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Have I mentioned this?
Jun. 4th, 2008 01:37 pmI have HPV. It happens. In fact, look at 3 of your closest friends. Chances are ONE of you doesn't have it.
HPV doesn't discriminate. It doesn't care about condom usage (although studies have shown that condoms DO weed it out vastly better than the dumber alternative of NOT using one, not to mention HALLO! There are other STDs out there), it doesn't care if you're fucking for the first time or the 100th time. It doesn't care if you are on partner #1 or #134. IT DOES NOT CARE.
There are currently over 70 identified strains of HPV.
A few of my friends (just this week!!) have come back with abby normal paps, and low squamous cells. So I think this is a good time to clear up some things about this annoying virus.
( Some facts and myths about HPV )( Common Questions )( HPV & Men )( Fun with charts )
HPV doesn't discriminate. It doesn't care about condom usage (although studies have shown that condoms DO weed it out vastly better than the dumber alternative of NOT using one, not to mention HALLO! There are other STDs out there), it doesn't care if you're fucking for the first time or the 100th time. It doesn't care if you are on partner #1 or #134. IT DOES NOT CARE.
There are currently over 70 identified strains of HPV.
A few of my friends (just this week!!) have come back with abby normal paps, and low squamous cells. So I think this is a good time to clear up some things about this annoying virus.
( Some facts and myths about HPV )( Common Questions )( HPV & Men )( Fun with charts )
DNA testing, wee.
Oct. 4th, 2007 01:07 pm DNA test could detect cervical cancer early: study
LONDON (Reuters) - A DNA test for the virus that causes cervical cancer helps detect potentially dangerous lesions earlier than the commonly used pap smear technique, Dutch researchers said on Thursday.
The test could mean fewer screenings for women and ensure that they receive earlier treatment for lesions that might lead to cancer, they said in the journal Lancet.
"It is a better test because you pick up more lesions," Chris Meijer, a pathologist at VU University Medical Centre in Amsterdam, said in a telephone interview. "And because you pick them up earlier, you have more time to treat the women."
In a pap smear, doctors scrape cells from the cervix and examine them under a microscope for abnormalities that could indicate precancerous lesions. The DNA test screens for evidence of infection by high-risk types of the human papillomavirus (HPV) that cause cervical cancer.
The Dutch study suggests the DNA test is better at indicating which women are at risk of precancerous lesions and should therefore have a biopsy, Meijer said.
"When you are HPV positive (in the test), the likelihood you have precancerous lesions is quite high," he said. "A (pap smear) is not sensitive enough to detect all the lesions."
Cervical cancer is caused by the HPV virus spread through sexual transmission and is the second most common type of cancer in women.
Merck and Co's. Gardasil and GlaxoSmithKline's Cervarix vaccines protect people against HPV infection. The tumors kill about 300,000 each year, mostly in developing countries.
In the study of more than 17,000 Dutch women aged 29 to 56, the researchers split the women into two groups, with one receiving conventional pap smears and the other getting additional DNA testing.
Five years later, the researchers tested the entire group using both tests and found that DNA screening helped detect 50 percent more of the potentially precancerous lesions.
"On the basis of this data, we suggest that the current screening interval of five years could be extended by at least one year," the researchers said in a statement. "The extension will be advantageous to women because of a reduction in the lifetime number of screening tests and referrals."
The findings indicate that the DNA test could stand as the primary screening method for cervical cancer, Guglielmo Ronco and Nereo Segnan of Italian cancer specialists CPO Piemonte in Turin wrote in a commentary in Lancet.
The results also seem to answer the question of whether the test is effective in helping to detect dangerous lesions, Ronco added in a telephone interview.
"This is an important thing," he said. "Up to now we knew that HPV (testing) allowed us to find more lesions but whether they were relevant wasn't sure."
LONDON (Reuters) - A DNA test for the virus that causes cervical cancer helps detect potentially dangerous lesions earlier than the commonly used pap smear technique, Dutch researchers said on Thursday.
The test could mean fewer screenings for women and ensure that they receive earlier treatment for lesions that might lead to cancer, they said in the journal Lancet.
"It is a better test because you pick up more lesions," Chris Meijer, a pathologist at VU University Medical Centre in Amsterdam, said in a telephone interview. "And because you pick them up earlier, you have more time to treat the women."
In a pap smear, doctors scrape cells from the cervix and examine them under a microscope for abnormalities that could indicate precancerous lesions. The DNA test screens for evidence of infection by high-risk types of the human papillomavirus (HPV) that cause cervical cancer.
The Dutch study suggests the DNA test is better at indicating which women are at risk of precancerous lesions and should therefore have a biopsy, Meijer said.
"When you are HPV positive (in the test), the likelihood you have precancerous lesions is quite high," he said. "A (pap smear) is not sensitive enough to detect all the lesions."
Cervical cancer is caused by the HPV virus spread through sexual transmission and is the second most common type of cancer in women.
Merck and Co's. Gardasil and GlaxoSmithKline's Cervarix vaccines protect people against HPV infection. The tumors kill about 300,000 each year, mostly in developing countries.
In the study of more than 17,000 Dutch women aged 29 to 56, the researchers split the women into two groups, with one receiving conventional pap smears and the other getting additional DNA testing.
Five years later, the researchers tested the entire group using both tests and found that DNA screening helped detect 50 percent more of the potentially precancerous lesions.
"On the basis of this data, we suggest that the current screening interval of five years could be extended by at least one year," the researchers said in a statement. "The extension will be advantageous to women because of a reduction in the lifetime number of screening tests and referrals."
