to look at breast cancer incidences (40,000/year)
to see that since birth control pills became available, breast cancer rates shot way up after a period of time.
Too much KFC, thats what did it. (and other things evidently)
"Some fear the HPV vaccine’s protection would boost young girls’ appetite for an early sexual life."
HUH?
Keep in mind that most women clear the virus spontaneously. Up to 90% of women who test positive at time zero will be negative at 2-3 years so taking a snapshot during a brief time doesn't tell you how many women are infected in their lifetimes.
See Ho et.al. NEJM 1998:338;423-8
Independent, long term testing, imho, is needed waaaaay before mandatory inoculations.
The clinical trials were conducted at multiple academic medical centers, not by Merck directly. They were controlled, double-blinded studies that took place over several years. In other words, the independent long-term testing has already occurred.
I agree, and I jumped all over you because you initially stated "Breast cancer caused by the pill dwarfs that number [emphasis added]."
WHAT IS CERVICAL CANCER? Cervical cancer is cancer of the cervix (the lower part of the uterus that connects to the vagina). Cervical cancer is caused by certain types of HPV. When a female becomes infected with certain types of HPV and the virus doesn’t go away on its own, abnormal cells can develop in the lining of the cervix. If not discovered early and treated, these abnormal cells can become cervical precancers and then cancer.
GARDASIL is the only vaccine that may help guard against diseases caused by HPV Types 16 and 18, which cause 70% of cervical cancer cases, and HPV Types 6 and 11, which cause 90% of genital warts cases.
So as we can see, gardasil only works on 4 strains of HPV, 30% of the others can cause cancer, 10% can cause warts. It doesn't say in the article if those 3700 cases of cervical cancer, how many of them were cancers caused by strain types 16 and 18, So gardasil may not be as efective and we are being led to believe, and it certainly will not prevent all HPV at all. These other strains may even be the most common as well!!!
"GARDASIL may not fully protect everyone and does not prevent all types of cervical cancer, so it is important to continue regular cervical cancer screenings.
Anyone who is allergic to the ingredients of GARDASIL should not receive the vaccine. GARDASIL is not for women who are pregnant.
GARDASIL will not treat these diseases and will not protect against diseases caused by other types of HPV."
That is the most bizarre statement I've seen today.
Do you also think it's child abuse to let your children play outside? They might be hit by a car, struck by lightning, or crushed by a falling meteor.
It's child abuse to take your child in a car (to the doctor to get a vaccination, maybe?) Auto accidents are the major cause of death for children.
Child abuse to have your child take a bath? He could drown! What about letting him go swimming?
How about sending your child to school, or even more, preschool? Preschools/daycares are the major transmission point for genuine infectious diseases (which HPV is not) from which many children die each year.
EGAD!
Yes, I've read the vaccine literature. I even lecture on the subject. It's true that it only prevents 70% of cancers which is why we will continue to screen women with Pap smears for the forseeable future. That and the fact that the vaccine won't protect women already infected. In time vaccines with broader coverage will be available. Gardasil is just the first (although huge) step.
I used to take viox. for 5 months, then guess what happened?
Like I would ever trust anything this company says.
I'm not nearly as familiar with Vioxx as I am with Gardasil so I really can't comment on it. I just recently saw a case of cervical cancer in a 19 year old woman. I also recently diagnosed the cervical cancer that killed a 25 year old woman, leaving her 6 kids motherless. Just a few examples of the terrible things I've seen during my career. So my bias is toward giving the vaccine, and the science supports me. Show me science that points in the other direction and I may reconsider.
Which 70%? The common or rare HPV cancers? That's what I'd like to see clarified.
As mentioned, This drug certainly isn't warranted for manditory inoculation. Personal choice, sure, at least the taxpayer doesn't pay for it, and isn't liable for it should it turn out to be another viox.
HPV type 16 causes 50-55% of all cervical cancers. Type 18 causes about 15% so the two together cause around 70% of all cervical cancer. There are two main subtypes of cervical cancer (called squamous cell carcinoma and adenocarcinoma) and both are HPV related.
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