Posts Tagged Human Papillomavirus

The HPV Vaccine and U.S. Immigration

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A girl’s attempt to gain U.S. citizenship may be derailed by refusal to have the human papillomavirus (HPV) vaccine. Simone Davis, a 17-year-old girl born in Britain, seeks to become a U.S. citizen but is confronted by immigration laws mandating that she receive the HPV vaccine that protects against the sexually transmitted human papillomavirus commonly attributed to cervical cancer.

This vaccine requirement stems from the 1996 Immigration and Nationality Act, which mandates that prior to being granted permanent resident status, immigrants must receive all vaccines recommended by the Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP). In 2008, however, the U.S. Citizenship and Immigration Services (USCIS) updated the list of vaccines required of immigrants to include HPV, a move criticized by a number of advocacy groups who say the mandate places undue burden on those seeking to enter the U.S., and in particular, to women and girls.

Some organizations and advocate groups that focus on immigrant rights and women’s health have questioned the necessity of forcing individuals to receive the vaccine considering that HPV isn’t communicable in public settings. Of the 14 required vaccines, 13 of which aim to prevent infectious diseases considered highly contagious, Gardasil alone targets a sexually transmissible virus. Another worry is that cost may pose unfair financial burden placed on women, possibly acting as a significant financial barrier to seeking citizenship (the vaccine costs $360, plus clinic fees).

Simone protests the HPV vaccine for several reasons; her story reported by abcnews.com. As a devout Christian, Simone has taken a virginity pledge and doesn’t understand she why she should be required to take the vaccine when she doesn’t believe herself to be at risk. Her guardian and paternal grandmother, whom Simone calls “Nanny,” was also upset by this mandate and filed a waiver to the U.S. Citizenship and Immigration Services on moral and religious grounds but was rejected. Now facing the possibility of being separated from her Nanny, with only 30 days to appeal the decision before she must reapply as an adult (which requires a five year wait to become eligible for citizenship), Simone questions why none of her American classmates were required to take the HPV vaccine. Simone’s Nanny claims the issue is not simply about religion, and instead highlights their desire to have the same rights of any U.S. citizen.

Deborah Arrindell, ASHA’s vice-president of health policy, says “This vaccine has enormous potential to protect women’s health, no one’s debating that. What’s troubling is the requirement extends only to immigrants, and doesn’t apply to U.S. citizens. One has to question just how much public health is advanced by requiring the vaccine for a such a narrow segment of the population.” Jon Abramson, chairman of the CDC’s Advisory Committee for Immunization Practices when the body recommended the vaccine for U.S. citizens last year, further purports that this policy is “not a good idea.”

There are some indications, however, that the HPV vaccine requirement may be reconsidered. Within the month CDC is expected to release new criteria to determine which vaccines should be mandated for U.S. immigrants. Whether this new criteria will affect Simone Davis’ situation, or the lives of other female immigrants, has yet to seen.

HPV and Cervical Cancer Prevention, HPV Vaccines

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HPV Vaccine Shown to Prevent Genital Warts in Men

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Recent results of a Phase III clinical trial involving Gardasil, a vaccine against four strains of human papillomavirus (HPV), indicate that the vaccine may help prevent genital warts in boys and men. Results of the study, funded by Merck, the manufacturer of Gardasil, were presented earlier this month at the annual meeting of the European Research Organization on Genital Infection and Neoplasia (EUROGIN).

Currently in the U.S., Gardasil is only approved for use in for girls and women aged 9-26. Yet while the vaccine provides protection against two strains of HPV associated with 70 percent of cervical cancer in females, it also protects against strains of HPV that cause genital warts that HPV Newseffect both males and females. The study evaluated approximately 4000 males between 16 through 23 years of age. Study participants received either three doses of Gardasil at regular intervals or a placebo. All participants were followed for 36 months. At the time of vaccination, participants had no evidence of genital lesions, no history of genital warts and five or fewer lifetime sexual partners.