The findings indicate that the DNA test could stand as the primary screening method for cervical cancer, Guglielmo Ronco and Nereo Segnan of Italian cancer specialists CPO Piemonte in Turin wrote in a commentary in Lancet.
The results also seem to answer the question of whether the test is effective in helping to detect dangerous lesions, Ronco added in a telephone interview.
"This is an important thing," he said. "Up to now we knew that HPV (testing) allowed us to find more lesions but whether they were relevant wasn't sure."
A subject near and dear to my heart...
Sep. 20th, 2007 10:20 amThey could be silently suffering RIGHT NOW and not even know it.
It doesn't have to be that way.
DO something - make a difference - declare your love.
Don't wait until there's no choice, do it while you have one.
There is no excuse.
Read
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angry_biscuit's story. Celebrate Elissa's life and musical legacy. Save someone YOU love.[click here for more]
Call for worldwide use of cervical cancer vaccines
LONDON (Reuters) - International health experts called on Tuesday for rapid worldwide access to promising but expensive cervical cancer vaccines that have the potential to save a quarter of a million lives a year.
Merck & Co. Inc.'s recently launched Gardasil and GlaxoSmithKline Plc's Cervarix, which is expected to be approved next year, protect women against human papillomavirus (HPV), the virus that causes most cases of the disease.
They are likely to be embraced in rich countries but uptake in the developing world -- where 80 percent of cervical cancer deaths occur -- is uncertain, given their high price and potential resistance to vaccinating girls aged 9 to 13 years against the sexually transmitted virus.
The call for global access came at a conference in London bringing together 60 health experts from multilateral agencies, government, charities and the drug industry.
"There is usually a 15 to 20 year delay between the time that new vaccines are approved in the West and the time they reach developing countries," said Nothemba Simelela of the International Planned Parenthood Federation.
"The world cannot afford to wait 20 years to begin saving women from cervical cancer."
Death rates from the second most common female cancer are increasing in the developing world, where more than 95 percent of women never have a cervical smear test.
PRICE CRITICAL
Price will be a key factor in determining how quickly the new vaccines are used in poor countries.
Gardasil costs $375 in the United States and 300 to 360 euros ($397-477) in Europe for a course of three injections. Glaxo's product is expected to be priced similarly.
Officials from Merck and Glaxo attending the conference said they would cut the cost for developing nations substantially but stopped short of promising a not-for-profit price.
Julian Lob-Levyt, secretary-general of the GAVI Alliance, said the price needed to come down to below $10 in the long term.
"That's the kind of figure that the poorest countries are indicating to us, but we are prepared to subsidize the price at the outset in anticipation that it then declines," he told Reuters.
GAVI -- a partnership for vaccines grouping governments, the World Bank and the private sector -- was likely to formally endorse use of the new HPV vaccines in the next 12 to 18 months, he added.
Gardasil and Cervarix are the first vaccines for cancer and consequently set an important strategic precedent for the international community.
In the past, the world has been used to giving simple shots against childhood diseases that cost a few pennies -- but that model is changing as more complex vaccines are developed.
"It's just a matter of time before other vaccines will be out there for cancer ... and hopefully it's just a matter of time before we have a vaccine for HIV/ AIDS," said Howard Zucker, assistant director-general for health technology at the World Health Organization.
"This should be a model for the future when other vaccines come to market."
LONDON (Reuters) - International health experts called on Tuesday for rapid worldwide access to promising but expensive cervical cancer vaccines that have the potential to save a quarter of a million lives a year.
Merck & Co. Inc.'s recently launched Gardasil and GlaxoSmithKline Plc's Cervarix, which is expected to be approved next year, protect women against human papillomavirus (HPV), the virus that causes most cases of the disease.
They are likely to be embraced in rich countries but uptake in the developing world -- where 80 percent of cervical cancer deaths occur -- is uncertain, given their high price and potential resistance to vaccinating girls aged 9 to 13 years against the sexually transmitted virus.
The call for global access came at a conference in London bringing together 60 health experts from multilateral agencies, government, charities and the drug industry.
"There is usually a 15 to 20 year delay between the time that new vaccines are approved in the West and the time they reach developing countries," said Nothemba Simelela of the International Planned Parenthood Federation.
"The world cannot afford to wait 20 years to begin saving women from cervical cancer."
Death rates from the second most common female cancer are increasing in the developing world, where more than 95 percent of women never have a cervical smear test.
PRICE CRITICAL
Price will be a key factor in determining how quickly the new vaccines are used in poor countries.
Gardasil costs $375 in the United States and 300 to 360 euros ($397-477) in Europe for a course of three injections. Glaxo's product is expected to be priced similarly.
Officials from Merck and Glaxo attending the conference said they would cut the cost for developing nations substantially but stopped short of promising a not-for-profit price.
Julian Lob-Levyt, secretary-general of the GAVI Alliance, said the price needed to come down to below $10 in the long term.
"That's the kind of figure that the poorest countries are indicating to us, but we are prepared to subsidize the price at the outset in anticipation that it then declines," he told Reuters.
GAVI -- a partnership for vaccines grouping governments, the World Bank and the private sector -- was likely to formally endorse use of the new HPV vaccines in the next 12 to 18 months, he added.
Gardasil and Cervarix are the first vaccines for cancer and consequently set an important strategic precedent for the international community.
In the past, the world has been used to giving simple shots against childhood diseases that cost a few pennies -- but that model is changing as more complex vaccines are developed.
"It's just a matter of time before other vaccines will be out there for cancer ... and hopefully it's just a matter of time before we have a vaccine for HIV/ AIDS," said Howard Zucker, assistant director-general for health technology at the World Health Organization.
