We and other blogger friends have blogged about Gardasil before here and there -- and in a quick and dirty drive-by post, we thought we'd update you on the latest developments:
The AP press reports that federal health officials approved expanding the use of Gardasil, the cervical cancer vaccine, to prevent cancers of the vagina and vulva:
"The Food and Drug Administration first approved Gardasil in 2006 for the prevention of cervical cancer in girls and women ages 9 to 26. The vaccine works by protecting against strains of the human papillomavirus, or HPV, that cause about 70 percent of cervical cancers. The HPV virus, transmitted by sexual contact, causes genital warts that sometimes develop into cancer.
'There is now strong evidence showing that this vaccine can help prevent vulvar and vaginal cancers due to the same virus for which it also helps protect against cervical cancer' said Dr. Jesse Goodman, director of the FDA center that oversees vaccines."
Full Story can be accessed here.
Showing posts with label cervical cancer. Show all posts
Showing posts with label cervical cancer. Show all posts
Monday, September 15, 2008
Thursday, June 05, 2008
Cervical Cancer Vaccine: Do we need it?
By: Jenny Walters
As you watch television, you cannot go a day or even a couple hours without seeing the commercial for Gardasil, “the first ever cervical cancer vaccine.” Gardasil claims to stop cervical cancer before is starts. The Gardasil vaccine is recommended for girls ages 11 to 12, but can be used in girls as young as 9. According to an article from the Mayo Clinic, written by Bobby Gostout, MD, and entitled Cervical cancer vaccine: Who needs is, how it works, Gardasil is the newest addition to the official childhood immunization schedule.[1]
Cervical cancer affects 10,000 women a year and leads to 4,000 deaths.1 In 2005, according to the World Health Organization, there were an estimated 500,000 new cases of cervical cancer. Cervical cancer is the leading cause of death in women, even with treatment.
Various strains of the human papillomavirus (HPV), are responsible for most cases of cervical cancer.1 HPV spreads through sexual contact. Gardasil specifically blocks two cancer-causing types of HPV: types 16 and 18. Gardasil also blocks types 6 and 11, which are associated with genital warts and mild Pap test abnormalities.
The Gardasil vaccine allows young girls immune system to become “activated before their likely to encounter HPV.” Vaccinating young girls also allows for higher antibody levels, which results in greater protection against cervical cancer.1
To see earlier positive effects of the Gardasil vaccine, the Center for Disease Control (CDC) recommends a “catch-up immunization for girls and women ages 13 to 26” be administered.1 Currently, the vaccine is not required for school enrollment, but may be in the future.1 Gardasil has been proven to be “remarkably safe.”1
Common side effects include: soreness at the injection site, low-grade fever or flu-like symptoms. There were no reports of clinical trial discontinuation due to serious side effects. So what does this all mean?
As a mother and wife, HPV is not a threat I worry about now. However, during nursing school, I had a class of about 18 girls. Of those 18 girls, almost every one of them had the HPV infection. It seemed as though each week I would hear of another student having an abnormal Pap test due to HPV. HPV is non-discriminating, it can affect anyone. If the Gardasil vaccine can help block HPV infection, than maybe one day cervical cancer will no longer be the number one killer of women.
[1] Gostout B, MD. Cervical cancer vaccine: who needs it, how it works. Sep 2007. Available at: http://www.mayoclinic.com/health/cervical-cancer-vaccine/WO00120. Accessed on Jun 02, 2008.
As you watch television, you cannot go a day or even a couple hours without seeing the commercial for Gardasil, “the first ever cervical cancer vaccine.” Gardasil claims to stop cervical cancer before is starts. The Gardasil vaccine is recommended for girls ages 11 to 12, but can be used in girls as young as 9. According to an article from the Mayo Clinic, written by Bobby Gostout, MD, and entitled Cervical cancer vaccine: Who needs is, how it works, Gardasil is the newest addition to the official childhood immunization schedule.[1]
Cervical cancer affects 10,000 women a year and leads to 4,000 deaths.1 In 2005, according to the World Health Organization, there were an estimated 500,000 new cases of cervical cancer. Cervical cancer is the leading cause of death in women, even with treatment.
Various strains of the human papillomavirus (HPV), are responsible for most cases of cervical cancer.1 HPV spreads through sexual contact. Gardasil specifically blocks two cancer-causing types of HPV: types 16 and 18. Gardasil also blocks types 6 and 11, which are associated with genital warts and mild Pap test abnormalities.
