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.
Get the girls vaccinated! It will save a lot of lives. And it's just plain nuts to think that a vaccine would be a greater impetus for sexual activity compared with surging teen hormones.
See Ho et. al., NEJM 1998:338:423-8
See also Sawaya, et. al. Obstet. Gynecol. 1999
Sorry I don't have a more specific citation for the second article right at hand.
Regardless of government mandates, insurers do cover this vaccination. It is in their economic best interests to do so when you consider how much it costs to treat cervical cancer.
Glaxo Smith Kline is currently in late stage clinical trials for it's HPV vaccine so there will be competition soon.
I have no medical training but I always had a suspicion that cervical cancer in young women was caused by sexual promiscuity. Growing up in a small town, you know who was and so many of them had hysterectomies in their 20s because of cervical cancer. The evidence was just anecdotal but I still always thought it had something to do with sex.
IF the drug does what its makes claim, it is a wonderful thing and both my girls will get the regimen as soon as they are eligible.
I'm not sure I'm crazy about paying for other folks to get it though. Let the doctors advise and the parents decide for their children.
Heck, when we finally get Hillary-Care, we won't have to pay for anything!
1121 girls age 9-15 were in the study (not control) group that determined safety and efficacy.
The same can happen here with this shot. Making it mandatory is STUPID. Besides it's unconstitutional to FORCE anyone to have a shot, especially for a std that MAY develop into cancer. In fact, most of the time it DOESN'T, and goes away on it's own, natually via your own immune system.
Actually the vaccine is currently approved for females age 9-26. It's important to vaccinate girls before they become sexually active. As a pathologist I have diagnosed far too many cases of cervical cancer to accept the arguments against vaccination.
You don't know what you are taking about. HPV does infect men. But men don't have cervexes so they are not succeptible to cancer from the virus and that's why so many women have the virus. Men don't know they are carriers.
They lost me on this one. Are they saying that a Tetnus shot makes you more likely to want to step on a rusty nail?
This is mostly but not entirely true. Certainly men are carriers. Penile cancer, while rare, does occur and is also linked to HPV. Also, men who engage in anal intercourse are at high risk of cancer there due to HPV infection. Their risk is similar to women who don't get Pap smear screening.
Wghich is a great argument for educating young men in proper condom use as well.
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