"This should be a model for the future when other vaccines come to market."
New Hampshire was a cool state because of the whole "Live free or DIE" motto. How badass, right?
Well, they got just so much cooler in my world.
They have to remember. The boys need to get vaccinated TOO.
N.H. to offer girls free cancer vaccine
By NORMA LOVE, Associated Press Writer Wed Nov 29, 6:26 PM ET
CONCORD, N.H. - New Hampshire announced plans Wednesday to become the first state to offer the new cervical-cancer vaccine free to all girls. Beginning in January, the vaccine against the human papilloma virus, or HPV, will be provided to girls ages 11 through 18 as part of a state program that offers various immunizations to children at no cost.
The program is paid for by the federal government and insurance companies.
The Food and Drug Administration approved the vaccine in June for girls as young as 9. It prevents infection from some strains of HPV, a sexually transmitted virus that can cause cervical cancer and genital warts. Cervical cancer is the No. 2 cancer killer in women.
"We cannot overstate the huge breakthrough in this vaccine," New Hampshire Public Health Director Mary Ann Cooney said.
State officials hope about 17,000 girls — a quarter of those eligible — will come forward for the vaccinations next year.
Officials want to vaccinate girls before they become sexually active, because the vaccine does not protect those who have already been exposed to HPV.
"Some say giving the vaccination to 11-year-old girls is a license to promiscuity. I disagree," New Hampshire Health and Human Services Commissioner John Stephen said. He urged abstinence, noting that the vaccine will not protect girls from other sexually transmitted diseases, including HIV, or from getting pregnant.
A total of $4.8 million has been budgeted for the vaccine next year.
Well, they got just so much cooler in my world.
They have to remember. The boys need to get vaccinated TOO.
N.H. to offer girls free cancer vaccine
By NORMA LOVE, Associated Press Writer Wed Nov 29, 6:26 PM ET
CONCORD, N.H. - New Hampshire announced plans Wednesday to become the first state to offer the new cervical-cancer vaccine free to all girls. Beginning in January, the vaccine against the human papilloma virus, or HPV, will be provided to girls ages 11 through 18 as part of a state program that offers various immunizations to children at no cost.
The program is paid for by the federal government and insurance companies.
The Food and Drug Administration approved the vaccine in June for girls as young as 9. It prevents infection from some strains of HPV, a sexually transmitted virus that can cause cervical cancer and genital warts. Cervical cancer is the No. 2 cancer killer in women.
"We cannot overstate the huge breakthrough in this vaccine," New Hampshire Public Health Director Mary Ann Cooney said.
State officials hope about 17,000 girls — a quarter of those eligible — will come forward for the vaccinations next year.
Officials want to vaccinate girls before they become sexually active, because the vaccine does not protect those who have already been exposed to HPV.
"Some say giving the vaccination to 11-year-old girls is a license to promiscuity. I disagree," New Hampshire Health and Human Services Commissioner John Stephen said. He urged abstinence, noting that the vaccine will not protect girls from other sexually transmitted diseases, including HIV, or from getting pregnant.
A total of $4.8 million has been budgeted for the vaccine next year.
Things:
- Gym. Went to the gym last night. Had a personal training session with Charlie. He was really nice, and I did lots of things that didn't make me *GROAN* sore today, but things to make me aware that yes, I apparently have muscles.
Also, I found out why my balance is so shit poor. My hip area is *really* flexible. Like, not hamstrings, but hips. And because of that overflexibility, my muscles can't control things cause my tendons are so loose. So. I have to work on becoming like, unflexible. But that isn't going to happen. I never *tried* to become flexible. He says it's prolly genetic then, so I have to work on building up the muscles and core strength to rely on THAT to keep my balance.
It's nice to know I'm not *totally* batshit.
- Heroes. This show rocks my socks. Hiro was my favorite, and last night, he just TOTALLY assured his spot there. This show has sucked me in and my soul is okay with this.
- Girlie Crap. Gots to go to the gyno tonight. *shudder* I don't WANNA. But I havta. I'm always afraid I'm gonna get the phone call saying the squamous cells are back. I'm serious when I say I refuse to have them biopsy me again without throwing my ass under SOME sort of drugs. Just freeze my cooter. It didn't hurt NEARLY as bad.
- PARF. Squish has the pictures. Which means we *may never* see them. I hope I'm wrong. *HINT HUNNIE* But, I had an awesome time. I love our pub sing, but Jesus Christ, theirs blew ours away. Literally. The joust rocked hardcore. And the shows. Sunday, we spent all day running from show to show.
PING![[livejournal.com profile]](https://www.dreamwidth.org/img/external/lj-userinfo.gif)
madmage01!!! Which of the Tartan Terrors CD do you have? Cause between me, Squish and the Valchuck, we have them all. A burning party shall commence. Wanna know if we should throw you into the mix :) I'm officially a Tartan Terrors groupie. We saw almost all the shows we could see :)
- MDRF. No Liz, she got a ride out last weekend to complete her mission. We have an Eric (as of 10:45am), a Jared, a Valchuck, a Kim, a Jay, a Janete, an Angus and a PookieSquishieLoveCircus. I'm stoked. Gonna eat the faire.
- Food. Speaking of eating, I'm starving all the time. I haven't really been doing what the nutrtionist said at all, except really upping my intake of beef and dropping my intake of white flour (and not a whole lot went down either). But I'm getting hungry like a normal person. Hallelujiah.
- Personal News. I have awesome news relating to someone near and dear to my heart. I'm not really saying much yet cause it's not my news. But I will eventually. But I had to just *SQUEEEE* publically.