The Gardasil vaccine allows young girls immune system to become “activated before their likely to encounter HPV.” Vaccinating young girls also allows for higher antibody levels, which results in greater protection against cervical cancer.1
To see earlier positive effects of the Gardasil vaccine, the Center for Disease Control (CDC) recommends a “catch-up immunization for girls and women ages 13 to 26” be administered.1 Currently, the vaccine is not required for school enrollment, but may be in the future.1 Gardasil has been proven to be “remarkably safe.”1
Common side effects include: soreness at the injection site, low-grade fever or flu-like symptoms. There were no reports of clinical trial discontinuation due to serious side effects. So what does this all mean?
As a mother and wife, HPV is not a threat I worry about now. However, during nursing school, I had a class of about 18 girls. Of those 18 girls, almost every one of them had the HPV infection. It seemed as though each week I would hear of another student having an abnormal Pap test due to HPV. HPV is non-discriminating, it can affect anyone. If the Gardasil vaccine can help block HPV infection, than maybe one day cervical cancer will no longer be the number one killer of women.
[1] Gostout B, MD. Cervical cancer vaccine: who needs it, how it works. Sep 2007. Available at: http://www.mayoclinic.com/health/cervical-cancer-vaccine/WO00120. Accessed on Jun 02, 2008.
Tuesday, May 20, 2008
A disturbing prediction on cervical cancer deaths ...
Today's New York Times has an article summarizing the disturbing results of a new study looking at trends in cervical cancer morbidity and mortality in Latin America.
In an era in which most cases of cervical cancer can be prevented or detected early and treated, the study – sponsored by the Sabin Vaccine Institute, the Pan American Health Organization, and the US CDC, among others – concluded that cervical cancer-related deaths are likely to double in Latin America in the next 20 years. Fewer than five per cent of women in Africa, Asia and Latin America are screened for cervical cancer, as compared to 70% of women in North America and Europe. Most of these women also lack access to newly-approved HPV vaccines.
Does this truly have to be the case? Must we continue to needlessly condemn 250,000 poor women to death every year? Even if we accept the argument that current screening and treatment technologies – Pap smears and the HPV vaccine – are too costly to be used widely in resource-poor countries like Haiti and Nicaragua, what about lower cost screening technologies like VIA (visual inspection of the cervix using acetic acid)?
For almost a decade, it has been known that clinicians, usually nurse-midwives, can detect more than three-fourths of pre-cancerous and cancerous cervical lesions simply by wiping a patient's cervix with acetic acid (white vinegar) and examining it visually. That this method is not more widely used, particularly in light of a recent Lancet study showing that VIA is as effective as traditional screening methods in India, is shameful.
It's time to wake up and smell the vinegar ...
In an era in which most cases of cervical cancer can be prevented or detected early and treated, the study – sponsored by the Sabin Vaccine Institute, the Pan American Health Organization, and the US CDC, among others – concluded that cervical cancer-related deaths are likely to double in Latin America in the next 20 years. Fewer than five per cent of women in Africa, Asia and Latin America are screened for cervical cancer, as compared to 70% of women in North America and Europe. Most of these women also lack access to newly-approved HPV vaccines.
Does this truly have to be the case? Must we continue to needlessly condemn 250,000 poor women to death every year? Even if we accept the argument that current screening and treatment technologies – Pap smears and the HPV vaccine – are too costly to be used widely in resource-poor countries like Haiti and Nicaragua, what about lower cost screening technologies like VIA (visual inspection of the cervix using acetic acid)?
For almost a decade, it has been known that clinicians, usually nurse-midwives, can detect more than three-fourths of pre-cancerous and cancerous cervical lesions simply by wiping a patient's cervix with acetic acid (white vinegar) and examining it visually. That this method is not more widely used, particularly in light of a recent Lancet study showing that VIA is as effective as traditional screening methods in India, is shameful.
It's time to wake up and smell the vinegar ...
Monday, February 25, 2008
Is GARDASIL® a responsible mandate?
If the common goals between the public and the pharmaceutical giant Merck in the controversy over compulsory HPV vaccination were long-term cost containment and public safety by reduction and prevention of widespread disease (HPV and cervical cancer, in this case), and GARDASIL is supposed to achieve both objectives; then, mandatory GARDASIL vaccinations for young women is worth investigating.