Participants who were vaccinated with Gardasil were approximately 90 percent less likely to develop genital warts than those that received a placebo. No study participants experienced any serious side effects related to vaccination. Merck intends to submit a supplemental Biologics License Application for Gardasil to the FDA by the end of 2008 for the use of the vaccine in boys and men ages 9 to 26 for the prevention of genital warts.

ASHA’s fact sheet on HPV vaccines addresses some of the most common questions about Gardasil and other vaccines in development. ASHA’s website also offers recent data on the safety of Gardasil.

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FDA Issues Final Rule on Condom Labeling

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After an extended review, the federal Food and Drug Administration (FDA) recently published final rules governing the labeling of male latex condoms. Following the evaluation of both clinical and epidemiological research as well as public comments on proposed changes to labeling, the FDA concluded that “scientific evidence today continues to fully support the overall effectiveness of latex condoms in reducing the risk of transmission of common STIs.”

Changes to condom labeling were originally proposed in 2005. Among the proposed changes at that time included language specific to STDs: “Condoms provide less protection for certain STDs, including genital herpes and human papillomavirus (HPV) infection, that can also be How to Use A Condom spread by contact with infected skin outside the area covered by the condom. Condoms cannot protect against these STDs when they are spread in this way.”

When the FDA solicited public comment on the suggested changes in 2005, they received more than 100 responses from consumers, health professionals, industry, academia, state and Federal government agencies, as well as professional societies and organizations. After a review of public comment, as well as current research on condom effectiveness, the FDA concluded that recent studies confirmed that latex condoms can reduce transmission risk, and cited recent studies on HPV specifically that provided additional evidence to support this conclusion.

As stated in the federal register, “The benefit of this final rule is that establishing the labeling guidance as a special control ensures that manufacturers will provide consumers with the information they need to make an informed decision regarding the use of latex condoms and to use them safely and effectively. The labeling guidance helps ensure that information provided to consumers does not undervalue the overall STI-risk reduction provided by latex condom use, but does not exaggerate the effectiveness of latex condoms against certain types of STIs.”

This final rule will go into effect January 9, 2009. While latex condoms that were legally marketed prior to the effective date of this final rule will have 11 months from that date to comply with the new labeling requirements, new products will be required to comply immediately upon the rule taking effect.

My Daughter will soon be ONE LESS

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You guessed it! She’s started the 3 part vaccination process with Gardasil the Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant. If you’re not sure what that is, visit www.GARDASIL.com and read up on it.

It was just a matter of time before we got the vaccine going for my teen. When it first came out I knew it would take a little while for the insurance companies to get their act together, so we waited. When we went in a couple of weeks ago and had the opportunity to ask about this our family doctor insisted it was a smart choice.

Gardasil does NOT prevent against all 100+ types of HPV but it does prevent two types that can cause cervical cancer and two more types that can cause genital warts. Hello People, CERVICAL CANCER can be prevented? That’s the biggest reason to get your girls vaccinated when it comes time.

I asked my doctor when the four and two year old could get vaccinated and she told me that eventually they will be setting it up to encourage parents to have it done before Junior High School years.

So once you get the first shot you go back two months after the 1st appointment for another shot. Once you get the second shot you back back six months after the 1st appointment. (In other words, every two months until the three part series is completed.)

That’s definitely ONE LESS thing that we will have to worry about. Science and medical breakthrough never cease to amaze me.

When was the last time you had a Pap Test?

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A year after the first vaccine against human papillomavirus (HPV) was approved, women say they know that Pap tests are important, are having them regularly, and rely on their doctors more than any other source for information to help them make health decisions, according to a new nationwide survey of 1,421 women ages 18 to 45 who have heard of the new HPV vaccine.