- Grandpa. He's going for chemo. 2 weeks on, 1 week off, so I hear. They can't operate on the tumor cause his poor body has just been through too much with the heart surgery so recently and how he didn't recover well from that. So, he'll be chemo'ed and radiated. *sigh* Good vibes to the Grampie is really appreciated.
- California invasion of Jersey. The Minx & the Mister are coming out soon. I am SO excited I could scream. *beams*
- Work. I'm here. Usually not on time. I don't know what's wrong lately. I get up early and it's like I hit a time warp in the stairs. I get into the car and it's like, 15 minutes later than it should be (not including my time change to the car's clock). I don't get it.
- Car. Gracie needs and oil change. And I think *all* her speakers are somewhat shot. Squish found a manual online for $9 on how to change ALL the speakers in the car. So between him & Woodchuck, my car speakers should stop farting at me. It's beginning to drive me insane. Moreso than originally thought.
- Free time. I don't have any. I apologize. It happens. On free weeknights, I want to go to the gym. I want to get back into a cycle, and I think I'm gonna start going to the gym after work. I'll hit up the Parsippany branch cause that's like, 15 minutes from work. And in a demented way, it's sort of on way home from the LONG way home. Heh. Whatever. I need a routine. So tired of being winded.
- Gym. Went to the gym last night. Had a personal training session with Charlie. He was really nice, and I did lots of things that didn't make me *GROAN* sore today, but things to make me aware that yes, I apparently have muscles.
Also, I found out why my balance is so shit poor. My hip area is *really* flexible. Like, not hamstrings, but hips. And because of that overflexibility, my muscles can't control things cause my tendons are so loose. So. I have to work on becoming like, unflexible. But that isn't going to happen. I never *tried* to become flexible. He says it's prolly genetic then, so I have to work on building up the muscles and core strength to rely on THAT to keep my balance.
It's nice to know I'm not *totally* batshit.
- Heroes. This show rocks my socks. Hiro was my favorite, and last night, he just TOTALLY assured his spot there. This show has sucked me in and my soul is okay with this.
- Girlie Crap. Gots to go to the gyno tonight. *shudder* I don't WANNA. But I havta. I'm always afraid I'm gonna get the phone call saying the squamous cells are back. I'm serious when I say I refuse to have them biopsy me again without throwing my ass under SOME sort of drugs. Just freeze my cooter. It didn't hurt NEARLY as bad.
- PARF. Squish has the pictures. Which means we *may never* see them. I hope I'm wrong. *HINT HUNNIE* But, I had an awesome time. I love our pub sing, but Jesus Christ, theirs blew ours away. Literally. The joust rocked hardcore. And the shows. Sunday, we spent all day running from show to show.
PING
madmage01!!! Which of the Tartan Terrors CD do you have? Cause between me, Squish and the Valchuck, we have them all. A burning party shall commence. Wanna know if we should throw you into the mix :) I'm officially a Tartan Terrors groupie. We saw almost all the shows we could see :)- MDRF. No Liz, she got a ride out last weekend to complete her mission. We have an Eric (as of 10:45am), a Jared, a Valchuck, a Kim, a Jay, a Janete, an Angus and a PookieSquishieLoveCircus. I'm stoked. Gonna eat the faire.
- Food. Speaking of eating, I'm starving all the time. I haven't really been doing what the nutrtionist said at all, except really upping my intake of beef and dropping my intake of white flour (and not a whole lot went down either). But I'm getting hungry like a normal person. Hallelujiah.
- Personal News. I have awesome news relating to someone near and dear to my heart. I'm not really saying much yet cause it's not my news. But I will eventually. But I had to just *SQUEEEE* publically.
- Grandpa. He's going for chemo. 2 weeks on, 1 week off, so I hear. They can't operate on the tumor cause his poor body has just been through too much with the heart surgery so recently and how he didn't recover well from that. So, he'll be chemo'ed and radiated. *sigh* Good vibes to the Grampie is really appreciated.
- California invasion of Jersey. The Minx & the Mister are coming out soon. I am SO excited I could scream. *beams*
- Work. I'm here. Usually not on time. I don't know what's wrong lately. I get up early and it's like I hit a time warp in the stairs. I get into the car and it's like, 15 minutes later than it should be (not including my time change to the car's clock). I don't get it.
- Car. Gracie needs and oil change. And I think *all* her speakers are somewhat shot. Squish found a manual online for $9 on how to change ALL the speakers in the car. So between him & Woodchuck, my car speakers should stop farting at me. It's beginning to drive me insane. Moreso than originally thought.
- Free time. I don't have any. I apologize. It happens. On free weeknights, I want to go to the gym. I want to get back into a cycle, and I think I'm gonna start going to the gym after work. I'll hit up the Parsippany branch cause that's like, 15 minutes from work. And in a demented way, it's sort of on way home from the LONG way home. Heh. Whatever. I need a routine. So tired of being winded.
Cervical Cancer Vaccine Gets FDA Panel OK
By ANDREW BRIDGES, Associated Press Writer
10 minutes ago
WASHINGTON - A vaccine that blocks viruses that cause most cervical cancer is safe and effective and should be approved, a federal panel recommended Thursday. The drug maker said the vaccine could slash global deaths from the No. 2 cancer in women by more than two-thirds.
A Food and Drug Administration advisory committee voted 13-0 on five separate times to endorse Merck and Co.'s Gardasil. The anticipated cost of the vaccine, administered in three shots over six months, is $300 to $500 — a possible impediment to widespread vaccination campaigns.