Compulsory HPV vaccination for girls before they become sexually active is said to cut long-term costs in their healthcare (especially costs related to cervical cancer). However, these costs may be outweighed by long-term costs that are unknown at this time. According to Merck's website, GARDASIL has only been tested for over a decade, which is not sufficient in considering the long-term effects of a drug on a young woman's reproductive system. Currently, GARDASIL has not been evaluated for the potential to cause carcinogenicity or genotoxicity... it is not known whether GARDASIL can affect reproductive capacity (Merck 2007). Because a little over a decade is arguably insufficient time to recognize all of the implications that the drug may have on a woman of childbearing age who received the vaccine prior to, or during puberty, we do not know the long-term costs of what may result from the use of GARDASIL. And, we cannot assume that GARDASIL is cost efficient. We cannot consider this vaccine to be an effective one in reducing or preventing long-term, perhaps costly health problems.
As the second most common cause of cancer death in women worldwide, resulting in nearly a half-million diagnoses and 240,000 deaths each year (Merck 2007), and because 6 million people in this country become infected with HPV every year, and nearly 10,000 women are diagnosed with cervical cancer (Colgrove 2006), HPV and cervical cancer are undeniably very serious threats to public health. Compulsory HPV vaccination for girls before they become sexually active is said to significantly reduce or even prevent widespread cervical cancer. Because there is some evidence of its success in preventing four types of HPV, two of which are leading causes of cervical cancer, the fact that there are at least short-term benefits to GARDASIL is undeniable. However, the vaccine should be made accessible without mandating its use. From a moral standpoint, it seems that the use of the GARDASIL should be accessible at least for those at high risk (i.e., with family history of cervical cancer, etc.). Without long-term evidence of its efficacy and safety, it seems irresponsible (on the part of government, as well as Merck) to mandate its use, but also to deny its access completely.
The best possibility at this point is to wait until further, more conclusive and long-term research has been conducted. Given more time, competition will likely increase, which will inevitably reduce the cost to the consumer (or government), as well as provide more sound evidence regarding its long-term efficacy and safety.
References:
Merck. 2007. CDC Finalizes Advisory Panel Recommendations for GARDASIL®, Merck Cervical Cancer Vaccine. http://www.merck.com/newsroom/press_releases/product/2007_0322.html (accessed September 25, 2007).
Colgrove, J. 2006. The Ethics and Politics of Compulsory HPV Vaccination. http://www.natap.org/2006/newsUpdates/121106_05.htm (accessed February 20, 2008).
Sunday, February 24, 2008
Embracing the HPV Vaccine -- Warts and All?
We've posted before here and here about the HPV vaccine and debated whether or not it should be 'mandated' for girls; today in the NY Times an article in the Fashion and Style section (??) asks whether or not the parents would encourage their boys to get the vaccine. Currently, Gardasil is only FDA approved for girls and is marketed as preventing cervical cancer; but boys could benefit too, because the vaccine also protects against genital warts. Currently the vaccine is already approved for boys in Australia, Mexico and countries in the European Union; Merck will seek FDA approval for boys later this year. The question is, will the parents of young boys and girls in the USA buy it? Full article accessible here.
Monday, August 13, 2007
A Little Dab Will Do Ya ...
[cross-posted from GCM News ... sign up for the Global Campaign for Microbicides newsletter at http://global-campaign.org]
A simple technique using nothing more than cotton swabs and vinegar could help prevent the deaths of more than 250,000 women a year. Cervical cancer – a sexually transmitted disease caused by the human papilloma virus (HPV) – is the leading cause of cancer-related mortality in the developing world. Early diagnosis and treatment is key, but current screening and treatment technologies, such as Pap smears and the newly approved HPV vaccine, are too costly to be used widely in resource-poor countries. Fewer than five per cent of women in Africa, Asia and Latin America are screened for cervical cancer, as compared to 70% of women in North America and Europe.
In 1999, researchers in the U.S. and Zimbabwe showed that trained nurse-midwives who wiped a patient's cervix with acetic acid (white vinegar) accurately detected more than three-fourths of pre-cancerous and cancerous lesions; tissue harboring such lesions turned white when exposed to vinegar, and could be easily seen during a visual inspection of the cervix.
In a study recently published in the British medical journal The Lancet, researchers in India and France have built upon that finding to show that this method – visual inspection of the cervix using acetic acid (VIA) – is as effective as Pap smears for detection of cervical cancer and dysplasia. In the study, 49,311 sexually active women in Tamil Nadu were randomized to receive VIA or existing cervical screening and care. Women who were VIA-positive were offered further treatment, including cryotherapy to remove any lesions, or a referral if they had invasive cancer. Women who underwent VIA had a 25 percent reduction in cervical cancer incidence and a 35 percent reduction in deaths compared with the women who received standard screening and care.