However, the survey also revealed that nearly one in four uninsured women (24 percent) have not had a Pap test in the last three years, and Latinas are less aware than other women that HPV is sexually transmitted. The survey was conducted by Lake Research Partners for the American Social Health Association (ASHA) in June – one year after the Food & Drug Administration approved a vaccine that protects against the four strains of HPV responsible for 70 percent of cervical cancer cases.

Women who said they had not heard of the HPV vaccine that protects against cervical cancer were excluded from the survey, but more than 90 percent said they had heard of it. Of the women surveyed, a strong majority (85 percent) say women should get Pap tests once a year, and 87 percent say they have had one in the past three years.

Women understand the link between HPV and cervical cancer – more than eight in ten say that HPV is a cause of cervical cancer, and two-thirds (66 percent) say it is a major cause. Still, many also cite genetics and family history (80 percent), herpes (46 percent) and smoking (45 percent) as causes when, in fact, cervical cancer is caused by HPV.

Gardasil is the only cervical cancer vaccine

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Everything you ever wanted to know about Gardasil and more

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Gardasil Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine

Read this information with care before you or your child gets Gardasil. You or your child will need 3 doses of the vaccine. It is important to read this leaflet when you receive each dose. This leaflet does not take the place of talking with your health care professional about Gardasil.

(As you can see I picked up the leaflet from my doc’s office, came home, and then I copied it to my blog so that you guys could get access to the information. Not all doc’s offices have this information so I felt it would be a good idea to share it with you.)

What is Gardasil and what is it used for?

Gardasil is a vaccine (injection/shot) that helps protect against the following diseases caused by Human Papillomavirus (HPV) Types in the vaccine (6, 11, 16, and 18):

  • Cervical cancer (cancer of the lower end of the uterus or womb)
  • Abnormal and precancerous cervical lesions
  • Abnormal and precancerous vaginal lesions
  • Abnormal and precancerous vulvar lesions
  • Genital warts

Gardasil helps prevent these diseases – but it will not treat them. You or your child cannot get these diseases from Gardasil.

What other key information about Gardasil should I know?

  • Vaccination does not substitute for routine cervical cancer screening. Females who receive Gardasil should continue cervical cancer screening.
  • As with all vaccines, Gardasil may not fully protect everyone who gets the vaccine.
  • Gardasil will NOT protect against diseases due to non-vaccine HPV types. There are more than 100 HPV types; Gardasil helps protect against 4 types (6, 11, 16, and 18). These 4 types have been selected for Gardasil because they cause approximately 70% of cervical cancers and 90% of genital warts.
  • This vaccine will not protect you against HPV types to which you may have already been exposed.
  • Gardasil also will not protect against other diseases that are not caused by HPV.
  • Gardasil works best when given before you or your child has any contact with certain types of HPV (i.e., HPV types 6, 11, 16, and 18).

Who can receive Gardasil?

Gardasil is for girls and women 9 through 26 years of age. See “Who should not receive Gardasil?” below.

Who should not receive Gardasil?

Anyone who:

  • is allergic to any of the ingredients in the vaccine. A list of ingredients can be found at the end of this leaflet.
  • has an allergic reaction after getting a dose of the vaccine.

What should I tell my health care professional before I am vaccinated or my child is vaccinated with Gardasil?

It is very important to tell your health care professional if you or your child:

  • has had an allergic reaction to the vaccine.
  • has a bleeding disorder and cannot receive injections in the arm.
  • has a weakened immune system, for example, due to a genetic defect or HIV infection.
  • is pregnant or is planning to get pregnant. Gardasil is not recommended for use in pregnant women.
  • has any illness with a fever more than 100 degrees F (37.8 degrees C).
  • takes or plans to take any medicines, even those you can buy over the counter.

Your health care professional will decide if you or your child should receive the vaccine.

How is Gardasil given?

Gardasil is given as an infection. You or your child will receive 3 doses of the vaccine. Ideally the doses are given as:

  • First dose: at a date you and your health care professional choose.
  • Second dose: 2 months after the first dose.
  • Third dose: 6 months after the first dose.