The drug protects against the two types of human papillomavirus (HPV) believed responsible for about 70 percent of cervical cancer cases. The vaccine also protects against two other virus types that cause 90 percent of genital wart cases. All four virus types are sexually transmitted.
The FDA is not required to follow the recommendations of its outside panels of experts, but usually does. An agency decision is expected by June 8.
HPV is the most common sexually transmitted disease. It affects more than 50 percent of sexually active adults. The cervical cancer it can cause kills each year about 290,000 women worldwide, including 3,500 women in the United States, where regular pap smears often detect precancerous lesions and early cancer.
"This is certainly a wonderful, good step in addition to our screening processes" in helping eradicate cervical cancer, said Dr. Monica Farley, who heads the advisory panel. She is a bacterial infectious disease expert at the Emory University School of Medicine.
Making their case for approval, Merck officials suggested that development could make Gardasil the biggest advance in preventing cervical cancer since the pap test.
"Gardasil has the potential to meet an unmet medical need as the first vaccine to prevent cervical cancer," Merck's Dr. Patrick Brill-Edwards told the Vaccine and Related Biological Products advisory committee.
Several speakers said the vaccine should not replace screening. Merck said the drug is not intended to do that.
"We would like to see the FDA mandate some sort of labeling or other mechanism to communicate to health care providers and patients the continued need for regular cervical screening," said Amy Allina, program director of the National Women's Health Network.
Merck said the vaccine could be used in females age 9 to 26, but would work best when given to girls before they begin having sex.
Pending action by the FDA, the national Advisory Committee on Immunization Practices will decide in June whether to endorse routine vaccination with the vaccine.
The committee's HPV vaccine group is recommending giving the vaccine to girls 11 and 12. The 15-member committee of experts who advise the government will consider recommendations for females 13 to 26.
The committee's HPV vaccine workgroup is recommending the vaccine be given to girls 11 and 12, and the committee will consider recommendations for females 13 to 26.
Early opposition to Gardasil was based on concerns it could encourage sexual activity in the young. But that largely faded away because of vaccine's potential for reducing cancer.
FDA reviewers said Gardasil appears safe and effective, according to agency documents. One agency reviewer, Dr. Nancy Miller, told the advisory committee that Merck submitted data to support the use of the vaccine in females 9 to 26.
Miller said Gardasil does not necessarily protect against one or more of the four viruses in people already infected before they get the vaccine, and can increase their risk for precursors to cervical cancer.
Also, the drug does not protect against infection from the many other virus strains not included in the vaccine. In addition, the FDA staff highlighted five cases where children with birth defects were born to women who received the vaccine around the time of conception.
Merck, based in Whitehouse Station, N.J., developed the vaccine and tested it in more than 27,000 females and males.
Thursday's discussion focused on its use in preventing HPV-related disease in girls and women, including those as young as 9. But only 250 9-year-old girls and boys received Gardasil in trials.
By ANDREW BRIDGES, Associated Press Writer
10 minutes ago
WASHINGTON - A vaccine that blocks viruses that cause most cervical cancer is safe and effective and should be approved, a federal panel recommended Thursday. The drug maker said the vaccine could slash global deaths from the No. 2 cancer in women by more than two-thirds.
A Food and Drug Administration advisory committee voted 13-0 on five separate times to endorse Merck and Co.'s Gardasil. The anticipated cost of the vaccine, administered in three shots over six months, is $300 to $500 — a possible impediment to widespread vaccination campaigns.
The drug protects against the two types of human papillomavirus (HPV) believed responsible for about 70 percent of cervical cancer cases. The vaccine also protects against two other virus types that cause 90 percent of genital wart cases. All four virus types are sexually transmitted.
The FDA is not required to follow the recommendations of its outside panels of experts, but usually does. An agency decision is expected by June 8.
HPV is the most common sexually transmitted disease. It affects more than 50 percent of sexually active adults. The cervical cancer it can cause kills each year about 290,000 women worldwide, including 3,500 women in the United States, where regular pap smears often detect precancerous lesions and early cancer.
"This is certainly a wonderful, good step in addition to our screening processes" in helping eradicate cervical cancer, said Dr. Monica Farley, who heads the advisory panel. She is a bacterial infectious disease expert at the Emory University School of Medicine.
Making their case for approval, Merck officials suggested that development could make Gardasil the biggest advance in preventing cervical cancer since the pap test.
"Gardasil has the potential to meet an unmet medical need as the first vaccine to prevent cervical cancer," Merck's Dr. Patrick Brill-Edwards told the Vaccine and Related Biological Products advisory committee.
Several speakers said the vaccine should not replace screening. Merck said the drug is not intended to do that.
"We would like to see the FDA mandate some sort of labeling or other mechanism to communicate to health care providers and patients the continued need for regular cervical screening," said Amy Allina, program director of the National Women's Health Network.
Merck said the vaccine could be used in females age 9 to 26, but would work best when given to girls before they begin having sex.
Pending action by the FDA, the national Advisory Committee on Immunization Practices will decide in June whether to endorse routine vaccination with the vaccine.
The committee's HPV vaccine group is recommending giving the vaccine to girls 11 and 12. The 15-member committee of experts who advise the government will consider recommendations for females 13 to 26.
The committee's HPV vaccine workgroup is recommending the vaccine be given to girls 11 and 12, and the committee will consider recommendations for females 13 to 26.
Early opposition to Gardasil was based on concerns it could encourage sexual activity in the young. But that largely faded away because of vaccine's potential for reducing cancer.
FDA reviewers said Gardasil appears safe and effective, according to agency documents. One agency reviewer, Dr. Nancy Miller, told the advisory committee that Merck submitted data to support the use of the vaccine in females 9 to 26.