As promising as these results are, however, it is important to note that the Lancet study was performed at a clinic with dedicated staff and in an area where treatment for cervical cancer was readily available. The VIA screening method is simple and cheap, but many women in resource-poor countries still lack access to basic medical services, let alone treatment and care for cervical dysplasia or cancer. As always, technologies are only useful if they are not only effective but also available, affordable and acceptable to the people who need them.
The painful irony is that cervical cancer screening is of no use to women who cannot access treatment to prevent the onset of cancer. This breakthrough only underscores the need to advocate relentlessly for adequate access to the full spectrum of reproductive health care options, including (and especially) treatment for life threatening conditions. This is surely a case in which half a loaf really isn’t better than no loaf at all.
A simple technique using nothing more than cotton swabs and vinegar could help prevent the deaths of more than 250,000 women a year. Cervical cancer – a sexually transmitted disease caused by the human papilloma virus (HPV) – is the leading cause of cancer-related mortality in the developing world. Early diagnosis and treatment is key, but current screening and treatment technologies, such as Pap smears and the newly approved HPV vaccine, are too costly to be used widely in resource-poor countries. Fewer than five per cent of women in Africa, Asia and Latin America are screened for cervical cancer, as compared to 70% of women in North America and Europe.
In 1999, researchers in the U.S. and Zimbabwe showed that trained nurse-midwives who wiped a patient's cervix with acetic acid (white vinegar) accurately detected more than three-fourths of pre-cancerous and cancerous lesions; tissue harboring such lesions turned white when exposed to vinegar, and could be easily seen during a visual inspection of the cervix.
In a study recently published in the British medical journal The Lancet, researchers in India and France have built upon that finding to show that this method – visual inspection of the cervix using acetic acid (VIA) – is as effective as Pap smears for detection of cervical cancer and dysplasia. In the study, 49,311 sexually active women in Tamil Nadu were randomized to receive VIA or existing cervical screening and care. Women who were VIA-positive were offered further treatment, including cryotherapy to remove any lesions, or a referral if they had invasive cancer. Women who underwent VIA had a 25 percent reduction in cervical cancer incidence and a 35 percent reduction in deaths compared with the women who received standard screening and care.
As promising as these results are, however, it is important to note that the Lancet study was performed at a clinic with dedicated staff and in an area where treatment for cervical cancer was readily available. The VIA screening method is simple and cheap, but many women in resource-poor countries still lack access to basic medical services, let alone treatment and care for cervical dysplasia or cancer. As always, technologies are only useful if they are not only effective but also available, affordable and acceptable to the people who need them.
The painful irony is that cervical cancer screening is of no use to women who cannot access treatment to prevent the onset of cancer. This breakthrough only underscores the need to advocate relentlessly for adequate access to the full spectrum of reproductive health care options, including (and especially) treatment for life threatening conditions. This is surely a case in which half a loaf really isn’t better than no loaf at all.
Friday, February 02, 2007
Texas Governor Orders STD Vaccine For All Girls
From MSNBC:
And for those of you wondering how Gov. Perry has the authority to issue such an order:
See previous WBP posts here.
Bypassing the Legislature altogether, Republican Gov. Rick Perry issued an order Friday making Texas the first state to require that schoolgirls get vaccinated against the sexually transmitted virus that causes cervical cancer.
Perry also directed state health authorities to make the vaccine available free to girls 9 to 18 who are uninsured or whose insurance does not cover vaccines. In addition, he ordered that Medicaid offer Gardasil to women ages 19 to 21.
Beginning in September 2008, girls entering the sixth grade — meaning, generally, girls ages 11 and 12 — will have to receive Gardasil, Merck & Co.’s new vaccine against strains of the human papillomavirus, or HPV.
And for those of you wondering how Gov. Perry has the authority to issue such an order:
By employing an executive order, Perry sidestepped opposition in the Legislature from conservatives and parents’ rights groups...
The order is effective until Perry or a successor changes it, and the Legislature has no authority to repeal it, said Perry spokeswoman Krista Moody. Moody said the Texas Constitution permits the governor, as head of the executive branch, to order other members of the executive branch to adopt rules like this one.It'll be interesting to see how this plays out in the media, with the public, and I'm sure, eventually a courtroom. Bravo to Gov. Perry for taking the lead on this issue.
See previous WBP posts here.
Subscribe to:
Posts (Atom)