Make sure that you are your child gets all 3 doses. This allows you or your child to get the full benefits of Gardasil. If you or your child misses a dose, your health care professional will decide when to give the missed dose.

What are the possible side effects of Gardasil?

As with all vaccines, there may be some side effects with Gardasil. Gardasil has been shown to be generally well tolerated in women and girls as young as 9 years of age.

The most commonly reported side effects included:

  • pain, swelling, itching, and redness at the injection site.
  • fever.

Difficulty breathing (bronchospasm) has been reported very rarely. If you or your child has any unusual or sever symptoms after receiving Gardasil, contact your health care professional right away. For a more complete list of side effects, ask your health care professional.

What are the ingredients in Gardasil?

The main ingredients are purified inactive proteins that come from HPV Types 6, 11, 16, and 18. It also contains amorphous aluminum hydroxyphosphate sulfate, sodium chloride, L-histidine, polysorbate 80, sodium borate, and water for infection.

What are cervical cancer, precancerous lesions, and genital warts?

Cancer of the cervix is a serious disease that can be life-threatening. This disease is caused by certain HPV types that can cause the cells in the lining of the cervix to change from normal to precancerous lesions. If these are not treated, they can turn cancerous.

Genital warts are caused by certain types of HPV. They often appear as skin-colored growths. They are found on the inside or outside of the genitals. They can hurt, itch, bleed, and cause discomfort. These lesions are usually not precancerous. Sometimes, it takes multiple treatments to eliminate these lesions.

What is Human Papillomavirus (HPV)?

HPV is a common virus. In 2005, the Centers for Disease Control and Prevention (CDC) estimated that 20 million people in the United States had this virus. There are many different types of HPV; some cause no harm. Other can cause diseases of the genital area. For most people the virus goes away on its own. When the virus does not go away it can develop into cervical cancer, precancerous lesions, or genital warts, depending on the HPV type. See “What other key information about Gardasil should I know?”

Who is at risk for Human Papillomavirus?

In 2005, the CDC estimated that at least 50% of sexually active people catch HPV during their lifetime. A male or female of any age who takes part in any kind of sexual activity that involves genital contact is at risk. Many people who have HPV may not show any signs or symptoms. This means that they can pass on the virus to others and not know it.

Will Gardasil help me if I already have Human Papillomavirus?

You may benefit from Gardasil if you already have HPV. This is because most people are not infected with all four types of HPV contained in the vaccine. In clinical trails, individuals with current or past infection with one or more vaccine-related HPV types prior to vaccination were protected from disease caused by the remaining vaccine HPV types. Gardasil is not intended to be used for treatment for the above mentioned diseases. Talk to your health care professional for more information.

* This leaflet is a summary of information about Gardasil. If you would like more information, please talk to your health care professional or visit gardasil.com - This information was issued in June of 2006, Manufactured and Distributed by: MERCK & CO., INC., Whitehouse Station, NJ 08889, USA 96823 – This information is presented only for informational and educational reasons and should not take the place of your own doctor’s medical advice. Permission was granted to help spread the word about the HPV vaccine Gardasil.

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Cervical Cancer

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What is cervical cancer?

Cervical cancer is cancer of the cervix. The cervix is the part of the uterus that connects the upper part of the uterus (the womb) and the vagina.

Cervical cancer is a serious condition that can be life threatening. When a woman becomes infected with certain high-risk types of HPV and does not clear the infection, abnormal cells can develop in the lining of the cervix.

If not discovered early and treated, these abnormal cells can become cervical pre cancers and then possibly cancer. Most often this can take a number of years, although in rare cases it can happen within a year.

Who gets cervical cancer?

About half of all females diagnosed with cervical cancer are between 35 and 55 years old. What many of these women may not realize is that they were most likely exposed to one of the high-risk types of HPV during their teens and 20s.