Miller said Gardasil does not necessarily protect against one or more of the four viruses in people already infected before they get the vaccine, and can increase their risk for precursors to cervical cancer.
Also, the drug does not protect against infection from the many other virus strains not included in the vaccine. In addition, the FDA staff highlighted five cases where children with birth defects were born to women who received the vaccine around the time of conception.
Merck, based in Whitehouse Station, N.J., developed the vaccine and tested it in more than 27,000 females and males.
Thursday's discussion focused on its use in preventing HPV-related disease in girls and women, including those as young as 9. But only 250 9-year-old girls and boys received Gardasil in trials.
Make the Connection
I don't know if you have done this or not already but if you go to the following webpage, you can order a bracelet kit for free. Merck will then donate a $1 to cervical cancer research.
Just in case you don't know a whole lot about HPV and cervical cancer, here is a link for more imformation.
http://www.healthywomen.org/healthtopics/humanpapillomavirus
I don't know if you have done this or not already but if you go to the following webpage, you can order a bracelet kit for free. Merck will then donate a $1 to cervical cancer research.
Just in case you don't know a whole lot about HPV and cervical cancer, here is a link for more imformation.
http://www.healthywomen.org/healthtopics/humanpapillomavirus
WOOHOO!!!!
Mar. 13th, 2006 03:49 pmSO, I realize.
Hey, I need to call my cookie monster to see the results of my last pap.
Hey get this shit.
NORMAL CELLS MOTHERFUCKERS!!!
NORMAL!!! I HAVE TESTS SAYING THAT SOMETHING IN ME IS NORMAL!!!
*BWAHAHAHAHAH*
For YEARS I've had to go every 6 months for paps, cause of that STUPID HPV.
BUT!!!!! I can go ANUALLY AGAIN!! No more of this bi-annually shit.
And I got NEWS for y'all. If I have to get another biopsy, I'm saying NO! And telling those fuckers to go STRAIGHT to cryo. Cause the biopsy. Yeah. That shit hurt like WHOA.
I told my doctor. I was like, "I love you. You are a wonderfully kind and patient lil' lady. But I see you far too often."
*grins*
She said she understood. SHE IS SO CUTE!
Anyrate. This cooter, is CLEEAAAHRRR!!!!
Hey, I need to call my cookie monster to see the results of my last pap.
Hey get this shit.
NORMAL CELLS MOTHERFUCKERS!!!
NORMAL!!! I HAVE TESTS SAYING THAT SOMETHING IN ME IS NORMAL!!!
*BWAHAHAHAHAH*
For YEARS I've had to go every 6 months for paps, cause of that STUPID HPV.
BUT!!!!! I can go ANUALLY AGAIN!! No more of this bi-annually shit.
And I got NEWS for y'all. If I have to get another biopsy, I'm saying NO! And telling those fuckers to go STRAIGHT to cryo. Cause the biopsy. Yeah. That shit hurt like WHOA.
I told my doctor. I was like, "I love you. You are a wonderfully kind and patient lil' lady. But I see you far too often."
*grins*
She said she understood. SHE IS SO CUTE!
Anyrate. This cooter, is CLEEAAAHRRR!!!!
Results just in from the cookie monster!
Pap is still clear!!
*gleee*
*does a lil' dance*
Get to go back in six months though.
Joy.
*for those of you just joining our broadcast.... about a year and some months ago, I had pap come back with low squamous cells, so I had to get a biopsy, which showed precancerous cells. So THEN! I got to have them FROZEN OFF. The biopsy was prolly the most painful thing in my life (yes, I screamed bloody murder, just ask my mother) and I've dealt with some shit. Not to mention they don't like, NUMB you or anything. UGGHH.
And, heh. I have very few phobias. My biggest one? The gyno. Just something about putting my heels in those stirrups... I dunno.. horrifies me. I just about passed out after the cryosurgery. Smelling salts suck. So yeah. Now yer caught up. I think. Whatever.
Pap is still clear!!
*gleee*
*does a lil' dance*
Get to go back in six months though.
Joy.
*for those of you just joining our broadcast.... about a year and some months ago, I had pap come back with low squamous cells, so I had to get a biopsy, which showed precancerous cells. So THEN! I got to have them FROZEN OFF. The biopsy was prolly the most painful thing in my life (yes, I screamed bloody murder, just ask my mother) and I've dealt with some shit. Not to mention they don't like, NUMB you or anything. UGGHH.
And, heh. I have very few phobias. My biggest one? The gyno. Just something about putting my heels in those stirrups... I dunno.. horrifies me. I just about passed out after the cryosurgery. Smelling salts suck. So yeah. Now yer caught up. I think. Whatever.
Random thoughts...
Feb. 14th, 2005 01:16 pmSo. I called the gyno.
This cooter is CLEAR.
*cries with relief*
I don't have to get frozen again!!! *GLEE* I have to go for another re-pap in August.
I'm really, really, really happy about this.
Valentine's day.
Yeah, it's annoying. Whatever. I think it's SAD that this holiday was made up because couples forget to acknowledge each other through the course of the year, so they had to MAKE UP a holiday so they'd remember each other. Then again, I know how easily forgotten I was continuously, so I see the point in this. It's still sad that the American public for the most part forgets the most important person in their world.
In the 10 months JD & I were together, we managed to not have a Valentine's day together. I kinda had plans for what I'd do this year, but since we broke up, it doesn't really matter. All my plans got caboshed in the worst way.
Alan and I had a couple of really great Valentine's days. Once we went out to this Argentinian restaurant and had skirt steak and wine. We dressed up real nice. It was uber sweet. Abuela made SUCH a fuss over how pretty I looked. The woman had only seen me in sweats and t shirts, and here I was all dressie dressie. She took pictures. It was cute :)
Then, we went to Mount Fuji once. With Steph & Tim!! It was a great time. Ate like little piglets. Had a really good time after. LOL...
Last year, Janete & I were valentine-less, so we took in Grinch as well. Hehehe.. so it was the three of us walking arm in arm at the mall, acting like totally idiots.
This year.
Well, I found out I have my health. Quite honestly, that's probably the best thing I could have hoped for, all things considered.
Janete & Anne are my valentines this year. *smiles* Us single gals gots to stick together.
Janete got me a rose. I'm such a cheap valentine, I didn't get them shit. Maybe if they come over tonight, I'll do something nice nice :)
This cooter is CLEAR.
*cries with relief*
I don't have to get frozen again!!! *GLEE* I have to go for another re-pap in August.
I'm really, really, really happy about this.
Valentine's day.
Yeah, it's annoying. Whatever. I think it's SAD that this holiday was made up because couples forget to acknowledge each other through the course of the year, so they had to MAKE UP a holiday so they'd remember each other. Then again, I know how easily forgotten I was continuously, so I see the point in this. It's still sad that the American public for the most part forgets the most important person in their world.
In the 10 months JD & I were together, we managed to not have a Valentine's day together. I kinda had plans for what I'd do this year, but since we broke up, it doesn't really matter. All my plans got caboshed in the worst way.
Alan and I had a couple of really great Valentine's days. Once we went out to this Argentinian restaurant and had skirt steak and wine. We dressed up real nice. It was uber sweet. Abuela made SUCH a fuss over how pretty I looked. The woman had only seen me in sweats and t shirts, and here I was all dressie dressie. She took pictures. It was cute :)
Then, we went to Mount Fuji once. With Steph & Tim!! It was a great time. Ate like little piglets. Had a really good time after. LOL...
Last year, Janete & I were valentine-less, so we took in Grinch as well. Hehehe.. so it was the three of us walking arm in arm at the mall, acting like totally idiots.
This year.
Well, I found out I have my health. Quite honestly, that's probably the best thing I could have hoped for, all things considered.
Janete & Anne are my valentines this year. *smiles* Us single gals gots to stick together.
Janete got me a rose. I'm such a cheap valentine, I didn't get them shit. Maybe if they come over tonight, I'll do something nice nice :)
FANFUCKINGTASTIC!!
Nov. 1st, 2004 06:58 pmStudy: Vaccine Protects Against Cancer
By MARILYNN MARCHIONE, AP Medical Writer
WASHINGTON - Efforts to develop the world's first vaccine to prevent cervical cancer took a key step forward Monday with test results suggesting that it can provide long-lasting protection.
Four years after getting the vaccine, 94 percent of women were protected from infection with the virus that causes most cervical cancers and none had developed worrisome precancerous conditions, a study showed.
"We're thrilled about these results. The immune responses seem to be really long-lasting," said Dr. Eliav Barr, who leads development of the vaccine for Merck & Co. The company plans to seek U.S. Food and Drug Administration (news - web sites) approval next year for an expanded version of the vaccine that also could be used to prevent genital warts in both women and men.
The new study was funded by Merck and led by University of Washington researchers who presented results Monday at a meeting of the American Society for Microbiology.
"They showed clear effectiveness," said Dr. Scott Hammer, a Columbia University infectious disease expert who reviewed the work but has no ties to Merck or the study. "This is a very important issue for women's health around the world."
If the vaccine makes it to market, it would be the second developed to prevent cancer. The hepatitis B vaccine has dramatically reduced the number of infections that progress to liver cancer.
Cervical cancer strikes nearly half a million women worldwide each year and kills about half. In the United States, about 15,000 women get it and about 5,000 die.
Virtually all cases are caused by infection with human papilloma virus, or HPV, which is spread through sex. One strain, HPV-16, accounts for about half of all cervical cancers.
A previous study showed that HPV-16 infections were completely prevented in 768 women who had received the Merck vaccine 18 months earlier. None developed precancerous conditions either.
The new study followed 755 of these women for four years after vaccination. HPV-16 infections had taken hold in seven; none developed precancers. In a comparison group of 750 women who received dummy shots, infections took hold in 111 and precancers formed in 12.
Even though protection had waned for a small number of women in the study, the vaccine's effectiveness was still very high, said Dr. Douglas Lowy, a National Cancer Institute (news - web sites) scientist who invented the vaccine. The government gave rights to develop it to two companies — Merck and GlaxoSmithKline — and Merck's work is a little farther along, Lowy said.
"Revaccination might be advisable at some point," but it will take more study to know whether that is necessary or would improve effectiveness, he said.
Women in the study were ages 16 to 23 when they received the vaccine, given in three doses over six months.
"Most people think it would be recommended for young adolescents. The idea would be you would immunize people relatively soon before they become sexually active," because the germ is spread through sex, Lowy said.
Meanwhile, Merck is in the final stages of testing an expanded vaccine. Besides HPV-16, it contains strain 18, which causes another 10 percent to 20 percent of cervical cancers, as well as strains that cause genital warts in men and women, and penile and anal cancers in men.
About 25,000 women and men have been enrolled in that study in 34 countries, and results are expected next year, Barr said.
Giving the vaccine to men would not only prevent disease in them but also would prevent infections in their partners, said Steven Projan, a drug development expert with Wyeth who helped review research for the microbiology meeting. The vaccine also might prevent women already infected with HPV from developing cancer, he said.