The American Cancer Society estimated that in 2005 there were 10,370 new cases of cervical cancer diagnosed in the United States, and 3,710 women died from the disease.

How do I know if I have cervical cancer?

The usual way to detect cervical cancer is through a Pap test. If the results of a Pap test indicate that you have abnormal cervical cells, it’s important to follow your healthcare professional’s recommendations for more testing, such as repeat Pap testing, HPV DNA testing, colposcopy (examination of the cervix through a magnifying device), and possible biopsy (obtaining a tissue sample for analysis in the lab).

How is cervical cancer treated?

The three main methods are surgery (an operation to remove the cancer), radiation therapy (using high energy beams to destroy cancer cells), and chemotherapy (using medications to disrupt the growth of cancer cells). Sometimes treatment included two or more of these methods.

Before choosing a treatment, a healthcare professional will consider the size of the cancer, whether it has spread, the woman’s age and overall health, and patient preferences. The treatment that is right for one person may not be right for someone else.

These facts do not cover everything there is to know about cervical cancer. Talk to your healthcare professional or visit HPV.com for more information.

* This information was presented strictly for personal use as well as educational purposes. With all the discussion about ways we can prevent HPV I would think that this would help people get to the root of this issue.

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Abnormal Cervical Cells

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What are abnormal cervical cells?

Abnormal cervical cells (also called cervical dysplasia) are cells in the lining of the cervix that have changed in appearance.

The more severe the cervical abnormality, the more likely it is that cervical cancer cold develop in the future. Most often this can take a number of years, although in rare cases it can happen within a year.

What causes abnormal cervical cells?

Abnormal cervical cells may have a number of different causes, such as an infection or inflammation, but are commonly caused by certain type of HPV (human papillomavirus).

How do I know if I have abnormal cervical cells?

The usual way to detect abnormal cervical cells is through a Pap test. You may have additional testing, such as repeat Pap testing, HPV DNA testing, colposcopy, and possible biopsy.

An abnormal biopsy result may be reported as CIN (cervical intraepithelial neoplasia). The term CIN, along with a number (1 to 3), describes how much of the thickness of the lining of the cervix contains abnormal cells. A diagnosis of CIN 3 means there are severely abnormal cervical cells through the entire thickness of the lining of the cervix.

How are abnormal cervical cells treated?

Most abnormal cervical cells in the lining of the cervix will eventually go away on their own. If the abnormalities are mild, the healthcare professional may choose to closely monitor them. If the abnormalities are more severe, removing these cells can almost always prevent cervical cancer from developing in the future.

Methods commonly used to treat abnormal cervical cells include freezing, removing them using an electrical instrument, and conventional surgery. The treatment may have to be repeated if the abnormal cells reappear.

* These facts do not cover everything there is to know about abnormal cervical cells. Talk to your healthcare professional or visit HPV.com for more information.

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About HPV and cervical cancer

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Worldwide, cervical cancer affects more than 400,000 women annually and, after breast cancer, is the second-most-common malignancy found in women. Cervical cancer is caused by “high-risk” types of the human papillomavirus (HPV), which are sexually transmitted. It’s estimated that 80 percent of women will get an HPV infection at some point in their lives. However, in most cases, the infection goes away or is suppressed by the body without causing problems. It is only infections that persist that can cause abnormal cells to form that may develop into cervical cancer if not detected and treated early.

NEJM Report Finds HPV Test More Effective Than Pap in Determining Cervical Cancer Risk

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Quick Questions Answered about Genital Warts

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Here are the genital wart questions

1 in 3 adults has the Human Papillomavirus, the virus that causes genital warts and is also known as HPV. It is possible to carry the virus and not know it. So symptoms for HPV do not always show up.

As with the herpes virus it’s also possible to pass HPV even with condom use. The reason is because condoms do not cover the entire genital area. It’s also possible that the HPV virus can clear the body all on it’s own. At least that is what I’ve heard on those HPV commercials.

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