That is amazing. This thrills me. I'm so fucking excited!!!!
By MARILYNN MARCHIONE, AP Medical Writer
WASHINGTON - Efforts to develop the world's first vaccine to prevent cervical cancer took a key step forward Monday with test results suggesting that it can provide long-lasting protection.
Four years after getting the vaccine, 94 percent of women were protected from infection with the virus that causes most cervical cancers and none had developed worrisome precancerous conditions, a study showed.
"We're thrilled about these results. The immune responses seem to be really long-lasting," said Dr. Eliav Barr, who leads development of the vaccine for Merck & Co. The company plans to seek U.S. Food and Drug Administration (news - web sites) approval next year for an expanded version of the vaccine that also could be used to prevent genital warts in both women and men.
The new study was funded by Merck and led by University of Washington researchers who presented results Monday at a meeting of the American Society for Microbiology.
"They showed clear effectiveness," said Dr. Scott Hammer, a Columbia University infectious disease expert who reviewed the work but has no ties to Merck or the study. "This is a very important issue for women's health around the world."
If the vaccine makes it to market, it would be the second developed to prevent cancer. The hepatitis B vaccine has dramatically reduced the number of infections that progress to liver cancer.
Cervical cancer strikes nearly half a million women worldwide each year and kills about half. In the United States, about 15,000 women get it and about 5,000 die.
Virtually all cases are caused by infection with human papilloma virus, or HPV, which is spread through sex. One strain, HPV-16, accounts for about half of all cervical cancers.
A previous study showed that HPV-16 infections were completely prevented in 768 women who had received the Merck vaccine 18 months earlier. None developed precancerous conditions either.
The new study followed 755 of these women for four years after vaccination. HPV-16 infections had taken hold in seven; none developed precancers. In a comparison group of 750 women who received dummy shots, infections took hold in 111 and precancers formed in 12.
Even though protection had waned for a small number of women in the study, the vaccine's effectiveness was still very high, said Dr. Douglas Lowy, a National Cancer Institute (news - web sites) scientist who invented the vaccine. The government gave rights to develop it to two companies — Merck and GlaxoSmithKline — and Merck's work is a little farther along, Lowy said.
"Revaccination might be advisable at some point," but it will take more study to know whether that is necessary or would improve effectiveness, he said.
Women in the study were ages 16 to 23 when they received the vaccine, given in three doses over six months.
"Most people think it would be recommended for young adolescents. The idea would be you would immunize people relatively soon before they become sexually active," because the germ is spread through sex, Lowy said.
Meanwhile, Merck is in the final stages of testing an expanded vaccine. Besides HPV-16, it contains strain 18, which causes another 10 percent to 20 percent of cervical cancers, as well as strains that cause genital warts in men and women, and penile and anal cancers in men.
About 25,000 women and men have been enrolled in that study in 34 countries, and results are expected next year, Barr said.
Giving the vaccine to men would not only prevent disease in them but also would prevent infections in their partners, said Steven Projan, a drug development expert with Wyeth who helped review research for the microbiology meeting. The vaccine also might prevent women already infected with HPV from developing cancer, he said.
That is amazing. This thrills me. I'm so fucking excited!!!!
My dad just called me. He was worried about my cryosurgery and stuff. He had to sneak in a call. He also wanted to make sure I got my shirt. Which I'm wearing, oddly enough. I do love it. Cept my NAME across the shoulder. But that's doable.
I think I get my phobias from him. He's incredibly claustrophobic... And he can't eat meat fat either. We have a lot of weird shit in common.
When he gets out, he wants a cheese burger, with bacon, taylor ham, and fried onions. Hehehe.
I think I'll make sure he gets it :)
I think I get my phobias from him. He's incredibly claustrophobic... And he can't eat meat fat either. We have a lot of weird shit in common.
When he gets out, he wants a cheese burger, with bacon, taylor ham, and fried onions. Hehehe.
I think I'll make sure he gets it :)
That was awful. The procedure itself was a fucking CAKEWALK.
But afterwards, I nearly passed out. They used smelling salts on me and when I could walk again, they put me in a room to lay down and put cold compresses on me.
My mom said I gave new meaning to the word "pale".
The cramping has subsided a bit. I no longer feel nauseous or faint. But I feel like shit. Utter fucking shit.
Ow.
I don't have to be poked again till I go to the gyno for a pap in January. Thank the Goddess. Ow.
But afterwards, I nearly passed out. They used smelling salts on me and when I could walk again, they put me in a room to lay down and put cold compresses on me.
My mom said I gave new meaning to the word "pale".
The cramping has subsided a bit. I no longer feel nauseous or faint. But I feel like shit. Utter fucking shit.
Ow.
I don't have to be poked again till I go to the gyno for a pap in January. Thank the Goddess. Ow.
Leaving work now...
Sep. 28th, 2004 12:28 pmhave my cryosurgery at 3.
Sends lots of good vibes and stuff.
This is gonna hurt :(
Sends lots of good vibes and stuff.
This is gonna hurt :(
YESSSSSSSSS!!
Sep. 10th, 2004 10:51 amNEGATIVE BEYOTCH!!!!! No cancer in this cootch!!!
Doctor just called me :) *phew*
I still have to get the precancerous shit frozen off my cervix, but they say it hurts less than the goddamned biopsy and it'd BETTER.
Jesus that sucked.
Doctor just called me :) *phew*
I still have to get the precancerous shit frozen off my cervix, but they say it hurts less than the goddamned biopsy and it'd BETTER.
Jesus that sucked.
